Abstract: Systems and methods are disclosed that provide smart alerts to users, e.g., alerts to users about diabetic states that are only provided when it makes sense to do so, e.g., when the system can predict or estimate that the user is not already cognitively aware of their current condition, e.g., particularly where the current condition is a diabetic state warranting attention. In this way, the alert or alarm is personalized and made particularly effective for that user. Such systems and methods still alert the user when action is necessary, e.g., a bolus or temporary basal rate change, or provide a response to a missed bolus or a need for correction, but do not alert when action is unnecessary, e.g., if the user is already estimated or predicted to be cognitively aware of the diabetic state warranting attention, or if corrective action was already taken.

Abstract: A control device for use with a steerable medical device comprises a steering shaft rotatable about a longitudinal axis thereof, a first steering cam is affixed to the steering shaft to rotate in unison therewith. A second steering cam is mounted on the steering shaft and freely rotatable about the longitudinal axis of the steering shaft independent of the steering shaft. A latch assembly is operatively connected to the first steering cam and the second steering cam and operable in an inactive configuration in which the first and second steering cams are positioned to maintain first and second steering wires in an un-tensioned or reduced tension state, and further operable in an active configuration in which the first and second steering cams are positioned to maintain the first and second steering wires in a tensioned state. A rotary knob assembly is also disclosed.

Abstract: Methods, systems, and devices are described for mapping and treating tissue during a medical procedure. In some cases, a device includes a mesh of wires with sensors coupled thereto. The device can be coupled to an expandable treatment element. The expandable treatment element can include multiple segments. The sensors can be used to map a tissue area and monitor the tissue during a medical procedure.

Abstract: An implantable externally driven fluid delivery system for localized delivery of medical agents and drugs, such as antibiotics, may be provided herein. The fluid delivery system includes a housing that incorporates a filling septum connected to a flexible internal reservoir. The reservoir is connected to a miniature diaphragm pump with coupled magnetic components. The entire fluid delivery system is implantable into a body cavity or surgically formed location that provides for local medical agent delivery. The reservoir is filled via percutaneous injection through the skin into the septum. Fluid delivery is achieved through proximity of the external controller that generates an oscillating or reversing magnetic field suitable to actuate the pump's diaphragm resulting in controlled fluid flow. Once local drug delivery treatment is complete, the controller can be discarded.

Abstract: A control device for use with a steerable medical device comprises a steering shaft rotatable about a longitudinal axis thereof, a first steering cam is affixed to the steering shaft to rotate in unison therewith. A second steering cam is mounted on the steering shaft and freely rotatable about the longitudinal axis of the steering shaft independent of the steering shaft. A latch assembly is operatively connected to the first steering cam and the second steering cam and operable in an inactive configuration in which the first and second steering cams are positioned to maintain first and second steering wires in an un-tensioned or reduced tension state, and further operable in an active configuration in which the first and second steering cams are positioned to maintain the first and second steering wires in a tensioned state. A rotary knob assembly is also disclosed.

Abstract: Robotic arms, and devices with such arms, having any combination of gear-driven actuator assemblies and cable-driven actuator assemblies, with some arm or device embodiments having solely gear-driven assemblies, some having solely cable-driven assemblies, and others having a combination of at least one of each. Further embodiments relate to arms or devices having one or more actuation assemblies with an actuator is disposed remotely (in a different component of the device—or even external to the device) in relation to the actuable component to which it is coupled.

Abstract: Devices for loading intravascular treatment devices into a sheath and associated systems and methods are disclosed herein. A sheathing tool may include, for example, a first channel extending to a first opening, the first channel configured to receive a treatment device in a constrained state therethrough. The treatment device may include an elongated member and a first element and a second element at a distal region of the elongated member. The second channel may extend to a second opening, the second opening surrounded by a sidewall and configured to receive the treatment device in the constrained state therethrough, wherein the second opening is spaced apart from the first opening by a gap, and wherein a length of the gap is great enough to allow the first element to self-expand over the sidewall while the second element generally maintains its diameter in the constrained state while crossing the gap.

Abstract: The present invention relates to tissue approximation and fixation, and surgical staples and staple placement devices for surgery and the like. The present invention includes surgical staples having solid first and second legs for anchoring into respective tissue portions, and an elastically deformable bridge monolithically formed with the first leg and the second leg, the legs each forming respective angles greater than 90 degrees with respective portions of said elastically deformable bridge. The present invention also includes staple insertion device comprising a handle portion and substantially parallel insertion portions extending from the handle, the insertion portions each having an interior lateral channel, and each insertion portions having a terminal point.

Abstract: A medical device delivery system can be used to advance a medical device to a target area within a patient's vasculature. The system can comprise a catheter, a support sheath, and a core member coupled to a medical device. The core member can be used to longitudinally advanced or retracting medical device within a lumen of the support sheath. The support sheath can be advanced within the catheter until a distal end of the support sheath contacts or abuts a reduced diameter section of the catheter lumen. Thereafter, the core member can be advanced into the catheter lumen toward the target area.

Abstract: A spinal implant which is configured to be deployed between adjacent vertebral bodies. The implant has at least one extendable support element with a retracted configuration to facilitate deployment of the implant and an extended configuration so as to expand the implant and effectively distract the disc space, stabilize the motion segments and eliminate pathologic spine motion. The implant has a minimal dimension in its unexpanded state that is smaller than the dimensions of the neuroforamen through which it typically passes to be deployed within the intervertebral space. The implant is provided with a locking system having a plurality of linked locking elements that work in unison to lock the implant in an extended configuration. Bone engaging anchors also may be provided to ensure secure positioning.

Abstract: A joint balancing insert with sensors and an actuated mechanism is disclosed. The joint balancing insert is used to balance a joint during arthroplasty surgery, as the sensors provide force, position and angular data relating to the movement of the joint, while the actuated mechanism allows for highly accurate and dynamic adjustments of the joint based on the data from the sensors. Various configurations of actuated mechanisms and sensors may be implemented in the insert to provide for manual or real time control of the insert, and customized interfaces are provided for visualized feedback of adjustments. Sensor data may also be collected and compared with expected or preferred data sets to provide adjustment recommendations and achieve better outcomes based on historical data.

Abstract: Disclosed herein is a valve assembly comprising a male luer end portion and a female luer end portion and a passage for the transfer of fluids extending between the male and female luer end portions, valve means movable between a first position, in which the passage is closed, and a second position, in which the passage is open, biasing means for biasing the valve means toward the first position, and actuating means extending into the male luer end portion and coupled to the valve means to actuate the valve means when a female luer end portion of a medical accessory is engaged with the male luer end portion.

Abstract: A spinal implant which is configured to be deployed between adjacent vertebral bodies. The implant has at least one extendable support element with a retracted configuration to facilitate deployment of the implant and an extended configuration so as to expand the implant and effectively distract the disc space, stabilize the motion segments and eliminate pathologic spine motion. The implant has a minimal dimension in its unexpanded state that is smaller than the dimensions of the neuroforamen through which it typically passes to be deployed within the intervertebral space. The implant is provided with a locking system having a plurality of linked locking elements that work in unison to lock the implant in an extended configuration. Bone engaging anchors also may be provided to ensure secure positioning.

Abstract: A fluid sample optimization device for optimizing a fluid sample collected by a fluid collection device from a fluid source, where a first portion of the fluid sample potentially has contaminants. The device includes an inlet configured to connect with the fluid source, an outlet configured to connect with the fluid collection device, a sample path connected between the inlet and the outlet, and a contaminant containment reservoir connected between the inlet and the outlet. The contaminant containment reservoir has an air permeable fluid resistor proximate the outlet, and is arranged to receive the first portion of the fluid sample from the fluid source to displace air therein, such that upon receipt of the first portion of the fluid sample and containment of the contaminants in the contaminant containment reservoir, subsequent portions of the fluid sample are conveyed by the sample path from the inlet to the outlet when subsequent pressure differentials are applied between the inlet and the outlet.

Abstract: Capping and cleansing devices for capping and cleansing needlefree connectors, particularly luer access devices such as needlefree vascular access connectors, and methods for using said devices, are described. The devices of the invention each include interconnected inner and outer housings that a user can transition between a locked or engaged position to allow the inner and outer housings to rotate in unison and an unlocked or disengaged position that allows the outer housing to rotate independently of the inner housing, and a compressible cleansing matrix secured in the device (preferably in a well in the outer housing).

Abstract: Capping and cleansing devices for capping and cleansing needlefree connectors, particularly luer access devices such as needlefree vascular access connectors, and methods for using said devices, are described. The devices of the invention each include interconnected inner and outer housings that a user can transition between a locked or engaged position to allow the inner and outer housings to rotate in unison and an unlocked or disengaged position that allows the outer housing to rotate independently of the inner housing, and a compressible cleansing matrix secured in the devices (preferably in a well in the outer housing).

Abstract: Devices for loading intravascular treatment devices into a sheath and associated systems and methods are disclosed herein. A sheathing tool may include, for example, a first channel extending to a first opening, the first channel configured to receive a treatment device in a constrained state therethrough. The treatment device may include an elongated member and a first element and a second element at a distal region of the elongated member. The second channel may extend to a second opening, the second opening surrounded by a sidewall and configured to receive the treatment device in the constrained state therethrough, wherein the second opening is spaced apart from the first opening by a gap, and wherein a length of the gap is great enough to allow the first element to self-expand over the sidewall while the second element generally maintains its diameter in the constrained state while crossing the gap.

Abstract: Methods, systems, and devices are described for mapping and treating tissue during a medical procedure. In some cases, a device includes a mesh of wires with sensors coupled thereto. The mapping device can be coupled to an expandable treatment element. Alternatively, the treatment device can be a separate device, and advanced through an access lumen in the mapping device. The expandable treatment element can include multiple segments.

Abstract: The present invention includes a suture adapted to be anchored into tissue, the suture comprising a length of an elongate flexible suture material and a plurality of barbed anchor articles slidingly disposed along a length of the suture material. The invention also includes a suture placement device designed to insert the anchors of the suture articles into opposing tissue surfaces and associated methods for approximating and/or affixing opposed tissue surfaces in surgical procedures and the like.

Abstract: Devices for loading intravascular treatment devices into a sheath and associated systems and methods are disclosed herein. A sheathing tool may include, for example, a first channel extending to a first opening, the first channel configured to receive a treatment device in a constrained state therethrough. The treatment device may include an elongated member and a first element and a second element at a distal region of the elongated member. The second channel may extend to a second opening, the second opening surrounded by a sidewall and configured to receive the treatment device in the constrained state therethrough, wherein the second opening is spaced apart from the first opening by a gap, and wherein a length of the gap is great enough to allow the first element to self-expand over the sidewall while the second element generally maintains its diameter in the constrained state while crossing the gap.