Abstract: A method of providing a fluid communication path to an implanted device. The method includes positioning at least a portion of a slender pointed element within a catheter, penetrating a septum of an implanted device with the slender pointed element positioned within the catheter, positioning at least a portion of the catheter within the implanted device, removing the slender pointed element from the catheter, and retaining at least a portion of the catheter within the implanted device.

Abstract: An exemplary infusion system for accessing an implanted device is disclosed comprising an insertion assembly, a hub comprising a sealable path configured to receive at least a portion of the insertion assembly, a flexible catheter attached to the hub and configured to receive at least a portion of the insertion assembly, and an extension tube attached to the hub. The hub may comprise a manifold element configured to provide fluid communication between the flexible catheter and the extension tube. The hub may also comprise a septum configured to seal the sealable path upon removal of the insertion assembly from the flexible catheter. The extension tube may also be configured to receive at least a portion of the insertion assembly. Exemplary methods of providing a fluid communication path to an implanted device are also disclosed.

Abstract: A guidance system for assisting with the insertion of a needle into a patient body 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 sensed characteristic to determine a 3-D position of the needle. The system includes 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: 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 access port for subcutaneous implantation is disclosed. Such an access port may comprise a body for capturing a septum for repeatedly inserting a needle therethrough into a cavity defined within the body. Further, the access port may include at least one feature structured and configured for identification of the access port subsequent to subcutaneous implantation. Methods of identifying a subcutaneously implanted access port are also disclosed. For example, a subcutaneously implanted access port may be provided and at least one feature of the subcutaneously implanted access port may be perceived. Further, the subcutaneously implanted access port may be identified in response to perceiving the at least one feature. In one embodiment, an identification feature is engraved or otherwise defined by the access port, so as to be visible after implantation via x-ray imaging technology.

Abstract: An exemplary infusion system for accessing an implanted device is disclosed comprising an insertion assembly, a hub comprising a sealable path configured to receive at least a portion of the insertion assembly, a flexible catheter attached to the hub and configured to receive at least a portion of the insertion assembly, and an extension tube attached to the hub. The hub may comprise a manifold element configured to provide fluid communication between the flexible catheter and the extension tube. The hub may also comprise a septum configured to seal the sealable path upon removal of the insertion assembly from the flexible catheter. The extension tube may also be configured to receive at least a portion of the insertion assembly. Exemplary methods of providing a fluid communication path to an implanted device are also disclosed.

Abstract: A feeding tube device for delivering a substance into a stomach of a patient. The feeding tube may include an overlapping segment integrally formed with and extending from the distal end of the feeding tube, and an inflation lumen defined within the feeding tube. The overlapping segment may surround at least a portion of the distal end of the feeding tube to form a balloon structure in communication with the inflation lumen.

Abstract: An exemplary infusion system for accessing an implanted device is disclosed comprising an insertion assembly, a hub comprising a sealable path configured to receive at least a portion of the insertion assembly, a flexible catheter attached to the hub and configured to receive at least a portion of the insertion assembly, and an extension tube attached to the hub. The hub may comprise a manifold element configured to provide fluid communication between the flexible catheter and the extension tube. The hub may also comprise a septum configured to seal the sealable path upon removal of the insertion assembly from the flexible catheter. The extension tube may also be configured to receive at least a portion of the insertion assembly. Exemplary methods of providing a fluid communication path to an implanted device are also disclosed.

Abstract: A safety needle assembly of an infusion set for infusing fluids into a subcutaneously implanted access port 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 to prevent exposure to a clinician.

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 feeding tube device for delivering a substance into a stomach of a patient. The feeding tube may include an overlapping segment integrally formed with and extending from the distal end of the feeding tube, and an inflation lumen defined within the feeding tube. The overlapping segment may surround at least a portion of the distal end of the feeding tube to form a balloon structure in communication with the inflation lumen.

Abstract: A valved catheter that allows placement and withdrawal of an accessing device or attachable unit without the risk of air embolism or blood loss. In one variation, the valved catheter includes a catheter tube having a necked portion in its proximal end that forms an integral valve, the necked portion being surrounded by a compression sleeve that biases the valve in a closed position. In another variation, the valved catheter is a dual lumen catheter with a corresponding bifurcating extension for engaging the valves in the catheter in order to establish fluid communication through the catheter.

Abstract: A feeding tube device for delivering a substance into a stomach of a patient is disclosed, comprising a feeding tube, an overlapping segment integrally formed with and extending from the distal end of the feeding tube, and an inflation lumen defined within the feeding tube. The overlapping segment may be configured to surround at least a portion of the distal end of the feeding tube to form a balloon structure in communication with the inflation lumen. The overlapping segment may also be sealed against at least a portion of the distal end of the feeding tube device. A second overlapping segment may also be integrally formed with and extend from the proximate end of the feeding tube, with the second overlapping segment configured to surround at least a portion of the proximate end of the feeding tube to form a second balloon structure. A corresponding method of manufacturing is also disclosed.

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 access port for subcutaneous implantation is disclosed. Such an access port may comprise a body for capturing a septum for repeatedly inserting a needle therethrough into a cavity defined within the body. Further, the access port may include at least one feature structured and configured for identification of the access port subsequent to subcutaneous implantation. Methods of identifying a subcutaneously implanted access port are also disclosed. For example, a subcutaneously implanted access port may be provided and at least one feature of the subcutaneously implanted access port may be perceived. Further, the subcutaneously implanted access port may be identified in response to perceiving the at least one feature. In one embodiment, an identification feature is engraved or otherwise defined by the access port, so as to be visible after implantation via x-ray imaging technology.

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 means for establishing a conductive pathway between a sterile field of the patient and a non-sterile field to enable passage of ECG signals from the catheter to the tip location sensor are also disclosed.

Abstract: A stitching device and method of operating the stitching device to form an embolic protection device is disclosed. The stitching device includes a clamping assembly and an advancing assembly. The clamping assembly holds a restraining member about a filter assembly while the advancing assembly threads or stitches a securing member through the restraining member. The clamping assembly includes a first clamping portion and a second clamping portion, each having an upper row of teeth and a lower row of teeth divided by a channel. The advancing assembly includes a threading assembly with an engagement member for engaging and advancing the securing member.

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.

Abstract: A feeding tube device for delivering a substance into a stomach of a patient is disclosed, comprising a feeding tube, an overlapping segment integrally formed with and extending from the distal end of the feeding tube, and an inflation lumen defined within the feeding tube. The overlapping segment may be configured to surround at least a portion of the distal end of the feeding tube to form a balloon structure in communication with the inflation lumen. The overlapping segment may also be sealed against at least a portion of the distal end of the feeding tube device. A second overlapping segment may also be integrally formed with and extend from the proximate end of the feeding tube, with the second overlapping segment configured to surround at least a portion of the proximate end of the feeding tube to form a second balloon structure. A corresponding method of manufacturing is also disclosed.

Abstract: Access ports for providing subcutaneous access to a patient are disclosed. Such access ports may include: at least one structural element configured for resisting deformation of the septum in response to a pressure developed within the reservoir. Further, an access port may be structured for accommodating: 1) a flow rate of at least about 1 milliliter per second; or 2) a pressure developed within the reservoir of at least about 35 psi. An infusion set is disclosed and may be structured for flowing a fluid at a flow rate of at least about 1 milliliter per second. Infusion tubing comprising a plurality of layers is disclosed. Methods of operating and flowing a fluid through an access port or an infusion set are disclosed. A method of identifying an access port for power injection is disclosed. Septums comprising at least one gel region are disclosed.