Abstract: A method can include inserting a distal tip of a needle through a sidewall of a vessel of a patient and into a lumen defined by the vessel while the needle is coupled with a catheter and while the catheter is coupled with a cannular stiffener that is positioned between the catheter and the needle with a distal tip of the stiffener being positioned proximally relative to a distal tip of the catheter. The method can include, with the distal tip of the needle positioned in the lumen of the vessel, holding the needle stationary relative to the vessel while simultaneously advancing the stiffener and the catheter over the needle until the catheter is located at a final indwelling position within the vessel. The method can also include retracting the stiffener and the needle fully from the catheter while the catheter remains at the final indwelling position within the vessel.

Abstract: A method can include engaging the pericardium of a patient at two engagement positions of the pericardium. The method can further include moving the two engagement positions of the pericardium away from each other to tension a portion of the pericardium. The method can further include advancing an access device through the tensioned portion of the pericardium to introduce the access device into the pericardial space of the patient. Other and further methods are also disclosed.

Abstract: A system can include a needle that includes a distal tip configured to be inserted into a vessel of a patient, the needle defining an outer surface. The system can further include a catheter that includes a distal end and an inner surface that defines a lumen within which a portion of the needle is positioned, the distal tip of the needle being at a position that is distal to the distal end of the catheter, the catheter further comprising a catching region of reduced diameter that extends inwardly at the distal end of the catheter.

Abstract: An apparatus and method 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. The stepped increase prevents any further insertion into the bone cortex. Embodiments can 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 embodiment of a tissue engagement device having a sheath, a first arm, a second arm, a first tissue engaging member, a second tissue engaging member, and an actuation cannula. At least a proximal portion of each arm is within the sheath and the tissue engaging members may be positioned on a distal end of each arm. The actuation cannula is also within the sheath, and can move within the sheath between a retracted position and an extended position. The actuation cannula moves at least a portion of each of the first and second arms into a region between an exterior surface of the actuation cannula and an interior surface of the sheath as the actuation cannula moves to the extended position. The engaging members are configured to pierce a desired tissue and anchor to the desired tissue layer when the actuation cannula is in the extended position.

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: A catheter insertion device includes a housing, a needle coupled to a needle hub, a catheter pre-disposed over the needle, a guidewire pre-disposed in a lumen of the needle, a guidewire advancement assembly configured to distally advance the guidewire with respect to the needle, and a catheter advancement assembly configured to distally advance the catheter with respect to the needle. The needle hub can be fixed to an interior of the housing with a distal section of the needle extending from the housing. The catheter advancement assembly can include a tail portion to engage the needle hub in order to prevent movement of the catheter advancement assembly. The catheter insertion device can also include a flash indicator with an elongate channel in fluid communication with the needle lumen. The elongate channel can include a viewable pathway to indicate to a user that the needle tip is within a blood vessel.

Abstract: A patency device for catheter assemblies and other elongate tubular devices used for establishing access to an interior body portion of a patient is disclosed. The patency device establishes and preserves patency of one or more lumens defined by the catheter assembly by providing impulses of positive pressure to fluid disposed in the lumen of the catheter assembly. In one embodiment, the patency device comprises a fluid reservoir configured to provide a fluid path to at least one lumen of the catheter assembly, and a pressure input portion. The pressure input portion is configured to provide pressure for one or more impulses of positive pressure to a fluid disposed within the lumen. The impulses are configured to dislodge occlusions that may have formed in the lumen. A negative pressure can then be provided to the lumen to aspirate the occlusion.

Abstract: An intraosseous access system can include a needle that defines a lumen and a longitudinal axis about which the needle can be rotated during an insertion event. The needle can include a proximal end that remains at an exterior of a patient during use, a distal end that can be inserted through the skin of the patient into contact with a bone of the patient, and a distal tip at a distalmost point of the distal end of the needle that is positioned at the longitudinal axis of the needle. The system can further include an obturator sized to be received within the lumen of the needle that can inhibit material from entering the needle as the system is inserted into the bone.

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.

Abstract: A method can include engaging the pericardium of a patient at two engagement positions of the pericardium. The method can further include moving the two engagement positions of the pericardium away from each other to tension a portion of the pericardium. The method can further include advancing an access device through the tensioned portion of the pericardium to introduce the access device into the pericardial space of the patient. Other and further methods are also disclosed.

Abstract: A method can include engaging the pericardium of a patient at two engagement positions of the pericardium. The method can further include moving the two engagement positions of the pericardium away from each other to tension a portion of the pericardium. The method can further include advancing an access device through the tensioned portion of the pericardium to introduce the access device into the pericardial space of the patient. Other and further methods are also disclosed.

Abstract: A system can include an elongated instrument that is positioned within a cannula portion of a cannula assembly. The system can include a shield that is coupled with both the elongated instrument and the cannula assembly when in an unlocked state. The shield can permit proximal movement of the elongated instrument relative thereto when in the unlocked state. The shield can automatically transition to a locked state to attach to a distal end of the elongated instrument to restrict access to a distal tip of the elongated instrument.

Abstract: A system for intraosseous access can include an elongated instrument that is positioned within a cannula portion of a cannula assembly. The system can include a shield that is coupled with both the elongated instrument and the cannula assembly when in an unlocked state. The shield can permit proximal movement of the elongated instrument relative thereto when in the unlocked state. The shield can automatically transition to a locked state to attach to a distal end of the elongated instrument to restrict access to a distal tip of the elongated instrument.

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.

Abstract: An insertion device for inserting a catheter into a patient's body is disclosed. In some embodiments, the insertion device combines needle insertion, guidewire advancement, catheter insertion, and needle shielding in a single device. In one embodiment, the insertion device comprises a housing including a hollow needle distally extending from the housing. At least a portion of the catheter is pre-disposed over the needle such that the catheter is disposed substantially external to the housing. A guidewire is included, as well as an advancement assembly that is configured to selectively advance the distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter. The advancement assembly is further configured to enable distal catheter advancement before shielding the needle after use. The insertion device is configured to be grasped and used by a single hand of a user.

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.

Abstract: A system can include a needle that includes a distal tip configured to be inserted into a vessel of a patient, the needle defining an outer surface. The system can further include a catheter that includes a distal end and an inner surface that defines a lumen within which a portion of the needle is positioned, the distal tip of the needle being at a position that is distal to the distal end of the catheter, the catheter further comprising a catching region of reduced diameter that extends inwardly at the distal end of the catheter.

Abstract: An intraosseous access system can include a hub coupled to a cannula that can be introduced into a bone of a patient. The system further includes a securement device that can couple with the hub when transitioned from an open orientation to a closed orientation. The securement device includes a first segment and a second segment that are spaced apart from each other when the securement device is in the open orientation and are approximated and secured to each other when the securement device is in the closed orientation. The first segment includes a first receptacle that receives a portion of the hub therein and contacts the hub to restrain movement of the hub relative to the securement device when the securement device is coupled with the hub in the closed orientation. The first segment also includes a first arm coupled to the first receptacle, the first arm biasing the first receptacle toward the hub when the securement device is coupled with the hub in the closed orientation.

Abstract: A system can include a handle and a needle fixedly secured to the handle. The needle can include a distal tip that can be inserted through a sidewall of a vessel of a patient. The system can further include a catheter that defines a lumen through which the needle extends and includes an engagement surface at an interior thereof. A stiffener can be positioned within the lumen of the catheter at an exterior of the needle and can include an engagement surface that can press distally on the engagement surface of the catheter to advance the catheter distally over the needle and through a lumen of the vessel when the stiffener is advanced distally over the needle. The system can further include a stiffener hub attached to the stiffener, the stiffener hub being movably coupled with the handle so as to translate relative thereto.