Open peripheral intravenous catheter system for blood collection

Abstract

A catheter system is provided herein, comprising a catheter having a distal end and a proximal end, the catheter defining a catheter lumen. The catheter system also comprises a catheter hub coupled to the proximal end of the catheter, the catheter hub further comprising a hub body having a distal end and a proximal end, the hub body having a cavity formed therein extending between the distal and proximal ends of the hub. The catheter hub also comprises an end port located at the proximal end of the hub, providing an opening to the cavity. A split partition connector of the catheter system is located at least partially within the end port, and the split partition connector is configured to seal the cavity in a closed configuration and to provide a fluid pathway to the catheter lumen in an open configuration.

Description

Technical Field

[0001] This application claims the priority of U.S. Utility Patent Application No. 18 / 139,409, titled "Blood Draw Compatible Open Peripheral Intravenous Catheter System", filed on April 26, 2023, the entire disclosure of which is incorporated herein by reference.

[0002] Provided herein are devices and systems for use in vascular access, particularly a catheter hub that is directly compatible with a blood draw device for advancing an instrument through an open peripheral intravenous catheter.

Background Art

[0003] Vascular access devices (VADs) are used in the medical field to access a patient's peripheral vascular system for the purpose of infusion therapy and / or blood draw. Common types of VADs include over-the-needle peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. VADs can be for short-term (days), medium-term (weeks), or long-term (months to years) indwelling. In some applications, open PIVC catheters are provided, and the indwelling catheter inserted into the patient's vascular system extends therefrom to a catheter hub having a port that provides for the coupling of additional instruments or devices thereto.

[0004] Instrument delivery devices are often used with a VAD to deliver instruments to an indwelling intravenous (IV) catheter, and the instrument delivery device advances the instrument beyond the tip of the indwelling catheter. When the instrument delivery device is used to collect blood, the instrument may, for example, be in the form of a flexible tube or catheter, but the instrument may also be a guidewire, occluder, wire, electrical wiring, probe, or sensor(s) in other embodiments. Typically, when employing an instrument delivery device with a VAD such as the open PIVC catheter described above, a connector or adapter is included, which is positioned between the catheter hub and the instrument delivery device. The adapter includes a coupler at its distal end that connects to a port on the catheter hub and a coupler at its proximal end that connects to the instrument delivery device, the proximal coupler often having a needleless connector within it for receiving the instrument delivery device. Once coupled to the catheter adapter, the instrument delivery device can be operated to advance the instrument from there, through the lumen of the catheter adapter, into the tip of the indwelling catheter, and then beyond the tip of the indwelling catheter. The adapter may also include a side port on it that allows for the connection of an extension set or fluid delivery system for introducing fluid into the adapter and open PIVC catheter for administration to a patient.

[0005] It is recognized that including an adapter in the catheter system (between the catheter hub and the instrument delivery device) can increase the difficulty of advancing the instrument into the indwelling catheter. Specifically, in a configuration where the instrument delivery device is connected to the catheter hub using a catheter connector, the male connector portion of the catheter connector typically engages with the proximal end port of the catheter hub, but cannot fill most of the cavity within the catheter hub. If at least a portion of the cavity within the catheter hub remains open, the distal end of the male connector portion remains spaced apart from the proximal opening of the lumen defined by the catheter (which is fixed at the distal end of the catheter hub), and therefore, when attempting to advance the instrument through this cavity (i.e., through the open cavity remaining between the male connector portion and the proximal opening of the catheter lumen), the instrument may not remain properly aligned with the catheter lumen. Thus, the instrument may become trapped within the cavity of the catheter hub, and as the instrument advances further, it may bend and double itself, thereby hindering the instrument's advance into and through the catheter.

[0006] Therefore, there is a need in the art for a catheter system that provides more efficient advancement of instruments through an open PIVC. The catheter system provides a catheter hub that is directly compatible with blood collection devices, thereby eliminating the need for a catheter adapter and simplifying the advancement of instruments through an open PIVC. [Overview of the Initiative]

[0007] Provided herein is a catheter system comprising a catheter and a catheter hub. The catheter has a distal end and a proximal end and defines the catheter lumen. The catheter hub is coupled to the proximal end of the catheter and includes a hub body having a distal end and a proximal end, the hub body having a cavity formed therein extending between the distal and proximal ends. The catheter hub also includes an end port provided at the proximal end of the hub and providing an opening to the cavity. The catheter system also includes a split septum connector at least partially located within the end port, the split septum connector configured to seal the cavity when in a closed configuration and to provide a fluid pathway to the catheter lumen when in an open configuration.

[0008] In some embodiments, the catheter hub further includes a side port extending from the hub body between the distal and proximal ends of the hub, the side port defining a side port lumen that is in fluid communication with the catheter lumen.

[0009] In some embodiments, the side port extends from the hub body at an angle of 15 to 165 degrees relative to the catheter lumen.

[0010] In some embodiments, the side port is a female lure connector.

[0011] In some embodiments, the catheter system further includes a needle-free access connector coupled to a side port.

[0012] In some embodiments, the cavity is a cylindrical cavity having a constant diameter along at least a large portion of its length between the distal end and the proximal end of the hub.

[0013] In some embodiments, the catheter system further includes a blood collection device, which is coupled to an end port and / or split partition connector.

[0014] In some embodiments, the blood collection device includes a secondary catheter; an introducer having a proximal and distal end and an upper and bottom surface defining an internal volume configured to movably receive the secondary catheter; an actuator movably coupled to move relative to the introducer to move the distal end of the secondary catheter from a position within the introducer to a position outside the introducer housing and to pass the distal end of the catheter; and a connector located at the distal end of the introducer coupled to an end port and / or split partition connector, the connector including an obtuse-angled cannula and a pair of locking arms.

[0015] In some embodiments, the split bulkhead connector includes a first ring and a second ring laterally spaced from the first ring, and a pair of locking arms engage with the split bulkhead connector by snapping in between the first ring and the second ring.

[0016] In some embodiments, when the blood collection device is coupled to an end port and / or split septum connector, the blunt (angled) cannula penetrates the split septum connector and into the cavity, and each of the blunt cannula and the cavity has a length such that the blunt cannula extends substantially to the distal end of the cavity.

[0017] In some embodiments, extending the blunt cannula near the distal end of its cavity brings the lumen of the blunt cannula adjacent to the catheter lumen.

[0018] In some embodiments, the catheter hub further includes a wedge positioned in a cavity adjacent to the distal end of the hub, the wedge being coupled to the proximal end of the catheter to hold the catheter in the catheter hub, the wedge containing a wedge lumen formed therein, and a blunt cannula extending near the distal end of the cavity of the blunt cannula, aligning the lumen of the blunt cannula directly with the wedge lumen.

[0019] In some embodiments, the split bulkhead connector is positioned entirely within the end port, and a pair of locking arms engage with grooves formed on the outer surface of the end port.

[0020] In some embodiments, the catheter system further includes a needle introducer coupled to a split septum connector, the needle extending through a catheter hub and through the catheter lumen, and the split septum connector is configured such that a first portion of the split septum connector is separated from a second portion of the split septum connector, and the initial configuration allows the needle to pass through the split septum connector without contacting the split septum connector.

[0021] In some embodiments, the catheter hub comprises an open peripheral intravenous catheter (PIVC) catheter hub.

[0022] In some embodiments, the split partition connector includes a side port formed thereon, and an integrated extension tube extends from the side port.

[0023] Furthermore, a catheter system including a catheter and a catheter hub is provided herein. The catheter has a distal end and a proximal end and defines a catheter lumen. The catheter hub is coupled to the proximal end of the catheter and includes a hub body having a distal end and a proximal end, the hub body having a cavity formed therein extending between the distal and proximal ends. The catheter hub also includes an end port provided at the proximal end of the hub and providing an opening to the cavity. The catheter system also includes a fluid cutoff located at or adjacent to the end port, the fluid cutoff configured to seal the cavity when in a closed configuration and to provide a fluid path to the catheter lumen when in an open configuration.

[0024] In some embodiments, the fluid cutoff includes a stopcock valve within a cavity adjacent to an end port and an actuator disposed on an outer surface of the hub body and operable to open and close the stopcock valve.

[0025] In some embodiments, the catheter system further includes a split septum connector within the cavity and proximal to the stopcock valve.

[0026] In some embodiments, the catheter system further includes a deformable tube coupled to and extending proximally from the end port, and the fluid cutoff is a slide clamp disposed on the deformable tube and operable between an open position and a closed position to permit selective flow of fluid through the deformable tube.

[0027] In some embodiments, the catheter system further includes a blood sampling device coupled to a proximal coupler of the connector, the blood sampling device being configured to advance a secondary catheter through the distal end of the catheter, and including a connector coupled to the end port. The connector further includes a blunt cannula and a pair of locking arms, and when the blood sampling device is coupled to the end port and the fluid cutoff is in an open configuration, the blunt cannula penetrates into the cavity, and the blunt cannula and the cavity each have a length such that the blunt cannula extends substantially to the distal end of the cavity.

Brief Description of the Drawings

[0028] [Figure 1] FIG. 1 is a perspective view of a catheter system including an open PIVC catheter assembly and an attached blood sampling device and fluid delivery system, according to one aspect or one embodiment of the present application. [Figure 2] FIG. 2 is a top view of a portion of the catheter system of FIG. 1. [Figure 3] FIG. 3 is a cross-sectional view of the catheter system of FIG. 1. [Figure 4]Figure 4 is a cross-sectional view of the catheter system in Figure 1, showing the instrument in the first position. [Figure 5] Figure 5 is a cross-sectional view of the catheter system in Figure 1, showing the instrument in the second position. [Figure 6] Figure 6 is a perspective view of a catheter system including an open PIVC catheter assembly and an attached needle introducer, according to an aspect or embodiment of the present application. [Figure 7A] Figure 7A is a diagram showing the catheter system of Figure 6 inserted through a catheter hub and a detachable split partition connector, according to an aspect or embodiment of the present application. [Figure 7B] Figure 7B shows the catheter system of Figure 6, with a needle withdrawn from the catheter hub and a detachable split septum connector. [Figure 8] Figure 8 shows the catheter system from Figure 6 with the split septum connector removed from the catheter hub when the needle introducer is attached. [Figure 9A] Figure 9A is a perspective view of an open PIVC catheter assembly having an open configuration integrated stopcock mechanism according to an aspect or embodiment of the present application. [Figure 9B] Figure 9B shows the open PIVC catheter assembly of Figure 9A with an integrated stopcock mechanism in a closed configuration. [Figure 10A] Figure 10A is a perspective view of an open PIVC catheter assembly in an open configuration with attached tubing and clamps, according to an aspect or embodiment of the present application. [Figure 10B] Figure 10B shows the open PIVC catheter assembly of Figure 10A with the clamp in a closed configuration. [Figure 11] Figure 11 is a perspective view of a catheter system including an open PIVC catheter assembly and an attached blood collection device, according to another aspect or embodiment of the present application. [Figure 12]Figure 12 is a cross-sectional view of the catheter system shown in Figure 11. [Figure 13] Figure 13 is a perspective view of a catheter system including an open PIVC catheter assembly and an attached blood collection device, according to another aspect or embodiment of the present application. [Modes for carrying out the invention]

[0029] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will remain immediately obvious to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of this disclosure.

[0030] Hereafter, for the purpose of explanation, “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “topmost,” “bottommost,” “horizontal,” “vertical,” and their derivatives shall be considered as relating to the present invention as oriented in the drawings. However, it will be understood that the present invention may presuppose various alternative modifications unless explicitly specified otherwise. It should also be understood that the specific devices shown in the accompanying drawings and described below are merely exemplary embodiments of the present invention. Therefore, specific dimensions and other physical features relating to the embodiments disclosed herein should not be considered limiting.

[0031] In this disclosure, the distal end of a component or device means the end furthest from the user's hand when the component or device is in use, i.e., when the user is holding the catheter insertion device in preparation for or during use, and the proximal end means the end closest to the user's hand. Similarly, in this application, the terms “distally” and “distally” mean the direction toward the distal tip of the needle or catheter of the system, and the terms “proximal” and “proximal” mean the direction opposite to the direction toward the distal tip of the needle or catheter.

[0032] Referring to Figure 1, a catheter system 10 according to an aspect or embodiment of the present disclosure is shown. The catheter system 10 includes a catheter 12 and an associated catheter hub 14, which together may provide an open PIVC catheter assembly 16. The catheter system 10 further includes an instrument delivery device 18 and / or an additional extension set or fluid delivery system 20 which may be directly connected to the catheter hub, providing to deliver instruments and / or fluids to and through the catheter 12.

[0033] As shown in Figures 1 to 5, the open PIVC catheter assembly 16 includes a catheter 12 and a catheter hub 14 that provide intravenous access to the patient's vascular system. In some embodiments, the catheter 12 may include a peripheral intravenous catheter, but it is recognized that the catheter 12 may also be provided as a midline catheter or a peripherally inserted central catheter. The catheter 12 may be formed of any suitable material and may be of any useful length, as is known to those skilled in the art. The proximal end 22 of the catheter 12 is coupled to the catheter hub 14 and extends distally therefrom to the distal end 24 of the catheter 12. The catheter 12 defines a lumen 26 therein, through which fluids can be administered to the patient, instruments can be introduced into the patient's vascular system, or blood can be drawn from the patient.

[0034] The catheter hub 14 comprises a main hub body 28 having a distal end 30 and a proximal end 32, along with stabilizing wings 34 extending from the main hub body 28 that provide for securing the hub to the patient's skin. The main hub body 28 defines within itself a cavity 36 extending between the distal end 30 and the proximal end 32 of the catheter hub 14. According to an aspect or embodiment of the present disclosure, the cavity 36 is configured as a generally cylindrical cavity having a constant diameter along at least a large portion of the length 37 of the cavity 36. A hub end port 38 is provided at the proximal end 32 of the main hub body 28, providing access to the cavity 36. An opening 40 is also formed at the distal end 30 of the main hub body 28 extending into the cavity 36, and the opening 40 also receives the proximal end 22 of the catheter 12 into it. In some embodiments, the opening 40 is sized to have a diameter similar to that of the catheter 12, so that the catheter 12 is secured within the opening, thereby securing the catheter 12 to the catheter hub 14.

[0035] As shown in Figure 3, according to some aspects or embodiments, the catheter hub 14 may include a wedge 42 positioned within a cavity 36 of the main hub body 28. The wedge 42 is positioned within the cavity 36 adjacent to the distal end 30 of the catheter hub 14 so that the wedge 42 can seat within the cavity 36. The wedge 42 includes openings 44, 46 formed therein at its opposing distal and proximal ends, and the wedge lumen 48 extends between the distal openings 44, 46. The wedge 42 is positioned within the cavity 36 so as to align with the distal opening 40 of the main hub body 28, and the distal opening 44 of the wedge 42 aligns with the distal opening 40 of the main hub body 28. With the openings of the wedge 42 and the main hub body 28 aligned, the catheter 12 extends through the distal opening 40 of the main hub body 28 into the distal opening 44 of the wedge 42, which is sized so that the catheter 12 is fixed within the opening 44 and fixed to the wedge 42, thereby fixing the catheter 12 to the catheter hub 14.

[0036] According to some aspects and embodiments, a hub end port 38 located at the proximal end 32 of the main hub body 28 is configured as a receptacle to receive a proximal coupler 50 therein. The proximal coupler 50 may be configured as a split bulkhead, needle-free connector (NFC), such as a Q-Syte® or SmartSite® NFC from Becton, Dickinson and Co., or any other suitable split bulkhead NFC (hereinafter, "split bulkhead connector 50") that is partially mounted within the proximal hub end port 38. The split partition connector 50 includes a split partition 52 within which an access control function is provided, thereby allowing peripheral devices (e.g., blood collection devices or vascular access probes for intravenous digital measurement of patient data such as temperature, pH, lactate, and / or other blood-based measurements) to physically and fluidly connect the split partition connector 50 to the catheter hub 14, and as a result, the split partition connector 50 allows the catheter hub 14 to be accessed multiple times by the peripheral device. In some embodiments, if the peripheral device is a blood collection device that introduces a secondary catheter into the catheter 12, the split partition connector 50 functions as a blood control function that can be accessed multiple times by the blood collection device to collect blood from the patient's vein. The split partition connector 50 also includes a pair of connecting rings 54, 56 formed around it, the first ring 54 and the second ring 56 being laterally spaced apart. The connecting rings 54, 56 provide engagement of an instrument delivery device 18 to the catheter hub 14, as will be described in more detail below.

[0037] According to some aspects and embodiments, the catheter hub 14 also includes and / or defines one or more additional ports, such as side ports 58 extending from the main hub body 28. The side ports 58 may be formed at desired locations along the length of the main hub body 28 between the distal end 30 and the proximal end 32 to facilitate flushing and / or fluid transfer through the side ports 58. The side ports 58 provide access to the catheter lumen 26 and define a lumen 60 that fluidizes with a cavity 36 to fluidize with the catheter lumen 26. In some embodiments, the side ports 58 are configured as female Luer connectors including a tapered internal cavity 62 and a threaded outer surface 64, the female Luer connectors being configured to mate with a corresponding male Luer connector of a connector 66 (Figure 1) coupled to the side ports 58. In some embodiments, the connector 66 may be an NFC providing controlled access to the catheter hub 14, and an extension set or fluid delivery system 20 is connected to the side ports 58 via the NFC 66. NFC66 may be configured as a split partition NFC such as Q-Syte® or SmartSite® NFC from Becton, Dickinson and Co., or any other suitable split partition NFC. Through connector 66, an extension set or fluid delivery system 20 may be connected to the side port 58 to fluidize the lumen 60 of the side port 58, and may deliver fluid, remove fluid, flush fluid, etc., such as providing fluid from a mounted IV bag (not shown), for example. In such embodiments, the side port 58 may allow flushing of the space in the cavity 36 between the split partition connector 50 and / or the side port 58 and the split partition connector 50.

[0038] Although not shown in Figure 1, it is recognized that some embodiments of the catheter hub 14 may have an extension set or fluid delivery system 20 integrated with it via a side port 58. That is, the extension set or fluid delivery system 20 (i.e., its extension tube 68) may be directly integrated with the side port 58, rather than the side port 58 being provided as an open female Luer connection to which a separate connector 66 (to which the extension tube 68 is connected) is attached.

[0039] In some embodiments, the arrangement of the side ports 58 can be such that the catheter hub 14 is configured as, for example, a Y-shaped or T-shaped catheter hub. In non-limiting embodiments, the side ports 58 extend from the main hub body 28 at an angle other than 72 degrees (for example, the side ports 58 extend at an angle of, for example, 15 to 165 degrees, including all values ​​and subranges in between, but not limited to). In non-limiting embodiments, two or more side ports 58 are included in the catheter hub 14.

[0040] As shown in Figures 1 to 5, the instrument delivery device 18 of the catheter system 10 is coupled to a split partition connector 50 provided at the hub end port 38 of the catheter hub 14. According to some aspects or embodiments, the instrument delivery device 18 includes an introducer 70, a connector 72, an instrument 74 (Figures 4 and 5), and an actuator 76. The instrument 74 may be one of several devices suitable for insertion into the patient's vascular system, including, for example, a secondary catheter, a guidewire, or a probe. A portion of the actuator 76 is configured to advance along the upper surface of the introducer 70, which then facilitates the advancement of the instrument 74 through the introducer 70, connector 72, and catheter hub 14, and distally out through the catheter 12. In some embodiments, a Luer adapter, Luer lock access device (LLAD), or other connecting device 78 may be provided at the proximal end of the introducer 70 to allow connection of another component 80, such as a syringe or vacuum tube, to the instrument delivery device 18 to facilitate blood collection. According to one embodiment, the instrument delivery device 18 functions as a blood collection device that facilitates blood collection from a patient by inserting a secondary catheter through the catheter 12, and the blood is collected in a syringe or vacuum tube attached to the device; therefore, the blood collection device 18 and the secondary catheter 74 will be referred to below.

[0041] As shown in detail in Figures 1A and 1B, and in further detail in Figures 3 and 4, the connector 72 of the blood collection device 18 is configured to be physically and fluidly coupled to an introducer 70, and to couple the introducer 70 to a catheter hub 14. The connector 72 has a blunt cannula 82, a first arm 84, and a second arm 86, and the connector 72 also defines a lumen 88 extending through the blunt cannula 82. The blunt cannula 82 is positioned between the first arm 84 and the second arm 86 and may have an inner diameter similar to or slightly larger than the outer diameter of a portion of the secondary catheter 74 (the diameter of the surface that at least partially defines the lumen 88) so that the lumen 88 of the connector 72 can receive a portion of the secondary catheter 74 as the secondary catheter 74 advances through the lumen 88 of the connector 72. To secure the connector 72 to the catheter hub 14, the first arm 84 and the second arm 86 act to grip the split partition connector 50 located at the hub end port, and the first and second arms engage with the split partition connector by snapping in between its first ring and second ring.

[0042] To provide the desired engagement between the blood collection device 18 and the catheter hub 14, the catheter hub 14 is specifically configured and sized to receive the blunt cannula 82 of the connector 72, as best shown in Figure 3. That is, the catheter hub 14 is configured such that a cavity 36 provided in the main hub body 28 receives the blunt cannula 82, allowing the secondary catheter 74 to be accurately and reliably advanced into the lumen 26 of the catheter 12. As described above, the cavity 36 has a cylindrical profile with a constant diameter along at least the majority of the length 37 of the cavity 36, and as a result, when the connector 72 engages with the catheter hub 14 (via the split partition connector 50), it can receive the blunt cannula 82 and guide it accurately into the cavity 36 without obstruction. Furthermore, the cavity 36 is configured to have a length 37 designed to accommodate the entire length of the blunt cannula 82, so that when the blood collection device 18 is connected to the catheter hub 14 (via the split partition connector 50), the blunt cannula 82 passes completely through the cavity 36 and extends to a position where the lumen 88 of the connector 72 is directly adjacent to the lumen 48 of the wedge 42 (or adjacent to the lumen 26 of the catheter 12 if the wedge 42 is not included). When the blunt cannula 82 is positioned adjacent to the wedge 42 in this way, the distal opening of the lumen 88 passing through the blunt cannula 82 is positioned directly adjacent to the wedge lumen 48 and close to the proximal end 22 of the catheter 12, so that the lumen 88 within the blunt cannula 82 is directly aligned with the wedge lumen 48.

[0043] As described above, at least a portion of the secondary catheter 74 is movably positioned within the introducer 70. The proximal end portion of the secondary catheter 74 is coupled to an actuator 76, and in this way the actuator 76 can be moved relative to the introducer 70 to move the secondary catheter 74 between a first position in which the secondary catheter 74 is positioned within the introducer 70 (for example, the entire secondary catheter 74 is positioned within the introducer 70 or within the introducer 70 and the connector 72) and a second position in which the distal end portion 90 of the secondary catheter 74 is at least partially positioned distal to the connector 72 and the catheter hub 14 when the connector 72 is coupled to the catheter hub 14.

[0044] Referring to Figures 4 and 5, the changes in the blood collection device 18 between the first and second configurations are shown. The blood collection device 18 can be configured in the first configuration before use, and can be switched from the first configuration (Figure 4) to the second configuration (Figure 5) by a user (e.g., a physician, nurse, technician, venotomer, etc.) to position at least the distal end portion 90 of the secondary catheter 74 distal to the introducer 70 (e.g., inside or distal to the indwelling catheter 12).

[0045] When the secondary catheter 74 is positioned in a first position within the introducer 70, the blood collection device 18 is shown in the first configuration of Figure 4. In some embodiments, when the secondary catheter 74 is in the first position, substantially the entire secondary catheter 74 is positioned within the introducer 70. In other embodiments, when the secondary catheter 74 is in the first position, it is positioned within the introducer 70 and the connector 72.

[0046] The actuator 76 (Figure 1) is positioned proximal when the blood collection device 18 is in a first configuration, and the user can engage the actuator 76 to move it relative to the introducer 70, which moves the secondary catheter 74 from a first position (e.g., located inside the introducer 70) to a second position. In this way, the secondary catheter 74 is moved through the internal volume of the introducer 70 and the lumen 88 of the connector 72.

[0047] When the secondary catheter 74 is positioned in the second position, the blood collection device 18 is in the second configuration shown in Figure 5. The second position of the secondary catheter 74 is reached when the distal end portion 90 of the secondary catheter 74 is positioned in the desired location within / through the catheter 12 relative to the distal end 30 of the catheter hub 14. In some examples, for instance, the distal end 90 of the secondary catheter 74 can be substantially flush with the distal end 24 of the catheter 12 when the secondary catheter 74 is in the second position. In other examples, the distal end 90 of the secondary catheter 74 can extend beyond the distal end 24 of the catheter 12 by a predetermined distance (e.g., the distal end of the distal end 24 of the catheter 12), and as a result, the distal end 90 of the secondary catheter 74 is positioned in a vein beyond the distal end 24 of the catheter 12 by a predetermined distance (e.g., in a vein where there is virtually no debris (e.g., fibrin / thrombus) surrounding the distal end 24 of the catheter 12 otherwise).

[0048] When the secondary catheter 74 is in a second position (for example, when the blood collection device 18 is in a second configuration, as shown in Figure 5), the user can establish fluid communication between the component 80 (e.g., fluid reservoir, fluid source, syringe, etc.) and the secondary catheter 74. With the secondary catheter 74 in fluid communication with the component 80, the blood collection device 18 can aspirate a certain amount of blood from a vein, at least partially, by positioning the distal end 90 of the secondary catheter 74 at a predetermined and / or desired distance beyond the distal end 24 of the indwelling catheter 12.

[0049] Advantageously, the structure of the catheter hub 14 and its mating with the blood collection device 18 facilitate the advancement of the secondary catheter 74 from a first position to a second position. That is, since the cavity 36 of the catheter hub 14 has a length 37 such that it accommodates the entire length of the blunt cannula 82, the blunt cannula 82 may be positioned adjacent to the proximal end 22 (or wedge 42) of the catheter 12, and as a result, the lumen 88 can be directly adjacent to and aligned with the lumen 26 of the catheter 12. Thus, the secondary catheter 74 can advance linearly through the lumen 88 of the connector 72 into the lumen 26 of the catheter 12 without any opportunity for the secondary catheter 74 to be deflected or otherwise trapped / caught in the cavity 36 of the catheter hub 14.

[0050] Referring here to Figure 6, the open PIVC catheter assembly 16 (including the catheter 12 and associated catheter hub 14) described above is shown to be included in a catheter system 10 according to another aspect or embodiment of the present disclosure. In the use of the catheter system 10 shown in Figure 6, a needle introducer 92 is provided for use with the open PIVC catheter assembly 16 to provide initial insertion of the catheter 12 into the patient's blood vessel.

[0051] As shown in Figure 6, the needle introducer 92 generally includes a needle hub 94 and a needle 96. The needle hub 94 is configured to be grasped by the user during insertion of the needle 96 and catheter 12 into the patient's vascular system. The needle hub 94 is located at the proximal end 32 of the catheter hub 14 and is secured to it via a connection to a split septum connector 50. The needle 96 extends distally from the needle hub 94, passing through the split septum connector 50 and the catheter hub 14, extending into / through the lumen 26 of the catheter 12. A needle cover 98 may be coupled to the distal end 32 of the catheter hub 14 and positioned over the catheter 12 and needle 96 to prevent accidental contact with the tip of the needle 96.

[0052] In the operation of the needle introducer 92, the needle cover 98 may be removed first, and then the user may grasp the needle hub 94 and apply a pushing force to penetrate the needle 96 through the patient's skin, and then use further pushing force to insert the needle 96 and catheter 12 into the patient's vascular system. Once the needle 96 and catheter 12 are inserted into the patient, the user may then pull back the needle hub 94 to retract the needle 96 from the catheter 12, the needle hub 94 is disconnected from the split septum connector 50, and the needle 96 is withdrawn from the catheter hub 14 via the split septum connector 50.

[0053] Referring here to Figures 7A and 7B, in some embodiments, the split partition connector 50 may be specifically configured to accommodate the passage of a needle 96 through the split partition 52 without including the integrity of the split partition 52. That is, when the needle 96 is positioned for an extended period to pass through the split partition 52 of the connector 50 when the catheter system 10 is provided in its in-package configuration (i.e., before actual use of the needle introducer 92), the split partition connector 50 may be configured to prevent its deformation (i.e., compression hardening) during such an in-package configuration. As shown in the embodiments of Figures 7A and 7B, in some aspects or embodiments, the split partition connector 50 may be configurable in an initial configuration (Figure 7A) in which the first portion 100 of the split partition connector 50 is separated from the second portion 102 of the split partition connector 50. In this initial configuration, the needle 96 passes through the split septum connector 50 without contacting it, in order to prevent deformation of the split septum connector 50 when the catheter system 10 is in its package configuration.

[0054] As shown in Figure 7B, the first and second portions 100, 102 of the split septum connector 50 can be coupled following the retraction of the needle 96 from the connector 50. That is, when the needle 96 / catheter 12 is inserted into the patient's vascular system and then the needle 96 is removed / retracted from the split septum connector 50 and catheter hub 14, the split septum connector 50 is pushed from its sides, closing or coupling the first and second portions 100, 102, and locking and snapping the split septum connector 50. When the split septum connector 50 is closed in this way, it can function normally, sealing the cavity 36 in the catheter hub 14 until the device / component is introduced through the split septum 52.

[0055] In yet another embodiment, as shown in Figure 8, the split septum connector 50 may be provided separately from the catheter hub 14 while the catheter system 10 is in its package configuration, in order to prevent compression setting or other deformation of the split septum connector 50 while the catheter system 10 is in its package configuration. In this configuration, the split septum connector 50 may be joined to the catheter hub 14 after the needle 96 / catheter 12 has been inserted into the patient's vascular system using the needle introducer 92, and after the needle introducer 92 has been removed from and moved from the catheter hub 14.

[0056] According to additional aspects or embodiments of the present disclosure, the open PIVC catheter assembly 16 (including the catheter 12 and associated catheter hub 14) may have other devices connected to or contained therein that provide a fluid cutoff for sealing the cavity 36 of the catheter hub 14 from the external environment. The fluid cutoff can address the above-mentioned problems relating to compression hardening or other deformation that occurs within the split partition connector 50 during storage in its in-package configuration of the catheter system 10 when the needle introducer 92 is connected to the open PIVC catheter assembly 16. According to various embodiments, the fluid cutoff may be provided instead of, or in addition to, the split partition connector 50, with a fluid cutoff receiving passage through which the needle 96 passes during storage in its in-package configuration of the catheter system 10.

[0057] Referring here to Figures 9A and 9B, the open PIVC catheter assembly 104 is shown to include a fluid cutoff in the form of a stopcock mechanism 106 incorporated into the catheter hub 14, according to another aspect or embodiment of the present disclosure. The stopcock mechanism 106 includes a stopcock valve 108 located in a cavity 36 of the catheter hub 14 adjacent to the hub end port 38, and an actuator 110 located on the outer surface of the hub body. The actuator 110 may be configured as a lever or switch that is operable / movable between a first position and a second position to open and close the stopcock valve 108, thereby providing an opening to the cavity 36 or sealing the cavity 36, respectively.

[0058] When the needle introducer 92 is coupled to the catheter hub 14 (for example, as shown in Figure 6) and stored in its in-package configuration (i.e., before actual use of the needle introducer 92), the stopcock valve 108 is maintained in its open configuration, as shown in Figure 9A, allowing the needle 96 to pass through the stopcock valve 108 and through the cavity 36 of the catheter hub 14 and catheter 12. When the needle introducer 92 is used to insert the needle 96 / catheter 12 into the patient's vascular system and the needle introducer 92 is detached from the catheter hub 14 and moved, the needle 96 is withdrawn from the catheter hub 14 and detached through the stopcock valve 108, and the stopcock valve 108 may be closed (via the movement of the actuator 110) to seal the cavity 36 in the catheter hub 14, as shown in Figure 9B. When the stopcock valve 108 is closed, a device or component such as the blood collection device 18 or another instrument delivery device described in detail above can be coupled to the proximal end 32 of the catheter hub 14. If it is then desirable to introduce an instrument (e.g., a secondary catheter 74) into the catheter hub 14 and bring it out through the catheter 12, the stopcock valve 108 can be opened to allow the instrument to advance into the catheter 12.

[0059] In some embodiments, when a needle introducer 92 is used and removed from the catheter hub 14, a split partition connector 50 may be provided at the hub end port 38. The split partition connector 50 is located at the hub end port 38 proximal to the stopcock valve 108 and functions to control access to the catheter hub 14 and the catheter 12. As described in detail above, an instrument delivery device such as a blood collection device 18 can be connected to the split partition connector 50 and advance a secondary catheter 74 into the catheter 12 by passing through its partition 52 (via a blunt cannula 82).

[0060] Referring here to Figures 10A and 10B, the open PIVC catheter assembly 112 is shown according to another aspect or embodiment of the present disclosure, and the open PIVC catheter assembly 112 includes a fluid cutoff in the form of a deformable tube 114 and a slide clamp 116 located at the proximal end 32 of the catheter hub 14. In one embodiment, the deformable tube 114 is connected to the hub end port 38 by a connector 118 provided at the proximal end 120 of the deformable tube 114 and extends proximal therefrom. The deformable tube 114 may be made of deformable silicone or another suitable material, such as being clamped by the slide clamp 116. The slide clamp 116 is positioned along the length of the tube 114 between the hub end port 38 and the connector 118 and is operable in open and closed configurations to selectively close the internal lumen 122 of the tube 114.

[0061] When the needle introducer 92 is coupled to the connector 118 on the proximal end 120 of the deformable tube 114 and the catheter system 10 is stored in its in-package configuration (i.e., before actual use of the needle introducer 92), the slide clamp 116 is maintained in its open configuration, as shown in Figure 10A, providing an open lumen 122 within the tube 114, allowing the needle 96 to pass through the tube 114 and through the cavity 36 of the catheter hub 14 and catheter 12. When the needle 96 / catheter 12 is inserted into the patient's vascular system using the needle introducer 92 and the needle introducer 92 is detached from the connector 118, the needle 96 is withdrawn from the catheter hub 14 and exits through the tube 114, and the slide clamp 116 is closed, as shown in Figure 10B, to clamp the deformable tube 114 and seal the cavity 36 within the catheter hub 14. When the slide clamp 116 is closed, a device or component such as the blood collection device 18 or another instrument delivery device, as described in detail above, can be coupled to the connector 118 at the proximal end of the tube 114. If it is then desirable to introduce an instrument (e.g., a secondary catheter 74) into the catheter hub 14 and bring it out through the catheter 12, the slide clamp 116 can be opened to allow the instrument to advance through the lumen 122 of the tube 114 into the catheter 12.

[0062] Referring here to Figures 11 and 12, a catheter hub 130 that can be directly coupled to the instrument delivery device 18 of the catheter system 10 is shown according to another aspect or embodiment. The catheter hub 130 is configured similarly to the catheter hub 14 shown in Figures 1 to 10, and the catheter hub 130 may include a main hub body 132 and stabilizing wings 134 extending from the main hub body 132. However, the catheter hub 130 is configured as a single-port catheter hub that does not include a side port thereon.

[0063] The main hub body 132 of the catheter hub 130 defines a cavity 136 within it, which extends between the distal end 138 and the proximal end 140 of the catheter hub 130. According to an aspect or embodiment of the present disclosure, the proximal end portion 142 of the cavity 136 is configured as a tapered female Luer cavity, and the distal end portion 144 of the cavity 136 is configured as a generally cylindrical cavity having a constant diameter along at least a large portion of its length 37. A hub end port 146 is provided at the proximal end 140 of the main hub body 132, providing access to the cavity 136. An opening 148 is also formed at the distal end 138 of the main hub body 132, which extends into the cavity 136, and the opening 148 also receives the proximal end 22 of the catheter 12.

[0064] According to some aspects and embodiments, a hub end port 146 located at the proximal end 140 of the main hub body 132 is configured to define a tapered proximal end portion 142 of the cavity 136 and to receive a split partition connector 50 therein. As shown in Figure 12, the hub end port 146 may be configured to house the entire split partition connector 50 therein, such that the split partition connector 50 is located inside the catheter hub 130. When the split partition connector 50 is located inside the catheter hub 130, the hub end port 146 may include a groove 150 formed on its outer surface that provides a place for connecting a blood collection device 18 (or other instrument delivery device), and the arms 84, 86 on the connector 72 of the blood collection device 18 engage with the catheter hub in the groove 150.

[0065] When engaging the blood collection device 18 with the catheter hub 130, the configuration of the distal end portion 144 of the cavity 136, which has a cylindrical profile and a length 37 designed to accommodate the entire length of the blunt cannula 82, allows the connector 72 to receive the blunt cannula 82 and guide it precisely through the cavity 136 without obstruction when the connector 72 engages with the catheter hub 130. Once the blunt cannula 82 extends fully through the cavity 136, the lumen 88 of the connector 72 may be positioned directly adjacent to the lumen 26 of the catheter 12 (or adjacent to the lumen 48 of the wedge 42, if included). The structure of the catheter hub 130 and its fitting with the blood collection device 18 thus beneficially facilitate the advancement of the secondary catheter 74 from the first position to the second position, allowing the secondary catheter 74 to advance linearly through the lumen 88 of the connector 72 into the lumen 26 of the catheter 12, eliminating the opportunity for the secondary catheter 74 (as in Figures 4 and 5) to be deflected, trapped, or caught within the cavity 136 of the catheter hub 130.

[0066] Referring here to Figure 13, a catheter hub 152 is shown that, according to another aspect or embodiment, can be directly coupled to the instrument delivery device 18 of the catheter system 10. The catheter hub 152 is configured as a single-port catheter hub without side ports, similar to the catheter hub 130 in Figures 11 and 12, but the hub end port 154 at the proximal end 156 of the main hub body 158 is configured to accept only a portion of the proximal coupler 160 into it (rather than accepting the entire split partition connector 50, as in Figures 11 and 12). As previously stated, the proximal coupler 160 may be configured as an NFC including a split partition that functions as an access control function, thereby allowing peripheral devices (e.g., blood collection devices or vascular access probes for intravenous digital measurement of patient data such as temperature, pH, lactate, and / or other blood-based measurements) to be physically and fluidly coupled to the catheter hub 152. As can be seen in Figure 13, the proximal coupler 160 includes a pair of connecting rings 162, 164 formed around it, with a first ring 162 and a second ring 164 laterally spaced apart, to provide engagement of the instrument delivery device 18 (i.e., arms 84, 86) to the catheter hub 152. Furthermore, the proximal coupler 160 includes a side port 166 integrally formed distal to the split septum valve within it. The side port 166 can be positioned substantially perpendicular to the lumen formed within / through the coupler 160. An extension set 168 may be integrated with the side port 166, which can be used to deliver fluid, remove fluid, deliver flush fluid, and / or similar. An extension tube 170 may extend from the side port 166 and control access to the extension set 168 using a proximal access port 172 coupled to the proximal end portion of the extension tube 170. The clamp 174 may also be provided on the extension tube 170, and the clamp 174 is configured to selectively restrict the flow through the extension tube 170.

[0067] This disclosure has been described in detail for illustrative purposes based on what is currently considered to be the most practical and preferred embodiments or aspects, but such details are for that purpose only, and this disclosure is not limited to the disclosed embodiments or aspects, but rather intended to encompass modifications and equivalent arrangements that fall within the spirit and scope of the appended claims. For example, this disclosure is intended to be, wherever possible, to allow one or more features of any embodiment to be combined with one or more features of any other embodiment.

Claims

1. A catheter having a distal end and a proximal end, comprising a catheter that defines the catheter lumen, A catheter hub connected to the proximal end of the catheter, wherein the catheter hub is A hub body having a distal end and a proximal end, wherein the hub body has a cavity extending between the distal end and the proximal end, An end port located at the proximal end of the hub and providing an opening to the cavity, Includes a catheter hub, A split partition connector, at least partially disposed within the end port, wherein the split partition connector is configured to seal the cavity when in a closed configuration and to provide a fluid path to the catheter lumen when in an open configuration, A catheter system equipped with the following features.

2. The catheter system according to claim 1, wherein the catheter hub further comprises a side port extending from the hub body between the distal end of the hub and the proximal end of the hub, and the side port defines a side port lumen that is in fluid communication with the catheter lumen.

3. The catheter system according to claim 2, wherein the side port extends from the hub body at an angle of 15 to 165 degrees with respect to the catheter lumen.

4. The catheter system according to claim 2, wherein the side port is provided with a female Luer connector.

5. The catheter system according to claim 2, further comprising a needle-free access connector coupled to the side port.

6. The catheter system according to claim 1, wherein the cavity comprises a cylindrical cavity having a constant diameter along at least a large portion of its length between the distal end of the hub and the proximal end of the hub.

7. The catheter system according to claim 1, further comprising a blood collection device, wherein the blood collection device is coupled to the end port and / or the split partition connector.

8. The blood collection device is, Secondary catheter and An introducer having a proximal end and a distal end, as well as an upper and lower surface, defines an internal volume configured to movably receive the secondary catheter, An actuator movably coupled to the introducer, wherein the actuator is configured to move relative to the introducer to move the distal end of the secondary catheter from a position within the introducer to a position outside the housing of the introducer, passing the distal end of the catheter, and A connector located at the distal end of the introducer coupled to the end port and / or the split partition connector, the connector comprising a blunt cannula and a pair of locking arms, The catheter system according to claim 7, comprising:

9. The catheter system according to claim 8, wherein the split partition connector includes a first ring and a second ring laterally spaced from the first ring, and the pair of locking arms engage with the split partition connector by snapping in between the first ring and the second ring.

10. The catheter system according to claim 8, wherein when the blood collection device is coupled to the end port and / or the split septum connector, the blunt cannula penetrates the split septum connector and enters the cavity, and each of the blunt cannula and the cavity has a length such that the blunt cannula extends substantially to the distal end of the cavity.

11. The catheter system according to claim 10, wherein the extension of the cavity of the blunt cannula to approximately the distal end causes the lumen of the blunt cannula to be adjacent to the catheter lumen.

12. The catheter system according to claim 11, wherein the catheter hub further comprises a wedge positioned within the cavity adjacent to the distal end of the hub, the wedge being coupled to the proximal end of the catheter to hold the catheter in the catheter hub, the wedge including a wedge lumen formed therein, and the extension of the blunt cannula to the vicinity of the distal end of the blunt cannula to directly align the lumen of the blunt cannula with the wedge lumen.

13. The catheter system according to claim 8, wherein the split partition connector is fully positioned within the end port, and the pair of locking arms engage with grooves formed on the outer surface of the end port.

14. The catheter system according to claim 1, further comprising a needle introducer coupled to the split partition connector, wherein the needle extends through the catheter hub and through the catheter lumen, and the split partition connector is configured such that a first portion of the split partition connector is separated from a second portion of the split partition connector, and the needle passes through the split partition connector without contact.

15. The catheter system according to claim 1, wherein the catheter hub comprises an open intravenous catheter (PIVC) catheter hub.

16. The catheter system according to claim 1, wherein the split partition connector includes a side port formed thereon, and an integrated extension tube extends from the side port.

17. A catheter having a distal end and a proximal end, comprising a catheter that defines the catheter lumen, A catheter hub connected to the proximal end of the catheter, wherein the catheter hub is A hub body having a distal end and a proximal end, wherein the hub body has a cavity extending between the distal end and the proximal end, An end port located at the proximal end of the hub and providing an opening to the cavity, Includes a catheter hub, A fluid cutoff located at or adjacent to the end port, wherein the fluid cutoff is configured to seal the cavity when in a closed configuration and to provide a fluid path to the catheter lumen when in an open configuration, A catheter system equipped with the following features.

18. The aforementioned fluid cutoff is The stopcock valve in the cavity adjacent to the end port, An actuator is provided on the outer surface of the hub body and is operable to open and close the stopcock valve. The catheter system according to claim 17, comprising:

19. The catheter system according to claim 17, further comprising a split partition connector within the cavity and proximal to the stopcock valve.

20. The catheter system according to claim 19, further comprising a deformable tube coupled to the end port and extending proximal therefrom, wherein the fluid cutoff is positioned on the deformable tube and is operable between an open position and a closed position, and comprises a slide clamp that allows fluid to flow selectively through the deformable tube.

21. The catheter system further comprises a blood collection device that can be coupled to the proximal coupler of the connector, the blood collection device configured to advance a secondary catheter through the distal end of the catheter, the blood collection device includes a connector coupled to the end port, the connector includes a blunt cannula and a pair of locking arms, The catheter system according to claim 19, wherein when the blood collection device is coupled to the end port and the fluid cutoff is in the open configuration, the blunt cannula penetrates into the cavity, and the blunt cannula and the cavity each have a length such that the blunt cannula extends substantially to the distal end of the cavity.

Images