Abstract: The invention is directed to an electrosurgical device having a shapeable elongate cutting electrode having a free distal end with an exposed length of at least 0.5 inch and secured by its proximal end to the distal end of a handle. The electrosurgical device is designed for use with a high frequency electrosurgical generator which has an output at a frequency of between about 1 MHz and about 10 MHz, preferably about 3 to about 8 MHz. Preferably, the output has an essentially sinusoidal waveform with little harmonic distortion. The methods provide for the enhanced cutting of a variety of tissue including muscular, connective, glandular and fatty tissue. The device is particularly suitable in performing a breast biopsy.

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: 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: A device for accessing and for isolating a desired site within a patient's body, and for obtaining a body of tissue from a patient at the site that includes an electrosurgical cutting electrode near the distal tip of a shaft, an anchoring mechanism and an electrosurgical side-cutting device. Methods are provided for accessing a target site within a patient's body, anchoring a body of tissue at the site, and isolating the body of tissue at the site. The method may be performed for a surgical biopsy or lumpectomy at the target site within a patient's body.

Abstract: The invention is directed to devices for two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure. One procedure involves providing a valve to form a passageway through the patient's left ventricular wall at the apex of the patient's heart and configured to advance instruments through the valved passageway to connect the valve leaflets of the patient's heart valve, e.g. the mitral valve, in a “Bow-Tie” configuration to prevent or minimize regurgitation through the valve. The second procedure is directed to a pacing lead with a housing and a pacing lead implanting device which are configured to pass through a trocar in the patient's chest and implanting the pacing lead on an exposed epicardial region of the patient's heart wall. The pacing lead has a penetrating electrode which is secured within the heart wall. One or both procedures may be performed on a patient with CHF.

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.

Abstract: An intravascular device for the formation of linear lesions which has particular utility in the treatment of atrial fibrillation and flutter. The intravascular device has an outer delivery member with a distal section which has an elongated opening and a support element coextending with the opening. An EP device having a plurality of electrodes on its distal section is slidably disposed within the inner lumen of the delivery member but it is secured by its distal end within the distal extremity of the delivery member at least while in operation. In this manner an axial force in the proximal direction on the proximal extremity of the EP device, which extends out of the patient during the procedure, will cause the distal shaft section of the EP device to arch outwardly out of and away from the distal section of the delivery shaft along an inner side of the curved distal section and engage the surface of the patient's heart chamber.

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 apparatus and method are provided for precisely isolating a target lesion in a patient's body tissue, resulting in a high likelihood of “clean” margins about the lesion when it is removed for diagnosis and/or therapy. This approach advantageously will often result in the ability to both diagnose and treat a malignant lesion with only a single percutaneous procedure, with no follow-up percutaneous or surgical procedure required, while minimizing the risk of migration of possibly cancerous cells from the lesion to surrounding tissue or the bloodstream. In particular, the apparatus comprises a biopsy instrument having a distal end adapted for entry into the patient's body, a longitudinal shaft, and a cutting element disposed along the shaft. The cutting element is actuatable between a radially retracted position and a radially extended position.

Abstract: An instrument assembly and method are described for isolating a target lesion in a patient's body tissue, resulting in a high likelihood of “clean” margins about the lesion when it is removed for diagnosis and/or therapy. This approach advantageously will often result in the ability to both diagnose and treat a malignant lesion with only a single percutaneous procedure, with no follow-up percutaneous or surgical procedure required. In particular, the instrument assembly has a distal end adapted for entry into the patient's body, a longitudinal shaft, and a cutting element disposed along a distal portion of the shaft. The cutting element is actuatable between a retracted position within an electrically insulating recess and a radially extended position and is rotatable about its axis in the radially extended position to isolate a desire tissue specimen from surrounding tissue by defining a peripheral margin about the tissue specimen.

Abstract: An apparatus and method are provided for precisely isolating a target lesion in a patient's body tissue, resulting in a high likelihood of “clean” margins about the lesion when it is removed for diagnosis and/or therapy. This approach advantageously will often result in the ability to both diagnose and treat a malignant lesion with only a single percutaneous procedure, with no follow-up percutaneous or surgical procedure required, while minimizing the risk of migration of possibly cancerous cells from the lesion to surrounding tissue or the bloodstream. In particular, the apparatus comprises a biopsy instrument having a distal end adapted for entry into the patient's body, a longitudinal shaft, and a cutting element disposed along the shaft. The cutting element is actuatable between a radially retracted position and a radially extended position.

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 intravascular device for the formation of linear lesions which has particular utility in the treatment of atrial fibrillation and flutter. The intravascular device has an outer delivery member with a distal section which has an elongated opening and a support element coextending with the opening. An EP device having a plurality of electrodes on its distal section is slidably disposed within the inner lumen of the delivery member but it is secured by its distal end within the distal extremity of the delivery member at least while in operation. In this manner an axial force in the proximal direction on the proximal extremity of the EP device, which extends out of the patient during the procedure, will cause the distal shaft section of the EP device to arch outwardly out of and away from the distal section of the delivery shaft along an inner side of the curved distal section and engage the surface of the patient's heart chamber.

Abstract: Devices and methods are disclosed for treating a uterine disorder which receive its blood supply from a uterine artery. In particular, uterine fibroids are effectively treated by occluding the uterine arteries using trans-vaginal, trans-uterine, transrectal, or retroperitoneal approaches. The devices and methods are advantageous because the inventive procedures may be performed by a patient's gynecologist in the course of treatment, avoiding the need for referrals to specialist practitioners and for more radical treatments, such as hysterectomies. The methods include both temporary and permanent occlusion of the arteries. A cannula carries an imaging device and a member which will easily penetrate tissue, the member including a device which partially or completely, and temporarily or permanently, occludes a uterine artery.

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: 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: A device and system for accessing and anchoring a patient's sentinel lymph node after a radiopharmaceutical is injected at or near a lesion site within a patient's body. The migration of and accumulation of the radiopharmaceutical in a sentinel node of the patient is monitored from outside the patient's body. The sentinel node can then be accessed through a cannula and an anchoring device may be employed to fix the location of the sentinel node. The anchoring device has at least one radially extending members which penetrate into the sentinel node. Preferably, the radially extending members are RF powered to facilitate entry into the sentinel node. With the anchor device secured to the sentinel node as a locator, subsequent procedures may be performed.

Abstract: A tissue acquisition system includes radio frequency (RF) cutter loops which are extendable out a cannula to cut cylindrical tissue samples from a tissue of interest in a patient. The cannula includes inner and outer cannulae which are mutually rotatable and include cutouts through which the cutting loop can be rotated and longitudinally extended to perform the cuts. The tissue samples are then aspirated proximally through the cannula for collection.

Abstract: An intraluminal catheter having an expandable tubular open-walled element for immobilizing at least part of the catheter within a patient's body lumen, generally comprising an elongated shaft and a tubular open-walled element secured to the shaft, wherein the tubular open-walled element is at least in part expandable from an unexpanded diameter to a larger diameter expanded diameter within the body lumen. The expanded diameter configuration is configured to contact a wall defining the body lumen and thereby releasably secure at least part of the catheter within the body lumen. A cannula member, used for delivering or removing fluids from the body lumen, can be positioned in one or more optimal perfusion locations within the body lumen during use, independent of the secured site. When occlusion of the axial flow is necessary, an optional occluding member may be reversibly deployed so that it expands inside and against the expanded tubular open-walled element.