Abstract: Provided packaged orthodontic assemblies and methods compressively retain an orthodontic appliance in a container along opposing sides of the appliance adjacent the bonding surfaces of its base. This can be done using a mechanism that limits contact between the appliance and the container while accommodating a substantial range of transverse base dimensions. This engagement mechanism allows an adhesive-coated appliance to be retained in a consistent orientation for convenient dispensing, while limiting potentially adverse interactions between the adhesive and the container. By avoiding loss of the adhesive components during storage, these assemblies and methods can extend shelf life and provide consistent adhesive handling properties.

Abstract: A dental contact adjustment tool. The novel dental tool includes a handle and a support structure for coupling a marking apparatus to the handle such that the marking apparatus is at an angle appropriate for delivering a marking medium to an interproximal area of a tooth. In an illustrative embodiment, the support structure includes an angled shaft having a first end coupled to the handle and a second end coupled to a retaining mechanism for holding the marking apparatus at a substantially right angle to the shaft. The marking medium is a transferable medium that will transfer from a tooth to an artificial crown upon contact. In the illustrative embodiment, the marking medium is graphite, and the marking apparatus includes a solid piece of graphite held by a retaining body adapted to interface with the retaining mechanism of the support structure.

Abstract: The attenuation and other optical properties of a medium are exploited to measure a thickness of the medium between a sensor and a target surface. Disclosed herein are various mediums, arrangements of hardware, and processing techniques that can be used to capture these thickness measurements and obtain three-dimensional images of the target surface in a variety of imaging contexts. This includes general techniques for imaging interior/concave surfaces as well as exterior/convex surfaces, as well as specific adaptations of these techniques to imaging ear canals, human dentition, and so forth.

Abstract: A medical device and method of delivery of the medical device within a patient's body are disclosed by the present invention. The medical device includes a first elongate member and a second elongate member. A first portion and a second portion of the second elongate member are configured to form a defined non-planar shape such that the first portion is a first arm of the defined non-planar shape and the second portion is a second arm of the defined non-planar shape.

Abstract: A hernia repair device is provided which may include a soft tissue repair prosthesis and an expandable device configured to be removably connected with the soft tissue repair prosthesis. When expanded, the expandable device may be configured to position the soft tissue repair prosthesis adjacent a hernia defect. The soft tissue repair prosthesis may include at least one loop or slit configured to receive a portion of the expandable device. The prosthesis may include a tether to hoist, locate or position the soft tissue repair prosthesis. The expandable device may include indicia for positioning the prosthesis relative to the edge of the hernia defect.

Abstract: Implantable prostheses for repairing soft tissue defects near an anatomical tube and methods for their manufacture are described. Exemplary prostheses may be implanted at a soft tissue repair site, for example, in treating an inguinal hernia. An implantable prosthesis may include a patch made up of two co-knit fabric layers, and a passageway for receiving an anatomical cord extending through the fabric layers. The passageway is configured through the first fabric layer so as to minimize the prospects of the cord-like structure contacting the portion of the second fabric layer defining the passageway therethrough. The passageway through the first fabric layer may include a barrier.

Abstract: A method for making a polymer with a porous layer from a solid piece of polymer is disclosed. In various embodiments, the method includes heating a surface of a solid piece of polymer to a processing temperature and holding the processing temperature while displacing a porogen layer through the surface of the polymer to create a matrix layer of the solid polymer body comprising the polymer and the porogen layer. In at least one embodiment, the method also includes removing at least a portion of the layer of porogen from the matrix layer to create a porous layer of the solid piece of polymer.

Abstract: An implantable lumen filter (200) is described. The implantable lumen filter includes a body (202) having a proximal end (202a), a distal end (202b), and a generally tapered outer surface (204). The outer surface is formed by a plurality of struts (206a, 206b). The plurality of struts forms a plurality of apertures (210). The apertures are dimensioned to inhibit and/or to lyse particulates of a selected size from passing through the apertures. The body (202) is transitionable from a collapsed state toward a deployed state. The implantable lumen filter includes an engaging portion (220) having a proximal end (220a) and a distal end (220b). The proximal end of the engaging portion is connected to a distal end of the body. The engaging portion has a generally annular shape and is configured to engage an inner surface of a body lumen.

Abstract: A graft is used to interconnect two vessels, such as an artery and a vein for hemodialysis. The graft includes a body having first and second ends, and a wall to define a passageway formed in the body. The wall includes a plurality of tubular layers, such as a first layer and one or more second layers disposed radially inward relative to the first layer. Each second layer has first and second ends that can be enclosable. The second layer is removable from the graft body from within the passageway of the graft body after clot formation. A grasper can be used to attach with at least one of the ends of the second layer. In response to withdrawal of the grasper, the corresponding end of the second layer gathers radially inward away from a layer adjacent to the second layer.

Abstract: In some embodiments, a ureteral stent includes an elongate member having a first portion and a second portion, which is coupled to the first portion. The first portion of the elongate member is configured to be disposed within a kidney of a patient. The second portion of the elongate member, which has a sidewall that defines a lumen, is configured to deliver fluid from a first location of the sidewall of the second portion to a second location of the sidewall of the second portion via capillary action. The second portion of the elongate member is configured to be disposed within at least one of a bladder and a ureter of the patient.

Abstract: The production of microstructured surfaces in magnesium alloys, containing zinc as the major alloying element, in particular in absorbable implants such as stents, wherein microstructures in sizes of up to 5 ?m (micrometers) are generated on a magnesium alloy base body of the absorbable implant, for example of the absorbable stent, by way of optionally combined, pickling and electrochemical micropolishing processes, and allow better adhesion of a polymer coating (including higher break resistance) and higher corrosion resistance. The microstructured surface is produced out of the bulk material and exhibits no delamination from the base material during the mechanical deformation of the implant.

Abstract: A method of assembling of a stent graft (20) including temporarily diameter reduction arrangements to enable partial release of a stent graft to assist with positioning before complete release. The diameter reduction arrangement includes a release wire (72) and flexible threads (74, 80) extending to struts (76) of a self expanding stent (70) either side of the release wire and being pulled tight. Removal of the release wire enables full expansion of the self expanding stent.

Abstract: A stent device includes a first graft member, a second graft member and a stent frame defining a central axis. The frame has an abluminal surface engaged with the first graft member and a luminal surface engaged with the second graft member such that the first graft member and the second graft member encapsulates the stent frame along the length of the central axis. The stent frame includes a configuration where the stent frame is disposed on a curvature such that the abluminal surface has a radius of curvature of approximately 20 millimeters about a center of the curvature and the luminal surface defines a substantially constant effective cross-sectional area at any portion generally transverse to the central axis of the stent frame disposed about the curvature.

Abstract: There is disclosed an apparatus and method of manufacture relating to a pre-sutured, high-strength allograft tendon construct. One embodiment of the allograft tendon construct includes first and second tendon lengths that are positioned longitudinally in parallel to one another. A whip stitched pattern secures the first and second tendon lengths at a free end, forming a stitched end portion that abuts an unstitched middle portion. The whip stitched pattern includes a plurality of sutures that originate adjacent to the free end and progress or advance inward toward the unstitched middle portion. A multiple knot bundle is applied immediately prior to a final suture, such that the final suture loops about the multiple knot bundle and locks the multiple knot bundle in place beneath the final suture. Other embodiments are also disclosed.

Abstract: A prosthetic capsular device configured to be inserted in an eye includes a housing structure and a ring structure. The housing structure includes a first side, a second side opposite the first side, a third side, a fourth side opposite the third side, a posterior side including a refractive surface, an anterior side opposite the posterior side, and a longitudinal axis. The first side, the second side, the third side, the fourth side, the posterior side, and the anterior side at least partially define a cavity configured to contain an intraocular device (e.g., an IOL). The anterior side includes an opening. The ring structure includes a ring structure portion extending radially outward from proximate one of an end of the first side and an end of the second side.

Abstract: A scleral prosthesis includes an elongated body configured to be implanted into scleral tissue of an eye. The elongated body includes opposing first and second ends. Multiple portions form the first end of the body and part of a remainder of the body between the first and second ends. The first and second ends are wider than the remainder of the body. The multiple portions of the body are separated by empty space such that the multiple portions meet at a point between the first and second ends of the body and are not connected to each other between that point and the first end of the body. The second end of the body is integral with the remainder of the body and not divided into multiple separated portions.

Abstract: An intraocular lens for insertion into the capsular bag of an eye contains an optic, an outer periphery, and an outer support structure. The optic has a periphery and centered about an optical axis. The outer periphery is disposed about the optic and configured to engage an equatorial region of the capsular bag of an eye. The outer support structure is disposed along the periphery and spaced from the optic with voids outer support structure and the optic. The intraocular lens further comprises a first intermediate member and a weakened region disposed along the outer periphery between the outer support structure and the first intermediate member. The first intermediate member operably couples the optic and the outer support structure. The weakened region is attached to, and configured to provide relative motion between, the outer support structure and the first intermediate member in response to the ciliary muscle of the eye.

Abstract: Various systems and techniques for inserting an intraocular lens are disclosed. In particular implementations, a system and a technique for inserting an intraocular lens may include the ability to move, in response to a force being applied in a first direction along a longitudinal axis, a first plunger tip along the longitudinal axis and into a delivery cartridge to fold an intraocular lens and move in a second direction along the longitudinal axis in response to the applied force being reduced. The system and the technique may also include the ability to engage a second plunger tip and move, in response to a force being applied in the first direction along the longitudinal axis, the second plunger tip along the longitudinal axis and into the delivery cartridge to insert the intraocular lens.

Abstract: The present invention provides a modular prosthetic valve device having two or more device modules for percutaneous delivery unassembled at or near the valve implantation site and assembly at least in part using a self-assembly member, and a system and method of folding, delivering and assembling the device. The device modules may include a support structure and a valve module. The valve module has an unassembled, folded delivery configuration, and an unfolded, assembled (via the self-assembly member) working configuration. The valve module may be a single-piece leaflets substructure or a plurality of valve sections. The self-assembly member has a delivery configuration and may be reverted to a preset configuration for valve module assembly. The unassembled valve module may be rolled along its circumferential axis towards its height to a folded diameter equivalent to one rolled leaflet, providing a percutaneous valve device having a smaller delivery diameter than pre-assembled valve devices.

Abstract: A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable frame, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the frame attached thereto. The frame may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes an integrated handle shaft and balloon catheter. A valve holder is stored with the heart valve and the handle shaft easily attaches thereto to improve valve preparation steps.

Abstract: A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

Abstract: Described embodiments are directed toward prosthetic valves having leaflets that move asymmetrically in that a leaflet second side region of the leaflet initially moves toward the open position before a leaflet first side region and the leaflet first side region initially moves toward the closed position before the leaflet second side region. In the fully open position, the leaflet first side region opens less than the leaflet second side region. Asymmetric opening and final open position, in synchrony with the other leaflets having the same motion and final open position creates spiral flow exiting the open valve that increases blood flow on the downstream side of the leaflet and thus reduces stagnation of the blood that might lead to thrombus formation. Controlled asymmetric movement of the leaflet reduces closing volume by initiating closure on the leaflet first side region and finishing closures on the leaflet second side region.

Abstract: A prosthetic heart valve configured to replace a native heart valve and for post-implant expansion and having a valve-type indicator thereon visible from outside the body post-implant. The indicator communicates information about the valve, such as the size or orifice diameter of the valve, and/or that the valve has the capacity for post-implant expansion. The indicator can be an alphanumeric symbol or other symbol or combination of symbols that represent information about the characteristics of the valve such as the valve size. The capacity for post-implant expansion facilitates a valve-in-valve procedure, where the valve-type indicator conveys information to the surgeon about whether the implanted valve is suitable for the procedure and informs the choice of the secondary valve.

Abstract: A method of implanting a collapsible prosthetic heart valve is disclosed. The prosthetic heart valve includes three biological leaflets mounted within a self-expanding tubular leaflet frame formed of nitinol. The method comprises loading a collapsed prosthetic heart valve into a distal end of a delivery tube. The distal end of the delivery tube is inserted into a vasculature of a patient and positioned proximal to an aortic valve. The prosthetic heart valve is expelled into an annulus of the aortic valve and expanded. The prosthetic heart valve includes cusp positioners that engage sinus cavities above the valve annulus and rotationally orient the prosthetic valve. Preferred embodiments of the cusp positioners do not occlude the coronary arteries.

Abstract: A replacement prosthetic heart valve for engagement with a structure of a previously implanted prosthetic heart valve. The replacement heart valve includes a stent structure including a generally tubular body portion with an interior area and a series of wire portions arranged in a mesh-like configuration, and at least one stent post engaging structure extending radially outwardly from the body portion for engaging with an outer surface of a stent post of the previously implanted prosthetic heart valve. The stent structure further includes at least two leaflets attached within the interior area of the tubular body portion of the stent structure.

Abstract: A delivery device for a stented heart valve that includes a handle, an inner catheter shaft extending from the handle and having an enlarged bumper element at a distal end, an outer catheter shaft extending from the handle and slidably coupled around the inner catheter shaft, and a retraction mechanism for controlling longitudinal movement of the outer catheter shaft relative to the inner catheter shaft. The outer catheter shaft includes a generally cylindrical housing at a distal end that is structured to receive the bumper element therein.

Abstract: A device for reshaping the tricuspid valve comprises a stent that is deployed in the right ventricular outflow tract (RVOT) adjacent to the tricuspid valve and expanded to a size sufficient to reduce the annular diameter or size of the tricuspid valve, thereby improving coaptation of the leaflets and reducing regurgitation. Embodiments of the device are deliverable percutaneously.

Abstract: Disclosed systems for implanting annuloplasty rings and other prosthetic devices can comprise a plurality of microanchors, sutures threaded through the microanchors, the sutures passing through the prosthetic device, individual microanchor guides, such as tubes or spears, for each microanchor that contain the microanchors during delivery and allow for positioning and deployment of the microanchors into annular tissue. The systems can also comprise a bracket that is temporarily coupled to the prosthetic device, holds the plurality of microanchor guides in position relative to one another and relative to the prosthetic device, and/or guides the sutures passing through the prosthetic device. The prosthetic device can include suture locking mechanisms to secure the prosthetic device to the sutures and to the implanted microanchors after the deployment devices have been removed.

Abstract: An implantable prosthesis for percutaneous placement within a vein that forces opposing portions of the vessel wall of a vein together to create a new valve of autologous vein tissue to be operable to alternate between a valve closed configuration and a valve open configuration. When in a preset closed configuration, the implantable prosthesis pushes or pulls portions of the vessel wall of the vein together to substantially close the vein lumen and prevent retrograde blood flow from backflowing through the new valve in the valve closed configuration. The implantable prosthesis has leg portions that may be pushed apart in response to antegrade blood flow through the vein to allow the new valve to achieve the valve open configuration.

Abstract: A subcutaneous prosthesis for a penis provides two sides of an elongated cylinder, the sides hinged along a top longitudinal edges of the sides. One end of the prosthesis has a gauze sheath providing a means to secure the prosthesis from moving relative to the corpora cavernosa around which it is placed. When the penis is erect it grows in girth thereby causing the two sides of the cylindrical prosthesis to spread divergently and forcing a press-rib against the deep dorsal vein of the penis, thereby restricting blood flow.

Abstract: Tissue fixation devices are provided. The devices include a first component and a second component, the components having different rates of in vivo degradation. The first component and second component are arranged so that, upon degradation of one of the components, the other component provides a scaffold into which bone can grow.

Abstract: Described herein are methods and compositions comprising a mixture of silk polymer and hydroxyapatite. The methods described herein can be used to prepare a mixture of silk polymer and hydroxyapatite and further provide mixtures that can be molded into a desired shape. Also encompassed herein are compositions comprising a mixture of silk polymer and hydroxyapatite having a desired shape, which can further be implanted, for example, to facilitate bone healing or tooth structure or support. Such compositions can also include agents, such as therapeutic agents, or cells.

Abstract: An implantable device includes at least one solid structure having an external surface and a volume beneath the surface. One or more of a first conductor or set of conductors is disposed externally and/or internally on or within the structure and an array of elongate electrically conductive elements are disposed radially outwardly within the volume. A breach is detected when a conductive fluid intrudes into the volume through the surface.

Abstract: A partial rim implant for an acetabulum in a pelvic bone comprises a ridge, a bearing surface, and a fixation surface. The ridge is oriented to replace a labrum. The bearing surface is configured to align with the articulating surface of the acetabulum. The bearing surface extends from the ridge toward the apex of the acetabulum. The fixation surface is configured to fix the implant to a prepared bone surface of the pelvic bone.

Abstract: A modular femoral prosthesis for use during performance of a hip revision procedure includes a proximal body component, a distal stem component, and a locking bolt. Surgical instruments and methods for use in implanting such a modular femoral prosthesis are disclosed.

Abstract: Methods for predetermining a contour of a resected bone surface and assessing a fit of a prosthesis on the resected bone surface, for designing prostheses to fit discrete patient populations, and for designing customized prostheses.

Abstract: A plug-on module for pushing onto a free end of a shaft formed for implantation in a long bone, comprising a holding body with an axial bore for the shaft at its lower end and a joint head as a part of a joint endoprosthesis, wherein the joint head is offset downwards in the axial direction from the upper end of the holding body sufficiently far and in such a way that the shaft protrudes upwards beyond the joint head. With such a quasi-offset arrangement the range of usage for the plug-in module is extended to cases in which previously a shorter through-going shaft would have been required and therefore a troublesome adjustment operation to exchange the through-going shaft would have to have been carried out.

Abstract: A modular humeral head resurfacing implant including a head, an anchoring stem, and a modular extended articulation flange. The head includes an exterior hemispherical articulating surface defining a terminating rim, an interior concave surface opposite to the exterior articulating surface, and a first coupling mechanism proximate to the terminating rim. The anchoring stem is coupled to the interior concave surface and extends along a stem axis that extends through an axial center of the head. The articulation flange includes a second coupling mechanism configured to cooperate with the first coupling mechanism to fasten the articulation flange to the head and an outer articulating surface that is curved along substantially its entire length and is substantially flush with the exterior hemispherical articulating surface when the articulation flange is fastened to the head.

Abstract: A toe bone implant for correction of toe bone deformities is provided. The toe bone implant includes a first portion having a socket portion. The toe bone implant also includes a second portion having a ball portion operatively connected to the socket portion. The toe bone implant is implanted in a joint such that the ball portion is configured to rotate a predetermined amount respective to the socket portion.

Abstract: Devices and methods are provided for immobilizing facet joints of the vertebral column. Embodiments of the invention provide an implant that is inserted in a facet joint from which cartilage has been removed, and which retains the approximate original spacing of the facets in the joint. A retaining arrangement, such as an adhesive, a threaded fastener, or a screw is then used to secure the implant in the joint.

Abstract: The present invention relates generally to medical devices and methods for use in spinal surgery. In particular, the disclosed devices relate to a spinal fixation system and an intervertebral spinal implant assembly sized and dimensioned for the lumbar spine implantable via an anterior or anterolateral approach. The devices include an implant, bone screws, and an improved locking mechanism to prevent the back out of screws.

Abstract: The present invention relates to an adjustable prosthetic limb socket system having a partial rigid support, a non-elastic, flexible support and adjustment means. The adjustable socket system of the present invention can be used for several types of amputations including transfemoral amputations, transtibial amputations, transhumeral amputations, transradial amputations, and other types of amputations. The present invention further includes kits having the adjustable prosthetic limb socket system, as well as methods of making the adjustable prosthetic limb socket system. Methods of using the socket system are further encompassed by the present invention.

Abstract: Implantable pressure-actuated systems to deliver a drug and/or other substance in response to a pressure difference between a system cavity and an exterior environment, and methods of fabrication and use. A pressure-rupturable membrane diaphragm may be tuned to rupture at a desired rupture threshold, rupture site, with a desired rupture pattern, and/or within a desired rupture time. Tuning may include material selection, thickness control, surface patterning, substrate support patterning. The cavity may be pressurized above or evacuated below the rupture threshold, and a diaphragm-protective layer may be provided to prevent premature rupture in an ambient environment and to dissipate within an implant environment. A drug delivery system may be implemented within a stent to release a substance upon a decrease in blood pressure. The cavity may include a thrombolytic drug to or other substance to treat a blood clot.

Abstract: An expandable stent for implanting in a body lumen, such as a coronary artery, peripheral artery, or other body lumen. In one aspect, the stent includes a butterfly pattern to which connecting links are attached. In another aspect, the stent embodies a non-directional structure.

Abstract: A system, method, computer-readable medium, apparatus, and device for simulating placement of an expandable device in a cavity is provided. For example, a three or more dimensional image of a cavity, e.g., a tubular cavity, geometry is acquired. A centerline of the cavity, and a perimeter of the cavity based on the centerline of the cavity and the three-dimensional image of the cavity geometry, are determined. The length of a wire of the expandable device as the wire rotates along the perimeter of the cavity in a deployment direction is determined. A pitch of the rotation of the wire based on a local diameter at the centerline site of rotation and in-air parameters of the expandable device is determined. A deployed device length of the expandable device along the centerline of the cavity is determined. A processor is usable to determine and/or calculate each of the above.

Abstract: A stent graft delivery system (50) has a stent graft (74) retained on it. The stent graft has an exposed proximally extending self expanding stent (76) which is retained in a distally opening capsule (78) at the distal end of a nose cone dilator (58) on the delivery system. A trigger wire (80) extends from a release mechanism (82) the distal end of the delivery system into a first aperture (84) in the capsule, around a proximal bend (86) of the exposed stent and out of the first aperture in the capsule and extending proximally into a second aperture (88). The trigger wire prevents premature release of the exposed stent.

Abstract: A balloon is inflated from a collapsed configuration, then deflated. A polymeric stem is then disposed over the deflated balloon and the stent crimped to the balloon.

Abstract: The present invention relates to a device for intermittently obstructing a bodily opening, such as a gastric opening, and includes a proximal member connected to a distal member by a tether. The proximal member includes an apron member surrounding a first occluding member, which is formable from an elongated and narrower configuration to a contracted or expanded but wider configuration. When employed in the stomach, the device of the present invention is arranged transluminally, with the distal member disposed in the duodenum and the proximal member disposed against the pyloric valve, intermittently occluding the pyloric valve and preventing or delaying the flow of gastric contents through the pyloric valve. In certain embodiments, a reservoir may be included for releasing a substance of interest, for example for releasing insulin from a reservoir disposed in the distal member. Sensors, actuators, and data transmission devices may also be included.

Abstract: An Ankle-Foot Orthosis, or AFO, has a vertical portion and a horizontal portion joined together. The horizontal portion is fixed to a shoe, which is selected by a user, by separating at least part of the sole such that the horizontal portion can be adhered near or between a midsole of the sole of a shoe. The horizontal portion provides the necessary structure needed to connect a shoe to the vertical portion of the AFO such that a user suffering with a weakness or deformity can walk with a more normal gait. In an alternate embodiment, the AFO is removable from a shoe such that it can be replaced onto the same or a different shoe.

Abstract: Toe cushioning device for protecting a patient's toes. A toe cushion device includes two tubular cushions positioned in a transverse plane on the plantar side of a patient's toes during use. The toe cushion relieves foot or toe pain and conforms to the changing contour of the patient's foot and toes during use.