Abstract: A drill bit and method for normalizing bone is provided. The drill bit has a non-round drill bit core that is adapted to cut hard bone and to not cut soft bone. The drill bit has a cutting edge which may be positioned within a compression zone of the non-round drill bit core. The rotational speed of the drill bit and the profile of the drill bit core are tuned so that hard bone recovers into a cutting zone defined by the cutting edge while soft bone remains outside of the cutting zone. The insertion torque of the drill bit can be measured to determine when the normalization is adequate.

Abstract: A multifocal IOL including at least one diffractive surface including a plurality of discrete, adjacent, diffractive, concentric rings, having a radial phase profile cross-section with a near-symmetrical diffractive surface topography, and an odd number, greater than three, of diffractive orders and an asymmetrical distribution of energy flux over the diffractive orders.

Abstract: An internal bone fixation device that includes a support frame that is strong but able to absorb compressive forces and that surrounds a porous architecture that helps facilitate bone fusion.

Abstract: A thigh prosthetic component for connecting to a thigh shaft. The component includes a pivotable knee joint and an upper part and a lower part connected by ventral and dorsal arms. The ventral arm is articulated to the upper part and to the lower part via distinct axes. The dorsal arm is articulated to the upper part and to the lower part via distinct axes. The component further includes an ankle pivotably connecting a foot part to a lower leg unit connected to the knee joint. The lower leg unit has ventral and dorsal connecting elements transmitting thrust and traction. The ventral connecting element is pivoted to the foot part and to the lower part. The dorsal connecting element is articulated to the foot part and to the upper part and the dorsal articulated arm such that an adjustment of the knee joint from stance to swing positions causes a dorsal extension of the foot part.

Abstract: A device promotes triple flexion of the hip, knee and ankle. The device includes a belt, knee cuff, ankle wrap, foot wrap and two pairs of adjustable bands. The device is configured to promote triple flexion in the hip, knee and ankle of the user during the swing phase of walking when the user has the belt wrapped around the user's waist, the knee cuff wrapped around the user's knee, the ankle wrap wrapped around the user's ankle and the foot wrap wrapped around the user's foot.

Abstract: An earpiece, earphone, earbud or earplug includes an inflatable element operatively attached to a distal end by an inflation channel, and an anti-distal end of the inflation channel that provides a pressuring force via fluid transfer of a fluid to maintain an expansion of the inflatable element. The inflatable element can be pressurized to a gauge pressure range between 0.05 bar and 3.0 bar. In some embodiments, the inflatable element is pressurized to a gauge pressure range from 0.3 bar to 0.25 bar and maintains such gauge pressure range for at least 12 hours. In some embodiments, the inflatable element uses a material of a predetermined permeability for a given density of fluid and a given thickness of the inflatable element such that an inflation pressure drops from 1.2 atmospheres to 1 atmospheres in 8 hours after the inflatable element is pressurized to 1.2 atmospheres. Other embodiments are disclosed.

Abstract: A disposable absorbent article is described herein. The disposable absorbent article includes a topsheet, a backsheet, and an absorbent system disposed between the topsheet and the backsheet. At least a portion of the has a plurality of conforming features such that the absorbent article has a blot residual value of less than 30 mg and a bending stiffness of less than 12.

Abstract: An apparatus for conveying and applying a discrete part to a substrate includes a plurality of transfer puck assemblies, a drive assembly, and a translation mechanism. The plurality of transfer puck assemblies is adapted to convey the discrete part to the substrate, and each transfer puck assembly includes at least one puck segment. The drive assembly is configured to rotate each transfer puck assembly about a drive axis. The translation mechanism is configured to translate the at least one puck segment in an axial direction as the plurality of transfer puck assemblies are being rotated about the drive axis to move the discrete part to a profiled configuration prior to application of the profiled discrete part to the substrate.

Abstract: Disclosed is a method for transferring cut-out nonwoven material members, the method including feeding a continuous web of a nonwoven material towards cutter and anvil roll, passing the continuous web between the cutter and anvil roll, the cutter roll having knives protruding from the circumferential surface, the knives having an edge with a first outline shape seen in a circumferential direction of the cutter roll, cutting the continuous web thereby forming cut-out nonwoven material members having a second outline shape corresponding to the first outline shape of the respective edge of the knives, and transferring the cut-out members to a vacuum roll having an outer circumferential surface that includes a plurality of vacuum ports arranged in a pattern, the pattern including pattern units each having a third outline shape, the pattern units fitting within the second outline shape of the cut-out members.

Abstract: A disposable article includes a topsheet, a backsheet, and an absorbent core disposed between the topsheet and backsheet; and an elasticized waist gasketing element. The elasticized waist gasketing element has a lateral outboard edge and a longitudinal array of elastic members. The longitudinal array includes a primary waist elastic member disposed inboard of the waist edge by a minimum longitudinal distance A, a secondary waist elastic member disposed inboard of the primary waist elastic member by a minimum longitudinal distance B. The waist gasketing element comprises a Force Ratio of at least about 1.1.

Abstract: An absorbent article may have a Product Hip-to-Side Silhouette from 0.5 to about 1.8 and a Relaxed Product Side Length that is greater than about 65% of the Relaxed Product Length. An array of absorbent articles may have an Array Average Product Hip-to-Side Silhouette from about 0.5 to about 1.8.

Abstract: An osmotic sanitary collection bag for collecting fluid discharged from the vagina during menstruation. The osmotic sanitary collection bag includes an absorbent sponge having a plurality of drainage apertures disposed therethrough. Elongated adhesive strips extend away from the sponge and are adhered to a first surface of a conventional sanitary device to secure the osmotic sanitary collection bag in place. A collection bag abuts the absorbent sponge and is disposed in underlying relation to the absorbent sponge and the drainage apertures. The absorbent sponge is laced with salt, alcohol, and an odor-masking substance, such as sodium bicarbonate.

Abstract: A segmented skirted surgical mesh for use in reconstructing a soft tissue defect, the segmented skirted surgical mesh comprising: a base layer of surgical mesh, the base layer of surgical mesh comprising an outer edge; and a segmented continuous skirt of surgical mesh comprising an outer edge and an inner edge which defines a central opening, the segmented continuous skirt of surgical mesh being secured to the base layer of surgical mesh at the outer edge of the continuous skirt of surgical mesh, and the segmented continuous skirt of surgical mesh comprising a plurality of slits formed in the segmented continuous skirt of surgical mesh, wherein the plurality of slits extend outwardly from the inner edge of the segmented continuous skirt of surgical mesh, whereby to form a plurality of flaps of surgical mesh in the segmented continuous skirt of surgical mesh, such that at least one of the flaps of surgical mesh can be lifted away from the base layer of surgical mesh and secured to soft tissue without causin

Abstract: Storage devices, loading devices, delivery systems, kits, and associated methods for implantable medical devices are described. An example embodiment of a storage device includes a storage member, a first cap, and a second cap. The storage member has a first end, a second end, and a main body that defines a first opening, a second opening, a passageway, a separating wall, and a plurality of holes. The passageway has a first portion and a second portion. The first portion extends from the first end of the storage member to the separating wall and the second portion extends from the second end of the storage member to the separating wall. Each hole of the plurality of holes extends through the separating wall and provides access between the first portion and the second portion. Each of the first and second caps is releasably attached to the storage member.

Abstract: Medical Implant (100), comprising a microbial cellulose tube (1), comprising a wall (2) having an inner surface (3) and an outer surface (4), wherein the wall comprises several layers (5, 6, 7) of microbial cellulose, wherein said layers are concentric or substantially concentric to a longitudinal axis (L) of the tube, a stent (9) which placed inside of the microbial cellulose tube (1), wherein an outer surface (10) of the stent contacts the inner surface (3) of the microbial cellulose tube (1), and method for producing such implant. The implant can be covered with newly created bile duct epithelium, thereby creating a new bile duct from body cells. The implant can be removed after completion of creation of the new bile duct. So, the implant as suitable as a temporary implant. The implant can be used for surgery, such as surgery of gall bladder, bile duct and/or liver, e.g. gall bladder removal, hepatobiliary malignancy surgery or liver transplantation.

Abstract: Disclosed are methods and devices for regulating fluid flow to and from a region of a patient's lung, such as to achieve a desired fluid flow dynamic to a lung region during respiration and/or to induce collapse in one or more lung regions. Pursuant to an exemplary procedure, an identified region of the lung is targeted for treatment. The targeted lung region is then bronchially isolated to regulate airflow into and/or out of the targeted lung region through one or more bronchial passageways that feed air to the targeted lung region. An exemplary flow control device is configured to block fluid flow in the inspiratory direction and the expiratory direction at normal breathing pressures and allow fluid flow in the expiratory direction at higher than normal breathing pressures.

Abstract: This document provides implantable intraluminal stent graft medical devices. In some embodiments, the stent graft devices provided herein are implantable in bodily conduits that have side branches, and the stent graft devices are operable to allow the flow of fluids between the conduit and the side branches. In some embodiments, the walls of the stent graft devices provided herein include compliant channels which allow for fluid communication between the interior and the exterior of the stent graft devices. In some embodiments, the compliant channels are configured to inhibit or reduce tissue ingrowth, tissue bridging, and/or endothelialization.

Abstract: A variety of configurations of implant management devices are provided. The configurations provide different combinations of features for maintaining a location of an implant with respect to the device and managing filaments of the implant. One exemplary embodiment of a device includes a generally rectangular-shaped body having an implantable body retainer, an opening disposed a distance apart from the retainer and configured to receive a ligament graft therein, and a fold extending across the body and intersecting the opening. Folding one end of the body towards a bottom surface of the body along the fold can form a filament loop engaging region to hold in tension a filament loop extending from the implant. Additional filament(s) associated with the implant can be managed by various filament retention features. Methods for preparing a ligament graft for implantation by relying upon indicia formed on a surface of the device body are also provided.

Abstract: Medical implants comprising biocompatible materials and having surface features that may assist in biocompatibility upon implantation in the body are described. Methods for manufacturing such implants are also described. The manufacturing process may include applying a biocompatible material to a texturized surface of a mold. The implants may include various features to assist their positioning, fixation, and/or identification during and/or after implantation.

Abstract: A system includes a heart valve and a device that functions to minimize a possibility for suture becoming entangled with a commissure post of the heart valve during an implantation procedure. In some examples, the device is a suture guard that includes one or more features that deflect suture to help minimize entanglement of the same with the commissure posts of the heart valve. In some examples, the features operate to deflect the commissure posts radially inwardly, while in other examples, the features overlay the commissure posts without deflecting that same.

Abstract: In one embodiment, an implantable prosthetic valve can comprise an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, and a leaflet structure positioned within the frame and secured thereto. The prosthetic valve can further comprise an outer skirt positioned around an outer surface of the frame, the outer skirt comprising pericardial tissue having a fibrous parietal layer defining a first surface of the outer skirt and a serous parietal layer defining a second surface of the outer skirt, the pericardial tissue having been fixed by cross-linking.

Abstract: Aspects of the disclosure relate to prosthetic valves having a frame, a frame cover, and a leaflet construct. Some aspects are directed to a diametric taper for the prosthetic valve for achieving enhanced performance of the prosthetic valve under operational conditions, enhanced compressibility and delivery characteristics, and other additional or alternative advantages. Other aspects are directed toward unique assembly and attachment methods for securing leaflet constructs to support structures. Other aspects are directed toward features for interacting with transcatheter delivery systems. Still other aspects are directed to such apparatuses, systems, and methods for valve replacement, such as cardiac valve replacement.

Abstract: A prosthetic heart valve including a stent frame and a valve structure. The valve structure is disposed within a lumen of the stent frame. The stent frame is configured to self-expand from a compressed condition for transluminal delivery. The stent frame has a lattice structure forming a tubular shape defining a circumference and a plurality of closed cells arranged to define a band exhibiting a variable radial stiffness. The prosthesis can be deployed such that the band applies a minimal force on to anatomical locations relating to the heart's conductive pathways. A region of the band otherwise having low radial stiffness is located at or over a conductive pathway upon final implant.

Abstract: A prosthetic heart valve includes a frame, a valve component, and an actuation mechanism. The frame has a plurality of struts interconnected by a plurality of joints and is movable between expanded and compressed configurations. The valve component is inside the frame and has a plurality of leaflets. The actuation mechanism has a first expansion element coupled to the frame at a first location and a second expansion element coupled to the frame at a second location. The actuation mechanism is configured such that moving the first expansion element and the second expansion element toward each other in a first direction results in the frame moving from the compressed configuration to the expanded configuration, and such that moving the first expansion element and the second expansion element away from each other in a second direction results in the frame moving from the expanded configuration to the compressed configuration.

Abstract: A first catheter has a first lumen therealong, a first-catheter proximal portion, and a steerable first-catheter distal portion that is transluminally advanceable to the heart. A second catheter has second lumen therealong, a second-catheter proximal portion, and a steerable second-catheter distal portion. The second catheter extends through the first lumen, such that the second-catheter proximal portion extends proximally out from the first-catheter proximal portion, the second-catheter distal portion extends distally out from the first-catheter distal portion, and within at least the first-catheter proximal portion, the first lumen and the second lumen are coaxial on a longitudinal axis. A first handle is coupled to the first-catheter proximal portion, and extends obliquely away from the first-catheter proximal portion at a nonzero angle with respect to the longitudinal axis. A second handle is coupled to the second-catheter proximal portion, and is disposed proximally from the first handle.

Abstract: Embodiments of a catheter assembly are disclosed. The catheter assembly comprises a shaft; at least one connector assembly. The connector assembly can comprise a first connector portion and a second connector portion, wherein the first connector portion is fixedly coupled to a distal end of the shaft, and is coupled to the second connector portion with a limited degree of freedom of movement by at least one radially extending pin retained within at least one slot on the second connector portion. The at least one slot can have an oversized circumferential dimension that allows limited rotation of the second connector portion relative to the first connector portion about a longitudinal axis of the shaft.

Abstract: A leaflet support for use with a native valve of a heart of a subject includes a frame that defines an array of adjoining cells, as well as an aperture between an upstream side and a downstream side of the frame. When placed against an annulus of the heart, the frame facilitates blood flow, via the cells, between the upstream side and the downstream side. The leaflet support further includes a barrier that is impermeable to blood flow, and that is coupled to the frame in a manner that obstructs blood flow through the aperture. The leaflet support further includes ventricular legs, that each extend radially outward and upstream, toward the frame. Other embodiments are also described.

Abstract: The present disclosure relates to methods and systems for aligning annuloplasty rings during surgical procedures and selectively engaging portions of the targeted annuli. Specifically, the disclosure is directed to methods and systems for aligning an annuloplasty ring or a toroidal portion thereof with natural fiducials present at or near an annular target, and engaging the annulus at the points aligned with the natural fiducials.

Abstract: A graft collar includes a body of cylindrical shape, including an upper surface and a spaced apart lower surface defining an outer wall and surface therebetween; an engagement section located on the upper surface of the body sized and shaped to engage a head of a bone fastener; an through hole extending axially through the body between the upper surface and the lower surface thereof, the through hole being sized to receive therethrough an elongate threaded shank extending from the head of the bone fastener, where the graft collar is formed from at least one of soft cadaveric allograft, hard cadaveric allograft, and synthetic bone void fillers.

Abstract: Presently disclosed is a sacroiliac joint implant. In an embodiment, a sacroiliac joint implant includes a porous body configured to promote bone growth. The porous body may have a window that is configured to hold a graft material. The porous body may also include a first face and second face configured to contact the sacrum and the ilium of the sacroiliac joint when the implant is maintained in compression within the sacroiliac joint.

Abstract: An acetabular cup assembly for use with liners is described. The acetabular cup assembly includes a cup and a liner. The cup has an outer surface, a generally concave inner surface and a top face. The inner surface includes a cylindrical band having a plurality of inward-facing recessed scallops, a tapered wall adjacent to the band, and an inner spherical surface adjacent the tapered wall. The inner spherical surface has a substantially uniform radius of curvature. A single groove interrupts the spherical surface. The liner has a substantially convex outer surface and includes a rim and a plurality of outward-projecting scallops adjacent the rim. The scallops of the liner are configured to engage the scallops of the cup when the liner is seated in the cup. Related methods of use are also provided.

Abstract: Off-center liners can be used with an acetabular cup in hip replacement or revision surgical procedures. The liners (of metal or plastic) can be laterally spaced from the acetabular cup, angled relative to the acetabular cup and/or have an opening that is offset relative to the axis of the acetabular cup. The liners have an orientation indicator that identifies where the liner should be impacted (e.g., impaction location or point) by the impactor to ensure the liner is impacted in a square manner relative to the acetabular cup.

Abstract: A hinged articulating spacer system for revision knee arthroplasty includes a femur rod for a femur, and a tibia rod for a tibia. The tibia rod is hingedly couplable to the femur rod to form a hinged rod assembly. A pre-formed femoral spacer component includes bone cement impregnated with an antibiotic. The pre-formed femoral spacer defines an opening that receives the hinged rod assembly. A pre-formed tibial spacer component includes bone cement impregnated with an antibiotic. The pre-formed tibial spacer defines an opening that receives the hinged rod assembly.

Abstract: Systems (500, 1000) and methods (1700) for fabricating a soft tissue implant (100, 400). The methods generally involve: receiving implant data representative of the target implant; determining a planned weaving path for forming the soft tissue implant; and communicating the planned weaving path to an output device.

Abstract: An orthopedic assembly includes a tibial prosthesis that includes a body that defines an anterior side and a posterior side. The body further incudes a recess in the anterior side of the joint prosthesis and a plurality of openings that extend through the body from the anterior side to the posterior side thereof. At least a first and second opening of the openings are positioned at respective lateral and medial sides of a longitudinal axis of the tibial prosthesis. A modular insert is positioned within the recess of the body such that at least a portion of the modular insert is positioned between the openings of the body. The modular insert is formed separately from the tibial prosthesis and has a porous outer surface to promote tissue ingrowth.

Abstract: Implants, device, systems and methods for replacing an articulation surface in a joint, for example, shoulder prostheses with stemless humeral components or stemmed humeral components. Methods for using the shoulder prostheses with stemless humeral components or stemmed humeral components are also disclosed.

Abstract: The invention relates to a modular humeral prosthesis for an inverse shoulder prosthesis, comprising an anatomical shaft (1) and a separable epiphyseal head (2) which may be angularly orientated by rotation about the longitudinal axis (XX) of the anatomical shaft. The anatomical shaft and the epiphyseal head comprise complementary angular indexing means (11, 28) for relative rotational fixation.

Abstract: An intervertebral cage and intervertebral cage apparatus and a method for using the intervertebral cage and/or the intervertebral cage apparatus. The intervertebral cage can be any desired material including a memory material. The intervertebral cage apparatus can include the intervertebral cage and one or both of a variable volume pouch and a deployment cable. The variable volume pouch can be inserted into an internal volume of the intervertebral cage and affixed to the intervertebral cage. The variable volume pouch can be filled with material to achieve an expanded state. The variable volume pouch can assist in the deployment of the intervertebral cage. The deployment cable can be attached to the intervertebral cage and can include features to facilitate that attachment. The deployment cable can apply a force to the intervertebral cage to deploy the intervertebral cage, and can include features to lock the intervertebral cage in the deployed configuration.

Abstract: A spinal interbody device (IBD) includes a solid wall that at least partially defines a boundary of the IBD and a porous body connected to the solid wall. The porous body includes a plurality of sections that form at least a portion of both a superior and inferior bone interface side of the IBD. Each section of the porous body has a different porosity than an adjacent section such that the porosities increase toward a center of the IBD.

Abstract: A method of performing a transcorporeal procedure including placement of a vertebral body replacement device into a transcorporeal void within a cervical spine is disclosed. The method includes creating a working channel through a vertebral body of a vertebra by removing at least a portion of the vertebral body of the vertebra, beginning anteriorly and extending inwardly toward the epidural space, the working channel extending from an anterior wall through a posterior wall, and placing the vertebral body replacement device within the working channel, the placement of the vertebral body replacement device leaving the inferior and superior endplates to perform their function and leaving at least a portion of the intervertebral disc functional thereby avoiding an intervertebral fusion to an adjacent vertebra.

Abstract: An expandable implant includes an upper plate configured to receive a first anchoring member, an upper support mechanically coupled to the upper plate, a lower plate configured to receive a second anchoring member, and a lower support mechanically coupled to the lower plate. The implant further includes a control member including a shaft and configured to control movement between the upper support and the lower support, a front portion configured engage the upper support and the lower support and further configured to receive the head of the control member, and a rear portion configured engage the upper support and the lower support and further configured to engage a portion of the shaft, wherein turning the control member causes the front portion to move in a direction towards the rear portion, such that the upper support moves relative to the lower support in a direction away from the lower support.

Abstract: An implant stabilizes two adjacent bones of a joint, while enabling a natural kinematic relative movement of the bones. Support components are connected to each bone of the joint, and a flexible core is interposed between them. The core and at least one of the support components are provided with a smooth sliding surface upon which the core and support component may slide relative to each other, enabling a corresponding movement of the bones. The surfaces may have a mating curvature, to mimic a natural movement of the joint. The core is resilient, and may bend or compress, enabling the bones to move towards each other, and or to bend relative to each other.

Abstract: An implant assembly is shown and described. The implant has at least one or a plurality of elastic, resilient or flexible arms that each have a detent adapted to retain at least one screw in a locked position in the implant. At least one of the arms has a portion that extends into a screw aperture such that an arm axis is generally parallel to the axis of the screw after the screw is received in the implant. In another embodiment, means or a system for locking the multi-component implant members together is shown.

Abstract: Disclosed is an angle-expandable spinal cage including an upper plate and a lower plate disposed to face each other, a frame disposed between the upper plate and the lower plate, the frame having a space formed therein, a block disposed between the upper plate and the lower plate and disposed in front of the frame, and a driving bolt having one end thereof connected to the frame and a remaining end thereof connected to the block. The angle-expandable spinal cage is implanted into an affected area while occupying the minimum angle thereof and to be expanded between vertebral bodies.

Abstract: A surgical implant and a surgical kit. The surgical implant has a body having at least one interior surface, the body forming a peripheral support for the implant. The surgical implant has a porous insert comprised of a porous material, having at least one axially-extending hole, and attached to the body along the at least one interior surface such that the porous material extends across a height of the body. The porous insert has a locking mechanism formed in the porous insert or extending from the porous insert, the locking mechanism minimizing movement of the porous insert from within the body. The surgical kit includes the surgical implant and an intervertebral insertion device.

Abstract: The present invention provides an expandable fusion device capable of being installed inside an intervertebral disc space to maintain normal disc spacing and restore spinal stability, thereby facilitating an intervertebral fusion. In an exemplary embodiment, the present invention provides an intervertebral implant. The intervertebral implant may be configured to transition from a collapsed configuration having a first height and a first width to an expanded configuration having a second height and a second width.

Abstract: A method for inserting an intervertebral disc prosthesis into a space between two vertebrae involves inserting the prosthesis partway into the space under constraint to prevent endplates of the prosthesis from articulating, releasing the prosthesis from constraint, and inserting the unconstrained prosthesis farther into the space. In some embodiments, the method involves grasping the prosthesis with a grasping device to insert the prosthesis partway under constraint, loosing the grasping device to release the prosthesis from constraint, and pushing the prosthesis farther into the disc space using the grasping device and/or one or more separate pusher devices. A system includes a grasping device, at least one separate pushing device, and optionally a vertebral spreading device and/or a vertebral midline indicator device.

Abstract: A method for manufacturing a customized sleeve for a prosthesis, comprises the following steps: (a) providing a mold of an end of a limb of an individual who is intended to receive said prosthesis; (b) providing a preform made of an elastomer material, said preform comprising an open proximal end and a closed distal end; (c) positioning said preform on the mold; (d) positioning on said preform at least one element from: a polymer reinforcement, a layer of an elongation-preventing fabric, a distal cup and an air discharge sheath; (e) positioning a vacuum cover around the preform; (f) creating a vacuum and injecting a polymer cross-linkable at room temperature into said vacuum cover so as to form a coating having a uniform thickness over the preform and each element which is positioned on said preform.

Abstract: One embodiment of the invention incudes a single cylinder zigzag strut Z stent cylinder fixedly joined to a braided stent such that a portion of the joined Z stent cylinder extends beyond the termination end of the braided wire stent. The Z stent cylinder can have a larger in diameter than the braided stent when expanded.

Abstract: A device and method for predictably and controlling the collapsing of a collapsible and expandable stent for subsequent translation through a delivery sheath lumen to an anatomical target such as a heart valve or intravascular location for expansion and implantation. The loading device defines in inner lumen comprising a successively decreasing, from the proximal to the distal direction, inner diameter to a region of constant inner diameter wherein the stent is in a collapsed configuration. The device and method may provide for an at least partially collapsed configuration of the stent that may be further collapsed as a part of the implantation procedure and may comprise a stent that is pre-loaded for future use.