Catheter assembly with differentiating markings for usage thereof

Abstract

A catheter assembly is provided that includes a catheter having a catheter distal end and a catheter proximal end, a catheter adapter coupled to the catheter proximal end and including a lumen in fluid communication with the catheter and an adapter port in fluid communication with the lumen, a near-patient connector connected to the adapter port via an extension tube and including an access port, and an extension set coupled to the near-patient connector. One or more of the catheter adapter, the near-patient connector and the extension set comprises markings thereon indicating at least one of pressure capability, flow rate allowance, and port function.

Description

Attorney Docket No. 09846-2501607 (P-29654.WO01) CATHETER ASSEMBLY WITH DIFFERENTIATING MARKINGS FOR USAGE THEREOF CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Patent Application No. 63 / 635,207 entitled “Catheter Assembly with Differentiating Markings for Usage Thereof” filed April 17, 2024, the disclosure of which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION Field of the Invention

[0002] The present invention is directed to a catheter assembly that provides for insertion of and access to an indwelling catheter. Background of the Invention

[0003] Vascular access devices (VADs) are used in the medical field to access peripheral vasculature of a patient for purposes of infusion therapy and / or blood withdrawal. Common types of VADs include over-the-needle peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. The VAD may be indwelling for short term (days), moderate term (weeks), or long term (months to years).

[0004] In some instances, the VAD is part of a larger catheter system or assembly, where tubing extends out from an adapter or connector of the VAD to provide additional flexibility for medical professionals in terms of administering and / or withdrawing fluids from the VAD – with such tubing being part of an extension set that is integrated with the VAD (an integrated catheter system) or provided separate from the VAD (a non-integrated catheter system), according to various embodiments. Examples of existing integrated catheter systems from Becton, Dickinson and Company (“BD”) include the BD Nexiva™ closed peripheral IV catheter system, the BD Nexiva™ Diffusics™ closed IV catheter system, and the BD “Next” Nexiva™ closed peripheral IV catheter system, as non-limiting examples.

[0005] It is recognized that different catheter systems, such as those mentioned above, may be differently configured as relates to pressure capabilities, flow rate allowances, and the like. As an example, the BD Nexiva™ Diffusics™ closed IV catheter system is configured to 63C0981.DOCX Page 1 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) have high pressure capabilities (i.e., enable high pressure fluid injection / administration), whereas other catheter systems may not have such have high pressure capabilities. Thus, it is of importance for a clinician to know what type of catheter system they are employing for use, in order to ensure that the catheter system is being used in accordance with any usage restrictions associated therewith. However, the appearance of many existing catheter systems are similar, with the only differentiation between the various catheter systems being provided on the packaging thereof – with different artwork, coloring, and lettering on the packaging indicating the type of catheter system and the capabilities thereof. Thus, once a catheter system is unpackaged, it is possible for a clinician to be unaware of the specific catheter system and its capabilities / limitations, including the pressure capabilities thereof, the type / location of connections that may be made thereto (e.g., high pressure connection / port), etc. Still further, there is often no way for a clinician to identify which length of PIVC has been previously placed in a specific vein, which can make subsequent usage of the catheter system more difficult.

[0006] Accordingly, a need exists for catheter systems that include differentiating markings made or applied directly thereon. The differentiating markings may identify the specific catheter system, indicate individual connections on the catheter system and appropriate connecting devices and / or uses for those connections, and / or coach a clinician as to appropriate usage of the catheter system. The markings may also enable a clinician to determine the length of PIVC that has been previously placed in a specific vein of the patient. SUMMARY OF THE INVENTION

[0007] Provided herein is a catheter assembly that includes a catheter having a catheter distal end and a catheter proximal end, and a catheter adapter coupled to the catheter proximal end and including a lumen in fluid communication with the catheter, the catheter adapter including an adapter port in fluid communication with the lumen. The catheter assembly also includes a near-patient connector connected to the adapter port via an extension tube, the near patient connector comprising an access port, and an extension set coupled to the near-patient connector. One or more of the catheter adapter, the near-patient connector and the extension set comprises markings thereon indicating at least one of pressure capability, flow rate allowance, and port function. 63C0981.DOCX Page 2 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01)

[0008] In some embodiments, the markings comprise one or more of a first marker color and a second marker color, with the first marker color indicating a high-pressure capability and the second marker color indicating a blood draw functionality.

[0009] In some embodiments, all or a portion of the near-patient connector is formed of a material having the first marker color or the second marker color.

[0010] In some embodiments, the access port of the near-patient connector comprises a proximal port, and wherein the near-patient connector further comprises a distal port and a side port, with the extension tube coupled to the distal port and the extension set coupled to the side port.

[0011] In some embodiments, the catheter assembly includes one or more rings or lines affixed to or formed on the near-patient connector, each of the one or more rings or lines having the first marker color or the second marker color, wherein the one or more rings or lines are positioned adjacent one or more of the proximal port, the distal port, and the side port.

[0012] In some embodiments, the access port comprises a needle-free connector or seal therein, the needle-free connector or seal having the first marker color or the second marker color.

[0013] In some embodiments, the catheter adapter comprises a septa canister attached to a proximal end thereof, the septa canister housing a septa therein, and wherein the septa canister is formed of a material having the first marker color or the second marker color.

[0014] In some embodiments, the catheter adapter comprises a soft, pliable nose portion attached to a distal end thereof, the nose portion formed of a material having the first marker color or the second marker color.

[0015] In some embodiments, the markings comprise textual markings, the textual markings comprising an alphanumeric descriptor, an alphabetical descriptor, or a numeric descriptor.

[0016] In some embodiments, the textual markings indicate a pressure capability.

[0017] In some embodiments, the textual markings indicate a flow rate allowance.

[0018] In some embodiments, the textual markings indicate a length of the catheter.

[0019] In some embodiments, the textual markings are provided on a body of the near- patient connector.

[0020] In some embodiments, the near-patient connector comprises a grip wing provided on an underside thereof, the grip wing including a flat top surface including the textual or numerical markings thereon. 63C0981.DOCX Page 3 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01)

[0021] In some embodiments, the catheter adapter comprises a support wing attached thereto, the support wing including a flat top surface including the textual or numerical markings thereon.

[0022] In some embodiments, the markings comprise an arrow applied on the access port of the near-patient connector and indicating a connection point for connecting an external device thereto.

[0023] In some embodiments, the extension set comprises a fluid conduit comprising a proximal end and a distal end coupled to the near-patient connector, a luer connection attached to the proximal end of the fluid conduit, and a clamp positioned on the fluid conduit between the proximal and distal ends thereof, the clamp configured to provide for selective occlusion of the fluid conduit.

[0024] In some embodiments, the clamp includes the markings thereon, the markings provided on a body of the clamp or an insert attached to the clamp.

[0025] In some embodiments, the markings on the clamp comprise at least one of a marker color and textual markings.

[0026] In some embodiments, the extension set includes a connector overmold positioned on the luer connection, the connector overmold including the markings thereon, the markings on the luer connection comprising at least one of a marker color and textual markings.

[0027] In some embodiments, the access port of the near-patient connector comprises a proximal port, wherein the near-patient connector is a y-connector further comprising a distal port and a side port, with the extension tube coupled to the distal port and the extension set coupled to the side port, and wherein the markings comprise textual markings indicate a flushing order for the near-patient connector for flushing via the proximal port and the side port.

[0028] In some embodiments, the near-patient connector comprises an anti-reflux valve therein.

[0029] In some embodiments, the near-patient connector comprises a single-port luer connector and valve structure, wherein the markings are provided on the single-port luer connector and valve structure.

[0030] In some embodiments, the access port of the near-patient connector comprises a proximal port, and wherein the near-patient connector is a y-connector further comprising a distal port and a side port, with each of the proximal port and the side port comprising a non- luer connection configured to engage a blunt cannula or provide needle access. 63C0981.DOCX Page 4 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01)

[0031] Also provided herein is a catheter assembly that includes a catheter having a catheter distal end and a catheter proximal end, a catheter adapter coupled to the catheter proximal end and including a lumen in fluid communication with the catheter, the catheter adapter including an adapter port in fluid communication with the lumen, and an integrated connector assembly extending out from the adapter port and comprising an extension tube and a near-patient connector, the near patient connector comprising a single port connector.

[0032] In some embodiments, the catheter assembly further comprises a needle-free connector connected to the single port connector.

[0033] In some embodiments, the catheter assembly further comprises a stabilizing element coupled to the single port connector.

[0034] Also provided herein is a system for facilitating blood draw and / or administering of fluids for a patient. The system includes a catheter assembly including a catheter, a catheter adapter, and an integrated connector assembly comprising an extension tube and a single port near-patient connector. The system also includes a delivery device connected to the catheter assembly via the single port connector, the delivery device comprising a housing, a coupling device at a distal end of the housing, and a catheter tubing received within the housing and movable therein via an advancement member, the catheter tubing moveable from a first or retracted position inside the housing to a second or advanced position outside of the housing, such that a distal end thereof may be routed into the catheter assembly and into or out past the indwelling catheter. The extension tube and the near-patient connector are configured to facilitate introduction of the catheter tubing therethrough. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] FIG. 1 is a top view of a vascular access system including a catheter assembly and instrument delivery device, in accordance with an aspect of the disclosure;

[0036] FIG. 2A is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure;

[0037] FIG. 2B is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure;

[0038] FIG. 2C is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure;

[0039] FIG. 2D is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure; 63C0981.DOCX Page 5 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01)

[0040] FIG. 2E is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure;

[0041] FIG. 2F is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure;

[0042] FIG. 2G is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure;

[0043] FIG. 2H is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure;

[0044] FIG. 2J is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure;

[0045] FIG. 2K is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure;

[0046] FIG. 2L is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure;

[0047] FIG. 2M is a catheter assembly with a near-patient connector having indicator markings thereon, in accordance with an aspect of the disclosure;

[0048] FIG. 3A is a catheter assembly with an extension set having indicator markings thereon, in accordance with an aspect of the disclosure;

[0049] FIG. 3B is a catheter assembly with an extension set having indicator markings thereon, in accordance with an aspect of the disclosure;

[0050] FIG. 3C is a catheter assembly with an extension set having indicator markings thereon, in accordance with an aspect of the disclosure;

[0051] FIG. 4A is a catheter assembly with a catheter adapter having indicator markings thereon, in accordance with an aspect of the disclosure;

[0052] FIG. 4B is a catheter assembly with a catheter adapter having indicator markings thereon, in accordance with an aspect of the disclosure;

[0053] FIG. 4C is a catheter assembly with a catheter adapter having indicator markings thereon, in accordance with an aspect of the disclosure;

[0054] FIG. 5 is a catheter assembly, in accordance with another aspect of the disclosure;

[0055] FIG. 6 is a catheter assembly, in accordance with another aspect of the disclosure;

[0056] FIG. 7 is a catheter assembly, in accordance with another aspect of the disclosure;

[0057] FIG. 8 is a catheter assembly, in accordance with another aspect of the disclosure;

[0058] FIG. 9 is a catheter assembly, in accordance with another aspect of the disclosure; 63C0981.DOCX Page 6 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01)

[0059] FIG. 10 is a catheter assembly, in accordance with another aspect of the disclosure; and

[0060] FIG. 11 is a catheter assembly, in accordance with another aspect of the disclosure. DESCRIPTION OF THE INVENTION

[0061] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0062] As used in this specification, the words "proximal" and "distal" refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device (e.g., the end of the device being manipulated by the user) would be the proximal end of the device.

[0063] Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, are not to be considered as limiting as the invention can assume various alternative orientations.

[0064] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention.

[0065] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0066] As used herein, “at least one of” is synonymous with “one or more of”. For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C. 63C0981.DOCX Page 7 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01)

[0067] Referring to FIG. 1, shown is a non-limiting embodiment of a system 10 for facilitating blood draw and / or administering of fluids for a patient. As shown in FIG.1, system 10 may include a catheter assembly 12 that provides access to the vasculature of a patient. According to embodiments of the disclosure, the catheter assembly 12 may have any of a number of suitable configurations, including being constructed / arranged as an integrated catheter assembly or a non-integrated catheter assembly that includes an extension set with a near-patient access port. Thus while FIG. 1 illustrates an integrated catheter assembly 12, it is recognized that aspects of the disclosure may be directed to other catheter assemblies. In FIG. 1, the catheter assembly 12 includes a catheter adapter 14 and associated catheter 16. The catheter adapter 14 may include a distal end 18 and a proximal end 20. In some embodiments, the catheter adapter 14 may include an additional adapter port 22 that may disposed between the distal end 18 and the proximal end 20 or disposed at the proximal end 20. The catheter adapter 14 may include a first lumen 24 extending through the distal end 18 and the proximal end 20, and the first lumen 24 may be sealed at proximal end 20 of catheter adapter 14, such as by a split-septum connector or self-healing septum connector 25. The catheter 16 extends from the distal end 18 of catheter adapter 14 and may be configured as a PIVC that is placed into a vein of the patient, with a distal end or tip 26 of the catheter 16 positioned appropriately within the vein to enable a blood draw from the patient. Catheter 16 may be formed of any suitable material and may be of any useful length, as known to those of skill in the art.

[0068] In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 30 extending from the port 22. First fluid conduit 30 may be formed of any suitable material known to those of skill in the art and may have a distal end 32 and a proximal end 34. The distal end 32 of first fluid conduit 30 is coupled to port 22, while the proximal end 34 of first fluid conduit 30 may be coupled to a near-patient connector 36 (hereafter “connector 36”). Connector 36 may be a t-connector (e.g., one side port arranged at a 80 degree angle relative to a longitudinal axis of connector 36), a y-connector (e.g., one side port arranged at a 15-85 degree angle relative to a longitudinal axis of connector 36), or any other type of connector known in the art. The connector 36 includes a second lumen 38 therethrough, having any number of branches suitable for the type of connector, such as a branch extending between distal and proximal ends of connector 36 and a branch provided to a port 44 of the connector 36.

[0069] In some non-limiting embodiments or aspects, catheter assembly 12 may include a needleless access connector 46 coupled to the proximal end of connector 36, with the needleless access connector 46 providing a near-patient access port to the catheter assembly 12. The 63C0981.DOCX Page 8 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) needleless access connector 46 may be configured as a split-septum connector or self-healing septum connector, as examples.

[0070] In some non-limiting embodiments or aspects, catheter assembly 12 may also include an extension set 48 coupled to the port 44 of the connector 36. The extension set 48 may include a second fluid conduit 50 coupled to port 44 at end 52 of the conduit 50 and a luer connection 54 (e.g., needleless access connector) at opposing end 56, with a clamp 58 provided on second fluid conduit 50 that allows for occlusion thereof. The extension set 48 may be used to provide a fluid path to or from the catheter assembly 12 to enable fluid or medication delivery, blood aspiration, or connection to an ex-vivo hemodynamic monitoring device that monitors blood pressure, heart rate, and / or pulse contour of a patient, as non-limiting examples.

[0071] According to aspects of the disclosure, system 10 further includes a delivery device 60 that may be operated to introduce an instrument (e.g., catheter tubing or a sensing probe, as non-limiting examples) into the vasculature of the patient, with such an instrument enabling a blood draw or blood gas analysis, for example. As shown in FIG.1 according to a non-limiting embodiment, the delivery device 60 is configured as a blood draw device that includes at least a housing 62, a coupling device or “lock” 64, a catheter tubing 66, and an advancement member 68. The catheter tubing 66 is moveable within the housing 62 so as to provide for advancement thereof from a first or retracted position inside the housing 62 to a second or advanced position outside of the housing 62, such that a distal end thereof may be routed into the catheter assembly 12 and into or out past the indwelling catheter 16. In some embodiments, the catheter tubing 66 may include a first length.

[0072] According to aspects of the disclosure, the catheter assembly 12 may include one or more indicator markings 70 that indicate a particular characteristic of the catheter assembly 12 (or of specific components thereof) to a clinician or other user. As shown in the illustrated, non-limiting embodiments of FIGS. 2A-2M, FIGS. 3A-3C, and FIGS. 4A-4C, indicator marking(s) 70 can be arranged on any number of components of catheter assembly 12, and at any number of locations on those components, of catheter assembly 12. According to non- limiting embodiments, indicator marking(s) 70 can be arranged on catheter adapter 14, on connector 36, or on extension set 48 (i.e., on clamp 58 or on luer connection 54). As defined herein, the indicator marking(s) 70 may be considered / defined to include one or more of the following: a color, a color change, a pattern, a symbol, a picture, an icon, an alphanumeric descriptor, an alphabetical descriptor, a numeric descriptor, a line, and other suitable indicator markings. In some embodiments, the indicator marking(s) 70 may be stamped, embossed, laser-drilled, two-shot molded, marked, scribed, or created in other suitable manners. 63C0981.DOCX Page 9 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01)

[0073] In some embodiments, and as shown in FIGS. 2A-2M, the indicator marking(s) 70 may be provided on the connector 36 and / or a component associated therewith. As indicated above, the indicator marking(s) 70 may include one or more of the following: a color, a color change, a pattern, a symbol, a picture, an icon, an alphanumeric descriptor, an alphabetical descriptor, a numeric descriptor, a line, and another suitable indicator marking.

[0074] In some embodiments, one or more portions of the connector 36 include coloration that is indicative of a characteristic or capability of the connector 36 (or of a port thereof) or of a connection point / type for an external device that may be coupled to the connector (e.g., a fluid delivery device (syringe) or blood draw device, as non-limiting examples). One or more portions of the connector 36 may be colored in a first marking color or a second marking color that indicate a capability or connection type of the connector 36. As a non-limiting example, one or more portions of the connector 36 may be colored purple or dark blue to indicate that the marked portion / port of the connector 36 has a high-pressure capability, such as being configured for use in high-pressure administration of a fluid (e.g., fluid administration at pressures up to 325 PSI, or potentially up to 350 PSI, as non-limiting examples), as may be provided via connection of a fluid delivery device (e.g., syringe) thereto. As another non- limiting example, one or more portions of the connector 36 may be colored red to indicate that the marked portion / port of the connector 36 is configured for connection to a blood draw device (i.e., the marked port is the port to which a blood draw device is to be connected). According to embodiments, the portions / components themselves may be formed of a colored material (i.e., a purple / red polymeric material), or a colored ring or line may be applied to the specified portions / components. Each or all of the subcomponents / portions of the connector 36 - i.e., an upper connector body 72, a lower Y-port connector body 74, a flexible internal sealing subcomponent (i.e., needleless access connector 46), and / or the fluid conduit 30 - may be colored purple and / or red. Additionally, combinations of purple and red could be applied to indicate both the blood draw and high-pressure capability of a port or insertion point.

[0075] In some embodiments, one or more portions of the connector 36 include markings 70 thereon that are indicative of a characteristic or capability of the connector 36 (or of a port thereof) or of a connection point / type for an external device that may be coupled to the connector 36 (e.g., a fluid delivery device or blood draw device). As a non-limiting example, one or more portions of the connector 36 may include an alphanumeric descriptor, an alphabetical descriptor, or a numeric descriptor may indicate a flow rate, max pressure capability (e.g., 325 PSI), and / or catheter length associated with the connector 36 (or for the overall catheter assembly 12). As another non-limiting example, one or more portions of the 63C0981.DOCX Page 10 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) connector 36 may include a symbol such as an arrow that indicates an insertion point for coupling of an external device to the connector 36 (e.g., the marked port is the port to which a fluid delivery device or blood draw device is to be connected). The printed text or symbols on the connector 36 may be used in conjunction with the colorization of components of the connector 36, to provide multiple types of information to a user of the catheter assembly 12.

[0076] Based on the above, a number of different configurations of markings 70 may be provided on the connector 36. Following here below are a number of non-limiting examples of markings 70 and marking configurations for the connector 36.

[0077] In the embodiment of FIG. 2A, the lower Y-port connector body 74 and the fluid conduit 30 are each formed as a colored component (purple and / or red), with printed text (an alphanumeric descriptor) provided on the lower Y-port connector body 74, the tubing, and the upper connector body 72 that indicate catheter length, pressure capability and flow rate, respectively.

[0078] In the embodiment of FIGS. 2B-2D, only the lower Y-port connector body 74 is formed as a colored component (purple or red), with an alphanumeric descriptor provided only on the lower Y-port connector body 74 indicating max pressure and / or flow rate (FIG. 2B), with an alphanumeric descriptor provided on both the lower Y-port connector body 74 and the upper connector body 72 indicating max pressure and flow rate (FIG. 2C), or with an alphanumeric descriptor provided on only the upper connector body 72 indicating max pressure and / or flow rate (FIG. 2D).

[0079] In the embodiment of FIGS. 2E and 2F, only the upper connector body 72 is formed as a colored component (purple or red), with an alphanumeric descriptor provided only on the upper connector body 72 indicating max pressure, catheter length, and / or flow rate (FIG. 2E), or with no alphanumeric descriptor provided (FIG. 2F).

[0080] In the embodiment of FIG. 2G, upper connector body 72 is formed as a colored component with a first marking color (purple) while the lower Y-port connector body 74 is formed as a colored component with a second marking color (red), with printed text (an alphanumeric descriptor) provided on both the upper connector body 72 and the lower Y-port connector body 74, that indicate flow rate and catheter length, respectively.

[0081] In the embodiment of FIG. 2H, the needleless access connector (septa) 46 within upper connector body 72 is formed as a colored component (purple or red).

[0082] In the embodiment of FIG. 2J, colored lines or rings (purple and / or red) may be applied onto the connector 36 at various locations, such as at a distal port 76, a proximal port 78, and / or a side port 44 thereof, with such rings being secured onto the connector 36 (i.e., as 63C0981.DOCX Page 11 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) separate components or rings) or stamped, marked, or scribed onto the connector 36. The colored lines / rings convey information to the user, while maintaining clarity for the visualization of blood and / or advancing of an instrument through the connector 36.

[0083] In the embodiment of FIG. 2K, symbols (such as arrows) may be provided on the connector 36 at one or more locations, such as at the proximal near port 78, with an arrow indicating an insertion / connection point (i.e., port) at which an external device may be coupled to the connector 36 (e.g., a fluid delivery device or blood draw device). In some embodiments, the arrow may be provided as a colored arrow (purple or red), to provide additional information as to the type of device to be coupled to the connector 36 at the designated insertion / connection point.

[0084] In the embodiment of FIG. 2L, a marking 70 in the form of an alphanumeric descriptor is provided on the connector 36 (either on the lower Y-port connector body 74 or the upper connector body 72) that provides instructions on performing a flushing of the connector 36. For example, a marking of “First Flush” may be provided on connector 36, indicating that a flushing of connector 36 should first be performed via an injection of flushing fluid through proximal near port 78 and needleless access connector 46 before performing of a subsequent flushing of connector 36 through port 44 – with such a subsequent flushing being performed through a far port of extension set 48 (i.e., luer connection 54 of extension set 48, at proximal end 56 of fluid conduit 50). Performing a first flush of connector 36 through proximal near port 78 and needleless access connector 46 prevents blood from being left in the connector 36 after performing of a blood draw. Additionally, performing of a first flush of the connector 36 through proximal near port 78 and needleless access connector 46 and a second / last flush through a far port (i.e., through the extension set 48 and port 44) does the best job of cleaning the catheter assembly 12 of residual blood or other contamination, resulting in less likelihood of clotting within the catheter assembly.

[0085] In some embodiments, in order to provide additional space for markings 70 on the connector 36, a separate / additional overmold component 80 (e.g., an overmolded grip wing) may be applied to part of the lower Y-port connector body 74, as shown in FIG. 2M. The overmold component 80 may be positioned on an underside of the connector 36 (i.e., on a surface / side facing the skin of the patient) and may be configured to include a flat upper surface thereon. The overmold component 80 may include an alphanumeric descriptor provided only on the flat upper surface that indicates one or more of catheter length, flow rate, and / or max pressure capability. In some embodiments, the overmold component 80 may be formed as a colored component (purple or red), to provide further information to a user of the catheter 63C0981.DOCX Page 12 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) assembly 12. The overmold component 80 may be formed of an elastomeric / compliant material that provides a user with an improved grip on the connector 36.

[0086] In some embodiments, one or more components of the extension set 48 include markings 70 thereon that are indicative of a characteristic or capability of the extension set 48 (or of a port thereof) or of a connection point / type for an external device that may be coupled to the extension set 48 (e.g., a fluid delivery device). As a non-limiting example, one or more portions of the extension set 48 may include an alphanumeric descriptor, an alphabetical descriptor, or a numeric descriptor may indicate a flow rate and / or pressure capability associated with the extension set 48 (or for the overall catheter assembly 12) or a “No CT” designation - to indicate that extension set port with the clamp on it is not designed for high- pressure computed tomography (CT) contrast media. As another non-limiting example, one or more components of the extension set 48 may be colored in a first marking color or a second marking color that indicate a pressure capability or connection of the set. The printed text on the extension set 48 may be used in conjunction with the colorization of components of the extension set 48, to provide multiple types of information to a user of the catheter assembly 12.

[0087] Based on the above, a number of different marking configurations may be provided on the extension set 48. Following here below are a number of non-limiting examples of markings 70 and marking configurations for the extension set 48.

[0088] In the embodiment of FIG. 3A, the clamp 58 on fluid conduit 50 of extension set 48 includes an insert 82 on a side thereof that includes printed text (an alphanumeric descriptor). According to one embodiment, the printed text on insert 82 may indicate a “No CT” designation.

[0089] In the embodiment of FIG. 3B, the clamp 58 is formed as a colored component (purple and / or red), to provide information regarding a pressure capability or connection type of the extension set 48. The clamp 58 may also include printed text (an alphanumeric descriptor) provided directly thereon that may indicate a flow rate for the extension set 48. According to one embodiment, the luer connection 54 of extension set 48 (at proximal end 56 of fluid conduit 50) may also include printed text thereon, such as a “No CT” designation.

[0090] In the embodiment of FIG.3C, the luer connection 54 of extension set 48 (at proximal end 56 of fluid conduit 50) may include an overmolded sleeve 84 that is formed as a colored component (purple and / or red) and may include printed text (an alphanumeric descriptor) provided directly thereon that may indicate a characteristic or capability of the luer connection 54. 63C0981.DOCX Page 13 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01)

[0091] In some embodiments, one or more components of the catheter adapter 14 include markings 70 thereon that are indicative of a characteristic or capability of the catheter adapter 14 (or of a port thereof) or of a connection point / type for an external device that may be coupled to the catheter adapter 14. As a non-limiting example, one or more portions of the catheter adapter 14 may include an alphanumeric descriptor, an alphabetical descriptor, or a numeric descriptor may indicate a flow rate and / or pressure capability associated with the catheter adapter 14 (or for the overall catheter assembly 12). As another non-limiting example, one or more components of the catheter adapter 14 may be colored in a first marking color or a second marking color that indicate a pressure capability or connection point / type of the catheter adapter 14. The printed text or symbols on the catheter adapter 14 may be used in conjunction with the colorization of components of the catheter adapter 14, to provide multiple types of information to a user of the catheter assembly 12.

[0092] Based on the above, a number of different configurations of markings 70 may be provided on the catheter adapter 14. Following here below are a number of non-limiting examples of markings 70 and marking configurations for the catheter adapter 14.

[0093] In the embodiment of FIG.4A, a support wing 86 of the catheter adapter 14 (provided as part of a “second shot”, along with a soft distal nose 88, in manufacturing the adapter) includes printed text (an alphanumeric descriptor) thereon, with the printed text indicating a pressure capability of the catheter adapter 14.

[0094] In the embodiment of FIG. 4B, in addition to the support wing 86 including an alphanumeric descriptor thereon, the soft distal nose 88 provided on catheter adapter 14 (as part of a second shot in the manufacturing process) is formed as a colored component (purple and / or red), to provide information regarding a pressure capability or connection type of the catheter adapter 14.

[0095] In the embodiment of FIG. 4C, a septa housing or “canister” 90 (that houses septum 25) at the proximal end 20 of catheter adapter 14 is formed as a colored component (purple and / or red), to provide information regarding a pressure capability or connection type of the catheter adapter 14.

[0096] Referring now to FIG. 5, shown is another non-limiting embodiment of a catheter assembly 12 that may be used as part of a system (also including a blood draw device 60, as shown in FIG.1) for facilitating blood draw. The catheter assembly 12 of FIG.5 is identical to the catheter assembly 12 of FIG.2A, for example, except that an additional valve 92 is provided in connector 36, such as in the lower Y-port connector body 74. The valve may be configured to be open for / during a near port flush (i.e., flush through proximal near port 78 and needleless 63C0981.DOCX Page 14 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) access connector 46) and during aspiration (e.g., such as a blood draw via a connected delivery device), but closed during a flush of connector 36 through a far port (i.e., through the extension set 48 and port 44). That is, a near port flush through proximal near port 78 and needleless access connector 46 would open the valve 92, as would engagement / insertion of a blunt cannula (such as on lock of delivery device 60) into valve 92 during a blood draw, while a far port flush (through port 44, via extension set 48) or back pressure would close the valve 92.

[0097] In another embodiment, and as shown in FIG. 6, rather than providing a valve 92 in the lower Y-port connector body 74 of connector 36, an anti-reflux valve 94 may be provided in upper connector body 72.

[0098] Referring now to FIG. 7, shown is another non-limiting embodiment of a catheter assembly 102 that may be in connection with facilitating blood draw and / or administering of fluids for a patient. According to embodiments of the disclosure, the catheter assembly 102 may have any of a number of suitable configurations, including being constructed / arranged as an integrated catheter assembly or a non-integrated catheter assembly that includes an extension set with a near-patient access port. Thus while FIG.7 illustrates an integrated catheter assembly 102, it is recognized that aspects of the disclosure may be directed to other catheter assemblies. In FIG.7, the catheter assembly 102 includes a catheter adapter 104 and associated catheter 106. The catheter adapter 104 may include a distal end 108 and a proximal end 110. In some embodiments, the catheter adapter 104 may include an additional adapter port 112 that may disposed between the distal end 108 and the proximal end 110 or disposed at the proximal end 110. The catheter adapter 104 may include a first lumen 114 extending through the distal end 108 and the proximal end 110, and the first lumen 114 may be sealed at proximal end 110 of catheter adapter 104, such as by a split-septum connector or self-healing septum connector 115. The catheter 106 extends from the distal end 108 of catheter adapter 104 and may be configured as a PIVC that is placed into a vein of the patient, with a distal end or tip 116 of the catheter 106 positioned appropriately within the vein to enable a blood draw from the patient. Catheter 106 may be formed of any suitable material and may be of any useful length, as known to those of skill in the art.

[0099] The catheter assembly 102 includes a fluid conduit 120 extending from the port 112. Fluid conduit 120 may be formed of any suitable material known to those of skill in the art and may have a distal end 122 and a proximal end 124. The distal end 122 of fluid conduit 120 is coupled to port 112, while the proximal end 124 of fluid conduit 120 may include a near-patient connector 126 (hereafter “connector 126”) coupled thereto. The connector 126 is configured as a single-port connector, in that it includes only a proximal connection port 128 thereon that 63C0981.DOCX Page 15 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) provides for coupling of an external device thereto. As shown in FIG. 7, a needleless access connector 130 is coupled to the proximal port 128 of connector 126, with the needleless access connector 130 providing a near-patient access port to the catheter assembly 102. The needleless access connector 130 may be configured as a split-septum connector or self-healing septum connector, as examples.

[0100] The single-port integrated catheter assembly 102 of FIG. 7 provides an advantage over the catheter assembly 12 of FIG. 1 when used for high power injections (e.g., fluid administration at pressures up to 325 PSI, or potentially up to 350 PSI, as non-limiting examples), in that the single-port connector 126 does not include an additional far port. That is, the catheter assembly 102 may be desireable when performing power injections, as dual- port connectors (such as connector 36 in FIG. 1) may require use of a cap to keep the far port from leaking. Additionally, with the catheter assembly 102 including a shortened fluid conduit 120 to which connector 126 is coupled, the catheter assembly 102 is suitable for use in a blood draw where a blood draw device (such as delivery device 60) is to be connected to the catheter assembly 102. That is, as compared to existing single-port integrated catheter assemblies that include an extension set with a lengthier fluid conduit tube that make use of a blood draw device therewith more challenging, the catheter assembly 102 allows for a simpler introduction and advancement of a secondary catheter tube (from the blood draw device) to be advanced through the connector 126 and through the catheter assembly 102 – with this simplified introduction / advancement of the secondary catheter tube enabled by the shortened fluid conduit 120 and an internal geometry of the connector 126 that allows passage of the secondary catheter tube therethrough.

[0101] Additional variants of catheter assembly 102 are illustrated in FIGS. 8-10. In FIG. 8, the catheter assembly 102 includes an additional independent stabilization element 132 (FIG. 8) separate from a support wing 134 provided on catheter adapter 104. In FIG. 9, the catheter assembly 102 is configured such that connector 126 is fixed / integrated with fluid conduit 120, rather than being a separate component that may be connected (i.e., added / removed) to fluid conduit 120 (as in FIG.7). In FIG.10, a proximal end of the fluid conduit 120 may include a valve 136 and luer connection 138 provided thereon that provide for fluid flow control through fluid conduit 120 and for connection of the needleless access connector 130 and an external device, such as a blood draw device (e.g., device 60, FIG. 1), to the catheter assembly 102. The luer connection 138 can be, for example, a female luer connector. The valve 136 can be, for example, a PowerPICC SOLO™2 Valve from Becton, Dickinson and Company, or another suitable valve that closes off the proximal end of fluid conduit 120 and 63C0981.DOCX Page 16 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) that may open responsive to application of a positive pressure or external force thereto (e.g., a blunted cannula of device 60 being advanced therethrough). In any of the embodiments of catheter assembly 102 shown in FIGS. 7-10, the catheter assembly 102 may include any of the indicator markings shown and described in FIGS. 2A-2M, FIGS. 3A-3C or FIGS. 4A-4C. As an exemplary embodiment, the catheter assembly 102 of FIG. 10 is shown with the valve 136 and luer connection 138 including indicator markings 70 thereon regarding a max flow rate.

[0102] Referring now to FIG. 11, shown is another non-limiting embodiment of a catheter assembly 152 that may be in connection with facilitating blood draw and / or administering of fluids for a patient. According to embodiments of the disclosure, the catheter assembly 152 may be constructed / arranged as an integrated catheter assembly or a non-integrated catheter assembly that includes an extension set with a near-patient access port. In FIG.11, the catheter assembly 152 includes a catheter adapter 154 and associated catheter 156. The catheter adapter 154 may include a distal end 158 and a proximal end 160. In some embodiments, the catheter adapter 154 may include an additional adapter port 162 that may disposed between the distal end 158 and the proximal end 160 or disposed at the proximal end 160. The catheter adapter 154 may include a first lumen 164 extending through the distal end 158 and the proximal end 160, and the first lumen 164 may be sealed at proximal end 160 of catheter adapter 154, such as by a split-septum connector or self-healing septum connector 165. The catheter 156 extends from the distal end 158 of catheter adapter 154 and may be configured as a PIVC that is placed into a vein of the patient, with a distal end or tip 166 of the catheter 156 positioned appropriately within the vein to enable a blood draw from the patient. Catheter 156 may be formed of any suitable material and may be of any useful length, as known to those of skill in the art.

[0103] The catheter assembly 152 includes a fluid conduit 170 extending from the port 162. Fluid conduit 170 may be formed of any suitable material known to those of skill in the art and may have a distal end 172 and a proximal end 174. The distal end 172 of fluid conduit 170 is coupled to port 162, while the proximal end 174 of fluid conduit 170 may include a near-patient connector 176 (hereafter “connector 176”) coupled thereto. The connector 176 is configured as a non-luer, compact y-connector. The connector 176 may include a proximal port 178 and a side / far port 180 – with an extension set 182 connected to port 180. The proximal port 178 may be configured to connect with a blunt cannula or provide needle access therethrough, according to embodiments. In other embodiments, a Q-SyteTMvalve from Becton, Dickinson and Co., or another suitable split-septum NFC may be provided on connector 176, with flushability features including an offset tubing inlet and / or proximally directing diversion features also included in the connector 176 to improve flushability. 63C0981.DOCX Page 17 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01)

[0104] Beneficially, embodiments of the disclosure thus provide a catheter assembly that includes indicator markings thereon that may differentiate the catheter assembly from other similar configured / constructed catheter assemblies, while also indicating particular characteristics of the catheter assembly (or of specific components thereof) to a user. The markings may coach the user of the catheter assembly regarding appropriate locations for connecting external devices thereto, such as by indicating proper ports for high-pressure injections and / or blood draw to be performed. The markings may also indicate to a user the length of a PIVC that has been previously placed / inserted in a specific vein of a patient.

[0105] Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment. 63C0981.DOCX Page 18 of 24

Claims

Attorney Docket No. 09846-2501607 (P-29654.WO01) THE INVENTION CLAIMED IS 1. A catheter assembly comprising: a catheter having a catheter distal end and a catheter proximal end; a catheter adapter coupled to the catheter proximal end and including a lumen in fluid communication with the catheter, the catheter adapter including an adapter port in fluid communication with the lumen; a near-patient connector connected to the adapter port via an extension tube, the near patient connector comprising an access port; and an extension set coupled to the near-patient connector; wherein one or more of the catheter adapter, the near-patient connector and the extension set comprises markings thereon indicating at least one of pressure capability, flow rate allowance, and port function.

2. The catheter assembly of claim 1, wherein the markings comprise one or more of a first marker color and a second marker color, with the first marker color indicating a high-pressure capability and the second marker color indicating a blood draw functionality.

3. The catheter assembly of claim 2, wherein all or a portion of the near-patient connector is formed of a material having the first marker color or the second marker color.

4. The catheter assembly of claim 2, wherein the access port of the near-patient connector comprises a proximal port, and wherein the near-patient connector further comprises a distal port and a side port, with the extension tube coupled to the distal port and the extension set coupled to the side port.

5. The catheter assembly of claim 4, further comprising one or more rings or lines affixed to or formed on the near-patient connector, each of the one or more rings or lines having the first marker color or the second marker color, wherein the one or more rings or lines are positioned adjacent one or more of the proximal port, the distal port, and the side port.

6. The catheter assembly of claim 4, wherein the access port comprises a needle-free connector or seal therein, the needle-free connector or seal having the first marker color or the second marker color. 63C0981.DOCX Page 19 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) 7. The catheter assembly of claim 2, wherein the catheter adapter comprises a septa canister attached to a proximal end thereof, the septa canister housing a septa therein, and wherein the septa canister is formed of a material having the first marker color or the second marker color.

8. The catheter assembly of claim 2, wherein the catheter adapter comprises a soft, pliable nose portion attached to a distal end thereof, the nose portion formed of a material having the first marker color or the second marker color.

9. The catheter assembly of claim 1, wherein the markings comprise textual markings, the textual markings comprising an alphanumeric descriptor, an alphabetical descriptor, or a numeric descriptor.

10. The catheter assembly of claim 9, wherein the textual markings indicate a pressure capability.

11. The catheter assembly of claim 9, wherein the textual markings indicate a flow rate allowance.

12. The catheter assembly of claim 9, wherein the textual markings indicate a length of the catheter.

13. The catheter assembly of claim 9, wherein the textual markings are provided on a body of the near-patient connector.

14. The catheter assembly of claim 9, wherein the near-patient connector comprises a grip wing provided on an underside thereof, the grip wing including a flat top surface including the textual or numerical markings thereon.

15. The catheter assembly of claim 9, wherein the catheter adapter comprises a support wing attached thereto, the support wing including a flat top surface including the textual or numerical markings thereon. 63C0981.DOCX Page 20 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) 16. The catheter assembly of claim 1, wherein the markings comprise an arrow applied on the access port of the near-patient connector and indicating a connection point for connecting an external device thereto.

17. The catheter assembly of claim 1, wherein the extension set comprises: a fluid conduit comprising a distal end and a proximal end, the distal end coupled to the near-patient connector; a luer connection attached to the proximal end of the fluid conduit; and a clamp positioned on the fluid conduit between the proximal and distal ends thereof, the clamp configured to provide for selective occlusion of the fluid conduit.

18. The catheter assembly of claim 17, wherein the clamp includes the markings thereon, the markings provided on a body of the clamp or an insert attached to the clamp.

19. The catheter assembly of claim 18, wherein the markings on the clamp comprise at least one of a marker color and textual markings.

20. The catheter assembly of claim 17, wherein the extension set further comprises a connector overmold positioned on the luer connection, the connector overmold including the markings thereon, the markings on the luer connection comprising at least one of a marker color and textual markings.

21. The catheter assembly of claim 1, wherein the access port of the near-patient connector comprises a proximal port, and wherein the near-patient connector is a y-connector further comprising a distal port and a side port, with the extension tube coupled to the distal port and the extension set coupled to the side port, and wherein the markings comprise textual markings indicate a flushing order for the near-patient connector for flushing via the proximal port and the side port.

22. The catheter assembly of claim 1, wherein the near-patient connector comprises an anti-reflux valve therein. 63C0981.DOCX Page 21 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) 23. The catheter assembly of claim 1, wherein the near-patient connector comprises a single-port luer connector and valve structure, and wherein the markings are provided on the single-port luer connector and valve structure.

24. The catheter assembly of claim 1, wherein the access port of the near-patient connector comprises a proximal port, and wherein the near-patient connector is a y-connector further comprising a distal port and a side port, with each of the proximal port and the side port comprising a non-luer connection configured to engage a blunt cannula or provide needle access.

25. A catheter assembly comprising: a catheter having a catheter distal end and a catheter proximal end; a catheter adapter coupled to the catheter proximal end and including a lumen in fluid communication with the catheter, the catheter adapter including an adapter port in fluid communication with the lumen; and an integrated connector assembly extending out from the adapter port and comprising an extension tube and a near-patient connector, the near patient connector comprising a single port connector.

26. The catheter assembly of claim 25, further comprising a needle-free connector connected to the single port connector.

27. The catheter assembly of claim 25, further comprising a stabilizing element coupled to the single port connector.

28. A system for facilitating blood draw and / or administering of fluids for a patient, the system comprising: the catheter assembly of claim 25; and a delivery device connected to the catheter assembly via the single port connector, the delivery device comprising: a housing; a coupling device at a distal end of the housing; and a catheter tubing received within the housing and movable therein via an advancement member, the catheter tubing moveable from a first or retracted position inside 63C0981.DOCX Page 22 of 24Attorney Docket No. 09846-2501607 (P-29654.WO01) the housing to a second or advanced position outside of the housing, such that a distal end thereof may be routed into the catheter assembly and into or out past the indwelling catheter; wherein the extension tube and the near-patient connector are configured to facilitate introduction of the catheter tubing therethrough. 63C0981.DOCX Page 23 of 24

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