Integrated peripheral intravenous catheter with improved access to extension tube port probe

Abstract

To provide a vascular access device such as an integrated catheter which facilitates probe access to a device fluid passage via an extension tube side port and to the inside of a vascular system of a patient, enables access to the vicinity of a catheter adapter, and shortens the length of a required probe.SOLUTION: The vascular access device includes: a catheter for insertion into a biological site; and a catheter adapter having a catheter hub and a side port, the catheter hub having a first end operatively coupled to the catheter, a second end opposite the first end, and an inner wall defining an internal fluid passageway therebetween, the side port in fluid communication with the internal fluid passageway, a lumen wall of the side port including a protrusion configured to deflect a probe entering the catheter hub from the side port toward the first end.SELECTED DRAWING: Figure 4

Description

[Technical Field]

[0001] The present invention relates to vascular access devices, and more particularly to an improved integrated catheter system that allows fluid pathway and / or probe access to a patient's vascular system via an extension tube side port, and methods of using the integrated catheter system. [Background technology]

[0002] Peripheral intravenous catheters (PIVCs) allow rapid access to the vascular system. A probe can be placed within the catheter's flow channel and advanced into the vascular system to allow for the administration of fluids or medications, the withdrawal of blood, and / or the placement of sensors to measure system or patient data. Integrated catheters are becoming popular for many reasons. They combine the individual components of a PIVC (e.g., catheter device, extension tubing, and needleless connector) into a single integrated device, reducing the risk of IV catheter injury, blood exposure, and needlestick injury to healthcare professionals. Summary of the Invention [Problem to be solved by the invention]

[0003] Some probes have limitations for their use with integrated catheters. For example, the Velano Vascular PIVC blood sampling system is currently only compatible with non-integrated PIVCs and certain needleless connectors with an unobstructed fluid path, such as the SmartSite™ and Q-Syte™ needleless connectors, and therefore does not currently work with integrated catheters such as the Nexiva™ or Nexiva™ Diffusics™ closed IV catheter systems. This limitation relates to the length requirements for a probe to be advanced into the vasculature using an integrated catheter, from the Luer adapter at the end of the extension tube, through the extension tube, catheter adapter, catheter, and beyond the catheter tip. Another limitation relates to the probe's inability to follow the fluid path of the existing integrated catheter and reach the vasculature unimpeded. With Nexiva™ and other integrated catheters, a probe that enters the catheter adapter via the extension tube may not be able to rotate within and beyond the catheter while being advanced through the system.

[0004] It would therefore be desirable to have a vascular access device, such as an integrated catheter, that facilitates probe access to the device fluid passageways and into the patient's vasculature through extension tube side ports without such hindrance, and that also allows access closer to the catheter adapter, reducing the length of the probe required. [Means for solving the problem]

[0005] In one aspect, a vascular access device is disclosed. In embodiments, the vascular access device is an integrated catheter.

[0006] In embodiments, a vascular access device includes a catheter for insertion into a biological site, and a catheter adapter having a catheter hub and a side port, the catheter hub having a first end operably coupled to the catheter, a second end opposite the first end, and an interior wall defining an interior fluid passage therebetween, the side port being in fluid communication with the interior fluid passage.

[0007] In embodiments, the contact angle of the probe entering the catheter hub from the side port is greater than 90 degrees. In certain embodiments, the contact angle is greater than 90 degrees along the length of the internal fluid passage to the first end. In embodiments, the entrance angle of the probe entering the catheter hub from the side port is less than 45 degrees.

[0008] In embodiments, the angle between the inner wall and the longitudinal axis of the side port (i.e., the "side port angle") is greater than 90 degrees. In embodiments, the inner wall defines a transition step between a larger diameter portion of the internal fluid passage proximal to the second end and a smaller diameter portion of the internal fluid passage at the first end. In some embodiments, with respect to the transition step, the contact angle of the probe entering the catheter hub from the side port is greater than 90 degrees.

[0009] In aspects, the vascular access device includes a component configured to direct the path of a probe entering the catheter hub from the side port toward the first end. In certain embodiments, the component is: a) a protrusion extending into the side port, the internal fluid passage, and / or the lumen of the extension tube; b) at least partially a septum within the catheter hub; or c) a combination of the protrusion and the septum. In embodiments, the vascular access device includes an access adapter, with or without a separate Luer adapter, in fluid communication with the side port and allowing insertion of the probe into the catheter through the side port.

[0010] In one aspect, a method of using a vascular access device is disclosed, the method including inserting a probe into an extension tube, advancing the probe through the extension tube and into a side port, advancing the probe from the side port through an internal fluid passage into a catheter, and advancing the probe through the catheter into the peripheral vasculature of a subject. In embodiments, the probe maintains a contact angle with an interior wall of the internal fluid passage that is greater than 90 degrees along the length of the internal fluid passage. [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 1 shows an integrated catheter with a needleless connector and air vent plug. [Figure 2] FIG. 2 shows a catheter adapter with a side port. [Figure 3] FIG. 3 shows a catheter adapter with a side port and a probe. [Figure 4] FIG. 4 shows a catheter adapter with a side port, a probe, and a protrusion within the side port. [Figure 5] FIG. 5 shows a catheter adapter with a side port, a probe, and an extended catheter wedge. [Figure 6] FIG. 6 shows a catheter adapter with a side port, probe, and septum feature. [Figure 7] FIG. 7 shows a catheter adapter with a side port, a probe, an expanding catheter wedge, and a protrusion within the side port. [Figure 8] FIG. 8 shows a catheter adapter with a side port, a probe, and a convex catheter wedge that forms part of the inner wall of the catheter hub. [Figure 9] FIG. 9 shows a catheter adapter with a side port, a probe, and a concave catheter wedge that forms part of the inner wall of the catheter hub. [Figure 10] FIG. 10 shows a catheter adapter with a side port that has a shallow entrance angle to the catheter hub. [Figure 11] FIG. 11 shows an integrated catheter with a probe adapter and a Luer adapter. [Figure 12] FIG. 12 shows an integrated catheter with a needleless connector and a Luer adapter. [Figure 13] FIG. 13 shows an integrated catheter with a fluid control adapter and a Luer adapter. [Figure 14] FIG. 14 shows an integrated catheter with a non-luer septum adapter and a luer adapter. [Figure 15A] FIG. 15A shows a side port configured with a single port near access adapter as the luer adapter, illustrating one of three configurations of near access adapters used in embodiments herein. [Figure 15B] FIG. 15B shows an extension tube configured with a dual port near access adapter as two Luer adapters, illustrating one of three configurations of near access adapters used in embodiments herein. [Figure 15C] FIG. 15C shows a dual port near patient access adapter configured as a Luer adapter and an extension tube configured with a secondary extension tube, illustrating one of three configurations of the near access adapter used in the embodiments herein. [Figure 16A] FIG. 16A illustrates another configuration of a near-access adapter for insertion of a probe into an integrated catheter, according to some embodiments herein. [Figure 16B] FIG. 16B is a detailed view of the near access adapter of FIG. 16A. [Figure 17A] FIG. 17A illustrates another configuration of a near-access adapter for insertion of a probe into an integrated catheter, according to some embodiments herein. [Figure 17B] FIG. 17B is a detailed view of the near access adapter of FIG. 17A. [Figure 18] FIG. 18 shows another configuration of a near-access adapter for inserting a probe into an integrated catheter, including an integrated SmartSite™ needleless connector. [Figure 19] FIG. 19 shows another configuration of a near-access adapter for inserting a probe into an integrated catheter, including an integrated SmartSite™ needleless connector. [Figure 20] FIG. 20 shows another configuration of a near-access adapter for inserting a probe into an integrated catheter, including an integrated MaxZero™ needleless connector. DETAILED DESCRIPTION OF THE INVENTION

[0012] Various embodiments are described with reference to the drawings, in which like elements are generally referenced by numerals or the like. The relationship and function of the various elements of the embodiments may be better understood by reference to the detailed description that follows. However, the embodiments are not limited to those shown in the drawings. It should be understood that the drawings are not necessarily to scale, and in some cases, details not necessary to an understanding of the embodiments disclosed herein, such as conventional manufacturing and assembly details, may be omitted.

[0013] The present invention, as defined by the claims, may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey an enabling disclosure to those skilled in the art. As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. References herein to industry standards (e.g., ASTM, ANSI, IEEE standards) are defined to conform to the standards currently published as of the initial filing date of this disclosure for units, measurements, and test criteria conveyed by these standards, unless expressly stated otherwise. As used herein, the terms "proximal" and "distal" are used in their common usage to refer to the handle / doctor-end of a device or related object and the tool / patient-end of a device or related object, respectively. The terms "about," "substantially," "generally," and other terms of degree, when used in reference to volumes, dimensions, proportions, or other quantitative or qualitative values, are intended to convey clear, identifiable values ​​within standard parameters understood by those skilled in the art (e.g., medical device engineers experienced in the field) and should be interpreted to include any legal equivalents, minor but functionally insignificant variations, standard manufacturing tolerances, and at least mathematically significant figures (though not necessarily as broad as the full range). When a range of values ​​is provided herein, it is understood to include the upper and lower limits of the range, as well as all values ​​therebetween. For example, a range of 90 to 120 degrees means values ​​from about 90 degrees to about 120 degrees, and is understood to include all possible values ​​between 90 degrees and 120 degrees.

[0014] The present invention relates to an improved integrated catheter system that allows probe access to a device's fluid pathway and / or a patient's vasculature through an extension tube side port. Conventional probes may be incompatible with existing integrated catheters for a number of reasons. First, the path from the Luer adapter through the extension tube, catheter adapter, catheter, catheter tip, and beyond the catheter tip to the vasculature is long, creating significant intraluminal frictional resistance and necessitating a long probe that is more difficult to manipulate. Second, the probe makes several turns along this fluid pathway, increasing the likelihood of encountering obstacles before reaching the vasculature. Therefore, an integrated catheter system that minimizes sharp turns within the fluid pathway and / or reduces the distance the probe must travel would enable the use of probes with integrated catheters through extension tube side ports.

[0015] As used herein, a "vascular access device" refers to any integrated or non-integrated catheter configured to allow medical personnel access to the vascular system. As used herein, an "integrated catheter" refers to a closed intravenous catheter system that integrates the individual components typically assembled by a clinician during peripheral IV cannula insertion. For example, as further described herein, an integrated catheter may include a catheter, catheter adapter, side port, and extension tubing, and may include additional integrated components. Current designs for integrated catheters, such as the BD Nexiva™, BD Pegasus™, and BD Intima II™, include a side port positioned at an angle (typically 45 degrees) relative to the catheter hub. This limits the ability to use probes such as the Velano Vascular blood sampling device. The disclosed improvements enable the use of these types of probes with integrated catheter systems.

[0016] As used herein, a "probe" or "vascular probe" is a device that can be placed within the fluid path of a catheter system and advanced into a patient's vasculature (using a combination of tip openings and / or side holes) for fluid or drug administration, blood withdrawal, and / or placement of sensors to measure system or patient data. Sensors are commonly deployed to observe patient diagnostic information, blood chemistry, other blood parameters, pressure, flow rate, drug ID, microbial detection, or other data of interest. Probes can be used in conjunction with, for example, intravascular ultrasound, photoacoustic imaging, or near-infrared spectroscopy to assess vascular dynamics in near real time. Thus, a probe may be a wire, cannula, or other tube, or any other extending (hollow or solid) structure that can pass through the vasculature and (generally) be retracted after use.

[0017] In one aspect, a vascular access device is disclosed.

[0018] In an embodiment, the vascular access device is an integrated catheter.

[0019] In embodiments, the vascular access device includes a catheter for insertion into a biological site and a catheter adapter having a catheter hub and a side port. The catheter hub can have a first end operably coupled to the catheter, a second end opposite the first end, and an interior wall defining an internal fluid passage therebetween, and the side port can be in fluid communication with the internal fluid passage. In some embodiments, the vascular access device further includes an extension tube connected to and fluidly coupled with the side port.

[0020] As used herein, the term "inner wall" refers to the lumen wall of the catheter hub approximately opposite the side port. In other words, the inner wall is generally understood to refer to the inner surface of the catheter hub that an advancing probe first encounters, assuming the probe is advanced coaxially with the major axis of the side port and is not otherwise deflected by other features described below. It is understood that the inner wall may be part of the catheter hub or, in some cases, may be at least partially formed by another component that abuts the catheter hub. For example, integrated catheters often include a catheter wedge that is inserted into the catheter adapter to secure the catheter to the catheter adapter. This catheter wedge may form and define a portion of the "inner wall" that an advancing probe first encounters. Thus, in some embodiments, a vascular access device includes a catheter wedge that defines at least a portion of the inner wall.

[0021] In some embodiments, the contact angle of the probe entering the catheter hub from the side port is greater than 90 degrees.

[0022] As used herein, the term "contact angle" when referring to a probe may refer to the angle between the longitudinal axis of the probe at its tip and the interior wall at the point of contact, measured from the distal end of the catheter hub's long axis. Thus, "contact angle" may be understood to capture the angle at the initial moment when the probe tip makes contact with the interior wall. A 90-degree contact angle, commonly found in existing integrated catheters, reveals a configuration in which the longitudinal axis of the probe closest to the tip is perpendicular to the interior wall at the point of contact. This approximately 90-degree contact angle is determined in part by the angle between the side port and the catheter hub, as well as the internal structure of the catheter hub. A 180-degree contact angle is associated with a configuration in which the longitudinal axis of the probe closest to the tip is parallel to the interior wall at the point of contact and directed toward the distal end of the catheter hub (i.e., generally toward the catheter lumen).

[0023] Alternatively, the "side port angle" may be defined by the angle between the interior wall and the longitudinal axis of the side port, without being specifically defined in terms of the advancing probe.

[0024] As mentioned above, one limitation of existing integrated catheters is the risk that the advancing probe will encounter the inner wall at a contact angle of 90 degrees, causing the probe to be wedged against the inner wall and not advance further into the catheter, or that it will encounter the inner wall at a contact angle of less than 90 degrees, causing it to be directed proximally toward the needle and septum and away from the catheter lumen.

[0025] It is also understood that the probe initially contacts the interior wall of the catheter hub and then deflects along its path relative to the interior wall, resulting in a contact angle that dynamically changes along the length of the internal fluid passage. Clinical probes are generally made using flexible materials and structures that may facilitate some degree of deflection as they advance through the system. Thus, in some embodiments, the contact angle is greater than 90 degrees along the length of the internal fluid passage until the first end. For example, the initial contact angle may be 100 degrees, and as the probe deflects toward the catheter, the contact angle may increase between 100 degrees and 180 degrees until the probe effectively advances parallel to the interior wall and may not even contact the interior wall, and until the probe reaches the first end of the catheter hub or a more distal portion of the system.

[0026] In some embodiments, the inner wall has a tapered surface.

[0027] In some embodiments, the inner wall further defines a transition step between a larger diameter portion of the internal fluid passage proximal to the second end and a smaller diameter portion of the internal fluid passage at the first end, hi certain embodiments, a contact angle of a probe entering the catheter hub from the side port relative to the transition step is greater than 90 degrees.

[0028] A contact angle greater than 90 degrees facilitates advancement of the probe through the catheter adapter and into the catheter. Thus, in some embodiments, the contact angle is greater than about 100, 110, 120, 130, 140, 150, 160, or 170 degrees. In preferred embodiments, the contact angle is greater than about 120 degrees. In some embodiments, the contact angle is about 180 degrees. The ability to advance the probe depends on several variables, including the contact angle, the material composition of the probe, the length of the probe already advanced, the coefficient of friction with the internal surface of the system, the lubricity and stiffness of the probe, etc. In some cases, a contact angle slightly greater than 90 degrees may be sufficient to advance the probe with a gentle force. In other cases, such as with longer probe lengths, a larger contact angle of 105, 110, 115, or 120 degrees or more may be required to facilitate advancement.

[0029] Various adaptations to the disclosed vascular access devices can be envisioned to direct the path of the probe through the side port and catheter hub and into the catheter, including changes in the slope, shape, or orientation of the interior wall and components configured to deflect the path of the probe before it contacts the interior wall of the catheter hub.

[0030] In some embodiments, the slope of the inner wall decreases relative to the long axis of the catheter hub to increase the contact angle with the advancing probe, as shown, for example, in Figures 6 and 8. Similarly, the inner wall may have a convex or concave shape so that the advancing probe has a sufficient contact angle to direct the probe toward the first end of the catheter hub, as shown, for example, in Figures 9 and 10.

[0031] In one embodiment, the vascular access device includes a component configured to direct the path of the probe entering the catheter hub from the side port to the first end.

[0032] In embodiments, the component is a) a side port, an internal fluid passage, and / or a protrusion extending into the lumen of the extension tube, b) at least partially a septum within the catheter hub, or c) a combination of a protrusion and a septum.

[0033] As used herein, "protrusion" may refer to any extension, bump, projection, or other modification to the lumen wall of a side port, internal fluid passage, and / or extension tube to cause deflection of an advancing probe. Protrusions may be introduced at the aforementioned locations or into the catheter hub itself to increase the contact angle of the probe with the inner wall (i.e., to promote the probe toward the catheter lumen). The protrusions may be introduced during the manufacture (e.g., molding) of the side port, extension tube, or catheter hub, or may be introduced secondarily as a separate component joined to the catheter hub using methods known in the art, such as heat staking, a forming operation, or using adhesives, etc.

[0034] Integrated catheters typically include an integrated needle and a mechanism for safely storing and disposing of the needle after use. In these cases, the used needle is typically retracted through a self-sealing septum to minimize leakage. In some embodiments, the septum may be positioned at least partially within the catheter adapter, such that the advancement probe is deflected by the septum (e.g., toward the first end of the catheter hub) and is within the path of the advancement probe.

[0035] Other components and adaptations to the side port, internal fluid passages or other portions of the catheter hub, and / or extension tube that direct the path of the probe from the side port into the catheter hub to the first end may also be envisioned as being within the scope of the present invention.

[0036] In some embodiments, the component completely directs (i.e., deflects) the path of the probe as it enters the catheter hub so that the probe never encounters an interior wall and instead passes directly through the first end and into the catheter.

[0037] Other means for directing the path of the probe may also be envisioned, which do not necessarily involve modifications to the interior wall and separate components.

[0038] In one aspect, the entrance angle of the probe entering the catheter hub from the side port is less than about 45 degrees. As used herein, the term "entrance angle" may refer to the angle between the advancing probe and the longitudinal axis of the catheter hub, measured from the distal end of the catheter hub. Alternatively, "entrance angle" may refer to the angle between the longitudinal axis of the side port and the longitudinal axis of the catheter hub, measured from the distal end of the catheter hub.

[0039] In conventional integrated catheters, the entrance angle between the side port and the longitudinal axis of the catheter hub is approximately 45 degrees, as shown, for example, in FIG. 5. As previously discussed, the entrance angle of the side port can affect the path the probe takes through the side port and into the catheter hub, thereby affecting both the entrance angle of the probe itself and the contact angle of the probe with the inner wall. Thus, a shallower (smaller) side port entrance angle is associated with a larger contact angle, which can facilitate advancement of the probe through the catheter hub, as shown in FIG. 11. In some embodiments, the entrance angle of the side port is less than about 45 degrees, less than about 40 degrees, less than about 35 degrees, less than about 30 degrees, less than about 25 degrees, less than about 20 degrees, less than about 15 degrees, or less than about 10 degrees.

[0040] Various methods for directing the probe's path and increasing the contact angle are described herein, including, for example, side ports, internal fluid passages, and / or protrusions in the extension tube. These mechanisms are expected to, in some cases, alter the entrance angle of the probe as it enters the catheter hub through the side port. In some embodiments, the entrance angle of the probe as it enters the catheter hub through the side port is less than about 45 degrees, less than about 40 degrees, less than about 35 degrees, less than about 30 degrees, less than about 25 degrees, less than about 20 degrees, less than about 15 degrees, or less than about 10 degrees.

[0041] A vascular access device (e.g., an integrated catheter) desirably reduces the distance a probe must travel to reach a patient's vasculature. Optimally, the vascular access device allows for insertion of the probe into an access adapter and side port located near the catheter adapter without the need for a separate Luer adapter. In this way, the overall length of the probe path can be reduced compared to traditional integrated catheters because the probe access adapter is closer to the catheter adapter than the Luer adapter used to administer or withdraw fluids through the integrated catheter.

[0042] Thus, in one aspect, the vascular access device further includes an access adapter in fluid communication with the side port, allowing for insertion of a probe into the catheter through the side port, with or without a separate Luer adapter. A variety of access adapters may be used. In embodiments, the access adapter is selected from the group consisting of a Luer adapter, a needleless connector, a fluid control valve, and a non-luer proprietary access valve designed specifically for probe access. Using the disclosed vascular access device, the access adapter may be positioned much closer to the catheter adapter than a Luer adapter. The use of such "near-patient" or "near-catheter adapter" access reduces frictional resistance that would otherwise be encountered with a longer probe path. This "near-patient" access may be facilitated, and in some cases required, by a contact angle greater than 90 degrees, as discussed above.

[0043] It will be further understood that one or any combination of the above features can be utilized to facilitate passage of the probe through the side port of the catheter adapter and into the catheter. For example, in some embodiments, the vascular access device includes: a) a protrusion that extends into the side port, internal fluid passage, and / or lumen of the extension tube; b) a septum, at least partially, within the catheter hub; c) an enlarged, concave, or convex interior wall; and / or d) a side port entrance angle of less than 45 degrees.

[0044] In one aspect, a method of using a vascular access device is disclosed. In an embodiment, the vascular access device is an integrated catheter.

[0045] In an embodiment, the method includes inserting a probe into an extension tube of a vascular access device, advancing the probe through the extension tube and into a side port, advancing the probe from the side port through an internal fluid passage into a catheter, and advancing the probe through the catheter and into the peripheral vasculature of the subject.

[0046] In some embodiments, the probe maintains a contact angle with the interior wall of greater than 90 degrees along the length of the interior fluid passage.

[0047] In some embodiments, the probe passes through an access adapter before being inserted into the extension tube, and the access adapter is in fluid communication with the extension tube and allows for insertion of the probe into the catheter through a side port, with or without a separate Luer adapter.

[0048] In other embodiments, the probe is threaded directly into the side port (no extension tubing required) through the access adapter, with or without a separate luer adapter.

[0049] 1 illustrates an embodiment of an integrated catheter 100 with a needleless connector 110 and an air vent plug 111. As shown, the integrated catheter 100 includes a catheter adapter 101 with a catheter hub 102, a catheter 103, a side port 105, two radial wings 106, a needle housing 107, and an extension tube 108. The extension tube 108 is fluidly connected to the side port 105 and terminates in a y-adapter 109, which leads to a Q-Syte™ needleless connector 110 and an air vent plug 111.

[0050] FIG. 2 illustrates another embodiment of a catheter adapter 101, including a catheter hub 102, a side port 105, radial wings 106, and an extension tube 108. As shown, the side port 105 is joined to the extension tube 108 at a bond pocket 104. As the probe advances distally through the integrated catheter, the inner diameter of the downstream (more distal) passageway in the probe's path generally increases, particularly at the joint. Thus, the IDS (inner diameter of the side port) is generally larger than the IDE (inner diameter of the extension tube), facilitating probe advancement. FIG. 2 also illustrates the inner surface of a septum 201, which is associated with needle retraction.

[0051] FIG. 3 shows another embodiment of a catheter adapter 101 including a catheter hub 102 and a side port 105. The inner surface of the septum 201 is shown on the right side of the catheter hub 102 and forms a seal to prevent blood and other fluid leakage after needle retraction. A catheter 103 (not shown) is secured to the catheter adapter 101 with a catheter wedge 202. An inner wall 203 is shown within the catheter hub 102 and defines an internal fluid passageway 204 between a first end of the catheter hub 102 operably coupled to the catheter and a second end of the catheter hub 102 opposite the first end. A probe 205 is advanced through the side port 105 and contacts the inner wall 203. The catheter wedge 202 defines a portion of the inner wall 203, including the portion contacted by the probe 205 in this embodiment. The contact angle A of the probe 205 with the inner wall 203 is approximately 90 degrees, and the entrance angle B of the probe 205 is approximately 45 degrees. Therefore, the probe 205 contacts the inner wall 203 and does not easily advance into the catheter 103 .

[0052] FIG. 4 shows another embodiment of a catheter adapter 101 including a catheter hub 102 and a side port 105, with a catheter wedge 202 defining a portion of an interior wall 203. The probe 205 encounters a protrusion 206 (within the side port 105) and is deflected toward the first end of the catheter hub 102 (i.e., deflected distally). As shown, compared to the embodiment of FIG. 3, the contact angle A of the probe 205 is correspondingly increased (greater than 90 degrees), and the entrance angle B of the probe 205 is correspondingly decreased (less than 45 degrees). This facilitates the path of the probe toward the catheter 103 (i.e., to the left in FIG. 4). In the illustrated embodiment, the probe 205 can be advanced into the catheter 103 after contacting the interior wall 203 (e.g., with little additional force).

[0053] 5 shows another embodiment of a catheter adapter 101 including a catheter hub 102, a catheter wedge 202, and a side port 105, where the catheter wedge 202 defines a portion of an inner wall 203. In this embodiment, the slope of the inner wall 203 is reduced relative to the long axis of the catheter hub (i.e., the "expanded" inner wall), increasing the contact angle A with the probe 205. Thus, the probe 205 is shown contacting the inner wall 203 and pointing toward the catheter 103 (not shown), which is facilitated by the reduced slope of the inner wall 203.

[0054] Figure 6 shows another embodiment of a catheter adapter 101 including a catheter hub 102, a catheter wedge 202, and a side port 105, with the catheter wedge 202 defining a portion of an inner wall 203. In this embodiment, the septum 201 is displaced distally within the catheter hub 102 compared to its position in Figures 3, 4, and 5. A probe 205 advances within the side port 105 and contacts the septum 201, thereby directing the probe 205 toward the first end of the catheter hub 102 and the catheter 103 (i.e., to the left in Figure 6). A septum-probe contact point 207 is also shown.

[0055] FIG. 7 shows another embodiment of a catheter adapter 101, including a catheter hub 102, a catheter wedge 202, and a side port 105, where the catheter wedge 202 defines a portion of the inner wall 203. In this embodiment, a protrusion 206 extends into the lumen of the side port 105, directing the probe 205 toward the first end of the catheter hub 102 (i.e., to the left in FIG. 7). In addition, the slope of the inner wall 203 again decreases relative to the long axis of the catheter hub (i.e., forming the expanded inner wall). The combination of these features increases the contact angle A with the probe 205 (greater than 90 degrees). Thus, the probe 205 is shown first deflected by the protrusion 206, then contacts the inner wall 203, and is then directed toward the catheter 103 (i.e., to the left in FIG. 7).

[0056] 8 shows another embodiment of a catheter adapter 101 including a catheter hub 102, a catheter wedge 202, and a side port 105, where the catheter wedge 202 defines a portion of an inner wall 203. In this embodiment, the inner wall 203 has a convex surface at the point of contact with the probe 205 that helps to orient the probe 205 toward the first end of the catheter hub 102 and the catheter 103 (i.e., toward the left in FIG. 8).

[0057] 9 shows another embodiment of a catheter adapter 101 including a catheter hub 102, a catheter wedge 202, and a side port 105, where the catheter wedge 202 defines a portion of an inner wall 203. In this embodiment, the inner wall 203 has a concave surface at the point of contact with the probe 205 that helps to orient the probe 205 toward the first end of the catheter hub 102 and the catheter 103 (i.e., to the left in FIG. 9).

[0058] Figure 10 shows another embodiment of a catheter adapter 101 including a catheter hub 102, a catheter wedge 202, and a side port 105, where the catheter wedge 202 defines a portion of an inner wall 203. In this embodiment, the inner wall 203 has a slope similar to that shown in Figures 3 and 4, but the side port 105 is tilted such that the entrance angle of the side port 105 is reduced. Thus, the entrance angle B of the probe 205 is reduced (less than 45 degrees) and the contact angle A of the probe 205 is increased (greater than 90 degrees), urging the probe 205 toward the catheter 103 (i.e., to the left in Figure 10).

[0059] It is contemplated that any of the aforementioned features for directing probe 205 into catheter 103 (including any combination thereof) may be present in a given vascular access device or integrated catheter.

[0060] 11-14 illustrate various configurations of near-patient access adapters for use with the disclosed vascular access devices.

[0061] 11 shows an integrated catheter with a catheter hub 102, catheter 103, side port 105, wings 106, needle housing 107, and extension tube 108. In this configuration, extension tube 108 terminates in a dual-port y-adapter 109 with a probe adapter 301 and a Luer adapter 303. As shown, probe adapter 301 is configured to provide near-patient access, allowing insertion of a probe 205 into extension tube 108 and through side port 105, catheter hub 102, and catheter 103, as shown. While a Luer adapter is shown, the integrated adapter can also be configured without a Luer adapter for this access.

[0062] 12 shows an integrated catheter with a catheter hub 102, catheter 103, side port 105, wings 106, needle housing 107, extension tube 108, and clamp 304. In this configuration, extension tube 108 terminates in a dual-port y-adapter 109 with a detachable needleless connector 305 and a secondary extension tube 302 that leads to a luer adapter 303.

[0063] 13 shows an integrated catheter with a catheter hub 102, catheter 103, side port 105, wings 106, needle housing 107, and extension tube 108. In this configuration, extension tube 108 terminates in a dual port y-adapter 109 with a fluid control adapter 306 and a secondary extension tube 302 that leads to a luer adapter 303.

[0064] 14 shows an integrated catheter with a catheter hub 102, catheter 103, side port 105, wings 106, needle housing 107, and extension tube 108. In this configuration, extension tube 108 terminates in a dual port y-adapter 109 with a non-luer septum adapter 307 and a secondary extension tube 302 that leads to a luer adapter 303.

[0065] It will be understood that the disclosed vascular access devices (eg, integrated catheters) can be used in any number of other configurations for near-patient access.

[0066] Accordingly, Figures 15A, 15B, and 15C illustrate three configurations of near access adapters for use with embodiments herein. As shown, Figure 15A illustrates a side port 105 connecting to an extension tube 108 configured with a single-port near access adapter as a Luer adapter 303. Figure 15B illustrates an extension tube 108 configured with a dual-port near access adapter as two Luer adapters 303. Figure 15C illustrates an extension tube 108 configured with a dual-port near patient access adapter configured as a Luer adapter 303 and a secondary extension tube 302.

[0067] FIG. 16A shows a detailed view of a near-access adapter for insertion of a probe into a vascular access device (e.g., an integrated catheter), according to some embodiments herein. As shown, extension tube 108 is configured with a Luer adapter 303 connected via a dual-port y-adapter 109 and secondary extension tube 302, which terminates in an access adapter 305 for insertion of probe 205. Also shown on the right side of FIG. 16 is a conical fitting (unlabeled), which facilitates insertion of probe 205 into access adapter 305. As shown, the inner diameter IDT of extension tube 108 is larger than the inner diameter IDL of the lumen of y-adapter 109 to facilitate passage of probe 205 through the system (FIG. 16B).

[0068] FIG. 17A shows another configuration of a near-access adapter for inserting a probe into a vascular access device (e.g., an integrated catheter). As shown, a dual-port y-adapter 109 terminates in the near-access adapter, in this case configured as an integrated Q-Syte™ needleless connector 110. A secondary extension tube 302 leads to a separate dual-port y-adapter 109, which terminates in a separate Q-Syte™ needle connector 110 and air vent plug 111. In this embodiment, access to the side port 105 of the near-access adapter is clear, allowing for much shorter probe lengths than conventional designs. FIG. 17B shows a detailed view of the near-access adapter shown in FIG. 17A.

[0069] 18 and 19 show another configuration of a near-access adapter for insertion of a probe 205 into a vascular access device (e.g., an integrated catheter). As shown, a dual-port y-adapter 109 terminates in an integrated SmartSite™ needleless connector 308 with a separate secondary extension tube 302. In FIG. 18, the probe 205 is shown advanced into the system via the integrated SmartSite™ needleless connector 308 as the inner diameter of the downstream extension tube 108 increases.

[0070] FIG. 20 illustrates another configuration of a near-access adapter for inserting a probe 205 into a vascular access device (e.g., an integrated catheter). As shown, a dual-port y-adapter 109 terminates in an integrated MaxZero™ needleless connector 309 with a separate Luer adapter 303 coupled directly to the y-port adapter 109 (i.e., no secondary extension tube). The probe 205 is shown advancing through the system via the Luer adapter 303, resulting in a larger inner diameter for the downstream extension tube 108. In this case, the probe 205 cannot pass through the MaxZero™ needleless connector 309 because the MaxZero™ does not have an opening or slit that would allow the probe to pass unobstructed through the y-adapter 109 and extension tube 108. Therefore, the probe 205 must pass through the Luer adapter 303.

[0071] Although some embodiments of vascular access devices are described herein for use with detachable needleless connectors, other embodiments and configurations may use non-detachable needleless connectors.

[0072] Thus, various single or dual port near access adapters, with or without a separate Luer adapter, allow for passage of a probe into the disclosed vascular access devices (eg, integrated catheters).

[0073] Those skilled in the art will understand that embodiments not explicitly set forth herein may be practiced within the scope of the present invention, including that features described herein for different embodiments may be combined with each other and / or with currently known or future-developed technology while remaining within the scope of the claims. Although specific terms are used herein, they are used in a generic and descriptive sense only and not for purposes of limitation, unless otherwise defined by context, usage, or other explicit dictation. Accordingly, the foregoing detailed description is intended to be considered illustrative and not limiting. It is also to be understood that the appended claims, including all equivalents, are intended to define the spirit and scope of the present invention. Furthermore, the advantages described above are not necessarily the only advantages of the present invention, and it is not necessarily expected that all described advantages will be achieved by every embodiment of the present invention. In the event of a conflicting disclosure or definition from this application that is inconsistent with a document incorporated by reference, the disclosure or definition in this specification shall prevail.

[0074] The present invention includes the following embodiments. [1] A vascular access device, a catheter for insertion into a biological site; and a catheter adapter having a catheter hub and a side port; the catheter hub has a first end operably coupled to the catheter, a second end opposite the first end, and an interior wall defining an interior fluid passage therebetween, the side port being in fluid communication with the interior fluid passage; A vascular access device, characterized in that a contact angle of a probe entering the catheter hub from the side port is greater than 90 degrees. [2] The vascular access device described in paragraph 1, wherein the contact angle is greater than 90 degrees along the length of the internal fluid passage to the first end. [3] The vascular access device described in 1 or 2, characterized in that the contact angle is greater than 120 degrees. [4] The vascular access device of claim 1, 2, or 3, further comprising a component configured to direct the path of a probe entering the catheter hub from the side port toward the first end, the component comprising: a) a protrusion extending into the side port, an internal fluid passage, and / or the lumen of the extension tube; b) a septum within the catheter hub, at least in part; or c) a combination of a protrusion and a septum. [5] The vascular access device described in 4, characterized in that the entrance angle of the probe entering the catheter hub from the side port is less than 45 degrees. [6] The vascular access device described in 1, 2, 3, or 4, further comprising a catheter wedge that defines at least a portion of the inner wall. [7] The vascular access device described in 1, 2, 3, 4, or 6, further comprising an extension tube connected to and fluidly coupled with the side port. [8] The vascular access device described in 1, 2, 3, 4, 6, or 7, further comprising an access adapter in fluid communication with the side port, allowing insertion of a probe into the catheter through the side port, with or without a separate Luer adapter. [9] The vascular access device described in 8, wherein the access adapter is selected from the group consisting of a luer adapter, a needleless connector, a fluid control valve, and a non-luer proprietary access valve.

[10] An integrated catheter, catheters for insertion into biological sites; a catheter adapter having a catheter hub and a side port; the catheter hub has a first end operably coupled to the catheter, a second end opposite the first end, and an interior wall defining an interior fluid passage therebetween, the side port being in fluid communication with the interior fluid passage; An integrated catheter, wherein the angle between the inner wall and the longitudinal axis of the side port is greater than 90 degrees.

[11] The integrated catheter described in paragraph 10, wherein the entrance angle of the longitudinal axis of the side port is less than 45 degrees relative to the long axis of the catheter hub.

[12] The integrated catheter described in paragraphs 10 or 11, further comprising a catheter wedge that defines at least a portion of the inner wall.

[13] The integrated catheter according to paragraphs 10, 11, or 12, characterized in that the inner wall opposite the side port has a tapered surface.

[14] The integrated catheter according to paragraphs 10, 11, or 12, characterized in that the inner wall opposite the side port has a convex or concave surface.

[15] An integrated catheter, catheters for insertion into biological sites; a catheter adapter having a catheter hub and a side port; the catheter hub has a first end operably coupled to the catheter, a second end opposite the first end, and an interior wall defining an interior fluid passage therebetween, the side port being in fluid communication with the interior fluid passage; the inner wall further defines a transition step between a larger diameter portion of the internal fluid passage proximal to the second end and a smaller diameter portion of the internal fluid passage at the first end; The integrated catheter is characterized in that, with respect to the transition step, the contact angle of the probe entering the catheter hub from the side port is greater than 90 degrees.

[16] The integrated catheter described in paragraph 15, further comprising a probe at least partially within the side port.

[17] The integrated catheter described in paragraphs 15 or 16, characterized in that the transition step is configured to facilitate passage of a probe from a side port into the lumen of the catheter via an internal fluid passage.

[18] A method of using the vascular access device described in 7, inserting the probe into the extension tube; advancing the probe through the extension tube and into the side port; advancing the probe from the side port through the internal fluid passage and into the catheter; advancing the probe through the catheter into the peripheral vasculature of a subject; A method comprising:

[19] The method of claim 18, wherein the probe maintains a contact angle with the interior wall of the interior fluid passage greater than 90 degrees along the length of the interior fluid passage.

[20] The method of claim 18 or 19, wherein the probe passes through an access adapter before being inserted into the extension tube, the access adapter being in fluid communication with the extension tube and allowing insertion of the probe into the catheter through the side port with or without a separate Luer adapter.

Claims

1. 1. A vascular access device comprising: a catheter for insertion into a biological site; a catheter adapter having a catheter hub and a side port, the catheter hub having a first end operatively coupled to the catheter, a second end opposite the first end, and an interior wall defining an internal fluid passage therebetween, the side port being in fluid communication with the internal fluid passage, the lumen wall of the side port including a protrusion configured to deflect a probe entering the catheter hub away from the side port toward the first end; A vascular access device comprising:

2. 10. The vascular access device of claim 1, further comprising a septum configured to form a seal at the second end to deflect a probe entering the catheter hub from the side port toward the first end.

3. The vascular access device of claim 2 , wherein the septum is configured to house a needle inserted into the second end.

4. The vascular access device of claim 1 , further comprising a catheter wedge defining at least a portion of the inner wall.

5. The vascular access device of claim 4 , wherein the probe contacts the catheter wedge at a contact angle greater than 90 degrees.

6. The vascular access device of claim 5 , wherein the contact angle is greater than 90 degrees along the length of the internal fluid passage to the first end.

7. The vascular access device of claim 5 or 6, wherein the contact angle is greater than 120 degrees.

8. The vascular access device of any of claims 1 to 7, wherein an entrance angle of the probe from the side port into the catheter hub is less than 45 degrees.

9. The vascular access device of any preceding claim, further comprising an extension tube connected to and fluidly coupled with the side port.

10. The vascular access device of claim 9 , wherein an inner diameter of the side port is larger than an inner diameter of the extension tube.

11. 11. The vascular access device of claim 9 or 10, further comprising an access adapter connected to the extension tube, the access adapter enabling insertion of a probe into the catheter through the side port.

12. The vascular access device of claim 11 , wherein the access adapter defines a lumen with an inner diameter smaller than an inner diameter of the extension tube.

13. 13. The vascular access device of claim 11 or 12, wherein the access adapter is selected from the group consisting of a luer adapter, a needleless connector, a fluid control valve, and a non-luer only access valve.

14. A vascular access device according to any one of claims 1 to 13, and a probe configured to be inserted through the side port of the catheter adapter and through the catheter; A system comprising:

15. The system of claim 14 , wherein the probe is configured to administer a fluid.

16. The system of claim 14 , wherein the probe is configured to draw blood.

17. The system of claim 14 , wherein the probe is configured for placement of a sensor.

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