Abstract: In one embodiment according to the present invention, a stent is described having a generally cylindrical body formed from a single woven nitinol wire. The distal and proximal ends of the stent include a plurality of loops, some of which include marker members used for visualizing the position of the stent. In another embodiment, the previously described stent includes an inner flow diverting layer.

Abstract: A prosthesis 100 is compressed in a device 10 by being wrapped in a flexible sheet 60 inside a cartridge 12, the opposite edges of the sheet being led out through a longitudinal slit 40 in the cartridge and attached respectively to the outer surface of cartridge 23 and the inner surface of a surrounding shell 50; subsequent relative rotation of the shell 50 pulls the sheet 60 outwardly of the cartridge causing compression of the prosthesis. Stop projections 72, 73 are provided to limit the rotation to less than one complete revolution. End pieces 14, 16 of the device have tubes 22, 32 aligned with the prosthesis when compressed and a pusher rod 90, FIG. 4, is pushed through the tubes to push the prosthesis into an introducer sheath 36. The or each end piece 14, 16 may incorporate a ratchet mechanism 120 to prevent rotation in the wrong direction.

Abstract: A stent loading and deployment device includes an outer elongate tubular member having opposed proximal and distal ends and an inner elongate tubular member having opposed proximal and distal ends and slidably disposed within the outer tubular member. When the distal ends of the outer tubular member and the inner tubular member are axially aligned, a stent deployment region is defined there in between. The device further includes a stent loading member having opposed proximal and distal ends and slidably disposed between the outer tubular member and the inner tubular member. The distal end of the stent loading member is slidable to a distal position past the distal end of the outer tubular member for receiving a stent and is further slidable toward the proximal end of the outer tubular member to a location past the stent deployment region for disengagement of a stent from the stent loading member.

Abstract: A prosthesis delivery and deployment device includes an elongate and flexible outer catheter. The outer catheter has a tubular wall of layered construction, including translucent layers, opaque layers, and a braid composed of helically wound metal filaments. The outer catheter has a translucent distal adapted to constrain a radially self-expanding prosthesis in a radially reduced, axially elongated state. Because the stent constraining region is translucent, an endoscope can be used to visually monitor the stent when so constrained. Radiopaque markers can be mounted to the outer catheter and to an inner catheter used to deploy the prosthesis, to afford a combined visual and fluoroscopic monitoring for enhanced accuracy in positioning the prosthesis, both before and during its deployment.

Abstract: An improved tubular structure adapted to increase in diameter upon application of axial force is provided. Increase in diameter is achieved by constructing the tube from multiple layers of material that move relative to each other during axial elongation of the tube. The tube of the present invention can be used both to avoid problems in “necking” found in many prior tube devices, and to provide additional benefits that increases in diameter of the tube during axial elongation can provide. As such, the tube of the present invention may be useful as a manufacturing aid, as a deployment sheath (for example, to deliver medical devices), and in other applications that may benefit from easier tubular sheath removal.

Abstract: A self-expanding medical device delivery system includes a plurality of trigger wires. The trigger wires retain a self-expanding medical device by forming a bend about structural members located on the proximal portion of the medical device. The proximal portions of the trigger wires have a greater diameter than the distal portions of the trigger wires to provide increased bending strength. An operator releases the self-expanding medical device by withdrawing the trigger wires in the distal direction. In some embodiments, a small portion at the proximal end of each trigger wire has a smaller diameter than the rest of the proximal portion. In other embodiments, the proximal and distal portions of each trigger wire each have a greater diameter than the center of the trigger wire.

Abstract: A stent delivery system, a core assembly, and methods of operating the same are provided. The delivery system can comprise a catheter and the core assembly. The core assembly can comprise a constraining member, protruding member, a core member, and a stent extending along the core member. The tubular constraining member can be spaced apart from the core member and define a capture area. The protruding member can be disposed along the core member at least partially distal of the capture area. The stent can have a first portion disposed within the capture area and a second portion, distal to the first portion, extending across or over an outer surface of the protruding member so that the protruding member and the constraining member cooperate to inhibit expansion of the first portion of the stent.

Abstract: A stent delivery system configured to deliver a stent to a target region of a body lumen may include a catheter; a stent associated with the catheter, the stent having a first region and a second region; a balloon associated with the catheter, the balloon having a first balloon portion associated with the catheter proximate the first region of the stent and a second balloon portion associated with the catheter proximate the second region of the stent; and a sheath about the stent and the balloon, the sheath maintaining the stent in an undeployed configuration for delivery to a target region of a body lumen.

Abstract: A delivery system for delivering a device within a body lumen. The delivery system includes a self-expanding stent/graft composite prosthesis and a deployment device. The deployment device includes an outer sheath which overlies the graft, and a stent retaining means for maintaining the one end of the stent in a radially compressed state. The outer sheath is retractable with respect to the graft, and the stent retaining means is removable to allow the stent end to radially expand. The deployment device may further include an inner sheath to overlie the composite and is retractable with respect to the composite. An endoluminal prosthesis including a graft attached to one stent and a second stent unattached within the graft lumen.

Abstract: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath pair is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath pair is removed by a health professional before placing the scaffold within the body.

Abstract: One embodiment of the apparatus comprises a housing with a sheath portion projecting distally therefrom. The sheath portion has a sheath with a lumen, and a bearing surface in the sheath lumen or aligned with the sheath lumen, and located at or near a distal end of the sheath. The implant is at least partially positioned in the apparatus, and comprises an implant body and a tether connected to the implant body. The tether extends from the implant body distally within the sheath portion and around the bearing surface, where the tether changes direction, and extends back proximally from the bearing surface along and within the sheath portion. The apparatus is configured to move the first tether portion proximally and thereby draw the implant body distally along and within the sheath lumen.

Abstract: Various features are described that are adapted to improve performance of interference-relief type delivery systems. A delivery system provided herein comprises an implant comprising a socket at a proximal end of the implant; an elongate sleeve having (i) a proximal section, (ii) a distal section slidably disposed within the socket, and (iii) a window between the proximal section and the distal section, the window extending through a wall of the sleeve; and a core member having a proximal portion slidably received within the proximal section of the sleeve and a distal portion extending through the window to a space outside the sleeve and within the socket. The distal portion of the core member provides an interference fit with the distal section of the sleeve within the socket until the core member is withdrawn.

Abstract: Prosthesis delivery devices and methods are provided that enable precise control of prosthesis position during deployment. The catheter for delivering a prosthesis to a treatment site in a body lumen typically carries one or more self-expanding tubular prostheses within a sheath. A radially expandable control member is positionable within the prostheses and has an expanded shape which engages an inner surface of the prostheses to urge the prostheses outwardly against the sheath. The radially expandable control member therefore controls axial position of the prostheses during deployment. Thus one or more prostheses may be deployed at a treatment site precisely. When multiple prostheses are deployed, excessive spacing or overlap between adjacent prostheses is minimized. The prostheses of the present invention are often deployed in stenotic lesions in peripheral arteries as well as coronary arteries and other body lumens.

Abstract: A stent delivery system includes an expandable stent, a catheter, and a sheath. The expandable stent includes proximal and distal ends, and a first interlock structure. The catheter includes an elongated member having a second interlock structure displaceably arranged about an outer surface thereof for engaging the first interlock structure of the stent. The sheath is mounted on the elongated member and is positionable in a transport position in which the sheath covers the stent mounted on the elongated member and a deploy position in which the stent is exposed.

Abstract: The present disclosure comprises devices, systems, and methods having an inverted sheath configured to cover, and in some instances constrain, a medical device and to retract through eversion, thus enabling the deployment of medical device at the treatment site. A constraining sheath can evert hydraulically. A constraining sheath can be configured to neck down a medical device to achieve a lower delivery profile. Furthermore, a constraining sheath can comprise a balloon to expand or positionally or structurally adjust a medical device.

Abstract: An endoprosthesis deployment system includes an axial catheter, an outer sheath extending parallel to the axial catheter, and an inner sheath positioned transversely between the axial catheter and outer sheath, the inner sheath including first and second inner sheath sections extending along the axial catheter, each of said first and said second inner sheath sections mounted for axial movement relative to the other inner sheath section.

Abstract: A delivery system for delivering and deploying stents with proximal and distal apices includes a “guidewire lumen, a distal apex release lumen, a proximal apex release lumen, a distal apex capture device and a proximal apex capture device. The distal and proximal apex capture devices include a first distal capture portion and a second distal capture portion fixedly connected to the guidewire lumen and distal apex release lumen, respectively, and a first and second proximal capture portions, respectively. The first proximal capture portion is fixedly connected to the distal end of the apex release lumen and has fingers extending toward the first distal capture portion in a distal direction. The second proximal capture portion is fixedly connected to the distal end of the proximal apex release lumen and has fingers extending toward the second distal capture portion in a distal direction.

Abstract: An apparatus for removing emboli from a vessel during an interventional procedure comprising a catheter. The catheter includes: an elongate member having a lumen extending from the proximal end to the distal end; a dilation element disposed on a distal portion of the elongate member, the dilation element having a contracted state and an expanded state; an occlusion element disposed on a distal portion of the elongate member, the occlusion element being disposed proximal of the dilation element, and the occlusion element having a contracted state and an expanded state; and one or more aspiration ports disposed on a distal portion of the elongate member, the one or more aspiration ports being in fluid communication with the lumen, and one or more of the aspiration ports being disposed proximal of the dilation element and distal of the occlusion element.

Abstract: Some embodiments are directed to a deployment system for deploying a stent graft within a passageway, comprising a delivery catheter having an outer sheath, a proximal end, and a distal end, a stent having a first end and a second end, a graft having a first end and a second end, and at least one connecting element extending from the second end of the stent to the first end of the graft so as to connect the stent to the graft. In some embodiments, the stent can be supported within the outer sheath at a first axial position in a collapsed state, and the graft can be supported within the outer sheath at a second axial position different than the first axial position in a collapsed state, such that the stent does not overlap or substantially overlap the graft in the collapsed state within the deployment system.

Abstract: A catheter for delivering a prosthesis to a treatment site in a body lumen comprises an elongate flexible member and a sheath slidably disposed thereover. A plurality of self-expanding tubular prostheses are carried in axially spaced apart locations along the elongate member, within the sheath. The prostheses may be selectively interlocked with one another and are constrained by the sheath in a radially contracted configuration. The prostheses are separately releasable from the sheath when the sheath is retracted relative to the elongate member. The catheter also has a pusher member slidably disposed along the elongate member within the sheath. The pusher is adapted to move past the prostheses in a first direction without displacing the prostheses, while in a second direction the pusher engages a selected prosthesis so as to move the prosthesis with the pusher to interlock the selected prosthesis with a second prosthesis.

Abstract: A method of loading an article, such as a self-expanding stent, into a structure, such as a delivery catheter, including the steps of chilling the article to a predetermined temperature, reducing article size a predetermined amount, inserting fluid into the article, whereby the fluid forms a substantially solid plug with respect to the article, and moving the frozen article. Also provided is an apparatus for loading an article into a structure including: an article size reduction element, a chiller connected to the size reduction element, a cold source communicatively connected to the chiller, and a fluid supply communicatively connected to the size reduction element.

Abstract: An introducer (10) includes release wires (42?) that constrain at least one stent (4?) while the remainder of a stent graft (18) is expanded during deployment. By allowing the constrained stent (4?) to expand after an adjacent stent (4), the constrained stent (4?) overlaps with the interior of the adjacent stent (4) where the stent graft (18) is deployed within a curved body lumen (70).

Abstract: Medical devices and related methods are disclosed for delivering an implant into the body of a patient. The devices include a damping assembly having an internal chamber with a varying inner diameter, and a piston slideably disposed therein. The piston is operably connected with a catheter portion such that movement of the piston is associated with concurrent movement of the catheter for implant delivery. The varying inner diameter of the damping assembly results in a decrease in damping force during implant delivery, thus providing a substantially constant velocity of implant delivery.

Abstract: The invention is directed to a device (100) comprising a medical implant (30), in particular a stent, for implantation in an animal body and/or human body, wherein the medical implant (30) is disposed on a distal end (16) of a carrier (10) for positioning at the intended site, and the medical implant (30) is enclosed at least temporarily by an outer sleeve (20). The outer sleeve (20) on the distal end (18) of the carrier (10) is detachably attachable or attached to the carrier (10).

Abstract: This invention relates to the design and function of a single-tether compressible valve replacement prosthesis which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed combats the process of wear on anchoring tethers over time by using a plurality of stent-attached, centering tethers, which are themselves attached to a single anchoring tether, which extends through the ventricle and is anchored to a securing device located on the epicardium.

Abstract: An intraluminal endoprosthesis having a conically shaped first end and a tubular shaped balloon-expandable stent for a main body is disclosed. The conically shaped first end may form a flare to the main body and is particularly well suited for in ostium use. The first end is preferably self-expanding and the main body is preferably balloon-expandable. Also disclosed is a delivery device for delivering intraluminal ostial endoprosthetic devices, especially those disclosed herein, to a site for deployment. The delivery device may comprise an over-the-wire system or may comprise a rapid-exchange shuttle system. The self-expanding portion of the endoprosthesis is encapsulated in a sheath or other restraining apparatus on the delivery device. The balloon-expandable stent portion of the endoprosthesis is crimped onto a balloon delivery device.

Abstract: A radiopaque nitinol stent for implantation in a body lumen is disclosed. The stent is made from a superelastic alloy such as nickel-titanium or nitinol, and includes a ternary element including tungsten. The added tungsten in specified amounts improve the radiopacity of the nitinol stent comparable to that of a stainless steel stent of the same strut pattern coated with a thin layer of gold. Furthermore, the nitinol stent has improved radiopacity yet retains its superelastic and shape memory behavior and further maintains a thin strut/wall thickness for high flexibility.

Abstract: An insertion system for release of a self-expanding stent device 18 in a body vessel has a first grip 33, which is fixedly connected to a shaft 15, a second grip 36, which is mounted on the shaft 15 to be movable in axial direction, a sheath 19, which, in a distal portion thereof, keeps the stent device radially compressed and which is fixedly connected to the second grip 36, and a retention element 17, which is fixedly connected to the shaft 15 and is guided in the sheath 19, wherein the retention element 17 holds the stent device 18 in its axial position relative to the first grip 33 when the sheath 19 is being retracted. Reference means 25 with an optical reference mark 26 are arranged for continuous monitoring of the axial position of the stent device 18.

Abstract: The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is constrained to a reduced delivery diameter for delivery within the vasculature by at least one sleeve. The implant can be constrained to other diameters, such as an intermediate diameter. The sleeves can be expanded, allowing for expansion of the diameter of the expandable implant, by disengaging a coupling member from the sleeve or sleeves from outside of the body of the patient. The expandable implant can comprise an apposition line or lines which facilitate bending of the expandable implant to improve conformation of the expandable implant to the vasculature of the patient.

Abstract: A method of temporarily reducing the diameter of a stent graft (10) and a stent graft with its diameter reduced. The stent graft has a tubular body and self expanding stents.

Abstract: An implant centering system includes a sensor connected to a hollow cylindrical anchor via at least two struts. The hollow cylindrical anchor is transformable between a radially compressed configuration for delivery and a radially expanded configuration for lodging against a vessel wall. The struts longitudinally relocate the sensor between a first position in which the sensor is longitudinally spaced apart from the radially compressed anchor, and a second position in which the sensor is at least partially within a lumen of the radially expanded anchor and radially centered within vessel. In one embodiment, the struts are heat-set into a curved configuration and an externally applied force longitudinally relocates the sensor until the struts lock over center into their heat-set configuration. In another embodiment, radial expansion of the anchor longitudinally relocates the sensor without an externally applied force.

Abstract: In various embodiments, the medical device delivery system described herein can be configured to position and deliver a medical device in a body lumen. The medical device delivery system can comprise an elongate member, a medical device and a leash. During deployment, the medical device can be tethered to the catheter by the leash, to stabilize and prevent unwanted shifting of the medical device as it deploys at the treatment site.

Abstract: Medical device delivery systems that include a distal protection feature are provided. A distal tip member that includes a distal protection device and a mounting region for a self-expandable, intraluminal medical device is slidably disposed within a passageway defined by a tubular member.

Abstract: A device and method for endovascular repair of a patient's aorta is disclosed. The device includes a frame component that has a balloon-expandable frame and a self-expanding frame secured to the balloon-expandable frame. The device also includes a valve element positioned at the proximal end of the frame component. The device may include another prosthetic component that may be secured to the frame component. The prosthetic component may include at least one conduit configured to receive a covered stent.

Abstract: A catheter assembly including a side branch locator that is moveable between a retracted position within a main vessel of a vessel bifurcation, and an extended position wherein a distal end of the side branch locator extends into a branch vessel of the vessel bifurcation. The side branch locator includes a first end fixed relative to a portion of the catheter assembly that remains in the main vessel. A second end of the side branch locator is moveable between the retracted and extended positions. The catheter assembly can include a moveable sheath that holds the side branch locator in the retracted position. The catheter assembly can further include a stent having a lateral branch opening through which the side branch locator extends.

Abstract: Disclosed are stent holding devices having a support mandrel and one or more stent retaining fixtures disposed on the mandrel. The retaining fixture may include a character identifier to facilitate tracking a stent mounted on the holding device. The retaining fixture may include a conical protrusion and a conical recess to allow any number of retaining fixtures to engage each other and be stacked on the mandrel. The retaining fixture may include a tubular member having a spiral cut that enables the diameter of the tubular member to be adjusted to allow for a frictional fit on the mandrel. The retaining fixture may have a Z-shaped or T-shaped structure configured to retain a stent. The stent retaining fixture may also have a filament for retaining a stent.

Abstract: Configurations are described for assisting in the execution of a percutaneous procedure while protecting the vascular pathway to the operational theater, which may comprise diseased tissue. A railed sheath may be controllably expandable and collapsible, and may comprise two or more elongate rail structures configured to assist in the distribution of loads to associated diseased tissue structures, while also contributing to the deployment of percutaneous tools by maintaining alignment of such tools with the railed catheter and associated anatomy.

Abstract: A method and device may be used to avoid surgically re-opening a stoma or the like in an animal, including human beings. The stoma stabilitating device comprises an anchoring portion, preferably flat, that includes an opening configured to surround a stoma. The anchoring portion preferably includes an inner tension ring attached to an inner edge to define the opening and a tension ring attached to an outer edge. The anchoring portion may include additional structural rings. The device may be of a mesh construction and used to maintain, for example, a stoma, a fistula, a tracheotomy and any other pathway from outside the body to the inner part of the body. The device may be used to maintain an open pathway for air and to maneuver devices within a cavity. The device may also be used internally.

Abstract: In combination a device for delivering a stent within an intraluminal cavity and a stent including an elongated member configured to receive a stent thereon, a stent mounted on the elongated member and movable between a smaller diameter delivery position and an expanded placement position and a tubular portion attached to the elongated member. First and second stent engaging arms and a pusher arm extend distally of the tubular portion. The first and second engaging arms configured to constrain the stent in an area between the arms and the pusher arm configured to contact the proximal portion of the stent. The engaging arms are movable between a closed stent constraining position and an open stent release position. The delivery system can also be used to deliver other vascular implants.

Abstract: A delivery system for delivering and deploying a stent graft includes a curved guidewire catheter, an apex release catheter, an apex capture device, a relatively rigid, hollow catheter, and a distal nose. The apex capture device includes a distal capture portion fixedly connected to the distal end of the guidewire catheter and having a distal portion and a proximal stopper having an exposed side facing distally in a plane approximately perpendicular to a longitudinal axis of the curved guidewire catheter. The apex capture device also includes a proximal capture portion fixedly connected to the distal end of the apex release catheter and has fingers extending toward the distal capture portion in a distal direction that define an interior cavity to receive the proximal stopper. The proximal and distal capture portions of the apex capture device define a stent capture state.

Abstract: Present invention is a stent apparatus wherein a stent covering member holds a stent, which scaffolds a blood vessel from the inside when implanted in the blood vessel, in contracted state. The stent is formed of a biodegradable polylactic acid (PLA) as a tubular shape, shape memorized to a size capable of, when implanted in a vessel, scaffolding the blood vessel from the inside. This stent is held by the stent covering member in contracted state and mounted on a balloon of a balloon. The covering member is formed of a biodegradable polymer having elasticity as a cylindrical shape having an inner diameter to keep the stent in contracted state and, when the stent is expanded to the shape memorized shape, plastically deformed to release the holding of the stent. The stent and the stent covering member disappear in a vessel after they are implanted in the vessel.

Abstract: A filter may have an apical hub and a plurality of divergent legs. A first attachment member may be separate from, but attached to the second end of at least one of the plurality of divergent legs. A second attachment member may be separate from, but attached to a stent. The first and second attachment members may be separate from, but attachable to one another to releasably attach the filter to the stent. One of the first attachment member and the second attachment member may include an attachment wire that is positioned in a lumen of a tubular member or one of the first attachment member and the second attachment member may comprise a cannula. In some implementations, an upward motion applied to the retrieval connection member may disengage at least one attachment wire of the first attachment member from the second attachment member.

Abstract: The disclosure pertains to a medical device deployment system comprising a restraint member which holds the embolic protection filter in a restrained, or partially collapsed, state for insertion into a lumen and transit to a desired deployment site. The restraint member comprises two or more portions which differ in their mechanical ability to resist the radial forces exerted by various portions of the medical device when it is in a restrained, or partially collapsed, state. The restraint member is maintained in a restraint configuration by an actuation member which engages portions of the restraint member lying on opposite sides of a generally axial gap until deployment of the medical device is desired. Withdrawal of the actuation member allows the restraint member to release the medical device which may then return to a deployed state. The invention also provides a method for assembling a medical device deployment system.

Abstract: A delivery device for positioning and deploying an implantable device within a lumen is provided. The delivery device includes inner and outer tubular members slidable to each other between at least a first hold position and a second release position, a handle and a deployment mechanism adapted for an operator to use a first hand for operating the delivery device and moving the tubular members between the first and second positions. The delivery device further includes a protective member adapted for insulating at least a portion of the outer tubular member from the tendency of the operator to use his or her second hand to grab the outer tubular member during operations or from other external forces.

Abstract: Systems and methods are disclosed for delivering a stent to a lumen internal to a body of a patient and for sheathing a stent just prior to an insertion procedure. One embodiment comprises a delivery device having a partially sheathed configuration, a fully sheathed delivery configuration, and a deployed configuration. A panchor (combination pusher and anchor) is configured to engage and limit proximal and distal movement of the implantable device. An outer sheath surrounds a distal portion of an inner member and retains the implantable device near the distal end. The outer sheath is slidably moveable relative to the inner member to deploy the implantable device. Proximal movement of a trigger results in movement of the outer sheath to deploy the implantable device. A sheathing mechanism is configured to crimp and fully sheathe the implantable device prior to a deployment procedure.

Abstract: A delivery system for a medical device. The delivery system comprises an inner member, a retractable sheath disposed over the inner member and being slideable over the inner member, and a retraction member coupled to the retractable sheath and disposed at least in portion within the retractable sheath, the retraction member being slideable over the inner member. An axial movement of the retraction member retracts or actuates the retractable member.

Abstract: A method of prosthesis delivery comprises advancing first, second and third guidewires through a first vessel, positioning the second guidewire in a second vessel that branches from the first vessel, positioning the third guidewire in a third vessel that branches from the first vessel, advancing a prosthesis over the first, second, and third guidewires to the vicinity of one of the second and third vessels, and deploying the prosthesis. The prosthesis can comprise a tubular stent-graft having a first eyelet adapted to receive a guidewire and a second eyelet adapted to receive a guidewire.

Abstract: Medical devices may be utilized for local and regional therapeutic agent delivery. These therapeutic agents or compounds may reduce a biological organism's reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the prevention of thrombosis. The drugs, agents, and/or compounds may also be utilized to treat specific disorders, including restenosis, vulnerable plaque, and atherosclerosis in type 2 diabetic patients.

Abstract: The present disclosure provides a delivery system for a self-expanding implant (31) which includes a sheath (41, 42) which surrounds and constrains the implant prior to delivery and a confining element (80) which surrounds the sheath during storage. The confining element preferably includes elongate members (81) running axially along the sheath, which compress the sheath and the stent to reduce hoop stress in the system without promoting undesired adhesion between layers of the sheath.

Abstract: Polymer stents with break-away links and methods of forming the links for improved stent retention on an expandable member during delivery are disclosed.