Abstract: Methods and devices are disclosed for manipulating alignment of the foot to treat patients with flat feet, posterior tibial tendon dysfunction and metatarsophalangeal joint dysfunction. An enlargeable implant is positioned in or about the sinus tarsi and/or first metatarsal-phalangeal joint of the foot. The implant is insertable by minimally invasive means and enlarged through a catheter or needle. Enlargement of the implant alters the range of motion in the subtalar or first metatarsal-phalangeal joint and changes the alignment of the foot or toe.

Abstract: In order to position an ankle prosthesis including a tibial implant and a talus implant provided with a talo-calcaneal anchoring keel, the invention proposes a surgical instrumentation assembly including: a tibial phantom (60) of the tibial implant, adapted so as to be attached to the tibia (T) of a patient, and an aiming guide (80) adapted for setting into place an instrumentation element (90) through the talus (A) and the calcaneus (C) of the patient, along an axis (Z-Z) for implanting the talo-calcaneal anchoring keel, the tibial phantom and the aiming guide mechanically cooperating with each other to restrict movement of the tibial phantom and the aiming guide relative to each other along vertical and medio-lateral directions, wherein the aiming guide is configured to guide placement of the instrumentation element.

Abstract: A multi-component ankle joint assembly incorporated into reconditioned end surfaces established between an upper tibia bone and an opposing and lower talus bone. A first component is anchored into the upper tibia reconditioned end surface and exhibits a first exposed support surface. A second component is anchored into the lower talus reconditioned end surface of and exhibits a second exposed support surface. A spherical shaped intermediate component is supported in at least one of eccentric or rotational fashion between the first and second anchored components. The spherical shaped component includes a multi-layer composition having a softer outer layer and at least one harder interior layer establishing an eccentric rotational interface therebetween.

Abstract: The invention relates to an ankle prosthesis including a talar implant, a tibial implant, and an intermediate implant designed to be mounted to move relative to said talar implant in order to impart mobility to the ankle, said prosthesis further including embedded adjustment structure designed to alternate between a releasing state, in which they allow the intermediate implant to move relative to the tibial implant, and a locking state, in which they hold the prosthesis in the chosen assembly configuration, said prosthesis being characterized in that said adjustment structure can be controlled to be operable while the prosthesis is in the assembled state in vivo.

Abstract: A sinus-canalis internal-fixation device is configured in a shape modeled after the anatomical form and dimensions of a sinus tarsi of an ankle-bone structure of a patient, which anatomically twists and curves and is surrounded by the anatomically irregular surfaces of the talus (ankle bone) and calcaneus (heel bone). The surfaces of the sinus-canalis internal-fixation device mirror the anatomically irregular surfaces of the talus (ankle bone) and calcaneus (heel bone) surrounding the sinus-canalis internal-fixation device. The sinus-canalis internal-fixation device comprises an anatomical shaft and anatomical superior, inferior, and posterior pegs connected to the top, bottom, and back end of the anatomical shaft, respectively. Further, if desired, the sinus-canalis internal-fixation device can be cannulated and/or comprise at least one groove, recess, opening, ridge, and/or hill integrated thereinto.

Abstract: A system for fastening prosthetic implants such as ankle prostheses is provided. The ankle prosthesis includes: a talar implant having a body for mounting to a top of a talus and with at least one talar fastening hole; a tibial implant having a plate for mounting to a bottom of a tibia, a flange extending from the plate for bearing against an anterior surface of the tibia, the flange comprising at least one tibial fastening hole; a mobile bearing for positioning between the talar implant and the tibial implant; and a plurality of fasteners for locking engagement with the at least one talar fastening hole and the at least one tibial fastening hole, each of the fasteners comprising locking means and an elongated unthreaded body.

Abstract: Total ankle arthroplasty with a tibial plate, a talar plate and a middle or core component. The ankle arthroplasty may allow for varus or valgus accommodation through the use of a core component with various medial and lateral heights in varus and valgus orientations. In addition the resurfacing of the talus is accomplished with a talar plate with a curved orientation that is congruent to one surface of the core component to allow for appropriate ankle manipulation.

Abstract: An ankle implant having a bearing, a tray and a bone screw. The tray is implanted to a talus bone. The tray includes a stem extending from the tray for connecting to the bone screw. The bone screw includes a shank and an enlarged head proximate its distal end. The bearing is connected to the tray.

Abstract: One embodiment of the invention includes a sinus tarsi implant with a proximal portion that includes a spherical portion. The spherical portion may include apertures for tissue in-growth. The implant design limits patient discomfort due to pressure points. Other embodiments are disclosed.

Abstract: A surgical instrument including at least one tibial phantom generally corresponding to at least certain features of the tibial implant. The tibial phantom includes a top surface adapted to move freely against the prepared bottom end of the tibia. At least one talus phantom generally corresponding to at least certain features of the talus implant is engaged with the prepared top surface of the talus. At least one phantom skid is located between the tibial phantom and the talus phantom. The phantom skid is engaged with the tibial phantom such that dynamic engagement between the phantom skid and the talus phantom through at least extension and flexion of the ankle joint positions the tibial phantom on the prepared bottom end of the tibia. The phantom skid can either be a part of the tibial phantom or a separate component.

Abstract: One embodiment of the invention includes a sinus tarsi implant with an inverted thread profile having a lip or lips at the thread crest. The lips may help hold tissue in-growth and give greater purchase to the implant. The implant may also include voids that traverse threads. The voids may create an open area for soft tissue to grow into. The voids may be relatively small and consequently promote faster tissue in-growth. Thus, the lips and/or voids limit migration. They do this without creating sharp edges or pressure points (or at least limiting such creation) that are typically associated with techniques (e.g., cutting deep negative thread spaces) used to prevent migration. Therefore, the embodiments of the invention limit migration while also limiting patient discomfort. Other embodiments are disclosed.

Abstract: The present invention contemplates an implant for insertion in various bones of the human foot and ankle to repair injuries and deformities. In one preferred embodiment the implant device includes a trapezoidal body member when viewed from the top with substantially vertical sidewalls consisting of at least two intersecting sidewalls that define a head end having a head-height. The sidewalls diverge at their respective tail ends to define a concave shape and a tail-height that is substantially the same as the head height, thus giving the implant a top and bottom that are substantially parallel when viewed from the front, side, or back views. The top and bottom portions further include friction-enhancing serrations.

Abstract: A prosthesis and kit for replacing an ankle joint, and methods of applying the devices or systems. The prosthesis is an intramedullary device directed towards replacement of either of the tibia or fibula bone, wherein the prosthesis is a replacement for the lateral malleolus or the medial malleolus, respectively.

Abstract: Methods and devices are disclosed for manipulating alignment of the foot to treat patients with flat feet, posterior tibial tendon dysfunction and metatarsophalangeal joint dysfunction. An inflatable implant is positioned in or about the sinus tarsi and/or first metatarsal-phalangeal joint of the foot. The implant is insertable by minimally invasive means and inflatable through a catheter or needle. Inflation of the implant alters the range of motion in the subtalar or first metatarsal-phalangeal joint and changes the alignment of the foot.

Abstract: An orthopedic prosthesis, system and method has a dual bearing component that, along with first and second bone anchoring components, provides multi-axial movement separately with respect to both the first and second bone anchoring components. An ankle prosthesis, system and method may thus be fashioned utilizing these principles that includes a dual bearing component, a tibial component adapted for attachment to the tibia bone, and a talar component adapted for attachment to the talus or calceneus bone of the foot. The dual bearing component includes a superior bearing providing gliding articulation/translation between it and the tibial component, and an inferior bearing providing gliding articulation/translation between it and the talar component. A bearing component plate provides a base or foundation for the superior and inferior bearings. The superior bearing is bonded to the bearing component plate while the inferior bearing moves with respect to the bearing component plate.

Abstract: Implant devices, and method of using the same, are provided. The implant devices have a head and a stem. The head has an upper surface, a perimeter surface, and a lower surface. The upper surface is blended into the perimeter surface. The perimeter surface is blended into the lower surface. The upper surface has a general shape of at least a portion of a superior articular surface of a talus and at least a portion of a medial articular surface of a talus. The stem has a cylindrical portion, which optionally has at least one circumferential groove.

Abstract: A surgical instrument including at least one tibial phantom generally corresponding to at least certain features of the tibial implant. The tibial phantom includes a top surface adapted to move freely against the prepared bottom end of the tibia. At least one talus phantom generally corresponding to at least certain features of the talus implant is engaged with the prepared top surface of the talus. At least one phantom skid is located between the tibial phantom and the talus phantom. The phantom skid is engaged with the tibial phantom such that dynamic engagement between the phantom skid and the talus phantom through at least extension and flexion of the ankle joint positions the tibial phantom on the prepared bottom end of the tibia. The phantom skid can either be a part of the tibial phantom or a separate component.

Abstract: A fibular implant is provided. The implant includes a stem anchored to the fibula and a joint body. The stem is at least partially covered with a bony-in-growth surface. The joint body includes an articulating surface for articulating with the talus. The articulating surface is polished to reduce friction in the ankle joint.

Abstract: Implants for ankles are disclosed herein. An embodiment of the implant includes a base and a stem. The base includes an upper surface and a lower surface, the upper surface is contoured to contact a distal tibia and the lower surface is contoured to contact a talus. The stem is attachable to the lower surface of the base and protrudes from the base. The stem is implantable into the talus.

Abstract: An ankle implant for use in ankle arthroplasty in total ankle replacement is provided. The implant includes an upper prosthesis anchored to the tibia and a lower prosthesis anchored to the talus. The lower prosthesis is operable associated with the upper prosthesis. The implant also includes a stem which is rigidly removably connected to the second member. The stem includes a portion for attachment to the calcaneous. The stem is be adapted to be in a first position in the calcaneous when the stem is in a first relative position with respect to the lower prosthesis, and to provide for a second position in the calcaneous when the stem is in a second relative position with respect to the lower prosthesis.

Abstract: A subtalar implant device includes a rounded end cap region, a threaded region having threads, and a core having a first end, a second end, a core exterior and a longitudinal axis. The threads can have a shape that varies between the first end and the second end of the core. For example, the threads can include an outer edge having an edge width that varies. Further, the threads can include a thread depth that can vary between the first end and the second end of the core. A thread radius of curvature varies at a different rate than a core radius of curvature. The core can define one or more core apertures that extend through the core at various angles relative to the longitudinal axis. In one embodiment, two core apertures are positioned at an angle greater than zero degrees relative to each other.

Abstract: A total ankle replacement system, novel surgical method for total ankle replacement, and novel surgical tools for performing the surgical method are described. The total ankle replacement system includes the calcaneus in fixation of a lower prosthesis body, thereby significantly increasing the amount of bone available for fixation of the lower prosthesis body and allowing the lower prosthesis body to be anchored with screws. The total ankle replacement system further includes a long tibial stem which can also be anchored into the tibia with, for example, screws, nails, anchors, or some other means of attachment. The novel surgical arthroscopic method allows introduction of ankle prostheses into the ankle joint through an exposure in the tibial tubercle. Various novel surgical instruments, such as a telescoping articulating reamer and a talo-calcaneal jig, which facilitate the novel surgical method, are also described.

Abstract: A monolithic interpositional arthroplasty implant for use in repairing gyngylmus joints such as the joints of the ankle. The implant is a monolithic tibiotalar implant having a first major surface shaped to be positioned against a tibia. The tibia is allowed to articulate across the first major surface. A second major surface is shaped to be positioned against the talus.

Abstract: A semi-constrained ankle prosthesis includes a tibial component configured to be coupled to a surgically-prepared surface of the distal end of a tibia, and a bearing insert locked to the tibial component. The bearing insert is rotative relative to the tibial component and has an articular surface formed in an inferior surface thereof.

Abstract: A total ankle replacement system, novel surgical method for total ankle replacement, and novel surgical tools for performing the surgical method are described. The total ankle replacement system includes the calcaneus in fixation of a lower prosthesis body, thereby significantly increasing the amount of bone available for fixation of the lower prosthesis body and allowing the lower prosthesis body to be anchored with screws. The total ankle replacement system further includes a long tibial stem which can also be anchored into the tibia with, for example, screws, nails, anchors, or some other means of attachment. The novel surgical arthroscopic method allows introduction of ankle prostheses into the ankle joint through an exposure in the tibial tubercle. Various novel surgical instruments, such as a telescoping articulating reamer and a talo-calcaneal jig, which facilitate the novel surgical method, are also described.

Abstract: An ankle implant for use in ankle arthroplasty in total ankle replacement is provided. The implant includes an upper prosthesis anchored to the tibia and a lower prosthesis anchored to the talus. The lower prosthesis is operable associated with the upper prosthesis. The implant also includes a stem which is rigidly removably connected to the second member. The stem includes a portion for attachment to the calcaneous. The stem is be adapted to be in a first position in the calcaneous when the stem is in a first relative position with respect to the lower prosthesis, and to provide for a second position in the calcaneous when the stem is in a second relative position with respect to the lower prosthesis.

Abstract: A total ankle replacement system, novel surgical method for total ankle replacement, and novel surgical tools for performing the surgical method are described. The total ankle replacement system includes the calcaneus in fixation of a lower prosthesis body, thereby significantly increasing the amount of bone available for fixation of the lower prosthesis body and allowing the lower prosthesis body to be anchored with screws. The total ankle replacement system further includes a long tibial stem which can also be anchored into the tibia with, for example, screws, nails, anchors, or some other means of attachment. The novel surgical arthroscopic method allows introduction of ankle prostheses into the ankle joint through an exposure in the tibial tubercle. Various novel surgical instruments, such as a telescoping articulating reamer and a talo-calcaneal jig, which facilitate the novel surgical method, are also described.

Abstract: Implant devices, and method of using the same, are provided. The implant devices have a head and a stem. The head has an upper surface, an anterior surface, a posterior surface, a lateral surface and a lower surface. The anterior surface, the lateral surface, and the lower surface are approximately perpendicular to and intersect each other. The anterior surface and the posterior surface are approximately parallel to each other. Preferably, the upper surface has a general shape of at least a portion of a superior articular surface of a talus and at least a portion of a medial articular surfaces of a talus. The stem has a truncated conical portion and a cylindrical portion. The cylindrical portion is affixed to the lower surface of the head, and the truncated conical portion is affixed to the cylindrical portion.

Abstract: A device and method of manufacturing and implanting a custom subtalar arthroereisis implant having side surfaces which are mirrored in topography with the sinus tarsi of a patient. The implant is formed using images of the patient standing in a weight bearing position with their sinus tarsi and the surrounding bone structure in an anatomically correct alignment. Once implanted, the implant urges and maintains the anatomically correct alignment thereby minimizing any patient tendency for abnormal motion between said patent's talus and calcaneus.

Abstract: A method prepares an ankle joint of a patient for replacement. The patient includes a tibia (20) having a medial portion (22), a talus (40), and an ankle (10) having a medial portion. The method employs a cutting alignment apparatus (50) including a first portion external to the patient and a second portion, and surgically prepares and exposes the medial portion of the ankle for replacement. The second portion of the cutting alignment apparatus is coupled to the tibia, and a cutting guide (90) is disposed with respect to the cutting alignment apparatus. The medial portion of the tibia is detached, a portion of the tibia proximate the talus is cut, and a portion of the talus proximate the tibia is cut. An ankle prosthesis (100) is installed to the ankle, and the medial portion of the tibia is reattached.

Abstract: A method for implanting a malleolar implant in an ankle joint. A spacer block is positioned between a lower portion of a tibia and an upper portion of an astragalus in the ankle joint. A guide attached to the spacer block is positioned opposite an outer surface of a fibular malleolus. A bore aligned with the guide is formed through the fibular malleolus. The spacer block is removed from between the tibia and the astragalus. A shank of the malleolar implant is engaged with the bore from an inner surface of the fibular malleolus. The shank is advanced into the bore so an inner surface of a head of the malleolar implant engages the inner surface of the fibular malleolus.

Abstract: Methods of implanting an ankle prosthesis in a subject having an ankle joint in need of replacement.

Abstract: A prosthetic joint according to the present invention includes a first implant component for attachment to a first bone and a second implant component for attachment to a second bone. The first implant component has a condylar portion that includes first and second condylar bearing surfaces and similarly, the second implant component has bearing surfaces that receive and are complementary to the first and second condylar bearing surfaces. Each of the first and second condylar bearing surfaces and each of the bearing surfaces of the second implant component has a cross-section in a coronal plane that exhibits two different radii and a contact point is established between the first and second condylar bearing surfaces and the bearing surfaces of the second implant component. The bearing surfaces of the respective implant components are configured such that varus and valgus rotation of the first implant component relative to the second implant component causes the contact point to move outwardly.

Abstract: A joint prosthesis system is suitable for cemented fixation. The system has two metal implant components and a bearing. One of the metal implant components has an articulation surface for articulation with the bearing. The other metal implant component has a mounting surface for supporting the bearing. One of the metal implant components includes an extension, such as a stem or pegs, with an exposed outer surface. The metal implant component from which the extension extends comprises titanium and the exposed outer surface of the extension comprises a different form of titanium. A method of making the joint prosthesis is also disclosed.

Abstract: A joint prosthesis with three components is disclosed. The prosthesis includes a first component, a composite component and a bearing component. The bearing can be mounted on and fixed to the composite component and has an articulation surface to articulate with an articulation surface of the first component. The composite component has an extension for stabilizing the component when implanted. The extension has an end opposite the bearing. The composite component includes a porous base or preform molded to a solid polymer portion. The solid polymer portion engages the bearing component and extends into the extension and defines the end of the extension. The bearing is made of a different polymer. The composite component may be made by injection molding.

Abstract: A total ankle replacement system is presented. The total ankle joint replacement procedure can be used to treat persons with disability, deformity, or that are suffering from osteoarthritis and other arthritic conditions. The total ankle joint assembly generally comprises a tibial component, a talar component, and a bearing component, where the bearing component is positioned between and articulates with the tibial component and talar component to mimic the natural ankle joint movement.

Abstract: A medical device having body contacting surfaces provided with a film of amorphous calcium phosphate having a thickness of 1 nm to 10000 nm and an average dissolution rate calculated as the time taken to remove 95% of the film of at least 1 nm h?1 as determined in accordance with ASTM Standard P1926-03. The characteristics of the film are such that the film is relatively rapidly dissolved from the surface by body fluids. This dissolution of the surface film of amorphous calcium phosphate is sufficiently fast to prevent the attachment of bacteria, thus preventing them forming a biofilm and keeping the cells in a planktonic (non-biofilm) state where they are more vulnerable to the body's defences. The invention is particularly applicable to implants (e.g. orthopaedic implants such as prosthetic hips) but may also be applied to “non-implanted” devices such as surgical instruments.

Abstract: The present invention relates to improved biomedical implantable material comprising a plurality of pores, of which one or more of the pores are interconnected below the surface of the material. The improved biomedical implantable material may be used in biomedical implant devices such as orthopedic implants, spinal implants, neurocranial implants, maxillofacial implants, and joint replacement implants. The present invention also relates to a method of preparing an improved biomedical implantable material, comprising subjecting an implantable material to a pore-forming treatment and optionally further subjecting the material to a surface-modifying treatment. The biomedical implantable material may be used in other applications, which as applications where two surfaces are contacted and bonding between the surfaces is required.

Abstract: The present invention relates to methods for making oxidation resistant medical devices that comprise polymeric materials, for example, ultra-high molecular weight polyethylene (UHMWPE). The invention also provides methods of making antioxidant-doped medical implants, for example, doping of medical devices containing cross-linked UHMWPE with vitamin E by diffusion and materials used therein.

Abstract: An elongate, longitudinally oriented outer sleeve includes an outer sleeve surface and has a sleeve body. A stem-receiving cavity extends from a distal sleeve end into the sleeve body. The distal sleeve end includes a sleeve interference protrusion extending from the distal sleeve end away from the sleeve body. A joint articulating member includes an elongate, longitudinally oriented stem. The joint articulating member includes a joint articulating surface spaced apart from a distal stem end by an angularly extending connector neck. When the stem is inserted into the stem-receiving cavity, the stem and the outer sleeve are configured for selective relative rotation about a shared longitudinal axis, and the connector neck impinges upon the sleeve interference protrusion responsive to a predetermined amount of relative rotation between the stem and the outer sleeve to prevent relative rotation between the stem and the outer sleeve outside a predetermined range of allowable rotation.

Abstract: Methods and devices for deploying biological implants are disclosed. The biological implants can include orthopedic, multi-component ankle implants. The target site can be prepared by fixing a rigid, alignable guide or jig with saw holes to the bone(s). Saws configured to fit through the saw holes can then be inserted through the saw holes to cut the bone(s). The jig can then be removed. Slidable implants can be positioned. Implants needing to be forced into place can be attached to elongated members to gently hold the implant and to provide a non-implant surface on which to apply the force.

Abstract: A system for modifying a talocalcaneal spatial relationship in a foot in a body, including a subtalar spacer having an articulating surface and implanted in the sinus tarsi of the foot and a fastener that fastens the subtalar spacer to a bone surface in the foot, in which the articulating surface of the subtalar spacer directs relative movement between the calcaneus and the talus of the foot.

Abstract: The present invention provides an irradiated crosslinked polyethylene containing reduced free radicals, preferably containing substantially no residual free radical. Disclosed is a process of making irradiated crosslinked polyethylene by irradiating the polyethylene in contact with a sensitizing environment at an elevated temperature that is below the melting point, in order to reduce the concentration of residual free radicals to an undetectable level. A process of making irradiated crosslinked polyethylene composition having reduced free radical content, preferably containing substantially no residual free radicals, by mechanically deforming the polyethylene at a temperature that is below the melting point of the polyethylene, optionally in a sensitizing environment, is also disclosed herein.

Abstract: Methods and devices are disclosed for manipulating alignment of the foot to treat patients with flat feet, posterior tibial tendon dysfunction and metatarsophalangeal joint dysfunction. An enlargeable implant is positioned in or about the sinus tarsi and/or first metatarsal-phalangeal joint of the foot. The implant is insertable by minimally invasive means and enlarged through a catheter or needle. Enlargement of the implant alters the range of motion in the subtalar or first metatarsal-phalangeal joint and changes the alignment of the foot or toe.

Abstract: An endoprosthesis for replacing the ankle joint includes a lower component which is configured to be connected to the ankle bone, an upper component which is configured to be connected to the shin bone, and an intermediate part which forms a slide joint both with the lower and upper components. The intermediate part, which is wedge-shaped in sagittal section, is provided in order to compensate for anatomical or surgical irregularities. The upper component can also be wedge-shaped in frontal or sagittal section.

Abstract: A prosthesis is installed in a cavity that traverses a joint between a talus and a calcaneus. The cavity is established by intramedullary guidance with respect to the major axis of the tibia by access through the calcaneus.

Abstract: A joint resurfacing system for repairing defects in the articular surface of bones in the foot. The system includes a hemiarthroplasty implant for the talus resulting in minimal removal of the underlying bone. The implant device comprises a first curved surface and a second curved surface, with the second curved surface coupled to an articular surface of a talus bone via a dynamic fixation device.

Abstract: A method of installing an ankle prosthesis system provides an artificial talar joint surface and a family of talar stem components having different physical characteristics. Each talar stem component in the family is sized and configured to be attached to the artificial talar joint surface. The method selects an ankle region to be treated and analyzes the morphology of the ankle region. The method selects among the family one of the talar stem components having a desired physical characteristic based upon the analysis. The method forms a prosthesis-receiving cavity that traverses the joint between the talus and a calcaneus and installs the selected one of the talar stem components in the prosthesis-receiving cavity to prevent movement of the joint. The method attaches the artificial talar joint surface to the selected one of the talar stem components.

Abstract: A fixed-bearing ankle prosthesis may include tibial and talar components whose articulating surfaces directly contact one another. The tibial component defines medial and lateral concave condylar facets separated by a convex central portion. The talar component includes medial and lateral convex condyles separated by a concave central portion. The condyles each have a single radius of curvature in a medial-lateral plane such that each condyle has a circular-arc cross-section continuously extending from the respective medial or lateral edge of the talar component to the concave central portion. The medial-lateral radii of the condyles are smaller than corresponding radii of the condylar facets.

Abstract: An artificial joint (3), particularly for replacing a talocrural joint, including a first primary joint surface (1) that forms an articular fossa (4) particularly for replacing the tibia composed of concave curvatures extending parallel to a primary function plane of the joint (3), which corresponds to the sagittal plane, and a second primary joint surface (2) which cooperates with the first primary joint surface (1) as a component of a condoyle (5) that replaces the talus and has convex curvatures (7, 8, 9, 10) on the primary function plane that are adapted to the first primary joint surface (1).