Blood collection equipment

Abstract

The blood collection device includes a catheter, an introducer having a proximal end portion and a distal end portion, an actuator movably coupled to the introducer, the actuator configured to move relative to the introducer to move the catheter between a first position in which the catheter is disposed within the introducer and a second position in which the distal end portion of the catheter is disposed beyond the distal end portion of the introducer, the second position in which the distal end portion of the catheter is disposed beyond the distal end portion of the introducer such that at least a first portion of the catheter is disposed within the peripheral venous line when the introducer is coupled to the peripheral venous line, and a catheter support movably coupled to the introducer. The catheter support includes a bracket portion and a hub portion including a passageway and extending from the bracket portion. The bracket portion of the catheter support is biased against a portion of the introducer.

Description

[Technical field]

[0001] The present invention relates to a blood collection device. [Background technology]

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 309,336, entitled "BLOOD COLLECTION DEVICE," filed February 11, 2022, the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] A typical hospitalized patient encounters a needle every time a physician orders a laboratory test. The standard procedure for blood collection involves using a metal needle (a "butterfly needle") to "poke" a patient's vein in the arm or hand. Blood collection is a manual, labor-intensive process, with the average patient requiring several hours of direct skilled labor during a typical hospital stay. Not only is this needlestick painful, and it is also a major source of patient dissatisfaction, but nurses or specialized blood collection personnel (phlebotomists) often have difficulty finding a vein in approximately 10-15% of patients, resulting in multiple painful "poke" attempts. This significantly increases material and labor costs (needles and tubes must be disposed of after every attempt) and increases pain and bruising for the patient.

[0004] The current blood collection process is inefficient, taking an average of 7-10 minutes, with 10% of patients taking more than 21 minutes. These 10% of patients are referred to as difficult IV access, or more commonly "tough stick" patients. When superficial veins are not readily apparent, blood can be forced into the vein by massaging the vein from the wrist to the elbow, tapping the site with the index and middle fingers, applying a warm, moist washcloth to the site for 5 minutes, or lowering the limb to the bedside to allow the vein to fill. Each of these methods is time consuming and therefore costly.

[0005] Peripheral intravenous catheters (PIVs) are inserted in most patients during hospitalization and are used to infuse fluids and medications; however, they are not designed for blood sampling. When PIVs are left inserted for more than a day, aspiration failure rates reach 20-50%. Blood drawn through PIVs is often hemolyzed, defined as the rupture of red blood cells and the release of their contents into the surrounding fluid, resulting in the sample being discarded and the need for repeated blood draws.

[0006] Several barriers may contribute to the drawbacks of extracting blood via a PIV. First, most catheters are formed from soft bioreactive polymers, which may lead to potential stenosis or collapse of the catheter when negative pressure is applied for aspiration. Another barrier is that longer indwelling times may increase debris (e.g., fibrin / platelet clots) accumulating at the tip of the catheter and within the lumen of the catheter and / or PIV. Similarly, such debris may at least partially occlude the lumen of the vein in which the PIV is placed. In some instances, this debris (e.g., fibrin / platelet clots) around the PIV may result in reduced blood flow (e.g., both upstream and downstream) within the portion of the vein surrounding the inserted PIV, which in turn results in inadequate and / or inefficient aspiration. Another barrier is due to the "suction cup" effect, where the negative pressure created by aspiration through the catheter and the possible tortuous path of the vein results in the tip of the catheter adhering to the wall of the vein. Increased negative pressure can cause the vein to burst and "blow out the vein," a concern for phlebotomists during aspiration via PIV.

[0007] Some of these shortcomings can be overcome by using a fluid transfer device in which a catheter is inserted into and / or through the PIV. However, during deployment of the catheter of the fluid transfer device, particularly when the proximal end portion of the catheter reaches the S-curve region of the PIV near where the PIV enters the skin, curves upward within the PIV, and curves again to pass along the vein, the catheter of the fluid transfer device is subjected to column loads that can cause bending, twisting, and / or deformation of the catheter of the fluid collection. As the catheter bends, it can move in random directions to create a sine wave, and then flatten against the sidewall of the housing of the fluid transfer device as the force increases. Further application of force can cause the catheter to double back and collapse. Thus, there is a need for a fluid transfer device that at least solves this problem. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Pat. No. 8,366,685 [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a perspective view of a fluid transfer device of the present invention in a first configuration. [Diagram 2] FIG. 2 is a top view of the fluid transfer device of the present invention shown in FIG. [Diagram 3] FIG. 3 is an exploded view of the fluid transfer device of the present invention shown in FIG. [Figure 4] FIG. 4 is a perspective view of a first member of an introducer included in the fluid transfer device of the present invention of FIG. [Diagram 5] FIG. 5 is a perspective view of a second member of an introducer included in the fluid transfer device of the present invention of FIG. [Figure 6] FIG. 6 is a side view of the second member shown in FIG. [Figure 7] FIG. 7 is an enlarged view of the area of ​​the second member identified as A1 in FIG. [Figure 8] 8 is a rear perspective view of an introducer formed by joining the first member shown in FIG. 4 to the second member shown in FIG. [Figure 9] FIG. 9 is a front perspective view of the introducer shown in FIG. [Figure 10] FIG. 10 is a cross-sectional view of the introducer taken along line 10-10 of FIG. [Figure 11] 11 is a rear perspective view of a lock included in the fluid transfer device of the present invention of FIG. [Figure 12] FIG. 12 is a top view of a lock included in the fluid transfer device of the present invention of FIG. [Figure 13] FIG. 13 is a cross-sectional view of the lock taken along line 13-13 of FIG. [Figure 14] FIG. 14 is an exploded perspective view of the catheter, secondary catheter, and actuator included in the fluid transfer device of the present invention of FIG. [Figure 15] FIG. 15 is a perspective view of the actuator shown in FIG. [Figure 16] FIG. 16 is a side view of the actuator shown in FIG. [Figure 17] FIG. 17 is a front view of the actuator shown in FIG. [Figure 18] FIG. 18 is a cross-sectional view of the fluid transfer device of the present invention taken along line 18-18 of FIG. [Figure 19A] 19A is a perspective view of the catheter support shown in FIG. [Figure 19B] FIG. 19B is a front view of the catheter support shown in FIG. 5 with an optional engagement member. [Figure 20] FIG. 20 is a side perspective view of the introducer of the fluid transfer device of the present invention of FIG. 1 with the second member of the introducer removed. [Figure 21]21 is a perspective view of a catheter support within the introducer of the fluid transfer device of the present invention of FIG. [Figure 22A] FIG. 22A is a side perspective view of the introducer of the fluid transfer device of the invention of FIG. 1 in a first configuration with the second member of the introducer removed. [Figure 22B] FIG. 22B is a side perspective view of the introducer of the fluid transfer device of FIG. 1 when the fluid transfer device of the present invention transitions from the first configuration to the second configuration and the second member of the introducer is removed. [Figure 22C] FIG. 22C is a side perspective view of the introducer of the fluid transfer device of the invention of FIG. 1 in a second configuration with the second member of the introducer removed. [Diagram 23] FIG. 23 is a side cross-sectional view of an actuator and catheter support of a fluid transfer device of the present invention just prior to nesting a portion of the actuator within a portion of the passageway of the catheter support. [Figure 24] FIG. 24 is a side view of the fluid transfer device of the present invention of FIG. 1 in a first configuration. [Diagram 25] FIG. 25 is a cross-sectional view of the fluid transfer device of the present invention in a first configuration taken along line 25-25 of FIG. [Figure 26] FIG. 26 is an enlarged cross-sectional view of a portion of the fluid transfer device of the present invention identified by area A2 in FIG. [Figure 27] FIG. 27 is an enlarged cross-sectional view of a portion of the fluid transfer device of the present invention identified by area A3 in FIG. [Figure 28] FIG. 28 is a side view of the fluid transfer device of FIG. 1 as the fluid transfer device of the present invention transitions from a first configuration to a second configuration. [Figure 29] FIG. 29 is an enlarged view of a portion of the fluid transfer device of the present invention identified by area A4 in FIG. [Diagram 30] FIG. 30 is a side view of the fluid transfer device of the present invention of FIG. 1 in a second configuration. [Diagram 31]FIG. 31 is a cross-sectional view of the fluid transfer device of the present invention in the second configuration taken along line 25-25 in FIG. [Diagram 32] FIG. 32 is an enlarged cross-sectional view of a portion of the fluid transfer device of the present invention identified by area A5 in FIG. [Figure 33A] FIG. 33A is a perspective view of an arrangement for coupling an actuator to a catheter support. [Figure 33B] FIG. 33B is a cross-sectional view of the actuator of FIG. 33A including a hinge in a flexible beam. [Figure 33C] FIG. 33C is a cross-sectional view of an alternative configuration of the catheter support of FIG. 33A. [Figure 33D] FIG. 33D is a cross-sectional view of another alternative configuration of the catheter support of FIG. 33A. [Diagram 34] FIG. 34 is a side view of an alternative configuration for coupling the actuator to the catheter support. [Figure 35A] FIG. 35A is a top view of a fluid transfer device of the present invention in a first configuration, the fluid transfer device having a catheter support with a locking protrusion. [Figure 35B] FIG. 35B is a top view of the fluid transfer device of the present invention of FIG. 35A in a second configuration. [Diagram 36] FIG. 36 is a perspective view of a catheter support having a locking projection. [Figure 37] FIG. 37 is a cross-sectional view of the catheter support of FIG. [Figure 38] FIG. 38 is a cross-sectional view of the catheter support of FIG. 36 positioned in an introducer of a fluid transfer device of the present invention. [Figure 39A] FIG. 39A is a top view of a fluid transfer device of the present invention in a first configuration, the fluid transfer device having a catheter support with two locking protrusions. [Figure 39B] FIG. 39B is a top view of the fluid transfer device of the present invention of FIG. 39A in a second configuration. [Diagram 40] FIG. 40 is a cross-sectional view of the catheter support of FIGS. 39A and 39B. [Diagram 41] FIG. 41 is a partial cutaway view of a blood collection device according to a further aspect or embodiment of the present application showing a catheter support. [Diagram 42] FIG. 42 is a perspective view of the catheter support of FIG. [Diagram 43] FIG. 43 is a cross-sectional view of a blood collection device according to a further aspect or embodiment of the present application. [Diagram 44] FIG. 44 is an enlarged cross-sectional view of the blood collection device of FIG. [Diagram 45] FIG. 45 is a partial cutaway view of the blood collection device of FIG. [Figure 46] FIG. 46 is a partial cutaway view of a blood collection device according to a further aspect or embodiment of the present application. [Figure 47] FIG. 47 is an enlarged view of the blood collection device of FIG. [Figure 48] FIG. 48 is a front view of an actuator of a blood collection device according to a further aspect or embodiment of the present application. [Figure 49] FIG. 49 is a front view of an actuator of a blood collection device according to a further aspect or embodiment of the present application. [Figure 50] FIG. 50 is a front view of an actuator of a blood collection device according to a further aspect or embodiment of the present application. [Figure 51] FIG. 51 is a front view of an actuator of a blood collection device according to a further aspect or embodiment of the present application. [Figure 52] FIG. 52 is a partial front view of a prior art actuator and introducer of a blood collection device. [Figure 53] FIG. 53 is a partial front view of an actuator and introducer of a blood collection device according to a further aspect or embodiment of the present application. [Figure 54] FIG. 54 is a perspective view of a prior art blood collection device. [Figure 55] FIG. 55 is a perspective view of a blood collection device according to a further aspect or embodiment of the present application. [Figure 56]FIG. 56 is a perspective view of a blood collection device according to a further aspect or embodiment of the present application. [Figure 57] FIG. 57 is a cross-sectional view of a connection between a first member and a second member of an introducer of a blood collection device according to a further aspect or embodiment of the present application. [Figure 58] FIG. 58 is a cross-sectional view of a connection between a first member and a second member of an introducer of a blood collection device according to a further aspect or embodiment of the present application. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] As used herein, unless expressly specified otherwise, all numerical values, such as those representing values, ranges, amounts or percentages, may be read as if preceded by the word "about" even if the term is not expressly indicated. Any numerical range described herein is intended to include all subranges contained therein. For example, a range "1 to 10" is intended to include any and all subranges between and including the recited minimum value of 1 and the recited maximum value of 10, i.e., all subranges beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less, as well as all subranges between, for example, 1 to 6.3, or 5.5 to 10, or 2.7 to 6.1. Plural forms include the singular form and vice versa. When ranges are given, any endpoints of those ranges and / or numbers within those ranges can be combined with the scope of the invention. "Including", "such as", "for example", and similar terms mean "including / such as / for example" but are not limited to.

[0011] For purposes of the following description, the spatial orientation terms used shall be relative to the referenced embodiments as described in the accompanying drawings, figures, or in the detailed description below. However, it should be understood that the embodiments described below may assume many alternative variations and configurations. It should also be understood that the specific components, devices, features, and sequences of operations described herein in the accompanying drawings, figures, or otherwise are merely illustrative and should not be considered limiting.

[0012] As used herein, the term "catheter" is used synonymously to describe an element configured to define a passageway for moving bodily fluids from a first location to a second location, e.g., a fluid passageway for moving bodily fluids outside the body. Although a catheter can be configured to receive a trocar, guidewire, or introducer for delivery of the catheter to a volume within the patient's body, a catheter as referred to herein need not include or receive a trocar, guidewire, or introducer.

[0013] As used herein, the terms "Y adapter" and "T adapter" are used to refer to a dual port IV extension set. In this manner, the terms "Y adapter" and "T adapter" generally describe the overall shape of a dual port IV extension set. For example, as used herein, a Y adapter is substantially "Y" shaped, including a single port at a first end and two ports arranged at an angle at a second end. Furthermore, the terms "Y adapter" and "T adapter" are included by way of example only, not limitation. For example, in some embodiments, a device may include a single port IV extension set (e.g., a single port adapter) or a multi-port IV extension set (e.g., an adapter having two or more ports).

[0014] As used herein, the terms "proximal" and "distal" refer, respectively, to directions closer and further from a user who will bring the device into contact with a patient. Thus, for example, the end of the device that first contacts the patient's body is the distal end, and the opposite end of the device that is manipulated by the user is the proximal end of the device.

[0015] The present invention is directed to a fluid transfer device for phlebotomy via a peripheral intravenous line or catheter, and a method of using the fluid transfer device to draw blood or administer drugs to a patient.

[0016] 1-32 illustrate a fluid transfer apparatus 200 according to the present invention. The fluid transfer device 200 may be of any suitable shape, size, or configuration, and may, for example, be coupled to a peripheral intravenous catheter (PIV) via a lock and / or adapter (not shown in FIGS. 1-32). As described in further detail herein, a user may transition the fluid transfer device 200 from a first configuration to a second configuration in order for the fluid transfer device 200 to advance the catheter 260 through an existing, placed, and / or indwelling PIV, such that at least an end of the catheter 260 is disposed in a distal position relative to the PIV. Additionally, with peripheral venous lines having shapes, sizes, and / or configurations that may vary based on, for example, the manufacturer of the PIV and / or its intended use, the fluid transfer device 200 may be positioned to allow the fluid transfer device 200 to be coupled to a PIV having any suitable configuration, and then to advance at least a portion of the catheter 260 through the PIV without substantially reconfiguring the catheter 260 in an undesirable manner. Additionally, the fluid transfer device 200 can be manipulated by a user to position the distal surface of the catheter 260 a predetermined and / or desired distance beyond the distal surface of a PIV that is disposed within a portion of a vein receiving a substantially unobstructed flow of blood.

[0017] 1-3, the fluid transfer device 200 includes an introducer 210, a lock 240, a catheter 260, a secondary catheter 265, an actuator 270, and a catheter support 280. The introducer 210 may be of any suitable shape, size, or configuration. For example, the introducer 210 may be an elongated member having a substantially circular cross-sectional shape, or the shape of the introducer 210 and / or one or more features or surface finish of at least a portion of an outer surface of the introducer 210 may be arranged to enhance the ergonomic properties of the fluid transfer device 200, which may in some cases enable the fluid transfer device 200 to be operated by a user with one hand (i.e., one-handed use).

[0018] As shown in Figures 3-10, the introducer 210 of the fluid transfer device 200 includes a first member 220 and a second member 230 coupled to collectively form the introducer 210. As shown in Figure 4, the first member 220 includes a proximal end portion 221, a distal end portion 222, and an inner surface 223. The inner surface 223 has a first portion 226 and a second portion 227. The proximal end portion 221 of the first member 220, and more specifically, the proximal wall of the first member 220, defines a notch 224 configured to selectively receive a portion of a secondary catheter 265, as described in further detail herein.

[0019] As shown in FIGS. 5-7, the second member 230 has a proximal end portion 231, a distal end portion 232, an inner surface 233, and an outer surface 235. As described above with reference to the first member 220, the proximal end portion 231 of the second member 230, and more specifically, the proximal wall of the second member 230, defines a notch 234 configured to selectively receive a portion of the secondary catheter 265. The outer surface 235 of the second member 230 may optionally include a set of ribs 236 distributed along the length of the second member 230. More specifically, each rib 236 extends along the width of the second member 230 and is continuously distributed along the length of the second member 230. In this manner, the outer surface 235 defines alternating local minima and local maxima disposed along the length of the second member 230. As described in further detail herein, a portion of the actuator 270 is configured to advance along an outer surface 235 that forms a set of ribs 236 when a user moves the actuator 270 relative to the introducer 210, which in turn vibrates the actuator 270 and the catheter 260 coupled thereto. In some examples, this vibration can facilitate advancement of the catheter 260 through, for example, a portion or portions of the fluid transfer device 200, a portion of the PIV, and / or a portion of the vasculature. Additionally, in some examples, the vibration can provide a user with a tactile and / or audible indicator associated with the position of the catheter 260 relative to the introducer 210 and / or the PIV, as described in further detail herein.

[0020] The ribs 236 formed by the outer surface 235 of the second member 230 may be of any suitable shape, size, and / or configuration. For example, as shown in FIGS. 6 and 7, the set of ribs 236 includes a first portion 237 having a first size and shape and a second portion 238 having a second size and shape different from the first size and shape. The first portion 237 of the ribs 236 may have any suitable configuration and / or arrangement. For example, each rib of the first portion 237 may be substantially uniform having substantially the same size and shape. Alternatively, each rib included in the first portion 237 may have a different size and shape than the remaining ribs of the first portion 237. For example, the size and shape of each rib within the first portion 237 may increase from a proximal-most rib having a smallest size and shape to a distal-most rib having a largest size and shape. Additionally, although the ribs of the first portion 237 are shown as being substantially symmetrical, each rib of the first portion 237 may be asymmetrical. For example, a proximal surface of each rib may have a first pitch (angle) and a distal surface of each rib may have a second pitch that is greater than the first pitch. Such an asymmetric arrangement may cause a portion of actuator 270 to move along outer surface 235 with a first set of properties when moved in a distal direction and move along outer surface 235 with a second set of properties that are different from the first set of properties when moved in a proximal direction. For example, a portion of actuator 270 may move more freely along outer surface 235 in a distal direction than in a proximal direction.

[0021] Similarly, the second portion 238 of the ribs 236 can have any suitable configuration and / or arrangement. For example, each rib 236 of the second portion 238 can be substantially uniform having substantially the same size and shape as the remaining ribs 236 of the second portion 238. As shown in FIG. 9, each rib of the second portion 238 can have a size and shape that is larger than the size and shape of each rib of the first portion 237. Increasing the size of the ribs 236 of the second portion 238 can result in a greater amount of vibration as the actuator 270 moves along the outer surface 235 (as described above) or can result in an increase in force sufficient to move a portion of the actuator 270 along the outer surface 235. Although the ribs 236 of the second portion 238 are shown and described as being substantially uniform and having a larger size than the ribs 236 of the first portion 237, the ribs of the second portion 238 can have any of the arrangements and / or configurations described above with reference to the ribs of the first portion 237.

[0022] As the set of ribs 236 transitions from the first portion 237 to the second portion 238 at a given point along the length of the second member 230 (see, e.g., FIG. 7 ), the size and shape of each rib 236 in the set of ribs 236 may increase from the proximal-most rib in the first portion 237 having the smallest size and shape to the distal-most rib in the second portion 238 having the largest size and shape, such that the size and shape of each of the ribs in the set of ribs 236 increases with each successive rib, e.g., in the distal direction.

[0023] The set of ribs 236 may include more than first portion 237 and second portion 238. For example, the second member may include a set of ribs having first and second portions having a similar size, shape, and configuration as first portion 237 of second member 230, and a third portion disposed between the first and second portions and having a similar size, shape, and configuration as second portion 238 of second member 230. In this configuration, second member 230 includes proximal portions of the ribs and distal end portions of the ribs that are smaller than inner portions of the ribs disposed therebetween.

[0024] The arrangement of the set of ribs 236 on the second member 230 may be such that the proximal-most rib and the distal-most rib are larger and / or have a shape that is operable to at least temporarily maintain portions of the actuator 270 in a proximal position relative to the proximal-most rib and a distal position relative to the distal-most rib, respectively.

[0025] Although the set of ribs 236 is shown formed only on the exterior surface 235 of the second member 230, the first member 220 may include an exterior surface forming a set of ribs as an alternative to or in addition to the set of ribs 236 on the second member 230. In such embodiments, the set of ribs of the first member 220 may be and / or have any of the configurations and / or arrangements described above with reference to the set of ribs 236 of the second member 230. If ribs are provided on the first member 220 in addition to the ribs 236 provided on the second member 230, the ribs of the first member 220 may be offset from the ribs 236 of the second member 230. For example, the ribs of the first member 220 may have alternating local minima and maxima such that the local minima and maxima of the ribs of the first member 220 are aligned with or offset from the local maxima and minima of the ribs 236 of the second member 230, respectively, as described above with reference to the ribs 236 distributed along the length of the second member 230. Alternatively, the ribs of the first member 220 may be at various positions relative to the ribs 236 of the second member 230. In this manner, the introducer 210 may provide a variable arrangement of ribs that may provide, for example, tactile feedback as the actuator 270 moves relative to the introducer 210.

[0026] As shown in FIGS. 8-10, the first member 220 is configured to be coupled to the second member 230 to collectively form the introducer 210. For example, the first member 220 and the second member 230 can be coupled via ultrasonic welding, adhesives, mechanical fasteners, one or more tabs, snaps, pins, etc. to form the introducer 210. Bonding the first member 220 to the second member 230 to form the introducer 210, e.g., during a manufacturing process, can facilitate and / or simplify one or more manufacturing processes. For example, forming the introducer 210 from the first member 220 and the second member 230 can reduce undesirable changes in the shape and / or size of the inner surfaces 227, 233, e.g., due to draft angles and / or manufacturing tolerances during manufacturing, and in some cases can reduce the likelihood of the catheter 260 twisting, bending, and / or deformation during use of the fluid transfer device 200. Forming the introducer 210 from the first member 220 and the second member 230 can also allow at least the inner surface 227 of the first member 220 to form a serpentine shape that would otherwise present challenges when manufacturing the introducer 210 from a single workpiece.

[0027] Alternatively, the introducer 210 may be formed monolithically, for example, via injection molding and / or any other suitable manufacturing process, where the introducer 210 is formed from a single workpiece rather than two workpieces, i.e., the first member 220 and the second member 230. Thus, when referring to features of the introducer 210, such features may be formed and / or defined by the first member 220, may be formed and / or defined by the second member 230, may be formed and / or defined by the first member 220 and the second member 230 collectively, or may be formed and / or defined by a corresponding portion of the introducer 210 when the introducer 210 is formed from a single workpiece.

[0028] The first member 220 and the second member 230 collectively form the proximal end portion 211 and the distal end portion 212 of the introducer 210 and collectively define the interior volume 213 of the introducer 210. As shown in FIG. 10 , the proximal end portion 211 of the introducer 210 defines an opening 217. Specifically, the opening 217 is collectively formed and / or defined by a notch 224 of the first member 220 and a notch 234 of the second member 230. The arrangement of the proximal end portion 211 may be such that a portion of the opening 217 defined by the notch 224 of the first member 220 has a first size and / or shape and a portion of the opening 217 defined by the notch 234 of the second member 230 has a second size and / or shape that is smaller than the first size and / or shape, such that a portion of the opening 217 is constricted, pinched, occluded, and / or otherwise reduced. As described in further detail herein, the opening 217 is configured to receive a portion of the secondary catheter 265, which can be moved within the opening 217 from a larger portion of the opening 217 to a reduced portion of the opening 217, e.g., the portion formed by the notch 234 of the second member 230, to occlude, pinch, and / or clamp the secondary catheter 265.

[0029] As shown in FIG. 9 , the distal end portion 212 of the introducer 210 may include and / or otherwise form a coupler 216, and the distal end portion 222 of the first member 220 and the distal end portion 232 of the second member 230 may collectively form the coupler 216 at the distal end portion 212 of the introducer 210. The coupler 216 may be of any suitable shape, size, and / or configuration. For example, the coupler 216 may form a set of threads, which may form a threaded coupling with an associated threaded portion of the lock 240, as described in further detail herein. Although not shown in FIG. 9 , the distal end portion 212 of the introducer 210 may include and / or be configured to receive a seal that may selectively seal and / or fluidly isolate the interior volume 213 of the introducer 210 from at least an open portion of the coupler 216. During use, the seal can be transitioned from a sealing or closed configuration to an open configuration, for example, to allow passage therethrough of a portion of the catheter 260. The seal can contact an outer surface of the catheter 260 or a secondary catheter to define a seal operable to limit and / or substantially prevent backflow of fluid between the outer surface of the catheter and the seal.

[0030] The seal may be any suitable type of seal. For example, the seal may be an O-ring, a one-way valve, a diaphragm, a self-healing diaphragm, a check valve, a single crack valve, and / or any other suitable seal or valve member. The seal may be configured to define and / or otherwise have a predetermined "cracking" pressure such that the seal transitions from a closed and / or sealed configuration to a substantially open configuration, e.g., in response to an increase in pressure within the introducer 210. For example, the seal may be a positive pressure seal, or the like. Alternatively, the seal may be a fluid seal, such as a saline lock. Although not shown in FIGS. 3-10, the introducer 210 may include devices, mechanisms, assemblies, and / or the like that can be operated to increase pressure within the introducer 210, e.g., via air or other suitable fluid or liquid, to transition the seal from a closed configuration to an open configuration. For example, the introducer 210 may include and / or be coupled to valves, pumps, syringes, fluid sources, mechanical actuators, electrical actuators, and the like.

[0031] The inner surface 223 of the first member 220 and the inner surface 233 of the second member 230 collectively define the interior volume 213 of the introducer 210. As shown in FIG. 12, the arrangement of the inner surfaces 223, 233 is such that the interior volume 213 has and / or defines a serpentine cross-sectional shape. For example, the interior volume 213 can have a substantially S-shaped or at least partially S-shaped cross-sectional shape. More specifically, the inner surface 223 of the first member 220 includes and / or forms a flange 225 configured to separate a first portion 226 of the interior surface 223 from a second portion 227 of the interior surface 223. Thus, the serpentine cross-sectional shape of the interior volume 213 forms and / or defines a first portion 214 of the interior volume 213 and a second portion 215 of the interior volume 213. In this manner, the first portion 214 of the interior volume 213 is spaced apart from the second portion 215 of the interior volume 213 without being fluidly isolated from the interior volume 213. In other words, the first portion 214 of the interior volume 213 defines an axis that is parallel to and offset from the axis defined by the second portion 215 of the interior volume 213.

[0032] 10, the first portion 214 of the internal volume 213 extends through the wall of the introducer 210, as do the slots 218, channels, tracks, openings, etc., in fluid communication with the first portion 214 of the internal volume 213. Conversely, the second portion 215 of the internal volume 213 is completely defined and / or surrounded, at least circumferentially, by the introducer 210. The serpentine cross-sectional shape of the internal volume 213 is such that the second portion 215 is not visible through the slots 218 and is outside the line of sight of the slots 218 in fluid communication with the first portion 214 of the internal volume 213, which limits and / or substantially prevents contamination of the catheter 260 disposed therein.

[0033] The second portion 215 of the internal volume 213 is substantially aligned with at least a portion of the opening 217 defined in the proximal end portion 211 of the introducer 210 and at least a portion of the opening defined by the coupler 216. Additionally, the second portion 215 of the internal volume 213 is configured to be substantially aligned with the lock 240 such that an axis defined by the second portion 215 of the internal volume 213 is substantially coaxial with an axis defined by a portion of the lock 240 when the lock is coupled to the coupler 216 of the introducer 210, as described in further detail herein. In this manner, the second portion 215 of the internal volume 213 can accommodate a portion of the actuator 270 and a portion of the catheter 260. Thus, the actuator 270 can be moved relative to the introducer 210 to move the catheter 260 between a first position in which the catheter 260 is fully disposed within the second portion 215 of the internal volume 213, the coupling 216, and / or the lock 240, and a second position in which at least a portion of the catheter 260 extends outside the second portion 215 of the internal volume 213 and distal to the introducer 210, as described in further detail herein.

[0034] The lock 240 of the fluid transfer device 200 may be of any suitable shape, size, and / or configuration. As described above, the lock 240 is configured to be physically and fluidly coupled to the introducer 210 and configured to couple the introducer 210 to the PIV and / or any suitable intermediate device or adapter coupled to the PIV. The lock 240 has a coupler 241, a proboscis 242, a first arm 243, and a second arm 250, as shown in FIGS. 11-14. In addition, the lock 240 defines a lumen 255 extending through the coupler 241 and the proboscis 242. The coupler 241 is configured to couple the lock 240 to the coupler 216 of the introducer 210. Specifically, the coupler 241 includes and / or forms one or more protrusions configured to selectively engage threads defined and / or formed by the coupler 216 of the introducer 210, thereby forming a threaded joint.

[0035] Proboscis 242 extends from coupler 241 and is disposed between first arm 243 and second arm 250. Proboscis 242 may be of any suitable shape, size, and / or configuration. In some embodiments, the configuration of proboscis 242 may be related to or at least partially based on the size and / or shape of the PIV, the size and / or shape of an adapter, e.g., an extension set, a Y adapter, a T adapter, etc., or the collective size and / or shape of the PIV and adapter. For example, proboscis 242 may have a length sufficient to extend through at least a portion of the PIV or adapter. When the adapter is coupled to the PIV, proboscis 242 may have a length sufficient to extend through the adapter, at least partially into or through the PIV, and may have a length sufficient such that at least a portion of proboscis 242 is distal to the PIV. Additionally, proboscis 242 may have an outer diameter similar to or slightly smaller than an inner diameter of the PIV and / or a portion of the adapter coupled to it. For example, an outer surface of proboscis 242 can contact an inner surface of a PIV when proboscis 242 is disposed therein. In this manner, proboscis 242 can provide structural support to at least a portion of the PIV in which proboscis 242 is disposed. Similarly, proboscis 242 can have an inner diameter that at least partially defines lumen 255 that is similar to or slightly larger than an outer diameter of a portion of catheter 260, as described in further detail herein.

[0036] The first arm 243 and the second arm 250 of the lock 240 may be of any suitable shape, size, and / or configuration. As shown in Figures 11 and 12, the first arm 243 has a first end 244, a second end 245 including a tab 246, and a pivot portion 247 disposed between the first end 244 and the second end 245. The tab 246 disposed on and / or formed by the second end 245 extends from the second end 245 toward the proboscis 242. In this manner, the tab 246 can selectively engage with a portion of the PIV and / or a portion of an adapter coupled to the PIV to couple the lock 240 thereto, as described in further detail herein.

[0037] A pivot portion 247 of the first arm 243 extends laterally from the coupler 241, the proboscis 242, and / or the second arm 250. A first end 244 of the first arm 243 is proximal to the pivot portion 247, and a second end 245 of the first arm 243 is distal to the pivot portion 247. Thus, the first arm 243 can function as a lever configured to pivot about an axis defined by the pivot portion 247 in response to an applied force. For example, a user can apply a force to the first end 244 sufficient to pivot the first end 244 of the first arm 243 toward the coupler 241, as shown by arrow AA in FIG. 12, and to pivot the second end 245 of the first arm 243 away from the proboscis 242, as shown by arrow BB in FIG. 12.

[0038] As described above with reference to the first arm 243, the second arm 250 of the lock 240 has a first end 251, a second end 252 including a tab 253, and a pivot portion 254 disposed between the first end 251 and the second end 252. The first arm 243 and the second arm 250 may be substantially similar in shape and function and are disposed in opposite positions and orientations relative to the coupler 241 and proboscis 242 such that the lock 240 is substantially symmetrical about its longitudinal axis. Thus, the description of the first arm 243 applies similarly to the second arm 250, and therefore the second arm 250 will not be described in further detail herein.

[0039] As described above, the lock 240 is configured to be coupled to a PIV and / or an adapter coupled to the PIV. For example, a user can apply a lateral force to the first end 244 of the first arm 243 and the first end 251 of the second arm 250 to pivot the first arm 243 and the second arm 250 from a first position toward a second position, respectively. Thus, the pivoting of the first arm 243 increases the space defined between the proboscis 242 and the second end 245 and the tab 246 of the first arm 243. Similarly, the pivoting of the second arm 250 increases the space defined between the proboscis 242 and the second end 252 and the tab 253 of the second arm 250. In this manner, the increased space between the proboscis 242 and the arms 243, 250 is sufficient to allow a portion of the PIV and / or an adapter coupled to the PIV to be inserted into the space. Once the PIV and / or adapter portion is in a desired position relative to the lock 240, the user can remove the force, and the arms 243, 250 will then pivot toward their respective first positions. As a result, the second ends 245, 252 will move toward the proboscis 242 until the tabs 246, 253 are positioned in contact with the PIV and / or adapter portion. The tabs 246, 253 are configured to engage with the PIV and / or adapter portion to temporarily couple the lock 240 to the PIV and / or adapter. The lock 240 may be configured to establish three points of contact with the PIV and / or adapter, namely, the tabs 246, 253, and the outer surface of the proboscis 242, as described above. The tabs 246 and 253 may be configured to generate an audible output, such as a vibration output, such as a click, a tactile bump, etc., when positioned in contact with the PIV and / or adapter portion, which may indicate to the user that the lock 240 is properly coupled to the PIV and / or adapter.

[0040] The arms 243, 250 of the lock 240 may be positioned to extend horizontally relative to the introducer 210, i.e., the arms 243, 250 extend outwardly from the sides of the fluid transfer device 200, as shown in Figure 1, or may be positioned to extend vertically relative to the introducer 210, i.e., the arms 243, 250 extend outwardly from the top and bottom of the fluid transfer device 200. Providing the arms 243, 250 in a vertical position reduces the space required to store the fluid transfer device 200.

[0041] As shown in FIG. 13, the proboscis 242 and the coupler 241 may collectively define a lumen 255. The lumen 255 of the lock 240 defines an axis (not shown) that is aligned with and / or substantially coaxial with an axis defined by the second portion 215 of the interior volume 213. Thus, when the fluid transfer device 200 transitions between the first and second configurations, the lumen 255 of the lock 240 receives a portion of the catheter 260. The lumen 255 may have a size and / or shape based at least in part on the size and / or shape of the catheter 260. For example, the lumen 255 may have an inner diameter that is slightly larger than an outer diameter of at least a portion of the catheter 260. The lock 240 acts as an external guide that supports and / or guides the catheter 260 as it is moved within the lumen 255, which may reduce and / or substantially prevent undesirable bending, twisting, flexing, and / or deformation of the catheter 260.

[0042] Although the lock 240 is shown and described above as including a proboscis 242, the lock need not form a proboscis. For example, the lock may include a relatively short hub or the like configured to engage with a portion of the PIV and / or an adapter coupled to the PIV. Alternatively, the fluid transfer device may include and / or be used with a proboscis or guide member that is not formed with or by the lock configured to be disposed between, for example, the PIV and an adapter, such as an IV extension set. For example, such a proboscis or guide member may have an inner surface that is funnel-shaped and / or similar in shape to the inner surface of the proboscis 242. In this manner, the inner surface of such a proboscis and / or guide member may guide a portion of the catheter 260 as it moves between a first position and a second position. In some embodiments, the lock 240 including a proboscis 242 may be used in conjunction with such an external or separate proboscis and / or guide member by inserting a portion of the proboscis 242 of the lock 240 into the proboscis and / or guide member when the lock 240 is coupled to an adapter, for example, an IV extension set.

[0043] An actuator 270 of the fluid transfer device 200 is coupled to the catheter 260 and can move along the length of the introducer 210 to transition the fluid transfer device 200 between its first configuration, in which the catheter 260 is in a first position, and its second configuration, in which the catheter 260 is in a second position. The actuator 270 can be of any suitable shape, size, and / or configuration. For example, the actuator 270 can have a size and shape related to and / or based at least in part on the size and / or shape of the introducer 210.

[0044] 13-17, the actuator 270 includes a first portion 271, a second portion 275, and a wall 277 extending therebetween. The first portion 271 of the actuator 270 is disposed at least partially within the first portion 214 of the interior volume 213 defined by the introducer 210, and the second portion 275 of the actuator 270 is disposed within the second portion 215 of the interior volume 213.

[0045] The first portion 271 of the actuator 270 includes an engagement member 272. The arrangement of the actuator 270 is such that the engagement member 272 is disposed outside the introducer 210, with the remaining portion of the first portion 271 being within a first portion 214 of an interior volume 213 defined by the introducer 210. The engagement member 272 can thus be engaged and / or manipulated by a user, for example, by the user's finger or thumb, to move the actuator 270 relative to the introducer 210. The engagement member 272 can include, for example, a set of ridges and / or any suitable surface finish that can enhance the ergonomic properties of the actuator 270 and / or the fluid transfer device 200.

[0046] The engagement member 272 includes a tab 273 disposed at or near a proximal end portion of the engagement member 272. The tab 273 may be any suitable tab, rail, ridge, bump, protrusion, knob, roller, slider, etc. extending from a surface of the engagement member 272. The tab 273 is configured to selectively engage with an outer surface 235 of the second member 230 of the introducer 210. More specifically, the tab 273 contacts the ribs 236 formed by the second member 230 and moves along each successive rib as the actuator 270 moves along the length of the introducer 210.

[0047] As discussed above with reference to the set of ribs 236 of the second member 230, the tab 273 can have any suitable shape, size, and / or configuration. For example, as shown in FIG. 16, the tab 273 can include a substantially rounded surface that can move along the set of ribs 236. The size and / or shape of the tab 273 can be based at least in part on the size and / or shape of the ribs 236 such that a desired surface area of ​​the tab 273 contacts the ribs 236 as the actuator 270 moves relative to the introducer 210. Additionally, the amount of friction defined between a set of ribs 236 and the tab 273 can be based at least in part on the surface area of ​​the tab 273 that contacts the set of ribs 236. Additionally, the amount of friction defined between a set of ribs 236 and the tab 273 can be based at least in part on the location of the tab 273 relative to each rib. For example, the amount of friction defined between the tab 273 and the rib may increase as the tab 273 approaches, e.g., a local maximum, and may decrease as the tab 273 moves away from the local maximum. The tab 273 may have a size and / or shape that allows the tab 273 to move with substantially less friction between each adjacent rib, e.g., between adjacent local maxima, such that a desired amount of "play" between the tab 273 and the set of ribs 236 may be allowed.

[0048] If the first portion 237 of the set of ribs 236 has a smaller size than the second portion 238 of the set of ribs 236, then the first portion or first surface area of ​​the tab 273 can contact the first portion 237 of the set of ribs 236 and the second portion or second surface area of ​​the tab 273 can contact the second portion 238 of the set of ribs 236. In this manner, the tab 273 can move along the first portion 237 having the first set of characteristics and can move along the second portion 238 having the second set of characteristics that are different from the first set of characteristics. For example, a force sufficient to move the tab 273 along the second portion 238 of the set of ribs 236 may be greater than a force sufficient to otherwise move the tab 273 along the first portion 237 of the set of ribs 236. Alternatively or additionally, movement of the tab 273 along the second portion 238 of the set of ribs 236 may result in a greater amount of vibration of the actuator 270 than an amount of vibration resulting from movement of the tab 273 along the first portion 237 of the set of ribs 236, for example. Similarly, the shape of tab 273 can be such that tab 273 moves distally along the set of ribs 236 in response to an applied force that is insufficient to move proximally along the set of ribs 236. For example, as shown in FIG. 16 , tab 273 can have an asymmetric shape, with the proximal surface of tab 273 having a greater pitch than the pitch of the distal surface.

[0049] While the engagement member 272 and the tab 273 are specifically shown and described above, in other embodiments, the actuator can include engagement members and / or tabs having any suitable configuration. For example, while the tab 273 is shown as being disposed at or near the proximal end portion of the engagement member 272, in other embodiments, the engagement member can include a first tab disposed at or near the proximal end portion and a second tab disposed at or near the distal end portion, each of which can selectively contact a set of ribs disposed on the outer surface of the introducer 210. In some embodiments, the space defined between the surface of the wall 277 and the surface of the engagement member 272 can be increased or decreased, which can result in an increase or decrease in the amount of movement of the actuator 270 in a direction other than axial relative to the introducer 210, such that an increase or decrease in the space between the surface of the wall 277 and the surface of the engagement member 272 results in an increase or decrease in the amount that the actuator 270 can "tilt" relative to the introducer 210. In other embodiments, the arrangement of the engagement member 272, tab 273, and / or set of ribs 236 of the introducer 210 can be modified, changed, tuned, adjusted, and / or otherwise altered so that the actuator 270 moves relative to the introducer 210 with a desired set of characteristics. For example, the arrangement of the actuator 270 and / or introducer 210 can increase or decrease the amount that the actuator 270 vibrates when moving relative to the introducer 210, can increase or decrease the amount of force sufficient to move the actuator 270 relative to the introducer 210, and can increase or decrease the amount of movement of the actuator 270 relative to the introducer 210 in any suitable direction other than axially (i.e., proximally and distally).

[0050] 17 and 18, the second portion 275 has a cross-sectional shape based at least in part on a cross-sectional shape, e.g., an at least partially circular cross-sectional shape, of the second portion 215 of the interior volume 213 defined by the introducer 210. In this manner, the inner surface 223 of the first member 220 and the inner surface 233 of the second member 230 can support and / or guide the second portion 275 of the actuator 270 as the actuator 270 moves relative to the introducer 210. As shown, the second portion 275 defines an opening 276 configured to receive the proximal end portion 261 of the catheter 260 and the distal end portion 267 of the secondary catheter 265. In some embodiments, the proximal end portion 261 of the catheter 260 can form a friction fit with the inner surface of the second portion 275 of the actuator 270 when the proximal end portion 261 is disposed in the opening 276. Similarly, the distal end portion 267 of the secondary catheter 265 can form a friction fit with the inner surface of the second portion 275 of the actuator 270 when the distal end portion 267 is disposed in the opening 276. Thus, the catheter 260 and the secondary catheter 265 can be maintained in a fixed position relative to the actuator 270 and therefore can move simultaneously with the actuator 270 as the actuator 270 moves relative to the introducer 210.

[0051] The wall 277 of the actuator 270 couples the first portion 271 of the actuator 270 to the second portion 275 of the actuator 270. As shown in FIGS. 17 and 18, the wall 277 has a serpentine cross-sectional shape based at least in part on the serpentine cross-sectional shape of the interior volume 213 defined by the introducer 210. In this manner, the first portion 271 of the actuator 270 can define an axis that is parallel to, but offset from, the axis defined by the second portion 275 of the actuator 270. For example, the wall 277 can have a substantially S-shaped or at least partially S-shaped cross-sectional shape, or the wall 277 can form a dogleg shape, or the like. The wall 277, and thus the serpentine cross-sectional shape of the actuator 270, is such that the second portion 275 of the actuator 270 cannot be seen through the first portion 214 of the interior volume 213 and is outside the line of sight of the first portion 214 of the interior volume 213 defined by the introducer 210. Similarly, when the catheter 260 is in the first position, the catheter 260 is not visible through the first portion 214 of the interior volume 213 defined by the introducer 210. That is, the shape of the actuator 270 and / or the introducer 210, e.g., the serpentine cross-sectional shape of the interior volume 213, the height and / or width of the introducer 210, etc., are configured such that the catheter 260 is at least partially isolated within the second portion 215 of the interior volume 213 when the catheter 260 is in the first position. In this manner, the structure of the introducer 210 and / or the actuator 270 can protect and / or isolate the catheter 260 from the volume outside the introducer 210, thereby limiting and / or substantially preventing contamination of the catheter 260. For example, in some embodiments, the introducer 210 and / or the actuator 270 can function as a "sneeze guard" or the like configured to at least partially isolate the catheter 260 when the catheter 260 is in the first position.

[0052] As described above, at least a portion of the catheter 260 and at least a portion of the secondary catheter 265 are movably disposed within the second portion 215 of the interior volume 213 defined by the introducer 210. As shown in FIG. 14, the catheter 260 has a proximal end portion 261 and a distal end portion 262 and defines a lumen 263 (see, e.g., FIG. 28). The proximal end portion 261 of the catheter 260 is coupled to a second portion 275 of the actuator 270. In this manner, the actuator 270 can be moved relative to the introducer 210 to move the catheter 260 between a first position in which the catheter 260 is disposed within the introducer 210, e.g., the catheter 260 is disposed entirely within the introducer 210 or within the introducer 210 and the lock 240, and a second position in which the distal end portion of the catheter 260 is disposed at least partially at a location distal to the lock 240 and / or the PIV (not shown) when the lock 240 is coupled to the PIV. The distal end portion 262 can be of any suitable shape, size, and / or configuration and can define at least one opening in fluid communication with the lumen 263. For example, the distal end portion 262 of the catheter can be substantially similar to any of those described in U.S. Patent No. 6,285,333, entitled "SYSTEM AND METHOD FOR VENOCETOMY VIA A PERIPHERAL IV CATHETER," filed on April 26, 2012 (referred to herein as the "'685 Patent"), the disclosure of which is incorporated herein by reference in its entirety.

[0053] Although the invention is described herein as including a catheter and a secondary catheter, the catheter and secondary catheter may be replaced by a probe or guidewire that is inserted into or through the PIV in the same manner as a catheter, or the probe or guidewire may be inserted into or through the PIV through a catheter of the fluid transfer device.

[0054] The catheter 260 may be of any suitable shape, size, and / or configuration. For example, at least a portion of the catheter 260 may have an outer diameter substantially equal to or slightly smaller than an inner diameter defined by the lumen 255 of the lock 240, as described above, or an outer surface of the catheter 260 may be configured to contact an inner surface of the lock 240 that defines at least a portion of the lumen 255. In this manner, the inner surface of the portion of the lock 240 that defines the lumen 255 may guide the catheter 260 as it moves between the first and second positions. Such an arrangement may limit and / or substantially prevent bending, deformation, flexion, and / or kinking of the catheter 260 as it moves between the first and second positions. Additionally, the length of the catheter 260 may be sufficient to define a predetermined and / or desired distance between a distal surface of the catheter 260 and a distal surface of the PIV when the catheter 260 is in the second position, as described in further detail herein.

[0055] The catheter 260 may be formed from any suitable material or combination of materials such that the catheter 260 can have any suitable stiffness or durometer. For example, the catheter 260 may be formed from a relatively flexible biocompatible material having a Shore durometer of about 20 Shore A to 50 Shore D, about 20 Shore A to 95 Shore D, about 70 Shore D to 85 Shore D, and / or any other suitable range of Shore durometers. At least a portion of the catheter 260 may be formed from a braided material, or the like, which may modify, change, and / or alter the flexibility of the catheter 260 in response to bending forces. Forming at least a portion of the catheter 260 from a braided material may increase the amount of deformation of the catheter 260 in response to bending forces before buckling, kinking, and / or otherwise disturbing the lumen 263 of the catheter 260. Similarly, forming at least a portion of the catheter 260 from a braided material may result in compression and / or deformation in response to compressive forces (e.g., axial forces, etc.) exerted in the direction of a longitudinal centerline defined by the catheter 260. In this manner, the catheter 260 may absorb some of the forces associated with, for example, impacting an obstacle or the like. In some instances, such a configuration may reduce buckling and / or kinking of the catheter 260 as well as reduce and / or substantially prevent damage to the vascular structure that may result from impact of the catheter 260. Additionally, forming at least a portion of the catheter 260 from a braided material may increase the amount of vibration transmitted through the catheter 260 in response to a portion of the actuator 270 advancing along a set of ribs 236 of the introducer 210, as described above. Although the catheter 260 is described above as including at least a portion formed of a braided material, at least a portion of the catheter 260 may be formed from and / or include a support wire, a stent, a fenestrated catheter, and / or the like, as described in the '685 patent, incorporated by reference above.

[0056] The secondary catheter 265 has a proximal end portion 266 and a distal end portion 267 and defines a lumen 268 (see, e.g., FIG. 25 ). A portion of the secondary catheter 265 is disposed within and extends through the opening 217 of the introducer 210, which may be collectively defined by the notches 224, 234 of the first and second members 220, 230, respectively. Thus, the proximal end portion 266 is at least partially disposed outside the introducer 210 and the distal end portion 267 is at least partially disposed within the second portion 215 of the interior volume 213 defined by the introducer 210. As described above, the secondary catheter 265 can be moved within the opening 217 between a first position and a second position to selectively clamp, pinch, twist, bend, and / or deform a portion of the secondary catheter 265, which in turn occludes, pinches, twists, closes, seals, etc., the lumen 268 of the secondary catheter 265. For example, the first position can be associated with and / or aligned with a first portion of the opening 217 having a circumference and / or diameter greater than the circumference and / or diameter of a second portion of the opening 217 associated with and / or aligned with the second position. Thus, a user can manipulate the secondary catheter 265 to occlude the lumen 268 of the secondary catheter 265, thereby limiting, restricting, and / or substantially preventing fluid flow therethrough.

[0057] As shown in FIG. 14 , a proximal end portion 266 of the secondary catheter 265 is coupled to and / or otherwise includes a coupler 269. The coupler 269 is configured to physically and fluidly couple the secondary catheter 265 to any suitable device, such as, for example, a fluid reservoir, a fluid source, a syringe, a vacuum container holder (e.g., having a sheathed needle or configured to be coupled to a sheathed needle), a pump, etc. A distal end portion 267 of the secondary catheter 265 is at least partially disposed within a second portion 215 of the interior volume 213 defined by the introducer 210 and is coupled to a second portion 275 of the actuator 270. In some embodiments, the secondary catheter 265 can have a larger diameter than the catheter 260 such that a proximal end portion 261 of the catheter 260 is at least partially disposed within a lumen 268 defined by the secondary catheter 265 when the catheter 260 and the secondary catheter 265 are coupled to the second portion 275 of the actuator 270. Such a configuration can, for example, reduce and / or substantially prevent leakage associated with fluid flowing between catheter 260 and secondary catheter 265. Such a configuration can also limit, reduce, and / or substantially prevent hemolysis of a volume of blood as it flows through catheter 260 and secondary catheter 265. In this manner, when coupler 269 is coupled to a fluid reservoir, fluid source, syringe, vacuum container, pump, etc., secondary catheter 265 establishes fluid communication between catheter 260 and the reservoir, source, pump, etc.

[0058] 3, 19-24, 25, 31 and 32, the catheter support 280 includes a bracket portion 281 and a hub portion 282. The bracket portion 281 of the catheter support 280 is disposed at least partially within a first portion 214 of an interior volume 213 defined by the introducer 210, and the hub portion 282 of the catheter support 280 is disposed within a second portion 215 of the interior volume 213.

[0059] The bracket portion 281 of the catheter support 280 may optionally include an engagement member 284. The arrangement of the catheter support 280 is such that the engagement member 284 is disposed on the exterior of the introducer 210, with the remaining portion of the bracket portion 281 being within the first portion 214 of the interior volume 213 of the introducer 210. The engagement member 284 may thus be engaged and / or manipulated by a user, for example, by the user's finger or thumb, to move the catheter support 280 relative to the introducer 210. The engagement member 284 may include, for example, a set of ridges and / or any suitable surface finish that can increase the ergonomic catheter support of the catheter support 280 and / or the fluid transfer device 200.

[0060] The engagement member 284 may optionally have any of the features described above with respect to the engagement member 272 of the actuator 270, including, but not limited to, tabs that interact with a set of ribs 236 on the outer surface of the second member 230 of the introducer 210.

[0061] The hub portion 282 has a cross-sectional shape based at least in part on a cross-sectional shape, e.g., an at least partially circular cross-sectional shape, of the second portion 215 of the interior volume 213 defined by the introducer 210. In this manner, the inner surface 223 of the first member 220 and the inner surface 233 of the second member 230 can support and / or guide the hub portion 282 of the catheter support 280 as the catheter support 280 moves relative to the introducer 210.

[0062] Hub portion 282 defines a passageway 285 having a proximal opening 287 at a proximal end of hub portion 282 and a distal opening 288 at a distal end of hub portion 282. Passageway 285 is sized and shaped to allow catheter 260 to pass freely through passageway 285 while being contained to prevent excessive movement of catheter 286 within second portion 215 of interior volume 213 of introducer 210. Passageway 285 may be substantially cylindrical with a circular cross-section.

[0063] The passageway 285 may include two portions, having a proximal portion 289 adjacent to and in fluid communication with the proximal opening 287 and a distal portion 290 adjacent to and in fluid communication with the distal opening 288. The proximal portion 289 of the passageway 285 may be sized and shaped to receive at least a portion of the second portion 275 of the actuator 270. For example, the proximal opening 287 may be larger than the distal opening 288. The distal portion 290 of the passageway 285 may be substantially cylindrical with a circular cross-section having a diameter equal to the diameter of the distal opening 288. The proximal portion 289 may be substantially conical or funnel-shaped such that the proximal end of the proximal portion 289 of the passage 285 has a diameter equal to the diameter of the proximal opening 287, and the diameter of the proximal portion 289 of the passage 285 decreases until the distal end of the proximal portion 289 of the passage 285, which is in fluid communication with the distal portion 290 of the passage 285, has a diameter equal to the diameter of the distal portion 290 of the passage 285.

[0064] As shown in FIG. 21, a notch 291 may be provided in a conical or funnel-shaped proximal portion 289 of the passageway 285 .

[0065] As shown in Figures 19A and 19B, the bracket portion 281 may have a serpentine cross-sectional shape based at least in part on the serpentine cross-sectional shape of the interior volume 213 of the introducer 210. In this manner, the bracket portion 281 of the catheter support 280 may define an axis that is parallel to, but offset from, the axis defined by the hub portion 282 of the catheter support 280. For example, the bracket portion 281 may have a substantially S-shaped or at least partially S-shaped cross-sectional shape, or the bracket portion 281 may form a dog-leg shape, or the like. The serpentine cross-sectional shape of the bracket portion 281, and thus the catheter support 280, may be such that the hub portion 275 of the catheter support 280 is not visible through the first portion 214 of the interior volume 213 and is outside the line of sight of the first portion 214 of the interior volume 213 defined by the introducer 210. The catheter support 280 may have substantially the same overall outer shape as the actuator.

[0066] At least a portion of the bracket portion 281 of the catheter support 280 has a profile that corresponds to an outer surface of a flange 225 provided on an inner surface of the introducer 210, such that the bracket portion 281 fits over and at least partially covers the flange 225 and is movable relative to the introducer 210 from the proximal end portion 211 of the introducer 210 to the distal end portion 212 of the introducer 210 and vice versa along the flange 225. As the catheter support 280 moves relative to the introducer 210, the bracket portion 281 moves within the first portion 214 of the internal volume 213 and the hub portion 282 moves within the second portion 215 of the internal volume 213.

[0067] The opening 276 of the actuator 270 and the passageway 285 of the catheter support 280 may be coaxial.

[0068] The catheter 260 is coupled to the second portion 275 of the actuator 270 and extends to the distal end portion 212 of the introducer 210. Without the catheter support 280, the length of the catheter 260 that extends this distance would be unsupported. The force at which the catheter 260 buckles is inversely proportional to the square of the effective length. Thus, as the effective length of the catheter 260 increases, the buckling force decreases and the resistance of the catheter to buckling decreases. The catheter support 280 supports the catheter 260, thereby shortening the effective length of the catheter 280 and increasing the force required to buckle the catheter 260 and decreasing the tendency of the catheter 260 to buckle.

[0069] The hub portion 282 of the catheter support 280 is disposed between the actuator 270 and the distal end portion 212 of the introducer 210, and the catheter 260 passes through a hub passage 285 of the hub portion 282 such that the hub portion 282 divides the unsupported length of the catheter 260 into two smaller portions that are more resistant to bending, twisting, flexing, and / or deformation.

[0070] 22-32, the fluid transfer device 200 can be in a first configuration prior to use and can be transitioned from the first configuration (FIGS. 22A and 24-27) to a second configuration (FIGS. 22C and 30-32) by a user, such as a doctor, physician, nurse, technician, phlebotomist, etc., to place a distal end portion 262 of the catheter 260 in a distal position relative to the introducer 210, such as within or distal to an indwelling PIV (not shown). When the catheter 260 is placed in the first position within the introducer 210, the fluid transfer device 200 is in the first configuration. Substantially the entire catheter 260 can be placed within the introducer 210 when the catheter 260 is in the first position. The introducer 210 can include a seal or the like (as described above) capable of substantially sealing the distal end portion 212 of the introducer 210 to isolate the catheter 260 within the second portion 215 of the interior volume 213. Alternatively, as shown in FIGS. 25 and 26, the catheter 260 can be disposed within the introducer 210 and the lock 240 when the catheter 260 is in the first position. Although a seal is described above as being included within the distal end portion 212 of the introducer 210, in other embodiments, the lock 240 can include a seal or the like capable of forming a substantially fluid-tight seal with an inner surface of the lock 240 that defines the lumen 255. Thus, a seal disposed within the lock 240 can isolate the catheter 260 within the second portion 215 of the interior volume 213. However, the introducer 210 and / or the lock 240 need not include a seal. For example, the PIV and / or the adapter, e.g., an extension set coupled to the PIV, can include a seal that transitions from a closed configuration to an open configuration when lock 240 is coupled thereto. Although not shown, catheter 260 can be disposed within a flexible sheath or the like that can maintain catheter 260 in a substantially sterile environment while catheter 260 is in the first position, e.g., in embodiments in which introducer 210 and / or lock 240 do not include a seal.

[0071] 23A and 25, the actuator 270 is disposed in a proximal position and the catheter support 280 is disposed in an intermediate position between the actuator 270 and the distal end portion 212 of the introducer 210. In some embodiments, the tab 273 of the first portion 271 of the actuator 270 may be disposed within a recess or detent, or otherwise in contact with a proximal-most rib, configured to temporarily and releasably maintain the actuator 270 in the proximal position until a force is exerted by a user to move the actuator 270 distally.

[0072] The proximal end portion 261 of the catheter 260 is coupled to the second portion 275 of the actuator 270, the catheter 260 extends through the second portion 215 of the internal volume 213 of the introducer 210, through the passage 285 of the hub portion 282, and the distal end portion 262 of the catheter 260 is received in the lumen of the coupler 216 and / or the lumen 255 of the lock 240.

[0073] The initial pre-use position of the catheter support 280 may be set such that in the first configuration, the position of the hub portion 272 along the unsupported portion of the catheter 260 extending from the second portion 275 of the actuator 270 to the distal end portion 212 of the introducer 210 may be at a center point of the unsupported portion of the catheter or may be offset from the center point of the unsupported length of the catheter 260. For example, in the first configuration, the hub portion 282 of the catheter support 280 may be disposed at a position corresponding to the position of the actuator 270 when advancement of the distal end portion 262 of the catheter 260 into the PIV meets resistance and requires additional force to be provided to the actuator 270 to further advance the catheter 260. For example, the location of the hub portion 282 of the catheter support 280 may correspond to a location of the actuator 270 corresponding to advancement of the distal end portion 262 of the catheter 260, and may correspond to the point where the distal end portion 262 encounters a region where the catheter 260 must turn to traverse an S-curve, such as a region where the catheter 260 must enter the skin, curve upward, and curve again to pass along a vein. As described above, a portion of the secondary catheter 265 is disposed in the opening 217 defined by the introducer such that the distal end portion 267 of the secondary catheter 265 is at least partially disposed in the second portion 215 of the interior volume 213 and is coupled to the second portion 275 of the actuator 270 while the proximal end portion 266 of the secondary catheter 265 is disposed outside of the introducer 210.

[0074] With the fluid transfer device 200 in the first configuration, a user can manipulate the fluid transfer device 200 to couple the lock 240 to an indwelling PIV and / or an adapter, such as an extension set, coupled to the PIV.

[0075] With the fluid transfer device 200 coupled to the PIV and / or adapter, a user can engage the engagement member 272 of the first portion 271 of the actuator 270 to move the actuator 270 relative to the introducer 210, which moves the catheter 260 from a first position disposed within the introducer 210 toward a second position in which the distal end portion 262 of the catheter 260 extends into and / or through the PIV. In this manner, the catheter 260 is disposed outside and distal to the lock 240, through the second portion 215 of the interior volume 213, the passageway 285 of the hub portion 282 of the catheter support 280, and the lumen 255 of the lock 240, and at least the distal end portion 262 of the catheter 260, as shown by arrow CC in FIG.

[0076] After actuator 270 has moved partially distally and catheter 260 has advanced partially toward the second position, actuator 270 contacts hub portion 282 of catheter support 280. The distal end of second portion 275 of actuator 270 may abut the proximal end of hub portion 282 or may be sized and shaped to be at least partially received within proximal portion 289 of passageway 285 of hub portion 282.

[0077] As the actuator 270 advances further distally, the actuator 270 pushes the hub portion 282 of the catheter support 280 distally and the catheter support 280 advances within the second portion 215 of the internal volume 213 of the introducer 210 until the catheter support 280 abuts the distal wall of the introducer 210.

[0078] As discussed above, the arrangement of the actuator 270 and introducer 210 is such that advancing the actuator 270 relative to the introducer 210 advances the tab 273 along the outer surface 235, and more specifically, the set of ribs 236 of the second member 230 of the introducer 210. For example, as shown in FIG. 27, the tab 273 contacts a set of ribs 236, which may result in vibration of the actuator 270 as it moves relative to the introducer 210. In some examples, the vibration of the actuator 270 may generate a haptic, tactile, and / or audible output that may provide an indication associated with, for example, the position of the introducer 210, the lock 240, and / or the distal end portion 262 of the catheter 260 relative to the PIV. For example, the tab 273 and set of ribs 236 of the actuator 270 may collectively produce a "click" sound as the tab 273 passes over each rib, the introducer 210 may include indicators or the like that may indicate to the user the relative position of the distal end portion 262 of the catheter 260, or the number of times the actuator 270 vibrates by moving relative to the number of ribs may be associated with and / or otherwise provide an indication of the relative position of the distal end portion 262 of the catheter 260.

[0079] In some examples, the user can stop movement of the actuator 270 relative to the introducer 210 based on a haptic, tactile, and / or audible output indicating a desired placement of the distal end portion 262 of the catheter 260 relative to the PIV such that the catheter 260 is positioned in the second position before the actuator 270 is advanced to its distal-most position. As described in further detail herein, the catheter 260 is positioned in the second position when the distal end portion 262 of the catheter 260 is positioned in a desired position relative to the distal end portion of the PIV. For example, the distal face of the catheter 260 can be substantially flush with the distal end of the PIV, the distal face of the catheter 260 can extend a predetermined distance beyond the distal end of the PIV, or the distal face of the catheter 260 can be positioned within the PIV proximal to the distal end of the PIV when the catheter 260 is in the second position.

[0080] As shown in Figures 22C and 30-32, in some examples, the catheter 260 can be in the second position when the actuator 270 is in a distal-most position. In this manner, the distal surface of the catheter 260 is positioned within the vein at a predetermined distance beyond the distal surface of the PIV. In some examples, positioning the distal surface of the catheter 260 at a predetermined and / or desired distance from the distal surface of the PIV can position the distal surface of the catheter 260 at a location within the vein that is substantially free of debris, e.g., fibrin / thrombus, that may otherwise surround the distal surface of the PIV.

[0081] In some instances, an indwelling PIV can substantially occlude at least a portion of the vein in which the PIV is placed. Thus, PIVs are often suitable for delivering fluids rather than aspirating blood. However, the venous system is a capacitance system and thus reroutes blood flow through a different vein by forming a bypass around the occlusion or substantial occlusion. Furthermore, the alternative venous structure typically rejoins the vein in which the PIV is placed a given distance downstream of the PIV, thus delivering at least a portion of the blood flow that would flow through the vein in which the PIV is placed. Similarly, a vein typically has many branch vessels connected to it that also deliver blood flow to the vein in which the PIV is placed.

[0082] Thus, the predetermined and / or desired distance between the distal surface of the catheter 260 and the distal surface of the PIV may be sufficient to position the distal surface of the catheter 260 downstream of one or more branching blood vessels in fluid communication with the vein in which the PIV is located such that the distal surface of the catheter 260 can extend beyond the distal surface of the PIV and at least one branching blood vessel is located between the distal surface of the catheter 260 and the distal surface of the PIV when the catheter 260 is in the second position. Thus, when the lumen 263 of the catheter 260 extends through the proximal end portion 261 and the distal end portion 262 of the catheter 260, positioning the distal surface of the catheter 260 a predetermined and / or desired distance from the distal surface of the PIV may result in the lumen 263 of the catheter 260 being in fluid communication with a substantially unblocked or unrestricted blood flow, e.g., a portion of the vein not blocked by the PIV and / or a portion of the vein that receives debris associated with the placement of the PIV.

[0083] The predetermined and / or desired distance can be about 0.0 mm when the distal surface is flat, up to about 100 millimeters (mm), e.g., from about 10 mm to about 90 mm, from about 20 mm to about 80 mm, from about 30 mm to about 70 mm, from about 30 mm to about 60 mm, or from about 40 mm to about 50 mm. For example, the fluid transfer device 200 may be configured such that the actuator 270 moves approximately 95 mm along the introducer 210 to position the distal face of the catheter 260 approximately 40 mm past the distal face of the PIV to which the fluid transfer device 200 is coupled, the fluid transfer device 200 may be configured such that the actuator 270 moves approximately 47 mm along the introducer 210 to position the distal face of the catheter 260 approximately 20 mm past the distal face of the PIV to which the fluid transfer device 200 is coupled, or the fluid transfer device 200 may have any suitable stroke length to position the distal face of the catheter 260 at a predetermined and / or desired distance from the distal face of the PIV.

[0084] While the predetermined and / or desired distance is described above as a positive distance, i.e., the distal surface of the catheter 260 is distal to the distal surface of the PIV, the predetermined and / or desired distance can be associated with a negative distance, where the distal surface of the catheter 260 is in a proximal position relative to the distal surface of the PIV. For example, in some examples, the predetermined and / or desired distance can be about 0.0 mm when the distal surface is flat, and up to about -50 mm, e.g., about -10 mm to about -40 mm, or about -20 mm to about -30 mm. In some examples, the predetermined and / or desired distance can be less than -50 mm when the distal surface of the catheter 260 is more than 50 mm proximal to the distal surface of the PIV. The catheter 260 can be positioned in the second position such that the distal end portion 262 of the catheter 260 remains within the PIV in a distal position, e.g., a kink. For example, an indwelling PIV can have one or more portions that are twisted, such as a portion of the PIV where a peripheral intravenous catheter connects to a hub. In such an example, the predetermined and / or desired distance can be such that a distal surface of catheter 260 is distal to the portion of the PIV that forms the twist, e.g., the location where the peripheral intravenous catheter connects to the hub. By placing a distal surface of catheter 260 distal to the twisted portion of the PIV, but remaining within the PIV, a fluid flow path can be formed that is not sufficiently restricted to allow blood to be drawn through catheter 260.

[0085] For example, as shown in FIGS. 22C and 30-32, when the catheter 260 is in the second position and the fluid transfer device 200 is in the second configuration, a user may establish fluid communication between the catheter 260 and a fluid reservoir, fluid source, syringe, or the like. For example, as described above, a user may physically and fluidly couple the coupler 269 of the secondary catheter 265 to a fluid reservoir, fluid source, syringe, or the like. Although establishing fluid communication between the catheter 260 and a fluid reservoir or fluid source after placing the catheter 260 in the second position is described, a user may establish fluid communication between the catheter 260 and a fluid reservoir or fluid source prior to moving the actuator 270 relative to the introducer 210. Once the catheter 260 is in fluid communication with a fluid reservoir and / or fluid source, the fluid transfer device 200 may then transfer fluid from the patient or to the patient via the catheter 260 extending through and beyond the PIV. For example, a user can physically and fluidly couple the fluid transfer device 200 to a fluid reservoir, vacuum container, syringe, etc., and then aspirate a volume of blood from a vein based at least in part on positioning the distal surface of the catheter 260 at a predetermined and / or desired distance beyond the distal surface of the PIV.

[0086] In other examples, a user can physically and fluidly couple the fluid transfer device 200 to a fluid source or the like, and then deliver a volume of fluid from the fluid source to a portion of a vein at a location downstream of the PIV that receives substantially unimpeded and / or unrestricted blood flow. Placing the distal surface of the catheter 260 at a predetermined and / or desired distance beyond the distal surface of the PIV can reduce potential harm associated with the injection of a corrosive drug. By placing the distal surface of the catheter 260 within a portion of a vein that receives blood flow that would otherwise be impeded and / or restricted by an indwelling PIV, the corrosive drug can be contained in the bloodstream and delivered to a target location. Thus, a volume of the corrosive drug is not retained within the debris or placed in a location within the vein that would otherwise receive little blood flow.

[0087] Once the desired amount of blood has been collected and / or the desired amount of drug has been delivered to the patient, the user can move the actuator 270 proximally, thereby placing the fluid transfer device 200 in the third (used) configuration. The catheter support 280 may remain stationary at the distal end portion 212 of the introducer 210 or may be coupled to the actuator 270 such that proximal movement of the actuator 270 pulls the catheter support 280 proximally.

[0088] When the catheter support 280 is not coupled to the actuator 270 and the catheter support 280 includes an engagement member 284, the engagement member 284 can be engaged and / or manipulated by a user to manually move the catheter support 280 in the proximal direction.

[0089] When the actuator 270 is coupled to the catheter support 280, the opening 276 of the actuator 270 and the passageway 285 of the catheter support 280 are coaxial.

[0090] The actuator 270 may be coupled to the catheter support 280 when the actuator 270 and the catheter support 280 first contact when both are in an intermediate position, or the actuator 270 may be coupled to the catheter support 280 when the catheter support 280 abuts against the distal end wall of the introducer 210.

[0091] Any suitable coupling may be provided for coupling the actuator 270 to the catheter support 280. For example, when the actuator 270 contacts the catheter support 280, a portion of the second portion 275 of the actuator 270 may be received in a proximal portion 289 of the passageway 285 of the hub portion 282 of the catheter support 280. For example, the portion of the second portion 275 of the actuator 270 may be coupled to the hub portion 282 of the catheter support 280 by an interference fit, a snap fit, or a friction fit between an inner surface of the hub portion 282 of the catheter support 280 and an outer surface of the second portion 275 of the actuator 270.

[0092] 33A, one of the protrusions and recesses may be provided on a surface of a flexible beam 293 at the distal end of the engagement member 272 of the actuator 270, and the other of the protrusions and recesses may be provided on a surface of the bracket portion 281 of the catheter support 280 exposed in the slot 218 of the introducer 210, or on the optional engagement member 284 of the catheter support 280. For example, as shown in FIG. 33, the protrusions 294 may be provided on a bottom surface of the flexible beam 293, and the recesses 295 may be provided on a top surface of the catheter support 280. Alternatively, the recesses may be provided on a side or another surface of the catheter support 280. When the catheter support 280 is adjacent the distal end wall of the introducer 210 and the user continues to move the actuator 270 distally, the flexible beam 293 is deflected upwardly a small amount such that the flexible beam 293 moves over the catheter support 280 and the protrusion 294 is received in the recess 295. A cam surface 296 may be provided on the distal end of the flexible beam 293 and / or the proximal end of the catheter support 280 to facilitate bending of the flexible beam 293.

[0093] A stop 297 may be provided on the flexible beam 293 distal to the protrusion 294. When the actuator 270 is advanced such that the stop 297 abuts the catheter support 280, further advancement of the actuator 270 relative to the catheter support 280 is limited to avoid disengagement of the protrusion 294 from the recess 295.

[0094] As shown in FIG. 33B, the flexible beam 293 may optionally include a hinge 320 that includes a thinned region that allows for adjustment of the force required to couple and uncouple the actuator 270 and the catheter support 280.

[0095] Optionally, a storage stop 298 for stopping proximal movement of the catheter support 280 may extend from the introducer 210, for example, the storage stop 298 may extend upward from the flange 225 of the introducer 210 (FIG. 33). A groove 299 may be provided in a portion of the first portion 271 of the actuator 270 that slides along the flange 225 of the introducer 210 as the actuator 270 moves to advance the catheter 260. No such groove is provided in the bracket portion 281 of the catheter support 280. As the combined actuator 270 and catheter support 280 move proximally, the actuator 270 passes over the storage stop 298 received in the groove 299, and the catheter support 280 abuts the storage stop 298, stopping the proximal movement of the catheter support 280. The actuator 270 can then be moved further proximally while the catheter support 280 remains stationary. 33, when a retraction stop 298 is provided in combination with the above coupling, further force applied to engagement member 272 of actuator 270 will cause flexible beam 293 to bend, disengaging projection 294 from recess 295 and disengaging actuator 270 from catheter support 280. Retraction stop 298 may be positioned to stop catheter support 280 in the same position that catheter support 280 was in when catheter 260 was in the first position.

[0096] 21, the storage detent may include a detent 327 that extends into a slot 328 in the introducer 210. The slot 328 may be provided on a flange 225 provided on the inner surface of the introducer 210. The detent 327 engages a bracket portion 281 of the catheter support 280 to limit the movement of the catheter support 280. As the actuator 270 moves proximally and abuts the catheter support 280, the proximal force applied to the catheter support 280 by the actuator 270 overcomes the force of the detent 327 on the catheter support 280, releasing the catheter support 280 from the detent 327, and the actuator 270 pushes the catheter support 280 proximally until the catheter support 280 abuts the distal end portion 212 of the introducer 210. When the actuator 270 is coupled to the catheter support 280, the actuator 270 moves proximally, pulling the catheter support 280 proximally, and when the catheter support 280 encounters the detent 327, the proximal movement of the catheter support 280 is restricted.

[0097] 33C and 33D, instead of the recess 295, the catheter support may include a releasable lock 322 that is engaged by a protrusion 294 on the flexible beam 293. The releasable lock 322 includes a stop portion 323 and an engagement portion 324. The stop portion 323 extends from the catheter support 280 and is received in and moves along a groove in the introducer 210 as the catheter support 280 moves relative to the introducer 210. When the stop portion 323 abuts the proximal end of the groove, further proximal movement of the catheter support 280 is no longer possible. The engagement portion 324 of the releasable lock 322 may include a bulge that interacts with the protrusion 294 on the flexible beam 293 of the actuator 270. 33C, the stop portion 323 of the releasable lock 322 may extend from a bottom surface of the bracket portion 281 of the catheter support 280, and the engagement portion 324 of the releasable lock 322 may extend from a top surface of the bracket portion 281 of the catheter support 280. In this configuration, the stop portion 323 may ride in a groove on a flange 225 provided on the inner surface of the introducer 210. Alternatively, as shown in FIG. 33D, the stop portion 323 of the releasable lock 322 may extend from a bottom surface of the bracket portion 281 of the catheter support 280, and the engagement portion 324 of the releasable lock 322 may extend laterally from a side surface of the bracket portion 281 of the catheter support 280.

[0098] As the actuator 270 moves proximally and abuts the catheter support 280, the actuator 270 pushes the catheter support proximally until the catheter support 280 abuts the distal end portion 212 of the introducer 210. When the catheter support 280 abuts the distal end wall of the introducer 210 and the user continues to move the actuator 270 distally, the flexible beam 293 is deflected upwardly a small amount, forcing the protrusion 294 over the engagement portion 324 of the releasable lock 322. The surface of the protrusion 294 on the flexible beam 293 and / or the engagement portion 324 of the releasable lock 322 may be rounded and / or include cam surfaces to facilitate movement of the protrusion 294 over the engagement portion 324. Then, as the actuator 270 moves proximally, the engagement between the projection 294 and the engagement portion 324 of the releasable lock 322 allows the actuator 270 to pull the catheter support 280 proximally until the catheter support 280 abuts the proximal end of the groove and stops the proximal advancement of the catheter support 280. As the user continues to move the actuator 270 proximally, the flexible beam 293 is deflected upwardly a small amount, causing the projection 294 to press onto the engagement portion 324 of the releasable lock 322, thereby disengaging the actuator 270 from the catheter support.

[0099] In another example, as shown in FIG. 34, an engagement projection 301 including a hook 302 may extend from a distal end of the engagement member 272 of the actuator 270, and a corresponding pivotable projection 303 having a hook 304 may extend from a proximal end of the catheter support 280. The engagement projection 301 on the actuator 270 defines a recess 305 for receiving the pivotable projection 303 of the catheter support 280. The recess 305 has a sloped bottom surface 306 closest to the engagement member 272 of the actuator 270. The pivotable projection 303 pivots about a pin 307 that rides in a cam slot 308 defined in the introducer 210. The cam slot 308 comprises two portions, a retaining portion 309 and a moving portion 310. The retaining portion 309 is provided at a proximal end of the moving portion 310 and forms a downward angle, e.g., a right angle, with the moving portion 310. The retaining portion 309 is disposed at a position corresponding to a desired position of the catheter support 280 when the catheter 260 is in the first position. The moving portion 310 extends from the retaining portion 309 to the distal end portion 212 of the introducer 210.

[0100] As the actuator 270 moves distally and abuts the catheter support 280, the pivotable projection 303 is received in a recess 305 defined by the engagement projection 301. The pivotable projection 303 is pivoted clockwise by the sloped bottom surface 306 of the recess 305. The hook 302 of the engagement projection 301 engages with the hook 304 of the pivotable projection 303, and the sloped bottom surface 306 transitions the pin 307 from the retaining portion 309 of the cam slot 308 to the moving portion 310 of the cam slot 308. Further distal movement of the actuator 270 moves the catheter support 280 distally, with the pin 307 riding on the moving portion 310 of the cam slot 308.

[0101] As the combined actuator 270 and catheter support 280 are moved proximally and the pin 307 reaches the proximal end of the moving portion 310 of the cam slot 308, the pin 307 transitions into the retaining portion 309 of the cam slot 308 and the pivotable protrusion 309 rotates in a counterclockwise direction disengaging the hook 304 of the pivotable protrusion 303 from the hook 302 of the engagement protrusion 301. The actuator 270 can then be moved further proximally while the catheter support 280 remains stationary.

[0102] In a third configuration, the catheter 260 may be disposed within and isolated within the distal introducer 210, such as, for example, a seal. For example, the actuator 270 may be disposed in a proximal-most position with the catheter 260 in the first position. Additionally, once the actuator 270 and catheter 260 are in a desired position, the user may manipulate the secondary catheter 265 within the opening 217 such that a surface of the introducer 210 that defines a smaller portion of the opening 217 contacts and clamps the secondary catheter 265. Thus, the lumen 268 of the secondary catheter 265 may be substantially obstructed, occluded, blocked, pinched, etc. to restrict and / or substantially prevent fluid flow therethrough. Clamping the secondary catheter 265 may reduce and / or substantially prevent fluid leakage through the secondary catheter 265. The fluid transfer device 200 may then be separated from the fluid reservoir, fluid source, syringe, etc., and safely discarded.

[0103] As shown in Figures 35-38, the catheter support 280a may include at least one locking projection 312 extending outwardly from the catheter support 280a. The locking projection 312 is sized and shaped such that when the fluid transfer device 300 is in the second configuration with the catheter support 280 at the distal end portion 212 of the introducer 210 and the catheter 260 introduced into the PIV, the locking projection 312 is received in the space between the arms 243, 250 of the lock 240 and the coupler 241, blocking the first ends 244, 251 of the arms 243, 250 of the lock 240 from being depressed and releasing the lock 240 from the PIV. Interference of the locking projection 312 with the release of the lock 240 requires the user to retract the catheter support 280 and the actuator 270, thereby retracting the catheter 260 from the PIV, before disconnecting the lock 240 from the PIV. This ensures that the introducer 210 is not removed from the PIV while the catheter 260 is received within the PIV, and potentially within the patient's vein.

[0104] The locking projection 312 may extend from a slot 218 in the introducer 210 and includes a first portion 313 extending laterally outward, a second portion 314 extending downwardly from the first portion 313, and a third portion 315 extending distally from the second portion 314, the third portion 315 entering a space between one of the arms 243, 250 of the lock 240 and the coupler 241. The first portion 316 may be connected to a bracket portion 281 of the catheter support 280 via the slot 218 and may be the engagement member 284 if an engagement member 284 is provided on the catheter support 280.

[0105] Alternatively, if the lock 240 is vertically oriented, the protrusion may extend from a slot 218 in the first member 220 of the introducer 210 through which the wall 277 of the actuator 270 passes.

[0106] 39 and 40, the catheter support 280b may have multiple protrusions 312a, 312b, for example, one protrusion 312a corresponding to the first arm 243 of the lock 240 and one protrusion 312b corresponding to the second arm 250 of the lock 240. The protrusions 312a, 312b may include a common first portion 316 extending laterally outwardly over a top outer surface of the introducer 210, a second portion 317 extending downwardly from the first portion 316 on the opposite side of the outer surface of the introducer 310, and a third portion 318 extending distally from the second portion 317, the third portion 318 entering the space between the arms 243, 250 of the lock 240 and the coupler 241. The first portion 316 is connected to the bracket portion 281 of the catheter support 280 via the slot 218 and may be the engagement member 284 if an engagement member 284 is provided on the catheter support 280. The second protrusion 312b may be a mirror image of the first protrusion 312a.

[0107] 41 and 42, in a further aspect or embodiment, a bracket portion 281 of the catheter support 280 is biased against a portion of the introducer 210. The bracket portion includes a cantilever arm 328 having a first end 329 extending from a hub portion 282 of the catheter support 280 and a second end 330 opposite the first end 329, where prior to assembly, the second end 330 of the cantilever arm 328 defines a first distance between the second end of the cantilever arm and the hub portion, and after assembly within the introducer 210, the cantilever arm 328 defines a second distance between the second end 330 of the cantilever arm 328 and the hub portion 282, the second distance being greater than the first distance. The gap between the hub portion 282 and the bracket portion 281 is sufficiently small such that the cantilever arm 328 pinches an internal rib portion of the introducer 210. This provides friction between the introducer 210 and the catheter support 280 so that the catheter support 280 only moves when pushed by the assembly tool or actuator 270, and not under gravity. This also increases the force required to overcome the detent 327. This clearance is created by rotating the bracket portion 281 to cantilever the bracket portion 281 in the axial direction of the device 200. The cantilever arm 328 is molded with a curved downward shape, but can also be angled downward.

[0108] 43-45, in a further aspect or embodiment, the catheter support 280 includes a first end 332 and a second end 333 disposed opposite the first end 332, the second end 333 of the catheter support 280 includes a nose cone 334 configured to engage with a lead-in surface 335 of the introducer 210. The nose cone 334 is configured to match the lead-in surface 335 of the introducer 210 and self-align when the catheter support 280 is pushed all the way distally. The nose cone 334 may also engage with a press fit with the introducer 210 to lock it in place when the introducer 210 is fully advanced. The back end of the catheter support 280 has a large funnel that leads to a through hole, as described above. It is easy to feed the catheter 260 into the large funnel in the catheter support 280, and then feed the catheter 260 into the small hole in the introducer 210. The large funnel also has a section cut away to make it even easier to insert the catheter into the large funnel. The catheter 260 can be loaded from the back of the support 280 or from the side. The support 280 is then stored proximally after the catheter 260 is assembled. The support 280 can then be pushed back into the same position by the actuator 270 and the same nosecone 334 can again align the support 280 with the introducer 210 to center the catheter 260 in the hole of the introducer 210. A stop may also be included in the introducer 210, which can also prevent the support 280 from advancing too far distally and prevent the nosecone 334 from contacting the introducer 210, preventing interactions that could push the introducer 210 and affect the sealing ability.

[0109] 46 and 47, the actuator 270 includes a cam member 337 configured to engage and move the cantilever arm 328. The cam member 337 of the actuator 270 is configured to lift the cantilever arm 328 over the detent 327. The cam member 337 is angled and configured to engage the cantilever arm 328 to cam away from the detent 327. If the friction between the detent 327 and the arm 328 is less than the catch of the arm 328 and the detent 327, the force pushing the arm 328 over the detent 327 can be reduced. This can be accomplished by either lubrication, coatings, material differences, additives in the resin to increase lubricity, or by using a shallower angle than the detent angle. The detent angle can be steeper and the feature can lift to a steeper angle with an acceptable force. The detent angle can be square, which requires the feature to fully lift the arm catch to clear the detent. The advantage of a steeper detent angle is that it holds the support more firmly in place before use.

[0110] With reference to FIGS. 48-51, further aspects or embodiments of the finger interface of the actuator 270 are shown. A round, nearly flat finger interface surface with ribs, such as the finger interface shown in FIG. 29, requires a significant amount of force (F) to get the frictional force (X) required to slide it forward. Most of the force (F) from the healthcare worker is pushing down on the actuator (Y) which does not actually advance the actuator 270. Changing the shape of the actuator 270, as shown in FIGS. 48-51, 48-51 allows more fingers (F) to push it forward (X) and repositions the ribs to be more effective in providing friction, or a smaller catch. The actuator 270 may have ribs (as shown), touch bumps, or a rough surface to add friction.

[0111] 52 and 53, in a further aspect or embodiment, the introducer 210 includes a detent 338 adjacent the rib 236, and the distal end 339 of the actuator 270 includes a tab 340 configured to engage the detent 338 and the rib 236 as the actuator 270 moves relative to the introducer 210. The tab 340 is similar to the tab 273, as described above, and functions similarly. The detent 338 prevents the actuator 270 from moving forward prior to use of the device 200. As shown in FIG. 52, in prior art devices, the actuator pinch is directly under the side where the medical practitioner pushes to advance the actuator. As shown below, most of the force applied to advance the actuator actually pushes the top of the pinch into the detent, making it difficult to overcome and advance. Moving the slot and tab 340 to the other end of the actuator 340 is still configured to pinch the introducer 210 and hold the actuator 270 in the detent 338, but it is no longer the force that advances the actuator 270 directly over the tab 340. A downward force from the healthcare worker will no longer drive the top of the pinch into the detent 338 and will be more difficult to overcome, thereby reducing the force required to advance the actuator 270.

[0112] 54-56, in a further aspect or embodiment, the detent 338 is located intermediate the proximal end portion 231 and the distal end portion 232 of the introducer 210, and the introducer 210 includes a forward reducer 342 that extends from the proximal end portion 331 to the detent 338. For smaller gauges, such as 24ga, it is desirable to shorten the working length of the device 200 to accommodate a shorter introducer catheter and extend less into the vein. As shown in FIG. 54, conventional devices use an additional section that limits the actuator travel on the distal end, which requires an additional section, and the small catheter tube still needs to be the same length as the full extension device. With reference to FIGS. 46 and 47, and with reference to FIGS. 55 and 56, the device 200 can incorporate the forward reducer 342 as part of the introducer 210, which keeps the overall part count of the product the same. The advance reducer 342 is also at the proximal end portion 231 so that the overall length of the catheter 260 can be shortened, which increases the flow rate of the device. Alternatively, the advance reducer 342 can be incorporated into the distal end portion 232 of the introducer 210. The detents 338 and ratchet ribs 236, both small and large, are part of the introducer 210, such as the second member 230, so that they can be adjusted and optimized for shorter working lengths.

[0113] 57 and 58, in a further aspect or embodiment, the first member 220 of the introducer 210 includes a plurality of pegs 344 and the second member 230 of the introducer 210 includes a plurality of apertures 345 configured to receive the respective pegs 344. The pegs 344 are secured within the respective apertures 345 via ultrasonic welding 346 to secure the first member 220 of the introducer 210 to the second member 230 of the introducer 210. In one aspect or embodiment, the pegs 344 are larger than the apertures 345. Ultrasonic energy is used to vibrate the introducer 210 with the pegs 344 until the overlap between the pegs 344 and the apertures 345 melts and bonds. The ultrasonic energy is then stopped and the molten plastic hardens again creating a strong and tight bond. Each peg 344 and aperture 345 interface creates an independent bond so that failure of one does not compromise the rest. The pegs 344 and openings 345 also help align them with one another and have features to capture any excess plastic that may flow away from the joint, as shown in Figures 56 and 58. A variety of fitting types can be used, such as step, butt, tongue and groove, and shear fittings.

[0114] In use, as described above, the proximal end portion of the secondary catheter is coupled to a fluid reservoir, fluid source, syringe, vacuum container holder (e.g., having a shielded needle or configured to be coupled to a shielded needle), pump, etc., and the lock of the fluid transfer device is coupled to the PIV. The actuator is moved relative to the introducer to advance the catheter from a first position, where the catheter is disposed within at least one of the internal volume of the introducer and the lock, toward a second position, where the catheter is disposed beyond at least a portion of the PIV and a distal surface of the catheter is disposed a desired distance within the PIV or a patient's vein. Once the catheter is inserted a desired distance through the PIV, a blood sample is drawn from the patient or a drug is injected into the patient. Once the aspiration or injection of the sample is completed, the actuator is moved relative to the introducer to retract the catheter from the PIV until at least the distal surface of the catheter is received within the lock and the lock is disengaged from the PIV.

Claims

1. 1. A blood collection device comprising: a catheter having a proximal end portion and a distal end portion and defining a lumen extending through said proximal end portion and said distal end portion; an introducer having a proximal end portion and a distal end portion, the introducer defining an interior volume configured to movably receive the catheter, the distal end portion of the introducer having a lock configured to couple the introducer to an indwelling peripheral venous line; an actuator movably coupled to the introducer, the actuator having a first portion disposed outside the introducer and a second portion disposed in the interior volume of the introducer and coupled to the proximal end portion of the catheter, the actuator configured to move relative to the introducer to move the catheter between a first position in which the catheter is disposed within the introducer and a second position in which the distal end portion of the catheter is disposed beyond the distal end portion of the introducer and at least a first portion of the catheter is disposed within the peripheral venous line when the introducer is coupled to the peripheral venous line; a catheter support movably coupled to the introducer and defining a passageway disposed between the actuator and the distal end portion of the introducer, the catheter support comprising a bracket portion and a hub portion extending from the bracket portion and including the passageway; Equipped with the catheter extends from the second portion of the actuator through the passageway of the catheter support to the distal end portion of the introducer, and during movement of the actuator to move the catheter from the first position to the second position, the actuator contacts at least a portion of the catheter support and moves the catheter support relative to the introducer; The bracket portion of the catheter support is biased against a portion of the introducer.

2. 2. The blood collection device of claim 1, wherein the bracket portion comprises a cantilever arm having a first end extending from the hub portion of the catheter support and a second end opposite the first end, prior to assembly, the second end of the cantilever arm defining a first distance between the second end of the cantilever arm and the hub portion, and after assembly within the introducer, the cantilever arm defining a second distance between the second end of the cantilever arm and the hub portion, the second distance being greater than the first distance.

3. The blood collection device of claim 2 , wherein the actuator comprises a cam member configured to engage and move the cantilever arm.

4. 4. The blood collection device of claim 3, further comprising a detent disposed in a slot of the introducer, the detent being configured to engage the catheter support to limit movement of the catheter support, and the cam member of the actuator being configured to lift the cantilever arm over the detent.

5. 1. A blood collection device comprising: a catheter having a proximal end portion and a distal end portion and defining a lumen extending through said proximal end portion and said distal end portion; an introducer having a proximal end portion and a distal end portion, the introducer defining an interior volume configured to movably receive the catheter, the distal end portion of the introducer having a lock configured to couple the introducer to an indwelling peripheral venous line; an actuator movably coupled to the introducer, the actuator having a first portion disposed outside the introducer and a second portion disposed in the interior volume of the introducer and coupled to the proximal end portion of the catheter, the actuator configured to move relative to the introducer to move the catheter between a first position in which the catheter is disposed within the introducer and a second position in which the distal end portion of the catheter is disposed beyond the distal end portion of the introducer and at least a first portion of the catheter is disposed within the peripheral venous line when the introducer is coupled to the peripheral venous line; a catheter support movably coupled to the introducer and defining a passageway disposed between the actuator and the distal end portion of the introducer, the catheter support having a first end and a second end disposed opposite the first end; Equipped with the catheter extends from the second portion of the actuator through the passageway of the catheter support to the distal end portion of the introducer, and during movement of the actuator to move the catheter from the first position to the second position, the actuator contacts at least a portion of the catheter support and moves the catheter support relative to the introducer; The second end of the catheter support comprises a nose cone configured to engage a lead-in surface of the introducer.

6. The blood collection device of claim 5 , wherein the nosecone is engageable with the introducer to lock in place when the introducer is fully advanced.

7. The blood collection device of claim 6 , wherein the nosecone press-fits into and engages the introducer.

8. The blood collection device of claim 5 , wherein the lead-in surface of the introducer is configured to self-align as the catheter support advances to the second position.

9. 1. A blood collection device comprising: a catheter having a proximal end portion and a distal end portion and defining a lumen extending through said proximal end portion and said distal end portion; an introducer having a proximal end portion and a distal end portion, the introducer defining an interior volume configured to movably receive the catheter, the distal end portion of the introducer having a lock configured to couple the introducer to an indwelling peripheral venous line; an actuator movably coupled to the introducer, the actuator having a first portion disposed outside the introducer and a second portion disposed in the interior volume of the introducer and coupled to the proximal end portion of the catheter, the actuator having a proximal end and a distal end disposed opposite the proximal end, the actuator being configured to move relative to the introducer to move the catheter between a first position where the catheter is disposed within the introducer and a second position where the distal end portion of the catheter is disposed beyond the distal end portion of the introducer and is disposed within the peripheral venous line when at least a first portion of the catheter is coupled to the peripheral venous line; a catheter support movably coupled to the introducer and defining a passageway disposed between the actuator and the distal end portion of the introducer; Equipped with the catheter extends from the second portion of the actuator through the passageway of the catheter support to the distal end portion of the introducer, and during movement of the actuator to move the catheter from the first position to the second position, the actuator contacts at least a portion of the catheter support and moves the catheter support relative to the introducer; A blood collection device, wherein the introducer comprises a detent and a plurality of ribs, and the distal end of the actuator comprises a tab configured to engage the detent and the plurality of ribs when the actuator moves relative to the introducer.

10. 10. The blood collection device of claim 9, wherein the detent is disposed between the proximal and distal end portions of the introducer, the introducer including a forward reducer extending from the proximal end portion to the detent.

11. 1. A blood collection device comprising: a catheter having a proximal end portion and a distal end portion and defining a lumen extending through said proximal end portion and said distal end portion; an introducer having a proximal end portion and a distal end portion, the introducer comprising a first member attached to a second member, the introducer defining an interior volume configured to movably receive the catheter, the distal end portion of the introducer having a lock configured to couple the introducer to an indwelling peripheral venous line; an actuator movably coupled to the introducer, the actuator having a first portion disposed outside the introducer and a second portion disposed in the interior volume of the introducer and coupled to the proximal end portion of the catheter, the actuator configured to move relative to the introducer to move the catheter between a first position in which the catheter is disposed within the introducer and a second position in which the distal end portion of the catheter is disposed beyond the distal end portion of the introducer and at least a first portion of the catheter is disposed within the peripheral venous line when the introducer is coupled to the peripheral venous line; a catheter support movably coupled to the introducer and defining a passageway disposed between the actuator and the distal end portion of the introducer; Equipped with the catheter extends from the second portion of the actuator through the passageway of the catheter support to the distal end portion of the introducer, and during movement of the actuator to move the catheter from the first position to the second position, the actuator contacts at least a portion of the catheter support and moves the catheter support relative to the introducer; a first member of the introducer comprising one of a peg and an opening, and a second member of the introducer comprising the other of the peg and the opening, the peg being secured within the opening via ultrasonic welding to secure the first member of the introducer to the second member of the introducer.

12. 12. The blood collection device of claim 11, further comprising a plurality of pegs disposed on one of the first and second members of the introducer and a plurality of openings in the other of the first and second members of the introducer for receiving the respective plurality of pegs.

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