Abstract: Apparatus and methods are provided for thermally and/or mechanically treating tissue, such as valvular structures, to reconfigure or shrink the tissue in a controlled manner. The apparatus comprises a catheter in communication with an end effector which induces a temperature rise in an annulus of tissue surrounding the leaflets of a valve or in the chordae tendineae sufficient to cause shrinkage, thereby causing the valves to close more tightly. Mechanical clips can also be implanted over the valve either alone or after the thermal treatment. The clips are delivered by a catheter and may be configured to traverse directly over the valve itself or to lie partially over the periphery of the valve to prevent obstruction of the valve channel. The clips can be coated with drugs or a radiopaque coating. The catheter can also incorporate sensors or energy delivery devices, e.g., transducers, on its distal end.

Abstract: A handheld ultrasound instrument is disclosed having enhanced diagnostic modes including pulse wave Doppler, time-motion analysis, and tissue harmonic imaging. An external electrocardiograph (ECG) recording unit is also disclosed. The ECG unit is adaptable to be used with the handheld ultrasound instrument to provide for ECG monitoring while performing an ultrasound scan in B-mode, Doppler, color Doppler, M-mode, and PW mode. The enhanced handheld ultrasound instrument further includes a security mechanism allowing any combination of the diagnostic modes to be enabled by the manufacturer, and later to enable or disable any one or group of the diagnostic modes. The invention also discloses a method for a manufacturer to maintain a database of handheld ultrasound instrument capabilities after the instruments enter the stream of commerce.

Abstract: A portable apparatus which allows a user to perform self-diagnostic evaluation of nerve sensory latency between a pair of epidermal locations proximal to nerve conduction paths. The device provides a simple and low-cost self-diagnostic apparatus which may be used for the detection and ongoing monitoring of sensory latency, such as sensory latency which is the result of carpal tunnel syndrome. The apparatus is powered by a single battery which provides power to all circuitry of the apparatus. Upon power activation, the device generates a series of high voltage stimulus pulses at an electrode in epidermal contact with the user/operator. The nerve response voltage is detected by a second electrode located along nerve pathway and the time delay between stimulus and response is displayed and periodically updated as each new response is detected.

Abstract: An apparatus for placing a pacing electrode in the coronary sinus so as to pace the left ventricle of the heart comprises a preshaped, flexible catheter having a distal end and a predetermined shape in an unflexed or steady state condition to facilitate placement of a distal end into the os of the coronary sinus within the right atrium of the heart. The catheter includes a first lumen which extends from an entry port at the proximal end of the catheter end of the catheter, through the catheter and terminating at an exit port at the distal end of the catheter. The catheter also includes a second lumen which extends from a first port in the vicinity of the proximal end of the catheter through the catheter and terminating at a second port which is in fluid communication with an inflatable/deflatable balloon in the vicinity of the distal end of the catheter. An inflating/deflating device, such as a syringe, is attachable to the first port of the second lumen of the catheter, for inflating/deflating the balloon.

Abstract: A temporary balloon-type electrode for insertion and temporary fixation in a blood vessel of a heart, for determining a suitable place therein for a subsequently inserted and fixed permanent electrode, has a catheter and an inflatable and deflatable balloon member disposed at a distal end portion of the catheter. The balloon member has at least one radially expandable hollow body. At least one electrode surface contact member is disposed at a peripheral portion of the hollow body, and flow passages are provided for allowing a blood flow to pass the balloon member when inflated. The temporary balloon-type electrode is particularly suited for use in coronary sinus and peripheral coronary veins of the heart.

Abstract: An apparatus and method for relieving stress on a heart muscle tissue in a wall of a heart having a chamber. A plurality of biocompatible and implantable elongate strips are configured to be connected to the heart wall and disposed about the chamber such that the elongate strips are arranged in spaced relation to one another. The elongate strips are bendable and are sufficiently resistant to elongation such that natural stretching of the heart wall does not cause elongation of the plurality of strips.

Abstract: A helical element for insertion into tissue comprises a helical element having an insertion end, a protruding end and an open central area within the wire, rods, filaments, cables or the like that form the helix. The helical element has at least its insertion end covered by a cap of a water-soluble or water-dispersible composition. The cap is provided with a surface shape in a cross-section in which surface variations are present in the cross-section which create a surface orientation where a line from the center of the cross-section can intersect the surface, and a line perpendicular to said radius at a point of intersection with said surface forms four quadrants, three of said quadrants containing water-soluble or water-dispersible cap material. There is either a hollow area within the composition within the open central area or the material is more porous than the remaining material.

Abstract: A helical element for insertion into tissue comprises a helical element having an insertion end, a protruding end and an open central area within the wire, rods, filaments, cables or the like that form the helix. The helical element has at least its insertion end covered by a cap of a water-soluble or water-dispersible composition. The cap is provided with a surface shape in a cross-section in which surface variations are present in the cross-section which create a surface orientation where a line from the center of the cross-section can intersect the surface, and a line perpendicular to said radius at a point of intersection with said surface forms four quadrants, three of said quadrants containing water-soluble or water-dispersible cap material. There is either a hollow area within the composition within the open central area or the material is more porous than the remaining material.

Abstract: An anchor is provided for securing an elongated cylindrical member, such as a lead cable, to surrounding tissue. The anchor has a simple design that allows the anchor to be held in place on, e.g., a lead cable, without the need for sutures. In addition, the anchor may be manipulated to allow the anchor to move along the cylindrical member. Manipulation of the anchor is straight-forward, simple, and does not require tools, yet the anchor is reliably held in place, requiring intentional manipulation to be released. The anchor includes two coaxial sleeves holding the ends of a coaxial spring. As one sleeve is rotated in relation to the other, the spring is twisted, causing the inner diameter of the spring to increase or decrease. Once the inner diameter of the spring is increased to the point that is becomes larger than the outer diameter of the cylindrical member it surrounds, the anchor can slide on the cylindrical member.

Abstract: A helical element for insertion into tissue comprises a helical element having an insertion end, a protruding end and an open central area within the wire, rods, filaments, cables or the like that form the helix. The helical element has at least its insertion end covered by a cap of a water-soluble or water-dispersible composition. The composition of the cap comprises a water-soluble or water dispersible component having a hydrogel mixed therein. In one embodiment, there is either a hollow area within the composition within the open central area or the material is more porous than the remaining material. The helical element preferably comprises an electrical lead, such as a positive endocardial lead, with an electrode at the protruding or distal end of the lead. The helical element may comprise any biocompatable material with sufficient structural integrity to provide a secure attachment to tissue in a patient.

Abstract: A suction assisted ablation device having a support surface, suction elements disposed adjacent the support surface, at least one electrode and at least one suction conduit is provided. The device may further include fluid openings, which allow fluid to irrigate target tissue and aid in ablation. A method for ablating tissue using suction is also provided.

Abstract: An electrode device intended for medical equipment and arranged to be attached to a tissue of a body part of a patient, the electrode device including a clamping member, wherein the clamping member also includes a relatively thin metal sheet to be brought into an electrical connection with the body part, and is also configured and arranged to connect an electric conductive cable member to the clamping member for establishing an electric connection with the medical equipment, the connection being provided in such a way that the cable member is releasably connected to the clamping member, wherein the metal sheet forms a clip, which is arranged to be clamped to the body part by plastic deformation of the metal sheet without extending through the tissue and in such a way that electric signals are transferable between the medical equipment and the body part.

Abstract: A lead assembly adapted for endocardial fixation to a human heart is provided. The lead assembly includes a lead body that has a proximal end provided with a connector for electrical connection to a cardiac stimulator. The cardiac stimulator may be a pacemaker, a cardioverter/defibrillator, or a sensing instrument. The distal end of the lead body is connected to a tubular electrode housing. The lead body consists of one or more noncoiled conductor cables surrounded by a coextensive insulating sleeve. Each conductor cable consists of a conducting element covered by a coextensive insulating sleeve. The conducting element may be a single filament wire or a plurality of individual conductor wires. In contrast to conventional leads, the lead body of the present invention does not require coiled conductor wires. Lead body diameters of 1.04 mm or smaller are possible.

Abstract: A lead assembly adapted for endocardial fixation to a human heart is provided. The lead assembly includes a lead body that has a proximal end provided with a connector for electrical connection to a cardiac stimulator. The cardiac stimulator may be a pacemaker, a cardioverter/defibrillator, or a sensing instrument. The distal end of the lead body is connected to a tubular electrode housing. The lead body consists of one or more noncoiled conductor cables surrounded by a coextensive insulating sleeve. Each conductor cable consists of a conducting element covered by a coextensive insulating sleeve. The conducting element may be a single filament wire or a plurality of individual conductor wires. In contrast to conventional leads, the lead body of the present invention does not require coiled conductor wires. Lead body diameters of 1.04 mm or smaller are possible.

Abstract: A double balloon endrotrachael tube has a hose section (1) and at least two adjacent balloons (3; 6) that may be independently inflated. Atraumatic sensors for monitoring the motor larynx nerves are associates to the upper balloon (3). For that purpose, electric and/or electromagnetic sensors (4) are arranged on the surface of said balloon.

Abstract: Endocardial implantable cardiac leads are disclosed for applying electrical stimulation to and/or sensing electrical activity of the heart at one or more distal electrode positioned at a cardiac implantation site within a cardiac vessel adjacent to and at a desired orientation to the left ventricle or atrium of the heart. The distal electrode(s) is supported by a tubular electrode support having a diameter large enough to bear against the blood vessel wall and a support lumen that allows blood to flow through it. A retention stent extends proximally from a distal stent end fixed to the tubular electrode support to a proximal stent end. After advancement to the cardiac implantation site employing a lead delivery mechanism, the retention stent is expandable from a collapsed stent state in which the outer diameter of the retention stent is less than the inner diameter of the vessel to an expanded stent state.

Abstract: A single pass endocardial lead is provided which is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead includes a main body which extends into two distal leg portions, each having at least two electrodes coupled therewith. The first leg is for positioning within the ventricle of the heart. The second leg is for positioning within the atrium of the heart. Both the first leg and the second leg are bipolar and are adapted for positioning and fixation to the heart wall. The first and second legs can be fixated to the heart wall using either passive or active fixation structures. A movement assembly for advancing a helix comprises an externally threaded collar which engages with an internally threaded housing or housing insert.

Abstract: An apparatus and method for relieving stress on a heart muscle tissue in a wall of a heart having a chamber. A plurality of biocompatible and implantable elongate strips are configured to be connected to the heart wall and disposed about the chamber such that the elongate strips are arranged in spaced relation to one another. The elongate strips are bendable and are sufficiently resistant to elongation such that natural stretching of the heart wall does not cause elongation of the plurality of strips.

Abstract: A retractable lead having a distal tip electrode is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The electrode includes a fixation helix for securing the electrode to cardiac tissue, which may or may not be electrically active. The electrode further includes an electrode tip having a mesh screen disposed on a surface at the distal end of the electrode tip, which can be used as a sensing or pacing interface with the cardiac tissue. The mesh screen provides a guiding mechanism for the helix as it travels out of the electrode for securing the electrode to the heart or other muscle or organ. The guiding mechanism may include a groove within the mesh screen. Alternatively, the guiding mechanism includes a guiding bar on which the fixation helix rides on during extension or retraction.

Abstract: A helical element for insertion into tissue comprises a helical element having an insertion end, a protruding end and an open central area within the wire, rods, filaments, cables or the like that form the helix. The helical element has at least its insertion end covered by a cap of a water-soluble or water-dispersible composition. There is either a hollow area within the composition within the open central area or the material is more porous than the remaining material. The helical element preferably comprises an electrical lead, such as a positive endocardial lead, with an electrode at the protruding or distal end of the lead. The helical element may comprise any biocompatable material with sufficient structural integrity to provide a secure attachment to tissue in a patient. Where the helical element is also to provide an active (electrically active) function, the composition of the helical element should also be electrically conductive.

Abstract: A single-pass endocardial lead electrode is adapted for implantation within a single chamber of the heart. The lead includes a first electrode and a second electrode. The first and second electrodes are placed within the same chamber of the heart. In one embodiment, two electrodes are placed on a curved distal end of the lead. In another embodiment, the lead includes multiple legs, each leg carrying an electrode. The lead is attached to a pulse generator for producing pulses to the multiple sites within the heart.

Abstract: The present invention is directed to a medical electrical lead having active fixation which features an improved fixation helix. In particular the present invention is a medical electrical lead having a fixation helix which features microgrooves. The microgrooves are dimensioned so as to minimize the foreign body response of the tissue into which the helix is implanted. The microgrooves preferably consist of a series of grooves parallel to the longitudinal axis of the helix, each groove has a depth of between approximately 0.1 to 30 microns, preferably between approximately 0.1 and 3, with 1 micron preferred; a width of between approximately 0.1 to 30 microns, preferably between approximately 0.1 and 3, with 1 micron preferred; and is spaced apart from every other groove by a distance of between approximately 0.1 to 30 microns, preferably between approximately 0.1 and 3, with 1 micron preferred.

Abstract: A system for passively anchoring mid-lead electrodes on an endocardial catheter lead includes at least one fibrosis-anchoring opening positioned along the exterior surface of the catheter lead body proximal or distal to the mid-lead electrodes for passively securing the catheter lead against the interior wall of the heart. Within the fibrosis-anchoring openings a suitable material is provided for anchoring the catheter lead body to the heart wall by fibrosis. Preferably, the fibrosis-anchoring openings comprise at least a pair of openings positioned only partially around the exterior of the catheter lead body at locations both proximal and distal to the mid-lead electrodes, with the catheter lead body between the fibrosis-anchoring openings being preformed to bias the mid-lead electrodes against the heart wall.

Abstract: An implantable electrical lead of the type having a rigid, insulative electrode head carrying an advanceable helical electrode. The electrode head is mounted to an elongated insulative lead body less rigid than said electrode head and which carries an extensible conductor coupled to the helical electrode and an inextensible conductor mechanically coupled to the proximal end of the lead. A second electrode is mounted to said lead body adjacent the electrode head and is coupled to the inextensible conductor. The inextensible electrical conductor is mechanically coupled to the electrode head such that poximally directed traction forces applied to the proximal end of the lead body are applied to the head by the inextensible conductor and not by the second electrode.

Abstract: An implantable electrical lead of the type which has an insulative rigid electrode head carrying an advanceable helical electrode. The electrode head is mounted toan elongated insulative lead body which is less rigid than the electrode head and which carries an extensible conductor coupled to the helical electrode and an inextensible conductor coupled to the proximal end of the lead body. A second electrode is mounted to said lead body adjacent the electrode head and is coupled to the inextensible conductor by a conductive sleeve which is mechanically coupled to electrode head so that proximally directed traction forces applied to the lead body are applied by the inextensible conductor directly to the electrode head.

Abstract: The present invention is directed to a single pass medical electrical lead. In one embodiment, the lead features a pair of bipolar electrodes positioned along the lead body so that they are positioned in the ventricle and atrium respectively when the lead is implanted. The lead body features a 90 degree bent reinforced section. The bend has a radius of curvature approximately 13 mm and begins approximately 90 mm from the distal end. This curved section is approximately 40 mm in length when straightened. The ventricular electrodes are positioned approximately 28 mm apart. The bend has at least one tine extending therefrom, an electrode is mounted on the tine.

Abstract: A transvenous lead specifically designed for coronary sinus implantation. The lead features a fixation ring positioned adjacent to the electrode. The ring is constructed so as to be readily pliable and bent. The ring functions to wedge or fix the lead within the coronary sinus in such a manner that the electrode is pushed against the vessel wall while the flow of blood through the vessel is not impeded. In alternative embodiments the electrode is positioned on the ring itself. In further alternative embodiments the distal portion of the lead features a pre bent nose to assist in the positioning of the lead into the coronary sinus. The nose may be oriented relative to the ring in any acceptable manner to permit the ring and the electrode to be properly positioned relative to anywhere along the coronary sinus wall.

Abstract: Various endocardial lead assemblies are disclosed that may be particularly useful for placement within the coronary sinus. The lead assemblies may have open ends or closed ends. Lead assemblies having closed ends may be implanted using conventional implantation procedures. Lead assemblies have open ends may be implanted by first locating a stylet within the patient's body and, then, inserting the lead into the patient's body along the stylet. Each disclosed lead assembly uses one or more stents which expand to contact the inner surface of a body vessel once the lead has been properly positioned. Thus, the stents fix the lead at the desired location. Additionally, the stents may be used as electrodes for pacing and/or sensing.

Abstract: A transvenous lead specifically designed for coronary sinus implantation. The lead of the present invention features an electrode/anchoring portion at its distal end. The electrode/anchoring portion features a dual tapered self-propelling spiral electrode. Through this design the electrode supplies excellent direct electrical contact to the inside of the vessel. The dual tapered spiral permits the electrode to either be propelled forward within the vessel and toward the more distal locations by turning in a first direction and also permits the electrode to be propelled backwards within the vessel toward the more proximal locations by turning in a second, opposite direction. The spiral shape does not obstruct blood flow. The taper to the spiral also permits the electrode portion to be placed through any valves which may be within the vessel without causing damage.

Abstract: A probe for an implanted medical device, more particularly for a cardiac pacemaker. The probe (10) has at its extremity a cylindrical body (14) supporting one or more electrodes (18) and a means of anchorage (34) extending radially around the exterior. A deformable sleeve (24), made of a supple material, covers the cylindrical body and supports the anchorage means. The sleeve has one end (or part) (26) attached to the body at the distal extremity of the probe, and one part (28) that is free or unconnected to the body spreading proximally in relation to the attached part and supporting the anchorage means. The free part is essentially applied in a separable manner against the body on the aforementioned distal region.

Abstract: The present invention includes within its scope a temporary lead for pacing, sensing, monitoring, or defibrillating at least a portion of a human or animal organ, and methods for implanting and making same. The lead has at least two electrodes and distal and proximal ends, and a novel weakened zone disposed between the blunt end of a needle and at least two electrical connectors attached to the proximal end of the lead body. The novel weakened zone permits the needle to be separated from the connectors by application of a sufficiently large bending moment or pulling force thereto. Following separation of the connectors from the needle, the connectors may be attached directly and quickly to an external electrical apparatus.

Abstract: A system for passively anchoring mid-lead electrodes on an endocardial catheter lead includes at least one fibrosis-anchoring opening positioned along the exterior surface of the catheter lead body proximal or distal to the mid-lead electrodes for passively securing the catheter lead against the interior wall of the heart. Within the fibrosis-anchoring openings a suitable material is provided for anchoring the catheter lead body to the heart wall by fibrosis. Preferably, the fibrosis-anchoring openings comprise at least a pair of openings positioned only partially around the exterior of the catheter lead body at locations both proximal and distal to the mid-lead electrodes, with the catheter lead body between the fibrosis-anchoring openings being pre-formed to bias the mid-lead electrodes against the heart wall.

Abstract: A lead assembly includes a proximal end that has a connector for electrical connection to a cardiac stimulator, such as a pacemaker, a cardioverter/defibrillator, or a sensing instrument. The lead assembly includes an elongated proximal tubular portion that extends distally from the connector. The distal end of the proximal tubular portion is provided with a branch assembly that is joined distally to two elongated distal lead branches. The distal branches are provided, respectively, with lead tips that each function as electrodes for transferring electrical signals from and/or to the myocardium. The branch assembly includes structure for enabling a surgeon to selectively manipulate the distal branches using a single stylet passed through a single lumen in the proximal tubular portion.

Abstract: A lead assembly adapted for transvenous implantation into a human heart is provided. The lead assembly includes a connector for electrical connection to a cardiac stimulator. An elongated sheath assembly projects from the connector. The sheath assembly includes an inner elastic insulating sheath that includes a coextensive lumen for receipt of a stylet. An outer elastic insulating sheath is disposed around the inner sheath, thereby defining an elongated annular space. The outer sheath has an aperture that defines a gripping region. A biasing wire is disposed in the annular space. The biasing wire is connected to the connector proximally and is approximately coterminous at its distal end with the outer sheath. The biasing wire has a plurality of coils exposed by the aperture in the gripping region. By first stretching and then relaxing the lead assembly, the coils of the biasing wire pinch small portions of the myocardium to laterally fix the lead assembly at a given location in the heart.

Abstract: An implantable devices for the effective elimination of an arrhythmogenic site from the myocardium is presented. By inserting small biocompatible conductors and/or insulators into the heart tissue at the arrhythmogenic site, it is possible to effectively eliminate a portion of the tissue from the electric field and current paths within the heart. The device would act as an alternative to the standard techniques for the removal of tissue from the effective contribution to the hearts electrical action which require the destruction of tissue via energy transfer (RF, microwave, cryogenic, etc.). This device is a significant improvement in the state of the art in that it does not require tissue necrosis. In one preferred embodiment the device is a non conductive helix that is permanently implanted into the heart wall around the arrhythmogenic site.