Abstract: Disclosed herein are magnetically trackable stylets and methods thereof. A magnetically trackable stylet can include a stylet body including a core wire, a magnetic assembly, and an outer construction over the core wire and the magnetic assembly. The magnetic assembly can include one or more magnetic field-producing elements disposed alongside the core wire in a magnetically trackable distal portion of the stylet body. The outer construction, which can be an overmolded layer, a reflowed layer, a potting layer, or a shrink-wrapped layer, can be around the core wire and the magnetic assembly. The stylet body can be configured to be disposed in a lumen of a medical device such as a catheter for magnetically tracking a tip of the medical device in vivo without breakage of the stylet body due to bending-related fatigue. A method of such a magnetically trackable stylet can include a method of using the stylet.

Abstract: Disclosed herein are integrated catheter-placement devices and methods thereof. An exemplary device includes an intravascular catheter, a needle, an access guidewire, and a blood egress-mitigating means for mitigating blood egress from the device. The intravascular catheter includes a catheter tube and catheter hub. The catheter extends from a body of the device. The needle includes a needle shaft and a needle hub. The needle shaft extends through the catheter tube by way of a catheter-tube lumen thereof. The access guidewire is disposed in a needle lumen of the needle. The blood egress-mitigating means mitigates blood egress from the device by mitigating blood egress from an annular space within the needle shaft while still allowing the access guidewire to axially move within the needle lumen. The annular space is defined by a luminal surface of the needle shaft and a surface of the access guidewire.

Abstract: An insertion device to assist in accessing an access port that has been subcutaneously implanted in the body of a patient is disclosed. The implanted access port is accessed by a needle of a needle assembly, such as a needle-based infusion set. The insertion device may include a body having a stabilizing portion and a guide portion. The stabilizing portion stabilizes a position of the implanted access port when the body is placed on the skin of the patient atop the implanted access port. The guide portion is designed to guide a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

Abstract: A non-coring needle for use in accessing an implanted medical device is disclosed. The non-coring needle is configured to include a compact bevel face relative to standard non-coring needles. In one embodiment, the non-coring needle comprises a hollow cannula that defines a lumen and terminates at a sharpened distal tip. The cannula includes a proximal portion and a bent distal portion. The distal portion defines a bevel face extending proximally from the distal tip, and the bevel face includes the lumen distal opening. The bevel face defines an open angle of at least about one degree with respect to a longitudinal axis of the proximal portion of the cannula. The bevel face is also laterally offset from the proximal portion of the cannula by an offset distance of no more than about 0.010 inch. A portion of the bevel face is dulled to prevent access port septum coring.

Abstract: A needle assembly to prevent fluid/vapor escape so as to reduce or prevent fluid exposure to a clinician during use of the needle assembly. The needle assembly may include a handle portion with a needle extending therefrom, and a base portion releasably coupled to the handle portion. The base portion may include a safety assembly to shield a distal tip of the needle and prevent user contact therewith. The base portion may further include a self-sealing pad covering a bottom external surface thereof. The self-sealing pad may include an upper surface designed to mate with the base portion and a raised portion compressively positioned in the opening of the bottom external surface. The needle assembly may further include a fluid isolation component.

Abstract: An insertion assembly and method of manufacturing an insertion assembly. The method includes forming a catheter assembly including a catheter hub and a catheter, inserting a needle into the catheter assembly such that a distal tip of the needle extends distal of a distal end of the catheter, and permanently adhering an interface pad to the catheter hub. The interface pad can include a foam material including a haemostatic agent. The haemostatic agent can include microdispersed oxidized cellulose. The foam material can further include an antimicrobial agent such as chlorhexidine gluconate.

Abstract: A non-coring needle for use in accessing an implanted medical device is disclosed. The non-coring needle is configured to include a compact bevel face relative to standard non-coring needles. In one embodiment, the non-coring needle comprises a hollow cannula that defines a lumen and terminates at a sharpened distal tip. The cannula includes a proximal portion and a bent distal portion. The distal portion defines a bevel face extending proximally from the distal tip, and the bevel face includes the lumen distal opening. The bevel face defines an open angle of at least about one degree with respect to a longitudinal axis of the proximal portion of the cannula. The bevel face is also laterally offset from the proximal portion of the cannula by an offset distance of no more than about 0.010 inch. A portion of the bevel face is dulled to prevent access port septum coring.

Abstract: A non-coring needle for use in accessing an implanted medical device is disclosed. The non-coring needle is configured to include a compact bevel face relative to standard non-coring needles. In one embodiment, the non-coring needle comprises a hollow cannula that defines a lumen and terminates at a sharpened distal tip. The cannula includes a proximal portion and a bent distal portion. The distal portion defines a bevel face extending proximally from the distal tip, and the bevel face includes the lumen distal opening. The bevel face defines an open angle of at least about one degree with respect to a longitudinal axis of the proximal portion of the cannula. The bevel face is also laterally offset from the proximal portion of the cannula by an offset distance of no more than about 0.010 inch. A portion of the bevel face is dulled to prevent access port septum coring.

Abstract: An insertion device to assist in accessing an access port that has been subcutaneously implanted in the body of a patient is disclosed. The implanted access port is accessed by a needle of a needle assembly, such as a needle-based infusion set. The insertion device may include a body having a stabilizing portion and a guide portion. The stabilizing portion stabilizes a position of the implanted access port when the body is placed on the skin of the patient atop the implanted access port. The guide portion is designed to guide a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

Abstract: An insertion device to assist in accessing an access port that has been subcutaneously implanted in the body of a patient is disclosed. The implanted access port is accessed by a needle of a needle assembly, such as a needle-based infusion set. In one embodiment, the insertion device comprises a body that includes a stabilizing portion and a guide portion. The stabilizing portion stabilizes a position of the implanted access port when the body is placed on the skin of the patient atop the implanted access port. The guide portion guides a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

Abstract: A safety needle set for delivering fluid to an access port, the safety needle set having insertion and safety configurations. The safety needle set includes a needle assembly and a base assembly. The needle assembly includes a needle having a distal end with a non-coring tip, the distal end angled with respect to a proximal end of the needle. The needle assembly also includes a pair of foldable wings coupled to the needle, including a first wing and a second wing. The first wing may have a recess, and the second wing may have a protrusion, such that when the first wing contacts the second wing in a wing folded configuration, the recess receives the protrusion. The base assembly includes a housing, a safety needle assembly at least partially disposed in an interior of the housing, and an interface pad coupled to a bottom surface of the housing.

Abstract: A needle assembly to prevent fluid/vapor escape so as to reduce or prevent fluid exposure to a clinician during use of the needle assembly. The needle assembly may include a handle portion with a needle extending therefrom, and a base portion releasably coupled to the handle portion. The base portion may include a safety assembly to shield a distal tip of the needle and prevent user contact therewith. The base portion may further include a self-sealing pad covering a bottom external surface thereof. The self-sealing pad may include an upper surface designed to mate with the base portion and a raised portion compressively positioned in the opening of the bottom external surface. The needle assembly may further include a fluid isolation component.

Abstract: A non-coring needle for use in accessing an implanted medical device is disclosed. The non-coring needle is configured so as to include a compact bevel face relative to standard non-coring needles. In one embodiment, the non-coring needle comprises a hollow cannula that defines a lumen and terminates at a sharpened distal tip. The cannula includes a proximal portion and a bent distal portion. The distal portion defines a bevel face extending proximally from the distal tip, and the bevel face includes the lumen distal opening. The bevel face defines an open angle of at least about one degree with respect to a longitudinal axis of the proximal portion of the cannula. The bevel face is also laterally offset from the proximal portion of the cannula by an offset distance of no more than about 0.010 inch. A portion of the bevel face is dulled to prevent access port septum coring.

Abstract: A non-coring needle for use in accessing an implanted medical device is disclosed. The non-coring needle is configured so as to include a compact bevel face relative to standard non-coring needles. In one embodiment, the non-coring needle comprises a hollow cannula that defines a lumen and terminates at a sharpened distal tip. The cannula includes a proximal portion and a bent distal portion. The distal portion defines a bevel face extending proximally from the distal tip, and the bevel face includes the lumen distal opening. The bevel face defines an open angle of at least about one degree with respect to a longitudinal axis of the proximal portion of the cannula. The bevel face is also laterally offset from the proximal portion of the cannula by an offset distance of no more than about 0.010 inch. A portion of the bevel face is dulled to prevent access port septum coring.

Abstract: Medical device kits for use in placing, maintaining, altering, and/or removing medical devices in, on, and/or from the body of a patient are disclosed. Such medical device kits can include one or more wrap assemblies for use in the placement/maintenance procedure. In accordance with present embodiments, the one or more wrap assemblies of the medical device kit can include various features to assist the clinician performing the particular procedure. In one embodiment, a medical wrap assembly is disclosed, comprising a foldable wrap body that includes a front surface, wherein the front surface is configured to define a sterile field. A plurality of pockets is included on the front surface of the wrap body. The pockets are configured to contain therein a plurality of medical components. The medical components are arranged in the pockets in a predetermined order of use for the medical procedure.

Abstract: A safety needle assembly of an infusion set is disclosed. The needle assembly is configured to prevent fluid/vapor escape therefrom so as to reduce or prevent fluid exposure to a clinician using the needle assembly. In one embodiment, the needle assembly comprises a handle portion including a needle extending therefrom, the needle defining a lumen for passage of a fluid therethrough. The needle assembly also includes a safety assembly defining a needle hole through which the needle initially extends. The safety assembly is selectively and axially slidable along the needle in order to shield a distal tip of the needle and prevent user contact therewith. A fluid isolation component is included in the safety assembly for isolating fluid escape from the needle. In another embodiment, an interface pad is included on the bottom of the needle assembly and includes an antimicrobial and/or haemostatic agent to protect the needle insertion site.

Abstract: An insertion device to assist in accessing an access port that has been subcutaneously implanted in the body of a patient is disclosed. The implanted access port is accessed by a needle of a needle assembly, such as a needle-based infusion set. In one embodiment, the insertion device comprises a body that includes a stabilizing portion and a guide portion. The stabilizing portion stabilizes a position of the implanted access port when the body is placed on the skin of the patient atop the implanted access port. The guide portion guides a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

Abstract: A non-coring needle for use in accessing an implanted medical device is disclosed. The non-coring needle is configured so as to include a compact bevel face relative to standard non-coring needles. In one embodiment, the non-coring needle comprises a hollow cannula that defines a lumen and terminates at a sharpened distal tip. The cannula includes a proximal portion and a bent distal portion. The distal portion defines a bevel face extending proximally from the distal tip, and the bevel face includes the lumen distal opening. The bevel face defines an open angle of at least about one degree with respect to a longitudinal axis of the proximal portion of the cannula. The bevel face is also laterally offset from the proximal portion of the cannula by an offset distance of no more than about 0.010 inch. A portion of the bevel face is dulled to prevent access port septum coring.

Abstract: A safety needle assembly of an infusion set is disclosed. The needle assembly is configured to prevent fluid/vapor escape therefrom so as to reduce or prevent fluid exposure to a clinician using the needle assembly. In one embodiment, the needle assembly comprises a handle portion including a needle extending therefrom, the needle defining a lumen for passage of a fluid therethrough. The needle assembly also includes a safety assembly defining a needle hole through which the needle initially extends. The safety assembly is selectively and axially slidable along the needle in order to shield a distal tip of the needle and prevent user contact therewith. A fluid isolation component is included in the safety assembly for isolating fluid escape from the needle. In one embodiment, the fluid isolation component includes a self-sealing pad that prevents needle leakage when the distal tip is shielded by the safety assembly.

Abstract: A medical needle shield apparatus is provided that includes a needle hub (104) having an outer needle cannula (103) extending therefrom. An inner needle (106) is disposed for slidable movement with the outer needle cannula (103). At least one shield (101) is extensible from a retracted position to an extended position to enclose a distal end of the inner needle (101). The shield (101) includes a binding member (105) disposed within the shield (101) and defines binding surfaces (122) that form an aperture (138) configured for slidable receipt of the inner needle (106). The binding member (105) includes a binding member reset surface (107) aligned with a reset surface (108) for engagement therewith to allow reuse of a shielded needle apparatus.