Abstract: Methods and apparatus are provided for cauterizing predetermined volumes of abnormal biological tissue using a user selectable or adjustable energy applicator including two or more electrodes having electrode parameters configured cause cauterization of predetermined volumes when operated in a bipolar mode. The energy applicators are employed with a control device that couples the energy applicators to a power source and includes circuitry for interrupting activation of the energy applicator when the current between the two or more electrodes decreases more than a predetermined amount from the current sensed upon initial activation of the energy applicator.

Abstract: Apparatus and methods are provided for monitoring cardiac output using bioelectrical impedance techniques in which first and second electrodes are placed in the trachea and/or bronchus in the vicinity of the ascending aorta, while an excitation current is injected into the thorax via first and second current electrodes, so that bioelectrical impedance measurements based on the voltage drop sensed by the first and second electrodes reflect voltage changes induced primarily by blood flow dynamics, rather than respiratory or non-cardiac related physiological effects. Additional sense electrodes may be provided, either internally, or externally, for which bioelectrical impedance values may be obtained. Methods are provided for computing cardiac output from bioelectrical impedance values. Apparatus and methods are also provided so that the measured cardiac output may be used to control administration of intravenous fluids to an organism or to optimize a heart rate controlled by a pacemaker.

Abstract: An ultrasound imaging and biopsy system is provided in which an upper compression member of the system includes a thin, flexible, sterile and disposable membrane that compresses the tissue and permits a biopsy instrument to be readily inserted therethrough. In a preferred embodiment, a table is provided that houses an ultrasound scanning system beneath a sonolucent window forming a lower compression surface. Methods of using the system to perform real-time image-guided biopsy of tissue disposed on the window are also provided.

Abstract: Apparatus and methods are provided for first expanding a body lumen of a body vessel or organ and then deploying a prosthesis to maintain the lumen patent. The apparatus includes a catheter having a balloon member formed of a biocompatible material, a balloon cutting element, and a thermally activated shape memory alloy prosthesis disposed within the balloon. The prosthesis is formed of nickel-titanium alloy having a reduced diameter in the martensite phase, and an expanded diameter in the austenite phase. The balloon member is inflated using a first fluid having a temperature below the martensite transition temperature to expand the body lumen and a second fluid having a temperature sufficient to cause the prosthesis to transition to the expanded diameter, trapping the material of the balloon member against the body wall. A cutting device disposed on the catheter then severs balloon member to release the prosthesis.

Abstract: Apparatus having a dilatation mechanism is provided wherein a plurality of radially expanding members are coupled to a plunger. The radially expanding members deflect outwardly in response to application of an hydraulic load to the plunger. The apparatus may be used in dilating vessels to treat obstructive vascular disease, or used in delivery systems to deploy vascular prostheses such as stents and grafts. Methods of using the apparatus are also provided.

Abstract: Apparatus is provided that combines radiography equipment with an ultrasonic transducer to generate ultrasonic images of the internal structure of biological tissue that are in registration with an X-ray image. The apparatus includes an examination table having a radiolucent and sonolucent window for imaging the biological tissue with an ultrasound and X-ray subsystems without moving the patient. In alternative embodiments, the ultrasound transducer may be an annular array transducer mounted on a moveable or a linear array of ultrasonic transducing elements. The X-ray images are preferably generated digitally using a line X-ray source and detector.

Abstract: A bifurcated graft comprising two sections is provided that is implanted in two consecutive steps in a bifurcated body lumen. A first section of the graft comprises a main portion having a joining region and a first leg extending from the main portion adjacent to the joining region. The main portion of the graft is implanted in the body lumen upstream of the bifurcation, while the first leg extends into a first branch of the body lumen. A second section of the graft, which is implanted in a separate step, comprises second a leg that extends into the second branch of the body lumen and a proximal portion that interconnects with the joining region of the first section.

Abstract: Methods and apparatus are provided for cauterizing predetermined volumes of abnormal biological tissue using a user selectable or adjustable energy applicator including two or more electrodes having electrode parameters configured to cause cauterization of predetermined volumes when operated in a bipolar mode. The energy applicators are employed with a control device that couples the energy applicators to a power source and includes circuitry for interrupting activation of the energy applicator when the current between the two or more electrodes decreases more than a predetermined amount from the current sensed upon initial activation of the energy applicator.

Abstract: Apparatus is provided that combines mammography equipment with an ultrasonic transducer to generate ultrasonic images of the internal structure of breast tissue that are in geometric registration with a mammogram. The apparatus includes a radiolucent and sonolucent compression plate, and in alternative embodiments, a gantry driven ultrasound transducer or a phased array ultrasonic transducer. Methods are provided for generating a mammogram and a plurality of corresponding ultrasound images without moving the breast between the mammogram exposure and the ultrasound imaging. Methods are also provided for viewing and analyzing the ultrasound images. Apparatus and methods are also provided for enhancing X-ray images obtained from conventional mammographic systems, and with reduced overall X-ray dosage to the patient.

Abstract: Apparatus and methods are provided for performing an in situ characterization of a tissue mass which may be normal, malignant, or benign, and, based on the measured characteristics of the tissue mass, therapeutically treating the tissue mass to cause necrosis of the tissue. In an illustrative preferred embodiment, the characterization of the tissue is accomplished by measuring an electrical property of the tissue, such as electrical impedance, while treatment is accomplished by supplying heat to the tissue to induce cauterization.

Abstract: Apparatus and methods are provided for compressing biological tissue for use with a radiographic or sonographic imaging system that enhances imaging of the tissue near a patient's chest wall. The apparatus includes a compression assembly having first and second compression surfaces, and structure for positioning the first compression surface relative to the second compression surface so that the first and second compression surfaces experience a lateral translation as they move towards one another. In addition the first and second compression surfaces may be tilted slightly relative to a plane orthogonal to the patient's chest wall to enhance the traction effect and to provide partial imaging within the patient's chest wall.

Abstract: Apparatus and methods are provided for first expanding a body lumen of a body vessel or organ and then deploying a prosthesis to maintain the lumen patent. The apparatus includes a catheter having a balloon member formed of a biocompatible material, a balloon cutting element, and a thermally activated shape memory alloy prosthesis disposed within the balloon. The prosthesis is formed of nickel-titanium alloy having a reduced diameter in the martensite phase, and an expanded diameter in the austenite phase. The balloon member is inflated using a first fluid having a temperature below the martensite transition temperature to expand the body lumen and a second fluid having a temperature sufficient to cause the prosthesis to transition to the expanded diameter, trapping the material of the balloon member against the body wall. A cutting device disposed on the catheter then severs balloon member to release the prosthesis.

Abstract: Apparatus and methods are provided for positioning a needle or cannula of a biopsy device for insertion into a tissue mass by correlating, in real-time, the actual needle or cannula position prior to insertion with its probable trajectory once inserted. In a preferred embodiment, a biopsy device support block is mechanically coupled to an ultrasound transducer to provide alignment of the biopsy device with the ultrasound image in at least one plane. Continued ultrasound scanning of a selected trajectory may be provided to assess depth of penetration of the needle or cannula of the biopsy device, when inserted.

Abstract: Apparatus and methods are provided for use in open surgical and transluminal methods for supplying long-term retrograde perfusion of the myocardium via a conduit disposed between the left ventricle and the coronary sinus. In a first method, an opening is formed between the left ventricle and the coronary sinus, and the coronary ostium is partially occluded using a stent that prevents the pressure in the coronary sinus from exceeding a predetermined value. In an alternative method, a first end of a conduit is inserted transeptally through the right atrium and obliquely into the posterior septal endocardium of the left ventricle via the posterior pyramidal space, while a second end of the conduit is inserted into the coronary sinus via the coronary ostium. A pressure-limiting valve is included in the conduit. In either method, the outlet from the left ventricle to the coronary sinus may include a one-way valve to prevent backflow from the coronary sinus into the left ventricle during cardiac diastole.

Abstract: Apparatus for conducting an imaging examination and/or biopsy of biological tissue that enable a patient to remain in an inclined, seated orientation, so that the tissue is readily presented for examination and biopsy, while the examination and biopsy site is screened from the patient's view. Apparatus also provided for enhancing imaging of the patient's tissue near the chest wall, and for conducting image-guided biopsy.

Abstract: Apparatus and methods are provided for monitoring cardiac output using bioelectrical impedance techniques in which one or more interior electrodes are placed in the trachea in the vicinity of the ascending aorta, and one or more exterior electrodes are disposed near the suprasternal notch, so that the resulting bioelectrical impedance measurements reflect voltage changes induced primarily by blood flow dynamics, rather than respiratory or non-cardiac related physiological effects. Apparatus and methods are also provided so that the measured cardiac output may be used to control administration of intravenous fluids to a patient or to optimize heart rate for those patients having pacemakers.

Abstract: Apparatus and methods are provided for monitoring cardiac output using bioelectrical impedance techniques in which first and second electrodes are placed in the trachea and/or bronchus in the vicinity of the ascending aorta, while a sense current is injected into the thorax via first and second source electrodes, so that the resulting bioelectrical impedance measurements reflect voltage changes induced primarily by blood flow dynamics, rather than respiratory or noncardiac related physiological effects. Apparatus and methods are also provided so that the measured cardiac output may be used to control administration of intravenous fluids to a patient or to optimize heart rate for those patients having pacemakers.

Abstract: Apparatus is provided that combines mammography equipment with an ultrasonic transducer to generate ultrasonic images of the internal structure of breast tissue that are in geometric registration with a mammogram. The apparatus includes a radiolucent and sonolucent compression plate, and in alternative embodiments, a gantry driven ultrasound transducer or a phased array ultrasonic transducer. Methods are provided for generating a mammogram and a plurality of corresponding ultrasound images without moving the breast between the mammogram exposure and the ultrasound imaging. Methods are also provided for viewing and analyzing the ultrasound images. Apparatus and methods are also provided for enhancing X-ray images obtained from conventional mammographic systems, and with reduced overall X-ray dosage to the patient.

Abstract: Apparatus and methods are provided for positioning a biopsy needle for insertion into a tissue mass by correlating, in real-time, the actual needle position prior to insertion with its probable trajectory once inserted. In a preferred embodiment, the biopsy needle location is tracked electronically and projected over a previously stored or real-time image of the tissue, thus allowing a clinician to observe which features of an imaged tissue the biopsy needle is likely to intersect upon insertion. Continued ultrasound scanning of a selected trajectory may be provided to assess depth of penetration of the biopsy needle, when inserted. Apparatus is also provided for expanding the region scanned by an ultrasound transducer beyond the periphery of a compression plate.

Abstract: Methods are provided for use in open surgical and transluminal methods for supplying long-term retrograde perfusion of the myocardium via a conduit disposed between the left ventricle and the coronary sinus. In a first method, an opening is formed between the left ventricle and the coronary sinus, and the coronary ostium is partially occluded using a stent that prevents the pressure in the coronary sinus from exceeding a predetermined value. In an alternative method, a first end of a conduit is inserted transeptally through the right atrium and obliquely into the posterior septal endocardium of the left ventricle via the posterior pyramidal space, while a second end of the conduit is inserted into the coronary sinus via the coronary ostium. A pressure-limiting valve is included in the conduit. In either method, the outlet from the left ventricle to the coronary sinus may include a one-way valve to prevent backflow from the coronary sinus into the left ventricle during cardiac diastole.