Abstract: A device for encapsulating tissue specimens includes a wand assembly, a sheath, and a guide assembly. The guide assembly pulls, draws, or otherwise moves the sheath about the tissue specimen. The wand assembly is disposed proximate to the tissue specimen, typically either adjacent or through the specimen. The guide assembly has sheath deployment members that are disposed about the tissue specimen. The sheath, which is attached to ends of the sheath deployment members and the wand assembly, is drawn over the tissue specimen as the sheath deployment members are pushed or pulled. In another aspect of the device, the guide assembly is an arm or a housing that rotates about the tissue specimen. The sheath, which is secured at one end to the guide assembly and at another end to the wand assembly, is drawn over the tissue specimen as the guide assembly rotates.

Abstract: Devices and methods are provided for applying vacuum near to devices for delivering treatments to tissue adjacent a body cavity, effective to draw adjacent tissue near to such devices and to enhance treatment of the tissue. Body cavities include natural body cavities and cavities remaining after removal of tissue such as cancerous tissue. A device may include an inner balloon assembly with an inflation conduit. A sheath assembly having a fluid-permeable sheath wall may enclose the inner balloon assembly. Vacuum applied to the space between the sheath and the inner balloon is useful to draw tissue into contact with the device, improving treatment effectiveness. Methods for treating tissue with such devices and systems are also provided. Treatments may include providing radioactive material for radiation treatment, providing chemotherapeutic material for chemotherapy, providing thermal treatment, and combinations thereof. Systems may include devices of the invention and a vacuum source.

Abstract: The invention is directed to devices and methods for accessing a desired target site within a patient's body and for separating and collecting a tissue specimen from the target site. The device includes a probe member or cannula with a penetrating distal tip, and a tissue cutting member which is disposed within the probe member to cut a tissue specimen from supporting tissue at the biopsy site. This probe is releasably secured to a housing to provide a plurality of discrete orientations of the probe about its longitudinal axis. Vacuum may be provided to the inner lumen of the cutting member to transport tissue through the inner lumen thereof. Rotation (and optionally longitudinal reciprocation) of the tissue cutter is effective to separate a tissue specimen from surrounding tissue at the target site. Vacuum or fluid pressure may be used to move the specimen cut from the target site proximally within the inner lumen defined at least in part by the culling member for collection.

Abstract: A high frequency electrosurgical power generator configured to produce electrical power at a frequency of about 1 to about 14 MHz and preferably having an essentially sinusoidal waveform with a voltage level up to 1,000 Vrms, and a current level up to 5 Amps. The output of the high frequency electrosurgical power generator is connected to an electrosurgical tool configured to receive the voltage and current produced by the electrosurgical power generator and deliver the voltage and current to an electrosurgical site. The output of the electrosurgical generator preferably is an essentially sinusoid waveform with a frequency between about 3 MHz and about 8 MHz, up to about 700 volts rms, up to about 2 amps, with a total power of up to 1,000 watts.

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: The invention provides devices and methods for use in removing tissue samples from within a patient's body. The devices include instruments having shafts for cutting a path to a tissue mass, and an inflatable balloon or balloons attached to the shaft effective to dilate the path upon inflation in order to aid in the removal of tissue masses from within the body of a patient. The devices also include instruments having dilation plates that may be inserted into a path leading to a tissue mass to be removed, and the plates separated effective to dilate the path to aid in the removal of tissue masses. Methods include inserting a device into a path leading to a tissue mass, and inflating a balloon or separating plates, thereby widening the path, and removing the tissue mass. Such devices and methods find use, for example, in biopsy and in lumpectomy procedures.

Abstract: A biopsy site marker comprises small bodies or pellets of gelatin which enclose substantially in their interior a radio (X-ray) opaque object. The gelatin pellets are deposited into the biopsy site, typically a cylindrical opening in the tissue created by the recent use of a vacuum assisted large core biopsy device, by an applicator device that includes an elongated cylindrical body that forms a flexible tube and a piston slidable in the tube. One end of the tube is placed into the biopsy site. Typically, several gelatin pellets, only some of which typically do, but all of which may contain the radio opaque object, are deposited sequentially into the site through the tube. The radio opaque objects contained in the gelatin bodies are of a non-biological configuration and readily identifiable as man-made object, so that in observation by typical mammography equipment they do not assume the shape of a line, whereby they are readily distinguishable from granules and lines of calcification.

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: 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: An electrosurgical tool includes a cutting loop, which can be an RF cutting loop, which is secured to a shaft which rotates about an axis which is perpendicular to the longitudinal axis of the tool.

Abstract: Devices and methods are provided for applying vacuum near to devices for delivering treatments to tissue adjacent a body cavity, effective to draw adjacent tissue near to such devices and to enhance treatment of the tissue. Body cavities include natural body cavities and cavities remaining after removal of tissue such as cancerous tissue. A device may include an inner balloon assembly with an inflation conduit. A sheath assembly having a fluid-permeable sheath wall may enclose the inner balloon assembly. Vacuum applied to the space between the sheath and the inner balloon is useful to draw tissue into contact with the device, improving treatment effectiveness. Methods for treating tissue with such devices and systems are also provided. Treatments may include providing radioactive material for radiation treatment, providing chemotherapeutic material for chemotherapy, providing thermal treatment, and combinations thereof. Systems may include devices of the invention and a vacuum source.

Abstract: Devices and methods are provided for applying vacuum near to devices for delivering treatments to tissue adjacent a body cavity, effective to draw adjacent tissue near to such devices and to enhance treatment of the tissue. Body cavities include natural body cavities and cavities remaining after removal of tissue such as cancerous tissue. A device may include an inner balloon assembly with an inflation conduit. A sheath assembly having a fluid-permeable sheath wall may enclose the inner balloon assembly. Vacuum applied to the space between the sheath and the inner balloon is useful to draw tissue into contact with the device, improving treatment effectiveness. Methods for treating tissue with such devices and systems are also provided. Treatments may include providing radioactive material for radiation treatment, providing chemotherapeutic material for chemotherapy, providing thermal treatment, and combinations thereof. Systems may include devices of the invention and a vacuum source.

Abstract: Devices, methods and systems for obtaining biopsy tissue samples are provided. Flexible hollow tubes with a rail and a tip cutting element advance within a shaft with an aperture and a bore having a ramp, so that the cutting element emerges from the aperture and cuts tissue as it moves over the ramp. Either or both shaft and bore may have guides, which may engage each other to guide the tube along a tissue cutting pathway. A tube may have a rail and the bore a channel which engages the rail and guides the tube. Cut tissue may be acquired and transported proximally within the tube by suction to a tissue collection chamber. Multiple tissue samples may be obtained from a single insertion point by rotation and/or translation of the shaft between biopsies.

Abstract: The invention provides materials, devices and methods for marking biopsy sites for a limited time. The biopsy-marking materials are ultrasound-detectable bio-resorbable powders, with powder particles typically between about 20 microns and about 800 microns in maximum dimension, more preferably between about 300 microns and about 500 microns. The powders may be formed of polymeric materials containing cavities sized between about 10 microns and about 500 microns, and may also contain binding agents, anesthetic agents, hemostatic agents, and radiopaque markers. Devices for delivering the powders include tubes configured to contain the powders and to fit within a biopsy cannula, the powders being ejected by action of a syringe. Systems may include a tube containing powder, and a syringe containing sterile saline. The tube may be configured to fit within a biopsy cannula such as a Mammotome® or SenoCor 360™ cannula.

Abstract: A solution for forming a marker or filler mass for an intracorporeal site. The solution contains a polar, water soluble non-aqueous solvent such as dimethyl sulfoxide and a bioabsorbable, essentially water insoluble polymer such as polylactic acid, or copolymers of lactic acid and glycolic acid. The solution may be delivered to the biopsy site by a suitable syringe and delivery tube. The delivery tube is preferably provided with a releasable radiopaque element on the distal tip which can be released within the polymeric marker mass formed in the biopsy cavity.

Abstract: The invention is directed to marker delivery devices and methods of using such devices. The delivery devices embodying features of the invention include a delivery cannula with a discharge opening and a releasable plug disposed in the inner lumen of the delivery cannula so as to at least partially occlude the discharge opening. The releasable plug prevents ingress of tissue, body fluids and the like into the bore of the tube, and prevents the premature discharge of any markers proximal to the releasable plug from passing through the discharge opening before the distal end of the cannula is properly positioned at a desired location within a patient's body. The releasable plug preferably has an MRI detectable element. Preferably, at least one remotely detectable marker mass is provided in the inner lumen of the cannula proximal to the releasable plug.

Abstract: The invention is directed to an intracorporeal marker, a delivery device and assembly for such marker and the method of delivering one or more of the markers to an intracorporeal location within a patient. The marker is a body formed at least in part of a bioabsorbable fibrous material such as a fibrous mat or fabric. The delivery devices preferably also include one or more bioabsorbable short term markers which are configured to expand within the body cavity due to contacting a body fluid. The fibrous marker has a radiographically detectable member which preferably hold a portion of the fibrous body in a compressed condition. Preferably, the fibrous marker has a fibrous felt core formed of bioabsorbable material with a fabric jacket formed of bioabsorbable material. Therapeutic, diagnostic and binding agents may be incorporated into the fibrous body of the marker.

Abstract: A device and method of using the device to access a desired tissue site within a patient's body and separating a tissue specimen from the tissue site suitable for evaluation. The device includes a probe member having an arcuate tissue-cutting RF powered electrode secured to and distally spaced from the distal end of the probe and a small dimensioned distal extremity which when an inner lumen thereof is subjected to a vacuum, secured tissue for the specimen to the surface of the distal extremity. A circular tissue-cutting blade preferably secured to the distal end of a supporting tube is configured to rotate and move longitudinally along the shaft of the probe member effective to sever a tissue specimen from tissue secured to the surface of the distal extremity of the probe member. The supporting tube covers the separated specimen, and may be disposed within an accessing cannula.

Abstract: Devices and methods are provided for applying vacuum near to devices for delivering treatments to tissue adjacent a body cavity, effective to draw adjacent tissue near to such devices and to enhance treatment of the tissue. Body cavities include natural body cavities and cavities remaining after removal of tissue such as cancerous tissue. A device may include an inner balloon assembly with an inflation conduit. A sheath assembly having a fluid-permeable sheath wall may enclose the inner balloon assembly. Vacuum applied to the space between the sheath and the inner balloon is useful to draw tissue into contact with the device, improving treatment effectiveness. Methods for treating tissue with such devices and systems are also provided. Treatments may include providing radioactive material for radiation treatment, providing chemotherapeutic material for chemotherapy, providing thermal treatment, and combinations thereof. Systems may include devices of the invention and a vacuum source.

Abstract: A device and method for treatment of a tissue specimen disposed in surrounding tissue has a tissue specimen isolating tool and a tissue specimen damager. The tissue specimen isolating tool isolates the tissue specimen from the surrounding tissue. The tissue specimen damager damages the tissue, with a possible end result being necrosis. The severing tool may have a cutting member that is extendable to an outwardly radially bowed position about device. The tissue specimen is isolated by rotating the cutting member about the tissue specimen. The cutting member may be functionally connected to a cutting member radio frequency generation source. The tissue specimen damager may damage the tissue specimen using ionizing radiation, cutting devices, thermal treatment devices, chemical treatment devices, or sealing an outer boundary of the tissue specimen.