Abstract: Packaging systems are configured for improving long-term stability of a composition. Packaging systems may include a packaging container defining an enclosed volume. The packaging system may additionally include a removable cover that enables the packaging container to be opened and closed such that the packaging container system includes a sealed or sealable volume to contain a main composition in fluid communication with a sacrificial composition. The main composition may include one or more volatile or gas-releasing materials and the sacrificial material may include a stabilizing component that replaces the at least one volatile or gas-releasing component within the main composition or displaces the at least one volatile or gas-releasing component within the enclosed volume. The sacrificial composition helps maintain stability of the main composition by accelerating equilibrium of vapors or gases within the headspace of the sealed interior volume.

Abstract: The intraoral imaging system described herein may comprise an intraoral adapter. The intraoral adapter may be operably coupled to a mobile device. The intraoral adapter may comprise an elongated housing comprising a viewing channel. The viewing channel may define a field of view of an intraoral region of a subject's mouth for intraoral scanning using a camera of a mobile device. The elongated housing may comprise a flange that is positioned outside of the field of view of the intraoral region of the subject's mouth. The intraoral imaging system may further comprise an image processing unit configured to (i) process a plurality of intraoral images and/or videos captured using the camera of the mobile device, and (ii) determine a dental condition of the subject based at least in part on the plurality of intraoral images and/or videos.

Abstract: The endodontic point containing ultrasonic deformable material is a filler for root canal therapy that decreases in viscosity when subjected to ultrasonic waves. Once the point is inserted into a prepared tooth space, such as a prepared and cleaned root canal, the point is subjected to ultrasonic waves. The ultrasonic waves cause the viscosity of the point to lower, thus allowing the point to flow into voids in the tooth space and allow air to escape from the voids. The point then hardens and remains in the shape acquired when at low viscosity once application of the ultrasonic waves is stopped.

Abstract: A distributed system includes one or more servers configured to provide computing devices access to portals hosted by the one or more servers, where the portals include a patient intake portal accessible by a first computing device located at an office of an intake dentist or orthodontist, and an approving portal accessible by a second computing device remote from the first computing device. The distributed system includes a dental aligner fabrication system including a fabrication computing device and dental aligner fabrication equipment. The patient intake portal is configured to provide a plurality of status updates to the intake dentist or orthodontist regarding a status of the patient, where the plurality of status updates include an indication that the dental aligners have been sent to the patient.

Abstract: Orthodontic systems for monitoring treatment. The systems can include at least one orthodontic appliance that includes one or more sensors. A processor in communication with the sensor(s) is configured to receive sensor data from the sensor(s), where the sensor data corresponds to a force acting on one or more teeth. The processor is further configured to predict tooth movement based on the sensor data. The predicted tooth movement is determined by predicting how much teeth will move based on a direction and a magnitude of the force. The processor is further configured to compare the predicted tooth movement to an expected tooth movement, where the expected tooth movement is based on a treatment stage of a treatment plan. The processor is further configured to modify the treatment plan if the predicted tooth movement does not match the expected tooth movement based on the treatment stage of the treatment plan.

Abstract: Creating a digital tooth model of a patient's tooth using interproximal information is provided. Interproximal information is received that represents a space between adjacent physical teeth of the patient. A digital teeth model of a set of physical teeth of the patient that includes the adjacent physical teeth is received. One or more digital tooth models is created that more accurately depicts one or more of the physical teeth than the corresponding digital teeth included in the digital teeth model based on the interproximal information.

Abstract: Systems and methods of simulating, modeling, and validating orthodontic treatment are disclosed. The method may include designing an orthodontic treatment system or force system, generative a displacement field between a first position of a patient's teeth and a second position, modeling the three-dimensional force-displacement model generated by the treatment system or force system, and validating the treatment system or force system. The methods disclosed herein may be iterated to optimize the orthodontic force system or treatment system.

Abstract: A method of producing a custom dental anchor application appliance may be provided. The appliance may be for mounting one or more anchors to teeth of a patient. The appliance may be for use in orthodontic aligner treatment. The method may include forming a dental appliance. The forming may be done using a three-dimensional printing approach. The appliance may include a body. The body may include at least one anchor-locating area. The anchor-locating area may be shaped to conform to a mounting area on a surface of a tooth. The appliance may include a receiving structure. The receiving structure may be configured to removably support a dental anchor. The dental anchor may be of a predefined configuration in a fixed position and orientation relative to the body.

Abstract: An improved preparation method uses an additional preparation tray as part of a multi-step tray alignment system which achieves orthodontic tooth movement. The preparation tray incorporates openings in the tray for the application of a bonding preparation fluid, such as an etching agent, or alternately, an etching and bonding agent, in the correct location and amount. The openings are at least the size and shape of the tooth attachments and greatly reduce the tooth surface area accessible to the clinician. This confines the bonding preparation fluid to an area equal to, or slightly larger than, the attachment contact area. The method and apparatus provide faster application, vastly reduced cleanup, less tooth enamel damage, and less chair time for the patient.

Abstract: Hybrid orthodontic archwire designs are disclosed. Hybrid archwires may have bracket-archwire sections and interproximal archwire sections in which each section can vary in cross-section shape, size, and/or material properties. Bracket-archwire sections may be configured to promote torque control and may have rectangular cross-sections. Interproximal archwire sections may be configured to be bent into force-promoting loops and may have round cross sections. Each archwire section may be straight or bent into any shape. Hybrid archwires may have sliding sections and non-sliding sections. Non-sliding sections may have male connectors configured to prevent the archwire from sliding relative to the orthodontic brackets and/or may have cross-sectional shapes, sizes, or coatings that resist sliding relative to sliding sections. Sliding sections may have linear archwire segments. Hybrid archwires may have distal or posterior non-sliding sections and an intermediate anterior or medial sliding section.

Abstract: A self-ligating bracket system comprising a body, an archwire slot receivable for an archwire, and a locking mechanism, the locking mechanism configured to allow a ligating sliding member to move between an open position, such that an archwire may be inserted into and/or removed from the archwire slot, and a closed position, such that an archwire is retained within the archwire slot.

Abstract: A temporary alignment system, methods, and accessories for holding a dental coping to an implant abutment using a separable fastener using the same threads in the implant abutment used for definitive attachment are disclosed. The disclosed temporary fasteners initially orient and hold a coping against an implant abutment with a force along the same axis as the semi-definitive screw. The aligned coping can be picked-up in a closed-tray impression process without unscrewing the temporary fastener. Embodiments include threaded posts that release copings from the implant abutment through axial forces. Some embodiments include a threaded post with separable cap that is picked-up with the coping. Methods and accessories for using the separable fastener assembly or portions of it during conversion of an existing prosthesis for screw attachment or fabrication and fitting of a new prosthesis are described.

Abstract: A dental prosthesis system, for the use with at least two dental implants, wherein the dental prosthesis is divided in a first prosthetic part and a second prosthetic part, jointed by a prosthetic screw, and wherein the first prosthetic part is connected to the dental implants through at least two connectors, and such dental prosthesis has an engaging and guidance system, including two female elements, disposed on the top of the first prosthetic part, and two corresponding male elements, disposed on the bottom of the second prosthetic part, whereby the connection between the two female elements and the two male elements is releasable.

Abstract: A system and method for creating a model of a patient's mandible and any teeth supported from the mandible and manipulating the mandible relative to anatomical features of the patient's maxilla. The system uses markers positioned on the mandible and on the maxilla to create a functional mandibular axis that approximates an axis through the condyles of the patient. The functional mandibular axis and geometric and anatomical information about the patient's upper and lower jaw are then used to create prostheses for the patient. The system is also used for making corrections to the prosthesis.

Abstract: Provided herein are systems and methods for scoring a post-treatment tooth position of a patient's teeth. A patient's dentition may be scanned and/or segmented. Raw dental features, principal component analysis (PCA) features, and/or other features may be extracted and compared to those of other teeth, such as those obtained through automated machine learning systems. A classifier can identify and/or output the post-treatment tooth position of the patient's teeth.

Abstract: A semi-automated veterinary medicine delivery device may sense whether and how much air may have been incorporated into a dose delivered to an animal. The device may also sense an incomplete injection in some cases, and may cause a second dose to be administered to make up for the incomplete dose. The device may compare a position sensor on a syringe in combination with a current sensor on a motor attached to the syringe to detect any abnormalities. In the case of an improper dose, the device may alert the user and administer a second dose.

Abstract: The present disclosure provides for an ear cleaning device comprising an integral body, and a central handle portion of the integral body that supports a first whisk-like bulbous end, with the first whisk-like bulbous end being integral with the central handle portion. The first whisk-like bulbous end further comprises flexible intertwined wire-like loops used in the removal of ear was or debris. The first whisk-like bulbous end being of a size that averts insertion thereof to an ear canal.

Abstract: The motorized ear-cleaning device is a tool. The motorized ear-cleaning device is a therapeutic device. The motorized ear-cleaning device is adapted for use with the ear of a patient. The motorized ear-cleaning device cleans the ear. The motorized ear-cleaning device comprises a working element, a handle structure, and drive circuit. The working element attaches to the handle structure. The drive circuit mounts in the drive structure. The drive circuit rotates the working element. The rotation of the working element rubs against the ear. The working element generates a friction used to clean the ear.

Abstract: In some embodiments, a wound monitoring and/or therapy apparatus can include a wound dressing configured to be positioned over a wound. The wound dressing can support one or more sensors. The one or more sensors can include an optical sensor array cluster, which can include an optical sensor and single light source. In some embodiments, the wound dressing can include a substantially stretchable wound contact layer that includes a wound facing side and a non-wound facing side opposite the wound facing side, the wound facing side configured to be positioned in contact with a wound. The non-wound facing side of the wound contact layer can support a plurality of electronic components and a plurality of electronic connections that connect at least some of the plurality of the electronic components. The electronic components can include one or more sensors configured to obtain measurements of the wound or the periwound, or both.

Abstract: Systems, methods, and apparatuses for treating a tissue site are described. In some embodiments, the system may include a pouch having an upstream layer, a downstream layer, and an absorbent member enclosed between the upstream layer and the downstream layer. The upstream layer and the downstream layer may each include a hydrophobic side and a hydrophilic side. The hydrophilic side of both the upstream layer and the downstream layer may be positioned facing the absorbent member. The hydrophobic side of both the upstream layer and the downstream layer may form a portion of an exterior surface of the pouch such that fluid incident on the pouch is distributed laterally along the exterior surface of the pouch before being absorbed by the absorbent member.

Abstract: A medical dressing is provided. The dressing has a central portion and a border portion, and comprises a backing layer, an adhesive body contact layer and a pad arranged in the central portion between the backing layer and the adhesive body contact layer. The pad is symmetric about a longitudinal center line and the dressing comprises a lobed portion on each side of the center line. The central portion of the dressing has a tensile strength in the longitudinal (y) direction of at least 60 N, preferably at least 70 N at an elongation of 25%, as measured by the test method ASTM D 882-12. The medical dressing may be used for pressure ulcer prevention, such as at the sacrum region of a human body.

Abstract: A composite moldable splint and method for using the same is described. In some embodiments, the splint has at least a partially fluid-filled inner volume, which in some embodiments may include foam, rubber, water, or pelletized material, enclosed by a flexible liner, surrounded by a thermoplastic layer that is flexible and moldable when heated. The inner volume, which may include a thermoactive adhesive having differing viscosity characteristics at a plurality of temperatures, provides the ability to mold the cushion into a wide range of shapes and contours, such as when forming around a body part. The thermoplastic layer provides the ability of the cushion to be molded when heated, while the inner volume tends to maintain a shape, and allows the thermoplastic layer to stay in its formed shape as the cushion cools. The cushion may be used in a range of medical applications for stabilizing patients and body parts.

Abstract: A multifunctional piece of athletic and/or work wear is presented. When worn as a compression sleeve to play rugby, American football and other ball-carrying sports (with oblong or round balls), or when worn to carry objects during physical labor, an object contact surface positioned on the inner forearm of the sleeve can grip the carried object with increased friction while an outside facing surface of the sleeve can be smooth to deflect defenders or objects that may impact the sleeve, can be padded to protect from impacts, can provide protection from contusions and lacerations, and/or can provide active cooling. The garment can further include static or dynamic readable symbols or images woven or knitted into the garment (rather than printed or fused onto the garment).

Abstract: A method for forming an absorbent pad including a first layer, a second layer and an absorbent material interposed between the first and the second layer and arranged according to a spreading pattern M1 having at least one channel which is free of absorbent material, includes a step of feeding a first web, intended to form the first layer of the pad; a step of feeding a second web, intended to form the second layer of the pad; a step of spreading the absorbent material on the first web according to the spreading pattern M1; a step of spreading an adhesive on the first web according to a gluing pattern; a step of welding the first web and the second web according to a welding pattern M3 including at least one welding zone at the channel on the pad.

Abstract: Absorbent articles herein may provide a topsheet, a backsheet, an absorbent core disposed between the topsheet and the backsheet. The absorbent core may comprise at least one channel having a shape. The backsheet graphics may substantially match the shape.

Abstract: A garment comprises a main body including a front portion, a back portion, and a gusset connecting the front portion and the back portion. The gusset has left and right lateral edges partially defining respective left and right leg openings of the garment. A layer of absorbent material is coupled to an inner face of the main body at least at the gusset. A layer of waterproof material is sandwiched between the main body and the layer of absorbent material. Left and right elastic bands couple the layer of absorbent material and the layer of waterproof material to the main body along the respective left and right lateral edges of the gusset. A method for manufacturing the absorbent garment is also provided.

Abstract: An absorbent garment that includes a longitudinal axis and a lateral axis. The absorbent garment also includes a front region, a back region and a crotch region, with the crotch region being disposed between the front region and the back region. The crotch region includes an absorbent assembly. The absorbent garment further includes a front panel in the front region, wherein the front panel includes an inner layer, an outer layer and a front longitudinal end; a back panel in the back region, wherein the back panel includes an inner layer, an outer layer and a back longitudinal end. The front panel and the back panel each include a stranded elastic area between their inner and outer layers. The front panel also includes a stretch banded area disposed between the inner and outer layers. The stretch banded area is disposed adjacent the front longitudinal end.

Abstract: Absorbent articles comprising a multilayer outer cover comprising a first outer layer and a second outer layer comprising a component that exhibits at least partial elastic recovery after mechanical activation in the machine direction; an inner layer, disposed between the first outer layer and the second outer layer, the inner layer comprising elastic strands; and wherein at least one of the first outer layer and second outer layer is laminated to the inner layer.

Abstract: An absorbent article is provided, the absorbent article comprising a nonwoven material. The nonwoven material comprises core/sheath bicomponent fibers wherein the core is formed of PET resin. The present disclosure also provides a wipe comprising a nonwoven material, the nonwoven material comprising core/sheath bicomponent fibers wherein the core is formed of PET resin. The PET has less than 150 ppm of antimony.

Abstract: An absorbent structure comprising one or more absorbent layers wherein the absorbent structure exhibits a first cycle Peak Force compression between about 30 grams and about 150 grams. The absorbent structure further exhibits a fifth cycle dry recovery energy between 0.1 mJ and 2.8 mJ.

Abstract: A diaper 1 has a disposal tape 10 on its outer surface. The disposal tape 10 is composed of a fixed portion 12, an extensible portion 15, and a fastening portion 18 arranged in that order along the longitudinal direction X1 of the disposal tape 10 and Z-folded in that order. Unfolded, the extensible portion 15 is extensible in the longitudinal direction X1 of the disposal tape 10. The disposal tape 10 in the unfolded configuration has a first connection region 31 where the extensible portion 15 and the fastening portion overlap and a second connection region 32 where the extensible portion 15 and the fixed portion 12 overlap. At least one of the first and second connection regions has a bonded region 33 and a non-bonded region 36 where the extensible portion 15 and the fastening portion 18 or fixed portion 12 are not bonded, the non-bonded region 36 being located longitudinally proximal to the bonded region 33.

Abstract: Pelvic implant having a frame with two arms and a sheet are disclosed. The sheet may be held under tension in the assembled implant. The implant may be planar (flat) or may be non-planar. The implant may be contoured laterally. A curved non-planar implant may be convex or concave in a rostro-caudal direction. The implants may (optionally) include two additional arms and a second sheet for supporting a urethra and/or a bladder neck. Methods for constructing and assembling the implants are disclosed. A method ultrasonically welding the frame of the implant without thermally damaging the sheet is disclosed. Methods of implantation of the implants are disclosed.

Abstract: A repair prosthetic for repairing a hernia is disclosed. In some embodiments, the repair prosthetic includes a patch body, a frame that assists in spreading the patch body from a reduced configuration to an expanded configuration, and a plurality of tethers attached to the patch body at locations between the frame and a periphery of the patch body. In various embodiments, the tethers can be tensioned to mitigate curling or creasing in the patch body to flatten the patch to facilitate attachment to tissue.

Abstract: An assembly includes a medical device having a stent and a prosthetic valve connected to the stent. The prosthetic valve includes valve leaflets. The assembly further includes a buffer piece having a leaflet cover and a removable attaching structure. The leaflet cover protects the valve leaflets and the removable attaching structure removably attaches the buffer piece to the medical device. The buffer piece prevents contact, imprinting, abrasion, and/or damage to the valve leaflets.

Abstract: A catheter device is disclosed comprising; an elongate sheath (503) with a lumen and a distal end for positioning at a heart valve (6), an embolic protection device (200) for temporarily positioning in the aortic arch for deflection of embolic debris from the ascending aorta to the descending aorta, said embolic protection device is connectable to a transluminal delivery unit (130) extending proximally from a connection point (131), and having: a frame with a periphery, a blood permeable unit within said periphery for preventing embolic particles from passing therethrough with a blood flow downstream an aortic valve into side vessels of said aortic arch to the brain of a patient, and at least one tissue apposition sustaining unit (300, 350) extending from said catheter, into said aortic arch, and being attached to said embolic protection device at a sustaining point (502), for application of a stabilization force offset to said connection point at said embolic protection device, such as at said periphery, and

Abstract: Aspects of the present disclosure are directed toward catheter-based apparatuses, such as componentry utilized with or as part of catheters, or as catheters or catheter assemblies. As may be implemented in accordance with one or more embodiments, a method and/or apparatus involves a filter having a frame that forms a perimeter of the filter and separates opposing surfaces thereof. An articulated arm is connected to the frame and configured therewith to, when deployed within a tubular organ, engage with opposing inner sidewall portions of the tubular organ and to utilize the inner sidewall portions to seal filter to the inner sidewall by applying force to the frame.

Abstract: An integrally woven or knitted textile, such as a tubular graft or sheet, includes a base textile layer and at least one pouch or flap. In the case of a graft, the textile has at least one longitudinal tubular graft portion, and at least one pouch or flap integrally woven from at least a portion of the same set of yarns. Methods of making the same are also disclosed.

Abstract: An implantable graft may include a main section having walls formed with a woven fabric, the main section having a main lumen extending therethrough. The implantable graft may also include a bifurcated section having walls formed with the woven fabric, where the bifurcated section extends from main section, where the bifurcated section includes a first branch and a second branch, and where the first branch and the second branch each include a branch lumen in fluid communication with the main lumen. At least one branch of the bifurcated section may include a branch taper formed by a seam connecting a first woven layer and a second woven layer. A seam extension may extend outwardly along the seam of the branch taper, the seam extension being a single-layer woven structure.

Abstract: A composite scaffold having a highly porous interior with increased surface area and void volume is surrounded by a flexible support structure that substantially maintains its three-dimensional shape under tension and provides mechanical reinforcement during repair or reconstruction of soft tissue while simultaneously facilitating regeneration of functional tissue.

Abstract: A method of implanting a graft onto a proximal humerus includes securing a first suture anchor to a first portion of the proximal humerus and securing a second suture anchor to a second portion of the proximal humerus. The first suture anchor includes a first suture and the second suture anchor includes a second suture. The graft is inserted over the proximal humerus. The method further includes positioning the graft relative to the proximal humerus such that a lateral portion of the graft is oriented over a greater tuberosity of the proximal humerus and a medial portion of the graft is oriented over the medial greater tuberosity. The graft is secured to the proximal humerus via the first suture member and the second suture member. The method may also include securing the graft anteriorly to the subscapularis and/or posteriorly to the infraspinatus.

Abstract: Embodiments herein relate to an implant for insertion into a patient. The implant comprises a plurality of unit cells arranged to form a three-dimensional lattice structure, the three-dimensional structure comprising a resting volume of the implant. The plurality of unit cells are arranged to form a porous network of the three-dimensional structure, and wherein the three-dimensional structure is a reversibly compressible three-dimensional structure, wherein a bulk porosity of the three-dimensional structure of the implant is at least 50%. Also disclosed is a method of tissue reconstruction or tissue augmentation. The method comprises implanting into the body of a subject an implant of the disclosure.

Abstract: A corneal implant designed for correcting irregularities of the corneal curvature of a subject, the implant having a dome-shaped structural body configured to impose a regular curvature to the corneal portions designed to be in contact with the implant. The structural body includes an outer peripheral ring and an inner reticular structure. The inner reticular structure includes at least one first and one second series of beams intersecting each other. The beams of the first series have a respective first end connected to the outer peripheral ring. The total area of void portions within the meshes of the reticular structure is between 50 and 99.9% of the surface area of the reticular structure. The inner reticular structure includes an innermost peripheral ring and the beams of the second series include annular beams arranged concentrically to each other.

Abstract: A device and method for aspirating graft tissue and delivering the graft tissue to a target delivery site (for example, when performing Descemet's membrane endothelial keratoplasty). In one embodiment, an injector comprises a cylinder and a plunger at least partially located within the cylinder, the plunger being rotatably advanceable and retractable within the cylinder. In one aspect of the embodiment, rotating the plunger in a first direction within the cylinder controllably aspirates a graft tissue into the injector and rotating the plunger in a second direction opposite the first direction controllably ejects the graft tissue from the injector.

Abstract: An ophthalmic device includes an optic including an optic axis and a closed-loop haptic structure coupled to the optic via a frame surrounding the optic, the closed-loop haptic structure including a closed loop extending from first and second attachment points to the frame. The closed loop includes a first hinge and a second hinge. The first hinge has a first section having a first component extending in a first angular direction, a second section having a second component extending in a second angular direction opposite to the first angular direction, and a first connecting section between the first section and the second section. The second hinge has a third section having a third component extending in the second angular direction, a fourth section having a fourth component extending in the first angular direction, the fourth section being connected to the second section to form the closed loop.

Abstract: Apparatus for use in implanting intraocular lenses, the apparatus including an axial elongate hollow conduit having first and second ends and defining an intraocular lens injection pathway extending along a longitudinal axis, the axial elongate hollow conduit being formed at the first end with a syringe connector defining a removable syringe mounting location and a pusher element located within the axial elongate hollow conduit between the syringe connector and the second end, at least one of the axial elongate hollow conduit and the pusher element being formed with mutually communicating conduits for enabling viscoelastic material to pass through the syringe connector and the pusher element to a location between the pusher element and the second end of the axial elongate hollow conduit.

Abstract: Implementations described and claimed herein provide systems and methods for manufacturing customized cardiovascular devices. In one implementation, patient cardiovascular data for a patient is received at a controller. The patient cardiovascular data is captured using a patient interface. A printing profile for a cardiovascular medical device is received at the controller. A patient specific three-dimensional model of the cardiovascular medical device customized for the patient using the patient cardiovascular data and the printing profile is generated. The patient specific three-dimensional model of the cardiovascular medical device is sliced into a plurality of outlines using the controller. Print instructions based on the plurality of outlines are generated using the controller. A polymeric material is manipulated according to the print instructions into a customized polymeric cardiovascular medical device for the patient.

Abstract: Some embodiments of the present disclosure provide a stent-valve for transcatheter implantation to replace a cardiac valve. In some embodiments, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation. In some embodiments, the stent-valve comprises a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue. In some embodiments, the paravalve seal comprising material that swells in response to contact with blood or components thereof.

Abstract: Prosthetic devices and frames for implantation at a cardiac valve annulus are provided that include an annular frame (having an inflow end and an outflow end) and a plurality of axial frame members that bridge two circumferentially extending rows of angled struts. The axial frame members can include a plurality of axially extending leaflet attachment members and a plurality of axial struts in a 1:1 ratio. Along each of the two rows, the frame can have at least three angled struts between adjacent axial frame members.

Abstract: Stented prosthetic heart valves including a stent frame having a plurality of stent frame support structures collectively defining an interior surface, an exterior surface and a plurality of cells. The stented prosthetic heart valve further including a valve structure including valve leaflets disposed within and secured to the stent frame and defining a margin of attachment. The stented prosthetic heart valve including one or both of an outer paravalvular leakage prevention wrap and an inner skirt for supporting the valve leaflets. In various embodiments, the outer wrap is positioned entirely on one side of the margin of attachment. In embodiments including an inner skirt, the outer wrap and the inner skirt are on opposite sides of the margin of attachment such that the inner skirt and the outer wrap do not overlap. In other embodiments, the outer wrap includes a plurality of zones having varying thickness.

Abstract: Embodiments of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such embodiments can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some embodiments can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some embodiments include an elastic outer cover positioned outside the outer layer. Embodiments of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.