Abstract: An implant for marking an area within a living body includes a matrix material and a marking material. The implant is formable to fit the shape and size of a cavity in the human body. The implant is configured to support tissue surrounding the cavity and to allow in-growth of fibrous tissue into and replace at least a portion of the matrix material.

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. In an aspect of the encapsulating device, 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. 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: 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: A device for localizing a target tissue mass in a body includes a tubular trocar portion having a distal end and a proximal end portion that is removably attachable to a handle portion. The trocar portion contains at least a first plurality of locator wires that are movable between a retracted position within the trocar and a deployed position extending radially from the trocar. The first plurality of locator wires mounted for axial movement within the trocar portion between a proximal retracted position and a deployed distal position. The second plurality of locator wires is mounted for movement between a distal retracted position and a proximal deployed position. The locator wires are electrically energized to facilitate their deployment electrosurgically.

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

Abstract: 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: 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 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: 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: 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: 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 marker delivery device is described which has an obturator with an elongated shaft, an inner lumen, a proximal end, and a substantially sealed distal end. One or more tissue markers are deployed within the inner lumen of the elongated shaft of the obturator. Preferably, the tissue marker(s) is disposed within an inner lumen of a marker delivery tube which is disposed within the inner lumen of the elongated shaft of the obturator. The marker delivery tube has an opening for discharging the tissue markers into a body (e.g. biopsy) cavity. The distal tip of the marker delivery tube is configured to penetrate the substantially sealed distal end of the obturator so that tissue markers can be delivered while the obturator is in place within the body. Preferably, the obturator includes a detectable element capable of producing a relatively significant image signature during MRI.

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 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: A tissue marking implant includes a matrix material and a dye marker. The implant, which can be formed entirely of bioresorbable material such as a collagen foam, is sized and shaped to replace excised tissue. The implant supports surrounding tissue upon implantation, while allowing for in-growth of fibrous tissue to replace the implant. According to various alternative embodiments, the implant is elastically compressible, or can be formed from self-expanding foam or sponges, and can be implanted through a cannula or by injection, as well as by open procedures. The implant can carry therapeutic and diagnostic substances. The dye marker leaches from the implant such that a surgeon, upon subsequent surgical intervention, visibly recognizes the tissue marked by the dye marker.

Abstract: The invention is directed to devices and methods for separating and collecting a tissue specimen from a patient's target site. The device includes a probe member with a penetrating distal tip and a tissue receiving aperture, and a tissue cutting member which is rotatable disposed within the probe member to cut a tissue specimen drawn into the interior of the device through the aperture. The longitudinal edges of the aperture are preferably sharpened to engage the cutting edges of the tissue cutting member. Vacuum may be provided in the inner lumen of the cutting member to transport tissue therethrough. Rotation, rotational oscillation and/or longitudinal reciprocation of the tissue cutting member is effective to separate a tissue specimen from surrounding tissue. An accessing cannula having an tissue receiving aperture may be concentrically disposed within the probe member and about the tissue cutting member.

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.