Abstract: Translation screw assemblies that can include a screw, housing, load plate, and collet are described herein. The translation screw assembly advantageously allows for relative translation, angulation or pivoting, and/or rotation between the screw and the housing. Occipital plate assemblies are also described herein. An occipital plate assembly can include a plate body and one or more rod receiving assemblies. The plate assembly can include an occipital protuberance tab that can be bent relative to or sheared off from the plate body. The rod receiving assembly can include a pivot post, housing, clamp plate, and retaining washer. The rod-receiving assemblies advantageously allow for relative medial-lateral translation, medial-lateral angulation, and/or cranial-caudal angulation between the rod-receiving assemblies or portions thereof (e.g., the housings) and plate body.

Abstract: A spinal implant assembly comprising an intervertebral device configured to be installed in a spinal disc space, the intervertebral device having a head component and a body component, the spinal implant assembly further comprising a coupling body for coupling the head component of the intervertebral device and an elongate member, the coupling body and head component each having a longitudinal axis, wherein the head component can be received by the coupling body with its longitudinal axis at a selected angle within a predetermined range of angles relative to the longitudinal axis of the coupling body.

Abstract: An apparatus for stabilizing an atlantoaxial junction while allowing for axial rotation in cases of acquired ligamentous injury or fracture of the dens.

Abstract: In some embodiments, a connector can be configured to couple a first fixation element (e.g., a first rod) to a second fixation element (e.g., a second rod). One or both of the first and second fixation elements can be included with the connector, or one or both can be separately provided. In some instances, at least one of the fixation elements is previously implanted in a patient. The connector can provide one or more degrees of freedom between the first and second fixation elements. The connector can also include a locking element configured to (1) lock one or more of the fixation elements to the connector, and (2) lock one or more of the degrees of freedom between the fixation elements. The connector can be configured to snap onto or otherwise engage a fixation element in a manner that provides tactile and/or audible feedback to the surgeon.

Abstract: An implantable device may be provided. The implantable device may comprise an upper assembly comprising a ramped base and a pair of opposing windows. The pair of opposing windows may extend upward from either lateral side of the ramped base. A gripping assembly may be disposed in each window. The implantable device may further comprise a lower assembly comprising a ramped base and a pair of opposing windows. The pair of opposing windows may extend down from either lateral side of the ramped base. A gripping assembly is disposed in each window. The implantable device may further comprise a ramped actuator assembly disposed between the upper assembly and the lower assembly. The ramped actuator may be configured to transition the implantable device from a collapsed form having a first height to an expanded form having a second height and wherein the second height is greater than the first height.

Abstract: Lamina plates can include various features that allow a surgeon to couple the plate to a vertebra, such as a plurality of receiving holes for receiving a spinal fixation element. The plate can be shaped and the receiving holes positioned such that spinal fixation elements can be installed with reduced exposure of the spine and along a trajectory that enhances purchase with bone. The lamina plate can include one or more features for coupling at least one receiver head to the plate for receiving a spinal stabilization element. Since the receiver head can be coupled to the plate after the plate is implanted, it does not restrict the range of angles or trajectories at which the spinal fixation elements can be installed.

Abstract: Provided is a bone joining device suitable for joining a first bone piece to a second bone piece. Also provided is a method of j oining a first bone piece with a second bone piece in a living mammal. The method comprises inserting the above bone joining device between the first bone piece and the second bone piece.

Abstract: An instrument for bending a surgical rod includes first and second arm assemblies. The first arm assembly includes first and second arms having respective first and second receiving portions configured to receive the surgical rod therein. The second arm assembly includes third and fourth arms having respective third and fourth receiving portions configured to receive the surgical rod therein. The instrument is reconfigurable from an initial configuration in which the first and third receiving portions of the respective first and third arms engage the surgical rod such that transitioning the first and third arms towards each other bends the surgical rod in a first orientation and transitioning the first and third arms away from each other bends the surgical rod in a second orientation opposite to the first orientation.

Abstract: Apparatus, including a multiplexer, having a first output and multiple first inputs receiving analog input signals and an analog feedback signal and cycling through and selecting the signals for transfer in sequential signal groupings to the first output. The apparatus also includes an amplification circuit, having a second output and a second input connected to the multiplexer first output, that amplifies signals corresponding to the analog input signals with a selected gain so as to generate respective amplified analog signals at the second output. Circuitry selects a characteristic of the respective amplified analog signals from an initial signal grouping, feeds the characteristic back for input to the multiplexer as the analog feedback signal, selects a subsequent characteristic of the respective amplified analog signals from a subsequent signal grouping, and adjusts the amplification circuit gain so that the analog feedback signal and the subsequent characteristic have the same amplitude.

Abstract: A catheter adapted to measure a contact force includes a proximal segment, a distal segment, a spring segment extending from the proximal segment to the distal segment, at least one magnet disposed on one of the proximal segment and the distal segment, and at least one inductive sensor disposed on the other one of the proximal segment and the distal segment opposite the at least one magnet. The spring segment is configured to permit displacement between the distal segment and the proximal segment in response to an application of the force on the distal segment. The at least one inductive sensor includes a first plate of high magnetic permeability material, and at least one coil disposed adjacent to the first plate of high magnetic permeability material. The coil is configured to output a signal indicative of the displacement between the inductive sensor and the opposite magnet.

Abstract: A system and method for determining the optimum dose of cryotreatment to an area of target tissue to achieve isolation based on the time to effect (TTE). The system may generally include a treatment device, a sensing device, and a processor programmed to calculate the optimum dose of cryotreatment, in seconds, based on TTE. The TTE may be based on electrical signals received by the processor from the sensing device. The processor may be further programmed to automatically terminate a cryoablation procedure when the optimum dose of cryotreatment has elapsed. The optimum dose of cryotreatment may be the time, in seconds, it takes to achieve isolation, which may be the time it takes for an area of tissue to reach approximately ?20° C.

Abstract: Electrosurgical wands. At least some of the illustrative embodiments are electrosurgical wands having features that reduce contact of tissue with an active electrode of a wand, decrease the likelihood of clogging, and/or increase the visibility within surgical field. For example, wands in accordance with at least some embodiments may comprise standoffs, either along the outer perimeter of the active electrode, or through the main aperture in the active electrode, to reduce tissue contact. Wands in accordance with at least some embodiments may implement slots on the active electrodes to increase bubble aspiration to help keep the visual field at the surgical site clear. Wands in accordance with at least some embodiments may implement aspiration flow pathways within the wand that increase in cross-sectional area to reduce the likelihood of clogging.

Abstract: Electrosurgical methods and systems. At least some of the illustrative embodiments are methods including maintaining plasma proximate to an active electrode in a first energy range, and a second energy range. During periods when plasma is proximate to the active electrode, the illustrative method may include controlling flow of fluid drawn into an aperture of an electrosurgical wand, and in some situations increasing fluid flow drawing into the aperture responsive to the active electrode being in operational relationship with tissue, and in other cases decreasing fluid flow drawing into the aperture responsive to the active electrode being in operational relationship with tissue. Further, during periods when plasma is proximate to the active electrode, the illustrative method may include providing output energy at a default energy setpoint, and then providing output energy at a second energy setpoint.

Abstract: The present invention relates to a cauterizing method for strengthening the circulation of gi • acupoints of a human body by using a moxibustion device.

Abstract: The present disclosure provides for a device and methods of use to endoluminally ablate and/or occlude a body vessel using a current to perform resistive heating. The device includes a resistive coil, which in some embodiments has a portion with a first, higher average pitch which can be electrified, and a second, lower average pitch, which is not electrified but aids in relieving mechanical stress. The device may have a support, which may be a wire guide, around which the coil is disposed. The device may provide a minimal diameter and flexibility for navigation of tortuous vessels.

Abstract: There is provided an energy device for surgical operation capable of suppressing fixation of body tissue, wherein a coating layer is formed on an outer periphery of a base material constituting an operational area portion transmitting energy in an energy device for surgical operation operating in the operational area portion, and is comprised of a base coating formed on the base material and an outermost coating formed on the base coating. The base coating is made from silicon oxide or a compound containing silicon oxide, and the outermost coating is made from polysiloxane or a compound containing polysiloxane or a compound containing a partly fluorinated polysiloxane, and the coating layer has a good adhesiveness and is applicable to a complicated form.

Abstract: A surgical instrument includes a housing, an energizable member, a proximal hub, and a deployment mechanism. The energizable member is movable between a storage position and a deployed position. The proximal hub is disposed within the housing, coupled to the energizable member, and translatable relative to the housing along a translation axis to deploy the energizable member. The deployment mechanism is configured to selectively translate the proximal hub and includes an actuator movable along a surface of the housing that extends in non-parallel orientation relative to the translation axis. The actuator is operably coupled to the proximal hub and is movable along the surface of the housing in non-parallel orientation relative to the translation axis between a proximal position and a distal position to translate the proximal hub along the translation axis and move the energizable member between the storage position and the deployed position.

Abstract: A surgical instrument includes an end effector assembly and a deployment mechanism for deploying a proximal hub associated with an energizable member between proximal and distal positions. The deployment mechanism includes a rotatable shaft, a cord including a proximal end engaged to the rotatable shaft and a distal end engaged to the proximal hub, a biasing member positioned to bias the proximal hub towards the distal position, and a gear assembly operably coupled to the rotatable shaft. The gear assembly is configured to move the proximal hub from the distal position to the proximal position against the bias of the biasing member by rotating the rotatable shaft relative to the cord to at least partially wind-up the cord about the rotatable shaft.

Abstract: Delivery systems, and methods using the same, having an ultrasound viewing window for improved imaging and a needle for ablation treatment of target tissues. In an embodiment, the target tissue is a fibroid within a female's uterus. In an embodiment, the delivery system includes a rigid shaft having a proximal end, a distal end, and an axial passage extending through the rigid shaft. In an embodiment, the axial passage is configured for removably receiving the ultrasound imaging insert having an ultrasound array disposed a distal portion.

Abstract: Delivery systems, and methods using the same, having an ultrasound viewing window for improved imaging and a needle for ablation treatment of target tissues. In an embodiment, the target tissue is a fibroid within a female's uterus. In an embodiment, the delivery system includes a rigid shaft having a proximal end, a distal end, and an axial passage extending through the rigid shaft. In an embodiment, the axial passage is configured for removably receiving the ultrasound imaging insert having an ultrasound array disposed a distal portion.

Abstract: Presented are a method and apparatus for surgical procedures. An exemplary apparatus includes a body having a longitudinal axis and a connection opening at a first end of the longitudinal axis, the connection opening including an electrical connection to an electrical circuit maintained within the body and an air path extending through the longitudinal axis of the body. The apparatus further includes a tube assembly having a distal end and a mating end along a tube longitudinal axis, the tube assembly having a vacuum inlet circumscribing an electrode extending from the distal end, the vacuum inlet operable for receiving surgical smoke, the vacuum inlet fluidly connected to an air tube extending through the tube longitudinal axis, the mating end operable to be removably affixed to the connection opening thereby connecting the electrode with the electrical connection and the air path with the air tube, and a first button.

Abstract: An apparatus for delivering energy, and in particular laser energy, to a tissue is adapted to minimize or eliminate burn back caused by contact between the energy delivery apparatus and bodily fluids by (i) preventing the energy delivery apparatus from contacting bodily fluids or tissues that might burn or cause the apparatus to burn; and/or (ii) monitoring the apparatus to detect overheating in order to withdraw the apparatus or control the energy supply in case overheating is detected. The apparatus is applicable, by way of example, to treatment of blood vessels using endovascular techniques.

Abstract: A surgical robot assembly for use with an MRI includes a surgical robot, a controller, cables, a dedicated room ground and a filter. The surgical robot includes at least one ultrasonic motor and all the motors therein are ultrasonic motors. The controller is spaced from the surgical robot and is positioned outside the MRI room. The controller has at least one analog output; at least one digital input, at least two digital output, and at least one encoder reader channel. The cables are operably attaching the motors of the surgical robot to the controller and are RF shielded. The cables are operably connected to the dedicated room ground. The filter is operably connected to the cables which are operably connected between the motors of the surgical robot and the controller and the filter has a cut off frequency tuned to the MRI.

Abstract: Floating electromagnetic field generator systems and methods are provided. The system comprises a surgical bed portion. The system also comprises a brace component disposed within the surgical bed portion. Additionally, the system comprises a first arm that is attached to the brace component. The first arm is positioned adjacent to the surgical bed portion. Additionally, the first arm has at least one field generator coil embedded therein. The system also comprises a second arm that is attached to the brace component. The second arm is positioned adjacent to the surgical bed portion. Additionally, the second arm has at least one field generator coil embedded therein. The second arm is positioned parallel to the first arm.

Abstract: A medical robot cover covers an external surface of a medical robot including: a main unit that stands on a base; and an arm member attached to one end of the main unit in a swingable or extensible manner. The medical robot cover includes: an attaching portion to be wound around at least one of the main unit and the arm member, on an inner circumferential surface of the cover facing the external surface of the medical robot. Therefore, the medical robot cover can be easily placed on the medical robot. Further, the medical robot cover can be restricted from being damaged due to extension or swinging of the arm member, and can be restricted from inhibiting the action of the arm member.

Abstract: Portable support cart systems are provided. The support cart can include a trailer-hitch-type connection that can attach to a movable bed, such as a gurney, for easily and conveniently transporting the cart system together with the bed. Also provided are detachable frames for transporting medical support components, as well as methods of using the same. The detachable frame can be detachably mounted on a portable cart or a movable bed, such as a gurney.

Abstract: A package for a medical device includes a tray with a top surface, a bottom surface, a proximal end, a distal end, and first and second lateral sides that extend between the proximal and distal ends. The package has a retainer sleeve wrapped around the tray, the retainer sleeve including a top panel covering the top surface of the tray, a bottom panel covering the bottom surface of the tray, and a connecting panel extending between the top and bottom panels and covering one of the first and second lateral sides of the tray. The top panel of the retaining sleeve includes a proximal edge, a distal edge, an outer edge, a cut that extends inwardly from the outer edge, and an extended tab that extends along the outer edge of the top panel and distally beyond the cut formed in the outer edge of the top panel. The extended tab is tucked under the connecting panel and disposed between the connecting panel and one of the first and second lateral sides of the tray covered by the connecting panel.

Abstract: A packaging assembly for an electromagnetic trackable surgical tool and wiring thereof. The packaging assembly includes a first tray with at least one first retention member configured to couple the surgical tool to the first tray. The packaging assembly further includes a second tray configured to couple with the first tray. The second tray has at least one second retention member configured to couple the wiring of the surgical tool to the second tray.

Abstract: Systems and methods for preparing and completing surgical and medical procedures. In particular, kits are provided for improving preparation and completion time for a medical or surgical procedure in which the kit includes modularized compartments containing sterilized medical or surgical equipment and wherein the medical or surgical equipment is organized and/or ordered within the kit to generally correspond to the sequence of steps of the medical or surgical procedure. The kit is particularly applicable to recanalization procedures for stroke patients as well as revascularization procedures for acute myocardial infarction patients where a kit enables faster preparation and completion of these procedures.

Abstract: The present invention relates to a surgical skull clamp (1) and a method for the manufacture of a surgical skull clamp (1). In one embodiment of the surgical skull clamp (1) at least a part of the surgical skull clamp (1) has at least two different structures.

Abstract: The disclosure relates to methods for attaching a dental implant surgical guide and a dental implant to a dental surgical site including: assembling an implant combination, positioning the dental implant surgical guide including a double open-ended guide cylinder at the dental surgical site; rotating the implant combination through the double open-ended guide channel; and attaching a cap comprising a hollow cylinder to the double open-ended guide channel so the rim of the implant mount body is sandwiched between the dental surgical guide and the cap. The disclosure further relates to a dental prosthesis apparatus including: an abutment; a dental implant; a dental implant surgical guide including a first and a second double open-ended guide cylinder connected by a support bar; an implant mount including a rim; and a cap operable to engage the dental implant surgical guide and sandwich the rim between the cap and the dental implant surgical guide.

Abstract: A safety device for tethering an object during intraoral use, such as a dental finger driver. A tether includes a semi-rigid tip portion connected to a flexible, inelastic tail. The tip portion is oriented parallel with the length of the tail during use. The tail may be formed from a filament, such as nylon monofilament. The tip portion may be formed from plastic. The tip can be easily inserted through an aperture in the device being tethered, with the tail portion being pulled through the aperture and secured to the intraoral object. The tail portion may be secured by a knot, a stopper, or a loop formed in a second end of the tail, through which the tip may be passed.

Abstract: A NiTi alloy root canal file with a flexibility gradient, having a tip, middle portion and rear portion divided along the longitudinal direction. The internal microstructure of the tip is martensite, of the rear portion is austenite, and of the middle portion is a combination of martensite and austenite. The microstructure of martensite is continuously reduced and the microstructure of austenite is continuously increased as the distance from the tip increases. A manufacturing method for the NiTi alloy root canal file with a flexibility gradient. As the internal microstructure of the NiTi alloy root canal file with a flexibility gradient gradually changes along the axial direction and the strength also gradually changes, the flexibility and strength show a gradient change along the axial direction of the root canal file, providing excellent cutting property, high anti-fatigue life and significantly improving operation performance, safety, and life of the root canal files.

Abstract: Provided is a silicate glass, a method for preparing a silicate glass-ceramics by using the silicate glass, and a method for preparing a lithium disilicate glass-ceramics by using the silicate glass, and more particularly, to a method for preparing a glass-ceramics that has a nanosize of 0.2 to 0.5 ?m and contains lithium disilicate and silicate crystalline phases. A nano lithium disilicate glass-ceramics containing a SiO2 crystalline phase includes: a glass composition including 70 to 85 wt % SiO2, 10 to 13 wt % Li2O, 3 to 7 wt % P2O5 working as a nuclei formation agent, 0 to 5 wt % Al2O3 for increasing a glass transition temperature and a softening point and enhancing chemical durability of glass, 0 to 2 wt % ZrO2, 0.5 to 3 wt % CaO for increasing a thermal expansion coefficient of the glass, 0.5 to 3 wt % Na2O, 0.5 to 3 wt % K2O, and 1 to 2 wt % colorants, and 0 to 2.0 wt % mixture of MgO, ZnO, F, and La2O3.

Abstract: A teeth adjustment arrangement includes a plurality of end retainers adapted for affixing to abutting teeth respectively; and a space expansion unit coupled between the end retainers to create an opposed expansion force against the end retainers for enlarging a corrective space between the abutting teeth corresponding to an associated tooth therebetween. Therefore, the associated tooth is adapted to concurrently move within the corrective space and align with the abutting teeth at the same time.

Abstract: An intra-oral expander device comprises: a transverse expansion assembly, which can be anchored in opposed positions to the upper dental arch and is expandable in a respective plane of action to produce a palatal expansion; and a longitudinal expansion assembly, which is carried by the transverse expansion assembly and is able to exert an action of postero-anterior thrust on the upper front teeth. The longitudinal expansion assembly is mounted on the aforesaid transverse expansion assembly, with possibility of adjustment of the orientation with respect to the plane of action of said transverse expansion assembly.

Abstract: A medical implant includes a base portion configured for implantation into a bone of a patient. The base portion is formed from an electrically insulating and biocompatible base material with retaining features on an outer surface of the base portion for gripping the bone in the patient and at least two discontinuous regions formed of titanium on the outer surface.

Abstract: A fixation facilitator mechanically associated with an intraosseous dental implant fixture.

Abstract: The present invention includes apparatuses and methods for making a final hybrid prosthesis to be attached to one or more dental implants. One preferred method includes the step of making a temporary hybrid prosthesis and at about the same time also making a duplicate temporary hybrid prosthesis. The duplicate temporary hybrid prosthesis permits the final hybrid prosthesis to be made with fewer visits to a restorative dentist and with less dental laboratory time than is currently needed when making a final hybrid prosthesis.

Abstract: A pacifier for rinsing an infant's or child's mouth and teeth having an aperture extending through its front lip shield and connecting to a port near the front of the pacifier. The port preferably connects the aperture to enclosed channels or tubes preferably contained entirely within the body walls of the pacifier. The enclosed channels or tubes allow fluid communication with beveled openings located on the top side of the pacifier. The beveled openings are preferably forwardly angled to point towards the lip shield and the interior surface of the infant's or child's upper teeth when the pacifier is placed in the infant's or child's mouth so that when water is pushed through the aperture, the water is pushed through the port, the enclosed channels, and out of the beveled openings, and rinses the mouth and teeth.

Abstract: A light-guiding mouthguard assembly has a light-transmittable mouthguard and two light-guiding strips. The light-transmittable mouthguard has a teeth-containing channel formed along a curve as a teeth arch. The two light-guiding strips are located on opposite sides of the teeth-containing channel respectively. Each one of the two light-guiding strips is mounted through two opposite terminals of the light-transmittable mouthguard along the teeth-containing channel. An exterior surface of each one of the two light-guiding strips is light-transmittable.

Abstract: A medical device including an artificial contractile structure which may be advantageously used to assist the functioning of a hollow organ. Specifically, the medical device includes an artificial contractile structure with at least one contractile element adapted to contract an organ, in such way that the contractile element is in a resting or in an activated position, at least one actuator designed to activate the contractile structure, and at least one source of energy for powering the actuator. The medical device also includes a means for reducing corrosion of the medical device hence reducing the risk of the device dysfunction and patient contamination.

Abstract: An implantable mesh for use in reconstructing tissue includes a mesh body and one or more extensions extending from the mesh body. Each mesh extension has a first end and a second end, wherein the first end of the mesh extension is integrated into or part of the mesh body. Each mesh extension is configured to permit multiple anchor points with surrounding tissue upon implantation. In one embodiment, a fixation device is at the second end of each mesh extension. Methods of using the implantable mesh are also provided.

Abstract: A method for structuring a surface of an implant (100) made from a plastic material by means of a counter-body (200) comprises the following steps: providing (S110) of a counter-body (200) including a surface (210); forming (S120) of a first surface structure (212) on the surface (210) of the counter-body, wherein a first surface structure (212) comprises a non-regular, randomly distributed pattern; and forming (S130) of a second surface structure (112) on the implant (100) by using the counter-body (200), wherein the second surface structure and the first surface structure (212) are complementary to each other.

Abstract: Devices and methods are provided for making a variable textured breast implant when used in conjunction with a breast implant mandrel having a molding surface and a stem depending therefrom.

Abstract: Medical devices and methods for making and using a medical device are disclosed. An example medical device may include a stent that comprises a first covered region formed of one or more interwoven filaments and a covering. The stent may also comprise a second uncovered region adjacent the first covered region. The second uncovered region may include a knitted filament. A first end of the knitted filament may be attached to the first covered region. The knitted filament is configured to be unraveled to remove both the first covered region and the second uncovered region of the stent while the first end of the knitted stent remains attached to the first covered region.

Abstract: A primary stent-graft is deployed into a primary vessel to exclude an aneurysm. To maintain perfusion to a branch vessel covered by the primary stent-graft, a gutter filling stent-graft is deployed in parallel to the primary stent-graft. The gutter filling stent-graft includes a balloon that is pressurized and inflated by the patient's own blood thereby sealing any gutters formed around the gutter filling stent-graft. By sealing the gutters, the chance of type I endoleaks, migrations, and overall failure to exclude the aneurysm is minimized.

Abstract: Methods and devices are provided for anchoring a ligament or tendon to bone. In one embodiment, a biceps tenodesis system is provided and includes a sheath inserter tool, an expandable sheath configured to couple to the sheath inserter tool, an expander inserter tool, and an expander configured to couple to the expander inserter tool. The sheath inserter tool is configured to advance the expandable sheath, with a tendon disposed therearound, into a bone hole, and the expander inserter tool is configured to advance the expander through an outer shaft of the sheath inserter tool and to drive the expander into the sheath. The expander is configured to be received within a lumen extending at least partially through the expandable sheath to thereby expand the sheath. In this way, the system delivers the tendon or ligament into the bone hole and locks the sheath and tendon within the bone hole.

Abstract: Systems and tools are provided for anchoring a ligament or tendon to bone. In one embodiment, a sheath is provided having a first sidewall with proximal and distal ends and a second sidewall with proximal and distal ends. The distal ends of the first and second sidewalls can be coupled to one another by a hinge pin such that the first and second sidewalls pivot relative to one another about the hinge pin. A sheath inserter tool is also provided and it can be configured to couple to the sheath and to advance the expandable sheath, with a tendon disposed therearound, into a bone hole. An expander is also provided for expanding the sheath. In this way, a tendon or ligament is delivered into the bone hole and the sheath and tendon are locked within the bone hole.

Abstract: Multifocal intraocular lens with extended depth of field that comprises, in at least one of the surfaces (2), a small zone with a multifocal profile with a defined optical axis (3) and, in the peripheral region and coaxial to the multifocal zone, a ring-shaped opaque mask (1) that partially or totally block light to produce a small aperture effect and, therefore, the multifocal profile has a radius equal or larger than the internal radius of the mask (1), and there is at least one transition between focal zones or one diffractive step inside the internal radius of the mask (1).