Abstract: A tissue collector includes: an elongated sheath; a bag; a wire bending portion; and an extending portion which is arranged at the distal end portion of the sheath so as to protrude forward from the distal end portion along the longitudinal axis and enter an inside of the bag. The extending portion intersects with the opening surface that is defined by an opening end of the opening portion. The extending portion is configured to be capable of extending inside the bag from an opening surface toward the bottom portion.

Abstract: An end effector for a surgical fastening device includes a fastener and a tube defining a longitudinal axis. The tube includes an outer surface and an inner surface. The inner surface defines a lumen that extends along the longitudinal axis. The tube defines depressions that may be arranged helically about the tube along the longitudinal axis. The end effector may include one or more ribs extending along the tube.

Abstract: A suture assembly including a first suture having a generally O-shaped configuration having a first arm, a second arm, a first bridge connecting the first arm to the second arm, and a second bridge connecting the first arm to the second arm. The first bridge opposes the second bridge so that the first suture includes a closed loop. A second suture having a first arm, a second arm and a bridge connecting the first arm to the second arm. The first arm of the second suture is wrapped around the first arm of the first suture in a first direction, and the second arm of the second suture is wrapped around the second arm of the first suture in a second, opposite direction. The suture assembly is capable of assuming (i) a longitudinally-extended, radially-contracted first configuration, and (ii) a longitudinally-contracted, radially-expanded second configuration.

Abstract: A suture anchor for tissue repair that has a proximal section and a main section where the proximal and main sections are formed of different materials. Only the proximal section is formed of a biologic material, such as human cortical bone. The proximal section is about one-third of the body of the anchor.

Abstract: A suture securing assembly comprises a two-bodied anchor and an associated delivery system which enhances fixation of a micro anchor in a bone hole or tunnel, as well as improving suture lock within bone. Initially, the two bodies are separated by a length of an inner shaft of the delivery system. The proximal body is fixed on the inner shaft of the delivery system and cannot move relative to the handle until after insertion into the bone, when the delivery system is disengaged from the anchor. The distal body further includes expansion wings and/or other features for increasing suture lock within the bone hole.

Abstract: According to an aspect, a medical device includes a needle member and a handle member. The handle member is coupled to the needle member. The handle member has a substantially flat portion. The handle member defines a groove. The groove is disposed on the substantially flat portion of the handle member.

Abstract: A suturing device includes a curved needle, a suture, an elongate body, an actuator and a curved needle holder. The suture connects with the curved needle. The actuator is operable between a first operating position and a second operating position. The curved needle holder extends away from a distal end portion or is provided as part of the distal end portion of the elongate body. The curved needle holder includes a distal end section having a distal-most tip. The curved needle holder defines a curved needle passage and a distal opening. Movement of the actuator from the first operating position toward the second operating position moves the curved needle with respect to the curved needle holder toward a released condition. The distal end section is configured to allow the curved needle to release from the curved needle holder at a location offset from the distal-most tip.

Abstract: An implant insertion device is adapted for use with a shape memory implant. The shape memory implant includes a bridge interconnecting first and second legs. The shape memory implant is movable between a first shape in which the first and second legs are substantially non-parallel and a second shape in which the first and second legs are substantially parallel. The implant insertion device engages the shape memory implant to maintain the shape memory implant in its second shape until the delivery of the shape memory implant into tissue or bone.

Abstract: An exemplary medical apparatus may include a surgical tool; a feeder belt located at least partially within the surgical tool; a plurality of staples affixed to and frangibly separable from the feeder belt; and a forming station positioned within the surgical tool that receives the feeder belt; where motion of the feeder belt through the forming station bends at least one staple relative to the feeder belt substantially at the junction between that staple and the feeder belt in order to work harden that junction within the surgical tool. Another exemplary medical apparatus may include a surgical tool; a feeder belt located at least partially within the surgical tool; staples affixed to and frangibly separable from the feeder belt; and a channel within the surgical tool that receives the feeder belt; where motion of the feeder belt through the channel bends at least one staple at least at one location, thereby work hardening that staple at each location at which it bends.

Abstract: An apparatus includes a body, a motorized end effector, and a control system. The end effector extends distally from the body and comprises a stapling assembly operable to drive staples into tissue. The control system is in communication with the end effector. The control system comprises a motor, a firing trigger, a switch assembly, and a movable member in communication with the firing trigger. A resilient member is engaged with the movable member. The firing trigger and the resilient member are configured to cooperate to move the movable member into engagement with the switch to thereby activate the motor. The switch assembly is configured to couple a power source with the motor to thereby activate the motor in response to actuation of the firing trigger.

Abstract: A surgical instrument can comprise a handle, a motor, and a shaft extending from the handle. The handle and/or the shaft can define a longitudinal axis. The surgical instrument can further comprise a fastener cartridge comprising a plurality of fasteners removably stored therein, an anvil configured to deform the fasteners, a closure drive configured to move the anvil toward and away from the fastener cartridge which is rotatable about the longitudinal axis, and a firing drive configured to deploy the fasteners from the fastener cartridge which is rotatable about the longitudinal axis. The surgical instrument can further comprise a transmission comprising a first operating configuration which connects the motor to the closure drive and a second operating configuration which connects the motor to the firing drive.

Abstract: A bone staple insertion tool for inserting a bone staple into a patient includes a body having a proximal portion, a distal surface and a fulcrum. The body defines a longitudinal axis and the fulcrum is positioned on the distal surface. The distal surface has a first end and a second end. A bone staple mount is fixed to the body and extends from the body proximate the first end. A force applicator is movably attached to the body. The force applicator has a gripping portion and a staple pin portion. The staple pin portion is positioned proximate the second end. The force applicator is configured to receive the bone staple. Upon actuation of the gripping portion, the staple pin portion bends the inter-axis of the bone staple across the fulcrum to an expanded state, wherein the first and second legs are positioned substantially parallel to the longitudinal axis.

Abstract: The present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to enhance the properties of repaired or adjoined tissue at a target surgical site, especially when sealing an anastomosis between adjacent intestinal sections to improve tissue viability under hypoxia conditions, prevent tissue inflammation, and to prevent leakage. The present invention further relates to hypothermic circular stapling instruments configured to pre-cool the tissues being joined by staples.

Abstract: A motorized surgical instrument is disclosed. The surgical instrument includes a displacement member, a motor coupled to the displacement member, the motor operable to translate the displacement member, a control circuit coupled to the motor, and a position sensor coupled to the control circuit. The control circuit is configured to receive a position output of the position sensor indicative of at least one position of the displacement member and control velocity of the motor to translate the displacement member at a plurality of velocities corresponding to the position output. Each of the plurality of velocities is maintained in a predetermined zone.

Abstract: Surgical instruments are disclosed which comprise an improved staple firing and/or tissue cutting member. A surgical instrument comprising a first jaw and a second jaw is disclosed, wherein the second jaw is movable relative to the first jaw to capture the tissue of a patient between the first jaw and the second jaw. The surgical instrument further comprises a cutting member movable toward a distal jaw end during a cutting stroke. The cutting member comprises a coupling portion comprising a first cam configured to engage the first jaw, a second cam configured to engage the second jaw, and a body connecting the first cam and the second cam. The cutting member further comprises a bar attached to the coupling portion, wherein the bar comprises a cutting edge configured to cut the patient tissue during the cutting stroke.

Abstract: A staple cartridge assembly comprises a staple cartridge, an anvil and a cutter, wherein the cutter comprises a first end and a second end; the staple cartridge assembly also comprises a rotation shaft and an auxiliary closing member which is connected with the rotation shaft; the staple cartridge assembly is also provided with a driving component capable of driving the rotation shaft to rotate; the driving component drives the rotation shaft to drive the auxiliary closing member to move in the process in which the staple cartridge assembly is converted from an original status to a closed status; when at least the staple cartridge assembly is in the closed status, one end surface of the auxiliary closing member abuts against the anvil to apply a force to the anvil for driving the anvil to be closed towards the staple cartridge.

Abstract: An apparatus includes a body and a shaft assembly. The body includes a rotary drive output, a linear drive output, and a control module. The shaft assembly includes a distal end and a proximal end. The distal end includes a type of end effector configured to operate on tissue. The proximal end is configured to removably couple with the body assembly. The proximal end includes one or both of a rotary drive input configured to couple with the rotary drive output or a linear drive input configured to couple with the linear drive input. The shaft assembly is configured to actuate the end effector in response to movement of one or both of the rotary drive input or the linear drive input. The control module is configured to selectively actuate the rotary drive output or the linear drive output based on the type of end effector of the shaft assembly.

Abstract: The present disclosure provides a surgical cartridge assembly including a proximal end, a distal end, and an elongate channel. The elongate channel includes a base and at least one opening within the base. The surgical cartridge assembly further includes a cartridge body configured to be removably received within the elongate channel and a slot configured to receive a cutting member. In addition, the surgical cartridge assembly includes at least one lockout tab extending from the proximal end of the cartridge body, wherein the at least one lockout tab is configured to cover the at least one opening when the cartridge body is received within the elongate channel, and wherein the at least one lockout tab disables a lockout mechanism to allow the cutting member to advance distally through the slot.

Abstract: Jaw assemblies for a surgical stapler are provided. The jaw assemblies comprise a first jaw having a first clamping surface and a plurality of staples disposed therein and second jaw assembly having a second clamping surface. The jaw assemblies can be actuated from a closed configuration in which the first clamping surface contacts or is adjacent to the second clamping surface to an open configuration in which the second jaw is pivoted away from the first jaw to a stapling position in which the second clamping surface is parallel to the first clamping surface and spaced apart from the first clamping surface. A pivoting link or sliding pivot joint can couple the second jaw to the first jaw to facilitate motion between the closed position, the open position, and the stapling position.

Abstract: A surgical fastener applying apparatus for applying fasteners to body tissue. The apparatus includes a cartridge receiving half-section defining an elongated channel member, an anvil half-section, and a clamping lever. The cartridge receiving half-section releasably receives a cartridge and a firing assembly. The clamping lever includes a protrusion in a sidewall which is receivable in a bifurcated depression formed in a sidewall of the cartridge receiving half-section to releasably retain the clamping lever in a non-clamped position and in a clamped position. The apparatus includes a disposable firing assembly and SULU.

Abstract: A surgical end effector comprising a first jaw and a second jaw is disclosed. The first jaw comprises a staple cartridge including a plurality of staples. The second jaw comprises an anvil comprising an anvil surface and a plurality of staple-forming pockets defined in the anvil surface. The second jaw is movable relative to the first jaw. The second jaw comprises an unclamped position, a first clamped position, and a second clamped position. The first clamped position is different than the second clamped position. The anvil surface is in contact with the staple cartridge when the second jaw is in the first clamped position. The staples are configured to be formed against the staple-forming pockets when the second jaw is in the second clamped position. The anvil surface and the staple cartridge are not in contact with each other when the second jaw is in the second clamped position.

Abstract: A detachable motor-powered surgical instrument. The instrument may include a housing that includes at least one engagement member for removably attaching the housing to an actuator arrangement. A motor is supported within the housing for supplying actuation motions to various portions of a surgical end effector coupled to the housing. The housing may include a contact arrangement that is configured to permit power to be supplied to the motor only when the housing is operably attached to the actuator arrangement.

Abstract: A surgical instrument configured to be coupled to a robotic surgical system is disclosed. The surgical instrument comprises an end effector, a threaded drive shaft, a firing member drivable by the threaded drive shaft, a closure system configured to move a iaw of the end effector toward a closed position, and a housing assembly coupleable with the robotic surgical system and comprising an array of electrical contacts. The surgical instrument further comprises a first motor configured to drive the closure system, a second motor configured to drive the threaded drive shaft, a first decoupleable electrical contact configured to supply power to the first motor from a power system, and a second decoupleable electrical contact configured to supply power to the second motor from the power system. The power system is selectively interrupted unless a signal is provided to the power system from the robotic surgical system.

Abstract: The present disclosure relates to the field of embolic coils. More specifically, the present disclosure relates to systems and methods for actively releasing an embolic coil from a delivery device into a body lumen of a patient. Delivery systems of the present disclosure may allow an embolic coil to be advanced external to the distal end of a delivery catheter without being automatically released, thereby allowing the embolic coil to be repositioned prior to deployment.

Abstract: An intranasal occlusion device having an inflatable balloon within a sponge that is used to prevent drainage of fluid, such as blood and other fluids into the airway during sinus and nasal minor procedures or surgeries, and methods of using the device to occlude an intranasal cavity of a patient. The device provides for suction to remove the fluid and may facilitate office-based minor procedures or surgeries.

Abstract: An intrasaccular flow diverter includes a wire structure (e.g., a braided wire or a laser-cut hypotube), a thin-film mesh placed over the wire structure, and crimps fixing the thin-film mesh to the wire structure at each crimp. The wire structure and the thin-film mesh between adjacent crimps are expanded radially to form thin-film covered spheroid structures. When deployed in an aneurysm, the spheroid structures may volumetrically fill the aneurysm sac. An intrasaccular flow diverter with an umbrella structure includes a wire structure with a plurality of crimps along the wire structure, and a thin-film covered umbrella structure at one end of the wire structure. The wire structure between adjacent crimps is expanded radially to form a spheroid structure. When deployed in an aneurysm, the thin-film covered umbrella structure may cover the aneurysm neck.

Abstract: A hemostatic device is provided to stop bleeding at a puncture site on an artery of a patient, the device comprising a transparent flexible band to be wrapped at the site where the bleeding is to be stopped, a curved compression member having an inner peripheral side and possessing a first curved portion in its first half and a second curved portion in its second half, a first balloon provided on the inner peripheral side in the first half of the curved compression member and a second balloon provided on the inner peripheral side in the second half of the curved compression member. The bleeding from a first artery is stopped by compressing the first artery at the puncture site using inflation of the first balloon and blood flow in the first artery is increased by compression of a second artery using inflation of the second balloon.

Abstract: A method of correcting an alignment between bones of a foot may involve positioning a first cutting slot of a bone cutting guide over a first metatarsal and inserting a first fixation pin through a first fixation aperture of the bone cutting guide and into the first metatarsal. The method may also involve inserting a cutting member through the first cutting slot to remove a portion of the first metatarsal and adjusting an alignment of the first metatarsal relative to a first cuneiform. In some examples, the method further includes positioning a second cutting slot of the bone cutting guide over the first cuneiform and inserting a second fixation pin through a second fixation aperture of bone cutting guide into the first cuneiform. The method can involve inserting a cutting member through the second cutting slot to remove a portion of the first cuneiform and causing the first metatarsal to fuse to the first cuneiform in the moved position.

Abstract: Various surgical devices and methods are disclosed herein. Also disclosed is multi-component prosthesis, which can be used as an ankle prosthesis. One of the disclosed surgical alignment systems includes a guide arm, a ratchet arm frame configured to be coupled slidably to the guide arm, a ratchet arm configured to be coupled to the ratchet arm frame, and a sagittal sizing guide body configured to be coupled to the ratchet arm. The sagittal sizing guide body includes a first radiopaque object disposed at a first position and a second radiopaque object disposed at a second position that is spaced apart from the first position.

Abstract: Systems and methods for monitoring an operative site during a surgical procedure using a computer controlled surgical device. In general, the methods include the steps of processing one or more defined cutting paths having one or more cut regions; determining a correlation between the cut region and one or more critical regions to generate an alert, wherein the alert indicates a movable end-effector is within a defined proximity of the critical region; and requiring a user acknowledgment of the alert to allow processing of the cutting path to continue. Also described herein are systems and methods for minimizing user fatigue during a semi-computer controlled surgical procedure. In general, the methods includes the step of requiring a user generated acknowledgment in response to a computer generated alert, wherein the user acknowledgment is generated using a user controller, the user controller being minimally intrusive to the user experience.

Abstract: Alignment guide systems, fixation guide devices, and methods for positioning and inserting an intramedullary nail are disclosed. The alignment guide system includes a targeting guide with a first end and a second end, an alignment wire rotatably engaging a second end of the targeting guide, and a guide sleeve insert engaging an opening in the first end of the targeting guide. The fixation guide device including a frame including a first end and a second end, a compression device slidingly coupled to the first end of the frame, and the intramedullary nail secured to a nail attachment apparatus of the frame. A method of inserting an intramedullary nail into two bones for fixation of the two bones is also disclosed.

Abstract: The invention relates to an improved-structure instrument (1) for allowing the alignment of fixing screws (2) to be inserted in transverse holes (3, 13) of nails (4) for long bones, in particular medullary nails, of the type comprising an arched arm (15) having a free distal end (6) connectable to a proximal end (16) of a head (7) of the nail (4) in which the transverse holes (3, 13) are formed, and a proximal handle portion (5), as well as a connection portion (20) between the distal end (6) and the proximal handle portion (5). Advantageously, the connection portion (2) comprises at least one through-hole (23, 33) for receiving a guide tube (10) for a drilling bit, the through-hole (22, 33) having an axis coinciding with the axis of one of the transverse holes (3, 13) and manually operated quick-locking means (25) are associated with the through-hole (23, 33) so as to lock in a stable position the corresponding tube (10) inserted in the instrument (1).

Abstract: A wedge osteotomy method inserts a first wire into a first bone of the foot, distal from tissue to be removed. A second wire is inserted into a second bone, so the tissue to be removed is distal from the second wire. A cut guide is pivoted about the first wire, until a first axis of the cut guide is parallel with a longitudinal axis of the first metatarsal. The cut guide has a slot perpendicular to the first axis for guiding a cutter to cut bone, while the first axis is aligned with the longitudinal axis of the first metatarsal. The cut guide is then pivoted about the second wire, until the first axis is aligned with the longitudinal axis of the talus, and bone is cut through the slot, to form a second planar cut into or through bone material.

Abstract: A balloon catheter prevents detachment of a balloon from an inner shaft without using a conventional sleeve or heat-shrinkable tube. The balloon catheter includes a balloon, an inner shaft, and a tip having a proximal end portion that covers an outer periphery of a distal end of the balloon. The distal end of the balloon is sandwiched between the inner shaft and the proximal end portion of the tip, thereby joining the distal end of the balloon to the inner shaft and the tip.

Abstract: Mechanical thrombectomy apparatuses that may be configured to prevent or reduce jamming (e.g., “anti jamming” thrombectomy devices), grab clot, and/or macerate the thrombus, e.g., clot, being removed. These mechanical thrombectomy apparatuses may include a tractor comprising a flexible tube of material that inverts as it rolls over itself while being drawn into a catheter in a conveyor-like motion. In particular, described herein are mechanical thrombectomy apparatuses having tractors selectably extendable projections that may aid in grabbing and/or macerating a clot. Also described herein are seesawing tractors for mechanical thrombectomy apparatuses.

Abstract: Mechanical thrombectomy apparatuses that may be configured to prevent or reduce jamming (e.g., “anti-jamming” thrombectomy devices), grab clot, and/or macerate the thrombus, e.g., clot, being removed. These mechanical thrombectomy apparatuses may include a tractor comprising a flexible tube of material that inverts as it rolls over itself while being drawn into a catheter in a conveyor-like motion. In particular, described herein are mechanical thrombectomy apparatuses having tractors selectably extendable projections that may aid in grabbing and/or macerating a clot. Also described herein are seesawing tractors for mechanical thrombectomy apparatuses.

Abstract: A thrombectomy device including a profiled member made from a piece of mesh material. The piece in a relaxed condition in axial cross section has a generally cylindrical outer profile. The piece includes a central cross part with a generally S shaped profile, with respective side parts extending circumferentially in a clockwise direction from each end of the cross part, to provide a free end located adjacent an opposite end of the cross part.

Abstract: Numerous devices are described. One device may comprise: a handle including a wire attachment portion; an actuator movably mounted to the handle, the actuator including a reaction chamber; a plunger movably mounted to the actuator, the plunger including a distal stop with a sheath attachment portion, and a proximal stop located in the reaction chamber; a resilient element including a distal end attached to the proximal stop, and a proximal end movable relative to plunger; and a force reduction element located in the reaction chamber between the resilient element and a reaction surface in the cavity. The resilient element may bias the plunger distally relative to the actuator, and be compressed when a proximally-directed force is applied to the plunger. The force reduction element may dissipate a portion of the proximally-directed force. Related devices and methods are also described.

Abstract: A platform of devices for removing obstructions and other objects within a blood vessel or other interior lumen of an animal is provided. The system may be deployed in the lumen from a catheter(s) and may include a strain gauge for measuring tension on the pull wire. A number of different baskets designs are disclosed. Methods of manufacturing such baskets out of a single tube of a memory metal without the need for any welding, and methods of use are also disclosed.

Abstract: An ultrasonic surgical blade includes a body having a proximal end, a distal end, and an outer surface. The distal end is movable relative to a longitudinal axis in accordance with ultrasonic vibrations applied to the proximal end. At least a portion of the outer surface of the body comprises a lubricious coating adhered thereto. The lubricious coating has a coefficient of friction that is less than the coefficient of friction of the outer surface of the body.

Abstract: A scar subcision devices comprising a first elongated element comprising a pivotal connection to a second elongated element, the first elongated element having a blunt distal end, the second elongated element having a proximal-facing cutting edge at a distal end thereof, the device having a first state wherein the cutting edge is retracted to a location within an outer perimeter of the first elongated element, and a second state wherein the cutting edge is exposed outside of the outer perimeter of the first elongated element and the device transitioning between the first state and the second state by the first elongated element and the second elongated element rotating relative to each other about the pivotal connection are disclosed. Methods are also disclosed.

Abstract: A medical device may include a handle having a first portion and a second portion angled with respect to the first portion. The handle may further include a rail extending along the first portion of the handle. The rail may include a groove. The handle may also include a first actuator longitudinally moveable with respect to the handle along the rail and a second actuator rotatable about an axis collinear to a longitudinal axis of the first portion. Further, the handle may include a shaft longitudinally fixed relative to the first actuator.

Abstract: A device handle is disclosed for grinding substances inside a body lumen, the device handle comprising: a high-speed drive source configured to rotate a treatment member connected to a distal end of a drive shaft; and a low-speed drive source connected to a revolution shaft, and wherein the revolution shaft is configured to cause the treatment member to move about a central axis of the revolution shaft, and wherein the central axis of a proximal portion of the revolution shaft is different from a central axis of the treatment member.

Abstract: A rotational atherectomy device may include a flexible, elongated, rotatable drive shaft with a system of eccentric abrading heads attached thereto. At least part of the eccentric enlarged abrading heads have a tissue removing surface—typically an abrasive surface. The abrading heads may be at least partially hollow. Preferably the eccentric enlarged abrading heads have centers of mass spaced radially from the rotational axis of the drive shaft, enabling the eccentric abrading heads to work together to open a stenotic lesion to a diameter substantially larger than the outer resting diameter of the enlarged abrading heads when operated at high speeds. The system of eccentric abrading heads may have unbalanced centers of mass to stimulate greater rotational diameters and may be arranged in a manner providing a debris-removing augering effect. Alternatively, a rotational atherectomy device may include a system of eccentric abrading heads with balanced centers of mass.

Abstract: A medical device includes a conductive body having a surface and a sensor conformally formed on the surface and including a piezoelectric polymer formed about a portion of the surface and following a contour of the surface. The piezoelectric polymer is configured to generate or receive ultrasonic energy. Electrical connections conform to the surface and are connected to an electrode in contact with the piezoelectric polymer. The electrical connections provide connections to the piezo electric polymer and are electrically isolated from the conductive body over a portion of the surface.

Abstract: Expandable access sheaths and methods for use thereof are disclosed. The access sheath may have an expandable element and flexible membrane. The access sheath may be configured to move between a non-expanded configuration and an expanded configuration. The access sheath may be biased towards the non-expanded configuration.

Abstract: Devices and methods for exploiting intramural (e.g., subintimal) space of a vascular wall to facilitate the treatment of vascular disease, particularly total occlusions. For example, the devices and methods disclosed herein may be used to visually define the vessel wall boundary, protect the vessel wall boundary from perforation, bypass an occlusion, and/or remove an occlusion.

Abstract: The present invention describes a system, devices and methods for percutaneous pedicle screw revision procedures. The present invention utilizes a tulip rod stub/connector adapted to be used to extend pedicle screw/rod constructs with minimal disruption to surrounding soft tissue and without having to remove existing hardware.

Abstract: An orthopedic implant kit comprising a lockable poly-axial screw, a tissue dilatation sleeve, a screw driver, a screw extender, a rod, rod-reduction device, a set screw driver, a torque limiting device and a screw releasing device.

Abstract: A spinal construct includes a fastener configured for attachment with sacral and/or pelvic tissue of a body. A connector includes a mating element engageable with the fastener and includes a receiver. A spinal implant is engageable with the receiver between a capture configuration and a removable configuration. A multi-axial fastener is connected with the spinal implant. Systems, implants, instruments and methods of use are disclosed.