Abstract: The invention is directed to two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure, and devices and systems for such procedures. One procedure involves providing a valved passageway through the patient's left ventricular wall at the apex of the patient's heart and advancing 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 involves advancing a pacing lead and a pacing lead implanting device 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: 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: One embodiment having features of the invention is directed to a guide block for an MRI device which has a block body with a proximal face, a distal face, and four parallel passageways extending between the two faces. The first passageway is centrally disposed, the second passageway is disposed vertical or horizontal to the first, the third passageway is located diagonal to the first and has a longitudinal opening in fluid communication with the first passageway, and the fourth passageway is diagonal to the first and in an opposite side of the body from the third passageway. In an alternative embodiment the guide block has at least one passageway that is not parallel to the longitudinal axis.

Abstract: One embodiment having features of the invention is directed to a guide block for an MRI device which has a block body with a proximal face, a distal face, and four parallel passageways extending between the two faces. The first passageway is centrally disposed, the second passageway is disposed vertical or horizontal to the first, the third passageway is located diagonal to the first and has a longitudinal opening in fluid communication with the first passageway, and the fourth passageway is diagonal to the first and in an opposite side of the body from the third passageway. In an alternative embodiment the guide block has at least one passageway that is not parallel to the longitudinal axis.

Abstract: A surgical ablation probe assembly particularly suitable for ablating tissue on a surface of a patient's heart having an ablation member and a stabilizing member for guiding the probe assembly to an intracorporeal location such as a surface of the patient's heart. The elongated ablation member generally has at least one ablation electrode on a distal shaft section. The stabilizing member has a vacuum lumen which applies a vacuum to the inner chamber of the stabilizing member to aspirate fluid from within the chamber or about the stabilizing member and can aid in holding the stabilizing member to an intracorporeal surface such as the epicardial or endocardial surface of the patient's heart. The probe assembly may also have a removable stylet to help retain the shape of the distal portion. The assembly is suitable for treating a patient for atrial arrhythmia, by forming linear or curvilinear lesions and preferably a continuous lesion on the surface of the patient's heart.

Abstract: The invention provides marker delivery devices, assemblies, and methods. Assemblies embodying features of the invention include marker delivery devices having a delivery tube with an orifice, markers, and a plug releasably disposed in the tube occluding the orifice. The plug prevents markers from passing through the orifice before the marker is to be placed at a desired location within a patient's body, prevents ingress of tissue into the bore of the tube, and allows markers to pass out of the orifice when marker delivery is desired. Guidance of a delivery tube to a desired location within a patient's body may include the use of an imaging device, with or without the use of a guide cannula. The plug may itself serve as a marker, and may be the sole marker. Markers may be detectable by ultrasound, X-ray, magnetic resonance imaging, and other imaging devices, and may include bioactive elements.

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 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: An electrosurgical biopsy device includes a stylet and a cannula movably mounted on a base. The stylet has a shaft with a head at its distal end and a stylet ablation element extending distally from the head. The stylet shaft is disposed through the cannula for axial translation therein between withdrawn and extended positions. In use, the stylet and the cannula are pushed through the skin and the underlying tissue until the stylet head is adjacent a targeted tissue mass. Next, the stylet is extended distally from the distal end of the cannula so that its head penetrates the tissue mass. The cannula ablation element is then activated, and the cannula is pushed through the tissue mass toward the stylet head, thereby cutting a “core” through the tissue mass that is captured as a tissue specimen within the distal end of the cannula.

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: 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: 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 is directed to a minimally invasive therapeutic procedure, particularly for patients with congestive heart failure, and devices and systems for such procedures. this procedure involves providing a valved passageway through the patient's left ventricular wall at the apex of the patient's heart and advancing 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. Improved devices for this procedure include a minimally invasive grasping device having an inner lumen for advancing connecting members and other instruments through the device to the distal end thereof. Other improved instruments include a leaflet connector with an artificial cordae tendenae strand secured to an end of the leaflet connector.

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 is directed to two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure, and devices and systems for such procedures. One procedure involves providing a valved passageway through the patient's left ventricular wall at the apex of the patient's heart and advancing 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 involves advancing a pacing lead and a pacing lead implanting device 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 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: 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 orthopedic implant assembly comprising a stabilizing element, a securing element which attaches the stabilizing element to the bone, and a stopping member in the stabilizing element which inhibits the securing element from loosening or backing out of the bone. The stabilizing element has at least one bore with the stopping member therein. In one embodiment, the stopping member has a reversibly expandable inner and outer diameter to allow the securing element to pass posteriorly through the stopping member, but thereafter prevent or inhibit the securing element from anteriorly backing out of the posterior section of the transverse passageway.