Abstract: An improved catheter is provided. The catheter may include a deflectable member located at a distal end of the catheter. The deflectable member may comprise an ultrasound transducer array. The catheter may include a lumen extending from a proximal end of the catheter to the distal end. The lumen may be used to deliver an interventional device to a point distal to the distal end of the catheter. The deflectable member may be selectively deflectable in a pivot-like manner through an arc of at least 90 degrees. In embodiments where the deflectable member includes an ultrasound transducer array, the ultrasound transducer array may be operable to image both when aligned with the catheter and when pivoted relative to the catheter. When pivoted relative to the catheter, the ultrasound transducer array may have a field of view distal to the distal end of the catheter.

Abstract: A split-tip catheter for placement within the vasculature of a patient and for use in hemodialysis or other suitable procedures. In one embodiment, the split-tip catheter includes a catheter body defining a first lumen and a second lumen, and a split distal region extending from a distal end of the catheter body. The split distal region includes an arterial segment defined by an outer wall enclosing an arterial segment lumen, the arterial segment lumen in fluid communication with the catheter body first lumen, and a venous segment defined by an outer wall enclosing a venous segment lumen, the venous segment lumen in fluid communication with the catheter body second lumen, the venous segment outer wall extending from the catheter body distal end to a distal nose portion. The distal nose portion may taper distally from a first outer perimeter to a second outer perimeter smaller than the first outer perimeter.

Abstract: A catheter assembly, includes a catheter body, a tubular structure and a stabilizing cuff around a longitudinal length of the tubular structure. The tubular structure may be affixed to an exterior surface of the catheter body, and may include a tapered outer surface at a first terminal end of the tubular structure. The tapered outer surface may have a first outer diameter at the first terminal end of the tubular structure and a second outer diameter greater than the first outer diameter at a terminal end of the tapered outer surface opposite the first terminal end. The tubular structure may have a third outer diameter greater than the first outer diameter at a second terminal end of the tubular structure opposite the first terminal end.

Abstract: A split-tip catheter for placement within the vasculature of a patient and for use in hemodialysis or other suitable procedures is disclosed. In one embodiment, the split-tip catheter includes a catheter body that defines a first lumen and a second lumen. The catheter body further comprises a split distal region, including a venous segment that defines a distal portion of the first lumen and an arterial segment that defines a distal portion of the second lumen. The venous segment includes a recess extending proximally of a nose portion; and a lateral opening in fluid communication with the first lumen. The arterial segment is separate from the venous segment and is removably seatable in the recess provided by the venous segment such that it “nests” therein. The arterial segment also includes a lateral opening in fluid communication with the second lumen.

Abstract: A catheter assembly includes a catheter, a tubular structure affixed to an exterior surface of the catheter, and a stabilizing cuff affixed to, and at least partially embedded within, the tubular structure. The tubular structure may include a tapered surface extending from an end of the tubular structure to an exterior surface of the catheter. A method of manufacturing a catheter assembly may include positioning a tubular structure about a catheter, positioning a stabilizing cuff near the tubular structure, and partially embedding at least a portion of the stabilizing cuff within the tubular structure while shaping the tubular structure to form a tapered surface. A temporary sleeve may be positioned about the tubular structure prior to shaping the tubular structure. The tubular structure may also be preformed to include a tapered end prior to positioning the tubular structure about the catheter.

Abstract: A multi-lumen catheter including an elliptical cross-sectional profile configuration that enhances fluid flow rate while minimizing the average diameter of the catheter body is disclosed. In one embodiment the catheter includes an elongate catheter tube defining a plurality of lumens. At least a portion of the longitudinal length of the catheter tube may define an elliptical cross section, in turn defined by a major axis and a minor axis. In one embodiment, a ratio of the major axis to the minor axis of the elliptical cross section is between about 1.3 and about 1.4. The catheter body can define two, three, or more lumens. In one embodiment, a dual-lumen catheter tube includes an aspect ratio of about 1.1:1, and each lumen thereof includes an inner surface defined by a plurality of radii and an hourglass-shaped septum.

Abstract: An ultrasound catheter probe assembly capable of scanning a three-dimensional volume is provided. The ultrasound catheter probe assembly contains a plurality of ultrasonic transducers disposed along a central axis of the ultrasound catheter probe assembly. The plurality of ultrasonic transducers is disposed on a mechanism operable to reciprocally pivot the plurality of ultrasonic transducers enabling the plurality of ultrasonic transducers to scan a three-dimensional volume. A helically disposed electrical interconnection member may be disposed about a pivot axis of the plurality of ultrasonic transducers and may electrically interconnect the plurality of ultrasonic transducers to an ultrasound imaging system. The ultrasound transducer catheter probe assembly may be fluid-filled and contain bubble position control and fluid expansion compensation features.

Abstract: An ultrasound catheter probe assembly capable of scanning a three-dimensional volume is provided. The ultrasound catheter probe assembly contains a plurality of ultrasonic transducers disposed along a central axis of the ultrasound catheter probe assembly. The plurality of ultrasonic transducers is disposed on a mechanism operable to reciprocally pivot the plurality of ultrasonic transducers enabling the plurality of ultrasonic transducers to scan a three-dimensional volume. A helically disposed electrical interconnection member may be disposed about a pivot axis of the plurality of ultrasonic transducers and may electrically interconnect the plurality of ultrasonic transducers to an ultrasound imaging system. The ultrasound transducer catheter probe assembly may be fluid-filled and contain bubble position control and fluid expansion compensation features.

Abstract: A reinforced multi-lumen catheter and method of manufacturing the same. An assembly for manufacturing the multi-lumen catheter includes a proximal catheter body substrate including a septum, a first and second distal catheter body substrate, a first and second mandrel, a reinforcing element and a sleeve. The reinforcing element is positioned over the proximal catheter body substrate and at least a proximal region of the first and second distal catheter body substrates.

Abstract: An improved catheter is provided. The catheter may include a deflectable member located at a distal end of the catheter. The deflectable member may comprise an ultrasound transducer array. The catheter may include a lumen extending from a proximal end of the catheter to the distal end. The lumen may be used to deliver an interventional device to a point distal to the distal end of the catheter. The deflectable member may be selectively deflectable in a pivot-like manner through an arc of at least 90 degrees. In embodiments where the deflectable member includes an ultrasound transducer array, the ultrasound transducer array may be operable to image both when aligned with the catheter and when pivoted relative to the catheter. When pivoted relative to the catheter, the ultrasound transducer array may have a field of view distal to the distal end of the catheter.

Abstract: An insertion device for use in assisting with the placement of a medical device within the body of a patient is disclosed. For example, the insertion device can be employed to assist with the placement of an introducer, which provides a conduit for insertion of a catheter into the body. In one embodiment, the insertion device comprises a needle that is removably disposed within a bore defined by the medical device, and a needle retraction assembly. The needle retraction assembly can position the needle in any one of a first position wherein a distal tip of the needle is disposed a predetermined distance distal to a distal end of the medical device, a second position wherein the needle distal tip is disposed distal but proximate to the distal end of the medical device, and a third position wherein the needle distal tip is retracted within the medical device bore.

Abstract: A multi-lumen catheter including an elliptical cross-sectional profile configuration that enhances fluid flow rate while minimizing the average diameter of the catheter body is disclosed. In one embodiment the catheter comprises an elongate catheter tube defining a plurality of lumens. At least a portion of the longitudinal length of the catheter tube defines an elliptical cross section, in turn defined by a major axis and a minor axis. A ratio of the major axis to the minor axis of the elliptical catheter tube cross section is between about 1.3 and about 1.4 in one embodiment. The catheter body can define two, three, or more lumens, in one embodiment.

Abstract: A catheter assembly includes a catheter, a tubular structure affixed to an exterior surface of the catheter, and a stabilizing cuff affixed to, and at least partially embedded within, the tubular structure. The tubular structure may include a tapered surface extending from an end of the tubular structure to an exterior surface of the catheter. A method of manufacturing a catheter assembly may include positioning a tubular structure about a catheter, positioning a stabilizing cuff near the tubular structure, and partially embedding at least a portion of the stabilizing cuff within the tubular structure while shaping the tubular structure to form a tapered surface. A temporary sleeve may be positioned about the tubular structure prior to shaping the tubular structure. The tubular structure may also be preformed to include a tapered end prior to positioning the tubular structure about the catheter.

Abstract: A split-tip catheter for placement within the vasculature of a patient and for use in hemodialysis or other suitable procedures is disclosed. In one embodiment, the split-tip catheter includes a catheter body that defines a first lumen and a second lumen. The catheter body further comprises a split distal region, including a venous segment that defines a distal portion of the first lumen and an arterial segment that defines a distal portion of the second lumen. The venous segment includes a recess extending proximally of a nose portion; and a lateral opening in fluid communication with the first lumen. The arterial segment is separate from the venous segment and is removably seatable in the recess provided by the venous segment such that it “nests” therein. The arterial segment also includes a lateral opening in fluid communication with the second lumen.

Abstract: A hemodialysis catheter, including an elongate body with an outer wall enclosing an arterial lumen and a venous lumen, and a method of making same. The catheter includes a first continuous loop and a second continuous loop formed from a distal extension of the outer wall, the first continuous loop beginning at a first side of the distal end of the body to define a first enclosed opening, and the second continuous loop beginning at a second side of the distal end of the body to define a second enclosed opening.

Abstract: A catheter tube for insertion into a body of a patient is disclosed. The catheter tube includes a distal portion that remains stable during fluid infusion into the patient, thus reducing or eliminating whipping of the catheter distal tip, even during power injection. In one embodiment, the catheter tube defines at least one lumen and is formed from a tube material that defines a proximal portion and a distal portion of the catheter tube. The catheter tube is configured such that the arithmetic product of an elastic modulus and an area moment of inertia for at least a portion of the distal portion of the catheter tube defined by the catheter tube material is greater relative the arithmetic product of an elastic modulus and an area moment of inertia for at least a portion of the proximal portion of the catheter tube.

Abstract: A catheter assembly is disclosed comprising a catheter, a tubular structure affixed to an exterior surface of the catheter, and a stabilizing cuff affixed to, and at least partially embedded within, the tubular structure. The tubular structure may include a tapered surface extending from an end of the tubular structure to an exterior surface of the catheter. A method of manufacturing a catheter assembly is also disclosed. For example, such a method may comprise positioning a tubular structure about a catheter, positioning a stabilizing cuff near the tubular structure, and partially embedding at least a portion of the stabilizing cuff within the tubular structure while shaping the tubular structure to form a tapered surface. A temporary sleeve may be positioned about the tubular structure prior to shaping the tubular structure. The tubular may also be performed to include a tapered end prior to positioning the tubular structure about the catheter.

Abstract: A split-tip catheter for placement within the vasculature of a patient and for use in hemodialysis or other suitable procedures is disclosed. In one embodiment, the split-tip catheter includes a catheter body that defines a first lumen and a second lumen. The catheter body further comprises a split distal region, including a venous segment that defines a distal portion of the first lumen and an arterial segment that defines a distal portion of the second lumen. The venous segment includes a recess extending proximally of a nose portion; and a lateral opening in fluid communication with the first lumen. The arterial segment is separate from the venous segment and is removably seatable in the recess provided by the venous segment such that it “nests” therein. The arterial segment also includes a lateral opening in fluid communication with the second lumen.

Abstract: A hemodialysis catheter, including an elongate body with an outer wall enclosing an arterial lumen and a venous lumen, and a method of making same. A loop extends from a distal end of the body and defines an enclosed opening. An arterial inlet in fluid communication with the arterial lumen, and a venous outlet in fluid communication with the venous lumen, are positioned on the loop.

Abstract: Methods for manufacturing multi-lumen catheter tubes are disclosed. The described methods may be employed to manufacture a reinforced catheter tube suitable for use in power injectable and torqueable multi-lumen catheters, for example. In one embodiment, a method for manufacturing a multi-lumen catheter tube comprises first clamping a flexible sheet of catheter tube material between first and second mandrels. The mandrels may be D-shaped, or may include another suitable cross sectional profile. The first and second mandrels are rotated with respect to the flexible sheet so as to wrap the flexible sheet about the mandrels. Adjacent portions of the flexible sheet are joined along a longitudinal length thereof to define a closed catheter tube including first and second lumens. The first and second lumens may conform to the D-shaped profile of the respective mandrels.