Patent Application
20240358966
Provided herein are devices and systems for use in vascular access, and, in particular, a catheter hub that is directly compatible with a blood draw device to provide for advancement of an instrument through an open peripheral intravenous catheter.
Vascular access devices (VADs) are used in the medical field to access peripheral vasculature of a patient for purposes of infusion therapy and/or blood withdrawal. Common types of VADs include over-the-needle peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. The VAD may be indwelling for short term (days), moderate term (weeks), or long term (months to years). For some applications, an open PIVC catheter is provided where an indwelling catheter in inserted into the vasculature of a patient and extends out therefrom to a catheter hub having a port thereon that provides for coupling of additional instruments or devices thereto.
Instrument delivery devices are often used with VADs to deliver an instrument into the indwelling intravenous (IV) catheter thereof, with the instrument delivery device advancing the instrument beyond the tip of the indwelling catheter. When the instrument delivery device is used to collect blood, as one example, the instrument can be in the form of a flexible tube or catheter, but the instrument may also be a guidewire, obturator, wire, electrical wiring, probe, or sensor(s), in other implementations. Typically, when employing an instrument delivery device with a VAD, such as the open PIVC catheter referenced above, a connector or adapter is included that is positioned between the catheter hub and the instrument delivery device. The adapter includes a coupler at a distal end thereof that connects with a port of the catheter hub and a coupler at a proximal end thereof that connects with the instrument delivery device, with the proximal end coupler often having a needle-free connector therein for receiving the instrument delivery device. When coupled to the catheter adapter, the instrument delivery device may be operated to advance the instrument out therefrom and through a lumen of the catheter adapter, into and then out beyond the tip of the indwelling catheter. The adapter may also include a side port thereon that enables connection of an extension set or fluid delivery system thereto, for introducing fluids into the adapter and to the open PIVC catheter for administering to the patient.
It is recognized that the inclusion of the adapter in the catheter system (between the catheter hub and the instrument delivery device) may increase the difficulty of advancing the instrument into the indwelling catheter. That is, in configurations where a catheter connector is used to connect an instrument delivery device to the catheter hub, a male connection portion of the catheter connector typically couples with the proximal end port of the catheter hub but may not fill a majority of a cavity within the catheter hub. With at least a portion of the cavity in the catheter hub remaining open, a distal end of the male connection portion remains spaced apart from a proximal opening of the lumen defined by the catheter (which is secured to the distal end of the catheter hub) and thus, when attempting to advance the instrument through this cavity (i.e., through the open cavity portion remaining between the male connection portion and the proximal opening of the catheter lumen), the instrument may not remain aligned properly with the catheter lumen. Accordingly, the instrument may become trapped within the cavity of the catheter hub and, as the instrument is further advanced, the instrument may kink and double over on itself, thereby inhibiting advancement of the instrument into and through the catheter.
Accordingly, a need exists in the art for a catheter system that provides for more efficient advancement of an instrument through an open PIVC. The catheter system provides a catheter hub that is directly compatible with a blood draw device, thereby negating the need for a catheter adapter and simplifying advancement of an instrument through the open PIVC.
Provided herein is a catheter system that includes a catheter and a catheter hub. The catheter has a catheter distal end and a catheter proximal end and defines a catheter lumen. The catheter hub is coupled to the catheter proximal end and includes a hub body having a hub distal end and a hub proximal end, the hub body having a cavity formed therein extending between the hub distal end and the hub proximal end. The catheter hub also includes an end port provided at the hub proximal end and that provides an opening into the cavity. The catheter system also includes a split-septum connector positioned at least partially within the end port, the split-septum connector configured to seal the cavity when in a closed configuration and provide a fluid path to the catheter lumen when in an open configuration.
In some embodiments, the catheter hub further includes a side port extending out from the hub body between the hub distal end and the hub proximal end, the side port defining a side port lumen in fluid communication with the catheter lumen.
In some embodiments, the side port extends out from the hub body at an angle relative to the catheter lumen of between 15-165 degrees.
In some embodiments, the side port is a female luer connection.
In some embodiments, the catheter system further includes a needle-free access connector coupled to the side port.
In some embodiments, the cavity is a cylindrical cavity having a constant diameter along at least a majority of a length thereof between the hub distal end and the hub proximal end.
In some embodiments, the catheter system further includes a blood draw device, the blood draw device coupled to the end port and/or the split-septum connector.
In some embodiments, the blood draw device includes a secondary catheter, an introducer having a proximal end and a distal end and a top surface and a bottom surface that define an inner volume configured to movably receive the secondary catheter, an actuator movably coupled to the introducer and configured to move relative to the introducer to move a distal end of the secondary catheter from a position within the introducer to a position outside the introducer housing and past the catheter distal end of the catheter, and a connector positioned at the distal end of the introducer that is coupled to the end port and/or the split-septum connector, the connector comprising a blunt cannula and a pair of locking arms.
In some embodiments, the split-septum connector includes a first ring and a second ring spaced apart laterally from the first ring, wherein the pair of locking arms engages the split-septum connector by snapping-in between the first ring and the second ring.
In some embodiments, when the blood draw device is coupled to the end port and/or the split-septum connector, the blunt cannula penetrates through the split-septum connector and into the cavity, with each of the blunt cannula and the cavity having a length such that the blunt cannula extends approximately to a distal end of the cavity.
In some embodiments, extension of the blunt cannula to approximately the distal end of the cavity places a lumen of the blunt cannula adjacent the catheter lumen.
In some embodiments, the catheter hub further includes a wedge positioned within the cavity adjacent the hub distal end, the wedge coupled to the catheter proximal end to retain the catheter to the catheter hub, and wherein the wedge includes a wedge lumen formed therein, and extension of the blunt cannula to approximately the distal end of the cavity directly aligns the lumen of the blunt cannula with the wedge lumen.
In some embodiments, the split-septum connector is positioned entirely within the end port, and wherein the pair of locking arms engages a groove formed on an outer surface of the end port.
In some embodiments, the catheter system further includes a needle introducer coupled to the split-septum connector, with a needle extending through the catheter hub and through the catheter lumen, and wherein the split-septum connector is configured to have an initial configuration where a first portion of the split-septum connector is separated from a second portion of the split-septum connector, such that the needle passes through the split-septum connector without making contact therewith.
In some embodiments, the catheter hub comprises an open peripheral intravenous catheter (PIVC) catheter hub.
In some embodiments, the split-septum connector includes a side port formed thereon, with an integrated extension tube extending out from the side port.
Also provided herein is a catheter system that includes a catheter and a catheter hub. The catheter has a catheter distal end and a catheter proximal end and defines a catheter lumen. The catheter hub is coupled to the catheter proximal end and includes a hub body having a hub distal end and a hub proximal end, the hub body having a cavity formed therein extending between the hub distal end and the hub proximal end. The catheter hub also includes an end port provided at the hub proximal end and that provides an opening into the cavity. The catheter system also includes a fluid cut-off positioned at or adjacent the end port, the fluid cut-off configured to seal the cavity when in a closed configuration and provide a fluid path to the catheter lumen when in an open configuration.
In some embodiments, the fluid cut-off includes a stop cock valve within the cavity adjacent the end port and an actuator positioned on an outer surface of the hub body and operable to open and close the stop cock valve.
In some embodiments, the catheter system further includes a split-septum connector within the cavity and proximal from the stop cock valve.
In some embodiments, the catheter system further includes a deformable tubing coupled to the end port and extending our proximally therefrom, with the fluid cut-off being a slide clamp positioned on the deformable tubing and actuatable between an open position and a closed position to selectively allow fluid flow through the deformable tubing.
In some embodiments, the catheter system further includes a blood draw device coupleable to the proximal coupler of the connector, with the blood draw device configured to advance a secondary catheter past the catheter distal end of the catheter and including a connector that is coupled to the end port. The connector further includes a blunt cannula and a pair of locking arms and, when the blood draw device is coupled to the end port and when the fluid cut-off is in the open configuration, the blunt cannula penetrates into the cavity, with the blunt cannula and the cavity each having a length such that the blunt cannula extends approximately to a distal end of the cavity.
The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.
For the purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawings. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.
In the present disclosure, the distal end of a component or of a device means the end furthest away from the hand of the user and the proximal end means the end closest to the hand of the user, when the component or device is in the use position, i.e., when the user is holding a catheter insertion device in preparation for or during use. Similarly, in this application, the terms “in the distal direction” and “distally” mean in the direction toward the distal tip of the needle or catheter of the system, and the terms “in the proximal direction” and “proximally” mean in the direction opposite the direction of the distal tip of the needle or catheter.
Referring to
As shown in
The catheter hub 14 is constructed of a main hub body 28 having a distal end 30 and a proximal end 32, along with stabilizing wings 34 extending out from the main hub body 28 that provide for securing of the hub to the skin of a patient. The main hub body 28 defines a cavity 36 therein that extends between the distal end 30 and the proximal end 32 of the catheter hub 14. According to aspects or embodiments of the disclosure, the cavity 36 is configured as a generally cylindrically shaped cavity that has a constant diameter along at least a majority of a length 37 of the cavity 36. A hub end port 38 is provided at the proximal end 32 of the main hub body 28 that provides access into the cavity 36. An opening 40 is also formed at the distal end 30 of the main hub body 28 that extends into the cavity 36, with the opening 40 also receiving the proximal end 22 of the catheter 12 therein. In some embodiments, the opening 40 is sized to have a similar diameter to catheter 12 so that catheter 12 is secured within the opening, thereby anchoring the catheter 12 to the catheter hub 14.
As shown in
In accordance with some aspects and embodiments, the hub end port 38 at the proximal end 32 of main hub body 28 is configured as a receptacle that receives a proximal coupler 50 therein. The proximal coupler 50 may be configured as a split-septum, needle-free connector (NFC) such as, e.g., Q-Syte™ or SmartSite™ NFCs from Becton, Dickinson and Co., or any other appropriate split-septum NFC, that is fitted partially within the proximal hub end port 38—hereafter “split-septum connector 50.” The split-septum connector 50 includes a split septum 52 therein that serves as an access control feature whereby a peripheral device (e.g., a blood draw device or a vascular access probe for in-vein 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 hub 14, such that the split-septum connector 50 allows the catheter hub 14 to be accessed multiple times by the peripheral device. In some embodiments, where the peripheral device is a blood draw device that introduces a secondary catheter into catheter 12, the split-septum connector 50 functions as a blood control feature that may be accessed multiple times by the blood draw device to draw the blood from a vein of the patient. The split-septum connector 50 also includes a pair of connection rings 54, 56 formed about a perimeter thereof, with a first ring 54 and a second ring 56 spaced laterally apart. The connection rings 54, 56 provide for engagement of the instrument delivery device 18 to the catheter hub 14, as will be explained in further detail below.
In accordance with some aspects and embodiments, the catheter hub 14 also includes and/or defines one or more additional ports, such as a side port 58 that extends out from the main hub body 28. The side port 58 may be formed in a desired position along a length of the main hub body 28, between the distal end 30 and the proximal end 32, to facilitate flushing and/or fluid transfer via the side port 58. The side port 58 defines a lumen 60 that is in fluid communication with the cavity 36, so as to provide access to and be in fluid communication with the catheter lumen 26. In some embodiments, the side port 58 is configured as a female luer connection that includes a tapered inner cavity 62 and a threaded outer surface 64, with the female luer connection configured to mate with a corresponding male luer connection of a connector 66 (
While not shown in
In some embodiments, the arrangement of side port 58 can be such that the catheter hub 14 is constructed as, for example, a Y-shaped or a T-shaped catheter hub. In non-limiting embodiments, side port 58 extends from main hub body 28 at an angle relative to the main hub body 28 that is not 72 degrees (e.g., side port 58 extends at an angle of, for example and without limitation, 15-165 degrees, with all values and subranges therebetween inclusive). In non-limiting embodiments, more than one side port 58 is included in catheter hub 14.
As shown in
As shown in more detail in
To provide a desired engagement between the blood draw device 18 and the catheter hub 14, the catheter hub 14 is specifically configured and sized to receive the blunt cannula 82 of connector 72, as best shown in
As described above, at least a portion of the secondary catheter 74 is movably disposed within the introducer 70. A proximal end portion of the secondary catheter 74 is coupled to the actuator 76 and, in this manner, 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 disposed within the introducer 70 (e.g., the entire secondary catheter 74 is disposed 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 disposed in a position distal to the connector 72 and the catheter hub 14 when the connector 72 is coupled to the catheter hub 14.
Referring now to
The blood draw device 18 is shown in the first configuration of
The actuator 76 (
The blood draw device 18 is in the second configuration of
With the secondary catheter 74 in the second position (e.g., with the blood draw device 18 in the second configuration shown, for example, in
Beneficially, the construction of catheter hub 14 and the mating thereof with blood draw device 18 facilitates advancement of the secondary catheter 74 from the first position to the second position. That is, with the cavity 36 of catheter hub 14 having a length 37 such that it accommodates a full length of the blunt cannula 82, the blunt cannula 82 may be positioned adjacent the proximal end 22 of catheter 12 (or the wedge 42), such that the lumen 88 is brought directly adjacent to and into alignment with the lumen 26 of catheter 12. Accordingly, the secondary catheter 74 can be advanced through the lumen 88 of connector 72 and into the lumen 26 of catheter 12 in a straight line-without any opportunity for the secondary catheter 74 to deflect or otherwise become trapped/caught within the cavity 36 of the catheter hub 14.
Referring now to
As shown in
In operation of the needle introducer 92, the needle cover 98 may first be removed and a user may then grasp the needle hub 94 and apply a pushing force thereto that causes the needle 96 to pierce the skin of a patient, with a further pushing force then causing the needle 96 and the catheter 12 to be inserted into the vasculature of the patient. Upon insertion of the needle 96 and catheter 12 into the patient, the user may then pull back on the needle hub 94 to retract the needle 96 out from the catheter 12, with the needle hub 94 being disconnected/separated from the split-septum connector 50 and the needle 96 pulled out from the catheter hub 14 through the split-septum connector 50.
Referring now to
As shown in
In still other embodiments, and as shown in
According to additional aspects or embodiments of the disclosure, the open PIVC catheter assembly 16 (including catheter 12 and associated catheter hub 14) described above may have other devices connected thereto or included therein that provide a fluid cut-off to seal the cavity 36 of catheter hub 14 from the external environment. The fluid cut-off may address the issue described above regarding compression setting or other deformation occurring in a split-septum connector 50 during storage of the catheter system 10 in its in-the-package configuration, when a needle introducer 92 is connected to the open PIVC catheter assembly 16. The fluid cut-off may be provided in place of or in addition to a split-septum connector 50, according to various embodiments, with the fluid cut-off accommodating passage of the needle 96 therethrough during storage of the catheter system 10 in its in-the-package configuration.
Referring now to
When a needle introducer 92 is coupled to the catheter hub 14 (as shown in
In some embodiments, upon use and removal of the needle introducer 92 from the catheter hub 14, a split-septum connector 50 may be provided in the hub end port 38. The split-septum connector 50 is positioned in the hub end port 38 proximal from the stop cock valve 108, with the split-septum connector 50 functioning to control access into the catheter hub 14 and catheter 12. As described in detail above, an instrument delivery device such as blood draw device 18 may be connected to the split-septum connector 50 and penetrate through the septum 52 thereof (via blunt cannula 82) to advance a secondary catheter 74 into the catheter 12.
Referring now to
When a needle introducer 92 is coupled to the connector 118 on the proximal end 120 of deformable tubing 114 and the catheter system 10 is stored in its in-the-package configuration (i.e., prior to actual use of the needle introducer 92), the slide clamp 116 is maintained in its open configuration, as shown in
Referring now to
The main hub body 132 of catheter hub 130 defines a cavity 136 therein that extends between distal and proximal ends 138, 140 of the catheter hub 130. According to aspects or embodiments of the disclosure, a proximal end portion 142 of the cavity 136 is configured as a tapered female luer cavity, while a distal end portion 144 of the cavity 136 is configured as a generally cylindrically shaped cavity that has a constant diameter along at least a majority of a length 37 thereof. A hub end port 146 is provided at the proximal end 140 of the main hub body 132 that provides access into the cavity 136. An opening 148 is also formed at the distal end 138 of the main hub body 132 that extends into the cavity 136, with the opening 148 also receiving the proximal end 22 of the catheter 12 therein.
In accordance with some aspects and embodiments, the hub end port 146 at the proximal end 140 of main hub body 132 defines the tapered proximal end portion 142 of the cavity 136 and is configured to receive a split-septum connector 50 therein. As shown in
In engaging the blood draw device 18 to the catheter hub 130, the configuration of the distal end portion 144 of the cavity 136—with 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 hub 130. With the blunt cannula 82 extending entirely through the cavity 136, the lumen 88 of the connector 72 may be positioned directly adjacent the lumen 26 of catheter 12 (or adjacent the lumen 48 of a wedge 42, if included). The construction of catheter hub 130 and the mating thereof with blood draw device 18 thus beneficially facilitates advancement of the secondary catheter 74 from the first position to the second position, with the secondary catheter 74 advancing through the lumen 88 of connector 72 and into the lumen 26 of catheter 12 in a straight line-without any opportunity for the secondary catheter 74 (
Referring now to
Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.
