Abstract: Embodiments of a modulable absorption light adjustable lens (MALAL) comprise a light adjustable lens that is capable of changing its optical properties upon an adjusting irradiation, including a photo-modifiable material; and a modulable absorption front protection layer, including a modulable absorption compound whose absorption properties can be modulated with a modulating stimulus. Other embodiments include a method of adjusting an optical property of a modulable absorption light adjustable lens, the method comprising: reducing an absorption of a modulable absorption compound of a modulable absorption front protection layer of the MALAL by a modulating stimulus, the MALAL having been previously implanted into an eye; and changing an optical property of a light adjustable lens of the MALAL by applying an adjusting irradiation.

Abstract: The present disclosure relates to an intraocular lens. An intraocular lens in accordance with some embodiments of the present disclosure comprises a first optical portion including an optical lens and a support portion configured to be coupled with the first optical portion, wherein the first optical portion may be formed to be detachable from the support portion in a state where the support portion is inserted into an eye of a user.

Abstract: An anchor for a prosthetic heart valve includes a core, a first cover layer, and a second cover layer. The core includes a plurality of helical turns. One or more outflow turns of the plurality of helical turns has a diameter configured to be disposed on an outflow side of a native valve, and one or more inflow turns of the plurality of helical turns has a diameter configured to be disposed on an inflow side of a native valve. The first cover layer is disposed over and contacts the helical core, and the first cover layer includes a first material. The second cover layer is disposed over and contacts the first cover layer, and the second cover layer includes a second material, which is different than the first material.

Abstract: First and second atrial arms and first and second ventricular arms are advanced to the heart. The first ventricular arm is moved distally by applying a pulling force to the first ventricular arm at a first fixed connection point that is at a portion of the first ventricular arm that is farthest from a first articulation site of the first atrial arm and the first ventricular arm, and the second ventricular arm is moved distally by applying a pulling force to the second ventricular arm at a second fixed connection point that is at a portion of the second ventricular arm that is farthest from a second articulation site of the second atrial arm and the second ventricular arm. Subsequently, the first native leaflet is clamped between the first arms, and the second native leaflet is clamped between the second arms. Other embodiments are also described.

Abstract: A replacement heart valve system may include a replacement heart valve implant including an expandable framework configured to shift from a radially collapsed to a radially expanded configuration, wherein the framework is self-biased toward the radially expanded configuration, and a plurality of valve leaflets attached to the framework. The replacement heart valve system may include an implant delivery system including a handle and an elongate shaft assembly including a tubular member fixedly attached to the handle, and an implant holding portion configured to constrain the framework in the radially collapsed configuration. The elongate shaft assembly includes an expandable balloon disposed on the tubular member within the implant holding portion, the balloon being configured to shift between deflated and inflated configurations. When the framework is constrained within the implant holding portion, at least a portion of the framework extends distal of the balloon in the deflated configuration.

Abstract: Devices, systems, and methods relate to implants, such as prosthetic valves for replacing native heart valves. Delivery systems for delivering the implants to an implantation site are also disclosed herein. A prosthetic valve may include a valve body supporting a plurality of prosthetic valve leaflets and one or more adjustable anchors coupled to the valve body for anchoring the prosthetic valve to leaflets of a native heart valve, wherein at least one of the adjustable anchors is axially slidable relative to the valve body for conforming to the native anatomy of the native heart valve.

Abstract: A delivery apparatus for an expandable prosthetic heart valve can include a handle, a shaft having a proximal portion and a distal portion, the proximal portion being coupled to the handle, and a nosecone coupled to the distal portion of the shaft. The nosecone can include a proximal portion and a distal portion coupled to the proximal portion. The distal portion can be configured to flexibly curve relative to the proximal portion and the proximal portion is formed of a first material that is relatively harder than a second material forming the distal portion.

Abstract: Method and devices for displacing leaflets of an existing valvular structure at an aortic valve position away from coronary ostia of an aorta are disclosed. An example method can include implanting a prosthetic heart valve within a native valve or previously implanted heart valve such that a commissure of the prosthetic heart valve is circumferentially aligned with a mid-portion of a leaflet of the native or previously implanted heart valve. The method further includes, during radially expanding the prosthetic heart valve into the native or previously implanted heart valve, applying pressure to the mid-portion of the leaflet with the commissure such that the leaflet is displaced away from the commissure and toward an inflow end of the prosthetic heart valve.

Abstract: A prosthetic valve includes an expandable valve frame and leaflets supported therein. A plurality of elongate anchor arms extends from an outlet end portion of the valve frame. Each elongate anchor arm includes anchoring protrusions, such as barbs, for engaging surrounding tissue. During delivery to the treatment site, the anchoring protrusions face inwardly. When released from the delivery catheter, the anchoring arms evert such that the anchoring protrusions reverse orientation and face outwardly. In this position, the protrusions can engage surrounding tissue and thereby secure the prosthetic valve within a native heart valve.

Abstract: A delivery apparatus for a prosthetic heart valve includes a handle, one or more actuator drivers, and a gearbox disposed within the handle and coupled to rotate the actuator drivers relative to the handle. The gearbox can include a counter-rotation gear train that can be operated to rotate two sets of actuator drivers in opposite directions. One or more of the actuator drivers can have an associated torque limiter that prevents overloading of the actuator driver. The gearbox can be pivotably mounted within the handle. The gearbox can be configured to engage a stop member within the handle to limit pivoting of the gearbox in a predetermined direction. The handle can include a sensor that is positioned to measure torque applied to the prosthetic heart valve while rotating the actuation drivers.

Abstract: Heart valve prosthesis are disclosed that include a frame or support structure having an inflow portion, a valve-retaining tubular or central portion and a pair of support arms. The inflow portion radially extends from a first end of the valve-retaining tubular portion and the pair of support arms are circumferentially spaced apart and radially extend from an opposing second end of the valve-retaining tubular portion.

Abstract: Valve repair devices are disclosed herein. The valve repair devices are configured to reduce or inhibit regurgitant blood flow through a native heart valve. The valve repair devices are configured to be positioned within the native heart valve orifice and attached to the native heart valve. The device can be connected to leaflets of the native valve by a variety of different types of paddles.

Abstract: An automatic repair device with oppositely oriented inflow and outflow portions may be positioned within an annulus of a heart valve. The outflow portion of the automatic repair device is shorter than the inflow portion and is asymmetrical, whereas the inflow portion is symmetrical. Both the inflow and outflow portions of the automatic repair device are shaped such that lateral pressure is not applied to the annulus after implantation is complete. The smaller outflow portion is especially shaped to conform to a mitral valve annulus and anterior leaflet to further reduce stress on adjacent cardiac structures after implantation. The automatic repair device is preferably constructed of memory shape material, such that the automatic repair device is compressible to fit within most catheters or trocars for implantation in the annulus. Upon implantation at the annulus, the automatic repair device automatically expands to return to its original shape and dimensions.

Abstract: A method of valve implantation includes installing a leaflet lasso on a host leaflet assembly at an implantation site within a patient's body. The method includes positioning an expandable prosthetic heart valve in a crimped state within a central region of the host leaflet assembly. The method includes radially expanding the prosthetic heart valve to a working diameter. During at least a portion of radially expanding the prosthetic heart valve, the prosthetic heart valve contacts a central lasso portion of the leaflet lasso and applies a radial force to the central lasso portion that results in folding of at least one leaflet of the leaflet assembly.

Abstract: Using a catheter, a device is delivered to the heart of a subject. The device includes a cord and multiple anchors distributed along the cord. Subsequently, the device is arranged in an arrangement at the tissue such that the cord is positioned and laid out correspondingly to the tissue. While the device remains in the arrangement, (i) a first subset of the anchors which are positioned for successful anchoring is identified, and (ii) subsequent to the identifying, for each of the anchors of the first subset, a respective anchor launcher is actuated to drive the anchor into the tissue. Subsequently, for each of the anchors that remain not driven into the tissue, (i) the anchor is positioned for successful anchoring, and (ii) a respective anchor launcher is actuated to drive the anchor into the tissue. Other embodiments are also disclosed.

Abstract: The present invention is generally directed to an implant for sacroiliac (SI) Joint fixation. Specifically, the present invention is generally directed to an implant for SI Joint fixation comprising a pair of anchor members connected to one another by an adjustable connector assembly. In accordance with embodiments of the present invention, the dual anchor pieces may be inserted into the sacroiliac joint, a first anchor member into the sacrum, a second anchor member into the ilium. An adjustable connector assembly may hold the pair of anchor members together. The adjustable connector assembly may be used to distract or compress the sacroiliac joint.

Abstract: The application is directed to devices and methods where one or more magnetic or magnetizable implants provides therapeutic benefits to a patient. The implant may be useful for expanding the range of motion of joints or dynamically providing different responses to changing conditions in the body where the implant is placed. An electromagnet is placed on or in a bone on one side of a joint, and another electromagnet or magnetically active material is placed on or in a bone on the opposing side of the joint. The electromagnet may be continuously energized to relieve pressure in the joint space, or may be energized in response to forces applied to the joint.

Abstract: Implantable orthopedic pain management devices are disclosed, including a body with a top surface, a bottom surface, and at least two substantially parallel surfaces, the two substantially parallel surfaces having substantially similar radii of curvature and are substantially trapezoidally shaped, the top surface having a top radius of curvature and the bottom surface having a bottom radius of curvature, the body being configured to be disposed in a joint such that the surfaces are configured to be in intermittent contact with bone surfaces of one or more bones comprising the joint, the body not being coupled to the one or more bones, and a peripheral protrusion disposed substantially at an intersection of at least two surfaces, the peripheral protrusion being formed with the body, substantially spherical, and configured to prevent expulsion of the body from the joint.

Abstract: Various implementations include anchoring nails, fixation apparatuses, spinal fixation systems, and related methods described in this disclosure. Certain implementations include a fixation nail for an interbody fusion procedure, the fixation nail including: a body having an arcuate primary axis extending from a distal end to a proximal end thereof, the body having an outer surface that enables complete insertion and removal of the fixation nail into an interbody without threaded engagement, and the body further including an elongated recess spanning a majority of a length of the body, the elongated recess sized to at least partially encompass at least one of tissue or bone during insertion into a patient.

Abstract: A system and methods are provided for treating radial head fractures. The system includes an implant, a sterile instrument kit for radial head arthroplasty, and a head sizer and assembly tray for sizing and assembling implants. The implant includes a head that is coupled with a stem. The head is adapted to be placed into sliding contact with a capitellum of the radiocapitellar joint. The stem is configured to be inserted into a hole reamed into a medullary canal of the radial head. The sterile instrument kit comprises a multiplicity of instruments including any one or more of trial heads and trial stems, a starter awl, a reamer, a planar, an inserter cap, and an impactor. The instruments are configured for implanting the implant into the radiocapitellar joint such that the implant restores biomechanical properties of the joint.

Abstract: A modular implant system includes a baseplate, a bearing insert and a latch. The baseplate is adapted to receive the bearing insert. The bearing insert has an articular surface and a plate-contacting surface opposite the articular surface and the latch is adapted for disposal through a hole in the bearing insert. The system is adapted so that when the plate-contacting surface of the bearing insert is disposed on the baseplate and the latch is disposed through the hole in the bearing insert, the latch is rotatable from a first position to a second position. In the first position, the bearing insert is removable from the baseplate. In the second position, the bearing insert is held in place on the baseplate.

Abstract: Implantable orthopedic pain management devices are disclosed, including a body with a top surface having a radius of curvature, and a bottom surface with another radius of curvature, configured to be surgically implanted in a joint and to prevent contact between one or more bones in the joint, the body not being coupled to the one or more bones, and a peripheral protrusion disposed substantially about a perimeter of the body and having a substantially circular cross section, the peripheral protrusion being configured to prevent expulsion of the body from the joint.

Abstract: An interbody implant is provided that may expand lordotically and has an additional plate to secure the implant and its expansion.

Abstract: Methods and apparatus for providing correction of one or more maladies or conditions of the spinal column of a living being. In one embodiment, the apparatus includes an implantable device configured to be selectively adjustable in one or more portions thereof so as to permit correction of asymmetries or irregularities of the spinal column via insertion into one or more affected intervertebral disc spaces. In one variant, the implantable device includes upper and lower host elements which are hinged or can pivot relative to one another, and an insertable distraction mechanism which is adjustable to enable one side or the other of the implantable device to alter height. In another variant, both sides of the implantable device can be adjusted for height via the host elements and one or more pivots or hinges. In one implementation, the distraction mechanism is adjustable from multiple approaches into the disc space.

Abstract: An embodiment includes an orthopedic fusion system comprising: a cage; a curved first channel coupling a lateral wall of the cage to a superior surface of the cage; a curved second channel coupling the lateral wall of the cage to an inferior surface of the cage; a third channel coupling the superior surface of the cage to the inferior surface of the cage; a curved first anchor configured to slide within the first channel; a curved second anchor configured to slide within the second channel; and a resilient member comprising a resilient first arm that projects across a portion of the first channel and a resilient second arm that projects across a portion of the second channel. Other embodiments are described herein.

Abstract: The present disclosure relates to the technical field of medical supplies, in particular to a fusion cage. The fusion cage comprises a main body, which is a flat-shaped porous structural body and composed of a plurality of structural units. The fusion cage provided by the present disclosure is the flat-shaped porous structural body composed of the plurality of structural units, the porosity of the whole structure of the fusion cage is controlled by using the parametrization design, so the elastic modulus of a fusion body is effectively reduced, and then each structural unit comprises the basal body and the plurality of extension portions extending from the surface of the basal body, the surfaces of the basal body and/or the extension portions are composed of the plurality of curved surfaces through smooth connection, and such design effectively reduces the problem of stress concentration, and improving the postoperative recovery effect of patients.

Abstract: Disclosed herein are systems and methods for intervertebral body fusion that provide more robust support within the disc space. Intervertebral body fusion devices can have a unitary monolithic body including a plurality of body segments interconnected with each other by flexure members. Devices be configured to be inserted through an opening in a compressed configuration and then expanded within the disc space to an expanded configuration. In the expanded configuration, devices can have a greater mediolateral or transverse to the disc space footprint. This wider footprint provides greater support for the vertebrae relative to the size of the opening through which the device is inserted.

Abstract: An intervertebral scaffolding system is provided having a laterovertically-expanding frame operable for a reversible collapse from an expanded state into a collapsed state, the laterovertically-expanding frame having a stabilizer that slidably engages with the distal region of the laterovertically-expanding frame and is configured for retaining the laterovertically-expanding frame from a lateral movement that exceeds the expanded state. The expanded state, for example, can be configured to have an open graft distribution window that at least substantially closes upon the reversible collapse.

Abstract: A method for performing lumbar interbody fusion surgery may include forming an access corridor through a facet joint of a patient, removing disc material from a disc space of the patient via one or more instruments advanced through the access corridor, and advancing an interbody device through the access corridor and into the disc space.

Abstract: The present technology is generally directed to expandable intervertebral devices, and associated devices, systems, and methods. In some embodiments, an intervertebral device is configured to transition between multiple different states, for example, between an unexpanded state and an expanded state. The expansion of the intervertebral device can include horizontal/lateral expansion and/or vertical/lordotic expansion. In some embodiments, the intervertebral device includes locking features configured to hold or “lock” the intervertebral device in an expanded state, e.g., to inhibit or prevent the intervertebral device from transitioning away from and/or out of the expanded state.

Abstract: A variable lordotic interbody spacer including a face plate, superior and inferior endplates coupled to the face plate via a hinge, an actuation frame between the endplates, and an actuation screw. The face plate includes actuation and stabilizer channels. Each of the endplates has endplate arms coupled by an endplate base, and includes actuation ramp recesses. The actuation frame includes frame arms coupled by a frame base in a generally U-shaped configuration, each actuation frame arm having a stabilizer feature passing through a corresponding stabilizer channel and having actuation ramp pins fitted to a corresponding ramp recesses. The actuation screw passes through the actuation channel, with a head retained at the front surface and a threaded end coupled to the actuation frame. When operated, the actuation screw moves the actuation frame between the superior endplate and the inferior endplate to adjust an angle therebetween.

Abstract: The present disclosure provides various surgical instruments and delivery systems to properly implant spinous stabilization devices, such as for example, interspinous, interlaminar stabilization devices, in a less invasive manner than what is currently performed. The delivery system may be a tubular delivery system through which instruments and devices can pass. Methods for using these surgical instruments and delivery systems are also provided.

Abstract: Embodiments herein are generally directed to spinal implants, systems, apparatuses, and components thereof that can be used in spinal fusion and/or stabilization procedures, as well as methods of installation. The spinal implants may be expandable. In some embodiments, the spinal implants may be configured to be backfilled with bone graft material after insertion.

Abstract: Various aspects of this disclosure relate to a prosthetic cover comprising an array of sensors, which transmit signals to an array of electrodes in a liner that fits over a residual limb of an amputee. Different interactions with the prosthetic cover cause different activation of the electrodes to transmit electrical current through different areas of the residual limb and modulate neurons differently within the residual limb.

Abstract: A prosthetic thumb having a rotation drive and articulation mechanism for causing rotation and flexion of metacarpal and phalange segments. A rotational mounting arrangement with angular contact bearing is preloaded axially. A flexion drive has a motor and gearbox adjacent and coplanar to each other, and mechanically coupled to a worm drive having a worm wheel on a second, parallel plane. A rigid linkage rotationally connects with the phalange and the worm wheel and causes flexion of the phalange segment. The thumb rotation drive rotates a metacarpal rotation wheel to cause rotation. A fixation plate supports the mechanism, such that a single structure takes all forces applied to the thumb digit, such as the plate and/or wrist, and not to a prosthetic hand structure. A potentiometer detects rotational position of the thumb digit. Some embodiments have a hollow worm gear with threaded shaft therethrough for high torque pressing states.

Abstract: A prosthetic hand with a waterproof cover and/or a filament-based digit securement mechanism. A first annular recess on the digit aligns with a second corresponding annular recess on a chassis to form a groove into which the filament is inserted. The prosthetic hand may comprise a waterproof cover that protects the interior components of the prosthetic hand. A thumb cover and a dorsal cover attach to a palm cover. A thumb cover interface is adhered via a clamp with an exterior sealing ring. A dorsal cover interface has a sealing ring. The thumb cover may be flexible and have three layers. The dorsal cover may be rigid and have a latch that snaps onto the chassis. The cover may be put onto the palm portion with the thumb and thumb cover, and then the prosthetic digits may be attached to the chassis thereafter.

Abstract: Modular systems including a foot controller, cable(s), and prosthetic tool is provided herein. The foot controller can include two sets of wheels that are perpendicularly mounted. Both sets can be coupled to a pulley with a specific gear ratio designed to handle degrees-of-freedom of the tool and having two open loops of cable wrapped around. The cables can be mounted to the pulley and the prosthetic tool on each end. The cables can be Bowden cables that transmit motion and are threaded through a hollow Teflon cable with an outer steel casing. The user can swap cables of different lengths according to the specific task or application of the tool. The prosthetic tool can be mounted to the human body via a socket or brace, which are connected to the cable(s). Either one or both set of cables can be attached to the tool to achieve the intended degrees-of-freedom.

Abstract: A system for powering a prosthetic arm is disclosed. The system includes at least one internal battery located in the prosthetic arm, at least one external battery connected to the prosthetic arm, and a master controller configured to connect either the at least one internal battery or the at least one external battery to a power bus to power the prosthetic arm.

Abstract: Embodiments relate to prosthetic limbs and liners. An embodiment of the prosthetic liner is housed in a prosthetic limb and includes a liner body. The liner body includes a first end for receiving a body part of a user. The first end includes a liquid-retentive portion. The liner body includes an inner surface. The inner surface contacts with the body part. The inner surface includes a plurality of microchannels. The microchannels are formed along the inner surface. The microchannels are connected at one end to the liquid-retentive portion. At least one of the plurality of microchannels is configured to receive liquid droplets and direct the received liquid droplets to the liquid-retentive portion. The liner body also includes an outer surface opposite to the inner surface. The outer surface faces an interior surface of the prosthetic limb and is provided in an interior cavity of the prosthetic limb.

Abstract: A biodegradable double-J stent and a method of manufacturing a biodegradable double-J stent are provided. The stent comprises a main tube, a first retaining tube, and a second retaining tube, each fabricated from a biodegradable material. The first and second retaining tubes are curl-shaped and are connected to two ends of the main tube, respectively. The method of manufacturing a biodegradable double-J stent comprises the steps of: (a) providing a tube made of a biodegradable material; and (b) bending two ends of the tube to render the two ends curl-shaped and keeping a middle segment between the two ends straight. The two curl-shaped ends define a first retaining tube and a second retaining tube, respectively, and the middle segment defines a main tube. The biodegradable double-J stent precludes a ureteral obstruction which might otherwise occur with conventional double-J stents not removed in a timely manner.

Abstract: An implantable medical device including an expandable device having a longitudinal length and operable to be compressed to a first diameter and deployed to a second diameter, wherein the second diameter is greater than the first diameter, and wherein a first portion that is less than the longitudinal length of the expandable device and a second portion that is less than the longitudinal length of the expandable device are defined on the expandable device. The medical device includes a first constraining member operable to constrain the first portion of the expandable device at the first diameter; a second constraining member operable to constrain the second portion of the expandable device at the first diameter.

Abstract: A lumbar support belt to be worn by a user includes an inner support belt having an inner surface adapted to contact the user when worn and an outer surface. The inner support belt having opposed free ends and an elongated section with a therebetween with a center. The lumbar support belt further including a rigid outer belt formed in two sections which are adjustable in length and attached to the outer surface of the inner support belt and an elastic reinforcement assembly secured to the outer surface of the inner support belt located at the center of the elongated section. The rigid outer belt cooperates with the elastic reinforcement assembly to actively expand the elastic reinforcement assembly when the rigid outer belt is secured around the user and the two sections are connected to one another by a buckle to provide concentrated lumbar support.

Abstract: Cervical collars, components thereof, and methods of using them overcome issues with conventional cervical collars.

Abstract: Methods and apparatus for collecting fluids discharged from a urethra. An apparatus can include a housing with a rear and front portion a coupled together. A baseplate, inside the housing, includes an angled circumferential side surface adjacent to an inside surface of the housing, a main aperture, and a valve aperture extending through the baseplate. A discharge tube is coupled to the baseplate. An elastomeric tube extends from outside the housing to a termination point past the baseplate within the housing, the baseplate and the housing configured such that the collection tube is pinched and held in place between the baseplate angled circumferential side surface and an inside surface of the vented housing. One-way valves positioned in each valve aperture communicate air through the baseplate into the collection tube. A urethra tube, configured for collecting discharged urine, is positioned in a proximal end of the collection tube.

Abstract: The present hernia belt ostomy support system and method is designed to provide support to a hernia and house a medical device (e.g., an ostomy appliance) within a compartment, wherein the device is comfortable, supportive, inconspicuous, and aesthetically pleasing.

Abstract: An apparatus for collecting urine from a user includes a sheath portion having a first end and a second end, wherein the first end is configured to make a seal with a penis of a user. An outlet is positioned at the second end and is configured to enable urine to exit the sheath portion. A channel is operably coupled to the outlet to convey urine away from the sheath portion. A check valve is coupled to the channel at or near the outlet to enable air to enter the channel but prevent the exit of air or liquids. In certain embodiments, the channel is coupled to a collection chamber which is in turn coupled to a vacuum device. The vacuum device may be configured to pull air bubbles into the channel to assist in conveying the urine into the collection chamber. A corresponding method is also disclosed.

Abstract: An apparatus for collecting urine from a user includes a sheath portion having a first end and a second end, wherein the first end is configured to make a seal with a penis of a user. An outlet is positioned at the second end and is configured to enable urine to exit the sheath portion. A channel is operably coupled to the outlet to convey urine away from the sheath portion. A throttle valve is coupled to the channel at or near the outlet to enable air to enter the channel in a regulated manner. In certain embodiments, the channel is coupled to a collection chamber which is in turn coupled to a vacuum device. The vacuum device may be configured to pull air bubbles into the channel to assist in conveying the urine into the collection chamber. A corresponding method is also disclosed.

Abstract: A female external catheter includes a hollow body portion including a urethral inlet in fluid communication with an outlet. A wicking material covers the urethral inlet, and a catheter tube is coupled to the outlet, the catheter tube configured to transport urine away from the hollow body portion. The hollow body portion includes a finger portion with an opening configured to receive only a single finger to enable manipulation of the female external catheter in order to position and hold the wicking material against a urethral outlet of a female user.

Abstract: Cup supports having a head portion defining an aperture for receiving a specimen cup for the collection of a liquid and a handle portion extending from the head portion. The head portion and the handle portion can be integrally formed, and in some embodiments the cup support is adapted to absorb liquid that impinges on it during use.

Abstract: A digitally-printed anti-snoring dental device is provided. The device includes a unitary upper appliance comprising an upper tray, an upper right specialized attachment and an upper left specialized attachment; a unitary lower appliance comprising a lower tray, a lower right specialized attachment and a lower left specialized attachment; at least one elastic attached to the upper right specialized attachment and to the lower right specialized attachment; and at least one elastic attached to the upper left specialized attachment and to the lower right specialized attachment. Each of the upper right specialized attachment, the upper left specialized attachment, the lower right specialized attachment, and the lower left specialized attachment includes an open ball hook configured to retain the at least one elastic thereon.