Abstract: A method for using a medical device in connection with a catheter for regulation or transfer of fluids to and from a patient. The method may include obtaining and using a medical device including a diaphragm having two unidirectional slit valves disposed therein that actuate in different directions, one slit valve actuating in one direction in response to infusion-induced pressure and another slit valve actuating in another direction in response to aspiration-induced pressure. The method may include infusing fluid through one of the unidirectional slit valves, through a lumen, and into a patient's body. The method may also include aspirating fluid from a patient's body through the lumen and another unidirectional slit valve.

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 medical device is disclosed comprising a diaphragm having at least one slit valve disposed therein, and a valve housing configured to secure the diaphragm at a peripheral portion of the diaphragm, wherein a central portion of the diaphragm is positioned relative to the peripheral portion of the diaphragm such that compressive forces acting on the peripheral portion of the diaphragm create moment forces which bias the slit valve in a closed position. A method is disclosed for using the device in connection with a catheter for regulation of fluids to and from a patient.

Abstract: A catheter assembly for use in accessing a vasculature of a patient during renal replacement or other therapies is disclosed. In one embodiment, the catheter assembly includes a catheter body that defines first and second lumens. The catheter body defines a distal tip region that includes a venous lateral opening that is in fluid communication with the first lumen and an arterial lateral opening that is in fluid communication with the second lumen.

Abstract: A catheter assembly for use in accessing a vasculature of a patient during renal replacement or other therapies is disclosed. In one embodiment, the catheter assembly includes a catheter body that defines first and second lumens. The catheter body defines a distal tip region that includes a venous lateral opening that is in fluid communication with the first lumen and an arterial lateral opening that is in fluid communication with the second lumen.

Abstract: A catheter connection system and a method of connecting the catheter connection system to a catheter. The catheter connection system includes a hub assembly and a collar. The hub assembly includes a cannula extending from a distal end thereof, and a collet defining an inner surface spaced apart from the cannula to permit passage of a catheter wall between the body and the cannula.

Abstract: A pre-curved catheter tube of a catheter assembly or other elongate medical device and methods for forming such a device using a heating procedure is disclosed. Pre-curving of the catheter tube is desirable to impart to the catheter assembly a desired positional configuration when the catheter assembly is inserted into a patient. The heating procedure may include heat sterilization procedures commonly used to sterilize medical devices prior to use. In one embodiment, therefore, a catheter assembly is disclosed, comprising an elongate catheter tube defining at least one lumen, and a tube constraint. The tube constraint is included with the catheter assembly and is configured to temporarily constrain the catheter tube in a curved configuration during a heating procedure of the catheter assembly so as to permanently form the catheter tube in the curved configuration after the heating procedure is complete and the catheter tube is released from the tube constraint.

Abstract: A catheter connection system and a method of connecting the catheter connection system to a catheter. The catheter connection system includes a hub assembly and a collar. The hub assembly includes a cannula extending from a distal end thereof, and a collet defining an inner surface spaced apart from the cannula to permit passage of a catheter wall between the body and the cannula.

Abstract: A safety needle assembly of an infusion set 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. In one embodiment, the fluid isolation component includes a self-sealing pad that prevents needle leakage when the distal tip is shielded by the safety assembly.

Abstract: A catheter connection system and a method of connecting the catheter connection system to a catheter. The catheter connection system includes a hub assembly and a collar. The hub assembly includes a cannula extending from a distal end thereof, and a collet defining an inner surface spaced apart from the cannula to permit passage of a catheter wall between the body and the cannula.

Abstract: A needle guide assembly for inserting a needle into the body of a patient in order to access a subcutaneous target, such as a vessel, is disclosed. In one embodiment, the needle guide assembly comprises a needle guide body that is configured to at least indirectly and removably attach to an image producing device, such as an ultrasound probe. The needle guide body defines at least first and second elongate guide channels. Each guide channel defines a unique insertion angle with respect to a longitudinal axis of the ultrasound probe. Further, each guide channel is configured to accept needles of differing gauges. In other embodiments other needle guide assemblies are disclosed that include multiple guide channels for inserting a needle at a variety of insertion angles into the patient's body. Related methods are also disclosed. In yet other embodiments, needle guide assemblies including needle stop features are disclosed.

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 connection system and a method of connecting the catheter connection system to a catheter. The catheter connection system includes a hub assembly and a collar. The hub assembly includes a cannula extending from a distal end thereof, and a collet defining an inner surface spaced apart from the cannula to permit passage of a catheter wall between the body and the cannula.

Abstract: A catheter connector system, including a catheter hub and a coupling member. The catheter hub includes a cannula portion connected to a housing portion and a distal interface including a tapered seal post fixed to the housing portion, a deformable sealing element surrounding the tapered seal post, and a retention collar surrounding the sealing element. The coupling member includes an opening to receive the distal interface, an inwardly extending portion to engage the retention collar, and an actuating member to engage the deformable sealing element.

Abstract: A catheter connection system is disclosed. In one embodiment, a catheter connection system may include at least two components and a deformable sealing element positioned between the at least two components configured to allow, upon deformation, fluid flow through the at least two components. In another embodiment, the catheter connection system may include a sealing element positioned between at least two components, wherein the components are coupled to one another by a locking member.

Abstract: A catheter connection system and a method of connecting the catheter connection system to a catheter. The catheter connection system includes a hub assembly and a collar. The hub assembly includes a cannula extending from a distal end thereof, and a collet defining an inner surface spaced apart from the cannula to permit passage of a catheter wall between the body and the cannula. The collet includes a proximal barb on an outer surface and the collar includes an attachment barb on an inner surface, engagement of the respective barbs acting to provide a permanent connection between the collar on the collet, while permitting free rotation of the collar about the collet.

Abstract: A catheter connector for a subcutaneously placed catheter. The catheter connector can be configured for a single lumen catheter or a multiple lumen catheter. The connector facilitates precise positioning of both distal and proximal ends of a catheter, providing enhanced functionability and patient comfort.

Abstract: A catheter connector system that allows trimming of the proximal end of a catheter (single or multiple lumen) prior to the placement of a connector hub. In one variation, the catheter connector system comprises a catheter, a connector sheath including a soft collet, and a connector hub including a cannula for engaging the catheter and a connector hub interface for receiving the connector sheath.

Abstract: A catheter assembly for use in accessing a vasculature of a patient during renal replacement or other therapies is disclosed. In one embodiment, the catheter assembly includes a catheter body that defines first and second lumens. The catheter body defines a distal tip region that includes a venous lateral opening that is in fluid communication with the first lumen and an arterial lateral opening that is in fluid communication with the second lumen.

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.