Abstract: A pressure sensor is deployed in the right atrium and is in contact with the tissue of the fossa ovalis. The fossa ovalis acts as a membrane and the pressure sensor determines the relative and/or absolute pressure within the left atrium while remaining within the right atrium. A variety of embodiment are provided to deploy and anchor the sensor into the proper position.

Abstract: A method of measuring pressure through a septum in a patient's heart is provided. A lead inserted into the right side of a heart is routed through the septum to gain access to the left side of the heart. The lead includes a mounting mechanism that secures the lead to one or both sides of the septal walls. The lead also includes one or more sensors for measuring cardiac pressure on the left side of the heart and, as necessary, the right side of the heart.

Abstract: An anchored implantable pressure monitor.

Abstract: A coiled member of a medical device extends along a length of an elongate body of the device. A surface of the coiled member extends at an angle, with respect to a longitudinal axis of the body, from a first edge to a second edge, toward the proximal end of the body, such that the first edge of the surface is disposed in close proximity to the body and the second edge of the surface is spaced apart from the body.

Abstract: An implantable pressure monitor.

Abstract: Minimally invasive introducers and methods that can be used for rotationally securing devices within the human body. Introducers can include a distal element for releasably engaging a lead head controllable from a proximal control located outside of the body. An inner stem can extend between a proximal portion and a distal portion, and be pivotally and rotatably coupled to the distal lead engagement mechanism. An outer tube can be rotatably disposed over the inner stem and be flexibly coupled over the pivot to rotationally drive the distal element. A helical epicardial-myocardial lead electrode can be secured and oriented straight ahead and introduced through a port or small incision with the introducer in a straight configuration. The introducer can then be bent and rotated to screw the helical electrode into the heart.

Abstract: A pressure sensor is deployed in the right atrium and is in contact with the tissue of the fossa ovalis. The fossa ovalis acts as a membrane and the pressure sensor determines the relative and/or absolute pressure within the left atrium while remaining within the right atrium. A variety of embodiment are provided to deploy and anchor the sensor into the proper position.

Abstract: Disclosed is a lead anchor comprising a body made of an elastomeric material and defining a first opening and a second opening through which a lead can pass, one or more fasteners disposed within the body, with the ends of the fasteners protruding from the body, wherein the ends are configured and arranged to be clamped down to secure a lead passing through the body.

Abstract: A method for inserting a lead electrode into body tissue using a rotatable lead introducer is described. The introducer can include a distal element for releasably engaging a lead head controllable from a proximal control located outside of the body. An inner stem can extend between a proximal portion and a distal portion, and be pivotally and rotatably coupled to the distal lead engagement mechanism. An outer tube can be rotatably disposed over the inner stem and be flexibly coupled over the pivot to rotationally drive the distal element. A helical epicardial-myocardial lead electrode can be secured and oriented straight ahead and introduced through a port or small incision with the introducer in a straight configuration. The introducer can then be bent and rotated to screw the helical electrode into the heart.

Abstract: A lead body includes an electrode coupled to an intermediate portion of the lead body. A distal end of the lead includes a pre-formed, biased shape adapted to passively fixate the distal end of the lead within a pulmonary artery with the electrode positioned in the right ventricle or ventricular outflow tract. The lead body can include a preformed J-shape, with the electrode coupled to the intermediate portion of the lead body and located distally from a bottom of the pre-formed J-shape. The lead body can include a section of the intermediate portion of the lead body being less stiff than adjacent sections of the lead body with the electrode coupled to the intermediate portion of the lead body and located distally from the less stiff section.

Abstract: An implantable lead for delivering electrical stimuli to a human heart has a stimulating electrode for transmitting electrical stimuli to the myocardium after implantation, and a mapping electrode for use during implantation. The mapping electrode is configured to deliver electrical stimuli to the heart and to sense intrinsic cardiac activity, for the purpose of finding a suitable fixation position in the myocardium. During the implantation procedure, the mapping electrode is electrically connected to the conductor. The lead is configured to electrically disconnect the mapping electrode from the conductor after a suitable fixation position has been determined.

Abstract: An implantable cardiac patch is configured to be joined to a surface of a heart and includes a body portion having an inner surface configured to be joined to the surface of the heart. The body portion also has a plurality of pores extending into the body portion from the inner surface. A plurality of electrodes are attached to the body portion such that the electrodes are positioned proximate the surface of the heart, and a lead is electrically connected to the electrodes at a connecting portion of the lead. The lead has a proximal end configured for joining to an implantable device.

Abstract: A pressure sensor is deployed in the right atrium and is in contact with the tissue of the fossa ovalis. The fossa ovalis acts as a membrane and the pressure sensor determines the relative and/or absolute pressure within the left atrium while remaining within the right atrium. A variety of embodiment are provided to deploy and anchor the sensor into the proper position.

Abstract: An implantable lead includes a lead body, having a distal end and a proximal end, configured to be implanted in a patient. An electrode assembly is provided at the distal end of the lead body, wherein the electrode assembly includes an electrode that is configured to deliver stimulating pulses. The electrode extends between a base and a tip at a distal end of the electrode. A shielding member is provided on the electrode assembly and is positioned to cover at least a portion of the electrode to electrically shield the electrode from RF fields. Optionally, the shielding member may include a shielding conductor that wraps about and extends longitudinally along a length of the electrode from the base to the tip. The shielding conductor may extend from the proximal end of the lead body at least to the distal end of the lead body.

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: A catheter for anchoring an electrode in a coronary sinus includes an elongate catheter body adapted to be inserted into a coronary sinus and at least one electrode on the catheter body. The elongate catheter body also includes at least one anchor movable between an undeployed configuration and a deployed configuration. When the anchor is in the undeployed configuration, the catheter may be introduced into and removed from the coronary sinus. When the anchor is in the deployed configuration, the anchor engages a tissue surface of the coronary sinus to inhibit movement between the catheter body and the coronary sinus, preferably without completely occluding the coronary sinus. The anchor may be a section of the catheter body having an expandable axial cross-section, an expandable member mounted on the catheter body, one or more wire anchors, or a flexible section of the catheter body.

Abstract: An improved medical lead assembly and method of use is provided. The lead assembly includes a lead body, and a spring member positioned adjacent to the lead body. The spring member may be deployed a selectable amount to maintain the lead body in a fixed location within a patient's body. The spring member may be an expandable coil, a mesh structure that is similar to a stent, or any other similar device that may be positioned in a low-profile state during a lead implant procedure. After the lead is positioned at a target destination, the spring member may be deployed an amount that is selected based on the characteristics of the surrounding tissue, including vessel size. According to one aspect of the invention, the lead assembly may provide means for facilitating chronic lead extraction.

Abstract: The present application discloses a tissue marker that may be permanently applied to cardiac (or other) tissue by means such as, but not limited to, a minimally-invasive procedure to allow for pre- and post-op lesion site testing, with the marker also preferably being radiopaque to facilitate post-op imaging. More specifically, the marker may preferably comprise or include an electrode as part of an integrated assembly. The marker may be mounted on the tissue with a suitable tissue retention member for securing the marker in place. The disclosed examples include one or more tissue retention members, and in an exemplary embodiment comprises a pair of clips for securing the assembly to a target tissue. Each retention member or clip has a conductive lead with an electrically conductive surface in the form of a patch associated therewith.

Abstract: A system and method for the intra corporal, measuring of blood pressure includes a substantially rigid sensor structure and an antenna structure, which are separate components. The anchor structure is used to mount the within an appropriate location in the cardiovascular system, such as in the cardiac septum. The substantially rigid sensor structure includes at least one capacitive pressure sensor. Measured values are transmitted telemetrically from the sensor structure to an extra corporal monitoring device.

Abstract: A system and method for the intra corporal, telemetric measuring of blood pressure, particularly within the heart or a great vessel, includes a substantially rigid sensor chip mounted in a holder and an antenna. The holder is anchored within an appropriate location in the cardiovascular system, such as in the cardiac septum, via a catheter or other minimally-invasive procedure to position at least one capacitive pressure sensor on the chip in the blood flow to be sensed. Measured values are transmitted telemetrically from the chip to an extra corporal monitoring device.

Abstract: Devices, systems, and methods for remotely monitoring physiologic cardiovascular data are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for the delivery of the sensor to the epicardial surface of the heart. In addition, various disclosed embodiments provide for a memory device capable of receiving the physiologic cardiovascular data collected by the sensors and transmitting such data wirelessly to a remote location.

Abstract: Disclosed herein is an implantable medical lead. In one embodiment, the lead includes a ring electrode, a tip electrode, first and second helically wound coaxial conductor coils, and a distal coil transition. The coils extend between the proximal and distal ends of the lead. The distal coil transition is proximal to the ring electrode and near the distal end and is where the first coil transitions from being outside the second coil proximal of the distal coil transition to being inside the second coil distal of the distal coil transition.

Abstract: In a suture sleeve and implantation method for one or more implantable leads, the suture sleeve is adapted to be inserted into a vein to secure and protect the one or more leads from damage when a suture thread is positioned and tied around the vein in the region over the suture sleeve to secure the suture sleeve and prevent bleeding from the vein. The suture sleeve has two or more lead receiving through holes into each of which a medical implantable lead may be inserted. The suture sleeve is formed such that at least all of the holes except one are provided with sealing means, which easily can be broken or removed when inserting a lead into the hole such that, when inserted into a vein, bleeding is prevented from a through hole of the sleeve by the sealing means even if no lead is positioned in the hole. The invention also relates to a method for implanting one or more electrical leads into a vein.

Abstract: A bipolar electrode (1) that can be implanted is provided with at least two poles at its distal end, namely a cathode (4) and an anode (6) spaced apart therefrom. Further, an anchoring is provided at the distal end of the electrode (1), provided for example as a helical screw (5). The different poles are arranged on different shafts or tubes (3) and (7) displaceable in reference to each other, in which the exterior shaft or tube (7) first can be pushed over the anchor (5) in order to protect it during implantation. In the operational state, the poles are adjusted by a relative motion of the two shafts carrying them with regard to their relative positioning.

Abstract: Described herein are devices and methods for treating tissue, comprising a catheter with a plurality of access sites and a plurality of sensors associated with the access sites. The catheter may be positioned along a tissue surface and the sensors may be used to identify a target site along the tissue surface using the plurality of sensors. Analysis of the tissue surface by the sensors is performed without requiring repositioning of the catheter. In some examples, the access sites of the catheter are side openings along a length of the catheter and the plurality of sensors are electrodes configured to measure electrophysiology parameters. In these examples, the catheter may comprise an internal lumen which permits a treatment device, such as an ablation catheter, to be slidably positioned at the desired target site without requiring displacement of the catheter. In other examples, the catheter may comprise a plurality of fixed ablation elements associated with the plurality of access sites.

Abstract: Minimally invasive introducers and methods that can be used for rotationally securing devices within the human body. Introducers can include a distal element for releasably engaging a lead head controllable from a proximal control located outside of the body. An inner stem can extend between a proximal portion and a distal portion, and be pivotally and rotatably coupled to the distal lead engagement mechanism. An outer tube can be rotatably disposed over the inner stem and be flexibly coupled over the pivot to rotationally drive the distal element. A helical epicardial-myocardial lead electrode can be secured and oriented straight ahead and introduced through a port or small incision with the introducer in a straight configuration. The introducer can then be bent and rotated to screw the helical electrode into the heart.

Abstract: An apparatus for and method of measuring pressure through a septum in a patient's heart is provided. A lead inserted into the right side of a heart is routed through the septum to gain access to the left side of the heart. The lead includes a mounting mechanism that secures the lead to one or both sides of the septal walls. The lead also includes one or more sensors for measuring cardiac pressure on the left side of the heart and, as necessary, the right side of the heart.

Abstract: A medical electrical lead, which may be useful in coupling an implantable medical device, is comprised of a first and second lead. The first lead has a first electrode coupled adjacent a distal end portion thereof. The distal end portion of the first lead is anchorable in the coronary sinus of a patient. The second lead is coupled with and moveable along the first lead. The second lead has a second electrode located thereon wherein the position of the first and second electrodes may be varied relative to one another by movement of the second lead along the first lead. A rubber tip holds the relative position of each electrode.

Abstract: An apparatus for and method of measuring pressure through a septum in a patient's heart is disclosed. A lead inserted into the right side of a heart is routed through the septum to gain access to the left side of the heart. The lead includes an attachment structure that secures the lead to one or both of the septal walls. The attachment structure may include at least one protruding tine, membrane, inflatable balloon, involuted spiral or J-lead that engage one or more sides of the septum. The lead also includes one or more sensors for measuring cardiac pressure on the left side of the heart and, as necessary, the right side of the heart.

Abstract: An implantable myocardial stimulation lead comprises a lead body having a distal end and a proximal end, and an electrical connector carried by the proximal end of the lead body. An electrode header carried by the distal end of the lead body has an axis and includes a helical fixation element extending along the axis, the electrode header having a surface configured to receive a driver for rotating the electrode header to screw the helical fixation element into the tissue of the heart. The lead body carries along its length a strain relief member resisting excessive bending of the lead body.

Abstract: According to this technique of packaging a sensor device implantable in a living body so as to provide protection of the sensor device and to the living body itself, an electrical conductor of the sensor device is sealed in an insulating substrate extending between proximal and distal ends. The distal end of the electrical conductor is externally connected to an external sensor on the sensor device and the proximal end of the electrical conductor is externally connected to a distal end of a lead wire extending proximally to a pulse generator and these connections are embedded in an insulative sheath. The external sensor, substrate, and insulative sheath are encapsulated in a thin film of hermetic material without interference with the lead wire. In another embodiment, a layer of insulating material may underlie the hermetic material to encapsulate the external sensor and the substrate.

Abstract: A contact lens with a conductive outer shell (one electrode of a two-electrode electrophoresis device) and a preferably soft, preferably disposable contact lens for contacting a patient's eye, assists in delivering dilation drops or other medicaments to a patient's eye. Advantageously, the lens is used with a relatively small hand-held power source. Electrophoresis can be used to help deliver dilation drops more rapidly, regardless of the delivery apparatus used for the electrophoresis.

Abstract: A proximal end of a lead body carries a connector assembly. A first electrical conductor within the lead body electrically connects a tip electrode to a first electrical contact on the connector assembly. A collar electrode is carried by a distal end portion of the lead body. A second electrical conductor within the lead body electrically connects the collar electrode to a second electrical contact on the connector assembly. A ring electrode, carried by the distal end portion of the lead body, is disposed proximally of the collar electrode in spaced-apart relationship thereto and is connected through a switching device to a node point along the first conductor. The switching device has a first state permitting an electrical current to be conducted between the ring electrode and the node point and a second state in which the ring electrode is electrically isolated from the node point. Preferably, the switching device comprises a diode.

Abstract: Electrical cardiac therapy devices including electrode lead assemblies having appendages coupled to an electrode. The appendage may take the form of a riser and a head having various characteristics. A further embodiment may include a cover and/or other features coupling the electrode to the riser. A lead may be provided for electrical coupling to the electrode. The lead may couple to the electrode exclusive of the riser and head. An implantable housing containing electrical circuitry for using the electrode to stimulate cardiac activity is also illustrated.

Abstract: A method and apparatus for placing an epicardial lead over a desired, predetermined location on the left ventricle using a minimally invasive approach. A thoracoscope having a handle portion and a probe tube defining a central opening is placed through an incision in the patient generally aligned with the desired position for the pacing lead. An introducer and pacing lead are placed within the central opening of the thoracoscope and moved into contact with the pericardium at the desired lead location. An attachment member of the pacing lead attaches an electrode of the pacing lead to the pericardium. The pacing lead includes a mesh disk surrounding the electrode to aid in long term attachment of the electrode to the heart. Alternatively, the pericardium can be incised such that the lead is placed directly over the epicardial surface of the left ventricle.

Abstract: Certain embodiments of the present invention concern an implantable electrode line having a proximal and a distal end, an outer electrode line surface and an electrode line longitudinal axis. The implantable electrode line is characterized in that the electrode line in the region of the distal end has a surface region with a microstructure, the surface region being provided for lateral contact with a vessel wall and being arranged at a spacing relative to the distal end which measures a plurality of electrode line diameters. The microstructure is formed by a plurality of microstructure elements which are arranged on the electrode line surface and which are distributed over the surface region both in the longitudinal direction and also in the peripheral direction and which have a component extending radially, wherein the microstructure elements are of a radial extent which is a fraction of the electrode line diameter.

Abstract: The present invention provides for a method and apparatus providing pacing to improve the hemodynamics of the heart for patients with AV nodal block, right/left bundle branch block, and heart failure. A lead body having at least one conductor with an insulative sleeve is introduced into the right atrium of a heart. A partially masked helical electrode connected to the conductor is then secured preferably into the atrial aspect of the atrioventricular septum. The electrical conductor is then rotated such that an unmasked portion of the electrode is moved to a depth within the heart tissue substantially near the heart's intrinsic conduction system. This method and apparatus allow pacing in a natural manner via low power stimulation of the heart's intrinsic conduction system.

Abstract: During fabrication of an electrical medical lead, a cut end of a stranded wire conductor is subjected to electrical current sufficient to heat and weld the strands together upon discharge of a high voltage between the cut end and a ground metal plate formed of a material of the stranded wire conductor. The discharge of weld energy between the stranded wire cut end and the ground plate induces heat in the wire strands at the stranded wire cut end and the ground plate sufficient to transfer conductive material from the ground plate to fuse the wire strands together. The fusing inhibits unraveling of the wire strands at the fused cut end, whereby the insertion of the stranded wire cable through a lead body lumen and the connection of the fused stranded wire cut end to a further lead component, e.g., a proximal lead connector element or distal electrode, is facilitated.

Abstract: A medical electrical lead includes a first electrode and a second electrode positioned distal to the first electrode; a first portion of a first cable conductor extends through a channel of the first electrode to couple with the second electrode and a second cable conductor, insulated from the first cable conductor and coupled to the first electrode, is wound about a second portion of the first cable which extends proximally from the first portion.

Abstract: An intracardial electrode lead comprises a distal end, a proximal end and an elongate electrode lead body which includes a helical coil having a lumen and a sheath enclosing the helical coil. The distal end of the electrode lead carries a an electrode. The electrode is electrically connected to a connection at the proximal end of the electrode lead for communication with a medical device. The distal end has a sleeve with a proximal end and a distal end, which is enclosed by the distal end of the helical coil at the sleeve proximal end and contacts a lip seal at its distal end. The lip seal elastically closes a distal opening of the lumen. The sleeve is also electrically connected to the electrode, which has an external surface and projects distally beyond the lip seal.

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 electrical lead includes an elongate body having a proximal end and a fixation member joined to the elongate body and distally disposed from the proximal end of the elongate body, wherein the fixation member is capable of being extended from and retracted toward the elongate body. A method includes advancing an electrical lead into vasculature and extending a fixation member from the body of the electrical lead to fixedly engage the electrical lead within the vasculature. The method may further include retracting the fixation member toward the body of the electrical lead to unengage the electrical lead within the vasculature and retracting the electrical lead from the vasculature.

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: A single electrode probe for a cardiac pacemaker system, in particular for a DDD cardiac pacemaker system, has an electrode line with a bifurcated section, at the beginning of which the electrode line divides into two electrode line portions which rejoin at the end of the section to again form one portion, wherein at least one of the portions has at least one electrode for the delivery of electrical energy to adjoining myocardium.

Abstract: An body implantable stimulation lead is provided including tip electrode patterns and configurations producing low noise, clean sensed signals devoid of far field components, such sensed signals being generated irrespective of the direction of the incident depolarization wavefront. The invention also provides high pacing impedances and advantageous anode-to-cathode surface area ratios. Further, implantable leads utilizing the features of the present invention are particularly suitable for left side stimulation therapies.

Abstract: An implantable therapy delivery system has a therapy delivery element that is inserted or implanted into a human body and anchored or fixed to tissue to delivery a therapy to a patient. In one embodiment an implantable neurostimulator uses an electrical stimulation lead to delivery a therapy such as sacral nerve stimulation, peripheral nerve stimulation, and the like. In another embodiment the implantable therapeutic substance delivery device, also known as a drug pump, is connected to a catheter to deliver a therapy to treat conditions such as spasticity, cancer, pain, and the like. The therapy delivery element is anchored to tissue using an adjustable anchor having a therapy grip element, at least two extension elements connected to the therapy grip element, and a tissue fixation element connected to the extension elements.

Abstract: A medical electrical lead is provided that is readily manufactured using a minimal number of parts, has a reduced size and improved reliability during implantation and extraction. The lead includes a modular electrode head assembly that is joined to a lead body at a butt joint. The butt joint is stabilized in at least four possible ways: insulation tubing that spans the joint is bonded to the electrode head assembly; two cabled conductors extending the length of the lead body are coupled to the electrode head assembly; an electrode head alignment peg interlocks with and is bonded to the lead body; and a coil electrode is positioned across the butt joint on the outer diameter of the assembly and the lead body. The lead size is minimized by using a compact retraction stop mechanism, a low-friction, press-fit drive shaft seal, and a small diameter coiled conductor insulated by a thin-walled insulating tube.

Abstract: A method of making a temporary medical electrical lead for pacing or defibrillating a heart of a patient.

Abstract: An improved system for monitoring the status of an IMD such as a medical electrical lead during an implant procedure is provided. The system includes a signal generator for supplying a first signal such as a constant current or voltage to the IMD. A resulting voltage or current signal is generated, respectively, and may be sensed as an indication of the impedance of a portion of the body that is proximal to one or more electrodes carried by the lead. This impedance indication is converted to an audible signal having a frequency that is proportional to the amplitude of the impedance indication. The pitch of the audible signal therefore rises when measured impedance increases, and drops as the impedance decreases. These pitch changes allow a user to determine positional information associated with the IMD, including the degree of lead tissue contact and extent of fixation of a device to tissue.

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.