Abstract: The present disclosure provides systems and methods for implanting an implantable cardiac monitor. An injection system includes an implantable cardiac monitor (CM), a plunger, a plunger handle coupled the plunger, and an injector housing. The injector housing includes a tube extending from a first end of the injector housing to a second end of the injector housing, the tube configured to receive the ICM and the plunger, and at least one leaflet formed at the second end of the injector housing, the at least one leaflet configured to rotate outward when a user operates the plunger handle to push the ICM through the injector housing second end via the plunger.

Abstract: Methods and systems for accessing an operating cavity when performing endoscopic surgery comprising. The systems and methods include at least one obturator-free cannula unit and a trocar assembly. The trocar assembly includes a single dedicated functional obturator independent of the cannula unit and an endoscopic cannula. The invention also provides a system and methods for providing continuous flow of carbon dioxide during a laparoscopic procedure.

Abstract: A uterine manipulator device includes a shaft including a proximal end and a distal end, a cervical cup positioned on the shaft near the distal end, and a cutting tool. The cervical cup includes a first base and an annular wall with a rim. The cutting tool positioned along the rim of the cervical cup is rotatably coupled to the rim.

Abstract: External fixator assemblies, systems, and methods thereof. An external fixator system may include a plurality of fixator assemblies configured to connect a plurality of pins, for example, positioned on opposite sides of a fractured bone, with one more rods. The fixator assemblies may include a plurality of clamp assemblies which are configured to rotate relative to one another when the fixator assembly is in an unlocked position.

Abstract: External fixator assemblies, systems, and methods thereof. An external fixator system may include a plurality of fixator assemblies configured to connect a plurality of pins, for example, positioned on opposite sides of a fractured bone, with one more rods. The fixator assemblies may include a plurality of clamp assemblies positioned along a shaft and which are configured to rotate relative to one another when the fixator assembly is in an unlocked position.

Abstract: A pectus excavatum correction apparatus includes two pectus bars each made of a stick plate. Each bracket of the apparatus has a plate shape with a length-direction bent part. The first side of the bent part is hooked onto an upper or lower part of a rib and a second side of the bent part faces an outer surface of the pectus bar. Each of a first and second bridge has through-holes provided in two length-direction ends of the bridge. Each coupling unit includes a supporting part provided between the rib and the pectus bar, a slide protruding from an outer surface of the supporting part, and a second coupling part coupled to the first coupling part to press and fix the pectus bar, the bracket, and the bridge. The second distance is greater or less than the first distance within a preset range.

Abstract: An adjustable spinal implant device, comprising: a sliding portion provided with a tongue; and, a non-sliding portion provided with a slot adapted for receipt of the tongue; wherein the tongue is slidably and rotatably positioned within the slot. Methods of use include adjusting a spinal implant to an implant site by at least one of sliding and rotating at least a first portion with respect to a second portion of the implant; and, securing the spinal implant to the implant site.

Abstract: A percutaneous access device includes an inner tube and an outer tube disposed about at least a portion of the inner tube. The outer tube may be sized to span from a skin incision in a patient to a site proximate the spine of the patient. The distal end of the outer tube may be adapted to releasably engage a bone anchor. The inner tube may be adjustable relative to the outer tube between a first position and a second position in which the distal end of the inner tube contacts the bone anchor. A bone anchor assembly includes a bone anchor having a distal bone engaging portion and a receiving member having a recess for receiving a spinal fixation element. The proximal end of the receiving member may have an arcuate groove formed on an exterior surface thereof to facilitate connection of an instrument to the receiving member.

Abstract: A percutaneous access device includes an inner tube and an outer tube disposed about at least a portion of the inner tube. The outer tube may be sized to span from a skin incision in a patient to a site proximate the spine of the patient. The distal end of the outer tube may be adapted to releasably engage a bone anchor. The inner tube may be adjustable relative to the outer tube between a first position and a second position in which the distal end of the inner tube contacts the bone anchor. A bone anchor assembly includes a bone anchor having a distal bone engaging portion and a receiving member having a recess for receiving a spinal fixation element. The proximal end of the receiving member may have an arcuate groove formed on an exterior surface thereof to facilitate connection of an instrument to the receiving member.

Abstract: Devices, systems and methods for dynamically stabilizing the spine are provided. The devices include an expandable spacer having an undeployed configuration and a deployed configuration, wherein the spacer has axial and radial dimensions for positioning between the spinous processes of adjacent vertebrae. The systems include one or more spacers and a mechanical actuation means for delivering and deploying the spacer. The methods involve the implantation of one or more spacers within the interspinous space.

Abstract: A spinal implant includes an intermediate portion and a first portion extending in a transverse orientation from the intermediate portion. The first portion includes an inner surface connectable with vertebral tissue adjacent a lamina. A second portion is spaced from the first portion and extends in a transverse orientation from the intermediate portion. The second portion includes an inner surface connectable with vertebral tissue adjacent a lamina. At least one of the first portion and the second portion includes an outer surface having a mating element engageable with a mating element of a surgical instrument. Systems, surgical instruments and methods are disclosed.

Abstract: A method for manipulating a vertebra includes connecting a first bone anchor to a first vertebra, connecting a second bone anchor to a second bone anchor, positioning a spinal rod in a receiving member of the first bone anchor and in a receiving member of the second bone anchor, connecting a first instrument to the receiving member of the first bone anchor, and manipulating the first instrument to rotate first bone anchor and the first vertebra relative to the second vertebra.

Abstract: Joint implants, such as joint implants used for placement in toes to treat hammertoe are described. More particularly, joint implants that include a proximal portion configured to be inserted into a first bone, a distal portion configured to be inserted into a second adjacent bone, and an elongated body positioned between the distal and distal portion is described. The elongated body can define a length and include at least one metal rod extending from the proximal portion to the distal portion and a porous mesh extending along at least a portion of the elongated body length. The porous mesh can be configured to allow for bony in-growth upon implantation, wherein the elongated body defines a generally square cross section and is configured to be inserted into drilled circular holes in the first and second hones. Methods of fusing two adjacent phalanges of a two are also described.

Abstract: This disclosure relates to bone fixation plate and a system for treatment of injuries of the distal tibiofibular syndesmosis. The bone fixation plate provides an improved stability to the distal fibula.

Abstract: A bone plate according to an exemplary aspect of the present disclosure includes, inter alia, a body portion. The body portion includes a first slotted portion extending at least partially through the body portion and a plurality of teeth adjacent the first slotted portion for engaging a driver in the first slotted portion. The body portion also includes a second slotted portion extending at least partially through the body portion and a ramped portion at least partially surrounding the second slotted portion. The ramped portion tapers from an outer surface of the body portion toward an inner surface of the body portion.

Abstract: Bone plates for rigidly fixing fragments of a bone to one another are provided. In certain aspects, the apparatus is a bone plate that has an outer edge that conforms to a shape of a pedicle and/or lamina of the vertebra or a long bone, and an inner section that facilitates access to the fractured area when the plate is secured to the bone.

Abstract: A three-dimensional mini-plate with an oblique orientation for use in immobilizing fractures in facial bones such as the mandible. The plate's oblique orientation permits it to be better matched to oblique fractures such that its edges do not interfere with tooth roots or the inferior margin of the mandible.

Abstract: A first method, for reducing and stabilizing at least one of a fracture in, a dislocation of, and a subluxation of at least one bone, includes forming a hole in the at least one bone. The first method also includes anchoring a first portion of a cable relative to the at least one bone and positioning a second portion of the cable in the hole in the at least one bone. With the second portion of the cable positioned in the hole in the at least one bone, the method includes both tensioning the cable to a measurable and adjustable tension and, with the cable tensioned to the measurable tension, anchoring a third portion of the cable relative to the at least one bone.

Abstract: An apparatus for anchoring cable to bone includes an anchor configured to be anchored in a bone and a cable fixed to the anchor. The cable is configured to be tensioned to a measurable and adjustable tension to cause a measurable and adjustable compression of the bone by the cable. The apparatus may include a cable housing having a proximal portion, a distal portion, and a passage. The distal portion is detachably and co-rotatably engageable with the anchor and the passage is open to and extends from a distal end of the distal portion. The apparatus also includes a cable having a fixed-end portion and a free-end portion. The fixed-end portion of the cable is fixed to the anchor and the free-end portion of the cable is non-fixedly positionable in the passage of the cable housing.

Abstract: Fiber-reinforced polymer matrix composite material bone screws having threads surfaced with a metallic layer are described. In some embodiments, the metallic layer comprises a plurality of anchors placed to engage with the composite material and resist shearing when the bone screw is inserted or removed.

Abstract: A washer for supporting a through-bone cable extending through a pass-through hole in bone includes a bone-engaging surface, a cable-engaging surface opposing the bone-engaging surface, a pass-through aperture extending through the washer along a first axis from the bone-engaging surface to the cable-engaging surface, and a channel extending from proximate the pass-through aperture along a second axis where the second axis is non-parallel to the first axis.

Abstract: Disclosed herein is a washer assembly for use with a bone. The washer assembly comprises a first portion, comprising a first washer, a first stem non-movably fixed to and extending from the first washer, and a first internal channel defined by the first washer and the first stem. The washer additionally includes a second portion, comprising a second washer, a second stem non-movably fixed to and extending from the second washer, and a second internal channel defined by the second washer and the second stem. The first portion is movable relative to the second portion, to adjust a distance between the first washer and the second washer, and the first internal channel of the first washer is retained in coaxial alignment with the second internal channel of the second washer as the first portion moves relative to the second portion.

Abstract: A fastener assembly that can be used for the fixation or anchoring of orthopedic devices or instruments to bone tissue. In particular, a low profile variable angle or fixed angle fastener assembly is able to securely connect the orthopedic device to bone tissue. The fastener assembly may have a locking mechanism that will quickly and easily lock the fastener assembly with respect to the orthopedic device.

Abstract: A cement-directing structure for use in cement-injection bone therapy includes a collapsible, self-restoring braided structure with regions of differential permeability to the bone cement. The regions of differential permeability may be provided by areas where the braided mesh density is greater or lesser than surrounding areas and/or by means of a baffle. After the structure is placed in a void within a bony structure, cement is injected into the interior of the structure then oozes out in preferred directions according to the locations of the regions of differential permeability.

Abstract: The invention relates to a mixing device for mixing PMMA bone cement from a monomer liquid and a cement powder, the mixing device comprising at least one cartridge having an evacuable interior for mixing of the bone cement, a mixing device for mixing the content in the interior of the at least one cartridge, which is arranged movably in the interior, a receptacle for receiving a separate container containing the monomer liquid or comprising an integrated container containing the monomer liquid, an opening device, which is arranged in the region of the receptacle in a manner movable relative to the receptacle so that, by moving the opening device, a separate container arranged in the receptacle is openable by means of the opening device, or the opening device is arranged in the region of the integrated container in a manner movable relative to the integrated container so that, by moving the opening device, the integrated container is openable by means of the opening device, a pressure pump, in which a movable

Abstract: An apparatus for crimping a cable, the apparatus including a crimp body, an elongate shaft, a neck coupling and interposed between the crimp body and the elongate shaft, and a central passage extending through the crimp body, neck, and elongate shaft. The cross-sectional dimension of the central passage is at least large enough to receive the cable.

Abstract: The disclosed technology is directed to a RF power generator and feedback control system used to regulate the electrical power delivered to a cutting filament (i.e., a cutting electrode) of an electrosurgical instrument. The electrosurgical instrument uses the delivered energy to form a cutting arc for ablating a tissue mass to access a target tissue therein. The instrument forms a basket-like receptacle around the target tissue to excise the target tissue from the ablated tissue mass. As the instrument forms the receptacle, the length of exposed filament ablating the tissue changes. To this end, the RF power generator described herein is configured to vary the total power delivered during the deployment of the instrument based on a measurement of output power derived from a differential phase angle between a current sense output and a voltage sense output, in some embodiments, to maintain a uniform power density along the length of exposed filament.

Abstract: The current invention concerns systems, devices and methods for the ablation of a vessel's wall from the inside, more specifically to implant devices and to the ablation of the wall of one or more pulmonary veins (PV) from the inside, preferably transmural ablation and preferably at the level of the antrum. Hereby, one or more implant devices can be implanted in the vessels and can subsequently be heated by external energy-providing means.

Abstract: A surgical apparatus and methods for severing and welding tissue, in particular blood vessels. The apparatus includes an elongated shaft having a pair of relatively movable jaws at a distal end thereof. A first heating element on one of the jaws is adapted to heat up to a first temperature and form a welded region within the tissue, while a second heating element on one of the jaws is adapted to heat up to a second temperature and sever the tissue within the welded region. The first and second heating elements may be provided on the same or opposite jaws. A control handle provided on the proximal end of the elongated shaft includes controls for opening and closing the jaws, and may include an actuator for sending current through the first and second heating elements. The first and second heating elements may be electrically connected in series, and the first heating element may be bifurcated such that it conducts about one half of the current as the second heating element.

Abstract: The present disclosure relates to systems and methods for regulating, maintaining and/or controlling the temperature of fluids and tissues during therapeutic or ablative tissue treatment applications. In particular, the present disclosure relates to a multi-purpose subassembly that is easy to use, supports all infusion and fluid-cooled ablation systems, and readily and reliably accepts a variety of tubing designs to decrease preparation time and minimize user error during setup and use.

Abstract: This disclosure is directed to an ablation electrode having a cylindrical body in which a first conducting layer has an exterior surface and an interior surface and a second conducting layer is connected to a desired position on the interior surface of the first conducting layer forming a thermocouple at the desired position.

Abstract: A device for treating a tissue includes a capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough, the capsule releasably coupled to a proximal portion of the device and clip arms, proximal ends of which are slidably received within the channel of the capsule so that the clip arms are movable between an open configuration, and a closed configuration. A core member is coupled to the clip arms, the core member including a proximal portion and a distal portion releasably connected to one another so that, when the core member is subjected to a predetermined load, the proximal and distal portions are separated from one another. An electrically conductive control member is connected to the core member, a proximal end of the connected member connected to a power source for delivering an electrical current to the clip arms.

Abstract: A radiowave current electrode having a shank for connection to a source of radiowave current or electrosurgical RF energy and at one end an active radiowave current electrode, the active end being shaped to perform a radiowave current procedure involving the application of the RF energy from an electrically conductive active surface of the active end to tissue to modify the tissue, the active surface having a plurality of spaced outwardly-projecting regions each shaped such that its outermost region is equal to or narrower than its innermost region, and such that more of the RF energy emanating from the active surface and passing to the tissue occurs via the outwardly-projecting regions. As a further feature, an adjacent section of the active end is coated with a substantially transparent insulating layer consisting essentially of a parylene plastic to render it inactive.

Abstract: An end effector assembly is provided. The end effector assembly includes a pair of first and second jaw members including respective seal plates adapted to connect to a source of electrosurgical energy. The first and second jaw members operable in a first bipolar mode of operation for treating tissue and a second bipolar mode of operation for separating tissue. A dissector translatable through one of the first and second jaw members is in electrical communication with one of the seal plates of the first and second jaw members and activatable in the second bipolar mode of operation for separating tissue when the first and second jaw members are in one of the open and clamping position and tissue is adjacent thereto.

Abstract: An end effector assembly for use with an instrument for sealing vessels and cutting vessels includes a pair of opposing first and second jaw members which are movable relative to one another from a first spaced apart position to a second position for grasping tissue therebetween. Each jaw member includes a pair of spaced apart electrically conductive tissue contacting surfaces which each have an insulator disposed therebetween, the conductive surfaces are connected to an electrosurgical energy source. The first jaw member includes an electrically conductive cutting element disposed within the insulator which extends towards the second tissue contacting surface to create a gap therebetween. The cutting element is inactive during the sealing process while the two pairs of electrically conductive surfaces are activated to seal tissue.

Abstract: A surgical instrument probe or electrode including an elongated shaft with a rod having an end effector on a distal end of the elongated shaft, a sealing means, and a pencil hub on a proximal end of the elongated shaft. The end effector on the distal end of the elongated shaft may be a hook or a spatula, and the rod may be attached to an electrosurgical energy source to enable the end effector to perform a cauterizing function. The rod may be between about 100 mm to about 400 mm and include a diameter of less than about 3 mm.

Abstract: Systems and methods are disclosed for providing and using an irrigated ablation catheter. The catheter includes a distal electrode assembly having a plurality of spines forming a basket shaped electrode assembly in communication with a system controller. The catheter also includes a pull-wire disposed within a lumen of a spine collar. The spine collar further includes a silicone seal for preventing encroachment of irrigation fluid and other bodily fluids into the pull-wire lumen.

Abstract: Apparatus and methods are described, including an expandable structure and one or more sets of electrodes disposed on the surface of the expandable structure. Each one of the sets comprises an ablating electrode, and at least one sensing electrode that is electrically isolated from the ablating electrode. The sensing electrode is contained within the ablating electrode. Other embodiments are also described.

Abstract: A method for treatment evaluation includes applying energy through a probe to ablate tissue at a plurality of sites in an organ in a body of a patient, thereby creating lesions in the tissue including at least first and second lesions at respective first and second, mutually-adjacent sites. Location coordinates and respective treatment parameters are recorded at each of the sites with respect to the applied energy. Based on the recorded treatment parameters, respective measures of size of the lesions are computed, including at least respective first and second measures of the first and second lesions. An indication of contiguity between at least the first and second lesions is generated responsively to the first and second measures and to a distance between the location coordinates of the first and second sites.

Abstract: Guided ablation instruments are disclosed for creating lesions in tissue, especially cardiac tissue for treatment of arrhythmias, including atrial fibrillation. In one aspect of the invention, a percutaneous catheter is disclosed with an endoscope positionable in the instrument's distal end region to obtain an image. The image allows the clinician to determine whether contact has been achieved (or blood has been cleared from an ablative energy transmission path) before ablation begins or while ablation is occurring. In one embodiment, percutaneous ablation catheters are disclosed having at least one central lumen and one or more balloon structures at the distal end region of the instrument. Also disposed in the distal end region are an illuminating light source and an endoscope capable of collecting sufficient light to relay an image to the user. The instruments can further include an ablation element.

Abstract: Systems, methods and devices for creating an effect using microwave energy to specified tissue are disclosed herein. A system for the application of microwave energy to a tissue can include, in some embodiments, a signal generator adapted to generate a microwave signal having predetermined characteristics, an applicator connected to the generator and adapted to apply microwave energy to tissue, the applicator comprising one or more microwave antennas and a tissue interface, a vacuum source connected to the tissue interface, a cooling source connected to said tissue interface, and a controller adapted to control the signal generator, the vacuum source, and the coolant source. The tissue may include a first layer and a second layer, the second layer below the first layer, and the controller is configured such that the system delivers energy such that a peak power loss density profile is created in the second layer.

Abstract: A microwave ablation system includes an antenna assembly configured to deliver microwave energy from a power source to tissue and a coolant source operably coupled to the power source and configured to selectively provide fluid to the antenna assembly via a fluid path. The system also includes a controller operably coupled to the power source and a sensor operably coupled to the fluid path and the controller. The sensor is configured to detect fluid flow through the fluid path and the controller is configured to control the energy source based on the detected fluid flow.

Abstract: The present application relates to a device (10) for cutting hair. The device (10) has a skin contacting face (13) that is arranged to be placed against a surface of the skin (16) of a user during use, and an optical system (20) configured to direct a cutting laser beam (18) across a cutting zone (15) parallel to and spaced from said skin contacting face (13) to cut hairs (17) extending into the cutting zone (15). The device also has a detector (40) configured to generate information indicative of the presence of one or more objects representative of hair (17) and/or skin (16) in the cutting zone (15), and a controller (27). The controller (27) is able to determine the presence of one or more objects representative of hair (17) and/or skin (16) in the cutting zone (15) and to adjust one or more characteristics of the optical system (20) in dependence on the information generated by the detector (40).

Abstract: The present invention relates to a method for determining a state of tissue sealing during a tissue sealing process. According to the disclosed method, an optical probe beam is used to irradiate a tissue region. A signal indicative of optical scattering in the tissue region is generated from a portion of the optical probe beam that has passed through or been returned by the tissue region. The onset of tissue sealing is indicated by the successive occurrence in time of a turning point and a point of inflection in the optical scattering signal. An energy-based tissue sealing or tissue-cutting device for use in accordance with the method is also disclosed.

Abstract: The present disclosure is directed to orthopedic implants and methods of rapid manufacturing orthopedic implants using in vivo data specific to an orthopedic implant or orthopedic trial. Specifically, the instant disclosure utilizes permanent orthopedic implants and orthopedic trials (collectively, “implants”) outfitted with kinematic sensors to provide feedback regarding the kinematics of the trial or implant to discern which implant is preferable, and thereafter rapid manufacturing the implant.

Abstract: An instrument for treating tissue during a medical procedure includes a hand-held portion and a working portion. The hand-held portion is manually supported and moved by a user and the working portion is movably coupled to the hand-held portion. A tracking device is attached to the hand-held portion for tracking the instrument. The tracking device is in communication with a control system, which is used to keep the working portion within or outside of a boundary. A plurality of actuators are operatively coupled to the working portion. The control system instructs the actuators to move the working portion relative to the hand-held portion during the medical procedure in order to maintain a desired relationship between the working portion and the boundary.

Abstract: The present invention relates to a system and method to aid the placement of surgical devices under radiographic image guidance. More particularly, embodiments of the invention relate to a system utilizing radiopaque markers, an external light source projected onto the skin or surgical site in conjunction with a target guide holder. Using a radiographic image to identify landmarks for skin entry and bone entry points to facilitate the accurate placement of surgical devices. An exemplary system utilizes a radiopaque marker, target guide holder and external laser markers to determine intra-operative angles, trajectories and positioning coordinates to facilitate placement of needles, guide wires, surgical hardware, trocars and cannulae for the surgical placement of orthopedic implantation devices.

Abstract: A system for controlling a treatment device includes a system for visually tracking different axially spaced tissue levels and treatment regions within each axially spaced tissue level for application of radiofrequency energy by electrodes of a device to a body region of a patient to perform a surgical procedure, the system comprising a graphic display configured to display a plurality of tissue level indicators, each tissue level indicator corresponding to one of the different axially spaced tissue levels, and a numeric indicator associated with each tissue level indicator configured to indicate a distance from a fixed reference to a designated region within the patient, the numeric indicator automatically changing in response to axial repositioning of the electrodes of the device within the patient.

Abstract: The robot for arteriography comprises a fixed base and a movable receptacle. The receptacle comprises a recipient receiving an elongate flexible member. A drive system drives the receptacle relative to the base. The receptacle comprises a drive module rigidly connected to the elongate flexible member in translation in operational configuration of the robot. The drive module is actuated in order to generate a rotational movement of the elongate flexible member.

Abstract: A surgical system uses a single entry port in a wide variety of surgeries. To insert multiple surgical instruments into a patient through a single entry port requires that the shaft (262A1) of at least one (260A1) of the surgical instruments be bent between the base of the surgical instrument (260A1) and the point where the shaft contacts a channel in an entry guide (270A). Each surgical instrument (260A1, 260A2) is positioned by an instrument manipulator positioning system (231A) so that when the shaft is inserted in a channel of the entry guide (270A), any bending of the shaft does not damage the surgical instrument and does not inhibit proper operation of the surgical instrument.