Catheter system

Abstract

A catheter system includes a catheter having a catheter distal end and a catheter proximal end, where the catheter defines a catheter lumen. The catheter system further includes a catheter hub coupled to the catheter proximal end, where the catheter hub further includes a catheter hub body having a catheter hub distal end and a catheter hub proximal end, the catheter hub body having a cavity formed therein extending between the catheter hub distal end and the catheter hub proximal end. The catheter hub also includes an end port at the proximal end of the catheter hub, and the end port provides an opening into the lumen. A separation membrane connector of the catheter system is at least partially positioned within the end port, wherein the separation membrane 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. The catheter system provides more efficient advancement of the instrument through the open PIVC.

Description

Technical Field

[0001] Devices and systems for vascular access are provided herein, and more particularly, a catheter system is provided that is directly compatible with a blood withdrawal device to provide for advancement of the device through an open peripheral intravenous catheter. Background Art

[0002] Vascular access devices (VADs) are used in the medical field to access a patient's peripheral vasculature for infusion therapy and / or blood extraction purposes. 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 indwelled for short-term (days), medium-term (weeks), or long-term (months to years). For some applications, an open PIVC catheter is provided, in which an indwelling catheter is inserted into the patient's vasculature and extends from the vasculature to a catheter adapter having a port on the catheter adapter for connecting additional instruments or devices to the catheter adapter.

[0003] The instrument delivery device is typically used with a VAD to deliver the instrument to its indwelling intravenous (IV) catheter, wherein the instrument delivery device advances the instrument beyond the end of the indwelling catheter. When the instrument delivery device is used to collect blood, as an example, the instrument can be in the form of a flexible tube or catheter, but in other embodiments, the instrument can also be a guidewire, an occluder, a guide wire, a wire, a probe, or (multiple) sensors. Typically, when an instrument delivery device with a VAD is used, such as the open PIVC catheter mentioned above, a connector or adapter is included between the catheter adapter and the instrument delivery device. The adapter includes a coupler at its distal end and a coupler at its proximal end, the distal coupler is connected to the port of the catheter adapter, and the proximal coupler is connected to the instrument delivery device, wherein the proximal coupler typically has a needleless connector therein for receiving the instrument delivery device. When connected to the catheter adapter, the instrument delivery device can be operated to push the instrument out of it, and through the lumen of the catheter adapter, into the end of the indwelling catheter, and then out beyond the end of the indwelling catheter. The adapter may also include a side port thereon that enables an extension set or fluid delivery system to be connected thereto so as to introduce fluid into the adapter and open PIVC conduit for administration to the patient.

[0004] It should be recognized that the inclusion of an adapter (between the catheter adapter and the instrument delivery device) in the catheter system may increase the difficulty of advancing the instrument into the indwelling catheter. That is, in a configuration where the instrument delivery device is connected to the catheter adapter using a catheter connector, the male connection portion of the catheter connector is typically coupled to the proximal port of the catheter adapter, but may not fill a large portion of the cavity in the catheter adapter. In the case where at least a portion of the cavity in the catheter adapter remains open, the distal end of the male connection portion is spaced apart from the proximal opening of the lumen defined by the catheter (which is fixed to the distal end of the catheter adapter), and therefore, when attempting to advance the instrument through the cavity (i.e., through the open lumen portion maintained between the male connection portion and the proximal opening of the catheter lumen), the instrument may not remain properly aligned with the catheter lumen. Therefore, the instrument may be trapped in the cavity of the catheter adapter, and as the instrument is further advanced, the instrument may be kinked and overlapped on itself, thereby preventing the instrument from advancing into and through the catheter.

[0005] 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 a blood withdrawal device, thereby eliminating the need for a catheter adapter and simplifying advancement of instruments through an open PIVC. Utility Model Content

[0006] The present invention provides a catheter system, which includes: a catheter, the catheter having a catheter distal end and a catheter proximal end, the catheter defining a catheter lumen; a catheter adapter, the catheter adapter coupled to the catheter proximal end, the catheter adapter including: a catheter adapter body, the catheter adapter body having a catheter adapter distal end and a catheter adapter proximal end, the catheter adapter body having a cavity formed therein, the cavity extending between the catheter adapter distal end and the catheter adapter proximal end; and an end port, the end port being located at the catheter adapter proximal end and providing an opening into the cavity; and a separator membrane connector, the separator membrane connector being at least partially positioned within the end port, the separator membrane connector being 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.

[0007] In some embodiments, the catheter adapter further includes a side port extending from the catheter adapter body between the catheter adapter distal end and the catheter adapter proximal end, the side port defining a side port lumen in fluid communication with the catheter lumen.

[0008] In some embodiments, the side port extends from the catheter adapter body at an angle between 15 degrees and 165 degrees relative to the catheter lumen.

[0009] In some embodiments, the side port is a female Luer connection.

[0010] In some embodiments, the catheter system further includes a needleless access connector coupled to the side port.

[0011] In some embodiments, the lumen is a cylindrical lumen having a constant diameter along at least a majority of its length between the distal end of the catheter adapter and the proximal end of the catheter adapter.

[0012] In some embodiments, the catheter system further comprises a blood withdrawal device coupled to the end port and / or the dividing membrane connector.

[0013] In some embodiments, a blood extraction device includes: a secondary catheter; an introducer having a proximal end and a distal end and a top surface and a bottom surface, wherein the proximal end and the distal end and the top surface and the bottom surface define an internal volume configured to movably receive the secondary catheter; an actuator movably connected to the introducer and 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 introducer and through the catheter distal end of the catheter; and a connector positioned at the distal end of the introducer, the connector being connected to an end port and / or a separating membrane connector, the connector comprising a blunt-tipped cannula and a pair of locking arms.

[0014] In some embodiments, the dividing membrane connector includes a first ring and a second ring laterally spaced apart from the first ring, wherein the pair of locking arms engage the dividing membrane connector by snapping between the first ring and the second ring.

[0015] In some embodiments, when the blood extraction device is coupled to the end port and / or the septum connector, the blunt tip cannula penetrates the septum connector and enters the cavity, wherein each of the blunt tip cannula and the cavity has a length such that the blunt tip cannula extends substantially to the distal end of the cavity.

[0016] In some embodiments, the lumen of the blunt tip cannula is positioned adjacent to the lumen of the catheter by extending the blunt tip cannula substantially to the distal end of the cavity.

[0017] In some embodiments, the catheter adapter further comprises a wedge positioned within the cavity and adjacent to the distal end of the catheter adapter, the wedge being coupled to the proximal end of the catheter to retain the catheter to the catheter adapter, wherein the wedge comprises a wedge lumen formed therein, the lumen of the blunt tip cannula being directly aligned with the wedge lumen by extending the blunt tip cannula substantially to the distal end of the cavity.

[0018] In some embodiments, the dividing membrane connector is positioned completely within the end port, and wherein the pair of locking arms engage a groove formed on an outer surface of the end port.

[0019] In some embodiments, the catheter system further comprises a needle guide coupled to the separator membrane connector, wherein the needle extends through the catheter hub and through the catheter lumen, and wherein the separator membrane connector is configured to have an initial configuration in which a first portion of the separator membrane connector is separated from a second portion of the separator membrane connector such that the needle passes through the separator membrane connector without contacting the separator membrane connector.

[0020] In some embodiments, the catheter adapter comprises an open peripheral intravenous catheter (PIVC) catheter adapter.

[0021] In some embodiments, the dividing membrane connector includes a side port formed thereon, wherein an integrated extension tube extends from the side port.

[0022] The present invention also provides a catheter system, which includes: a catheter, the catheter having a catheter distal end and a catheter proximal end, the catheter defining a catheter lumen; a catheter adapter, the catheter adapter connected to the catheter proximal end, the catheter adapter including: a catheter adapter body having a catheter adapter distal end and a catheter adapter proximal end, the catheter adapter body having a cavity formed therein, the cavity extending between the catheter adapter distal end and the catheter adapter proximal end; and an end port, the end port being located at the catheter adapter proximal end and providing an opening into the cavity; and a fluid shutoff portion, the fluid shutoff portion being located at or near the end port, the fluid shutoff portion being 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.

[0023] In some embodiments, the fluid shutoff portion includes a shutoff stopcock positioned within the cavity and adjacent the end port and an actuator positioned on an outer surface of the catheter adapter body and operable to open and close the shutoff stopcock.

[0024] In some embodiments, the catheter system further comprises a septum connector located within the lumen and proximal to the shut-off stopcock.

[0025] In some embodiments, the catheter system also includes a deformable tubular member that is connected to the end port and extends proximally from the end port, wherein the fluid shutoff portion is a sliding clamp that is positioned on the deformable tubular member and can be actuated between an open position and a closed position to selectively allow fluid to flow through the deformable tubular member.

[0026] In some embodiments, the catheter system further comprises a blood extraction device connectable to the proximal connector of the septum connector, wherein the blood extraction device is configured to advance the secondary catheter through the catheter distal end of the catheter and comprises a connector connected to the end port. The connector further comprises a blunt cannula and a pair of locking arms, and when the blood extraction device is connected to the end port and when the fluid shutoff is in an open configuration, the blunt cannula penetrates into the cavity, wherein 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

[0027] Figure 1 is a perspective view of a catheter system according to an aspect or embodiment of the present application, the catheter system including an open PIVC catheter assembly and an attached blood extraction device and fluid delivery system;

[0028] Figure 2 yes Figure 1 a top view of a portion of a catheter system;

[0029] Figure 3 yes Figure 1 A cross-sectional view of a catheter system;

[0030] Figure 4 yes Figure 1 A cross-sectional view of a catheter system showing the instrument in a first position;

[0031] Figure 5 yes Figure 1 A cross-sectional view of a catheter system showing the instrument in a second position;

[0032] Figure 6 is a perspective view of a catheter system according to an aspect or embodiment of the present application, the catheter system including an open PIVC catheter assembly and an attached needle introducer;

[0033] Fig. 7A According to one aspect or embodiment of the present application, Figure 6 A catheter system wherein a needle is inserted through a catheter hub and a detachable septum connector;

[0034] Figure 7B Shows Figure 6 A catheter system wherein the needle is retracted from the catheter hub and the detachable septum connector;

[0035] Figure 8 Shows Figure 6 The catheter system of claim 1, wherein the septum connector is removed from the catheter hub when the needle introducer is attached;

[0036] Fig. 9Ais a perspective view of an open PIVC catheter assembly according to an aspect or embodiment of the present application with an integrated stopcock mechanism in an open configuration;

[0037] Fig. 9B Shows Fig. 9A An open PIVC catheter assembly in which the catheter assembly has an integrated shut-off stopcock mechanism in a closed configuration;

[0038] Fig. 10A is a perspective view of an open PIVC catheter assembly according to an aspect or embodiment of the present application with tubing attached and a clamp in an open configuration;

[0039] Fig. 10B Shows Fig. 10A An open PIVC catheter assembly wherein the clamp is in a closed configuration;

[0040] Fig.11 is a perspective view of a catheter system according to another aspect or embodiment of the present application, the catheter system including an open PIVC catheter assembly and an attached blood extraction device;

[0041] Fig.12 yes Fig.11 A cross-sectional view of a catheter system; and

[0042] Fig.13 is a perspective view of a catheter system according to another aspect or embodiment of the present application, the catheter system including an open PIVC catheter assembly and an attached blood withdrawal device. DETAILED DESCRIPTION

[0043] This application claims priority to U.S. Application No. 18 / 139,409, filed on April 26, 2023, entitled “Blood Draw Compatible OpenPeripheral Intravenous Catheter System,” the entire disclosure of which is incorporated herein by reference.

[0044] The following description is provided to enable those skilled in the art to make and use the described aspects intended for implementing the utility model. However, various modifications, equivalents, variations and substitutions will be apparent 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 the present disclosure.

[0045] For the purpose of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall be related to the orientation of the present invention in the accompanying drawings. However, it should be understood that the present invention may take various alternative changes unless explicitly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following description are merely exemplary aspects of the present invention. Therefore, the specific dimensions and other physical characteristics related to the aspects disclosed herein should not be considered limiting.

[0046] In the present disclosure, when the component or device is in the use position, that is, when the user holds the catheter insertion device in preparation for use or during use, the distal end of the component or device refers to the end farthest from the user's hand, and the proximal end refers to the end closest to the user's hand. Similarly, in the present application, the terms "in the distal direction" and "distal" mean in the direction toward the distal end of the needle or catheter of the system, and the terms "in the proximal direction" and "proximally" mean in the direction opposite to the direction of the distal end of the needle or catheter.

[0047] refer to Figure 1 , a catheter system 10 is shown according to one aspect or embodiment of the present disclosure. The catheter system 10 includes a catheter 12 and an associated catheter hub 14, which together can provide an open PIVC catheter assembly 16. The catheter system 10 also includes an instrument delivery device 18 and / or an additional extension kit or fluid delivery system 20, which can be directly connected to the catheter hub to provide delivery of instruments and / or fluids into and through the catheter 12.

[0048] like Figures 1 to 5 As shown, open PIVC catheter assembly 16 includes catheter 12 and catheter seat 14, which provide intravenous access to the patient's vascular system. In some embodiments, catheter 12 may include a peripheral intravenous catheter, but it should be appreciated that catheter 12 may also be provided as a midline catheter or a peripherally inserted central catheter. Catheter 12 can be formed of any suitable material and can have any useful length, as known to those skilled in the art. The proximal end 22 of catheter 12 is coupled to catheter seat 14 and extends distally from the catheter seat away from the distal end 24 of catheter 12. Catheter 12 defines an inner cavity 26 therein, through which fluid can be administered to the patient, an instrument can be introduced into the patient's vascular system, or blood can be extracted from the patient.

[0049] The catheter adapter 14 is composed of a catheter adapter body 28 having a distal end 30 and a proximal end 32 and a stabilizing wing 34 extending from the catheter adapter body 28, which is used to fix the catheter adapter to the patient's skin. The catheter adapter body 28 defines a cavity 36 extending between the distal end 30 and the proximal end 32 of the catheter adapter 14. According to aspects or embodiments of the present disclosure, the cavity 36 is configured as a generally cylindrical cavity having a constant diameter along at least a majority of the length 37 of the cavity 36. A catheter adapter end port 38 is provided at the proximal end 32 of the catheter adapter body 28, which provides access to the cavity 36. An opening 40 extending into the cavity 36 is also formed at the distal end 30 of the catheter adapter body 28, and the opening 40 also receives the proximal end 22 of the catheter 12 therein. In some embodiments, the size of the opening 40 is designed to have a diameter similar to that of the catheter 12, so that the catheter 12 is fixed in the opening, thereby anchoring the catheter 12 to the catheter adapter 14.

[0050] like Figure 3 As shown, according to some aspects or embodiments, catheter adapter 14 can include a wedge 42 positioned within cavity 36 of catheter adapter body 28. Wedge 42 is positioned within cavity 36 adjacent distal end 30 of catheter adapter 14 such that wedge 42 can be seated within cavity 36. Wedge 42 includes openings 44, 46 formed therein at opposing distal and proximal ends thereof, with a wedge lumen 48 extending between distal and proximal openings 44, 46. Wedge 42 is positioned within cavity 36 so as to align with distal opening 40 within catheter adapter body 28, wherein distal opening 44 within wedge 42 is aligned with distal opening 40 within catheter adapter body 28. With the opening of wedge 42 and the opening of catheter adapter body 28 aligned, catheter 12 extends through distal opening 40 in catheter adapter body 28 and into distal opening 44 in wedge 42, wherein distal opening 44 in wedge 42 is sized such that catheter 12 is secured within opening 44 and to wedge 42, thereby anchoring catheter 12 to catheter adapter 14.

[0051] According to some aspects and embodiments, catheter adapter end port 38 at proximal end 32 of catheter adapter body 28 is configured as a receptacle that receives proximal coupler 50 therein. Proximal coupler 50 may be configured as a separator membrane, a needle-free connector (NFC), such as the Q-Syte® connector from Becton, Dickinson and Co. TM or SmartSite TMNFC, or any other suitable septum NFC, which is partially assembled within the proximal catheter adapter end port 38, is hereinafter referred to as "septum connector 50". The septum connector 50 includes a septum 52 therein, which serves as an access control feature, whereby a peripheral device (e.g., a blood extraction device or a vascular access probe for intravenous digital measurement of patient data such as temperature, pH, lactate and / or other blood-based measurements) can be physically and fluidically coupled to the catheter adapter 14, so that the septum connector 50 allows the catheter adapter 14 to be accessed multiple times by the peripheral device. In some embodiments, where the peripheral device is a blood extraction device that introduces a secondary catheter into the catheter 12, the septum connector 50 serves as a blood control feature that can be accessed multiple times by the blood extraction device to extract blood from the patient's vein. The septum connector 50 also includes a pair of connecting rings 54, 56 formed around its periphery, wherein the first ring 54 and the second ring 56 are laterally spaced apart. The connecting rings 54 and 56 are used to engage the instrument delivery device 18 to the catheter adapter 14, which will be described in further detail below.

[0052] According to some aspects and embodiments, catheter adapter 14 further includes and / or defines one or more additional ports, such as a side port 58 extending from catheter adapter body 28. Side port 58 can be formed at a desired location along the length of catheter adapter body 28 between distal end 30 and proximal end 32 to facilitate flushing and / or fluid delivery via side port 58. Side port 58 defines a lumen 60 in fluid communication with cavity 36 to provide access to and fluid communication with catheter lumen 26. In some embodiments, side port 58 is configured as a female Luer connector including a tapered lumen 62 and a threaded outer surface 64, wherein the female Luer connector is configured to couple to a connector 66 ( Figure 1 ) of a corresponding male Luer connector. In some embodiments, connector 66 may be a NFC that provides controlled access to catheter adapter 14, wherein an extension kit or fluid delivery system 20 is connected to side port 58 via NFC 66. NFC 66 may be configured as a separator membrane NFC, such as Q-Syte from Becton, Dickinson and Co. TM or SmartSite TMNFC, or any other suitable separator membrane NFC. Via connector 66, an extension kit or fluid delivery system 20 can be connected to side port 58 so as to be in fluid communication with lumen 60 of side port 58 and can deliver fluid, remove fluid, flush fluid, and / or the like, such as, for example, providing fluid from an attached IV bag (not shown). In such an embodiment, side port 58 is capable of flushing separator membrane connector 50 and / or the space within cavity 36 between side port 58 and separator membrane connector 50.

[0053] Although Figure 1 1 , but it will be appreciated that some embodiments of catheter adapter 14 can have an extension set or fluid delivery system 20 integrated therewith via side port 58. That is, extension set or fluid delivery system 20 (i.e., extension tube 68 thereof) can be directly integrated with side port 58, rather than side port 58 being provided as an open female Luer connection to which a separate connector 66 is attached (extension tube 68 is connected thereto).

[0054] In some embodiments, the arrangement of side ports 58 can be such that catheter adapter 14 is configured as, for example, a Y-shaped or T-shaped catheter adapter. In a non-limiting embodiment, side port 58 extends from catheter adapter body 28 at an angle other than 72 degrees relative to catheter adapter body 28 (e.g., side port 58 extends at an angle, such as, but not limited to, 15 degrees to 165 degrees, including all values ​​and subranges therebetween). In a non-limiting embodiment, more than one side port 58 is included in catheter adapter 14.

[0055] like Figures 1 to 5 As shown, the instrument delivery device 18 of the catheter system 10 is coupled to a septum connector 50 disposed in the catheter adapter end port 38 of the catheter adapter 14. According to some aspects or embodiments, the instrument delivery device 18 includes an introducer 70, a connector 72, an instrument 74 ( Figure 4 and Figure 5) and an actuator 76. The instrument 74 can be any of a variety of devices suitable for insertion into the vasculature of a patient, including, for example, a secondary catheter, a guidewire, or a stylet. A portion of the actuator 76 is configured to advance along the top surface of the introducer 70, which in turn facilitates the advancement of the instrument 74 through the introducer 70, the connector 72, the catheter hub 14, and distally through the catheter 12 and beyond the catheter. In some embodiments, a Luer adapter, Luer lock access device (LLAD), or other connection device 78 can be provided at the proximal end of the introducer 70 to enable another component 80 to be connected to the instrument delivery device 18, such as a syringe or a vacuum container, to facilitate blood extraction. According to one embodiment, the instrument delivery device 18 is used as a blood extraction device that inserts a secondary catheter through the catheter 12 to facilitate the extraction of blood from the patient, wherein the blood is collected in a syringe or vacuum container attached to the device, and therefore reference will be made to the blood extraction device 18 and the secondary catheter 74 below.

[0056] like Figure 3 and Figure 4 , connector 72 of blood extraction device 18 is configured to be physically and fluidically coupled to introducer 70, and is configured to couple introducer 70 to catheter adapter 14. Connector 72 has a blunt cannula 82, a first arm 84, and a second arm 86, wherein connector 72 further defines a lumen 88 extending through blunt cannula 82. Blunt cannula 82 is disposed between first arm 84 and second arm 86, and may have an inner diameter (a diameter of a surface that at least partially defines lumen 88) that is similar to or slightly larger than an outer diameter of a portion of secondary catheter 74, such that lumen 88 of connector 72 may receive a portion of secondary catheter 74 when the secondary catheter is advanced therethrough. To secure connector 72 to catheter adapter 14, first arm 84 and second arm 86 are used to clamp septum connector 50 positioned in an end port of the catheter adapter, wherein the first arm and second arm engage the septum connector by snapping between first and second rings thereof.

[0057] In order to provide the desired engagement between blood withdrawal device 18 and catheter adapter 14, catheter adapter 14 is specifically configured and dimensioned to receive blunt-tipped cannula 82 of connector 72, such as Figure 3That is, catheter adapter 14 is configured such that cavity 36 disposed in catheter adapter body 28 is configured to receive blunt-tipped cannula 82 in a manner that enables accurate and reliable advancement of secondary catheter 74 into lumen 26 of catheter 12. As previously described, cavity 36 has a cylindrical profile having a constant diameter along at least a majority of length 37 of cavity 36, such that when connector 72 is engaged with catheter adapter 14 (via septum connector 50), blunt-tipped cannula 82 can be received and accurately guided into cavity 36 without obstruction. In addition, cavity 36 is configured to have a length 37 designed to accommodate the full length of blunt-tipped cannula 82, such that when blood extraction device 18 is coupled to catheter adapter 14 (via septum connector 50), blunt-tipped cannula 82 fully extends through cavity 36 to a position where lumen 88 of connector 72 is directly adjacent to wedge lumen 48 of wedge 42 (or adjacent to lumen 26 of catheter 12 if wedge 42 is not included). With the blunt cannula 82 positioned adjacent to the wedge 42 in this manner, the distal opening of the lumen 88 (which passes through the blunt cannula 82) is positioned directly adjacent to the wedge lumen 48 and proximal to the proximal end 22 of the catheter 12 such that the lumen 88 in the blunt cannula 82 is directly aligned with the wedge lumen 48.

[0058] As described above, at least a portion of secondary catheter 74 is movably disposed within introducer 70. The proximal portion of secondary catheter 74 is coupled to actuator 76, and in such a manner that actuator 76 is movable relative to introducer 70 to move secondary catheter 74 between a first position in which secondary catheter 74 is disposed within introducer 70 (e.g., the entire secondary catheter 74 is disposed within introducer 70 or disposed within introducer 70 and connector 72) and a second position in which distal portion 90 of secondary catheter 74 is at least partially disposed away from connector 72 and catheter adapter 14 when connector 72 is coupled to catheter adapter 14.

[0059] Reference now Figure 4 and Figure 5 , showing the change of the blood drawing device 18 between the first configuration and the second configuration. The blood drawing device 18 can be in the first configuration prior to use, and can be changed from the first configuration ( Figure 4 ) is converted to the second construction ( Figure 5 ) to position at least the distal portion 90 of the secondary catheter 74 in a distal position relative to the introducer 70 (e.g., within or distal to the indwelling catheter 12).

[0060] The blood extraction device 18 is shown in a first position when the secondary conduit 74 is in the introducer 70. Figure 4In some embodiments, when the secondary conduit 74 is in the first position, substantially the entire secondary conduit 74 is located within the introducer 70. In other embodiments, when the secondary conduit 74 is in the first position, the secondary conduit 74 is disposed within the introducer 70 and the connector 72.

[0061] When the blood drawing device 18 is in the first configuration, the actuator 76 ( Figure 1 ) is disposed in a proximal position, and a user can engage actuator 76 to move it relative to introducer 70, which in turn moves secondary conduit 74 from a first position (e.g., disposed within introducer 70) toward a second position. In this manner, secondary conduit 74 moves through the interior volume of introducer 70 and through lumen 88 of connector 72.

[0062] When the secondary conduit 74 is disposed in the second position, the blood extraction device 18 is in Figure 5 The secondary catheter 74 reaches the second position when the distal portion 90 of the secondary catheter 74 is arranged in a desired position relative to the distal end 30 of the catheter adapter 14 and enters / passes through the catheter 12. In some cases, for example, when the secondary catheter 74 is in the second position, the distal end 90 of the secondary catheter 74 can be substantially flush with the distal end 24 of the catheter 12. In other cases, the distal end 90 of the secondary catheter 74 can extend beyond the distal end 24 of the catheter 12 (e.g., distal to the distal end 24 of the catheter 12) a predetermined distance so that the distal end 90 of the secondary catheter 74 is positioned within the vein a predetermined distance beyond the distal end 24 of the catheter 12 (e.g., at a location within the vein that is substantially free of debris (e.g., fibrin / blood clots) that would otherwise surround the distal end 24 of the catheter 12).

[0063] When the secondary conduit 74 is in the second position (e.g., when the blood extraction device 18 is in the Figure 5 In the second configuration shown, a user can establish fluid communication between component 80 (e.g., a fluid reservoir, a fluid source, a syringe, and / or the like) and secondary conduit 74. With secondary conduit 74 in fluid communication with component 80, blood drawing device 18 can draw a volume of blood from a vein based at least in part on positioning distal end 90 of secondary conduit 74 a predetermined and / or desired distance beyond distal end 24 of indwelling catheter 12.

[0064] Advantageously, the structure of catheter adapter 14 and its engagement with blood extraction device 18 facilitates advancement of secondary catheter 74 from the first position to the second position. That is, where lumen 36 of catheter adapter 14 has a length 37 such that it can accommodate the full length of blunt-tipped cannula 82, blunt-tipped cannula 82 can be positioned adjacent proximal end 22 (or wedge 42) of catheter 12 such that lumen 88 is directly adjacent to and aligned with lumen 26 of catheter 12. Thus, secondary catheter 74 can be advanced in a straight line through lumen 88 of connector 72 and into lumen 26 of catheter 12 without any opportunity for secondary catheter 74 to deflect or otherwise become trapped / captured within lumen 36 of catheter adapter 14.

[0065] Reference now Figure 6 , shows that the catheter system 10 according to another aspect or embodiment of the present invention includes the above-mentioned open PIVC catheter assembly 16 (including the catheter 12 and the associated catheter hub 14). Figure 6 In use of the illustrated catheter system 10, a needle introducer 92 is provided for use with the open PIVC catheter assembly 16 to initially insert the catheter 12 into a patient's blood vessel.

[0066] like Figure 6 As shown, the needle guide 92 as a whole includes a needle hub 94 and a needle 96. The needle hub 94 is configured to be grasped by a user during the insertion of the needle 96 and the catheter 12 into the patient's vascular system. The needle hub 94 is positioned at the proximal end 32 of the catheter hub 14 and is fixed to the proximal end via a connection with the septum connector 50. The needle 96 extends distally from the needle hub 94, wherein the needle 96 passes through the septum connector 50 and extends through the catheter hub 14 and then enters / passes through the lumen 26 of the catheter 12. A needle cover 98 can be coupled to the distal end 32 of the catheter hub 14 and positioned over the catheter 12 and the needle 96 to prevent accidental contact with the tip of the needle 96.

[0067] When operating needle introducer 92, needle cover 98 may be removed first, and then the user may grasp needle hub 94 and apply a push force thereto, which causes needle 96 to pierce the patient's skin, and then another push force is used to insert needle 96 and catheter 12 into the patient's vascular system. After inserting needle 96 and catheter 12 into the patient's body, the user may then pull needle hub 94 backward to retract needle 96 from catheter 12, wherein needle hub 94 is disconnected / separated from septum connector 50 and needle 96 is pulled out of catheter hub 14 through septum connector 50.

[0068] Reference now Fig. 7A and Figure 7BIn some embodiments, the septum connector 50 can be specifically configured to allow the needle 96 to pass therethrough without sacrificing the integrity of the septum 52. That is, when the catheter system 10 is provided in its in-package configuration (i.e., before the needle introducer 92 is actually used), because the needle 96 is positioned to pass through the septum 52 of the connector 50 for an extended period of time, the septum connector 50 can be configured to prevent its deformation (i.e., compression setting) during this in-package configuration. Fig. 7A and Figure 7B In some aspects or embodiments, the separator membrane connector 50 may be capable of being positioned in an initial configuration ( Fig. 7A ), in which the first portion 100 of the dividing membrane connector 50 is separated from the second portion 102 of the dividing membrane connector 50. In this initial configuration, the needle 96 passes through the dividing membrane connector 50 without contacting the dividing membrane connector 50 to prevent deformation of the dividing membrane connector 50 when the catheter system 10 is in the in-package configuration.

[0069] like Figure 7B As shown, after needle 96 is retracted from septum connector 50, first and second portions 100, 102 of septum connector 50 may be joined. That is, needle 96 / catheter 12 is inserted into the patient's vasculature, and after needle 96 is subsequently removed / retracted from septum connector 50 and catheter adapter 14, septum connector 50 may be pressed from the side of the septum connector to close or join first and second portions 100, 102 and snap-lock septum connector 50. After septum connector 50 is closed in this manner, septum connector 50 may function in a normal manner, i.e., sealing cavity 36 within catheter adapter 14, until a device / component is introduced through septum 52.

[0070] In yet other embodiments, Figure 8 As shown, to prevent compression setting or other deformation of septum connector 50 when catheter system 10 is in its packaged configuration, septum connector 50 can be disposed separately from catheter adapter 14 when catheter system 10 is in its packaged configuration. In this configuration, septum connector 50 can be coupled to catheter adapter 14 after needle 96 / catheter 12 is inserted into the patient's vasculature using needle introducer 92, and after needle introducer 92 is disconnected and removed from catheter adapter 14.

[0071] According to additional aspects or embodiments of the present invention, the open PIVC catheter assembly 16 described above (including the catheter 12 and the associated catheter adapter 14) can have other devices connected thereto or included therein that provide a fluid shutoff to seal the cavity 36 of the catheter adapter 14 from the external environment. When the needle introducer 92 is connected to the open PIVC catheter assembly 16, the fluid shutoff can address the above-mentioned issues regarding compression setting or other deformation that occurs in the separator membrane connector 50 during storage of the catheter system 10 in its packaged configuration. According to various embodiments, a fluid shutoff can be provided in place of or in addition to the separator membrane connector 50, wherein the fluid shutoff accommodates the passage of the needle 96 therethrough during storage of the catheter system 10 in its packaged configuration.

[0072] Reference now Fig. 9A and Fig. 9B According to another aspect or embodiment of the present invention, an open PIVC catheter assembly 104 is shown, which includes a fluid shutoff portion in the form of a shutoff mechanism 106 incorporated into the catheter adapter 14. The shutoff mechanism 106 includes a shutoff valve 108 located within the cavity 36 of the catheter adapter 14 and adjacent to the catheter adapter end port 38 and an actuator 110 located on the outer surface of the catheter adapter body. The actuator 110 can be configured as an operating lever or switch that is operable / movable between a first and a second position to open and close the shutoff valve 108, thereby providing an opening into the cavity 36 or sealing the cavity 36, respectively.

[0073] When needle guide 92 is connected to catheter adapter 14 (e.g., Figure 6 When the needle guide 92 is actually used, the stopcock 108 is kept in the position shown in FIG. Fig. 9A 108 and may be shown in its open configuration to allow needle 96 to pass through stopcock 108 and continue through lumen 36 of catheter adapter 14 and catheter 12. After needle 96 / catheter 12 is inserted into the patient's vasculature using needle introducer 92 and after needle introducer 92 is disconnected and removed from catheter adapter 14 (wherein needle 96 is withdrawn from catheter adapter 14 and out through stopcock 108), stopcock 108 may be closed (via movement of actuator 110) to seal lumen 36 within catheter adapter 14, as shown. Fig. 9B After closing stopcock 108, a device or component may be coupled to proximal end 32 of catheter adapter 14, such as blood extraction device 18 or another instrument delivery device as described in detail above. Subsequently, when it is desired to introduce an instrument (e.g., secondary catheter 74) into catheter adapter 14 and out through catheter 12, stopcock 108 may be opened to allow the instrument to be advanced into catheter 12.

[0074] In some embodiments, after needle introducer 92 is used and removed from catheter adapter 14, septum connector 50 can be disposed in catheter adapter end port 38. Septum connector 50 is positioned in catheter adapter end port 38 proximal to stopcock 108, wherein septum connector 50 is used to control access to catheter adapter 14 and catheter 12. As described in detail above, an instrument delivery device such as blood withdrawal device 18 can be connected to septum connector 50 and penetrate its septum 52 (via blunt-tipped cannula 82) to advance secondary catheter 74 into catheter 12.

[0075] Reference now Fig. 10A and Fig. 10B , shows an open PIVC catheter assembly 112 according to another aspect or embodiment of the present disclosure, wherein the open PIVC catheter assembly 112 includes a deformable tubular member 114 and a fluid shutoff in the form of a sliding clamp 116 at the proximal end 32 of the catheter adapter 14. The deformable tubular member 114 is coupled to and proximally extends from the catheter adapter end port 38, wherein in one embodiment, a connector 118 is disposed at the proximal end 120 of the deformable tubular member 114. The deformable tubular member 114 may be constructed of silicone or other suitable material that is deformable, such as by being pinched by the sliding clamp 116. The sliding clamp 116 is positioned along the length of the tubular member 114 between the catheter adapter end port 38 and the connector 118, and is operable in an open configuration and a closed configuration to selectively close the lumen 122 of the tubular member 114.

[0076] When the needle guide 92 is connected to the connector 118 on the proximal end 120 of the deformable tube 114 and the catheter system 10 is stored in its packaged configuration (i.e., before the needle guide 92 is actually used), the sliding clamp 116 is maintained in its open configuration, such as Fig. 10A 14, so as to provide an open lumen 122 within tubing 114 that allows needle 96 to pass through tubing 114 and through lumen 36 of catheter adapter 14 and catheter 12. After needle 96 / catheter 12 is inserted into the patient's vasculature using needle introducer 92, and after needle introducer 92 is disconnected and removed from connector 118 (wherein needle 96 is withdrawn from catheter adapter 14 and out through tubing 114), sliding clamp 116 can be closed to clamp and seal deformable tubing 114 and lumen 36 within catheter adapter 14, as shown. Fig. 10BAfter closing the sliding clamp 116, a device or component can be coupled to the connector 118 at the proximal end of the tubing 114, such as the blood extraction device 18 or another instrument delivery device as described in detail above. Subsequently, when it is desired to introduce an instrument (e.g., the secondary catheter 74) into the catheter adapter 14 and out through the catheter 12, the sliding clamp 116 can be opened to allow the instrument to be advanced through the lumen 122 of the tubing 114 and into the catheter 12.

[0077] Reference now Fig.11 and Fig.12 , shows a catheter hub 130 that can be directly coupled to the device delivery device 18 of the catheter system 10 according to another aspect or embodiment. The catheter hub 130 is configured to Figure 1 to Figure 1 0, wherein catheter adapter 130 may include a catheter adapter body 132 and stabilizing wings 134 extending from catheter adapter body 132. However, catheter adapter 130 is configured as a single-port catheter adapter and does not include a side port thereon.

[0078] Catheter adapter body 132 of catheter adapter 130 defines therein a cavity 136 extending between a distal end 138 and a proximal end 140 of catheter adapter 130. According to aspects or embodiments of the present disclosure, a proximal portion 142 of cavity 136 is configured as a tapered female Luer cavity, while a distal portion 144 of cavity 136 is configured as a generally cylindrical cavity having a constant diameter along at least a majority of its length 37. A catheter adapter port 146 is provided at proximal end 140 of catheter adapter body 132, which provides access to cavity 136. An opening 148 extending into cavity 136 is also formed at distal end 138 of catheter adapter body 132, wherein opening 148 also receives proximal end 22 of catheter 12 therein.

[0079] According to some aspects and embodiments, catheter adapter end port 146 located at proximal end 140 of catheter adapter body 132 defines a tapered proximal portion 142 of cavity 136 and is configured to receive septum connector 50 therein. Fig.12 As shown, catheter adapter end port 146 can be configured to receive the entire septum connector 50 therein, such that septum connector 50 is internal to catheter adapter 130. With septum connector 50 positioned internal to catheter adapter 130, catheter adapter end port 146 can include a groove 150 formed on an outer surface thereof that provides a location for connecting blood withdrawal device 18 (or other instrument delivery device) thereto, wherein arms 84, 86 on connector 72 of blood withdrawal device 18 engage the catheter adapter within groove 150.

[0080] When the blood withdrawal device 18 is engaged to the catheter adapter 130, the configuration of the distal portion 144 of the cavity 136 (having a cylindrical profile and a length 37 designed to accommodate the full length of the blunt cannula 82) allows the blunt cannula 82 to be received and accurately guided through the cavity 136 without obstruction when the connector 72 is engaged with the catheter adapter 130. With the blunt cannula 82 fully extended through the cavity 136, the lumen 88 of the connector 72 can be positioned directly adjacent to the lumen 26 of the catheter 12 (or, if included, adjacent to the wedge lumen 48 of the wedge 42). The configuration of the catheter adapter 130 and its engagement with the blood withdrawal device 18 thus advantageously facilitates advancement of the secondary catheter 74 from a first position to a second position, wherein the secondary catheter 74 is advanced in a straight line through the lumen 88 of the connector 72 and into the lumen 26 of the catheter 12, while the secondary catheter 74 (e.g., Figure 4 and Figure 5 ) without any opportunity to deflect or otherwise become trapped / captured within lumen 136 of catheter adapter 130.

[0081] Reference now Fig.13 , shows a catheter hub 152 that can be directly coupled to the device delivery device 18 of the catheter system 10 according to another aspect or embodiment. The catheter hub 152 and Fig.11 and Fig.12 130 in that catheter adapter 152 is configured as a single-port catheter adapter that does not include a side port thereon; however, catheter adapter 152 is configured such that catheter adapter end port 154 at proximal end 156 of catheter adapter body 158 is configured to receive only a portion of proximal coupler 160 therein (rather than a proximal coupler 160 as in the embodiment of the present invention). Fig.11 and Fig.12 As previously described, proximal coupler 160 can be configured as NFC including a separator membrane that serves as an access control feature whereby a peripheral device (e.g., a blood extraction device or a vascular access probe for intravenous digital measurement of patient data such as temperature, pH, lactate, and / or other blood-based measurements) can be physically and fluidically coupled to catheter adapter 152. Fig.13As can be seen in the figure, the proximal coupler 160 includes a pair of connecting rings 162, 164 formed around its periphery, wherein the first ring 162 and the second ring 164 are spaced laterally apart to provide engagement of the instrument delivery device 18 (i.e., arms 84, 86) with the catheter adapter 152. In addition, the proximal coupler 160 includes a side port 166 integrally formed thereon, which is distal to the separating membrane valve therein. The side port 166 can be arranged generally perpendicular to the lumen formed in / through the proximal coupler 160. An extension kit 168 can be integrated with the side port 166, which can be used to deliver fluids, remove fluids, flush fluids, and / or the like. An extension tube 170 can extend from the side port 166, wherein a proximal access port 172 is coupled to the proximal end portion of the extension tube 170 to control access to the extension kit 168. A clamp 174 can also be provided on the extension tube 170, and the clamp 174 is configured to selectively restrict flow through the extension tube 170.

[0082] Although for the purpose of illustration, the present disclosure is described in detail based on what is currently considered to be the most practical and preferred embodiments or aspects, it should be understood that such details are only for the purpose of illustration, and the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, the present application is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that one or more features of any embodiment can be combined with one or more features of any other embodiment to the extent possible.

Claims

1. A catheter system, characterized in that: The catheter system comprises: a catheter having a catheter distal end and a catheter proximal end, the catheter defining a catheter lumen; A catheter hub coupled to the proximal end of the catheter, the catheter hub comprising: a catheter adapter body having a catheter adapter distal end and a catheter adapter proximal end, the catheter adapter body having a cavity formed therein extending between the catheter adapter distal end and the catheter adapter proximal end; and an end port located at a proximal end of the catheter adapter and providing an opening into the lumen; and A separator membrane connector is at least partially positioned within the end port, the separator membrane connector being 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.

2. The catheter system according to claim 1, characterized in that The catheter adapter also includes a side port extending from the catheter adapter body between the catheter adapter distal end and the catheter adapter proximal end, the side port defining a side port lumen in fluid communication with the catheter lumen.

3. The catheter system according to claim 2, characterized in that The side port extends from the catheter adapter body at an angle between 15 and 165 degrees relative to the catheter lumen.

4. The catheter system according to claim 2, characterized in that The side port includes a female Luer connection.

5. The catheter system according to claim 2, characterized in that The catheter system also includes a needleless access connector coupled to the side port.

6. The catheter system according to claim 1, characterized in that The lumen includes a cylindrical lumen having a constant diameter along at least a majority of the length of the cylindrical lumen between the catheter adapter distal end and the catheter adapter proximal end.

7. The catheter system according to claim 1, characterized in that The catheter system further comprises a blood extraction device coupled to the end port and / or the dividing membrane connector.

8. The catheter system according to claim 7, characterized in that The blood extraction device comprises: secondary duct; an introducer having proximal and distal ends and top and bottom surfaces, the proximal and distal ends and top and bottom surfaces of the introducer defining an interior volume configured to movably receive the secondary conduit; an actuator movably coupled to the introducer, the actuator 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 introducer and past the catheter distal end of the catheter; and A connector of the blood extraction device is positioned at the distal end of the introducer, the connector of the blood extraction device is coupled to the end port and / or the separating membrane connector, the connector of the blood extraction device comprising a blunt cannula and a pair of locking arms.

9. The catheter system according to claim 8, characterized in that The dividing membrane connector includes a first ring and a second ring laterally spaced apart from the first ring, and wherein the pair of locking arms engage the dividing membrane connector by snapping between the first ring and the second ring.

10. The catheter system according to claim 8, characterized in that When the blood extraction device is coupled to the end port and / or the septum connector, the blunt cannula penetrates the septum connector and enters the cavity, each of the blunt cannula and the cavity having a length such that the blunt cannula extends substantially to the distal end of the cavity.

11. The catheter system according to claim 10, characterized in that The lumen of the blunt tip cannula is disposed adjacent to the catheter lumen by extending the blunt tip cannula substantially to the distal end of the cavity.

12. The catheter system according to claim 11, characterized in that The catheter adapter also includes a wedge positioned within the cavity adjacent the distal end of the catheter adapter, the wedge coupled to the proximal end of the catheter to retain the catheter to the catheter adapter, and wherein the wedge includes a wedge lumen formed therein, the lumen of the blunt cannula being directly aligned with the wedge lumen by extending the blunt cannula substantially to the distal end of the cavity.

13. The catheter system according to claim 8, characterized in that The dividing membrane connector is positioned completely within the end port, and wherein the pair of locking arms engage grooves formed on an outer surface of the end port.

14. The catheter system according to claim 1, characterized in that The catheter system also includes a needle guide coupled to the septum connector, wherein the needle extends through the catheter hub and through the catheter lumen, and wherein the septum connector is configured to have an initial configuration in which a first portion of the septum connector is separated from a second portion of the septum connector such that the needle passes through the septum connector without contacting the septum connector.

15. The catheter system according to claim 1, characterized in that The catheter adapter includes an open peripheral intravenous catheter adapter.

16. The catheter system according to claim 1, characterized in that The dividing membrane connector includes a side port formed thereon, wherein an integrated extension tube extends from the side port of the dividing membrane connector.

17. A catheter system, characterized in that: The catheter system comprises: a catheter having a catheter distal end and a catheter proximal end, the catheter defining a catheter lumen; A catheter hub coupled to the proximal end of the catheter, the catheter hub comprising: a catheter adapter body having a catheter adapter distal end and a catheter adapter proximal end, the catheter adapter body having a cavity formed therein, the cavity extending between the catheter adapter distal end and the catheter adapter proximal end; and an end port located at a proximal end of the catheter adapter and providing an opening into the lumen; and A fluid shutoff is positioned at or near the end port, the fluid shutoff being 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.

18. The catheter system according to claim 17, characterized in that The fluid cutoff portion comprises: a stop cock located within the cavity adjacent the end port; and An actuator is positioned on an outer surface of the catheter adapter body and is operable to open and close the shutoff stopcock.

19. The catheter system according to claim 18, characterized in that The catheter system also includes a septum connector located within the cavity and proximal to the stopcock.

20. The catheter system according to claim 19, characterized in that The catheter system also includes a deformable tubular member connected to the end port and extending proximally from the end port, and wherein the fluid shutoff portion includes a sliding clamp positioned on the deformable tubular member and capable of being actuated between an open position and a closed position to selectively allow fluid to flow through the deformable tubular member.

21. The catheter system of claim 19, wherein: The catheter system further includes a blood extraction device, the blood extraction device being coupleable to the proximal coupler of the septum connector, the blood extraction device being configured to advance a secondary catheter through the catheter distal end of the catheter, the blood extraction device including a connector coupled to the end port, the connector of the blood extraction device including a blunt cannula and a pair of locking arms; and wherein the blunt cannula penetrates into the cavity when the blood extraction device is coupled to the end port and when the fluid shutoff portion is in the open configuration, the blunt cannula and the cavity both having a length such that the blunt cannula extends substantially to a distal end of the cavity.

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