Abstract: The disclosure describes a device for asymmetrical irradiation of a body cavity or site, such as after removal of tissue, e.g. biopsy or lumpectomy. The device includes an elongated tubular shaft having an inner lumen and a tubular wall with a plurality of lumens extending within the wall which are configured for receiving a radiation source. The distal portion of the tubular shaft is cut into a plurality of longitudinally separated wall segments with a lumen extending within at least one of the wall segments. A support member is positioned within the separated wall segments to support and position the wall segments in a desired configuration for brachytherapy. An expandable member such as an inflatable balloon is mounted on the distal shaft portion about the separated wall segments wall which when inflated secures the distal shaft portion within a desired intracorporeal site for brachytherapy treatment.

Abstract: A marker delivery device includes an elongated delivery cannula which has a distal end section, an inner lumen and a discharge opening in the distal end section in communication with the inner lumen. At least one elongated fibrous marker body is slidably disposed within the inner lumen of the elongated delivery cannula. The at least one elongated fibrous marker body includes a plurality of bioabsorbable polymeric strands. The strands are compressed to a compressed configuration and bound together in the compressed configuration with a polymer binding agent prior to insertion into the elongated delivery cannula. A releasable plug is disposed within a distal portion of the inner lumen and distal to the at least one elongated fibrous marker body so as to at least partially occlude the discharge opening in the distal end section.

Abstract: The invention is directed to a system and device for separating and collecting a tissue specimen from a target site within a patient. The device includes a probe component which is releasably secured to the driver component. The probe component has an elongated tubular section, a penetrating distal tip and a tissue receiving aperture in the distal end of the tubular section proximal to the distal tip, and a tissue cutting member which is slidably disposed within the probe member to cut a tissue specimen drawn into the interior of the device through the aperture by applying a vacuum to the inner lumen of the tissue cutting member. The driver has drive members for operating the elements of the probe component. The tissue penetrating distal tip preferably has a triple concave curvature shape with three curved cutting edges leading to a sharp distal point.

Abstract: The invention is directed to a system and device for separating and collecting a tissue specimen from a target site within a patient. The device includes a probe component which is releasably secured to the driver component. The probe component has an elongated tubular section, a penetrating distal tip and a tissue receiving aperture in the distal end of the tubular section proximal to the distal tip, and a tissue cutting member which is slidably disposed within the probe member to cut a tissue specimen drawn into the interior of the device through the aperture by applying a vacuum to the inner lumen of the tissue cutting member. The driver has drive members for operating the elements of the probe component. The tissue penetrating distal tip preferably has a triple concave curvature shape with three curved cutting edges leading to a sharp distal point.

Abstract: Devices and methods are provided for temporarily maintaining access to a body cavity in a targeted tissue region within a patient's body. One embodiment of the catheter device includes an elongated shaft having a proximal shaft section which is flexible enough to be folded or coiled into a configuration for deployment within the patient. An alternate embodiment includes a catheter device having one or more detachable proximal shaft sections and having at least one one-way valve to restrict fluid flow of inflation fluid to flow to the balloon. After deployment of the catheter device completely within the patient, the opening through which the catheter device is deployed is closed, e.g. by sutures, adhesives and the like to minimize infection at the site. Within a few days or weeks after the tissue has been evaluated for cancer, the temporary catheter device may be removed from the patient.

Abstract: An obturator with an elongated shaft, a proximal end, a substantially closed distal end and a MRI detectable distal shaft portion, which does not interfere with magnetic resonance imaging of tissue proximate thereto. Preferably, the distal shaft portion has an effective MRI detectable mass so as to provide a clear, T1-weighted image within an outline of the distal shaft portion upon magnetic resonance imaging.

Abstract: The invention is directed to a system and method for separating and collecting one or more tissue specimens from a target site within a patient and flushing the specimen to remove blood, debris and the like before the specimen is removed from the biopsy device. The flow of flushing fluid to the tissue collector is preferably controlled to coincide with delivery of one or more specimens to the collecting tray or basket of the device or after the receipt of the specimen within the tissue collector to ensure that the fluid is applied to a fresh specimen. The tissue tray or basket within the tissue collector has an open or foraminous portion to facilitate removal of fluid, such as the applied fluid and blood, and other debris from the tissue specimens on the tray. Vacuum is provided within the tissue collector, preferably under the tray to remove fluid and debris from the collector interior.

Abstract: A method for maintaining access to a biopsy site within a patient, includes forming a passageway from an opening in an exterior site on the patient to a desired location for a biopsy specimen within the patient; removing a tissue specimen from the desired location thereby leaving a biopsy cavity; providing a temporary catheter having an elongate shaft, a flexible proximal shaft section, and a distal shaft section having a cavity filling member thereon; inserting the cavity filling member on the distal shaft section into the biopsy cavity; inflating the cavity filling member after inserting the cavity filling member within the biopsy cavity, but before closing the opening, using the flexible proximal shaft section; placing the flexible proximal shaft section at an intracorporeal location; and closing the opening so as to seal the passageway.

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 an inflatable balloon having at least two layers. The inflatable balloon has an expansion of more than 25% and less than 200% when inflated from the un-inflated condition to a turgid condition, preferably more than 50% and less than 150%. In the turgid condition the polymeric material(s) of the balloon layers are at or near the elastic limit of the balloon layer material. The balloon may contain or be formed of or be coated with radiopaque material to facilitate positional or symmetry verification.

Abstract: A novel method of partial breast radiation utilizing a breast implant which can provide a stable and improved target for stereotactic radiation treatment.

Abstract: The invention is directed to a system and device for separating and collecting a tissue specimen from a target site within a patient. The device includes a probe component with an elongated tubular section, a penetrating distal tip and a tissue receiving aperture in the distal end of the tubular section proximal to the distal tip, and a tissue cutting member which is slidably disposed within the probe member to cut a tissue specimen drawn into the interior of the device through the aperture by applying a vacuum to the inner lumen of the tissue cutting member. The device also has a driver component to which the probe component is releasably secured. The driver has a drive member for adjusting the orientation of the tubular section and thus the aperture therein and one or more drive members for moving the tissue cutting member within the tubular section to sever a tissue specimen from tissue extending into the interior of the tubular section through the aperture.

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 an inflatable balloon having at least two layers. The inflatable balloon has an expansion of more than 25% and less than 200% when inflated from the un-inflated condition to a turgid condition, preferably more than 50% and less than 150%. In the turgid condition the polymeric material(s) of the balloon layers are at or near the elastic limit of the balloon layer material. The balloon may contain or be formed of or be coated with radiopaque material to facilitate positional or symmetry verification.

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 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: A medical device system and method provide an RF electrosurgical generator coupled to an electrosurgical electrode via a patient box disposed in close proximity to the patient. An RF signal is delivered from the generator to the patient box where signal power is increased and the RF signal delivered to the electrosurgical electrode. The patient box is coupled to the electrosurgical electrode by a short cable capable of carrying an HV, high frequency 5 MHz signal without leakage. An electrical characteristic associated with the electrosurgical electrode is monitored and a desired RF power output and duty cycle maintained by adjusting DC input voltage applied to an RF amplifier, responsive to the monitoring. The system determines when the electrosurgical cutting electrode has started cutting and switches from a start mode to a run mode having a different RF duty cycle and a reduced RF power output controlled by a servo system.

Abstract: Devices and methods are provided for securely affixing a medical instrument to desired tissue in a patient's body, using a fixation agent. Such medical instruments may comprise localization wires or tissue acquisition instruments, such as biopsy instruments, for example. In the case of tissue acquisition instruments, the inventors have discovered significant advantages for securely affixing the distal end of the tissue acquisition instrument to a particular tissue target area. For example, such an approach permits the imaging environment to be uncoupled from the procedural environment so that expensive and often unavailable imaging equipment, such as stereotactic imaging equipment, need not be used. In a preferred embodiment, a bonding agent, such as adhesive, surgical glue, or a solvent, is used as the fixation agent.

Abstract: The invention is directed biopsy site markers and methods of marking a biopsy site, so that the location of the biopsy cavity is readily visible by conventional imaging methods, particularly by ultrasonic imaging. The biopsy site markers of the invention have high ultrasound reflectivity, presenting a substantial acoustic signature from a small marker, so as to avoid obscuring diagnostic tissue features in subsequent imaging studies, and can be readily distinguished from biological features. The several disclosed embodiments of the biopsy site marker of the invention have a high contrast of acoustic impedance as placed in a tissue site, so as to efficiently reflect and scatter ultrasonic energy, and preferably include gas-filled internal pores. The markers may have a non-uniform surface contour to enhance the acoustic signature. The markers have a characteristic form which is recognizably artificial during medical imaging.

Abstract: An ultrasound-detectable biopsy marker mass has a detectable in-vivo lifetime during which the marker mass remains readily detectable by ultrasound imaging. The ultrasound-detectable biopsy marker mass is formed of particles of a bio-resorbable material having bubble cavities and having a particle size between about 200 microns and about 500 microns.

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: An intracorporeal marker delivery device includes a delivery tube which has a tapered, tissue penetrating distal tip, an inclined discharge orifice in the tapered distal tip and an inner bore extending to the orifice. A plurality of remotely detectable markers, which are formed at least in part of bioresorbable material, are slidably disposed within the inner bore. A plug having an inclined exposed surface, which is formed at least in part of bioresorbable material, is releasably secured within the inner bore of the delivery tube distal to the plurality of remotely detectable markers disposed therein to retain the plurality of remotely detectable markers within the inner bore. The plug is disposed at least in part within the inclined discharge orifice. A plunger is slidably disposed within the inner bore proximal to the plurality of remotely detectable markers.