Abstract: A method for manufacturing a dental restoration part according to patient-specific requirements is provided, which dental restoration part comprises a prosthesis base, wherein the prosthesis base carries at least one prefabricated artificial tooth, in particular a large number of prefabricated artificial teeth. It is also intended for the prosthesis base to have a surface on the side facing away from the prefabricated artificial teeth, i.e. on the side opposite thereof, and a three-dimensional layer of material to be applied to this surface of the prosthesis base using a three-dimensional additive method, by which the prosthesis base will be fabricated according to the patient-specific specifications.

Abstract: A facebow-free transfer method includes: registering virtual upper and lower casts respectively to an upper teeth part of a virtual maxilla model and a lower teeth part of a virtual mandible model so as to form a virtual teeth and jaw model; mounting the virtual teeth and jaw model on a virtual articulator; generating a virtual occlusion transfer module that is mounted on the virtual articulator and that has a part extending to and fitting in an in-between space of virtual upper and lower casts of the virtual teeth and jaw model; and creating an actual occlusion transfer device that is to be mounted on an articulator based on the virtual occlusion transfer module.

Abstract: Apparatus and methods are provided for treating urinary incontinence, fecal incontinence, and other pelvic defects or dysfunctions, in both males and females, using one or more lateral implants to reinforce the supportive tissue of the urethra. The implants can be configured as a sling device having at least one extension arm and a tissue support portion having an eyelet, wherein a portion of the at least one extension arm is adapted to slide through and adjustably attach with the eyelet.

Abstract: A surgical implant (20) comprises a flexible, areal basic structure (22) having a first face and a second face and being provided with pores (26) extending from the first face to the second face. A barrier layer (24) having a first face and a second face is placed, with its second face, at the first face of the basic structure (2) and attached to the basic structure (22). The barrier layer (24) is deformed into at least part of the pores (26) where it forms, in a respective pore (10), a barrier region (28).

Abstract: The present disclosure in one aspect provides a sterile packaging container comprising a container body with a cross-sectional shape that is constant along the majority of the longitudinal axis, a cover and a closure assembly that inhibits the passage of microbial contaminants. The container is configured such that the interior of the container can be sterilized. The sterile packaging container described herein allows one to manufacture a sterile packaging tube exercising the smallest possible volume.

Abstract: An absorbable vascular filter is disclosed for deployment within a vessel for temporary filtering of body fluids. An embodiment is configured for the placement of such absorbable vascular filter within the inferior vena cava (IVC) to filter emboli for the prevention of pulmonary embolism (PE) for a limited duration in time. Once protection from PE is complete, the filter is biodegraded according to a planned schedule determined by the absorption properties of the filter components. Hence the temporary absorbable vascular filter obviates the long term complications of permanent IVC filters such as increased deep vein thrombosis, neighboring organ puncture from filter fracture and embolization while also circumventing the removal requirement of metal retrievable IVC filters.

Abstract: A retrieval catheter operable by a single clinician that will neither displace a deployed stent nor cause undue trauma to the vascular lumen or lesion. The retrieval catheter may be sized to accommodate both a guidewire and a balloon wire. The retrieval catheter is easy to navigate through tortuous passageways and will cross a previously deployed stent or stent-graft easily with minimal risk of snagging on the deployed stent or stent graft. The sheath and dilator are adapted to allow a guidewire or balloon wire to pass through the walls of both and to allow the sheath and dilator to move axially with respect to each other.

Abstract: A method of implanting a device in a heart includes inserting an implant into a blood vessel with a delivery apparatus. The implant includes a stent member and an adjustment member. The stent member is circumferentially expandable and contractible. The adjustment member is coupled to the stent member. The delivery apparatus includes a rotatable shaft and a locking mechanism coupled to an end portion of the shaft. The shaft of the delivery apparatus is releasably coupled to the adjustment member of the implant by the locking mechanism of the delivery apparatus. The method further includes positioning the implant at an implantation location within a heart by manipulating the delivery apparatus, and rotating the shaft of the delivery apparatus relative to the stent member of the implant to actuate the adjustment member of the implant. Actuating the adjustment member results in circumferential expansion or contraction of the stent member.

Abstract: There is disclosed a collagen construct comprising a plurality of elongate strips, wherein each strip contains a plurality of collagen fibres that are substantially aligned along the length of the respective strips, and the strips are braided or woven together to produce a collagen construct in the form of a rope that can be used for replacing tendons or ligaments, such as cruciate ligaments. Also disclosed is a method for making or producing the collagen construct from a collagen membrane having a plurality of collagen fibres being substantially aligned parallel to each other in a common direction. The membrane is cut along cut lines that are orientated substantially parallel to that common direction, thereby to separate elongate strips from the membrane. The strips are then braided or woven together to form the collagen construct.

Abstract: A method for manufacturing a breast implant includes producing a silicone shell of the breast implant by rotating a mold containing a silicone material to evenly spread the silicone material over an inner surface of the mold. Subsequently, an elastic filler material including silicone foam is formed in the shell by (i) injecting into the mold a mixture comprising silicone gel and gas bubbles and (ii) rotating the mold to homogenize the mixture.

Abstract: The present ruptured prosthesis removal device provides a quick, safe, and effective means to remove ruptured implants RI and all foreign material, while eliminating silicone contamination of the patient tissue, the surgical instrument, and personal protective equipment of the surgical staff. The present medical device in one or more embodiments, can include a receptacle configured to be connected to a vacuum source, with an anti-clog member therein to enable continuous vacuum flow throughout the procedure and/or a lubricous coating to prevent the silicone gel from adhering to the device. The present device enables complete explantation of a ruptured implant in a minimal time period with increased efficacy.

Abstract: A breast implant is provided which includes a filling, or core having a lower overall density relative to silicone gel-filled or saline-filled implant. The core may be a composite including flexible bodies, for example, air-containing or gas-containing bodies, and a gel medium between or around the bodies.

Abstract: An intraocular lens insertion device which dramatically reduces the possibility that a plunger damages an intraocular lens, and which can safely and surely insert an intraocular lens into an eye is provided. An intraocular lens insertion unit comprises a lens disposing part for disposing an intraocular lens, a plunger for pushing out the intraocular lens disposed at the lens disposing part, a transition part for deforming the intraocular lens pushed out by the plunger, and a nozzle for ejecting the deformed intraocular lens. The plunger has a lens contact part for contacting the outer edge of the intraocular lens, and a protrusive part for pushing the lens contact part downward the intraocular lens by the deformation of the intraocular lens, both lens contact part and protrusive part are provided at the leading end of the plunger.

Abstract: An auditory prosthesis (1, 101) for middle-ear, in particular for reconstructing the ossicular chain, the auditory prosthesis (1, 101) comprising a portion (2) configured to contact the tympanic membrane, wherein said portion (2) comprises a substrate (4) provided with a coating (6) made of biocompatible silicone, wherein said coating (6) is integrally fixed to said substrate (4) and is adapted to contact, at least partially, the tympanic membrane.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; and a pair of paddles formed from the strip of material and connected to the coaption element. The paddles are movable between an open position and a closed position and the paddles are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material having first and second edges surrounding a central portion; a coaption element formed from the strip of material; and a pair of paddles formed from the strip of material and connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; a pair of paddles formed from the strip of material and connected to the coaption element; a cap attached to the paddles; and a pair of extension members connected to the cap and movable between an open position and a closed position. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaption element causes the pair of paddles to move to the open position. In the closed position the extension members are biased in a closing direction.

Abstract: The disclosure relates to a device for supporting functions of a heart valve and methods for making and using the same. The device includes a flow optimizer configured to be located in the valve and having a cross sectional area that reduces a regurgitation orifice of the valve during systole. The device includes an anchoring mechanism coupled to the flow optimizer and configured to fix a position of the flow optimizer relative to the valve. The flow optimizer allows hemodynamic flow during diastole, minimizing risk of inducing atrioventricular pressure gradient and thrombogenesis, and seals or minimizes the regurgitation orifice during systole and reinstates efficacy of the valve. The anchoring system requires no traumatic interaction with the valve, atrium and ventricle. Implantation of the device can be achieved without invasive surgery. The device permits intra-procedural optimization of the positioning of the flow optimizer.

Abstract: A prosthetic spacer assembly includes a spacer body, a first anchor, and a second anchor. The first anchor and the second anchor are each connected to the spacer body. The first anchor is configured to capture a first native valve leaflet between the first anchor and the spacer body. The second anchor is configured to capture a second native valve leaflet between the second anchor and the spacer body.

Abstract: Prosthetic valved conduits are provided that include a leaflet construct coupled between two portions of a conduit. Each leaflet has a free edge and a leaflet attachment edge. The leaflet attachment edge is disposed between a first conduit distal end and a second conduit proximal end that are coaxial therebetween defining a junction.

Abstract: A holder for a hybrid heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The hybrid heart valve includes a non-expandable, non-compressible prosthetic valve and a self-expandable anchoring stent, thereby enabling attachment to the annulus without sutures. A first suture connects the holder to the valve and constricts an inflow end of the anchoring stent. A second suture connects the holder to the valve and extends down three holder legs to loop through fabric on the valve. Both sutures may loop over a single cutting well on the holder so that severing the first and second sutures at the single cutting well simultaneously releases the tension in the first suture, permitting the inflow end of the anchoring stent to expand, and disconnects the valve holder from the prosthetic heart valve.

Abstract: A prosthetic heart valve may include a stent, a valve assembly, a flange, and a plurality of coupling tubes. The stent may have a collapsed condition, an expanded condition, and a plurality of cells arranged in circumferential rows, the stent having a longitudinal axis, an inflow end and an outflow end. The valve assembly may be disposed within the stent. The flange may comprise a plurality of braided wires and may have a flared portion. The plurality of coupling tubes may couple the flange to the stent so that the flared portion is adjacent the inflow end of the stent. Each of the coupling tubes may have a first end receiving corresponding ones of the braided wires and a second end coupled to a corresponding portion of the stent.

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stented valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

Abstract: Systems and apparatuses herein include a longitudinal member having opposite first and second end portions, a tension of the longitudinal member being adjustable to repair an atrioventricular valve of the patient. A delivery tool can be configured to couple the first end portion of the longitudinal member to a first portion of heart tissue, couple the second end portion of the longitudinal member to the leaflet, adjust tension of the longitudinal member, assume a first diameter at a portion of the delivery tool that passes between the leaflets of the atrioventricular valve, during coupling of the first end portion of the longitudinal member to the first portion of heart tissue, and assume a second diameter that is smaller than the first diameter, at the portion of the delivery tool that passes between the leaflets of the atrioventricular valve, during adjusting of the tension of the longitudinal member.

Abstract: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support structure and an expandable prosthetic valve are advanced through the aortic arch of a patient using a delivery system. The support structure is delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior). The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

Abstract: An apparatus for partially supporting a leaflet of a regurgitant heart valve comprises at least one subvalvular device including a subvalvular supporting portion including a leaflet-contacting upper supporter surface longitudinally spaced from an oppositely facing lower supporter surface. A supporter perimeter wall extends longitudinally between the upper and lower supporter surfaces, with at least a portion contacting a subvalvular cardiac wall adjacent to the heart valve. An anchor portion is adjacent to, and longitudinally spaced from, the upper supporter surface. The anchor portion includes a leaflet-contacting lower anchor surface longitudinally spaced from an oppositely facing upper anchor surface. A connector neck is interposed longitudinally between, and is directly attached to both of, the upper supporter surface and the lower anchor surface. The connector neck penetrates longitudinally through at least one of a base of the leaflet and an annulus of the heart valve at a manufactured puncture site.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element having four layers; and a pair of paddles connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; a collar connected to the coaption element; and a pair of paddles formed from the strip of material and connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a collar; a coaption element attached to the collar; and a pair of paddles are connected to the coaption element. The collar has a plurality of engagement portions configured to releasably engage a delivery apparatus. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. The paddles are circumferentially disposed between the engagement portions.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element; a pair of paddles connected to the coaption element; a catch point formed by a portion of at least one of the coaption element and the pair of paddles when the paddles are in the open position; and a cover covering connected to the coaption element and the paddles for covering the catch point. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element; a pair of paddles connected to the coaption element; a first cover extending from a distal end of the device and covering at least a portion of the paddles; and a second cover extending from a proximal end of the device and covering at least a portion of the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element formed from a strip of material; a pair of extension members; a pair of paddles formed from the strip of material and connected to the coaption element; and a cap attached to the paddles. The paddles are movable between an open position and a closed position, are disposed over the extension member, and are configured to attach to the native valve of the patient. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The cap has a retention body for receiving attachment portions of the extension members, a retaining nut, and a retaining bolt for securing the retaining nut.

Abstract: A method of manufacturing a valve repair device for repairing a native valve of a patient includes: folding a strip of material formed from shape-memory alloy around a jig to form a coaption element and a pair of paddles connected to the coaption element, wherein the paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient; and heat treating the strip of material to shape-set the strip of material in the shape of the coaption element and paddles.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; a pair of paddles formed from the strip of material and connected to the coaption element; a cap attached to the paddles; and a pair of extension members connected to the cap and the paddles via attachment portions. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The extension members extend to end portions attached to the strip material. The end portions extend beyond the strip of material.

Abstract: Apparatus and methods are described herein for positioning an epicardial anchor device and measuring the load of a tether extending from a prosthetic heart valve and coupled to the epicardial anchor device. In some embodiments, an apparatus includes a handle assembly coupled to an elongate member and a docking member coupled to a distal end of the elongate member. The docking member can be releasably coupled to an epicardial anchor device configured to secure a tether extending from a prosthetic heart valve implanted with a heart at a location on an exterior of a ventricular wall of the heart. A force sensor device is coupled to the handle assembly and can measure a force exerted on the force sensor device. The force is associated with a tension of the tether extending through the elongate member and handle assembly.

Abstract: A bone graft implant and methods of using the same are provided herein.

Abstract: A method for manufacturing a medical component (11) insertable, at least in segments, into a body of an object, in particular of a living being, comprising a channel structure (12) including at least one, in particular tubular, channel (13), through which a medium and/or at least one functional element can be passed, wherein the medical component (1) is manufactured, at least in segments, in particular completely, with the aid of an additive manufacturing method via successive, layer-by-layer, selective exposure and associated successive, layer-by-layer, selective solidification of construction material layers made of a construction material (3) solidifiable with the aid of an energy beam (4).

Abstract: An interbody spacer for the spine is provided. The interbody spacer includes a cage and bone screws configured to anchor the cage between two vertebrae of the spine. The cage includes a screw plate configured to mate with the cage in a front-loading fashion. The screw plate is interchangeable with another screw plate configured to receive a different number of bone screws. For example, one screw plate adapted for three bone screws is interchangeable with another screw plate adapted for four bone screws and removably connected to the same cage. The screw plate is connectable intraoperatively or pre-assembled. Each screw plate is also provided with an anti-backout mechanism to retain the bone screws and prevent the bone screws from backing out with respect to the screw plate. The anti-backout mechanism includes a cover plate, locking screw or retaining ring.

Abstract: A medical implant has a hierarchical surface roughness and includes an implant body, which includes a combination of meso-scale surface features, micro-scale surface features, and nano-scale surface features.

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

Abstract: A tibial prosthesis, and, particularly, a fixed bearing tibial prosthesis has a two-pronged securement mechanism. The securement mechanism may or may not be angled. Advantageously, the securement mechanism, working alone or in cooperation with other securement features, minimizes micromotion between the tibial tray and tibial bearing component.

Abstract: A system and method for sharing and absorbing energy between body parts. In one particular aspect, the system facilitates absorbing energy between members forming a joint such as between articulating bones.

Abstract: A Charcot trabecular system and method is provided. The Charcot trabecular system embodies a threaded bolt-like fastener, wherein a middle portion of the shank of the systemic fastener is made of a porous material, while the remaining portions of the systemic fastener denser provides a denser material. The porous shank portion may be made of material dimensioned and adapted to pass blood and particulate bone matter therethrough. As a result, in use when connecting bones together, the denser material provides for stabilization and structural support to the associated damaged joint, while the porous shank facilitates optimal bone healing via boney ingrowth and bone ongrowth through and around the implanted systemic fastener.

Abstract: The present disclosure includes devices, apparatuses, kits, and methods for replacing a nucleus pulposus of an intervertebral disc with an implantable nuclear prosthesis filled with a curable silicone material in situ. Configurations of the present spinal implant devices include a flexible body defining an outer fillable enclosure that defines an outer chamber, an inner fillable enclosure that defines an inner chamber, and a proximal plug configured to be coupled to the inner fillable enclosure.

Abstract: An expandable, adjustable inter-body fusion device is presented. The inter-body fusion device can have a first plate, a second plate, and an insert positioned substantially there between the first plate and the second plate. The first plate, the second plate, and the insert define an interior cavity. Moving the insert longitudinally with respect to the first and second plates increases or decreases the distance of the first plate with respect to the second plate, effectively expanding the inter-body fusion device and increasing the volume of the interior cavity. The angle between the first plate and the second plate is selectively adjustable.

Abstract: An intervertebral implant for implantation in an intervertebral space between vertebrae. The implant includes a body extending from an upper surface to a lower surface. The body has a front end, a rear end and a pair of spaced apart first and second side walls extending between the front and rear walls such that an interior chamber is defined within the front and rear ends and the first and second walls. The body defines an outer perimeter and an inner perimeter extending about the internal chamber. At least one of the side walls is defined by a support structure and an integral porous structure, the porous structure extending from the outer perimeter to the inner perimeter. The porous structure embeds or encapsulates at least a portion of the support structure.

Abstract: Anchoring devices, anchoring systems for intervertebral implants, intervertebral implants, and instruments and methods for implanting implants are disclosed. In preferred configurations, these various objects share the feature of comprising or cooperating with an anchoring device having a body comprising at least one curved plate elongated along a longitudinal axis, designed to be inserted through a passage crossing at least a part of implant, in order to penetrate into at least one vertebral endplate and attach implant onto this vertebral endplate by means of at least one stop retaining the implant, characterized in that the body comprises at least one longitudinal rib on at least a part of at least one of its faces, said rib being designed to cooperate with a groove made in passage of implant. In some preferred configurations, anchoring device comprises withdrawal stops or latches, and/or means for withdrawing the anchor from an inserted position.

Abstract: The present invention provides a support element for implantation into or between a subject's bones, characterized in that: the support element is a hollow nestable structure having expandable elasticity, and can be in a contracted configuration or a distended configuration. The present invention also provides an implant component, comprising: the support element; and a limiting member to prevent the support element from expanding and thereby keep the support element in the contracted configuration. The present invention also provides an implant system applicable to a subject's spine, the implant system comprising: the support element as a first support element; and optionally one or a plurality of the support elements in the hollow nestable structure of the first support element. The support element can be nested until the support provided by the entire implant system reaches the desired level.

Abstract: Disclosed herein are insertion and extraction instruments for orthopaedic procedures that are used for inserting and extracting trials and implants. The instruments include a body extending along a central axis having first and second arms extending from the body along first and second axes. The first and second arms may be moveable with the distal ends of the arms being configured to engage first and second engagement feature of a trial or an implant. The first and second axes define an angle therebetween such that when the distal end of the first arm is received in a first engagement feature of the implant and the distal end of the second arm is in the second engagement feature, the distal ends of the arms are urged against respective first and second side walls of the first and second arms to secure the instrument to the trial or implant.

Abstract: Disclosed herein are systems and methods for bone preparation with designed areas having accurate tolerance profiles to enable improved initial fixation and stability for cementless implants and to improve long-term bone ingrowth/ongrowth to an implant. One method includes preparing a bone surface to receive a prosthetic implant thereon by resecting the bone surface using a first cutting path to create a first resected region and resecting the bone of the patient using a second cutting path to create a second resected region at least partially overlapping the first resection region. The second cutting path is different than the first cutting path and either manual or robotic cutting tools can be used for creating the first and second resected regions.