Abstract: A trans-septal guide catheter for providing access through the septum separating a first heart chamber from a second heart chamber that includes an elongated guide catheter body extending between guide catheter proximal and distal ends. A distal segment of the guide catheter is adapted to be inserted through the septum to locate the distal segment of the guide catheter within one of the first heart chamber and the second heart chamber. The catheter body encloses a guide catheter lumen adapted to provide access into the one of the first heart chamber and the second heart chamber through a guide catheter lumen proximal end opening and a guide catheter lumen distal end opening. A retention mechanism engages the septum and maintains the distal segment of the guide catheter extending into the one of the first heart chamber and the second heart chamber.

Abstract: A fixation device for retaining a leadless medical implant to tissue includes an array of elongate tines having self-expanding distal portions. The fixation tines may be advanced between an implant body and an outer jacket to deploy the tines from a delivery configuration in which the tines are constrained by the outer jacket to an expanded configuration in which the distal end portions of the tines are released from the outer jacket. The implant and fixation device are contained within a sheath for delivery to the treatment site and a pusher within the sheath advances the fixation device relative to the implant body and deploys the tines. A distal end of the implant having an electrode may form a distal tip of the delivery system, and a potential implantation site may be tested prior to deployment of the fixation device to allow for easy repositioning of the implant.

Abstract: A cardiac lead includes a half-domed or semi-spherical shaped distal assembly and an active fixation mechanism. The half-domed or semi-spherical shape provides directionality as to whether a flat side of the lead is facing the myocardial tissue and therefore the active fixation mechanism can be deployed safely into the myocardial tissue.

Abstract: An apparatus for and method of measuring pressure through a septum in a patient's heart. 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 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: In a method and device for mounting an elongated member inside an elongated, elastic, flexible tubing, initially having an inside cross-sectional dimension that is approximately equal to or less than the outside cross-sectional dimension of the elongated member, the inner cross-sectional dimension of the flexible tubing is expanded by applying a pressurized fluid to the inner bore of the tubing, and inserting the elongated member into the tubing while the pressurized fluid is being applied.

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: 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 fixation device for a subcutaneous implantable medical device includes a deformable tip portion that reduces in width when coupled with a fixation tool such that implantation of the implantable medical device through tissue is facilitated. Upon release from the fixation tool, the fixation device returns to its initial shape and stably secures the position of the implantable medical device.

Abstract: A fixation device for a subcutaneous implantable medical device includes a deformable tip portion that reduces in width when coupled with a fixation tool such that implantation of the implantable medical device through tissue is facilitated. Upon release from the fixation tool, the fixation device returns to its initial shape and stably secures the position of the implantable medical device.

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: Some embodiments of an electrical stimulation system employ wireless electrode assemblies to provide pacing therapy, defibrillation therapy, or other stimulation therapy. In certain embodiments, the wireless electrode assemblies may include a guide wire channel so that each electrode assembly can be advanced over a guide wire instrument through the endocardium. For example, a distal tip portion of a guide wire instrument can penetrate through the endocardium and into the myocardial wall of a heart chamber, and the electrode assembly may then be advanced over the guide wire and into the heart chamber wall. In such circumstances, the guide wire instrument (and other portions of the delivery system) can be retracted from the heart chamber wall, thereby leaving the electrode assembly embedded in the heart tissue.

Abstract: Systems provide a stimulation electrode assembly sized and configured for placement in an adipose tissue region to stimulate a nerve in the adipose tissue region comprising an elongated lead sized and configured to be implanted within the adipose tissue region, the lead including at least two electrically conductive portions to apply electrical stimulation to nerve tissue in the adipose tissue region, and at least two expandable anchoring structures deployable from the lead to engage adipose tissue and resist dislodgment and/or migration of the at least two electrically conductive portions within the adipose tissue region.

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: What is described is a method of implanting one or more electrodes of a pacing or defibrillation lead in heart tissue. The method comprises positioning a distal end of a catheter against a surface of the heart tissue, extending a distal end of a first electrode from a lumen of the catheter such that the distal end of the first electrode penetrates the surface, and retracting the first electrode to fix a hook feature of the first electrode in the heart tissue.

Abstract: An implantable medical electrode device, in particular a cardiovascular cardiac pacemaker or defibrillator electrode device, comprises an elongate, tubular electrode body (2), a fixing zone (4) in front of the distal end (3) of the electrode body (2), in which the externally closed peripheral envelope (8) of the electrode body (2) is reversibly expandable into a body lumen (27) for detachable fixing of the electrode device (1), and an expansion apparatus, situated in the fixing zone (4), for controlling the expansion and contraction in the fixing zone (4).

Abstract: An intravenous pacemaker electrode comprises an electrode tip provided for transmission of stimulation pulses to the heart as well as at least one fixing element provided for fixing the electrode tip to the heart, of which the form and/or arrangement can be changed relative to the electrode tip, as well as a suitable actuation element for magnetic actuation of the fixing element.

Abstract: An epicardial pacing lead including a flexible, elongated lead body. The epicardial pacing lead has a proximal end and a distal end. An electrode is coupled to the lead body near the distal end. A housing is coupled to the lead body proximal to the electrode. A platform is at least partially encompassed by the housing. The platform includes at least four tines. Each tine is adapted for engagement with the epicardium and includes an upper section extending outwardly from the platform and a lower section extending distally at an angle to the upper section.

Abstract: An electrode system includes an implantable electrode having at least one electrode contact, an insertion tool, and a technique or method that allows the electrode contact to be positioned within soft tissue at a selected target stimulation site.

Abstract: A lead assembly includes an elongate body having a conductor electrically coupled with an electrode coupled to the elongate body. The lead assembly includes a push tube extending along at least a portion of the elongate body. A distal tip is coupled to the elongate body substantially adjacent to the distal end of the elongate body. The distal tip is sized and shaped to couple with a push tube distal end. In one option, the distal tip includes a seat to receive the push tube distal end. In another option, the seat is a side rail seat and a guide wire extends along the elongate body and is slidably coupled with the side rail seat. The lead assembly includes, optionally, an active fixation device slidably coupled with a portion of the elongate body, and the active fixation device is sized and shaped to couple with the push tube.

Abstract: An implantable medical elongated member includes at least one expandable fixation member disposed within a recess defined by the elongated member. Upon implantation in a patient, the expandable fixation member expands from a first state to a second state and protrudes past an outer surface of the elongated member, thereby enabling the expandable fixation member to engage with surrounding tissue to substantially fix a position of the elongated member.

Abstract: Systems and methods provide a stimulation electrode assembly comprising an elongated lead sized and configured to be implanted within an adipose tissue region. The lead includes an electrically conductive portion to apply electrical stimulation to nerve or muscle in the adipose tissue region and at least one expandable anchoring structure deployable from the lead to engage adipose tissue and resist dislodgment and/or migration of the electrically conductive portion within the adipose tissue region.

Abstract: A cardiac lead for placement in the vicinity of a patient's heart is described. The lead includes a self-expanding fixation mechanism, which in a retracted position, is contained within a cavity disposed at a distal end of the lead. In an expanded position, the fixation mechanism extends axially from the distal end of the lead and expands radially into contact with a desired lumen site.

Abstract: A medical, implantable electrode device, in particular a cardiological electrode device, comprises an elongate electrode body (2) having a proximal and a distal end (1) for insertion into the body of the patient and multiple strut-like anchoring elements (4), which are attached laterally to the electrode body (2) before the distal end (1) for fixing the electrode device in the patient and are distributed around the circumference, which each project having their longitudinal axis (SL) at an acute angle (W1) opening in the direction of the proximal end in relation to the electrode body axis (KL). The anchoring elements have a preferred direction around the circumference in such a way that upon engagement of the anchoring elements (4) in a body part of the patient, a rotation of the electrode body (2) is opposed by a greater resistance in one rotational direction than in the opposite direction.

Abstract: An implantable medical electrode device, in particular a cardiovascular cardiac pacemaker or defibrillator electrode device, comprises an elongate, tubular electrode body (2), a fixing zone (4) in front of the distal end (3) of the electrode body (2), in which the externally closed peripheral envelope (8) of the electrode body (2) is reversibly expandable into a body lumen (27) for detachable fixing of the electrode device (1), and expansion means, situated in the fixing zone (4), for controlling the expansion and contraction in the fixing zone (4).

Abstract: A catheter system includes a mapping catheter having an open lumen and a mapping arrangement provided at a distal end of the mapping catheter. A balloon catheter is movably disposed within the open lumen of the mapping catheter. The balloon catheter has an open lumen dimensioned to receive a lead. A balloon arrangement is provided at a distal end of the balloon catheter and inflatable with an inflation mechanism provided at a proximal end of the balloon catheter. The balloon arrangement is dimensioned to prevent movement of the lead upon inflation of the balloon arrangement, and to permit movement of the lead within the open lumen of the balloon catheter upon deflation of the balloon arrangement.

Abstract: An apparatus and method for treating atrial fibrillation with ablation therapy in which a stent is deployed within a pulmonary vein and tissue surrounding the stent is ablated with radiofrequency energy to stop discharges from ectopic foci in the vein from reaching the left atrium. The deployed stent can then be left in place to prevent stenosis of the vein as well as allowing repeat ablation procedures as needed.

Abstract: An implantable electrode lead including: a distal portion having at least one electrode; a proximal portion having a connector for connection to an implantable stimulation generator includes a power source for the electrode and is disposed in a living body; and a conductor portion which is connected to the distal portion and the proximal portion and is composed of an electrical conductor for transmission of electrical signals and an insulator covering the outside of the electrical conductor, and a fixation portion having a tip end and a base end for disposing over a part of the conductor portion, wherein a lubricant coating layer is provided on a part of the surface of the conductor portion, and the lubricant coating layer is absent on the conductor portion surface ranging at least from the portion disposed at the base end of the fixation portion to the portion provided with the electrode, of the surface of the conductor portion.

Abstract: A fixation arrangement on the outer surface of an electrode head at distal end of a pacing lead includes an attachment mechanism having at least one tine, the tine being connected to the electrode head by a tine base portion that includes an electrically controlled heat-responsive positioner. The electrically controlled heat responsive positioner allows the angular position of the tine relative to the electrode head to be selective adjusted by a temperature change in the positioner.

Abstract: An implantable lead adapted to transmit electrical signals between a connector assembly on a proximal end of the lead and at least one electrode carried by a distal end of the lead comprises a helical fixation element extendable and retractable from the distal end of the lead, the header comprising (a) an inner header part comprising an electrically conductive material that is substantially transparent fluoroscopically, the inner header part having a distal end, (b) an outer header part comprising an electrically insulating material, and (c) a collar attached to the distal end of the inner header part. The collar comprises a material that is substantially opaque fluoroscopically. The collar may be electrically conductive, and electrically and mechanically connected, preferably by means of an overlap joint, to the distal end of the inner header part.

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: An implantable medical device, external unit, and method for establishing communication between them are disclosed. The external unit learns the frequencies of transmission and reception for the implant. The transmit frequency of the implant is learned by the external unit measuring a difference between the transmit frequency of the implant and the external unit's receive frequency. The receive frequency of the implant is learned by the measured difference between its transmit frequency and the receive frequency of the external unit when the implant has a fixed transmit and receive frequency difference. Otherwise, the receive frequency is learned by the implant measuring the difference between its receive frequency and the transmit frequency of the external unit and by sending an indication of the difference to the external unit through the return signal. The external unit may anticipate a beginning of the implant's preset communication period based on its internal clock.

Abstract: A catheter system includes a mapping catheter having an open lumen and a mapping arrangement provided at a distal end of the mapping catheter. A balloon catheter is movably disposed within the open lumen of the mapping catheter. The balloon catheter has an open lumen dimensioned to receive a lead. A balloon arrangement is provided at a distal end of the balloon catheter and inflatable with an inflation mechanism provided at a proximal end of the balloon catheter. The balloon arrangement is dimensioned to prevent movement of the lead upon inflation of the balloon arrangement, and to permit movement of the lead within the open lumen of the balloon catheter upon deflation of the balloon arrangement.

Abstract: Methods and endocardial screw-in leads for enabling provision of electrical stimulation to the heart, particularly the His Bundle in the intraventricular septal wall. An endocardial screw-in lead having a distal end coupled to a retractable fixation helix wherein a distal portion of the fixation helix extends beyond the lead distal end when the fixation helix is fully retracted or partially extended is positioned in proximity to the His Bundle in the septal wall. The lead body is rotated to attach the distal portion of the fixation helix into the septal wall. The fixation helix is rotated with respect to the lead body to fully extend the fixation helix so that a portion of the fixation helix is in proximity to the His Bundle, enabling provision of electrical stimulation to the His Bundle and/or to sense electrical signals of the heart traversing the His Bundle through the fixation helix.

Abstract: A lead assembly includes insulative tubing with at least one tine coupled thereto, and a lumen extends through the tubing. The tine has a first position that extends away from the exterior of the tubing, and a second compressed position. In the second compressed position, the tine at least partially compresses the lumen.

Abstract: An apparatus and method of electrically connecting components of an implantable medical device are disclosed. One embodiment is an apparatus having at least one electrical connector comprising a tab section and a housing at least partially enclosing the electrical connectors, wherein the housing is molded into sealing engagement with the electrical connectors and the tab section is capable of removal from the electrical connector after the housing is molded.

Abstract: An improved system and method that is capable of delivering multiple electrode assemblies to predetermined implant sites within a body is disclosed. The system includes an elongated member such as an introducer sheath. The introducer includes an elongated channel along at least a distal end portion of the introducer. The elongated channel opens to the exterior surface of the introducer through an elongated slot. One or more electrode assemblies may be retained within the elongated channel such that the leads exit the introducer via the elongated slot. The elongated introducer further includes a lumen that is in fluid communication with channel through openings, or gaps. The electrode assemblies are loaded within the channel at predetermined positions with respect to the openings. A distal end of a stiffening member such as a stylet may then be advanced within the lumen and through a selected one of the openings to engage an electrode assembly.

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 surgical apparatus for delivering fluid to treat a lesion comprising an elongated member having a distal tip and a plurality of slots formed in a sidewall proximal of the distal tip, a plurality of fluid delivery members positioned in the elongated member and having a lumen and at least one opening communicating with the lumen for delivering fluid to the lesion, and an actuator actuable to a first position to move the plurality of fluid delivery members from a retracted position within the elongated member to a first deployed position extending radially with respect to the elongated member and actuable to a second position to move the plurality of fluid delivery members from the first position to a second deployed position extending further radially from the elongated member.

Abstract: A medical electrical lead with a tip-ring assembly optimized to resist damage during extraction. The lead includes an elongated plastic tube and at least two elongated conductors mounted in the plastic tube. A tip-ring assembly is mounted to the distal end of the tube, the tip-ring assembly including a ring electrode coupled to one of the conductors, a tip electrode located distal to the ring electrode and coupled to another of the conductors and two molded plastic components separately fabricated of a plastic harder than the plastic tube, adhered to one another and together defining a circumferential groove in which the ring electrode is located and mechanically coupled to the tip electrode. The tip electrode may be provided with a proximally extending electrode shank covered by a tine sleeve which is fabricated of a plastic softer than the molded plastic components and is adhered to more distally located molded plastic component.

Abstract: An endocardial lead comprising an elongate body having a first defibrillation coil electrode, a second defibrillation coil electrode and a first pacing/sensing electrode. The first defibrillation coil electrode has a first end and a second end, where the first end is at or near the distal end of the elongate body and the second end spaced longitudinally from the distal end. The first pacing/sensing electrode is spaced longitudinally along the peripheral surface from the second end of the first defibrillation coil electrode. The second defibrillation coil electrode is spaced longitudinally along the peripheral surface from the first pacing/sensing electrode to afford positioning the first defibrillation coil longitudinally adjacent an apical location of the right ventricle of a heart with the first pacing/sensing electrode within the right ventricle of the heart and the second defibrillation coil within the right atrial chamber or a major vein leading to the right atrial chamber of the heart.

Abstract: A catheter system having a tip section with fixation means for use in treatment of tissues, such as mapping pulmonary veins or ablating tumors in a natural body conduit or cavity by applying RF energy, wherein the catheter system passes through a natural body opening to reach the target tissue, wherein the catheter system stays at a desired position via its fixation means having needle-like attachments, and delivers therapeutic RF energy to the target tissue for improved tissue treatment.

Abstract: A medical device is insertable and/or implantable into a body of a patient. The medical device includes a plurality of hollow and/or collapsible tines which are adapted to assist in deployment of the medical device into the body and in preventing inadvertent removal or dislodging of the medical device from the body. The tines are coupled to the medical device body at a coupling end and extend away from the device to a free end. The tines can have a number of configurations such as cylindrical or cone shaped. In addition, the cross section of the free end of the tines can be elliptical, where the free end extends to a tip. Another cross section includes a semi-circle including an open portion which can face towards or away from the medical device body. The tines also include coiled structures which can have a radial axis perpendicular to the radial axis of the medical device.

Abstract: A body implantable lead for placement in a selected coronary vein includes a resilient retention structure for inhibiting displacement of the lead because of heart beat action, breathing or other body movement. The retention structure includes a plurality of resilient projections that are attached to the lead body and which are adapted to project at a predetermined acute angle to the axis of the lead body when unconstrained. Prior to being routed through the vascular system, the projections can be bonded to the lead body to provide a low profile with a biodegradable adhesive. Following exposure to body fluids, the adhesive dissolves, releasing the projections so that they can engage the walls of the vein in which the lead is disposed.

Abstract: The present invention provides a pacing system with a lead having a fixation element for providing stable fixation relative to the patient's SVC, preferably providing for positioning of the atrial electrodes near the sinus node. In a first embodiment, an adjustable loop is provided for engaging the inside wall of the SVC so as to obtain fixation of the lead just above the sinus node. Other embodiments utilize tine arrangements for providing the fixation relative to the SVC.

Abstract: An implantable pacing lead system for pacing a patient's heart, including a delivery catheter and a lead delivered by the delivery catheter. The lead takes the form of a single non-diverging filament having a proximal end and a distal end and carries an electrode mounted to a distal portion of the lead body. An active fixation device is mounted fixedly to, and extends laterally from, the lead body proximal to and longitudinally spaced from the electrode. During advancement of the lead through the vasculature the active fixation device is located within the delivery catheter. At the point of desired location of the active fixation device, it is advanced out of the delivery catheter and engaged with heart tissue. The lead body has greater torsional rigidity proximal to the active fixation device than distal to the active fixation device.

Abstract: A cardiac lead is provided that is capable of deforming in situ to accommodate difficult myocardial structures. The lead includes a connector for coupling to a cardiac stimulator and a flexible tubular sleeve coupled to the connector. The sleeve is composed of a thermally-sensitive shape-memory polymeric material and is deformable in situ into a permanent shape. An electrode is coupled to the sleeve and a conductor wire is coupled to the connector and to the first electrode.

Abstract: A body implantable lead for placement in a selected coronary vein includes a resilient retention structure for inhibiting displacement of the lead because of heart beat action, breathing or other body movement. The retention structure includes a plurality of resilient projections that are attached to the lead body and which are adapted to project at a predetermined acute angle to the axis of the lead body when unconstrained. Prior to being routed through the vascular system, the projections can be bonded to the lead body to provide a low profile with a biodegradable adhesive. Following exposure to body fluids, the adhesive dissolves, releasing the projections so that they can engage the walls of the vein in which the lead is disposed.

Abstract: A catheter system having a tip with fixation means for use in treatment of tissues, such as ablating tumors in a natural body conduit or cavity by applying RF energy through the tip, wherein the catheter system passes through a natural body opening to reach the target tissue, wherein the catheter system stays at a desired position via its fixation means, and delivers therapeutic RF energy to the target tissue for improved tissue treatment.

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.