Abstract: A method of placing a dental implant analog in a physical model for use in creating a dental prosthesis is provided. The physical model, which is usually based on an impression of the patient's mouth or a scan of the patient's mouth, is prepared. The model is scanned. A three-dimensional computer model of the physical model is created and is used to develop the location of the dental implant. A robot then modifies the physical model to create an opening for the implant analog. The robot then places the implant analog within the opening at the location dictated by the three-dimensional computer model.

Abstract: The present invention relates to an implant-driver tool and method of using same for proper insertion of implants into a predrilled drillhole in a bone.

Abstract: An apparatus for intraoral scanning includes an elongate handheld wand that has a probe. One or more light projectors and two or more cameras are disposed within the probe. The light projectors each has a pattern generating optical element, which may use diffraction or refraction to form a light pattern. Each camera may be configured to focus between 1 mm and 30 mm from a lens that is farthest from the camera sensor. Other applications are also described.

Abstract: In some examples, a dressing filler for treating a tissue site may include a plurality of filler elements and a tissue interface layer. Each of the filler elements may include a first surface and a second surface opposite the first surface and separated from the first surface by a thickness. The tissue interface layer may include a first side configured to be positioned facing the tissue site and a second side positioned opposite the first side. The first surface of each of the filler elements may be coupled to the second side of the tissue interface layer. Also provided are other apparatuses, dressings, systems, and methods suitable for treating a tissue site.

Abstract: A compression bandage in the form of a knit obtained by warp stitch technology on the basis of synthetic yarns and comprising two textile surfaces of respective textile structures that may be identical or different, the surfaces being interconnected by spacer yarns, each surface including elastic yarns, the bandage being characterized in that said knit presents: longitudinal stretch measured in compliance with the standard EN 14704-1 lying in the range 30% to 160%; and threshold shear stress greater than or equal to 2800 Pa.

Abstract: A negative pressure wound therapy system includes at least one sensor coupled to a wound dressing for a wound of a patient, and a control circuit. The at least one sensor is configured to output an indication of a displacement of the wound dressing. The control circuit is configured to receive the indication of the displacement of the wound dressing, calculate a therapy parameter corresponding to the indication of the displacement, and output the therapy parameter.

Abstract: Embodiments of negative pressure wound therapy systems and methods are disclosed. In one embodiment, an apparatus includes a wound dressing, negative pressure source, user interface, sensor, and control circuitry. The user interface can receive an activation input. The sensor can detect whether the wound dressing is positioned over a wound. The control circuitry can cause supply of negative pressure in response to receipt of the activation input and a determination that the sensor detects that the wound dressing is positioned over the wound. In addition, the control circuitry can prevent supply of negative pressure in response to a determination that the sensor does not detect that the wound dressing is positioned over the wound.

Abstract: Absorbent articles are provided that comprise shaped, soft and textured nonwoven fabrics. The nonwoven fabrics may be a topsheet and an outer cover nonwoven material of the absorbent article. A portion of a wearer-facing surface of the topsheet may have a TS7 in the range of about 1 dB V2 rms of about 1 to about 4.5 dB V2 rms and a TS750 in the range of about 6 dB V2 rms to about 30 dB V2 rms. A portion of a garment-facing surface of the outer cover nonwoven material may have a TS7 in the range of about 1 dB V2 rms of about 1 to about 4.5 dB V2 rms and a TS750 in the range of about 6 dB V2 rms to about 30 dB V2 rms. The nonwoven fabrics of the present disclosure provide soft materials with texture.

Abstract: A packaged elongate sanitary protection product includes a folded sanitary product and a circular package. The sanitary product has first and second arcuate end portions comprising first and second ends, respectively, separated by a central portion, and a pair of longitudinal side edges connecting the first and second ends. The arcuate end portions have an effective radius and a maximum width, substantially equal to twice the effective radius. The central portion has a minimum width between about 75% and about 90% of the maximum width, and the sanitary product has a length between about 225% and about 285% of the maximum width. In addition, first and second fold lines are located a distance from each end equal to about 85% to about 105% of the maximum width of the arcuate end portions. The sanitary protection product is folded in a Z-configuration on first and second fold lines to form a substantially circular folded sanitary protection product, which is enveloped in the circular package.

Abstract: Disclosed is a disposable absorbent article having an outer shell and a detachable disposable absorbent core insert supported on an inside surface of the outer shell. The core insert is attached to the inside surface and is detachable therefrom. The inside surface further includes a retaining structure for receiving the absorbent core insert, the core insert being attachable with the retaining structure and detachable from the retaining structure.

Abstract: A menstrual product dispenser including a rear face, intended for attaching the dispenser to a vertical support, two side faces and a front face. The dispenser also includes: at least one storage compartment suitable for receiving at least one container comprising a plurality of the menstrual products, referred to as the product refill, each refill comprising a plurality of menstrual products of the same type, a base, which is rigidly connected to the rear face and the side faces, for retaining the at least one product refill in the dispenser, and at least one compartment for distributing at least one of the menstrual products. The at least one distribution compartment is rigidly connected to the base of the dispenser. The dispenser is suitable for distributing one menstrual product of each type in the distribution compartment.

Abstract: Actuator (1) for a medical device (100), comprising an electromotor, a mechanical transmission, and magnetic coupling means arranged for transmitting a mechanical torque from the electromotor to the mechanical transmission when said electromotor is powered by an energy source, wherein said electromotor and a first part of the magnetic coupling means kinematically linked to the electromotor are arranged and hermetically sealed in a first casing module, and wherein said mechanical transmission and a second part of the coupling means kinematically linked to said mechanical transmission are arranged in a second casing module, said first and second casing modules comprising each complementary fastening means such that said first and second casing modules can be removably connected to each other in such a way that said first and second parts of the magnetic coupling means magnetically couple together upon connection of said first and second casing modules.

Abstract: A cuff for use an as artificial sphincter includes an inflatable chamber and a backing. The inflatable chamber includes opposing inside and outside surfaces and inflated and deflated states. The backing is adjacent the outside surface of the chamber. The inside surface of the chamber includes two or more grooves that define the location of fold lines of the inflatable chamber when the inflatable chamber is in the inflated state. The inflatable chamber and backing are configured to surround a duct of a patient with the inside surface of the chamber facing the duct and the grooves extending substantially parallel to the duct.

Abstract: A coated surgical mesh, the coated surgical mesh comprising: a surgical mesh, the surgical mesh comprising a first surface and a second surface; and a tissue ingrowth-preventing coating applied to the second surface of the surgical mesh; wherein the tissue ingrowth-preventing coating penetrates a controllable amount part way through the surgical mesh.

Abstract: A mesh deployment device is configured to place a surgical mesh on tissue retro muscularly. In particular, the mesh deployment device includes an arm assembly that is transitionable between a retracted configuration, in which, stationary and covering arms are in superposed relation such that the surgical mesh is supported by the supporting arm therebetween, and a deployed configuration, in which, the stationary, covering, and supporting arms are circumferentially spaced apart to support the surgical mesh thereon.

Abstract: An example medical device for treating a body lumen is disclosed. The medical device includes an expandable scaffold including first and second regions, each of the first and second regions include a plurality of interstices located therein. The medical device also includes a covering spanning each of the plurality of interstices of the first region. The second region is free of the covering. A biodegradable gripping material is disposed on an outer surface of the covering. Further, the expandable scaffold is configured to shift from a collapsed state to an expanded state and the second region is configured to contact an inner surface of the body lumen in the expanded state. Additionally, the gripping material is designed to initially prevent migration of the expandable scaffold upon implantation in the body lumen until the second region is secured to the inner surface of the body lumen.

Abstract: A device having one or more adjustable loops or coils associated with an implant body for use in soft tissue reconstructions is provided. One exemplary embodiment of a device includes a body and a suture filament, with the filament being used to form a self-locking sliding knot disposed on a top side of the body and a plurality of adjustable coils that are substantially disposed on the body's bottom side. Terminal ends of the filament located above the body's top side can be passed through an opening of a Lark's Head knot from opposite sides, thus forming a self-locking sliding knot, and then the terminal ends can be tensioned to adjust a circumference of the coils. Changing a coil's circumference changes a location of a ligament graft disposed on the coil. Other configurations of devices and systems, as well as methods for performing ACL repairs, are also provided.

Abstract: An orthopedic implant with an inferior portion having a tibia contact surface configured to extend over a tibia; a superior portion opposite to the inferior portion having a tendon contact surface configured to change a position of a patellar tendon by lifting or tilting the patellar tendon when the curved surface of the first portion is engaged with the tibia; and a fixation mechanism adapted to attach the orthopedic implant to the tibia, the orthopedic implant being further configured to change shape from a first configuration to a second configuration in response to a load applied between the tendon contact surface and the tibia contact surface. The invention also addresses corresponding methods.

Abstract: The present disclosure is directed to Myointegration, the improvement of breast implant apparatus, system and methods for a design that extends the breast implant centrifugally, or in which a separate device is utilized in combination with a breast implant, that has one or more straps originating from the breast implant extension or from the separate device. The one or more straps are looped through the pectoralis major muscle then back into the implant extension or the separate device repeatedly. The straps are eventually attached in some manner to themselves, to the implant extension, or to the separate device. Since the pectoralis major muscle contains neuromuscular spindles that sense length, velocity and acceleration, when the user changes position from supine to vertical, the gravitational force generated by the mass of the breast implant pulls on the strap or straps, which pulls the muscle and stimulates the neuromuscular spindles, thereby generating lift of the implanted breast insert.

Abstract: Methods and systems wherein laser induced refractive index changes by focused femtosecond laser pulses in optical polymeric materials or optical tissues is performed to address various types of vision correction.

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 engineered vocal fold mucosa, including an engineered lamina propria layer and an engineered squamous epithelium layer, is disclosed. The engineered lamina propria is made by seeding and culturing human vocal fold fibroblasts within a polymerized collagen scaffold, and the engineered squamous epithelium is made by culturing human vocal fold epithelial cells on the scaffold surface. The resulting engineered vocal fold mucosa is not immunogenic, and is capable of exhibiting the vibratory function and acoustic output of a native vocal fold mucosa. Accordingly, the engineered vocal fold mucosa may be implanted into the larynx to treat voice impairment.

Abstract: Described embodiments are directed toward prosthetic valves having leaflets of a particular shape that improves bending character without requiring a long length valve. In accordance with an embodiment, a prosthetic valve comprises a leaflet frame, a plurality of leaflets that are coupled to the leaflet frame, where each leaflet has a free edge and a base. The base of each leaflet is truncated in which the leaflet in cross section shows a line in an alpha plane onto the leaflet frame.

Abstract: Stent-valves (e.g., single-stent-valves and double-stent-valves) and associated methods and systems for their delivery via minimally-invasive surgery are provided. The stent-valves include a stent component having a first flared end region and a second end, a plurality of leaflets coupled to the stent, and a sealing element coupled to the first end region.

Abstract: A cardiac valve delivery system includes a lead configured to be inserted through a venous system to a heart, the lead having a distal end with a myocardial attachment apparatus, and a transcatheter prosthesis element configured to be delivered along the lead. The transcatheter prosthesis is configured with an anchoring element located on the outside rim of the prosthesis, configured to fix the transcatheter prosthesis in place along the lead. The prosthesis is also movable along the lead and steerable towards the appropriate angulation with the lead.

Abstract: The present application discloses an implant loading apparatus comprising a guider and a guide base. The guider is sleeved on the exterior of the guide base. The guide base comprises a guide column, a connecting section, and a base connected in the axial direction. Fixing sections are provided on either end of the connecting section. The guide base is removably connected to the guider via the fixing sections. The guide base is provided with the two fixing sections that fit the guider to implement twice removable fixing, thus favoring a coaxial operation. A valve stent is neither twisted nor tilted during a compression process, thus increasing loading efficiency, greatly reducing the operation difficulty of a surgery, and allowing the implementation of a single person operation.

Abstract: A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus via a transaortic approach. The system includes a balloon catheter for delivering a balloon-expandable prosthetic heart valve through an introducer from an approach from outside the patient, through a minimally-invasive opening in the chest cavity through an incision in the aorta, and into the aorta and aortic annulus. The balloon catheter includes a flexible, tapered tip just distal of the balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

Abstract: Transcatheter delivery system for a self-expandable heart valve prosthesis (29) comprising a handle (17, 17?), a hollow shaft (6) a distal tip (1, 1?, 1??) and an actuation mechanism for moving a valve prosthesis (29) towards said distal tip (1, 1?, 1??) or said handle (17, 17?), said hollow shaft (6) being adapted to slidingly receive a compressed valve prosthesis (29); the system being characterized by the fact that it includes a valve prosthesis crimping tool that comprises a hollow conical element (21), a detachable transfer tube (24) and a pulling device (26); said conical element (21) being adapted to let a valve prosthesis (29) in an expanded state enter the conical element (21) through its basis and enter said transfer tube (24) in a compressed state, said valve prosthesis (29) being pulled by said pulling device (26) when crossing said conical element (21) and entering said transfer tube (24), said transferring tube (24) being adapted to be temporarily connected to said conical element (21).

Abstract: A prosthetic heart valve reinforcement ring is disclosed for reinforcing a natural heart valve with leaflets. The prosthetic ring includes a ring body sized and dimensioned to fit around the annulus of the heart valve. The ring body has an inner surface with a plurality of grooves on the inner surface of the ring body, where each of grooves is configured to grasp a suture. A method of reinforcing a natural heart valve is also disclosed. Sutures are provided around an annulus of a natural heart valve with leaflets. A prosthetic ring is selected that is sized to fit around the annulus. The prosthetic ring is attached to the annulus by inserting sutures into the grooves until the leaflets are properly closed. The fit of the prosthetic ring is adjusted by individually manipulating the sutures in the grooves. The sutures are tied, securing the prosthetic ring in place.

Abstract: Scaffolds for use in bone tissue engineering include a skeleton and a host component. Methods of preparation of scaffolds include identification of biodegradation properties for the skeleton and the host component. The skeleton is constructed to form a three-dimensional shape. The skeleton is constructed of a first material and has a first rate of biodegradation. The host component fills the three-dimensional shape formed by the skeleton. The host component is constructed of a second material and has a second rate of biodegradation. The first rate of biodegradation is slower than the second rate of biodegradation.

Abstract: Lamina plate assemblies, systems, and methods thereof. A lamina plate assembly may be configured to provide lamina support following laminectomy, for example, in cervical and lumbar cases. The lamina plate assembly may include a generally elongate body having a first free end, a second free end, and a posterior portion disposed between the first free end and the second free end. Different embodiments of securing portions are used to secure the lamina plate assembly to a vertebra.

Abstract: Customizable scapular anchor (1) for fixing a glenoid component of a shoulder joint prosthesis to a patient's scapula with compromised anatomy, comprising a glenoid support (2), said glenoid support (2) being defined by a pin element (3) for fixing said glenoid component to said scapular anchor (1) and by a flange (4) integral with said pin element (3), said flange (4) having a distal surface (5) adapted to be placed at least partially in contact with a glenoid cavity of said scapula and a proximal surface (6) opposite said distal surface (5); wherein at least one customized portion (5, 7, 8) is specifically shaped with respect to the bone morphology of a single patient's scapula with compromised anatomy; the customized portion (5, 7, 8) comprises at least one coracoid support projection (7) arranged to abut at a coracoid process (52) of the scapula (50).

Abstract: An expandable intervertebral total disc replacement implant, including an inferior component, including a first core including a first outer surface and a first inner surface, and a first arm telescopingly engaged with the first core, a superior component, including a second core including a second outer surface and a second inner surface, and a second arm telescopingly engaged with the second core, and an expansion mechanism connected to the first core, the second core, and at least one of the first arm and the second arm.

Abstract: An implant for therapeutically separating bones of a joint has two endplates each having an opening through the endplate, and at least one ramped surface on a side opposite a bone engaging side. A frame is slideably connected to the endplates to enable the endplates to move relative to each other at an angle with respect to the longitudinal axis of the implant, in sliding connection with the frame. An actuator screw is rotatably connected to the frame. A carriage forms an open area aligned with the openings in the endplates. The openings in the endplates pass through the carriage to form an unimpeded passage from bone to bone of the joint. The carriage has ramps which mate with the ramped surfaces of the endplates, wherein when the carriage is moved by rotation of the actuator screw, the endplates move closer or farther apart.

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; and an actuation subassembly comprising 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, wherein the cam frame comprises a proximal frame end, a distal frame end, and lateral frame sides, wherein cams disposed on the lateral frame sides selectively engage at least one of the first endplate or the second endplate.

Abstract: An expandable implant includes an upper main support, a lower main support, an upper pivoting support, and a lower pivoting support. The upper main support and the upper pivoting support are configured to engage a first portion of bone, and the lower main support is coupled to the upper main support and configured to engage a second portion of bone. The upper main support is adjustable relative to the lower main support to adjust height of the implant. The upper pivoting support is rotatably movable relative to the upper main support. The lower pivoting support is coupled to the upper pivoting support, configured to engage the second bone portion, and is rotatably movable relative to the lower main support. Adjusting the upper main support relative to the lower main support causes adjustment of the upper pivoting support relative to the lower pivoting support.

Abstract: An interbody device may include a main body and an arm movably connected thereto. The device may have a first end, a second end opposite the first end in a direction of a longitudinal axis of the device, a first side, a second side opposite the first side in a direction of a first transverse axis of the device, a third side, and a fourth side opposite the third side in a direction of a second transverse axis of the device. An overall distance between the first side and the second side may increase along at least a majority of a length of the device in a direction from the first end toward the second end, and an overall distance between the third side and the fourth side may increase along at least a majority of the length in a direction from the second end toward the first end.

Abstract: A device and methods for intervertebral spinal fusion of adjacent intervertebral bodies. An intervertebral spacer is positioned within a narrow disc space between adjacent intervertebral bodies of a patient. The spacer is arranged with upper and lower guides. The guides are adapted to simultaneously guide the deployment of upper and lower anchors of an anchoring device into their respective intervertebral bodies. The spacer is also adapted to lock the upper and lower anchors to the spacer in the deployed position.

Abstract: Disclosed is an assembly and method for implant installation between adjacent vertebral bodies of a patient. The implant has a support body and a rotatable insert therein and the support body is curved for installation between adjacent vertebral bodies transforaminally. An installation instrument is also disclosed for removable attachment to implant and engagement with the rotatable insert to selectively permit rotation between the insert and the support body. The installation instrument extends along a longitudinal tool axis and when the installation instrument is in a first position the insert is rotationally fixed with respect to the support body and when the installation instrument is in a second position the support body may rotate with respect to the insert.

Abstract: Interbody fusion devices and related methods of manufacture are described herein. An example interbody fusion device can include a plurality of vertebral endplates, and a body extending between the vertebral endplates. The body and the vertebral endplates can define an internal cavity. Additionally, each of the vertebral endplates can include a lattice structure and a frame surrounding the lattice structure, where the lattice structure being configured to distribute load. Each of the vertebral endplates can also include a plurality of micro-apertures having an average size between about 2 to about IO micrometers (?m), and a plurality of macro-apertures having an average size between about 300 to about 800 micrometers (?m).

Abstract: Expandable fusion devices, systems, and methods. The expandable fusion device includes one or more integrated deployable retention spikes configured to resist expulsion of the device when installed in the intervertebral disc space. The implant may include upper and lower main endplates, an actuator assembly configured to cause an expansion in height of the upper and lower main endplates, and a sidecar assembly including a sidecar carrier, an upper carrier endplate pivotably coupled to an upper spike, and a lower carrier endplate pivotably coupled to a lower spike such that forward translation of the sidecar carrier pushes against the upper and lower carrier endplates, thereby deploying the upper and lower spikes.

Abstract: A system and method for improving installation of a prosthesis which may include assembly of a modular prosthesis. Devices include prosthesis installation tools, prosthesis assembly tools, site preparation systems, and improved power tools used in implant site preparation, the tools including a secondary motion that preferably includes an ultrasonic vibration.

Abstract: This disclosure includes an expansion driver for adjusting expandable implants, the expansion driver including: a first driver having a first gear disposed at a first end thereof; and a second driver having a second gear disposed at a first end of the second driver; and a handle operably connected to the first driver and the second driver, the handle having at least one bevel gear rotatably attached thereto, the at least one bevel gear engaging each of the first gear and the second gear; wherein upon a rotation of the handle a torque is applied to at least one of the first driver or the second driver.

Abstract: A prosthetic system includes a prosthetic knee having a controller and a hydraulic unit pivotally connected to the controller. The hydraulic includes a reserve hydraulic cylinder, a brake hydraulic cylinder, and a hydraulic cylinder having a lower hydraulic compartment. A flow system fluidly connects the hydraulic cylinder, the reserve hydraulic cylinder, and the brake cylinder. The flow system has first and second flow paths in communication with the lower hydraulic compartment and the reserve hydraulic cylinder. The first flow path is in communication with lower hydraulic compartment and the reserve hydraulic cylinder via the brake cylinder. The second flow path bypasses the brake hydraulic cylinder.

Abstract: A method for enabling movement of an object, having a plurality of degrees of freedom, by a user. The method comprising: receiving a first and second plurality of reference signals from first and second test subjects respectively, generated in response to respective reference intended movements; and determining a set of first of and second profiles. The method also comprises determining profile-pairs, which each comprise a first profile and a second profile that correspond to the same degree of freedom of the object; determining a reference set of profiles based on a mathematical combination of each profile-pair; and providing the reference set of profiles for determining an intended movement of the object based on a plurality of user signals received from a respective plurality of different sensors associated with the user. The intended movement comprises simultaneous movements with respect to at least two degrees of freedom of the plurality of degrees of freedom.

Abstract: The prosthetic device is a general use prosthetic device for shower and daily mobility applications which provides a semi-custom fit. The semi-custom fitment of the leg height and anatomical sizing of the affected leg amputation are possible via configurable liner pads which can be interchanged within the support socket based on need by the wearer. The device is capable of being used on either the left or right leg with no modifications to the device and can be secured to the wearers residual limb via a friction fit between the socket liner and limb. Furthermore, an ergonomic handle and grip provides another point of control for the device to assure safety and security.

Abstract: The present invention relates generally a manufacturing process which results in a completely hydrogel polymer device that maintains lumen patency which allows for numerous applications. One or more physical post-implantation dimensions of the device can be controlled by placing it in a solution that has a predetermined osmolarity and/or pH. In addition, the device can deliver an absorbed therapeutic agent to a target anatomical site. Alternatively, the device can function as a selective membrane to selectively absorb one or more target molecules from a body fluid.

Abstract: A mandrel for forming a stent with a tapered profile and one or more anti-migration features includes a first stent shaping segment having a first diameter, a second stent shaping segment having a second diameter less than the first diameter and a tapered segment disposed therebetween. A third stent shaping segment is releasably securable to the second stent shaping segment and has a third diameter greater than the second diameter. One or more movable pins are outwardly extendable from corresponding apertures formed within the tapered segment. An actuation element is engagable with the first stent shaping segment and includes a tapered surface configured to engage the one or more movable pins and support the one or more movable pins extended from the corresponding apertures.

Abstract: A stent comprises a framework that includes a sequence of cells that each occupy a discrete segment of the stent length, and each of the cells includes a plurality of struts with ends connected at respective vertices. An adjacent pair of the cells are attached to one another by a plurality of T-bars that each include a column defining a long axis that extends parallel to the stent axis, and a top bar attached to one end of the column. An opposite end of the column is attached to a first cell, and the top bar is attached at opposite ends to a second cell of the adjacent pair of cells. The column has a minimum width perpendicular to the long axis that is wider than a maximum width of each of the struts, and the column defines at least one slot. The top bar includes a curved edge on an opposite side from the column, and the curved edge straddles the long axis.

Abstract: An exoskeleton device includes an expandable section. The expandable section may be positioned over an expander, such as a balloon catheter, and expand upon expansion of the expander. The expandable section may include struts that rotate as the expandable section expands. Edges of the struts may score surfaces (e.g., pathology, tissue, etc.) against which the struts are forced as the expandable element expands. The expandable element may carry a medicament, which may be delivered upon expansion of the expandable element.