Abstract: A shaped guidewire for use in medical applications is disclosed. The guidewire is shaped so as to prevent inadvertent advancement of the guidewire into the corpus of a patient during use. In one embodiment, the guidewire includes an elongate body that defines proximal and distal ends. The guidewire body further defines a shaped portion that is positioned intermediate the proximal and distal ends. The shaped portion of the guidewire is at least partially composed of a shape memory material, such as nitinol, and is deflected from a longitudinal axis defined by an undeflected portion of the guidewire body. The shaped portion is disposed in one embodiment at the proximal end of the guidewire. In another embodiment, a proximal portion of the nitinol guidewire can be treated to impart malleability and enable deflection by a clinician. Methods for forming the shaped or malleable guidewire to include a deflected portion are disclosed.

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: 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: An integrated catheter placement system for accurately placing a catheter within a patient'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. 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: 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 tunneler for producing a subcutaneous tunnel in connection with the placement of a catheter within a body of a patient is disclosed. In one embodiment, the tunneler comprises an elongate tunneler member and a sheath. The tunneler member includes a handle on its proximal end and a tapered distal end. The sheath defines an elongate lumen inside which the tunneler member is initially received. The tunneler member is configured to define a tunnel through subcutaneous tissue while disposed in the sheath, then is removable from the sheath lumen thereafter. The sheath is configured to remain within the tunnel so that a catheter can be inserted through the sheath within the tunnel. The sheath is splittable in one embodiment so as to enable its removal from the tunnel while leaving the catheter in place.

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'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 shaped guidewire for use in medical applications is disclosed. The guidewire is shaped so as to prevent inadvertent advancement of the guidewire into the corpus of a patient during use. In one embodiment, the guidewire includes an elongate body that defines proximal and distal ends. The guidewire body further defines a shaped portion that is positioned intermediate the proximal and distal ends. The shaped portion of the guidewire is at least partially composed of a shape memory material, such as nitinol, and is deflected from a longitudinal axis defined by an undeflected portion of the guidewire body. The shaped portion is disposed in one embodiment at the proximal end of the guidewire. In another embodiment, a proximal portion of the nitinol guidewire can be treated to impart malleability and enable deflection by a clinician. Methods for forming the shaped or malleable guidewire to include a deflected portion are disclosed.