Abstract: A variable stiffness rod is provided for use in spine stabilization systems. The variable stiffness rod system includes an outer member having a cannulation that retains a flexible tensioning inner member that can be used to adjust the stiffness of the rod via an adjustable end cap assembly that couples the inner member to the outer member at least at one end of the fixation rod.

Abstract: An osseous anchoring implant, various embodiments of which comprise an osseous anchor and a head bearing fixation structure capable of receiving and fixing at least one bar, the head of the implant being traversed by at least one duct, which receives the bar through a lateral aperture, and by a threaded channel, whose axis is not parallel to the axis of the duct, which receives a fixation screw of the bar, the implant being characterized in that it comprises fixation structure of the head on the part of the implant which extends from the osseous anchor, these fixation structures allowing, prior to blocking and fixing, at least a determined mobility of the head around at least one axis not parallel to the axis of symmetry of the osseous anchor. The fixation screw of the bar may comprise a ball and socket at its base.

Abstract: This invention relates to a orthopedic implant that comprises a shape memory polymeric material. The orthopedic implant can be fabricated or molded in a desired configuration selected to provide support or tension to bony structures. Examples of implantable devices include spinal rods, bone plates, and bone fixation cords. The orthopedic implant can be deformed to a second configuration different from the first configuration either prior to implantation or after implantation. When desired, the shape memory polymeric material can be induced to revert to it original molded configuration. This can compress the attached bony structure and/or promote arthrodesis.

Abstract: A tulip head apparatus includes a chuck housing configured to join to a head of a screw. The chuck housing comprises an upward slot extending from a bottom for enabling the chuck housing to expand to enable entry of the head and to contract to retain the head. A plurality of downward slots extends from a top for enabling a portion of the chuck housing to contract and expand. A plurality of hook structures are disposed about the top. A rotating head includes a hollow portion having a circular groove and to accept the chuck housing in which a contraction of the portion enables entry of the chuck housing and expansion of the portion engages the hook structures with the groove to secure the chuck housing within the rotating head and enable the rotating head to rotate about the chuck housing.

Abstract: In accordance with embodiments of the present invention, a rod extension for extending a fusion construct is provided. The rod extension allows a surgeon to connect a stabilization rod implant to at least a portion of a patient's spine, and also to connect the stabilization rod implant to an existing implant that has been previously installed in the patient. The existing fusion implant typically includes at least one existing pedicle screw, at least one existing rod, and at least one existing connector interconnecting the existing pedicle screw to the existing rod. The extension implant comprises a rod, an offset beam connected to the rod, and a clamp interconnected to the offset beam, wherein the clamp can be secured to the existing rod, thereby extending the fusion construct. A method of use is also provided.

Abstract: A method for osteosynthesis of a spinal column using an assembly including a bone anchor, a connector and a ring, the method comprising: inserting an anchoring part of the bone anchor into bone, the bone anchor including the anchoring part and a head, the head positioned to be in contact with the connector and ring; inserting a connecting member into the connector; and applying a force to the connecting member such that the connecting member applies the force against the ring and the bone anchor, wherein the head of the bone anchor contacts the connector, ring and connecting member during the application of the force.

Abstract: The disclosed screw assemblies include a screw that attaches onto the bone, a housing member that connects and inter-locks the bone screw to the rod, and one or more locking members that permit immobilization of various components of the assembly relative to one another while still permitting some relative movement. The bone screws and bone screw assemblies described herein permit flexible stabilization of the spine.

Abstract: A posterior vertebral plating system comprising a plate and a plurality of attachment members. The plate has a plurality of holes extending through the plate from an upper surface to a lower surface, and the plate is configured to extend along the posterior side of at least two vertebrae adjacent at least one boney structure of each of the vertebrae. The holes are spaced in such a way that a first plurality of holes is positionable over a boney structure of a first vertebra to define a plurality of fixation points to the first vertebra and a second plurality of holes is positionable over boney structure of a second vertebra to define a plurality of fixation points to the second vertebra. The attachment members are insertable through the holes of the plate and into the boney structure of a corresponding vertebra to fix the plate to the vertebra.

Abstract: A bone plate has an underside on the side of the bone, an upper side and a plurality of holes in the plate connecting the underside with the upper side, with a central hole axis. At least one of these holes in the plate has an internal jacket surface that tapers towards the underside, while the internal jacket surface has N?3 recesses which extend radially away from the axis of the hole.

Abstract: A retainer member formed of bone secures tissue relative to a bone. The retainer member forms an opening in a compact outer layer of the bone. The retainer member is enclosed in a tubular member or sleeve to prevent breaking of the retainer member during formation of the opening in the bone. The extent of movement of the retainer member into the hone in the patient's body is determined as the retainer member is moved into the bone. A suture may be connected with the retainer member and used to connect tissue with the bone. The retainer member may be positioned across a fracture in a bone to hold portions of the hone relative to each other. The retainer member may be used at a joint between end portions of bones to immobilize the joint and be released by breaking the retainer member.

Abstract: A bone screw assembly includes a screw body, including anchor portion and rod-receiving portion, and a rod seat movably mounted in the screw body to allow for controlled angulation between a spinal connection element disposed in the rod seat and the screw body. The rod seat is pivotable in one or more selected directions about one or more axes relative to the screw body. The rod seat may include a first lower rod seat element disposed in a recess of the screw body having a cylindrical bottom surface to facilitate pivoting in a first direction. A second lower rod seat element is stacked on the first lower rod seat element and has a conical bottom surface abutting a top surface of the first lower rod seat element to facilitate pivoting in a second direction.

Abstract: The disclosed screw assemblies include a screw that attaches onto the bone, a housing member that connects and inter-locks the bone screw to the rod, and one or more looking members that permit immobilization of various components of the assembly relative to one another while still permitting some relative movement. The bone screws and bone screw assemblies described herein permit flexible stabilization of the spine.

Abstract: A bone anchoring element includes a shaft for anchoring in a bone, the shaft having a tubular body. The shaft comprises a plurality of barb elements, wherein each barb element is formed as continuous one-piece part with the tubular body. Each barb element is moveable between a first position adjacent to the tubular body and a second position further from the tubular body than the first position. The barb elements are arranged along at least one helical line around an axis of the shaft.

Abstract: Red light implants for delivering red light to spinal implants to enhance osteointegration.

Abstract: The present invention provides methods of using electromagnetic radiation in the visible portion of the spectrum to modulate mitochondrial function in the treatment of various conditions, including Alzheimer's disease, other dementias, hypoxia and diabetic peripheral neuropathy, and sensory disorders of the extremities.

Abstract: An output assembly is sized for placement in the middle and inner ear, such that removal of bone can be decreased. The output assembly may comprise at least one photo detector, a demultiplexer and an optical array sized to pass through an incision in the eardrum. An input transducer assembly is configured to transmit a multiplexed optical signal to the output assembly. The input assembly can be configured to transmit the multiplexed optical signal through the eardrum, such that tissue removal can be decreased and the device can be placed without removal of bone, for example. The multiplexed optical signal may comprise a pulse width modulated signal so as to decrease the effect of non-linearities of the light source and light detector and provide quality sound to the user.

Abstract: A medical treatment apparatus applies heat to the skin so that the skin may be gradually collapsed without incision and thereby a tumor mass beneath the skin may be exposed to the outside and allowed to be removed. This apparatus includes a cup-like container, oil, and a wick. The container is placed on the first part of the skin that covers a target tumor, and has a vertically penetrated cylindrical shape. The oil is contained in the container and is in contact with the first part of the skin. The wick is placed in the oil so as to catch flame. The temperature of the oil gradually rises while the flame lives on the wick, so heat is continuously applied to the first part of the skin from the oil. This apparatus may further include at least one of a cooling unit and a cooling water pipe placed at an outside of the container, enclosing the container, being in contact with the second part of the skin that is located at the outside of the container, and cooling the second part of the skin.

Abstract: Devices and methods for cooling vessel walls to inhibit restenosis in conjunction with medical procedures such as coronary artery angioplasty. One catheter device includes a distal tube region having coolant delivery holes radially and longitudinally distributed along the distal region. In some devices, holes spray coolant directly onto the vessel walls. In other embodiments, a balloon or envelope is interposed between the coolant and the vessel walls and the coolant returned out of the catheter through a coolant return lumen. Some direct spray devices include an occlusion device to restrict blood flow past the region being cooled. Pressure, temperature, and ultrasonic probes are included in some cooling catheters. Some cooling catheters are coiled perfusion catheters supporting longer cooling periods by allowing perfusing blood flow simultaneously with vessel wall cooling.

Abstract: A stent graft introducer has a pusher, a nose cone, a region between the pusher and the nose cone for a stent graft, a sleeve extending over the pusher and proximally to the nose cone to cover the stent graft when retained in the region. An indwelling auxiliary catheter with a pre-curved proximal end is fitted into the introducer. The nose cone has an elongate groove and the auxiliary catheter has its proximal end in the elongate groove. In a partially retracted position of the sleeve the curved proximal end of the indwelling auxiliary catheter is exposed and uncovered by the sleeve and in an advanced position of the sleeve the curved proximal end of the indwelling auxiliary catheter is straightened, extends along the length of the groove in the nose cone and is covered by the sleeve.

Abstract: A device includes an expandable implant and a hollow stent internally defining a central passage. The hollow stent defines a retention opening of the implant near the distal end thereof. The inventive device also includes a wire-type link for releasably fixing the implant to the stent, which has a traction section introduced into the opening and extending inside the central passage. For the wire-type link, the device includes an internal insulation channel arranged in the central passage and axially fixed with respect to the stent. The insulation channel receives only one wire-type link and defines a channel which is devoid of a link at least between the proximal end of the stent and the retention opening and is placed in the central channel.

Abstract: An introducer for use in the implantation and retrieval of a device in a patient includes a catheter (43) within which a stylet (14) is slidably carried, the stylet (14) being biased to a retracted position by a spring (35) and deployable by depression of an actuator (50). A locking device (40) locks the stylet (14) relative to the catheter (43) such that the locking device (40) must be disengaged prior to operation of the actuator (50). In the preferred embodiment, both the locking device (40) and the actuator (50) must be actuated by movement thereof in a direction substantially perpendicular to the direction of motion of the stylet (14). In an alternative embodiment, it is the catheter (43) which moves relative to the stylet (14).

Abstract: Several embodiments are set forth of devices, systems and methods for modifying an atrial appendage such as a left atrial appendage (LAA). In one embodiment, a device includes a body that is collapsible and self-expanding. The body includes a textured surface with protruding portions and recessed portions. The body may be formed of a reticulated foam material and may exhibit a substantially spherical geometry or a truncated spherical geometry. The body may be substantially hollow. In one embodiment, portions of the textured surface may be metalized or have a coating placed thereon to enhance frictional engagement of the body with the atrial appendage wall. In another embodiment, a mesh bag is disposed within an LAA and one or more self-expanding bodies are disposed within the mesh bag. The mesh bag is then secured to retain the self-expanding bodies within the bag and the LAA.

Abstract: A deployment sheath for medical devices is provided that includes one or more pleats in its pre-deployment state that are allowed to open during deployment so as to facilitate easier device deployment and sheath removal. Preferably, the sheath is removed by everting it over itself during the delivery process. By orienting the pleats along the length of the sheath, preferably helically around the sheath, the sheath undergoes a predictable enlargement during deployment so as to relieve friction of the everted sheath sliding along itself during deployment. This allows the sheath to be removed with less tension than previous everting sheath constructions and assures more accurate device placement in a patient.

Abstract: Metal foils, wires, and seamless tubes with increased mechanical strength are provided. As opposed to wrought materials that are made of a single metal or alloy, these materials are made of two or more layers forming a laminate structure. Laminate structures are known to increase mechanical strength of sheet materials such as wood and paper products and are used in the area of thin films to increase film hardness, as well as toughness. Laminate metal foils have not been used or developed because the standard metal forming technologies, such as rolling and extrusion, for example, do not lend themselves to the production of laminate structures. Vacuum deposition technologies can be developed to yield laminate metal structures with improved mechanical properties. In addition, laminate structures can be designed to provide special qualities by including layers that have special properties such as superelasticity, shape memory, radio-opacity, corrosion resistance etc.

Abstract: An endovascular prosthesis of the present invention includes an expandable stent and a means for sealably attaching a tubular graft to the stent within the stent's lumen. The means of sealably attaching a graft includes membranes, foams, polymeric materials and combinations thereof. Additionally, the present invention includes methods of forming an endovascular prosthesis and methods of implanting an endovascular prosthesis within a vessel to provide sealable securement of a tubular graft within the stent's lumen.

Abstract: A total aortic arch reconstruction graft, including a first, hollow cylindrical segment in the shape of an aortic arch, a second, hollow cylindrical segment having a first end joined to the second end of the first segment, and a second end adapted to be inserted into the descending aorta of a patient, the second segment having an expandable outer wall covered with an expandable stent, and a collar having a diameter larger than the diameter of said first segment, the collar located at a juncture where the first end of the second segment is joined to the second end of the first segment, with a plurality of separate, non-absorbable double-armed sutures pre-attached to the collar. A surgical procedure for total replacement of a patient's aortic arch is also disclosed.

Abstract: The present invention provides a multilayer-coated stent for controlled drug release, comprising: a first base layer formed on a stent support and made of poly(ethylene-co-vinylacetate) or polystyrene-ethylene-butylene rubber polymer; a second coating layer formed on the first base layer and made of a biocompatible or a bioabsorbable polymer and a drug component; and a third coating layer formed on the second coating layer and made of a biocompatible or a bioabsorbable polymer and a drug component different from the drug component of the second coating layer. The inventive stent can deliver a broad range of therapeutic substances for a long time and prevent the early rapid release of the drug components in blood. Also, unlike the existing drug-coated stents, the inventive stent includes two kinds of drugs complementary to each other, but can optimize the efficacy of the drugs by differentiating the control of drug release according to time.

Abstract: Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle.

Abstract: A prosthesis for implantation at a native semilunar valve includes a prosthetic distal valve, which includes a pliant material configured to collapse inwardly towards a longitudinal axis of the prosthesis during diastole, and to open outwardly during systole, and a distal fixation member configured to be positioned in a downstream artery of the subject. The apparatus also includes a proximal fixation member coupled to the distal fixation member, and configured to be positioned at least partially on a ventricular side of the native semilunar valve. The proximal fixation member is shaped so as to define a lattice that is shaped so as to define an intermediary portion that is coupled to the pliant material of the valve and diverges outwardly from the longitudinal axis, and a distal portion that is distal to the intermediary portion and diverges outwardly from the intermediary portion of the lattice. Other embodiments are also described.

Abstract: Extracellular matrix (ECM) material conduits are disclosed. Methods for regenerating atrioventricular valves to replace defective atrioventricular valves within a heart of a subject using the ECM material conduits are also disclosed. Methods of sterilizing and decellularizing an ECM material are also disclosed.

Abstract: A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient's native valve annulus. Methods of making and using prosthetic heart valves are also disclosed.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, a plurality of commissure features disposed on the stent, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features. Each commissure feature includes a body having a proximal end a distal end, and a plurality of eyelets arranged in at least two rows and at least two columns for attaching the body to the plurality of leaflets.

Abstract: A heart valve prosthesis has a supported valve including a biological valve portion mounted within a support structure. The supported valve has inflow and outflow ends spaced axially apart from each other. A fixation support member includes an inflow portion that extends from a radially inner contact surface of the fixation support member radially outwardly and axially in a direction of the inflow end of the supported valve. An outflow portion of the fixation support member extends from the radially inner contact surface radially outwardly and axially in a direction away from the inflow portion of the fixation support member. The radially inner contact surface is attached to a radially outer surface of the supported valve adjacent the inflow end of the supported valve.

Abstract: Systems, devices and methods for securing tissue including the annulus of a mitral valve. The systems, devices and methods may employ catheter based techniques and devices to plicate tissue and perform an annuloplasty.

Abstract: Pathology of the human knee can arise from excessive and/or uneven loading of regions within the joint. Methods and apparatus are disclosed that enable displacement of soft tissue around the knee, without displacing or severing bone thereby altering the mechanical load distribution within the joint in a less invasive manner than previous techniques.

Abstract: A tendon anchoring device may include an implant having a pair of spaced apart legs for straddling a tendon. A push rod removably attached to the implant may be utilized to guide and push a portion of the tendon into a pre-drilled bore in a bone. A fixation member may be slid along the push rod and threadably engage an inner surface of the pre-drilled bore to thereby anchor the tendon to the bone while a force is applied to the push rod. Once the fixation member has been installed, the push rod may be disengaged from the implant and removed from the bore. The implant may remain permanently straddled over the tendon inside of the bore.

Abstract: A dilator that facilitates implantation of an interspinous spacer is provided. The dilator includes a proximal portion and a tapered distal portion interconnected by an elongated body portion. The tapered distal portion is ideally suited for splitting ligamentous tissue for creating a posterior midline pathway through the supraspinous ligament as well as for distracting the adjacent spinous processes. Two oppositely located and longitudinally extending channels or grooves are formed in the outer surface of the dilator for stabilizing the dilator with respect to the spinous processes. An accompanying cannula together with the dilator form a system for the distraction of the adjacent spinous processes, stabilization of the spinous processes with respect to the system and creation of a working channel for the implantation of an interspinous spacer.

Abstract: An intervertebral body fusion implant device configured for being engaged between two adjacent vertebrae comprises an implant device body having an upper bone engaging portion and a lower bone engaging portion, a plurality of protrusions extending from each one of the upper and lower bone engaging portions, and a guide rail extending from each one of the bone engaging portions. A passage extends between the upper bone engaging portion and the lower bone engaging portion. The guide rail of each one of the bone engaging portions extends beyond a tip portion of each one of the protrusions thereof. Each one of the guide rails extends substantially parallel with each other one of the guide rails.

Abstract: Placement apparatus and methods of use for impanation of spacers within an inter-vertebral disc space. In one embodiment, the load-bearing superstructure of the implant is subdivided and the bone forming material is positioned within an internal space of the placement instrument but external to the load bearing elements themselves. At least a portion of the bone graft material is freely contained within the disc space. A method of using the device is also described. In one embodiment, the placement device is used to place the implantable spacers at opposing ends of the disc space using a directly lateral surgical approach.

Abstract: A prosthetic disc for insertion between adjacent vertebrae includes a core having upper and lower curved surfaces, upper and lower plates, and peripheral restraining structure on at least one of the upper plate, the lower plate and the core. Each plate has an outer surface which engages a vertebra and an inner curved surface which slides over the curved surface of the core. The peripheral restraining structure serves to hold the core against a curved surface of at least one of the plates during sliding movement of the plates over the core.

Abstract: A prosthetic intervertebral disc is formed of first and second end plates sized and shaped to fit within an intervertebral space and to be implanted from the back of the patient, thereby decreasing the invasiveness of the procedure. The posterior approach provides for a smaller posterior surgical incision and avoids important blood vessels located anterior to the spine particularly for lumbar disc replacements. The first and second plates are each formed of first, second and third parts are arranged in a first configuration in which the parts are axially aligned to form a low profile device appropriate for insertion through the small opening available in the TLIF or PLIF approaches described above. The three parts of both of the plates rotate and translate with respect to one another in situ to a second configuration or a deployed configuration in which the parts are axially unaligned with each other to provide a maximum coverage of the vertebral end plates for a minimum of insertion profile.

Abstract: The present invention provides an expandable fusion device capable of being installed inside an intervertebral disc space to maintain normal disc spacing and restore spinal stability, thereby facilitating an intervertebral fusion. In one embodiment, the fusion device includes a central ramp, a first endplate, and a second endplate, the central ramp capable of being moved in a first direction to move the first and second endplates outwardly and into an expanded configuration. The fusion device is capable of being deployed down an endoscopic tube.

Abstract: The present invention provides an expandable fusion device capable of being installed inside an intervertebral disc space to maintain normal disc spacing and restore spinal stability, thereby facilitating an intervertebral fusion. In one embodiment, the fusion device includes a central ramp, a first endplate, and a second endplate, the central ramp capable of being moved in a first direction to move the first and second endplates outwardly and into an expanded configuration. The fusion device is capable of being deployed down an endoscopic tube.

Abstract: An intervertebral fusion device comprising inferior and superior fusion cage devices that provide an ability to correct spondylolisthesis via in-situ adjustment.

Abstract: The present invention provides an expandable fusion device capable of being installed inside an intervertebral disc space to maintain normal disc spacing and restore spinal stability, thereby facilitating an intervertebral fusion. In one embodiment, the fusion device includes a central ramp, a first endplate, and a second endplate, the central ramp capable of being moved in a first direction to move the first and second endplates outwardly and into an expanded configuration. The fusion device is capable of being deployed down an endoscopic tube.

Abstract: System for replacing a disk between two vertebrae includes an intervertebral cage having an oblong body including at least two portions and separated by a gap extending along a curved axis and opening out through an opening at a first end of the body, and at least one introducer guide rod, a curved longitudinal core having cross-sections substantially complementary to the cross-sections of the gap so as to enable the core and the two portions of the body to slide relative to one another, elements for mounting a first end of the core to co-operate with an end of the guide rod so that the curved core projects from the end, and a push rod mounted to move relative to the guide rod so as to come into contact via one end against the end of the body in order to push the body in translation relative to the core.

Abstract: A composite interbody vertebral implant for facilitating fusion of adjacent vertebrae. The implant includes a first endplate of a porous metal material and a second endplate of a porous metal material which are configured to allow bone in-growth. The implant also includes a polymeric body positioned between and bonded to the first and second endplates such that polymeric material of the polymeric body is impregnated into pores of the first and second endplates to bond the components together. The implant may include a cavity extending through the composite implant configured to receive bone growth material to facilitate fusion between a first vertebra and a second vertebra.

Abstract: An implant assembly for a spinal column includes at least a plate and an interbody implant attached to the plate. The interbody implant is positioned in the spinal disc space and the plate extends extradiscally for attachment to the first and second vertebrae outside the disc space. The assembly may include recesses in the bottom surface of the plate, spacers, and spacing portions extending from the bottom surface of the plate that allow the plate to be secured to the interbody implant when the trailing end of the interbody implant is positioned in a recessed, flush or overhanging position relative to the laterally facing surfaces of the vertebrae.

Abstract: Instrumentation is disclosed for inserting an interbody spinal fusion implant for implantation at least in part within and across the generally restored height of a disc space between two adjacent vertebral bodies of a human spine. The implant has an external housing and a substantially hollow internal rotatable member having bone engaging projections that are deployable through the housing to penetrably engage the adjacent vertebral bodies.

Abstract: Prosthetic artificial joints are described, including hip, knee and shoulder joints. In some embodiments, a artificial joint prosthesis includes: a bone-facing surface of a artificial joint prosthesis, the bone-facing surface configured to face a bone-prosthesis interface in vivo; a non-contact surface of the artificial joint prosthesis, the non-contact surface adjacent to the bone-facing surface of the artificial joint prosthesis; at least one fluid deflection structure positioned adjacent to the non-contact surface, the fluid deflection structure positioned to deflect synovial fluid away from the bone-prosthesis interface in vivo; and a mechanism attached to the fluid deflection structure, the mechanism operable to move the fluid deflection structure to direct synovial fluid away from the bone-prosthesis interface in vivo.