Abstract: Medical device kits for use in placing, maintaining, altering, and/or removing medical devices in, on, and/or from the body of a patient are disclosed. Such medical device kits can include one or more wrap assemblies for use in the placement/maintenance procedure. In accordance with present embodiments, the one or more wrap assemblies of the medical device kit can include various features to assist the clinician performing the particular procedure. In one embodiment, a medical wrap assembly is disclosed, comprising a foldable wrap body that includes a front surface, wherein the front surface is configured to define a sterile field. A plurality of pockets is included on the front surface of the wrap body. The pockets are configured to contain therein a plurality of medical components. The medical components are arranged in the pockets in a predetermined order of use for the medical procedure.

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 dressing for use in protectively covering and isolating a medical device placed on and/or through the skin surface of a patient is disclosed. Examples of such devices include infusion needles for accessing subcutaneously implanted access ports, catheters of various types and purposes, insulin infusion needles, etc. In one embodiment, a dressing for covering a medical device on a skin surface of a patient is disclosed and comprises a dressing portion that is configured to rest against a skin surface of a patient, with the dressing portion defining a hole, and a polymeric cover film that is at least indirectly attached to the dressing portion. The cover film includes a pliable domed portion aligned with the hole of the dressing portion. The pliable domed portion defines a cavity that is configured to receive therein the medical device when the dressing is placed on the skin of the patient.

Abstract: A procedure kit that removably retains components to be used during a medical procedure, such as the insertion of a catheter into a patient, is disclosed. The procedure kit is securable to a surface or structure such that the kit is positioned as desired by the clinician, thus minimizing chances that the kit will fall to the ground or undesirably move. In one embodiment, the procedure kit comprises a body defining a plurality of pockets that are sized to removably receive therein components for use in the medical procedure, an openable flap that covers at least a portion of the pockets; and an adhesive portion included on a portion of the body to enable the procedure kit to be secured to a structure or surface proximate to the patient, such as the sterile drape covering the patient.

Abstract: An access port includes an access port body and a needle-penetrable septum. The access port body can be of integral single-piece construction, and can define a reservoir aligned with an access opening. The access port body can further define an annular groove between the reservoir and the opening. The annular groove can have a diameter greater than a diameter of the access opening and a diameter of the reservoir. The needle-penetrable septum can include an upper portion disposed in the access opening and an annular flange disposed in the annular groove. The annular flange can extend radially outward from a lower portion of the septum, and can have a diameter greater than a diameter of the upper portion of the septum. The needle-penetrable septum can further include an annular reinforcement structure disposed within the annular flange.

Abstract: A catheter for insertion into a body of a patient, and methods of making and using. The catheter can include a distal portion that remains stable during fluid infusion into the patient, thus reducing or eliminating whipping of the catheter distal tip. The catheter includes at least one lumen and can be configured such that the arithmetic product of an elastic modulus and an area moment of inertia for the distal portion of the catheter is greater than the arithmetic product of an elastic modulus and an area moment of inertia for a proximal portion. The catheter can be attached to an implantable access port that may include features for use as a power injectable access port.

Abstract: A septum for sealably covering a fluid cavity defined in an implantable device, which may be an access port, and methods for assembling the implantable device. The septum may include a resilient septum body, an annular flange extending radially outward from the septum body, and a reinforcement component disposed in the annular flange for reinforcing engagement with a corresponding annular groove defined in a body of the implantable device. The reinforcement component may inhibit unintended detachment of the septum from the implantable device.

Abstract: An access port for providing subcutaneous access to a patient is disclosed. In one embodiment, the port includes an internal body defining a fluid cavity that is accessible via a septum. A compliant outer cover including silicone is disposed about at least a portion of the body. A flange is included with the port body and is covered by the outer cover. The flange radially extends about a perimeter of the port body proximate the septum so as to impede penetration of a needle substantially into the outer cover in instances where the needle misses the septum. The flange can further include both an anchoring feature for securing the outer cover to the port body and an identification feature observable via x-ray imaging technology for conveying information indicative of at least one attribute of the access port. The outer cover provides a suitable surface for application of an antimicrobial/antithrombotic coating.

Abstract: A catheter placement system includes a catheter assembly, an external ultrasound probe, a tip location sensor, and a console. The catheter assembly includes a catheter, a magnetic component producing a magnetic field, and an electrocardiogram (ECG) sensor designed to measure an intravascular ECG signal. The external ultrasound probe includes user input controls. The tip location sensor is configured to detect the magnetic field of the magnetic component when the catheter is disposed in the patient, the magnetic field providing magnetic field information for locating the magnetic component relative to the tip location sensor, and to receive the intravascular ECG signal from the ECG sensor. The console is coupled to the tip location sensor and includes a processor and a display. The display is configured to show an image from the external ultrasound probe, a graphical representation of the magnetic component, and successive ECG waveforms detected by the ECG sensor.

Abstract: A stabilized catheter tube for insertion into a body of a patient. 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. 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 the distal portion of the catheter tube is greater relative the arithmetic product of an elastic modulus and an area moment of inertia for the proximal portion of the tube. In one embodiment, the catheter tube is operably attached to an implantable access port and includes an enlarged distal portion relative a proximal portion of the catheter tube.

Abstract: A full-surround contact antimicrobial dressing is disclosed. The dressing includes a transparent body that covers a skin insertion site through which a catheter assembly passes for disposal within the body of a patient. The transparency of the dressing body enables inspection of the skin insertion site. In one embodiment, therefore, an antimicrobial full-surround contact dressing for use with a medical device inserted into a skin surface of a patient via a skin insertion site is disclosed and comprises a transparent flat body, an antimicrobial adhesive substance disposed on a bottom surface of the body, and a slit defined in the body. The slit is configured to enable the body to be placed fully around a perimeter of the medical device on the skin surface at the skin insertion site such that the bottom surface of the body fully surrounds and contacts the skin insertion site.

Abstract: A method for power injection of fluids through an access port includes implanting the access port in a patient, palpating the access port, imaging the access port, and introducing contrast media into the patient through the access port at a rate in a range from about two milliliters per second to about five milliliters per second. The access port may include a housing, a first septum, a second septum, and a radiographic indicator. The first septum and the second septum may respectively cover a first reservoir and a second reservoir of the access port. The first septum may include a first sub-pattern of protrusions and the second septum may include a second sub-pattern of protrusions. The radiographic indicator may include a first portion including information pertaining to the first sub-pattern, and a second portion including information pertaining to the second sub-pattern. The imaging identifies the radiographic indicator.

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 intravascular introduction of the catheter. The ultrasound probe includes user input controls for controlling use of the ultrasound probe in an ultrasound mode and use of the tip location sensor in a tip location mode. In another embodiment, 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.

Abstract: An access port for providing subcutaneous access to a patient is disclosed. In one embodiment, the port includes an internal body defining a fluid cavity that is accessible via a septum. A compliant outer cover including silicone is disposed about at least a portion of the body. A flange is included with the port body and is covered by the outer cover. The flange radially extends about a perimeter of the port body proximate the septum so as to impede penetration of a needle substantially into the outer cover in instances where the needle misses the septum. The flange can further include both an anchoring feature for securing the outer cover to the port body and an identification feature observable via x-ray imaging technology for conveying information indicative of at least one attribute of the access port. The outer cover provides a suitable surface for application of an antimicrobial/antithrombotic coating.

Abstract: An access port for subcutaneous implantation into a body of a patient is disclosed. The port is typically subcutaneously connected to a catheter, a distal portion of which is disposed within a vein or other vessel of the patient. The port is configured with enhanced fluid handling features to improve fluid flow therethrough while reducing the likelihood of clotting or occlusions in the attached catheter, thus improving system patency. In one embodiment, for instance, an implantable access port is disclosed and comprises a body defining a reservoir, a needle-penetrable septum covering an opening to the reservoir, a stem defining an outlet to the reservoir, and a deformable element included in the reservoir. The deformable element is operably connected to a main portion of the septum and deforms in response to displacement of the septum to counteract a change in volume within the reservoir and prevent blood ingress into the catheter.

Abstract: An integrated catheter placement system for placing a catheter in a vasculature of a patient. The system includes a system console with a tip location mode and an ultrasound mode viewable on a display, a magnetic assembly emanating a magnetic field, a tip location sensor designed to sense the magnetic field, and an ultrasound probe for ultrasonically imaging an internal portion of the patient. The magnetic field may provide magnetic field information for locating the magnetic assembly relative to the tip location sensor. The tip location sensor is designed to communicate the magnetic field information to the system console. The system console is designed to display an icon representative of a location of the magnetic assembly relative to the tip location sensor in the tip location mode.

Abstract: An implantable multi-lumen access port including indicators for ascertaining characteristics of the port is disclosed. In one embodiment, the access port comprises a housing that defines a first reservoir and a second reservoir. A first septum and second septum are respectively coupled with the housing to provide selective access to the first and second reservoirs. Each septum includes a plurality of protrusions defined about a periphery thereof that are palpable after implantation of the port in a patient to determine a relative position of the first septum with respect to the second septum. A radiographically observable indicator is also included on a base of the housing, so as to provide information relating to a characteristic of the dual-lumen port, such as suitability for power injection of fluids. The indicator in one embodiment includes a substantially rigid radiopaque component.

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 intravascular introduction of the catheter. The ultrasound probe includes user input controls for controlling use of the ultrasound probe in an ultrasound mode and use of the tip location sensor in a tip location mode. In another embodiment, 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.

Abstract: Medical device kits for use in placing, maintaining, altering, and/or removing medical devices in, on, and/or from the body of a patient are disclosed. Such medical device kits can include one or more wrap assemblies for use in the placement/maintenance procedure. In accordance with present embodiments, the one or more wrap assemblies of the medical device kit can include various features to assist the clinician performing the particular procedure. In one embodiment, a medical wrap assembly is disclosed, comprising a foldable wrap body that includes a front surface, wherein the front surface is configured to define a sterile field. A plurality of pockets is included on the front surface of the wrap body. The pockets are configured to contain therein a plurality of medical components. The medical components are arranged in the pockets in a predetermined order of use for the medical procedure.

Abstract: An access port for providing subcutaneous access to a patient is disclosed. In one embodiment, the port includes an internal body defining a fluid cavity that is accessible via a septum. A compliant outer cover including silicone is disposed about at least a portion of the body. A flange is included with the port body and is covered by the outer cover. The flange radially extends about a perimeter of the port body proximate the septum so as to impede penetration of a needle substantially into the outer cover in instances where the needle misses the septum. The flange can further include both an anchoring feature for securing the outer cover to the port body and an identification feature observable via x-ray imaging technology for conveying information indicative of at least one attribute of the access port. The outer cover provides a suitable surface for application of an antimicrobial/antithrombotic coating.