Abstract: A leaflet including fibers oriented at an angle relative to at least one free edge of the leaflet. A leaflet including mechanisms for increasing coaptation height, preventing billowing, and reducing stress in critical regions of the leaflet. A prosthetic heart valve, including three leaflets operatively attached together. A method of using a prosthetic heart valve, by applying pressure to the valve, forming a pocket with material of three leaflets operatively attached together and increasing coaptation height, reducing billowing of the leaflets toward a ventricle, and reducing stress in critical regions of the leaflet. A chorded valve including at least one leaflet, wherein bundles of fibers exit said free edges as tethers an can be anchored to tissue. A method of using the chorded valve, by anchoring the tethers to tissue, forming a pocket with the material of leaflets and increasing coaptation height, and reducing billowing of leaflets toward an atrium.

Abstract: A prosthetic atrioventricular tissue valve comprising a continuous tubular member formed from a first biocompatible material, the tubular member having proximal and distal ends, and at least one valve leaflet formed therein, the distal end of the tubular member including cardiovascular structure engagement means for connecting the tubular member to a cardiovascular structure, the cardiovascular structure engagement means comprising a plurality of elongated members that extend distally from the distal end of the tubular member.

Abstract: The present embodiments provide a prosthesis comprising first and second segments, and an axially extendable segment coupled to the first and second segments. A valve is coupled to at least one of the axially extendable segment or the second segment. The axially extendable segment comprises a first state in which the valve at least partially overlaps with the first segment, and the axially extendable segment comprises a second state in which the valve lacks an overlap with the first segment.

Abstract: A delivery system and a method for deploying a cardiovascular prosthetic implant using a minimally invasive procedure are disclosed. The delivery system comprises an introducer catheter, a delivery catheter having a proximal end and a distal end, and a seal assembly, wherein an outer diameter of the distal end of the delivery catheter is greater than an inner diameter of the distal end of the introducer catheter.

Abstract: This disclosure relates to a catheter system for introducing a heart valve stent into the body of a patient. The catheter system includes a catheter tip having a seat portion for accommodating the stent in its collapsed state and a stent holder for releasably fixing the stent, wherein the seat portion is constituted by a first sleeve and a second sleeve, said sleeves being moveable relative to each other and relative to the stent holder, and a catheter shaft for connecting the catheter tip to a handle.

Abstract: A delivery apparatus for a prosthetic implant can include an elongate first shaft, a first suture guide coupled to the first shaft, an elongate second shaft, and a second suture guide coupled to the second shaft. The first shaft can extend coaxially through the second shaft and the second suture guide, the first suture guide can be disposed distal to the second suture guide, and the first suture guide and the second suture guide can be configured to be axially movable relative to each other.

Abstract: The present disclosure includes a method comprising inserting an implant proximate a mitral valve, the implant comprising a tubular body and a plurality of piercing members, the tubular body comprising an upper diameter and a lower diameter. The method also includes engaging tissue proximate the mitral valve by the plurality of piercing members and transitioning the tubular body from a first structural configuration to a second structural configuration by application of an expansive force to the tubular body proximate the upper diameter, the first structural configuration having the upper diameter smaller than the lower diameter and the second structural configuration having the upper diameter larger than the lower diameter. The present disclosure also includes associated systems and implants.

Abstract: Percutaneous or minimally invasive systems configured to deliver a synthetic chord to an internal body location are provided. Aspects of the percutaneous or minimally invasive systems include a synthetic chord present in a percutaneous minimally invasive delivery device. The systems and methods of the invention find use in a variety of applications, such as cardiac valve, e.g., mitral valve, repair.

Abstract: An annuloplasty device for repairing a heart valve comprises a first and a second support member that overlap each other and form a scissor linkage. The first and second support members are configured to pinch leaflets of the heart valve.

Abstract: A venous valve prosthesis includes a frame and a prosthetic valve coupled to the frame. With the venous valve prosthesis implanted in a vein, the prosthetic valve includes a closed configuration wherein an outer surface of the prosthetic valve is in contact with a wall of the vein around a circumference of the prosthetic valve to prevent blood from flowing past the prosthetic valve between the wall of the vein and the outer surface of the prosthetic valve. The prosthetic valve is configured to move to an open configuration such that at least a portion of an outer wall of the prosthetic valve partially collapses away from the wall of the vein in response to antegrade blood flow through the vein to enable blood flow between the outer surface of the prosthetic valve and the wall of the vein.

Abstract: Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

Abstract: Medical devices, systems, and methods reduce the distance between two points in tissue, often for treatment of congestive heart failure and often in a minimally invasive manner. An anchor is inserted along an insertion path through a first wall of the heart. An arm of the anchor is deployed and rotationally positioned according to a desired alignment. Application of tension to the anchor may draw the first and second walls of the heart into contact along a desired contour so as to effect a desired change in the geometry of the heart. Additional anchors may be inserted and aligned with the first anchor to close off a portion of a ventricle such that the ventricle is geometrically remodeled and disease progression is reversed, halted, and/or slowed.

Abstract: A device for measuring an internal dimension of a native cardiac valve annulus includes an elongated support member having a proximal portion and a distal portion. A measuring portion is coupled to the distal portion, and an indicator is coupled to the proximal portion of the support member. The measuring portion is biased towards a deployed configuration such that when deployed it applies an outwardly directed radial force to the native valve annulus.

Abstract: Methods of producing bone graft materials are provided. Aspects of the methods include comminuting an initial bone source to produce a particulate bone composition, cleaning the particulate bone composition and then combining the cleaned particulate bone composition with an organic acid solution in a manner sufficient to produce a bone graft material. Aspects of the invention also include kits that find use in practicing the methods, as well as bone graft materials produced by the methods. The methods and bone graft materials produced thereby find use in a variety of applications, e.g., spinal fusion and bone void filling applications.

Abstract: Prosthetic tegmen plates are provided. The prosthetic tegmen plates include a body that defines at least one engagement surface that substantially conforms to a region of a corresponding surface of a subject's temporal bone having a tegmen defect. The prosthetic tegmen plates are configured to cover the tegmen defect. Methods for manufacturing prosthetic tegmen plates by additive manufacturing and surgically implanting prosthetic tegmen plates are also provided.

Abstract: One aspect of the present disclosure provides a method of manufacturing an orthopedic prosthesis. This particular method includes providing a porous metal layer (22) positioned against a metal substrate at an interface between the porous metal layer and the metal substrate. Additional steps include providing an electrode (132) and providing an intermediate element or coating positioned between and in contact with the electrode and the porous metal layer where the intermediate element includes tantalum in contact with tantalum of the porous metal layer. In a further step, an electrical current is directed to the interface between the porous metal layer and the metal substrate to bond the porous metal layer to the metal substrate.

Abstract: An orthopaedic screw includes a main body having a torqueing end, an inner chamber formed therein, and at least two mating features separated by a separation gap, the separation gap extending into the inner chamber, at least one of the at least two mating features having a first tapered portion with an increasing width and a second tapered portion with a decreasing width; and a support member removably placed in the inner chamber of the main body and having a support portion at least partially filling the separation gap between the at least two mating features.

Abstract: The present invention provides an artificial knee joint that can reconstruct an anterior cruciate ligament in a state close to an original function. An artificial knee joint (1) that is used in a total knee replacement includes a femur member (10) and a tibia member (20). The tibia member (20) has a ligament insertion hole (20h) which pierces the tibia member (20) and which is formed at a position where once an anterior cruciate ligament (ACL) exists in a knee replaced for the artificial knee joint (1). Therefore, a ligament can be provided such that a distal end (DT) of a femur (F) and a proximal end (PE) of a tibia (T) are joined to each other by passing the ligament through the ligament insertion hole (20h), which allows the anterior cruciate ligament (ACL) to be reconstructed so as to be in the substantially same state as a knee replaced for the artificial knee joint (1).

Abstract: A set of distal femoral knee prostheses which are designed to be more narrow in medial/lateral dimensions with increasing anterior/posterior size than existing prostheses to more closely correspond to the physical anatomy of female patients. The prostheses are designed to have a substantially trapezoidal shape or profile when viewed distally which features a more pronounced narrowing of the medial/lateral dimensions beginning at the posterior end of the prostheses and progressing anteriorly to the anterior end of the prostheses. Additionally, the prostheses each include a reduced profile patellar sulcus and reduced profile anterior condyles to more closely conform to the anatomy of a resected femur, and also include sulcus tracking optimized to conform to female anatomy.

Abstract: A reverse shoulder replacement system including a humeral liner defining a split curvature bearing surface that includes a plurality of curvature regions. The plurality of curvature regions are configured to engage a glenosphere of a glenoid implant individually or in combination to provide an improved fit between the glenosphere and the humeral liner.

Abstract: Modular humeral implants and methods of use. A humeral implant can include a stem portion, a metaphyseal portion, a locking element, and an intermediate portion. The intermediate portion can include at least one spacer. Each spacer can include a proximal engagement feature, a distal engagement feature, a lumen extending longitudinally through the spacer, and a pin slidable within the lumen of the spacer. Distal movement of a locking element in the metaphyseal portion can translate the pin of each spacer to secure the metaphyseal portion, the intermediate portion, and the stem portion in a locked configuration.

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: The invention concerns a surgical implant (1) for correcting the mutual positioning or orientation of the bones of a patient designed to be inserted between at least two bone bodies (2, 3) of said patient, and comprising: a main body (5) extending along a longitudinal axis (X-X?), a plurality of fins (9), each fin (9) being provided with a junction edge (10) connecting said fin (9) to said main body (5), such that said fins (9) protrude from said main body (5) from the respective junction edge (10) thereof, the surgical implant (1) being characterized in that each fin (9) has a sufficient flexibility so that it can be deformed along a direction centripetal and/or parallel to the longitudinal axis (X-X?) under the action of at least one of the bone bodies (2, 3) when said surgical implant (1) is inserted between said bone bodies (2, 3). Surgical implants.

Abstract: A system includes and implant and an elongate device. The implant includes a first bone engaging portion and a flexible portion coupled to an end of the first bone engaging portion at an engagement portion. The flexible portion is configured to be compressed toward a longitudinal axis defined by the flexible portion. The elongate device includes an engagement end that is sized and configured to engage the engagement portion of the implant.

Abstract: An implant device for osseous integration includes a plurality of connection bars and at least one frame bar. These connection bars are connected with each other to form a three-dimensional (3D) grid structure. The frame bar is connected with at least two of the connection bars to define at least one edge of the 3D grid structure. Wherein, the frame bar has a diameter substantially greater than that of these connection bars.

Abstract: Disclosed are bone spacing implants for bone fusion with an open helix locking system and insertion instrumentation for implanting a spacer and fixating with a helix lock without removal of instrumentation between steps. Implanting methods comprise the steps of: positioning a coil driver over an elongate shaft portion of a bone spacer inserter; loading a helical lock implant on a distal end of an elongate shaft portion wherein an elongate shaft portion occupies a central core space of the helical lock; positioning and fixing a selected bone spacer implant to the bone spacer inserter instrument; advancing the bone spacer and helical lock instrumentation assembly into an intervertebral space; advancing through rotation a coil driver transmitting torsional forces against a butt surface of a helix lock until the helix lock is fully threaded into adjacent bone and the bone spacer.

Abstract: Orthopedic implants, particularly interbody spacers, have a combination of correct pore size and stiffness/flexibility. When the implants have the proper pore size and stiffness, osteocytes are able to properly bridge the pores of the implant and then experience a proper compressive load to stimulate the bone cells to form bone within the pores. An implant includes a body formed of an osteoconductive material and having a stiffness of between 400 megapascals (MPa) and 1,200 MPa. Additionally, the body includes a plurality of pores having an average size of between 150 microns and 600 microns. The pores permit the growth of bone therein. The body is formed of packs of coils which may be formed using an additive manufacturing process and using traditional orthopedic implant materials such as titanium and titanium alloys while still achieving desired stiffness and pore sizes of the implants.

Abstract: An intervertebral implant includes a body and a plate. The body has an upper surface defining an upper plane and a lower surface defining a lower plane. First and second fastener holes of the plate are configured to retain the heads of first and second fasteners. A portion of each of the shanks of the first and second fasteners extends from the first and second fastener holes beyond the upper plane. The shank portions of the first and second fasteners are curved in a direction away from the upper surface. The third fastener hole is configured to retain the head of the third fastener between the upper and lower planes. A portion of the shank of the third fastener extends from the third fastener hole beyond the lower plane. The shank portion of the third fastener is curved in a direction away from the lower surface.

Abstract: A cage for implanting in bone includes a main body having a fastener mounting receiver. The main body includes a first surface that contacts a first bone surface, a second surface that contacts a second bone surface, a side wall extending between the first and second surfaces, and a front wall comprising a connection surface, wherein the fastener mounting receiver extends from the connection surface. A fastener is placed within the fastener mounting received and configured to engage and fix a plating device on the connection surface of the main body.

Abstract: The present invention provides an intervertebral implant for implantation in a treated area of an intervertebral space between vertebral bodies of a spine. The implant includes a spacer portion having an inferior and superior surface, wherein the inferior and superior surfaces each have a contact area capable of engaging with anatomy in the treated area, and the inferior and superior surfaces define a through-hole extending through the spacer body. The present invention further provides screw holes extending from a side portion to the inferior and superior surfaces of the spacer portion and a plate portion coupled to the spacer portion through a coupling means, wherein the plate portion contains screws holes for receiving screws. A screw back out prevention mechanism adapted on the plate portion and prevents the back out of screws from the screw holes.

Abstract: A cage for implanting in bone that has a first plate having a surface that contacts a first bone surface, a second plate having a surface that contacts a second bone surface, a intermediary plate that dynamically couples to the first plate and the second plate, an actuator that drives and causes the intermediary plate to move between the first plate and the second plate along a predetermined direction, and an anchor that attaches to the first plate and the second plate to engage the actuator to drive the actuator longitudinally along the predetermined direction.

Abstract: An implant (500, 600) includes first and second arms (14a, 14b) hinged to a base (12) at spaced-apart locations. An actuator (18, 22a, 22b, 602, 604, 606) is deployed to rotate the arms from an initial position in opposing angular motion towards a final position. A rigid bridging element (28) bridges between the arms so that deployment of the arms towards the final position displaces the bridging element away from the base. Engagement between the bridging element and at least one of the arms is via a double pin-in-slot engagement in which two non-collinear pins (30, 40) are engaged in respective non-parallel slots (32, 42).

Abstract: An intervertebral implant, alone and in combination with an insertion tool for inserting same and a method for inserting same. The implant has upper and lower parts which have universal movement relative to each other. Each of the upper and lower parts also has a surface engaging an adjacent vertebrae. Each part has a keel extending from said surface into a cutout in the adjacent vertebrae, and each keel has an anterior opening recess therein. An insert tool has a pair of arms which are received in the recess of the keels through the anterior opening to securely hold and insert the implant. Projections and matching indentations in each arm and the base of its recess securely attached each arm within its keel.

Abstract: Instrumentation for implanting a cervical disc replacement device includes cervical disc replacement trials for determining the appropriate size of replacement device to be implanted, an insertion plate for maintaining the elements of the replacement device in fixed relation to one another for simultaneous manipulation, an insertion handle for attachment to the insertion plate for manipulation of the elements, an insertion pusher for releasing the insertion handle from the insertion plate, a drill guide that cooperates with the insertion plate to guide the drilling of tap holes for bone screws to be placed through bone screw holes in the flanges of the replacement device, clips that are applied to the flanges after placement of the bone screws to resist screw backout, and a clip applicator for applying the clips to the flanges.

Abstract: A cage or spacer device for harvesting bone graft material for use in bone fusion surgery, e.g., spinal fusion. The device is inserted between facing surfaces of the bones to be fused, and a chamber is formed in the device for containing a slurry of morselized bone and blood to be effused from the bones. In one embodiment, a bone cutter assembly including a cannula having a bend at a distal end is inserted in the chamber for operation. A wire having a cutting tip is passed inside the cannula so that the tip projects a determined distance from the distal end of the cannula. Accordingly, the cutting tip strikes and cuts grooves in the facing surfaces of the bones when the cannula is rotationally driven about its axis. The mentioned slurry effuses from the grooved surfaces and remains in the chamber to promote a solid and healthy fusion.

Abstract: Devices and methods for preparing a surgical site, and in particular vertebral members, which may include a retractable tool and an actuator. The tool may include distal and proximal members. A distal side of the distal member may be fixed in a longitudinal direction and pivotable at a point of rotation. A proximal side of the proximal member may be pivotably connected to the actuator. In a retracted position, the distal member may be pivotably connected to the proximal member longitudinally in between the point of rotation and the proximal side of the proximal member. Moving the actuator in a distal direction may push the proximal member and the distal member such that the proximal member pivots with respect to the actuator and distal member, the distal member pivots with respect to the proximal member and point of rotation, and the proximal member and distal member move laterally outward.

Abstract: A design method for design of a rig is presented. The rig comprises a hollow tubular shell, and the interior of said shell defines at least first and second intersecting cylinders. The design method comprises identifying a damage area, presenting a 3D view of identified damage area and generating a 3D model of a virtual rig. The generating comprises virtually placing in 3D view a shape covering or partly covering damage area, and creating, based on the position of the virtually placed shape, a position of hollow tubular rig shell of the virtual rig. The method further comprises selecting the at least first and second intersecting cylinders of the virtual rig, based on the size and form of the virtually placed shape, and creating a positioning surface of the virtual rig which is a bone and/or cartilage-engaging end of hollow tubular shell. The positioning surface is adapted to follow the surface surrounding the virtually placed shape when the virtual rig is placed in a virtual model of the joint.

Abstract: A cylinder head, an element and a base plate of a longitudinal piston engine having a cylinder head body and a base plate comprising at least one element, the base plate being interposed between a combustion chamber and the cylinder head body, comprising an upper face facing the cylinder head body and an opposing lower face arranged to face the combustion chamber and being attached to the cylinder head body, the cylinder head body being made from a material with a mass density and hardness that are less than those of the material constituting the base plate. The base plate and the body are assembled by screws for fastening the base plate to the cylinder head that are located towards the periphery of the base plate and of the body and by at least one part for fastening the cylinder head to the base plate including a threaded end designed to be engaged in a corresponding orifice of the base plate, said orifice being located closer to the center of the base plate than the fastening screws.

Abstract: A method of reproducing a central axis of a femoral neck prior to resection during an implantation process includes the step of attaching a frame to the acetabulum of a patient, wherein the frame includes first and second movable arms and a lockable swivel bearing. The method further includes the steps of orienting and locking the swivel bearing in position and utilizing the position of the swivel bearing to position acetabular instrumentation to match a planned acetabular implant orientation.

Abstract: A prosthetic adapter including a lower connector, an upper connector rotatably coupled to the lower connector, and a locking mechanism for preventing the upper connector from rotating relative to the lower connector. The locking mechanism is arranged to generally automatically retain a locked position when the lower connector is rotated to an original, predetermined alignment. An activation member is connected to and arranged for operating the locking mechanism.

Abstract: An ankle-foot prosthesis includes a foot plate, an ankle frame attached to the foot plate, a yoke pivotally connected to the ankle frame and including a member for attaching to a leg, a damper having a first end connected to the yoke and a second end connected to the ankle frame, and a control mechanism for switching the damper between low and high settings.

Abstract: A movement assistance method includes following steps: detecting a center of pressure; generating a gravity scale according to the center of pressure; measuring a joint angle and estimating a user external torque and a motor torque; generating a compensated assistive torque according to the user external torque, the joint angle, the motor torque and the gravity scale.

Abstract: An adjustable prosthetic device and a fitting tool for positing the prosthetic device on a limb are described. The prosthetic device comprises two or more adjustable paddles that are movably coupled with an adapter via connectors. The connectors allow the paddles to be repositioned relative to a user's limb. The paddles are sized and dimensioned to capture lost motion between the limb and the prosthetic device through skeletal compression and tissue displacement. The fitting tool comprises two or more compression bars that removably couple with the two or more paddles of the prosthetic device. The fitting tool also comprises two or more linear actuators that control the positions of the compression bars and the paddles relative to the limb.

Abstract: An improved structure of a connection and adjustment assembly of a support socket joint of a prosthesis includes a connector, in which a vertical through hole and a horizontal through hole are formed. A support socket is provided on the connector and receives therein an arrest axle extending through the vertical through hole. The horizontal through hole receives therein a shaft, which has an end having a toothed wheel engageable with the arrest axle and an opposite end to which a second one-way bearing, a sleeve, and a knob cap are mounted. The knob cap has an interior that is an elliptical configuration corresponding to and mating an outside elliptical configuration of the sleeve. Pressing a knob causes movement of the sleeve and thus components mounted to the shaft so as to have the toothed wheel disengage from the arrest axle, allowing the arrest axle to be withdrawn out.

Abstract: The invention relates to a medical implant (1) for the occlusion of a patients auricula sinistra by endovascular means, said implant having a cage structure (10) comprising a plurality of webs (3) that are proximally attached to a retaining ring (4) via connecting webs (2) and distally limited by a rim of converging webs (3), wherein said implant (1) consists of a self-expanding material, has in contracted state the shape of a slotted tube and, after expansion, assumes the cage structure (10) of a diameter larger than that of the retaining ring (4) and wherein at least one or several anchor elements (7) are arranged within or distally to the cage structure (10); said anchor elements being proximally connected directly or indirectly with the retaining ring (4), therein (a) the one or more anchor elements (7a) are provided at the distal end with a tip (8) with barb (9), with tip (8) and barb (9) projecting beyond the cage structure (10) with the intention for the tip (8) and barb (9) to be anchored in the muscl

Abstract: The disclosure provides biodegradable implantable devices such as a stent comprising a biodegradable polymeric wherein the polymeric material is treated to control crystallinity and/or Tg. The stent is capable to expand at body temperature in a body lumen from a crimped configuration to a deployed diameter and have sufficient strength to support a body lumen.

Abstract: A method of manufacturing a polymeric stent by forming a pattern on a polymer tube with a laser, where the pattern formed on the polymer tube comprises a plurality of repeating units comprising a plurality of unit cells, each having a V-shaped configuration and polymeric stents formed by the methods. The pattern may be formed on the polymer tube (e.g., polylactic acid tube) using a second harmonic generator laser in which a wavelength ranging from 940 nm to 1552 nm is converted.

Abstract: A radially expansible annular stent is disclosed. The stent comprises a plurality of stenting turns around a lumen centred on a longitudinal axis. Adjacent turns of the stent are joined by connector struts. The stent annulus has a wall thickness related to the material from which it is formed. The radial thickness of the connector struts is smaller than that of the stent annulus. A method of making such a stent is also disclosed. The method includes cutting the connector struts from a tubular workpiece with a laser beam. The laser beam is aimed so as to be offset from a longitudinal axis of the workpiece to provide the reduced radial thickness of the connector struts.

Abstract: A bidirectional twistable stent is disclosed. The stent comprises a cylinder-shaped stent body having a plurality of axially arranged rows of struts encircling a central lumen and a plurality of flex connectors that connect at least two adjacent rows of struts in such a manner that allows the stent to be twisted clockwise or counter clockwise without causing deformation of any struts in the stent body. Also disclosed are the method of making the stent, method of using the stent, and a kit containing the stent.

Abstract: A stent includes wavy-line pattern bodies having a wavy-line pattern and arranged side-by-side in an axial direction LD, and coiled elements arranged between the wavy-line pattern bodies adjacent and extending in a spiral manner around an axis. All apices on opposite sides of the wavy-line pattern of the wavy-line pattern bodies that are adjacent are connected by way of the coiled element. When viewing in a radial direction RD, a circular direction CD of the wavy-line pattern bodies is inclined with respect to the radial direction RD, and a winding direction of one of the coiled elements located at one side in the axial direction LD with respect to the wavy-line pattern bodies and a winding direction of one other of the coiled elements located at the other side in the axial direction LD are opposite.