Abstract: A method of making an access port, includes providing a port body defining a fluid cavity, positioning a septum over the fluid cavity, and securing the septum to the port body. The septum includes a lower portion having a first diameter, an upper portion joined to the lower portion at a juncture, the upper portion having a second diameter less than the first diameter at the juncture, and a plurality of palpation features joined to the upper portion. Each of the palpation features includes a first end adjacent a central axis of the septum, and a second end extending radially outward, overlapping the juncture.

Abstract: A catheter assembly or other elongate tubular device for use in establishing vascular or other access within the body of a patient is disclosed. The catheter assembly is equipped with one or more sensors that enable monitoring of one or more physiological aspects of the patient or physical aspect of the catheter assembly itself when the catheter assembly is disposed within the patient. Such aspects include central venous pressure, body temperature, ECG heart signals, oxygen levels, ultrasound data, glucose, etc. The catheter assembly includes the ability to wirelessly transmit or otherwise forward data relating to the detected physiological parameters to another location, such as a patient electronic medical record, smartphone or other mobile device, nurse station, etc. Catheter assemblies configured to detect the frequency of catheter flushing, flushing quality, etc., are also disclosed.

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: A catheter assembly or other elongate tubular device for use in establishing vascular or other access within the body of a patient is disclosed. The catheter assembly is equipped with one or more sensors that enable monitoring of one or more physiological aspects of the patient or physical aspect of the catheter assembly itself when the catheter assembly is disposed within the patient. Such aspects include central venous pressure, body temperature, ECG heart signals, oxygen levels, ultrasound data, glucose, etc. The catheter assembly includes the ability to wirelessly transmit or otherwise forward data relating to the detected physiological parameters to another location, such as a patient electronic medical record, smartphone or other mobile device, nurse station, etc. Catheter assemblies configured to detect the frequency of catheter flushing, flushing quality, etc., are also disclosed.

Abstract: A catheter placement system designed to establish a conductive pathway through a sterile barrier from a sterile field to a non-sterile field. The catheter placement system can include a stylet having a first connector including a piercing component, and a sensing component, and a data-receiving component having a second connector. The data-receiving component can be designed for positioning in the non-sterile field under the sterile barrier. The first connector can be designed to conductively connect to the second connector of the data-receiving component through the sterile barrier via the piercing component without compromising the sterile field.

Abstract: A method of making an access port, includes providing a port body defining a fluid cavity, positioning a septum over the fluid cavity, and securing the septum to the port body. The septum includes a lower portion having a first diameter, an upper portion joined to the lower portion at a juncture, the upper portion having a second diameter less than the first diameter at the juncture, and a plurality of palpation features joined to the upper portion. Each of the palpation features includes a first end adjacent a central axis of the septum, and a second end extending radially outward, overlapping the juncture.

Abstract: A guidance system for assisting with the insertion of a needle into a patient body utilizing ultrasound imaging or other suitable imaging technology. The guidance system can include an imaging device including a probe for producing an image of an internal body portion target, such as a blood vessel. One or more sensors can be included with the probe. The sensors can sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system can include a processor that uses data relating to the sensed characteristic to determine a 3-D position of the needle. The system can include a display for depicting the position of the needle. A needle assembly including a hub, cannula, and magnetic element is also disclosed, wherein a magnetic axis of the magnetic element is configured to be coaxially aligned with the needle cannula.

Abstract: A catheter assembly or other elongate tubular device for use in establishing vascular or other access within the body of a patient is disclosed. The catheter assembly is equipped with one or more sensors that enable monitoring of one or more physiological aspects of the patient or physical aspect of the catheter assembly itself when the catheter assembly is disposed within the patient. Such aspects include central venous pressure, body temperature, ECG heart signals, oxygen levels, ultrasound data, glucose, etc. The catheter assembly includes the ability to wirelessly transmit or otherwise forward data relating to the detected physiological parameters to another location, such as a patient electronic medical record, smartphone or other mobile device, nurse station, etc. Catheter assemblies configured to detect the frequency of catheter flushing, flushing quality, etc., are also disclosed.

Abstract: A low-profile access port for subcutaneous implantation within the body of a patient is disclosed. The access port includes a receiving cup that provides a relatively large subcutaneous target to enable a catheter-bearing needle to access the port without difficulty. In addition, the access port includes a valve/seal assembly to permit pressurized fluid injection through the port while preventing backflow. In one embodiment, therefore, a low-profile access port comprises a body including a conduit with an inlet port at a proximal end thereof, and a receiving cup. The receiving cup is concavely shaped to direct a catheter-bearing needle into the conduit via the inlet port. The receiving cup is oriented substantially toward a skin surface when subcutaneously implanted within the patient to ease needle impingement thereon. A valve/seal assembly disposed in the conduit enables passage of the catheter therethrough while preventing fluid backflow.

Abstract: A catheter assembly or other elongate tubular device for use in establishing vascular or other access within the body of a patient is disclosed. The catheter assembly is equipped with one or more sensors that enable monitoring of one or more physiological aspects of the patient or physical aspect of the catheter assembly itself when the catheter assembly is disposed within the patient. Such aspects include central venous pressure, body temperature, ECG heart signals, oxygen levels, ultrasound data, glucose, etc. The catheter assembly includes the ability to wirelessly transmit or otherwise forward data relating to the detected physiological parameters to another location, such as a patient electronic medical record, smartphone or other mobile device, nurse station, etc. Catheter assemblies configured to detect the frequency of catheter flushing, flushing quality, etc., are also disclosed.

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: 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: A guidance system for assisting with the insertion of a needle or other medical component into the body of a patient is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body portion target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the detectable characteristic sensed by the sensors to determine a position and/or orientation of the needle in three spatial dimensions. The system includes a display for depicting the position and/or orientation of the needle together with the image of the target.

Abstract: A method of making an access port, includes providing a port body defining a fluid cavity, positioning a septum over the fluid cavity, and securing the septum to the port body. The septum includes a lower portion having a first diameter, an upper portion joined to the lower portion at a juncture, the upper portion having a second diameter less than the first diameter at the juncture, and a plurality of palpation features joined to the upper portion. Each of the palpation features includes a first end adjacent a central axis of the septum, and a second end extending radially outward, overlapping the juncture.

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 access port for providing subcutaneous access to a patient is disclosed. The access port includes a septum including palpable identification indicia thereon. In particular, the access port in one embodiment includes a body that defines a fluid cavity and a needle-penetrable septum covering the fluid cavity for providing access thereto. The septum defines an outer periphery. One or more palpation features are included on the septum. The palpation features each include a portion that extends in a radial direction beyond the outer periphery of the septum. The palpation features are therefore disposed relatively farther away from each other, simplifying palpation and identification thereof after the port has been subcutaneously implanted into a patient. The palpation features can be indicative of an attribute of the port, such as its ability to withstand fluid pressures and flow rates associated with power injection, for instance.

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 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: Multi-lumen catheters with improved tip configurations, including a triple-lumen catheter which may be useful for apheresis. In one variation, the catheter has three lumens with distal openings angularly spaced apart and staggered axially with respect to one another. In another variation, the catheter has two lumens exiting distally and one centrally positioned lumen exiting proximally. A third variation is a catheter with a single distal opening and two proximal openings. The staggered lumen openings along the axial length of the catheter may decrease recirculation while maximizing flow rates.

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 introduction of the catheter. 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. Various methods for establishing a conductive pathway between a sterile field of the patient and a non-sterile field are also disclosed.