Abstract: A medical stimulation lead is provided. The medical stimulation lead includes an elongated lead body including a substantially rounded cross-section and including a first biased portion forming a first section of the substantially rounded cross-section and a second biased portion forming a second section of the substantially rounded cross-section. A plurality of electrodes are provided connected to the elongated lead body. A restraining body is removably connected to the elongated lead body releasably exerting a force substantially counter to the biases of the first biased portion and the second biased portion. The retraining body releasably maintains the substantially rounded cross-section of the elongated lead body, wherein removal of the restraining body permits the first biased portion and the second biased portion to expand, dividing the substantially rounded cross-section.

Abstract: A device for implantation in the vasculature of a patient can include a fixation mechanism for anchoring the device in place while allowing for easy removal of the device. The fixation mechanism can include a detachable and/or biodegradable portion that can allow for removal from the bulk of the device in order to allow for the bulk to simply be pulled from the body without likelihood of injury. These devices also can include electrode assemblies that do not promote fibrous ingrowth, further reducing the likelihood for injury upon extraction of the device.

Abstract: A fixation device for retaining a leadless medical implant to tissue includes an annular collar and an array of self-expanding tines extending from the collar. When deployed, the annular collar encircles the implant and the tines are preset to splay outwardly from the implant to grab body tissue and anchor the implant at a treatment site. The implant and fixation device are contained within a sheath for delivery to the treatment site and a pushing force is applied to a pusher of the delivery system to distally advance the fixation device relative to the implant and deploy 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 if the potential implantation site is determined to be unacceptable.

Abstract: A pacing lead for implantation in the pericardial space includes an elongated lead body, a compression fixation element, and at least one electrode on either the lead body or the fixation element. The fixation element defines a resilient structure, and is positioned and dimensioned so that when the lead is disposed in the pericardial space, the resilient fixation element is compressed between the parietal and visceral pericardium, thereby biasing the electrode against the myocardium and providing positional stabilization to the lead. Further positional stability may be provided mechanically with structures enabling the application of adhesive or with fixation screw or tine elements.

Abstract: A medical electrical lead includes a glue segment to adhere the lead to a treatment site. The glue segment, which may be disposed within a tip electrode of the lead, includes tissue adhesive which may encapsulated within a capsule.

Abstract: Some embodiments relate to a method of implanting a cardiac lead. An expansion module is implanted in a target region within vasculature, the target region being defined by a portion of a brachiocephalic vein and a portion of a corresponding subclavian vein. The expansion module is transitioned from a collapsed state to an expanded state within the target region to contact the vasculature. A cardiac lead is implanted through the expansion module, the cardiac lead defining an intermediate section corresponding to the target region. The intermediate section of the cardiac lead includes a surface treatment adapted to reduce at least one of cell proliferation, thrombosis, fibrosis, and inflammation at the target region.

Abstract: Methods and systems for transvenously accessing the pericardial space via the vascular system and atrial wall, particularly through the superior vena cava and right atrial wall, to deliver treatment in the pericardial space are disclosed. A steerable instrument is advanced transvenously into the right atrium of the heart, and a distal segment is deflected into the right atrial appendage. A fixation catheter is advanced employing the steerable instrument to affix a distal fixation mechanism to the atrial wall. A distal segment of an elongated medical device, e.g., a therapeutic catheter or an electrical medical lead, is advanced through the fixation catheter lumen, through the atrial wall, and into the pericardial space. The steerable guide catheter is removed, and the elongated medical device is coupled to an implantable medical device subcutaneously implanted in the thoracic region. The fixation catheter may be left in place.

Abstract: An implantable medical lead of the invention comprises an electrically active helix electrode extendable and retractable relative to a distal tip of the lead, an electrically conductive mapping collar disposed at the lead's distal tip and a proximal end carrying an electrical connector assembly. The electrical connector assembly comprises a first terminal connected to the helix electrode and a second terminal separately connected to the mapping collar. An advantage of the independent helix electrode and mapping collar circuits is that the implanting physician can confirm from separate electrode impedance readings that the helix is in fact extended and fully embedded within the myocardium. Further, the independent mapping collar and helix electrode circuits may be used, in conjunction with a configurable or programmable switch network, to provide the implanting physician with a choice of electrode impedances.

Abstract: A lead assembly comprises a lead body extending from a lead proximal end portion to a lead distal end portion with at least one conductor disposed therein. A lead lumen extends within the lead body and is dimensioned and configured to removably and rotatably seat a driver therein. The driver includes a driver body extending from a driver proximal end to a driver distal end and having a stylet or guidewire lumen disposed therein. An extendable and retractable active fixation mechanism is disposed at the lead distal end portion. The active fixation mechanism is actuatable by rotation of the driver. In one example, the at least one conductor includes a first conductor and a second conductor, in which the first conductor is co-radial with the second conductor. In another example, the driver distal end includes a portion extractably engagable with the lead distal end portion.

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: Guide catheters for facilitating implantation of cardiac leads for applying electrical stimulation to and/or sensing electrical activity of the heart through one or more electrodes positioned at an implantation site within a heart chamber or cardiac vessel adjacent a heart chamber. Such a cardiac lead has low torqueability and pushability through a pathway to enable attachment of the cardiac lead at the implantation site. The catheter body comprises a delivery lumen to introduce a small diameter cardiac lead and a guide lumen to receive a guide tool to locate the catheter body distal end at the implantation site. The small diameter lumen within a small diameter guide tube extends distally from the delivery exit port of the delivery lumen. The catheter body is shaped to bias the delivery lumen exit port toward the heart.

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: 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: Devices for enhancing minimally invasive cardiac surgery include a visualization device including an inflatable balloon at or near the distal end. Some visualization devices also include one or more lumens for allowing the introduction of one or more devices to a surgical site through the visualization device. Systems of the invention involve a visualization device which has at least one lumen for allowing introduction of an ablation device and/or other devices. A visualization device with an inflatable balloon may be positioned to create a space between a heart and pericardium when the balloon is inflated.

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: An implantable anchor for anchoring a lead or catheter relative to biological tissue, implantable system including such an anchor and a lead or catheter, and a method of use of such anchor. The anchor comprises a body having a channel adapted to receive a catheter or lead, and a cover mounted on the body for pivoting motion along a lateral axis, that is an axis that extends generally in the lateral direction perpendicular to the catheter or lead, between an open position in which the anchor is adapted to allow a lead or catheter to be placed in or moved along the channel, and a locked position in which the anchor is adapted to retain a lead or catheter within the channel.

Abstract: A method of delivering a myocardial infarction patch to a surface of a heart is disclosed herein. In one embodiment, the method includes deploying the patch from an intra pericardial lead.

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: The present application describes an intravascular implantable pacing and/or defibrillation system. The described system includes a pulse generator that is implantable within a blood vessel and proportioned to blood flow through the blood vessel, and at least one electrode attachable to the pulse generator. During implantation, the pulse generator is introduced into a patient's vasculature, advanced to a desired vessel and anchored in place within the vessel. The electrode or electrodes are placed within the heart or surrounding vessels as needed to deliver electrical pulses to the appropriate location.

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: A method for detecting the myocardial state of a heart with a measuring apparatus which includes inserting a bipolar cardiological measuring electrode (4) into a heart division (8) at an acute attachment angle (9) on the myocardium (6) of less than 90°, measuring a cardiological stimulation signal such as an IEGM in sequential cardiac cycles, and in addition, determining the positive and negative maximum amplitudes Vp and Vn of the IEGM, ascertaining an asymmetry factor ? of the stimulation signal (IEGM) of sequential cardiac cycles according to the equation ?=(Vp?|Vn|)/(Vp+|Vn|) and storing the asymmetry factor ? of sequential cardiac cycles for analysis.

Abstract: The present invention relates to an anchor device comprising an elongated tubular body having an expandable member disposed on its distal end portion. The invention also relates to a system adapted to position and anchor the distal end of an ablation device at a location where a pulmonary vein extends from the atrium.

Abstract: A medical electrical lead includes a lead body and a connector terminal. A conductor extends from the lead body to the connector terminal along a helical path through a transition zone.

Abstract: Devices and methods for stabilizing a lead in a cardiac vein.

Abstract: According to embodiments of the present invention, a cardiac lead system adapted for fixation to a vessel including an expandable fixation mechanism adapted to engage an inner surface of the vessel and a lead member comprising an anchor structure at distal end, the anchor structure configured to removably engage with fixation mechanism. Such anchor structure may be helical, and may removably engage fixation mechanism upon rotation or an application of torque, and may be extendable and/or retractable. Fixation mechanism may be polymer coated weave and/or mesh to trap anchor structure. Lead member and/or fixation mechanism may include electrodes and/or sensors, and lead member may include L-shape, S-shape, spiral, and/or sinusoidal shape for positioning of electrodes and/or sensors or for facilitated engagement of anchor structure. A guide wire attached to fixation mechanism during deployment may, prior to detachment, serve to guide lead member to a target site at fixation mechanism.

Abstract: A cardiac pacemaker or other implantable electrostimulation device has one or more durable fine wire leads to the heart or other electrostimulation site. The lead is formed of a core of silica or glass fiber or similar material, with a protective coating preferably including a metal buffer for conduction. The lead can be unipolar or bipolar (or even with three or more conductors), of small diameter and preferably with an anchoring configuration at the distal end of the lead. The anchor feature can take any of several nonlinear forms such that once implanted in a constrained configuration, the anchor can be released to the expanded, nonlinear configuration. The electrostimulation leads of the invention are extremely durable, can be bent through small radii and can exhibit long life without fatigue failure.

Abstract: An implantable medical lead configured for improved MRI safety and heating reduction performance is disclosed herein. In one embodiment, the lead includes a tubular body having a proximal end and a distal end with a lead connector near the proximal end. In this embodiment the lead further includes a conductor extending longitudinally within the tubular body and having a proximal end that is electrically coupled to the connector and a distal end electrically coupled to a contact pin. The lead in this embodiment further includes a filter element electrically coupled to a distal end of the contact pin and a flange electrically coupled between a proximal end of the filter element and a proximal portion of an electrode. In this embodiment the flange and the proximal portion of the electrode form at least a first part of a hermetic chamber enclosing the filter element.

Abstract: An anchor for a medical implant, a method of manufacturing an anchor, and a delivery system and method for delivering a medical implant, such as for monitoring physiological parameters, for example, for diagnosing and/or monitoring and/or treating cardiovascular diseases, such as CHF and CHD. The anchor includes a base member, arms, legs, features for securing the medical implant to the base member, and features for connecting the anchor to a connector. The anchor has a deployed configuration in which the arms radially project from a first end of the base member and the legs radially project from an opposite end of the base member. When deployed, the arms and legs terminate at extremities that are opposing but not aligned with each other.

Abstract: An implantable medical system for delivering pacing pulses to HIS bundle of a heart of a patient when implanted in said patient includes a medical lead, which is adapted to be attached with a distal end to tissue of said heart, including a at least two electrodes arranged being electrically separated from each other. The implantable medical device connectable to the medical lead includes a pacing circuit adapted to deliver the pacing pulses to said heart via the medical lead, a selection device connected between the pacing circuit and the electrodes adapted to selectively activate at least one of said electrodes, and a processing device adapted to control the selection device to selectively activate at least one of the electrodes to direct the pacing pulses to the HIS bundle.

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: Some embodiments of pacing systems employ wireless electrode assemblies to provide pacing therapy. The wireless electrode assemblies may wirelessly receive energy via an inductive coupling so as to provide electrical stimulation to the surrounding heart tissue. In certain embodiments, the wireless electrode assembly may be pivotable so that the proximal end of the wireless electrode assembly may be shifted to a position against the heart wall after the distal end has been secured to the heart wall.

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: A catheter for injecting a therapeutic or diagnostic agent into an organ, in particular the heart, including a flexible exterior tube having a proximal end and a distal end, inside which a needle is mounted to slide axially between retracted and deployed positions in which a tip of the needle, adapted to be inserted into the organ, is withdrawn inside the exterior tube and projects from the distal end thereof, respectively. Actuation elements are adapted to slide the needle between the retracted and deployed positions. The catheter includes elements for fixing the catheter to the organ, the needle being decoupled from the fixing elements so that the needle is able to slide relative to the fixing elements, at least in an unfolded position of the fixing elements. The fixing elements include a suction cup mounted so that it may be retracted into a lumen of the exterior tube.

Abstract: A retention device for anchoring a medical device within the vasculature is described. The device may include expandable member coupled to an intravascular medical device and proportioned for receipt within a vessel. At least a portion of the expandable member is expandable to radially engage a vessel wall and to thereby retain the medical device within the vessel. The system is suitable for a variety of intravascular devices, including but not limited to ICD's, pacemakers, and intravascular drug delivery systems.

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: A lead anchor includes a body defining a first opening and a second opening through which a lead can pass. A protrusion and a corresponding depression may be provided within the body that cooperate to form a non-linear path for the lead through the housing to resist movement of the lead within the lead anchor.

Abstract: A radio frequency antenna is provided for use with a medical device for implantation into an animal. The antenna comprises a coil formed by a wire that includes a core formed of a shape-memory material with an electrically conductive first layer applied to an outer surface of the core. A second layer, of an electrically insulating and biologically compatible material, extends around the first layer. If necessary to reduce friction, a lubricant is placed between the first and second layers. If second layer is formed of a porous material or a non-biological compatible material, a biological compatible outer layer surrounds the second layer thereby providing a barrier that is impermeable to body fluids of the animal.

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 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: Instrumented retrievable implantable device (2), comprising an expandable section, for placement inside a body lumen, preferably in a blood vessel. The device (2) comprises a joined sensor (70) for monitoring one or more physiological parameter for diagnostic or therapeutic purposes. Data access is assured by a passive RF transponder, in communication with an external readout unit or an implanted device, providing as well to the energy supply of the sensor (70). The shape of the device of the invention (2) allows repositioning and retrieval by micro-invasive methods, by means of a link section (20) capable of being coupled with a grabbing device (45) mounted on a catheter (40).

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: Devices and methods for stabilizing an electrical lead in a cardiac vein of a heart using a tether and a stent anchor. The stent anchor may include a proximal eccentric apex such that the distal electrode of the lead lies against and establishes electrical contact with tissue 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: A medical electrical lead configured for use in stimulating the left side of the heart (i.e., the left ventricle). In one embodiment, the lead includes an elongate lead body including an inner surface. An inflatable member is disposed on the outer surface of the body between its proximal and distal ends, the inflatable member being adapted when inflated to impart a radial force on and frictionally engage a surface of the coronary sinus or coronary vein for fixation of the distal end of the lead therein. The lead further includes a conductive member extending from the proximal end toward the distal end, and an inner insulating layer positioned between the conductive member and the inner surface of the body. Separation between the inner insulating layer and the inner surface of the body defines an inflation lumen in fluid communication with the inflatable member.

Abstract: In a medical implantable lead for monitoring and/or controlling of an organ inside a human or animal body, and a method for the manufacture thereof, two electrical conductors are each connected to a respective electrode for receiving or transmitting of electrical signals from or to the organ, and a tubular header is provided in a distal end of the lead. One electrode is positioned in the outermost distal end of the lead whereas the other is a ring electrode that is mounted by a coupling on the outside of the header. The coupling and the header are integrated into one unitary piece of an electrically insulating material having a coupling portion, and the coupling portion is adapted configured for quick fixing connection of the ring electrode to the header.

Abstract: Devices for enhancing minimally invasive cardiac surgery include a visualization device including an inflatable balloon at or near the distal end. Some visualization devices also include one or more lumens for allowing the introduction of one or more devices to a surgical site through the visualization device. Systems of the invention involve a visualization device which has at least one lumen for allowing introduction of an ablation device and/or other devices. A visualization device with an inflatable balloon may be positioned to create a space between a heart and pericardium when the balloon is inflated.

Abstract: An retaining device for attaching to a contractile organ such as a digestive tract organ or stomach is provided. One aspect may include a lead for stimulating a digestive organ. The device may be an electrical stimulation device configured to deliver electrical signals to the organ.

Abstract: Methods and apparatus for implanting a medical device within a living body. The apparatus includes an elongate sleeve positionable with a living body, such as within a blood vessel, and a medical device insertable into the sleeve. During use, the sleeve is retained within the body, and the medical device is sealed within the sleeve. The sleeve substantially avoids biological growth onto the medical device, and thus permits removal of the medical device independently of the sleeve.