Abstract: Devices and methods for an autovance intraosseous device. The autovance intraosseous device can include a trigger activated system or pressure activated system that causes a needle to advance distally for a predetermined distance. The predetermined distance ensures a needle tip extends through the bone cortex, to access the medullary cavity, without penetrating a far wall of the medullary cavity. The advancement can be driven by a spring based system or an electric motor.

Abstract: Embodiments disclosed herein are directed to apparatus and methods for a stepped needle for an intraosseous device that uses the outer surface of the bone cortex as a reference point. Since the thickness of the bone cortex does not vary significantly between patients, the accuracy of needle placement can be improved. The device includes a needle with a stepped increase in outer diameter disposed along the needle shaft. The abrupt change in outer diameter provides a substantial increase in insertion force. In embodiments, the stepped increase prevents any further insertion into the bone cortex. Embodiments include a tapered needle lumen for medullary access confirmation and an overtube that is rotatably and slidably engaged to protect surrounding tissues and prevent needle stick injuries. Further, a needle hub can be rotatable or slidable, and can transition an overtube to an extended position to prevent accidental needle stick injuries.

Abstract: An intraosseous access system with a sterile access assembly provided within a sterile packaging. The access assembly can be sealed within the sterile packaging by a lid that can allow for gas sterilization. The sterile packaging provides both mechanical protection and a sterile barrier during handling and transport. In an embodiment, a disposable intraosseous access system is provided with the access assembly pre-attached to the driver, and a sterile packaging or cap disposed thereover, configured to provide both mechanical protection and a sterile barrier during handling and transport. In an embodiment, once the cap is removed, the access assembly extends from a retracted position within the driver, to a deployed position. After used the access assembly can be retracted to provide safe disposal. The system can further include an extension set also disposed within the sterile environment provided by the driver or the cap.

Abstract: Constant-torque intraosseous access devices and methods thereof are disclosed. An intraosseous access device can include a constant-torque spring assembly disposed in a housing, a drive shaft extending from the housing, and an intraosseous needle coupled to the drive shaft configured to provide intraosseous access to a medullary cavity of a patient. A method of such an intraosseous access device can include inserting a distal end of the intraosseous needle through skin at an insertion site of a patient; applying force to bone at the insertion site with the distal end of the intraosseous needle, which starts winding a metal ribbon of the constant-torque spring assembly from an output spool onto a storage spool, thereby starting rotation of the intraosseous needle; and drilling through the bone until the intraosseous needle enters a medullary cavity of the patient, thereby achieving intraosseous access with the intraosseous access device.

Abstract: Disclosed herein are intraosseous access devices having various operating mechanisms, as well as methods of the intraosseous access devices. For example, an intraosseous access device includes, in some embodiments, a constant-torque spring assembly, a drive shaft, an intraosseous needle, and an interlock mechanism. The constant-torque spring assembly is disposed in a housing, and the drive shaft extends from the housing. The drive shaft is coupled to the constant-torque spring assembly. The intraosseous needle is coupled to the drive shaft. The intraosseous needle is configured for drilling through bone and providing intraosseous access to a medullary cavity of a patient. The interlock mechanism is configured to prevent rotation of the intraosseous needle and the drilling therewith until the interlock mechanism is disengaged.

Abstract: A catheter for insertion into a body of a patient, and methods of making and using. The catheter can include a distal portion that remains stable during fluid infusion into the patient, thus reducing or eliminating whipping of the catheter distal tip. The catheter includes at least one lumen and can be configured such that the arithmetic product of an elastic modulus and an area moment of inertia for the distal portion of the catheter is greater than the arithmetic product of an elastic modulus and an area moment of inertia for a proximal portion. The catheter can be attached to an implantable access port that may include features for use as a power injectable access port.

Abstract: An access device configured for inserting an intraosseous catheter into an interior portion of a bone is disclosed. In one embodiment, an intraosseous access device is disclosed, comprising a device body, a trocar needle included with the device body, and an intraosseous catheter removably disposed on the trocar needle. The device body is configured to enable a user of the access device to manually insert a distal tip of the trocar needle through a skin surface of a body of a patient to an external surface of a bone of the patient. An advancement mechanism is also disclosed and is configured to selectively and distally advance the trocar needle and intraosseous catheter a predetermined distance into an internal portion of the bone of the patient after the distal tip of the trocar needle has been inserted to the external surface of the bone.

Abstract: Embodiments disclosed herein are directed to a system including an intravenous (IV) pump, a vascular access device (VAD), securement devices, and methods thereof. The intravenous (IV) pump, vascular access device (VAD), and securement device can include a sensor, printed circuit board (PCB), communication module, and the like to determine the characteristics of the VAD device in use, the fluid being administered, and physiological characteristics of the patient. The pump unit can utilize this information to modify the flow characteristics of the fluid being administered. The VAD characteristics can be predetermined and stored on the VAD, derived from sensors, or derived from remote databases using a unique identifier. Fluid and physiological characteristics can be determined from sensors located on the pump, VAD, securement device or combinations thereof.

Abstract: A method for making a catheter. The method includes forming a catheter tube including an outer wall circumscribing at least one lumen and having a closed distal end, and creating a slit valve in a distal segment of the catheter tube proximal of the closed distal end. The slit valve includes a slit through the outer wall and a compliant segment designed to facilitate inward deflection of a portion of the outer wall along the slit when negative pressure is applied to the at least one lumen. The compliant segment is circumferentially spaced apart from the slit.

Abstract: An insertion device includes a housing, a sheath, a guidewire, and a wheel assembly. The housing has a distal opening at a distal end and a proximal opening at a proximal end. The sheath is coupled to the proximal end of the housing and has an interior in communication with a proximal opening of the housing. The guidewire extends through the proximal opening and into the sheath. The guidewire includes a feature to limit distal advancement of the guidewire. The wheel assembly is rotatably coupled to the housing and connected to the guidewire such that rotation of the wheel assembly distally advances the guidewire through the distal opening of the housing.

Abstract: An ultrasound probe assembly includes an ultrasound probe, an ultrasound cap, a solid hydrogel component, and a cover. The ultrasound probe can include a probe head and an orientation indicator. The probe head includes an acoustic surface. The ultrasound cap can include an opening defined by an opening perimeter, and a base configured to support a removable needle guide. The base can be aligned with the orientation indicator. The solid hydrogel component can include a probe-contacting side contacting the acoustic surface, a skin-contacting side extending through the opening, and an outer perimeter larger than the opening perimeter. The cover can be configured to cover the hydrogel component and at least a portion of the ultrasound cap.

Abstract: A bi-directional valve assembly, including valves for use in closed-ended catheters or other elongate tubular devices, is disclosed. In one embodiment, a catheter assembly for insertion into a body of a patient is disclosed and comprises an elongate catheter tube including an outer wall that at least partially defines at least one lumen that extends between a proximal end and a closed distal end thereof. The catheter tube includes a valve assembly that in turn includes a linear slit valve defined through the outer wall of a distal segment of the catheter tube, and a deformation region. The deformation region includes a compliant segment disposed in the outer wall of the catheter tube and a thinned portion of the outer wall. The compliant segment and thinned portion of the deformation region cooperate to preferentially deform the outer wall and open the slit valve during aspiration through the catheter tube.

Abstract: An insertion tool for inserting a catheter into a patient's body is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component. Guidewire and catheter locking systems are also disclosed.

Abstract: An insertion tool for inserting a catheter into a patient's body is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component. Guidewire and catheter locking systems are also disclosed.

Abstract: An insertion tool for inserting a catheter into a patient's body is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component. Guidewire and catheter locking systems are also disclosed.

Abstract: A probe cap for use with an ultrasound probe including a head portion and an acoustic surface is disclosed. In one embodiment, the probe cap includes a body that defines a cavity sized for releasably receiving the head portion of the probe therein. The probe cap body further defines a hole that is proximate the acoustic surface of the head portion. A compliant spacer component is disposed in the hole. The spacer component can include a hydrogel and provides an acoustic path between the acoustic surface and a tissue surface of a patient. The spacer component includes a skin contact surface that defines a concavity and is deformable against the tissue surface. Additional embodiments disclose various probe cap and accompanying needle guide designs for use in assisting a clinician with ultrasound probe use and needle insertion into a patient.

Abstract: A guidance system for assisting with the insertion of a needle into a patient is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. The guidance system can include an imaging device including a probe for producing an image of an internal body target, such as a vessel. One or more sensors can be included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system can include a processor that uses data relating to the sensed characteristic to determine a 3-D position of the needle, and a display for depicting the position of the needle. A needle assembly including a hub, cannula, and magnetic element is also disclosed, in which a magnetic axis of the magnetic element can be configured to be coaxially or otherwise aligned with the cannula axis.

Abstract: An insertion tool for inserting a catheter into a patient's body includes a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with the catheter pre-disposed over the needle, and a guidewire pre-disposed in the needle. The insertion tool can include a guidewire advancement assembly that can include a first finger pad for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. The insertion tool can further include a catheter advancement assembly that can include a second finger pad for selectively advancing the catheter into the patient. The first and second finger pads can be positioned such that a user can begin to advance the second finger pad after advancing the first finger pad without substantially re-positioning the thumb or finger of the user.