Abstract: A prosthesis-packaging case (20) comprises a primary packaging case (30) for housing a prosthesis (10) and a secondary packaging case (40) for housing the primary packaging case (30), wherein the prosthesis (10) and the primary packaging case (30) are respectively made of a material containing zirconia, the secondary packaging case (40) is made of a heat-resistant material, and the prosthesis (10) is subjected to ?-ray sterilization treatment and heat treatment while double-packaged with the primary packaging case (30) and secondary packaging case (40) to change a color of the prosthesis (10) to a color approximate to that of a natural bone.

Abstract: A permeable plug may be temporarily deployed in a patient to protect blood vessels from blockage by various debris. The plug includes a body formed from a filtering material. The body is collapsible for delivery to a location in a blood vessel and expandable to a filtering configuration in which the body occupies a cross-section of the blood vessel and is held in place by its own expansive force. At least one stud is connected to the body for use in deployment of the plug within the blood vessel and retrieval of the plug from the blood vessel.

Abstract: A stent comprised of a scaffolding structure having components configured to allow at least a portion of the stent to decrease in diameter in response to an axial force applied to the stent. Further, the components and elements of the stent may be configured to balance transverse forces applied to the stent, thus reducing the incidence of infolding.

Abstract: A stent graft (2) for placement in the thoracic arch of a patient has a first tubular body portion (6) with a first lumen therein for placement in the ascending aorta of a patient and a second tubular body portion (8) to extend along the thoracic arch and down the descending aorta. The second tubular body portion is of a lesser diameter than the first tubular body portion. There is a step portion (10) between the first body portion and the second body portion. The step portion is joined to and continuous with the first portion and the second portion. A first side of each of the first body portion, the step portion and the second body portion are substantially aligned so that there is a step (18) defined on a second side opposite to the first side of the body portion. There is an aperture (30) in the step portion and an internal tube (32) extending from the aperture towards the first body portion.

Abstract: A device includes a first end portion, a second end portion, an intermediate portion, and a graft material. The first end portion has a first end diameter. The second end portion has a second end diameter smaller than the first end diameter. The first end portion comprises a first material. The second end portion comprises a second material different than the first material. The intermediate portion is between the first end portion and the second end portion. The intermediate portion tapers between the first end portion and the second end portion. The graft material is coupled to at least the intermediate portion.

Abstract: An adjustable, knotless button/loop/needle construct for fixation of cranial cruciate ligament deficient stifle. The adjustable, knotless construct includes two fixation devices (for example, two buttons) and at least one flexible, adjustable loop attached to at least one of the fixation devices (e.g., the buttons). Preferably, a needle is attached to each of the fixation devices (e.g., the buttons). The adjustable, knotless construct has an adjustable loop length and allows adjustment in one direction while preventing or locking the construct from loosening in the opposite direction, due to applied tensile forces. The construct and technique of the present invention provides an improved knotless system for cruciate ligament repair.

Abstract: Described herein is an extension device to extend ocular tissue within an irideocorneal angle of an eye of a patient, comprising a flexible body and a plurality of tensioning features disposed on the body. The body is sized and configured to be disposed within the irideocorneal angle. The body has a curved longitudinal axis, a channel extending from a first end to a second end, an inner convex side, and an outer concave side. The body is flexible between a first flexed condition and a second unflexed condition. The body has a first radius of curvature in the first flexed condition and a second radius of curvature in the unflexed condition. Each tensioning feature is shaped and sized to grasp the ocular tissue within the irideocorneal angle.

Abstract: An ocular adaptive lens prosthesis apparatus is provided. In some implementations the apparatus includes a tunable liquid crystal lens encapsulated in the ocular prosthesis with control electronics and a power source. The tunable liquid crystal lens is driven in response to a convergence signal to provide accommodation. In some embodiments the tunable liquid crystal device corrects other visual shortcomings of the natural eye. The ocular prosthesis has a remote programmable tunable liquid crystal lens controller configured to recalibrate the tunable liquid crystal lens to compensate for dynamic adaptation of the eye over time. A coil is employed to transmit a convergence signal between a pair of ocular prostheses in a dual eye vision correction system.

Abstract: A scleral prosthesis includes an elongated body having a first free end and a second free end opposite the first free end. A maximum width of the body at each end is wider than a maximum width of the body between the ends. The body includes multiple first portions that form the first free end of the body and a part of the body between the ends. The first portions are separated lengthwise along a substantial portion of a total length of the body. The first portions of the body are biased so that they maintain separation from one another without external interference but are configured to be pushed towards each other. The body is configured to receive and retain, between the first portions of the body, an insert that is configured to maintain the separation of the first portions.

Abstract: Disclosed is an accommodating intraocular lens device for treatment of an eye including a stabilization haptic (120) configured to be positioned within a region of an eye and a lens body having a sealed chamber containing a fixed volume of optical fluid. The lens body includes a shape changing membrane (145) configured to outwardly bow in a region surrounding the optical axis of the eye; a shape deformation membrane configured to undergo displacement relative to the first shape changing membrane; and a static element (150). An inner surface of the shape changing membrane, an inner surface of the shape deformation membrane and an inner surface of the static element collectively form the sealed chamber. The lens device also includes a force translation arm (115) having a first end configured to contact an outer surface of the shape deformation membrane of the lens body and a second end configured to engage a ciliary structure of the eye.

Abstract: A multifocal ophthalmic lens includes an ophthalmic lens and a diffractive element. The ophthalmic lens has a base curvature corresponding to a base power. The diffractive element produces constructive interference in at least four consecutive diffractive orders corresponding a range of vision between near and distance vision. The constructive interference produces a near focus, a distance focus corresponding to the base power of the ophthalmic lens, and an intermediate focus between the near focus and the distance focus.

Abstract: A virtual aperture integrated into an intraocular lens is disclosed. Optical rays which intersect the virtual aperture are widely scattered across the retina causing the light to be virtually prevented from reaching detectable levels on the retina. The use of the virtual aperture helps remove monochromatic and chromatic aberrations yielding high-definition retinal images. For a given definition of acceptable vision, the depth of field is increased over a larger diameter optical zone. In addition, thinner intraocular lenses can be produced since the optical zone can have a smaller diameter. This in turn allows smaller corneal incisions and easier implantation surgery.

Abstract: Described embodiments are directed toward centrally-opening, leaflet valve devices and systems for transcatheter delivery having a two-piece valve body as well as methods of making and delivering the two-piece valve devices. A transcatheter valve includes a collapsed configuration and an expanded configuration. The transcatheter valve can further include an everted configuration and a non-everted configuration.

Abstract: An implant system may include a delivery sheath having an actuator mechanism, an anchoring assistance device including an expandable scaffold including a mid-body section, a cusp interface section, and a crown end arrangement, and a replacement heart valve implant. The cusp interface section includes a plurality of loop portions arranged at radial intervals about the expandable scaffold. Each loop portion is circumferentially spaced apart from another loop portion by a region having a deployment ring, the region being configured to span a commissure of the aortic valve and extending distally a shorter distance from the distal end than the loop portions. An elongate deployment member is configured to releasably engage with the deployment rings to actuate the expandable scaffold from a delivery configuration to a deployed configuration. The replacement heart valve implant is configured to be at least partially disposed within the expandable scaffold in the deployed configuration.

Abstract: Systems and methods for medical interventional procedures, including approaches to valve implant. In one aspect, the methods and systems involve a modular approach to treatment.

Abstract: A delivery catheter for a prosthetic heart valve, the valve expandable from a collapsed condition for delivery to an ex paneled condition for implantation, the delivery catheter comprising: a holder for engaging the valve in the collapsed state of the valve, the holder configured such that (i) in response to a radial compression force exerted thereon, the holder has a first shape defining an exposed engagement region for engaging at least a portion of the collapsed prosthetic heart valve for restraining axial displacement of the prosthetic valve in at least one axial direction of the catheter, and (ii) in response to removal of the radial compression force upon expansion of the valve, at least a portion of the holder transitions to a second shape.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: A tensioning device is provided comprising a locking device. The locking device comprises a locking enclosure comprising a groove and a locking pin comprising teeth. The tensioning device further comprises a suture comprising first and second portions. The first and second portions of the suture and the locking pin are positioned within the groove of the locking enclosure and the locking pin is movable within the groove between a first, outer position in which the teeth are disengaged from the suture so that the locking device is movable along the first and second portions of the suture and a second, inner position in which the teeth are engaged with the suture so that the locking device is not movable along the suture. Methods for treating mitral valve regurgitation are also provided.

Abstract: Devices and methods for controlling blood perfusion pressure. In an exemplary device for controlling blood perfusion pressure within a vessel of the present disclosure, the device comprises an elongated body having a lumen, a proximal end configured for placement in a first area having a first blood pressure, and a distal end configured for placement in a second area having a second blood pressure, partial occluder positioned within the lumen of the elongated body between the proximal end and the distal end, the partial occluder configured so not to fully occlude a blood vessel, wherein the partial occluder is configured to equalize the first blood pressure at the first area with the second blood pressure at the second area.

Abstract: A dual poppet valve assembly for a pump assembly of an implantable penile prosthesis having a suction poppet engagable by a plurality of fingers allowing free travel of the poppet and to prevent vacuum lockup of the pump assembly. The suction poppet can also include an elongated shaft receivable within a corresponding bore of a cylinder poppet to prevent the suction poppet from becoming misaligned during the operation of the pump assembly.

Abstract: An implant and methods for use in various procedures are disclosed. According to an example of the present application, an orthopedic implant is disclosed. The implant can include a base and a body. The base can comprise a porous metal material configured to encourage bone ingrowth into the base. The body can be coupled to the base and can comprise a second material that differs from the porous metal material of the base.

Abstract: A femoral slideway and femoral slideway/femur-size template combination is employed to create an installed knee prosthesis that creates a reduced amount of stress in the collateral ligaments relative to previous prosthesis. In one embodiment, the reduced stress is achieved by employing a femoral slideway/femur-size template combination which results in installation of a femoral slideway which has a smaller dorsal-ventral dimension than a corresponding dimension of the femur prior to resection.

Abstract: An assembly for replacing a vertebral disc. The assembly includes an implant and a device for positioning the implant between two adjacent vertebrae. The implant includes a body having an internal compartment enclosed by an outer wall, and an endoskeleton coupled to the body. The device includes a cannula, a container coupled to the cannula, the container having a first end and a second end, a plunger threadingly coupled to the cannula and to the first end of the container, and a conduit coupled to the second end of the container and in fluid communication with the body of the implant. The implant is positioned within the cannula in an undeployed state and is deployed within a vertebral disc to receive a biological fluid in a second state.

Abstract: An implantable orthopedic stability device is disclosed. The device can have a contracted and an expanded configuration. A method of using the device between adjacent vertebral body surfaces for support and/or fixation of either or both of the adjacent vertebrae is also disclosed.

Abstract: An implantable orthopedic stability device is disclosed. The device can have a contracted and an expanded configuration. A method of using the device between adjacent vertebral body surfaces for support and/or fixation of either or both of the adjacent vertebrae is also disclosed.

Abstract: Method and apparatus are disclosed for distracting tissue and particularly spinal tissue. The device and method may include insertion of at least one elongated member and an augmenting member to form a structure between the tissues to be distraction, such that a dimensional aspect of the structure is augmented upon movement of the augmenting structure.

Abstract: An implant for the application in spinal or trauma surgery is provided that has a variable axial length, the implant including a first member and a second member guided relative to the first member to be movable relative thereto in an axial direction for adjusting an overall length of the implant; and at least one engagement member that is in a first configuration configured to engage the first member and the second member such that the first member and the second member are locked with respect to each other and in a second configuration configured to engage the first member such that the second member is movable with respect to the first member; wherein, in the second configuration, the engagement member is configured to be secured against disengagement from the first member by an abutment, and wherein the engagement member is a monolithic part.

Abstract: Disclosed are improved spinal implants that are configured to help prevent post-operative migration of the implant. In some embodiments, the implant system includes multi-axial tooth geometry and other geometrical configurations such as but not limited to peripheral curvatures that aid in the prevention of such post-operative migration. Also disclosed are asymmetrical implants having superior and inferior surfaces with different angulations relative to the sagittal midline.

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: A surgical instrument includes a shaft having a distal end connectable with an implant, and a handle connected to a proximal end of the shaft. The instrument defines an internal fluid channel through which a fluid can be passed. A kit includes the instrument and a spinal implant that is expandable through the introduction of the fluid therein. A method of using the instrument includes passing a fluid through an internal fluid channel defined by the instrument and toward the implant.

Abstract: An orthopedic surgical instrument for positioning an acetabular prosthetic component in a patient's surgically-prepared acetabulum includes a surgical tool configured to be coupled to the acetabular prosthetic component, and a gravity-based position indicator removably coupled to the surgical tool. The position indicator includes a first marking indicating a first position of the acetabular prosthetic component, and a second marking indicating a second position.

Abstract: A lower limb prosthesis comprises an attachment section (10), a shin section (12), a foot section (14), a knee joint (16) pivotally connecting the attachment section (10) and the shin section (12), and an ankle joint (22) pivotally connecting the shin section (12) and the foot section (14). The knee joint includes a dynamically adjustable knee flexion control device (18) for damping knee flexion. The prosthesis further comprises a plurality of sensors (52, 53, 54, 85, 87) each arranged to generate sensor signals indicative of at least one respective kinetic or kinematic parameter of locomotion or of walking environment, and an electronic control system (100) coupled to the sensors (52, 53, 54, 85, 87) and to the knee flexion control device (18) in order dynamically and automatically to modify the flexion control setting of the knee joint (16) in response to signals from the sensors.

Abstract: Knee orthoses or prostheses can be used to automatically, when appropriate, initiate a stand-up sequence based on the position of a person's knee with respect to the person's ankle while the person is in a seated position. When the knee is moved to a position that is forward of the ankle, at least one actuator of the orthosis or prosthesis is actuated to help raise the person from the seated position to a standing position.

Abstract: A method for creating tubular inserts is useful for creating custom fitted inserts that correspond to the anatomy of a patient and solve the problem of pressure points, wear of the implant, damage to surrounding tissue, and denting. Surface measurements of the affected portion of a patient's internal cavity are obtained. Those measurements are used to design a core. The core is 3D printed with a soluble material. The core is wrapped with a thin filament or film such that the contours from the core develop on the outer surface of the covering. The covering is hardened and the core is dissolved away, leaving a custom-made implant device that can be deposited in the patient's cavity.

Abstract: A method of manufacturing a tubular medical implant, such as a stent, includes introducing a liquid polymer material into an axial lumen of an elongate metal tube, the metal tube having an inner wall defining the lumen; allowing the polymer material to solidify within the metal tube lumen, the solidified polymer forming a high friction surface in contact with the inner wall of the metal tube; securing the metal tube, including the solidified polymer material therein, to a collet of a laser etching system; and laser etching a predetermined pattern of openings in the metal tube.

Abstract: A plaque tack can be used for holding plaque against blood vessel walls such as in treating atherosclerotic occlusive disease. The plaque tack can be formed as a thin, annular band for holding loose plaque under a spring or other expansion force against a blood vessel wall. Focal elevating elements and/or other features, such as anchors, can be used to exert a holding force on a plaque position while minimizing the amount of material surface area in contact with the plaque or blood vessel wall and reducing the potential of friction with the endoluminal surface. This approach offers clinicians the ability to perform a minimally invasive post-angioplasty treatment and produce a stent-like result without using a stent.

Abstract: A system for treating a bifurcation includes first and second delivery catheters. The first catheter has a first shaft, a first expandable member adjacent the distal end of the first shaft, an auxiliary expandable member disposed under the first expandable member, and a first radially expandable stent disposed over both the first expandable member and the auxiliary expandable member. The second delivery catheter has a second shaft, and a second expandable member adjacent the distal end of the second shaft. A portion of the second catheter is disposed under a portion of the first stent, and a portion of the second delivery catheter passes through a side hole in the first stent. The first stent is crimped over the first and second catheters such that the first stent remains attached to the first and the second catheters during advancement of the catheters through a blood vessel.

Abstract: Stent delivery systems and associated methods for delivering stents are disclosed herein. In several embodiments, a handle assembly for delivering a stent from a tubular enclosure can include a first lead screw having a first lead thread of a first pitch and first handedness, a second lead screw having a second lead thread of a second pitch and second handedness different from the first handedness, and a housing defining threads of the first and second pitches. The first lead screw can be in mechanical communication with the tubular enclosure, and the second lead screw can be in mechanical communication with the stent. Upon rotation of a portion of the housing, the housing threads can engage the lead screws so as to induce simultaneous translations of the lead screws in opposite directions. The simultaneous translations are configured to deploy the stent from the tubular enclosure.

Abstract: A vascular prosthesis deployment device and related methods are disclosed. In some embodiments the deployment device may provide audible, tactile, or visual feedback to a practitioner as to the degree of deployment of a prosthesis. The deployment device may also provide mechanical advantage when deploying a prosthesis. The deployment device may be configured to incrementally deploy a prosthesis.

Abstract: In one aspect, a gastric balloon structure includes multiple isolated non-concentric inflatable chambers and a valve system for introducing fluid into each chamber, where the structure assumes, upon inflating, a curved shape conforming to a natural three-dimensional kidney shape of the gastric cavity.

Abstract: The present application describes an implant system useable for positioning an implant device such as a device useful for restricting passage of ingested food into the stomach. In one embodiment, the disclosed system includes a plurality of anchors that may be coupled to tissue within the stomach, or to a tissue tunnel formed by plicating stomach wall tissue. The anchor includes a loop. During use, the implant device is inserted through the loop and expanded such that it retains its position within the loop until removed. Instruments for implanting and explanting the implant device are also described.

Abstract: One or more medical devices may be provided that may be used, for example, in bariatric surgery including a vertical sleeve gastrectomy. Occlusion devices can be integrated with a catheter or tube to occlude one or more proximal or distal landmarks of a stomach and a stapling guide may be used to occlude a lateral boundary of the stomach to define a cavity. A volume of the potential resultant sleeve may be determined by inserting fluid or gas into the catheter or tube, measuring pressure, and calculating the volume of the cavity.

Abstract: Described herein is an improved device and method for acquiring, and optionally, fastening a tissue fold. The device has an improved configuration for forming a single, two-layer tissue fold.

Abstract: A device for facilitating or enhancing torso and pelvis stability exercises includes two elongate semi-cylindrical resiliently compressible members so coupled to one another as to maintain a mutually parallel configuration, the resiliently compressible members each having a planar side and a cylindrically arcuate side, the planar sides being co-planar with one another. A user attachment component holds the resiliently compressible members to the user with the planar sides in contact with the user in one use configuration and so that the arcuate sides are in contact with the user in an alternate use configuration.

Abstract: An anterior cruciate ligament support band is disclosed that includes an elastic, generally x-shaped body with a pair of diverging upper arms and a pair of diverging lower arms. The respective ends of the upper arms may be fastened to each other and the respective ends of the lower arms may be fastened to each other. The body is placed against the posterior side of the wearer's leg at the knee joint, while the ends of the upper arms are fastened together above the knee joint on the front of the leg and the ends of the lower arms are fastened together below the knee joint on the front of the leg.

Abstract: A stabilizing and mobility-enhancing brace for the shoulder joint is a device for providing structural support to the user's shoulder joint while allowing a degree of mobility for the user's shoulder and the user's arm. The device includes a shoulder joint brace for providing stability to the shoulder as well as an elbow brace for providing stability to the arm. The elbow brace is connected to the shoulder joint brace through a mobility strap and a deltoid connector strap that enable movement of the user's arm. The mobility strap is engaged through a strap groove on the shoulder joint brace and is able to slide over a roller assembly within the strap groove. The shoulder joint brace is also secured to a lateral thoracic brace worn on the user's body via a torso strap assembly. The elbow brace is fastened in place via a plurality of elbow securing straps.

Abstract: According to the invention, a system for increasing the effectiveness of a mechanical joint brace worn by a user is disclosed. A sleeve may fit around, and to either side, of a user's joint. The sleeve may include a first portion which applies compressive pressure on a proximate side of the joint, a second portion disposed around the joint, and a third portion which applies compressive pressure on a distal side of the joint. A first set of pads may be disposed and compressed between at least a first portion of a mechanical joint brace worn over the sleeve and the proximate side of the joint. A second set of pads may be disposed and compressed between at least a second portion of the mechanical joint brace worn over the sleeve and the distal side of the joint.

Abstract: A trunk supporting exoskeleton comprises: a supporting trunk; thigh links configured to move in unison with a wearer's thighs; and first and second torque generators located on both left and right halves of the wearer substantially close to the wearer's hip. The torque generators couple the supporting trunk to the thigh links, and generate torque between the thigh links and the supporting trunk. When the wearer bends forward such that a predetermined portion of the supporting trunk passes beyond a predetermined angle from vertical, a torque generator(s) imposes a resisting torque between the supporting trunk and the thigh link(s), causing the supporting trunk to impose a force against the wearer's trunk, and the thigh link(s) to impose a force onto the wearer's thigh. When the predetermined portion does not pass beyond the predetermined angle, the torque generators impose no resisting torques between said supporting trunk and respective thigh links.

Abstract: A fiber-reinforced composite article useful in supporting or immobilizing an injured body part is disclosed. The composite is a multi-layer, flexible precursor including fiber reinforcement plies, which can be rapidly cured into a rigid body using a thermosetting resin. Methods of making and using the same are also disclosed, along with kits containing such composite articles.

Abstract: A multi-layered composite material suitable for use in orthopedics includes a foam core layer bonded between two layers of thermoformable polymer material. The thermoformable material is heat formable within a target temperature range allowing for rapid heating and application to a patient such as in the form of a splint. While within the target temperature range, the composite material includes a dwell time sufficiently long to enable proper fitment and adjustment, yet not overly long requiring extended periods of holding the composite material in place. The composite material is very light yet extremely rigid and easily conformable to patients.