Abstract: An apparatus and method for in vivo and ex vivo control, detection and measurements of radiation in brachytherapy accomplished through scintillating material detection. One example includes scintillating fibers placed along a delivery guide such as a catheter for measuring applied radiation levels during brachytherapy treatments, sensing locations of a radiation source or providing feedback of sensed radiation. The catheter may also be a mammosite type catheter. The scintillating fibers provide light output levels correlating to the levels of radiation striking the fibers. The output may then be used to measure and compute radiation distribution maps using Monte Carlo reconstruction simulation. Adjustments to a radiation treatment may be made as needed based on actual and measured applied dosages. Characteristics of a radiation source may also be measured using scintillating materials.

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: An endoscopic medical tool is endoscopically inserted into a body cavity in order to eject a member into the body cavity, and includes: a flexible sheath having an inner cavity; an elastically deformable stopper which is provided projecting out toward the inner cavity in a distal end portion of the sheath, and prevents the member which has been loaded inside the sheath from falling out of the sheath; and a pusher which is inserted into the sheath in a freely advancing and retracting manner, and which pushes out and ejects the member from the sheath. In the endoscopic medical tool, the stopper is formed in only a partial region of the inner cavity so that the stopper does not continuously formed over the entire circumference of the inner cavity.

Abstract: A brachytherapy multiple needle loading device and method are provided. The device allows multiple implantation devices to be loaded at the same time and has a gating retention mechanism that allows the user to load sources into implantation devices at a desired rate. A packaging unit of the device has a two part configuration that allows removal of implantation devices that have been loaded with sources. The packaging unit may be opaque or translucent to allow visual inspection of the sources.

Abstract: An applicator for delivering brachytherapy includes elongate members movable between collapsed and expanded configurations for delivering brachytherapy within a lumpectomy cavity, a vaginal cavity, or other target region. The elongate members may be expandable into a symmetrical or asymmetrical expanded configuration, e.g., into a generally spherical, pear-shaped, or planar configuration. A system for delivering brachytherapy includes the applicator and an access device for lining and/or dilating a body cavity and/or for receiving the applicator therein. The access device is advanced into a body cavity, an expandable member on the access device is inflated, the applicator is advanced into the access device, and the elongate members are expanded to deliver radiation to the target region.

Abstract: The disclosure is directed to radiation catheter devices, methods for controlled application of irradiation to tissue at a body site, such as a cavity formed after removal of tissue, e.g. cancer, using such radiation catheter devices, solutions for forming a more lubricious luminal surface and method for lining lumens of such devices to improve the frictional characteristics thereof. The catheter device includes a flexible elongated shaft which is formed of low durometer polymeric material, which can be readily folded or coiled for securing the shaft to or under the skin of the patient and a radiation lumen lined with high durometer polymeric material to improve the frictional characteristics. The elongated shaft has at least one inner lumen for receiving a radiation source which has a layer of high durometer polymeric material that provides lower surface friction to facilitate advancement of a radiation source therein.

Abstract: An applicator for delivering brachytherapy includes elongate members movable between collapsed and expanded configurations for delivering brachytherapy within a lumpectomy cavity, a vaginal cavity, or other target region. The elongate members may be expandable into a symmetrical or asymmetrical expanded configuration, e.g., into a generally spherical, pear-shaped, or planar configuration. A system for delivering brachytherapy includes the applicator and an access device for lining and/or dilating a body cavity and/or for receiving the applicator therein. The access device is advanced into a body cavity, an expandable member on the access device is inflated, the applicator is advanced into the access device, and the elongate members are expanded to deliver radiation to the target region.

Abstract: Featured is a robot and a needle delivery apparatus. Such a robot comprises a plurality of actuators coupled to control locating any of number of intervention specific medical devices such as intervention specific needle injectors. Such a robot is usable with image guided interventions using any of a number of types of medical imaging devices or apparatuses including MRI. The end-effector can include an automated low needle delivery apparatus that is configured for dose radiation seed brachytherapy injection. Also featured is an automated seed magazine for delivering seeds to such an needle delivery apparatus adapted for brachytherapy seed injection.

Abstract: An apparatus and method for in vivo and ex vivo control, detection and measurements of radiation in brachytherapy accomplished through scintillating material detection. One example includes scintillating fibers placed along a delivery guide such as a catheter for measuring applied radiation levels during brachytherapy treatments, sensing locations of a radiation source or providing feedback of sensed radiation. The catheter may also be a mammosite type catheter. The scintillating fibers provide light output levels correlating to the levels of radiation striking the fibers. The output may then be used to measure and compute radiation distribution maps using Monte Carlo reconstruction simulation. Adjustments to a radiation treatment may be made as needed based on actual and measured applied dosages. Characteristics of a radiation source may also be measured using scintillating materials.

Abstract: A brachytherapy shielding system configured to be used with a brachytherapy application includes a balloon catheter and a body made from a magnetic material positioned within an inflatable portion, such as a balloon portion, of the balloon catheter. The brachytherapy shielding system is arranged to shield skin tissue exposed to a radiation source during intracavitary radiation therapy.

Abstract: An automated system for delivery of seeds or other therapeutic or diagnostic capsules to internal organs of the patient's body for radiation brachytherapy includes a needling mechanism, a 2DOF robot, an ultrasound probe driver, a 5DOF passive platform, and an easy lock cart. The needling mechanism implants radioisotope seeds by its cannula and stylet driven by two moving stages pushed by DC motors with ball screw transmission. Force sensors are included for detecting insertion forces and bending force. In another embodiment, the needle is rotated for insertion into the patient and can also be used for tissue removal for biopsy. The two embodiments are usable together or separately.

Abstract: A handheld radiation delivery system is disclosed that includes a two-part delivery module comprising a reusable portion that contains a radioactive source wire and a disposable portion that includes a drive assembly for moving the radioactive source wire between storage and treatment positions. A disposable applicator tip is provided that includes a cannula for receiving the radioactive source wire when in the treatment position and a mechanism for limiting the number of uses of the device. A handheld cable actuator is operatively connected to the disposable portion of the handpiece to impart motion to the source wire.

Abstract: A radioprotection device includes a body positionable in a living organism adjacent to both healthy and unhealthy tissue, where the living organism has a predetermined body temperature. The device includes a cooling element disposed within the body. The cooling element permits cooling of the healthy tissue adjacent to the body to a protective temperature greater than 0° C. and less than the predetermined body temperature during a therapeutic time period during which radiation is applied to the unhealthy tissue. The body discourages cooling of the unhealthy tissue to the protective temperature during the therapeutic time period, thereby providing greater radioprotection to the healthy tissue than the unhealthy tissue during the therapeutic time period.

Abstract: A system for extending the visual capabilities and working channel of a bronchoscope including a probe having optic and/or tracking capabilities at a distal tip thereof and capable of being advanced through the working channel of a standard bronchoscope. The probe also includes a working channel through which various diagnostic and treatment tools may be advanced.

Abstract: A catheter needle, for irradiating tumors, formed by an elongated plastic tube with parts partly unfoldable outwards which can lock themselves in the tissue, and a closed end. The closed end has a reinforced sharp pointed shape with which tissue can be punctured. In the improved version, therefore, a point from a harder material is provided which is provided in or around the plastic so that the catheter needle has sufficient sharpness like a conventional metal needle. Thus, the catheter needle can puncture the skin and harder, deeper-lying tissues directly without pre-puncturing or other aids.

Abstract: The disclosure is directed to catheter devices and methods for controlled application of irradiation to tissue adjacent a body site, such as cavity after removal of tissue, e.g. cancer. The catheter device includes one or more inflatable, toroidal balloons on the distal shaft section of the device which surrounds and is spaced from one or more radiation guide members. Preferably at least one radiation guide members extend away from a central longitudinal axis to provide asymmetrical irradiation. Connecting members may extend between the radiation guide members and the toroidal balloon.

Abstract: An apparatus is described for transporting and positioning a capsule, in which a radioactive source is present, from a screened safe into an applicator to be temporarily placed in the body of the patient. The apparatus is provided with a safe for storing at least one capsule and with a larger number of applicators, which can be connected, via transport tubes, to passages in a switch-connecting plate, wherein the capsules, or a dummy instead of one of the capsules, can each, via their own tube and switch, independently of one another, be introduced into a transport tube selected by the respective switch and can be displaced therein independently of one another in a manner programmable with regard to location and residence time, by a transport wire slidable via a drive motor.

Abstract: Methods and devices for minimally-invasive delivery of radiation to the posterior portion of the eye including a cannula comprising a distal portion connected to a proximal portion and a means for advancing a radionuclide brachytherapy source (RBS) toward the tip of the distal portion; a method of introducing radiation to the human eye comprising inserting a cannula between the Tenon's capsule and the sclera of the human eye and emitting the radiation from the cannula on an outer surface of said sclera.

Abstract: The present disclosure provides a brachytherapy apparatus, system and method that delivers partial breast irradiation treatment for post-lumpectomy patients via introduction of a catheter-like device through a trocar. The apparatus may be introduced post-surgically with local anesthesia under image guidance into the previous excision site and into a cavity by a surgeon. The brachytherapy apparatus includes one or more thin-walled tubes, each of said thin-walled tubes being configured to contain one or more radioactive sources, at least one radiation source configured to deliver a prescribed dose of radiation, a whisk adjuster configured to permit adjustment of each of the one or more thin-walled tubes so that the tubes substantially conform to a size of the body cavity; and an expansion element configured to expand outwardly said one or more thin-walled tubes within the cavity so that the thin-walled tubes substantially conform to a shape and/or size of the body cavity.

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: The invention relates to an implant for treating a cavity that is created as a result of a resection, the implant being modular and the modules being interconnectable.

Abstract: A method and device for applying a radioactive source to a tissue site is disclosed. The device facilitates the precise placement of, for example, 125Iodine seeds relative to the surgical margin, assures the seeds remain fixed in their precise position for the duration of the treatment, overcomes the technical difficulties of manipulating the seeds through the narrow surgical incision, and reduces the radiation dose to the clinicians. The device incorporates the radioactive seeds into a fastening means, preferably surgical staples, used in the surgical procedure. In this way, the seeds are concurrently secured in position directly adjacent to the surgical resection and remain immobile.

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: A radioactive member for use in brachytherapy comprising a molded elongate, bioabsorbable carrier material with spaced radioactive sources disposed therein, and methods for the manufacture thereof. The radioactive members may be used in the treatment of, for example, prostate cancer.

Abstract: An applicator system for interstitial radiation therapy that uses a brachytherapy needle assembly for simultaneously dispensing an effective amount of medicine, such as anti-inflammatory agents, along with radioactive seeds. A medicine cartridge or a modified seed cartridge, having a reservoir on its proximal end, can be attached to the applicator body for dispensing medicine into a needle or medicine can be injected into the needle via a three-way fitting attached to the applicator body. Alternatively, a modified stylet having a reservoir on its proximal end containing medicine can be used to deliver medication to a needle. Additionally, the brachytherapy needle or the radioactive seeds and spacers can be coated with medication that would be absorbed by the body upon implantation.

Abstract: A vaginal brachytherapy applicator has an insertable tip section, preferably rigid or at least firm enough to retain its shape when inserted, and a tubular handle section extending proximally from the tip section. A common lumen extends from the handle into and through most of the length of the tip section. In one embodiment the tip section is made of a flexible open-celled foam material with a substantially impermeable outer skin, and in this case the tip section can be contracted, or stretched lengthwise to reduce its diameter, for ease of insertion, then re-expanded to its nominal and working configuration prior to insertion of a radiation source into the lumen and irradiation of tissue surrounding the tip section.

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: Apparatus, systems and methods are provided 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: An automatic stage allows rapid and more precise needle placement for radiation therapy using implantable radioactive seeds.

Abstract: Apparatuses and methods for percutaneously implanting objects, such as radioactive seeds or markers, in patients. In one embodiment, a device for percutaneously implanting an object in a patient includes a handle, a cannula projecting outwardly from the handle, and an actuator movably disposed relative to the handle. In one aspect of this embodiment, the cannula can be configured to releasably hold the object and percutaneously penetrate the patient. In another aspect of this embodiment, the actuator can be operably connected to the cannula and operable to move the cannula relative to the handle and release the object within the patient. In a further aspect of this embodiment, the cannula can include a tip portion having a restriction configured to releasably hold the object for implantation in the patient.

Abstract: Devices and methods are disclosed for treatment to tissue surrounding a body cavity or other intracorporeal site, such as after removal of tissue, e.g. cancer. Such a device includes a treatment location on a distal portion of the device with one or more radiation shielding components that partially encircle a radiation source at the treatment location to control emitted radiation from the radiation source. The device minimizes radiation damage to healthy tissue surrounding the body cavity or other site while irradiating tissue not shielded by the radiation shielding components. 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 to seal the passageway leading to the body cavity.

Abstract: The invention provides magazines for radioactive brachytherapy seeds. The seed magazines provided herein include housing, seed holder, and pusher components, and optionally have a slidable shield to protect a user from radiation.

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: Provided in some embodiments is a device suitable for treating an eye that includes a housing and a plurality of fins. The housing includes a base and a rim coupled to the perimeter of the base. The base and the rim at least partially define a cavity in the housing, and the cavity is configured to accept one or more radiation seeds. The plurality of fins at least partially reside within or proximate the cavity of the housing. At least a portion of the fins are configured such that radiation emitted from one or more radiation seeds positioned in the cavity is substantially directed toward a center portion of the eye during use.

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: The disclosure describes devices and methods for asymmetrical irradiation at a body cavity or site, such as after removal of tissue, e.g. biopsy or cancer. One device includes a lumen which is off-set or off-settable from a longitudinal axis to increase the intensity of radiation received from a radiation source by a first tissue portion surrounding the body cavity and to reduce or minimize radiation received by a second tissue portion (e.g. healthy tissue) surrounding the body cavity.

Abstract: In an embodiment, a brachytherapy device includes a cartridge adapted for use with a brachytherapy applicator. A plurality of anchor seeds are stacked parallel to one another within the cartridge. Each anchor seed includes a radioactive seed that is at least partially encapsulated by a polymeric material. Additionally, each anchor seed can include at least one protrusion on an outer surface of the encapsulating polymeric material to a reduce a tendency for the anchor seed to migrate and rotate within a patient's body after the anchor seed is implanted.

Abstract: A point-of-care seed stranding device for automating assembly of brachytherapy seed strands for implantation in patients. The device includes a number of features to reduce the potential for mistakes by the user, as well as to reduce the potential for damaging the radioactive seeds during the stranding process. Tactile feedback may be provided to prevent exertion of too much force in the packing step of the stranding process, as well as to indicate that the seed and/or strand cartridges are empty and need to be replaced. The device may also include a mechanism for holding seeds or spacers in place to allow automated packing of seeds or spacers having corresponding geometries. The device may also be provided with a seed counter which can be employed to preset the number of seeds in a strand and which disables the device from dispensing or packing additional seeds once the preset number of seeds has been packed into the strand.

Abstract: The invention relates to a device for drug administration and/or monitoring the status of a patient, said device comprising at least one measuring means for measuring at least one body parameter of a patient for at least ?1 measuring cycle, the measuring means being located in or in the vicinity of a bio-implantable and/or bio-implementable needle.

Abstract: This invention relates to a device for brachytherapy treatment of a tissue growth on the inner surface of an airway lumen. The invention also relates to a device for treatment of an obstructing tissue growth on the inner surface of an airway lumen. The device is comprised of a cylindrical tube having a proximal end, a distal end, and a continuous open cavity therebetween, wherein the device is deployed against the inner surface of the lumen. There is at least one longitudinal channel contained within the wall of the tube for positioning a treatment radiotherapy source in close proximity to said tissue growth.

Abstract: The invention provides magazines for radioactive brachytherapy seeds. The seed magazines provided herein include housing, seed holder, and pusher components, and optionally have a slidable shield to protect a user from radiation.

Abstract: A brachytherapy seed cartridge assembly includes an elongate movable shield, formed from a radiation-shielding material, that is slideably supported so as to movable between an extended position and a retracted position. The cartridge assembly also provides a quick-connect feature for a more efficient assembly and disassembly.

Abstract: Radiation shielding devices are provided herein. In particular, the devices provided herein can be adapted to shield radiation emitted by one or more radioactive brachytherapy seeds contained within, for example, a vial or a cartridge.

Abstract: Tissue marking apparatus for marking a tissue mass of interest within the body of a patient are disclosed. The tissue marking apparatus include a handle, a tube operatively coupled to a distal end of the handle, a push rod disposed within the tube and extending into the handle, a firing mechanism retained within the handle and operatively coupled to a proximal end of the push rod, and a potential energy source configured and adapted to rapidly drive the push rod distally through the tube upon an activation of the firing mechanism. The tissue marking apparatus further includes a marker configured and dimensioned to be slidably received within the tube at a location distal of the push rod. The marker includes a capsule defining a chamber therein, an elongate tail extending from a distal end thereof, and at least one radioactive bead retained within the chamber of the capsule.

Abstract: A brachytherapy device is provided for treating a target tissue through an external surface area of the target tissue. The device includes an insertion member having a proximal portion, a distal portion, and at least one lumen extending therethrough. A fluid retaining member is mated to the distal portion of the insertion member and has a first surface shaped to conform to a predetermined external surface area of a tissue to be treated, and a cavity formed therein in fluid communication with the at least one lumen in the insertion member. A plurality of anchor members can be distributed about a periphery of the first surface to anchor the first surface to an external surface area of a tissue to be treated.

Abstract: The invention relates to a support and positioning system for at least one miniaturized element in the form of a cylinder. The system comprises a tube comprising an upper part, a median part and a lower part, the upper part being provided with an orifice into which the element is inserted and enabling displacement of the element as far as the median part that has a diameter slightly greater than the diameter of the cylinder forming the element, the lower part being connected to means for controlled injection of a gas to inject a gas inside the tube so as to levitate the element to the required height in the median part of the tube, the lower part of the tube being provided with an element removal orifice, the tube also comprising means of dissipating static electricity inside the tube. Application for characterization of miniaturized radioactive sources.

Abstract: A seed anchor includes a tubular anchor body having a plurality of partial cylindrical walls splayed outwardly at an axial end of the anchor body to form an anchoring structure configured to resist axial movement of the seed anchor in a direction opposite an insertion direction when the seed anchor is implanted into tissue.

Abstract: A brachytherapy device may include an expandable outer cage an expandable inner cage positioned within the outer cage and configured to receive radioactive material at its perimeter. The expandable inner cage may be configured to expand, and the outer cage may be configured to expand to a variable diameter greater than the inner cage diameter so as to fill resected cavities of various diameters.

Abstract: While performing prostate brachytherapy in which radioactive seeds are implanted into the prostate, both X-ray and transrectal ultrasound (TRUS) data are collected. The X-ray data indicate all of the implanted seeds, but not their relative position within the prostate. The TRUS data correspond to both axial and longitudinal ultrasound images. A subset of the implanted seeds can be automatically (or manually) detected in the TRUS data (using longitudinal ultrasound images), and the prostate is indicated in the TRUS data (using axial ultrasound images). Registration is performed between the X-ray and TRUS data, thereby identifying the disposition of all implanted seeds within the prostate, enabling dosimetry to be intraoperatively determined. A medical practitioner can thus determine whether and where to implant additional seeds to achieve a desired optimal dosage and do so before the prostate brachytherapy procedure is concluded.

Abstract: A device for manufacturing a brachytherapy array having a planar base which includes a working area comprising at least one planar major surface defining a first array of apertures, and a holding mechanism for holding a planar surgical mesh over the working area of said planar base. Also, a method for forming a brachytherapy array using this device.