Abstract: An implantable catheter lead or electrode lead includes an elongated flexible lead body with the fixation means attached to the lead body, for the purpose of effecting fixation of the catheter lead or electrode lead in a predetermined position within a vessel or a bodily cavity of a patient. A releasable attachment is provided between the lead body and the fixation means such that an explantation of the catheter lead or electrode lead is possible after the attachment is released while the fixation means remains in place within the body of the patient.

Abstract: A lead assembly includes a nerve stimulation lead and at least one anchoring unit. The nerve stimulation lead includes electrodes disposed at a distal end that are electrically coupled to terminals disposed at the proximal end by a plurality of conductive wires. The at least one anchoring unit includes at least one elongated member and at least one fastener. The at least one elongated member extends along at least a portion of the nerve stimulation lead with a distal end of the at least one elongated member extending outwards from the nerve stimulation lead in proximity to the distal end of the nerve stimulation lead. The at least one fastener is attached to the distal end of the at least one elongated member and is configured and arranged for anchoring the at least one elongated member against a bony structure or against soft tissue abutting a bony structure.

Abstract: A leadless intra-cardiac medical device (LIMD) configured to be implanted entirely within a heart of a patient includes a housing configured to be securely attached to an interior wall portion of a chamber of the heart, and a stabilizing intra-cardiac (IC) device extension connected to the housing. The stabilizing IC device extension may include a stabilizer arm, and/or an appendage arm, or an elongated body or a loop member configured to be passively secured within the heart.

Abstract: A device comprising: a lead extending between a proximal end and a distal end, the lead comprising, at its distal end portion, an electrode element configured for fixing in a first body tissue, the lead further comprising: an anchoring element disposed between the proximal and the distal end for anchoring the device to a second tissue; and an elastic element disposed between the anchoring element and the distal end and configured so as to permit the pulling of the distal end away from the anchoring element against the biasing force of the elastic element.

Abstract: A pre-sutured anchor including a deformable anchor sleeve with a lumen sized to receive the therapy delivery element. An outer surface of the anchor sleeve including one or more annular compression grooves oriented generally co-axial to the lumen. At least one compression member is located in a compression groove in an open configuration. The compression member includes at least one stop. A suture material pre-tied in a self-locking compression knot extends around each compression member. The suture material includes distal ends adapted to receive a tension force that is transmitted as a radial compression force to deform the compression members and substantially engage the stop in a compressed configuration. The anchor sleeve compressively engages the therapy delivery element in the compressed configuration.

Abstract: An assembly for introducing a leadless intra-cardiac medical device includes a sheath having an internal passage, wherein the sheath is configured to be maneuvered into the heart of the patient. A housing may be retained within the internal passage, wherein the housing is configured to be pushed out of the sheath, the housing having a first anchoring member configured to anchor the housing to a first implant location within the heart. The assembly may also include an electrode trailing the housing within the internal passage, wherein the electrode is also configured to be pushed out of the sheath. The electrode has a second anchoring member configured to anchor the electrode to a second implant location within the heart. A conductive wire connects the housing to the electrode, wherein movement of the housing out of the sheath causes the electrode to follow the movement to a distal end of the sheath.

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 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: This disclosure is directed to an implantable medical device having a housing that encloses at least a communication module. The implantable medical device also includes a first electrode electrically coupled to the communication module and an electrically conductive fixation mechanism that is mechanically coupled to the housing and electrically coupled to the communication module within the housing. The electrically conductive fixation mechanism includes a dielectric material that covers part of a surface of the fixation mechanism. A portion of the electrically conductive fixation mechanism is not covered by the dielectric material such that the portion of the electrically conductive fixation mechanism is exposed to form a second electrode that is electrically coupled to the communication module. The communication module is configured to communicate using the first electrode and second electrode.

Abstract: Techniques for determining an attachment stability of leadless pacing device (LPD) implanted within a patient are described. For example, the LPD may detect one or more stability metrics from one or more electrodes of the LPD and/or an activity sensor within the LPD. Based on one or more of these stability metrics, e.g., a mechanical motion of the LPD, a stability module within the LPD may determine the attachment stability of the LPD within the patient. If the attachment stability is insufficient to provide efficacious therapy or indicates at least partial dislodgement of the LPD from tissue, the LPD may wirelessly transmit stability information to an external device. In some examples, the LPD may be implanted within a chamber of the heart.

Abstract: A system for therapeutically stimulating a His bundle includes an implantable pulse generator and a multi-polar medical electrical lead. The generator is configured for subcutaneous implantation and to generate a pacing stimulus. The lead includes a connector assembly, a flexible tubular body, a distal tip assembly and coil conductors. The body extends intravascularly from the generator to a location proximate the His bundle and includes a proximal end, a distal end, and a longitudinal lumen. The tip assembly includes an electrode, a fixation helix, and a shank portion. The helix extends to a location proximate the His bundle and is operable as an electrically isolated electrode. The shank portion extends within the lumen and includes a receptacle for receiving a stylet tip. The conductors extend longitudinally through the lumen and are coupled to the electrode and the helix. One or both of the conductors defines a stylet lumen.

Abstract: A device comprises a medical implant and an actively deployable clip attached to the medical implant that operates to restrict movement of the medical implant once the actively deployable clip is deployed within a body of a patient. In some embodiments, the medical implant is an electrical lead for electrical stimulation. The actively deployable clip is operable to fixate the medical implant to a body tissue once deployed, such that the actively deployable clip performs a similar function to a suture. In this manner, embodiments of the invention may provide a medical implant that requires few or even no sutures to properly fixate the implant within the patient.

Abstract: An implantable lead may have a distal assembly including a coupler, a fixation helix secured to the coupler and a housing in which the fixation helix and the coupler are disposed. The distal assembly may include an annular seal that is disposed between the coupler and the housing and that provides an at least substantially fluid-tight seal between the coupler and the housing.

Abstract: An implantable medical lead has at least one electric conductor running along a lead body and electrically interconnecting at least one electrode at the distal portion of the lead with at least one lead terminal at the proximal portion of the lead. The lead also has at least one closed channel running along at least a portion of the lead body. The closed channel contains an extracorporeally detectable detection substance. A rupture to the lead will cause the detection substance to leak out of the channel and outside of the lead body. Lead damage can be confirmed by the absence of or a reduced amount of said detection substance inside the lead.

Abstract: A lead for an implantable cardiac prosthesis, with protection against the thermal effects of MRI fields by terminating the lead head (10) with an electrically insulating tubular outer housing (28) and an anchoring mechanism. The tubular housing (28) carries an electrically isolated thermally conductive solid part in the outer region of its distal end forming a heat sink. The heat sink thermally conductive material is for example titanium, associated with an electrically insulating coating such as a diamond deposition. The anchor may be a projecting helical anchoring screw (20), axially extending the tubular housing, which is an electrically conductive active screw on at least one end portion.

Abstract: A transseptal cannula assembly for directing blood from the heart of a patient and a minimally invasive method of implanting the same. The transseptal cannula assembly includes a flexible cannula body having proximal and distal portions with a lumen therebetween, a tip coupled to the distal portion of the flexible cannula body, and first and second anchors coupled to the tip. The anchors can be configured to be deployed from a contracted state to an expanded state and are configured to engage opposite sides of the heart tissue when in the expanded state. The anchors resist movement of the cannula assembly along a lengthwise central axis of the flexible cannula body.

Abstract: Tools and methods are particularly suited for certain cardiac conditions involving use of a catheter for pacing of the right and left ventricles from a lead in the right ventricle, e.g., to facilitate mechanically and/or electrically synchronous contractions for resynchronization. Certain aspects involve pacing and/or mapping by delivering pulses to a cardiac site useful for improving heart function as measured, e.g., by QRS width, fractionation, late LV activation timing, mechanical synchronicity of free wall and septal wall, effective throughput/pressure, or a combination thereof. In one embodiment, a catheter arrangement includes a fixation mechanism to attach the catheter arrangement to heart tissue, individually-addressable electrodes for providing pacing signals to the heart tissue, and an elongated structure that supports the fixation mechanism and the electrodes.

Abstract: Disclosed is an implantable anchor for anchoring a catheter, including (by way of non-limiting example) an implantable lead, such as may be used for spinal cord stimulation, to the body of a patient, along with a method for its use. The anchor comprises an elongate body have a central lumen extending through the body from its proximal end to its distal end, which central lumen is configured to snugly receive the catheter body. In addition to the central lumen, a second lumen is provided in the proximal end of the anchor and is configured to receive an injector so that adhesive may be injected into the anchor surrounding at least a portion of the catheter body. In doing so, the anchor may be fixed to the catheter body, such that when the anchor is sutured in place within the patient's body, migration of the catheter may be avoided.

Abstract: A lead system has an elongate body, an active fixation assembly movable relative to the elongate lead body, including a non-stationary electrode. The lead system further includes a non-stationary electrode member and an electrical interconnect electrically connected between the non-stationary electrode member and the stationary electrode member. The electrical interconnect provides a reliable electrical interconnection between the stationary electrode and the non-stationary electrode, while allowing the non-stationary electrode to move relative to the stationary electrode.

Abstract: There is disclosed various embodiments of an implantable anchor for anchoring a medical lead within a patient. The implantable anchor includes a body having at least one lumen for receiving a medical lead, a cam integrated with the body and rotatable to extend into the lumen for engaging, compressing and twisting the medical lead to inhibit the movement of the lead with respect to the anchor. The body of the anchor may include at least one slot, sized and positioned to receive a portion of the lead to further facilitate the inhibition of the movement of the lead. The cam may include a handle for facilitating the rotation and locking of the cam.

Abstract: A lead anchor includes a plurality of parallel tubular members and at least one suture element configured and arranged for receiving a suture to suture the lead anchor to patient tissue. Each tubular member defines a lead lumen having a first opening and a second opening through which a lead can pass.

Abstract: Methods and devices for implanting pacing electrodes or other apparatus, or for delivering substances, to the heart of other tissues within the body. A guided tissue penetrating catheter is inserted into a body lumen (e.g., blood vessel) or into a body cavity or space (e.g., the pericardial space) and a penetrator is advanced from the catheter to a target location. In some embodiments, a substance or an apparatus (such as an electrode) may be delivered through a lumen in the penetrator. In other embodiments, a guidewire may be advanced through the penetrator, the penetrating catheter may then be removed and an apparatus (e.g., electrode) may then be advanced over that guidewire. Also disclosed are various implantable electrodes and electrode anchoring apparatus.

Abstract: An implantable medical system for anchoring a medical lead implanted in a patient includes a medical lead, an anchoring device received coaxially over the medical lead, and at least one fastener secured circumferentially about the anchoring device to cause compression of the anchoring device on the medical lead. The anchoring device includes an elastomeric sleeve having a substantially elongate, hollow, and tubular body and a compression governor coaxially secured about the elastomeric sleeve. The compression governor is adapted to limit compressive forces exerted on the lead by the anchoring device at a predetermined limit and provides a visual indicator that the predetermined limit has been reached.

Abstract: A medical pacing wire comprising a clamp that is adapted to be moved between an open position and a closed position and further adapted to allow a user to attach an electrode to a living tissue. In particular embodiments, the medical pacing wire may include a memory shape alloy having a memory state, which is adapted to cause the clamp to move from the closed position toward the open position when the memory shape alloy is caused to move from a non-memory state to the memory state. Also, in some embodiments, the clamp may comprise a superelastic material, and the medical pacing wire may be adapted to allow a user to remotely cause the clamp to substantially release the living tissue that has been closed within the clamp without substantially damaging the living 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: An implantable medical system includes a medical lead including an insulating sheath and a conductor and an anchoring device. The anchoring device defines an inner lumen adapted to coaxially receive the medical lead, where the inner lumen has an effective diameter. The anchoring device includes a sleeve including a substantially elongate body defining an outer surface and an inner bore. The anchoring device also has a compression member including a first end, a second end, and an intermediate portion between the first and second ends. The compression member is at least partially embedded in the sleeve such that compression of the first and second ends of the compression member toward one another causes the effective diameter of at least a portion of the inner lumen of the anchoring device to reversibly increase.

Abstract: An implantable member has a body with a distal end portion and either a fixation portion of the body disposed near the distal end portion or a fixation device attached to a tip of the distal end portion of the body. The fixation portion can include at least one surface feature of the body that facilitates fixation of the implantable member within tissue when implanted.

Abstract: A method of inserting a pacing lead having a preformed shape into a coronary sinus to pace the left atrium includes providing a lead having an elongated body and proximal and tip sections. The sections are configured such that a first angle less than 90 degrees is defined between the lead body and proximal section and a second angle is defined between the tip and proximal sections. The method further comprises advancing the pacing wire towards the opening of the coronary sinus and advancing the wire into the coronary sinus, such that the first angle is compressed by the coronary sinus opening and a tip electrode included on the tip section contacts the wall of the coronary sinus near the left atrium operably extending the second angle to assure constant contact between the wall of the coronary sinus and the tip electrode.

Abstract: This document discusses, among other things, a lead body extending longitudinally along a lead axis, a driver axially displaceable relative to the lead body, and a driven member coupled to the lead body and displaceable away from the lead axis. The driven member at least partially defines an expandable passage having at least one internal dimension. The driver is displaceable into the expandable passage and has at least one outer dimension that is larger than the at least one internal dimension of the expandable passage. An example method includes disposing a first member having a first cross-section in a lead assembly having a lead axis, an expandable passage, and a displaceable member proximate the expandable passage. The method further includes urging the first member into the expandable passage in the lead assembly, and urging the displaceable member away from the lead axis to expand the expandable passage.

Abstract: A lead anchor includes a body defining at least one first portion of a lead lumen, the body having a first opening and a second opening. An obstructing member is disposed within the body. The obstructing member defines a second portion of the lead lumen. A spring is disposed in the body and configured and arranged to operate on the obstructing member so that the second portion of the lead lumen is coterminous with the at least one first portion of the lead lumen and forms a continuous lead path when the spring is compressed and the second portion of the lead lumen is offset from the at least one first portion of the lead lumen when the spring is not compressed.

Abstract: A pacing lead for implantation in a coronary sinus having an opening and a wall defining an interior and presenting a diameter dimension. The pacing lead includes an elongated lead body, a resilient fixation element, and at least one electrode on either the lead body or the fixation element. The fixation element extends from the pacing portion and defines a loop structure laterally adjacent the pacing portion. The loop structure presents a predetermined width dimension greater than the diameter dimension of the coronary sinus, wherein when the loop structure is inserted into the opening of the coronary sinus, the loop structure is laterally compressed by the wall of the coronary sinus and the electrode is biased against the wall of the coronary sinus.

Abstract: An endoluminal treatment device and method includes introducing an endoluminal device into a lumen of a patient and engaging a wall of the lumen with an implant device. The implant device can be a drug delivery device or medical device.

Abstract: A pacing lead having a lead body configured into a pre-formed J-shape. The lead includes a pacing electrode coupled to an intermediate portion of the lead body and located distally from a bottom of the pre-formed J-shape. The lead is adapted to be placed within a heart in a J-shaped configuration with the electrode positioned proximate a ventricular septum or a right ventricular outflow tract such that at least a portion of the distal end of the lead body is located within a pulmonary artery. In one embodiment, the distal end of the lead is configured to be passively fixated within the pulmonary artery. Another aspect includes a lead body wherein a section of the intermediate portion of the lead body is less stiff than adjacent sections of the lead body. The lead includes a pacing electrode coupled to the intermediate portion of the lead body and located distally from the less stiff section.

Abstract: The invention includes a implantable medical electrical lead for electrical stimulation of body tissue that includes at least one electrode; a lead body; and at least one modifiable portion, wherein the at least one modifiable portion has a first configuration and a second configuration, wherein the first configuration exists when axial tension is exerted on the at least one modifiable portion, and wherein the second configuration exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration. Kits, and systems and methods of using the lead are also included.

Abstract: A system for stimulation/defibrillation of the left ventricle endocardially or from a vein in the coronary system including: a lead body (10) having a lumen, a distal end (12) with an anchor (14) connectable to a wall of a heart chamber or of a vein of the coronary system, and a proximal side with a connector (22) having a first terminal (26). The lumen of the lead houses a microcable (28) with an active free part (30) that emerges from the distal end. An insert (38) formed on the lead body includes a first electrical connection to the first terminal (26) of the connector, and a coupler selectively movable between (i) a released position wherein the microcable is free to slide in lumen of the lead body, and (ii) a closed position, wherein the microcable is both mechanically immobilized in the lead body and electrically connected to first electrical connection.

Abstract: In one embodiment, the present invention provides a cardiac lead device including a fixation mechanism slidably attached to the lead such that when the fixation mechanism is expanded in to contact with a body lumen, the lead may be moved relative to the fixation mechanism if desired. Such lead movement may be limited by complimentary structure on the lead body and the fixation mechanism that prevents the lead from moving unless sufficient force is applied to the lead.

Abstract: An implantable medical lead is disclosed herein wherein the lead employs a helical distal tip anchor having improved fixation capabilities. The implantable medical lead may include a body and a helical anchor. The body may include a distal end and a proximal end. The helical anchor may be at least one of extending and extendable from the distal end. The helical anchor may include at least one loop including first and second straight sides that intersect at a first corner.

Abstract: A medical electrical lead comprises a flexible, elongate lead body extending along a longitudinal axis and having a proximal end and a distal end. A protective distal tip structure is disposed on the distal end of the lead body. The tip structure includes a plurality of compliant projections each extending distally from the distal end of the body in the direction of the longitudinal axis. The projections are configured to contact and bear against cardiac tissue when the lead is implanted, and are deformable under the action of an axially or radially directed force. The projections optionally include a coating over a substrate. The coating can include a hydrogel material and/or a pharmaceutical agent such as a steroid for reducing inflammation at the implantation site.

Abstract: An active fixation cardiac lead is disclosed that includes an elongated lead body having opposed proximal and distal end portions and an interior lumen that extends therethrough. A rotatable fixation element is operatively associated with the distal end portion of the lead body and a tubular torque-transmitting member extends through the interior lumen of the lead body. The tubular torque-transmitting member has a distal end connected to the fixation element and a proximal end connected to a rotatable actuator operatively associated with the proximal end portion of the lead body. Preferably, the rotatable actuator is part of a connector assembly that is operatively associated with the proximal end portion of the lead body.

Abstract: There is disclosed various embodiments of an implantable anchor for permanently anchoring a medical lead. The implantable anchor may include a body having a longitudinal lumen, an access opening defined within a side of the body and in communication with the longitudinal lumen, a locking opening defined on an interior surface of the body, an arm having an interior face, the arm rotatably coupled to the body such that the arm is movable from a first position in which the arm covers the access opening to a second position in which the arm does not cover the access opening, and a locking feature protruding from the interior face of the arm and sized to extend into the locking opening.

Abstract: An implantable medical electrical lead for electrical stimulation of body tissue that includes at least one shape memory polymer portion that has a first configuration and a second configuration, wherein the second configuration is obtained upon exposure of the shape memory polymer portion to a transition stimulus, and wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration; and at least one electrode configured to provide electrical stimulation of body tissue, wherein the lead has a proximal end and a distal end. Systems and kits as well as methods of utilizing the leads of the invention are also included.

Abstract: A cardiac lead includes a lead body that defines a passage, a conductive element that extends through the passage, and a fixation assembly. The fixation assembly includes a threaded member threadably engaged with the conductive element such that rotation of the threaded member causes the threaded member to translate longitudinally relative to the conductive element. A fixation element has a first end coupled to the threaded member and a second end coupled to a fixed location. A resilient membrane extends over the fixation element such that rotation of the threaded member affects the resilient membrane radially with respect to the conductive element.

Abstract: A fixation mechanism coupled to an implantable device body extends from a proximal portion of the body to a distal portion of the body and includes a fixation element and a push tube segment. A push tube segment of the mechanism extends proximally from the fixation mechanism to the proximal portion of the body and is adapted to deploy the mechanism.

Abstract: Instrumented retrievable implantable device, including an expandable section, for placement inside a body lumen, preferably in a blood vessel. The device includes a joined sensor 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. The shape of the device allows repositioning and retrieval by micro-invasive methods, by means of a link section coupleable with a grabbing device mounted on a catheter.

Abstract: A transvenously implantable medical device (TIMD) includes an electrical lead and a control module. The electrical lead includes one or more electrodes and is adapted for transvenous implantation. The electrical lead is also pre-biased to expand from a collapsed state to an expanded state to mechanically engage an internal wall of a blood vessel. The control module is secured to and in electrical communication with the electrical lead. The control module includes a signal management component and a power component disposed in a housing adapted for implantation into the blood vessel. The control module is adapted for at least one of stimulating and sensing a physiologic response using the one or more electrodes of the electrical lead.

Abstract: A lead includes a lead body with a stylet receiving lumen, a distal tip, and a distal portion proximal of the distal tip that is biased to assume a non-linear configuration. Insertion of a stylet into the lumen causes the distal portion to transition from the non-linear configuration to a generally linear configuration. The lead also includes a first arm member having a distal end and a proximal end coupled to the lead body proximal of the distal tip; and a nosepiece, at least a portion of which is biodegradable. The nosepiece is configured to receive the distal tip of the lead body and the distal end of the first arm member such that the lead body, first arm member and nosepiece form a closed arrangement prior to biodegradation of the nosepiece and an open arrangement after biodegradation of the nosepiece.

Abstract: An ultra-wideband assembly is provided. The assembly includes a non-conductive tapered core having a conductive wire wound on an outer surface of the non-conductive tapered core, a low-frequency inductor coupled to the non-conductive tapered core via the distal end of the conductive wire and configured to allow mounting of the non-conductive tapered core at an angle with respect to the circuit board. The low frequency inductor is being disposed on a dielectric board configured to be coupled to the circuit board. The assembly includes an ultra-wideband capacitor coupled to the non-conductive tapered core via the proximate end of the conductive wire, the ultra-wideband capacitor being also coupled to the transmission line on the dielectric board.

Abstract: A delivery system for implanting a biostimulation device comprising a stylet extending along an axis from knob end to a threaded end configured to engage an internally threaded nut of the biostimulation device and a catheter tube configured to axially contain the stylet. The catheter tube comprises a feature that engages a corresponding feature on the biostimulation device whereby the stylet can be rotated relative to the catheter tube for disengagement of the stylet threaded end from the biostimulation device threaded end.

Abstract: A lead having a distal end electrode assembly adapted for implantation on or about the heart or within a vein and for connection to a system for monitoring or stimulating cardiac activity. The electrode assembly includes conductive fixation features, such as conductive tines or flexible members, in combination with non-conductive fixation features. The conductive fixation features also include tines coated with a conductive material. The fixation features further include conductive tines which are retractable. A defibrillation coil is optionally disposed at the distal end of the lead in combination with the conductive tines.

Abstract: A lead system has an elongate body, an active fixation assembly movable relative to the elongate lead body, and a low variation friction member frictionally engaged with the active fixation assembly. In an option, the active fixation assembly undergoes greater torsional resistance as the active fixation assembly is moved in a direction to retract the lead.