Abstract: Fixation guide devices and methods for positioning and inserting an intramedullary nail are disclosed. The fixation guide devices include a frame with a first end and a second end, a compression device removably coupled to the first end of the frame, and the intramedullary nail secured to a nail attachment apparatus of the frame. An intramedullary nail including a body with a fastening end, a closed end, and at least two openings is also disclosed. A compression device includes a compression member, a knob, and a bolt secured in the knob and rotatably engaging the compression member is also disclosed. An alignment guide is disclosed and includes a base member, an alignment member, and a fixation guide. A method of inserting an intramedullary nail into two bones for fixation of the two bones is also disclosed.

Abstract: A fluid management system for use in a tissue resection procedure includes a controller. An inflow pump is operated by the controller and configured to provide fluid inflow through a flow path to a site in patient's body. An outflow pump is operated by the controller and configured to provide fluid outflow through a flow path from the site in patient's body. A motor driven resecting device may be provided for resecting tissue at the site. The controller is configured to actuate an inflow pump and an outflow pump in response to various signals and various algorithms are provided to provide malfunction warnings and assure safe operation.

Abstract: The present invention relates generally to the field of micro-scale or millimeter scale devices and to the use of multi-layer multi-material electrochemical fabrication methods for producing such devices with particular embodiments relate to shredding devices and more particularly to shredding devices for use in medical applications. In some embodiments, tissue removal devices are used in procedures to removal spinal tissue and in other embodiments, similar devices are used to remove thrombus from blood vessel.

Abstract: An ultrasonic instrument comprises a handle assembly or other kind of body configured to receive an ultrasonic transducer and a shaft assembly having an acoustic waveguide and an ultrasonic blade. The ultrasonic blade is in acoustic communication with the acoustic waveguide such that the ultrasonic transducer is operable to drive the ultrasonic blade to vibrate ultrasonically via the acoustic waveguide. The ultrasonic instrument further comprises an actuation assembly disposed within the handle assembly. The actuation assembly includes a plurality of buttons disposed about the handle assembly in an angularly spaced array. Each button may be depressed independently of the rest to thereby actuate a switch assembly such that power is provided to the ultrasonic transducer, the acoustic waveguide, and the ultrasonic blade. The actuation assembly is operable to convert radial movement of the buttons into longitudinal, transverse, and/or pivotal movement that actuates the switch assembly.

Abstract: An atherectomy device with an exchangeable drive shaft is disclosed, having a drive shaft gear at a distal end of the exchangeable drive shaft for meshing engagement with a prime mover gear on the output shaft of the prime mover. The exchangeable drive shaft is inserted into an opening at the distal end of the handle housing and moved axially in a proximal direction. Surface features on at least the prime mover housing and the engageable drive shaft help to align the drive shaft gear with the prime mover gear for meshing engagement.

Abstract: A rotary catheter comprising a motor-driven flexible shaft rotatably disposed in a flexible tube having a fluid channel between them, a distal portion of the flexible shaft extending out of the tube and being free to move radially relative to the tube enabling the fluid channel to ingest large particles eased by motions between the rotating flexible shaft and the flexible tube, and pump means containing a thrombolytic drug connected to the fluid channel for infusing the drug through the fluid channel to the obstruction. An asymmetrical tip that is affixed to a distal end of the shaft has a substantially narrower cross section than its effective diameter so that fluid can flow alongside the tip and reach the area that the tip impacts the obstruction with the side of the tip and the tube aspirates fluid and the resulting particles into the channel.

Abstract: The present invention is a method for performing a percutaneous laminoplasty that includes entering a first introducer needle introducing a first tool wire into an epidural space above a selected lamina, entering a first catcher exit needle that that is caught with the first introducer needle and pulled through a patient body and entering a second introducer needle introducing a second tool wire into the epidural space below the selected lamina. The method also includes entering a second catcher exit needle that is caught within the epidural space and pulled through the patient body, moving the caught first introducer needle and the first catcher exit needle back and forth to cut the lamina and moving the caught second introducer needle and the second catcher exit needle back and forth to cut the lamina. There is also a method for performing a percutaneous foraminoplasty.

Abstract: A trocar assembly for creating a pneumatic seal during a minimally-invasive surgical procedure. The trocar assembly including an elongated body having a lumen extending therethrough. The proximal end portion of the body defining a housing. A fluid supply plenum is defined in the housing configured to deliver pressurized insufflation fluid to a nozzle. The nozzle configured for directing pressurized fluid into the lumen and creating a pneumatic seal. A fluid return plenum is defined in the housing configured to collect spent insufflation fluid from as patient's abdominal cavity. The fluid return plenum including a plurality of axially and radially oriented elongate vanes configured to permit spent insufflation fluid to proceed between the vanes and direct spent insufflation fluid back to the fluid return plenum.

Abstract: A steerable medical device can include a sheath defining a longitudinal axis having a deflectable distal end portion, and at least one lateral passage extending therethrough and configured to accommodate at least one steering cable and a steering handle operatively associated with a proximal end portion of the sheath and having an actuation mechanism operatively connected to the at least one steering cable accommodated within the at least one lateral passages of the sheath for steering the deflectable distal end portion of the sheath in at least one direction relative to the longitudinal axis thereof.

Abstract: The invention relates to a sampling needle, in particular to a needle suitable for oocyte retrieval from a human or animal subject, said needle comprising a first tubular region in fluid communication with a second tubular region, the first tubular region comprising a leading end for insertion into a subject and the second tubular region comprising a trailing end for fluid communication with a means for receiving a fluid, in which the first tubular region has an outer diameter which is less than the outer diameter of the second tubular region and the first tubular region has an inner diameter which is less than the inner diameter of the second tubular region. The invention also relates to a method of retrieving a sample, in particular an oocyte, from a human or animal subject.

Abstract: An embryo transfer syringe has a roller (30) coupled with the rear end of its plunger (15). The roller (30) is displaceable along an elongate housing (20) extending from the rear of the barrel (10) of the syringe. The roller (30) can be manually engaged through a slot (23) along the housing (20) to rotate it and roll it along the housing thereby smoothly and controllably displacing the plunger (15).

Abstract: A hand-held skin-treatment apparatus includes a deformable cover enclosing a longitudinally-extending volume. The cover has an exterior surface with a selected surface roughness. An elongated rigid support member is arranged within the volume. A compliant member is disposed within the volume and at least partly between the support member and the cover, so that the cover is held substantially stationary with respect to the compliant member. Another apparatus includes an elongated flexible support member. A tip protrudes transversely from a distal end of the support member and a handle is attached to the proximal end. An elongated compliant member is attached to the support member along the length of the compliant member. A cover encloses the tip, part of the compliant member, and a corresponding part of the support member, and has lower surface roughness over a dorsal side than over a ventral side of the support.

Abstract: A polyaxial bone screw assembly includes a threaded shank body having an integral upper portion receivable in an integral receiver, the receiver having an upper channel for receiving a longitudinal connecting member and a lower cavity cooperating with a lower opening. The receiver can have crimp tabs, but is devoid of spring tabs and collet-like flexible structures. A down-loadable compression insert (some with lock and release feature), a down-loadable friction fit split retaining ring and an up-loadable shank upper portion cooperate to provide for pop- or snap-on assembly of the shank with the receiver either prior to or after implantation of the shank into a vertebra. The shank and receiver once assembled cannot be disassembled. The receiver and insert include aligned tool receiving apertures for lock and release of the polyaxial mechanism.

Abstract: Treatment of spinal irregularities, including, in one or more embodiments, dynamic spine stabilizers and systems that can be used to stabilize one or more motion segments in a patient's spine. Spine stabilization systems may comprise a first bone fastener configured to attach the spine stabilization system to a first vertebra. Spine stabilization systems further may comprise a second bone fastener configured to attach the spine stabilization system to a second vertebra. Spine stabilization systems further may comprise a dynamic spine stabilizer configured to connect the first bone fastener and the second bone fastener with at least some relative movement between the first bone fastener and the second bone fastener.

Abstract: A reduced shock breakaway set screw for use with medical implants and constructs for the spine having improved geometry of the groove area between the upper head portion and lower threaded portion of the set screw. The groove area of the set screw has circular and noncircular portions which in at least one embodiment comprise upper and lower radii separated by a flattened groove bottom. Other embodiments have apertures running between the groove area and an internal cylindrical bore and/or ridges or ribs running across the groove area. The improved geometry serves to slow down the fracturing process during shearing thereby increasing the proportion of energy dissipated as heat from plastic deformation of the material to the amount of energy released as kinetic energy from elastic deformation, thus reducing shock to the patient and physician without changing the preset break-off torque for the set screw.

Abstract: A closure for an open headed medical implant, such as a bone screw. The closure having a cylindrical body having an axis of rotation and also having a radially outer surface with a thread or other guide and advancement structure thereon. The body having a plurality of apertures that open onto a top surface of the body and that are parallel to but spaced from the axis of rotation. The closure also has a break-off head centrally attached by a neck to the top surface of the body.

Abstract: A bone anchoring element includes an anchoring section for anchoring in the bone and a receiving part connected to the anchoring section. The receiving part includes an opening suitable for accommodation of a stabilization rod having a rod axis, the opening being limited along the rod axis by two side walls. The side walls include guides orientated along the rod axis for guiding at least one connection rod therethrough.

Abstract: An interspinous spacer assembly for insertion and/or implantation between spinous processes of adjacent superior and inferior vertebrae includes an interspinous spacer member sized and configured for insertion into the interspinous space located between adjacent spinous processes and an engagement mechanism for operatively coupling the spacer member to the adjacent spinous processes and for preventing migration of the assembly once implanted. The interspinous spacer assembly is adjustable to conform to the individual anatomy of a patient's spine.

Abstract: Provided is a bi-dimensionally adjustable spacing device configured to be placed between the spinous processes of at least two adjacent vertebrae and also adjusted laterally to securely contact the lateral surfaces of the spinous process. A method of using the device to treat spinal disorders is also provided.

Abstract: A spinal implant includes an elongated body dimensioned and configured to function as a spacer, for placement in a target interspinous process space, between two adjacent spinous processes, a distal anchor associated with a distal end of the body, and a proximal anchor mounted for longitudinal movement along the body between a first position spaced apart from the head and a second position approximated with the head, adapted to compress the two adjacent spinous processes, in conjunction with the distal anchor.

Abstract: This application describes surgical instruments and implants for building a posterior fixation construct across one or more segments of the spinal column. More specifically, the application describes instruments and methods for building a posterior fixation construct across one or more segments of the spinal column in a minimally invasive fashion.

Abstract: A system for reducing deformities of the vertebrae in the spine includes a first reduction assembly, a second reduction assembly, and a reduction drive assembly. The first reduction assembly is configured for attachment to a first reduction tower that attaches to a first vertebra. The second reduction assembly is configured for attachment to a second reduction tower that attaches to a second vertebra. The reduction drive assembly includes an arcuate rack gear operably coupling the first reduction assembly to the second reduction assembly to translate the first reduction assembly relative to the second reduction assembly along an arcuate path in a first plane.

Abstract: Orthopedic fastener devices for fixation of fractured bones are disclosed. The orthopedic fastener device is in the form of an orthopedic fastener having an IM nail coated on its external surface with a bioabsorbable or biodegradable hydrogel. Also disclosed are hydrogel coated orthopedic fastener devices in the form of a K-wire or bone screw, a method for stabilizing a fractured long bone fracture by inserting an orthopedic fastener into the medullary canal of the bone and a kit for fastener implantation.

Abstract: A new shape changing bone implant and instrument for the fixation of structures to include bone tissue. This new implant stores elastic mechanical energy to exert force on fixated structures to enhance their security and in bone affect its healing response. This unique implant locks into bone and then simultaneously expands and shortens to lock into bone and then pull the bone segments together. This implant once placed changes shape in response to geometric changes in the implant's and bone's materials structure. The implant may be fabricated from any biocompatible material that acts elastically when deformed including but not limited to nitinol, stainless steel, titanium, and their alloys as well as polymers such as polyetheretherketone, silicone elastomer and polyethylene.

Abstract: A humeral nail device for fixing proximal humerus fractures and rotator cuff tears. The humeral nail device includes a flexible proximal humerus nail adapted to be inserted into a humerus and a fixation bracket attached to the nail adapted to repair soft tissue injuries.

Abstract: A device includes a housing and a locking assembly disposed within a spaced defined by the housing. The housing defines a hole that extends through the housing. The locking assembly is configured to allow the device to slide along an elongate orthopedic device in a first direction and to hinder the device from sliding along an elongate orthopedic device in a second direction that is opposite the first direction.

Abstract: An orthopedic plate has a first end and a second end each including a locking screw hole that receives a locking screw and spaced from that hole is a closed compression housing that extends from the bone-facing side of the plate and which receives a compression screw that forms an angle of from about 10° to about 70° with a longitudinal axis of the plate. The first and second compression housings are offset from each other and have opposing openings that face toward each other so as to allow the screws projecting therethrough to have crossing directions.

Abstract: A surgical plate device that incorporates a screw locking mechanism in each screw hole by which the surgical plate device is affixed to a bony segment. The screw locking mechanism includes a tab structure emanating from an interior portion (or either surface) of the surgical plate that is biased into a portion of the corresponding screw hole. When a screw is inserted into the screw hole, the head of the screw temporarily biases the tab structure out of the screw hole, until the head of the screw passes below the plane of the tab structure, at which point the tab structure rebounds into the previously occupied portion of the screw hole, thereby covering a portion of the head of the screw and preventing it from “backing out.

Abstract: Systems, devices, and methods for longitudinal closure of a dissected sternum are provided. The system includes first and second reinforcing members, fasteners, and closure members. Each reinforcing member is configured to be placed on an outer surface of a respective sternum portion, such that each reinforcing member is longitudinally disposed on an opposite side of a sternum opening with respect to the other reinforcing member. Fasteners may be placed in holes defined in the reinforcing members to secure a respective reinforcing member to a corresponding sternum portion. The closure members, which may be sternal closing wires, may then be wrapped around the sternum portions and the reinforcing members transversely to close the sternum opening. Because the reinforcing members include extended regions having lateral edges that extend away from a midline of the respective reinforcing member, the closure members are moved away from the edges of the bone.

Abstract: An anchoring device includes (a) a flexible member extending from a proximal end to a distal end and (b) an elongated anchor member extending from a first end to a second end and attached to the distal end of the flexible member such that the anchor member is movable between an insertion configuration in which the anchor member is substantially parallel to the flexible member and a locked configuration in which the anchor member is substantially perpendicular to the flexible member in combination with (c) a flexible removal element extending from a proximal end to a distal end attached to the first end of the anchor member.

Abstract: A surgical bone fixation screw having a head, an end segment distally from the head and an intermediate shank having outwardly protruding screw threads. The improvement is a self guiding, threadless, elongated end segment having a smooth outer surface with no cutting edges, a length of at least 8 mm and preferably 15 mm and a bluntly rounded end with an outer contour that is smoothly blended to the shank. Most preferably, the bluntly rounded end is substantially a prolate hemispheroid.

Abstract: A woven retention device for interfacing with a bone surface is provided that includes a sleeve body that can surround a fastener, a proximal end for receiving the fastener, and a distal end. The sleeve body includes interwoven monofilaments of different diameters forming a substantially tubular lattice with protuberances distributed on interior and exterior surfaces of the lattice at a predetermined spatial relationship. In a first state, the sleeve body has a plurality of combinations of filament cross-section geometries at the intersection points, forming a plurality of protuberance thicknesses as measured in a radial direction of the sleeve body. In a second state when a fastener is inserted into the tubular lattice, pressure from the fastener is transmitted to the tubular lattice such that the spatial relationship of the protuberances changes according to a function of bone density and an interfacing surface shape of the fastener.

Abstract: A bone cement system according to the present disclosure includes a housing, a dispenser housing, a plunger, and a pressure release system. The housing has a proximal end, a distal end, and a throughbore that extends from the proximal end to the distal end. The dispenser housing is received in the throughbore and is adapted to receive bone cement. The plunger is releasably coupled to the proximal end of the housing and received into the dispenser housing so that movement of the plunger relative to the dispenser housing dispenses bone cement from the distal end of the housing. The pressure release system is coupled to the housing and includes a body that is movable within a plane perpendicular to a longitudinal axis of the housing, without translating the body along the longitudinal axis of the housing, to reduce the pressure of bone cement exiting the distal end of the housing.

Abstract: Systems and methods for height restoration and stabilization of a bone structure. An expandable member is directed in a contracted state to a first target site within the bone structure. The expandable member is transitioned from a contracted state to an expanded state within the bone structure. A curable material is delivered to a second target site within the bone structure while the expandable member remains in the expanded state within the bone structure at the first target site. The expandable member is transitioned from the expanded state to the contracted state. The expandable is removed member from the bone structure. Transitioning the expandable member to the expanded state may alter the vertebral body from a fractured height to a restored height greater than the fractured height. The curable material may be delivered within the vertebral body while the first expandable member maintains the vertebral body at the restored height.

Abstract: A surgical rod scorer is provided. The surgical rod scorer includes a pair of elongated shaft members that are pivotably coupled to one another and movable from a spaced-apart configuration to an approximated configuration. Each of the shaft members includes a handle member that is configured for gripping by a user and jaw member that is configured to support respective first and second cutting assemblies thereon. The first and second cutting assemblies each include one or more cutting elements thereon configured and dimensioned to score surgical rod when the jaw members are in the approximated configuration and rotated about the surgical rod.

Abstract: Systems and associated methods for repairing first and second bone fragments include a bone compression device characterized by an elongated fastener and an anchor. The fastener includes an externally-threaded shank, an enlarged head, and a bore extending through both. The anchor includes an internally-threaded bore configured to receive the threaded shank of the fastener at a first end of the anchor, and an enlarged shoulder at a second end. The fastener inserts fittedly into a first bore formed in the first and second bone fragments, with the head engaging a rim of the first bore. The anchor inserts fittedly into a second bore formed in the second bone fragment, the anchor shoulder engaging a rim of the second bore. During compression of the bone segments, a small space is maintained between the second end of the anchor and an intersection of the first bore and the second bore.

Abstract: Various embodiments of a device for tensioning an apparatus for fusion, stabilization, and/or fixation of bones are disclosed. In one embodiment, a device for tensioning an orthopedic device is provided, the device comprising: a screw drive; a screw gear; a body portion comprising a first cam lever and a second cam lever; and a cable operatively connected to the orthopedic device and operatively connected to the body portion; wherein rotation of the screw gear causes translation of the screw drive.

Abstract: An instrument and method for applying thermal energy to targeted tissue. An instrument and method for tissue thermotherapy. In one embodiment, a method includes providing a vapor source comprising a pump configured for providing a flow of liquid media from a liquid media source into a vaporization chamber having a heating mechanism, actuating the pump to provide the liquid into the vaporization chamber, applying energy from the heating mechanism to convert a substantially water liquid media into a minimum water vapor level for causing an intended effect in tissue. For examples such levels can comprise at least 60% water vapor, at least 70% water vapor, at least 80% water vapor or at least 90% water vapor for causing an intended effect in tissue.

Abstract: An apparatus includes a body, a shaft, an ultrasonic element, and an annular clamp pad. The shaft extends distally from the body. The ultrasonic element is located at the distal end of the shaft. The ultrasonic element includes a distally presented annular face. The clamp pad is movable toward the distally presented annular face of the ultrasonic element. When tissue is compressed between the clamp pad and the distally presented annular face of the ultrasonic element, the ultrasonic element may be activated with ultrasonic energy. The resulting ultrasonic vibrations may sever and seal the tissue captured between the distally presented annular face and the clamp pad, resulting in an anastomosis. The apparatus may thus be used to join two hollow tubular tissue structures, such as portions of a gastrointestinal tract.

Abstract: Thermochemical ablation techniques may provide ablation of bodily tissue using chemical reaction energy.

Abstract: Embodiments of the invention are directed to a medical device with a handpiece that provides enhanced comfort of use, maneuverability, and for a variety of hand-held options to the user. Embodiments of the invention include handpieces that include a grip panel comprised of a friction-enhancing material to facilitate gripping of the handpiece by an operator. In addition, embodiments of the invention include handpieces having a generally symmetrical configuration in order to facilitate grasping by an operator's left or right hand.

Abstract: An apparatus and method for performing cardiac ablations employs a catheter comprising an anchoring device and an ablating device to perform the ablations to electrically isolate the pulmonary veins and left atrium from surrounding atrial tissue. The anchor can comprise a balloon-type device, a stent-like device, a strut-like device, a spring-strut-like device, an umbrella-like device, a mushroom-like device, or other device that allows the catheter to maintain a position with respect to target tissue. The ablator can comprise a balloon ablator, an umbrella ablator, a pinwheel ablator, an umbrella ablator incorporating a cinch mechanism, a mushroom balloon ablator and a segmented balloon or pinwheel ablator. The anchor and ablator can also comprise a combination mushroom balloon anchor section and mushroom balloon ablator section. The anchor and ablator can include electrodes for measuring a conductance therebetween when in deployed position, so as to determine the effectiveness of the ablation.

Abstract: Bipolar electrosurgical forceps are provided with dual irrigating tubes that deliver irrigating liquid to the opposed surfaces of the tips of the forceps to prevent the sticking of body tissue to the tips. To reduce the manufacturing costs of the forceps and enable the forceps to be single use, disposable forceps, each tube of the dual irrigating tools is a plastic tube adhered along one of the opposing surfaces of the pair of forceps arms. Each tube also has a flat nozzle at the distal end of the tube that disburses irrigating liquid across the opposed surfaces of the forceps arm distal and tips.

Abstract: A medical treatment device to treat and join body tissues, includes at least a pair of holding members which is configured to hold the body tissues to be treated, an energy output portion provided on at least one of the pair of holding members and connected to an energy source to form a joined portion by supplying energy to the body tissues held by the pair of holding members to join the body tissues, and a join condition maintenance assistance portion capable of applying a substance which prevents infiltration of the fluid to the body tissues to be treated to provide assistance so that a joined state of the body tissues is maintained.

Abstract: A bipolar electrosurgical instrument has a handle and an operation tool. The operation tool is mounted on a front end of the handle and has multiple holes densely formed in and spread over at least one working surface of the operation tool. With the multiple holes formed on the at least one working surface of the operation tool, tissues of a surgical site can be heated uniformly and adhesion of the surgical site is minimized. Moreover, since the multiple holes are directly formed on the at least one working surface, the multiple holes do not become shallow under long-term use and no toxic gas would be released when the operation tool is heated to high temperature. Accordingly, anti-adhesion effect of the operation tool and health of medical staffs can be assured.

Abstract: Embodiments of a guide and flexible sleeve for use with catheters for ablation or other medical procedures are disclosed. An exemplary catheter comprises a guide element having a proximal end and a distal end, the distal end configurable in a desired shape. A flexible sleeve is conformable to the guide element so that the flexible sleeve slides over the guide element, the flexible sleeve has a proximal end and a distal end. A controller couples to the flexible sleeve. The controller operates to move the flexible sleeve at least part way between the distal end of the guide element and the proximal end of the guide element. At least one ablation element disposed at the distal end of the flexible sleeve operates to form a substantially continuous ablative lesion when the flexible sleeve is in contact with a contiguous volume of target tissue.

Abstract: Medical device systems, methods and devices are provided for treating a valve in a heart to minimize valve regurgitation. The medical device system includes an RF energy source, a handle, a treatment catheter, and a treatment device. The handle is operatively coupled to the RF energy source and coupled to the treatment catheter. The treatment device includes exposed electrode portions of one or more electrodes operatively coupled to the RF energy source and configured to contact tissue of a valve annulus. Further, one or more of the exposed electrode portions include a marker associated therewith. With this arrangement, a physician may view the one or more markers and selectively activate particular exposed electrode portions with RF energy to selectively treat a portion of the valve annulus.

Abstract: A medical device for tissue ablation may include a catheter shaft, an expandable member disposed on or coupled to the catheter shaft, and a plurality of elongate electrode assemblies each constructed as a flexible circuit. The expandable member may be configured to shift between an unexpanded configuration and an expanded configuration. The plurality of electrode assemblies may be disposed on an outer surface of the expandable member. Each of the plurality of electrode assemblies may include a temperature sensor aligned with two or more electrodes.

Abstract: Cardiac catheterization is conducted using a probe having a balloon assembly, in which a spring has a resting axially elongated configuration and a torsed, axially shortened configuration. An inflatable balloon is twisted about the spring and mechanically linked to the spring. A flexible sheath is disposed about the spring within the balloon, the sheath and the wall of the balloon defining a chamber to contain a fluid flowing therein and thereout for inflation of the balloon and deflation of the balloon so as to energize and de-energize the spring.

Abstract: A method and apparatus for treatment of heart failure, hypertension and renal failure by stimulating the renal nerve. The goal of therapy is to reduce sympathetic activity of the renal nerve. Therapy is accomplished by at least partially blocking the nerve with drug infusion or electrostimulation. Apparatus can be permanently implanted or catheter based.