Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Abstract: Apparatus for endovascularly replacing a patient's heart valve, including: a replacement valve adapted to be delivered endovascularly to a vicinity of the heart valve; an expandable anchor adapted to be delivered endovascularly to the vicinity of the heart valve; and a lock mechanism configured to maintain a minimum amount of anchor expansion. The invention also includes a method for endovascularly replacing a patient's heart valve. In some embodiments the method includes the steps of: endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve; expanding the anchor to a deployed configuration; and locking the anchor in the deployed configuration.

Abstract: Apparatus for endovascularly replacing a patient's heart valve, including: a replacement valve adapted to be delivered endovascularly to a vicinity of the heart valve; an expandable anchor adapted to be delivered endovascularly to the vicinity of the heart valve; and a lock mechanism configured to maintain a minimum amount of anchor expansion. The invention also includes a method for endovascularly replacing a patient's heart valve. In some embodiments the method includes the steps of: endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve; expanding the anchor to a deployed configuration; and locking the anchor in the deployed configuration.

Abstract: Prosthetic heart valves having elastic leaflets and an elastic support structure are described. The support structure can exhibit a precursory transition from the closed position to the open position. The support structures can exhibit a sinusoidal movement profile at a base edge during the precursory transition.

Abstract: Valve holders and introducers for delivering a prosthetic heart valve to an implant site are in various embodiments configured to facilitate insertion of prosthetic valves through small incisions or access sites on a patient's body. The valve holders can also be configured to reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valve during implantation. A valve holder according to embodiments of the invention includes features that reduce or eliminate mistakes during implantation of the prosthetic valves, such as a removable activator dial and a removable handle that prevent implantation of the valve prior to proper deployment or adjustment of the holder. An introducer is provided which can facilitate passing of a prosthetic valve between adjacent ribs of a patient. Valve holders and introducers according to the various embodiments can be used in minimally invasive procedures, such as thoracotomy procedures.

Abstract: A transapical introducer includes a housing near a proximal end of the introducer, a first valve in the housing, a proximal tube coupled to the housing, and a distal tube coupled to a distal end of the proximal tube.

Abstract: An apparatus including an implant configured to be coupled to cardiac tissue of a patient, the implant including a sleeve; a spool coupled to the implant; a flexible contracting member coupled to the spool and the sleeve such that winding the contracting member around the spool tightens the contracting member; and a tissue anchor including a distal tissue coupling element configured to couple the tissue anchor to the cardiac tissue of the patient; and a proximal implant-receiving element configured to receive at least a portion of the implant and facilitate coupling of the implant to the tissue anchor; and a proximal implant-receiving element including an implant-restraining element coupled to a portion of the implant-receiving element, the implant-restraining element being configured to restrain the implant from separating from the implant-receiving element.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a stent having a collapsed condition, an expanded condition, and cells arranged in circumferential rows. The stent has an anterior side configured to be disposed adjacent an anterior native valve leaflet and a posterior side configured to be disposed adjacent a posterior native valve leaflet. A valve assembly having a plurality of leaflets is disposed within the stent and a flange is disposed about the stent. The flange includes a flared portion adjacent the inflow end and a body portion extending from the flared portion to the outflow end, the flange extending between a first set of attachment points adjacent the inflow end, and a second set of attachment points adjacent the outflow end.

Abstract: An implant for implantation around a circumferential tissue structure in a heart, includes a flexible elongated component having a longitudinal axis and a first distal end portion, a second distal end portion and an intermediate portion extending between the first and second distal end portions, and an inner lumen extending longitudinally between the first and second distal end portions and through the intermediate portion; and a locking member for allowing the first distal end portion to be fixedly connected to the second distal end portion so as to provide the elongated component as a closed loop. The first distal end portion is provided with a first distal opening which connects the inner lumen with an outside of the component. The second distal end portion is provided with a second distal opening which connects the inner lumen with the outside of the component.

Abstract: A cord can be affixed to an annulus or adjacent tissue using anchors distributed about the cord to anchor respective regions of the cord to the annulus or adjacent tissue. Anchor launchers (which are supported by support arms) launch the anchors to embed them in the annulus or adjacent tissue. Flexible radio-opaque protrusions protrude distally beyond the anchor launchers. Progressive advancement of an anchor launcher in a distal direction beyond a point at which a protrusion makes contact with the annulus or adjacent tissue results in progressive deflection of the protrusion. This deflection can be visualized using fluoroscopy to ensure that the cord is positioned correctly before the anchors are launched. Some embodiments use an open loop of cord, in which case the cord can subsequently be used to constrict the annulus. Other embodiments use a closed loop of cord to prevent expansion of the annulus.

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: A bone graft system includes a two-dimensional mesh sheet sized and shaped to, when folded along fold lines, form a three-dimensional graft containment structure configured to be packed with a bone graft material for placement within a target area of a bone, the mesh sheet including a first end flap connected to a remaining portion of the mesh sheet via a first fold line and a second end flap connected to the remaining portion of the mesh sheet via a second fold line, a third fold line extending from the first fold line to the second fold line so that the remaining portion is configured to be wrapped around folded first and second end flaps to form the graft containment structure, the first and second end flaps substantially corresponding to a profile of the target area of the bone.

Abstract: An intervertebral disc is provided having an upper plate, a lower plate, and a core. The upper and lower plates include outer vertebral body contacting surfaces which are provided with attachment enhancing features to ensure bone integration. The attachment enhancing features shown include one or more fins, serrations and teeth. An opposite surface of the plates from the vertebral body contacting surfaces is formed with a recess which serves as a bearing surface for the core. In order to form an intervertebral disc with a lower disc height, at least one of the recesses is provided opposite a corresponding dome shaped portion on the vertebral body contacting surfaces. This allows the plates to be formed with a thinner profile for a smaller overall disc height. In addition to providing a lower overall height to the artificial disc, the dome shaped portion of the plates also provides a more anatomically shaped outer vertebral body contacting surface.

Abstract: Total knee replacement is the standard treatment for advanced knee osteoarthritis. An improved method of treating an osteochondral defect for knee osteoarthritis of dogs is provided, which is a composite tissue for treating or preventing a disease, disorder, or condition associated with an osteochondral defect with new technique. The new technique of custom made instruments and implants for dog and small animals is applied for different breeds of dogs regardless of their sizes and weights. The tool is a custom made instruments, which is based on capture of image based (CT or computed X-ray) to be transferred to electronic 3D model and apply 3D preoperative planning to design the tools are used to perform the knee surgery.

Abstract: Embodiments of a system and method for assessing hip arthroplasty component movement are generally described herein. A method may include receiving data from a sensor embedded in a femoral head component, the femoral head component configured to fit in an acetabular component, determining information about a magnetic field from the data, and outputting an indication of an orientation, coverage, or a force of the femoral head component relative to the acetabular component.

Abstract: Systems, devices, and methods for providing orthopedic augments having recessed pockets that receive a fixation material. The orthopedic augments include an outer surface that interfaces with a patient's tissue or bone, and an inner surface that interfaces with an implant, the inner surface defining a recessed pocket configured to receive a fixation material, a rim around at least a portion of the recessed pocket, and a port in the rim, wherein the recessed pocket extends along the inner surface in at least a direction laterally from the port.

Abstract: The present invention relates to a partial joint replacement (1000), encompassing a shell-like segment (100) with a concave inner contour (3) for the arrangement on at the bone structure of a patient, wherein the segment (100) comprises a lateral section (5) and a medial section (7) along a longitudinal direction (x), and wherein the outer contour (1) of the segment (100) comprise in longitudinal direction (x) at least one inflection point (9).

Abstract: An artificial joint implant (1) comprising a first element (2) with a socket (4) and a second element (3) with a ball head (5), wherein said ball head (5) is insertable in said socket (4) such as to form a ball-and-socket connection between said first element (2) and said second element (3), and the movement of said ball head (5) in said socket (4) is restricted by means of a protrusion (6.1; 6.2) engaged in a groove (7), whereby said protrusion (6.1; 6.2) has a central axis A2 and is protruding from the surface of said socket (4) and said groove (7) is provided on the surface of said ball head (5) or vice versa; —said groove (7) is positioned along a great circle of said ball head (5) or of said socket (4), —said protrusion (6.1; 6.2) has a shape allowing rotation of the protrusion around its central axis A2 when received in the groove (7); and —the surface roughness of the protrusion (6.1; 6.2) and/or of the groove (7) is at most 25 micrometers.

Abstract: The present invention provides a femoral prosthesis for a femur which can enable or allow deep knee flexion without creating excessive tension in the ligamentous structure of the knee. The femoral prosthesis includes an internal non-articulating surface, an external articulating surface, a medial condyle and a lateral condyle. The height of the medial condyle is less than the height of the lateral condyle. A proximal-posterior tip of the medial condyle is rounded and is shifted inwards relative to the native level of the proximal-posterior region of the femur bone to facilitate knee flexion. A method of mounting a femoral prosthesis on a femur is also described.

Abstract: An articulating joint includes a base member, a suspended member and at least one tension member. The base member includes at least two base member peripheral anchors and a base member intermediate anchor located between the base member peripheral anchors. The suspended member includes at least two suspended member peripheral anchors and a suspended member intermediate anchor located between the suspended member peripheral anchors. The at least one tension member couples the base member peripheral anchors to the suspended member peripheral anchors and couples the base member intermediate anchor to the suspended member intermediate anchor so that the base member and the suspended member are configured for constrained relative articulation with the suspended member partially received within the base member.

Abstract: An expansible intervertebral implant is disclosed, various embodiments of which comprise an elongated body along a longitudinal axis comprised between a proximal end and a distal end, a flexible arm mounted in the vicinity of the distal end of the longitudinal body and movable between: a folded-back position with the arm substantially parallel to the axis, and a deployed position with the arm not parallel to the axis and away from the body to expand said implant along an axis, by assuming the general shape of a circular arc, a means for deployment of said flexible arm for deploying the latter from the folded-back position to the deployed position, by the sliding of a proximal portion of said flexible arm with respect to the body inducing an increase in the space occupied by the implant, greater than the space of the implant in the folded-back position.

Abstract: Various embodiments comprise an expansible intervertebral implant intended to be implanted in a space between two adjacent vertebrae to at least partly supplant an intervertebral disc, said implant being able to expand along three substantially mutually orthogonal axes so as to comply with the lordosis of the patient while still having increased stability and reliability.

Abstract: Coiled spinal implants for disc, vertebral body, and spinal motion segment replacement or reconstruction comprise a plurality of loops and spaces between the loops, with the loops formed of a hollow material and having a plurality of apertures or a longitudinal gap that extend(s) through the sidewalls of the loops and into the hollow center. The coiled implants include one or more balloons within the hollow center, the spaces between the coil loops, and/or within the central void that the coil surrounds. Filling the balloon expands the loops and thereby increases the height of the coil. Bone graft material or bone cement may be deployed from the apertures or gap.

Abstract: A sacro-iliac implant includes a body having a proximal portion and a distal tip. The proximal portion includes an inner surface and a uniform diameter. The inner surface includes a first mating surface engageable with a first instrument surface and a second mating surface engageable with a second instrument surface. Systems, constructs, instruments and methods are disclosed.

Abstract: An expandable spinal implant includes a distal projection extending from only one side of the implant, ending in an anterior tip, the anterior portion and anterior tip defining an elongated distal end hook, which is wider than the proximal end. The distal end hook rotates around the spinal cord, aligning the implant with a desired pathway, then inserts into place in the disc space between the vertebrae. The elongated widened distal end hook provides a TLIF approach, distributes loads, provides anterior rim engagement, and creates lordosis.

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 body, a first endplate, and a second endplate, a middle ramp piece, a stem, and two ramp pins. The middle ramped piece is operable to move to generate lordotic expansion of the first and second endplates followed by parallel expansion. The fusion device is operable to be 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 body, a first endplate, and a second endplate, a middle ramp piece, a stem, and two ramp pins. The middle ramped piece is operable to move to generate lordotic expansion of the first and second endplates followed by parallel expansion. The fusion device is operable to be deployed down an endoscopic tube.

Abstract: An expandable housing for an interbody fusion system has movable tapered external helical threaded members that travel along tracking to operably engage against the top and bottom shell members, urging them apart to cause expansion in the height of the housing. In an embodiment, the tapered members are disposed in a dual arrangement such that independent engagement of the tapered members along lateral portions of the top and bottom shells cause an angular tilt to the exterior surface of the housing when the tapered members are moved to different degrees. This function permits adjustment in the angular relationship between adjacent vertebrae and assists the lordotic adjustment of the patient's spine. When the functions of the device are used in combination by the surgeon, the device provides an effective tool for in situ adjustment when performing lateral lumbar interbody fusion.

Abstract: An expandable intervertebral implant includes a first endplate and a second endplate, a first wedge member and a second wedge member spaced from the first wedge member that couple the first and second endplates together. The first and second wedge members configured to translate along an actuation member housed between the first and second endplates to cause the implant to expand from a first collapsed configuration into a second expanded configuration. The actuation member has a first threaded section spaced apart from a second threaded section where the first and second threaded sections are at an angle with each other. Between the first and second threaded sections on the actuation member there is a section that permits the first and second threaded sections to rotate in the same rotational direction.

Abstract: This invention improves upon prior art total disc replacements (TDRs) by more closely replicating the kinematics of a natural disc. The preferred embodiments feature two or more fixed centers of rotation (CORs) and an optional variable COR (VCOR) as the artificial disk replacement (ADR) translates from a fixed posterior COR that lies posterior to the COR of the TDR to facilitate normal disc motion. The use of two or more CORs allows more flexion and more extension than permitted by the facet joints and the artificial facet (AF). AF joint-like components may also be incorporated into the design to restrict excessive translation, rotation, and/or lateral bending.

Abstract: Systems and methods may display an indication of an impact force from a driving device. A method may include displaying the indication of the impact force with a light. The light may be located on the driving device, a component attached to the driving device, a user interface, or the like. Different colors may be used to indicate different impact forces. For example, a first light color may correspond to an impact force below a first threshold, a second light color may correspond to an impact force above a second threshold, and a third light color may correspond to an impact force between the thresholds. The impact force may be detected using a sensor, which may output a voltage to cause the illumination.

Abstract: A measurement device is provided for measuring a resected femoral head. The device comprises a base (102) with a support rod (104) extending transversely from the base and extending in a direction corresponding to a height of a resected femoral head. A femoral head support (108) is attached to a base proximate an end of the support rod (104) for supporting a severed end of a femoral head at a selected incline between about 30° and 60° relative to the base such that a height of the resected femoral head extends in the general direction of the support rod. A transverse height indicating arm (120) is adjustable up the height of the support rod (104) so as to measure the height of a resected femoral head (106) positioned on the femoral head support in use. The transverse height indicating arm (120) may carry adjustable offset indicating arm (122).

Abstract: Embodiments of a system and method for assessing hip arthroplasty component movement are generally described herein. A method may include receiving data from a sensor embedded in a femoral head component, the femoral head component configured to fit in an acetabular component, determining information about a magnetic field from the data, and outputting an indication of an orientation, coverage, or a force of the femoral head component relative to the acetabular component.

Abstract: A trial for insertion into a disc space between adjacent vertebrae in order to facilitate sizing of an interbody spinal implant includes an end portion and a shaft portion. The end portion is dimensioned to approximate the dimensions of an available interbody spinal implant. The trial includes passages extending through at least portions of the end portion and the shaft portion to facilitate access to the disc space during use of the trial.

Abstract: A prosthetic foot comprises: i) a lower lamina having a wavy shape comprising a curved front portion and a curved rear portion, whose concavities are oriented upwards with respect to a vertical direction (V), and an intermediate, mostly curved portion having a concavity facing away with respect to the concavities said front and rear portions, ii) a sickle-shaped front lamina comprising a lower end portion restrained to said lower lamina close to its front portion, an upper end portion configured so as to allow connection of a mounting member of the prosthetic foot, as well as an intermediate, mainly curved portion arranged between the lower end portion and the upper end portion, iii) a rear lamina comprising an upper portion restrained to the front lamina close to its upper end portion, and a lower portion restrained to the lower lamina at its curved rear portion.

Abstract: Powered limb prostheses with multi-stage transmissions are provided.

Abstract: A gait assistance apparatus including at least one sensor configured to sense a step motion of a user, and an operator configured to determine assistance forces of a right step and a left step of the user based on step motion information of the user and adjust the assistance force for at least one of the right step or the left step of the user based on a result of proportionally adding together the assistance forces of the right step and the left step based on a variable ratio may be provided.

Abstract: In some aspects, methods are provided for controlling a powered lower limb device. A stance phase control method is disclosed in which the required joint torque is determined based on the difference between two joint angles, such as the knee joint and the ankle joint. A swing control method is also disclosed that employs feedback-based minimum jerk trajectory control. In other embodiments, a joint assembly for use in modular lower limb device is provided. The joint assembly includes a reconfigurable slider-crank mechanism that is configurable to provide a plurality of different ranges of rotational travel, rotational speeds, and torques, for customization according to different anatomical joints. The joint assembly may include a compact coupling device for coupling a ball screw of the slider-crank mechanism to an output shaft of a motor. When employed to form a modular orthosis, the joint assembly may be adapted for self-alignment as its length adjustment method during setup.

Abstract: A method of transferring intrinsic hand muscles along with a respective nerve and blood supply; and allowing signal detection by a surface electrode is provided. The method further includes transferring muscles of a forearm along with a respective nerve and blood supply; and allowing signal detection by a surface electrode.

Abstract: A medical device includes a polymer stent scaffold crimped to a catheter having an expansion balloon. A process for forming the medical device includes placing the scaffold on a support supported by an alignment carriage, and deionizing the scaffold to remove any static charge buildup on the scaffold before placing the scaffold within a crimper to reduce the scaffold's diameter. The polymer scaffold is heated to a temperature below the polymer's glass transition temperature to improve scaffold retention without adversely affecting the mechanical characteristics of the scaffold when deployed to support a body lumen.

Abstract: Various embodiments of the present disclosure generally comprise devices and methods for the controlled over-expansion of a body conduit and controlled constriction or expansion of a vessel in a patient. In various embodiments, a device comprises a bio-corrodible expandable support structure and an implant coaxially adjacent the support structure. Contraction of the implant can occur when the support structure is bioabsorbed.

Abstract: This invention relates to a stent and a stent set. In accordance with this invention there is provided a stent comprising a tubular stent body made of mesh and an opening in the tubular body.

Abstract: A radially expandable, tubular stent, includes a first section having a first crush resistance force and a second section have a second crush resistance force, wherein the first crush resistance force is less than the second crush resistance force. The first section is connected to the second section to form a tube, connection of the first and second sections extending in an axial direction of the tube.

Abstract: A radially expandable, tubular stent, includes a first section having a first crush resistance force and a second section have a second crush resistance force, wherein the first crush resistance force is less than the second crush resistance force. The first section is connected to the second section to form a tube, connection of the first and second sections extending in an axial direction of the tube.

Abstract: Examples of a stent is provided with interlocking joints removably coupling adjacent axial stent segments. Mating elements forming the interlocking joints maintain circumferential and axial engagement when the stent is in the radially compressed configuration, for example, during tracking of the stent to a treatment site of a body vessel, and become disengaged during radial expansion of the stent. The length of mating elements may be sized as large as the strut width. When disengaged, the disconnected the axial stent segments remain discrete stent structures separated from one another along the point of treatment.

Abstract: A stent is disclosed that improves passing properties and an expansion force while securing a cross-sectional area of the stent and decreasing a decreasable diameter of the stent. The stent has linear struts, which form an outer periphery of a cylindrical shape and a link portion connecting the struts to each other, in which the struts of the cylindrical shape are mounted on an outer peripheral surface of a dilatable and deformable balloon. The stent has a plurality of strut cross-sectional portions in a cross section perpendicular to an axial direction of the struts of the cylindrical shape, the strut cross-sectional portions adjacent to each other in a circumferential direction of the struts have shapes different from each other, and surfaces of the strut cross-sectional portions adjacent to each other are in contact with each other when the struts are mounted on the outer peripheral surface of the balloon.

Abstract: Post deployment radial force recovery of biodegradable scaffolds are described where a high molecular weight polymer may be formed into a high molecular weight scaffold by solution casting into a tubular substrate such that the scaffold retains its mechanical properties through processing. The tubular substrate is laser cut and subsequently crimped onto a catheter for deployment into a body lumen. The polymeric scaffold may retain its mechanical properties and result in increased radial strength post-deployment in a saline environment, e.g., within a body lumen. This scaffold enhancement may be attributable at least in part to entanglement of high molecular weight polymer chains as one factor that effects radial force recovery and also to the design or geometry of the scaffold as another factor that effects radial force recovery after deployment.

Abstract: An endoluminal prosthesis assembly includes a delivery system having an introduction end, an operator end, and a stent graft retention region. An endoluminal prosthesis is disposed at the stent graft retention region. The prosthesis comprises a tubular body, an inner lumen extending between proximal and distal ends of the tubular body, at least one fenestration disposed in a sidewall of the body, and an internal branch at least partially formed with the sidewall of the body and disposed in parallel alignment with the prosthesis. A guide wire having a first end and a second end is pre-loaded with the prosthesis in the delivery system. At least a portion of the guide wire is disposed within the internal branch and the inner lumen of tubular body of the prosthesis prior to delivery of the prosthesis and during delivery and deployment of the prosthesis.

Abstract: A stent delivery system and method are provided. The stent delivery system includes an elongate shaft including a proximal portion, a distal portion, at least one lumen extending at least partially therethrough, and a stent receiving portion on the distal portion of the elongate shaft. A stent is positioned on the stent receiving portion of the elongate shaft, the stent having a first position and a second position. A proximal constraining member is positioned on a proximal end of the stent. A distal constraining member is positioned on a distal end of the stent. A restraining member disposed throughout a length of the elongate shaft and releasably engaged with at least one of the proximal constraining member and the distal constraining member, the restraining member having a proximal end and a distal end. The stent is in the first position, the distal restraining member applies an axial mechanical force to the distal constraining member.

Abstract: A stent delivery system includes an elongate shaft including a proximal portion, a distal portion, at least one lumen extending at least partially therethrough, and a stent receiving portion on the distal portion of the elongate shaft. A stent is positioned on the stent receiving portion of the elongate shaft, the stent having a first configuration and a second configuration. A proximal constraining arrangement is engaged with a proximal end of the stent. A distal constraining arrangement is engaged with a distal end of the stent. The stent delivery system includes a handle assembly comprising a first shuttle operably connected to the proximal constraining arrangement and a second shuttle operably connected to the distal constraining arrangement. A brake assembly positioned is within the handle assembly, the proximal constraining arrangement being coupled to a portion of the brake assembly.