Fluid delivery device with deflection biased catheter support - Patent Application 20070122997
The fluid delivery device addresses catheter deformation issues in VADs by using a pre-biased catheter support to stabilize the catheter within the introducer, ensuring smooth advancement and consistent fluid flow through PIVCs.
Patent Information
- Application Number
- JP2025513042
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-08-30
- Filing Date
- 2023-08-29
- Publication Date
- 2025-09-04
AI Technical Summary
Existing fluid delivery devices for vascular access devices (VADs) face issues with catheter bending, kinking, and buckling during deployment, particularly at the curved regions of peripheral intravenous catheters (PIVCs), leading to deformation and inefficient fluid administration.
A fluid delivery device with an introducer featuring a catheter support that includes a passage configured to pre-bias the catheter downward, minimizing bending and buckling by guiding the catheter through a slotted or non-linear passageway that encourages controlled curvature, thereby stabilizing the catheter as it advances into the PIVC.
The solution effectively reduces catheter deformation and enhances the stability of fluid delivery by minimizing bending and buckling, ensuring smooth advancement and consistent fluid flow through the vascular access device.
Smart Images

Figure 2025529221000001_ABST
Abstract
Description
[Technical Field]
[0001] The present invention relates to a fluid delivery device for introducing a catheter into an indwelling catheter of a vascular access device. [Background technology]
[0002] This application claims priority to U.S. Patent Application No. 17 / 899,099, filed August 30, 2022, entitled "Fluid Delivery Device with Deflectively Biased Catheter Support," the entire disclosure of which is incorporated herein by reference in its entirety.
[0003] Catheters are frequently used to administer fluids both inside and outside the body. Patients in various settings, including hospitals and home care, receive fluids, medications, and blood products through vascular access devices (VADs), which include catheters inserted into the patient's vascular system. A typical VAD includes a plastic catheter inserted into a patient's vein, and the length of the catheter can vary from a few centimeters, for example, if the VAD is a peripheral intravenous catheter (PIVC), to many centimeters, for example, if the VAD is a central venous catheter (CVC).
[0004] Recent developments in the field of PIVCs have resulted in technologies designed to facilitate fluid delivery using indwelling PIVCs and associated fluid delivery devices. The primary method by which these devices function is through the use of an introducer to insert a catheter, probe, tube, or other instrument through the catheter lumen of the PIVC. The introducer is then attached to the PIVC's catheter adapter, which allows for catheter insertion. For example, the catheter adapter may include a needleless access connector that allows for the introduction of a catheter to access the PIVC and access the patient's vasculature. Fluids can then be infused into the patient or blood samples can be withdrawn using syringes and / or vacutainers without requiring an additional needlestick.
[0005] An introducer for a fluid delivery device typically includes a housing, a catheter movable within the housing and extendable therefrom for advancement into the indwelling PIVC, and an advancement member or actuator that can be actuated by an operator relative to the housing. That is, the actuator is moved distally by the operator, causing corresponding movement of the catheter relative to the housing, so that the catheter can be advanced from the distal end of the housing into the indwelling PIVC. However, during deployment of the fluid delivery device catheter, particularly when the distal end portion of the catheter reaches the curved region of the PIVC (near where the PIVC enters the skin) and is curved back and forth as it passes along the vein, the fluid delivery device catheter experiences column loads that can cause the catheter to bend, twist, and / or deform. As the catheter bends, it moves in random directions, forming a sinusoidal wave, and as the force increases, it flattens against the sidewall of the fluid delivery device housing. Further force applied to the catheter by further movement of the actuator can cause the catheter to fold back, or "buckle."
[0006] To address the issue of catheter buckling, some introducers include a support member, or catheter support, located within the introducer housing at a location between the actuator and the distal end of the housing. The catheter is routed through the catheter support to shorten the unsupported length of the tube, effectively increasing the resistance the flow tube can withstand before buckling. However, if the load on the tube is high enough, the tube can still bend. Because the tube is vertically offset downward within the housing (to accommodate part of the actuator within the housing), the gap at the top is much larger than the gap at the bottom, and if a sufficiently high load is applied to the tube, the tube tends to bend upward. When the tube bends upward, additional force applied by the user to the actuator acts to deform and buckle the tube rather than pushing it forward, while when the tube bends downward, the force applied to the actuator acts to advance the tube rather than deforming it.
[0007] Therefore, there is a need for a fluid delivery device and its introducer that can advance the catheter into the PIVC while minimizing the possibility of bending, kinking, or deformation of the catheter. Furthermore, if the catheter is subjected to a load sufficient to cause bending, it is desirable for the fluid delivery device and introducer to bias the tube downward to minimize the possibility of buckling of the catheter. Summary of the Invention
[0008] Provided herein is a fluid delivery device for advancing a catheter into an indwelling catheter of a vascular access device. The fluid delivery device includes an introducer having a proximal end portion and a distal end portion, the distal end portion being connectable to the vascular access device and defining an interior volume configured to movably receive the catheter. The fluid delivery device also includes an actuator connected to the introducer and configured to move relative to the introducer to move the catheter between a first position where the catheter is disposed within the introducer and a second position where a distal end portion of the catheter is disposed beyond the distal end portion of the introducer, thereby allowing at least a first portion of the catheter to be disposed within the indwelling catheter. The fluid delivery device further includes a catheter support movably coupled to the introducer and positioned between the actuator and the distal end portion of the introducer, the catheter support defining a passage therein for receiving the catheter to provide support for a length of the catheter extending between the actuator and the distal end portion of the introducer, the passage of the catheter support configured to encourage and / or pre-bias the catheter downwardly.
[0009] In some embodiments, the catheter support includes a bracket portion and a hub portion, the hub portion including a top surface and a bottom surface, and a central axis of the hub portion extending longitudinally between a proximal end and a distal end of the hub portion.
[0010] In some embodiments, the catheter includes a proximal opening and a distal opening, and an open slotted passageway extending between the proximal opening and the distal opening, the open slotted passageway including an upper portion generally aligned with the distal opening and a lower portion perpendicularly below the upper portion and open along the bottom surface of the hub portion, wherein the catheter is urged to curve downwardly from the upper portion to the lower portion within the open slotted passageway.
[0011] In some embodiments, the passageway includes a proximal opening and a distal opening, and a closed slotted passageway extending between the proximal opening and the distal opening, the closed slotted passageway including an upper portion generally aligned with the distal opening and a lower portion vertically below the upper portion and terminating at a vertical position between the central axis of the hub portion and the bottom surface, wherein the catheter is urged to curve downward from the upper portion to the lower portion within the closed slotted passageway.
[0012] In some embodiments, the proximal opening, the distal opening, and the top are aligned with a tubing path along which the length of the catheter extends between the actuator and the distal end portion of the introducer.
[0013] In some embodiments, the proximal opening, the distal opening, and the top are offset vertically downward from a tubular path along which the length of the catheter extends between the actuator and the distal end portion of the introducer, thereby preloading the catheter and forcing it to bend downward.
[0014] In some embodiments, in response to the actuator moving along the housing to advance the catheter from the first position toward the second position, the catheter can bend downward only at the catheter support.
[0015] In some embodiments, the passageway includes a curved passageway, a central region of the passageway between the proximal and distal ends of the hub portion being offset vertically upward from the proximal and distal openings of the passageway, the curved passageway pre-biasing the catheter downward.
[0016] In some embodiments, the passageway includes a sinusoidal passageway that shifts vertically as it passes between the proximal and distal ends of the hub portion, the sinusoidal passageway pre-biasing the catheter downward.
[0017] In some embodiments, the proximal end of the hub portion is configured to engage with the actuator, such that during movement of the actuator to move the catheter from the first position to the second position, the actuator contacts the proximal end and moves the catheter support relative to the introducer.
[0018] In some embodiments, the distal end portion of the introducer includes a lock configured to couple the introducer to the vascular access device.
[0019] A fluid delivery device for advancing a catheter into an indwelling catheter of another vascular access device is provided, the fluid delivery device including an introducer having a proximal end portion and a distal end portion, the distal end portion being connectable to the vascular access device and defining an interior volume configured to movably receive the catheter. The fluid delivery device also includes an actuator movably connected to the introducer and configured to move relative to the introducer to move the catheter between a first position where the catheter is disposed within the introducer and a second position where a distal end portion of the catheter is disposed beyond the distal end portion of the introducer, whereby at least a first portion of the catheter may be disposed within the indwelling catheter. The fluid delivery device further includes a catheter support movably coupled to the introducer and positioned between the actuator and the distal end portion of the introducer, the catheter support including a bracket portion and a hub portion, the hub portion defining a passage therein for receiving the catheter to provide support for a length of the catheter extending between the actuator and the distal end portion of the introducer, the passage including proximal and distal openings, and a slotted passage extending between the proximal and distal openings, the slotted passage configured to encourage downward bending of the catheter within the slotted passage.
[0020] In some embodiments, the slotted passageway comprises an open slotted passageway having an upper portion generally aligned with the distal opening and a lower portion vertically below the upper portion, the lower portion terminating at a vertical position between the central axis and the bottom surface of the hub portion, wherein the catheter is urged to curve downward from the upper portion toward the lower portion within the closed slotted passageway.
[0021] In some embodiments, the slotted passageway comprises a closed slotted passageway including an upper portion generally aligned with the distal opening and a lower portion vertically below the upper portion, the lower portion terminating at a vertical position between the central axis and the bottom surface of the hub portion, wherein the catheter is urged to curve downward from the upper portion toward the lower portion within the closed slotted passageway.
[0022] In some embodiments, the proximal opening, the distal opening, and the top are aligned with a tubing path along which the length of the catheter extends between the actuator and the distal end portion of the introducer.
[0023] In some embodiments, the proximal opening, the distal opening, and the top are offset vertically downward from a tubular path along which the length of the catheter extends between the actuator and the distal end portion of the introducer, thereby preloading the catheter and forcing it to bend downward.
[0024] In some embodiments, the proximal end of the catheter support is configured to engage with the actuator, such that during movement of the actuator to move the catheter from the first position to the second position, the actuator contacts the proximal end and moves the catheter support relative to the introducer.
[0025] A fluid delivery device for advancing a catheter into an indwelling catheter of another vascular access device is provided, the fluid delivery device including an introducer having a proximal end portion and a distal end portion, the distal end portion being connectable to the vascular access device and defining an interior volume configured to movably receive the catheter. The fluid delivery device also includes an actuator movably connected to the introducer and configured to move relative to the introducer to move the catheter between a first position where the catheter is disposed within the introducer and a second position where a distal end portion of the catheter is disposed beyond the distal end portion of the introducer, whereby at least a first portion of the catheter may be disposed within the indwelling catheter. The fluid delivery device further includes a catheter support movably coupled to the introducer and positioned between the actuator and the distal end portion of the introducer, the catheter support defining a passage therein for receiving the catheter to provide support for a length of the catheter extending between the actuator and the distal end portion of the introducer, the passage including a non-linear passage configured to pre-bias the catheter downward as the catheter enters and exits the catheter support.
[0026] In some embodiments, the non-linear passageway comprises an arcuate passageway, a central region of the arcuate passageway between the proximal and distal ends of the hub portion being offset vertically upward from the proximal and distal openings of the passageway, and the curved passageway pre-biases the catheter downwardly.
[0027] In some embodiments, the non-linear passageway comprises a sinusoidal passageway that shifts vertically as it passes between the proximal and distal ends of the hub portion, the sinusoidal passageway pre-biasing the catheter downward. [Brief explanation of the drawings]
[0028] [Figure 1] FIG. 1 is a perspective view of a fluid delivery device in which embodiments of the present application may be incorporated. [Figure 2] 2 is a top view of the fluid delivery device shown in FIG. 1. FIG. [Figure 3] 3 is an exploded view of the fluid delivery device of FIG. 1. FIG. [Figure 4] 4 is a perspective view of a first member of an introducer housing included in the fluid delivery device of FIG. 1; [Figure 5] 5 is a perspective view of a second member of an introducer housing included in the fluid delivery device of FIG. 1. FIG. [Figure 6] 6 is a rear perspective view of the introducer housing formed by connecting the first member shown in FIG. 4 to the second member shown in FIG. [Figure 7] 7 is a front perspective view of the introducer housing shown in FIG. 6. FIG. [Figure 8] FIG. 8 is a cross-sectional view of the introducer taken along line 8-8 of FIG. [Figure 9] 9 is a rear perspective view of a lock included in the fluid delivery device of FIG. 1. FIG. [Figure 10] 10 is an exploded perspective view of a catheter, a secondary catheter, and an actuator included in the fluid delivery device of FIG. 1. FIG. [Figure 11] FIG. 11 is a perspective view of the actuator shown in FIG. [Figure 12] 12 is a cross-sectional view of the fluid delivery device taken along line 12-12 of FIG. [Figure 13] 13 is a rear perspective view of a catheter support included in the fluid delivery device of FIG. 1. FIG. [Figure 14] 14 is a front perspective view of the catheter support of FIG. 13. FIG. [Figure 15]15 is a perspective view of a portion of the fluid delivery device of FIG. 1 with the second introducer housing portion removed. [Figure 16A] 16A is a rear perspective view of a catheter support that may be included in the fluid delivery device of FIG. 1 according to one embodiment of the present invention. [Figure 16B] FIG. 16B is a front perspective view of the catheter support of FIG. 16A. [Figure 16C] FIG. 16C is a rear view of the catheter support of FIG. 16A. [Figure 16D] FIG. 16D is a front view of the catheter support of FIG. 16A. [Figure 17A] 17A is a rear perspective view of a catheter support that may be included in the fluid delivery device of FIG. 1 according to another embodiment of the present invention. [Figure 17B] FIG. 17B is a front perspective view of the catheter support of FIG. 17A. [Figure 17C] FIG. 17C is a rear view of the catheter support of FIG. 17A. [Figure 17D] FIG. 17D is a front view of the catheter support of FIG. 17A. [Figure 18A] 18A is a front view of a catheter support that may be included in the fluid delivery device of FIG. 1 according to another embodiment of the present invention. [Figure 18B] FIG. 18B shows the catheter support of FIG. 18A positioned within the introducer of FIG. 1 relative to the distal end of the actuator and housing. [Figure 19A] 19A is a front view of a catheter support that may be included in the fluid delivery device of FIG. 1 according to another embodiment of the present invention. [Figure 19B] FIG. 19B shows the catheter support of FIG. 19A positioned within the introducer of FIG. 1 relative to the distal end of the actuator and housing. [Figure 20A] 20A is a rear perspective view of a catheter support that may be included in the fluid delivery device of FIG. 1 according to another embodiment of the present invention. [Figure 20B]FIG. 20B is a front perspective view of the catheter support of FIG. 20A. [Figure 20C] FIG. 20C is a side view of the catheter support of FIG. 20A, showing the passageway of the catheter support in phantom. [Figure 21A] 21A is a rear perspective view of a catheter support that may be included in the fluid delivery device of FIG. 1 according to another embodiment of the present invention. [Figure 21B] FIG. 21B is a front perspective view of the catheter support of FIG. 21A. [Figure 21C] FIG. 21C is a side view of the catheter support of FIG. 21A, showing the passageway of the catheter support in phantom. [Figure 22] FIG. 22 is a side view of the blood collection device of FIG. 1 in a first configuration, showing the placement of the actuator and catheter support. [Figure 23] FIG. 23 is a side view of the blood collection device of FIG. 1 in a second configuration, illustrating the placement of the actuator and catheter support. DETAILED DESCRIPTION OF THE INVENTION
[0029] The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.
[0030] As used herein, the terms "proximal" and "distal" refer to directions closer to and further from a user who contacts a device with a patient. Thus, for example, the end of a device that first contacts a patient's body is the distal end, and the opposite end of the device (e.g., the end of the device that is manipulated by a user) is the proximal end of the device.
[0031] Spatial or directional terms such as "left," "right," "inner," "outer," "above," "below," etc. should not be considered limiting as the present invention may assume various alternative orientations.
[0032] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall refer to the present invention as oriented in the drawings. However, it should be understood that the present invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings, and described in the following specification, are merely exemplary embodiments of the present invention.
[0033] The terms "first," "second," etc. are not intended to refer to a particular order or chronology, but rather to different conditions, characteristics, or elements.
[0034] As used herein, "at least one of" is synonymous with "one or more of." For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of A only, or one or more of B only, or one or more of C only, or one or more of A and one or more of B, or one or more of A and one or more of C, or one or more of B and one or more of C, or one or more of all of A, B, and C.
[0035] The present invention relates to a fluid delivery device for phlebotomy via a peripheral intravenous line or catheter, and a method for using the fluid delivery device to advance a flexible tube or catheter into a peripheral intravenous line for subsequent blood withdrawal and / or medication administration to a patient.
[0036] 1-21 illustrate a fluid delivery device 200 and its components according to an embodiment of the present invention. The fluid delivery device 200 can be of any suitable shape, size, or configuration and can be coupled to a PIVC (not shown in FIGS. 1-21 ), for example, via a lock and / or adapter. As described in further detail herein, a user can transition the fluid delivery device 200 from a first configuration to a second configuration to advance a catheter through an existing, placed, and / or indwelling PIVC (i.e., when the fluid delivery device 200 is coupled to the PIVC) such that at least an end of the catheter is positioned distal to the PIVC. Furthermore, because peripheral venous lines each have different shapes, sizes, and / or configurations based, for example, on the manufacturer of the PIVC and / or its intended use, the fluid delivery device 200 can be positioned to couple the fluid delivery device 200 to a PIVC in any suitable configuration and then advance at least a portion of the catheter through the PIVC. Additionally, the fluid delivery device 200 can be manipulated by the user to position the distal face of the catheter a predetermined and / or desired distance from the distal face of the PIVC within a portion of the vein receiving substantially unobstructed blood flow.
[0037] 1-3 , fluid delivery device 200 includes an introducer 210, a lock 240, a catheter 260, a secondary catheter 265, an actuator 270, and a catheter support 280. Introducer 210 can be any suitable shape, size, or configuration. For example, in some embodiments, introducer 210 can be an elongated member having a substantially circular cross-sectional shape. In some embodiments, the shape of introducer 210 and / or one or more features or surface finish of at least the outer surface of introducer 210 can be arranged to improve the ergonomics of fluid delivery device 200, potentially allowing a user to operate fluid delivery device 200 with one hand (i.e., one-handed use).
[0038] 2-8 , introducer 210 of fluid delivery device 200 includes an introducer housing 218 having a first housing member 220 and a second housing member 230 coupled to form housing 218. First housing member 220 includes a proximal end portion 221, a distal end portion 222, and an inner surface 223. Inner surface 223 has a first portion 224 and a second portion 225, which in one embodiment is a flange. Proximal end portion 221 of first housing member 220, and more specifically, the proximal wall of first housing member 220, defines a notch 226 configured to selectively receive a portion of a secondary catheter 265, as described in further detail herein.
[0039] Second housing member 230 has a proximal end portion 231, a distal end portion 232, an inner surface 233, and an upper surface 235. As described above with reference to first housing member 220, proximal end portion 231 of second housing member 230, and more particularly, the proximal wall of second housing member 230, defines a notch 234 configured to selectively receive a portion of secondary catheter 265.
[0040] The top surface 235 of the second housing member 230 includes a set of ribs 236 distributed along the length of the second housing member 230, with each rib 236 extending along the width of the second housing member 230. The ribs 236 formed on the top surface 235 of the second housing member 230 can be of any suitable shape, size, and / or configuration. For example, the set of ribs 236 includes a first portion 237 having a first size and shape and a second portion 238 having a second size and shape that is different from the first size and shape. Each rib of the second portion 238 has a size and shape that is larger than the size and shape of each rib of the first portion 237.
[0041] As described in further detail herein, a portion of actuator 270 is configured to advance along upper surface 235, which forms set of ribs 236, when a user moves actuator 270 relative to introducer housing 218, causing actuator 270 (and catheter 260 coupled thereto) to vibrate. In some cases, this vibration may facilitate, for example, advancing catheter 260 through a portion of fluid delivery device 200, a portion of the PIVC, and / or a portion of a blood vessel. In some cases, larger size ribs on second portion 238 may increase the amount of vibration as actuator 270 moves along upper surface 235 (as described above). In some cases, larger size ribs on second portion 238 may increase the force sufficient to move a portion of actuator 270 along upper surface 235.
[0042] 6-8 , the first housing member 220 is configured to be coupled to the second housing member 230 to collectively form the introducer housing 218. In some embodiments, forming the introducer housing 218 from the first housing member 220 and the second housing member 230 can reduce undesirable deformation of the shape and / or size of the inner surfaces 223 and 233 during manufacturing (e.g., due to draft angle and / or manufacturing tolerances) and, in some cases, can reduce the likelihood of kinking, bending, and / or deformation of the catheter 260 during use of the fluid delivery device 200. In some embodiments, forming the introducer housing 218 from the first housing member 220 and the second housing member 230 allows at least the inner surface 223 of the first housing member 220 to form a serpentine shape that would be challenging if the introducer housing 218 were manufactured from a single workpiece.
[0043] The first housing member 220 and the second housing member 230 collectively form the proximal end portion 211 and the distal end portion 212 of the introducer housing 218 and collectively define the interior volume 213 of the introducer housing 218. As shown in FIG. 6 , the proximal end portion 211 of the introducer housing 218 defines an opening 217. Specifically, the opening 217 is collectively formed and / or defined by a notch 226 of the first housing member 220 and a notch 234 of the second housing member 230. The proximal end portion 211 is arranged such that the portion of the opening 217 defined by the notch 226 of the first housing member 220 has a first size and / or shape, and the portion of the opening 217 defined by the notch 234 of the second housing 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 opening 217 is narrowed, pinched, occluded, and / or reduced. As described in further detail herein, opening 217 is configured to receive a portion of secondary catheter 265, and secondary catheter 265 can move within opening 217 from the larger portion of opening 217 to the reduced portion of opening 217 (e.g., the portion formed by notch 234 in second housing member 230) to occlude, pinch, and / or clamp secondary catheter 265.
[0044] As shown in FIG. 7 , the distal end portion 212 of the introducer housing 218 includes and / or forms a coupler 216. In other words, the distal end portion 222 of the first housing member 220 and the distal end portion 232 of the second housing member 230 collectively form the coupler 216 at the distal end portion 212 of the introducer housing 218. The coupler 216 can be of any suitable shape, size, and / or configuration. For example, in this embodiment, the coupler 216 forms a threaded set that can form a threaded connection with an associated threaded portion of the lock 240, as described in further detail herein. Although not shown in FIG. 7 , the distal end portion 211 of the introducer housing 218 can include and / or be configured to receive a seal (not shown) that can selectively seal and / or fluidly isolate the interior volume 213 of the introducer housing 218 (from at least the open portion of the coupler 216). During use, the seal transitions from a sealed or closed configuration to an open configuration, for example, to allow passage of a portion of the catheter 260. In some embodiments, the seal can contact an outer surface of the catheter 260 to define a seal therebetween, which is operable to limit and / or substantially prevent backflow of fluid between the outer surface of the cannula and the seal.
[0045] The inner surface 223 of the first housing member 220 and the inner surface 233 of the second housing member 230 collectively define the interior volume 213 of the introducer housing 218. As shown in FIG. 8 , the inner surfaces 223 and 233 are arranged such that the interior volume 213 has a serpentine cross-sectional shape and / or defines a serpentine cross-sectional shape. For example, the interior volume 213 can have a substantially S-shaped or at least partially S-shaped cross-sectional shape. More specifically, the interior surface 223 of the first housing member 220 includes and / or forms a ridge, tab, flange, protrusion, and / or wall configured to separate a first portion 224 of the interior surface 223 from a second portion 225 of the interior surface 223. Thus, the serpentine cross-sectional shape of the interior volume 213 forms and / or defines the first portion 214 of the interior volume 213 and the second portion 215 of the interior volume 213. In this manner, first portion 214 of interior volume 213 is spaced apart without being fluidly isolated from second portion 215 of interior volume 213. In other words, first portion 214 of interior volume 213 defines an axis that is parallel to and offset from the axis defined by second portion 215 of interior volume 213.
[0046] 8 , the first portion 214 of the internal volume 213 extends through the wall of the introducer housing 218. Similarly, the introducer housing 218 defines a slot, channel, track, opening, etc. (e.g., collectively defined by the first housing member 220 and the second housing member 230) that is in fluid communication with the first portion 214 of the internal volume 213. Conversely, the second portion 215 of the internal volume 213 is completely defined and / or surrounded (at least circumferentially) by the introducer housing 218. The serpentine cross-sectional shape of the internal volume 213 is shaped such that the second portion 215 is not visible (e.g., outside the line of sight) through the slot (which is in fluid communication with the first portion 214 of the internal volume 213), thereby limiting and / or substantially preventing contamination of the catheter 260 disposed therein.
[0047] In this embodiment, second portion 215 of internal volume 213 is substantially aligned with, for example, a portion of opening 217 and a portion of the opening defined by coupler 216. Furthermore, second portion 215 of internal volume 213 is configured to be substantially aligned with lock 240 when the lock is coupled to coupler 216 of introducer housing 218. In other words, an axis defined by second portion 215 of internal volume 213 is substantially coaxial with an axis defined by a portion of lock 240, as described in further detail herein. In this manner, second portion 215 of internal volume 213 can movably accommodate, for example, a portion of actuator 270 and a portion of catheter 260. Thus, the actuator 270 can move relative to the introducer housing 218 to move the catheter 260 between a first position in which the catheter 260 is fully positioned within the second portion 215 of the internal volume 213 and a second position in which at least a portion of the catheter 260 extends outside the second portion 215 of the internal volume 213 and is distal to the introducer housing 218.
[0048] The lock 240 of the fluid delivery device 200 can be of any suitable shape, size, and / or configuration. As previously described, the lock 240 is configured to be physically and fluidly coupled to the introducer housing 218 and configured to couple the introducer 210 to the PIVC and / or any suitable intermediate device or adapter coupled to the PIVC. The lock 240 has a coupler 241, a blunt needle cannula 242, a first arm 243, and a second arm 250, as shown in FIG. 9 . Further, the lock 240 defines a lumen 255 extending through the coupler 241 and the blunt needle cannula 242. The coupler 241 is configured to couple the lock 240 to the coupler 216 of the introducer housing 218. Specifically, in this embodiment, the coupler 241 includes and / or forms one or more protrusions configured to selectively engage with threads defined and / or formed by the coupler 216 of the introducer housing 218, thereby forming a threaded connection.
[0049] Blunt needle cannula 242 extends from coupler 246 and is disposed between first arm 243 and second arm 250. Blunt needle cannula 242 can be of any suitable shape, size, and / or configuration. In some embodiments, blunt needle cannula 242 can have a length sufficient to extend at least partially into or through the PIVC, through at least a portion of the PIVC, or through an adapter. Additionally, blunt needle cannula 242 can have an inner diameter (the diameter of the surface that at least partially defines lumen 255) that is comparable to or slightly larger than the outer diameter of a portion of catheter 260. Thus, lumen 255 of lock 240 can receive a portion of catheter 260 when fluid delivery device 200 transitions between the first and second configurations.
[0050] As described above, at least a portion of catheter 260 and at least a portion of secondary catheter 265 are movably disposed within second portion 215 of interior volume 213 defined by introducer housing 218. As shown in FIG. 10 , catheter 260 has a proximal end portion 261 and a distal end portion 262 and defines lumen 263. Proximal end portion 261 of catheter 260 is coupled to second portion 275 of actuator 270. In this manner, actuator 270 can move relative to introducer housing 218 to move catheter 260 between a first position in which catheter 260 is disposed within introducer housing 218 (e.g., catheter 260 is disposed entirely within introducer housing 218 or within introducer housing 218 and lock 240) and a second position in which a distal end portion of catheter 260 is at least partially disposed distal to lock 240 and / or PIVC (not shown) when lock 240 is coupled to the PIVC, as described in more detail herein. Distal end portion 262 can be of any suitable shape, size, and / or configuration and can define at least one opening in fluid communication with lumen 263.
[0051] Secondary catheter 265 has a proximal end portion 266 and a distal end portion 267 and defines a lumen 268. A portion of secondary catheter 265 is disposed within and extends through opening 217 of introducer housing 218 (e.g., collectively defined by notches 223 and 233 in first and second housing members 220 and 230, respectively). Thus, proximal end portion 266 is disposed at least partially outside introducer housing 218, and distal end portion 267 is disposed at least partially within second portion 215 of interior volume 213 defined by introducer housing 218. As described above, the secondary catheter 265 can be moved within the opening 217 between a first position and a second position to selectively pinch, pinch, twist, bend, and / or deform a portion of the secondary catheter 265, thereby occluding, pinching, twisting, closing, sealing, etc. the lumen 268 of the secondary catheter 265. For example, the first position can be associated with and / or aligned with a first portion of the opening 217 having a circumference and / or diameter that is greater than the circumference and / or diameter of a second portion of the opening 217 associated with and / or aligned with the second position. Thus, a user can manipulate the secondary catheter 265 to occlude the lumen 268 of the secondary catheter 265, thereby restricting, restricting, and / or substantially preventing fluid flow therethrough.
[0052] 10 , a proximal end portion 266 of the secondary catheter 265 is coupled to and / or includes a coupler 269. The coupler 269 is configured to physically and fluidly couple the secondary catheter 265 to any suitable device, such as, for example, a fluid reservoir, a fluid source, a syringe, a vacuum container holder (e.g., having a sheathed needle or configured to be coupled to a sheathed needle), a pump, etc. A distal end portion 267 of the secondary catheter 265 is at least partially disposed within a second portion 215 of the interior volume 213 defined by the introducer housing 218 and is coupled to a second portion 275 of the actuator 270. In some embodiments, secondary catheter 265 can have a larger diameter than catheter 260, such that proximal end portion 261 of catheter 260 is at least partially disposed within lumen 268 defined by secondary catheter 265 when catheter 260 and secondary catheter 265 are coupled to second portion 275 of actuator 270. In some embodiments, such an arrangement can reduce and / or substantially prevent leakage associated with fluid flowing between catheter 260 and secondary catheter 265, for example. In some embodiments, such an arrangement can also limit, reduce, and / or substantially prevent hemolysis of blood as it passes through catheter 260 and secondary catheter 265. In this manner, when coupler 269 is coupled to a fluid reservoir, fluid source, syringe, vacuum reservoir, pump, etc., secondary catheter 265 establishes fluid communication between catheter 260 and the reservoir, fluid source, pump, etc.
[0053] The actuator 270 of the fluid delivery device 200 is coupled to the catheter 260 and is movable along the length of the introducer housing 218 to transition the fluid delivery device 200 between a first configuration in which the catheter 260 is in a first position and a second configuration in which the catheter 260 is in a second position. The actuator 270 can be of any suitable shape, size, and / or configuration. For example, 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 housing 218.
[0054] 11 and 12 , 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 housing 218, 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 actuator 270 is disposed such that the engagement member 272 is disposed outside the introducer housing 218, and the remainder of the first portion 271 is within the first portion 214 of the interior volume 213 defined by the introducer housing 218. Thus, the engagement member 272 can be engaged and / or manipulated by a user (e.g., the user's finger or thumb) to move the actuator 270 relative to the introducer housing 218. In some embodiments, the engagement member 272 can include a set of ridges and / or any suitable surface finish that can improve the ergonomics of the actuator 270 and / or fluid delivery device 200, for example.
[0055] The engagement member 272 includes a tab 273 located at or near a proximal end portion of the engagement member 272. The tab 273 may be any suitable tab, rail, ridge, bump, protrusion, knob, roller, slider, etc. extending from a surface of the engagement member 272. The tab 273 is configured to selectively engage the top surface 235 of the second housing member 230 of the introducer housing 218. More specifically, the tab 273 contacts the ribs 236 formed by the second housing member 230, and as the actuator 270 moves along the length of the introducer housing 218, it moves along each successive rib, and the interaction of the tab 273 with the ribs 236 causes the actuator 270 to vibrate.
[0056] 3 and 13-15, the catheter support 280 (or alternatively, the "support member") of the introducer 210 typically includes a bracket portion 281 and a hub portion 282. The bracket portion 281 of the catheter support 280 is at least partially disposed within a first portion 214 of an interior volume 213 defined by the introducer 210, and the hub portion 282 of the catheter support 280 is disposed within a second portion 215 of the interior volume 213.
[0057] 3 and 15, the bracket portion 281 of the catheter support 280 is disposed entirely within the first portion 214 of the interior volume 213 defined by the introducer 210. In other, not shown, embodiments, the bracket portion 281 of the catheter support 280 is disposed outside the introducer 210 and may optionally include an engagement member that a user can engage and / or manipulate, for example, with the user's finger or thumb, to move the catheter support 280 relative to the introducer 210.
[0058] The hub portion 282 has a cross-sectional shape, e.g., an at least partially circular cross-sectional shape, based at least in part on the cross-sectional shape of the second portion 215 of the interior volume 213 defined by the introducer 210. In this manner, the inner surface 223 of the first member 220 (FIG. 4) and the inner surface 233 of the second member 230 (FIG. 5) can support and / or guide the hub portion 282 of the catheter support 280 as the catheter support 280 moves relative to the introducer 210.
[0059] Hub portion 282 defines a passageway 285 having a proximal opening 287 at the proximal end of hub portion 282 and a distal opening 288 at the distal end of hub portion 282. Passageway 285 is sized and shaped to allow catheter 260 to pass freely through passageway 285 while at the same time at least partially containing and preventing excessive movement of catheter 260 within second portion 215 of interior volume 213 of introducer 210. Additionally, passageway 285 is configured and shaped to bias or curve catheter 260 downwardly as actuator 270 advances toward distal end portion 212 of introducer 210 to minimize the likelihood of catheter 260 buckling, as will be described in more detail below.
[0060] The passageway 285 may include two portions: a proximal portion 289 adjacent the proximal opening 287 and a distal portion 290 adjacent the distal opening 288. The proximal portion 289 of the passageway 285 may be sized and shaped to receive at least a portion of the second portion 275 of the actuator 270, for example, the proximal portion 289 may be substantially conical or funnel-shaped. As shown in FIG. 21 , a notch 291 may be provided in the conical or funnel-shaped proximal portion 289 of the passageway 285.
[0061] The bracket portion 281 may have a serpentine cross-sectional shape based at least in part on the serpentine cross-sectional shape of the interior volume 213 of the introducer 210. In this manner, the bracket portion 281 of the catheter support 280 may define an axis that is parallel to but offset from the axis defined by the hub portion 282 of the catheter support 280. For example, the bracket portion 281 may have a substantially S-shaped or at least partially S-shaped cross-sectional shape, or the bracket portion 281 may form a dog-leg shape, or the like. The serpentine cross-sectional shape of the bracket portion 281, and therefore the catheter support 280, may be shaped such that the hub portion 282 of the catheter support 280 is not visible through the first portion 214 of the interior volume 213 and is out of the line of sight of the first portion 214 of the interior volume 213 defined by the introducer 210.
[0062] At least a portion of the bracket portion 281 of the catheter support 280 has a profile that corresponds to the outer surface of a flange 225 provided on the inner surface of the introducer 210, such that the bracket portion 281 fits over and at least partially covers the flange 225 and is movable along the flange 225 relative to the introducer 210 from the proximal end portion 211 of the introducer 210 to the distal end portion 212 of the introducer 210 and vice versa. When the catheter support 280 is moved relative to the introducer 210, the bracket portion 281 moves within the first portion 214 of the internal volume 213, and the hub portion 282 moves within the second portion 215 of the internal volume 213.
[0063] In the illustrated non-limiting embodiment, the bracket portion 281 of the catheter support 280 includes a cantilever arm 292 biased against the flange 225 of the introducer 210. The cantilever arm 292 includes a first end 293 extending from the hub portion 282 of the catheter support 280 and a second end 294 opposite the first end 293. The cantilever arm 292 may be shaped with a downward curve or sloped downward so that the second end 294 is lower than the first end 293. The gap between the hub portion 282 and the bracket portion 281 is small enough to allow the cantilever arm 292 to wrap around the flange 225 of the introducer 210. This creates friction between the introducer 210 and the catheter support 280, such that the catheter support 280 does not move under gravity but only when pushed by the assembly tool or actuator 270.
[0064] The catheter support 280 of the introducer 210 is positioned within the introducer housing 218 at a location between the actuator 270 and the distal end 212 of the introducer 210. The catheter 260 is routed through a passageway 285 in the hub portion 282, shortening the unsupported length of the catheter 260 and effectively increasing the resistance the catheter 260 can withstand before buckling. That is, the force at which the catheter 260 buckles is inversely proportional to the square of its effective length. Thus, as the effective length of the catheter 260 increases, the buckling force required to buckle the catheter 260 decreases, making the catheter more susceptible to buckling. Catheter support 280 supports catheter 260, thereby shortening the effective length of catheter 280, increasing the force required to buckle catheter 260, and reducing the tendency of catheter 260 to buckle - i.e., catheter support 280 divides the unsupported length of catheter 260 into two smaller sections that are more resistant to bending, twisting, flexing, and / or deformation.
[0065] Although the catheter support 280 is positioned to reduce the unsupported length of the catheter 260 and increase the catheter's resistance to buckling, it is recognized that bending of the catheter 260 may still occur when the catheter 260 is loaded in response to movement of the actuator 270 toward the distal end 212 of the introducer 210. Because the catheter 260 is offset vertically downward within the introducer housing 218 (to accommodate the second portion 275 of the actuator 270 within the second portion 215 of the interior volume 213), the upper clearance between the housing 218 and the catheter 260 is much larger than the lower clearance, and the catheter 260 will tend to bow upward when subjected to sufficient load. When catheter 260 is bent upward, the additional force applied by the user to actuator 270 tends to deform and buckle catheter 260 rather than pushing it forward, while when catheter 260 is bent downward, the force applied to actuator 270 tends to advance catheter 260 rather than deforming it.
[0066] In view of the above, catheter support 280 may be configured to encourage and / or pre-bias catheter 260 to curve downward within the catheter support during operation of introducer 210. Figures 16A-16D, 17A-17D, 18A and 18B, 19A and 19B, 20A-20C, and 21A-21C illustrate embodiments of catheter support 280 that bias catheter 260 downward, allowing it to be advanced into the PIVC while minimizing the possibility of buckling.
[0067] 16A-16D, a catheter support 280a is shown that encourages downward bending of the catheter 260. As previously mentioned, the catheter support 280a generally includes a bracket portion 281 and a hub portion 282. The hub portion 282 includes a top surface 300 (from which the bracket portion 281 extends upward) and a bottom surface 301, and defines a passageway 285 having a proximal opening 287 at the proximal end of the hub portion 282 and a distal opening 288 at the distal end of the hub portion 282.
[0068] 16A-16D, the passageway 285 is formed as an open, slotted passageway 285a. The open, slotted passageway 285a is formed between a proximal opening 287 and a distal opening 288 and is generally described as including an upper portion 302 and a lower portion 303. The upper portion 302 of the passageway is generally aligned with the distal opening 288, a central axis 304 of the hub portion 282, and the path along which the length of the catheter 260 extends between the actuator 270 and the distal end portion 212 of the introducer 210. The lower portion 303 of the passageway is perpendicularly below the upper portion 302 and extends downward to a bottom surface 301 of the hub portion 282, along which the slotted passageway 285a is open.
[0069] As previously described, the catheter 260 is routed through the passageway 285 in the hub portion 282, reducing the unsupported length of the catheter 260. In this embodiment, the catheter 260 is received in the upper portion 302 of the open slotted passageway 285a and is retained there during normal operation of the introducer 210. However, if the catheter 260 is subjected to significant loads during operation of the introducer 210, for example, when the distal end portion 262 of the catheter 260 reaches the curved region of the PIVC and the actuator 270 is pushed further forward toward the distal end 212 of the introducer 210, the catheter 260 may begin to deflect or curve. During such a loading event, the configuration of the open slotted passageway 285a allows the catheter 260 to curve downward within the open slotted passageway 285a from the upper portion 302 toward the lower portion 303. That is, because the top and sides surrounding the upper portion 302 of the passageway 285a are closed, the catheter 260 can only bend downward at the location of the catheter support 280 when under load. As discussed above, when the catheter 260 bends downward, the chance of the catheter 260 buckling is minimized compared to when the catheter 260 bends upward. Thus, the catheter support 280a minimizes the chance of the catheter 260 buckling during use of the fluid delivery device 200.
[0070] 17A-17D, another embodiment of a catheter support 280b that encourages downward bending of the catheter 260 is shown. Similar to the catheter support of FIGS. 16A-16D, the catheter support 280b includes a slotted passageway formed in the hub portion 282 that extends between a proximal opening 287 and a distal opening 288. However, the slotted passageway of the catheter support 280b is a closed slotted passageway 285b. The closed slotted passageway 285b includes an upper portion 302 and a lower portion 303. The upper portion 302 of the passageway is generally aligned with the distal opening 288, the central axis 304 of the hub portion 282, and the path along which the length of the catheter 260 extends between the actuator 270 and the distal end portion 212 of the introducer 210. The lower portion 303 of the passage is vertically below the upper portion 302, extends downward from the upper portion 302, and terminates at a vertical position between the central axis 304 and the bottom surface 301 of the hub portion 282 (i.e., the lower portion 303 of the slotted passage is "closed").
[0071] The catheter support 280b causes the catheter 260 to be received in the upper portion 302 of the closed slotted passageway 285b and to remain there during normal operation of the introducer 210. However, if a significant load is applied to the catheter 260 during operation of the introducer 210, for example, when the distal end portion 262 of the catheter 260 reaches the curved region of the PIVC and the actuator 270 is pushed further forward toward the distal end portion 212 of the introducer 210, the catheter 260 may begin to deflect or bend. During such a loading event, the structure of the closed slotted passageway 285b causes the catheter 260 to bend downward within the closed slotted passageway 285b from the upper portion 302 toward the lower portion 303. That is, because the top and sides surrounding the upper portion 302 of the passageway are closed, the catheter 260 can only bend downward at the location of the catheter support 280 when a load is applied. The catheter 260 is urged to bend downward at the location of the catheter support 280, but the closed slotted passageway 285b structure keeps the catheter 260 within the passageway. Thus, the catheter support 280b minimizes the possibility of the catheter 260 buckling during use of the fluid delivery device 200.
[0072] Although catheter supports 280a, 280b each have a slotted passageway formed therein such that the upper portion 302 is generally aligned with the central axis 304 of the hub portion 282 and the path along which the length of the catheter 260 extends between the actuator 270 and the distal end portion 212 of the introducer 210, further embodiments of catheter supports may be configured to include slotted passageways where the openings 287, 288 and upper portion 302 of the passageway are vertically offset from the central axis 304 and the catheter path. That is, catheter supports 280c, 280d are configured such that the slotted passageway (either an open slotted passageway or a closed slotted passageway) is shifted downward within the hub portion 282.
[0073] 18A and 18B, catheter support 280c is shown as including an open slotted passageway 285c formed in hub portion 282, with passageway openings 287, 288 and upper portion 302 offset vertically downward from central shaft 304 and the catheter pathway along the length of catheter 260 between actuator 270 and distal end portion 212 of introducer 210. Because distal opening 288 and open slotted passageway 285c are offset vertically downward from the normal catheter pathway of catheter 260, catheter 260 is biased downward when held by upper portion 302, before any load is applied to catheter 260. Pre-biasing catheter 260 to curve downward minimizes the possibility of buckling of catheter 260. Additionally, the structure of the open slotted passage 285c allows the catheter 260 to bend further downward at the location of the catheter support 280c when a load is applied to the catheter support 280c, providing another means of minimizing the possibility of buckling of the catheter 260.
[0074] 19A and 19B, catheter support 280d is shown as including a closed slotted passageway 285d formed in hub portion 282, with openings 287, 288 and an upper portion 302 of the passageway offset vertically downward from central shaft 304 and the catheter pathway extending the length of catheter 260 between actuator 270 and distal end portion 212 of introducer 210. As mentioned above, because distal opening 288 and closed slotted passageway 285d are offset vertically downward from the normal catheter pathway of catheter 260, catheter 260 is biased downward when held by upper portion 302, this is before any load is applied to catheter 260. Pre-biasing the catheter 260 to bend downward minimizes the possibility of buckling of the catheter 260, and the structure of the closed slotted passage 285d allows the catheter 260 to bend further downward at the catheter support 280 when a load is applied to the catheter 260, providing another means of minimizing the possibility of buckling of the catheter 260.
[0075] 20A-20C, there is shown another embodiment of a catheter support 280e that encourages downward bending of a catheter 260. As previously mentioned, the catheter support 280e generally includes a bracket portion 281 and a hub portion 282, with the hub portion 282 defining a passageway 285 having a proximal opening 287 and a distal opening 288.
[0076] As shown in FIGS. 20A-20C , the passageway 285 is formed as a non-linear, curved, or arcuate passageway 285e. The arcuate passageway 285e is formed to curve upward within the hub portion 282, with a central region of the passageway (between the proximal and distal openings 287, 288 of the hub portion 282) offset vertically upward from the proximal and distal openings 287, 288 of the passageway. The arcuate passageway 285e may have a generally cylindrical profile to accommodate the passageway of the catheter 260 therethrough and to allow for movement of the catheter 260. The proximal and distal openings 287, 288 of the passageway are generally aligned with the central axis 304 of the hub portion 282 and the path of the catheter 260's length between the actuator 270 and the distal end portion 212 of the introducer 210.
[0077] As previously described, the catheter 260 is routed through the passageway 285 in the hub portion 282, reducing the unsupported length of the catheter 260. The curved passageway 285e has a central region that is offset vertically upward from the normal catheter path of the catheter 260, such that the catheter 260 is biased downward as it travels upward along the passageway 285e and enters the proximal opening 287 of the hub portion 282 and exits the distal opening 288 of the hub portion 282. Because the catheter 260 is pre-biased to curve downward, the likelihood of the catheter 260 buckling when a load is applied is minimized. Thus, the catheter support 280e minimizes the likelihood of the catheter 260 buckling during use of the fluid delivery device 200.
[0078] 21A-21C, there is shown another embodiment of a catheter support 280f that encourages downward bending of a catheter 260. As previously mentioned, the catheter support 280f generally includes a bracket portion 281 and a hub portion 282, with the hub portion 282 defining a passageway 285 having a proximal opening 287 and a distal opening 288.
[0079] 21A-21C, the passageway 285 is formed as a non-linear, wavy, or sinusoidal passageway 285f. The sinusoidal passageway 285f is formed to curve vertically upward and downward within the hub portion 282 as it passes between a proximal opening 287 and a distal opening 288 of the hub portion 282. The sinusoidal passageway 285f may have a generally cylindrical profile to accommodate the path of the catheter 260 therethrough and to allow for movement of the catheter 260. The proximal and distal openings 287, 288 of the sinusoidal passageway 285f may be generally aligned with the central axis 304 of the hub portion 282 and the path of the catheter 260 extending its length between the actuator 270 and the distal end portion 212 of the introducer 210.
[0080] As previously described, the catheter 260 is routed through the passageway 285 in the hub portion 282, reducing the unsupported length of the catheter 260. The sinusoidal passageway 285f allows the catheter 260 to curve vertically up and down as it passes through the hub portion 282, and the catheter 260 is biased downward as it enters the proximal opening 287 of the hub portion 282 and exits the distal opening 288 of the hub portion 282. The pre-biasing of the catheter 260 to curve downward minimizes the likelihood of the catheter 260 buckling when a load is applied. Thus, the catheter support 280f minimizes the likelihood of the catheter 260 buckling during use of the fluid delivery device 200.
[0081] 22 and 23, there is shown a change between a first and a second configuration of the fluid delivery device 200. The fluid delivery device 200 can be placed in the first configuration prior to use and can be transitioned by a user (e.g., a doctor, physician, nurse, technician, phlebotomist, etc.) from the first configuration ( FIG. 22 ) to the second configuration ( FIG. 23 ) to position at least the distal end portion 262 of the catheter 260 in a distal location relative to the introducer housing 218 (e.g., within an indwelling PIVC (not shown) or distal to an indwelling PIV).
[0082] When the catheter 260 is disposed in a first position within the introducer housing 218, the fluid delivery device 200 is in the first configuration of FIG. 22 . In some embodiments, when the catheter 260 is in the first position, substantially the entire catheter 260 is disposed within the housing 218. In such embodiments, the introducer housing 218 can include a seal or the like (as described above) that can substantially seal the distal end portion 212 of the housing 210 to isolate the catheter 260 within the second portion 215 of the interior volume 213. In other embodiments, when the catheter 260 is in the first position, the catheter 260 is disposed within the housing 210 and the lock 240.
[0083] When the fluid delivery device 200 is in the first configuration, the actuator 270 is disposed toward the proximal end portion 211 of the introducer 210. The proximal end portion 261 of the catheter 260 is coupled to the second portion 275 of the actuator 270, the catheter 260 extends through the second portion 215 of the interior volume 213 of the introducer 210 and the passageway 285 of the catheter support 280, and the distal end portion 262 of the catheter 260 is received in the lumen of the coupler 216 and / or the lumen 255 of the lock 240.
[0084] The initial, pre-use position of catheter support 280 can be set such that, in the first configuration, the position of hub portion 282 along the unsupported portion of catheter 260 (extending from second portion 275 of actuator 270 to distal end portion 212 of introducer 210) is at the center point of the unsupported portion of catheter 260 or can be set to be offset from the center point of the unsupported length of catheter 260. For example, in the first configuration, if distal end portion 262 of catheter 260 encounters resistance when advanced into the PIVC and additional force needs to be applied to actuator 270 to further advance catheter 260 (e.g., in the region where catheter 260 enters the skin, curves upward, and curves again to pass along the vein), hub portion 282 of catheter support 280 can be positioned at a position corresponding to the position of actuator 270.
[0085] To transition from the first configuration to the second configuration, a user engages engagement member 272 of first portion 271 of actuator 270 and moves actuator 270 relative to introducer housing 218, thereby moving catheter 260 from a first position (e.g., disposed within introducer housing 218) to a second position. In this manner, catheter 260 moves through second portion 215 of interior volume 213, passageway 285 of hub portion 282 of catheter support 280, and lumen 255 of lock 240, such that at least distal end portion 262 of catheter 260 is disposed outside of and distal to lock 240.
[0086] After actuator 270 has moved partially distally and catheter 260 has advanced partially toward the second position, actuator 270 contacts catheter support 280. In some embodiments, the distal end of second portion 275 of actuator 270 may abut the proximal end of hub portion 282 or may be sized and shaped to be at least partially received within proximal portion 289 of passageway 285 of hub portion 282. In other embodiments, the distal end of second portion 275 of actuator 270 may include a cam member (not shown) that contacts cantilever arm 292 of bracket portion 281 of catheter support 280.
[0087] As the actuator 270 advances further distally, the actuator 270 pushes the hub portion 282 of the catheter support 280 distally, and the catheter support 280 advances within the second portion 215 of the internal volume 213 of the introducer 210 until the catheter support 280 abuts the distal wall of the introducer 210, as shown in FIG. 23.
[0088] In some cases, when actuator 270 and catheter support 280 are in their distal-most positions, catheter 260 is considered to be in the second position, and distal end portion 262 of catheter 260 is positioned at a desired location relative to the distal end portion of the PIVC. In some cases, for example, when catheter 260 is in the second position, distal end portion 262 of catheter 260 can be substantially flush with the distal end portion of the PIVC. In other examples, distal end 262 of catheter 260 can extend a predetermined distance beyond the distal end of the PIVC (e.g., distal to the distal end of the PIVC), such that distal end 262 of catheter 260 is positioned within the vein a predetermined distance beyond the distal surface of catheter 260 (e.g., a location within the vein where there is substantially no debris (e.g., fibrin / thrombus) surrounding the distal end portion of the PIVC).
[0089] When catheter 260 is in the second position (e.g., when fluid delivery device 200 is in the second configuration as shown in FIG. 23 ), a user can establish fluid communication between catheter 260 and a fluid reservoir, a fluid source, a syringe, or the like. When catheter 260 is in fluid communication with the fluid reservoir and / or fluid source, fluid delivery device 200 can aspirate a volume of blood from a vein based, at least in part, on positioning the distal face of catheter 260 a predetermined and / or desired distance from the distal face of the PIVC. In some cases, after a desired amount of blood has been collected and / or a desired amount of medication has been delivered to the patient, the user can move actuator 270 proximally, such as by returning actuator 270 to its proximal-most position, to return catheter 260 to the first position.
[0090] While the present disclosure has been described in detail for purposes of illustration, based on embodiments or aspects presently considered to be the most practical and preferred, it should be understood that such details are for that purpose only, and the present disclosure is not limited to the disclosed embodiments or aspects, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.
Claims
1. 1. A fluid delivery device for advancing a catheter into an indwelling catheter of a vascular access device, the fluid delivery device comprising: an introducer having a proximal end portion and a distal end portion, the distal end portion being connectable to the vascular access device, the introducer defining an interior volume configured to movably receive the catheter; an actuator movably coupled to the introducer and configured to move relative to the introducer to move the catheter between a first position in which the catheter is disposed within the introducer and a second position in which a distal end portion of the catheter is disposed beyond the distal end portion of the introducer, thereby allowing at least a first portion of the catheter to be disposed within the indwelling catheter; a catheter support movably coupled to the introducer and positioned between the actuator and the distal end portion of the introducer, the catheter support defining a passage therein for receiving the catheter to provide support for a length of the catheter extending between the actuator and the distal end portion of the introducer; Equipped with the passageway of the catheter support is configured to encourage and / or pre-bias the catheter downwardly in the catheter support; Fluid delivery devices.
2. the catheter support includes a bracket portion and a hub portion, the hub portion including a top surface and a bottom surface, and a central axis of the hub portion extending longitudinally between a proximal end and a distal end of the hub portion; The fluid delivery device of claim 1 .
3. The passageway is a proximal opening and a distal opening; an open slotted passageway extending between the proximal opening and the distal opening, the open slotted passageway comprising: an upper portion generally aligned with the distal opening; a lower portion vertically below the upper portion and open along the bottom surface of the hub portion; Including, the catheter is urged to curve downwardly from the upper portion to the lower portion within the open slotted passage; an open slotted passageway; Including, The fluid delivery device of claim 2 .
4. The passageway is a proximal opening and a distal opening; a closed slotted passageway extending between the proximal opening and the distal opening, the closed slotted passageway comprising: an upper portion generally aligned with the distal opening; a lower portion vertically below the upper portion and terminating at a vertical location between the central axis of the hub portion and the bottom surface; Including, the catheter is urged to curve downwardly from the upper portion to the lower portion within the closed slotted passage; a closed slotted passage; Including, The fluid delivery device of claim 2 .
5. the proximal opening, the distal opening, and the top are aligned with a tubing path along which the length of the catheter extends between the actuator and the distal end portion of the introducer. The fluid delivery device of claim 3 .
6. the proximal opening, the distal opening, and the top are offset vertically downward from a tubular path along which the length of the catheter extends between the actuator and the distal end portion of the introducer, thereby preloading the catheter and forcing it to bend downward; The fluid delivery device of claim 3 .
7. In response to the actuator moving along the housing to advance the catheter from the first position toward the second position, the catheter can bend downward only at the catheter support. The fluid delivery device of claim 3 .
8. the passageway includes a curved passageway, a central region of the passageway between the proximal and distal ends of the hub portion being offset vertically upward from the proximal and distal openings of the passageway, the curved passageway pre-biasing the catheter downward; The fluid delivery device of claim 2 .
9. the passageway includes a sinusoidal passageway that shifts vertically as it passes between the proximal and distal ends of the hub portion, the sinusoidal passageway pre-biasing a downward curvature of the catheter; The fluid delivery device of claim 2 .
10. the proximal end of the hub portion is configured to engage the actuator, such that during movement of the actuator to move the catheter from the first position to the second position, the actuator contacts the proximal end to move the catheter support relative to the introducer. The fluid delivery device of claim 2 .
11. the distal end portion of the introducer includes a lock configured to couple the introducer to the vascular access device. The fluid delivery device of claim 1 .
12. 1. A fluid delivery device for advancing a catheter into an indwelling catheter of a vascular access device, the fluid delivery device comprising: an introducer having a proximal end portion and a distal end portion, the distal end portion being connectable to the vascular access device, the introducer defining an interior volume configured to movably receive the catheter; an actuator movably coupled to the introducer and configured to move relative to the introducer to move the catheter between a first position in which the catheter is disposed within the introducer and a second position in which a distal end portion of the catheter is disposed beyond the distal end portion of the introducer, thereby allowing at least a first portion of the catheter to be disposed within the indwelling catheter; a catheter support movably coupled to the introducer and positioned between the actuator and the distal end portion of the introducer, the catheter support including a bracket portion and a hub portion, the hub portion defining a passage therein for receiving the catheter to provide support for a length of the catheter extending between the actuator and the distal end portion of the introducer; Equipped with The passageway is a proximal opening and a distal opening; a slotted passageway extending between the proximal opening and the distal opening, the slotted passageway configured to encourage downward curvature of the catheter within the slotted passageway; Including, Fluid delivery devices.
13. The slotted passageway an open slotted passageway, an upper portion generally aligned with the distal opening; a lower portion vertically below the upper portion, the lower portion terminating at a vertical location between the central axis and the bottom surface of the hub portion; Including, the catheter is urged to curve downwardly from the upper portion to the lower portion within the closed slotted passage; an open slotted passageway; Including, The fluid delivery device of claim 12 .
14. The slotted passageway A closed slotted passageway, an upper portion generally aligned with the distal opening; a lower portion vertically below the upper portion, the lower portion terminating at a vertical location between the central axis and the bottom surface of the hub portion; Including, the catheter is urged to curve downwardly from the upper portion to the lower portion within the closed slotted passage; a closed slotted passage; Including, The fluid delivery device of claim 12 .
15. the proximal opening, the distal opening, and the top are aligned with a tubing path along which the length of the catheter extends between the actuator and the distal end portion of the introducer. The fluid delivery device of claim 13 .
16. the proximal opening, the distal opening, and the top are offset vertically downward from a tubular path along which the length of the catheter extends between the actuator and the distal end portion of the introducer, thereby preloading the catheter and forcing it to bend downward; The fluid delivery device of claim 13 .
17. a proximal end of the catheter support configured to engage the actuator, such that during movement of the actuator to move the catheter from the first position to the second position, the actuator contacts the proximal end to move the catheter support relative to the introducer; The fluid delivery device of claim 12 .
18. 1. A fluid delivery device for advancing a catheter into an indwelling catheter of a vascular access device, the fluid delivery device comprising: an introducer having a proximal end portion and a distal end portion, the distal end portion being connectable to the vascular access device, the introducer defining an interior volume configured to movably receive the catheter; an actuator movably coupled to the introducer and configured to move relative to the introducer to move the catheter between a first position in which the catheter is disposed within the introducer and a second position in which a distal end portion of the catheter is disposed beyond the distal end portion of the introducer, thereby allowing at least a first portion of the catheter to be disposed within the indwelling catheter; a catheter support movably coupled to the introducer and positioned between the actuator and the distal end portion of the introducer, the catheter support defining a passage therein for receiving the catheter to provide support for a length of the catheter extending between the actuator and the distal end portion of the introducer; Equipped with the passageway includes a non-linear passageway configured to pre-bias the catheter downward as the catheter enters and exits the catheter support. Fluid delivery devices.
19. the non-linear passageway includes an arcuate passageway, a central region of the arcuate passageway between the proximal and distal ends of the hub portion being offset vertically upward from the proximal and distal openings of the passageway, the curved passageway pre-biasing the catheter downward; 20. The fluid delivery device of claim 18.
20. the non-linear pathway includes a sinusoidal pathway that shifts vertically as it passes between the proximal and distal ends of the hub portion, the sinusoidal pathway pre-biasing the catheter downward; 20. The fluid delivery device of claim 18.