Abstract: Embodiments of the present disclosure are directed to systems, methods and device for providing embolic protection in a patient, and implantation of devices (and systems thereof) for enabling such functionality. In some embodiments, a device is configured for implantation in a body vessel including fluid flow. The device may assume, or be constrained to assume, an un-deployed state and a deployed state. In the un-deployed state, the device or a portion thereof is configured to reside in the lumen of a thin needle or cannula having a diameter of less than about 0.5 mm (for example). The needle may include a curved portion, fix the deployed state, the device has an axis which, when implanted, is positioned approximately parallel to the fluid flow of the vessel. In some embodiments, the device comprises a thin filament body whereby in a deployed state, at least a portion of the filament takes on a helical shape. In some embodiments, at least one helix coil has height or pitch greater than the coil diameter.

Abstract: Systems, devices, and methods are provided for retrieval of an implant from the prostatic urethra. Embodiments of retrieval systems can include a device for insertion into the patient and a proximal control device for use in grasping a portion of the implant and withdrawing the implant into a lumen of the retrieval system.

Abstract: Modifying corneal shape involves implantation of a segment of tissue in the corneal stroma, where the properties of the tissue segment and its anatomical placement provide a change in corneal topography. In particular, such methods and materials can be used for correction of defects in corneal shape, such as corneal ectasias.

Abstract: A prosthetic capsular device configured to be inserted in an eye after removal of a lens, in some embodiments, can comprise a housing structure comprising capable of containing an intraocular device. The housing structure can comprise an anterior portion comprising an anterior opening, a posterior portion comprising a posterior opening, and a continuous lateral portion between the anterior portion and the posterior portion.

Abstract: The present invention relates to a method of placing an artificial valve in a blood vessel of a mammal patient. The method involves placing the artificial valve into the blood vessel.

Abstract: A delivery system for an implantable medical device includes an outer shaft defining an outer shaft lumen and an inner shaft translatable within the outer shaft lumen, the inner shaft defining a lumen extending through the inner shaft. An actuation mechanism extends through the lumen and includes a coupler, a force translation rod that extends proximally from the coupler and a plurality of push pull rods that extend distally from the coupler and that releasably couple to the implantable medical device. The force translation rod includes a transition in electromagnetic permeability. The delivery system includes an inductive coil disposed relative to the force translation rod and positioned to detect a change in inductance resulting from the transition in electromagnetic permeability passing through the inductive coil.

Abstract: Various mechanically expandable prosthetic heart valves, as well as deliver apparatus, delivery assemblies, and methods for implanting such prosthetic heart valves. In one example, a prosthetic heart valve includes a mechanically expandable frame, a valve structure, and an actuator. The frame includes a plurality of struts and is movable between a radially compressed state and a radially expanded state. The valve structure includes a plurality of leaflets. The actuator is coupled to the frame and comprises an actuation lumen, a locking member, and a locking element. The actuation lumen is circumferentially spaced and axially parallel to the locking member. The actuation lumen is configured for receiving an axially movable actuation shaft that can move the frame between the radially compressed state and the radially expanded state. The locking element is rotatably coupled to the locking member and is configured to lock the frame at a desired state.

Abstract: A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient's native valve annulus. Methods of making and using prosthetic heart valves are also disclosed.

Abstract: A heart valve therapeutic device (1) comprises a coaptation assist valve (20) comprising a conduit (2) with an outer surface (3) for coaption with the native leaflets, and a prosthetic flow valve (5) mounted within the conduit (2) to allow one-way flow through the conduit (2). Support for the coaptation assist valve (20) is provided by a support (10) for positioning the conduit (2) across the native leaflets, and connectors (15) attaching the conduit (2) to the support (10).

Abstract: Methods and systems for replacing a native heart valve are disclosed. A system comprises a delivery catheter having a deflectable distal tip configured to bend in one or more directions relative to a native annulus of a native heart valve when the distal tip is positioned within an atrium of a heart and a helical anchor configured to be carried within the delivery catheter in a delivery configuration and to be axially movable relative to the deflectable distal tip. The helical anchor has a coiled configuration comprising a plurality of turns after being delivered from the deflectable distal tip into the heart, where the coiled configuration is configured to support a heart valve prosthesis.

Abstract: A stent of the aortic valve which is self-expandable and repositionable, preferably made from nitinol, consisting of two parts: the upper part and the lower part. The lower part is a mesh (1) laid out so that it creates a kind of cylinder wall on the entire height of the element. Also other shape of the mesh is acceptable, for example partially conical, or partially resembling flattened side wall of the cylinder. The upper part of the stent consists of derived from the mesh (1) upwards and arranged at equal intervals three arms (2) the height of which is slightly larger than the height of the mesh (1), a bit less than the height of the mesh (1) or equal to its height. The stent arms (2) are shaped in such a way that they form together a kind of an oval chalice bowl, and their end, peripheral part is preferably straight and also inclined to the middle.

Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having an upstream portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a mechanically isolated valve support coupled to the anchoring member and configured to support a prosthetic valve. The device can further include an atrial extension member extending radially outward from the upstream portion of the anchoring member and which is deformable without substantially deforming the anchoring member. In some embodiments, the upstream portion of the anchoring member and the extension member may be deformed while the valve support remains sufficiently stable.

Abstract: A method for replacing a native atrioventricular heart valve includes inserting a delivery catheter into the heart with a prosthetic apparatus retained in a compressed state inside of the delivery catheter. The prosthetic apparatus includes an annular anchoring member having a mesh structure made of Nitinol and defining a plurality of circumferentially extending rows of cells. A fabric layer is attached to an inner surface of the anchoring member. An annular support member made of Nitinol is disposed within the anchoring member. The support member is attached to the anchoring member with sutures. A prosthetic valve made of biological tissue is disposed within and secured to the support member. The method further includes allowing the prosthetic apparatus to self-expand to a radially expanded state in which the anchoring member contacts tissue of the native atrioventricular valve.

Abstract: An implantable prosthetic valve includes a radially collapsible and expandable annular frame having three commissure attachment posts and four rows of circumferential struts. The rows include a first row, a second row downstream of the first row, a third row downstream of the second row, and a fourth row downstream of the third row and defining an outflow end of the frame. Each row of circumferential struts includes angled struts arranged in a zig-zag pattern. A leaflet structure includes three leaflets forming three commissures, each commissure being connected to one of the commissure attachment posts only at locations along the commissure attachment posts between a first plane that is perpendicular to a longitudinal axis of the frame and intersects crowns of the third row of struts and a second plane that is perpendicular to the longitudinal axis and intersects crowns of the fourth row of struts.

Abstract: A heart valve prosthesis and methods of its implantation are described herein. The prosthesis can be implanted in a heart of a patient by positioning an upper support of an anchoring element into a left atrium of the patient. The upper support can expand adjacent to a native valve structure of the patient. Further, the upper support can be moved against the native valve structure in a direction toward a left ventricle of the patient. A lower support of the anchoring element can be positioned into the left ventricle, spaced apart from the upper support, the lower support being separate from the upper support and coupled to the upper support by a flexible connector. Finally, the lower support can expand within the left ventricle, and engagement members of the lower support can engage with tissue of the native valve structure.

Abstract: Medical device delivery assemblies are disclosed. The assembly may include a catheter-based delivery system. The assembly may include a pacing element to pace a patient's heart before, during, or after a procedure. The pacing element may be a detachable, implanting pacing element. The pacing element may be an implantable pacemaker and the implantable pacemaker may be disposed on a catheter-based delivery system. The assembly may include a prosthetic heart valve with one or more pacing elements on it. The pacing element may include a pacing strip or strips. These strips may be conductive or insulative. These strips may prevent, treat, or correct abnormal electrical communication in a heart.

Abstract: According to an aspect, an inflatable implant includes a fluid reservoir configured to hold fluid; an inflatable member; and a pump assembly configured to transfer fluid from the fluid reservoir to the inflatable member, the pump assembly including a pump bulb, the pump bulb having an outer surface, the pump bulb having a horizontal projection disposed on the outer surface and a vertical projection disposed on the outer surface.

Abstract: An extended release immunomodulatory implant operatively arranged to facilitate bone morphogenesis, including an inner portion including one or more interleukins, and an outer portion surrounding the inner portion, the outer portion including an antigen operatively arranged to activate an innate immune system.

Abstract: A sacroiliac fusion stabilizer (SIFS) for fusing a first bone fracture fragment to a second bone fracture fragment is provided. In one embodiment, the SIFS has a lazy-S shape with a series of protrusions at the ends of the SIFS. In another embodiment, the SIFS has two overlapping lazy-S shapes.

Abstract: A ceramic femoral resurfacing head prosthesis (110) comprises a ceramic convex outer contact surface (112) engagable with an acetabulum of a patient or an acetabular cup prosthesis and a concave inner fixation surface (114) having an inner-land portion (128), the ceramic convex outer contact surface (112) and the concave inner fixation surface (114) extending to intersect each other at a rim (116). A ceramic stem (120) projects from the concave inner fixation surface (114), and is adapted to be received by a stem bore. The concave inner fixation surface (114) includes a skirt (134) which is cylindrical or substantially cylindrical, or frusto-conical or substantially frusto-conical, and at least one circumferentially elongate recess (136) at the skirt (134).

Abstract: A stemless prosthetic shoulder joint may include a prosthetic humeral head and a stemless base. The stemless base may include a collar and an anchor extending from the collar intended to anchor the base into the proximal humerus. The anchor may include various features to enhance the fixation of the base, including hooks, threads, and/or expandable members that may be transitioned from a contracted insertion condition to an expanded implanted condition once the base is positioned in the bone. The anchor and/or collar may also include additional features to enhance fixation, such as geometries and surface features to enhance fixation to bone. The anchor may include a plurality of chisel slots to facilitate removal of bone during a revision surgery.

Abstract: This disclosure relates to orthopaedic implant systems and methods for restoring functionality to a joint. The implant systems disclosed herein include offset arrangements that may facilitate conversion of the implant system during a subsequent surgical procedure.

Abstract: Various embodiments of filling assemblies and methods are provided. The filling assembly can include a barrel and receiving block assembly configured to couple to a tube. The filling assembly can include a filling auger, wherein the filling auger is configured to rotate and translate to fill the tube with material. The method of filling a tube can include disposing flights of a filling auger within a barrel and receiving block assembly. The method can include coupling a tube to the barrel and receiving block assembly. The method can include rotating and translating flights of the filling auger within the barrel and receiving block assembly to fill the tube with material.

Abstract: A four-component artificial intervertebral disc may provide six degrees of movement: flexion, extension, lateral bending, axial rotation, axial deflection, and anterior/posterior translation. The disc may include a superior endplate, a superior core, an inferior core, and an inferior endplate. The superior endplate may include a concave mating surface, and the inferior endplate may include a spherical mating surface. The superior endplate may roll across the superior core to provide flexion, extension, and lateral bending. The superior endplate may twist or rotate atop the superior core to provide axial rotation, and the superior endplate may slide over the superior core to provide anterior/posterior translation. The superior core may be connected to the inferior core, and the inferior core may be connected to the inferior endplate. The inferior core may be made from a flexible material that may enable the artificial disc to expand or compress vertically.

Abstract: An interbody cage which comprises a cage body and a mobile rotational element which, when said mobile element is rotated around a longitudinal axis of the body of the cage, may engage one or both adjoining vertebrae and temporally distract the intervertebral space for easier insertion of the cage body. The rotational element may also be designed to durably engage the adjoining vertebrae after its rotation, so as to allow a durable increase of the distraction of the vertebrae. Methods of insertion of the interbody cage are provided wherein the vertebrae are first distracted by the insertion of the cage or of the mobile element, then further distracted by rotation of the mobile element, before the cage is fully inserted into the intervertebral space without the body's superior and inferior surfaces fully engaging the vertebrae in the process.

Abstract: This present subject disclosure provides a novel implant which is readily adjustable to provide a precise angle of lordosis. The implant may be positioned while in low profile, collapsed geometry, and may be expanded when in place to provide a precise angle of lordosis.

Abstract: A spinal prosthesis is provided, more particularly a spinal prosthesis having component parts capable of assembly during surgery in a spinal environment for providing stability and flexibility to the spine. The component parts include a ball-and-socket combination, a compressible pad, and anchors at each end of the prosthesis to secure the prosthesis in the spine.

Abstract: A device for introducing an implant (1) into blood vessels or hollow organs of the human or animal body. The device includes an implant (1), an insertion wire (14) and a release tube (13), wherein the implant (1) is deformable so that it fits into a microcatheter (8) and expands once the external constraint of the microcatheter (8) disappears, adapting to the diameter of the blood vessel or hollow organ, wherein a holding element (2) is arranged on the insertion wire (14) and the holding element (2) has at its periphery at least one groove (3) set into the holding element (2), running along the circumference of the holding element (2) and forming tracks in the form of curved lines, wherein the implant (1) has holding wired (5) extending proximally, which are fitted into the grooves (3).

Abstract: A surgical instrument comprises a member defining a first longitudinal axis and being connectable with an image guide via a lock for orientation relative to a sensor to communicate a signal representative of a position of a spinal implant connected with the member. A rod is disposable in a co-axial orientation with the member and is engageable with the spinal implant and rotatable via an actuator to fix the spinal implant with the member. Systems, implants, spinal constructs and methods are disclosed.

Abstract: Methods and apparatus for providing correction of one or more maladies or conditions of the spinal column of a living being. In one embodiment, the apparatus includes an implant delivery instrument and an implant for use therewith. In one variant, the implant delivery instrument includes a non-detachable distraction member for distraction of the disc space and a track for slidable delivery of an implant to the distracted disc space. In another variant, the implant delivery instrument includes a detachable distraction member for distraction of the disc space and a track for slidable delivery of an implant to the distracted disc space. In the latter variant, the distraction member is co-implanted in the disc space with the implant.

Abstract: A total artificial expansile disc and a method for posterior insertion between a pair of vertebral endplates are disclosed. The total artificial expansile disc includes at least one pair of substantially parallel plates that move apart along a first axis, in order to occupy a space defined by the vertebral endplates. In another embodiment, each of substantially parallel plates includes a first plate and a second sliding plate. An expansion device or tool is used to move the substantially parallel pair of plates apart along the first axis. A core is disposed between the pair of plates, and the core permits the vertebral endplates to move relative to one another. A ball limiter or ball extender prevents the core from being extruded from between the substantially parallel plates.

Abstract: An implant holder is provided with a first guide lumen and second guide lumen. The implant holder has a first position wherein the implant holder couples to an interbody implant, aligns the first guide lumen with a first hole in the interbody implant, and aligns the second guide lumen with a second hole in the interbody implant. The implant holder has a second position wherein the implant holder releases the interbody implant.

Abstract: Systems and methods for modular adjustable prosthetic volume compensation are disclosed herein. In one embodiment, a system for adjusting fit of a prosthetic device includes: a pump having a bleed actuator, a plunger and a pressure bulb. The system also includes a bladder fluidically coupled to the pump. The bladder lines a posterior section of an interior of a prosthetic device. A volume of the bladder is changeable by a pumping action of the pump. The volume of the bladder at least partially determines a space available inside the prosthetic device. The bleed actuator is configured to decrease a volume of the bladder. The plunger in operation squeezes the pressure bulb of the pump.

Abstract: A self-expandable stent includes a folded cylindrical sheet wall, which is folded along axes parallel to the longitudinal axis of the sheet of the cylindrical wall creating three or more drop shaped loops having an inner diameter and an end portion where the sheet of the cylindrical wall contacts each other along an contact surface parallel to the longitudinal axis, wherein each of the at least three bending loops are rotated towards the end portion of an adjacent loop, wherein the end portion has a curvature describing a bending diameter. The improvement includes providing a stent within a fold and deploy structure being able to exert sufficient compression ratios as well as sufficient radial outward forces on the vessel wall, once deployed.

Abstract: A stent graft includes a main body extending along a longitudinal axis when in a preinstalled configuration prior to insertion into a body of a patient. The stent graft also includes a mobile external coupling extending away from the main body and configured to align with a secondary blood vessel within the body to provide access thereto. The main body includes a plurality of stents extending thereabout. The stents include a first bracketing stent extending about a proximal side of the mobile external coupling, and a second bracketing stent located adjacent the first bracketing stent and extending about a distal side of the mobile external coupling. The first bracketing stent includes peaks that are aligned along a first axis, and the second bracketing stent includes peaks that are aligned along a second axis that diverges from the first axis relative to a circumferential direction toward the mobile external coupling.

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

Abstract: A ureteral stent may comprise an elongate member with an internal-luminal space. The member may have at least one end coiled in a pigtail-shape, a substantially straight portion, and a plurality of side ports wherein the plurality of side ports are located only in the substantially straight portion and are disposed along a spiral or helix where each side port is located radially and longitudinally offset relative to each adjacent side port.

Abstract: A stent device is provided. The stent device includes: at least one radially expandable body portion extending along a longitudinal axis of the stent device defining a lumen; and at least one outwardly flarable portion connected to the body portion. The outwardly flarable portion includes at least one radially expandable ring connected to the body portion and at least one flaring connector connected to the at least one ring configured to cause a crown of the at least one ring to automatically flare radially outwardly relative to other portions of the ring upon radial expansion of the body portion so as to form a flared crown. After radial expansion, the outwardly flaring portion may be held in place by a support strut that lessens its ability to collapse. A method of deploying the stent device is also provided.

Abstract: A method of donning a potentiating support for a hinge joint of a body includes positioning a garment proximate an area of a body; positioning an expandable and recoverable framework in abutment with the area of the body such that the framework spans a hinge joint of the body, the framework defining a plurality of permanent openings extending therethrough regardless of whether the support is donned; applying tension at points of the framework such that the framework is expanded and the framework is tensioned in its abutment with the area of the body, said step of applying tension being performed by pulling on one or more fastening components that are attached at one or more points to said framework; and affixing each of the fastening components to the garment while applying tension to the framework to secure the expanded framework in its forced abutment with the area of the body.

Abstract: A lower-leg exoskeleton that includes an actuator configured to be worn about a portion a leg of a user that is below the knee of the user; and a foot structure coupled to a first actuator end of the actuator, the foot structure configured to surround a portion of the foot of the user. The foot structure includes one or more sidewalls configured to extend around the foot of the user and including one or more sidewall attachment points for connecting to a base portion, and a base portion configured to reside at a base of the foot of the user and including one or more base attachment points coupling with the one or more sidewall attachment points.

Abstract: A shell for a walker includes a base configured to receive a foot of a user thereon, a pair of side bodies extending upwards from the base, the pair of side bodies configured to cover a left side and a right side of at least one from among an ankle and a part of a lower leg of the user, respectively, while the foot of the user is received by the base, and a tibial body that is rigid and fixed to each of the pair of side bodies, the tibial body configured to cover a tibia of the user while the foot of the user is received by the base. The shell is configured to receive the foot of the user at a rear side of the shell via an opening provided between rear sides of the pair of side bodies.

Abstract: A core muscle strengthening suit for scoliosis is described. The suit uses pieces of material constructed and assembled to transfer force generated by the wearer while walking to rotate the wearer's trunk in the direction of an existing axial twist to exercise and strengthen countervailing muscles in an attempt to maintain a normal gait. The resulting stronger rotational muscles persist in pulling the wearer's spine into alignment when the suit is removed.

Abstract: An ostomy bag emptying device comprising an ostomy bag with a sealed top end and a bottom end, said ostomy bag being attached by a commercially available means to a patient at a stoma site, an optional belt holding said ostomy bag in place, an external receptacle with a top, a bottom, a body side and an outer side; and a suspension mechanism of fixed or adjustable length by which said external receptacle is suspended at a stoma site from said belt is taught, together with a method of using said ostomy bag emptying device.

Abstract: The disclosure comprises a portable urinal device. The urinal device comprises a housing with an exterior surface and defines an interior cavity along with a first actuator and a second actuator. The urinal device also comprises a waste collector assembly. The waste collector assembly includes a bracket arm, activated by the first actuator from a closed position. The waste collector assembly further includes a plurality waste collector brackets. The waste collector brackets are configured to extend from the housing and translate vertically in the interior cavity. The translation of the waste collector brackets is activated by the second actuator. The waste collector assembly also includes a waste collector. The waste collector is configured to stay in a folded configuration while the waste collector assembly is in the housing. The waste collector is configured to expand to a container configuration when the waste collector bracket is extended from the interior cavity.

Abstract: The disclosure comprises a portable urinal device. The urinal device comprises a housing with a bracket arm movable from an open configuration to a closed configuration. The bracket arm is connectable to a waste assembly, which is configured to stay in a folded configuration when in the housing in the closed configuration, and to expand to an expanded configuration when the bracket is extended from the housing in the open configuration.

Abstract: A nose plug for the prevention of snoring and a method of forming the same. The nose plug may include a compressible section configured to be compressed and inserted into a nostril such that, once expanded, it creates an airtight seal with an inner wall of the nostril. Substantially half of volume of the compressible section may be inserted within the nostril. The nose plug may also include a second section attached to the compressible section, the second section comprising a lobe that remains outside the nostril to aid in extraction. The second section may be composed of the same material as the first material. Alternatively, the second section may be composed a material that is more elastic than the compressible section and may be bonded to the compressible section.

Abstract: A mandibular advancement device is provided comprising: an upper tray assembly comprising a rigid upper chassis and a maxillary tray; and a lower tray assembly comprising a rigid lower chassis and a mandibular tray. The upper and lower chassis define an interlocking arrangement configured to releasably lock the upper and lower tray assemblies into a selected one of a plurality of predefined positions. Each of the predefined positions defining a different offset between the upper and lower tray assemblies to enable adjustment of the degree of mandibular advancement when used.

Abstract: An implantable cerclage sacrocolpopexy medical device includes an elongate strip of flat, flexible material extending longitudinally from a first end to an opposite second end; a surgical needle attached to the first end of the elongate strip; and a loop at either the first end or the second end of the elongate strip. The medical device is positioned circumferentially around the cervix. The end of the elongate strip opposite the end having the loop is passed through the loop and attached to the sacrum or sacrospinous ligament.

Abstract: A thermal transfer device for providing thermal treatment to a patient. A patient support portion supporting and contacting the patient includes a first segment of a fluid flow path to receive a fluid from a fluid source. A flexible covering coupled and movable relative to the patient support portion defines a space therebetween that substantially conforms to the patient. The flexible covering includes a second segment of the fluid flow path. The fluid is circulated through an inlet, an outlet, and fluid flow path for supplying heat to or removing heat from the patient support portion and the flexible covering. A fluid circulation system with a controller may selectively adjust heat transfer from temperature zones defining the patient support portion. The thermal transfer device or a mattress cover may provide for controlling the microclimate, or conditions at or near the interface between the patient and the patient support portion.

Abstract: A device applies therapeutic treatment to a subject. The therapeutic treatment includes any two modalities applied simultaneously, the modalities selected from compression, heat, vibration, and massage. The device includes a main body; hinges coupled to the main body on each side of the main body; and respective plates connected to the hinges, wherein the respective plates contact opposing surfaces of a body.