Abstract: Medical dressings including stiffening systems fixedly attached to backing layers are described herein along with methods of using the medical dressings. The stiffening system is fixedly secured to the backing to limit flexing and stretching of the backing layer. Typically, the medical dressing and stiffening system is applied over a medical device that is secured to skin. The stiffening system covers some of the medical device and also extends beyond the medical device. The stiffening system stabilizes the medical device over the skin.

Abstract: A continuous meta-learning system operating at a server is described. In one aspect, a computer-implemented method includes accessing, at the server, a deployed machine learning model, metadata, and new prediction data for the deployed machine learning model, detecting a novel trend in the deployed machine learning model based on the new prediction data, generating label suggestions for the novel trend using metadata, querying a plurality of users to verify the label suggestions, detecting a consensus of the plurality of users, the consensus based on a rate of responses from the plurality of users that confirm the label suggestions, and in response to detecting the consensus, training a new machine learning model based on the new prediction data and the consensus of the plurality of users. The computer-implemented method also includes deploying the new machine learning model at the server.

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame comprising a plurality of struts defining openings between them. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a main body, opposing tabs on opposite sides of the main body, a coaptation edge portion, and a cusp edge portion. Each tab can be paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are fixed relative to the frame, and each leaflet can have opposing edge portions between the opposing tabs and the cusp edge portion that are unattached to the frame, each unattached edge portion defining a gap that extends radially into the main body of the leaflet.

Abstract: A post-deployment drift detection monitoring of a predictive model is described. The method includes accessing a predictive performance metric of a machine learning model that is deployed at a server, the machine learning model being trained with an initial set of training data containing historical data, the predictive performance metric being based on the initial set of training data and an additional set of training data, the additional set of training data containing training data collected since training the machine learning model, detecting a drift based on the predictive performance metric exceeding a drift detection threshold, generating a drift warning notification to a client device, the drift warning notification indicating that the predictive performance metric exceeds the drift detection threshold, receiving a user feedback from the client device, and adjusting one of the machine learning model or the drift detection threshold based on the user feedback.

Abstract: A prosthetic valve can include a radially expandable and compressible frame having a plurality of struts, each strut having a first end, a second end, and a length extending from the first end to the second end. Each strut further including a plurality of recesses disposed on one or more longitudinal edges of the strut and extending into a width of the strut. The prosthetic valve further including a valvular structure disposed within and coupled to the frame, the valvular structure comprising a plurality of leaflets, and a skirt mounted to the frame via one or more sutures. The recesses retain the one or more sutures and prevent the one or more sutures from sliding along the length of the strut.

Abstract: Outer skirts for a prosthetic heart valve are disclosed. As one example, a prosthetic heart valve can include an annular frame and an outer skirt disposed around an outer surface of the frame. The outer skirt can include a first portion comprising a polymeric material and a second portion comprising a fabric, where the polymeric material has a greater thromboresistance than the fabric.

Abstract: A prosthetic heart valve can include a radially expandable and compressible annular frame, a valvular structure, and a commissure cover. The frame can include a plurality of struts defining the annular frame, and a plurality of commissure support structures each defining a commissure opening positioned along a circumference of the annular frame. The valvular structure can be mounted within the frame, the valvular structure including a plurality of commissures each extending radially through a respective commissure opening to attach the valvular structure to the frame, each commissure having an outflow edge that extends from a radial outer surface of the frame. The commissure cover can be disposed at least partially over the outflow edge of the commissure and can define a ramped surface that extends from the radial outer surface of the frame to a radial outer surface of the commissure.

Abstract: A method of assembling a valvular structure can include folding an upper tab of a first leaflet onto a lower tab of the first leaflet, disposing a first end of a reinforcing member on the upper tab, disposing a commissure member adjacent the lower tab, and coupling the first end of the reinforcing member, the tabs of the first leaflet, and the commissure member to one another. The method can further include folding an upper tab of a second leaflet onto a lower tab of the second leaflet, disposing the second leaflet adjacent the first leaflet such that the commissure member is positioned between the lower tabs, disposing a second end of the reinforcing member on the upper tab of the second leaflet, and coupling the reinforcing member, the upper and lower tabs of the second leaflet, and the commissure member to one another to form a commissure.

Abstract: Devices are disclosed for the detection of illicit substances within beverages. A lateral flow assay device for testing beverages comprises a backing card, a plurality of pads adhered to the backing card, the plurality of pads comprising at least a sample pad, a stacking pad, and a conjugate pad, wherein the stacking pad has a first end and a second end, the stacking pad is overlapped by the sample pad by a first length at the first end, and the stacking pad overlaps the conjugate pad by a second length at the second end.

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end, an outflow end, and a plurality of struts. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion. The cusp edge portion of each leaflet can be folded toward the outflow end of the frame along a bending axis and a reinforcing member extends along an outflow surface of the cusp edge portion along the bending axis. The prosthetic heart valve can include a plurality of connecting skirts, each disposed between the cusp edge portion of an adjacent leaflet and the frame. First stitching secures the reinforcing member and the connecting skirts to the cusp edge portions and second stitching secures the connecting skirts to selected struts of the frame.

Abstract: A method of assembling a valvular structure can include folding an upper tab of a first leaflet onto a lower tab of the first leaflet, disposing a first end of a reinforcing member on the upper tab, disposing a commissure member adjacent the lower tab, and coupling the first end of the reinforcing member, the tabs of the first leaflet, and the commissure member to one another. The method can further include folding an upper tab of a second leaflet onto a lower tab of the second leaflet, disposing the second leaflet adjacent the first leaflet such that the commissure member is positioned between the lower tabs, disposing a second end of the reinforcing member on the upper tab of the second leaflet, and coupling the reinforcing member, the upper and lower tabs of the second leaflet, and the commissure member to one another to form a commissure.

Abstract: Medical dressings including stiffening systems fixedly attached to backing layers are described herein along with methods of using the medical dressings. The stiffening system is fixedly secured to the backing to limit flexing and stretching of the backing layer. Typically, the medical dressing and stiffening system is applied over a medical device that is secured to skin. The stiffening system covers some of the medical device and also extends beyond the medical device. The stiffening system stabilizes the medical device over the skin.

Abstract: An elevator tool for preparing a surgical site for an implant device is disclosed. The elevator tool comprises a distal paddle coupled to a paddle handle assembly and a positioning grip. The paddle handle assembly influences movement of the distal paddle and the positioning grip influences position of the distal paddle. The paddle handle assembly is coupled to the distal paddle with an inner shaft extending through the receiving grip whereby the distal paddle can be placed on the contralateral side of a bone and can be moved by the paddle handle assembly oriented on the ipsilateral side of the bone. The distal paddle comprises an elongated member having at least one arm configured to be rotated at least about 90 degrees by the paddle handle assembly to remove obstructions on the contralateral side of the vertebral body from a position oriented on the ipsilateral side of the vertebral body.

Abstract: An implant system comprising a staple and a cage is disclosed. The implant system is secured to the bone by moving the staple rotationally and longitudinally whereby tines of the staple and opposing tines frictionally and mechanically engage or embed themselves in the bone side walls. For vertebral applications, the cage defines an upper surface plane, a lower surface plane and a cage surface angle between these two planes whereby the cage surface angle may alter an endplate surface plane of one or more vertebral body when the cage is implanted in a vertebral body. Implant systems may be configured for use as an interbody or intrabody implant system. The implant system may also be configured for use in arthrodesis procedures with other joints within the body. The implant system may further comprise an anchor frame or plate to further secure the cage and staple to the anatomy.

Abstract: The insertion instrument (10) for inserting a modular intervertebral fusion device or components thereof into an inter-vertebral space comprises at least one superior (arm 16), (18) mounted on a superior support (12) such that the at least one superior arm extends from the superior support. The insertion instrument further comprises at least one inferior arm (20), (22) mounted on an inferior support (14) such that the at least one inferior arm extends from the inferior support.

Abstract: Systems and methods for tibial plateau leveling osteotomy (TPLO) are disclosed. According to some embodiments, an osteotomy method may include cutting a tibia with an arcuate cut to separate a tibial plateau of the tibia from a tibial base of the tibia, rotating the tibial plateau relative to the tibial base from a first orientation to a second orientation, and, with the tibial plateau in the second orientation relative to the tibial base, securing an implant to the tibia to secure the tibial plateau to the tibial base. Securing the implant to the tibia may include embedding a first leg of the implant into the tibial base, and embedding a second leg of the implant into the tibial plateau such that the first and second legs apply compression urging the tibial plateau toward the tibial base.

Abstract: An assembly for determining height and angle of an intervertebral device to be implanted in an intervertebral space. The assembly comprises a sizing instrument (12) comprising a support (18) attached to first and second arms (20), (22) which extend in generally a same direction from the support. The assembly also comprises superior and inferior endplates (14), (16) of the intervertebral device to be implanted. One of the superior and inferior endplates (14), (16) engages with a distal end of the first arm (20) and the other of the superior and inferior endplates (14), (16) engages with a distal end of the second arm (22), the superior and inferior endplates opposing each other when they are engaged with their respective arms.

Abstract: An implant system comprising a staple and a cage is disclosed. The implant system is secured to the bone by moving the staple rotationally and longitudinally whereby tines of the staple and opposing tines frictionally and mechanically engage or embed themselves in the bone side walls. For vertebral applications, the cage defines an upper surface plane, a lower surface plane and a cage surface angle between these two planes whereby the cage surface angle may alter an endplate surface plane of one or more vertebral body when the cage is implanted in a vertebral body. Implant systems may be configured for use as an interbody or intrabody implant system. The implant system may also be configured for use in arthrodesis procedures with other joints within the body. The implant system may further comprise an anchor frame or plate to further secure the cage and staple to the anatomy.

Abstract: The present disclosure describes devices, systems, and methods for intravascularly delivering an implantable device to a targeted anatomical site such as the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. A delivery catheter is concentrically positioned within an outer member and configured to advance the intravascular device relative to the outer member. The delivery catheter includes a distal can structure configured to house at least a portion of the intravascular device in a compressed, pre-deployed position.

Abstract: The present disclosure describes devices, systems, and methods for intravascularly delivering an implantable device to a targeted anatomical site such as the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. A delivery catheter is concentrically positioned within an outer member and configured to advance the intravascular device relative to the outer member. The delivery catheter includes a distal can structure configured to house at least a portion of the intravascular device in a compressed, pre-deployed position.