Abstract: A magnetic stylet includes a core element and a distal region. The core element may include a proximal end coupled to a tab, the proximal end having a first diameter, a transition region, and a distal region extending from the transition region to a distal end. The distal region may have a second diameter less than the first diameter. The distal section may include the transition region and the distal region of the core element, a magnetic element, a polymer member, and a closure element. The magnetic element may be positioned distal of the transition region of the core element. The polymer member may be circumferentially disposed about the distal region of the core element, the continuous permanent magnetic element, and at least a portion of the transition region of the core element. The closure element may be an epoxy that forms a rounded end distal of the polymer member.

Abstract: An integrated catheter placement system for placing a catheter in a vasculature of a patient. The system includes a system console with a tip location mode and an ultrasound mode viewable on a display, a magnetic assembly emanating a magnetic field, a tip location sensor designed to sense the magnetic field, and an ultrasound probe for ultrasonically imaging an internal portion of the patient. The magnetic field may provide magnetic field information for locating the magnetic assembly relative to the tip location sensor. The tip location sensor is designed to communicate the magnetic field information to the system console. The system console is designed to display an icon representative of a location of the magnetic assembly relative to the tip location sensor in the tip location mode.

Abstract: An elongated medical device includes a core element, a polymer member, a closure element, and a permanent magnetic element. The core element may have a distal region including a first region with a diameter greater than a diameter of a second region, the second region distal of the first region and terminating at a core element distal end. The polymer member may be circumferentially disposed about an entire length of the core element and extending distal of the core element distal end. The closure element may be affixed to a distal end of the polymer member. The permanent magnetic element may be disposed along the second region proximal to the core element distal end, and may include a plurality of permanent magnetic elements spaced apart along the second region.

Abstract: A stylet for use in guiding a distal tip of a catheter to a predetermined location within the body of a patient. In one embodiment the stylet is configured for use within a lumen of the catheter and comprises a core wire, an ECG sensor, and a magnetic assembly. The ECG sensor senses an ECG signal of a patient when the stylet is disposed within the lumen of the catheter and the catheter is disposed within the body of the patient. The magnetic assembly includes at least one element capable of producing a magnetic or electromagnetic field for detection by a sensor external to the patient. In another embodiment, the stylet includes a pre-shaped distal segment that is deflected with respect to a more proximal portion of the stylet, which in turn causes a distal segment of the catheter to be deflected when the stylet is received within the lumen.

Abstract: An integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to intravascular introduction of the catheter. The ultrasound probe includes user input controls for controlling use of the ultrasound probe in an ultrasound mode and use of the tip location sensor in a tip location mode. In another embodiment, ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart.

Abstract: A needle guide assembly for inserting a needle into the body of a patient in order to access a subcutaneous target, such as a vessel, is disclosed. In one embodiment, the needle guide assembly comprises a needle guide body that is configured to at least indirectly and removably attach to an image producing device, such as an ultrasound probe. The needle guide body defines at least first and second elongate guide channels. Each guide channel defines a unique insertion angle with respect to a longitudinal axis of the ultrasound probe. Further, each guide channel is configured to accept needles of differing gauges.

Abstract: A stylet for use in guiding a distal tip of a catheter to a predetermined location within the body of a patient. In one embodiment the stylet is configured for use within a lumen of the catheter and comprises a core wire, an ECG sensor, and a magnetic assembly. The ECG sensor senses an ECG signal of a patient when the stylet is disposed within the lumen of the catheter and the catheter is disposed within the body of the patient. The magnetic assembly includes at least one element capable of producing a magnetic or electromagnetic field for detection by a sensor external to the patient. In another embodiment, the stylet includes a pre-shaped distal segment that is deflected with respect to a more proximal portion of the stylet, which in turn causes a distal segment of the catheter to be deflected when the stylet is received within the lumen.

Abstract: A needle guide assembly for inserting a needle into the body of a patient in order to access a subcutaneous target, such as a vessel, is disclosed. In one embodiment, the needle guide assembly comprises a needle guide body that is configured to at least indirectly and removably attach to an image producing device, such as an ultrasound probe. The needle guide body defines at least first and second elongate guide channels. Each guide channel defines a unique insertion angle with respect to a longitudinal axis of the ultrasound probe. Further, each guide channel is configured to accept needles of differing gauges. In other embodiments other needle guide assemblies are disclosed that include multiple guide channels for inserting a needle at a variety of insertion angles into the patient's body. Related methods are also disclosed. In yet other embodiments, needle guide assemblies including needle stop features are disclosed.

Abstract: A catheter placement system for positioning a catheter in a vasculature of a patient using at least two different modalities. The catheter placement system includes a console with a display, a stylet removably positionable within a lumen of the catheter, a tip location sensor, and an external electrode. The stylet may include an electrocardiogram (ECG) sensor assembly for detecting ECG signals of a node of a heart of the patient, and a first connector in communication with the ECG sensor assembly. The tip location sensor may be configured to detect the stylet when the catheter is disposed within the vasculature of the patient, and to communicate information of the stylet to the console. The console may be configured to receive at least one aspect of the ECG signal detected by the ECG sensor assembly indicative of proximity of the ECG sensor assembly to the node.

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: An integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to intravascular introduction of the catheter. The ultrasound probe includes user input controls for controlling use of the ultrasound probe in an ultrasound mode and use of the tip location sensor in a tip location mode. In another embodiment, ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart.

Abstract: A medical article, such as a catheter, is secured with respect to a patient with a securement device. The securement device may include a retainer and anchor pad. Certain devices may further include, for example, straps, flaps, dressings, slots, and recesses for securing the medical article to the patient. The retainer may include a recess and/or a channel. At least one surface of the retainer may be coated with an adhesive. A support member may be coupled to the retainer. The support member may include a channel configured to receive a proximally extending portion of the medical article.

Abstract: A dressing for use in protectively covering and isolating a medical device placed on and/or through the skin surface of a patient is disclosed. Examples of such devices include infusion needles for accessing subcutaneously implanted access ports, catheters of various types and purposes, insulin infusion needles, etc. In one embodiment, a dressing for covering a medical device on a skin surface of a patient is disclosed and comprises a dressing portion that is configured to rest against a skin surface of a patient, with the dressing portion defining a hole, and a polymeric cover film that is at least indirectly attached to the dressing portion. The cover film includes a pliable domed portion aligned with the hole of the dressing portion. The pliable domed portion defines a cavity that is configured to receive therein the medical device when the dressing is placed on the skin of the patient.

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 medical article, such as a catheter, is secured with respect to a patient with a securement device. The securement device may include a retainer and anchor pad. Certain devices may further include, for example, straps, flaps, dressings, slots, and recesses for securing the medical article to the patient. The retainer may include a recess and/or a channel. At least one surface of the retainer may be coated with an adhesive.

Abstract: An elongated medical device includes a core element, a polymer member, a closure element, and a permanent magnetic element. The core element may have a distal region including a first region with a diameter greater than a diameter of a second region, the second region distal of the first region and terminating at a core element distal end. The polymer member may be circumferentially disposed about an entire length of the core element and extending distal of the core element distal end. The closure element may be affixed to a distal end of the polymer member. The permanent magnetic element may be disposed along the second region proximal to the core element distal end, and may include a plurality of permanent magnetic elements spaced apart along the second region.

Abstract: A method of treating a patient includes providing a guidewire having an elongate body defining a proximal end and a distal end, the elongate body including a shapeable portion disposed proximate the proximal end, the shapeable portion being malleable so as to be shaped into a shape and remain in the shape until reshaped. The distal end of the elongate body is advanced into a vasculature of the patient. The shapeable portion of the elongate body is shaped into a first shape that prevents advancement of the guidewire further into the vasculature of the patient.

Abstract: A stylet capable of being at least partially disposed within a lumen of a device is disclosed. This stylet may include an elongated body comprising a proximal end, a distal end, and at least one magnetic material. In certain embodiments, the elongated body may also include at least one core element, a tubular member circumferentially disposed about at least a portion of the core element, and/or at least one support member circumferentially disposed about at least a portion of the core element. In addition, a matrix material may be disposed between the core element and the tubular member to retain the magnetic material within the elongated body. A catheter assembly including a stylet and a corresponding method of manufacture are also disclosed.