Abstract: An endoluminal punch system including a sheath and dilator. The endoluminal punch may include energy delivery system capable of being transmitted from the proximal end to the distal end of the endoluminal punch to assist with tissue crossing and incisions. The dilator may include selectively deployable cutting mechanism to create incisions in tissue that are larger than their basic external diameter. The system may also be configured to reduce the risk of generating plastic emboli during insertion of the endoluminal punch.

Abstract: A delivery device, a cardiac pacing device and a fixation structure are disclosed. The fixation structure includes a casing, a driving member and an elastic member. The casing has a first internal cavity and a slot, and the driving member is partially received in the first internal cavity in such a manner that one end of the driving member protrudes out of the first internal cavity from a proximal end thereof and is detachably connected to the driving sheath. The elastic member is accommodated in the first internal cavity in such a manner that its one end is coupled to the driving member and the other end extends outwardly from the driving member and is inserted in the slot. The driving member is configured for fitted connection with the casing while being able to move in an axial direction of the casing to drive the elastic member to move in the slot, thereby causing the elastic member to protrude out of or move back into the slot.

Abstract: Intrauterine devices and methods for facilitating deployment thereof using a bumper are disclosed. In one embodiment, an intrauterine device comprises a structure including a first central support member and a deployment mechanism coupled to the first central support member. The intrauterine device further comprises a bumper positioned at a distal end of a second central support member and at a more distal position relative to a distal end of the structure so as to prevent the distal end of the structure from contacting the fundus of the uterus of a patient during deployment of the deployment mechanism. In another embodiment, the intrauterine device comprises a bumper coupled to the deployment mechanism and configured to move from a more distal to a more proximal position relative to a distal end of the structure.

Abstract: Systems and methods for controlled sympathectomy procedures for neuromodulation are disclosed. A system for controlled micro ablation procedures is disclosed. A guidewire including one or more sensors or electrodes for accessing and recording physiologic information from one or more anatomical sites within the parenchyma of an organ as part of a physiologic monitoring session, a diagnostic test, or a neuromodulation procedure is disclosed. A guidewire including one or more sensors and/or a means for energy delivery, for performing a neuromodulation procedure within a small vessel within a body is disclosed.

Abstract: A therapy assembly configured for at least partial insertion in a living body. At least one fixation structure is attached to the therapy delivery element proximate the electrodes. The fixation structure is configured to collapse radially inward and wrap circumferentially around the therapy delivery element to a collapsed configuration when inserted into a lumen of an introducer. The fixation structures deploy to a deployed configuration when the introducer is retracted. The fixation structure includes major surfaces generally parallel with, and extending radially outward from, a central axis of the therapy delivery element, proximal edge surface oriented toward the proximal end, and a distal edge surface oriented toward the distal end. The proximal and distal edge surfaces provide generally symmetrical resistance to displacement of the therapy delivery element within the living body in either a proximal direction or a distal direction along the central axis.

Abstract: A medical balloon device includes an outer member extending along an axis. An inflatable member has a proximal end extending from a first end of the outer member and a distal end. An inner member is positioned within the outer member and the inflatable member such that a first end of the inner member is coupled to the distal end of the inflatable member. A support member is movably disposed within the inner member and includes a first end configured to removably engage the first end of the inner member. Translation of the support member along the axis causes the inflatable member to move between a first position in which the inflatable member has a first length and a first profile and a second position in which the inflatable member has a second reduced length and a second reduced profile. Methods of use are disclosed.

Abstract: A leadless pacing device may include a housing having a proximal end and a distal end, and a set of one or more electrodes supported by the housing. The housing may include a first a distal extension extending distally from the distal end thereof. One or more electrodes may be supported by the distal extension. The leadless pacing device may be releasably coupled to an expandable anchor mechanism.

Abstract: An electrode catheter for use with an endocardial ablation catheter, wherein the electrode catheter receives the transmitted energy for ablating a portion of the heart. The electrode catheter comprises a proximal portion, a distal portion, and a longitudinal structure there between; and an electrode in communication with said electrode catheter, wherein said electrode receives the transmitted energy from the endocardial ablation catheter, or alternatively an epicardial ablation catheter.

Abstract: An implantable electrode for electrical stimulation of a body, for example, being a component of an implantable medical electrical lead, is preferably in the form of a coiled conductor wire, wherein the wire is formed by a tantalum (Ta) core directly overlaid with a platinum-iridium (Pt—Ir) cladding. When a maximum thickness of the Pt—Ir cladding defines a cladded zone between an outer, exposed surface of the electrode and the Ta core, a surface of the Ta core encroaches into the cladded zone by no more than approximately 50 micro-inches. The tantalum core may be cold worked to improve surface quality or formed from a sintered and, preferably, grain stabilized tantalum.

Abstract: A multi-branch stimulation electrode is disclosed herein. The multi-branch stimulation electrode can include a plurality of branches that extend from a hub. The branches can each include one or several stimulation contacts that can deliver an electrical current to tissue contacting the stimulation contacts. The stimulation contacts can be electrically connected with the lead. The lead can extend from the hub and can be connected with the pulse generator. The branches can include features to facilitate implantation including, for example, one or several removable stiffening elements.

Abstract: A lead receptacle having a lumen configured to traverse from an outer side of an outermost intercostal muscle to an inner side of an innermost intercostal muscle of an intercostal space of a patient and to support a lead traversing through the lumen. The lumen being configured to support one or more cardiac leads traversing through the intercostal space.

Abstract: Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrode assemblies that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Also disclosed are various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Abstract: An electrical stimulation lead includes at least one lead body and at least one thin, elongate anchoring element. The lead body defines at least one anchoring lumen extending longitudinally along at least a portion of the lead body and at least one open slot in the lead body where each anchoring lumen is open at one of the at least one open slot. For each anchoring element, the first end of the anchoring element is disposed in one of the at least one anchoring lumen and the second end of the anchoring element is configured and arranged preferentially to extend out of the open slot associated with the anchoring lumen and away from the lead body in a deployed configuration unless the second end is constrained in a constrained configuration adjacent or within the lead body.

Abstract: An instrument for deploying a surgical implant includes a handle, an elongated shaft extending from the handle, and a frame arm. The frame arm includes a clip pair for releasably attaching the surgical implant to the frame arm. The clip pair includes first and second clips operably coupled by a spring member. The first and second clips are repositionable from a closed position to an open position. The spring member biases the first and second clips towards the closed position. A lock bar is coupled to the frame arm and translatable between an unlocked position and a locked position. In the locked position, the lock bar maintains the first and second clips in either the open or the closed position. When the lock bar is in the unlocked position, the first and second clips are freely rotatable between the open and closed positions.

Abstract: An electrode lead comprises a tubular lead body, an electrode supported by the lead body, a rotatable member, a deployable member and a deployment mechanism. The rotatable member is contained within a distal end of the tubular lead body. The deployable member is attached to the rotatable member and comprises a tissue anchor. The deployment mechanism is configured to drive the deployable member along a central axis and out the distal end of the tubular lead body responsive to rotation of the rotatable member about the central axis. In one embodiment, the deployable member does not rotate about the central axis with the rotation of the rotatable member.

Abstract: An electrical lead system includes a shaft to which a series of expandable ring electrodes are attached that follows the contour of the vascular or muscular structures of the heart, such as cardiac veins, arteries, atrial appendages and trabeculae, and provides sensing of electrical cardiac impulses, pacing and high voltage shock or defibrillation. The lead system uses a variety of energy sources to stimulate the heart, such as ultrasound, electromagnetic and electric impulses.

Abstract: A device for accessing a vessel, duct or lumen, comprising a guidewire having a proximal end and a distal end, and at least one projection that extends from said guidewire at or near the distal end of the guidewire. When the guidewire is placed into the vessel, duct or lumen containing a flowing fluid, the drag on the guidewire is greater when the fluid is flowing from the proximal to distal end of the guidewire than it is when it is flowing distally-to-proximally, thereby helping to direct the guidewire. The device is particularly useful in crossing a narrowing in the vessel, duct or lumen, such as may occur in blood vessels containing a stenosis, such as due to atherosclerosis.

Abstract: A tine portion for an implantable medical device includes a hook segment and a distal segment terminated by a tissue-piercing tip, wherein the distal segment extends from the hook segment to the tip. The hook segment, which is elastically deformable from a pre-set curvature, has one of: a round cross-section and an elliptical cross-section, while the distal segment has a flattened, or approximately rectangular cross-section. One or a pair of the tine portions may be integrally formed, with a base portion, from a superelastic wire, wherein the base portion is configured to fixedly attach to the device, for example, being captured between insulative members of a fixation subassembly.

Abstract: Implantable leadless pacing devices and medical device systems including an implantable leadless pacing device are disclosed. An example implantable leadless pacing device may include a pacing capsule. The pacing capsule may include a housing. The housing may have a proximal region and a distal region. A first electrode may be disposed along the distal region. One or more anchoring members may be coupled to the distal region. The anchoring members may each include a region with a compound curve.

Abstract: A tine portion for an implantable medical device includes a hook segment and a distal segment terminated by a tissue-piercing tip, wherein the distal segment extends from the hook segment to the tip. The hook segment, which is elastically deformable from a pre-set curvature, has one of: a round cross-section and an elliptical cross-section, while the distal segment has a flattened, or approximately rectangular cross-section. One or a pair of the tine portions may be integrally formed, with a base portion, from a superelastic wire, wherein the base portion is configured to fixedly attach to the device, for example, being captured between insulative members of a fixation subassembly.

Abstract: A tine portion of an implantable medical device includes a hook segment and a distal segment terminated by a tissue-piercing tip, wherein the distal segment extends from a distal end of the hook segment to the tip. The hook segment, which is elastically deformable from a pre-set curvature, for example, defined by a single radius, preferably tapers from a first width thereof, in proximity to a proximal end thereof, to a smaller, second width thereof, in proximity to the distal end thereof, wherein the tip has a width that is greater than the second width of the hook segment. Alternately, the tine portion may include a hook segment that is defined by two radii and a straight section extending therebetween.

Abstract: A tine portion of an implantable medical device includes a hook segment and a distal segment extending therefrom, wherein the hook segment is pre-set to extend along a curvature and is elastically deformable therefrom to an open position. The distal segment includes a tooth and an end that surrounds the tooth, wherein the end includes a pair of legs and a distal arch. The legs extend along a length of, and on opposing sides of the tooth, and the distal arch extends between the legs, distal to a tissue-piercing tip of the tooth. When the hook segment is in the open position, and a force is applied along a longitudinal axis of the device, to push the distal arch of the distal segment against tissue, for initial tissue penetration, the legs of the end of the distal segment bend in elastic deformation to expose the tissue-piercing tip to the tissue.

Abstract: A stabilizer is disclosed for use with a cochlear implant receiver stimulator having a body portion and an electrode portion implanted subcutaneously adjacent to a body tissue. The stabilizer is provided for stabilizing the position of the implant receiver relative to the body tissue. The stabilizer has a tissue engaging portion for grippingly engaging the body tissue to fixedly position the stabilizer with respect to the body tissue. The stabilizer also includes a coupler portion for fixedly positioning the stabilizer with respect to the receiver stimulator. The tissue engaging portion and coupler portion cooperatively interact with the receiver stimulator and the body tissue to fix the relative position of the body tissue and receiver stimulator.

Abstract: Leads having distal electrodes may be used in application of test stimulation for purposes of implanting a lead having a fixation element distal to an electrode array. The fixation element is proximal the distal electrode. Accordingly, the distal electrode may be advanced beyond a distal end of an introducer while the fixation element may be retained in a retracted configuration by the introducer. If the test signals applied by the distal electrode indicate that the distal electrode is in the desired location of the patient, a series of markings on the lead may be used to facilitate placement of the electrode array at the location previously occupied by the distal electrode; i.e. the desired location of the patient. The electrodes of the electrode array may then be used to provide therapy to the patient.

Abstract: An implantable stimulation device for use in stimulation based treatments for diseases such as GERD or obesity is described. The device is provided with an anchoring unit which upon deployment assumes a shape optimized for the site of deployment. Sensing electrodes and stimulating electrodes in the device are also designed to assume a suitable shape upon deployment. A novel catheter is also provided for easy and expeditious deployment of the device.

Abstract: A leadless intra-cardiac medical device (LIMD) includes a housing configured to be implanted entirely within a single local chamber of the heart.

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: The invention provides an implantable multi-electrode device (300) and related methods and apparatuses. In one embodiment, the invention includes an implantable device (300) comprising: an assembly block (320); and a plurality of leads (340 . . . 348) radiating from the assembly block (320), each of the plurality of leads (340 . . . 348) containing at least one electrode (342A), such that the electrodes are distributed within a three-dimensional space, wherein the assembly block (320) includes a barb (350) for anchoring the assembly block (320) within implanted tissue.

Abstract: Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrode assemblies that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Also disclosed are various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Abstract: An implantable medical elongated member includes a first outer surface portion and a second outer surface portion extending around at least ten percent of an outer perimeter of the elongated member. A fixation element extends a distance from the first outer surface portion of the implantable medical elongated member. A longitudinally-extending section of the second outer surface portion proximate to a distal end of the elongated member is substantially devoid of any fixation elements that extend the distance from second outer surface portion.

Abstract: Medical leads include a lumen body at an end of the lead, and the lumen body includes multiple filar lumens. The lumen body is joined to a lead body, and electrical connectors are longitudinally spaced along the lumen body. Filars within the filar lumens are directed through filar passageways within the lumen body to attach to the electrical connectors on the lumen body. The filar passageways may be aligned with the filar lumens, and slots within the electrical connectors may be aligned with the filar passageways to facilitate assembly. The lumen body may provide additional stiffness to the end of the lead where the lumen body is located to facilitate lead insertion into the medical device. The filar lumens of the lumen body may have a longitudinally straight configuration so that the portions of filars within the filar lumens are held in a longitudinally straight configuration.

Abstract: An implantable medical electrical lead comprises a lead body extending between a distal end and a proximal end, and the distal end having at least one electrode of an electrode array extending longitudinally from the distal end toward the proximal end. The lead body at its proximal end may be coupled to a pulse generator, additional intermediate wiring, or other stimulation device. A fixation mechanism is formed on or integrally with the lead body proximal to the electrode array that is adapted to be implanted in and engage subcutaneous tissue, particularly muscle tissue, to inhibit axial movement of the lead body and dislodgement of the stimulation electrodes. The fixation mechanism comprises a plurality of tine elements arrayed in a tine element array along a segment of the lead.

Abstract: Tissue ablation probes and methods of treating diseased tissue are disclosed that include or use a partially uninsulated shaft that carries conductive elements such as electrode arrays. The shaft has an uninsulated outer surface that is electrically conductive and is electrically connected to one of the conductive elements. The uninsulated outer surface and one of the conductive elements are insulated from the other conductive element. Tissue ablation is performed “inside-out” and begins between the proximal and distal electrode arrays and migrates outwardly towards the electrode arrays when electrical current is applied to the probe.

Abstract: Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrode assemblies that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Also disclosed are various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Abstract: An implantable stimulation device for use in stimulation based treatments for diseases such as GERD or obesity is described. The device is provided with an anchoring unit which upon deployment assumes a shape optimized for the site of deployment. Sensing electrodes and stimulating electrodes in the device are also designed to assume a suitable shape upon deployment. A novel catheter is also provided for easy and expeditious deployment of the device.

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 medical device that includes a lead having a lead body extending from a proximal end to a distal end, and a housing having a connector block for receiving the proximal end of the lead body. A fixation mechanism is positioned proximal to an electrode coil located at the distal end of the lead body, and includes a locking sleeve and a mating portion positioned along the lead body proximal to the electrode. The fixation mechanism is capable of being advance from a first state corresponding to a first inner diameter of the locking sleeve and a second state corresponding to a second inner diameter of the locking sleeve greater than the first inner diameter to fixed position the electrode at a target site.

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: Medical leads include a lumen body at an end of the lead, and the lumen body includes multiple filar lumens. The lumen body is joined to a lead body, and electrical connectors are longitudinally spaced along the lumen body. Filars within the filar lumens are directed through filar passageways within the lumen body to attach to the electrical connectors on the lumen body. The filar passageways may be aligned with the filar lumens, and slots within the electrical connectors may be aligned with the filar passageways to facilitate assembly. The lumen body may provide additional stiffness to the end of the lead where the lumen body is located to facilitate lead insertion into the medical device. The filar lumens of the lumen body may have a longitudinally straight configuration so that the portions of filars within the filar lumens are held in a longitudinally straight configuration.

Abstract: A RF ablation device includes a probe assembly that has an elongate cannula having a lumen disposed interiorly of an external wall of the cannula. The elongate cannula includes a plurality of slots formed within the external wall that provide access to the lumen. The probe assembly includes an electrode member that is slidably disposed within the elongate cannula, the electrode member including a plurality of tines configured for passage through the plurality of slots. The slots are disposed in a staggered arrangement or pattern about the external wall of the cannula. The staggered arrangement of slots may be used in a monopolar or bipolar arrangement of the electrodes on the cannula. A bipolar arrangement of electrodes using the staggered configuration produces larger ablation areas in a shorter period of time as compared to prior designs.

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: Devices and methods utilizing a catheter to remodel soft tissue of a patient and, in a preferred embodiment, to reduce the volume of the left ventricle of a heart. In some embodiments, one or more sutures are passed through a wall of the ventricle. The ends of the one suture and, more preferably, the multiples sutures are drawn together to draw tissue portions towards one another. In some embodiments, a tissue remodeling clip is implanted into a wall of the ventricle. Ends of the clip are resiliently biased to move relative to one another to draw tissue portions towards one another. In some embodiments, a tissue remodeling anchor includes a base and a plurality of legs attached to the base. The legs of the tissue anchor are implanted into a wall of the ventricle and moved toward one another to draw tissue portions toward one another.

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: 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: 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: 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 medical device that includes a lead having a lead body extending from a proximal end to a distal end, and a housing having a connector block for receiving the proximal end of the lead body. A fixation mechanism is positioned proximal to an electrode coil located at the distal end of the lead body, and a fixation member or a plurality of fixation members extend from the fixation mechanism from a fixation member proximal end to a fixation member distal end. The fixation members are advanceable from a first position corresponding to the fixation member distal end being positioned along the lead during subcutaneous placement of the lead, to a second position corresponding to the fixation member distal end being positioned away from the lead to fixedly engage the lead at a target site.

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 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: 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.