Abstract: Prosthetic heart valves each includes a link extending along an axial direction and an axial frame. The axial frame includes a plurality of struts comprising a plurality of inner struts pivotally attached to a plurality of outer struts at a plurality of pivot nodes. A first pivot node of the plurality of pivot can be attached to the link and a second pivot node of the plurality of pivot nodes can move relative to the link in the axial direction. Methods of radially expanding a prosthetic heart valve can comprise radially expanding the radially expandable frame from a radially retracted orientation to a radially expanded orientation while the second pivot node axially translates relative to the link.

Abstract: An artificial heart valve and a delivery system therefor are disclosed. The artificial heart valve includes an outer stent (1) and an inner stent (2), the outer stent (1) is detachably connected to the inner stent (2), or when the artificial heart valve is in use, the inner stent (2) is located inside the outer stent (1), the inner stent (2) is not connected to the outer stent (1), the outer stent (1) includes an outer stent frame (11) and one-time leaflets (12) provided on the outer stent frame (11), the inner stent (2) includes an inner stent frame (21) and prosthetic leaflets (22) disposed within the inner stent frame (21). The delivery system includes a delivery sheath (31) and, disposed within the delivery sheath (31), a guidewire lumen (32) and a stent catheter (33), the stent catheter (33) is configured to be suitable for engagement with the artificial heart valve.

Abstract: A device and system for use with medical devices, such as catheter devices or systems. The device or system comprises an anchor for securing to tissue. In some examples, the device or system is used in treating a diseased native valve in a patient. The anchor may be part of a delivery device to implant a prosthetic valve. Subsequent to delivery, the components of the delivery device are actuated to secure the prosthetic valve within the diseased valve.

Abstract: A replacement heart valve device is disclosed. In some embodiments, the device includes a frame coupled to one or more leaflets that are moveable between open and closed configurations. In some embodiments, the frame comprises at least two frame sections that join at a pair of commissural posts. In some embodiments, the device may be geometrically accommodating to adapt to different vasculature shapes and sizes and/or to be able to change size while implanted within a growing patient.

Abstract: A prosthetic heart valve includes an annular frame including a plurality of strut members, the frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. A leaflet structure is situated at least partially within the frame, the leaflet structure including a plurality of leaflets, each leaflet having opposing commissure tab portions on opposite sides of the leaflet, each commissure tab portion being paired with an adjacent commissure tab portion of an adjacent leaflet to form a commissure, the commissure tab portions of each leaflet being folded such that each commissure tab portion forms a plurality of layers. A reinforcement member of a plurality of reinforcement members is positioned between the layers of each commissure tab portion. Each commissure tab portion of each leaflet is positioned entirely within the frame.

Abstract: Some embodiments described herein include a heart valve replacement system that may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, a prosthetic heart valve of the system includes structural features that securely anchor the prosthetic heart valve to the site of the native heart valve. Such structural features can provide robust migration resistance. In particular implementations, the prosthetic heart valves occupy a smaller delivery profile, thereby facilitating a smaller delivery catheter for advancement to the heart.

Abstract: A prosthetic heart valve including a frame, leaflet structure, and sealing member disposed around an outer surface of the frame is disclosed. An inflow end of the frame is defined by a plurality of spaced apart inflow apices. As one example, the sealing member has a circumferentially extending inflow edge and a circumferentially extending outflow edge, where the inflow edge is attached to the plurality of inflow apices, and where the inflow edge has an undulating shape around a circumference of the frame.

Abstract: The present invention relates to systems, assemblies and methods for detecting detachment of a prosthetic valve actuator. In an example, a prosthetic valve actuator detachment detection system comprises at least one actuator, a frame of the prosthetic valve movable by the at least one actuator between a radially compressed configuration and a radially expanded configuration, and at least one mechanical wave sensor.

Abstract: Aspects of the disclosure relate to systems, delivery devices and method for transcatheter delivery of a cardiac implant such as a prosthetic heart valve. Systems of the disclosure are configured to support the delivery device in an inferior vena cava and/or superior vena cava to reduce the potential for damage to heart tissue during delivery of the implant as the delivery device is articulated through the vasculature.

Abstract: An advancer includes an advancer hub and an advancer shaft extending distally from the advancer hub. The advancer shaft includes a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The advancer shaft is configured to be disposed around an outer shaft of a delivery catheter, and includes a split line configured to enable splitting the shaft to enable removal of the shaft from the outer shaft. The advancer hub configured to be mounted on the outer shaft of the delivery catheter, and includes a parting line to enable splitting of the advancer hub.

Abstract: Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.

Abstract: A delivery system for delivering a heart valve prosthesis includes a frame extending along a longitudinal axis between an inflow end and an outflow end. The frame includes a plurality of attachment members at one or more of the inflow end or the outflow end. The delivery system includes a coil assembly extending along a coil axis and attached to the plurality of attachment members. The coil assembly includes a first helical coil that receives a first attachment member of the plurality of attachment members. The coil assembly includes a second helical coil coaxial and intertwined with the first helical coil. The second helical coil receives a second attachment member of the plurality of attachment members. Methods of deploying a heart valve prosthesis at a treatment site are also provided.

Abstract: The active introducer sheath systems disclosed herein are expanded by activating a translation mechanism at the handle. The sheath has an inner cylindrical structure of comingled fixed and mobile elongate rods bound together by an attachment line. Activating the translation mechanism causes the mobile rods to move axially with respect to the fixed rods, changing the internal tension in the attachment line. Increased tension draws the fixed and mobile rods closer together, decreasing the diameter of the cylindrical structure. Decreased tension in the attachment line enables the fixed and mobile rods to move apart, increasing the diameter of the cylindrical structure. A prosthetic device, such as a prosthetic heart valve, can be routed through the expanded sheath and to the implantation site. During implantation, the sheath can be contracted back to its original outer diameter, and expanded again for retrieval of the delivery apparatus.

Abstract: A spring loaded, self-locking anchoring assembly converts a drive force, administered to an anchor of the anchoring assembly, to one or both of an axial translation force or a compression force. The axial translation force may be used to drive the anchor into tissue, while the compression force may be used to further draw together anchor components and tissue, and/or to lock together anchor components, to improve anchor efficacy in the presence of anatomical variations.

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: A system includes an anchor, a delivery tool, and a data-processing system. The delivery tool is configured to deliver the anchor to the heart of the subject, and to drive the anchor into tissue of the heart. The data-processing system is adapted to, subsequently to the delivery tool delivering the anchor to the heart, receive, via the delivery tool, a first electrical signal from the anchor, at the tissue, the anchor serving as an electrode. The data-processing system is adapted to receive, via the delivery tool, a second electrical signal from a distal part of the delivery tool within the heart. The data-processing system is adapted to, responsively to both the first signal and the second signal, determine a location of the anchor within the heart, and provide an output indicative of the location. Other embodiments are also disclosed.

Abstract: According to an aspect, an inflatable penile prosthesis includes a fluid reservoir configured to hold fluid, an inflatable member, and a pump assembly configured to transfer the fluid between the fluid reservoir and the inflatable member, the pump assembly including a pump bulb, a valve body, a valve disposed within the valve body, a first fluid port configured to be fluidly coupled to the fluid reservoir, and a second fluid port configured to be fluidly coupled to the inflatable member, the valve being configured to move between an inflation position and a deflation position, wherein the valve body includes a sealing surface configured to engage the valve to form seal, the valve body includes a slot disposed adjacent the sealing surface.

Abstract: The present disclosure sets forth a system and method for forming sheets of material, such as titanium mesh or plates, for surgical applications prior to surgery. The disclosed solutions provide this capability without incurring expense from use of PEEK or PEKK by manufacturing contoured plates based on a shape of an anatomical structure in a 3D image, such as a pre-defect MRI. The contoured plates are used to stamp the titanium mesh, plate, or other sheet of material into the shape of the bone prior to the defect. In some aspects, the mesh or other material layer can also be trimmed prior to surgery using, for example, a reproduction of the anatomical structure manufactured from a post-defect MRI of the same anatomical structure.

Abstract: Anatomically shaped augments that are configured for implantation in a bone and which have one or more reliefs. A distal end of an outer portion of the augment can have a shape that is configured to generally conform to the shape of a metaphyseal-diaphyseal junction of an intramedullary canal of a bone. A proximal end of the outer portion can have a shape that is configured to generally conform to a shape of the metaphyseal region of the intramedullary canal. The reliefs can be configured to reduce a size of the augment and enhance the degree of freedom in the implant positioning and/or sizing of the augment. Further, such reliefs may contour the augment so as to prevent cortical bone contact and/or prevent contact with the implant device that may be associated with misalignment between an intramedullary canal and metaphyseal or diaphyseal regions of the bone.

Abstract: Devices, systems and methods for surgical treatment of mid-foot disorders such as osteoarthritis, spacing disorders, or alignment disorders, including mid-foot arthroplasty devices and systems for the 2nd and 3rd tarsometatarsal (TMT) joint, implants for post-osteotomy spacing and+ realignment, arthroplasty articular implants, dowel grafts for TMT arthrodesis or fusion, dowel grafts for navicular cuneiform (NC) arthrodesis, dowel grafts for intercuneiform arthrodesis, and/or locking dowels for joint fusion.

Abstract: An implantable laminoplasty device is provided that can be used in minimally invasive surgery. The device includes a main housing with an inner housing slidably receivable by an outer housing. A gear is disposed in the main housing and engageable with a gear rack of the inner housing to adjust the length of the main housing. The gear defines an aperture configured to accept a tool to translate rotational movement into linear motion. A lock is slidably disposed in the main housing sized and configured to fix the length of the main housing when the desired length is achieved by slidable translation of the inner housing in the outer housing. The device also includes a laminar shelf portion and a lateral mass connection portion defining bone screws and both being hingedly connected to the main housing.

Abstract: An intervertebral implant for positioning within an intervertebral space between adjacent first and second vertebral bodies. The intervertebral implant includes an implant body extending along a longitudinal axis of the intervertebral implant that is adapted to align with a vertical axis of the spine. The implant body includes a top plate and a bottom plate disposed longitudinally opposite and spaced apart from the top plate along the longitudinal axis. Further, the implant body includes at least one cross-arm obliquely extending between the top plate and the bottom plate. Furthermore, the implant body includes a lattice structure disposed at least between the at least one cross-arm and the top plate and between the at least one cross-arm and the bottom plate.

Abstract: A method of forming a composite titanium body for use in forming spinal implant interbodies includes selecting a metal alloy body, carving out a top portion and a bottom portion from the metal alloy body, and bonding a porous material to the carved-out top and bottom portions. Multiple pieces may be cut from the composite titanium body, each having a front face formed of the metal alloy, top and bottom portions formed of the porous material, and with a medial portion of the metal alloy extending from the front face to the back. Methods and devices for spinal interbodies having locking mechanisms to prevent bone screw back-out are also described.

Abstract: An expandable interspinous process fixation system capable of restoring spinal stability and facilitating fusion. In one embodiment, the expandable interspinous process fixation system includes a central ramp, a first endplate, and a second endplate, the central ramp capable of being moved in a first direction to move the first and second endplates outwardly and into an expanded configuration. Each endplate supporting fixed and/or adjustable spinous process engaging plates.

Abstract: A bone part is repaired by a process. A first implant is attached to a first bone part. The first implant corresponds to an intraoperatively defined or an intraoperatively selected cutting path. A preoperatively defined second implant is attached to the first implant. The first implant and the second implant together augment the first bone part.

Abstract: The disclosure provides a tool for implanting an interphalangeal implant, an implant retainer for an interphalangeal implant, and a method for preparing an implantation tool for an implantation of an interphalangeal implant. The tool for implanting an interphalangeal implant comprises a limb support for supporting a limb, a driving rod, wherein the driving rod is movable for moving an interphalangeal implant towards the limb support, and an actuation mechanism for actuating the implant driver.

Abstract: A spinal implant includes a first member configured to penetrate tissue and a second member. The second member has an abutment engageable with a surgical instrument and at least one peripheral capture element engageable with a moveable arm of the surgical instrument. Systems, spinal constructs, surgical instruments and methods are disclosed.

Abstract: A tibial trial implant for use in a knee joint replacement operation includes an articulation component with an articulation surface for articulation with a femoral component, at least one support component having a bearing surface configured for bearing on a tibial plateau, a top side forming a ramp inclined relative to the bearing surface, and a guide device having a guide track parallel to the ramp. A bottom side of the articulation component has a support surface inclined parallel to the ramp. The articulation component is held on the guide device and supported with its support surface on the ramp in a manner linearly movable along the guide track relative to the support component. Relative movement between the articulation component and support component changes a proximodistal distance between the articulation surface of the articulation component and bearing surface of the support component.

Abstract: A device can include at least one of an exoskeleton comprising a preloaded elastic spring, a plurality of drums coupled to the preloaded elastic spring, and a cable coupled to a user, the plurality of drums and the preloaded elastic spring; and a robotic hand. The robotic hand includes a glove comprising digits, a tubing system in fluid communication with a fluid supply, a plurality of sensors coupled to the digits of the glove, and a plurality of soft actuators coupled to the tubing system and the plurality of sensors. The plurality of soft actuators comprises a thickened base, a fluid cavity above the thickened base defined by a tube, and a retaining device wrapped around the tube.

Abstract: A prosthetic finger device includes a base piece configured to fit on a proximal phalanx portion of the amputated finger, and a tip piece configured to fit on a middle phalanx portion of the amputated finger, wherein the tip piece is pivotally connected to the base piece by a hinge that is integrally formed with the tip piece and the base piece.

Abstract: Prosthetic arm controller systems, as disclosed and discussed herein, include: a first controller unit that is placed or located inside a shoe or a sock of a user or that is integrated into a foot sleeve that slides on to the foot of a user, wherein the first controller unit comprises at least two interactive buttons that the user can engage, a second controller unit that is removably clipped or otherwise removably attached to the side or top of the shoe or the sock, wherein the second controller unit comprises at least one microcontroller with at least one integrated gyroscope, at least one accelerometer, and an onboard wireless protocol antenna that wirelessly communicates at least one command to a prosthetic arm from the first controller unit or the second controller unit, and wherein the at least one command comprises at least one grip command, at least one rotate command, at least one bend command, or a combination thereof.

Abstract: The invention relates to an orthotic or prosthetic joint device with an upper part and a lower part arranged in a hinged manner on the latter, and fastening means for securing the joint device on a user, with at least one hydraulics unit between the upper part and the lower part, which hydraulics unit has a piston that is movable in a housing with an extension chamber and a flexion chamber and that is coupled to the upper part or the lower part, and which hydraulics unit is assigned a pressure supply device with a pump and a pressure accumulator via which the piston, controlled by a control device, is subjected to a pressure, wherein the pump can be operated in generator mode, the pressure accumulator can be coupled drivingly to the pump, and the hydraulic fluid can be conveyed by the pressure accumulator through the pump to the hydraulics unit.

Abstract: Technology is described which can provide a quick disconnect and overload protection mechanism for a prosthetic limb that is used with an osseointegrated percutaneous post. The technology can provide a way to easily don and doff a prosthetic limb. This quick disconnect may also provide a resettable torsional overload protection mechanism and/or a fusible link that may act to protect the osseointegrated percutaneous post from both axial and bending over-loads.

Abstract: An illustrative endoluminal implant having an elongated tubular member. The elongate tubular member having a proximal stent, a distal stent and an interconnecting sleeve. The proximal stent tapers from a first outer diameter adjacent the proximal end region to a second smaller outer diameter adjacent the distal end region. The distal stent has an outer diameter less than the first outer diameter of the proximal stent. The interconnecting sleeve is collapsible in response to an applied radial force such that the sleeve is positionable across a natural valve or sphincter.

Abstract: A device includes a flexible sheath, a member, an expansion device, and a therapeutic patch. The sheath has a length selected to extend from a distal end which, when the device is in operative configuration, is adjacent to the target site, to a proximal end. The member extends through the sheath from a proximal end to a distal end. The expansion device is coupled to and extends distally from a distal end of the member. The patch is wrapped around the expansion device and forced radially outward into contact with and adhere to a first target portion of tissue when the expansion device is moved to deployed configuration. The expansion device is movable, after the patch has been adhered to the portion as desired, from deployed configuration to insertion configuration to separate the patch from the expansion device leaving the patch in a desired position adhered to the portion.

Abstract: A device for deploying an implant in a patient's body comprises an elongate delivery tube having an inner element comprising an imaging head, an intermediate element comprising implant retainer formations and an outer element comprising an outer sheath, the inner and outer elements being retractable relative to the intermediate element. A handle at a proximal end of the delivery tube contains a hub assembly comprising hubs of the inner element, the intermediate element and the outer element. A hub carriage that is movable longitudinally within the handle with respect to the intermediate element hub supports the hubs of the inner element hub and the outer element for movement with the hub carriage to retract the inner and outer elements relative to the intermediate element.

Abstract: A system for deploying an implant in a patient's body comprises a deployment drive that is operable by moving a deployment control element from a first position in which the implant is undeployed, to a second position in which the implant is partially deployed, and to a third position in which the implant is fully deployed. A detent mechanism blocks movement of the control element from the second position to the third position and comprises a follower that is movable into a deployment stop position by moving the control element from the first position to the second position, hence blocking movement of the control element into the third position. A detent release element is movable into an unlock position, that movement moving the follower from the deployment stop position into a deployment release position that frees the control element for movement from the second position to the third position.

Abstract: The present invention discloses an improved knee support brace and a method of wearing the same. In a preferred embodiment, the knee support brace has a central brace panel foldable in configuration and formed having contoured vertical edges on opposite sides with an aperture centrally located therein adapted to be placed over the knee of the person wherein the aperture is located substantially in the middle of the panel substantially along the approximate vertical center line of the leg. The knee support brace also includes a pair of knee brace fastening means on each of the contoured vertical edges of the central brace panel and configured to secure the central brace panel in a wrapped position around the leg.

Abstract: An orthotic device for a medical boot includes a first arm for attachment to a first portion of the medical boot, and a second arm for attachment to a second portion of the medical boot. A hinge assembly adjustably fixes an angle between the first and second arms. The hinge assembly includes a first hinge component attached to the first arm, a second hinge component attached to the second arm, and an actuator extending from a proximal end toward a distal end. The distal end of the actuator is biased by a force from a biasing member into a locked position preventing the first and second hinge components from rotating relative to one another. The proximal end of the actuator when actuated, displaces the actuator from the locked position into an unlocked position allowing the second hinge component to rotate relative to the first hinge component.

Abstract: A device for enclosing a finger includes a protective shell having an opening for receiving the finger. The protective shell defines an interior cavity that is sized and shaped to allow extension and flexion of the finger within the shell.

Abstract: A novel container designed to enhance the utility and functionality of wheelchairs by providing a discrete, sanitary, and easily accessible storage solution for urinary catheter drainage bags. This innovative container can mitigate common issues associated with traditional catheter bag placement, such as infections, privacy concerns, and the risk of traumatic catheter removals. The container can be attached to various wheelchair models allows for the independence and dignity of users by providing simplified, private access to the catheter bag without requiring assistance. Additionally, the design ensures the catheter bag remains at an optimal position to prevent backflow and reduce the risk of catheter-associated urinary tract infections (CAUTIs).

Abstract: An ostomy system operable to inform an ostomate of an ostomy device condition useful in preventing leakage relative to the ostomy device includes a base plate, an electrode assembly, a coupling part connected to the electrode assembly, and a monitor device adapted to connect to the coupling part. The electrode assembly is configured to sense ostomy data including moisture propagation in the adhesive layer. The monitor device is configured to collect the ostomy data and inform the user of a future leakage condition.

Abstract: A tensioning system is configured to affix a medical device, such as an ostomy pouch, wound dressing, or medical tubing, to a user's body. In some examples, the tensioning system includes one or more elongated, adjustable flexible, stretchable straps to secure the medical device to the user's abdomen, increasing the tension of a flange of the medical device against the user's skin. A first end of each flexible strap is configured to removably couple to the medical device, e.g., via hooks, adhesive, laces, hook and loop, and/or a ring. A second end of each flexible strap (or a connector base thereupon) includes a skin-safe adhesive coating configured to adhere to the user's skin.

Abstract: Examples relate to urine collection container liner assemblies, and related systems and methods. A urine collection system includes a urine collection device configured to collect urine discharged from a user, a pump configured to draw urine from the urine collection device by applying at least a partial suction force to a reservoir within the urine collection device, a urine collection container in fluid communication with urine collection device, and a liner assembly configured to be disposed within the urine collection container. The liner assembly includes a liner extending from the lid to a closed bottom portion and defining an interior of the liner assembly.

Abstract: A device includes a flexible Peltier; a power supply in electrical communication with the flexible Peltier; a control switch electrically coupled to the power supply and the flexible Peltier. The control switch is configured to control direction of current supplied from the power supply to the flexible Peltier, and at least one flexible layer is coupled to the flexible Peltier. The at least one flexible layer is configured to retain the flexible Peltier about a portion of a subject.

Abstract: The present disclosure provides a method of treating a human subject suffering from a retinal disorder, the method comprising administering to the eye of the subject via intravitreal injection a composition comprising a compound of formula (I) as described herein.

Abstract: Described is a compressible tube comprising a tube body made of a specific laminate and shoulder and applicator, said applicator being suitable for applying a tube content in dosed droplets and comprises a sterile venting valve. The tube body has a restoring force (R) sufficient to essentially restore the original volume of the tube body after each of a predetermined number of applications. Such tube is especially suitable for the application of ophthalmic sterile drops.

Abstract: Provided herein are methods and devices for grasping and/or tearing trabecular meshwork of an eye of a subject. The devices may include a shaft and a tissue grabber coupled to the shaft. The tissue grabber may include an elongate lower foot configured to be inserted into Schlemm's canal, and a groove configured to grasp a portion of the trabecular meshwork. The methods may include: advancing a tissue grabber to Schlemm's canal of the eye, wherein the tissue gripper comprises a lower foot and a tissue grabbing region; advancing a tip of the lower foot through the trabecular meshwork and into Schlemm's canal; and advancing the lower foot within and relative to Schlemm's canal, wherein as the lower foot is advanced, a portion of the trabecular enters the tissue gripping region, is torn from surrounding tissue, and is collected within the tissue gripping region.

Abstract: A method and system for treating glaucoma can include positioning an intraocular shunt in eye tissue such that the shunt conducts fluid from the anterior chamber to a target outflow region in the eye, such as the suprachoroidal space and/or the subconjunctival space (or outside the conjunctiva).

Abstract: An inserter for treating glaucoma can comprise a housing, a needle, a plunger, a slider component, and a drive component. The drive component is disposed within a cavity of the housing and rotatable within the cavity to result in movement along a longitudinal axis of the inserter to the needle and the plunger upon rotation of the drive component. The slider component is coupled to the housing and slidable along an elongate groove of the drive component such that movement of the slider component along the axis rotates the drive component within the housing.