Systems and methods for adjusting lever lock length for compatibility with peripheral intravenous catheters (PIVCs) of various lengths - Patents.com

Abstract

A fluid transfer device for use with a peripheral intravenous catheter (PIVC), the fluid transfer device including an introducer body having a proximal end and a distal end, and a flow tube at least partially contained within the introducer body, the flow tube configured to be selectively extendable from the introducer body. The fluid transfer device also includes a lever lock coupled to a distal end of the introducer body, the lever lock including a lumen configured to allow the flow tube to pass therethrough, and an effective length of the lever lock relative to the distal end of the introducer body is adjustable to accommodate use of the fluid transfer device with indwelling PIVC catheters having various lengths.

Description

[Technical field]

[0001] The present disclosure relates generally to a blood collection device and associated assemblies, systems, and methods for use with a peripheral intravenous catheter (PIVC). The blood collection device is configured to be adjustable in effective length to enable blood collection through a PIVC having indwelling catheters of various lengths.

[0002] This application claims priority to U.S. Provisional Application No. 63 / 301,728, entitled "Systems and Methods for Adjusting the Length of Line Draw Lever Lock Components for Compatibility with Various Length Peripheral Intravenous Catheters (PIVC)," filed January 21, 2022, the entire disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0003] Catheters are commonly used to infuse fluids into a patient's vascular system. For example, catheters may be used to infuse saline, various medications, or total parenteral nutrition. Catheters may also be used to withdraw blood from a patient.

[0004] The catheter may be an over-the-needle peripheral intravenous catheter (PIVC). In this case, the catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing away from the patient's skin. The catheter and introducer needle are typically inserted at a shallow angle through the skin into the patient's vasculature. After properly placing the needle, the clinician may temporarily occlude flow in the vasculature, remove the needle, and leave the catheter in place (i.e., "indwelling") for future blood withdrawal and / or fluid injection.

[0005] To complete blood collection from a PIVC with an indwelling catheter, a fluid transfer device has been developed. The fluid transfer device is configured to overcome previous challenges associated with blood collection via a PIVC, such as potential catheter breakage and reduced blood flow due to debris accumulated on or within the catheter. One such device, the PIVO™ from Velano Vascular, Inc., is configured as a disposable device that is temporarily attached to the PIVC to collect a blood sample. Using an existing peripheral venous line as a conduit to the vasculature, the PIVO™ device advances a flexible internal flow tube through the PIVC, past the catheter tip, and into the vein to collect the blood sample. The flow tube is designed to extend beyond suboptimal draw conditions around the indwelling line to reach a venous location where blood flow is optimal for aspiration. Once blood collection is complete, the flow tube is retracted and the device is removed from the PIVC and discarded. One example of such a fluid transfer device is shown and described in U.S. Patent No. 10,300,247 B2, which is incorporated herein by reference in its entirety.

[0006] Referring to FIG. 1, an example of a PIVC system 100 utilizing a fluid transfer device as known in the art is shown. The PIVC system 100 includes a catheter adapter 102 from which an indwelling catheter 118 extends distally a distance A. The catheter adapter 102 may include a Y adapter, a straight adapter, or another suitable adapter. The catheter adapter 102 further includes a hub 114, and the catheter system 100 may include a fluid transfer device 104 having a lever lock 108, an introducer 110, and an actuator 112. The lever lock 108 may include a pair of deflectable arms 116A, 116B that allow selective attachment and detachment of the lever lock 108 to the hub 114 of the catheter adapter 102. Additionally, the lever lock 108 may include a coupler 117 for coupling the introducer 110 to the lever lock 108.

[0007] For example, as described in U.S. Patent No. 10,300,247 B2, the introducer 110 is configured to receive a flexible flow tube 120 that can be linearly fed through the indwelling catheter 118 via the actuator 112 such that at its full extension, the distal end of the flow tube 120 extends a distance B beyond the distal end of the indwelling catheter 118. In this manner, the flow tube 120 can access the patient's vasculature beyond the indwelling catheter 118, providing improved blood draw through the catheter adapter 102. The flow tube 120 can be fluidly coupled to, for example, the tube holder 106 via an extension tube 107 having a clamp 109 to enable blood draw via the PIVC system 100, for example, to a vacuum tube inserted into the holder 106. After blood draw is completed, the flow tube 120 can be retracted and the fluid transfer device 104 can be disconnected from the catheter adapter 102.

[0008] However, in some instances, the PIVC is provided with indwelling catheters of various lengths, with the particular length being selected based on, for example, the patient's anatomy, application, etc. For example, Becton Dickinson's BD NEXIVA™ Closed IV catheter system provides 20 gauge PIVCs with catheter lengths of 1.00 inches, 1.25 inches, and 1.75 inches, respectively. While these catheters with various lengths may allow for improved placement of the PIVC within the patient's vasculature, they may prove problematic when used with a fluid transfer device configured to withdraw blood via the PIVC. Specifically, as discussed above with respect to FIG. 1, the flow tube of the fluid transfer device typically has a maximum extension length that can be advanced beyond the distal tip of the indwelling catheter. That maximum length of the flow tube may be sufficient for proper projection from a PIVC with, for example, a 1.00 inch catheter length, but may not provide for proper projection from a PIVC with, for example, a 1.75 inch catheter length. Conversely, if a fluid transfer device is designed to provide adequate projection from a PIVC with a longer catheter length (e.g., 1.75 inches), the flow tube of that same device may extend an undesirable distance beyond the tip of a shorter (e.g., 1.00 inch) catheter. Summary of the Invention

[0009] Accordingly, the present disclosure relates generally to fluid transfer devices used to withdraw blood via a PIVC, and related assemblies, systems, and methods. The effective length of the fluid transfer device may be selectable and / or adjustable such that the length of the flow tube extending from the fluid transfer device is compatible with indwelling catheters of various lengths.

[0010] According to one embodiment of the present application, a fluid transfer device for use with a peripheral intravenous catheter (PIVC) includes an introducer body having a proximal end and a distal end, and a flow tube at least partially contained within the introducer body, the flow tube configured to be selectively extendable from the introducer body. The fluid transfer device also includes a lever lock coupled to a distal end of the introducer body, the lever lock including a lumen configured to allow the flow tube to pass therethrough, and an effective length of the lever lock relative to the distal end of the introducer body is adjustable to accommodate use of the fluid transfer device with indwelling PIVC catheters having various lengths.

[0011] In certain configurations, the lever lock includes an elongated coupler portion, a pair of deflectable arms, and a blunt cannula. The pair of deflectable arms may be configured to releasably couple the lever lock to a hub of a catheter adapter of a PIVC. At least a portion of the elongated coupler portion may be configured to be slidable within at least a distal portion of the introducer body. The distal portion of the introducer body may be tapered to limit the amount that the elongated coupler portion of the lever lock may slide relative to the distal portion of the introducer.

[0012] In certain configurations, the elongated coupler portion of the lever lock may include a plurality of external threads, and the distal portion of the introducer body may include a plurality of internal threads engageable with the external threads of the elongated coupler portion. The fluid transfer device may also include a spring-loaded pin coupled to the elongated coupler portion of the lever lock. The introducer body may also include at least two openings formed therein, and the spring-loaded pin of the elongated coupler portion of the lever lock may be configured to selectively engage with the at least two openings of the introducer body. A cantilever slider member may be coupled to a proximal portion of the elongated coupler portion of the lever lock, the cantilever slider member including a pair of engagement portions.

[0013] Optionally, the introducer body may further include at least two pairs of apertures formed therein, and the pair of engagement portions of the cantilever slider member is configured to selectively engage with the at least two pairs of apertures of the introducer body. The fluid transfer device may also include an actuator member movable relative to the introducer body, the actuator member configured to feed the flow tube through the introducer body and the lever lock. The proximal end of the introducer body may include a threaded interface.

[0014] According to another embodiment of the present invention, a fluid transfer device for use with a peripheral intravenous catheter (PIVC) includes an introducer body having a proximal end and a distal end, a flow tube at least partially contained within the introducer body and configured such that the flow tube is selectively extendable from the introducer body, and a first lever lock selectively coupleable to a distal end of the introducer body. The first lever lock may include a first lumen configured to allow the flow tube to pass therethrough. The fluid transfer device may also include a second lever lock selectively coupleable to a distal end of the introducer body, the second lever lock including a second lumen configured to allow the flow tube to pass therethrough. The length of the first lever lock may be shorter than the length of the second lever lock to accommodate use of the fluid transfer device with indwelling PIVC catheters having various lengths.

[0015] In a particular configuration, each of the first and second lever locks includes an elongated coupler portion, a pair of deflectable arms, and a blunt cannula. The pair of deflectable arms can be configured to releasably couple the lever lock to a hub of a catheter adapter of a PIVC.

[0016] In a particular configuration, the first lever lock is configured for use with an indwelling catheter having a length of 1.00 inches and the second lever lock is configured for use with an indwelling catheter having a length of 1.75 inches.

[0017] In accordance with another embodiment of the present invention, a fluid transfer device for use with a peripheral intravenous catheter (PIVC) includes an introducer body having a proximal end and a distal end, a flow tube at least partially contained within the introducer body and configured such that the flow tube is selectively extendable from the introducer body, and a lever lock coupled to the distal end of the introducer body, the lever lock may include an elongated coupler portion, and further, the elongated coupler portion of the lever lock is telescopic within at least the distal portion of the introducer body to accommodate use of the fluid transfer device with indwelling PIVC catheters having various lengths.

[0018] In certain configurations, the lever lock further includes a pair of deflectable arms and a blunt cannula, the pair of deflectable arms configured to releasably couple the lever lock to a hub of a catheter adapter of a PIVC. The fluid transfer device may also include a spring-biased pin coupled to the elongated coupler portion of the lever lock, the introducer body further including at least two openings formed therein, the spring-biased pin of the elongated coupler portion of the lever lock configured to selectively engage the at least two openings of the introducer body.

[0019] In a particular configuration, the fluid transfer device further includes a cantilever slider member coupled to a proximal portion of the elongated coupler portion of the lever lock, the cantilever slider member including a pair of engagement portions, the introducer body further including at least two pairs of openings formed therein, and the pair of engagement portions of the cantilever slider member configured to selectively engage with the at least two pairs of openings of the introducer body.

[0020] Further details and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings, in which like parts are designated with like reference numerals throughout. [Brief description of the drawings]

[0021] [Figure 1] FIG. 1 shows a PIVC system incorporating a fluid transfer device for blood collection according to the prior art. [Figure 2A] FIG. 2A shows a partial cross-sectional view of a blood collection fluid transfer device having a lever lock in a first configuration according to an embodiment of the present disclosure. [Figure 2B] FIG. 2B shows a partial cross-sectional view of the fluid transfer device of FIG. 2A with the lever lock in a second configuration. [Figure 3A] FIG. 3A shows a partial cross-sectional view of a blood collection fluid transfer device having a lever lock in a first configuration according to another embodiment of the present disclosure. [Figure 3B] FIG. 3B shows a partial cross-sectional view of the fluid transfer device of FIG. 3A with the lever lock in a second configuration. [Figure 4A] FIG. 4A shows a partial cross-sectional view of a blood collection fluid transfer device having a lever lock in a first configuration according to another embodiment of the present disclosure. [Figure 4B] FIG. 4B shows a partial cross-sectional view of the fluid transfer device of FIG. 4A with the lever lock in a second configuration. [Diagram 5] FIG. 5 shows a partial cross-sectional view of a blood collection fluid transfer device having a lever lock in a first configuration according to another embodiment of the present disclosure. [Figure 6A] FIG. 6A shows a partial cross-sectional view of a blood collection fluid transfer device having a lever lock in a first configuration according to another embodiment of the present disclosure. [Figure 6B] FIG. 6B shows a partial cross-sectional view of the fluid transfer device of FIG. 6A with the lever lock in a second configuration. [Figure 7A]FIG. 7A shows a partial cross-sectional view of a blood collection fluid transfer device having a lever lock of a first size according to another embodiment of the present disclosure. [Figure 7B] FIG. 7B shows a partial cross-sectional view of a second size lever lock for use in the fluid transfer device of FIG. 7A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present disclosure.

[0023] For purposes of description hereinafter, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal" and their derivatives refer to the invention as oriented in the drawings. It will be understood, however, that the invention may be subject to various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. As such, specific dimensions and other physical characteristics relating to aspects disclosed herein are not to be considered as limiting.

[0024] The embodiments of the present disclosure are described primarily in the context of a fluid transfer device for use with a PIVC, however, the embodiments of the present disclosure extend equally to use with other catheter devices.

[0025] 2A and 2B, a fluid transfer device 200 is shown, for example for use in conjunction with a PIVC. The fluid transfer device 200 includes an introducer body 202 having a distal end 203 and a proximal end 204. The proximal end 204 may be configured to include an interface (e.g., a threaded interface) for coupling the fluid transfer device 200 to a Luer Lock Access Device (LLAD), for example, for performing a blood draw. However, it should be understood that the proximal end 204 may have any suitable interface and / or coupling means.

[0026] Although not shown, it should be understood that the fluid transfer device 200 may be configured to include an actuator member that is movable relative to the introducer body 202. In some embodiments, the actuator may be configured to be slidable along at least a portion of the length of the introducer body 202, and the actuator is also coupled to the flexible flow tube 212 such that movement of the actuator along the introducer body 202 results in corresponding linear movement of the flow tube 212 relative to the introducer body 202. However, other forms of actuators and / or methods of actuation of the flow tube 212 relative to the introducer body 202 may also be utilized in accordance with the present disclosure.

[0027] 2A and 2B, the fluid transfer device 200 also includes a lever lock 205 configured to removably couple the fluid transfer device 200 to, for example, the hub of a catheter adapter, as shown and described above with respect to FIG. 1. Deflectable arms 208A, 208B enable such selective connection to the hub of a catheter adapter, and a blunt cannula 210 extends from a distal end of the lever lock 205, the blunt cannula 210 including a lumen 211 extending therethrough, which when interconnected fluidly couples the fluid transfer device 200 and a catheter adapter (not shown).

[0028] The lever lock 205 further includes an elongated coupler portion 206 extending from the distal end 203 of the introducer body 202. In some embodiments, the coupler portion 206 is substantially cylindrical and surrounds the lumen 211. However, it should be understood that the coupler portion 206 need not be cylindrical and may be formed in any suitable shape or shapes. The coupler portion 206 may be coupled with the introducer body 202 via any suitable means. In some embodiments, the coupler portion 206 may be fixedly attached to the introducer body 202, while in other embodiments, the coupler portion 206 may be movably coupled to the introducer body 202.

[0029] As mentioned above, the flow tube 212 of the fluid transfer device 200 is configured to be extendable (and retractable) from the introducer body 202 through the lumen 211 to be selectively positioned within the patient's vasculature beyond the distal end of the indwelling catheter, thereby allowing blood to be drawn through the fluid transfer device 200. However, due to variations in the length of the indwelling catheter, in some instances the flow tube may not extend sufficiently beyond the distal end of the indwelling catheter, or alternatively may extend an undesirable distance beyond the distal end of the indwelling catheter. Thus, according to one aspect of the present disclosure and as shown in FIGS. 2A and 2B, the fluid transfer device 200 is configured such that the length of the coupler portion 206 of the lever lock 205 may vary to accommodate indwelling catheters of various lengths. For example, with reference to FIG. 2A, the lever lock 205 has a length C that extends from the distal end 203 of the introducer body 202 to the distal end of the blunt cannula 210. However, with reference to Figure 2B, lever lock 205 has a length D extending from the distal end 203 of introducer body 202 to the distal end of blunt cannula 210, length D being greater than length C. To provide such a varied overall length, lever lock 205 may include a varied length coupler portion 206, as shown in Figures 2A and 2B.

[0030] Thus, the fluid transfer device 200 may be configured for use with indwelling catheters having a variety of lengths. For example, with reference to FIG. 2A, a lever lock 205 having an overall external length C may be utilized with a longer indwelling catheter (e.g., a 1.75 inch catheter). This is because the shorter length of the lever lock allows for a longer length of the flow tube 212 to be fed from the fluid transfer device 200, through the catheter adapter, and through (and beyond) the indwelling catheter. Conversely, with reference to FIG. 2B, a lever lock 205 having an overall external length D may be utilized with a shorter indwelling catheter (e.g., a 1.00 inch catheter) because the longer lever lock 205 allows for a shorter length of the flow tube 212 to be fed from the fluid transfer device 200. In this manner, the dimensions of the introducer body 202 and / or the flow tube 212 do not need to be altered to accommodate indwelling catheters of various lengths.

[0031] In some embodiments, the fluid transfer device 200 may include a lever lock 205 fixedly coupled to the distal end 203 of the introducer body 202. Thus, in such embodiments, a fluid transfer device 200 having a particular length of lever lock 205 may be specifically selected based on the length of a known indwelling catheter. Alternatively, in other embodiments, the lever lock 205 may be selectively separate from the introducer body 202, thereby allowing a user to select an appropriate length of lever lock 205 while still using a common introducer body 202.

[0032] Additionally, although FIGS. 2A and 2B show the lever lock 205 having two different lengths, it should be understood that the lever lock 205 may be provided with more than two lengths to accommodate other indwelling catheter lengths, such as, for example, 1.25 inches.

[0033] 3A and 3B, a fluid transfer device 300 according to another aspect of the present disclosure is shown. The fluid transfer device 300 includes an introducer body 302 having a distal end 303. Although not shown, it should be understood that the introducer body 302 further includes a proximal end, which may be configured to include an interface (e.g., a threaded interface) for coupling the fluid transfer device 300 to, for example, a Luer Lock Access Device (LLAD) to perform blood collection. However, it should be understood that the proximal end of the introducer body 302 may have any suitable interface and / or coupling means.

[0034] 2A and 2B, it should be appreciated that the fluid transfer device 300 may be configured to include an actuator member that is movable relative to the introducer body 302. In some embodiments, the actuator may be configured to be slidable along at least a portion of the length of the introducer body 302, and the actuator is also coupled to the flexible flow tube 312 such that movement of the actuator along the introducer body 302 results in corresponding linear movement of the flow tube 312 relative to the introducer body 302. However, the actuator is not limited to such a slidable configuration, and any suitable actuator mechanism may be utilized.

[0035] Fluid transfer device 300 also includes a lever lock 305 configured to removably couple fluid transfer device 300 to, for example, the hub of a catheter adapter. Deflectable arms 308A, 308B enable such selective connection to the hub of a catheter adapter, and blunt cannula 310 extends from a distal end of lever lock 305, blunt cannula 310 including a lumen extending therethrough, which when interconnected fluidly couples fluid transfer device 300 and a catheter adapter (not shown).

[0036] 3A and 3B, the lever lock 305 further includes an elongated coupler portion 306 that is sized and configured to fit within the distal end portion of the introducer body 302. In some embodiments, the coupler portion 306 is substantially cylindrical and surrounds the lumen 311. However, it should be understood that the coupler portion 306 need not be cylindrical and may be formed in any suitable shape or shapes. According to one aspect of the disclosure and as shown in FIGS. 3A and 3B, the fluid transfer device 300 is configured such that the coupler portion 306 of the lever lock 305 telescopically slides within the distal portion of the introducer body to accommodate indwelling catheters of various lengths. For example, referring to FIG. 3A, the lever lock 305 has a length E that extends from the distal end 303 of the introducer body 302 to the distal end of the blunt cannula 310. However, with reference to FIG. 3B, lever lock 305 has a length F extending from the distal end 303 of introducer body 302 to the distal end of blunt cannula 310, length F being greater than length E.

[0037] In some embodiments, the introducer body 302 may include an inner sidewall 304 that tapers inwardly as it approaches the distal end 303. In such a configuration, as the lever lock 305 is pulled to its maximum length, the outer surface of the coupler portion 306 (particularly the proximal end of the coupler portion 306) may form an interference fit with the inner sidewall 304, thereby substantially preventing the lever lock 305 from being completely removed from the introducer body 302 when pulled. Additionally and / or alternatively, although not shown, the coupler portion 306 and / or the inner sidewall 304 may include a detent and / or stop mechanism that engages the lever lock 305 at a desired position relative to the introducer body 302. In some embodiments, the lever lock 305 may include a tab or other mechanism for engaging a stop mechanism on the introducer body 302.

[0038] Thus, the fluid transfer device 300 may be configured for use with indwelling catheters having a variety of lengths. For example, with reference to FIG. 3A, the lever lock 305 may be positioned with an overall external length E to be utilized with a longer indwelling catheter (e.g., a 1.75 inch catheter) such that the shorter lever lock length results in a longer length of the fluid tube 312 fed from the fluid transfer device 300 through the catheter adapter, and the distal end 313 of the fluid tube 312 extends adequately beyond the indwelling catheter. Conversely, with reference to FIG. 3B, the lever lock 305 may be pulled outward to provide a longer overall external length F, allowing the fluid transfer device 300 to be utilized with a shorter indwelling catheter (e.g., a 1.00 inch catheter). In this manner, the dimensions of the introducer body 302 and / or the flow tube 312 do not need to be altered to accommodate indwelling catheters of various lengths.

[0039] 4A and 4B, a fluid transfer device 400 according to another aspect of the present disclosure is shown. The fluid transfer device 400 includes an introducer body 402 having a distal end 403 and a proximal end 404. The proximal end 404 may be configured to include an interface (e.g., a threaded interface) for coupling the fluid transfer device 400 to a Luer Lock Access Device (LLAD), for example, for performing a blood draw. However, it should be understood that the proximal end of the introducer body 402 may have any suitable interface and / or coupling means.

[0040] It should further be appreciated that the fluid transfer device 400 may be configured to include an actuator member that is movable relative to the introducer body 402. In some embodiments, the actuator may be configured to be slidable along at least a portion of the length of the introducer body 402, and the actuator is also coupled to a flexible flow tube (not shown) such that movement of the actuator along the introducer body 402 results in corresponding linear movement of the flow tube relative to the introducer body 402. However, the actuator is not limited to such a slidable configuration, and any suitable actuator mechanism may be utilized.

[0041] Fluid transfer device 400 further includes a lever lock 405 configured to removably couple fluid transfer device 400 to, for example, the hub of a catheter adapter. Deflectable arms 412A, 412B enable such selective connection to the hub of a catheter adapter, and blunt cannula 414 extends from a distal end of lever lock 405, blunt cannula 414 including a lumen extending therethrough, and fluidly couples fluid transfer device 400 and a catheter adapter (not shown) when interconnected.

[0042] The lever lock 405 further includes an elongated coupler body 410 that is sized and configured for slidable movement within the introducer body 402. In some embodiments, the coupler body 410 is substantially cylindrical. However, it should be understood that neither the coupler body 410 nor the introducer body need be cylindrical, but may be formed in any suitable shape or shapes.

[0043] 4A and 4B, the lever lock 405 may further include a pin 408 biased by a spring 409 and extending laterally from a proximal portion of the coupler body 410. Additionally, the introducer body 402 may include at least two openings 406, 407 formed therein, with a first opening 406 disposed near a proximal end portion of the introducer body 402 and a second opening 407 disposed near a distal end portion of the introducer body 402. Both the first opening 406 and the second opening 407 are aligned and sized to capture the spring biased pin 408 when the lever lock 405 is moved to a position proximate either of the respective openings 406, 407. In this manner, engagement between the pin 408 and the openings 406, 407 provides a stop for the lever lock 405, limiting further axial movement of the lever lock 405 unless a user manually depresses the spring-loaded pin 408 and pushes or pulls the lever lock 405 relative to the introducer body 402.

[0044] According to one aspect of the disclosure, as shown in FIGS. 4A and 4B, a fluid transfer device 400 is configured such that a coupler body 410 of a lever lock 405 is telescopically slidable within an introducer body 402 to accommodate indwelling catheters of various lengths, with the lever lock 405 selectively secured in a desired position by a pin 408 and respective openings 406, 407. For example, with reference to FIG. 4A, the lever lock 405 has a length G that extends from the distal end 403 of the introducer body 402 to the distal end of the blunt cannula 414. This position is "locked" by the engagement of the spring-loaded pin 408 with the first opening 406. Alternatively, with reference to FIG. 4B, the lever lock 405 has a length H that extends from the distal end 403 of the introducer body 402 to the distal end of the blunt cannula 414, with the length H being greater than the length G. This particular position is "locked" by the engagement of the spring-loaded pin 408 with the second opening 407. Thus, the fluid transfer device 400 may be configured for use with indwelling catheters having a variety of lengths. For example, with reference to FIG. 4A, the lever lock 405 (and pin 408) may be positioned relative to the first opening 406 to provide an overall external length G for use with longer indwelling catheters (e.g., 1.75 inch catheters) due to the shorter lever lock length resulting in a longer length of flow tubing delivered from the fluid transfer device 400, through the catheter adapter, and over the indwelling catheter. Conversely, with reference to FIG. 4B, the lever lock 405 (and pin 408) may be positioned relative to the second opening 407 to provide a longer overall external length H, allowing the fluid transfer device 400 to be utilized with shorter indwelling catheters (e.g., 1.00 inch catheters).

[0045] Although the embodiment shown in Figures 4A and 4B only shows the introducer body 402 as having two openings 406, 407, it should be understood that one or more additional openings may be provided on the introducer body 402 to accommodate indwelling catheters of other lengths (e.g., 1.25 inch catheters).

[0046] Additionally, although not shown in FIGS. 4A and 4B, it should be understood that labels or other indicia may be provided near each opening 406, 407 of the introducer body 402 to indicate which opening corresponds to which length of the indwelling catheter and / or type of catheter. Additionally, in some embodiments, the introducer body 402 may incorporate a "default" or "baseline" opening at its proximal end portion, where the baseline opening does not correspond to the length of the indwelling catheter and / or type of catheter. In this manner, the lever lock 405 may be set to a baseline position prior to any use, thereby requiring the user to specifically adjust the lever lock 405 to a desired position, which helps ensure that the correct position of the lever lock 405 is selected for the actual indwelling catheter length and / or type of catheter.

[0047] 5, a fluid transfer device 500 according to another aspect of the present disclosure is shown. The fluid transfer device 500 includes an introducer body 502 having a distal end 503 and a proximal end 507. Although not shown in FIG. 5, it should be understood that the proximal end 507 may be configured to include an interface (e.g., a threaded interface) for coupling the fluid transfer device 500 to a Luer Lock Access Device (LLAD), for example, for performing a blood draw. However, it should be understood that the proximal end 507 of the introducer body 502 may have any suitable interface and / or coupling means.

[0048] Additionally, although not shown, it should be understood that the fluid transfer device 500 may be configured to include an actuator member that is movable relative to the introducer body 502. In some embodiments, the actuator may be configured to be slidable along at least a portion of the length of the introducer body 502, and the actuator is also coupled to a flexible flow tube (not shown) such that movement of the actuator along the introducer body 502 results in corresponding linear movement of the flow tube relative to the introducer body 502. However, the actuator is not limited to such a slidable configuration, and any suitable actuator mechanism may be utilized.

[0049] Fluid transfer device 500 further includes a lever lock 505 configured to removably couple fluid transfer device 500 to, for example, the hub of a catheter adapter. Deflectable arms 512A, 512B enable such selective connection to the hub of a catheter adapter, and blunt cannula 514 extends from a distal end of lever lock 505, blunt cannula 514 including a lumen extending therethrough, which when interconnected fluidly couples fluid transfer device 500 and a catheter adapter (not shown).

[0050] The lever lock 505 further includes an elongated coupler body 510 that is sized and configured for slidable movement within the introducer body 502. In some embodiments, the coupler body 510 is substantially cylindrical. However, it should be understood that neither the coupler body 510 nor the introducer body need be cylindrical, but may be formed in any suitable shape or shapes.

[0051] 5, the lever lock 505 may be coupled to a cantilever slider member 515 that extends laterally from a proximal portion of the coupler body 510. Although not shown, the introducer body 502 may include a pair of slots formed along its axial length that are configured to receive respective coupling arms 516A, 516B of the cantilever slider member 515. This configuration of the cantilever slider member 515 allows the cantilever slider member 515 to be pinched or otherwise manually manipulated such that the hook-like engagement portions 517A, 517B can be engaged or disengaged from respective openings formed in the introducer body 502 via a cantilever action, as described in more detail below.

[0052] 5, the introducer body 502 can include opposing pairs of openings 504A, 504B, 506A, 506B, 508A, 508B formed therein. A first opposing pair of openings 504A, 504B can be disposed near a proximal end portion of the introducer body 502, a third opposing pair of openings 508A, 508B can be disposed near a distal end portion of the introducer body 502, and a second opposing opening 506A, 506B can be disposed therebetween. The opposing pairs of openings 504A, 504B, 506A, 506B, 508A, 508B are aligned and sized to capture respective engagement portions 517A, 517B of the cantilever slider member 515 when the lever lock 505 is moved into position adjacent the openings 504A, 504B, 506A, 506B, 508A, 508B. In this manner, the engagement between the engagement portions 517A, 517B and the openings 504A, 504B, 506A, 506B, 508A, 508B provides a stop for the lever lock 505, limiting further axial movement of the lever lock 505 unless a user manually actuates the cantilever slider member 515 to push or pull the lever lock 505 relative to the introducer body 402.

[0053] 5, the fluid transfer device 500 is configured such that the coupler body 510 of the lever lock 505 is telescopically slidable within the introducer body 502 to accommodate indwelling catheters of various lengths, with the lever lock 505 selectively secured in a desired position by engagement portions 517A, 517B and openings 504A, 504B, 506A, 506B, 508A, 508B. For example, in the position shown in FIG. 5, the lever lock 505 extends a relatively short length from the distal end 503 in a position suitable for use with an indwelling catheter (e.g., a 1.00 inch catheter) because the longer length of the lever lock allows for a shorter length of flow tubing to be delivered from the fluid transfer device 500, through the catheter adapter, and over the indwelling catheter. Conversely, if the lever lock 505 (and cantilever slider member 515) is positioned relative to the openings 504A, 504B and / or 506A, 506B to provide a shorter overall external length of the lever lock 505, the fluid transfer device 500 can be utilized with a longer indwelling catheter (e.g., a 1.25 inch catheter, a 1.75 inch catheter, etc.).

[0054] While the embodiment shown in FIG. 5 only illustrates the introducer body 502 as having three pairs of openings 504A, 504B, 506A, 506B, 508A, 508B, it should be understood that more or fewer opening pairs may be provided on the introducer body 502. Additionally, although not shown in FIG. 5, it should be understood that labels or other indicia may be provided proximate each opening 504A, 504B, 506A, 506B, 508A, 508B pair on the introducer body 502 to indicate which opening pair corresponds to which length of the indwelling catheter and / or type of catheter. Additionally, in some embodiments, the introducer body 502 may incorporate a "default" or "baseline" opening pair at its proximal end portion, where the baseline opening pair does not correspond to the length of the indwelling catheter and / or type of catheter. In this manner, the lever lock 505 can be set to a baseline position prior to any use, thereby requiring the user to specifically adjust the lever lock 505 to the desired position, which helps to ensure that the correct position of the lever lock 505 is selected for the actual indwelling catheter length and / or catheter type.

[0055] 6A and 6B, a fluid transfer device 600 according to another aspect of the present disclosure is shown. The fluid transfer device 600 includes an introducer body 602 having a distal end 603 and a proximal end (not shown). The proximal end may be configured to include an interface (e.g., a threaded interface) for coupling the fluid transfer device 600 to a Luer Lock Access Device (LLAD), for example, for performing a blood draw. However, it should be understood that the proximal end of the introducer body 602 may have any suitable interface and / or coupling means.

[0056] Additionally, although not shown, it should be understood that the fluid transfer device 600 may be configured to include an actuator member that is movable relative to the introducer body 602. In some embodiments, the actuator may be configured to be slidable along at least a portion of the length of the introducer body 602, and the actuator is also coupled to a flexible flow tube (not shown) such that movement of the actuator along the introducer body 602 results in corresponding linear movement of the flow tube relative to the introducer body 602. However, the actuator is not limited to such a slidable configuration, and any suitable actuator mechanism may be utilized.

[0057] Fluid transfer device 600 further includes a lever lock 605. Lever lock 405 is configured to removably couple fluid transfer device 600 to, for example, the hub of a catheter adapter. Deflectable arms 608A, 608B enable such selective connection to the hub of a catheter adapter, and blunt cannula 610 extends from a distal end of lever lock 605, blunt cannula 610 including a lumen extending therethrough, and fluidly couples fluid transfer device 600 and a catheter adapter (not shown) when interconnected.

[0058] The lever lock 605 further includes an elongated coupler body 606. As shown in Figures 6A and 6B, the coupler body 606 includes a plurality of external threads 611 extending along at least a portion of its length. Additionally, the introducer body 602 includes a proximal portion 604 having a plurality of internal threads 612, the internal threads 612 of the proximal portion 604 being dimensioned and configured to receive the external threads 611 of the coupler body 606. In some embodiments, both the coupler body 606 and the proximal portion 604 are substantially cylindrical.

[0059] According to one aspect of the disclosure, as shown in Figures 6A and 6B, the fluid transfer device 600 is configured such that the coupler body 606 of the lever lock 605 is axially translatable relative to the introducer body 602 to accommodate indwelling catheters of various lengths, and the lever lock 605 is selectively extended to a desired position by clockwise or counterclockwise rotation of the lever lock 605 relative to the introducer body 602. For example, with reference to Figure 6A, the lever lock 605 has a length J that extends from the distal end 603 of the introducer body 602 to the distal end of the blunt cannula 610. Alternatively, with reference to Figure 6B, the lever lock 605 has a length K that extends from the distal end 603 of the introducer body 602 to the distal end of the blunt cannula 610, where the length K is greater than the length J.

[0060] Thus, the fluid transfer device 600 may be configured for use with indwelling catheters having a variety of lengths. For example, with reference to FIG. 4A, the lever lock 605 may be positioned relative to the distal end 603 of the introducer body 602 to provide an overall external length J for utilization with longer indwelling catheters (e.g., 1.75 inch catheters) because a shorter lever lock length allows a longer length of flow tubing (not shown) to be delivered from the fluid transfer device 600, through the catheter adapter, and over the indwelling catheter. Conversely, with reference to FIG. 6B, the lever lock 605 may be positioned relative to the distal end 603 of the introducer body 602 to provide an overall external length K for utilization with shorter indwelling catheters (e.g., 1.00 inch catheters).

[0061] 6A and 6B, it is understood that the introducer body 602 and / or lever lock 605 may include one or more detents and / or stops configured to limit the adjustment position of the lever lock 605 relative to the introducer body 602. Additionally and / or alternatively, the coupler body 606 of the lever lock 605 may include markings and / or other indicia to provide guidance to a user regarding proper positioning of the lever lock 605 for use with a particular length of indwelling catheter.

[0062] 7A and 7B, a fluid transfer device 700 according to another embodiment of the present disclosure is shown. The fluid transfer device 700 includes an introducer body 702 having a distal end 710 and a proximal end 705. Although not shown, the proximal end 705 may be configured to include an interface (e.g., a threaded interface) for coupling the fluid transfer device 700 to a Luer Lock Access Device (LLAD), for example, for performing a blood draw. However, it should be understood that the proximal end 705 may have any suitable interface and / or coupling means.

[0063] As shown in FIG. 7A, the fluid transfer device 700 may include an actuator portion 704 movable relative to the introducer body 702. Specifically, the actuator portion 704 may include a rotational actuator rotatable in both clockwise and counterclockwise directions relative to the introducer body. The actuator portion 704 is coupled to a flexible flow tube 706 such that rotational movement of the actuator portion 704 results in corresponding linear movement of the flow tube 706 relative to the introducer body 702. In this manner, the flow tube 706 may be fed through and / or stored in the fluid transfer device 700 such that a distal end 708 of the flow tube 706 may extend beyond the indwelling catheter. However, it should be understood that other forms of actuators and / or methods of actuation of the flow tube 706 relative to the introducer body 702 may also be utilized in accordance with the present disclosure.

[0064] 7A, the fluid transfer device 700 also includes a first lever lock 711. The first lever lock 711 is configured to removably couple the fluid transfer device 700 to, for example, the hub of a catheter adapter. The deflectable arms 714A, 714B enable such selective connection to the hub of the catheter adapter, and a blunt cannula 716 extends from a distal end of the first lever lock 711, the blunt cannula 716 including a lumen (not shown) extending therethrough, which when interconnected fluidly couples the fluid transfer device 700 and the catheter adapter (not shown).

[0065] The first lever lock 711 further includes an elongated coupler portion 712 configured to be removably coupled to a distal end portion of the introducer body 702. In some embodiments, the coupler portion 712 is substantially cylindrical. However, it should be understood that the coupler portion 712 need not be cylindrical and may be formed in any suitable shape or shapes. The coupler portion 712 may be selectively coupled to the introducer body 702 via any suitable attachment method or mechanism, such as, for example, an interference fit, a cantilever snap fit, an annular snap fit, one or more magnets, a threaded interface, etc.

[0066] As previously mentioned, due to variations in the length of the indwelling catheter, in some instances the flow tube may not extend far enough beyond the distal end of the indwelling catheter, or alternatively may extend an undesirable distance beyond the distal end of the indwelling catheter. Thus, according to one aspect of the present disclosure, as shown in Figures 7A and 7B, a fluid transfer device 700 may be provided and / or packaged with a number of different lever locks, each configured to accommodate a particular length of indwelling catheter. For example, with reference to Figure 7A, a first lever lock 711 has a coupler portion 712 configured to extend a first length beyond the distal end 710 of the introducer body 702. However, with reference to Figure 7B, a completely separate second lever lock 721 may be provided. Similar to the first lever lock 711, the second lever lock 721 includes deflectable arms 722A, 722B to allow the second lever lock 721 to be selectively connected to a hub of a catheter adapter, and a blunt cannula 724 extends from a distal end of the second lever lock 721 to fluidly couple the fluid transfer device 700 and a catheter adapter (not shown) when interconnected. The second lever lock 721 may also include a coupler portion 723, which may be selectively coupled to the introducer body 702 via any suitable attachment method or mechanism, such as, for example, an interference fit, a cantilever snap fit, an annular snap fit, one or more magnets, a threaded interface, etc.

[0067] As shown in Figures 7A and 7B, the coupler portion 722 is shorter than the coupler portion 712 of the first lever lock 721. In this manner, the fluid transfer device 700 may include various lever locks for use with indwelling catheters having various lengths. For example, with reference to Figure 7A, the first lever lock 711 may be utilized with a shorter indwelling catheter (e.g., a 1.00 inch catheter) because the longer coupler portion 712 of the first lever lock 711 allows for a shorter length of the flow tube 706 to be delivered from the fluid transfer device 700, through the catheter adapter, and through (and beyond) the indwelling catheter. Conversely, with reference to Figure 7B, the second lever lock 721 may be utilized with a longer indwelling catheter (e.g., a 1.75 inch catheter) because the shorter coupler portion 723 allows for a longer length of the flow tube 706 to be delivered from the fluid transfer device 700. In this manner, the dimensions of the introducer body 702 and / or flow tube 706 do not need to be altered to accommodate indwelling catheters of various lengths.

[0068] In some embodiments, the fluid transfer device 700 is packaged with multiple lever locks of various sizes and configurations, thereby allowing a user to select an appropriate lever lock for connection to the introducer body depending on, for example, the length of the indwelling catheter, the application, etc. Although Figures 7A and 7B only show lever locks having two different lengths, it should be understood that the fluid transfer device 700 may include two or more different lever locks to accommodate other indwelling catheter lengths, such as, for example, 1.25 inches.

[0069] Additionally and / or alternatively, the first lever lock 711 and / or the second lever lock 721 may include markings and / or other indicia to provide guidance to a user regarding the proper selection of the lever lock(s) for use with an indwelling catheter of a particular length and / or a particular application. For example, the first lever lock 711 may be labeled "1.00" to indicate its intended use with an indwelling catheter having a length of 1.00 inches, and the second lever lock 721 may be labeled "1.75" to indicate its intended use with an indwelling catheter having a length of 1.75 inches.

[0070] Although several embodiments of a fluid transfer device configured for blood sampling during catheterization have been described in the foregoing detailed description, those skilled in the art may make modifications and variations to these embodiments without departing from the scope and spirit of the invention. Accordingly, the above description is intended to be illustrative rather than limiting. The invention described above is defined by the appended claims, and all changes to the invention that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. 1. A fluid transfer device for use with a peripheral intravenous catheter (PIVC), comprising: an introducer body having a proximal end and a distal end; a flow tube at least partially contained within the introducer body, the flow tube being configured to be selectively extendable from the introducer body; a lever lock coupled to the distal end of the introducer body, the lever lock including a lumen configured to allow the flow tube to pass therethrough, the effective length of the lever lock relative to the distal end of the introducer body being adjustable to accommodate use of the fluid transfer device with indwelling catheters of the PIVC having different lengths; A fluid transfer device comprising:

2. The fluid transfer device of claim 1 , wherein the lever lock includes an elongated coupler portion, a pair of deflectable arms, and a blunt cannula.

3. The fluid transfer device of claim 2 , wherein the pair of deflectable arms are configured to releasably couple the lever lock to a hub of a catheter adapter of the PIVC.

4. The fluid transfer device of claim 2 , wherein at least a portion of the elongated coupler portion is configured to be slidable within at least a distal portion of the introducer body.

5. The fluid transfer device of claim 4 , wherein the distal portion of the introducer body is tapered to limit the amount that the elongated coupler portion of the lever lock can slide relative to the distal portion of the introducer.

6. The fluid transfer device of claim 2 , wherein the elongated coupler portion of the lever lock includes a plurality of external threads, and the distal portion of the introducer body includes a plurality of internal threads engagable with the external threads of the elongated coupler portion.

7. The fluid transfer device of claim 2 , further comprising a spring-loaded pin coupled to the elongated coupler portion of the lever lock.

8. 8. The fluid transfer device of claim 7, wherein the introducer body further comprises at least two openings formed therein, and the spring-loaded pin of the elongated coupler portion of the lever lock is configured to selectively engage the at least two openings in the introducer body.

9. The fluid transfer device of claim 2 , further comprising a cantilever slider member coupled to a proximal portion of the elongated coupler portion of the lever lock, the cantilever slider member comprising a pair of engagement portions.

10. 10. The fluid transfer device of claim 9, wherein the introducer body further includes at least two pairs of openings formed therein, and the pair of engagement portions of the cantilever slider member are configured to selectively engage with the at least two pairs of openings of the introducer body.

11. The fluid transfer device of claim 1 , further comprising an actuator member movable relative to the introducer body, the actuator member configured to feed the flow tube through the introducer body and the lever lock.

12. The fluid transfer device of claim 1 , wherein the proximal end of the introducer body comprises a threaded interface.

13. 1. A fluid transfer device for use with a peripheral intravenous catheter (PIVC), comprising: an introducer body having a proximal end and a distal end; a flow tube at least partially contained within the introducer body, the flow tube being configured to be selectively extendable from the introducer body; a first lever lock selectively coupleable to the distal end of the introducer body, the first lever lock including a first lumen configured to allow the flow tube to pass therethrough; a second lever lock selectively coupleable to the distal end of the introducer body, the second lever lock including a second lumen configured to allow the flow tube to pass therethrough; and Including, A fluid transfer device, wherein the length of the first lever lock is shorter than the length of the second lever lock to accommodate use of the fluid transfer device with indwelling PIVC catheters having various lengths.

14. The fluid transfer device of claim 13 , wherein each of the first and second lever locks comprises an elongated coupler portion, a pair of deflectable arms, and a blunt cannula.

15. The fluid transfer device of claim 14 , wherein the pair of deflectable arms are configured to releasably couple the lever lock to a hub of a catheter adapter of the PIVC.

16. 14. The fluid transfer device of claim 13, wherein the first lever lock is configured for use with an indwelling catheter having a length of 1.00 inches and the second lever lock is configured for use with an indwelling catheter having a length of 1.75 inches.

17. 1. A fluid transfer device for use with a peripheral intravenous catheter (PIVC), comprising: an introducer body having a proximal end and a distal end; a flow tube at least partially contained within the introducer body, the flow tube being configured to be selectively extendable from the introducer body; a lever lock coupled to the distal end of the introducer body, the lever lock including an elongated coupler portion, the elongated coupler portion being extendable and retractable within at least the distal portion of the introducer body to accommodate use of the fluid transfer device with indwelling catheters of the PIVC having different lengths; A fluid transfer device comprising:

18. 18. The fluid transfer device of claim 17, wherein the lever lock further comprises a pair of deflectable arms and a blunt cannula, the pair of deflectable arms configured to releasably couple the lever lock to a hub of a catheter adapter of the PIVC.

19. 18. The fluid transfer device of claim 17, further comprising a spring-loaded pin coupled to the elongated coupler portion of the lever lock, the introducer body further including at least two openings formed therein, the spring-loaded pin of the elongated coupler portion of the lever lock configured to selectively engage the at least two openings of the introducer body.

20. 20. The fluid transfer device of claim 17, further comprising a cantilever slider member coupled to a proximal portion of the elongated coupler portion of the lever lock, the cantilever slider member including a pair of engagement portions, the introducer body further including at least two openings formed therein, the pair of engagement portions of the cantilever slider member configured to selectively engage the at least two openings of the introducer body.

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