Device and method for fluid delivery through placed peripheral venous catheter

Abstract

The invention relates to a device and method for fluid delivery through a placed peripheral venous catheter. An apparatus includes a catheter, an introducer, and an actuator. The distal end portion of the introducer is configured to be coupled to an indwelling peripheral vein line. An actuator is movably coupled to the introducer and configured to move the catheter between a first position in which the catheter is disposed within the introducer and a second position in which the distal 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: a longitudinal axis defined by a second portion of the actuator is not parallel to a longitudinal axis defined by the introducer; the second portion of the actuator exerts a force on the proximal end portion of the catheter to increase internal stress within a portion of the catheter.

Description

[0001] This application is a divisional application of invention patent application 202210117053.6, filed on February 8, 2022, entitled “Device and method for fluid delivery through a placed peripheral intravenous catheter”; and 202210117053.6 is a divisional application of invention patent application 201880019256.3, filed on March 21, 2018, entitled “Device and method for fluid delivery through a placed peripheral intravenous catheter”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to and the benefit of U.S. Provisional Patent Application Serial 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 which is incorporated herein by reference in its entirety. Technical Field

[0004] Embodiments described herein generally relate to fluid delivery medical devices. More specifically, embodiments described herein relate to devices and methods for delivering fluids to or from a patient through a placed peripheral intravenous catheter. Background Art

[0005] The typical hospitalized patient encounters a needle every time a physician orders a lab test. The standard procedure for blood extraction involves "sticking" a vein in the patient's arm or hand with a metal needle (a "butterfly needle"). Drawing blood is a manual, labor-intensive process that requires hours of direct skilled labor during a typical hospital stay for the average patient. Not only are such needle sticks painful, but they are also a major cause of patient dissatisfaction, yet nurses or professional phlebotomists (phlebotomists) often have difficulty finding a vein in approximately 10-15% of patients, resulting in multiple painful "stick" attempts. This results in significantly higher material and labor costs (needles and tubes must be disposed of after each attempt) and increased patient pain and bruising.

[0006] The current process of drawing blood is inefficient, taking an average of 7-10 minutes, with 10% of patients taking more than 21 minutes. These 10% of patients are referred to as difficult-to-access intravenous patients, or more commonly "hard-to-access" patients. If a superficial vein is not readily apparent, blood can be forced into the vein by massaging the arm from wrist to elbow, tapping the site with the index and middle fingers, applying a warm, wet washcloth to the site for 5 minutes, or by lowering the limb over the bedside to allow the vein to fill. Each of these methods is time consuming and therefore costly.

[0007] Peripheral IV catheters (PIVs) are inserted into most patients during hospitalization for the administration of fluids and medications. However, they are not designed for drawing blood. When a PIV is inserted for more than one day, aspiration failure rates reach 20-50%. Blood drawn from a PIV is often hemolyzed, defined as the rupture of red blood cells and the release of their contents into the surrounding fluid, resulting in discarded samples and the need for repeat blood draws.

[0008] Several barriers may contribute to the disadvantages of extracting blood through PIV. First, most catheters are formed of soft bio-reactive polymers, which can cause the catheter to narrow or collapse when negative pressure is applied to aspirate. Another barrier is that longer dwell times can increase the amount of debris (e.g., fibrin / platelet clots) that accumulates at the catheter tip and within the catheter and / or PIV lumen. Similarly, such debris may at least partially block the lumen of the vein in which the PIV is placed. In some cases, such debris (e.g., fibrin / platelet clots) around the PIV can lead to reduced blood flow within the portion of the vein around (e.g., upstream and downstream) the inserted PIV, which in turn leads to inappropriate and / or inefficient aspiration. Another barrier is attributed to the "suction cup" effect, in which the negative pressure generated by aspiration through the catheter and the possible tortuous path of the vein cause the catheter tip to adhere to the vein wall. As negative pressure increases, the vein can rupture, resulting in "blowing the vein," a concern for phlebotomists when aspirating through the PIV.

[0009] Therefore, there is a need for an improved system and method for phlebotomy via a peripheral intravenous catheter. Summary of the invention

[0010] This article describes a device and method for delivering fluid to or from a patient through a placed peripheral intravenous catheter. In some embodiments, a device includes a catheter, an introducer, and an actuator. The catheter has a proximal portion and a distal portion and defines an inner cavity passing therethrough. The introducer has a proximal portion and a distal portion and defines an inner space that is configured to movably accommodate the catheter. The distal portion of the introducer has a locking member that is configured to couple the introducer to an indwelling peripheral intravenous line. The actuator is movably coupled to the introducer and has a first portion disposed outside the introducer and a second portion disposed in the inner space of the introducer and coupled to the proximal portion of the catheter. The actuator is configured to move relative to the introducer so that the catheter moves between a first position and a second position, in which the catheter is disposed in the introducer, and in which the distal portion of the catheter is disposed to exceed the distal portion of the introducer, so that when the introducer is coupled to the peripheral intravenous line, at least the first portion of the catheter is disposed in the peripheral intravenous line. The first portion of the actuator contacts the outer surface of the guide such that (1) a longitudinal axis defined by the second portion of the actuator is not parallel to the longitudinal axis defined by the guide, and (2) the second portion of the actuator applies a force on the proximal portion of the catheter to increase internal stress within at least the second portion of the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 and 2 Schematic diagrams of a fluid delivery device in a first configuration and a second configuration, respectively, according to one embodiment.

[0012] Figure 3 is a perspective view of a fluid delivery device in a first configuration according to one embodiment.

[0013] Figure 4 yes Figure 3 Top view of the fluid delivery device shown in .

[0014] Figure 5 yes Figure 3 An exploded view of the fluid delivery device shown in .

[0015] Figure 6 is included in Figure 3 A perspective view of a first member of an introducer in a fluid delivery device.

[0016] Figure 7 is included in Figure 3 A perspective view of a second member of an introducer in a fluid delivery device.

[0017] Figure 8 yes Figure 7 A side view of the second member shown in FIG.

[0018] Fig. 9 is Figure 8 An enlarged view of a portion of the second member identified by area A1 in FIG.

[0019] Fig.10 It is through connection Figure 6 The first member shown in Figure 7 0026] Figure 2 is a rear perspective view of an introducer formed by the second member shown in FIG.

[0020] Fig.11 yes Fig.10 A front perspective view of the introducer shown in FIG.

[0021] Fig.12 is along Fig.11 A cross-sectional view of the introducer taken along line 12-12 in FIG.

[0022] Fig.13 and 14 They are included in Figure 3 Rear perspective view and top view of a locking member in a fluid delivery device.

[0023] Fig.15 is along Fig.14 A cross-sectional view of the locking member taken along line 15-15 in FIG.

[0024] Fig.16 is included in Figure 3 An exploded perspective view of a catheter, an auxiliary catheter and an actuator in a fluid delivery device.

[0025] Figure 17-19 They are Fig.16 Perspective, side and front views of the actuator shown in .

[0026] Fig. 20 is along Figure 4 A cross-sectional view of the fluid delivery device taken along line 20-20 in FIG.

[0027] Fig.21 Is in the first configuration Figure 3 A side view of a fluid delivery device.

[0028] Fig. 22 is along Figure 3 2 is a cross-sectional view of the fluid delivery device in a first configuration taken along line 22-22 in FIG.

[0029] Fig.23 is Fig. 22 An enlarged cross-sectional view of a portion of the fluid delivery device identified by area A2.

[0030] Fig.24 is Fig. 22 An enlarged cross-sectional view of a portion of the fluid delivery device identified by area A3.

[0031] Fig.25 yes Figure 3 A side view of a fluid delivery device as the fluid delivery device is transitioning from a first configuration to a second configuration.

[0032] Fig.26 is Fig.24 An enlarged view of a portion of the fluid delivery device identified by area A4.

[0033] Fig. 27 It is in the second configuration Figure 3 A side view of a fluid delivery device.

[0034] Fig.28 It is along Figure 3 2 is a cross-sectional view of the fluid delivery device in the second configuration taken along line 22-22 in FIG.

[0035] Fig.29 is Fig.28 An enlarged cross-sectional view of a portion of the fluid delivery device identified by area A5.

[0036] Fig.30 is a flow chart illustrating a method of using a fluid delivery device according to one embodiment.

[0037] Fig.31 is a cross-sectional side view of a fluid delivery device according to one embodiment.

[0038] Fig.32 is Fig.31 An enlarged cross-sectional side view of a portion of a fluid delivery device shown by area A6 in FIG.

[0039] Fig.33 It is in the second configuration Fig.31 A cross-sectional side view of a fluid delivery device.

[0040] Fig.34 It is in the second configuration Fig.31 A cross-sectional front view of a fluid delivery device.

[0041] Fig.35 is a side view of a fluid delivery device according to one embodiment.

[0042] Fig.36 is set at a predetermined angle relative to the target surface Fig.35 A side view of a fluid delivery device.

[0043] Fig.37 and 38is a side view of a fluid delivery device and a support member according to various embodiments.

[0044] Fig.39 is a front view of a fluid delivery device and a support member according to one embodiment.

[0045] Fig.40 yes Fig.39 A perspective view of the support structure.

[0046] Fig.41 is a front view of a fluid delivery device and a support member according to one embodiment.

[0047] Fig.42 is a cross-sectional side view of a fluid delivery device and an internal support member according to one embodiment.

[0048] Fig.43 yes Fig.42 A perspective view of the internal support member and actuator of the fluid delivery device shown in FIG.

[0049] Fig.44 and 45 is a cross-sectional side view of a fluid delivery device and an internal support member according to various embodiments.

[0050] Fig.46 is a flow chart illustrating a method of using a fluid delivery device according to one embodiment. DETAILED DESCRIPTION

[0051] In some embodiments, a device includes a catheter, an introducer and an actuator. The catheter has a proximal portion and a distal portion and defines an inner cavity passing therethrough. The introducer has a proximal portion and a distal portion and defines an inner space that is configured to movably accommodate the catheter. The distal portion of the introducer has a locking member that is 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 in the inner space of the introducer and coupled to the proximal portion of the catheter. The actuator is configured to move relative to the introducer so that the catheter moves between a first position and a second position, in which the catheter is disposed in the introducer, and in which the distal portion of the catheter is disposed to exceed the distal portion of the introducer, so that when the introducer is coupled to the peripheral venous line, at least the first portion of the catheter is disposed in the peripheral venous line. The first portion of the actuator contacts the outer surface of the guide such that (1) a longitudinal axis defined by the second portion of the actuator is not parallel to the longitudinal axis defined by the guide, and (2) the second portion of the actuator applies a force on the proximal portion of the catheter that is capable of increasing internal stress within at least the second portion of the catheter.

[0052] In some embodiments, a device includes a catheter, an introducer, and an actuator. The catheter has a proximal portion and a distal portion, and defines an inner cavity passing therethrough. The introducer has a proximal portion and a distal portion, and defines an inner space that is configured to movably accommodate the catheter. The distal portion of the introducer has a locking member that is configured to couple the introducer to an indwelling peripheral intravenous line. The locking member defines an inner cavity that is configured to movably accommodate the catheter. The actuator is coupled to the proximal portion of the catheter and is configured to move relative to the introducer in response to a first force applied to the actuator so that the catheter moves between a first position and a second position, in which the distal portion of the catheter is disposed in the inner cavity of the locking member, and in which the catheter extends through the locking member and the peripheral intravenous line when the locking member is coupled to the peripheral intravenous line, so that the distal portion of the catheter is distal to the peripheral intravenous line. The actuator is configured to exert a second force different from the first force on the proximal portion of the catheter when the actuator moves the catheter from the first position to the second position. When the actuator moves the catheter from the first position to the second position, the second force causes the catheter portion disposed between the actuator and the locking member to deflect.

[0053] In some embodiments, a method of using a fluid delivery device includes coupling a locking member of the fluid delivery device to an indwelling peripheral intravenous line. The fluid delivery device includes: an introducer having a distal portion coupled to the locking member; a catheter movably disposed in an interior space defined by the introducer; and an actuator coupled to a proximal portion of the catheter and configured to move relative to the introducer. A first force is applied to the actuator to move the actuator relative to the introducer to advance the catheter from a first position toward a second position, in which the distal portion of the catheter is disposed within an inner cavity defined by the locking member. When the actuator advances the catheter from the first position toward the second position, the actuator applies a second force different from the first force to the proximal portion of the catheter. When the catheter is advanced from the first position to the second position, a portion of the catheter disposed between the actuator and the locking member deflects a first amount in response to the second force. The portion of the catheter deflects a second amount greater than the first amount in response to (1) the second force and (2) the distal portion of the catheter striking an obstacle when the catheter is advanced from the first position to the second position.

[0054] In some embodiments, a device includes a catheter, an introducer and an actuator. The catheter has a proximal portion and a distal portion. The introducer has a proximal portion and a distal portion and is configured to be coupled to a peripheral venous line. The introducer defines an internal space that is configured to movably accommodate the catheter. The actuator includes a first portion and a second portion, the first portion being in contact with the outer surface of the introducer, and the second portion being disposed in the internal space and coupled to the proximal portion of the catheter. The actuator is configured to move relative to the introducer so that the catheter moves between a first position and a second position, in which the catheter is disposed in the introducer, and in which the distal portion of the catheter is disposed to exceed the distal portion of the introducer, so that when the introducer is coupled to the peripheral venous line, at least a portion of the catheter is disposed in the peripheral venous line. The contact between the outer surface and the first portion of the actuator causes the catheter to be biased when in the first position.

[0055] As used herein, the terms "catheter" and "cannula" are used interchangeably to describe an element configured to define a passage for moving a bodily fluid from a first location to a second location (e.g., a fluid passage for moving bodily fluid out of the body). Although a cannula may be configured to receive a trocar, guidewire, or introducer to deliver the cannula into a space within a patient's body, the cannula referred to herein need not include or receive a trocar, guidewire, or introducer.

[0056] As used in this specification, the terms "Y-adapter" and "T-adapter" are used to refer to a dual port IV extension. In this manner, the terms "Y-adapter" and "T-adapter" generally describe the overall shape of a dual port IV extension. For example, as used herein, a Y-adapter is substantially "Y" shaped, including a single port at a first end and two ports angled at a second end. Additionally, the terms "Y-adapter" and "T-adapter" are provided by way of example only and not limitation. For example, in some embodiments, a device may include a single port IV extension (e.g., a single port adapter) or a multi-port IV extension (e.g., an adapter having more than two ports).

[0057] As used in this specification, the words "proximal" and "distal" refer to directions closer to and farther from a user who places the device in contact with a patient, respectively. Thus, for example, the end of the device that first contacts the patient's body would be the distal end, and the opposite end of the device (e.g., the end of the device that is manipulated by the user) would be the proximal end.

[0058] As used herein, the term "stiffness" relates to the resistance of an object to deflection, deformation, and / or displacement caused by an applied force. Stiffness can be characterized based on the magnitude of the force applied to the object and the distance a first portion of the object is deflected, deformed, and / or displaced relative to a second portion of the object. When characterizing the stiffness of an object, the deflection 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, in some objects, the point of deflection is different from the point at which the force is applied.

[0059] Stiffness is an intensive property of an object being described and therefore depends on the materials from which the object is formed as well as certain physical characteristics of the object (e.g., shape and boundary conditions). For example, the stiffness of an object can be increased or decreased by selectively including materials having a desired elastic modulus, bending modulus, and / or hardness in the object. The elastic modulus is an intensive property (i.e., an intrinsic property) of the constituent material and describes the tendency of an object to deform elastically (i.e., non-permanently) in response to an applied force. In the presence of the same stress, a material with a high elastic modulus will not deflect as much as a material with a low elastic modulus. Thus, for example, the stiffness of an object can be increased by introducing a material with a high elastic modulus into an object and / or configuring the object with it.

[0060] Similarly, the hardness of a material is a strength property of the material it is made of and describes a measure of the material's resistance to various permanent deformations when a force is applied. When discussing hardness and the subsequent impact on catheter stiffness, the Shore durometer is often used. There are several scales of durometer, two of which are commonly used to describe plastics, polymers, elastomers, and / or rubbers, namely Type A and Type D, where Type A is generally used for softer materials and Type D is generally used for harder materials. The Shore durometer of a material is represented by a number between 0 and 100, with the higher number indicating a harder material, followed by the type of scale. For example, a first material may be measured as having a Shore durometer of 40 Shore A and a second material may be measured as having a Shore durometer of 20 Shore D. Therefore, according to the Shore durometer, the second material is harder and therefore stiffer than the first material.

[0061] As used herein, the words "clutch (noun)" and / or "clutch (verb)" refer to the transition of a catheter between a first configuration (e.g., "unclutched" configuration) and a second configuration (e.g., "clutched" configuration) in a predetermined and / or predictable manner. Specifically, when the "unclutched" configuration is changed to the "clutched" configuration, the catheter can be bent, flexed, bent, deformed, deflected, moved, compressed and / or reconfigured. In some cases, the catheter can be "clutched" and / or can be "clutched" in response to the distal end of the catheter hitting an obstacle, kink, bend, valve, etc., which can constrain, limit and / or substantially prevent it from moving further. In some cases, the clutch 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 combination of deflection and / or deformation forms that are out of the original or "unclutched" configuration. In some cases, the amount and / or manner in which the catheter deforms and / or deflects ("clutches") when transitioning to a clutched configuration can be adjusted by increasing or decreasing the stiffness, hardness, and / or strength of the material forming the catheter, increasing or decreasing the inner diameter and / or outer diameter of the catheter, increasing or decreasing the wall thickness of the catheter, increasing or decreasing the length of the substantially unsupported portion of the catheter, increasing or decreasing the range of movement and / or degrees of freedom of the catheter, increasing or decreasing the amount of force transmitted to the catheter, and / or any other suitable adjustment factor.

[0062] Figure 1 and 2 Schematic diagrams of a fluid delivery device 100 for performing bloodletting through a peripheral intravenous line or catheter in a first configuration and a second configuration, respectively, according to one embodiment. The fluid delivery device 100 (also referred to herein as a "delivery device") can have any suitable shape, size, and / or configuration. As further described in detail herein, the delivery device 100 is configured to be coupled to and / or engage an indwelling peripheral intravenous catheter (PIV) 105 to output fluid from a certain part of the patient's body (e.g., to aspirate blood) and / or to deliver fluid to a certain part of the patient's body (e.g., to infuse a drug or substance).

[0063] The delivery device 100 includes at least an introducer 110, a catheter 160 (or cannula), and an actuator 170. The introducer 110 can have 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 increase the ergonomics of the delivery device 100, which in some cases can allow a user to manipulate the delivery device 100 with one hand (i.e., one-handed use).

[0064] The introducer 110 has a proximal portion 111 and a distal portion 112 and defines an interior volume 113. Figure 1 and 2 113, but the proximal portion 111 of the introducer 110 may include an opening or port configured to movably accommodate a portion of the catheter 160. In this way, a first portion of the catheter 160 can be disposed within the interior volume 113, and a second portion of the catheter 160 can be disposed outside the interior volume 113. The opening or port can have any suitable configuration. For example, in some embodiments, the opening and / or port can include a seal or the like configured to form a substantially liquid-tight seal with the outer surface of the portion of the catheter 160 in which it is disposed. In other embodiments, the arrangement of the opening and / or port can allow a user to place the catheter 160 in selective contact with the surface of the proximal portion 111 defining the opening and / or port, which in turn can clamp and / or clamp the catheter 160 to selectively block the lumen of the catheter 160, as described in further detail herein with reference to specific embodiments.

[0065] The distal portion 112 of the introducer 110 includes and / or is coupled to a locking member configured to physically and fluidically couple the introducer 110 to the PIV 105 (see, e.g., Figure 2 For example, in some embodiments, the distal portion 112 may include a connector or the like, such as a Luer Lok TM , which is configured to be physically and fluidly coupled to an associated connector of the locking member. In some embodiments, the locking member 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 arrangement of the locking member is such that the locking member forms three points of contact with the PIV 105. In some embodiments, when a portion of the locking member (e.g., a proboscis, etc.) is inserted into a portion of the PIV 105, such an arrangement can provide structural rigidity and / or support to the PIV 105, as described in further detail herein.

[0066] In some embodiments, the distal portion 112 of the introducer 110 may include and / or be coupled to a support member or the like that is capable of placing 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 locking member may be such that a predetermined portion of the locking member is placed in contact with the target surface, thereby placing 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 and / or the like may be coupled to the distal portion 112 of the introducer 110 and configured to place the introducer 110 and / or the device 100 at a predetermined and / or desired angle relative to the target surface. In some cases, the target surface may be a skin surface of the body through which the PIV 105 is inserted (e.g., the outer surface of the patient's arm, etc.). In some embodiments, the predetermined angle may be, for example, between about 0° and about 30°, between about 4° and about 15°, between about 8° and about 10°, or any other suitable angle.

[0067] In some embodiments, the distal portion 112 of the introducer 110 (and / or the lock) can include a seal or the like that can be transported from a sealed configuration to a substantially open configuration to place at least a portion of the interior 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 allow, for example, the catheter 160 to be advanced therethrough in a distal direction while limiting and / or substantially preventing fluid flow outside the catheter 160 in a proximal direction through the seal.

[0068] As described above, the introducer 110 defines an interior volume 113 that extends between the proximal portion 111 and the distal portion 112. The interior volume 113 has and / or defines a first portion 114 and a second portion 115, the first portion 114 being configured to accommodate the first portion 171 of the actuator 170, and the second portion 115 being configured to accommodate the catheter 160 and the second portion 175 of the actuator 172, as shown. Figure 1 and 2 More specifically, the inner surface of the introducer 110 defining the inner volume 113 may have, for example, a tortuous cross-sectional shape ( Figure 1 and Figure 2113 ) such that the axis defined by the first portion 114 of the interior volume 113 is parallel to and offset from the axis defined by the second portion 115 of the interior volume 113. In this way, the first portion 114 of the interior volume 113 can be spaced apart from the second portion 115 of the interior volume 113 without being fluidly isolated therefrom. In some embodiments, the first portion 114 of the interior volume 113 can extend through the wall of the introducer 110. In other words, the introducer 110 can define a slot, channel, track, opening, etc. that is fluidly connected to the first portion 114 of the interior volume 113. In contrast, the second portion 115 of the interior volume 113 can be completely defined and / or enclosed (at least in the circumferential direction) by the introducer 110. In addition, in some embodiments, the tortuous cross-sectional shape of the interior volume 113 is such that the second portion 115 cannot be observed (e.g., out of sight) via a slot, etc. that is fluidly connected to the first portion 114 of the interior volume 113, which in turn can limit and / or substantially prevent contamination of the catheter 160 disposed therein.

[0069] Although not in Figure 1 and 2 110, but in some embodiments, the introducer 110 can include and / or can house an internal support member or the like. In such embodiments, the internal support member can be positioned within the interior volume 113 and can be configured to support and / or guide at least a portion of the catheter 160 disposed within the interior 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 in turn can maintain the sterility of the catheter 160 prior to use.

[0070] The catheter 160 of the delivery device 100 includes a proximal portion 161 and a distal portion 162, and defines a lumen 163 extending through the proximal portion 161 and the distal portion 162. The catheter 160 is movably disposed within the 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 be moved between a first position and a second position (e.g., via movement of the actuator 170) to transform the delivery device 100 between the first configuration and the second configuration, respectively. More specifically, when the catheter 160 is in the first position ( Figure 1 ) at least the distal end portion 162 of the catheter 160 is disposed within the second portion 115 of the interior volume 113 ( Figure 1 ), and when the catheter 160 is in the second position, at least a portion of the catheter 160 extends through the PIV 105 to place the distal end of the catheter 160 in a distal position relative to a portion of the PIV 105 ( Figure 2 ). Figure 1 and 2100, but in some embodiments, the delivery device 100 may include an auxiliary catheter or the like that is coupled to the actuator 170 and is in fluid communication with the catheter 160. In such embodiments, the auxiliary catheter may, for example, be disposed in a proximal position relative to the catheter 160 and may be configured to extend through an opening and / or port defined by the proximal portion 111 of the introducer 110. In this manner, the proximal portion of the auxiliary catheter may be coupled to a vacuum (air or liquid) source, a fluid reservoir, a fluid source, a syringe, and / or the like, which in turn places the catheter 160 in fluid communication therewith. Furthermore, in embodiments that include an auxiliary catheter, the catheter 160 may be disposed entirely within the introducer 110 when the catheter 160 is in the first position.

[0071] The catheter 160 can have any suitable shape, size and / or configuration. For example, in some embodiments, at least a portion of the catheter 160 can have an outer diameter substantially similar to or slightly smaller than the inner diameter defined by a portion of the distal portion 112 of the introducer 110 coupled to the locking member (e.g., between 10-Gauge and 30-Gauge). In this way, when the catheter 160 moves between the first position and the second position, the inner surface of a portion of the locking member can guide the catheter 160. In some embodiments, this arrangement can limit and / or can substantially prevent bending, deformation and / or kinking of the portion of the catheter 160 that moves between the first position and the second position. In some embodiments, when the catheter 160 is in the second position, the catheter 160 can have a length sufficient to place the distal surface of the catheter 160 at a desired position relative to the distal surface of the PIV 105. In other words, when the catheter 160 is in the second position, the length of the catheter 160 is sufficient to define a predetermined and / or desired distance between the distal surface of the catheter 160 and the distal surface of the PIV 105. In some cases, placing the distal surface of catheter 160 at a predetermined and / or desired distance from the distal surface of PIV 105 can, for example, place the distal surface of catheter 160 at a desired location within a vein, as described in further detail herein.

[0072] The catheter 160 may be formed of any suitable material or combination of materials, which in turn may result in the catheter 160 having any suitable hardness or strength. In some embodiments, at least a portion of the catheter 160 may be formed of a braided material, etc., which may change, modify and / or alter the flexibility of the catheter 160 in response to bending forces, etc. In some embodiments, the catheter 160 formed of a braided material, etc. may reduce the possibility of kinking and / or deforming in an undesirable manner. In addition, at least a portion of the catheter 160 formed of a braided material may be compressed and / or deformed in response to a compressive force (e.g., an axial force, etc.) applied in the direction of the longitudinal centerline defined by the catheter 160. In this way, the catheter 160 can absorb a portion of the force associated with, for example, hitting an obstacle, etc. As will be further described herein, in some cases, at least a portion of the catheter 160 may be deformed in response to a force associated with hitting such an obstacle, etc.

[0073] The actuator 170 of the delivery device 100 can have any suitable shape, size and / or configuration. As described above, the actuator 170 includes a first portion 171 movably disposed within the first portion 114 of the interior volume 113 and a second portion 175 movably disposed within the second portion 115 of the interior volume 113 and coupled to the catheter 160. Although not described herein, the actuator 170 may be configured to move the first portion 114 of the interior volume 113 to the first portion 171. Figure 1 and 2 113, but the actuator 170 can have a cross-sectional shape (e.g., a tortuous cross-sectional shape) associated with and / or corresponding to the cross-sectional shape of the interior volume 113. Therefore, the axis defined by the first portion 171 of the actuator 170 is parallel to the axis defined by the second portion 175 of the actuator 170 and is offset therefrom.

[0074] The arrangement of the actuator 170 and the introducer 110 is such that the first portion 171 extends through a slot or the like that is in fluid communication with the first portion 114 of the interior volume 113. As such, a first region of the first portion 171 of the actuator 170 is disposed outside of the introducer 110, while a second region of the first portion 171 of the actuator 170 is disposed within the first portion 114 of the interior volume 113. In this manner, a user may engage the first region of the first portion 171 of the actuator 170 and may move the actuator 170 relative to the introducer 110 to move the catheter 160 coupled to the second portion 175 of the actuator 170 between a first position and a second position. Although not described herein, the first region of the first portion 171 of the actuator 170 may be configured to move the catheter 160 coupled to the second portion 175 of the actuator 170 between a first position and a second position. Figure 1 and 21, but in some embodiments, the first portion 171 of the actuator 170 may include a lug, protrusion, and / or surface that contacts the outer surface of the introducer 110. In such embodiments, the outer surface of the introducer 110 may include, for example, a set of ribs, ridges, protrusions, grooves, and / or the like, along which the lug, protrusion, and / or surface of the first portion 171 is advanced as the actuator 170 moves relative to the introducer 110, which in turn produces a tactile output or feedback (acoustic, tactile, and visual) that can provide an indication to the user associated with the position of the distal portion 162 of the catheter 160.

[0075] 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 disposed at an angle relative 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 causes the actuator 170 to be tilted relative to the introducer 110. Thus, in some cases, the longitudinal centerline of the actuator 170 may not be parallel to the longitudinal centerline of the introducer 110. Furthermore, where the actuator 170 is coupled to the proximal portion 161 of the catheter 160, angling and / or tilting the actuator 170 may result in a force (e.g., a preload force, etc.) being applied to the catheter 160 sufficient to bend at least a portion of the catheter 160 (e.g., the catheter 160 is placed in a biased configuration), as described in further detail herein.

[0076] In some embodiments, the delivery device 100 can be disposed in a first configuration prior to use (e.g., delivered, stored, prepared, etc., in a first configuration). In use, a user can manipulate the delivery device 100 to couple the introducer 110 to the indwelling PIV 105 (e.g., via a locking member coupled to and / or assembled with the introducer 110). With the delivery device 100 coupled to the PIV 105, the user can engage the first portion 171 of the actuator 170 to move the actuator 170 relative to the introducer 110, which in turn moves the catheter 160 from a first position (e.g., disposed within the introducer 110) toward a second position. In some embodiments, the arrangement of the actuator 170 and the introducer 110 is such that advancement of the actuator 170 relative to the introducer 110 produces a tactile output and / or feedback that is configured to provide the user with an indicator associated with the position of the catheter 160 relative to the introducer 110 and / or the distal portion 162 of the PIV 105. For example, based on tactile feedback or any other suitable indicator, the user can place catheter 160 in the second position such that the distal surface of catheter 160 extends beyond the distal surface of PIV 105 a desired distance, as described above.

[0077] When the catheter 160 is in the second position (e.g., when the delivery device 100 is in Figure 2 In the case of the second configuration shown in FIG. 1 ), a user can establish fluid communication between a fluid reservoir, a fluid source, a syringe, and / or the like and catheter 160. For example, as described above, in some embodiments, a user can connect an auxiliary catheter (not shown) to a fluid reservoir, a fluid source, a syringe, and the like. Although described as establishing fluid communication between catheter 160 and a fluid reservoir or a fluid source after catheter 160 is placed in the second position, in other embodiments, a user can establish fluid communication between catheter 160 and a fluid reservoir or a fluid source before actuator 170 moves relative to introducer 110. Then, with catheter 160 in fluid communication with a fluid reservoir and / or a fluid source, delivery device 100 can output fluid from a patient via catheter 160 extending through PIV 105 and beyond PIV 105 or deliver fluid to a patient via catheter 160.

[0078] In some cases, when the user advances the catheter 160 (via the actuator 170) from the first position to the second position, the catheter 160 may hit an obstacle, etc. In some such instances, the catheter 160 may be configured to bend, deform, and / or reconfigure in response to the force applied by the user. That is, the force (e.g., activation or actuation force) applied by the user to the actuator 170 that is also sufficient to move the catheter 160 toward the second position causes at least a portion of the catheter 160 to deflect, deform, and / or reconfigure when the catheter 160 hits an obstacle, etc. In addition, where at least a portion of the catheter 160 is preloaded (e.g., bent, bent, offset, deflected, and / or deformed in response to the angle of the actuator 170, as described above), the deflection, deformation, and / or reconfiguration of a portion of the catheter 160 may be predetermined, expected, and the like.

[0079] As described above, the deflection, deformation, and / or reconfiguration of the portion of the catheter 160 in response to striking an obstacle can result in "clutching" (e.g., bending, curving, flexing, deflecting, deforming, compressing, etc.) of the catheter 160 and / or device 100, which reduces undesirable forces that would otherwise be applied, for example, to the wall of a vein, etc. In some embodiments, clutching of the catheter 160 can produce and / or can result in an audible, visual, and / or tactile indication that the catheter 160 has struck an obstacle, as described in further detail herein with respect to specific embodiments. In some cases, once the catheter 160 and / or device 100 is "clutched," the user can pause while the preloaded and / or clutched catheter 160 and / or device 100 applies a constant but linearly decreasing force to overcome an obstacle, etc. In some cases, the clutched catheter 160 and / or device 100 can automatically clutch (e.g., self-relieving at least a portion of the stress along the length of the catheter 160), thereby producing a safe and / or controlled process for overcoming an obstacle.

[0080] Figure 3-29 FIG. 2 shows a fluid delivery device 200 according to another embodiment. The fluid delivery device 200 (also referred to herein as a "delivery device") can have any suitable shape, size, or configuration and can be coupled to a PIV (eg, via a locking member and / or an adapter). Figure 3-29 ). As described in further detail herein, a user can transform the delivery 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 delivery device 200 is coupled thereto) such that at least one end of the catheter is disposed in a distal position relative to the PIV. In addition, in the case where each of the peripheral venous lines has a shape, size, and / or configuration that can vary based on, for example, the manufacturer of the PIV and / or its intended use, the delivery device 200 can be arranged to allow the delivery device 200 to be coupled to a PIV having any suitable configuration, and subsequently advance at least a portion of the catheter through the PIV without substantially kinking, snagging, breaking, and / or reconfiguring the catheter in an undesirable manner. In addition, the delivery device 200 can be manipulated by a user to place the distal surface of the catheter a predetermined and / or desired distance outside the distal surface of the PIV to be disposed within a portion of a vein that accommodates substantially unimpeded blood flow.

[0081] like Figure 3-5 As shown, the delivery device 200 includes an introducer 210, a locking member 240, a catheter 260, an auxiliary catheter 265, and an actuator 270. The introducer 210 can have any suitable shape, size, or configuration. For example, in some embodiments, the introducer 210 can be an elongated 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 increase the ergonomic performance of the delivery device 200, which in some cases can allow a user to manipulate the delivery device 200 with one hand (i.e., one-handed use).

[0082] like Figure 5-12 As shown, the guide 210 of the delivery device 200 includes a first member 220 and a second member 225, and the first member 220 and the second member 225 are connected to form the guide 210 together. Figure 6 As shown, the first member 220 includes a proximal portion 221, a distal portion 222, and an inner surface 224. The inner surface 224 has a first portion 224 and a second portion 225. The proximal portion 221 of the first member 220, more specifically, the proximal wall of the first member 220 defines a recess 226, which is configured to selectively accommodate a portion of the auxiliary conduit 265, as described in further detail herein.

[0083] like Figure 7-9As shown, the second member 230 has a proximal portion 231, a distal portion 232, an inner surface 233, and an outer surface 235. As described above with reference to the first member 220, the proximal portion 231 of the second member 230, more specifically, the proximal wall of the second member 230 defines a recess 234, which is configured to selectively accommodate a portion of the auxiliary conduit 265. The outer surface 235 of the second member 230 includes a set of ribs 236 distributed along the length of the second member 230. More specifically, each rib 236 extends along the width of the second member 230 and is continuously distributed along the length of the second member 230. In this way, the outer surface 235 defines alternating local minima and local maxima arranged along the length of the second member 230. As described in further detail herein, when a user moves actuator 270 relative to introducer 210, a portion of actuator 270 is configured to advance along outer surface 235 forming set of ribs 236, which in turn causes actuator 270 (and catheter 260 coupled thereto) to vibrate. In some cases, the vibration can, for example, facilitate advancement of catheter 260 through a portion of delivery device 200, a portion of the PIV, and / or a portion of the vasculature. Additionally, in some cases, the vibration can provide a user with a tactile and / or audible indicator associated with the position of catheter 260 relative to introducer 210 and / or the PIV, as described in further detail herein.

[0084] The ribs 236 formed by the outer surface 235 of the second member 230 can have any suitable shape, size and / or configuration. Figure 8 and 9As shown, the group of ribs 236 includes a first portion 237 having a first size and shape, and a second portion 238 having a second size and shape different from the first size and shape. The first portion 237 of the ribs 236 can have any suitable configuration and / or arrangement. For example, in this embodiment, each rib in the first portion 237 is substantially uniform, having 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 shape of each rib in the first portion 237 can increase from the most proximal rib having the smallest size and shape to the most distal rib having the largest size and shape. In addition, although the ribs of the first portion 237 are shown as being substantially symmetrical, in other embodiments, each rib of the first portion 237 can be asymmetrical. For example, in some embodiments, the proximal surface of each rib can have a first pitch (e.g., an angle), and the distal surface of each rib can have a second pitch greater than the first pitch. In some embodiments, this asymmetric arrangement can cause a portion of the actuator 270 to move along the outer surface 235 with a first set of features when moving in the distal direction, and to move along the outer surface 235 with a second set of features different from the first set of features when moving in the proximal direction. For example, in some embodiments, a portion of the actuator 270 can move more freely along the outer surface 235 in the distal direction than in the proximal direction.

[0085] Similarly, the second portion 238 of the ribs 236 can have any suitable configuration and / or arrangement. For example, in this embodiment, each rib in the second portion 238 is substantially uniform, having substantially the same size and shape as the remaining ribs in the second portion 238. Fig. 9 As shown, the size and shape of each rib in the second portion 238 is larger than the size and shape of each rib of the first portion 237. In some cases, the larger size of the ribs of the second portion 238 can result in a greater amount of vibration (as described above) when the actuator 270 moves along the outer surface 235. In some cases, the larger size of the ribs of the second portion 238 can result in an increase in the force sufficient to move that portion of the actuator 270 along the outer surface 235. Although the ribs of the second portion 238 are shown and described as being substantially uniform and having a larger size than the ribs of the first portion 237, in other embodiments, the ribs of the second portion 238 can have any arrangement and / or configuration described above with reference to the ribs of the first portion 237.

[0086] When the set of ribs 236 transitions from the first portion 237 to the second portion 238 at a given point along the length of the second member 230 (see, e.g. Fig. 9), in other embodiments, the size and shape of each rib in the set of ribs 236 can increase from the most proximal rib of the first portion 237 having the smallest size and shape to the most distal rib of the second portion 238 having the largest size and shape. In other words, in some embodiments, the size and shape of each rib in the set of ribs 236 can increase with each successive rib (e.g., in the distal direction). In other embodiments, the set of ribs 236 can include more than just 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 and 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 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 portion of the rib that are smaller than the middle portion of the rib disposed therebetween. In some embodiments, the arrangement of the set of ribs 236 of the second member 230 can be such that the proximal-most rib and the distal-most rib are larger and / or have a shape capable of at least temporarily maintaining the portion of the actuator 270 in a proximal position relative to the proximal-most rib and a distal position relative to the distal-most rib, respectively.

[0087] Although the set of ribs 236 is shown as being formed by only the outer surface 235 of the second member 230, in other embodiments, the first member 220 may include an outer surface that forms a set of ribs. In such embodiments, the set of ribs of the first member 220 may be and / or may have any configuration and / or arrangement described above with reference to the set of ribs 236 of the second member 230. In some embodiments, the ribs of the first member 220 may be offset from the ribs 236 of the second member 230. For example, in some embodiments, the ribs of the first member 220 may have alternating local minima and local maxima (as described above with reference to the ribs 236) that are distributed along the length of the first member 220, such that the local minima and local maxima of the ribs of the first member 220 are aligned with the local maxima and local minima of the ribs 236 of the second member 230, respectively (e.g., offset along the length of the introducer 210). In other embodiments, the ribs of the first member 220 may be in varying positions relative to the ribs 236 of the second member 230. In this manner, the guide 210 may provide a variable arrangement of ribs that may provide, for example, tactile feedback when the actuator 270 moves relative to the guide 210 .

[0088] Reference Figure 10-12, the first member 220 is configured to be coupled to the second member 230 to jointly form the introducer 210. For example, in some embodiments, the first member 220 and the second member 230 may be coupled to form the introducer 210 via ultrasonic welding, adhesives, mechanical fasteners, one or more tabs, snaps, pins, etc. In some embodiments, coupling the first member 220 to the second member 230 (e.g., during a manufacturing process) to form the introducer 210 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 changes in the shape and / or size of the inner surfaces 223 and 233 during manufacturing (e.g., due to draft angles and / or manufacturing tolerances), which in some cases can reduce the possibility of kinking, bending, and / or deformation of the catheter 260 during use of the delivery device 200. In some embodiments, forming the guide 210 from the first member 220 and the second member 230 may allow at least the inner surface 223 of the first member 220 to form a tortuous shape, which would be a challenge when manufacturing the guide 210 from a single workpiece.

[0089] In other embodiments, the first member 220 can be integrally formed (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, etc., rather than from two workpieces (i.e., the first member 220 and the second member 230). Therefore, when referring to 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 by the first member 220 and the second member 230 together, or formed and / or defined by corresponding portions of the guide 210 when the guide 210 is formed from a single workpiece.

[0090] The first member 220 and the second member 230 together form the proximal portion 211 and the distal portion 212 of the introducer 210, and together define the internal volume 213 of the introducer 210. Fig.10As shown, the proximal portion 211 of the introducer 210 defines an opening 217. Specifically, the opening 217 is 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 portion 211 makes a portion of the opening 217 defined by the notch 226 of the first member 220 have a first size and / or shape, and a portion of the opening 217 defined by the notch 234 of the second member 230 has a second size and / or shape that is smaller than the first size and / or shape. In other words, a portion of the opening 217 is contracted, squeezed, blocked and / or reduced. As described in further detail herein, the opening 217 is configured to accommodate a portion of the auxiliary catheter 265, which can be moved from a larger portion of the opening 217 to a reduced portion of the opening 217 (e.g., a portion formed by the notch 234 of the second member 230) within the opening 217 to block, squeeze and / or clamp the auxiliary catheter 265.

[0091] like Fig.11 As shown, the distal portion 212 of the guide 210 includes and / or forms a coupling 216. In other words, the distal portion 222 of the first member 220 and the distal portion 232 of the second member 230 together form a coupling 216 at the distal portion 212 of the guide 210. The coupling 216 can have any suitable shape, size and / or configuration. For example, in this embodiment, the coupling 216 forms a set of threads, which can be threadedly coupled with the associated threaded portion of the locking member 240, as described in further detail herein. Although not described in detail herein, the coupling 216 can be threadedly coupled with the associated threaded portion of the locking member 240. Fig.11 216, but the distal portion 211 of the introducer 210 may include and / or may be configured to house a seal that can selectively seal and / or fluidically isolate the interior volume 213 of the introducer 210 (at least from the opening portion of the coupler 216). In use, the seal can be transformed from a sealed or closed configuration to an open configuration to allow, for example, a portion of the catheter 260 to pass therethrough. In some embodiments, the seal can contact the outer surface of the catheter 260 to define a seal therebetween, which can limit and / or substantially prevent the backflow of fluid between the outer surface of the cannula and the seal.

[0092] 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 diaphragm, a self-repairing diaphragm, a check valve, a single crack valve, and / or any other suitable seal or valve member. In some embodiments, the seal is configured to define and / or 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 in response to, for example, an increase in pressure within the introducer 210. In some embodiments, the seal can be a positive pressure seal, etc. In other embodiments, the seal can be a fluid seal, such as a saline lock, etc. Although not described herein, the seal can be a fluid seal, such as a saline lock, etc. Figure 5-12 , but in some embodiments, the introducer 210 can include a device, mechanism, assembly, and / or the like that can be manipulated to increase pressure within the introducer 210 (e.g., by air or other suitable fluid or liquid) to transform the seal from a closed configuration to an open configuration. For example, the introducer 210 can include and / or can be coupled to a bulb, a pump, a syringe, a fluid source, a mechanical actuator, an electrical actuator, and / or the like. In other embodiments, the seal can have any other suitable configuration.

[0093] The inner surface 223 of the first member 220 and the inner surface 233 of the second member 230 together define the inner volume 213 of the introducer 210. Fig.12 As shown, the arrangement of the inner surfaces 223 and 233 makes the inner volume 213 have and / or define a tortuous cross-sectional shape. For example, the inner volume 213 can have a substantially S-shaped or at least partially S-shaped cross-sectional shape. More specifically, the inner surface 223 of the first member 220 includes and / or forms a ridge, a lug, a flange, a protrusion and / or a wall, which is configured to separate the first portion 224 of the inner surface 223 from the second portion 225 of the inner surface 223. Therefore, the tortuous cross-sectional shape of the inner volume 213 forms and / or defines the first portion 214 of the inner volume 213 and the second portion 215 of the inner volume 213. In this way, the first portion 214 of the inner volume 213 is spaced apart from the second portion 215 of the inner volume 213 without being isolated from its fluid. In other words, the first portion 214 of the inner volume 213 defines an axis parallel to and offset from the axis defined by the second portion 215 of the inner volume 213.

[0094] like Fig.12As shown, the first portion 214 of the interior volume 213 extends through the wall of the introducer 210. In other words, the introducer 210 defines (e.g., the first member 220 and the second member 230 together define) a slot, channel, track, opening, and / or the like that is in fluid communication with the first portion 214 of the interior volume 213. In contrast, the second portion 215 of the interior volume 213 is completely defined and / or enclosed (at least in the circumferential direction) by the introducer 210. The tortuous cross-sectional shape of the interior volume 213 is such that the second portion 215 cannot be observed (e.g., out of sight) through the slot (in fluid communication with the first portion 214 of the interior volume 213), which in turn can limit and / or substantially prevent contamination of the catheter 260 disposed therein.

[0095] In this embodiment, the second portion 215 of the interior volume 213 is substantially aligned with, for example, a portion of the opening 217 and a portion of the opening defined by the coupler 216. In addition, the second portion 215 of the interior volume 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, the axis defined by the second portion 215 of the interior volume 213 is substantially coaxial with the axis defined by a portion of the lock 240, as described in further detail herein. In this manner, the second portion 215 of the interior volume 213 can movably accommodate, for example, a portion of the actuator 270 and a portion of the catheter 260. Thus, the actuator 270 can be moved relative to the guide 210 to move the catheter 260 between a first position in which the catheter 260 is completely disposed within the second portion 215 of the interior volume 213, and a second position in which at least a portion of the catheter 260 extends outside the second portion 215 of the interior volume 213 to the distal side of the guide 210, as further described in detail herein.

[0096] The locking member 240 of the delivery device 200 can have any suitable shape, size and / or configuration. As described above, the locking member 240 is configured to be physically and fluidically coupled to the introducer 210 and is configured to couple the introducer 210 to the PIV and / or to any suitable intermediate device or adapter of the PIV. The locking member 240 has a coupling 241, a proboscis 242, a first arm 243 and a second arm 250, such as Figure 13-15 In addition, the locking member 240 defines an inner cavity 255 extending through the coupling 241 and the proboscis 242. The coupling 241 is configured to couple the locking member 240 to the coupling 216 of the introducer 210. Specifically, in this embodiment, the coupling 241 includes and / or forms one or more protrusions that are configured to selectively engage threads defined and / or formed by the coupling 216 of the introducer 210, thereby forming a threaded connection.

[0097] The proboscis 242 extends from the connector 246 and is disposed between the first arm 243 and the second arm 250. The proboscis 242 can have any suitable shape, size, and / or configuration. In some embodiments, the configuration of the proboscis 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 the adapter (e.g., an extension, a Y-shaped adapter, a T-shaped adapter, etc.), or the overall size and / or shape of the PIV and the adapter. For example, in some embodiments, the proboscis 242 can have a length sufficient to extend through at least a portion of the PIV (or adapter). In embodiments including an adapter coupled to the PIV, the proboscis 242 can be long enough to extend through the adapter and at least partially extend into or through the PIV. In some embodiments, the proboscis 242 can be long enough to extend through the adapter and the PIV so that at least a portion of the proboscis 242 is distal to the PIV. In addition, the outer diameter of the proboscis 242 can be similar to or slightly smaller than the inner diameter of a portion of the PIV and / or the adapter coupled thereto. For example, in some embodiments, the outer surface of the proboscis 242 can contact the inner surface of the PIV when the proboscis 242 is disposed therein. In this manner, the proboscis 242 can provide structural support for at least a portion of the PIV in which the proboscis 242 is disposed. Similarly, the proboscis 242 can have an inner diameter (the diameter of the surface that at least partially defines the lumen 255) that is similar to or slightly larger than the outer diameter of a portion of the conduit 260, as described in further detail herein.

[0098] The first arm 243 and the second arm 250 of the locking member 240 may have any suitable shape, size and / or configuration. Fig.13 and 14 As shown, the first arm 243 has a first end 244, a second end 245 including a lug 246, and a pivot portion 247 disposed between the first end 244 and the second end 245. The lug 246 disposed at and / or formed by the second end 245 extends from the second end 245 toward, for example, the proboscis 242. In this manner, the lug 246 can selectively engage a portion of the PIV and / or a portion of an adapter coupled to the PIV to couple the locking member 240 thereto, as described in further detail herein.

[0099] The pivot portion 247 of the first arm 243 extends in a lateral direction from the coupler 241, the proboscis 242, and / or the second arm 250. The first end 244 and the second end 245 of the first arm 243 are proximal to the pivot portion 247 and distal to the pivot portion 247, respectively. In this way, the first arm 243 can be used as a lever or the like, which is configured to pivot about an axis defined by the pivot portion 247 in response to an applied force. For example, in some cases, a user can apply a force on the first end 244 (e.g., toward the coupler 241) that is sufficient to cause the first end 244 of the first arm 243 to pivot toward the coupler 241 (e.g., toward the coupler 241). Fig.14 AA in FIG. 1 ), and the second end 245 of the first arm 243 is away from the proboscis 242 (as shown by the arrow AA in FIG. 1 ). Fig.14 ), as further described in detail herein.

[0100] As described above with reference to the first arm 243, the second arm 250 of the locking member 240 has a first end 251, a second end 252 including a lug 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 form and function, and are arranged in a relative position and orientation relative to the coupler 241 and the proboscis 242 (e.g., the locking member 240 is substantially symmetrical about its longitudinal axis). As such, the discussion of the first arm 243 is similarly applicable to the second arm 250, and therefore the second arm 250 will not be described in detail herein.

[0101] As described above, the locking member 240 is configured to be coupled to the PIV and / or to an adapter coupled to the PIV. For example, a user can apply a lateral force on the first end 244 of the first arm 243 and the first end 251 of the second arm 250 to pivot the first arm 243 and the second arm 250 from the first position toward the second position, respectively. Thus, the pivoting of the first arm 243 increases the space defined between the proboscis 242 and the second end 245 of the first arm 243 (and the lug 246). Similarly, the pivoting of the second arm 250 increases the space defined between the proboscis 242 and the second end 252 of the second arm 250 (and the lug 253). In this way, the increased space between the proboscis 242 and the arms 243 and 250 is sufficient to allow a portion of the PIV and / or an adapter coupled to the PIV to be inserted into the space. Once the portion of the PIV and / or adapter is in the desired position relative to the locking member 240, the user can remove the force, and the arms 243 and 250 pivot in turn toward their respective first positions. As a result, second ends 245 and 252 move toward proboscis 242 until lugs 246 and 253, respectively, contact a portion of the PIV and / or adapter. Lugs 246 and 253 are configured to engage a portion of the PIV and / or adapter to temporarily couple locking member 240 to the PIV and / or adapter. In some embodiments, locking member 240 may be configured to establish three points of contact with the PIV and / or adapter (i.e., lugs 246 and 253) and the outer surface of proboscis 242 (as described above). In some embodiments, lugs 246 and 253 may be configured to generate an audible output (e.g., a click), a vibration output (e.g., a tactile bump), and / or the like when in contact with a portion of the PIV and / or adapter, which may indicate to a user that locking member 240 is properly coupled to the PIV and / or adapter.

[0102] like Fig.15 As shown, the proboscis 242 and the coupler 241 together define a lumen 255. The lumen 255 of the locking member 240 defines an axis (not shown) that is aligned and / or substantially coaxial with the axis defined by the second portion 215 of the interior volume 213. Thus, when the delivery device 200 is transitioned between the first configuration and the second configuration, the lumen 255 of the locking member 240 accommodates a portion of the catheter 260. In some embodiments, the size and / or shape of the lumen 255 can be based at least in part on the size and / or shape of the catheter 260. For example, the inner diameter of the lumen 255 can be slightly larger than the outer diameter of at least a portion of the catheter 260. In such embodiments, the locking member 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, which in turn can reduce and / or substantially prevent undesirable bending, kinking, flexion and / or deformation of the catheter 260.

[0103] Although the locking member 240 is shown and described above as including the proboscis 242, in other embodiments, the locking member need not form a proboscis. For example, in some such embodiments, the locking member may include a relatively short hub, etc., which is configured to engage a portion of the PIV and / or an adapter connected to the PIV. In some embodiments, the fluid delivery device may include and / or may be used with a proboscis or guide member (not formed with a locking member or formed by a locking member) that is configured to be arranged, for example, between the PIV and an adapter such as an IV extension. For example, such a proboscis or guide member may have a funnel-shaped inner surface and / or an inner surface shaped similar to the proboscis 242. In this way, the inner surface of such a proboscis and / or guide member can guide a portion of the catheter 260 when the catheter 260 moves between the first position and the second position. In some embodiments, the locking member 240 (including the proboscis 242) can be used in conjunction with such an external or separate proboscis and / or guide member. In some such embodiments, when the locking member 240 is coupled to an adapter (eg, an IV extension), a portion of the proboscis 242 of the locking member 240 can be inserted into the proboscis and / or the guide member.

[0104] As described above, at least a portion of the catheter 260 and at least a portion of the auxiliary catheter 265 are movably disposed within the second portion 215 of the interior volume 213 defined by the introducer 210. Fig.16 As shown, the catheter 260 has a proximal portion 261 and a distal portion 262, and defines a lumen 263 (see, e.g., Fig.24). The proximal portion 261 of the catheter 260 is coupled to a second portion 275 of the actuator 270. In this manner, the actuator 270 can be moved relative to the introducer 210 to move the catheter 260 between a first position and a second position, in which 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 locking member 240), and in which the distal portion of the catheter 260 is at least partially disposed at a distal position of the locking member 240 and / or the PIV (not shown) when the locking member 240 is coupled to the PIV, as described in further detail herein. The distal portion 262 can have 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 portion 262 of the catheter can be substantially similar to any of those described in U.S. Patent 8,366,685, filed on April 26, 2012, entitled “Systems and Methods for Phlebotomy Through a Peripheral IV Catheter” (referred to herein as the “'685 patent”), the disclosure of which is incorporated herein by reference in its entirety.

[0105] The catheter 260 can have any suitable shape, size, and / or configuration. For example, in some embodiments, the outer diameter of at least a portion of the catheter 260 can be substantially similar to or slightly smaller than the inner diameter defined by the lumen 255 of the locking member 240, as described above. In some embodiments, the outer surface of the catheter 260 can be configured to contact the inner surface of the locking member 240, which defines at least a portion of the lumen 255. In this way, when the catheter 260 moves between the first position and the second position, the inner surface of the portion of the locking member 240 that defines the lumen 255 can guide the catheter 260. In some embodiments, this arrangement can limit and / or substantially prevent bending, deformation, and / or kinking of the catheter 260 when the catheter 260 moves between the first position and the second position. In addition, in some embodiments, the catheter 260 can have a length sufficient to place the distal surface of the catheter 260 relative to the distal surface of the PIV in a desired position when the catheter 260 is in the second position. In other words, when the catheter 260 is in the second position, the length of the catheter 260 is sufficient to define a predetermined and / or desired distance between a distal surface of the catheter 260 and a distal surface of the PIV, as described in further detail herein.

[0106] The catheter 260 may be formed of any suitable material or combination of materials, which in turn may result in the catheter 260 having any suitable hardness or strength. For example, in some embodiments, the catheter 260 may be formed of a relatively flexible biocompatible material having a Shore hardness of about 20 Shore A to 50 Shore D; about 20 Shore A to 95 Shore D; about 70 Shore D to 85 Shore D, and / or any other suitable range of Shore hardness. In some embodiments, at least a portion of the catheter 260 may be formed of a braided material, etc., which may change, modify and / or alter the flexibility of the catheter 260 in response to bending forces, etc. In other words, forming at least a portion of the catheter 260 from a braided material may increase the amount of deformation of the catheter 260 (in response to the bending force) before buckling, kinking and / or blocking the lumen 263 of the catheter 260. Similarly, forming at least a portion of the catheter 260 of a braided material may cause compression and / or deformation in response to a compressive force (e.g., an axial force, etc.) applied in the direction of a longitudinal centerline defined by the catheter 260. In this manner, catheter 260 can absorb a portion of the forces associated with, for example, striking an obstacle, etc. In some cases, such an arrangement can reduce buckling and / or kinking of catheter 260, as well as reduce and / or substantially prevent damage to vascular structures that may result from striking of catheter 260. Additionally, in some embodiments, for example, forming at least a portion of catheter 260 from a braided material can increase the amount of vibration transmitted through catheter 260 in response to the portion of actuator 270 being advanced along the set of ribs 236 of introducer 210 (as described above). While catheter 260 is described above as including at least a portion formed from a braided material, in other embodiments, at least a portion of catheter 260 can be formed from and / or can include a support wire, stent, fenestrated catheter, etc., such as those described in the '685 patent, which is incorporated herein by reference.

[0107] The secondary catheter 265 has a proximal portion 266 and a distal portion 267 and defines a lumen 268 (see, e.g., Fig.24). A portion of the auxiliary conduit 265 is disposed within and extends through the opening 217 of the introducer 210 (e.g., collectively defined by the notches 223 and 233 of the first and second members 220 and 230, respectively). As such, the proximal portion 266 is at least partially disposed outside of the introducer 210, and the distal portion 267 is at least partially disposed within the second portion 215 of the interior volume 213 defined by the introducer 210. As described above, the auxiliary conduit 265 can be moved within the opening 217 between a first position and a second position to selectively clamp, squeeze, kink, bend, and / or deform a portion of the auxiliary conduit 265, which in turn blocks, squeezes, kinks, closes, seals, etc., the lumen 268 of the auxiliary conduit 265. For example, the first position can be associated with and / or aligned with a first portion of the opening 217 having a greater circumference and / or diameter than a second portion of the opening 217 associated with and / or aligned with the second position. Thus, a user may manipulate the secondary catheter 265 to occlude the lumen 268 of the secondary catheter 265, thereby limiting, restricting, and / or substantially preventing fluid flow therethrough.

[0108] like Fig.16 As shown, the proximal portion 266 of the auxiliary catheter 265 is coupled to and / or includes a coupler 269. The coupler 269 is configured to physically and fluidically couple the auxiliary catheter 265 to any suitable device, such as a fluid reservoir, a fluid source, a syringe, an evacuated container holder (e.g., having a sheathed needle or configured to be coupled to a sheathed needle), a pump, etc. The distal portion 267 of the auxiliary catheter 265 is at least partially disposed within the second portion 215 of the internal volume 213 defined by the introducer 210 and is coupled to the second portion 275 of the actuator 270. In some embodiments, the auxiliary catheter 265 can have a larger diameter than the catheter 260, such that when the catheter 260 and the auxiliary catheter 265 are coupled to the second portion 275 of the actuator 270, the proximal portion 261 of the catheter 260 is at least partially disposed within the lumen 268 defined by the auxiliary catheter 265. In some embodiments, such an arrangement can, for example, reduce and / or substantially prevent leakage associated with fluid flowing between conduit 260 and auxiliary conduit 265. In some embodiments, such an arrangement can also limit, reduce and / or substantially prevent hemolysis of a volume of blood as the volume of blood flows through conduit 260 and auxiliary conduit 265. In this manner, when coupler 269 is coupled to a fluid reservoir, fluid source, syringe, evacuated container, pump, etc., auxiliary conduit 265 establishes fluid communication between the reservoir, source, pump, etc. and conduit 260.

[0109] The actuator 270 of the delivery device 200 is coupled to the catheter 260 that can move along the length of the introducer 210 to transition the delivery device 200 between its first configuration, in which the catheter 260 is in a first position, and its second configuration, in which the catheter 260 is in a second position. The actuator 270 can have any suitable shape, size, and / or configuration. For example, in some embodiments, the actuator 270 can have a size and shape that is associated with and / or based at least in part on the size and / or shape of the introducer 210.

[0110] like Figure 17-20 As shown, the actuator 270 includes a first portion 271, a second portion 275, and a wall 277 extending therebetween. The first portion 271 of the actuator 270 is at least partially disposed within the first portion 214 of the interior volume 213 defined by the introducer 210, and the second portion 275 of the actuator 270 is disposed within the second portion 215 of the interior volume 213, as described above. The first portion 271 of the actuator 270 includes an engagement member 272. The arrangement of the actuator 270 is such that the engagement member 272 is disposed outside of the introducer 210, while the remainder of the first portion 271 is located within the first portion 214 of the interior volume 213 defined by the introducer 210. In this way, the engagement member 272 can be engaged and / or manipulated by a user (e.g., by a finger or thumb of the user) to move the actuator 270 relative to the introducer 210. In some embodiments, engagement member 272 can include a set of ridges and / or any suitable surface finish that can, for example, enhance the ergonomics of actuator 270 and / or delivery device 200 .

[0111] The engagement member 272 includes a lug 273 disposed at or near a proximal portion of the engagement member 272. The lug 273 may be any suitable lug, track, ridge, protrusion, bump, knob, roller, slider, etc. extending from a surface of the engagement member 272. The lug 273 is configured to selectively engage an outer surface 235 of the second member 230 of the introducer 210. More specifically, the lug 273 contacts the ribs 236 formed by the second member 230, and as the actuator 270 moves along the length of the introducer 210, the lug 273 moves along each successive rib.

[0112] As described above with reference to the set of ribs 236 of the second member 230, the lugs 273 may have any suitable shape, size, and / or configuration. Fig.18As shown, the lug 273 may include a substantially circular surface that can move along the set of ribs 236. In some embodiments, the size and / or shape of the lug 273 is based at least in part on the size and / or shape of the ribs 236, so that when the actuator 270 moves relative to the guide 210, the desired surface area of ​​the lug 273 contacts the ribs 236. In some embodiments, the amount of friction defined between the set of ribs 236 and the lug 273 can be based at least in part on the surface area of ​​the lug 273 that contacts the set of ribs 236. In addition, the amount of friction defined between the set of ribs 236 and the lug 273 can be based at least in part on the position of the lug 273 relative to each rib. For example, in some embodiments, the amount of friction defined between the lug 273 and the rib can increase as the lug 273 moves, for example, closer to a local maximum, and can decrease as the lug 273 moves away from a local maximum. In some embodiments, the lug 273 can have a size and / or shape that allows the lug 273 to move between each adjacent rib (e.g., between adjacent local maxima) with relatively little friction. In other words, the arrangement of the lugs 273 and the set of ribs 236 may allow for a desired amount of "play" between adjacent ribs.

[0113] In the case where the first portion 237 of the set of ribs 236 has a smaller size than the second portion 238 of the set of ribs 236, the first portion or first surface area of ​​the lug 273 can be in contact with the first portion 237 of the set of ribs 236, while the second portion or second surface area of ​​the lug 273 can be in contact with the second portion 238 of the set of ribs 236. In this manner, the lug 273 can move along the first portion 237 with a first set of characteristics, and can move along the second portion 238 with a second set of characteristics that is different from the first set of characteristics. In some embodiments, for example, the force sufficient to move the lug 273 along the second portion 238 of the set of ribs 236 can be greater than the force sufficient to move the lug 273 along the first portion 237 of the set of ribs 236. In some embodiments, the movement of the lug 273 along the second portion 238 of the set of ribs 236 can cause, for example, an amount of vibration of the actuator 270 that is greater than the amount of vibration generated by the movement of the lug 273 along the first portion 237 of the set of ribs 236. Similarly, the shape of the lug 273 can be such that the lug 273 moves in a distal direction along the set of ribs 236 in response to an applied force that is insufficient to move the lug 273 in a proximal direction along the set of ribs 236. Fig.18 As shown, the lug 273 has an asymmetric shape, wherein the proximal surface of the lug 273 has a larger pitch than the pitch of the distal surface thereof.

[0114] Although the engagement member 272 and the lug 273 are specifically shown and described above, in other embodiments, the actuator may include an engagement member and / or lug having any suitable configuration. For example, although the lug 273 is shown as being disposed at or near the proximal portion of the engagement member 272, in other embodiments, the engagement member may include a first lug disposed at or near the proximal portion and a second lug disposed at or near the distal portion, each of which may 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 may increase or decrease, which may result in an increase or decrease in the amount of travel of the actuator 270 relative to the introducer 210 in directions 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 may result in, for example, an increase or decrease in the amount by which the actuator 270 may "tilt" relative to the introducer 210. In other embodiments, the arrangement of the engagement member 272, the lug 273, and / or the set of ribs 236 of the introducer 210 may be modified, altered, adjusted, adjusted, and / or changed so that the actuator 270 moves with a desired set of characteristics relative to the introducer 210. For example, in some embodiments, the arrangement of the actuator 270 and / or the introducer 210 may increase or decrease the amount that the actuator 270 vibrates as it 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., a proximal direction or a distal direction), and the like.

[0115] As shown in the figure, for example, Fig.19 and 20As shown, the second portion 275 has a cross-sectional shape (e.g., a cross-sectional shape that is at least partially based on the cross-sectional shape of the second portion 215 of the internal volume 213 defined by the introducer 210). In this way, when the actuator 270 moves relative to the introducer 210, the inner surface 223 of the first member 220 and the inner surface 233 of the second member 230 can support and / or guide the second portion 275 of the actuator 270. As shown, the second portion 275 defines an opening 276 that is configured to accommodate the proximal portion 261 of the catheter 260 and the distal portion 267 of the auxiliary catheter 265. In some embodiments, when the proximal portion 261 is disposed in the opening 276, the proximal portion 261 of the catheter 260 can form a friction fit with the inner surface of the second portion 275 of the actuator 270. Similarly, the distal portion 267 of the auxiliary catheter 265 can form a friction fit with the inner surface of the second portion 275 of the actuator 270 when the distal portion 267 is disposed in the opening 276. In this way, the catheter 260 and the auxiliary catheter 265 can be maintained in a fixed position relative to the actuator 270, so that they move simultaneously with the actuator 270 as the actuator 270 moves relative to the introducer 210.

[0116] 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. Fig.19 and 20As shown, the wall 277 has a tortuous cross-sectional shape that is at least partially based on the tortuous cross-sectional shape of the interior volume 213 defined by the introducer 210. In this way, the first portion 271 of the actuator 270 can define an axis that is parallel to but offset from the axis defined by the second portion 275 of the actuator 270. In some embodiments, for example, the wall 277 can have a substantially S-shaped or at least partially S-shaped cross-sectional shape. In some embodiments, the wall 277 can form, for example, a dog-leg shape, etc. The tortuous cross-sectional shape of the wall 277 (and thus the actuator 270) is such that the second portion 275 of the actuator 270 cannot be observed (e.g., out of sight) via the first portion 214 of the interior volume 213 defined by the introducer 210. Similarly, when the catheter 260 is in the first position, the catheter 260 cannot be observed through the first portion 214 of the interior volume 213 defined by the introducer 210. That is, the geometry of the actuator 270 and / or the introducer 210 (e.g., the tortuous cross-sectional shape of the interior volume 213, the height and / or width of the introducer 210, etc.) is configured such that when the catheter 260 is in the first position, the catheter 260 is at least partially isolated within the second portion 215 of the interior volume 213. In this manner, the structure of the introducer 210 and / or the actuator 260 can protect and / or isolate the catheter 260 from the volume external to the introducer 210, which in turn can limit and / or substantially prevent contamination of the catheter 260. For example, in some embodiments, the introducer 210 and / or the actuator 270 can function as a “sneeze guard” or the like that is configured to at least partially isolate the catheter 260 at least when the catheter 260 is in the first position.

[0117] Reference now Figure 21-29 The delivery device 200 can be in a first configuration prior to use, and can be changed from the first configuration ( Figure 21-24 ) to the second configuration ( Figure 27-29 ) to position at least a distal portion 262 of the catheter 260 in a distal position relative to the introducer 210 (e.g., within or distal to an indwelling PIV (not shown)). When the catheter 260 is disposed in the first position 260 within the introducer 210, the delivery device 200 is in a first configuration. In some embodiments, when the catheter 260 is in the first position, substantially the entire catheter 260 is disposed within the introducer 210. In such embodiments, the introducer 210 may include a seal or the like (as described above) that can substantially seal the distal portion 212 of the introducer 210 to isolate the catheter 260 within the second portion 215 of the interior volume 213. However, in Fig. 22 and 23In the embodiment shown in , when the catheter 260 is in the first position, the catheter 260 is disposed within the introducer 210 and the locking member 240. Although the seal is described above as being included in the distal portion 212 of the introducer 210, in other embodiments, the locking member 240 may include a seal or the like that can form a substantially fluid-tight seal with the inner surface of the inner cavity 243 defined in the locking member 240. Thus, the seal disposed within the locking member 240 can isolate the catheter 260 within the second portion 215 of the interior volume 213. In other embodiments, the introducer 210 and / or the locking member 240 need not include a seal. For example, in some embodiments, the PIV and / or an adapter (e.g., an extension) coupled to the PIV may include a seal that transitions from a closed configuration to an open configuration when the locking member 240 is coupled thereto. Although not shown, in some embodiments, the catheter 260 may be disposed within a flexible sheath or the like which may maintain the catheter 260 in a substantially sterile environment when the catheter 260 is in the first position (e.g., such embodiments where the introducer 210 and / or locking member 240 do not include a seal).

[0118] When the delivery device 200 is in the first configuration, the actuator 270 is disposed in a proximal position, such as Fig.24 In some embodiments, the lug 273 of the first portion 271 of the actuator 270 can be disposed within a groove or detent or in contact with a proximal rib that is configured to temporarily hold the actuator 270 in a proximal position until a force is applied (e.g., by a user) to move the actuator 270 in a distal direction. Additionally, as described above, a portion of the auxiliary catheter 265 is disposed in the opening 217 defined by the introducer, such that the distal portion 267 is at least partially disposed in the second portion 215 of the interior volume 213 and coupled to the portion 275 of the actuator 270, while the proximal portion 266 of the auxiliary catheter 265 is disposed outside of the introducer 210 (see, e.g., Fig.21 and 22 ).

[0119] With the delivery device 200 in the first configuration, a user can manipulate the delivery device 200 to couple the locking member 240 to the indwelling PIV and / or to an adapter (e.g., an extension, etc.) coupled to the PIV. For example, in some embodiments, a user can apply a force sufficient to pivot the first arm 243 and the second arm 250 of the locking member 240 so that a portion of the PIV and / or adapter can be inserted into a space defined between the arms 243 and 250 and, for example, the proboscis 242. In some embodiments, the proboscis 242 can be inserted into the PIV and / or adapter when the locking member 240 is coupled thereto. For example, in some embodiments, a portion of the proboscis 242 can be inserted into a hub or basket of the PIV and / or adapter. As described above, in some embodiments, the proboscis 242 is long enough to dispose at least a portion of the proboscis 242 within the PIV, which in turn supports and / or provides structural rigidity to the PIV. Once the PIV and / or adapter is positioned in a desired position relative to the locking member 240, the user can remove the force on the arms 243 and 250 of the locking member 240, which in turn moves toward the proboscis 242 until the lugs 246 of the first arm 243 and the lugs 253 of the second arm 250 are placed in contact with the surface of the PIV and / or adapter. In some embodiments, the arrangement of the locking member 240 is such that the lugs 246 and 253 and the proboscis 242 form three points of contact with the PIV and / or adapter, which collectively couple the locking member 240 thereto.

[0120] With the delivery device 200 coupled to the PIV and / or adapter, a user can engage the engagement member 272 of the first portion 271 of the actuator 270 to move the actuator 270 relative to the introducer 210, which in turn moves the catheter 260 from a first position (e.g., disposed within the introducer 210) toward a second position. In this manner, the catheter 260 moves through the second portion 215 of the interior volume 213 and the lumen 255 of the lock 240, and thus, at least the distal portion 262 of the catheter 260 is disposed outside and distal to the lock 240, as shown. Fig.25. In some embodiments, the arrangement of the lumen 255 of the locking member 240 and the catheter 260 can be such that the inner surface of the locking member 240 defining the lumen 255 contacts, supports and / or guides the catheter 260 when the catheter 260 is moved in the distal direction toward the second position. In addition, in some embodiments, moving the catheter 260 from the first position toward the second position can transform a seal (e.g., disposed in the locking member 240) from a closed or sealed configuration to an open configuration. In other embodiments, the user can manipulate the delivery device 200 (e.g., before moving the catheter 260 from the first position) to transform 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 delivery device 200 (e.g., the catheter 260 and / or the locking member 240) beyond a predetermined threshold to transform the seal into an open configuration. In some embodiments, the seal can be a one-way valve (e.g., a positive pressure valve or seal) that can transition from a sealed configuration to an open configuration, for example, when the pressure applied to a proximal portion of the seal exceeds the pressure applied to a distal portion of the seal (e.g., venous pressure applied to the seal).

[0121] As described above, the arrangement of the actuator 270 and the guide 210 is such that advancement of the actuator 270 relative to the guide 210 advances the lug 273 along the outer surface 235, and more specifically, along the set of ribs 236 of the second member 230 of the guide 210. Fig.26 As shown, the lug 273 contacts the set of ribs 236, and the set of ribs 236 can generate vibrations of the actuator 270 when the actuator 270 moves relative to the introducer 210. In some cases, the vibration of the actuator 270 can generate, for example, tactile, haptic and / or auditory outputs, which can provide an indication associated with the position of the distal portion 262 of the catheter 260 relative to the introducer 210, the locking member 240 and / or the PIV. For example, in some embodiments, the lug 273 of the actuator 270 and the set of ribs 236 can jointly generate a "click" sound when the lug 273 moves over each rib. In some embodiments, the introducer 210 can include markings, etc., which can indicate to the user the relative position of the distal portion 262 of the catheter 260. In other embodiments, the number of times the actuator 270 vibrates due to movement relative to the number of ribs can be associated with and / or provide an indication of the relative position of the distal portion 262 of the catheter 260.

[0122] In some cases, the user may stop moving the actuator 270 relative to the introducer 210 based on a tactile, tactile, and / or auditory output indicating the desired placement (e.g., the second position) of the distal portion 262 of the catheter 260 relative to the PIV. In other words, the catheter 260 may be placed in the second position before the actuator 270 is advanced to, for example, the most distal position. As described in further detail herein, the catheter 260 is disposed in the second position when the distal portion 262 of the catheter 260 is placed in the desired position relative to the distal portion of the PIV. In some cases, for example, when the catheter 260 is in the second position, the distal end of the catheter 260 may be substantially flush with the distal end of the PIV. In other cases, the distal end of the catheter 260 may extend beyond the distal end of the PIV by a predetermined distance (e.g., distal to the distal end of the PIV). In other cases, when the catheter 260 is in the second position, the distal end of the catheter 260 may be disposed within the PIV (e.g., near the distal end of the PIV).

[0123] like Figure 27-29 As shown, in some cases, when actuator 270 is in the most distal position, catheter 260 may be in the second position. In this manner, the distal surface of catheter 260 is positioned within the vein at a predetermined distance beyond the distal surface of catheter 260. In some cases, placing the distal surface of catheter 260 at this predetermined and / or desired distance from the distal surface of the PIV can, for example, place the distal surface of catheter 260 in an appropriate position within the vein that is substantially free of debris (e.g., fibrin / blood clots) surrounding the distal portion of the PIV.

[0124] In some cases, an indwelling PIV can substantially occlude at least a portion of the vein in which the PIV is located. Thus, PIVs are generally adapted for transporting fluids rather than aspirating blood. However, the venous system is a capacitive system, and therefore blood flow is rerouted through different veins (e.g., forming a bypass around an occlusion or substantial occlusion). Additionally, alternative venous structures typically reconnect veins in which the PIV is placed at a given distance downstream of the PIV, thereby transporting at least a portion of the blood flow that would flow through the vein in which the PIV is placed. Similarly, veins typically have many branch vessels connected thereto that similarly transport blood flow to the vein in which the PIV is placed.

[0125] Thus, in some cases, a predetermined and / or desired distance between the distal surface of catheter 260 and the distal surface of the PIV may be sufficient to place the distal surface of catheter 260 downstream of one or more branch vessels in fluid communication with the vein in which the PIV is disposed. In other words, the distal surface of catheter 260 may extend beyond the distal surface of catheter 260 such that at least one branch vessel is disposed between the distal surface of catheter 260 and the distal surface of the PIV when catheter 260 is in the second position. Thus, with the lumen 263 of catheter 260 extending through the proximal portion 261 and the distal portion 262 of catheter 260, placing the distal surface of catheter 260 at a predetermined and / or desired distance from the distal surface of the PIV places the lumen 263 of catheter 260 in fluid communication with a portion of the vein that accommodates substantially unimpeded or unrestricted blood flow (e.g., unimpeded by the PIV and / or debris associated with the indwelling of the PIV).

[0126] In some cases, for example, the predetermined and / or desired distance can be between about 0.0 millimeters (e.g., the distal surfaces are flush) and 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 between 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 can move about 95 mm along the introducer 210 (e.g., the delivery device 200 has a stroke of 95 mm) to position the distal surface of the catheter 260 about 40 mm beyond the distal surface of the PIV to which the delivery device 200 is coupled. In other embodiments, for example, the delivery device 200 can have a 47 mm stroke that positions the distal surface of the catheter 260 approximately 20 mm beyond the distal surface of the PIV to which the delivery device 200 is coupled. In other embodiments, the delivery device 200 can have any suitable stroke length to position the distal surface of the catheter 260 at a predetermined and / or desired distance from the distal surface of the PIV.

[0127] Although the predetermined distance and / or expected distance are described above as positive distances, i.e., the distal surface of the catheter 260 is distal to the distal surface of the PIV, in other embodiments, the predetermined and / or expected distance may be associated with the distal surface of the catheter 260 being in a proximal position relative to the distal surface of the PIV (e.g., a negative distance). For example, in some cases, the predetermined and / or expected distance may be between about 0.0 mm (e.g., the distal surface is flush) to about -50 mm, between about -10 mm to about -40 mm, between about -20 mm to about -30 mm, or between any other suitable range or sub-range therebetween. In some cases, the predetermined and / or expected distance may be less than -50 mm (e.g., the distal surface of the catheter 260 is greater than 50 mm proximal to the distal surface of the PIV). In some cases, the catheter 260 may be placed in a second position such that the distal portion 262 of the catheter 260 remains within the PIV, located away from, for example, a kink, etc. For example, in some cases, an indwelling PIV can have one or more kinked portions, such as a portion of the PIV where a peripheral intravenous catheter is coupled to a hub. In such cases, a predetermined and / or desired distance can cause the distal surface of catheter 260 to be distal to the portion of the PIV that forms the kink (e.g., where the peripheral intravenous catheter is coupled to the hub). In some such cases, placing the distal surface of catheter 260 distal to the kinked portion of the PIV but remaining within the PIV can result in a fluid flow path that is sufficiently unrestricted to allow blood to be drawn through catheter 260.

[0128] When the catheter 260 is in the second position (e.g., when the delivery device 200 is in the second configuration, e.g., Fig.25 and 26 or Figure 27-29), a user can establish fluid communication between a fluid reservoir, a fluid source, a syringe, etc. and the catheter 260. For example, as described above, in some embodiments, a user can physically and fluidically connect the connector 269 of the auxiliary catheter 265 to a fluid reservoir, a fluid source, a syringe, etc. Although it is described as establishing fluid communication between the catheter 260 and the fluid reservoir or fluid source after the catheter 260 is placed in the second position, in other embodiments, the user can establish fluid communication between the catheter 260 and the fluid reservoir or fluid source before moving the actuator 270 relative to the introducer 210. With the catheter 260 in fluid communication with the fluid reservoir and / or fluid source, the delivery device 200 can output fluid from the patient or deliver fluid to the patient via the catheter 260 extending through the PIV and beyond the PIV. For example, in some cases, a user can physically and fluidly connect the delivery device 200 to a fluid reservoir, an evacuated container, a syringe, etc., and can then draw a volume of blood from the vein based at least in part on positioning the distal surface of the catheter 260 a predetermined and / or desired distance beyond the distal surface of the PIV.

[0129] In other cases, a user can physically and fluidically couple the delivery device 200 to a fluid source, etc., and a volume of fluid can then be delivered from the fluid source to a portion of a vein at a downstream location of a PIV that accommodates substantially uninhibited and / or unrestricted blood flow. In some cases, for example, positioning the distal surface of the catheter 260 a predetermined and / or desired distance beyond the distal surface of the PIV can reduce potential hazards associated with the infusion of caustic drugs. For example, by positioning the distal surface of the catheter 260 within a portion of a vein that accommodates blood flow that will be inhibited and / or restricted by an indwelling PIV, the caustic drug can be entrained in the blood flow and delivered to a target location. Thus, a volume of the caustic drug is not retained within the debris or otherwise disposed in an appropriate location within a vein that accommodates a small amount of blood flow.

[0130] In some cases, once the desired amount of blood has been collected and / or once the desired volume of the drug has been delivered to the patient, the user can move the actuator 270 in the proximal direction, thereby placing the delivery device 200 in a third (use) configuration. In the third configuration, the catheter 260 can be disposed within the introducer 210 (e.g., at the distal end of the seal, etc.) and isolated therein. For example, in some embodiments, the actuator 270 can be placed in its most proximal position, wherein the catheter 260 is in the first position. In addition, once the actuator 270 and the catheter 260 are in the desired position, the user can, for example, manipulate the auxiliary catheter 265 within the opening 217 so that the surface of the introducer 210 defining the smaller portion of the opening 217 contacts and clamps the auxiliary catheter 265. In this way, the lumen 268 of the auxiliary catheter 265 can be substantially blocked, occluded, blocked, squeezed, etc., to limit and / or substantially prevent the flow of fluid therethrough. In some cases, clamping the auxiliary catheter 265, for example as described, can reduce and / or substantially prevent fluid from leaking through the auxiliary catheter 265. In some cases, the delivery device 200 can then be separated from the fluid reservoir, fluid source, syringe, etc. and safely discarded.

[0131] Fig.30 1 is a flow chart illustrating a method 10 for delivering fluid through a peripheral intravenous line using a fluid delivery device according to one embodiment. The method includes coupling a locking member of a fluid delivery device to an indwelling peripheral intravenous line (PIV) at step 11. The fluid delivery device can be any suitable device configured for fluid delivery through a PIV. For example, in this embodiment, the fluid delivery device can be substantially similar to the one described above with reference to Figure 3-29 The fluid delivery device 200 described above. Thus, the fluid delivery device includes an introducer coupled to a locking member, a catheter movably disposed in 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 together form the introducer. In such embodiments, the second member may have an outer surface that defines a set of ribs, etc., as described above with reference to Figure 7-12 In this way, the actuator can contact the ribs formed by the second member of the introducer. In addition, as described above with reference to the delivery device 200, the introducer can define an internal volume having a tortuous cross-sectional shape, which is configured to at least partially isolate a catheter disposed in the internal volume from a volume outside the introducer.

[0132] In step 12, with the locking member coupled to the PIV (and / or to an adapter coupled to the PIV), the actuator moves relative to the introducer to advance the catheter from a first position toward a second position, wherein the catheter is disposed within at least one of an internal volume defined by the introducer or the locking member, and wherein at least a portion of the catheter is disposed beyond at least a portion of the PIV. In this manner, the catheter can be advanced, for example, in a distal direction. In some embodiments, the locking member may include an inner surface defining an inner cavity configured to accommodate the catheter as the catheter moves toward the second position. In some embodiments, the inner surface of the locking member may contact, support, and / or guide the catheter as the catheter moves in a distal direction toward the second position.

[0133] As described above with reference to conveying device 200 in some embodiments, the arrangement of actuator and introducer makes the actuator advance relative to the introducer so that a part of the actuator advances along the rib formed by the outer surface of the introducer. In certain embodiments, the vibration of the actuator can be produced along the rib, which in turn can produce, for example, tactile, sense of touch and / or auditory output. Therefore, in step 13, when the actuator moves conduit from the first position toward the second position, the indication associated with the position of the distal end portion of conduit is provided to the user. For example, in certain embodiments, the actuator and the group of ribs can produce "click" sound, tactile vibration, etc. together. In certain embodiments, the introducer can include a mark that can indicate the relative position of the distal end portion of the conduit to the user, etc. In other embodiments, the number of times that the actuator vibrates due to moving along the rib can be associated with the relative position of the distal end portion of conduit and / or provide its indication.

[0134] In step 14, based at least in part on the indication, the catheter is placed in a second position such that the distal portion of the catheter is disposed at a predetermined and / or desired distance beyond at least a portion of the PIV (e.g., beyond the distal surface of the PIV). For example, the catheter may be placed in the second position after the actuator is moved at least a portion of the length of the introducer. In some embodiments, the catheter may be disposed in the second position when the actuator is placed in the distal-most position. As described above with reference to the delivery device 200, in some cases, the predetermined and / or desired distance beyond the portion of the PIV may position the distal surface of the catheter within a portion of the vein that is substantially free of debris (e.g., fibrin / blood clots) surrounding the distal portion of the PIV. Similarly, in some cases, positioning the distal portion of the catheter at a predetermined and / or desired distance from, for example, the distal portion of the PIV may place the lumen of the catheter in fluid communication with a portion of the vein that accommodates substantially unobstructed or unrestricted blood flow (e.g., unobstructed by the PIV and / or debris associated with the PIV's indwelling), as described in detail above. In this manner, a user may couple a delivery device to a fluid reservoir and / or a fluid source to respectively remove fluid from and / or deliver fluid to a patient.

[0135] Figure 31-34 FIG. 2 shows a fluid delivery device 300 according to one embodiment. The fluid delivery device 300 can have any suitable shape, size, and / or configuration. In some embodiments, the fluid delivery device 300 (also referred to as a "delivery device") can be the same as the one described above with reference to FIG. Figure 3-30 The delivery device 200 described in detail is similar and / or substantially the same. Therefore, unless otherwise explicitly described, certain parts and / or aspects of the delivery device 300 are not described in further detail herein, and the form and / or function of the delivery device 300 should be considered to be substantially similar to the corresponding parts and / or aspects of the delivery device 200.

[0136] like Fig.31 As shown, the delivery device 300 includes an introducer 310, a catheter 360, and an actuator 370. The introducer 310 includes a proximal portion 311 and a distal portion 312, and defines an internal volume 313. The distal portion 312 of the introducer 310 includes and / or is coupled to a locking member 340, which is configured to couple the introducer 310 to a placed 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 portion of the actuator 370, as described in further detail herein. In this manner, the introducer 310 can be used with reference to, for example, Figure 3-12 The introducer 210 described in detail is similar and / or substantially the same.

[0137] The catheter 360 is coupled to the actuator 370 and is movably disposed within the introducer 310. In addition, at least a portion of the catheter 360 can be movably disposed in the lumen defined by the locking member 340. The catheter 360 can have any suitable shape, size, and / or configuration. For example, in some embodiments, the catheter 360 can be substantially similar to the catheter 260 described in detail above. Therefore, the catheter 360 will not be described in detail herein.

[0138] Actuator 370 may have any suitable shape, size, and / or configuration. Fig.31 and 32 As shown, the actuator 370 includes a first portion 371 and a second portion 375, and a wall 377 disposed therebetween. The first portion 371 of the actuator 370 is configured to be movably coupled to the introducer 310. The second portion 375 of the actuator 370 is configured to be coupled to the proximal portion of the catheter 360 and the distal portion of the auxiliary catheter 365 ( Fig.31 The arrangement of catheter 360, auxiliary catheter 365 and actuator 370 is such that the lumen of catheter 360 is in fluid communication with the lumen of auxiliary catheter 365 to allow fluid to flow therebetween, as described above with reference to the arrangement of catheter 260, auxiliary catheter 265 and actuator 270.

[0139] The first portion 371 of the actuator 370 includes a lug 373 extending from the inner surface of the first portion 371 to contact the outer surface of the guide 310. For example, the lug 373 can be a protrusion, a bump, a ridge, a knob, etc., which is configured to contact the set of ribs 336 formed along the outer surface of the guide 310. Figure 31-34 In the embodiment shown in , the actuator 370 is disposed at an angle relative to the guide 310 due to the contact of the lug 373 with the set of ribs 336. That is, the contact between the lug 373 extending from the inner surface of the first portion 371 and the set of ribs 336 causes at least a portion of the actuator 370 to tilt, pivot, angle and / or shift such that the axis L1 of the longitudinal actuator 370 is not parallel to the longitudinal axis L2 of the guide 310, as shown in FIG. Fig.32 As shown. In this manner, a first force F1 is applied to the proximal portion of the actuator 370 in a first direction, while a second force F2 is applied to the distal portion of the actuator 370 in a second direction (e.g., equal and opposite forces). Thus, with the second portion 375 of the actuator 370 coupled to the proximal portion of the catheter 360 and a portion of the catheter 360 (e.g., at least the distal portion of the catheter 360) disposed within the lumen of the locking member 340, the angled arrangement and / or orientation of the actuator 370 results in stress being applied along the length of the catheter 360 disposed between the actuator 370 and the locking member 340. As shown Fig.31As shown, the stress applied along the length of the catheter 360 can be sufficient to bend, bend, deflect, deform, engage, and / or 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 preloading of the catheter 360 (e.g., preloaded stress).

[0140] As described in detail above with reference to device 200, actuator 370 can be moved along and / or relative to introducer 310 to move catheter 360 between a first position (e.g., a proximal position) and a second position (e.g., a distal position). In some cases, the arrangement of actuator 370 and catheter 360 can result in "clutching" of device 300 as actuator 370 is advanced along introducer 310. For example, a user can apply a force on first portion 371 of actuator to move actuator 370 in a distal direction relative to introducer 310, which in turn moves catheter 360 toward its second position (e.g., a distal position), as shown in FIG. Fig.33 370) may encounter or strike an obstacle or the like that impedes or prevents further distal movement of the catheter 360. In such a case, the preload of the catheter 360 caused by the tilting of the actuator 370 (described above) creates a stress concentration riser or the like along the length of the catheter 360 disposed between the actuator 370 and the locking member 340. Thus, in the event that the distal end of the catheter 360 contacts the obstacle, the force applied by the user to the first portion 371 of the actuator 370 (e.g., in the DD direction) causes the catheter 360 to "clutch" (e.g., deflect, deform, bend, flex, etc.). For example, in some embodiments, a portion of the catheter 360 may bend, deform, deflect, and / or move through a portion of the interior volume 313 (e.g., a portion of a wall 377 of the interior volume 313 that accommodates, for example, the actuator 370) to a "clutched" configuration, such as Fig.33 and Fig.34 shown.

[0141] In some cases, the clutching of the catheter 360 can provide an indication to the user that the movement of the catheter 360 is obstructed and / or blocked. For example, in some embodiments, the introducer 310 can be formed of a substantially transparent material, which can allow the user to visualize the state and / or configuration of the catheter 360. In some embodiments, the clutching and / or deformation of the catheter 360 can cause a portion of the catheter 360 to strike the inner surface of the introducer 310, which in turn can produce an audible (e.g., a "click") and / or tactile indication that the catheter 360 is in a clutched configuration (e.g., the movement of the catheter 360 is obstructed or blocked).

[0142] In some cases, the clutching of catheter 360 may provide and / or may form a self-releasing mechanism, etc., which may facilitate advancement of catheter 360 over an obstacle. For example, in some cases, when catheter 360 is clutched (i.e., Fig.33 and 34 After the catheter 360 is deformed as shown in the figure, the user can reduce and / or remove the force applied to the actuator 370 (e.g., in the DD direction), which in turn can allow the catheter 360 to be at least partially reconfigured. In some such cases, when the catheter 360 is reconfigured, the distal portion of the catheter 360 can move beyond and / or through obstacles, etc. For example, in some cases, the distal end of the catheter 360 can contact and / or impact a wall (e.g., a kinked wall) or a structure of the PIV, a PIV hub, an extension, etc. as the catheter 360 is advanced in the distal direction through which it passes. Such contact and / or impact can in turn result in the clutching of the catheter 360 (as described above). In this case, reducing and / or removing the force applied to the first portion 371 of the actuator 370 allows the catheter 360 to be reconfigured and / or transformed into an unclutched configuration, in which the distal portion of the catheter 360 moves beyond the obstruction wall and / or structure in a safe, controlled and / or predetermined manner. In this way, the clutching of the catheter 360 can provide a self-correcting mechanism or the like, allowing the catheter 360 to "disengage" in response to a reduction in force, which in turn allows the distal end of the catheter 360 to move along the catheter 360 and / or move beyond an obstruction.

[0143] In other cases, the catheter 360 may remain in the clutched configuration when the force applied to the actuator 370 is reduced and / or removed. In this case, the user can, for example, manipulate at least one of the device 300 and / or a portion of the patient to "disengage" the catheter 360. For example, in some cases, the catheter 360 can be inserted into a vein in the patient's arm through an indwelling PIV. In some such cases, the distal end of the catheter 360 can hit a kink in the indwelling PIV catheter, etc. (e.g., often at or near the insertion site of the PIV catheter), which in turn can transform the catheter 360 into a clutched configuration, as described above. In addition, in some cases, despite the reduction and / or removal of the force applied to the actuator 370, the catheter 360 can remain in the clutched configuration. In this way, the user can, for example, manipulate the patient's arm and / or can manipulate the device 300 (connected to the PIV) relative to the patient's arm to move and / or reconfigure the PIV relative to the PIV and the vein in which the catheter 360 is disposed. In some cases, catheter 360 may be transitioned to an unclubed configuration after manipulating the patient's arm and / or reconfiguring device 300 and / or the PIV relative to the vein.

[0144] In some embodiments, the clutch of the catheter 360 and / or the device 300 can be used to limit the force associated with hitting an obstacle. For example, in some cases, the catheter 360 can be advanced toward the vein through at least a portion of an indwelling peripheral intravenous line (PIV). When the catheter 360 is advanced into and / or through the PIV, it may be desirable to reduce or limit the force associated with the distal end of the catheter 360, thereby hitting the internal structure of the PIV, etc. In this way, the clutch of the catheter 360 in response to the distal end of the catheter 360 hitting the internal structure of the PIV (and / or any other structure, such as the internal structure of the extension piece, the vein wall or other vein structure, etc.) can play a role in limiting the force applied thereto. That is, the clutch of the catheter 360 absorbs, redirects and / or redistributes at least a portion of the force associated with the distal end of the catheter 360 hitting the structure. Therefore, the clutch of the catheter 360 can reduce and / or substantially prevent damage to the catheter 360, the structure of the PIV or the extension piece, the vein wall, etc. that may be caused by the collision with the distal end of the catheter 360.

[0145] In some embodiments, the catheter 360 disposed within the introducer 310 can be configured to engage, bend, flex, bend, and / or reconfigure in a predetermined and / or predictable manner, which can allow for "tuning" or control of one or more parameters, characteristics, dynamics, etc. of the device 300. For example, in some embodiments, the catheter 360 can be biased when in a first configuration (e.g., a proximal or unclutched configuration). In this configuration, the amount of bias can be increased or decreased by increasing or decreasing the angle of the actuator 370 relative to the introducer 310 (as described above), respectively. An increase or decrease in the amount of bias can result in an increase or decrease in the amount of preload stress and / or force along a portion of the catheter 360, respectively, which in turn can increase or decrease the likelihood or ease of transitioning the catheter 360 from an unclutched configuration to a clutched configuration, respectively.

[0146] In some cases, the manner in which the conduit 360 is engaged and / or engaged can be controlled and / or "tuned." For example, as described above, the conduit 360 can be in a biased or bent configuration when unengaged. In response to striking an obstacle, the conduit 360 can transition from an unengaged configuration to a clutched configuration such that the conduit 360 deflects in a sinusoidal manner (e.g., a curved shape, a generally S-shape, etc.), such as Fig.33 In some cases, further force applied to the actuator 370 may cause the catheter to bend or deflect, causing a portion of the catheter to move through a second portion 315 (e.g., a vertical portion, etc.) of the interior volume 313 of the introducer 310 and into a first portion 314 (e.g., a horizontal portion, etc.) of the interior volume 313 of the introducer, as shown. Fig.34As shown by arrow EE in . In addition, in some embodiments, a portion of the catheter 360 can be deflected, bent and / or clutched so that a portion of the catheter 360 extends through the first portion 314 of the internal volume 313 to be disposed outside the introducer 310. Therefore, in some embodiments, when transitioning from an unclutched configuration to a clutched configuration, the catheter 360 can have and / or can undergo four stages of deflection. In other embodiments, the range of movement of the catheter 360 when moving to the clutched configuration can be limited so 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 deflection or three-stage deflection, respectively. In this way, the catheter 360 and / or the device 300 can be configured to clutch in a predetermined, desired and / or predictable manner, which in turn can change, adjust, adjust and / or control one or more characteristics associated with the insertion of the catheter 360 into the vein through the indwelling PIV.

[0147] As described above with reference to the device 200, advancing the actuator 370 relative to the introducer 310 causes the lug 373 of the first portion 371 of the actuator 370 to move along the set of ribs 336. In some cases, the movement of the lug 373 along the set of ribs 336 can provide a user with tactile feedback, etc. associated with moving the catheter 360 between the first and second positions. Additionally, in some cases, vibration of the actuator 370 caused by the movement of the lug 373 along the set of ribs 336 can also cause vibration of the catheter 360. In some cases, the vibration of the catheter 360 when at least partially disposed in the vein can cause vasodilation or vasodilation of the vein, which in turn can increase the diameter of the vein. For example, an increase in the diameter of the vein and / or a decrease in the amount of constriction of the vein can increase access to a portion of the vein and / or increase blood flow through the vein, which in turn can result in better fluid delivery (e.g., blood) from the vein via the catheter 360 at least partially disposed in the vein.

[0148] Fig.35 and 36 4 is a schematic diagram of a fluid delivery device 400 according to one embodiment. The fluid delivery device 400 can be any suitable delivery device, such as those described herein. For example, the fluid delivery device 400 can be similar in form and / or function to the fluid delivery device 400 described above. Figure 3-29 The fluid delivery device 200 described herein is substantially the same. Fig.35 and Fig.36, but fluid delivery device 400 is not limited thereto and should be considered to be substantially the same as fluid delivery device 200 unless otherwise expressly stated. For example, fluid delivery device 400 (also referred to herein as a "delivery device" or "device") includes an introducer 410 having a proximal portion 411 and a distal portion 412. As described above with reference to delivery device 200, device 400 also includes a catheter movably disposed within the introducer and an actuator movably coupled to the introducer and fixedly coupled to the catheter. As described above, a user can apply a force on the actuator to move the actuator along introducer 410, which in turn causes the catheter to move between a first position, in which the catheter is disposed in introducer 410, and a second position, in which at least a portion of the catheter extends distally beyond introducer 410.

[0149] like Fig.35 and 36 As shown, the distal portion 412 of the introducer 410 is coupled to a locking member 440 that is configured to couple the device 400 to, for example, an extension 490 (e.g., an adapter such as a T-adapter or a Y-adapter) and / or a peripheral intravenous line (PIV) 405. The locking member 440 may be substantially similar to the locking member described above with reference to, for example, Figure 13-15 Thus, aspects of locking member 440 are described in further detail herein.

[0150] The locking member 440 includes a proboscis 442, a first arm 443, and a second arm 450. Fig.36 As shown, the first arm 443 and the second arm 450 can jointly engage the proximal portion 491 of the extension 490 to couple the device 400 thereto. In addition, when the locking member 440 is coupled thereto, the proboscis 442 can be at least partially disposed within the extension 490 to place the locking member 440 in fluid communication with the PIV 405 coupled to the distal portion 492 of the extension 490. Although shown and described as being coupled to the extension 490, in other embodiments, the first arm 443 and the second arm 450 can jointly engage a portion of the PIV 405 to couple the device 400 thereto (e.g., without using the extension 490).

[0151] like Fig.36As shown, the arrangement of the first arm 443 and the second arm 450 can be such that the device 400 is set at a predetermined and / or desired angle θ when connected to the extension 490 and / or the PIV 405 and when the first arm 443 or the second arm 450 is placed in contact with the target surface S. Further expanding, in some embodiments, the target surface S can be a patient's arm, and the PIV 405 can be pre-inserted therein to be at least partially set within a vein of the patient's arm (e.g., the PIV 405 is an indwelling PIV, etc.). The locking member 440 is rotatably connected to the distal portion 412 of the introducer 410, thereby allowing a user to rotate the locking member 440 to a desired orientation so that the first arm 443 or the second arm 450 is adjacent to the target surface S. In Fig.36 In the example shown in , the second arm 450 is adjacent to and in contact with the target surface S. When the locking member 440 is coupled to the extension member 490 and the extension member 490 is coupled to the indwelling PIV 405, the second arm 450 can be in contact with the target surface S so that the device 400 is set at a predetermined and / or desired angle θ relative to the target surface S, such as Fig.36 shown.

[0152] In some embodiments, the predetermined and / or desired angle θ may be between about 0° and about 30°. For example, in some embodiments, the predetermined and / or desired angle θ may be about 15°. In such embodiments, setting the device 400 at a predetermined and / or desired angle θ may, for example, facilitate advancement of the catheter from its first position to its second position so that at least the distal portion of the catheter extends through the PIV 405 and is placed within the vein. In some cases, the predetermined and / or desired angle θ of the device 400 may be approximately equal to and / or associated with the insertion angle of the PIV 405. Therefore, setting the device 400 at a predetermined and / or desired angle θ may limit and / or reduce the likelihood of kinking along the catheter, which in turn may facilitate the transport of bodily fluids (e.g., blood) therethrough. In addition, in some cases, setting the device 400 at a predetermined and / or desired angle θ may result in little movement of the device 400 and / or the PIV, little likelihood of disconnection and / or displacement, reduced risk of hematoma, thrombosis, clots, infection, etc., and / or may increase patient comfort.

[0153] Although the second arm 450 of the locking member 440 is described above as contacting the target surface S to place and / or maintain the delivery device 400 at a predetermined and / or desired angle θ relative to the target surface S, in other embodiments the fluid delivery device may include and / or may be coupled to any suitable device configured to place the delivery device at a predetermined and / or desired angle. For example, Fig.37 FIG. 5 shows a fluid delivery device 500 according to one embodiment. The form and / or function of the fluid delivery device 500 may be the same as those described above with reference to FIG. Fig.35 and36 The described fluid delivery device 400 is substantially the same. Therefore, the individual parts of the delivery device will not be described in detail here.

[0154] Fluid delivery device 500 (also referred to herein as a "delivery device" or "device") includes an introducer 510 having a proximal portion 511 and a distal portion 512. The distal portion 512 of the introducer 510 is coupled to a locking member 540, which in turn is configured to physically and fluidically couple the device 500 to an indwelling PIV ( Fig.37 ), as described in detail above. Fig.37 In the illustrated embodiment, the distal portion 512 of the introducer 510 is coupled to a support member 580. The support member 580 can have any suitable shape, size, or configuration. For example, in this embodiment, the support member 580 can be one or more extensions, posts, protrusions, rods, fingers, etc., each of which is coupled to and / or included in the distal portion 512 of the introducer 510. As described above with reference to the second arm 450 of the locking member 440, the support member 580 can contact the target surface S and can be arranged so that when the support member 580 is coupled to the distal portion 512 of the introducer 510, the device 500 is maintained and / or positioned at a predetermined and / or desired angle θ relative to the target surface S.

[0155] Although Fig.37 5. The support member 580 is specifically shown in FIG. 5, but it should be understood that the fluid delivery device may include and / or may be coupled to a support member having any suitable shape, size, and / or configuration. For example, Fig.38 FIG. 6 shows a fluid delivery device 600 according to one embodiment. The form and / or function of the fluid delivery device 600 may be the same as those described above with reference to FIG. Fig.37 The described fluid delivery device 500 is substantially the same. Therefore, the individual parts of the delivery device 600 will not be described in detail herein.

[0156] Fluid delivery device 600 (also referred to herein as a "delivery device" or "device") includes an introducer 610 having a proximal portion 611 and a distal portion 612. The distal portion 612 of the introducer 610 is coupled to a locking member 640, which in turn is configured to physically and fluidically couple the device 600 to an indwelling PIV ( Fig.38 ), as described in detail above. Fig.38In the illustrated embodiment, the distal 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 and a second surface 682, the first surface 681 being configured to contact the target surface S, and the second surface 682 being configured to form an angle relative to the first surface 681. In this manner, the second surface 682 can be placed in contact with a portion of the device 600 (e.g., the distal portion 612 of the introducer 610 and / or any other suitable portion of the device 600) to position and / or maintain the device 600 at a predetermined and / or desired angle θ relative to the target surface S.

[0157] Although support members 580 and 680 are described above as being included in and / or coupled to introducers 510 and 610, respectively, in other embodiments, support members may be included in and / or coupled to any suitable portion of a fluid delivery device. For example, Fig.39 and 40 FIG. 7 shows a fluid delivery device 700 according to one embodiment. The form and / or function of the fluid delivery device 700 may be the same as those described above with reference to FIG. Fig.35 and Fig.36 The described fluid delivery device 400 is substantially the same. Therefore, the individual parts of the delivery device 700 will not be described in detail herein.

[0158] The fluid delivery device 700 (also referred to herein as a "delivery device" or "device") includes an introducer 710 having a distal portion coupled to a locking member 740 (as described above). The locking member 740 includes a proboscis 742, a first arm 743, and a second arm 750. Fig.39 and 40 In the embodiment shown in , the delivery device 700 includes a support member 780 coupled to a locking member 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 that is configured to accommodate, for example, at least a portion of a proboscis 742 of the locking member 740. In other words, the proboscis 742 of the locking member 740 can be inserted into the first portion 783 of the support member 780, thereby coupling the support member 780 to the locking member 740. In some embodiments, the first portion 783 of the support member 780 and a portion of the proboscis 742 can together form a friction or press fit that can at least temporarily hold the support member 780 in a substantially fixed position relative to the locking member 740.

[0159] like Fig.40As shown, 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 arranged 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 arranged at a predetermined and / or desired angle relative to a plane defined by and / or parallel to the contact surface 785. Therefore, when the support member 780 is coupled to the locking member 740 and the contact surface 785 is placed in contact with a target surface (e.g., a portion of the patient's anatomical structure), the device 700 can be arranged 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 another embodiment, the predetermined and / or desired angle can be less than 0° or greater than 30°.

[0160] Although the support member 780 is described above as including a single member (ie, the second portion 784) extending from the first portion 783, in other embodiments, the support member may include any number of extensions (eg, second portions). Fig.41 FIG. 8 shows a fluid delivery device 800 according to one embodiment. The form and / or function of the fluid delivery device 800 may be the same as those described above with reference to FIG. Fig.39 and Fig.40 The described fluid delivery device 700 is substantially the same. Therefore, the individual parts of the delivery device 700 will not be described in detail herein.

[0161] Fluid delivery device 800 (also referred to herein as a "delivery device" or "device") includes an introducer 810 having a distal portion coupled to a locking member 840 (as described above). Locking member 840 includes a proboscis 842, a first arm 843, and a second arm 850. Fig.41 In the illustrated embodiment, the delivery device 800 includes a support member 880 coupled to the locking member 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 proboscis 842, as described above with reference to the support member 780. In addition, each second portion 884 includes a contact surface 885, as described above with reference to the support member 780.

[0162] However, in the arrangement of the second portion 884, the support member 880 may be different from the support member 780. For example, Fig.41As shown, support member 880 includes a set of three second portions 884 distributed around a portion of the circumference of first portion 883. In this manner, the set of second portions 884 can be placed in contact with a target surface (e.g., a portion of a patient's anatomy), and device 800 can be positioned and / or placed at a predetermined and / or desired angle relative to the target surface, as described above with reference to support member 780. Additionally, in some cases, the arrangement of the set of second portions 884 can provide lateral support to limit and / or substantially prevent rotation, tilt, sway, and / or any other undesirable movement of device 800 relative to the target surface.

[0163] Although not shown in delivery devices 100, 200, 300, 400, 500, 600, 700 and / or 800, any of the fluid delivery devices described herein may 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 FIG. 9 is a diagram showing a fluid delivery device 900 according to one embodiment. The form and / or function of the fluid delivery device 900 may be the same as those described above with reference to FIG. Figure 3-29 The described fluid delivery device 200 is substantially identical, and therefore the various parts of the delivery device 900 will not be described in detail herein.

[0164] The fluid delivery device 900 (also referred to herein as a "delivery device" or "device") includes an introducer 910, a catheter 960, an actuator 970, and an internal support member 986. As described in detail above with reference to the delivery device 200, the introducer 910 has a distal portion coupled to a locking member 940, which in turn is configured to couple the delivery device 900 to, for example, an indwelling PIV and / or an extension member (e.g., a Y-adapter, a T-adapter, etc.). The introducer 910 defines an internal volume 913 that is configured to receive and / or accommodate 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 on the exterior of the introducer 910. The second portion 975 of the actuator 970 is disposed within the interior volume 913 of the introducer 910 and is fixedly coupled to the distal portion of the catheter 960. In this manner, a user can apply a force on the first portion 971 of the actuator 970 to move the catheter 960 between a first position (e.g., a proximal position) in which the catheter 960 is disposed within the introducer 910 and / or within the lock 940, and a second position (e.g., a distal position) in which at least a portion of the catheter 960 extends distally beyond the lock 940, as described in detail above with reference to the delivery device 200.

[0165] like Fig.42 and 43As shown, the delivery device 900 also includes an internal support member 986, which is disposed within the internal volume 913 of the introducer 910 and surrounds at least a portion of the catheter 960. The internal support member 986 can have any suitable shape, size and / or configuration. For example, in this embodiment, the internal support member 986 is a substantially cylindrical tube whose diameter allows the internal support member 986 to be disposed within the internal volume 913 (or a portion thereof). In addition, 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 obstacle, etc. In such embodiments, disposing the internal support member 986 around at least a portion of the catheter 960 can limit the amount of deflection of the catheter 960 when transitioning to the "clutched" configuration. In some embodiments, such an arrangement can, for example, retain the catheter 960 within the interior volume 913 (or a desired portion thereof) of the introducer 910. That is, the internal support member 986 can support the catheter 960 and / or limit the amount of deflection of the catheter 960 that causes a portion of the catheter 960 to extend outside of the interior volume 913 (e.g., via an actuator slot, track, or opening).

[0166] The inner support member 986 includes and / or defines a slit 987 that spirals and / or wraps along the length of the inner support member 986, such as Fig.42 and 43 The second portion 975 of the actuator 970 may be disposed within the internal support member 986, and at least a portion of the wall 977 of the actuator 970 may 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 move within the internal support member 986. In the case where the wall 977 extends through the slit 987, the movement of the actuator 970 along the introducer 910 causes the rotation of the internal support member 986 as the wall 977 is advanced through the slit 987 (e.g., a spiral or coiled slit). In other words, the translational movement of the actuator 970 causes a similar translational movement of the catheter 960 and the rotational movement of the internal support member 986 around the catheter 960. Therefore, the internal support member 986 can support at least a portion of the catheter 960 disposed within the introducer 910. In addition, in some embodiments, the internal support member 986 can be configured to substantially maintain the sterility of the catheter 960 prior to use.

[0167] Although the internal support member 986 is shown and described above as a substantially cylindrical tube in which the conduit 960 is disposed, in other embodiments, the fluid delivery device may include any suitable internal support member. Fig.44 FIG. 1 shows a fluid delivery device 1000 according to one embodiment. The fluid delivery device 1000 may be similar in form and / or function to the above-referenced Fig.42 and Fig.43 The described fluid delivery device 900 is substantially identical, and therefore the various parts of the fluid delivery device 1000 will not be described in detail herein.

[0168] Fluid delivery device 1000 (also referred to herein as a "delivery 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 portion coupled to a locking member 1040, which in turn is configured to couple the delivery device 1000 to, for example, an indwelling PIV and / or an extension member (e.g., a Y-adapter, a T-adapter, etc.). The introducer 1010 defines an internal volume 1013 that is 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 in the internal volume 1013 and fixedly coupled to the catheter 1060. In this manner, a user can apply a force on the first portion 1071 of the actuator 1070 to move the catheter 1060 between a first position (e.g., a proximal position) in which the catheter 1060 is disposed within the introducer 1010 and / or the locking member 1040, and a second position (e.g., a distal position) in which at least a portion of the catheter 1060 extends distally beyond the locking member 1040, as described in detail above.

[0169] However, delivery device 1000 may differ from delivery device 900 in the arrangement of internal support members 1086. For example, Fig.44In the illustrated embodiment, the internal support member 1086 can be formed of a relatively flexible material and configured and / or arranged as, for example, a bellows. The internal support member 1086 is disposed in the internal volume 1013 between the second portion 1075 of the actuator 1070 and the internal distal surface of the introducer 1010, which 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. In the case where the internal support member 1086 is arranged and / or configured as a bellows, movement of the actuator 1070 causes compression, deformation, and / or collapse of the internal support member 1086. That is, movement of the actuator 1070 from the proximal position toward the distal position compresses the bellows formed by and / or included in the internal support member 1086. Conversely, when the actuator 1070 moves from the distal position toward the proximal position, the bellows formed by and / or included in the inner support member 1086 can expand and / or reconfigure to the pre-deformed configuration. Thus, the inner support member 1086 can, for example, support the catheter 1060 (e.g., when the catheter 1060 is transformed into a "clutched" configuration) and / or can fluidly isolate at least a portion of the catheter 1060 (e.g., substantially maintain the sterility of the catheter 1060), as described above with reference to the inner support member 986.

[0170] Although 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 conduit 1060 is disposed, in other embodiments, the fluid delivery device may include any suitable internal support member. Fig.45 FIG. 1 shows a fluid delivery device 1100 according to one embodiment. The form and / or function of the fluid delivery device 1100 may be the same as those described above with reference to FIG. Fig.42 and 43 The described fluid delivery device 900 is substantially the same. Therefore, the individual parts of the fluid delivery device 1100 will not be described in detail herein.

[0171] The fluid delivery device 1100 (also referred to herein as a "delivery 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 portion coupled to a locking member 1140, which in turn is configured to couple the delivery device 1100 to, for example, an indwelling PIV and / or an extension member (e.g., a Y-adapter, a T-adapter, etc.). The introducer 1110 defines an internal volume 1113 that is 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 in the internal volume 1113 and fixedly coupled to the catheter 1160. In this manner, a user can apply a force on 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 locking member 1140 and a second position (e.g., a distal position) in which at least a portion of the catheter 1160 extends distally beyond the locking member 1140, as described in detail above.

[0172] However, delivery device 1100 may differ from delivery device 900 in the arrangement of internal support members 1186. For example, Fig.45 In the illustrated embodiment, the internal support member 1186 can be formed of a relatively thin and flexible material that is arranged in, for example, a zigzag configuration (e.g., a set of wall segments arranged at alternating angles). The internal support member 1186 is disposed in 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 the 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.

[0173] The conduit 1160 is disposed within and / or extends through an opening or hole 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 "tuned" and / or set to adjust the amount of support provided to the catheter 1160. For example, in some embodiments, the openings or holes can be similar to and / or slightly larger than the outer diameter of the catheter 1160. In such embodiments, a relatively close tolerance between the size and / or diameter of the openings and the size and / or outer diameter of the catheter 1160 can result in a relatively high level of support, which in turn can reduce deflection and / or deformation of the catheter 1160, for example, when the catheter 1160 is transitioned from an unclutched configuration to a clutched configuration. In other embodiments, the openings and / or holes defined by each wall segment of the internal support member 1186 can be larger than the outer diameter of the catheter 1160 (e.g., a relatively large tolerance between them). In such embodiments, the larger size and / or diameter of the openings can allow the catheter 1160 to deflect relative to the internal support member 1186. Thus, in some embodiments, an increase in the size and / or diameter of the opening in the internal support member 1186 can result in an increase in the range of movement of the catheter 1160 (e.g., an increase in the amount of deflection and / or deformation when the catheter 1160 transitions from an unclutched configuration to a clutched configuration).

[0174] In some embodiments, the internal support member 1186 may be formed of a material having sufficient flexibility to bend, deform, flex, and / or reconfigure. For example, when the actuator 1170 moves along the guide 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). In addition, at least a portion of the internal support member 1186 can be configured to bend and / or flex in response to the catheter 1160 transitioning to a "clutched" configuration while substantially limiting the amount of deflection of the catheter 1160, which can cause a portion of the catheter 1160 to extend outside the guide 1110 (as described above with reference to the internal support member 986). Thus, the internal support member 1186 can support at least a portion of the catheter 1160 disposed within the guide 1110.

[0175] Although internal support member 1186 is shown as extending along substantially the entire length of catheter 1160, in other embodiments, the internal support member may extend along any suitable portion of the catheter (e.g., less than substantially the entire length of the catheter). Although internal support member 1186 is described above as being formed of a relatively thin and flexible material having a set of wall segments arranged in alternating angular directions, in other embodiments, the internal support member may have any suitable shape, size, and / or configuration. For example, in some embodiments, the fluid delivery device may include a spring (e.g., a coil spring) or the like that is disposed within the interior volume of the introducer and surrounds at least a portion of the catheter. In such embodiments, the spring or the like may support at least a portion of the catheter in a manner substantially similar to that described above with reference to internal support members 986, 1086, and / or 1186.

[0176] In other embodiments, the internal support member may be integrally formed with the catheter and / or coupled to the catheter. For example, in some embodiments, one or more portions of the catheter may be formed as support members. For example, these portions may have an increased wall thickness and / or may be formed of different constituent materials. In other embodiments, the internal support member may be selectively coupled to the catheter. For example, in some embodiments, the catheter may include a set of rings or beads that are movably coupled to the catheter and / or arranged along the length of the catheter. In some embodiments, the rings and / or beads may be uniformly and / or uniformly spaced, or may be randomly and / or unevenly spaced. In some embodiments, the rings and / or beads may 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 may be coupled to the catheter and may be temporarily held in a substantially fixed position. In some cases, when the catheter is advanced in the distal direction, the rings and / or beads may move so that the rings and / or beads are bound and / or slide to a certain position along, for example, the proximal portion of the catheter. As such, the rings and / or beads can be configured to increase the amount of support provided to the catheter as the catheter is advanced in a distal direction (eg, as the spacing between the rings and / or beads decreases).

[0177] In other embodiments, the introducer may include an internal support member formed by and / or having a deformable band and / or foam arranged along the inner surface (e.g., upper inner surface) of the catheter. In such embodiments, the band and / or foam may be configured to compress, bend, flex, deform, and / or reconfigure when the actuator and / or catheter are relative to it. For example, in some embodiments, foam, etc. may be arranged between the distal end surface of the internal volume of the actuator and the introducer, and may be compressed (e.g., axially) in response to the distal movement of the actuator. In other embodiments, the introducer may include foam, etc. along the upper surface of the internal volume, and may be, for example, deformed, displaced, deflected, and / or compressed laterally at or near the position of the actuator. In addition, when the actuator is advanced along the length of the introducer, a portion of the foam may be configured to return to an undeformed configuration when the actuator moves relative to the portion. Therefore, a portion of the foam proximal to the actuator (or a portion thereof) may be in an undeformed configuration, and a portion of the foam distal to the actuator (or a portion thereof) may be in an undeformed configuration. That is, as the actuator moves along the introducer, the actuator moves a predetermined and / or defined portion of the foam. In some embodiments, the foam can limit and / or reduce the open or unoccupied portion of the internal volume, which in turn can result in a limited and / or reduced range of motion of the conduit (e.g., when transitioning from an unclutched configuration to a clutched configuration). In some embodiments, deformation of the foam in response to movement of the actuator can further limit and / or reduce the open or unoccupied portion of the internal volume, which in turn can result in an increased amount of support provided to the conduit (e.g., a reduced range of motion).

[0178] Although some of the fluid delivery devices described herein are not explicitly shown with a peripheral intravenous line (PIV), it should be understood that any of the fluid delivery devices described herein may be connected to any suitable peripheral intravenous line (PIV). In some cases, using a PIV may include coupling the PIV to an IV extension and / or adapter (e.g., a single port adapter, a Y-adapter, a T-adapter, etc.). Therefore, although some delivery devices are described herein as being coupled to a PIV, it should be understood that, based on the circumstances and / or configuration, the delivery device may be coupled to a PIV or to an adapter coupled thereto (e.g., an extension). The delivery device may be configured to couple to any suitable available PIV, adapter, and / or extension. For example, although the first arm 243 and the second arm 250 of the locking member 240 are shown (e.g., in Fig.13 and 14) and having a given shape and / or configuration as described above, but in other embodiments, the locking member may include a first arm and a second arm having a size, shape and / or configuration that can allow the locking member to be coupled to a variety of PIVs, adapters and / or extensions. For example, in some embodiments, the arms of the locking member may be rounded, curved, bent, widened, etc. to allow the locking member to accommodate a portion of any suitable PIV, adapter and / or extension. In some embodiments, the arrangement of arms 243 and 250 of locking member 240 can allow locking member 240 to rotate approximately 360° around any suitable PIV, adapter and / or extension when coupled thereto. Additionally, in some embodiments, the ability to rotate locking member 240 to place the arms of locking member 240 in a predetermined position so that the surface of arm 243 or arm 250 is placed in contact with a surface, sets device 200 at a predetermined and / or desired angle relative to the surface, as described above with reference to Fig.35 and Fig.36 As described with reference to the apparatus 400 shown in FIG.

[0179] Although the proboscis 242 is shown and described above as having a particular size and / or shape, in other embodiments, the locking member may include a proboscis having any suitable length (e.g., longer or shorter than the proboscis 242), width (e.g., wider or narrower than the proboscis 242), and / or shape (e.g., curved, tapered, flared, etc.). In some embodiments, the proboscis may have a surface finish or feature, such as one or more threads, scratches (e.g., spiral scratches), ribs, grooves, etc. In some embodiments, the proboscis 242 may have a diameter and / or length that is associated with and / or based at least in part on one or more internal dimensions of an extension, PIV, etc. In other words, in some embodiments, the devices described herein may be configured for use with an extension and / or PIV having one or more desired internal dimensions (e.g., an inner diameter of a lumen defined by the extension, a length of the lumen, etc.). For example, in some embodiments, the extension may define a lumen, at least a portion of which has an inner diameter of about 1.0 millimeters (mm) to about 1.6 mm. In other embodiments, the extension may define a lumen (or a portion thereof) having a diameter associated with and / or slightly larger than the outer diameter of the catheter (eg, slightly larger than the diameter of a 30 Gauge catheter or approximately 0.20 mm).

[0180] In some embodiments, such an extension having one or more desired internal dimensions (inner diameters) can be used as a guide, etc., which is configured to guide a catheter 260 through the extension and / or at least a portion of the PIV without substantially bending, kinking, breaking, and / or substantially getting stuck. More specifically, in some embodiments, the extension can be coupled to a PIV hub, etc., such that a distal portion of the extension extends through a portion of the PIV hub or basket. In such embodiments, the extension can define an inner lumen having an inner diameter of approximately 1.4 mm at its distal portion (e.g., the inner lumen can taper toward the distal portion to a diameter of approximately 1.4 mm or can have a substantially constant diameter of approximately 1.4 mm between its proximal portion and its distal portion). In such embodiments, the extension can guide, for example, a distal portion 262 of a catheter 260 through the extension and hub or basket of the PIV and, for example, into a vein of a patient without substantially hitting an obstacle or "hooking" on one or more portions of the extension and / or the PIV. In this manner, the extension may be an adapter and / or guide that may allow the delivery device 200 to be used with any suitable PIV (eg, a commercially available PIV, etc.).

[0181] In other embodiments, the extension, PIV and / or any device described herein may include and / or be coupled to an external guide member, etc., which may be disposed between the components. Such an external guide member may be configured to guide the catheter as it is advanced in a distal direction (as described in detail above). For example, in some embodiments, the guide member may have a tapered shape and / or may be funnel-shaped, for example, having a larger diameter at the proximal portion and a smaller diameter at the distal portion. In some embodiments, such a guide member may be disposed between the introducer and the extension of any device described herein. In other embodiments, such a guide member may be disposed between the extension and the PIV. In other embodiments, such a guide member may be disposed between the introducer and the PIV of any device described herein. In other embodiments, any device described herein may include and / or be coupled to one or more guide members having any suitable configuration.

[0182] The embodiments described herein can be used to output fluid from or deliver fluid to a patient by accessing a vein via an indwelling PIV. As described above, for example, the delivery device 100 and / or 200 can be manipulated to place the distal surface of the catheter at a predetermined and / or desired distance from the distal surface of the PIV. In some cases, the embodiments described herein allow for effective blood drawing while maintaining the integrity of the sample. While extracting blood, the delivery device 100 and / or 200 can be configured to accommodate and / or generate a substantially laminar (e.g., non-turbulent or low-turbulence) blood flow through the delivery device 100 and / or 200, respectively, to reduce and / or substantially prevent hemolysis of the blood as the blood flows through the delivery device 100 and / or 200, respectively.

[0183] In some cases, when a delivery device such as described herein is used to collect a sample volume of blood (e.g., a blood culture), it may be desirable to occlude and / or block the lumen of the catheter when the catheter is inserted into the vein through the indwelling PIV. For example, in some embodiments, the delivery device 200 can be used to collect a certain volume of blood. In such an embodiment, the locking member 240 of the delivery device 200 can be connected to the indwelling PIV, and the fluid source can be connected to the connector 269 of the auxiliary catheter 265. In some embodiments, for example, the fluid source can be a squeezable ball or spherical object and / or a suitable form of fluid reservoir and pump (e.g., a syringe, etc.). The fluid source may include, for example, saline, etc. Therefore, with the fluid source connected to the connector 269, the fluid source is placed in fluid communication with the lumen 268 defined by the auxiliary catheter 265, which in turn connects the fluid source to the lumen 263 defined by the catheter 260.

[0184] In some embodiments, a fluid source or the like can be actuated to release a fluid (e.g., saline) flow through the catheters 260 and 265, thereby flushing the lumens 263 and 268, respectively. Once the flushing is completed, the catheter 260 can be, for example, placed in a fluid or hydraulic locking configuration and can be advanced to its second position (as described in detail above). In other embodiments, a fluid source or the like can be actuated (e.g., a squeeze ball can be squeezed) to release a fluid flow so that a substantially continuous fluid flow flows out of the catheter 260. In the case of fluid flowing out of the catheter 260, the delivery device 200 can be actuated to advance the catheter 260 to its second position (as described above). In this way, flushing the lumens 263 and 268 of the delivery device 200 before and / or during the advancement of the catheter 260 can limit and / or can substantially prevent contaminants from entering the fluid flow path defined by the lumens 263 and 268 (e.g., can be fluidly and / or hydraulically locked).

[0185] In some cases, once the catheter 260 is advanced to its second position, the fluid source can be, for example, reversed, etc., so that the reservoir of the fluid source contains the fluid flow. For example, in some cases, the squeeze ball or sphere can be actuated (squeezed), which in turn reduces the volume of the squeeze ball or sphere as the flow of the fluid contained therein is released. In some cases, after the catheter 260 is placed in its second position, the force can be removed from the squeeze ball or sphere, which in turn increases the volume of the squeeze ball or sphere. The increase in volume generates and / or causes a suction force, which in some cases can be used to draw any remaining saline and a certain volume of blood into the volume defined by the squeeze ball or sphere. In this way, "reversing" the fluid source, etc. can remove any remaining saline and can prime the delivery device 200. After priming the delivery device 200, any suitable fluid reservoir can be connected to the coupling 269 so that the clean blood flow is delivered from the vein to the fluid reservoir.

[0186] Although described above squeeze ball or spherical object, it should be understood that any suitable fluid reservoir and / or pump can be used to rinse and / or perfuse any conveying device described herein. Although the above embodiment is described as using fluids such as saline to rinse and / or perfuse catheter and / or conveying device, in other embodiments, catheter and / or conveying device can be rinsed and / or perfused via any suitable compressible fluid, incompressible fluid, etc. In other embodiments, gases such as air or any suitable inert gas can be used to form pneumatic locking members, rinse and / or perfuse. In other embodiments, guide wire and / or any other suitable occluding device can be arranged in the lumen of catheter, to limit and / or substantially prevent fluid from entering the lumen when catheter is advanced to the desired position in patient's vein. In some such embodiments, the occluding device can include, for example, one or more parts, which are configured to dissolve in response to a given temperature and / or in response to fluid contact within a predetermined time period. In other embodiments, occlusive devices, etc. may include deformable members, shape memory or change components (e.g., nickel-titanium alloy (Nitinol)), reversible valves (e.g., mechanical valves configured to transform in response to a force or pressure, or electric valves configured to transform in response to the flow of an electric current), and / or any other suitable components.

[0187] Although not shown, any conveying device described herein may include and / or may be coupled to a flash chamber, etc., which is configured to accommodate, for example, a first volume of blood (e.g., a pre-sample of blood). In some embodiments, the flash chamber may be coupled to a coupler 269 of an auxiliary conduit 295 of the conveying device 200 to accommodate the first volume of blood. In other embodiments, any suitable portion of the conveying device 200 may form a flash chamber, etc., which is configured to at least temporarily store the first volume of blood. In such an embodiment, the first volume of blood may flow through, for example, a one-way seal, such as a sponge seal, etc., and enter the flash chamber. The arrangement of the seal may be such that once the seal is wetted (e.g., with blood), the first volume of blood flow stops. Once the desired amount of blood is delivered to the flash chamber (e.g., the first volume), the conveying device 200 may be manipulated to deliver the second volume of blood (e.g., the sample volume) to a fluid reservoir (e.g., a sample reservoir).

[0188] Although the embodiments described herein can be used in various settings (ER, hospitalization, etc.), the following scenarios of taking out a sample volume of blood from a patient are provided by way of example. In some cases, for example, a peripheral intravenous line and / or catheter (PIV) is inserted into a patient's vein and an extension piece and / or adapter are attached according to standard guidelines. The PIV can be kept in the vein for a long time, and access to the vein can be provided for fluids (e.g., saline, blood, drug compounds, etc.) to be delivered to the patient. When blood is drawn, a user (e.g., a nurse, a physician, a phlebotomist, etc.) can stop delivering fluids to the patient, and if it is delivering fluids, it lasts for about 1-5 minutes to allow liquids to disperse from the blood drawing site. In order to draw a blood sample, a user attaches a conveying device (e.g., conveying device 100 and / or 200) to a port and / or a suitable portion of an extension piece and / or adapter, and the conveying device is transformed from a first configuration (e.g., a storage configuration) into a second configuration, in which the catheter portion included in the conveying device extends through the peripheral IV and enters the vein.

[0189] As described in detail above with reference to the delivery device 200, when the delivery device is in a second configuration to place the catheter in fluid communication with a portion of a vein containing unobstructed and / or uninhibited blood flow, the end of the catheter can be set at a predetermined and / or desired distance from the end of the PIV. For example, the end of the catheter can be in a distal position relative to the end portion of the PIV, and at least one branch vessel, valve, etc. 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, test tubes and / or syringes to the delivery device to extract a certain volume of blood. In some cases, the volume of blood can be a first volume of blood, which can be discarded and / or at least temporarily stored separately from the subsequent sample volume of blood (e.g., a volume of about 1-3 milliliters (mL) but up to 8-10 milliliters of blood can be a "waste" or "pre-sample" volume). In some cases, the waste volume can include contaminants, non-dispersed residual fluids, etc. After collecting the waste volume, the user can connect one or more negative pressure containers (e.g., sample containers) to the delivery device to collect the desired blood sample volume. Once the sample volume is collected, the delivery device can be converted from the second configuration to the first configuration and / or the third configuration (e.g., the "used" configuration). The delivery device can then be separated from the extension and / or adapter and safely discarded. In some cases, after the sample volume is collected but before the delivery device is converted from the second configuration, for example, a waste or pre-sample volume can be reinjected into the vein.

[0190] As described above, in some cases, the delivery devices described herein can be coupled to a fluid reservoir that is configured to hold a volume of body fluid (e.g., blood). In some cases, such a fluid reservoir can be a negative pressure container, such as etc. However, in some cases, it may be desirable to limit and / or control rapid changes in pressure through the delivery device and / or vein, which may result in hemolysis of the blood sample or portions thereof, collapse or "blow" the vein, etc. Thus, in some embodiments, any delivery device described herein may be configured to regulate negative pressure applied therethrough.

[0191] For example, as detailed above, the delivery device 200 includes an auxiliary conduit 265 in fluid communication with the conduit 260, and includes a coupler 269 configured to couple the delivery device 200 to a fluid reservoir (e.g., a negative pressure reservoir). In some embodiments, the auxiliary conduit 265 can be configured to adjust the negative pressure applied by the delivery device 200. For example, the auxiliary conduit 265 can be formed of a relatively flexible polymer material, etc., which can allow the auxiliary conduit 265 to bend, flex, deform, and / or reconfigure in response to the applied force. In addition, in some embodiments, the hardness or strength of the conduit 260 can be greater than the hardness or strength of the auxiliary conduit 265. In some cases, when the auxiliary conduit 265 is exposed to a negative pressure differential, the inner cavity 268 defined by the auxiliary conduit 265 is exposed to a rapid decrease in pressure, which in turn applies suction within the inner cavity 268, which drags the wall of the auxiliary conduit 265 inwardly, thereby reducing the inner diameter of the auxiliary conduit 265. Thus, reducing the diameter of the lumen 268 of the auxiliary catheter 265 results in an adjusted and / or reduced suction force being applied through the lumen 268 to or in the lumen 263 of the catheter 260. Likewise, reducing the amount and / or magnitude of the suction force applied through the lumen 263 of the catheter 260, in turn, adjusts and / or reduces the magnitude of the suction force applied to or in the vein. Thus, the negative pressure differential experienced by or in the vein (which may be sufficient to collapse the vein) is reduced.

[0192] In addition, when body fluid (e.g., blood) is delivered to the negative pressure reservoir by the delivery device 200, the negative pressure difference between the reservoir and the vein is reduced. In other words, when a certain volume of blood is delivered therein, the negative pressure or suction force applied by the negative pressure reservoir is reduced. In other words, when a certain volume of blood is delivered to the negative pressure reservoir, the negative pressure difference is balanced. In some embodiments, the reduction in the magnitude of the negative pressure and / or suction force applied by the negative pressure reservoir may cause the auxiliary conduit 265 to transition toward its undeformed configuration (i.e., the configuration before being exposed to negative pressure). That is, as the magnitude of the negative pressure and / or negative pressure difference decreases, the diameter of the inner cavity 268 defined by the auxiliary conduit 265 may increase or may return to a non-reduced diameter, which in turn may increase the fluid flow rate therethrough. Thus, selectively regulating the negative pressure delivered through auxiliary conduit 265 can result in a decrease in flow rate through auxiliary conduit 265 when a large pressure differential exists (e.g., due to a decrease in the diameter of the inner lumen) and can result in an increase in flow rate through auxiliary conduit 265 when the pressure differential is equalized (e.g., due to an increase in the diameter of the inner lumen).

[0193] In some embodiments, the arrangement and / or configuration of the auxiliary conduit 265 can be "adjusted" and / or controlled to adjust the negative pressure applied by the inner cavity. For example, the auxiliary conduit 265 may be formed of a material having sufficient flexibility to allow the auxiliary conduit 265 to deform in a desired manner when exposed to negative pressure. In other embodiments, the wall of the auxiliary conduit 265 may have a sufficiently thin thickness to allow the wall to deform when exposed to negative pressure. In addition, in some embodiments, the length and / or inner diameter of the auxiliary conduit 265 can be configured to, for example, reduce the flow rate of the fluid passing therethrough. In other embodiments, any combination of flexibility, wall thickness, length, diameter, etc. can be used to jointly control and / or adjust the negative pressure applied therethrough. In other embodiments, negative pressure, etc. can be adjusted in response to changes in the temperature of the auxiliary conduit 265. For example, in some cases, as warm blood begins to flow through, the temperature of the auxiliary conduit 265 increases. In some cases, the increase in temperature causes relaxation of the diameter (e.g., an increase in the inner diameter), thereby accelerating the flow of blood when the negative pressure decreases in the same time period. In some cases, cooling of the auxiliary conduit 265 may cause the inner diameter of the auxiliary conduit 265 to shrink and / or decrease.

[0194] In some cases, the delivery devices described herein may be assembled in one or more manufacturing processes and packaged in a pre-assembled configuration. For example, in some cases, the delivery device 200 may be assembled by coupling the catheter 260 and the auxiliary catheter 265 to the actuator 270; positioning the catheter 260, the auxiliary catheter 265, and the actuator 270 relative to the first member 220 or the second member 230 of the introducer 210; coupling the first member 220 and the second member 230 to form the introducer 210, wherein the actuator 270 and at least a portion of the catheter 260 and the auxiliary catheter 265 are disposed in the internal volume 213 of the introducer 210; and coupling the locking member 240 to the introducer 210. In some cases, the assembly of the delivery device 200 may be performed in a substantially sterile environment (e.g., an ethylene oxide environment, etc.). In other embodiments, the delivery device described herein may be packaged in a non-assembled configuration (e.g., a user may open the package and assemble the components to form the delivery device). The components of the delivery device may be packaged together or separately. In some embodiments, the delivery device may be packaged with, for example, a PIV, an extension, a Y-adapter or a T-adapter, and / or any other suitable components.

[0195] Any of the delivery devices described herein may be configured such that at least a portion of the catheter is biased and / or selectively deflected when the catheter is advanced from its first position to its second position, as described above with reference to Figure 31-34As described in detail in the device 300 shown in FIG. 1 . In addition, a device having such an arrangement can be configured such that the biasing or selective deflection of the catheter causes a predictable and / or desired deflection, deformation, and / or reconfiguration of at least a portion of the catheter in response to the distal portion of the catheter striking an obstacle when advancing from its first position to its second position. In other words, any device described herein can be configured to "clutch" (e.g., deflect in a desired or predetermined manner) in response to the catheter striking an obstacle.

[0196] For example, Fig.46 is a flow chart illustrating a method 20 of using such a fluid delivery device according to one embodiment. As described above with reference to device 300, a fluid delivery device (also referred to herein as a "device") may include an introducer, a catheter, and an actuator. The introducer may have a distal portion including a locking member configured to be coupled to a vascular access device. The catheter may be at least temporarily disposed within the introducer and may be coupled to a portion of an actuator. The actuator may, in turn, be movably coupled to the introducer and configured to move the catheter relative to the introducer, as described below.

[0197] As described above, the device can be used to deliver fluid to or from a patient. More specifically, in this example, the device can be configured to deliver a volume of bodily fluid (e.g., blood) from the patient's vasculature to a fluid collection device, such as a reservoir, a syringe, an evacuated container, etc., configured to be in fluid communication with a catheter. Thus, method 20 includes coupling a locking member of the device to an indwelling peripheral venous line (PIV) at step 21. In other words, the locking member is coupled to a PIV that is at least partially disposed within the patient's vasculature.

[0198] In step 22, a first force is applied on the actuator to move the actuator relative to the introducer, so that the catheter is advanced to the second position from the first position. For example, the actuator can be movably connected to the introducer, and can include a first portion arranged outside the introducer and a second portion arranged inside the introducer and connected to the proximal portion of the catheter. Like this, the user can engage the device and can apply a first force (for example, with his or her finger or thumb) to move the actuator relative to the introducer. As described above at least with reference to device 200 and / or 300, the catheter is arranged in the introducer when in the first position and is advanced toward the second position to place the distal end portion of the catheter in a distal position (for example, the outside and the distal side of the introducer) relative to the introducer.

[0199] In step 23, when the actuator advances the catheter from the first position toward the second position, a second force different from the first force is applied to the proximal portion of the catheter. As described above with reference to device 300, for example, the arrangement of the actuator and the introducer can make the first part of the actuator contact the outer surface of the introducer. In certain embodiments, the contact between the first part of the actuator and the outer surface of the introducer can be sufficient to make the actuator tilt or angle relative to the introducer so that the longitudinal axis of the actuator parallel to the longitudinal axis of the introducer is no longer non-parallel to the longitudinal axis of the introducer. In such an embodiment, the contact between the first part of the actuator and the outer surface of the introducer causes the second part of the actuator to apply a second force on the proximal portion of the catheter. In addition, the magnitude and direction of the second force are different from the magnitude and direction of the first force, respectively.

[0200] As described above with reference to device 300, the catheter is at least partially disposed within the introducer so that a portion of the catheter is disposed between an actuator (coupled to the proximal portion of the catheter) and a locking member (configured to movably accommodate the catheter). Method 20 includes, at step 24, deflecting a portion of the catheter disposed between the actuator and the locking member by a first amount in response to a second force as the catheter is advanced from a first position to a second position. For example, the locking member defines an inner cavity that movably accommodates the catheter. The inner cavity of the locking member may define a longitudinal axis parallel to the longitudinal axis of the introducer. More specifically, in some embodiments, the longitudinal axis of the locking member may be coaxial with the longitudinal axis of the introducer. As described above, the contact between the first portion of the actuator and the outer surface of the introducer causes the actuator to be tilted or angled relative to the introducer so that the longitudinal axis of the actuator is not parallel to the longitudinal axis of the introducer. In the case where the second portion of the actuator is coupled to the proximal portion of the catheter, the tilt or angle of the actuator (and / or the second force) similarly causes the proximal portion of the catheter to be angled or tilted relative to the introducer. Thus, with the catheter disposed within the lumen of the locking element (e.g., the distal portion of the catheter when the catheter is in the first position) and the proximal portion of the catheter coupled to the second portion of the actuator, a second force applied to the proximal portion of the catheter causes a deflection of the portion of the catheter disposed between the locking element and the actuator (e.g., as described above with reference to Fig.31 and 32 Detailed description is given in the accompanying drawings. Moreover, deflection of the portion of the catheter can bias the catheter and / or preload or pre-pressurize the catheter in a predetermined and / or desired manner.

[0201] In step 25, the portion of the catheter disposed between the locking member 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 portion of the catheter striking an obstacle as the catheter is advanced from the first position to the second position. For example, in some cases, the distal end of the catheter may strike an obstacle, such as a portion of the hub of the PIV, a bend or kink in the PIV catheter, a clot or debris within the PIV, or the vascular system of the patient, the wall of the vascular system, or other anatomical structure, etc. As such, the obstacle may resist and / or exert a reaction force on the distal end of the catheter that may limit and / or prevent further advancement (e.g., distal movement) of the catheter. In some devices in which a portion of the catheter is not deflected by the first amount (as described above, in step 24), the first force exerted on the actuator may be transmitted through the actuator and the catheter, which in turn may cause the distal portion of the catheter to be damaged, kinked, bent, broken, etc., when struck. In other cases, the distal end of the catheter may pierce the wall or anatomical structure of the vascular system in response to the impact therebetween. In other cases, the distal portion of the catheter may damage or puncture a portion of the PIV in response to impact therebetween.

[0202] However, use of the apparatus according to method 20 enables the impact between the distal portion of the catheter and the obstacle to deflect the second portion of the catheter by a second amount, as described in detail above with reference to apparatus 300 (see, e.g., Fig.33 and 34). Thus, at least a portion of the first force being applied by the distal end of the catheter to the obstacle is transmitted to a biased preloaded and / or prestressed portion of the catheter disposed between the locking member and the actuator, which in turn can deflect the portion of the catheter by a second amount. The arrangement of the device causes the catheter to deflect by a second amount in a predictable, predetermined and / or desired manner, which in turn limits and / or substantially prevents damage to the catheter, the device, the PIV and / or the patient's vascular system. In other words, the arrangement of the device causes the catheter to "clutch" in response to the distal portion of the catheter hitting the obstacle when the catheter is advanced from the first position to the second position. In addition, the device can be configured so that after "clutching" or deflecting the catheter, the user can reduce the magnitude of the first force applied to the actuator, which in turn can allow the catheter to "disengage" and / or reconfigure to reduce the amount of the second deflection. In some cases, such reconfiguration can, for example, allow the distal portion of the catheter to be repositioned relative to the obstacle, which in some cases can allow the distal portion to advance beyond the obstacle, which was previously limited and / or prevented due to the impact between them. Thus, method 20 can be used to advance a catheter while reducing, limiting and / or substantially preventing damage to the patient's device, PIV and / or vasculature. In addition, in some cases, once the catheter is placed in the second position, the device can be used to draw a volume of body fluid (e.g., blood), as described in detail above with reference to specific embodiments.

[0203] Although various embodiments have been described above, it should be understood that they are presented by way of example only, and not limitation. Where the schematic diagrams and / or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of the components may be modified. Although various embodiments have been described as having a combination of specific features and / or components, other embodiments may also have any combination of features and / or components from any of the embodiments described above.

[0204] Although embodiments have been specifically shown and described, it should be understood that various changes can be made in form and detail. For example, although the above shows and describes that the delivery device 200 includes a catheter 260 and an auxiliary catheter 265, each of which is coupled to the actuator 270, in other embodiments, the delivery device 200 may include a single catheter (e.g., catheter 260). For example, in some embodiments, at least the second portion 275 of the actuator 270 may be configured to transition between an open configuration and a closed configuration. In such embodiments, when the second portion 275 is in an open configuration, the catheter 260 may be placed in a desired position relative to the second portion 275. Then, the second portion 275 may be transformed from an open configuration to a closed configuration to keep 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 in the opening 276 may form a friction fit that is capable of keeping the catheter 260 in a fixed position relative to the actuator 270. Furthermore, the friction fit defined between the second portion 275 of the actuator 270 and the catheter 260 can isolate the portion of the catheter 260 distal to the actuator 270 from the portion of the catheter 260 proximal to the actuator 270. Thus, the portion of the catheter 260 proximal to the actuator 270 can extend through the opening 217 and at least partially outside of the introducer 210 without contaminating the portion of the catheter 260 distal to the actuator 270.

[0205] Any aspect and / or feature of the embodiments shown and described herein may be modified to affect the performance of the delivery device. For example, the ribs in the set of ribs 236 of the introducer 210 and the lugs 273 of the actuator 270 may have any suitable shape, size, configuration, and / or arrangement to produce a desired set of features associated with the movement of the actuator 270 relative to the introducer 210, as described above. As another example, any component of the delivery device 100 and / or 200 may be formed of any suitable material that can produce the desired hardness, strength, and / or stiffness of the component. For example, in some embodiments, at least the proboscis 242 of the locking member 240 may be formed of a substantially rigid material (e.g., metal or hard plastic). In such embodiments, when the proboscis 242 is at least partially disposed therein, forming at least the proboscis 242 from a substantially rigid material can increase the structural support provided by the proboscis 242 to the PIV. Similarly, the proboscis 242 can provide support and / or guide the catheter 260 as the catheter 260 moves therethrough.

[0206] Where the above methods and / or schematics indicate certain events and / or flow patterns occurring in a particular order, the ordering of certain events and / or flow patterns may be modified. In addition, certain events may be performed simultaneously and sequentially in parallel processing, where possible.

Claims

1. A system comprising: an adapter configured to couple to a hub of a peripheral intravenous access device (PIV), the PIV being at least partially inserted into a vein of a patient, the distal portion of the adapter comprising a guide extending through a seal of the hub and at least partially distal to the seal into a lumen of the PIV when the adapter is coupled to the hub of the PIV, the distal end of the guide being a distal-most portion of the adapter; and A fluid delivery device having an introducer, a catheter, and an actuator connected to the catheter, wherein the distal portion of the introducer is configured to be connected to the proximal portion of an adapter, the fluid delivery device having a first configuration and a second configuration, wherein the catheter is in the introducer and is proximal to the PIV, and wherein the catheter extends from the introducer through an inner cavity of the adapter and through at least a portion of the inner cavity of the PIV, the actuator being configured to move relative to the introducer to transition the fluid delivery device between the first configuration and the second configuration, the fluid delivery device having a top surface and a bottom surface, wherein the catheter is arranged to be closer to the bottom surface relative to the top surface in the fluid delivery device, thereby allowing the catheter to transition from an unengaged linear configuration to an engaged curved configuration by deflecting or deforming in a curved shape between the top surface and the bottom surface as the actuator and the catheter transition from the first configuration toward the distal side toward the second configuration.

2. The system according to claim 1, wherein: When the fluid delivery device is in the second configuration, the distal portion of the catheter is in the patient's vein and distal to the PIV.

3. The system according to claim 1, wherein: When the fluid delivery device is in the second configuration, at least the distal portion of the catheter is distal to the seal disposed within the PIV lumen.

4. The system according to claim 1, wherein: An adapter is an extension piece.

5. The system according to claim 1, wherein: When the adapter is coupled to the hub of the PIV and the fluid delivery device is transitioned from the first configuration to the second configuration, the guide at the distal end portion of the adapter guides the catheter into the lumen of the PIV distally toward the seal.

6. The system according to claim 5, wherein: The guide of the adapter has a first stiffness, the conduit of the fluid delivery device has a second stiffness less than the first stiffness, and the first stiffness is sufficient to open the seal without deforming the guide of the adapter.

7. The system according to claim 1, wherein: The introducer, when coupled to the adapter, is disposed at a predetermined angle relative to the skin surface, the predetermined angle being substantially equal to the insertion angle of the PIV.

8. The system according to claim 7, wherein: The predetermined angle is between 0 and 30 degrees.

9. The system according to claim 1, wherein: The PIV is at least partially inserted into a vein of the patient at an insertion angle, the system further comprising: A support member is configured to contact the patient's skin surface, and when the adapter is coupled to the hub of the PIV and the fluid delivery device is coupled to the adapter, the support member supports at least a portion of the adapter and the fluid delivery device to maintain the adapter and the fluid delivery device at an insertion angle of the PIV.

10. The system according to claim 1, wherein: When the adapter is coupled to the PIV, a portion of the adapter contacts the exterior of the PIV and a portion of the guide contacts the interior of the PIV.

11. A system comprising: an adapter having a proximal portion and a distal portion and defining an inner lumen, the distal portion of the adapter being configured to couple to a hub of a peripheral intravenous access device (PIV) to place the inner lumen of the adapter in fluid communication with the inner lumen of the PIV, the PIV being at least partially inserted into a vein of the patient at an insertion angle relative to a skin surface of the patient; and A fluid delivery device having an introducer, a catheter, and an actuator coupled to the catheter, the distal portion of the introducer being configured to couple to the proximal portion of an adapter, the fluid delivery device having a first configuration and a second configuration, wherein the catheter is in the introducer and proximal to the PIV, and in the second configuration the catheter extends from the introducer through an inner cavity of the adapter and through at least a portion of the inner cavity of the PIV, the actuator being configured to move relative to the introducer to transition the fluid delivery device between the first configuration and the second configuration, the fluid delivery device having a top surface and a bottom surface, wherein the catheter is disposed in the fluid delivery device closer to the bottom surface than the top surface, thereby allowing the catheter to transition from an unengaged linear configuration to an engaged curved configuration by deflecting or deforming in a curved shape between the top surface and the bottom surface as the actuator and the catheter transition from the first configuration distally to the second configuration; The adapter includes an arm that is configured to releasably engage the hub of the PIV to couple the adapter to the hub of the PIV, and the arm is configured to contact the patient's skin surface to maintain the adapter and the fluid delivery device at the insertion angle relative to the skin surface when the adapter is coupled to the hub of the PIV and the fluid delivery device is coupled to the adapter.

12. The system according to claim 11, wherein: The insertion angle is between 0 and 30 degrees.

13. The system according to claim 11, wherein: The arm holds the adapter and the fluid delivery device at the insertion angle such that an axis at the insertion angle relative to the skin surface extends through each of the PIV lumen, the adapter lumen, and the lumen defined by the conduit of the fluid delivery device.

14. The system according to claim 11, wherein: When the adapter is coupled to the hub of the PIV, the distal portion of the adapter extends into the PIV lumen and opens a seal disposed in the PIV lumen.

15. The system according to claim 11, wherein: The distal portion of the adapter includes a guide that extends through the seal of the hub and at least partially distally of the seal into the lumen of the PIV when the adapter is coupled to the hub of the PIV.

16. The system of claim 15, wherein: The guide of the adapter has a first stiffness, the conduit of the fluid delivery device has a second stiffness less than the first stiffness, and the first stiffness is sufficient to open the seal without deforming the guide of the adapter.

17. The system of claim 16, wherein: An adapter is an extension piece.

18. The system of claim 17, wherein: The seal of the PIV is a first seal, the proximal portion of the adapter is a proximal portion of the extension and includes a second seal, and the distal portion of the introducer includes a lock configured to couple the introducer to the extension; The lock of the introducer includes a guide that extends into the lumen of the extension and opens the second seal when the introducer is coupled to the adapter.

19. The system of claim 15, wherein: When the adapter is coupled to the PIV, a portion of the adapter contacts the exterior of the PIV and a portion of the guide contacts the interior of the PIV.

20. A system comprising: a peripheral venous access device (PIV) at least partially inserted into a vein of a patient at an insertion angle, the PIV comprising a hub defining a lumen and including a seal disposed within the lumen; an adapter having a distal portion and a proximal portion, the distal portion including a guide extending through the seal and into the lumen of the hub distal to the seal as the adapter is coupled to the hub of the PIV, the distal end of the guide being the most distal portion of the adapter; and A fluid delivery device having an actuator connected to a catheter and an introducer capable of being connected to a proximal portion of an adapter, the fluid delivery device having a first configuration and a second configuration, wherein the catheter of the fluid delivery device is in the introducer in the first configuration, and wherein the catheter extends from the introducer through an inner cavity of the adapter and through at least a portion of the inner cavity of the PIV when the introducer is connected to the adapter and the adapter is connected to the PIV in the second configuration, the actuator being configured to move relative to the introducer to transition the fluid delivery device between the first configuration and the second configuration, the fluid delivery device having a top surface and a bottom surface, wherein the catheter is arranged to be closer to the bottom surface relative to the top surface in the fluid delivery device, thereby allowing the catheter to transition from an unengaged linear configuration to an engaged curved configuration by deflecting or deforming in a curved shape between the top surface and the bottom surface as the actuator and the catheter transition from the first configuration distally to the second configuration.

21. The system of claim 20, wherein: When the adapter is coupled to the PIV, a portion of the adapter contacts the exterior of the PIV and a portion of the guide contacts the interior of the PIV.

22. The system of claim 20, further comprising: A support member extends from a surface of at least one of the adapter and the fluid delivery device and is configured to contact a surface of the patient's skin so as to maintain the adapter and the fluid delivery device at an insertion angle of the PIV when the adapter is coupled to the hub of the PIV and the fluid delivery device is coupled to the adapter.

23. The system of claim 22, wherein: The insertion angle is between 0 and 30 degrees.

24. The system of claim 22, wherein: The support holds the adapter and the fluid delivery device at the insertion angle such that an axis at the insertion angle extends through each of the PIV lumen, the adapter lumen, and a lumen defined by a catheter of the fluid delivery device.

25. The system of claim 20, wherein: In the second configuration the distal portion of the catheter is distal to the PIV and within the patient's vein.

26. The system of claim 20, wherein: The guide of the adapter has a first stiffness, the conduit of the fluid delivery device has a second stiffness less than the first stiffness, and the first stiffness is sufficient to open the seal without deforming the guide of the adapter.

27. The system of claim 20, wherein: The seal of the PIV is a first seal, and the proximal portion of the adapter includes a second seal; The distal portion of the introducer has a locking member that couples the introducer to the adapter, the locking member including a proboscis that extends into the lumen of the adapter and opens the second seal when the introducer is coupled to the adapter.

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