Abstract: The present application provides an orthopedic implant or a part thereof, comprising biodegradable magnesium alloy comprising magnesium and Ca in the range of 0.550-0.700 wt %, Zn in the range of 0.400-0.700 wt %, and Fe 50 ppm or less, the biodegradable magnesium alloy consisting of two phases comprising a first phase comprising magnesium and Zn and a second phase less noble than the first phase, the second phase comprising Mg2Ca precipitates larger than nano-sized. The present application also provides a method for preparing the biodegradable magnesium alloy, a method for preparing the orthopedic implant or the part thereof, and a method for treating a subject in need of therapy for a medical condition of a bone.

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 vascular graft may be configured to transition from an insertion state to a deployed state. The graft comprising a proximal end having an expandable mesh, a distal end having an expandable mesh, and at least one suture cuff positioned between the proximal and distal ends, wherein each suture cuff comprises additional material relative to the proximal and distal ends that is configured to form when the vascular graft transitions from the insertion state to the deployed state.

Abstract: Methods, systems, and media for presenting media content are provided.

Abstract: A transcatheter valve prosthesis and a method for implanting the prosthesis in a heart are disclosed. The prosthesis includes a tubular body a coupled to a prosthetic valve. A fabric may be disposed on an outer surface of the tubular body. The method includes partially deploying the tubular body from a catheter to at position distal of a distal edge of a native valve leaflet, and moving the catheter such that the deployed outflow end portion of the tubular body engages the distal edge of the native valve leaflet and lifts the native valve leaflet in the proximal direction towards an atrial chamber of the heart. Then, the tubular body can be fully deployed such that the native valve leaflet is captured between the outflow end portion and the inflow end portion.

Abstract: A hydrogel material for modulating an immune response in a human subject or other mammal includes a collection of microgel particles having one or more network cross linker components, wherein the microgel particles, when exposed to an endogenous or exogenous annealing agent, links the microgel particles together in situ to form a covalently-stabilized scaffold of microgel particles having interstitial spaces formed between the microgel particles and wherein the collection of microgel particles further includes at least one of an antigen and an adjuvant.

Abstract: The present invention comprises a novel and safer mechanism of deployment using a self-positioning, self-centering, and self-anchoring method. To embody the present invention, a disk-based valve apparatus allowing the repositioning and retrieval of the implantable valve while working on a dysfunctional valve structure is disclosed. The disk-based valve apparatus may comprise one or more disks, either proximal or distal, a valve-housing component and a valve component. The one or more disks may be either proximal or distal, may be either connected to each other or disconnected from each other and may either be symmetrical or have different shapes and dimensions. The disk-based valve apparatus may be self anchoring, such as anchored by pressure from the one or more disk, or may be anchored using any anchoring.

Abstract: Devices, systems, and methods for coupling a prosthetic implant to a fenestrated body are disclosed herein. In some embodiments, a branch stent graft is provided. The branch stent graft can include an engagement portion for engagement with an opening in a fenestrated body, such as a vessel wall or an aortic stent graft. The engagement portion of the branch stent graft can be coupled to the fenestrated body such that the branch stent graft can move, rotate or shift relative to the fenestrated body but such that axial movement of the branch stent graft is restricted and/or prevented.

Abstract: A replacement heart valve has an expandable frame configured to engage a native valve annulus and a valve body mounted to the expandable frame. The valve body can have a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and prevent flow in a second direction, the second direction being opposite the first direction.

Abstract: The subject matter of this specification can be embodied in, among other things, an indwelling catheter with an integrated coil section. The coil section, in use, is disposed outside of the urethra and can stretch and bend to accommodate various activities of a user by reducing frictional forces and trauma within the urethra. This improved catheter design results in an increase in range of motion and a decrease in pain for the user.

Abstract: A tissue anchoring device including an expandable frame and at least one anchor having a tissue penetrating portion. The anchor is attached to the expandable frame through a plurality of beams forming a frame or a tab that enable the anchor to elastically bend with respect to a longitudinal axis of the expandable frame.

Abstract: Proposed is a nitinol nanofiber with an average surface roughness that is enhanced through mechanical and chemical treatments. The enhanced surface roughness improves biocompatibility and promotes tissue growing, thereby improving the bioavailability of the nitinol nanofiber. The nitinol nanofiber undergoes infrared irradiation whereby the nitinol fiber exhibits improved tensile strength, elastic modulus, and maximum restorative stress. Therefore, fatigue fraction does not easily occur in the nitinol fiber even when the nitinol nanofiber has a constant roughness. The present invention provides bio-use or medical nitinol nanofibers that are highly biocompatible.

Abstract: A catheter having opposed tissue contacting surfaces for creating an anastomosis between two blood vessels is utilized to facilitate a method for percutaneously placing a biologic graft at a procedural site. The method may comprise steps of inserting a guidewire into a blood vessel, placing a sheath over the guidewire, advancing a biologic graft over the guidewire into the blood vessel at a biologic graft attachment site, advancing a catheter over the guidewire, pushing a distal tip of the catheter through the biologic graft, a vessel wall of the blood vessel, and into a lumen of the blood vessel, and creating an anastomosis between the biologic graft and the blood vessel by activating the catheter to apply energy to the vessel wall and to a wall of the biologic graft.

Abstract: The invention relates to a prosthetic valve (1) for regulating fluid flow between an upstream side (4) and a downstream side (5) and being operable between an open status and a closed status. The prosthetic valve comprises: —an orifice (2) arranged in a surrounding member (3) and extending between the upstream side (4) and the downstream side (5) wherein in the open status of the prosthetic valve (1) the fluid flow through the orifice is maximally enabled and wherein in the closed status of the prosthetic valve the fluid flow through the orifice in a restriction direction (21) from the downstream side (5) to the upstream side (4) is restricted; and—a leaflet (6) arranged in the orifice and being operable between an open status corresponding to the open status of the prosthetic valve and a closed status corresponding to the closed status of the prosthetic valve.

Abstract: The invention discloses a stent graft used for interventional treatment of abdominal aortic disease, comprising a tube body composed of a tubular covering and a plurality of annular stents, and the tube body comprises a first tube body and a second tube body that arranged in sequence from the proximal end to the distal end, wherein the diameter of the first tube body is greater than diameter of the second tube body; the first tube body and the second tube body are connected by a transition section as a whole; the diameter at central part of the transition section is smaller than the diameter of the proximal end of the transition section and the diameter of the distal end of the transition section; a plurality of fenestrations are disposed on the first tube body and the transition section.

Abstract: A distal end of a guide catheter is transvascularly advanced into a left ventricle of a heart of a subject. While the distal end of the guide catheter remains disposed in the left ventricle, a first tissue anchor of an implant is deployed from the distal end of the guide catheter. Subsequently, the guide catheter is retracted while progressively exposing the implant. Subsequently, a second tissue anchor of the implant is anchored to a posterior annulus of a mitral valve of the heart by deploying at least part of the second anchor within a left atrium of the heart, such that the implant extends from the first tissue anchor, over an atrial side of a posterior leaflet of the mitral valve, and to the second tissue anchor. Other embodiments are also described.

Abstract: Methods, devices, and kits for implanting a vascular graft to perform hemodialysis treatments on patients with renal failure are disclosed. The kits can include access devices comprised of an access catheter having a guidewire lumen and stylet lumen, a guide tube having a curved distal end, a stylet, an actuator handle and a vascular graft. The methods describe techniques for using the described kits and devices for performing vascular procedures, such as percutaneous implantation of the vascular graft.

Abstract: Methods and systems are described for assessing a vessel obstruction. The methods and systems obtain a volumetric image dataset of a myocardium and at least one coronary vessel, wherein the myocardium comprises muscular tissue of the heart. A three-dimensional (3D) image corresponding to a coronary vessel of interest is created from the volumetric image dataset. Feature data that represents features of both the myocardium and the coronary vessel of interest is generated. At least some of the feature data is determined by a first machine learning-based model based on the 3D image. A second machine learning-based model is used to determine at least one parameter based on the feature data, wherein the at least one parameter represents functionally significant coronary lesion severity of the coronary vessel of interest.

Abstract: An improved system for supporting (e.g., localization and/or positioning of) intravascular devices discussed herein provides for example a multi-element arrangement. A set of struts optionally projects from the intravascular device and contacts the vessel walls. The localization and positioning of the pump may be provided by the struts and/or by use of a tether opposing a propulsive force to ensure localization.

Abstract: A heart valve assembly includes an inner frame comprising a graft covering housing a prosthetic heart valve, wherein the graft covering extends around the prosthetic heart valve for providing sealing to the heart valve, an outer frame formed from a metallic material and defining a gridded configuration, and being secured to the graft covering by a plurality of stitches, and a sealing material positioned externally to the outer frame for providing sealing between the outer frame and a patient's anatomical wall to prevent paravalvular leaks. The sealing material includes a plurality of radially extending fibers that extend outwardly of the outer frame. The graft covering is made of polyester, polytetrafluoroethylene, expanded polytetrafluoroethylene, or a polymer.

Abstract: Embodiments of a prosthetic heart valve are disclosed. An implantable prosthetic valve can include an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end. The valve can include a valvular structure including two or more leaflets, each of the two or more leaflets having a leaflet inflow edge positioned at least partially outside of the frame and a leaflet outflow edge positioned within the frame, wherein at least a portion of each of the leaflet inflow edges is unsupported by the frame.

Abstract: The present disclosure provides an endoprosthesis where a preferably polymeric coating has a number of surface features such as protrusions or textures that are arranged in a micropattern. The endoprosthesis optionally has an expanded state and a contracted state, and in some cases includes a stent with a polymeric coating attached to an outer surface of the stent. The stent may have an inner surface defining a lumen, an outer surface, and a stent thickness defined between the inner surface and outer surface. The stent may comprise a plurality of surface textures extending from the stent surfaces, wherein the textures are arranged in a macropattern.

Abstract: An illustrative stent may comprise an elongated tubular member having a first end and a second end and an intermediate region disposed therebetween. The elongated tubular member may include at least one barb attached thereto. The barb may be configured to be tucked under a filament of the stent during delivery of the stent and protrude radially from the stent, when the stent is deployed.

Abstract: An airway support device of the present disclosure can be attached to tracheal and/or bronchial cartilage on opposing sides of a tracheal and/or bronchial wall to pull the tracheal and/or bronchial cartilages toward each other to reconstruct and/or reshape to a normal anatomy across the membranous tracheal and/or bronchial wall and thus relieving tension across the tracheal and/or bronchial wall. The airway support device can include at least two longitudinal strips that extend longitudinally along and are attached (e.g., sutured) to the trachea and/or bronchus on opposite sides of the tracheal and/or bronchial wall. Pairs of lateral strips extending from each of the longitudinal strips can be attached to each other under tension. The tracheal and/or bronchial wall can be attached (e.g., sutured) to the lateral strips to open the airway of the trachea and/or bronchus.

Abstract: An improved system for supporting (e.g., localization and/or positioning of) intravascular devices discussed herein provides for example a multi-element arrangement. A set of struts optionally projects from the intravascular device and contacts the vessel walls. The localization and positioning of the pump may be provided by the struts and/or by use of a tether opposing a propulsive force to ensure localization.

Abstract: A drive assembly for use with a delivery catheter for delivering an implantable medical device includes a drive motor configured to be operably coupled to an inner shaft of the delivery catheter such that operation of the drive motor causes the inner shaft to translate relative to the outer shaft and a controller. The controller is configured to receive a position signal from a position sensor indicating a position of the implantable medical device relative to the outer shaft as well as a motor signal indicating a rotational position of an output shaft of the drive motor. The controller is configured to output a control signal instructing operation of the drive motor based upon the indicated rotational position of the output shaft of the drive motor and the indicated position of the implantable medical device relative to the outer shaft.

Abstract: A medical fixation device having a device attachment portion, a compression bearing portion and a barb portion. The barb portion is separated from a device constraining means by the incorporation of the compression bearing portion.

Abstract: A method of treatment for a body vessel is provided. The body vessel includes a dissection flap formed from a wall of the body vessel, which longitudinally separates a natural body vessel lumen into a true lumen and a false lumen. One or more cuts are formed in the dissection flap with a cutting device or system. An expandable device is inserted within the true lumen, and expanded to reappose the dissection flap against the wall of the body vessel where the dissection flap was detached from the wall such that the false lumen is closed. A variety of cut patterns are disclosed.

Abstract: Devices, systems, and methods for coupling a prosthetic implant to a fenestrated body are disclosed herein. In some embodiments, a branch stent graft is provided. The branch stent graft can include an engagement portion for engagement with an opening in a fenestrated body, such as a vessel wall or an aortic stent graft. The engagement portion of the branch stent graft can be coupled to the fenestrated body such that the branch stent graft can move, rotate or shift relative to the fenestrated body but such that axial movement of the branch stent graft is restricted and/or prevented.

Abstract: A biocompatible and biodegradable construct having a base expandable member and an integral, internal support structure. The support structure is preferably formed from poly(glycerol sebacate) (PGS) or a magnesium alloy. The base member is preferably formed from acellular extracellular matrix (ECM) derived from small intestine submucosa (SIS) tissue that exhibits a flexible, porous, sponge-like structure adapted to expand upon absorption of a bodily fluid, wherein the construct seals a perivalvular leak when disposed proximate thereto.

Abstract: Disclosed herein is a stent which includes stent ring structures made up of at least one wire and at least one tubular connector through which a portion of the wire is disposed. The tubular connector includes a side wall with an aperture formed therethrough. A portion of the wire extends therethrough and acts as a barb. A method of making such a stent is also disclosed.

Abstract: An anastomotic coupler is provided. A ring forms an aperture operable to receive a tubular structure. The ring can include a plurality of receiving portions. A fixation device includes a housing and a cartridge. The cartridge includes a plurality of fasteners, and the housing is operable to receive the tubular structure such that the cartridge is inserted into a lumen of the tubular structure. The ring is aligned with the cartridge such that the receiving portions are aligned with the fasteners. Upon actuation of the fixation device, the fasteners puncture the tubular structure radially outward from the lumen and are received by the receiving portions such that the tubular structure is coupled with the ring.

Abstract: A power system, for powering a surgical instrument including an end effector and a motor configured to generate at least one motion to effectuate the end effector, includes a primary power source configured to supply a first power to operate the surgical instrument, wherein the primary power source is detachable from the surgical instrument, a secondary power source configured to supply a second power to operate the surgical instrument when the primary power source is detached from the surgical instrument, wherein the secondary power source is rechargeable, and wherein the primary power source is configured to charge the secondary power system, and a power management circuit configured to selectively transmit the first power from the primary power source and the secondary power from the secondary power source to operate the surgical instrument.

Abstract: In an embodiment, a surgical implant includes a body extending from a distal end to a proximal end, the body having a first section proximal to the distal end and a second section between the first section and the proximal end, a needle attachment member located at the distal end of the body, the needle attachment member configured to attach to a needle for insertion of the surgical implant into a patient's tissue, a plurality of first barbs located on the first section of the body, the first barbs pointed towards the proximal end of the body, and a plurality of second barbs located on the second section of the body, the second barbs pointed towards the distal end of the body, wherein the second barbs are configured to be folded inwardly for insertion of the surgical implant into the patient's tissue by the needle.

Abstract: A prosthesis may include a tubular frame comprising rings which are concentric along an axis of the tubular frame. The rings may have a serpentine shape with apexes in a longitudinal direction such that the rings are configured to move between a compressed configuration and an expanded configuration. A first ring of the rings can include a first apex that includes a first anchoring member extending radially outward and a first crossbar extending radially inward. The first ring can further include a second apex that neighbors the first apex. The first crossbar can extend toward the second apex and extend radially inward further than the second apex. When in the compressed configuration, the first crossbar can engage the second apex such that the first anchoring member is moved radially inward.

Abstract: A tissue anchor is provided that includes a proximal head at a proximal end of the tissue anchor, and a helical tissue-coupling element disposed about a longitudinal axis thereof, extending to the proximal head, and having a distal tissue-penetrating tip. The helical tissue-coupling element includes a first helical portion and a second helical portion more distal than the first axial portion. The first and the second helical portions of the helical tissue-coupling element have a first axial stiffness and a second axial stiffness, respectively. The second axial stiffness is greater than the first axial stiffness, such that if excessive tension is applied to the helical tissue-coupling element, the helical tissue-coupling element generally elongates along the first helical portion before along the second helical portion, such that the first helical portion serves as a mechanical fuse that reduces force applied to the second helical portion.

Abstract: An implant includes a collapsible anchor to be deployed within a lumen and a protrusion coupled to the anchor. The protrusion, in a constrained state, extends a distance from an exterior surface of the anchor and, in an unconstrained state, extends further from the exterior surface of the anchor. Also included is a biodegradable constraint, such as a biodegradable tube or suture, configured to maintain the protrusion in the constrained state until the constraint releases. The implant may include additional biodegradable constraints, each constraint configured to maintain the protrusion in a different constrained state and to degrade over a different predetermined period after the implant has been deployed within the lumen. The protrusion may include a bi-directional barb or an open loop. The protrusion may be configured to penetrate a wall of the lumen and to allow tissue to grow about the protrusion.

Abstract: The present embodiments provide a method for delivering a stent comprising providing a stent in a delivery state, where the stent comprises a plurality of interconnected strut segments that enable expansion of the stent from a delivery state to a deployed state. Stacking a frontal surface of a first strut segment at least partially behind a rear surface of a second strut segment in the delivery state. Aligning a sharpened tip of a first barb at least partially circumferentially behind at least one strut segment in the delivery state such that the sharpened tip is not radially exposed. Expanding the stent from the delivery state to a deployed state, wherein the first barb is exposed to a patient in the deployed state.

Abstract: A stent for use in a prosthetic heart valve has a plurality of expandable and collapsible closed cells, a portion of which form an annulus section adapted for placement within the annulus of the native heart valve. Anchor features of the stent residing within at least some closed cells are adapted to engage tissue of the heart, including native valve leaflets, the sinotubular junction, or another implanted device when the prosthetic valve is implanted in the heart. The anchor features may help to retain the prosthetic valve in position, without interfering with the opening and closing of the valve leaflets. Furthermore, the anchor features may be configured to allow the stent to be resheathed into a delivery device after the portion of the stent with the anchor feature has expanded out of the delivery device.

Abstract: The present embodiments provide a method for delivering a stent comprising providing a stent in a delivery state, where the stent comprises a plurality of interconnected strut segments that enable expansion of the stent from a delivery state to a deployed state. Stacking a frontal surface of a first strut segment at least partially behind a rear surface of a second strut segment in the delivery state. Aligning a sharpened tip of a first barb at least partially circumferentially behind at least one strut segment in the delivery state such that the sharpened tip is not radially exposed. Expanding the stent from the delivery state to a deployed state, wherein the first barb is exposed to a patient in the deployed state.

Abstract: A composite biomaterial having a continuous metal sheet with arcuate members that define a first fenestration pattern, and a polymer layer over at least one surface of the continuous metal sheet. The arcuate members elastically stretch to allow the continuous metal sheet to bend in more than one axis without buckling or wrinkling.

Abstract: An implantable medical device includes a frame that includes at least one elongate member. The implantable medical device also includes a fixation member that has a first cuff, a second cuff, a tissue engagement member configured to anchor to tissue at an implant site to thereby hold the implantable medical device in a position at the implant site, and a cuff joining member that has an arcuate shape and that is connected at a first end to the first cuff and at a second end to the second cuff. The first cuff substantially surrounds a perimeter of a first portion of the at least one elongate member, the second cuff substantially surrounds a perimeter of a second portion of the at least one elongate member, and the cuff joining member does not substantially surround a perimeter of any portion of the at least one elongate member.

Abstract: The present embodiments provide a stent comprising a plurality of interconnected strut segments that enable expansion of the stent from a delivery state to a deployed state. A first strut segment and a second strut segment, of the plurality of strut segments, each comprise frontal surfaces facing radially inward in the deployed state and rear surfaces facing radially outward in the deployed state. The frontal surface of the first strut segment is at least partially stacked behind the rear surface of the second strut segment in the delivery state. A first barb coupled to at least a portion of the first strut segment. A sharpened tip of the first barb is aligned at least partially circumferentially behind at least one strut segment in the delivery state such that the sharpened tip is not radially exposed.

Abstract: In one embodiment, a hook fastener has a plurality of hooks and a loop fastener has a plurality of loops to secure tissues sections to one another. At least one of these fasteners has a porous surface to allow tissue ingrowth to secure the fastener to the tissue. In another embodiment, only a single fastener is used, with a section of tissue being treated to engage and mate with the fastener. The disclosed tissue fastening systems can be used for a number of applications. One such example includes fastening tissue sections by wrapping a tissue fastener around the tissue and securing the fastener on itself. A suture may also be secured with the tissue fastener.

Abstract: The present disclosure relates to reticulated elastomeric matrices, and more particularly to at least partially degradable elastomeric elements that are compressible and exhibit resilience in their recovery and that can be employed in diverse applications including, without limitation, biological implantation, especially in humans.

Abstract: An expandable helical stent with a securement is provided. The stent is formed from flat or tubular metal in a helical coiled structure which has an undulating pattern. The main stent component may be formed of a single helically coiled component. Alternatively, a plurality of helically coiled ribbons may be used to form a stent heterogeneous in design, material, or other characteristi. The helical tubular structure may be secured with a securement, such as a weld, interlock or a polymer, to maintain the helical coils in a tubular configuration. The helical coils of the main stent component may be spaced apart or nestled to each other. The nestling of the undulation of adjacent helical coils contributes to maintaining the tubular shape of the helically coiled stent. In addition, the nestling of helical coils may prevent the polymer layer from sagging at any point between cycles of the helical coils.

Abstract: Methods and devices are disclosed for manipulating the airway, such as to treat obstructive sleep apnea. An implant is positioned within the body with respect to the airway. The spatial orientation of the airway is manipulated, directly or indirectly, to affect the configuration of the airway. In general, the implant is manipulated to displace the trachea in an inferior direction, resist superior displacement of the trachea and/or to alter the tracheal wall tension. The implant restrains the trachea in the manipulated configuration.

Abstract: Apparatus is provided, including a radially-expandable percutaneous implant, a tissue anchor, and a connecting element shaped so as to provide an annular loop surrounding a proximal portion of the tissue anchor in a manner which enables rotation of the anchor about a central longitudinal axis thereof when surrounded by the annular loop. The apparatus also includes a flexible longitudinal member coupled at a first portion thereof to at least a portion of the percutaneous implant and at a second portion to the connecting element. The annular loop of the connecting element facilitates rotation of the tissue anchor about the central longitudinal axis such that the anchor can rotate about the central longitudinal axis with respect to the annular loop, the flexible longitudinal member, and the percutaneous implant. Other applications are also described.

Abstract: An implantable medical device includes a frame that includes at least one elongate member. The implantable medical device also includes a fixation member comprising a first cuff, a second cuff, a tissue engagement member configured to anchor to tissue at an implant site to thereby hold the implantable medical device in a position at the implant site, and a cuff joining member comprising an arcuate shape and connected at a first end to the first cuff and at a second end to the second cuff. The first cuff substantially surrounds a perimeter of a first portion of the at least one elongate member, the second cuff substantially surrounds a perimeter of a second portion of the at least one elongate member, and the cuff joining member does not substantially surround a perimeter of any portion of the at least one elongate member.

Abstract: A stent for implantation in a body lumen for protecting from rupture a fibrous cap in order to treat vulnerable plaque. One embodiment of the stent achieves staged expansion through stronger and weaker circumferential regions, and includes optional anchors positioned at the circumferential transition between the stronger and weaker regions. During the first stage expansion, the weaker region expands moving the anchors laterally apart. The anchors straddle the fibrous cap and embed into the vessel wall. The second stage expansion of the stent exerts gentler stresses by the weaker region against the fibrous cap while the stronger region exerts greater stresses on the remainder of the vessel wall to open the vessel.