Abstract: The present invention relates to a device for changing a course of a vessel, a method of introducing the device, a method of changing a course of a vessel using the device, and a treatment method of brain-nervous system diseases, such as neurovascular compression syndrome, using the device. In treating a neurovascular compression syndrome, the present invention can reduce risks and side effects of the microsurgery (MVD), such as hearing loss or facial paralysis that may occur due to the microsurgery. Further, since an area of a metal surface is small, a risk of in-stent stenosis or thrombus generation is low even in a vessel of the brain having a small diameter, and a degree of vascular compression by its radial force is low, thereby making it possible to minimize intimal hyperplasia.

Abstract: Apparatus and methods for nipple and breast formation are described where devices precondition or expand a target nipple tissue to reduce the pressure exerted by the skin on an eventual implant. Generally, the apparatus comprises a mold having a contact surface which is cured in conformance with a breast upon which the mold is positionable, the contact surface having an adhesive for securement upon the breast, and the mold defining a cavity along the contact surface which conforms to a size of a nipple to be formed upon the breast and where the cavity further comprises the adhesive for securement to the nipple. A breast enlargement device comprises a cup larger than the target breast and further defines an inner surface which adheres to the breast when contacted.

Abstract: A method of manufacturing an artificial eye for fitting as a whole or partial replacement of a patient's original eye. This is done by providing an image of an iris on a substrate (100, 300) comprising at least a frontal region of an artificial eye, providing a support (108, 308) for the substrate, positioning the substrate and support in a mould (122, 322), and encapsulating the substrate within a mould material (136, 336).

Abstract: An electronic device can comprise a first electronic module; a second electronic module; and a hermetic electric interconnect to hermetically couple them. The hermetic electric interconnect can comprise a bottom metal layer; a bottom insulating layer, deposited on the bottom metal layer to insulate the bottom metal layer; an interconnect metal layer, deposited on the bottom insulating layer, and deposited to form a bottom sealing ring; and patterned to form electrical connections between contact pads, and to form a middle sealing ring; a patterned top insulating layer, deposited on the interconnect metal layer to insulate the interconnect metal layer; and patterned to form feedthrough holes; and a top metal layer, deposited on the top insulating layer to start forming contacts by filling the feedthrough holes; and patterned to complete forming contacts through the feedthrough holes, to form a separate barrier layer, and to complete forming the top sealing ring.

Abstract: A method for reducing the transmittance of ultraviolet radiation through an intraocular lens to 10% or less at 370 nm by (a) polymerizing a mixture comprising: at least one first monomer and a second monomer comprising a trisaryl-1,3,5-triazine moiety, (b) forming an optic portion from the copolymer wherein the second monomer is present in about 0.10 to about 0.20 percent by weight of the overall polymer and wherein the optic portion of the intraocular lens displays essentially the same physical properties such as, for example, refractive index as the optic portion of the intraocular lens formed from the polymerized mixture of (a) without the second monomer, but otherwise identical conditions.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, the stent being formed of a plurality of struts forming cells. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets and a cuff. At least one runner is coupled to a cell and configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition.

Abstract: A collapsible and expandable stent (320) extends in an axial direction from a proximal end to a distal end. The stent may include a plurality of first cells (324), each first cell having an open space defined by a first plurality of struts (322). The stent may further include a second cell (330) nested in the open space of one of the first cells, the second cell being defined by a second plurality of struts (330a-d). The stent may additionally include first and second connecting struts (332, 334) connecting the second cell to the one first cell. The second cell may be configured to pivot about the first and second connecting struts with respect to the one first cell. The pivoting may create a clearance space between the second cell and an outer perimeter of the stent in which portions of a native valve structure may be clamped.

Abstract: A prosthetic device for treating a mitral valve includes a prosthetic insert member insertable between leaflets of mitral valve. The insert member has an elongated cross-sectional profile for conforming to gap between leaflets of a mitral valve. The device also includes an anchoring member for attachment to heart tissue for maintaining the insert member in the mitral valve. The insert member includes a valve that permits one-way blood flow therethrough. An anchoring member secures the prosthetic insert member to a heart wall.

Abstract: A medical device includes an expandable conduit, a prosthetic heart valve and a delivery device, including a balloon catheter. The expandable conduit may include one or more inner or outer sleeves supported by a frame or stent. The sleeve(s) may be a bioprosthetic tissue wrapped, molded or sewn about the frame or stent. Coupled to an end of the expandable conduit is the prosthetic heart valve. The conduit and heart valve may be crimped on the balloon catheter for percutaneous deployment. The frame may be constructed of a balloon-expandable material for the conduit portion and a self-expandable material for the prosthetic heart valve portion. The prosthetic heart valve is anchored at the native heart valve and then the conduit to be expanded into place to protect the aorta. The self-expanding prosthetic heart valve avoids the need for balloon mounting. This provides for a smaller diameter and easier delivery.

Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having an upstream portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a mechanically isolated valve support coupled to the anchoring member and configured to support a prosthetic valve. The device can further include an atrial extension member extending radially outward from the upstream portion of the anchoring member and which is deformable without substantially deforming the anchoring member. In some embodiments, the upstream portion of the anchoring member and the extension member may be deformed while the valve support remains sufficiently stable.

Abstract: Prosthetic heart valve devices, heart valve replacement systems and associated methods for percutaneous heart valve replacement are disclosed herein. A transcatheter heart valve prosthesis configured in accordance herewith includes an expandable frame having a plurality of commissure posts extending therefrom, a radially expandable inflow member attached to the plurality of commissure posts, and a locking mechanism operably coupled to a wire. The wire is at least partially slideably disposed within a channel formed in a wall of the inflow member and the locking mechanism is configured to permit the wire to be advanced within the channel to thereby transition the inflow member into a deployed configuration that at least partially engages tissue at the native heart valve.

Abstract: An apparatus for repairing the function of a diseased valve includes a tubular first support member which is expandable to a first average diameter and has oppositely disposed proximal and distal first support member ends. A tubular second support member is spaced axially apart from the first support member and is expandable to a second average diameter that is smaller than the first average diameter. The second support member has oppositely disposed proximal and distal second support member ends. A tubular graft section interconnects the first and second support members and has oppositely disposed proximal and distal graft section ends axially spaced apart by a graft section body. The proximal graft section end is connected directly to the distal first support member end and the distal graft section end is connected directly to the proximal second support member end.

Abstract: A cutting stent device including a prosthetic component positioned within the central lumen of the stent. The stent device includes blades with cutting edges and beveled ends as disclosed and described in U.S. Pat. No. 8,876,882 issued Nov. 4, 2014, incorporated herein by reference in its entirety, The prosthetic component may be a tissue valve comprising bovine or porcine pericardium tissue. The cutting stent device including prosthetic component reduces, if not eliminates, “para-valvular leaking” as caused by mal-apposition. The stent device according to invention provides full apposition between the prosthetic component and native valve leaflets and annulus.

Abstract: The invention relates to a heart valve prosthesis for percutaneous replacement of a tricuspid valve including a stent-type support structure and a biological heart valve; the stent-type support structure can autonomously expand from a radially compressed state into a radially expanded state and includes a fluid-tight cover which extends like a tube over at least some portions of the support structure; the heart valve is arranged in a lateral opening in the support structure. Embodiments further relate to a system including a heart valve prosthesis of said type.

Abstract: A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.

Abstract: Heart valve delivery systems and methods for providing a clinician with feedback during a stented prosthetic heart valve delivery procedure. Feedback is provided using piezochromatic indicators incorporated into elements of the delivery device, such as the handle assembly, shaft assembly and capsule to indicate when detrimental forces, or forces nearing those that are detrimental, are being applied to the delivery device during the prosthetic heart valve loading, delivery or deployment procedure. Other embodiments incorporate a feedback indicator to indicate that a delivery device has previously been used and is not in a new condition.

Abstract: A delivery system includes a delivery catheter with a capsule configured to carry a prosthesis and a steering catheter for steering the delivery catheter. The delivery catheter can be advanced through a patient's vasculature to a target treatment area. The capsule can be opened and the prosthesis can be deployed into the target treatment area. Additionally, a method for delivering a prosthesis to a target treatment area includes advancing a delivery catheter through a patient's vasculature to the target treatment area, steering the delivery catheter toward the target treatment area, opening a capsule on the delivery catheter, and deploying the prosthesis into the target treatment area.

Abstract: A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.

Abstract: The present disclosure relates to numerous delivery devices and methods for transcatheter prosthetic heart valve loading, deployment and delivery utilizing at least one suture. Disclosed delivery devices utilize improved suture routing methods and configurations that reduce suture tangling and also provide the ability to adjust the prosthetic heart valve expansion and contraction prior to the final release of the prosthetic heart valve from the delivery device.

Abstract: The present disclosure relates to numerous devices and methods for transcatheter stented prosthetic heart valve loading and delivery. Such devices and methods reduce suture tangling and also provide the ability to adjust the stented prosthetic heart valve expansion and contraction prior to the final release of the stented prosthetic heart valve from the delivery device.

Abstract: Anchors for securing an implant within a body organ and/or reshaping a body organ are provided herein. Anchors are configured for deployment in a body lumen or vasculature of the patient that are curved or conformable to accommodate anatomy of the patient. Such anchors can include deformable or collapsible structures upon tensioning of a bridging element in a lateral direction, or segmented tubes that can be adjusted by tightening of one or more tethers extending therethrough. Such anchors can be used as a posterior anchor in a blood vessel in implant systems having a tensioned bridging element extending between the posterior anchor and an anterior anchor deployed at another location within or along the body organ. Methods of deploying such anchors, and use of multiple anchors or multiple bridging elements to a single anchor are also provided.

Abstract: Apparatus, systems, and methods for percutaneous valve replacement and/or augmentation are provided. The apparatus includes a valve having a valve frame, a valve leaflet coupled to the valve frame, and a leaflet transition member coupled to the valve leaflet. The valve leaflet and leaflet transition member can transition from a first position where the valve leaflet and leaflet frame are at least partially outside a lumen of the valve frame to a second position where the valve leaflet and the leaflet transition member are within the lumen of the valve frame.

Abstract: A method for reducing left ventricular volume, which comprises identifying infracted tissue during open chest surgery; reducing left ventricle volume while preserving the ventricular apex; and realigning the ventricular apex, such that the realigning step comprises closing the lower or apical portion of said ventricle to achieve appropriate functional contractile geometry of said ventricle in a dyskinetic ventricle of a heart.

Abstract: A penile prosthesis system including at least one cylinder that has an elongated inner opening, a cylinder spring positioned within the opening and adjacent to a distal end of the inner opening, an activation plunger positioned within a proximal end of the opening of the cylinder, and a plurality of discrete members within the inner opening between the cylinder spring and the plunger. The system further includes a pump comprising a spring and a tube connected to and extending from the cylinder and the pump, wherein the tube is configured for transferring fluid to the at least one cylinder upon activation of the pump.

Abstract: A bone implant to be disposed between a first bone section and a second bone section is disclosed. The bone implant includes a body structure, a plurality of through-hole structures and an extended channel structure. The body structure has a first end surface to be connected to the first bone section and a second end surface to be connected to the second bone section. The plurality of through-hole structures are disposed in the body structure, pass through the first end surface and the second end surface and have a through-hole axis. The extended channel structure is disposed in the body structure, wherein the extended channel structure enables a new bone section to grow along a direction other than the through-hole axis between the first bone section and the second bone section.

Abstract: A stabilization device is provided including an axle and a portion that can be affixed to a bone. The device is used to stabilize a joint while allowing motion of the joint along its natural trajectory and it is placed internally in order to prevent pin tract problems. Additionally, methods for using the device are provided that include, in various sequences, inserting the axle into a bone of a joint, adjusting the geometry of the device and attaching the fixable portion to another bone of the joint. The device can be provided as part of a system including an axis trajectory guide useful for locating the axis of rotation of the joint prior to insertion, adjustment and attachment of the device.

Abstract: According to some embodiments, a method of treating a joint of a patient comprises creating a recess in a bone located at or near a targeted joint, wherein the recess includes a generally wedge or truncated cone shape. In one embodiment, the recess in a bone comprises a surface opening along an outer surface of the bone and a bottom opening along the distal end of the recess, such that a diameter of the surface opening is generally smaller than a diameter of the bottom opening. The method additionally comprises providing a joint implant having a wedge or truncated cone shape, wherein a diameter of a top end of the joint implant is generally smaller than a diameter of a bottom end of the joint implant, inserting the joint implant within the recess.

Abstract: An implant for repairing an articular cartilage defect site including an implant fixation portion with an upper segment and at least one bone interfacing segment and a top articulating portion with an articulating surface and an engagement surface. The upper segment includes a supporting plate with a first locking mechanism segment. The engagement surface includes a second locking mechanism segment. The first locking mechanism segment with at least two channels is structured to couple to the second locking mechanism segment with at least two protrusions. The at least one bone interfacing segment structured for insertion into the articular cartilage defect site. An implant including an implant fixation portion, a top articulating portion, and a locking mechanism with a first locking segment coupled to the upper segment and a second locking segment coupled to the at least one engagement surface and structured to couple to the first locking segment.

Abstract: A prosthetic device, adapted to be implanted in the human body and adapted to prevent and/or treat an infection that can arise and/or which has arisen at a bone site or at an articular site, wherein the prosthetic device has a prosthetic body provided with at least one surface for coupling, during use, with the bone or articular site and with at least one cavity placed along the coupling surface, wherein the at least one cavity is adapted to include, contain or house at least one pharmaceutical or medical substance.

Abstract: A woven retention device, lattice device and woven patch device that are configured to receive a fastener in a bone hole can be configured to impede biofilm formation. The devices can be made of woven filaments that outline apertures of varying sizes and shapes and can serve as an interface between a fastener and the bone material. The devices can be configured to allow for optimal bone growth while at the same time minimizing the likelihood that biofilm forms thereon. The devices can be made of materials that facilitate soft tissue fixation, and screw-activated expansion.

Abstract: Apparatus and method for constructing a cartilage structure preferably has a first plate, and a blade mounted over the first plate. The blade preferably has (i) a predetermined shape, and (ii) a cutting edge protruding from the first plate and configured to cut a cartilage into the predetermined shape. A second plate preferably has a guide imprint adjacent a surface thereof, the guide imprint having a shape complimentary to the predetermined shape of the blade. A press preferably has (i) a first surface configured to mount the first plate, and (ii) a second surface configured to mount the second plate. Actuation structure is preferably configured to press together the press first and second surfaces to thereby cause the blade to cut the cartilage in the predetermined shape. The method utilizes similar structure to prepare at least two cartilages, which are joined together to form a three-dimensional cartilage structure.

Abstract: In an orthopaedic knee joint prosthesis, an intercondylar fossa of a femoral component cooperates with a spine formed in a tibial component to reproduce the screw home mechanism of a natural knee. When the femoral component and tibial component are positioned to correspond with slight flexion of the knee, the components are mutually rotationally locked against internal or external rotation. At higher degrees of flexion, such as greater than about 10-20 degrees of flexion, internal/external rotation of the tibia is permitted. The tibia is in an externally rotated position when locked, thereby reproducing the screw home mechanism and providing high stability.

Abstract: A shoulder replacement system including a humeral head having a curved exterior surface and a generally planar exterior surface. The humeral head can define a main body axis extending transversely from the generally planar exterior surface to the curved exterior surface. The humeral head can also include a polar axis extending parallel to the planar exterior surface from an outer edge of the humeral head intersecting the main body axis and an equatorial axis extending parallel to the planar exterior surface from the outer edge of the humeral head intersecting the main body axis and the polar axis. The shoulder replacement system can also include a humeral stem insertable into a humerus and a glenoid implant that can be engaged to bone defining a glenoid cavity and defining an articulating surface.

Abstract: Prosthetic replacement for a posterior element of a vertebra comprising portions that replace the natural lamina and the four natural facets. The prosthetic replacement may also include portions that replace one or more of the natural spinous process and the two natural transverse processes. If desired, the prosthesis replacement may also replace the natural pedicles. A method for replacing a posterior element of a vertebra is also provided.

Abstract: A spacer for separating bones of a joint, the spacer includes a first endplate configured to engage a first bone of the joint; a second endplate configured to engage a second bone of the joint; tissue engaging projections, wherein the tissue engaging projections are moveable from a retracted position to a deployed position; and an actuation subassembly that extends between the first endplate and the second endplate, wherein the actuation subassembly comprise a drive nut, a drive screw coupled to the drive nut, and a cam frame coupled to the drive screw, wherein the cam frame is disposed between the first endplate and the second endplate to engage the tissue engaging projections.

Abstract: An implantable orthopedic stability device is disclosed. The device can have a contracted and an expanded configuration. A method of using the device between adjacent vertebral body surfaces for support and/or fixation of either or both of the adjacent vertebrae is also disclosed.

Abstract: Improved bone plate systems are described herein. In some instances, a bone plate system can include a base plate, at least one retainer plate, and at least one spacer. The at least one retainer plate is configured to reside on the base plate in a free floating manner and can receive at least one fastener to secure the retainer plate to the at least one spacer, thereby providing a plate system that attaches to a spacer. In other instances, a bone plate system can include a base plate having one or more push plates that can engage at least one spacer.

Abstract: An expandable intervertebral implant (10) includes superior (20) and inferior (30) bone contacting members and at least one vertical wire netting (50) interconnecting the superior and inferior bone contacting members. The superior and inferior bone contacting members include at least two bone contacting components interconnected via one or more lateral wire nettings such that the implant is vertically and laterally expandable in situ from a first insertion configuration to a second expanded configuration. The vertical and lateral wire netting are preferably constructed of a plurality of individual link members. The present invention also preferably relates to an associated method of manufacturing the intervertebral implant such that the intervertebral implant can be manufactured as an integral component or part.

Abstract: A prosthetic knee joint with buffering and braking effects has an upper connecting base, a linking assembly, a braking assembly, and a lower connecting base. The upper connecting base has two extending lugs and an accommodating recess. The linking assembly has two linking arms respectively and pivotally connected to the upper connecting base. The braking assembly has a braking arm protruding into the accommodating recess of the upper connecting base and pivotally connected to the two extending lugs. The lower connecting base is connected to the linking assembly and the braking assembly. The upper connecting base, the linking assembly, the braking assembly and the lower connecting base form a four-bar linkage. A cushion between an abutter and a main body provides a buffering effect during walking. Thus, the prosthetic knee joint has simplified structure and reduced cost and is convenient in assembly and use.

Abstract: A joint assembly including a plurality of frames, each including contactors provided in opposite directions to each other and a middle portion configured to connect the contactors, and a connecting member configured to maintain a state in which contactors of two neighboring frames among the plurality of frames are in contact with each other is disclosed.

Abstract: A prosthesis or orthosis having a movement controlling mechanism (MCM) including a first MCM part, a second MCM part and one or more intermediate elements and biasing mechanism which, in a contacting mode of operation of the MCM, bias the intermediate elements against a MCM part.

Abstract: A degradable stent, including: a cylindrical magnesium alloy tube including an outer wall including barbs, and a magnesium alloy wire. In use, the cylindrical magnesium alloy tube is inserted in a broken or damaged lumen of human body, the barbs are inserted in the inner wall of the lumen, the magnesium alloy wire is wound around the magnesium alloy tube and the lumen, and the magnesium alloy tube is fixedly connected to the lumen of the human body.

Abstract: A method of implanting a prosthesis in a patient at a treatment site within a blood vessel includes advancing an outer catheter of a prosthesis delivery system in the patient distal to the treatment site, the outer catheter defining an inside diameter and advancing an inner sheath, having greater flexibility than the outer catheter and an outside diameter that is greater than the inside diameter of the outer catheter, and a guidewire lumen of the delivery system from the outer catheter to the treatment site along a guidewire while the outer catheter remains stationary relative to the patient, whereby advancing the inner sheath delivers the prosthesis to the treatment site. The inner sheath is retracted to deploy the prosthesis from within the inner sheath and at the treatment site after which the delivery system from the patient.

Abstract: A method of implanting a prosthesis in a patient at a treatment site includes advancing an outer catheter of a prosthesis delivery system in the patient distal to the treatment site. An inner sheath and a curved guidewire lumen of the delivery system are advanced from the outer catheter to the treatment site along a guidewire while the outer catheter remains stationary relative to the patient. Advancing the inner sheath causes rotation of the prosthesis to thereby rotationally align the prosthesis at the treatment site. The inner sheath is retracted to deploy a prosthesis from within the inner sheath and at the treatment site. The delivery system is then retracted from the patient.

Abstract: A gastroscopic method of treating obesity of a patient using a device adapted to stretch a part of the stomach wall of said patient. The method comprising the steps of: inserting said device into the stomach of said patient through the esophagus, placing said device in contact with the stomach wall and fixating said device to the stomach wall such that said device can stretch a part of said stomach wall.

Abstract: The current invention is a leg brace with two adjustable lateral supports connected to the footpad with a plurality of support straps that are connected between the lateral supports 10 and the lateral supports. The support straps can be attached around the leg that needs to be support with an attachment means such as a buckle mechanism or a hook and fastening system. The support straps would have built in one or more air bladders which would inflate with air using a built in air pump allowing the proper support and comfort for the user.

Abstract: The invention relates to an ankle-foot orthosis which comprises means that limit the plantar flexion of the foot and which is configured to provide support for a user's foot drop. The ankle-foot orthosis comprises a lower leg shell comprising a foot support (3) and a lower leg support (7), as well as heel fixing means which position and/or fix a user's heel in the lower leg support. The plantar flexion motion of the foot is limited by the complementary action of the elastic (23) and the non-elastic (25) plantar flexion limiting means. The plantar flexion limiting means further lead to a dynamic return of the foot to an angle substantially equal to the angle value a2.

Abstract: An orthosis includes a footplate having a heel portion, a midfoot portion, and a longitudinal axis extending between the heel and midfoot portions. A first deflection zone is defined along a length of the footplate anterior of the heel portion and through which the footplate is arranged to flex during gait to accommodate dorsiflexion of a foot of a user positioned on the footplate. At least one strut is connected to the heel portion of the footplate and extends upwardly therefrom and a connecting portion connects the at least one strut to the heel portion.

Abstract: A customizable ankle-foot orthotic. The orthotic including an ankle brace for installation around a wearer's ankle, the ankle brace including a first wing, a second wing, and a third wing anchored at a point between the first wing and the second wing, the second and third wings independently configurable to couple to a portion of the first wing to enable the wearer to customize the fit. a tension adjustment assembly including one or more strap loops; and an elastic strap operably linking the ankle brace to a wearer's shoe for applying an upward resistive force to the wearer's shoe to prevent inadvertent downward movement of a wearer's foot, the elastic strap threadable through the one or more strap loops such that the elastic strap wraps around the exterior face of the ankle brace and extends at a downward angle to engage the wearer's shoe.

Abstract: A restraint apparatus operable by a user for restraining a limb of a person to a restraining point including a cuff having a first end and a second end. The cuff is operable between an open configuration and a closed configuration. The cuff is secured around the limb of the person in the closed configuration and the first end and the second end are separated from each other in the open configuration. At least one tether is attached to the cuff. The tether comprises a coupler to couple the cuff to the restraining point when the cuff is in the closed configuration. The cuff is wearable by a least a portion of a hand of the user in the open configuration.