Abstract: Peripheral arterialization devices and methods of using the same. In an exemplary embodiment of a catheter for facilitating venous arterialization of the present disclosure, the catheter comprises an elongated body extending from a proximal end to a distal end and having a lumen defined therethrough along a longitudinal length of the elongated body, the elongated body configured to attach to a graft at or near the proximal end of the elongated body and further configured to permit fluid to flow through the graft, through the lumen, and out of one or more apertures defined within the elongated body at or near the distal end to facilitate venous arterialization upon at least partial implantation of the catheter into a vein of a patient.

Abstract: In some implementations, a radially self-expanding endograft prosthesis is provided that includes (i) distal flange that is self-expanding and configured to flip generally perpendicularly with respect to a body of the prosthesis to help seat the prosthesis against a tissue wall, (ii) a distal segment extending proximally from the distal flange that has sufficient stiffness to maintain a puncture open that is formed through a vessel wall (iii) a compliant middle segment extending proximally from the distal segment, the middle segment being more compliant than the distal segment, and having independently movable undulating strut rings attached to a tubular fabric, the combined structure providing flexibility and compliance to allow for full patency while flexed, the segment being configured to accommodate up to a 90 degree bend, (iv) a proximal segment having a plurality of adjacent undulating strut rings that are connected to each other.

Abstract: Devices and methods for treating defects in connective tissue are provided along with methods for making such devices. The devices can include acellular arterial tissue matrices that facilitate regrowth of the damaged tissue.

Abstract: Examples of the invention relate to transosseous suture constructs and methods for forming surgical attachments to a bone.

Abstract: The present disclosure provides devices and methods for treating the breast. The devices can include an acellular tissue matrix having a predefined shape. The shape can include a first edge with an S-shaped configuration and a second arcuate-shaped edge. The shape alternatively can include a first concave edge and a second convex edge.

Abstract: A fluid-filled soft prosthetic implant having a shell with a reinforced shell wall. The soft prosthetic implant may be for breast reconstruction or augmentation, or to restore the normal appearance of soft tissue in the buttocks, chin, calf, etc. The implants may be reinforced using several methods: reinforcement of the shell wall, non-homogeneous gel-filling, or both. At least a portion of the perimeter region desirably has a shell wall thickness greater than the average shell wall thickness of either the anterior face or the posterior face. The added material at the perimeter region strengthens that area in which a large percentage of implant ruptures occur. The reinforced perimeter also helps prevent the implant from collapsing or folding, which can cause undesirable rippling or wrinkling visible through the patient's skin. The remainder of the shell will desirably have a nominal wall thickness to retain the overall softness and supple feel of the implant.

Abstract: Embodiments disclosed herein are directed to intraocular lens systems having a plurality of materials therein, with at least some of the materials having a diffraction pattern therein and an electrically-modifiable index of refraction collectively configured to selectively alter an effective focal length of the intraocular lens system. Methods of modifying a focal length of an intraocular lens system are also disclosed.

Abstract: A Double Accommodating Intraocular Lens (DAIOL), which not only axially moves its flexible optic to accommodate, but also peripherally compresses or decompresses the optic to change its convexity or power, thus, double accommodating simultaneously upon contraction or expansion of the ciliary muscles and subsequently the lens capsule. The DAIOL includes a deployable semi-rigid or elastic haptic assembly and a flexible single optic. The DAIOL is further composed of three or four ring haptics and three or four deployable resilient lazy tongs, attached to a single elastically flexible plate encompassing a flexible optic. Accordingly, the radial compression of the capsular bag by the contraction of the ciliary muscles axially moves and radially compresses the flexible optic in the lens and vice versa upon radial expansion of the capsular bag, backward axial movement, and decompression of the optic, due to the resilient lazy tongs action, for double accommodation.

Abstract: A prosthetic heart valve includes a base and one or more heart valve leaflets. At least a portion of the leaflet including a composite material that contains a polymer substrate and a pre-stressed reinforcement element at least partially disposed in the polymer substrate.

Abstract: The present invention provides a method of making a prosthetic valve that can take a first form wherein the valve is open and a second form wherein the valve is closed, the valve comprising a leaflet assembly having at least one leaflet attached to a supporting element, the leaflet having a free margin that can move between a first position wherein the valve takes the first form and a second position wherein the valve takes the second form, the method comprising providing a textile structure, and forming the leaflet assembly from the textile structure, such that a selvedge of the textile structure forms the free margin of the leaflet, wherein the textile structure is made by weaving warp and fill threads into a two-layer woven fabric having two stacked and interconnected layers, the two layers having selvedges at one longitudinal edge, and wherein forming the leaflet assembly comprises connecting two lateral edges of a single piece of the fabric to make a substantially tubular structure wherein the inner laye

Abstract: Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smoothes the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. Interlocking members or flexible loops are included to limit expansion of the valve to one or two valve sizes, for example, with a 2-mm gap between each valve size. The valve may include an internal structural band with overlapped free ends having structure for limiting expansion, or external loops of suture may be added to the fabric covering which limits expansion.

Abstract: An implant device (V), such as a heart valve, for implantation in an animal body includes an annular structure and one or more elongated anchoring members deployable to a deployed condition for insertion into an animal body. The anchoring members are retractable from the deployed condition to a rolled up condition wherein the anchoring members protrude radially out from the annular structure of the device (V) to provide anchoring to a body structure (AS) of an animal. In the rolled up condition the anchoring members at least partly protrude axially of the annular structure of the device (V).

Abstract: Some embodiments of the present disclosure provide a stent-valve for transcatheter implantation to replace a cardiac valve. In some embodiments, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation. In some embodiments, the stent-valve comprises a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue. In some embodiments, the paravalve seal comprising material that swells in response to contact with blood or components thereof.

Abstract: A prosthetic heart valve configured to replace a native heart valve and for post-implant expansion and having a valve-type indicator thereon visible from outside the body post-implant. The indicator communicates information about the valve, such as the size or orifice diameter of the valve, and/or that the valve has the capacity for post-implant expansion. The indicator can be an alphanumeric symbol or other symbol or combination of symbols that represent information about the characteristics of the valve such as the valve size. The capacity for post-implant expansion facilitates a valve-in-valve procedure, where the valve-type indicator conveys information to the surgeon about whether the implanted valve is suitable for the procedure and informs the choice of the secondary valve.

Abstract: Disclosed herein are designs for improved inflatable structures for use during minimally invasive cardiovascular procedures. These inflatable structures facilitate the perfusion of blood through an anatomical structure, such as a heart valve, during the cardiovascular procedure. The inflatable structures are formed of a plurality of balloons arranged radially around a central location. The plurality of balloons form a lumen through which blood flows. Each balloon of the plurality is shaped or configured to stabilize the adjacent balloons, limiting their movement relative to each other. For example, some embodiments can feature balloons with a keystone shape that limits movement of the balloons inward toward the lumen. Some implementations can also include a support coil running through the lumen. The support coil holds enables the lumen to be open to perfusion even in the early stages of balloon inflation.

Abstract: A catheter that comprises a sheath that is connected at opposing ends to concentric tubes that move relative to each other in a manner that alternatively covers and exposes a medical device loaded onto the catheter. A portion of the sheath is arranged so as to invert upon itself so that axial movement of one tube relative to the other simultaneously moves the inversion point over or away from the device, alternatively covering or exposing the device.

Abstract: The present disclosure relates to methods for recellularization of valves in valve-bearing veins. This method is useful for producing an allogeneic venous valve, wherein a donor valve-bearing vein is decellularized and then recelluiarized using whole blood or bone marrow stem cells. The allogeneic valves produced by the methods disclosed herein are advantageous for implantation, transplantation, or grafting into patients with vascular diseases.

Abstract: The invention is directed to a pouch-like construct comprising mammalian tissue which can be used for preventing distension and/or resisting dilation of the heart in a mammal. Preferably, the pouch-like tissue construct has contractile properties. The invention further relates to a method for the preparation of a pouch-like construct comprising mammalian tissue which can be used for the above purposes.

Abstract: A heart implant alignment and delivery device includes an elongate body having an opening that is disposed near a distal end of the elongate body. The opening is configured so that a heart implant is positionable within the opening with the heart implant exposed to a surrounding environment and so that the heart implant is substantially aligned with the distal end of the elongate body. The device also includes an implant reposition member, such as a cable, that is releasably coupleable with the heart implant and that is operationally coupled with the elongate body so that a first operation of the implant reposition member causes the heart implant to be retractably deployed from the opening of the elongate body. The first operation of the implant reposition member may be effected via a handle mechanism that is attached to a proximal end of the elongate body.

Abstract: Provided is an osteosynthetic implant including a base material composed of magnesium or a magnesium alloy and a ceramic membrane containing magnesium and formed on a surface of the base material. The ceramic membrane includes a porous lower membrane layer disposed in a region adjacent to the base material and an upper membrane layer covering the lower membrane layer and serving as an outermost layer. The upper membrane layer is denser than the lower membrane layer.

Abstract: A device includes a bone cement or a biomaterial and a mesh structure impregnated with the bone cement or the biomaterial. The mesh structure reinforces the bone cement or the biomaterial and reinforces the material's fatigue properties. The mesh structure may be made of a shape memory alloy.

Abstract: A super-elastic implant system and method can include: a rigid mandrel; and an implant including a main body in the shape of a tube, the main body formed of a shape set material configured to have: a stress induced martensitic phase in a deformed shape having a straight end, the deformed shape based on the main body being constrained on the mandrel, and an austenitic phase having a non-linear curve, the non-linear curve in the location of the straight end, and the austenitic phase based on the main body being removed from the mandrel.

Abstract: The present invention discloses a composition of a knee implant comprising biomaterials such as combination of Ti—Nb—Zr alloy and tantalum to support osseointegration. The present invention further discloses a method of manufacturing customized patient-specific knee implant using 3D printing technology to suit the patient. The method involves the use of high energy source such as fiber laser or electron-beam. The base plate is mounted on the CNC. The energy source creates a melt pool on the base plate and the energy source is fed with a biomaterial in the form of wire or powder. The biomaterial is deposited on the base plate layer by layer, which solidifies in the melt pool of the base plate. The knee implant thus fabricated suits the elastic modulus of the bone and is useful as customized implant in patient undergoing replacement surgery.

Abstract: A method of making a spacer device or a device to be implanted in a human body that includes a containment body and is suitable for treating a bone seat or a joint seat of the human body includes a base portion and side walls that extend from the base portion and that delimit between them at least one cavity, wherein the containment body has a plurality of pores and/or at least one opening, configured to place the at least one internal cavity in communication with the outside of the containment body.

Abstract: An anchor for securing an implant within bone. In one embodiment, the anchor is used to aid in securing an acetabular cup within an acetabulum. The anchor may be implanted within an ischial defect of the pelvis, and is attached to an outer surface of the acetabular cup shell. The anchor is made at least in part of, and may be made entirely of, a porous metal material to facilitate the ingrowth of surrounding bone into the anchor for osseointegrating the anchor into the surrounding bone. The anchor may be secured to the acetabular shell by a screw fastener or by cement, for example. The anchor may be secured to the acetabular shell before the anchor and the acetabular shell are together implanted into the acetabulum, or the anchor may be implanted into the ischial defect, followed by seating the acetabular shell in the acetabulum and then securing the acetabular shell to the anchor.

Abstract: A method for producing a customised orthopaedic implant is provided. The method involves scanning a bone from which a diseased region of bone will be resected to obtain a three dimensional digital image of an unresected volume of bone; scanning the bone after a diseased region of bone has been resected to obtain a corresponding three dimensional digital image of a resected volume of bone; and comparing the three dimensional digital image of the unresected volume of bone to the corresponding three dimensional digital image of the resected volume of bone to estimate a volume of bone that has been resected. The estimate of the volume of bone that has been resected is used to design a customised orthopaedic implant that substantially corresponds to the configuration of the resected volume of bone, the implant being configured to substantially restore a biomechanical function of the bone. Finally the customised orthopaedic implant is manufactured and provided for insertion into the resected region of bone.

Abstract: A system for long bone arthroplasty includes humeral head prosthesis components, and an array of humeral head prosthesis components, each humeral head prosthesis component in the array having a convex articulation surface that is hemi-elliptical and defined by a major axis, a minor axis, an apex, and a base having an elliptical cross sectional shape defined by a major diameter along the major axis and a minor diameter along the minor axis. Each humeral head prosthesis component in the array is characterized by a ratio relationship of the minor diameter divided by the major diameter of the base, each having a major diameter and a minor diameter that is different from each of the other prosthesis components in the array, wherein as the major diameter is increased the ratio of the minor diameter to the major diameter is decreased.

Abstract: An orthopaedic shoulder prosthesis includes glenoid defect-filling component configured to be implanted within a defect in a glenoid of a patient. The glenoid defect-filling component includes a porous metallic body and a plurality of holes formed in the porous metallic body, the plurality of holes being arranged in a pattern to receive a number of pegs of a discrete polymer glenoid component.

Abstract: The present application generally relates to orthopedic systems, and in particular, to systems including independent plates and spacers. A plating system can include a spacer and a plate that is independent from the spacer. A number of locking mechanisms can be provided to secure the plate to the spacer. In some cases, the spacer includes a pair of notches that extend on an outer surface of the spacer. The plate can include a pair of lateral extensions that can engage the notches to secure the plate to the spacer. In other cases, the spacer includes an opening including a pair of inlets. The plate can include an enclosed posterior extension that can be received in the pair of inlets to secure the plate to the spacer.

Abstract: An apparatus and method for locating the position of a spinal implant in an intradiscal space patient during surgery, comprising a spinal implant formed of radiolucent material and a releasably attached inserter comprising a positioning element including thereon a marker of material more radiopaque than the material of the spinal implant. The positioning element extends into the implant such that the marker is positioned at a predetermined location within the implant, the positioning element with the radiopaque maker being removable from the spinal implant after insertion. In a particular method of locating the position of the spinal implant, the spinal implant is inserted from the lateral approach.

Abstract: A bone fusion device for insertion between bones that are to be fused together, such as, for example, the vertebrae of a spinal column The bone fusion device comprises at least one extendable tab and one or more tab extension assemblies. Each tab extension assembly is able to be adjusted in order to individually control the extension or contraction of a side of the tab thereby enabling adjustment of the height and/or angle of the tab with respect to the body of the bone fusion device. Each tab extension assembly is able to be individually adjusted such that the side controlled by each assembly is raised or lowered until the desired tab angle is achieved. The tab is advantageously positioned and angled to correspond to the vertebrae to help brace the device until the bone has fused.

Abstract: A spinal implant includes a first member defining a longitudinal axis and including a wall that defines an axial cavity. The first member further defines at least one lateral cavity configured for disposal of an instrument and is oriented transverse relative to the longitudinal axis. A second member includes an axial surface defining gear teeth and being configured for disposal with the axial cavity such that the teeth are offset from the longitudinal axis. The instrument is engageable with the teeth to axially translate the second member relative to the first member. Surgical instruments, systems and methods are disclosed.

Abstract: The present invention relates to an intervertebral disc prosthesis preferably comprising at least three pieces including an upper plate (1), a lower plate (2) and a mobile core (3) at least in relation to the lower plate (2), co-operation means (23, 33) allowing to limit or eliminate the movements of the core (3) in relation to the lower plate (2), in translation and in rotation, respectively, about an axis substantially parallel to the lower plate (2) and about an axis substantially perpendicular to the lower plate (2), at least one part of the surface of at least one plate being concave and complementary with a convex surface (30) of the core (3), with which it is in contact, wherein the tip (31) of the convex surface (30) of the core (3) is off centre, in at least one direction, in relation to the centre (32) of this convex surface (30).

Abstract: A prosthetic device can be used as a prosthesis following a discectomy or a corpectomy. The prosthetic device includes two endplates with staggered motion limiting members. The device can be configured to allow six degrees of motion when comparing one endplate relative to the other. The endplates can be configured to fix the joint by changing the body held within the device and by adding a locking plate and fasteners. A method teaches how to insert a device to an intervertebral space via an anterior incision.

Abstract: An interbody fusion cage having upper and lower canals for receiving the heads of bone screws that have been pre-installed in opposing vertebral body endplates. The proximal wall of the cage preferably has a vertical slot that communicates with each canal and is adapted to allow access by a screwdriver and tightening of the screws.

Abstract: An intervertebral spacer is designed particularly for patients who are not candidates for total disc replacement. The spacer maintains disc height and prevents subsidence with a large vertebral body contacting surface area while substantially reducing recovery time by eliminating the need for bridging bone. The intervertebral spacer or fusion spacer includes a rigid spacer body sized and shaped to fit within an intervertebral space between two vertebral bodies. In one embodiment, the spacer body has two opposed metallic vertebral contacting surfaces, at least one fin extending from each of the vertebral contacting surfaces and configured to be positioned within slots cut into the two vertebral bodies. Holes, if present, cover less than 40 percent of the entire vertebral body contacting surfaces to provide increased bone ongrowth surfaces and to prevent subsidence.

Abstract: A femoral extension prosthetic component for use in a unicondylar meniscal bearing unicompartmental knee replacement is described. The femoral component comprises a securing element and a bearing surface, the securing element adapted to abut and be connected to a distal end of a femur bone, and the bearing surface adapted to abut a meniscal bearing. The femoral component includes an entrapment portion adapted to extend beyond the meniscal bearing. Tibial components and meniscal bearings are also described, as well as methods of using such components.

Abstract: A system and method for allowing any surgeon, including those surgeons who perform a fewer number of a replacement procedure as compared to a more experienced surgeon who performs a greater number of procedures, to provide an improved likelihood of a favorable outcome approaching, if not exceeding, a likelihood of a favorable outcome as performed by a very experienced surgeon with the replacement procedure.

Abstract: The invention relates to a medical implant consisting of a first implant part and a second implant part for the connection of which there is provided a connecting device, wherein at least the first implant part comprises a connecting element receptacle, in which at least one connecting element of the connecting device can be disposed. In order to provide an implant of this type which is easier to handle, it is proposed, in accordance with the invention, that a securing device be provided for the purposes of securing the at least one connecting element in the connecting element receptacle. Moreover, the invention relates to a knee joint endoprosthesis having at least one implant of this type.

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 human assistance device has a rate gyro, first accelerometer, and second accelerometer disposed on a mobile body for sensing a physical state of the mobile body to provide a physical state measurement. The human assistance device can be a prosthetic, orthotic, and robotic device. An ATAN 2 function is performed on an output of the first accelerometer and an output of the second accelerometer. An output of the rate gyro and an output of the ATAN2 function is filtered to provide a filtered physical state measurement. The filtered physical state measurement is applied to a reference function to generate a reference command to control a non-gait motion of an actuator in the human assistance device. The reference command controls the human assistance device, for example to provide a shifting foot position while seated, with a natural, biological motion, without an artificial or mechanical appearance.

Abstract: An intracorporeal portion of a percutaneous device for a joint disarticulation prosthesis or joint replacement prosthesis, the intracorporeal portion having an extracorporeal portion or having means for rigidly coupling directly to an extracorporeal portion, the extracorporeal portion being for location exterior to the skin, the intracorporeal portion having an articulating component for articulating with an articulating surface, wherein the articulating component is intracorporeal when installed in a human or animal subject.

Abstract: Various embodiments of stents with radiopaque markers disposed within depots in the stent, are described herein.

Abstract: Devices, systems, and methods for improving airflow within an airway. One example embodiment includes a method for treating a subject. The method includes (1) placing an expandable object into one or more airways of the bronchial tree of the subject, (2) expanding the expandable object within at least one of the one or more airways such that at least a portion of a wall of the one or more airways is expanded, and (3) placing a stent in the airway such that a portion of the stent is adjacent to the portion of the wall of the one or more expanded airways.

Abstract: A compressible, self-expandable stent for splinting and/or keeping open a cavity, an organ duct, and/or a vessel in the human or animal body is disclosed. The stent is configured in a tubular fashion and has a mesh of at least one wire. At a distal end of the stent, a portion each of the wire is bent into a loop, whereas the portion of the wire is wrapped around to form a twist tie, by means of which the loop is closed.

Abstract: A medical stent may include a tubular support structure including a plurality of struts defining a plurality of cells disposed between the plurality of struts. A polymeric coating may be disposed over the tubular support structure such that a first portion of the plurality of cells are closed by the polymeric coating in a first region of the tubular support structure and a second portion of the plurality of cells in a second region of the tubular support structure remain open to fluid flow and/or tissue ingrowth therethrough. The struts in the first region of the tubular support structure and the struts in the second region of the tubular support structure may be at least partially covered by the polymeric coating.

Abstract: The present disclosure describes intraluminal support devices having high radial stiffness regions with smaller diameter and low radial stiffness regions with larger diameter. When deployed to the vasculature of a patient in need of treatment, the high radial stiffness region is sized such that it has approximately the diameter of the vessel in need of treatment, so that it produces substantially zero chronic radial force when the vessel is not being subjected to external compression. The low radial stiffness regions anchor the device to the vessel wall and provide a less-abrupt transition from the high radial stiffness structure. Methods of making and using such devices are also described.

Abstract: A stent is disclosed that has an elongated body composed of a bioabsorbable polymer having a proximal end, a distal end, two open spiral channels formed on the exterior surface of the body to provide fluid communication between the proximal end and the distal end. The stent also has a central lumen open at the proximal and distal ends of the stent for the passage of a guide wire. A method for using the stent and a kit containing the stent are also disclosed.

Abstract: Apparatus and methods are provided for treating lesions within a blood vessel include a two-layer angioplasty balloon designed for the simultaneous deployment of multiple balloon-expanded stents. The high-compliance (elastic) outer balloon secures stent position. The low-compliance (inelastic) inner balloon drives angioplasty and stent expansion. Stent deployment starts with the injection of a small quantity of fluid into the outer balloon, which bulges slightly at both ends and into the spaces between the stents and, once the stent has expanded a little, between the struts of the stents. The injection port to the outer balloon is then closed, and fluid is injected only into the inner balloon, which expands, opening the stents.