Abstract: A medical kit, including a split-tip catheter, a first intra-catheter stiffener element, a second intra-catheter stiffener element, a first guidewire, and a second guidewire. The split-tip catheter includes a first lumen in fluid communication with a first distal opening and a second lumen in fluid communication with a second distal opening with the first distal opening proximal to the second distal opening. The first intra-catheter stiffener element is designed for disposition in the first lumen, and the second intra-catheter stiffener element is designed for disposition in the second lumen. The first intra-catheter stiffener element includes a first guidewire lumen, and the second intra-catheter stiffener element includes a second guidewire lumen.

Abstract: Connection systems are disclosed for establishing one or more electrical connections through a drape. An example connection system includes a first connector and a second connector configured to connect to each other. The first connector includes a first-connector housing, an electrical lead extending from the first-connector housing, and at least a first piercing element within the first-connector housing configured to pierce the drape. The first piercing element is orthogonally connected to the electrical lead. The second connector includes a second-connector housing and at least a first receptacle within the second-connector housing. The first receptacle is configured to form at least a first electrical connection of the one or more electrical connections with the first piercing element when the first connector is disposed over the second connector with the drape therebetween. Methods are also disclosed herein for establishing one or more electrical connections through a drape with the connection systems.

Abstract: A method for positioning an endovascular device in or near the heart using electrocardiogram (ECG) signals. The method includes receiving an endovascular ECG signal including a plurality of waveforms, processing the endovascular ECG signal to calculate a P-wave amplitude and a spectral power for each predetermined time period, determining a maximum P-wave amplitude and an associated maximum spectral power, associating the maximum P-wave amplitude and the maximum spectral power with a predetermined location in or near the heart, calculating a location based on a ratio of the P-wave amplitude to the maximum P-wave amplitude and a ratio of the spectral power to the maximum spectral power, and displaying the location to a user.

Abstract: Devices and methods obtain and use endovascular electrograms (or electrocardiograms/ECGs) in a number of clinical applications and settings. In one embodiment, a method for locating an indwelling medical device within a vasculature of a patient includes identifying an endovascular ECG waveform complex from an endovascular ECG signal associated with the indwelling medical device, then calculating an absolute value of the energy of the endovascular ECG waveform complex over a predetermined segment thereof. A position of the medical device within the vasculature is then determined by observation of the absolute value of the energy of the predetermined segment of the endovascular ECG waveform complex.

Abstract: Devices and methods obtain and use endovascular electrograms in a number of clinical applications and settings. In one embodiment, methods for triggering analysis of an endovascular ECG waveform are based on the detection of a peak in a skin-based ECG waveform in order to determine a location of an indwelling medical device, such as a catheter. In another embodiment, the position of a catheter or other medical device within the vasculature can be determined by analysis of the energy profile of a detected P-wave. In yet other embodiments, magnetic connecting devices are used for establishing an operable connection through a sterile field.

Abstract: A method of performing a medical procedure, includes providing a catheter including a first lumen in fluid communication with a first distal opening and a second lumen in fluid communication with a second distal opening, advancing a distal end of a first intra-catheter stiffener element through the first lumen and out of the first distal opening, coupling the first intra-catheter stiffener element to the catheter, advancing a distal end of a second intra-catheter stiffener element through the second lumen and out of the second distal opening, coupling the second intra-catheter stiffener element to the catheter, and advancing the catheter into a patient.

Abstract: A medical device system includes a needle having a tip including a permanent magnet, and a magnet sensing device including a plurality of sensors configured to detect the magnetic field of the permanent magnet. The magnet sensing device is operable to localize a position of the permanent magnet relative to the magnet sensing device and to indicate a path of the needle on a display.

Abstract: A new apparatus, algorithm, and method are introduced herein to support navigation and placement of an intravascular catheter using the electrical conduction system of the heart (ECSH) and control electrodes placed on the patient's skin.

Abstract: A method of locating a tip of a central venous catheter (“CVC”) having a distal and proximal pair of electrodes disposed within the superior vena cava, right atrium, and/or right ventricle. The method includes obtaining a distal and proximal electrical signal from the distal and proximal pair of electrodes and using those signals to generate a distal and proximal P wave, respectively. A deflection value is determined for each of the P waves. A ratio of the deflection values is then used to determine a location of the tip of the CVC. Optionally, the CVC may include a reference pair of electrodes disposed within the superior vena cava from which a reference deflection value may be obtained. A ratio of one of the other deflection values to the reference deflection value may be used to determine the location of the tip of the CVC.

Abstract: Splitable-tip catheters are disclosed with bioresorbable adhesive to provide spatial separation of distal tip elements during use. The invention can be particularly useful in hemodialysis applications where it is desirable to separate blood extraction and return lumens. The adhesive facilitates insertion of the distal end of the catheter as an assembly, e.g., into a blood vessel using a single guidewire, while the bioresorbable nature of the adhesive allows the tip elements to separate in vivo.

Abstract: A safety needle assembly is described, including a cap, a housing movable relative to the cap from a first position adjacent the cap to an extended second position spaced from the cap, a hollow needle secured in and extending from the housing, and a collapsible sheath secured to both the cap and the housing. The sheath is concentrically disposed about the needle in a collapsed state with the housing in the first position. The sheath is extendable from the collapsed state to an extended state in response to movement of the housing from the first position to the second position.

Abstract: Splitable-tip catheters are disclosed with bioresorbable adhesive to provide spatial separation of distal tip elements during use. The invention can be particularly useful in hemodialysis applications where it is desirable to separate blood extraction and return lumens. The adhesive facilitates insertion of the distal end of the catheter as an assembly, e.g., into a blood vessel using a single guidewire, while the bioresorbable nature of the adhesive allows the tip elements to separate in vivo.

Abstract: A one-piece connector for removing a housing and needle of a Huber needle assembly from a patient. The connector has a frame that can be positioned about a surface on the housing of the needle assembly and a pair of wings that pivot toward one another to provide a gripping surface.

Abstract: A new device and a method are provided which allow for making an electrical connection between an electrolyte and an electric wire. A new connector is provided which allows to be used by a single sterile operator. A new valved device is provided which allows for maintaining the integrity and the pressure of a saline column in the central venous line. A new device is provided which allows for automatically maintaining a continuous flush of a saline syringe in order to allow for keeping the valves of central venous lines open and capable of electric conduction. A new syringe is provided which allows for simultaneous electrical connection between the fluid in the syringe and an electrical wire. Several new methods are provided for making an electrical connection to a central venous line during and after the catheter placement procedure.

Abstract: A catheter assembly includes a catheter, a first intra-catheter stiffener element, and a second intra-catheter stiffener element. The catheter includes a first lumen in fluid communication with a first distal opening and a second lumen in fluid communication with a second distal opening. The first intra-catheter stiffener element is configured for disposition through the first lumen such that a distal end thereof extends distally of the first distal opening, the first intra-catheter stiffener element including a first coupler at a proximal end thereof. The second intra-catheter stiffener element is configured for disposition through the second lumen such that a distal end thereof extends distally of the second distal opening, the second intra-catheter stiffener element including a second coupler at a proximal end thereof.

Abstract: Devices and methods obtain and use endovascular electrograms in a number of clinical applications and settings. In one embodiment, a method for locating an indwelling medical device within a vasculature of a patient includes identifying an endovascular ECG waveform complex from an endovascular ECG signal associated with the indwelling medical device, then calculating an absolute value of the energy of the endovascular ECG waveform complex over a predetermined segment thereof. A position of the medical device within the vasculature is then determined by observation of the absolute value of the energy of the predetermined segment of the endovascular ECG waveform complex.

Abstract: An adapter for an endovascular device and a catheter steering device are provided. The adapter for an endovascular device includes a body, a conductive metal ring and a conductive wire. The body includes a first open end, a second open end, a central lumen having a substantially cylindrical surface extending from the first open end to the second open end, and a channel extending from the central lumen to an external opening. The conductive metal ring is attached to the surface of the central lumen, and the conductive wire is coupled to the conductive metal ring and extends through the channel and the external opening. The steering device for a catheter that has a plurality of lumens with spaced distal openings includes a stylet for disposition within one of the plurality of lumens, and a steering member for disposition within a different one of the plurality of lumens.

Abstract: An adaptor for endovascular electrocardiography includes a member having two ends and an inner lumen such that when one of the ends is connected to a catheter and the other end is connected to a syringe, fluid from the syringe is flushed into the catheter through the inner lumen. The adaptor also includes a metal insert, disposed along the inner lumen of the member, which connects through a sealed electrical connection to the outer side of the member.

Abstract: Methods of locating a tip of a central venous catheter (“CVC”) relative to the superior vena cava, sino-atrial node, right atrium, and/or right ventricle using electrocardiogram data. The CVC includes at least one electrode. In particular embodiments, the CVC includes two or three pairs of electrodes. Further, depending upon the embodiment implemented, one or more electrodes may be attached to the patient's skin. The voltage across the electrodes is used to generate a P wave. A reference deflection value is determined for the P wave detected when the tip is within the proximal superior vena cava. Then, the tip is advanced and a new deflection value determined. A ratio of the new and reference deflection values is used to determine a tip location. The ratio may be used to instruct a user to advance or withdraw the tip.

Abstract: Devices and methods obtain and use endovascular electrograms in a number of clinical applications and settings. In one embodiment, methods for triggering analysis of an endovascular ECG waveform are based on the detection of a peak in a skin-based ECG waveform in order to determine a location of an indwelling medical device, such as a catheter. In another embodiment, the position of a catheter or other medical device within the vasculature can be determined by analysis of the energy profile of a detected P-wave. In yet other embodiments, magnetic connecting devices are used for establishing an operable connection through a sterile field.