Device and method for fluid transfer via a configured peripheral intravenous catheter

Abstract

To provide an improved system and method for venous blood sampling through a peripheral intravenous catheter.SOLUTION: An apparatus includes a catheter, an introducer, and an actuator. A distal end portion of the introducer is configured to couple to an indwelling peripheral intravenous line. The actuator is movably coupled to the introducer and is configured to move the catheter between a first position, in which the catheter is disposed within the introducer, and a second position, in which a distal end portion of the catheter is distal to the introducer. A first portion of the actuator is disposed outside the introducer and in contact with an outer surface of the introducer such that (1) a longitudinal axis defined by a second portion of the actuator is nonparallel to a longitudinal axis defined by the introducer and (2) the second portion of the actuator exerts, on a proximal end portion of the catheter, a force serving to increase an internal stress within a portion of the catheter.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - Reference to Related Applications

[1001] This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 474,202, filed on March 21, 2017, entitled "Devices and Methods for Fluid Transfer Through a Placed Peripheral Intravenous Catheter". The disclosure of this provisional patent application is hereby incorporated by reference in its entirety into this specification.

Background Art

[0002]

[1000] Embodiments described herein generally relate to fluid transfer medical devices. More particularly, embodiments described herein relate to devices and methods for transferring fluid to or from a patient through a placed peripheral intravenous catheter.

[0003]

[1001] Typical in - patients are pricked with a needle every time a physician orders a clinical test. The standard procedure for blood collection involves "sticking" a metal needle (a "butterfly needle") into a vein in the patient's arm or hand. Blood collection is a manual, labor - intensive process, and the average patient requires several hours of direct skilled labor during a typical hospital stay. This needle stick is not only painful and a major cause of patient dissatisfaction, but nurses or specialized phlebotomists often have difficulty finding a vein in approximately 10% - 15% of patients, resulting in multiple painful "sticks" being attempted. This significantly increases material and labor costs (the needles and tubes must be discarded for each attempt), as well as patient pain and injury.

[0004]

[1002] The current process for blood collection is inefficient, taking an average of 7 to 10 minutes and exceeding 21 minutes for 10% of patients. These 10% of patients are called patients with difficult intra-venous access or more generally "tough stick" patients. When superficial veins cannot be easily identified, blood can be forced into the vein by massaging the arm from the wrist to the elbow, gently tapping the area with the index and middle fingers, applying a warm, moistened towel to the area for 5 minutes, or lowering the arm bedside to allow blood to pool in the vein. Each of these methods is time-consuming and thus costly.

[0005]

[1003] Peripheral IV catheters (PIVs) are inserted for most patients during their hospital stay and are used to inject fluids and medications. However, PIVs are not designed for blood collection. If a PIV remains inserted for more than one day, the failure rate for aspiration reaches 20% - 50%. Blood drawn from a PIV often hemolyzes (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 necessitating repeated blood collection.

[0006]

[1004] There are several obstacles that can cause the drawbacks of blood collection from PIVs. First, most catheters are formed from soft bio-reactive polymers, which can lead to potential narrowing or collapse of the catheter when negative pressure is applied for aspiration. Another obstacle is that over time, debris (e.g., fibrin / platelet That is, there is a possibility that the thrombus increases. Similarly, such debris may at least partially occlude the lumen of the vein in which the PIV is placed. In some cases, this debris (fibrin / platelet thrombus) around the PIV may reduce blood flow (e.g., both upstream and downstream) within the portion of the vein around the inserted PIV, thereby making aspiration inappropriate and / or inefficient. Another obstacle is due to the "suction cup" effect, where negative pressure is generated by the catheter's suction and the venous path may be curved, causing the tip of the catheter to adhere to the venous wall. As the negative pressure increases, there is a possibility that the vein will burst, resulting in "blowing the vein", which is a concern for phlebotomists during aspiration with a PIV. Summary of the Invention

[0007]

[1005] Accordingly, there is a need for an improved system and method for venous blood collection using a peripheral intravenous catheter.

[0008]

[1006] Devices and methods for transferring fluid between a patient through a configured peripheral intravenous catheter are described herein. In some embodiments, the device includes a catheter, an introducer, and an actuator. The catheter has a proximal end portion and a distal end portion, defining a lumen therethrough. The introducer has a proximal end portion and a distal end portion, defining an internal volume configured to movably receive the catheter. The distal end portion of the introducer has a lock configured to couple the introducer to an indwelling peripheral venous line. The actuator is movably coupled to the introducer and has a first portion disposed outside the introducer and a second portion disposed within the internal volume of the introducer and coupled to the proximal end portion of the catheter. The actuator is configured to be moved 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 at least a first portion of the catheter is disposed within the peripheral venous line and the distal end portion of the catheter is disposed beyond the distal end of the introducer when the introducer is coupled to the peripheral venous line. The first portion of the actuator is placed in contact with the outer surface of the introducer such that (1) the longitudinal axis defined by the second portion of the actuator is non-parallel to the longitudinal axis defined by the introducer and (2) the second portion of the actuator exerts a force on the proximal end portion of the catheter that serves to increase the internal stress within at least the second portion of the catheter.

Brief Description of the Drawings

[0009]

Figure 1

[1007] Schematic diagrams of fluid transfer devices in first and second configurations, respectively, according to an embodiment.

Figure 2

[1007] Schematic diagrams of fluid transfer devices in first and second configurations, respectively, according to an embodiment.

Figure 3

[1008] Perspective view of a fluid transfer device in a first configuration according to an embodiment.

Figure 4

[1009] Top view of the fluid transfer device shown in FIG. 3.

Figure 5

[1010] Exploded view of the fluid transfer device shown in FIG. 3.

Figure 6

[1011] Perspective view of the first member of the introducer included in the fluid transfer device of FIG. 3.

Figure 7

[1012] Perspective view of the second member of the introducer included in the fluid transfer device of FIG. 3.

Figure 8

[1013] Side view of the second member shown in FIG. 7.

Figure 9

[1014] Enlarged view of a portion of the second member identified by region A1 in FIG. 8.

Figure 10

[1015] Rear perspective view of the introducer formed by coupling the first member shown in FIG. 6 to the second member shown in FIG. 7.

Figure 11

[1016] Front perspective view of the introducer shown in FIG. 10.

Figure 12

[1017] Cross-sectional view of the introducer taken along line 12-12 of FIG. 11.

Figure 13

[1018] Rear perspective view of the lock included in the fluid transfer device of FIG. 3.

Figure 14

[0018] Top view of the lock included in the fluid transfer device of FIG. 3.

Figure 15

[1019] Cross-sectional view of the lock taken along line 15-15 of FIG. 14.

Figure 16

[1020] Exploded perspective view of the catheter, second catheter, and actuator included in the fluid transfer device of FIG. 3.

Figure 17

[1021] Perspective view of the actuator shown in FIG. 16.

Figure 18

[1021] Side view of the actuator shown in FIG. 16.

Figure 19

[1021] Front view of the actuator shown in FIG. 16.

Figure 20

[1022] Figure 4 is a cross-sectional view of the fluid transfer device along line 20-20.

Figure 21

[1023] Figure 3 is a side view of the fluid transfer device in the first configuration.

Figure 22

[1024] Figure 3 is a cross-sectional view of the fluid transfer device in the first configuration along line 22-22.

Figure 23

[1025] Figure 22 is an enlarged cross-sectional view of a part of the fluid transfer device identified by region A2.

Figure 24

[1026] Figure 22 is an enlarged cross-sectional view of a part of the fluid transfer device identified by region A3.

Figure 25

[1027] Figure 3 is a side view of the fluid transfer device when transitioning from the first configuration to the second configuration.

Figure 26

[1028] Figure 24 is an enlarged view of a part of the fluid transfer device identified by region A4.

Figure 27

[1029] Figure 3 is a side view of the fluid transfer device in the second configuration.

Figure 28

[1030] Figure 3 is a cross-sectional view of the fluid transfer device in the second configuration along line 22-22.

Figure 29

[1031] Figure 28 is an enlarged cross-sectional view of a part of the fluid transfer device identified by region A5.

Figure 30

[1032] Figure is a flowchart showing a method of using a fluid transfer device according to an embodiment.

Figure 31

[1033] Figure is a cross-sectional side view of a fluid transfer device according to an embodiment.

Figure 32

[1034] Figure 31 is an enlarged cross-sectional side view of a part of the fluid transfer device indicated by region A6.

Figure 33

[1035] Figure 31 is a cross-sectional side view of the fluid transfer device in the second configuration.

Figure 34

[1036] Figure 31 is a cross-sectional front view of the fluid transfer device in the second configuration.

Figure 35

[1037] Side view of a fluid transfer device according to one embodiment.

Figure 36

[1038] Side view of the fluid transfer device of FIG. 35 arranged at a predetermined angle with respect to the target surface.

Figure 37

[1039] Side view of a fluid transfer device and a support member according to different embodiments.

Figure 38

[1039] Side view of a fluid transfer device and a support member according to different embodiments.

Figure 39

[1040] Front view of a fluid transfer device and a support member according to one embodiment.

Figure 40

[1041] Perspective view of the support member of FIG. 39.

Figure 41

[1042] Front view of a fluid transfer device and a support member according to one embodiment.

Figure 42

[1043] Cross-sectional side view of a fluid transfer device and an internal support member according to one embodiment.

Figure 43

[1044] Perspective view of the internal support member and the actuator of the fluid transfer device shown in FIG. 42.

Figure 44

[1045] Cross-sectional side views of fluid transfer devices and internal support members according to different embodiments.

Figure 45

[1045] Cross-sectional side views of fluid transfer devices and internal support members according to different embodiments.

Figure 46

[1046] Flowchart showing a method of using a fluid transfer device according to one embodiment.

DETAILED DESCRIPTION OF THE INVENTION

[0010]

[1047] In some embodiments, the device includes a catheter, an introducer, and an actuator. The catheter has a proximal end portion and a distal end portion and defines a lumen therethrough. The introducer has a proximal end portion and a distal end portion and defines an internal volume configured to movably receive the catheter. The distal end portion of the introducer has a lock configured to couple the introducer to a peripheral venous line. The actuator is movably coupled to the introducer and has a first portion disposed outside the introducer and a second portion disposed within the internal volume of the introducer and coupled to the proximal end portion of the catheter. The actuator is configured to be moved 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 at least a first portion of the catheter is disposed within the peripheral venous line and the distal end portion of the catheter is disposed beyond the distal end portion of the introducer when the introducer is coupled to the peripheral venous line. The first portion of the actuator contacts the outer surface of the introducer such that (1) the longitudinal axis defined by the second portion of the actuator is non-parallel to the longitudinal axis defined by the introducer and (2) the second portion of the actuator exerts a force on the proximal end portion of the catheter that serves to increase the internal stress within at least the second portion of the catheter.

[0011]

[1048] In some embodiments, the device includes a catheter, an introducer, and an actuator. The catheter has a proximal end portion and a distal end portion and defines a lumen therethrough. The introducer has a proximal end portion and a distal end portion and defines an internal volume configured to movably receive the catheter. The distal end portion of the introducer has a lock configured to couple the introducer to an indwelling peripheral venous line. The lock defines a lumen configured to movably receive the catheter. The actuator is coupled to the proximal end portion of the catheter and is configured to move relative to the introducer in response to a first force exerted on the actuator to move the catheter between a first position in which the distal end portion of the catheter is disposed within the lumen of the lock and a second position in which the distal end portion of the catheter extends through the lock and the peripheral venous line such that the distal end portion of the catheter is distal to the peripheral venous line. The actuator is configured to exert a second force different from the first force on the proximal end portion of the catheter when the actuator moves the catheter from the first position to the second position. The second force causes deflection of a portion of the catheter disposed between the actuator and the lock when the actuator moves the catheter from the first position to the second position.

[0012]

[1049] In some embodiments, a method of using a fluid transfer device includes coupling a lock of the fluid transfer device to an indwelling peripheral venous line. The fluid transfer device includes an introducer having a distal end portion coupled to the lock, a catheter movably disposed within an internal volume defined by the introducer, and an actuator coupled to the proximal end portion of the catheter and configured to move relative to the introducer. No. The first force acts on the actuator, moving the actuator relative to the introducer and advancing the catheter from a first position where the distal end portion of the catheter is disposed within the lumen defined by the lock to a second position. When the actuator advances the catheter from the first position to the second position, a second force different from the first force is exerted by the actuator on the proximal end portion of the catheter. The portion of the catheter disposed between the actuator and the lock is deflected by a first amount in response to the second force as the catheter is advanced from the first position to the second position. This portion of the catheter is deflected by a second amount greater than the first amount in response to (1) the second force and (2) the distal end portion of the catheter colliding with an obstruction as the catheter is advanced from the first position to the second position.

[0013]

[1050] In some embodiments, the device includes a catheter, an introducer, and an actuator. The catheter has a proximal end portion and a distal end portion. The introducer has a proximal end portion and a distal end portion and is configured to be coupled to a peripheral venous line. The introducer defines an internal volume configured to movably receive the catheter. The actuator includes a first portion in contact with the outer surface of the introducer and a second portion disposed within the internal volume and coupled to the proximal end portion of the catheter. The actuator is 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 at least a portion of the distal end portion of the catheter is disposed beyond the distal end portion of the introducer such that the distal end portion of the catheter is disposed within the peripheral venous line when the introducer is coupled to the peripheral venous line. The contact between the outer surface and the first portion of the actuator is such that the catheter is biased when the catheter is in the first position.

[0014]

[1051] As used herein, the terms "catheter" and "cannula" are used synonymously and refer to an element configured to define a passageway for moving body fluid from a first location to a second location (e.g., a fluid passageway for moving body fluid outside the body). A cannula can be configured to receive a trocar, guide wire, or introducer for delivering the cannula into a space within a patient's body, but a cannula as referred to herein is not necessarily required to include or receive a trocar, guide wire, or introducer.

[0015]

[1052] As used herein, the terms "Y adapter" and "T adapter" are used to refer to a two-port IV extension set. Thus, the terms "Y adapter" and "T adapter" generally describe the overall shape of a two-port IV extension set. For example, as used herein, a Y adapter is substantially in a "Y" shape and includes a single port at a first end and two ports disposed obliquely at a second end. Further, the terms "Y adapter" and "T adapter" are included by way of example only and not by way of limitation. For example, in some embodiments, the device can 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 three or more ports).

[0016]

[1053] As used herein, the terms "proximal" and "distal" refer to the direction closer to and away from, respectively, a user who disposes the device in 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 end on the opposite side of the device (e.g., the end of the device being operated by the user) is the proximal end of the device.

[0017]

[1054] As used herein, the term "stiffness" relates to the resistance of an object to deflection, deformation, and / or displacement due to an applied force. Stiffness is characterized by the amount of force applied to the object, as well as the resulting distance by which a first portion of the object deflects, deforms, and / or displaces relative to a second portion of the object. When characterizing the stiffness of an object, the deflected distance can be measured as the deflection of a portion of the object that is different from the portion of the object to which the force is directly applied. In other words, for some objects, the location of the deflection is separate from the location where the force is applied.

[0018]

[1055] Stiffness is a quantitative property of the described object and is thus determined by the material forming the object and certain physical characteristics of the object (such as shape and boundary conditions). For example, the stiffness of an object can be increased or decreased by selectively including in the object a material having a desired elastic modulus, flexural modulus, and / or hardness. The elastic modulus is an intensive property of the constituent material (i.e., inherent to the constituent material) and describes the tendency of an object to deform elastically (i.e., non-permanently) in response to an applied force. When equal stresses are applied, a material with a high elastic modulus deflects less than a material with a low elastic modulus. Thus, for example, the stiffness of an object can be increased by introducing into the object a material with a high elastic modulus and / or by constructing the object from such a material.

[0019]

[1056] Similarly, the hardness of a material is an intensive property of the constituent material and describes a measure of how the material withstands various types of permanent shape changes when a force is applied. When considering the effect on hardness and as a result the catheter stiffness, generally the Shore durometer scale is used. There are several scales for durometer hardness, but when describing plastics, polymers, elastomers and / or rubbers, generally two, namely type A and type D are used, with type A generally used for soft materials and type D generally used for hard materials. The Shore durometer hardness of a material is represented by a number from 0 to 100, with a larger number indicating a harder material, and the type of scale is indicated after the number. For example, a first material may be measured as having a Shore durometer hardness of 40 Shore A, and a second material may be measured as having a Shore durometer hardness of 20 Shore D. Thus, according to the Shore durometer hardness scale, the second material is harder and thus more rigid than the first material.

[0020]

[1057] As used herein, the terms "clutch" and / or "clutching" refer to the transition of a catheter between a first configuration (e.g., a "non-clutch" configuration) and a second configuration (e.g., a "clutch" configuration) in a predetermined and / or predictable manner. Specifically, the catheter can be bent, flexed, curved, deformed, deflected, moved, compressed, and / or reconfigured in another way when transitioning from a "non-clutch" configuration to a "clutch" configuration. In some examples, the catheter can "clutch" and / or be "clutched" in response to the distal end of the catheter hitting an obstacle, twist, bend, valve, etc. that inhibits, restricts, and / or substantially prevents its further movement. In some examples, the clutching of the catheter can be in the form of linear, sinusoidal, elliptical, curved, and / or logarithmic deflection and / or deformation, or any other form, or a combination of forms of deflection and / or deformation from the original or "non-clutch" configuration. In some examples, the amount and / or manner of deformation and / or deflection ("clutching") of the catheter when transitioning to the clutch configuration can be adjusted by increasing or decreasing the stiffness, hardness, and / or durometer of the constituent material forming the catheter, by increasing or decreasing the inner and / or outer diameter of the catheter, by increasing or decreasing the wall thickness of the catheter, by increasing or decreasing the length of the substantially unsupported portion of the catheter, by increasing or decreasing the range of motion and / or degrees of freedom of the catheter, by increasing or decreasing the amount of force transmitted to the catheter, and / or by other suitable adjustments.

[0021]

[1058] Figures 1 and 2 are, according to an embodiment, in a first configuration and a second configuration, respectively FIG. is a schematic view of a fluid transfer device 100 for venous blood collection by a peripheral venous line or catheter. The fluid transfer device 100 (also referred to herein as the "transfer device") can be of any suitable shape, size, and / or configuration. As described in more detail herein, the transfer device 100 is configured to be coupled to and / or otherwise engaged with an indwelling peripheral intravenous catheter (PIV) 105 to transfer fluid from a part of a patient (e.g., aspiration of blood) and / or to transfer fluid to a part of a patient (e.g., injection of a drug or substance).

[0022]

[1059] The transfer device 100 includes at least an introducer 110, a catheter 160 (or cannula), and an actuator 170. The introducer 110 can be of any suitable configuration. For example, in some embodiments, the introducer 110 can be an elongated member having a substantially circular cross-sectional shape. In some embodiments, the shape of the introducer 110 and / or one or more features or surface finishes of at least the outer surface of the introducer 110 can be arranged to improve the ergonomic aspects of the transfer device 100, thereby, in some cases, enabling a user to operate the transfer device 100 with one hand (i.e., single-handed use).

[0023]

[1060] The introducer 110 has a proximal end portion 111 and a distal end portion 112 and defines an internal volume 113. Although not shown in FIGS. 1 and 2, the proximal end portion 111 of the introducer 110 can include an opening or port configured to movably receive a portion of the catheter 160. Accordingly, a first portion of the catheter 160 can be disposed within the internal volume 113 and a second portion of the catheter 160 can be disposed outside the internal volume 113. The opening or port can be of any suitable configuration. For example, in some embodiments, the opening and / or port can include a seal or the like that is configured to form a substantially fluid-tight seal with the outer surface of the portion of the catheter 160 disposed therein. In other embodiments, the arrangement of the opening and / or port is such that the user can position the catheter 160 to selectively contact the surface of the proximal end portion 111 that defines the opening and / or port, as will be described in more detail herein with respect to specific embodiments, whereby the surface of the proximal end portion 111 can clamp and / or pinch the catheter 160 so as to selectively occlude the lumen of the catheter 160.

[0024]

[1061] The distal end portion 112 of the introducer 110 includes and / or is coupled to a lock configured to physically and fluidly couple the introducer 110 to the PIV 105 (see, e.g., FIG. 2). For example, in some embodiments, the distal end portion 112 can include a coupler such as a Luer Lok™ coupler configured to physically and fluidly couple to a related coupler of the lock. In some embodiments, the lock is configured to selectively engage and / or contact the PIV 105 to couple the introducer 110 thereto. For example, in some embodiments, the shape, size, and / or configuration of the lock is such that the lock forms three contact points with the PIV 105. In some embodiments, such an arrangement can provide structural rigidity and / or support to the PIV 105 when a portion of the lock (e.g., a protrusion, etc.) is inserted into a portion of the PIV 105, as described in more detail herein.

[0025]

[1062] In some embodiments, the distal end portion 112 of the introducer 110 can include and / or be coupled to a support member or the like operable when positioning the introducer 110 and / or the device 100 at a predetermined angle relative to the target surface. For example, in some embodiments, the arrangement of the lock can be such that positioning a predetermined portion of the lock in contact with the target surface positions the introducer 110 and / or the device 100 at a predetermined and / or desired angle relative to the target surface. In other embodiments, a support member or the like is coupled to the distal end portion 112 of the introducer 110 and can be configured to position the introducer 110 and / or the device 100 at a predetermined and / or desired angle relative to the target surface. In some examples, the target surface can be the skin surface of the body into which the PIV 105 is inserted (e.g., the outer surface of a patient's arm, etc.). In some embodiments, the predetermined angle can be, for example, from about 0° to about 30°, from about 4° to about 15°, from about 8° to about 10°, or any other suitable angle. roducer 110 and / or the device 100 at a predetermined and / or desired angle relative to the target surface. In some examples, the target surface can be the skin surface of the body into which the PIV 105 is inserted (e.g., the outer surface of a patient's arm, etc.). In some embodiments, the predetermined angle can be, for example, from about 0° to about 30°, from about 4° to about 15°, from about 8° to about 10°, or any other suitable angle.

[0026]

[1063] In some embodiments, the distal end portion 112 (and / or lock) of the introducer 110 can include a seal or the like, which can be transitioned from a sealed configuration to a substantially open configuration so as to place at least a portion of the internal volume 113 in fluid communication with the lock. In some embodiments, the seal can include a backflow prevention mechanism such as a one-way valve or the like, which can, for example, allow the catheter 160 to advance distally through the seal while restricting and / or substantially preventing fluid flow outside the catheter 160 in the proximal direction through the seal.

[0027]

[1064] As described above, the introducer 110 defines an internal volume 113 that extends between a proximal end portion 111 and a distal end portion 112. As shown in FIGS. 1 and 2, the internal volume 113 has and / or defines a first portion 114 configured to receive a first portion 171 of the actuator 170 and a second portion 115 configured to receive the catheter 160 and a second portion 175 of the actuator 172. More specifically, the inner surface of the introducer 110 that defines the internal volume 113 can have, for example, a tortuous cross-sectional shape (not shown in FIGS. 1 and 2), whereby the axis defined by the first portion 114 of the internal volume 113 is parallel to and offset from the axis defined by the second portion 115 of the internal volume 113. Thus, the first portion 114 of the internal volume 113 can be spaced apart without being fluidly isolated from the second portion 115 of the internal volume 113. In some embodiments, the first portion 114 of the internal volume 113 can extend through the wall of the introducer 110. In other words, the introducer 110 can define slots, channels, tracks, openings, etc. that are in fluid communication with the first portion 114 of the internal volume 113. Conversely, the second portion 115 of the internal volume 113 can be completely defined and / or (at least circumferentially) surrounded by the introducer 110. Further, in some embodiments, due to the tortuous cross-sectional shape of the internal volume 113, the second portion 115 cannot be seen through slots or the like that are in fluid communication with the first portion 114 of the internal volume 113 (e.g., the second portion 115 is out of sight), thereby limiting and / or substantially preventing contamination of the catheter 160 disposed therein.

[0028]

[1065] Although not shown in FIGS. 1 and 2, in some embodiments, the introducer 110 can include and / or receive an internal support member or the like. In such embodiments, the internal support member can be disposed within the internal volume 113 and configured to support and / or guide at least a portion of the catheter 160 disposed within the internal volume 113 of the introducer 110. In some embodiments, the internal support member can be configured to at least partially isolate a portion of the catheter 160, which can operate to maintain the sterility of the catheter 160 prior to use.

[0029]

[1066] The catheter 160 of the delivery device 100 includes a proximal end portion 161 and a distal end portion 162 and defines a lumen 163 that extends therethrough. The catheter 160 is movably disposed within a second portion 115 of the internal volume 113 defined by the introducer 110 and is coupled to the actuator 170. In some embodiments, the catheter 160 can move between a first position and a second position (e.g., via movement of the actuator 170) to transition the delivery device 100 between a first configuration and a second configuration, respectively. More specifically, when the catheter 160 is in the first position When in the first position (FIG. 1), at least the distal end portion 162 of the catheter 160 is disposed within the second portion 115 of the internal volume 113, and when the catheter 160 is in the second position (FIG. 2), at least a portion of the catheter 160 extends through the PIV 105 such that the distal end of the catheter 160 is disposed distally relative to a portion of the PIV 105. Although not shown in FIGS. 1 and 2, in some embodiments, the delivery device 100 can include a second catheter or the like that is coupled to the actuator 170 and in fluid communication with the catheter 160. In such embodiments, the second catheter can be disposed, for example, proximally relative to the catheter 160 and configured to extend through an opening and / or port defined by the proximal end portion 111 of the introducer 110. Thus, the proximal end portion of the second catheter can be coupled to a vacuum (air or liquid) source, a fluid reservoir, a fluid source, a syringe, etc., whereby the catheter 160 is in fluid communication therewith. Further, in embodiments including a second catheter, when the catheter 160 is in the first position, the catheter 160 can be fully disposed within the introducer 110.

[0030]

[1067] Catheter 160 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, at least a portion of catheter 160 can have an outer diameter (e.g., 10 gauge to 30 gauge) that is substantially the same as or slightly smaller than the inner diameter defined by a portion of the lock coupled to the distal end portion 112 of introducer 110. In this way, the inner surface of that portion of the lock can guide catheter 160 as catheter 160 moves between the first position and the second position. In some embodiments, such an arrangement can limit and / or substantially prevent bending, deformation, and / or kinking of a portion of catheter 160 that moves between the first position and the second position. In some embodiments, catheter 160 can have a length sufficient to position the distal surface of catheter 160 at a desired position relative to the distal surface of PIV 105 when catheter 160 is in the second position. In other words, the length of catheter 160 can be sufficient to define a predetermined and / or desired distance between the distal surface of catheter 160 and the distal surface of PIV 105 when catheter 160 is in the second position. Optionally, as described in more detail herein, by positioning the distal surface of catheter 160 at a predetermined and / or desired distance from the distal surface of PIV 105, for example, the distal surface of catheter 160 can be positioned at a desired position within a vein.

[0031]

[1068] Catheter 160 can be formed from any suitable material or combination of materials, whereby the catheter 160 can have any suitable rigidity or durometer hardness. In some embodiments, at least a portion of the catheter 160 can be formed from a braided material or the like, whereby the flexibility of the catheter 160 can be changed, modified, and / or altered in response to bending forces or the like. In some embodiments, forming the catheter 160 from a braided material or the like can reduce the likelihood of undesired kinking and / or other deformation. Further, by forming at least a portion of the catheter 160 from a braided material, compression and / or deformation can be effected in response to a compressive force (e.g., an axial force or the like) applied in the direction of the longitudinal centerline defined by the catheter 160. Thus, the catheter 160 can absorb, for example, a portion of the forces associated with striking an obstruction or the like. As described in further detail herein, in some examples, at least a portion of the catheter 160 can be deformed in response to forces associated with striking such an obstruction or the like.

[0032]

[1069] Actuator 170 of the delivery device 100 can be of any shape, size, and / or configuration. As described above, the actuator 170 includes a first portion 171 movably disposed within a first portion 114 of the internal volume 113 and a second portion 175 movably disposed within a second portion 115 of the internal volume 113 and coupled to the catheter 160. Although not shown in FIGS. 1 and 2, the actuator 170 can have a cross-sectional shape related to and / or otherwise corresponding to the cross-sectional shape of the internal volume 113 (e.g., a convoluted cross-sectional shape). Accordingly, the axis defined by the first portion 171 of the actuator 170 is parallel to and offset from the axis defined by the second portion 175 of the actuator 170. For example, a convoluted cross-sectional shape). Accordingly, the axis defined by the first portion 171 of the actuator 170 is parallel to and offset from the axis defined by the second portion 175 of the actuator 170.

[0033]

[1070] The arrangement of the actuator 170 and the introducer 110 is such that the first portion 171 extends through a slot or the like in fluid communication with the first portion 114 of the internal volume 113. Accordingly, the first region of the first portion 171 of the actuator 170 is disposed outside the introducer 110, and the second region of the first portion 171 of the actuator 170 is disposed in the first portion 114 of the internal volume 113. In this way, the user can operate the first region of the first portion 171 of the actuator 170 to move the actuator 170 relative to the introducer 110 and move the catheter 160 coupled to the second portion 175 of the actuator 170 between a first position and a second position. Although not shown in FIGS. 1 and 2, in some embodiments, the first portion 171 of the actuator 170 can include tabs, protrusions, and / or surfaces that are in contact with the outer surface of the introducer 110. In such embodiments, the outer surface of the introducer 110 can include, for example, a set of ribs, ridges, protrusions, grooves, etc., and as the actuator 170 moves relative to the introducer 110, along therewith, the tabs, protrusions, and / or surfaces of the first portion 171 advance, thereby providing the user with a tactile output or feedback (acoustic, tactile, and visual) that can provide an indicator related to the position of the distal end portion 162 of the catheter 160.

[0034]

[1071] In some embodiments, the arrangement of the first portion 171 of the actuator 170 and the outer surface of the introducer 110 is such that the actuator 170 is arranged at an angle with respect to the introducer 110. That is, the contact between the first portion 171 of the actuator 170 and the outer surface of the introducer 110 tilts the actuator 170 with respect to the introducer 110. Thus, in some examples, the longitudinal centerline of the actuator 170 may be non-parallel to the longitudinal centerline of the introducer 110. Further, with the actuator 170 coupled to the proximal end portion 161 of the catheter 160, the angling and / or tilting of the actuator 170 applies a force (e.g., a preloading force, etc.) sufficient to bend at least a portion of the catheter 160 (e.g., place the catheter 160 in a biased configuration), which is described in further detail herein.

[0035]

[1072] In some embodiments, the transfer device 100 can be arranged in a first configuration before use (e.g., in the first configuration, it is possible to transport, store, prepare, etc.). During use, the user can operate the transfer device 100 to couple the introducer 110 to the indwelling PIV 105 (e.g., via a lock coupled to and / or assembled with the introducer 110). With the transfer device 100 coupled to the PIV 105, the user can activate the first portion 171 of the actuator 170 to move the actuator 170 relative to the introducer 110, whereby the catheter 160 moves from a first position (e.g., disposed within the introducer 110) towards a second position. In some embodiments, the arrangement of the actuator 170 and the introducer 110 is such that by advancing the actuator 170 relative to the introducer 110, tactile output and / or feedback is generated that is configured to provide the user with an indicator related to the position of the distal portion 162 of the catheter 160 relative to the introducer 110 and / or the PIV 105. For example, based on the tactile feedback or any other suitable indicator, as described above, the user can position the catheter 160 in the second position such that the distal surface of the catheter 160 extends beyond the distal surface of the PIV 105 by a desired distance.

[0036]

[1073] With the catheter 160 in the second position (e.g., with the delivery device 100 in the second configuration shown in FIG. 2), the user can establish fluid communication between the fluid reservoir, fluid source, syringe, etc. and the catheter 160. For example, as described above, in some embodiments, the user can couple a second catheter (not shown) to the fluid reservoir, fluid source, syringe, etc. Although it has been described that fluid communication is established between the catheter 160 and the fluid reservoir or fluid source after the catheter 160 is placed in the second position, in other embodiments, the user can establish fluid communication between the catheter 160 and the fluid reservoir or fluid source before moving the actuator 170 relative to the introducer 110. And with the catheter 160 in fluid communication with the fluid reservoir and / or fluid source, the delivery device 100 can transfer fluid from or into the patient's body via the catheter 160 that extends through and beyond the PIV 105.

[0037]

[1074] In some examples, when the user advances the catheter 160 (via the actuator 170) from the first position to the second position, the catheter 160 may collide with an obstruction or the like. In some such examples, the catheter 160 can be configured to bend, deform, and / or otherwise reconfigure in response to the force exerted by the user. That is, the force (e.g., activation force or actuation force) applied by the user to the actuator 170, which would normally be sufficient to move the catheter 160 toward the second position, causes at least partial deflection, deformation, and / or reconfiguration of the catheter 160 when the catheter 160 collides with an obstruction or the like. Further, with at least a portion of the catheter 160 pre-loaded (e.g., bent, curved, biased, deflected, and / or deformed in response to the angle of the actuator 170 as described above), the deflection, deformation, and / or reconfiguration of that portion of the catheter 160 can be predetermined, predictable, etc.

[0038]

[1075] As described above, some deflection, deformation, and / or reconfiguration of the catheter 160 in response to a collision with an obstruction can result in “clutching” (e.g., bending, flexing, curving, deflecting, deforming, compressing, etc.) of the catheter 160 and / or the device 100 that reduces unwanted forces applied to walls such as veins. In some embodiments, as described in further detail herein with respect to particular embodiments, the clutching of the catheter 160 can generate and / or result in audible, visual, and / or tactile indicators that the catheter 160 has collided with an obstruction. In some examples, when the catheter 160 and / or the device 100 is “clutched,” the user can pause while the pre-loaded and / or clutched catheter 160 and / or device 100 applies a constant but linearly decreasing force to overcome the obstruction, etc. In some examples, the clutched catheter 160 and / or device 100 can automatically unclutch (e.g., self-release at least a portion of the stress along the length of the catheter 160), resulting in a safe and / or controlled process for overcoming the obstruction.

[0039]

[1076] Figures 3-29 illustrate a fluid transfer device 200 according to another embodiment. The fluid transfer device 200 (also referred to herein as the “transfer device”) can be of any suitable shape, size, or configuration and can be coupled, for example, to a PIV (not shown in Figures 3-29) via a lock and / or adapter. As described in further detail herein, the user can transition the transfer device 200 from a first configuration to a second configuration to advance a catheter through an existing, placed, and / or indwelling PIV (i.e., when the transfer device 200 is coupled to the PIV), such that at least the end of the catheter is positioned distally with respect to the PIV. Additionally, the peripheral venous line can be changed, respectively, for example, based on the manufacturer of the PIV and / or its intended use. By having a shape, size, and / or configuration that enables the delivery device 200 to be coupled to a PIV having any suitable configuration, and then advancing at least a portion of the catheter through the PIV such that the catheter is not substantially kinked, snagged, damaged, and / or otherwise undesirably reconfigured, the delivery device 200 can be positioned. Further, the user can operate the delivery device 200 to position the distal face of the PIV beyond a predetermined and / or desired distance such that the distal face of the catheter is disposed within a portion of a vein that receives substantially unobstructed blood flow.

[0040]

[1077] As shown in FIGS. 3-5, the delivery device 200 includes an introducer 210, a lock 240, a catheter 260, a second catheter 265, and an actuator 270. The introducer 210 can be of any suitable shape, size, or configuration. For example, in some embodiments, the introducer 210 can be an elongate member having a substantially circular cross-sectional shape. In some embodiments, the shape of the introducer 210 and / or one or more features or surface finishes of at least the outer surface of the introducer 210 can be arranged to improve the ergonomic aspects of the delivery device 200, and thereby, optionally, enable the user to operate the delivery device 200 with one hand (i.e., single-handed use).

[0041]

[1078] As shown in FIGS. 5-12, the introducer 210 of the delivery device 200 includes a first member 220 and a second member 225, which are coupled to form the introducer 210 collectively. As shown in FIG. 6, the first member 220 includes a proximal end portion 221, a distal end portion 222, and an inner surface 224. The inner surface 224 has a first portion 224 and a second portion 225. The proximal end portion 221 of the first member 220, more specifically, the proximal wall of the first member 220, defines a notch 226 configured to selectively receive a portion of the second catheter 265, as described in further detail herein.

[0042]

[1079] As shown in FIGS. 7-9, 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 respect to the first member 220, the proximal end portion 231 of the second member 230, more specifically, the proximal wall of the second member 230, defines a notch 234 configured to selectively receive a portion of the second catheter 265. The outer surface 235 of the second member 230 includes a set of ribs 236 disposed along the length of the second member 230. More particularly, each rib 236 extends along the width of the second member 230 and is disposed continuously along the length of the second member 230. Thus, the outer surface 235 defines alternating local minima and local maxima disposed along the length of the second member 230. As will be described in more detail herein, a portion of the actuator 270 is configured to advance along the outer surface 235 forming the set of ribs 236 when the user moves the actuator 270 relative to the introducer 210, thereby causing the actuator 270 (and the catheter 260 coupled to the actuator 270) to vibrate. Optionally, this vibration can facilitate, for example, the advancement of the catheter 260 through a portion or the delivery device 200, a portion of the PIV, and / or a portion of the vasculature. Further, optionally, as will be described in more detail herein, the vibration can provide a tactile and / or audible indicator to the user related to the position of the catheter 260 relative to the introducer 210 and / or the PIV.

[0043]

[1080] The ribs 236 formed by the outer surface 235 of the second member 230 can be of any suitable shape, size, and / or configuration. For example, as shown in FIGS. 8 and 9, 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 rib 236 can have any suitable configuration and / or arrangement. For example, in this embodiment, Each rib in the first portion 237 is substantially uniform and has substantially the same size and shape. In other embodiments, each rib included in the first portion 237 can have a size and shape different from the remaining ribs of the first portion 237. For example, in some embodiments, the size and / or shape of each rib in the first portion 237 can increase from the proximal rib having the smallest size and shape to the distal rib having the largest size and shape. Further, although the ribs of the first portion 237 are illustrated as being substantially symmetric, in other embodiments, each rib of the first portion 237 can be asymmetric. For example, in some embodiments, the proximal surface of each rib can have a first pitch (e.g., angle), and the distal surface of each rib can have a second pitch greater than the first pitch. In some embodiments, such an asymmetric arrangement can cause the above portion of the actuator 270 to move along the outer surface 235 having a first set of features when moving in the distal direction and to move along the outer surface 235 having a second set of features different from the first set of features when moving in the proximal direction. For example, in some embodiments, the above portion of the actuator 270 can move more freely along the outer surface 235 in the distal direction than in the proximal direction.

[0044]

[1081] Similarly, the second portion 238 of the rib 236 can have any suitable configuration and / or arrangement. For example, in this embodiment, each rib in the second portion 238 is substantially uniform and has substantially the same size and shape as the remaining ribs in the second portion 238. As shown in FIG. 9, each rib in the second portion 238 has a size and shape that is larger than the size and shape of each rib in the first portion 237. Optionally, the larger size of the ribs in the second portion 238 can increase the amount of vibration when the actuator 270 moves along the outer surface 235 (as described above). Optionally, the larger size of the ribs in the second portion 238 can increase the force that would otherwise be sufficient to move the above portion of the actuator 270 along the outer surface 235. The ribs of the second portion 238 are illustrated and described as being substantially uniform and having a size larger than the ribs of the first portion 237, but in other embodiments, the ribs of the second portion 238 can have any of the arrangements and / or configurations described above with respect to the ribs of the first portion 237.

[0045]

[1082] A set of ribs 236 transitions from a first portion 237 to a second portion 238 at a given location along the length of the second member 230 (see, e.g., FIG. 9). In other embodiments, the size and shape of each rib in the set of ribs 236 can increase from the proximal-most rib of the first portion 237, which has a minimum size and shape, to the distal-most rib of the second portion 238, which has a maximum size and shape. In other words, in some embodiments, the size and shape of each rib in the set of ribs 236 can increase for each successive rib (e.g., in the distal direction). In still other embodiments, the set of ribs 236 can include more than the first portion 237 and the second portion 238. For example, in some embodiments, the second member can include a set of ribs having a first portion, a second portion having a size, shape, and configuration similar to the first portion 237 of the second member 230, and a third portion disposed between the first portion and the second portion and having a size, shape, and configuration similar to the second portion 238 of the second member 230. That is, in such embodiments, the second member includes a proximal portion of the rib and a distal end portion of the rib, which are smaller than a central portion of the rib disposed therebetween. In some embodiments, the arrangement of the set of ribs 236 of the second member 230 is such that the proximal-most rib and the distal-most rib are relatively large and / or, in other ways, are shaped such that they are operable to at least temporarily maintain the above-described portion of the actuator 270 in a proximal position relative to the proximal-most rib and in a distal position relative to the distal-most rib, respectively.

[0046]

[1083] The set of ribs 236 is shown as being formed only by the outer surface 235 of the second member 230, but in other embodiments, the first member 220 can include an outer surface that forms a set of ribs. In such embodiments, the set of ribs of the first member 220 is the second It can be any of the configurations and / or arrangements described above with respect to the set of ribs 236 of the member 230, and / or can have any of them. In some embodiments, the ribs of the first member 220 can be offset from the ribs 236 of the second member 230. For example, in some embodiments, the ribs of the first member 220 can have alternating local minima and local maxima arranged along the length of the first member 220 (as described above with respect to the ribs 236), and the local minima and local maxima of the ribs of the first member 220 are aligned with the local maxima and local minima, respectively, of the ribs 236 of the second member 230 (offset, for example, along the length of the introducer 210). In other embodiments, the ribs of the first member 220 can be at varying positions relative to the ribs 236 of the second member 230. Thus, the introducer 210 can provide a variable arrangement of ribs that can provide, for example, tactile feedback when the actuator 270 moves relative to the introducer 210.

[0047]

[1084] As shown in FIGS. 10 to 12, the first member 220 is coupled to the second member 230 and configured to collectively form the introducer 210. For example, in some embodiments, 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. In some embodiments, coupling 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, in some embodiments, forming the introducer 210 from the first member 220 and the second member 230 can reduce undesirable variations in the shape and / or size of the inner surfaces 223 and 233 (e.g., due to draft and / or manufacturing tolerances) during manufacturing, thereby potentially reducing the likelihood of kinking, bending, and / or deformation of the catheter 260 during use of the transfer device 200. In some embodiments, forming the introducer 210 from the first member 220 and the second member 230 can enable the inner surface 223 of at least the first member 220 to form a convoluted shape that presents challenges when manufacturing the introducer 210 from a single workpiece.

[0048]

[1085] In other embodiments, the first member 220 can be formed as a single-piece structure (e.g., via injection molding and / or any other suitable manufacturing process). That is, the first member 220 can be formed from a single workpiece, such as a single workpiece rather than two workpieces, i.e., the first member 220 and the second member 230. Thus, when referring to the features of the first member 220, such features can be formed and / or defined by the first member 220, formed and / or defined by the second member 230, formed and / or defined collectively by the first member 220 and the second member 230, or, if the introducer 210 is formed from a single workpiece, formed and / or defined by the corresponding portion of the introducer 210.

[0049]

[1086] 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 internal space 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 the notch 226 of the first member 220 and the notch 234 of the second member 230. The arrangement of the proximal end portion 211 is such that the portion of the opening 217 defined by the notch 226 of the first member 220 has a first size and / or shape, and the 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. In other words, a part of the opening 217 is narrowed, pinched, blocked, and / or otherwise reduced. As will be described in more detail herein As described in more detail below, the opening 217 is configured to receive a part of the second catheter 265, and the second catheter 265 can be moved within the opening 217 from the larger portion of the opening 217 to the reduced portion of the opening 217 (for example, the portion formed by the notch 234 of the second member 230) to be blocked, pinched, and / or clamped.

[0050]

[1087] As shown in FIG. 11, the distal end portion 212 of the introducer 210 includes and / or is formed in other ways with a coupler 216. In other words, the distal end portion 222 of the first member 220 and the distal end portion 232 of the second member 230 collectively form the coupler 216 at the distal end portion 212 of the introducer 210. The coupler 216 can be of any suitable shape, size, and / or configuration. For example, in this embodiment, the coupler 216 forms a set of threads that can threadedly engage with the associated threaded portion of the lock 240, as described in more detail herein. Although not shown in FIG. 11, the distal end portion 211 of the introducer 210 can include a seal that can selectively seal and / or fluidly isolate the internal space 213 of the introducer 210 (at least from the open portion of the coupler 216), and / or can be configured to receive such a seal. In use, the seal is transitioned from a sealed or closed configuration to an open configuration to allow, for example, a portion of the catheter 260 to penetrate the seal. In some embodiments, the seal can contact the outer surface of the catheter 260 and define a seal therebetween that is operable to limit the amount of backflow of fluid between the outer surface of the cannula and the seal and / or substantially prevent backflow.

[0051]

[1088] The seal can be any suitable type of seal. For example, in some embodiments, the seal can be an O-ring, a one-way valve, a membrane, a self-healing membrane, a check valve, a simple crack valve, and / or any other suitable seal or valve member. In some embodiments, the seal is configured to define and / or otherwise have a predetermined "cracking" pressure. That is, in some embodiments, the seal can be configured to transition from a closed and / or sealed configuration to a substantially open configuration, for example, in response to an increase in pressure within the introducer 210. In some embodiments, the seal can be a positive pressure seal or the like. In other embodiments, the seal can be a fluid seal such as a saline lock. Although not shown in FIGS. 5-12, in some embodiments, the introducer 210 can include a device, mechanism, assembly, etc. that is operable to increase the 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 can include and / or be coupled to a valve, a pump, a syringe, a fluid source, a mechanical actuator, an electrical actuator, etc. In other embodiments, the seal can be any other suitable configuration.

[0052]

[1089] The inner surface 223 of the first member 220 and the inner surface 233 of the second member 230 collectively define the internal space 213 of the introducer 210. As shown in FIG. 12, the arrangement of the inner surfaces 223 and 233 is such that the internal space 213 has and / or defines a tortuous cross-sectional shape. For example, the internal space 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 ridge, tab, flange, protrusion, etc. configured to separate a first portion 224 of the inner surface 223 from a second portion 225 of the inner surface 223. Accordingly, the tortuous cross-sectional shape of the internal space 213 forms and / or defines a first portion 214 of the internal space 213 and a second portion 215 of the internal space 213. In this way, the first portion 214 of the internal space 213 is spaced apart from the second portion 215 of the internal space 213 without being fluidly isolated therefrom. In other words, the first portion 214 of the internal space 213 defines an axis that is parallel to and offset from the axis defined by the second portion 215 of the internal space 213.

[0053]

[1090] As shown in FIG. 12, the first portion 214 of the internal space 213 extends through the wall of the introducer 210. Similarly, the introducer 210 defines a slot, channel, track, opening, etc. (e.g., the first member 220 and the second member 230 collectively) that is in fluid communication with the first portion 214 of the internal space 213. Conversely, the second portion 215 of the internal space 213 is completely defined and / or (at least circumferentially) surrounded by the introducer 210. Due to the tortuous cross-sectional shape of the internal space 213, the second portion 215 cannot be seen through the slot (which is in fluid communication with the first portion 214 of the internal space 213) (e.g., the second portion 215 is out of sight), thereby limiting and / or substantially preventing contamination of the catheter 260 disposed therein.

[0054]

[1091] In this embodiment, the second portion 215 of the internal space 213 is substantially aligned with, for example, a part of the opening 217 and a part of the opening defined by the coupler 216. Further, the second portion 215 of the internal space 213 is configured to be substantially aligned with the lock 240 when the lock is coupled to the coupler 216 of the introducer 210. In other words, as described in more detail herein, the axis defined by the second portion 215 of the internal space 213 is substantially coaxial with the axis defined by a part of the lock 240. Thus, the second portion 215 of the internal space 213 can receive, for example, a part of the actuator 270 and a part of the catheter 260 movably. Therefore, as described in more detail herein, the actuator 270 is moved relative to the introducer 210 to move the catheter 260 between a first position where the catheter 260 is completely disposed within the second portion 215 of the internal space 213 and a second position where at least a part of the catheter 260 extends outside the second portion 215 of the internal space 213 and distally of the introducer 210.

[0055]

[1092] The lock 240 of the delivery device 200 can 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 to couple the introducer 210 to a PIV and / or any suitable intermediate device or adapter coupled to the PIV. As shown in FIGS. 13-15, the lock 240 has a coupler 241, a protrusion 242, a first arm 243 and a second arm 250. Further, the lock 240 defines a lumen 255 that extends through the coupler 241 and the protrusion 242. The coupler 241 is configured to couple the lock 240 to the coupler 216 of the introducer 210. Specifically, in this embodiment, the coupler 241 includes and / or forms one or more protrusions configured to selectively engage the threads defined and / or formed by the coupler 216 of the introducer 210, thereby forming a threaded connection.

[0056]

[1093] The protrusion 242 extends from the coupler 246 and is disposed between the first arm 243 and the second arm 250. The protrusion 242 can be of any suitable shape, size, and / or configuration. In some embodiments, the configuration of the protrusion 242 can be associated with 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 combined size and / or shape of the PIV and the adapter. For example, in some embodiments, the protrusion 242 can have a length sufficient to extend through at least a portion of the PIV (or the adapter). In embodiments including an adapter coupled to the PIV, the protrusion 242 can be long enough to pass through the adapter and extend at least partially within or through the PIV. In some embodiments, the protrusion 242 can be long enough to extend through the adapter and the PIV such that at least a portion of it is distal to the PIV. Further, the protrusion 242 can have an outer diameter that is the same as or slightly smaller than the inner diameter of a portion of the PIV and / or an adapter coupled to the PIV. For example, in some embodiments, the outer surface of the protrusion 242 can contact the inner surface when the protrusion 242 is disposed within the PIV. Thus, the protrusion 242 can provide structural support to at least a portion of the PIV in which the protrusion 242 is disposed. Similarly, the protrusion 242 can have an inner diameter (the diameter of the surface that at least partially defines the lumen 255) that is the same as or slightly larger than the outer diameter of a portion of the catheter 260, as described in more detail herein. small. For example, in some embodiments, the outer surface of the protrusion 242 can contact the inner surface when the protrusion 242 is disposed within the PIV. Thus, the protrusion 242 can provide structural support to at least a portion of the PIV in which the protrusion 242 is disposed. Similarly, the protrusion 242 can have an inner diameter (the diameter of the surface that at least partially defines the lumen 255) that is the same as or slightly larger than the outer diameter of a portion of the catheter 260, as described in more detail herein.

[0057]

[1094] The first arm 243 and the second arm 250 of the lock 240 can be of any suitable shape, size, and / or configuration. As shown in FIGS. 13 and 14, 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, for example, toward the protrusion 242. Thus, as described in more detail herein, the tab 246 can selectively engage with a part of the PIV and / or a part of an adapter coupled to the PIV to couple the lock 240 to the PIV.

[0058]

[1095] The pivot portion 247 of the first arm 243 extends laterally from the coupler 241, the protrusion 242, and / or the second arm 250. The first end 244 and the second end 245 of the first arm 243 are proximal and distal to the pivot portion 247, respectively. Thus, the first arm 243 can act as a lever or the like configured to pivot about an axis defined by the pivot portion 247 in response to an applied force. For example, optionally, as described in more detail herein, the user can apply a force sufficient to pivot the first end 244 of the first arm 243 (e.g., toward the coupler 241) (as indicated by arrow AA in FIG. 14) toward the coupler 241 and pivot the second end 245 of the first arm 243 (as indicated by arrow BB in FIG. 14) away from the protrusion 242.

[0059]

[1096] As described above with respect 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. In this embodiment, the first arm 243 and the second arm 250 are substantially similar in shape and function and are disposed in opposite positions and orientations with respect to the coupler 241 and the protrusion 242 (e.g., the lock 240 is substantially symmetric about its longitudinal axis). Accordingly, the considerations for the first arm 243 apply equally to the second arm 250, and thus the second arm 250 will not be described in further detail herein.

[0060]

[1097] 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, respectively, from a first position to a second position. Accordingly, pivoting of the first arm 243 increases the space defined between the protrusion 242 and the second end 245 (and tab 246) of the first arm 243. Similarly, pivoting the second arm 250 increases the space defined between the protrusion 242 and the second end 252 (and tab 253) of the second arm 250. Thus, the increased space between the protrusion 242 and the arms 243 and 250 is large enough to allow a portion of the PIV and / or an adapter coupled to the PIV to be inserted into that space. When a portion of the PIV and / or the adapter is in the desired position relative to the lock 240, the user can remove the force, whereupon the arms 243 and 250 pivot towards their respective first positions. As a result, the second ends 245 and 252 are such that the tabs 246 and 253 are each PIV And / or until it contacts a portion of the adapter, it moves toward the protrusion 242. The tabs 246 and 253 are configured to engage with the above-mentioned portion of the PIV and / or the adapter to temporarily couple the lock 240 to the PIV and / or the adapter. In some embodiments, the lock 240 can be configured to establish three contact points with the PIV and / or the adapter, namely, the tabs 246 and 253, and the outer surface of the protrusion 242 (as described above). In some embodiments, the tabs 246 and 253 can be configured to generate an audible output such as a click, a vibration output such as a haptic bump, etc., that can indicate to the user that the lock 240 is properly coupled to the PIV and / or the adapter when in contact with the above-mentioned portion of the PIV and / or the adapter.

[0061]

[1098] As shown in FIG. 15, the protrusion 242 and the coupler 241 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 a second portion 215 of the internal space 213. Accordingly, the lumen 255 of the lock 240 receives a portion of the catheter 260 when the transfer device 200 transitions between the first configuration and the second configuration. In some embodiments, the lumen 255 can have a size and / or shape that is at least partially based on the size and / or shape of the catheter 260. For example, the lumen 255 can have an inner diameter that is slightly larger than the outer diameter of at least a portion of the catheter 260. In such embodiments, the lock 240 can be an external guide or the like that can support and / or guide the catheter 260 as the catheter 260 moves within the lumen 255. Thereby, undesirable bending, kinking, deflection, and / or deformation of the catheter 260 can be reduced and / or substantially prevented.

[0062]

[1099] Although the lock 240 has been illustrated and described above as including the protrusion 242, in other embodiments, it is not essential for the lock to form a protrusion. For example, in some such embodiments, the lock can include a relatively short hub or the like configured to engage a part of the PIV and / or an adapter coupled to the PIV. In some embodiments, the fluid transfer device can include a protrusion or guide member (formed with or without the lock) configured to be disposed between, for example, the PIV and an adapter such as an IV extension set and / or can be used therewith. For example, such a protrusion or guide member can be in the shape of a bellows and / or can have an inner surface substantially similar to the inner surface of the protrusion 242. Thus, the inner surface of such a protrusion and / or guide member can guide a part of the catheter 260 as the catheter 260 moves between the first position and the second position. In some embodiments, the lock 240 (including the protrusion 242) can be used with such external or separate protrusions and / or guide members. In some such embodiments, a part of the protrusion 242 of the lock 240 can be inserted into the protrusion and / or guide member when the lock 240 is coupled to an adapter (such as an IV extension set).

[0063]

[1100] As described above, at least a portion of the catheter 260 and at least a portion of the second catheter 265 are movably disposed within a second portion 215 of an internal space 213 defined by the introducer 210. As shown in FIG. 16, the catheter 260 has a proximal end portion 261 and a distal end portion 262 and defines a lumen 263 (see, e.g., FIG. 24). The proximal end portion 261 of the catheter 260 is coupled to a second portion 275 of the actuator 270. Thus, by moving the actuator 270 relative to the introducer 210, the catheter 260 can be moved between a first position where the catheter 260 is disposed within the introducer 210 (e.g., the entire catheter 260 is disposed within the introducer 210 or within the introducer 210 and the lock 240) and a second position where, when the lock 240 is coupled to the PIV, at least a distal end portion of the catheter 260 is disposed distally relative to the lock 240 and / or the PIV (not shown). 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, in some embodiments, the distal end portion 262 of the catheter can be substantially similar to any of those described in U.S. Patent No. 8,366,685, entitled "Systems and Methods for Phlebotomy Through a Peripheral IV Catheter," filed April 26, 2012, the disclosure of which is hereby incorporated by reference in its entirety (referred to herein as the "‘685 patent"). It can also be moved between a second position where it is at least partially disposed. 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, in some embodiments, the distal end portion 262 of the catheter can be substantially similar to any of those described in U.S. Patent No. 8,366,685, entitled "Systems and Methods for Phlebotomy Through a Peripheral IV Catheter," filed April 26, 2012, the disclosure of which is hereby incorporated by reference in its entirety (referred to herein as the "‘685 patent").

[0064]

[1101] The catheter 260 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, at least a portion of the catheter 260 can have an outer diameter that is substantially the same as or slightly smaller than the inner diameter defined by the lumen 255 of the lock 240, as described above. In some embodiments, the outer surface of the catheter 260 can be configured to contact the inner surface of the lock 240 that defines at least a portion of the lumen 255. In this way, the inner surface of the above-described portion of the lock 240 that defines the lumen 255 can guide the catheter 260 as the catheter 260 moves between the first position and the second position. In some embodiments, such an arrangement can limit and / or substantially prevent bending, deformation, and / or refraction of the catheter 260 as the catheter 260 moves between the first position and the second position. Further, in some embodiments, the catheter 260 can have a length sufficient to position the distal surface of the catheter 260 at a desired position relative to the distal surface of the PIV when in the second position. In other words, as described in more detail herein, the length of the catheter 260 can be sufficient to define a predetermined and / or desired distance between the distal surface of the catheter 260 and the distal surface of the PIV when the catheter 260 is in the second position.

[0065]

[1102] Catheter 260 can be formed from any suitable material or combination of materials, whereby catheter 260 can have any suitable rigidity or durometer hardness. For example, in some embodiments, catheter 260 can be formed from a relatively flexible biocompatible material having a shore durometer hardness of about 20 shore A to 50 shore D, about 20 shore D to 95 shore D, about 70 shore D to 85 shore D, and / or any other suitable range of shore durometer hardness. In some embodiments, at least a portion of catheter 260 can be formed from a braided material or the like, whereby the flexibility of catheter 260 can be modified, changed, and / or altered in response to a flexing force or the like. In other words, by forming at least a portion of catheter 260 from a braided material, the amount of deformation of catheter 260 (in response to a flexing force) can be increased before the lumen 263 of catheter 260 buckles, kinks, and / or is otherwise occluded. Similarly, by forming at least a portion of catheter 260 from a braided material, compression and / or deformation can be effected in response to a compressive force (e.g., an axial force or the like) applied in the direction of the longitudinal centerline defined by catheter 260. Thus, catheter 260 can absorb a portion of the forces associated with colliding with an obstruction or the like. Optionally, such an arrangement can reduce the buckling and / or kinking of catheter 260 and reduce and / or substantially prevent damage to the vascular structure that might otherwise result from a collision of catheter 260. Further, in some embodiments, for example, by forming at least a portion of catheter 260 from a braided material, the amount of vibration transmitted through catheter 260 can be increased in response to a portion of actuator 270 advancing along a set of ribs 236 of introducer 210 (as described above). Although catheter 260 has been described above as including at least a portion formed from a braided material, in other embodiments, at least a portion of catheter 260 is a support wire, such as that described in the '685 patent incorporated herein by reference above It can be formed from and / or can include stents, fenestrated catheters, etc.

[0066]

[1103] The second catheter 265 has a proximal end portion 266 and a distal end portion 267 and defines a lumen 268 (see, for example, FIG. 24). A portion of the second catheter 265 is disposed within and extends through an opening 217 of the introducer 210 (collectively defined, for example, by notches 223 and 233 of the first member 220 and the second member 230, respectively). Thus, the proximal end portion 266 is disposed at least partially outside the introducer 210, and the distal end portion 267 is disposed at least partially within a second portion 215 of an internal space 213 defined by the introducer 210. As described above, the second catheter 265 can be moved between a first position and a second position within the opening 217 to selectively clamp, pinch, refract, bend, and / or otherwise deform a portion of the second catheter 265, thereby occluding, pinching, refracting, closing, sealing, etc. the lumen 268 of the second catheter 265. For example, the first position can be associated and / or aligned with a first portion of the opening 217 having a perimeter and / or diameter greater than the perimeter and / or diameter of a second portion of the opening 217 that is associated and / or aligned with the second position. Thus, the user can manipulate the second catheter 265 to occlude the lumen 268 of the second catheter 265, thereby restricting, limiting, and / or substantially blocking the amount of fluid flow therethrough.

[0067]

[1104] As shown in FIG. 16, the proximal end portion 266 of the second catheter 265 is coupled to the coupler 269 and / or includes the coupler 269 in other ways. The coupler 269 is configured to physically and fluidly couple the second catheter 265 to any suitable device, such as, for example, a fluid reservoir, a fluid source, a syringe, a vacuum container holder (e.g., configured to have or be coupled to a sheathed needle), a pump, etc. The distal end portion 267 of the second catheter 265 is disposed at least partially within a second portion 215 of the internal space 213 defined by the introducer 210 and is coupled to a second portion 275 of the actuator 270. In some embodiments, the second catheter 265 can have a diameter larger than that of the catheter 260, such that when the catheter 260 and the second catheter 265 are coupled to the second portion 275 of the actuator 270, the proximal end portion 261 of the catheter 260 is disposed at least partially within the lumen 268 defined by the second catheter 265. In some embodiments, such an arrangement can reduce and / or substantially prevent leakage associated with the fluid flowing between, for example, the catheter 260 and the second catheter 265. In some embodiments, such an arrangement can also limit, reduce, and / or substantially prevent the amount of hemolysis of the blood as a certain amount of blood flows through the catheter 260 and the second catheter 265. Thus, when the coupler 269 is coupled to a fluid reservoir, a fluid source, a syringe, a vacuum container, a pump, etc., the second catheter 265 establishes fluid communication between the reservoir, the fluid source, the pump, etc. and the catheter 260.

[0068]

[1105] The actuator 270 of the delivery device 200 is coupled to the catheter 260 and is movable along the length of the introducer 210 to transition the delivery device 200 between its first configuration where the catheter 260 is in the first position and its second configuration where the catheter 260 is in the second position. The actuator 270 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the actuator 270 can have a size and shape related to and / or at least partially based on the size and / or shape of the introducer 210.

[0069]

[1106] As shown in FIGS. 17 - 20, the actuator 270 includes a first portion 271, a second portion 275, and a wall 277 extending therebetween. As described above, the first portion 271 of the actuator 270 is at least partially disposed within a first portion 214 of the internal space 213 defined by the introducer 210, and the second portion 275 of the actuator 270 is disposed within a second portion 215 of the internal space 213. The first portion 271 of the actuator 270 includes an engagement member 272. The actuator 270 is arranged such that the engagement member 272 is disposed outside the introducer 210 while the remainder of the first portion 271 is within the first portion 214 of the internal space 213 defined by the introducer 210. Thus, the engagement member 272 can be engaged and / or manipulated by the user (e.g., by the user's finger) to move the actuator 270 relative to the introducer 210. In some embodiments, the engagement member 272 can include a set of ridges and / or any suitable surface finish that can improve the ergonomic aspects of, for example, the actuator 270 and / or the delivery device 200.

[0070]

[1107] ​The engagement member 272 includes a tab 273 disposed at or near the proximal end portion of the engagement member 272. The tab 273 can be any suitable tab, rail, ridge, protrusion, projection, knob, roller, slider, etc. that extends from the surface of the engagement member 272. The tab 273 is configured to selectively engage with the outer surface 235 of the second member 230 of the introducer 210. More specifically, the tab 273 contacts a rib 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.

[0071]

[1108] As described above with respect 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. 18, the tab 273 can include a substantially curved surface that can move along the set of ribs 236. In some embodiments, the size and / or shape of the tab 273 is at least partially based on the size and / or shape of the rib 236, such that when the actuator 270 moves relative to the introducer 210, the desired surface area of the tab 273 contacts the rib 236. In some embodiments, the amount of friction defined between the set of ribs 236 and the tab 273 can be at least partially based on the surface area of the tab 273 that contacts the set of ribs 236. Further, the amount of friction defined between the set of ribs 236 and the tab 273 can be at least partially based on the position of the tab 273 relative to each rib. For example, in some embodiments, the amount of friction defined between the tab 273 and the rib can increase as the tab 273 moves, for example, towards a local maximum, and can decrease as the tab 273 moves away from the local maximum. In some embodiments, the tab 273 can have a size and / or shape that allows the tab 273 to move with substantially low friction between each adjacent rib (e.g., between adjacent local maxima). In other words, the arrangement of the tab 273 and the set of ribs 236 can allow for a desired amount of "play" between adjacent ribs.

[0072]

[1109] By having the first portion 237 of the set of ribs 236 be of a smaller size than the second portion 238 of the set of ribs 236, the first portion or the first surface area of the tab 273 can contact the first portion 237 of the set of ribs 236, and the second portion or the second surface area of the tab 273 can contact the second portion 238 of the set of ribs 236. Thus, the tab 273 can move along the first portion 237 having the first set of features and can move along the second portion 238 having a second set of features different from the first set of features. In some embodiments, for example, the force sufficient to move the tab 273 along the second portion 238 of the set of ribs 236 can be made greater than the force that would otherwise be sufficient to move the tab 273 along the first portion 237 of the set of ribs 236. In some embodiments, moving the tab 273 along the second portion 238 of the set of ribs 236 can result in, for example, a greater amount of vibration of the actuator 270 than the amount of vibration that would otherwise result from the movement of the tab 273 along the first portion 237 of the set of ribs 236. Similarly, the shape of the tab 27 3 can be such that the tab 273 moves distally along the set of ribs 236 in response to an insufficient force being applied to move the tab 273 proximally along the set of ribs 236. For example, as shown in FIG. 18, the tab 273 has an asymmetric shape, where the proximal surface of the tab 273 has a greater pitch than the pitch of its distal surface.

[0073]

[1110] Although the engagement member 272 and the tab 273 have been specifically illustrated and described above, in other embodiments, the actuator can include an engagement member and / or a tab having any suitable configuration. For example, although the tab 273 is illustrated 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. 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 reduced, thereby resulting in a reduction or increase in the amount of movement of the actuator 270 relative to the introducer 210 in a direction other than the axial direction. That is, an increase or decrease in the space between the surface of the wall 277 and the surface of the engagement member 272 can result in an increase or decrease in the amount by which, for example, the actuator 270 can "tilt" relative to the introducer 210. In other embodiments, the arrangement of the engagement member 272, the tab 273, and / or the set of ribs 236 of the introducer 210 can be modified, altered, adapted, adjusted, and / or otherwise changed such that the actuator 270 moves relative to the introducer 210 having a desired set of characteristics. For example, in some embodiments, the arrangement of the actuator 270 and / or the introducer 210 can increase or decrease the amount of vibration when the actuator 270 moves relative to the introducer 210, increase or decrease the amount of force sufficient to move the actuator 270 relative to the introducer 210, increase or decrease the amount of movement of the actuator 270 relative to the introducer 210 in any suitable direction other than the axial direction (e.g., the proximal or distal direction), and the like.

[0074]

[1111] For example, as shown in FIGS. 19 and 20, the second portion 275 has a cross-sectional shape (e.g., at least partially circular cross-sectional shape) that is at least partially based on the cross-sectional shape of the second portion 215 of the internal space 213 defined by the introducer 210. In this way, 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 when 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 second 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 within the opening 276. Similarly, the distal end portion 267 of the second 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 within the opening 276. Accordingly, the catheter 260 and the second catheter 265 can be maintained in a fixed position relative to the actuator 270 and, thus, can move simultaneously with the actuator 270 when the actuator 270 moves relative to the introducer 210.

[0075]

[1112] 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. 19 and 20, the wall 277 has a contoured cross-sectional shape that is at least partially based on the contoured cross-sectional shape of the internal space 213 defined by the introducer 210. In this way, the first portion 271 of the actuator 270 is coupled to the second portion 275 of the actuator 270 An axis can be defined that is parallel to but offset from the thus-defined axis. In some embodiments, for example, the wall 277 can have a cross-sectional shape that is substantially S-shaped or at least partially S-shaped. In some embodiments, the wall 277 can form, for example, a zigzag shape or the like. Due to the tortuous cross-sectional shape of the wall 277 (and thus the actuator 270), the second portion 275 of the actuator 270 cannot be seen through the first portion 214 of the internal space 213 defined by the introducer 210 (e.g., the second portion 275 is out of the line of sight). Similarly, when the catheter 260 is in the first position, the catheter 260 cannot be seen through the first portion 214 of the internal space 213 defined by the introducer 210. That is, the geometric shape of the actuator 270 and / or the introducer 210 (e.g., the tortuous cross-sectional shape of the internal space 213, the height and / or width of the introducer 210, etc.) is configured such that when the catheter 260 is in the first position, it is at least partially isolated within the second portion 215 of the internal space 213. Thus, the structure of the introducer 210 and / or the actuator 260 can protect and / or isolate the catheter 260 from the space 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 act 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.

[0076]

[1113] Referring now to FIGS. 21 - 29, the transfer device 200 can be in a first configuration prior to use. By a user (e.g., a doctor, physician, nurse, technician, phlebotomist, etc.), the transfer device 200 can be shifted from the first configuration (FIGS. 21 - 24) to the second configuration (FIGS. 27 - 29) to position at least the distal end portion 262 of the catheter 260 distally with respect to the introducer 210 (e.g., within or distally to an indwelling PIV (not shown)). The transfer device 200 is in the first configuration when the catheter 260 is disposed at the first position 260 within the introducer 210. In some embodiments, when the catheter 260 is at the first position, substantially the entire catheter 260 is disposed within the introducer 210. In such embodiments, the introducer 210 can include a seal (such as described above) that substantially seals the distal end portion 212 of the introducer 210 to isolate the catheter 260 within the second portion 215 of the internal space 213. However, in the embodiments shown in FIGS. 22 and 23, the catheter 260 is disposed within the introducer 210 and the lock 240 when at the first position. Although the seal has been 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 that can form a substantially fluid - tight seal with the inner surface of the lock 240 defining the lumen 243. Thus, the seal disposed within the lock 240 can isolate the catheter 260 within the second portion 215 of the internal space 213. In yet other embodiments, it is not essential for the introducer 210 and / or the lock 240 to include a seal. For example, in some embodiments, the PIV and / or an adapter coupled to the PIV (e.g., an extension set) can include a seal that transitions from a closed configuration to an open configuration when the lock 240 is coupled.Although not shown, in some embodiments, the catheter 260 can be disposed within a flexible sheath or the like that can maintain the catheter 260 in a substantially sterile environment while the catheter 260 is in the first position (e.g., those embodiments in which the introducer 210 and / or lock 240 do not include a seal).

[0077]

[1114] 24, when the delivery device 200 is in the first configuration, the actuator 270 is disposed in a proximal position. In some embodiments, a tab 273 of a first portion 271 of the actuator 270 is disposed in a recess or detent, or is otherwise positioned relative to the proximal-most portion. 210。 Further, as described above, a portion of the second catheter 265 is disposed within the opening 217 defined by the introducer such that the distal end portion 267 is at least partially disposed within the second portion 215 of the interior space 213 and is coupled to the second portion 275 of the actuator 270 while the proximal end portion 266 of the second catheter 265 is disposed outside of the introducer 210 (see, e.g., FIGS. 21 and 22).

[0078]

[1115] With the transfer device 200 in the first configuration, the user can operate the transfer device 200 to couple the lock 240 to the retention PIV and / or an adapter (e.g., an expansion set, etc.) coupled to the PIV. For example, in some embodiments, the user can apply sufficient force to pivot the first arm 243 and the second arm 250 of the lock 240, thereby inserting a portion of the PIV and / or the adapter into the space defined between the arms 243 and 250 and, for example, the protrusion 242. In some embodiments, when the lock 240 is coupled, the protrusion 242 can be inserted into the PIV and / or the adapter. For example, in some embodiments, a portion of the protrusion 242 can be inserted into the hub or basket of the PIV and / or the adapter. As described above, in some embodiments, the protrusion 242 is long enough to place at least a portion of the protrusion 242 within the PIV, thereby supporting the PIV and / or providing structural rigidity to the PIV. When the PIV and / or the adapter are positioned in the desired position relative to the lock 240, the user can remove the force on the arms 243 and 250 of the lock 240, whereby the arms 243 and 250 move toward the protrusion 242 until the tabs 246 of the first arm 243 and the tabs 253 of the second arm 250 contact the surface of the PIV and / or the adapter. In some embodiments, the arrangement of the lock 240 is such that the tabs 246 and 253 and the protrusion 242 collectively form three contact points with the PIV and / or the adapter to which the lock 240 is coupled.

[0079]

[1116] With the transfer device 200 coupled to the PIV and / or adapter, the user can operate the engagement member 272 of the first portion 271 of the actuator 270 to move the actuator 270 relative to the introducer 210, whereby the catheter 260 moves from a first position (e.g., disposed within the introducer 210) toward a second position. Thus, the catheter 260 moves through the second portion 215 of the internal space 213 and the lumen 255 of the lock 240, and thus at least the distal end portion 262 of the catheter 260 is disposed outside and distally of the lock 240 as shown by arrow CC in FIG. 25. In some embodiments, the lumen 255 of the lock 240 and the placement of the catheter 260 may be such that as the catheter 260 moves distally toward the second position, the inner surface of the lock 240 defining the lumen 255 contacts, supports, and / or otherwise guides the catheter 260. Further, in some embodiments, moving the catheter 260 from the first position toward the second position may be operable to transition a seal (e.g., disposed within the lock 240) from a closed or sealed configuration to an open configuration. In other embodiments, the user can operate the transfer device 200 (e.g., prior to moving the catheter 260 from the first position) to transition the seal from a sealed configuration to an open configuration. For example, in some embodiments, the user can increase the pressure within at least a portion of the transfer device 200 (e.g., the catheter 260 and / or the lock 240) beyond a predetermined threshold to transition the seal to an open configuration. In some embodiments, the seal can be a one-way valve (e.g., a positive pressure valve or seal), which can transition from a sealed configuration to an open configuration when, for example, the pressure applied proximal to the seal exceeds the pressure applied distal to the seal (e.g., the venous pressure applied to the seal).

[0080]

[1117] As described above, the arrangement of the actuator 270 and the introducer 210 is such that, by advancing the actuator 270 relative to the introducer 210, the tab 273 advances along the outer surface 235 of the second member 230 of the introducer 210, more specifically, along a set of ribs 236. For example, as illustrated in FIG. 26, the tab 273 contacts a set of ribs 236, thereby being able to cause vibration of the actuator 270 as the actuator 270 moves relative to the introducer 210. Optionally, the vibration of the actuator 270 can produce a haptic, tactile, and / or audible output that can provide an indication related to the position of the distal end portion 262 of the catheter 260 relative to, for example, the introducer 210, the lock 240, and / or the PIV. For example, in some embodiments, the tab 273 of the actuator 270 and the set of ribs 236 can collectively produce a "clicking" sound as the tab 273 moves over each rib. In some embodiments, the introducer 210 can include indicia or the like that can indicate to the user the relative position of the distal end portion 262 of the catheter 260. In other embodiments, the number of times the actuator 270 vibrates as it moves relative to the number of ribs can be related to the relative position of the distal end portion 262 of the catheter 260 and / or can provide that indication in other ways.

[0081]

[1118] Optionally, the user can stop the movement of the actuator 270 relative to the introducer 210 based on haptic, tactile, and / or audible output indicating the desired placement (e.g., the second position) of the distal end portion 262 of the catheter 260 relative to the PIV. In other words, the catheter 260 can be placed in the second position before the actuator 270 advances, for example, to the most distal position. As described in more detail herein, when the distal end portion 262 of the catheter 260 is placed in the desired position relative to the distal end portion of the PIV, the catheter 260 is placed in the second position. Optionally, for example, when the catheter 260 is in the second position, the distal end of the catheter 260 can be substantially in the same plane as the distal end of the PIV. In other cases, the distal end of the catheter 260 can extend beyond the distal end of the PIV by a predetermined distance (e.g., distally relative to the distal end of the PIV). In still other cases, when the catheter 260 is in the second position, the distal end of the catheter 260 can be placed within the PIV (e.g., proximally relative to the distal end of the PIV).

[0082]

[1119] As shown in FIGS. 27-29, optionally, when the actuator 270 is in the most distal position, the catheter 260 can be in the second position. Thus, the distal surface of the catheter 260 is placed within the vein beyond a predetermined distance from the distal surface of the catheter 260. Optionally, by placing the distal surface of the catheter 260 beyond a predetermined and / or desired distance from the distal surface of the PIV, for example, the distal surface of the catheter 260 can be placed at a position within the vein where there is substantially no debris (e.g., fibrin / thrombus) that would otherwise surround the distal end portion of the PIV.

[0083]

[1120] In some cases, an indwelling PIV may substantially occlude at least a portion of the vein in which the PIV is placed. Thus, the PIV is often more suitable for delivering fluid rather than aspirating blood. However, the venous system is a capacitive system and thus changes the route of blood flow through different veins (e.g., forms a bypass around an occlusion or substantial occlusion). Further, alternative venous structures typically rejoin the vein in which the PIV is placed at a given distance downstream of the PIV and thus deliver at least a portion of the blood flow that would otherwise flow through the vein in which the PIV is placed. Similarly, the vein is typically joined by a number of branched blood vessels that also deliver blood flow to the vein in which the PIV is placed.

[0084]

[1121] Thus, in some cases, the predetermined and / or desired distance between the distal face of the catheter 260 and the distal face of the PIV may be sufficient to place the distal face of the catheter 260 downstream of one or more branched blood vessels that are in fluid communication with the vein in which the PIV is placed. In other words, the distal face of the catheter 260 can extend beyond the distal face of the catheter 260 such that when the catheter 260 is in the second position, at least one branched blood vessel is disposed between the distal face of the catheter 260 and the distal face of the PIV. Thus, with the lumen 263 of the catheter 260 extending through the proximal end portion 261 and the distal end portion 262 of the catheter 260, by placing the distal face of the catheter 260 at a predetermined and / or desired distance from the distal face of the PIV, the lumen 263 of the catheter 260 is placed in fluid communication with a portion of the vein that receives blood flow that is not substantially occluded or restricted (e.g., not occluded by the PIV and / or debris associated with the placement of the PIV).

[0085]

[1122] Optionally, for example, the predetermined and / or desired distance can be from about 0.0 millimeters (e.g., the distal surface is in the same plane) to about 100 millimeters (mm). In other embodiments, the predetermined and / or desired distance can be between about 10 mm and about 90 mm, between about 20 mm and about 80 mm, between about 30 mm and about 70 mm, between about 30 mm and about 60 mm, between about 40 mm and about 50 mm, or any other suitable range or sub-range therebetween. In some embodiments, for example, the delivery device 200 can be configured such that the actuator 270 moves along the introducer 210 by about 95 mm such that the distal surface of the catheter 260 is disposed more than about 40 mm beyond the distal surface of the PIV to which the delivery device 200 is coupled (e.g., the delivery device 200 has a 95 mm stroke). In other embodiments, for example, the delivery device 200 can have a 47 mm stroke such that the distal surface of the catheter 260 is disposed more than about 20 mm beyond the distal surface of the PIV to which the delivery device 200 is coupled. In yet other embodiments, the delivery device 200 can have any suitable stroke length such that the distal surface of the catheter 260 is disposed at a predetermined and / or desired distance from the distal surface of the PIV.

[0086]

[1123] For a given and / or desired distance, it has been described above as being a positive distance, i.e., the distal surface of catheter 260 is distal to the distal surface of the PIV. However, in other embodiments, the given and / or desired distance can be associated with the distal surface of catheter 260 being in a proximal position relative to the distal surface of the PIV (e.g., a negative distance). For example, optionally, the given and / or desired distance can be between about 0.0 mm (e.g., the distal surfaces are in the same plane) to about -50 mm, about -10 mm to about -40 mm, about -20 mm to about -30 mm, or any other suitable range or sub-range therebetween. Optionally, the given and / or desired distance can be less than -50 mm (e.g., the distal surface of catheter 260 is more than 50 mm proximal to the distal surface of the PIV). Optionally, catheter 260 can be positioned in a second position such that the distal end portion 262 of catheter 260, for example, remains in a position distal to refraction within the PIV. For example, optionally, the indwelling PIV can have one or more portions that refract, such as a portion of the PIV where the peripheral intravenous catheter attaches to the hub. In such cases, the given and / or desired distance can be such that the distal surface of catheter 260 is distal to the portion of the PIV that forms the refraction (e.g., where the peripheral intravenous catheter attaches to the hub). In some such cases, by positioning the distal surface of catheter 260 distal to the refractive portion of the PIV but within the PIV, the fluid flow path can be made not to be so restricted as to prevent blood from being aspirated through catheter 260.

[0087]

[1124] With catheter 260 in the second position (e.g., with the transfer device 200 in the second configuration as shown, for example, in FIGS. 25 and 26 or FIGS. 27 - 29), the user can establish fluid communication between a fluid reservoir, fluid source, syringe, etc. and catheter 260. For example, as described above, in some embodiments, the user physically and fluidly couples the coupler 269 of the second catheter 265 to a fluid reservoir, fluid source, syringe, etc. This can be done. Although it has been described that after the catheter 260 is placed in the second position, fluid communication is established between the catheter 260 and a fluid reservoir or fluid source, in other embodiments, the user can establish fluid communication between the catheter 260 and a fluid reservoir or fluid source before moving the actuator 270 relative to the introducer 210. With the catheter 260 in fluid communication with a fluid reservoir and / or fluid source, the transfer device 200 can then transfer fluid from or into the patient's body via the catheter 260 that extends through and beyond the PIV. For example, in some cases, the user can physically and fluidly couple the transfer device 200 to a fluid reservoir, a vacuum container, a syringe, etc., and then, based at least in part on positioning the distal end surface of the catheter 260 beyond a predetermined and / or desired distance from the distal end surface of the PIV, aspirate a quantity of blood from a vein.

[0088]

[1125] In other cases, the user can physically and fluidly couple the transfer device 200 to a fluid source, etc., and then deliver a quantity of fluid from the fluid source to a portion of a vein downstream of the PIV that receives a substantially unobstructed and / or unrestricted blood flow. Optionally, by positioning the distal end surface of the catheter 260 beyond a predetermined and / or desired distance from the distal end surface of the PIV, for example, possible damage related to the injection of a corrosive agent can be reduced. For example, by positioning the distal end surface of the catheter 260 within a portion of the vein that receives a blood flow that would otherwise be blocked and / or restricted by an indwelling PIV, the corrosive agent can be mixed into the blood flow and delivered to the target location. Thus, a quantity of the corrosive agent is not retained within the debris or, in other ways, placed at a location within a vein that receives little blood flow.

[0089]

[1126] In some cases, when a desired amount of blood is drawn and / or a desired amount of drug is delivered into the patient's body, the user can move the actuator 270 in the proximal direction, thereby changing the transfer device 200 to the third (used) configuration. In the third configuration, the catheter 260 can be disposed (e.g., distally relative to a seal, etc.) within the introducer 210 and isolated therein. For example, in some embodiments, the actuator 270 can be placed in its most proximal position, where the catheter 260 is in the first position. Further, when the actuator 270 and the catheter 260 are in the desired positions, the user can, for example, operate the second catheter 265 within the opening 217 such that the surface of the introducer 210 that defines the relatively small portion of the opening 217 contacts and clamps the second catheter 265. Accordingly, the lumen 268 of the second catheter 265 can be substantially occluded, blocked, shut off, pinched, etc. to limit the amount of fluid flow therethrough and / or substantially prevent fluid flow therethrough. Optionally, by clamping the second catheter 265 as described, fluid leakage through the second catheter 265 can be reduced and / or substantially prevented, for example. Optionally, the transfer device 200 can then be separated from a fluid reservoir, fluid source, syringe, etc. and safely discarded.

[0090]

[1127] Figure 30 is a flowchart showing a method 10 of transferring fluid by a peripheral intravenous line using a fluid transfer device according to an embodiment. The method includes, at 11, coupling a lock of the fluid transfer device to an indwelling peripheral intravenous line (PIV). The fluid transfer device can be any suitable device configured to transfer fluid by the PIV. For example, in this embodiment, the fluid transfer device can be substantially similar to the fluid transfer device 200 described above with reference to FIGS. 3-29. Thus, the fluid transfer device includes an introducer coupled to the lock, a catheter movably disposed within the introducer, and an actuator coupled to the catheter and in contact with an outer surface of the introducer. In some embodiments, the introducer includes a first member and a second member that collectively form the introducer. In such embodiments, the second member can have an outer surface that defines a set of ribs or the like, as described above with respect to the second member 230 in FIGS. 7- As described above with respect to the second member 230 in FIG. 12, it can have an outer surface that defines a set of ribs or the like. In this way, the actuator can contact the ribs formed by the second member of the introducer. Further, as described above with respect to the transfer device 200, the introducer can define an internal space, which has a tortuous cross-sectional shape configured to at least partially isolate the catheter disposed within the internal space from the space outside the introducer.

[0091]

[1128] At 12, with the lock coupled to the PIV (and / or an adapter coupled to the PIV), move the actuator relative to the introducer to advance the catheter from a first position where the catheter is disposed within at least one of the internal spaces defined by the introducer or the lock, to a second position where at least a portion of the catheter is disposed beyond at least a portion of the PIV. In this way, the catheter can be advanced, for example, in the distal direction. In some embodiments, the lock can include an inner surface that defines a lumen configured to receive the catheter as the catheter moves toward the second position. In some embodiments, the inner surface of the lock can contact, support, and / or otherwise guide the catheter as the catheter moves distally toward the second position.

[0092]

[1129] As described above with respect to the delivery device 200 in some embodiments, the arrangement of the actuator and the introducer is such that advancing the actuator relative to the introducer causes a portion of the actuator to travel along a rib formed by the outer surface of the introducer. In some embodiments, moving the actuator along the rib can cause vibration of the actuator, thereby generating a haptic, tactile, and / or audible output. Thus, at 13, provide an indication to the user that is related to the position of the distal end portion of the catheter when the actuator moves the catheter from the first position to the second position. For example, in some embodiments, the actuator and a set of ribs can collectively generate a "click" sound, a tactile vibration, etc. In some embodiments, the introducer can include indicia or the like that can indicate to the user the relative position of the distal end portion of the catheter. In other embodiments, the number of times the actuator vibrates by moving the actuator along the rib can be associated with the relative position of the distal end portion of the catheter and / or such number of times can provide an indication of the relative position.

[0093]

[1130] At 14, based at least in part on the above indicators, the catheter is positioned in a second position such that the distal end portion of the catheter is disposed beyond at least a portion of the PIV (e.g., the distal surface of the PIV) by a predetermined and / or desired distance. For example, after moving the actuator at least a portion of the length of the introducer, the catheter can be positioned in the second position. In some embodiments, when the actuator is positioned at the most distal position, the catheter can be positioned in the second position. As described above with respect to the delivery device 200, optionally, by a predetermined and / or desired distance beyond a portion of the PIV, the distal surface of the catheter can be placed within a portion of the vein that is substantially free of debris (e.g., fibrin / thrombus) that would otherwise surround the distal end portion of the PIV. Similarly, optionally, as described in detail above, for example, by positioning the distal end portion of the catheter a predetermined and / or desired distance from the distal end portion of the PIV, the lumen of the catheter can be placed in fluid communication with a portion of the vein that receives blood flow that is not substantially blocked or restricted (e.g., not blocked by the PIV and / or debris associated with the placement of the PIV). Thus, the user can couple the delivery device to a fluid reservoir and / or fluid source to transfer fluid from and / or into the patient's body, respectively.

[0094]

[1131] FIGS. 31 - 34 show a fluid delivery device 300 according to an embodiment. The fluid delivery device 300 can be of any suitable shape, size, and / or configuration. In some embodiments, the fluid delivery device 300 (also referred to as the "delivery device") can be the same as and / or substantially the same as the delivery device 200 described in detail above with reference to FIGS. 3 - 30. Accordingly, the parts and / or aspects of the delivery device 300 are not described in further detail herein and, unless otherwise specified, should be considered to have substantially the same form and / or function as the corresponding parts and / or aspects of the delivery device 200.

[0095]

[1132] As shown in FIG. 31, the transfer device 300 includes an introducer 310, a catheter 360, and an actuator 370. The introducer 310 includes a proximal end portion 311 and a distal end portion 312, and defines an internal volume 313. The distal end portion 312 of the introducer 310 includes and / or is coupled to a lock 340 configured to couple the introducer 310 to an arranged and / or indwelling PIV (not shown). As described above with reference to the introducer 210, the introducer 310 has an outer surface that includes and / or forms a set of ribs 336 arranged along the length of the introducer 310. The ribs 336 are configured to engage and / or contact a part of the actuator 370, as described in more detail herein. Thus, the introducer 310 can be the same as and / or substantially the same as the introducer 210 described in detail above with reference to FIGS. 3-12.

[0096]

[1133] The catheter 360 is coupled to the actuator 370 and is movably disposed within the introducer 310. Further, at least a part of the catheter 360 can be movably disposed within the lumen defined by the lock 340. The catheter 360 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the catheter 360 can be substantially the same as the catheter 260 described in detail above. Accordingly, the catheter 360 will not be described in further detail herein.

[0097]

[1134] Actuator 370 can be of any suitable shape, size, and / or configuration. As shown in FIGS. 31 and 32, actuator 370 includes a first portion 371 and a second portion 375, and a wall 377 disposed therebetween. The first portion 371 of actuator 370 is configured to be movably coupled to introducer 310. The second portion 375 of actuator 370 is configured to be coupled to the proximal end portion of catheter 360 and the distal end portion of second catheter 365 (FIG. 31). The arrangement of catheter 360, second catheter 365, and actuator 370 is such that, as described above with reference to the arrangement of catheter 260, second catheter 265, and actuator 270, the lumen of catheter 360 is in fluid communication with the lumen of second catheter 365 to allow fluid to flow therebetween.

[0098]

[1135] The first portion 371 of actuator 370 includes a tab 373 that extends from the inner surface of the first portion 371 and contacts the outer surface of introducer 310. For example, tab 373 can be a protrusion, bulge, ridge, knob, etc. configured to contact a set of ribs 336 formed along the outer surface of introducer 310. In the embodiments shown in FIGS. 31-34, as a result of tab 373 contacting the set of ribs 336, actuator 370 is disposed at an angle with respect to introducer 310. That is, the contact between tab 373 extending from the inner surface of the first portion 371 and the set of ribs 336 causes at least a portion of actuator 370 to be tilted, pivoted, skewed, and / or displaced in another way such that the longitudinal axis L1 of actuator 370 is non-parallel to the longitudinal axis L2 of introducer 310, as shown in FIG. 32. In this way, a first force F1 is applied to the proximal end portion of actuator 370 in a first direction, and a second force F2 is applied to the distal end portion of actuator 370 in a second direction (e.g., equal and opposite forces). Thus, the The second portion 375 of the actuator 370 is coupled to the proximal end portion of the catheter 360, and with a portion of the catheter 360 (e.g., at least the distal end portion of the catheter 360) disposed within the lumen of the lock 340, the angled placement and / or orientation of the actuator 370 results in a stress being applied along the length of the catheter 360 disposed between the actuator 370 and the lock 340. As shown in FIG. 31, the stress applied along the length of the catheter 360 can be sufficient to bend, flex, deflect, deform, clutch, and / or otherwise reconfigure at least a portion of the catheter 360 disposed between the actuator 370 and the lock 340. In other words, angling or tilting the actuator 370 results in a preload (e.g., a preload stress) of the catheter 360.

[0099]

[1136] As detailed above with reference to device 200, the actuator 370 can be moved along and / or relative to the introducer 310 to move the catheter 360 between a first position (e.g., proximal position) and a second position (e.g., distal position). In some examples, the arrangement of the actuator 370 and the catheter 360 can result in “clutching” of the device 300 as the actuator 370 advances along the introducer 310. For example, a user can apply a force to the first portion 371 of the actuator and move the actuator 370 distally relative to the introducer 310, whereby the catheter 360 is moved toward its second position (e.g., distal position) as indicated by arrow DD in FIG. 33. However, in some examples, the catheter 360 (e.g., the distal end of the catheter 360) may encounter or collide with an obstacle or the like that impedes or prevents further distal movement of the catheter 360. In such a case, due to the preloading of the catheter 360 resulting from the angulation of the actuator 370 (described above), stress concentration risers or the like are generated along the length of the catheter 360 disposed between the actuator 370 and the lock 340. Thus, when the distal end of the catheter 360 contacts an obstacle, “clutching” (e.g., deflection, deformation, bending, curving, etc.) of the catheter 360 occurs due to the force applied by the user to the first portion 371 of the actuator 370 (e.g., in the direction of DD). For example, in some embodiments, a portion of the catheter 360 can be bent, deformed, deflected, and / or moved through a portion of the internal volume 313 (e.g., the portion of the internal volume 313 that receives the wall 377 of the actuator 370) to be configured in a “clutch” configuration as shown in FIGS. 33 and 34.

[0100]

[1137] In some examples, clutching of the catheter 360 can provide an indication to the user that movement of the catheter 360 is impeded and / or blocked. For example, in some embodiments, the introducer 310 can be formed from a substantially clear and / or transparent material that enables the user to visually inspect the state and / or configuration of the catheter 360. In some embodiments, the clutching and / or deformation of the catheter 360 can be such that a portion of the catheter 360 impacts the inner surface of the introducer 310, which can generate an audible (e.g., "click") and / or tactile indication that the catheter 360 is in a clutched configuration (e.g., movement of the catheter 360 is impeded or blocked).

[0101]

[1138] In some examples, clutching of the catheter 360 can provide and / or form a self-release mechanism or the like that can facilitate advancement of the catheter 360 past an obstruction. For example, in some instances, after the catheter 360 has been clutched (i.e., deformed as shown in FIGS. 33 and 34), the user can reduce and / or remove the force applied to the actuator 370 (e.g., in the DD direction), which can enable the catheter 360 to at least partially reconfigure. In some such instances, upon reconfiguration of the catheter 360, the distal end portion of the catheter 360 can move over and / or through an obstruction or the like. For example, in some instances, catheter 3 The distal end of 60 can contact and / or collide with those walls (e.g., the refracted walls) or structures when the catheter 360 is advanced distally through the PIV, PIV hub, extension set, etc. This contact and / or impact can then result in the clutching of the catheter 360 (as described above). In such a case, by reducing and / or removing the force applied to the first portion 371 of the actuator 370, the catheter 360 can be reconfigured and / or transitioned to a non-clutch configuration in which the distal end portion of the catheter 360 moves safely, controllably, and / or in a predetermined manner over and past the obstructive wall and / or structure. Thus, the clutching of the catheter 360 can provide a self-correcting mechanism or the like that allows the catheter 360 to be "unclutched" in response to a decrease in force, whereby the distal end of the catheter 360 can move along and / or over the obstruction.

[0102]

[1139] In other examples, catheter 360 may remain in the clutch configuration when the force applied to actuator 370 is reduced and / or removed. In such examples, the user can, for example, manipulate at least one of device 300 and / or a portion of the patient to cause catheter 360 to be “unclutched”. For example, in some examples, catheter 360 may be inserted into a vein in the patient's arm via an indwelling PIV. In some such examples, the distal end of catheter 360 may collide with, for example, the kinked portion of the indwelling PIV catheter (e.g., often at or near the insertion site of the PIV catheter), thereby causing catheter 360 to potentially transition to the clutch configuration as described above. Further, in some examples, catheter 360 may remain in the clutch configuration despite the force applied to actuator 370 being reduced and / or removed. Thus, the user can, for example, manipulate the patient's arm and / or manipulate device 300 (coupled to the PIV) with respect to the patient's arm to move and / or reconfigure the PIV with respect to the vein in which the PIV and catheter 360 are disposed. In some examples, after manipulating the patient's arm and / or reconfiguring device 300 and / or the PIV with respect to the vein in another way, catheter 360 can transition to the non-clutch configuration.

[0103]

[1140] In some embodiments, the clutching of catheter 360 and / or device 300 can act to limit forces associated with collisions with obstructions. For example, in some instances, catheter 360 can be advanced toward a vein through at least a portion of an indwelling peripheral intravenous line (PIV). When catheter 360 advances within and / or through the PIV, it may be desirable to reduce or limit the forces associated with the distal end of catheter 360 colliding with the internal structure of the PIV, etc. Thus, the clutching of catheter 360 in response to the distal end of catheter 360 colliding with the internal structure of the PIV (and / or the internal structure of an extension set, the vein wall, or some other structure such as other venous structures, etc.) can act to limit the forces acting on the internal structure. That is, the clutching of catheter 360 absorbs, redirects, and / or redistributes at least a portion of the forces associated with the distal end of catheter 360 colliding with a structure. Accordingly, the clutching of catheter 360 can reduce and / or substantially prevent damage to the structure of catheter 360, the PIV or extension set, the vein wall, etc., which damage might otherwise result from a collision with the distal end of catheter 360.

[0104]

[1141] In some embodiments, catheter 360 disposed within introducer 310 can be configured to clutch, bend, flex, curve, and / or otherwise reconfigure in a predetermined and / or predictable manner, which can enable "tuning" or control of one or more parameters, characteristics, dynamics, etc. of device 300. For example, in some embodiments, catheter 360 can be biased when in a first configuration (e.g., a proximal configuration or a non-clutch configuration). In this configuration, the amount of bias can be increased or decreased, respectively, by increasing or decreasing the angle of actuator 370 relative to introducer 310 (as described above). An increase or decrease in the amount of bias can, respectively, It can result in an increase or decrease in the amount of preloaded stress and / or force along a part of the loop 360, which can respectively increase or decrease the possibility or ease of transition of the catheter 360 from a non-clutch configuration to a clutch configuration.

[0105]

[1142] In some examples, the manner in which the catheter 360 is clutched can be controlled and / or “regulated”. For example, as described above, the catheter 360 can be in a biased or curved configuration when not clutched. In response to a collision with an obstruction, the catheter 360 can transition from a non-clutch configuration to a clutch configuration such that, as shown in FIG. 33, the catheter 360 deflects in a sinusoidal shape (e.g., curved, substantially S-shaped, etc.). In some examples, an additional force applied to the actuator 370 can cause the catheter to bend or deflect, such that, as shown by arrow EE in FIG. 34, a portion of the catheter moves through a second portion 315 (e.g., a vertical portion, etc.) of the internal volume 313 of the introducer 310 and into a first portion 314 (e.g., a horizontal portion, etc.) of the internal volume 313 of the introducer. Further, in some embodiments, a portion of the catheter 360 can be deflected, bent, and / or clutched such that a portion of the catheter 360 extends through the first portion 314 of the internal volume 313 such that a portion of the catheter 360 is disposed outside of the introducer 310. Thus, in some embodiments, the catheter 360 can have and / or experience a four-stage deflection when transitioning from a non-clutch configuration to a clutch configuration. In other embodiments, the range of motion of the catheter 360 when moved to the clutch configuration can be limited such that the catheter 360 remains in the second portion 315 of the internal volume 313 or the first portion 314 of the internal volume 313 (e.g., the catheter 360 can move through two-stage deflections or three-stage deflections, respectively). Thus, the catheter 360 and / or the device 300 can be configured to clutch in a predetermined, desired, and / or predictable manner, thereby changing, adjusting, regulating, and / or otherwise controlling one or more characteristics associated with the insertion of the catheter 360 into a vein via an indwelling PIV.

[0106]

[1143] As described above with reference to device 200, when actuator 370 is advanced relative to introducer 310, tab 373 of the first portion 371 of actuator 370 is moved along a set of ribs 336. In some examples, the movement of tab 373 along the set of ribs 336 can provide the user with haptic feedback or the like related to moving catheter 360 between a first position and a second position. Additionally, in some examples, vibrations of actuator 370 resulting from tab 373 being moved along the set of ribs 336 can similarly result in vibrations of catheter 360. In some examples, vibrations of catheter 360 can cause vasodilation or vasorelaxation of the vein, at least partially while disposed within the vein, and as a result, the diameter of the vein may increase. The increase in the diameter of the vein and / or the decrease in the amount of constriction of the vein can allow for, for example, increased access to the vein and / or increased blood flow through the vein, thereby resulting in better fluid (e.g., blood) transfer from the vein through catheter 360, at least partially disposed therein.

[0107]

[1144] FIGS. 35 and 36 are schematic views of a fluid transfer device 400 according to an embodiment. The fluid transfer device 400 can be any suitable transfer device as described herein. For example, the fluid transfer device 400 can have substantially the same form and / or function as the fluid transfer device 200 described above with reference to FIGS. 3 - 29. Accordingly, while relevant portions of the fluid transfer device 400 are identified in FIGS. 35 and 36, the fluid transfer device 400 is not limited thereto and should be considered to be substantially the same as the fluid transfer device 200 unless specifically shown otherwise. For example, the fluid transfer device 400 (also referred to herein as the "transfer device" or "device") includes an introducer 410 having a proximal end portion 411 and a distal end portion 412. Transfer device 2 As described above with reference to 00, device 400 also includes a catheter movably disposed within an introducer and an actuator movably coupled to the introducer and fixedly coupled to the catheter. As described above, the user applies a force to the actuator to move the actuator along introducer 410, thereby moving the catheter between a first position in which the catheter is disposed within introducer 410 and a second position in which at least a portion of the catheter extends distally beyond introducer 410.

[0108]

[1145] As shown in FIGS. 35 and 36, the distal end portion 412 of introducer 410 is coupled to a lock 440 configured to couple device 400 to, for example, an extension set 490 (such as an adapter like a T-adapter or Y-adapter) and / or a peripheral intravenous line (PIV) 405. Lock 440 can be substantially similar to lock 240 described above with reference to FIGS. 13 - 15. Accordingly, aspects of lock 440 are described in further detail herein.

[0109]

[1146] Lock 440 includes a protrusion 442, a first arm 443, and a second arm 450. As shown in FIG. 36, first arm 443 and second arm 450 can engage collectively with the proximal end portion 491 of extension set 490 to couple device 400 thereto. Further, when lock 440 is coupled to extension set 490 to dispose lock 440 in fluid communication with PIV 405 coupled to the distal end portion 492 of extension set 490, protrusion 442 can be disposed at least partially within extension set 490. Although shown and described as being coupled to extension set 490, in other embodiments, first arm 443 and second arm 450 can engage collectively with a portion of PIV 405 to couple device 400 thereto (e.g., without using extension set 490).

[0110]

[1147] As shown in FIG. 36, the arrangement of the first arm 443 and the second arm 450 can be such that when coupled to the extension set 490 and / or the PIV 405, and when the first arm 443 or the second arm 450 is arranged to contact the target surface S, the device 400 is arranged at a predetermined and / or desired angle θ. Further magnifying, in some embodiments, the target surface S can be the patient's arm, and the PIV 405 can be pre-inserted to be at least partially disposed within the vein of the patient's arm (e.g., the PIV 405 is an indwelling PIV, etc.). The lock 440 is rotatably coupled to the distal end portion 412 of the introducer 410, thereby enabling the user to rotate the lock 440 to a desired orientation such that the first arm 443 or the second arm 450 is adjacent to the target surface S. In the example shown in FIG. 36, the second arm 450 is adjacent to and in contact with the target surface S. By the lock 440 coupled to the extension set 490 and by the extension set 490 coupled to the indwelling PIV 405, the second arm 450 can be in contact with the target surface S such that the device 400 is arranged at a predetermined and / or desired angle θ with respect to the target surface S as shown in FIG. 36.

[0111]

[1148] In some embodiments, the predetermined and / or desired angle θ can be between about 0° and about 30°. For example, in some embodiments, the predetermined and / or desired angle θ can be about 15°. In such embodiments, by arranging the device 400 at the predetermined and / or desired angle θ, for example, the advancement of the catheter from the first position to the second position can be facilitated such that at least the distal end portion of the catheter extends through the PIV 405 and is disposed within the vein. In some examples, the predetermined and / or desired angle θ of the device 400 can be approximately equal to and / or otherwise associated with the insertion angle of the PIV 405. Thus, arranging the device 400 at the predetermined and / or desired angle θ can limit and / or reduce the potential for refraction along the catheter, thereby facilitating the transfer of body fluid (e.g., blood) within the catheter. Further, some In that example, when the device 400 is arranged at a predetermined and / or desired angle θ, the movement of the device 400 and / or the PIV is reduced, the possibility of detachment and / or disengagement is reduced, the risks of hematoma, thrombosis, thrombus, infection, etc. are reduced, and / or the comfort of the patient can be enhanced.

[0112]

[1149] The second arm 450 of the lock 440 has been described above as being arranged in contact with the target surface S to arrange and / or maintain the transfer device 400 at a predetermined and / or desired angle θ with respect to the target surface S. However, in other embodiments, the fluid transfer device can include and / or be coupled to any suitable device configured to arrange the transfer device at a predetermined and / or desired angle. For example, FIG. 37 shows a fluid transfer device 500 according to an embodiment. The fluid transfer device 500 can have substantially the same form and / or function as the fluid transfer device 400 described above with reference to FIGS. 35 and 36, and thus each part of the transfer device will not be further detailed herein.

[0113]

[1150] The fluid transfer device 500 (also referred to herein as the "transfer device" or "device") includes an introducer 510 having a proximal end portion 511 and a distal end portion 512. The distal end portion 512 of the introducer 510 is coupled to a lock 540, which is configured to physically and fluidly couple the device 500 to an indwelling PIV (not shown in FIG. 37) as detailed above. As shown in FIG. 37, the distal end portion 512 of the introducer 510 is coupled to a support member 580. The support member 580 can be of any suitable shape, size, or configuration. For example, in this embodiment, the support member 580 can be one or more extensions, struts, protrusions, rods, finger-like portions, etc., each of which is coupled to and / or included in the distal end portion 512 of the introducer 510. As described above with reference to the second arm 450 of the lock 440, the support member 580 can contact the target surface S and can be arranged such that when the support member 580 is coupled to the distal end portion 512 of the introducer 510, the device 500 is maintained and / or positioned at a predetermined and / or desired angle θ with respect to the target surface S.

[0114]

[1151] Although the support member 580 is specifically shown in FIG. 37, it should be understood that the fluid transfer device can include and / or be coupled to a support member having any suitable shape, size, and / or configuration. For example, FIG. 38 shows a fluid transfer device 600 according to an embodiment. The fluid transfer device 600 can be substantially the same form and / or function as the fluid transfer device 500 described above with reference to FIG. 37, and thus each part of the transfer device 600 will not be further detailed herein.

[0115]

[1152] The fluid transfer device 600 (also referred to herein as the "transfer device" or "device") includes an introducer 610 having a proximal end portion 611 and a distal end portion 612. The distal end portion 612 of the introducer 610 is coupled to a lock 640, which is configured to physically and fluidly couple the device 600 to an indwelling PIV (not shown in FIG. 38) as detailed above. In the embodiment shown in FIG. 38, the distal end portion 612 of the introducer 610 is coupled to a support member 680 configured as a wedge or the like. For example, in some embodiments, the support member 680 can include a first surface 681 configured to be disposed in contact with the target surface S and a second surface 682 configured to form an angle with respect to the first surface 681. In this way, the second surface 682 can be disposed in contact with a portion of the device 600 (e.g., the distal end portion 612 of the introducer 610 and / or any other suitable portion of the device 600) so as to dispose and / or maintain the device 600 at a predetermined and / or desired angle θ with respect to the target surface S.

[0116]

[1153] The support members 580 and 680 have been described above as being included in and / or coupled to the introducers 510 and 610, respectively. However, in other embodiments, the support member may be included in and / or coupled to any suitable portion of the fluid transfer device. For example, FIGS. 39 and 40 show a fluid transfer device 700 according to an embodiment. The fluid transfer device 700 can have substantially the same form and / or function as the fluid transfer device 400 described above with reference to FIGS. 35 and 36, and thus each part of the transfer device 700 will not be described in further detail herein.

[0117]

[1154] The fluid transfer device 700 (also referred to herein as the "transfer device" or "device") includes an introducer 710 having a distal end portion coupled to a lock 740. The lock 740 includes a protrusion 742, a first arm 743, and a second arm 750. In the embodiments shown in FIGS. 39 and 40, the transfer device 700 includes a support member 780 coupled to the lock 740. More specifically, the support member 780 includes a first portion 783 and a second portion 784. The first portion 783 of the support member 780 can be substantially annular and / or can define an opening configured to receive at least a portion of the protrusion 742 of the lock 740. In other words, the protrusion 742 of the lock 740 is insertable into the first portion 783 of the support member 780, thereby coupling the support member 780 to the lock 740. In some embodiments, the first portion 783 of the support member 780 and a portion of the protrusion 742 can collectively form a friction fit or press fit that can hold the support member 780 in a position substantially fixed relative to the lock 740, at least temporarily.

[0118]

[1155] As shown in FIG. 40, the second portion 784 of the support member 780 extends from the first portion 783 and includes a contact surface 785. The first portion 783 is disposed at a predetermined and / or desired angle relative to the contact surface 785 of the second portion 784. In other words, the axis defined by the opening of the first portion 783 is disposed at a predetermined and / or desired angle relative to a plane defined by and / or parallel to the contact surface 785. Accordingly, when the support member 780 is coupled to the lock 740 and the contact surface 785 is disposed in contact with a target surface (e.g., a portion of a patient's anatomical structure), the device 700 can be disposed and / or placed at a predetermined and / or desired angle relative to the target surface. As described above, the predetermined and / or desired angle can be between about 0° and about 30°. For example, in some embodiments, the predetermined and / or desired angle can be about 15°. In other embodiments, the predetermined and / or desired angle can be about 25°. In still other embodiments, the predetermined and / or desired angle can be less than 0° or greater than 30°.

[0119]

[1156] The support member 780 has been described above as including a single member (i.e., the second portion 784) extending from the first portion 783. However, in other embodiments, the support member can include any number of extensions (e.g., the second portion). For example, FIG. 41 shows a fluid transfer device 800 according to an embodiment. The fluid transfer device 800 can have substantially the same form and / or function as the fluid transfer device 700 described above with reference to FIGS. 39 and 40, and thus, each part of the transfer device 700 will not be described in further detail herein.

[0120]

[1157] The fluid transfer device 800 (also referred to herein as the "transfer device" or "device") includes an introducer 810 having a distal end portion coupled to a lock 840 (as described above). The lock 840 includes a protrusion 842, a first arm 843, and a second arm 850. In the embodiment shown in FIG. 41, the transfer device 800 includes a support member 880 coupled to the lock 840. As described above with reference to the support member 780, the support member 880 includes a first portion 883 and a set of second portions 884 extending from the first portion 883. The first portion 883 is configured to be disposed around a portion of the protrusion 842 as described above with reference to the support member 780. Further, each second portion 884 includes a contact surface 885 as described above with reference to the support member 780.

[0121]

[1158] However, the support member 880 may be different from the support member 780 in the arrangement of the second portion 884. For example, as shown in FIG. 41, the support member 880 includes a set of three second portions 884 distributed around a part of the circumference of the first portion 883. In this way, the set of second portions 884 can be placed in contact with a target surface (e.g., a part of a patient's anatomical structure), and the device 800 can be arranged and / or positioned at a predetermined and / or desired angle with respect to the target surface as described above with reference to the support member 780. Further, the arrangement of the set of second portions 884 can, in some examples, provide lateral support that restricts and / or substantially prevents rotation, tipping, swaying, and / or any other undesirable movement of the device 800 with respect to the target surface.

[0122]

[1159] Although not shown in the transfer devices 100, 200, 300, 400, 500, 600, 700, and / or 800, any of the fluid transfer devices described herein can include an internal support member configured to guide, shield, protect, and / or support, for example, a catheter disposed within an introducer. For example, FIG. 42 shows a fluid transfer device 900 according to an embodiment. The fluid transfer device 900 can have substantially the same form and / or function as the fluid transfer device 200 described above with reference to FIGS. 3 - 29, and thus each part of the transfer device 900 will not be described in further detail herein.

[0123]

[1160] The fluid transfer device 900 (also referred to herein as the "transfer device" or "device") includes an introducer 910, a catheter 960, an actuator 970, and an internal support member 986. As described above with reference to the transfer device 200, the introducer 910 has a distal end portion coupled to a lock 940, and the lock 940 is configured to couple the transfer device 900 to, for example, an indwelling PIV and / or an extension set (e.g., a Y adapter, a T adapter, etc.). The introducer 910 defines an internal volume 913 configured to receive and / or house at least a portion of the catheter 960, the actuator 970, and the internal support member 986. As described above, the actuator 970 is movably coupled to the introducer 910 and includes a first portion 971, a second portion 975, and a wall 977 coupling the first portion 971 to the second portion 975. The first portion 971 of the actuator 970 is disposed outside the introducer 910. The second portion 975 of the actuator 970 is disposed within the internal volume 913 of the introducer 910 and is fixedly coupled to the distal end portion of the catheter 960. In this way, the user can, as described above with reference to the transfer device 200, apply a force to the first portion 971 of the actuator 970 to move the catheter 960 between a first position (e.g., a proximal position) where the catheter 960 is disposed within the introducer 910 and / or the lock 940, and a second position (e.g., a distal position) where at least a portion of the catheter 960 extends distally beyond the lock 940.

[0124]

[1161] As shown in FIGS. 42 and 43, the delivery device 900 also includes an internal support member 986 disposed within the internal volume 913 of the introducer 910 and around at least a portion of the catheter 960. The internal support member 986 can be of any suitable shape, size, and / or configuration. For example, in this embodiment, the internal support member 986 is a substantially cylindrical tube having a diameter that allows the internal support member 986 to be disposed within the internal volume 913 (or a portion thereof). Further, the internal support member 986 is configured to surround and / or substantially surround at least a portion of the catheter 960. In some embodiments, the internal support member 986 can support the catheter 960 to limit and / or substantially prevent undesirable deflection and / or deformation of the catheter 960. For example, as described above with reference to the delivery device 300, in some embodiments, the catheter 960 can be configured to "clutch" or deflect in response to the distal end of the catheter 960 hitting an obstruction or the like. In such embodiments, by disposing the internal support member 986 around at least a portion of the catheter 960, the amount of deflection of the catheter 960 when transitioning to the "clutch" configuration can be limited. In some embodiments, such an arrangement can, for example, maintain the catheter 960 within the internal volume 913 of the introducer 910 (or a desired portion thereof). That is, the internal support member 986 can support the catheter 960 and / or limit the amount of deflection of the catheter 960 that would otherwise (e.g., via an actuator slot, track, or opening) extend a portion of the catheter 960 outside of the internal volume 913.

[0125]

[1162] As shown in FIGS. 42 and 43, the internal support member 986 includes and / or defines a slit 987 that is helical and / or coiled along the length of the internal support member 986. The second portion 975 of the actuator 970 can be disposed within the internal support member 986, and at least a portion of the wall 977 of the actuator 970 can extend through the slit 987 defined by the internal support member 986 (see, e.g., FIG. 42). This arrangement of the actuator 970 and the internal support member 986 is such that when the user moves the actuator 970 along the length of the introducer 910, the second portion 975 of the actuator 970 and the catheter 960 are moved within the internal support member 986. Since the wall 977 extends through the slit 987, movement of the actuator 970 along the introducer 910 causes rotation of the internal support member 986 as the wall 977 advances through the slit 987 (e.g., a helical or coiled slit). Stated another way, the translational movement of the actuator 970 results in a similar translational movement of the catheter 960 and a rotational movement of the internal support member 986 about the catheter 960. Accordingly, the internal support member 986 can support at least a portion of the catheter 960 disposed within the introducer 910. Further, in some embodiments, the internal support member 986 can be configured to substantially maintain the sterility of the catheter 960 prior to use.

[0126]

[1163] The internal support member 986 is shown and described above as a substantially cylindrical tube in which the catheter 960 is disposed, but in other embodiments, the fluid transfer device can include any suitable internal support member. For example, FIG. 44 shows a fluid transfer device 1000 according to an embodiment. The fluid transfer device 1000 can have substantially the same form and / or function as the fluid transfer device 900 described above with reference to FIGS. 42 and 43, and thus, each portion of the fluid transfer device 1000 will not be described in further detail herein.

[0127]

[1164] The fluid transfer device 1000 (also referred to herein as the "transfer device" or "device") includes an introducer 1010, a catheter 1060, an actuator 1070, and an internal support member 1086. The introducer 1010 has a distal end portion coupled to a lock 1040, which is configured to couple the transfer device 1000 to, for example, an indwelling PIV and / or an extension set (such as a Y adapter, a T adapter, etc.). The introducer 1010 defines an internal volume 1013 configured to receive and / or accommodate at least a portion of the catheter 1060, at least a portion of the actuator 1070, and the internal support member 1086. As described above, the actuator 1070 is movably coupled to the introducer 1010 and includes a first portion 1071 disposed outside the introducer and a second portion 1075 disposed within the internal volume 1013 and fixedly coupled to the catheter 1060. In this way, the user can, as described above, apply a force to the first portion 1071 of the actuator 1070 to move the catheter 1060 between a first position (e.g., a proximal position) where the catheter 1060 is disposed within the introducer 1010 and / or the lock 1040 and a second position (e.g., a distal position) where at least a portion of the catheter 1060 extends distally beyond the lock 1040.

[0128]

[1165] However, the transfer device 1000 may differ from the transfer device 900 in the arrangement of the internal support member 1086. For example, in the embodiment shown in FIG. 44, the internal support member 1086 may be formed from a relatively flexible material and may be configured and / or arranged, for example, as a bellows. The internal support member 1086 is disposed within the internal volume 1013 between the second portion 1075 of the actuator 1070 and the internal distal surface of the introducer 1010 that at least partially defines the distal end of the internal volume 1013, such that at least a portion of the catheter 1060 is movably disposed within the internal support member 1086. Since the internal support member 1086 is arranged and / or configured as a bellows, movement of the actuator 1070 results in compression, deformation, and / or crushing of the internal support member 1086. That is, movement of the actuator 1070 from its proximal position to its distal position compresses the bellows formed by and / or otherwise included in the internal support member 1086. Conversely, when the actuator 1070 is moved from its distal position towards its proximal position, the bellows formed by and / or otherwise included in the internal support member 1086 can expand and / or reconfigure to a pre-deformed configuration. Thus, for example, the internal support member 1086 can support the catheter 1060 (e.g., when the catheter 1060 transitions to a "clutch" configuration) and / or can fluidly isolate at least a portion of the catheter 1060 (e.g., so as to substantially maintain the sterility of the catheter 1060), as described above with reference to the internal support member 986.

[0129]

[1166] The internal support member 1086 is shown and described above as forming a bellows or the like in which at least a portion of the catheter 1060 is disposed. In other embodiments, however, the fluid transfer device can include any suitable internal support member. For example, FIG. 45 shows a fluid transfer device 1100 according to one embodiment. The fluid transfer device 1100 can have substantially the same form and / or function as the fluid transfer device 900 described above with reference to FIGS. 42 and 43. Accordingly, each part of the fluid transfer device 1100 will not be described in further detail herein.

[0130]

[1167] The fluid transfer device 1100 (also referred to herein as the "transfer device" or "device") includes an introducer 1110, a catheter 1160, an actuator 1170, and an internal support member 1186. The introducer 1110 has a distal end portion coupled to a lock 1140 that is configured to couple the transfer device 1100 to, for example, an indwelling PIV and / or an extension set (such as a Y adapter, a T adapter, etc.). The introducer 1110 defines an internal volume 1113 configured to receive and / or accommodate at least a portion of the catheter 1160, the actuator 1170, and the internal support member 1186. As described above, the actuator 1170 is movably coupled to the introducer 1110 and includes a first portion 1171 disposed outside the introducer and a second portion 1175 disposed within the internal volume 1113 and fixedly coupled to the catheter 1160. In this way, the user can apply a force to the first portion 1171 of the actuator 1170 to move the catheter 1160 between a first position (e.g., a proximal position) in which the catheter 1160 is disposed within the introducer 1110 and / or the lock 1140 and a second position (e.g., a distal position) in which at least a portion of the catheter 1160 extends distally beyond the lock 1140, as detailed above.

[0131]

[1168] However, the transfer device 1100 may be different from the transfer device 900 in the arrangement of the internal support member 1186. For example, in the embodiment shown in FIG. 45, the internal support member 1186 can be formed from a relatively thin and flexible material arranged in, for example, a zigzag configuration (e.g., a set of wall segments arranged in alternating angular directions). The internal support member 1186 is disposed within the internal volume 1113 of the introducer 1110 between a distal surface that at least partially defines the distal end of the internal volume 1113 and a second portion 1175 of the actuator 1170. In other embodiments, the internal support member 1186 can extend along only a portion of the internal volume disposed between the actuator 1170 and the distal surface. It can extend along only a portion of the internal volume disposed between the actuator 1170 and the distal surface.

[0132]

[1169] Catheter 1160 is disposed within and / or extends through openings or holes defined in each wall segment (see, e.g., FIG. 45). In some embodiments, the size and / or diameter of the openings or holes defined in each wall segment can be “adjusted” and / or set to adjust the amount of support provided to catheter 1160. For example, in some embodiments, the openings or holes can be the same as and / or slightly larger than the outer diameter of catheter 1160. In such embodiments, a relatively tight tolerance between the size and / or diameter of the opening and the size and / or outer diameter of catheter 1160 can result in a relatively high level of support, thereby reducing the amount of deflection and / or deformation of catheter 1160 as, for example, catheter 1160 transitions from a non-clutch configuration to a clutch configuration. In other embodiments, the openings and / or holes defined by each wall segment of inner support member 1186 can be larger than the outer diameter of catheter 1160 (e.g., a relatively large tolerance therebetween). In such embodiments, the larger size and / or diameter of the openings can allow catheter 1160 to deflect relative to inner support member 1186. Thus, in some embodiments, an increase in the size and / or diameter of the openings of inner support member 1186 can result in an increase in the range of movement of catheter 1160 (e.g., an increase in the amount of deflection and / or deformation when catheter 1160 transitions from a non-clutch configuration to a clutch configuration).

[0133]

[1170] In some embodiments, the internal support member 1186 can be formed from a material having sufficient flexibility to bend, deform, flex, and / or otherwise reconfigure. For example, when the actuator 1170 moves along the introducer 1110, the second portion 1175 of the actuator 1170 can compress and / or fold the internal support member 1185 (e.g., reduce the angle defined between adjacent wall segments). Additionally, at least a portion of the internal support member 1186 can bend and / or flex in response to the catheter 1160 transitioning to a "clutch" configuration while substantially restricting the deflection amount of the catheter 1160 that would otherwise extend a portion of the catheter 1160 outside of the introducer 1110 (as described above with reference to internal support member 986). Accordingly, the internal support member 1186 can support at least a portion of the catheter 1160 disposed within the introducer 1110.

[0134]

[1171] The internal support member 1186 is shown as extending substantially along the entire length of the catheter 1160, but in other embodiments, the internal support member may extend along any suitable portion of the catheter (e.g., substantially shorter than the entire length of the catheter). The internal support member 1186 has been described above as being formed from a relatively thin and flexible material having a set of wall segments arranged in alternating angular directions, but in other embodiments, the internal support member can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the fluid transfer device can include a spring (e.g., a coil spring) disposed within the internal volume of the introducer and around at least a portion of the catheter. In such embodiments, the spring or the like can support at least a portion of the catheter in a manner substantially similar to the methods described above with reference to internal support members 986, 1086, and / or 1186.

[0135]

[1172] In other embodiments, the internal support member can be integrally formed with the catheter and / or coupled to the catheter in another manner. For example, in some embodiments, one or more portions of the catheter can be formed as the support member. Such portions can, for example, have an increased wall thickness and / or be formed from a different constituent material. In other embodiments, the internal support member can be selectively coupled to the catheter. For example, in some embodiments, the catheter can include a set of rings or beads that can be movably coupled and / or disposed along the length of the catheter. In some embodiments, the rings and / or beads can be evenly and / or uniformly spaced, or randomly and / or unevenly spaced. In some embodiments, the rings and / or beads can be configured to move along the length of the catheter in response to actuation of an actuator (e.g., movement of the catheter). For example, in some embodiments, each ring and / or bead can be coupled to the catheter and temporarily maintained in a substantially fixed position. In some examples, as the catheter is advanced distally, the rings and / or beads can move such that the rings and / or beads gather and / or slide to a position along, for example, the proximal end portion of the catheter. Thus, the rings and / or beads can be configured to increase the amount of support provided to the catheter as the catheter is advanced distally (e.g., as the spacing between the rings and / or beads decreases).

[0136]

[1173] In yet other embodiments, the introducer can include an internal support member formed of and / or having a deformable tape and / or foam disposed along the inner surface (e.g., upper inner surface) of the catheter. In such embodiments, the tape and / or foam can be configured to compress, bend, flex, deform, and / or otherwise reconfigure when the actuator and / or catheter is relative thereto. For example, in some embodiments, the foam or the like is disposed between the actuator and the distal face of the internal volume of the introducer and can be compressed (e.g., axially) in response to distal movement of the actuator. In other embodiments, the introducer can include a foam or the like along the upper surface of the internal volume and can be deformed, displaced, deflected, and / or compressed laterally, for example, at or near the position of the actuator. Further, when the actuator is advanced along the length of the introducer, a portion of the foam can be configured to return to an undeformed configuration when the actuator is moved relative to that portion. Thus, a portion (or a part thereof) of the foam proximal to the actuator can be in an undeformed configuration and a portion (or a part thereof) of the foam distal to the actuator can be in an undeformed configuration. That is, as the actuator moves along the introducer, the actuator displaces a predetermined and / or defined portion of the foam. In some embodiments, the foam can limit and / or reduce the unoccupied or unoccupied portion of the internal volume, thereby limiting and / or reducing the range of movement of the catheter (e.g., when transitioning from a non-clutch configuration to a clutch configuration). In some embodiments, the deformation of the foam in response to movement of the actuator can further limit and / or reduce the unoccupied or unoccupied portion of the internal volume, thereby providing an increased amount of support to the catheter (e.g., a reduced range of movement).

[0137]

[1174] Although some of the fluid transfer devices described herein are not explicitly shown with a peripheral intravenous line (PIV), it should be understood that any of the fluid transfer devices described herein can be coupled to any suitable peripheral intravenous line (PIV). In some examples, the use of a PIV can include coupling the PIV to an IV extension set and / or an adapter (e.g., a single port adapter, a Y adapter, a T adapter, etc.). Thus, although some of the transfer devices are described herein as being coupled to a PIV, it should be understood that, based on the circumstances and / or configuration, the transfer device can be coupled to either the PIV or an adapter (e.g., an extension set) coupled thereto. The transfer device can be configured to couple to any suitable commercially available PIV, adapter, and / or extension set. For example, with respect to the first arm 243 and the second arm 250 of the lock 240, they are illustrated and described as having a given shape and / or configuration (e.g., in FIGS. 13 and 14), but in other embodiments, the lock can have a size, shape, and / or configuration that enables the lock to be coupled to various PIVs, adapters, and / or extension sets. As an example, in some embodiments, the arms of the lock can be curved, bent, bowed, splayed, etc. such that the lock is able to receive a portion of any suitable PIV, adapter, and / or extension set. In some embodiments, the arrangement of the arms 243 and 250 of the lock 240 enables the lock 240 to be rotated substantially 360° about any suitable PIV, adapter, and / or extension set to which it is coupled. Further, in some embodiments, the ability to rotate the lock 240, for example, to position the arms of the lock 240 in a predetermined position, is such that, by placing the surface of the arm 243 or arm 250 in contact with a surface, as described above with reference to the device 400 shown in FIGS. 35 and 36, the device 200 is positioned at a predetermined and / or desired angle with respect to that surface. The lock can include a first arm and a second arm having a size, shape, and / or configuration that enables the lock to be coupled to various PIVs, adapters, and / or extension sets. As an example, in some embodiments, the arms of the lock can be curved, bent, bowed, splayed, etc. such that the lock is able to receive a portion of any suitable PIV, adapter, and / or extension set. In some embodiments, the arrangement of the arms 243 and 250 of the lock 240 enables the lock 240 to be rotated substantially 360° about any suitable PIV, adapter, and / or extension set to which it is coupled. Further, in some embodiments, the ability to rotate the lock 240, for example, to position the arms of the lock 240 in a predetermined position, is such that, by placing the surface of the arm 243 or arm 250 in contact with a surface, as described above with reference to the device 400 shown in FIGS. 35 and 36, the device 200 is positioned at a predetermined and / or desired angle with respect to that surface.

[0138]

[1175] Although the protrusion 242 is shown and described as having a particular size and / or shape, in other embodiments the lock can include a protrusion having any suitable length (e.g., longer or shorter than the protrusion 242), width (e.g., wider or narrower than the protrusion 242), and / or shape (e.g., curved, tapered, flared, etc.). In some embodiments, the protrusion can have a surface finish or feature such as one or more threads, screws (e.g., auger screws), ribs, grooves, etc. In some embodiments, the protrusion 242 can have a diameter and / or length that is related to and / or at least partially based on one or more internal dimensions of an expansion set, PIV, etc. In other words, in some embodiments, the devices described herein can be configured to be used with an expansion set and / or PIV having one or more desired internal dimensions, such as, for example, the inner diameter of a lumen defined by an expansion set, the length of the lumen, etc. For example, in some embodiments, the expansion set can define a lumen having an inner diameter of at least a portion thereof from about 1.0 millimeter (mm) to about 1.6 mm. In other embodiments, the expansion set can define a lumen (or a portion thereof) having a diameter that is related to and / or slightly larger than the outer diameter of a catheter configured to be inserted therein (e.g., a diameter that is slightly larger than the diameter of a 30-gauge catheter or about 0.20 mm).

[0139]

[1176] In some embodiments, such an extension set having one or more desired internal dimensions (inner diameters) can function as a guide or the like configured to guide the catheter 260 through at least a portion of the extension set and / or the PIV without substantially bending, kinking, breaking, and / or without substantially stacking. More specifically, in some embodiments, the extension set can be coupled to a PIV hub or the like such that the distal end portion of the extension set extends through a portion of the PIV hub or basket. In such embodiments, the extension set can define a lumen having an inner diameter of about 1.4 mm at its distal end portion (e.g., the lumen can taper to a diameter of about 1.4 mm towards the distal end portion or can have a substantially constant diameter of about 1.4 mm between its proximal end portion and its distal end portion). In such embodiments, the extension set can guide, for example, the distal end portion 262 of the catheter 260 through the hub or basket of the extension set and the PIV and into the patient's vein, for example, without substantially colliding with obstacles and without "catching" on one or more portions of the extension set and / or the PIV. Thus, the extension set can be an adapter and / or guide that enables the delivery device 200 to be used with any suitable PIV, such as a commercially available PIV or the like.

[0140]

[1177] In other embodiments, the extension sets, PIVs, and / or any of the devices described herein can include and / or be coupled to an external guide member or the like that can be disposed between components. Such an external guide member can be configured to direct the catheter as it advances distally (as detailed above). For example, in some In embodiments, the guide member can have a taper and / or can be funnel-shaped, for example, having a larger diameter at the proximal end portion and a smaller diameter at the distal end portion. In some embodiments, such a guide member can be disposed between an introducer and an extension set of any of the devices described herein. In other embodiments, such a guide member can be disposed between the extension set and the PIV. In still other embodiments, such a guide member can be disposed between an introducer and the PIV of any of the devices described herein. In still other embodiments, any of the devices described herein can include and / or be coupled to one or more guide members having any suitable configuration.

[0141]

[1178] Using the embodiments described herein, fluid can be transferred from or into a patient's body by accessing a vein through an indwelling PIV. As described above, the transfer device 100 and / or 200 can be manipulated, for example, to position the distal face of the catheter a predetermined and / or desired distance from the distal face of the PIV. In some examples, the embodiments described herein enable efficient blood sampling while maintaining the integrity of the sample. During blood sampling, the transfer device 100 and / or 200 can be configured to receive and / or generate a substantially laminar flow (e.g., non-turbulent or low-turbulent flow) of blood through each of the transfer devices 100 and / or 200 to reduce and / or substantially prevent hemolysis of the blood as it flows through each of the transfer devices 100 and / or 200.

[0142]

[1179] In some instances, when collecting a sample volume of blood (e.g., blood culture) using a transfer device as described herein, it may be desirable to occlude and / or otherwise block the lumen of the catheter when inserting the catheter through an indwelling PIV and into the vein. For example, in some embodiments, a large volume of blood can be collected using the transfer device 200. In such embodiments, the lock 240 of the transfer device 200 can be coupled to the indwelling PIV and a fluid source can be coupled to the coupler 269 of the second catheter 265. In some embodiments, for example, the fluid source can be a squeezable ball or valve, and / or a suitable form of fluid reservoir and pump (e.g., syringe, etc.). The fluid source can include, for example, saline solution or the like. Thus, with the fluid source coupled to the coupler 269, the fluid source is arranged to be in fluid communication with the lumen 268 defined by the second catheter 265, and the second catheter 265 places the fluid source in a state of being in fluid communication with the lumen 263 defined by the catheter 260.

[0143]

[1180] In some embodiments, by activating a fluid source, etc., the flow of fluid (e.g., saline) through catheters 260 and 265 can be released, thereby flushing lumens 263 and 268 respectively. When flushed, catheter 260 can be placed in a fluidly or hydraulically locked configuration and advanced to its second position (as described in detail above). In other embodiments, the fluid source can be activated, etc., to release the flow of fluid such that a substantially continuous flow of fluid elutes from catheter 260 (e.g., a squeeze bulb can be squeezed). With fluid eluting from catheter 260, the transfer device 200 can be activated to advance catheter 260 to its second position (as described above). Thus, flushing lumens 263 and 268 of the transfer device 200 before and / or during advancement of catheter 260 can limit and / or substantially prevent the entry of contaminants into the fluid flow path defined by lumens 263 and 268 (e.g., it can be fluidly and / or hydraulically locked).

[0144]

[1181] In some examples, when catheter 260 advances to its second position, the fluid source For example, a reservoir of a fluid source can be reversed such that it receives a fluid flow. For example, in some instances, a squeeze ball or valve can be actuated (compressed), whereby when the fluid flow contained therein is released, the volume of the squeeze ball or valve decreases. In some instances, after the catheter 260 is placed in its second position, a force can be removed from the squeeze ball or valve, whereby the volume of the squeeze ball or valve increases. The increase in volume creates and / or generates a suction force that, in some instances, can be operative to draw the remaining amount of saline and blood into the volume defined by the squeeze ball or valve. Thus, "reversing" a fluid source or the like can remove the remaining saline and prime the transfer device 200. After priming the transfer device 200, any suitable fluid reservoir can be coupled to the coupler 269 to transfer a clean blood flow from the vein to the fluid reservoir.

[0145]

[1182] Although the squeeze ball or valve has been described above, it should be understood that any suitable fluid reservoir and / or pump can be used to flush and / or prime any of the delivery devices described herein. Embodiments have been described above as using a fluid such as saline to flush and / or prime the catheter and / or delivery device, but in other embodiments, the catheter and / or delivery device can be flushed and / or primed via any suitable compressible fluid, incompressible fluid, etc. In other embodiments, a gas such as air or any suitable inert gas can be used to form an air lock, flush, and / or prime. In yet other embodiments, a guidewire and / or any other suitable occlusion device can be placed within the lumen of the catheter to limit and / or substantially prevent fluid from entering the lumen as the catheter advances to a desired location within the patient's vein. In some such embodiments, the occlusion device can include one or more portions configured to dissolve over a predetermined period, e.g., in response to a given temperature and / or in response to fluid contact. In other embodiments, the occlusion device or the like can include a deformable member, a shape memory or changeable component (e.g., a nickel-titanium alloy (nitinol)), a reversible valve (e.g., a mechanical valve configured to transition in response to force or pressure, or an electric valve configured to transition in response to a flow of electric current), and / or any other suitable member.

[0146]

[1183] Although not shown, any of the transfer devices described herein can include and / or be coupled to, for example, a flush chamber configured to receive a first blood volume (e.g., a blood pre-sample). In some embodiments, the flush chamber can be coupled to the coupler 269 of the second catheter 295 of the transfer device 200 to receive the first blood volume. In other embodiments, any suitable portion of the transfer device 200 can form a flush chamber or the like configured to at least temporarily store the first blood volume. In such embodiments, the first blood volume can flow into the flush chamber through a one-way seal such as a sponge seal. The seal can be arranged such that when the seal is wetted (e.g., with blood), the flow of the first blood volume stops. When the desired blood volume has been transferred to the flush chamber (e.g., the first volume), the transfer device 200 can be operated to transfer a second blood volume (e.g., a sample volume) to a fluid reservoir (e.g., a sample reservoir).

[0147]

[1184] The embodiments described herein can be used in various settings (ER, inpatients, etc.), and by way of example, provide the following scenario for withdrawing a sample volume of blood from a patient's body. In some examples, for instance, a peripheral intravenous line and / or catheter (PIV) is inserted into the patient's vein according to standard guidelines and an extension set and / or adapter is attached. The PIV can remain in the vein for an extended period of time and provide access to the vein for transferring fluids (e.g., saline, blood, drug compounds, etc.) to the patient. It is possible. When it is time to collect blood, the user (e.g., nurse, doctor, phlebotomist, etc.) can stop the fluid transfer to the patient for about 1 to 5 minutes to allow the fluid to disperse from the blood collection site if the PIV is transferring fluid. To collect a blood sample, the user attaches a transfer device (e.g., transfer devices 100 and / or 200) to the port and / or suitable part of the extension set and / or adapter, and transitions the transfer device from a first configuration (e.g., storage configuration) to a second configuration in which a portion of the catheter included in the transfer device extends intravenously through the peripheral IV.

[0148]

[1185] Although described in detail above with respect to the transfer device 200, when the transfer device is in the second configuration, the end of the catheter can be positioned at a predetermined and / or desired distance from the end of the PIV so as to place the catheter in fluid communication with a portion of the vein that receives an unobstructed and / or unblocked blood flow. For example, the end of the catheter can be in a distal position relative to the end of the PIV and at least one branched blood vessel, valve, etc. that is in fluid communication with the vein. Once the catheter is in the desired position, the user can attach one or more negative pressure collection containers, tubes and / or syringes to the transfer device to collect a quantity of blood. Optionally, the quantity of blood can be a first quantity of blood that can be discarded and / or stored separately from, at least temporarily, the subsequent quantity of sample blood (e.g., typically on the order of about 1 milliliter (mL) to 3 mL, although up to 8 mL to 10 mL of blood can be a "waste" or "presample" quantity). Optionally, the waste quantity can include contaminants, non-dispersed residual fluids, etc. After collection of the waste quantity, the user can couple one or more negative pressure containers (e.g., sample containers) to the transfer device to collect the desired quantity of blood sample. Once the sample quantity has been collected, the transfer device can be transitioned from the second configuration to the first configuration and / or the third configuration (e.g., a "used" configuration). The transfer device can then be separated from the extension set and / or adapter and discarded safely. Optionally, after collection of the sample quantity but before transitioning the transfer device from the second configuration, the waste or presample quantity can be reinjected, for example, intravenously.

[0149]

[1186] As described above, in some examples, the transfer device described herein can be coupled to a fluid reservoir configured to receive a quantity of bodily fluid (e.g., blood). In some examples, such a fluid reservoir can be a negative pressure container such as, for example, a Vacutainer®. However, in some examples, it may be desirable to limit and / or control a sudden change in pressure within the transfer device and / or within a vein. A sudden change in pressure can result in hemolysis of a blood sample or a portion thereof, a collapsed or blown vein, and the like. Accordingly, in some embodiments, any of the transfer devices described herein can be configured to regulate the negative pressure exerted therethrough.

[0150]

[1187] For example, as detailed above, the transfer device 200 includes a second catheter 265 that is in fluid communication with the catheter 260 and includes a coupler 269 configured to couple the transfer device 200 to a fluid reservoir (e.g., a negative pressure reservoir). In some embodiments, the second catheter 265 can be configured to regulate the negative pressure exerted through the transfer device 200. For example, the second catheter 265 can be formed from a relatively flexible polymeric material or the like that can be configured to bend, flex, deform, and / or otherwise reconfigure in response to a force applied to the second catheter. Further, in some embodiments, the catheter 260 can have a rigidity or durometer that is higher than the rigidity or durometer of the second catheter 265. In some examples, when the second catheter 265 is exposed to a negative pressure differential, the lumen 268 defined by the second catheter 265 is exposed to a sudden pressure drop, which in turn exerts a suction force within the lumen 268 that draws the wall of the second catheter 265 inwardly, thereby reducing the inner diameter of the second catheter 265. Accordingly, reducing the diameter of the lumen 268 of the second catheter 265 provides regulation and / or A reduced suction force is brought through lumen 268 and onto or into lumen 263 of catheter 260. Similarly, by reducing the amount and / or magnitude of the suction force exerted through lumen 263 of catheter 260, the magnitude of the suction force exerted on or within the vein is adjusted and / or reduced. Accordingly, the negative pressure differential experienced by or within the vein, which may be sufficient to collapse the vein, is reduced.

[0151]

[1188] Further, as bodily fluid (e.g., blood) is transferred through transfer device 200 to the negative pressure reservoir, the negative pressure differential between the reservoir and the vein decreases. In other words, the negative pressure or suction force exerted by the negative pressure reservoir decreases as the volume of blood is transferred therein. Stated another way, the negative pressure differential equalizes as the volume of blood is transferred into the negative pressure reservoir. In some embodiments, due to the decrease in the magnitude of the negative pressure and / or suction force exerted by the negative pressure reservoir, second catheter 265 may transition to a non-deformed configuration (i.e., the configuration prior to being subjected to the negative pressure). That is, as the magnitude of the negative pressure and / or negative pressure differential decreases, the diameter of lumen 268 defined by second catheter 265 may increase or return to a non-decreasing diameter, thereby increasing the fluid flow rate therethrough. Accordingly, by selectively adjusting the negative pressure transmitted through second catheter 265, in the case of a large pressure differential, the flow rate through second catheter 265 may decrease (e.g., due to a reduction in the diameter of the lumen), and as the pressure differential equalizes, the flow rate through second catheter 265 may increase (e.g., due to an increase in the diameter of the lumen).

[0152]

[1189] In some embodiments, the placement and / or configuration of the second catheter 265 can be "adjusted" and / or controlled to regulate the negative pressure exerted through the lumen. For example, the second catheter 265 can be formed from a material having sufficient flexibility to allow the second catheter 265 to deform in a desired manner when exposed to negative pressure. In other embodiments, the wall of the second catheter 265 can have a thickness that is thin enough to allow the wall to deform when exposed to negative pressure. Further, in some embodiments, the length and / or inner diameter of the second catheter 265 can be configured, for example, to reduce the fluid flow rate therethrough. In yet other embodiments, any combination of flexibility, wall thickness, length, diameter, etc. can be used to collectively control and / or adjust the negative pressure exerted therethrough. In still other embodiments, the negative pressure, etc. can be adjusted in response to a change in temperature of the second catheter 265. For example, in some instances, the temperature of the second catheter 265 increases when warm blood begins to flow. In some instances, the increase in temperature causes a relaxation of the diameter (e.g., an increase in the inner diameter), thus accelerating blood flow as the negative pressure decreases over the same period. In some instances, cooling of the second catheter 265 can result in a constriction and / or reduction of the inner diameter of the second catheter 265.

[0153]

[1190] In some examples, the transfer device described herein can be assembled and packaged in a pre-assembled form during one or more manufacturing processes. For example, in some examples, the transfer device 200 couples the catheter 260 and the second catheter 265 to the actuator 270, positions the catheter 260, the second catheter 265, and the actuator 270 relative to the first member 220 or the second member 230 of the introducer 210, couples the first member 220 and the second member 230 to form the introducer 210, wherein at least a portion of the actuator 270 and the catheter 260 and the second catheter 265 are disposed within the internal space 213 of the introducer 210, and can be assembled by coupling the lock 240 to the introducer 210. In some examples, the assembly of the transfer device 200 can be performed in a substantially sterile environment, such as, for example, an ethylene oxide environment. In other embodiments, the transfer device described herein can be packaged in an unassembled form (e.g., a user can open the package and assemble the components to form the transfer device). The components of the transfer device can be packaged together or separately. In some embodiments, the transfer device can be packaged, for example, with a PIV , an extension set, a Y adapter or a T adapter, and / or any other suitable components.

[0154]

[1191] Any of the delivery devices described herein can be configured such that at least a portion of the catheter is biased and / or selectively deflected as the catheter advances from its first position to its second position, as detailed above with reference to device 300 shown in FIGS. 31-34. Further, a device having such an arrangement can be configured such that the biasing or selective deflection of the catheter results in a predictable and / or desired deflection, deformation, and / or reconfiguration of at least a portion of the catheter in response to the distal end portion of the catheter striking an obstruction as the catheter advances from its first position to its second position. In other words, any of the devices described herein can be configured to “clutch” (e.g., deflect in a desired or predetermined manner) in response to the catheter striking an obstruction.

[0155]

[1192] For example, FIG. 46 is a flowchart showing a method 20 of using such a fluid delivery device according to an embodiment. As described above with reference to device 300, a fluid delivery device (also referred to herein as a “device”) can include an introducer, a catheter, and an actuator. The introducer can have a distal end portion that includes a lock configured to couple to a vascular access device. The catheter can be disposed at least temporarily within the introducer and can be coupled to a portion of the actuator. The actuator is movably coupled to the introducer and can be configured to move the catheter relative to the introducer, as described below.

[0156]

[1193] As described above, the device can be used to transfer fluid to or from a patient. More specifically, in this example, the device can be configured to transfer an amount of body fluid (e.g., blood) from a patient's vasculature to a fluid collection device such as a reservoir, syringe, vacuum container, etc. that is placed in fluid communication with a catheter. Accordingly, method 20 includes, at 21, coupling a lock of the device to an indwelling peripheral intravenous line (PIV). In other words, the lock is coupled to a PIV that is at least partially disposed within the patient's vasculature.

[0157]

[1194] At 22, a first force is applied to an actuator to move the actuator relative to an introducer so as to advance the catheter from a first position to a second position. For example, the actuator can be movably coupled to the introducer and can include a first portion disposed outside the introducer and a second portion disposed inside the introducer and coupled to the proximal end portion of the catheter. Accordingly, a user can engage the device and exert a first force (e.g., with their finger or thumb) to move the actuator relative to the introducer. As described above with reference to at least devices 200 and / or 300, the catheter is disposed within the introducer when in the first position and is advanced toward the second position to place the distal end portion of the catheter at a distal position of the introducer (e.g., outside and distal to the introducer).

[0158]

[1195] At 23, when the actuator advances the catheter from the first position toward the second position, a second force different from the first force is exerted on the proximal end portion of the catheter. As described above with reference to device 300, for example, the arrangement of the actuator and the introducer can be such that the first portion of the actuator contacts the outer surface of the introducer. In some embodiments, the contact between the first portion of the actuator and the outer surface of the introducer can be parallel to the longitudinal axis of the introducer, which would typically be the case for an actuator It can be sufficient to tilt or angle the actuator with respect to the introducer such that the longitudinal axis of the sheath is instead non-parallel to the longitudinal axis of the introducer. In such an embodiment, the contact between the first portion of the actuator and the outer surface of the introducer causes the second portion of the actuator to exert a second force on the proximal end portion of the catheter. Further, the second force has a magnitude and direction that are respectively different from the magnitude and direction of the first force.

[0159]

[1196] As described above with reference to device 300, the catheter is at least partially disposed within the introducer such that a portion of the catheter is disposed between an actuator (coupled to the proximal end of the catheter) and a lock (configured to movably receive the catheter). Method 20 includes, at 24, deflecting by a first amount a portion of the catheter disposed between the actuator and the lock in response to a second force when the catheter is advanced from a first position to a second position. For example, the lock defines a lumen configured to movably receive the catheter. The longitudinal axis of the lock's lumen can define a longitudinal axis parallel to the longitudinal axis of the introducer. More specifically, in some embodiments, the longitudinal axis of the lock can be coaxial with the longitudinal axis of the introducer. As described above, contact between the first portion of the actuator and the outer surface of the introducer tilts or angles the actuator relative to the introducer such that the longitudinal axis of the actuator is non-parallel with the longitudinal axis of the introducer. Since the second portion of the actuator is coupled to the proximal end portion of the catheter, the tilt or angle (and / or the second force) of the actuator similarly angles or tilts at least the proximal end portion of the catheter relative to the introducer. Thus, with the catheter disposed within the lumen of the lock (e.g., the distal end portion of the catheter when the catheter is in the first position) and with the proximal end portion of the catheter coupled to the second portion of the actuator, the second force applied to the proximal end portion of the catheter results in deflection of the portion of the catheter disposed between the lock and the actuator (e.g., as detailed above with reference to FIGS. 31 and 32). Further, deflection of that portion of the catheter is operable to bias the catheter and / or to pre-load or pre-stress the catheter in a predetermined and / or desired manner.

[0160]

[1197] At 25, the portion of the catheter disposed between the lock and the actuator is deflected by a second amount greater than the first amount in response to (1) the second force and (2) the distal end portion of the catheter hitting an obstruction when the catheter is advanced from the first position to the second position. For example, in some instances, when the catheter is advanced from the first position towards the second position, the distal end of the catheter can hit an obstruction such as, for example, a portion of the hub of the PIV, a bend or kink in the PIV catheter, a blood clot or debris in the PIV or the patient's vasculature, the wall of the vasculature or other anatomical structures, etc. Thus, the obstruction can resist and / or exert a reaction force on the distal end of the catheter, which can limit and / or prevent further advancement of the catheter (e.g., movement in the distal direction). In some devices where a portion of the catheter is not deflected by the first amount (described above at 24), the first force exerted on the actuator can be transmitted through the actuator and the catheter, such that the distal end portion of the catheter can be damaged, kinked, bent, broken, etc. in response to the collision. In other instances, the distal end of the catheter can puncture the wall of the vasculature or anatomical structure in response to the collision between them. In yet other instances, the distal end portion of the catheter can damage or puncture a portion of the PIV in response to the collision between them.

[0161]

[1198] However, the use of the device according to method 20 is such that, as detailed above with reference to device 300 (e.g., see FIGS. 33 and 34), the collision between the distal end portion of the catheter and the obstruction serves to deflect the second portion of the catheter by the second amount. Thus, at least a portion of the first force exerted by the distal end of the catheter on the obstruction is on the biased, pre-loaded catheter disposed between the lock and the actuator is transmitted to the stressed and / or pre-stressed portion, which serves to deflect that portion of the catheter by a second amount. The device is arranged such that the catheter deflects by the second amount in a predictable, predetermined, and / or desired manner, thereby limiting and / or substantially preventing damage to the catheter, the device, the PIV, and / or the patient's vasculature. In other words, the device is arranged such that the distal end portion of the catheter "clutches" in response to the distal end portion of the catheter colliding with an obstruction as the catheter advances from the first position to the second position. Further, the device is configurable such that after "clutching" or deflecting the catheter, the magnitude of the first force exerted by the user on the actuator is reduced, thereby enabling the catheter to "unclutch" and / or reconfigure in another way to reduce the amount of the second deflection. In some examples, such reconfiguration enables, for example, repositioning the distal end portion of the catheter relative to the obstruction, thereby, in some examples, enabling advancement of the distal end portion beyond the obstruction that was previously limited or prevented by a collision therebetween. Accordingly, method 20 can be used to advance the catheter while reducing, limiting, and / or substantially preventing damage to the device, the PIV, and / or the patient's vasculature. Further, in some examples, when the catheter is disposed in the second position, the device can be used to aspirate a volume of body fluid (e.g., blood), as detailed above with reference to certain embodiments.

[0162]

[1199] Although the various embodiments have been described above, it should be understood that they are presented by way of example and not limitation. The foregoing summary and / or embodiments illustrate some components arranged in some orientations or positions, but the arrangement of the components can be varied. The various embodiments have been described as having certain features and / or combinations of components, but other embodiments having any combination of any features and / or components from any of the embodiments described above are possible.

[0163]

[1200] Although embodiments have been particularly shown and described, it will be understood that various changes in form and detail can be made. For example, with respect to the transfer device 200, although shown and described as including a catheter 260 and a second catheter 265, each coupled to an actuator 270, in other embodiments, the transfer device 200 can include a single catheter (e.g., catheter 260). For example, in some embodiments, at least a second portion 275 of the actuator 270 can be configured to transition between an open configuration and a closed configuration. In such embodiments, when the second portion 275 is in the open configuration, the catheter 260 can be positioned at a desired position relative to the second portion 275. Then, the second portion 275 can be transitioned from the open configuration to the closed configuration to hold at least a portion of the catheter 260 within an opening 276 defined by the second portion 275. In such embodiments, the second portion 275 and the portion of the catheter 260 disposed within the opening 276 can form a friction fit operable to hold the catheter 260 in a fixed position relative to the actuator 270. Further, the friction fit defined between the second portion 275 of the actuator 270 and the catheter 260 can isolate a portion of the catheter 260 distal to the actuator 270 from a portion of the catheter 260 proximal to the actuator 270. Thus, the portion of the catheter 260 proximal to the actuator 270 can pass through the opening 217 and extend at least partially outside the introducer 210 without contaminating the portion of the catheter 260 distal to the actuator 270.

[0164]

[1201] Any of the aspects and / or features of the embodiments illustrated and described herein can be modified to affect the performance of the transfer device. For example, the ribs of the set of ribs 236 of the introducer 210 and the tab 273 of the actuator 270 can have any suitable shape, size, configuration, and / or arrangement to produce the desired set of features associated with the movement of the actuator 270 relative to the introducer 210, as described above. It can be. As another example, any of the components of the transfer device 100 and / or 200 can be formed from any suitable material that can provide the desired hardness, durometer hardness, and / or rigidity of the component. For example, in some embodiments, at least the protrusion 242 of the lock 240 can be formed from a substantially rigid material such as metal or hard plastic. In such embodiments, by forming at least the protrusion 242 from a substantially rigid material, the structural support provided to the PIV by the protrusion 242 when the protrusion 242 is at least partially disposed within the PIV can be increased. Similarly, the protrusion 242 can provide support to the catheter 260 as the catheter 260 moves therethrough and / or can guide the catheter 260 in other ways.

[0165]

[1202] The methods and / or general outlines described above show some events and / or flow patterns that occur in a certain order, but the order of some events and / or flow patterns can be changed. Further, some events can be executed simultaneously in parallel processes, if possible, and can be executed sequentially.

Claims

1. An introducer having a proximal end portion and a distal end portion and being connectable to a peripheral intravenous catheter, A catheter having a proximal end portion and a distal end portion and defining a lumen, A second catheter having a proximal end portion and a distal end portion and defining a lumen, wherein the proximal end portion of the catheter is disposed within the second catheter, The proximal end portion of the second catheter extends from the proximal end portion of the introducer such that at least a portion of the proximal end portion of the second catheter is disposed outside the introducer, The catheter has a first position where the distal end portion of the catheter is disposed within the introducer and a second position where the distal end portion of the catheter is disposed outside the introducer, When the catheter is in the first position and the second position, the distal end portion of the second catheter is disposed within the introducer, The proximal end portion of the second catheter disposed outside the introducer has a first length when the catheter is in the first position and a second length when the catheter is in the second position, A delivery device, wherein the second length is shorter than the first length.

2. The delivery device according to claim 1, wherein the second catheter has a diameter larger than that of the catheter.

3. The delivery device according to claim 1, wherein the proximal end portion of the second catheter includes a coupler configured to fluidly couple the second catheter to a fluid reservoir or a vacuum container holder.

4. The delivery device further comprising an actuator for receiving the proximal end portion of the catheter and the distal end portion of the second catheter, The delivery device according to claim 1, wherein the actuator is movable within the introducer to move the catheter from the first position to the second position.

5. The delivery device according to claim 4, wherein the actuator includes an engagement member disposed outside the introducer.

6. The delivery device according to claim 1, wherein the distal end portion of the introducer includes a coupler.

7. The delivery device according to claim 4, wherein the actuator is movable relative to the introducer in a distal direction and a proximal direction.

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