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: Methods and apparatus are disclosed for inserting flexible, multi-lumen catheters into blood vessels, and in particular, for inserting flexible, split-tip catheters into blood vessels. The invention accomplishes these objects by temporarily stiffening each catheter lumen and tip independently through use of intra-catheter stiffener elements disposed within the catheter lumens. This provides means for advancing the catheter/stiffeners assembly through a subcutaneous tunnel, and over a plurality of guidewires until a distal tip of the catheter is at a desired position within the vessel. The intra-catheter stiffener elements are sufficiently stiffening to allow advancing the catheter over guidewires, but sufficiently flexible to allow bending and looping of the catheter for proper placement within the vessel.

Abstract: A one-piece connector of plastic is provided for removing a housing and needle of a Huber needle assembly from a patient. The connector has a rectangular frame that can be positioned about a gripping surface on the housing of the needle assembly and a pair of wings that pivot upwardly to contact each other to provide a gripping surface for a user to pull the connector and housing of the needle assembly from the patient.

Abstract: Methods and apparatus are disclosed for inserting flexible, multi-lumen catheters into blood vessels, and in particular, for inserting flexible, split-tip catheters into blood vessels. The invention accomplishes these objects by temporarily stiffening each catheter lumen and tip independently through use of intra-catheter stiffener elements disposed within the catheter lumens. This provides means for advancing the catheter/stiffeners assembly through a subcutaneous tunnel, and over a plurality of guidewires until a distal tip of the catheter is at a desired position within the vessel. The intra-catheter stiffener elements are sufficiently stiffening to allow advancing the catheter over guidewires, but sufficiently flexible to allow bending and looping of the catheter for proper placement within the vessel.

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. In other embodiments, a guidance system for guiding rigid or other medical instruments is disclosed, together with various example implementations thereof.

Abstract: Devices and methods for obtaining and using endovascular electrograms in a number of clinical applications and settings are disclosed. In one embodiment, a method is disclosed for locating an indwelling medical device within a vasculature of a patient. The method comprises 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: A safety needle device includes a housing, a Huber needle, a cap and a sheath. The Huber needle has a first needle leg disposed in the housing and a second needle leg extending perpendicularly of the first needle leg. The cap is disposed over the second needle leg and is movable relative thereto from a first position with the second needle leg extending through the cap to a second position with a tip of the needle disposed in sealed relation in the cap. The sheath is concentrically disposed on and about the needle in a collapsed state, and secured to and between the housing and the cap. The sheath is extendable from the collapsed state to an extended state in response to movement of the cap from the first position to the second position.

Abstract: The site scrub brush is made of a block of foam material, such as a semi-closed hydrophilic polyurethane medical grade foam, with a thin layer of sealing material, such as any plastic polymer which is non-permeable in nature, about the periphery and bottom. The brush is compressible under finger pressure to enhance the scrubbing action of the brush on the outer surfaces of a luer received by the brush.

Abstract: The microbial scrub brush employs an insert of foam material that is impregnated with an anti-bacterial disinfectant that is housed within a housing of alcohol compatible material and sealed over by a removable lid. The insert is maintained in sterile condition until ready for use. After the removal of the lid, the insert of foam material is moved over the end of a female luer and rotated in order to clean the outer surface of the luer as well as the interior of the luer.

Abstract: The needle of a syringe, wire guide, biopsy needle, Huber needle and the like is drawn into a protective cap and sheath arrangement after use for disposal purposes. The cap is tethered to a housing in which the needle is mounted by the sheath. The sheath is made of a film material that has a high tensile strength and a low percent of elongation, such as polyester. The sheath is initially mounted about the needle in a collapsed accordion-like condition between the cap and housing. When the cap is moved along the needle, the sheath is played out over the needle. The cap houses a spring clip to snap over the bore through which the needle is retracted to prevent re-emergence of the needle. The flexible nature of the sheath allows the sheath to pass about the two legs of the Huber needle.

Abstract: Devices and methods for obtaining and using endovascular electrograms in a number of clinical applications and settings are disclosed. In one embodiment, methods are disclosed for triggering analysis of an endovascular ECG waveform 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 for establishing an operable connection through a sterile field are disclosed.

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: The invention includes 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 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: A system and method for measuring recirculation of blood in a catheter designed for implantation in a human is described. In one variation, the system comprises an artificial circulatory system and an ultrasonic detection device for measuring and comparing the density of a circulated blood simulant with a later introduced bolus saline. The system may be configured to simulate a human heart by providing the flow, pressure and dimensions of a typical human heart. In addition to simulating the circulatory system of a normal human heart, the system may also be configured to simulate particular negative conditions of a patient, such as stenotic condition, which would affect the recirculation measurement.

Abstract: An implantable infusion device (10) includes a lightweight, inert housing (12) which contains an infusate (18) for administration to a patient, and an enclosed, gas-impermeable variable volume chamber (30) which contains a pressure source, such as propellant, mechanical spring, or the like. The variable volume chamber may be in the form of a rigid-walled expandable bellows structure or a nonstretchable flexible bag and is attached to the housing so as not to obstruct the entry port for introduction of infusate. A recharging fluid flow path (31) is provided adjacent to where the variable volume chamber is attached to the housing. The infusate is delivered from the device via a catheter in response to expansion of the variable volume chamber against the volume of infusate in the housing. A separate bolus injection port (38) is provided which allows infusate to be safely introduced directly into the catheter and overrides the controlled pressure-driven delivery.

Abstract: An implantable infusion device includes a lightweight, inert housing which contains an infusate for administration to a patient, and an enclosed, gas-impermeable variable volume chamber which contains a pressure source, such as propellant, mechanical spring, or the like. The variable volume chamber may be in the form of a rigid-walled expandable bellows structure or a nonstretchable flexible bag and is attached to the housing so as not to obstruct the entry port for introduction of infusate. The infusate is delivered from the device via a catheter in response to expansion of the variable volume chamber against the volume of infusate in the housing. A separate bolus injection port is provided which allows infusate to be safely introduced directly into the catheter and overrides the controlled pressure-driven delivery. The lightweight housing may include integrally formed needle stops and suture fastening loops.

Abstract: A bolus tip for a multi-lumen catheter includes a first channel terminating distally in a first opening, and a second channel terminating distally in a second opening. The first opening may be positioned proximal the second opening along a longitudinal axis of the bolus tip and may be positioned on a side of the bolus tip opposite that of the second opening. The first and second openings may extend through an outer wall of the bolus tip to a dividing section. The bolus tip may also include a third channel sized for accommodating a guidewire.

Abstract: An improved bolus tip design for use in a multi-lumen catheter for the simultaneous injection and withdrawal of fluids to and from a patient. The improved bolus tip has a rounded elongate body consisting of an interfacing section and a nose section. A first channel opens to a first bolus cavity, which is formed into the bolus tip, and a second channel either extends through the nose section of the bolus tip, forming an outlet therefrom, or terminates at a second bolus cavity similar to the first bolus cavity. In the latter configuration, the second bolus cavity is located longitudinally between the fist bolus cavity and a tip of the nose section on a side directly opposite the first bolus cavity. The second bolus cavity is in fluid communication with the second channel.

Abstract: An implantable infusion device includes a lightweight, inert housing which contains an infusate for administration to a patient, and an enclosed, gas-impermeable variable volume chamber which contains a pressure source, such as propellant, mechanical spring, or the like. The variable volume chamber may be in the form of a rigid-walled expandable bellows structure or a nonstretchable flexible bag and is attached to the housing so as not to obstruct the entry port for introduction of infusate. The infusate is delivered from the device via a catheter in response to expansion of the variable volume chamber against the volume of infusate in the housing. A separate bolus injection port is provided which allows infusate to be safely introduced directly into the catheter and overrides the controlled pressure-driven delivery. The lightweight housing may include integrally formed needle stops and suture fastening loops.