Blood withdrawal device for advancing a catheter into an indwelling catheter of a vascular access device

Abstract

This utility model relates to a blood-drawing device for advancing a catheter into an indwelling catheter of a vascular access device. A blood-drawing device for advancing an extension catheter into an indwelling catheter includes a guide housing, an anti-kink support tube, a main propulsion member, and a secondary propulsion member. The main propulsion member is movable relative to the housing to move the catheter from a first catheter position within the guide to a second catheter position, in which the distal end of the catheter extends out of the indwelling catheter. The secondary propulsion member is located away from the main propulsion member and is movable relative to the housing to move the support tube from a first tube position within the guide to a second tube position, in which the distal end of the tube extends out of the indwelling catheter. When the support tube is in the second tube position, the support tube is coaxially arranged around a portion of the catheter to prevent the catheter from kinking during advancement from the first catheter position to the second catheter position.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 671,465, filed July 15, 2024, entitled “Blood Draw Device with Support Tube for Prevention of Kinking During Catheter Advancement,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This utility model relates to a blood-drawing device for guiding a catheter into an indwelling catheter of a vascular access device (VAD). Background Technology

[0004] Catheters are frequently used to administer fluids into and out of the body. In a variety of settings, including hospital and home care, patients receive fluids, medications, and blood products via vascular access devices (VADs), which consist of such catheters inserted into the patient's vascular system. For example, common VADs consist of a plastic catheter inserted into a patient's vein, with the length varying from a few centimeters when the VAD is a peripheral intravenous catheter (PIVC) to several centimeters when the VAD is a central venous catheter (CVC).

[0005] Recent developments in the field of PIVC (Portable Intravascular Coagulation) have led to the emergence of techniques designed to facilitate blood collection using indwelling PIVCs and associated blood collection devices. The primary method of operation for these devices involves inserting a catheter, probe, tube, or other instrument through the lumen of the PIVC using a guide, which is attached to a catheter adapter for catheter insertion. For example, the catheter adapter may include a needleless access connector through which the catheter can be introduced to provide access to the PIVC and into the patient's vascular system. Blood samples can then be collected using a syringe and / or a vacuum blood collection device without requiring additional needle pricks on the patient.

[0006] A typical blood collection device guide includes a housing, a catheter, and a propulsion member. The catheter is movable within the housing to extend from it and advance into the indwelling PIVC. The propulsion member can be actuated by the operator relative to the housing. That is, the propulsion member can be moved distally by the operator to cause a corresponding movement of the catheter relative to the housing, allowing the catheter to be pushed out from the distal end of the housing and into the indwelling PIVC. However, during catheter deployment, particularly when the distal portion of the catheter reaches the curved area of ​​the PIVC (near where the PIVC enters the skin) and bends back and forth as it passes through the vein, the catheter is subjected to a column load, which can cause bending, kinking, and / or deformation. When the catheter bends, it may move in random directions, generating a sine wave that then flattens against the sidewall of the blood collection device housing as the force increases. Additional forces applied to the catheter by further movement of the propulsion member can cause the catheter to fold and collapse, i.e., "buckle."

[0007] Therefore, there is a need for a blood-drawing device and its guide that advances the catheter into the PIVC while minimizing the possibility of catheter bending, kinking, or deformation. It is desirable that this anti-kinking feature be easily integrated into the blood-drawing device, enabling its mass production at low cost. Utility Model Content

[0008] This document provides a blood-drawing device for advancing a catheter into an indwelling catheter of a vascular access device. The blood-drawing device includes a guide comprising a housing having a proximal portion and a distal portion, wherein the housing defines an internal volume configured to movably receive the catheter. The blood-drawing device also includes a coupling member positioned at the distal portion and capable of coupling to the vascular access device; a catheter movably received within the internal volume; and a support tube movably received within the internal volume and defining a tube lumen therein, the tube lumen being configured to receive the catheter, wherein the support tube is formed of a flexible, kink-resistant material. The blood-drawing device also includes a main propulsion member movably coupled to the housing and configured to move relative to the housing to move the catheter between a first catheter position and a second catheter position. In the first catheter position, the catheter is disposed within the guide or within the guide and the connecting member. In the second catheter position, the distal portion of the catheter is disposed outside the distal portion of the guide and enters or extends distally through the distal end of the indwelling catheter. The blood-drawing device also includes a secondary propulsion member movably coupled to the housing, away from the main propulsion member, and configured to move relative to the housing to move a support tube between a first tube position and a second tube position. In the first tube position, the support tube is disposed within the guide or within the guide and the connecting member. In the second tube position, the distal portion of the support tube is disposed outside the distal portion of the guide and enters or extends distally through the distal end of the indwelling catheter. When the support fitting is in the second fitting position and the conduit moves from the first conduit position to the second conduit position, the support fitting is arranged coaxially around a portion of the conduit to prevent the conduit from twisting as the conduit is advanced from the first conduit position to the second conduit position.

[0009] In some embodiments, the support tube is formed of a shape memory alloy.

[0010] In some embodiments, the shape memory alloy comprises nitinol.

[0011] In some embodiments, the main propulsion member and the auxiliary propulsion member are arranged on the housing such that the conduit can only be moved from the first conduit position to the second conduit position by the main propulsion member along the housing after the support tube has moved from the first tube position to the second tube position by the auxiliary propulsion member moving distally along the housing.

[0012] In some embodiments, the blood-drawing device further includes one or more catheter support inserts positioned within the internal volume and between the main propulsion member and the secondary propulsion member, each of the one or more catheter support inserts receiving the catheter to provide support for the length of the catheter extending between the main propulsion member and the secondary propulsion member.

[0013] In some embodiments, for the corresponding catheter support insert closest to the main propulsion member among the one or more catheter support inserts, when the catheter is moved from the first catheter position to the second catheter position, the main propulsion member engages the catheter support insert during its movement, wherein the main propulsion member engages the catheter support insert and moves the catheter support insert relative to the housing.

[0014] In some embodiments, the one or more catheter support inserts include a plurality of catheter support inserts spaced apart along the length of the catheter between the main propulsion member and the secondary propulsion member.

[0015] In some embodiments, the support tube includes a sensor located at a distal end of the support tube and configured to acquire operational data as the support tube is advanced from the first tube position to the second tube position.

[0016] In some embodiments, the sensor includes a pressure sensor configured to assess the line pressure within the indwelling catheter as the support fitting moves from the first fitting position to the second fitting position.

[0017] In some embodiments, the sensor includes a near-infrared (NIR) sensor configured to provide positional data of the support fitting relative to the indwelling catheter and / or detect blockages within the indwelling catheter.

[0018] In some embodiments, the sensor includes a flow sensor configured to detect the flow rate of fluid entering the indwelling catheter.

[0019] In some embodiments, the flow sensor is housed in a split septum valve located at the distal end of the support fitting, which allows the conduit to pass through when the conduit is moved to the second conduit position.

[0020] In some embodiments, the secondary propulsion member includes an electronic module incorporated therein, the electronic module comprising: a communication module operatively connected to the sensor to receive signals from the sensor regarding acquired operational data; an integrated circuit configured to process the signals received by the communication module; and an indicator controlled by the integrated circuit and configured to generate an audio or visual alarm in response to the acquired operational data.

[0021] In some embodiments, the support fitting includes scale markings thereon that indicate the length by which the support fitting is advanced distally as it moves from the first fitting position to the second fitting position.

[0022] In some embodiments, each of the main propulsion member and the auxiliary propulsion member includes: a first portion including an engagement portion movable along the top surface of the housing; and a second portion located at least partially within the internal volume and connected to the first portion via a slot formed in the top surface of the housing; wherein, for the main propulsion member, the second portion is connected to the proximal end of the conduit, and wherein, for the auxiliary propulsion member, the second portion is connected to the proximal end of the support tube.

[0023] In some embodiments, each of the main propulsion member and the secondary propulsion member slides within the slot formed in the top surface of the housing to move relative to the housing.

[0024] In some embodiments, the connecting member includes a locking member comprising: a connector configured to engage the distal portion of the housing; a first arm and a second arm configured to engage the vascular access device or an adapter disposed between the vascular access device and the locking member; and a blunt sleeve extending from the connector and disposed between the first arm and the second arm, the blunt sleeve being configured to engage the vascular access device or the adapter; wherein an inner lumen extends through the blunt sleeve and the connector, and the support tube and the catheter are capable of being advanced distally through the inner lumen.

[0025] This document also provides another blood-drawing device for advancing a catheter into an indwelling catheter of a vascular access device. The blood-drawing device includes a guide comprising a housing having a proximal portion and a distal portion, wherein the housing defines an internal volume, and wherein the housing includes a slot formed therein. The blood-drawing device further includes: a primary propulsion member movably coupled to the housing and configured to slide within the slot of the housing; and a secondary propulsion member movably coupled to the housing and configured to slide within the slot of the housing, the secondary propulsion member being positioned remotely from the primary propulsion member. The blood-drawing device further includes: a catheter movably received within the internal volume, the catheter including a distal end and a proximal end, wherein the proximal end is fixed to the main propulsion member such that movement of the main propulsion member causes a corresponding movement of the catheter; and a support tube movably received within the internal volume, the support tube defining a tube lumen therein, the tube lumen being configured to receive the catheter, the support tube including a distal end and a proximal end, wherein the proximal end of the support tube is fixed to the secondary propulsion member such that movement of the secondary propulsion member causes a corresponding movement of the support tube. When each of the main propulsion member and the secondary propulsion member has moved to a corresponding distal position on the housing, a portion of each of the catheter and the support tube is disposed outside the distal portion of the guide, wherein the catheter is advanced into and through the support tube to prevent kinking of the catheter as it is advanced distally.

[0026] In some embodiments, the support tube is formed of a shape memory alloy, which is resistant to kinking when the support tube is advanced distally into the indwelling catheter of the vascular access device by the movement of the secondary propulsion member.

[0027] In some embodiments, the blood-drawing device further includes one or more catheter support inserts positioned within the internal volume and between the main propulsion member and the secondary propulsion member, each of the one or more catheter support inserts receiving the catheter to provide support for the length of the catheter extending between the main propulsion member and the secondary propulsion member. Attached Figure Description

[0028] Figure 1 A perspective view of a blood-drawing apparatus according to an embodiment of the present disclosure;

[0029] Figure 2 for Figure 1 A top view of the blood-drawing device shown;

[0030] Figure 3 for Figure 1An exploded view of a blood-drawing device;

[0031] Figure 4 for Figure 1 A perspective view of the first component of the housing included in the blood-drawing device;

[0032] Figure 5 for Figure 1 A perspective view of the second component of the guide housing included in the blood-drawing device;

[0033] Figure 6 To pass Figure 4 The first component shown is connected to Figure 5 Rear perspective view of the guide housing formed by the second component shown;

[0034] Figure 7 for Figure 6 The diagram shows a front perspective view of the guide housing.

[0035] Figure 8 For the guide along Figure 7 The cross-sectional view taken from line 8-8 in the diagram;

[0036] Figure 9 for Figure 1 A rear-view perspective view of the locking mechanism included in the blood-drawing device;

[0037] Figure 10 for Figure 1 An exploded perspective view of the extension catheter, support fittings, connecting fittings, and propulsion components included in the blood drawing device;

[0038] Figure 11A for Figure 10 A three-dimensional view of the main propulsion component shown;

[0039] Figure 11B for Figure 10 A three-dimensional view of the auxiliary propulsion component shown;

[0040] Figure 12A Along the blood drawing device Figure 2 A cross-sectional view taken from line 12A-12A in the diagram;

[0041] Figure 12B Along the blood drawing device Figure 2 A cross-sectional view taken from line 12B-12B in the diagram;

[0042] Figures 13 to 16 for Figure 1 A perspective view of the blood-drawing device in various states as it transitions from a first configuration to a second configuration, showing the positioning of the main propulsion component and the secondary propulsion component, as well as the extension catheter and support fittings;

[0043] Figure 17According to another embodiment of this disclosure Figure 1 A detailed perspective view of the distal portion of the support tube included in the blood-drawing device;

[0044] Figure 18 According to another embodiment of this disclosure Figure 1 A detailed perspective view of the distal portion of the support tube included in the blood-drawing device; and

[0045] Figure 19 According to embodiments of this disclosure Figure 1 A detailed perspective view of the auxiliary propulsion components included in the blood-drawing device. Detailed Implementation

[0046] The following description is provided to enable those skilled in the art to produce and use the described embodiments intended for implementing this invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all of these modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of this invention.

[0047] As used in this specification, the terms "proximal" and "distal" refer to the directions closer to and further away from the user who will bring the device into contact with the patient, respectively. Thus, for example, the end of the device that first contacts the patient's body will be the distal end, while the opposite end of the device (e.g., the end of the device manipulated by the user) will be the proximal end of the device.

[0048] Spatial or directional terms, such as “left,” “right,” “inner,” “outer,” “up,” “down,” etc., should not be considered as limitations, as this utility model can adopt various alternative orientations.

[0049] In the following description, for descriptive purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the present invention as oriented as shown in the accompanying drawings. However, it should be understood that the present invention may take various alternative variations unless explicitly stated to the contrary. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary aspects of the present invention.

[0050] The terms “first”, “second”, etc., do not refer to any specific order or sequence, but rather to different conditions, characteristics, or elements.

[0051] This utility model relates to a blood-drawing device for performing venous cut-off surgery via a peripheral venous line or catheter, wherein the blood-drawing device is operable to advance an extension fitting / extension catheter into an indwelling peripheral venous line, and then draw blood or administer medication to the patient.

[0052] Figures 1 to 18 A blood transfer device 200 (i.e., blood collection device 200) and its components according to an embodiment of the present invention are shown. The blood collection device 200 (e.g., commercially available from Becton, Dickinson and Company) The blood-drawing device 200 can have any suitable shape, size, or configuration and can be coupled to the vascular access device (VAD) 310, for example, via locking elements and / or adapters. As described in further detail herein, a user can change the blood-drawing device 200 from a first configuration to a second configuration to advance an extension catheter through an existing, placed, and / or indwelling catheter 312 of the VAD 310 (i.e., when the blood-drawing device 200 is coupled to the VAD), such that at least one end of the extension catheter is positioned distally relative to the indwelling catheter 312. Furthermore, where the indwelling catheters each have a shape, size, and / or configuration that can vary based on, for example, the manufacturer of the VAD 310 and / or its intended use, the blood-drawing device 200 can be arranged to allow the blood-drawing device 200 to be coupled to the VAD 310 having any suitable configuration and subsequently advance at least a portion of the catheter through the indwelling catheter 213. In addition, the blood-drawing device 200 can be operated by the user to place the distal surface of the extension catheter at a predetermined and / or desired distance beyond the distal end of the indwelling catheter 312, so as to be positioned within a portion of a vein receiving substantially unobstructed blood flow.

[0053] like Figures 1 to 3 As shown, the blood-drawing device 200 includes a guide 210, a connecting member or locking member 240 (hereinafter referred to as "locking member 240"), an extension conduit 260 (hereinafter referred to as "conduit 260"), a connecting tube 265, a main propulsion member 270, a support tube 280, and a secondary propulsion member 290. The guide 210 can have any suitable shape, size, or configuration. For example, in some embodiments, the guide 210 can be an elongated member having a generally circular cross-sectional shape. In some embodiments, the shape of the guide 210 and / or one or more features or surface finishes of at least one outer surface of the guide 210 can be configured to increase the ergonomics of the blood-drawing device 200, which in some cases allows a user to operate the blood-drawing device 200 with one hand (i.e., single-handed use).

[0054] like Figures 2 to 8As shown, the guide 210 of the blood collection device 200 includes a housing 218 having a first housing member 220 and a second housing member 230, which are coupled together to form the housing 218. The first housing member 220 includes a proximal portion 221, a distal portion 222, and an inner surface 223. The inner surface 223 has a first portion 224 and a second portion 225, wherein in one embodiment, the second portion 225 is a flange. The proximal portion 221 of the first housing member 220, more specifically, the proximal sidewall of the first housing member 220 defines a recess 226, which is configured to selectively receive a portion of a connecting tube 265, as described in further detail herein.

[0055] The second housing member 230 has a proximal portion 231, a distal portion 232, an inner surface 233, and a top surface 235. As described above with reference to the first housing member 220, the proximal portion 231 of the second housing member 230, and more specifically, the proximal sidewall of the second housing member 230, defines a recess 234, which is configured to selectively receive a portion of the connecting tube 265.

[0056] 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, wherein each rib 236 extends along the width of the second housing member 230. The ribs 236 formed by the top surface 235 of the second housing member 230 can have any suitable shape, size, and / or configuration. For example, a set of ribs 236 includes a first portion 237 having a first size and shape, and a second portion 238 having a second size and shape different from the first size and shape. The size and shape of each rib in the second portion 238 are larger than the size and shape of each rib in the first portion 237.

[0057] As described further in detail herein, a portion of the main propulsion member 270 is configured such that when a user moves the main propulsion member 270 relative to the housing 218 (which in turn causes the main propulsion member 270 (and the associated catheter 260) to vibrate), this portion propels along a top surface 235 forming a set of ribs 236. In some cases, this vibration can, for example, facilitate the propulsion of the catheter 260 through a portion of the blood-drawing device 200, a portion of the VAD 310, and / or a portion of the vascular system. In some cases, the larger dimensions of the ribs in the second portion 238 can cause a greater amount of vibration as the main propulsion member 270 moves along the top surface 235 (as described above). In some cases, the larger dimensions of the ribs in the second portion 238 can cause an increase in force that would otherwise be sufficient to move a portion of the main propulsion member 270 along the top surface 235.

[0058] Similar to the main propulsion member 270, a portion of the secondary propulsion member 290 is configured such that when the user moves the secondary propulsion member 290 relative to the housing 218 (which in turn causes the secondary propulsion member 290 to vibrate), this portion propels along the top surface 235 forming a set of ribs 236. In some cases, this vibration may, for example, facilitate the propulsion of a support tube 280 coupled to the secondary propulsion member 290 through a portion of the blood-drawing device 200, a portion of the VAD 310, and / or a portion of the vascular system.

[0059] like Figures 6 to 8 As shown, the first housing member 220 is configured to engage with the second housing member 230 to jointly form the housing 218. In some embodiments, forming the housing 218 from the first housing member 220 and the second housing member 230 can reduce undesirable variations in the shape and / or dimensions 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 likelihood of the catheter 260 kinking, bending, and / or deforming during use of the blood-drawing device 200. In some embodiments, forming the housing 218 from the first housing member 220 and the second housing member 230 can at least allow the inner surface 223 of the first housing member 220 to form a tortuous shape that would otherwise be challenging when manufacturing the housing 218 from a single workpiece.

[0060] The first housing member 220 and the second housing member 230 together form the proximal portion 211 and the distal portion 212 of the housing 218, and together define the internal volume 213 of the housing 218. Figure 6 As shown, the proximal portion 211 of the housing 218 defines an opening 217. Specifically, the opening 217 is formed and / or defined by a recess 226 of the first housing member 220 and a recess 234 of the second housing member 230. The arrangement of the proximal portion 211 is such that the portion of the opening 217 defined by the recess 226 of the first housing member 220 has a first size and / or shape, and the portion of the opening 217 defined by the recess 234 of the second housing member 230 has a second size and / or shape smaller than the first size and / or shape. In other words, a portion of the opening 217 is contracted, compressed, blocked, and / or otherwise reduced. As described in further detail herein, the opening 217 is configured to receive a portion of a connecting tube 265, which can move within the opening 217 from the larger portion of the opening 217 to the reduced portion of the opening 217 (e.g., the portion formed by the recess 234 of the second housing member 230) to block, compress, and / or clamp the connecting tube 265.

[0061] like Figure 7As shown, the distal portion 212 of housing 218 includes and / or otherwise forms a connector 216. In other words, the distal portion 222 of the first housing member 220 and the distal portion 232 of the second housing member 230 together form the connector 216 at the distal portion 212 of housing 218. The connector 216 can have any suitable shape, size, and / or configuration. For example, in this embodiment, the connector 216 forms a set of threads that can form a threaded connection with an associated threaded portion of the locking member 240, as described in further detail herein. Although in Figure 7 Not shown, but the distal portion 211 of housing 218 may include a seal (not shown) and / or may be configured to receive a seal (not shown) that can selectively seal and / or fluidly isolate the internal volume 213 of housing 218 (at least from the open portion of connector 216). In use, the seal can be switched from a sealed or closed configuration to an open configuration to allow, for example, a portion of support tube 280 and a portion of conduit 260 to pass through it. In some embodiments, the seal may contact the outer surface of support tube 280 to define a seal therebetween that is operable to limit and / or substantially prevent fluid backflow between the outer surface of the sleeve and the seal.

[0062] The inner surface 223 of the first housing member 220 and the inner surface 233 of the second housing member 230 together define the internal volume 213 of the housing 218. For example... Figure 8 As shown, the arrangement of inner surfaces 223 and 233 causes the internal volume 213 to have and / or define a tortuous cross-sectional shape. For example, the internal volume 213 may have a substantially S-shaped or at least partially S-shaped cross-sectional shape. More specifically, the inner surface 223 of the first housing member 220 includes and / or forms ridges, protrusions, flanges, projections, and / or walls configured to separate a first portion 224 of the inner surface 223 from a second portion 225 of the inner surface 223. Thus, the tortuous cross-sectional shape of the internal volume 213 forms and / or defines a first portion 214 and a second portion 215 of the internal volume 213. In this way, the first portion 214 of the internal volume 213 is spaced apart from, but not fluidly isolated from, the second portion 215 of the internal volume 213. In other words, the first portion 214 of the internal volume 213 defines an axis parallel to and offset from the axis defined by the second portion 215 of the internal volume 213.

[0063] like Figure 8As shown, a first portion 214 of the internal volume 213 extends through the wall of the housing 218. Similarly, the housing 218 defines (e.g., defined jointly by a first housing member 220 and a second housing member 230) slots, channels, tracks, openings, and / or the like that are in fluid communication with the first portion 214 of the internal volume 213. Conversely, a second portion 215 of the internal volume 213 is completely defined and / or closed by the housing 218 (at least in the circumferential direction). The tortuous cross-sectional shape of the internal volume 213 prevents the second portion 215 from being seen (e.g., out of sight) through the slots (in fluid communication with the first portion 214 of the internal volume 213), which in turn limits and / or substantially prevents contamination of the conduits 260 and support fittings 280 disposed therein.

[0064] In this embodiment, the second portion 215 of the internal volume 213 is substantially aligned with a portion of the opening 217 and a portion of the opening defined by the connector 216. Furthermore, the second portion 215 of the internal volume 213 is configured to be substantially aligned with the locking member 240 when the locking member is engaged with the connector 216 of the housing 218. In other words, the axis defined by the second portion 215 of the internal volume 213 is substantially coaxial with the axis defined by a portion of the locking member 240, as described in further detail herein. In this way, the second portion 215 of the internal volume 213 can movably receive, for example, a portion of the main propulsion member 270 and a portion of the conduit 260, as well as a portion of the secondary propulsion member 290 and a portion of the support tube 280. Therefore, the main propulsion member 270 and the auxiliary propulsion member 290 can be moved relative to the housing 218 to (1) move the conduit 260 between a first conduit position and a second conduit position, in which the conduit 260 is completely disposed within the second portion 215 of the internal volume 213, and in the second conduit position, at least a portion of the conduit 260 extends to the outside of the second portion 215 of the internal volume 213 and away from the housing 218, and (2) move the support tube 280 between a first tube position and a second tube position, in which the support tube 280 is completely disposed within the second portion 215 of the internal volume 213, and in the second tube position, at least a portion of the support tube 280 extends to the outside of the second portion 215 of the internal volume 213 and away from the housing 218, as described in further detail herein.

[0065] The locking member 240 of the blood drawing device 200 can have any suitable shape, size, and / or configuration. As described above, the locking member 240 is configured to be physically and fluidly coupled to the housing 218 and is configured to couple the guide 210 to the VAD 310 and / or to any suitable intermediate device or adapter coupled to the VAD 310. Figure 9As shown, the locking member 240 has a connector 241, a blunt sleeve 242, a first arm 243, and a second arm 250. Furthermore, the locking member 240 defines an inner cavity 255 extending through the connector 241 and the blunt sleeve 242. The connector 241 is configured to engage the locking member 240 with a connector 216 of the housing 218. Specifically, in this embodiment, the connector 241 includes and / or forms one or more protrusions configured to selectively engage threads defined and / or formed by the connector 216 of the housing 218, thereby forming a threaded connection.

[0066] A blunt sleeve 242 extends from the connector 241 and is disposed between the first arm 243 and the second arm 250. The blunt sleeve 242 can have any suitable shape, size, and / or configuration. In some embodiments, the blunt sleeve 242 may have a length sufficient to extend through at least a portion of the VAD 310 or through the adapter and at least partially enter or pass through the VAD 310. Furthermore, the blunt sleeve 242 may have an inner diameter similar to or slightly larger than the outer diameter of a portion of the support tube 280 and the catheter 260 (the diameter of the surface defining at least partially the lumen 255). Thus, when the blood-drawing device 200 changes between a first configuration and a second configuration, the lumen 255 of the locking member 240 can receive a portion of the support tube 280 and the catheter 260.

[0067] As described above, at least a portion of the conduit 260, the support fitting 280, and the connecting fitting 265 are movably disposed within a second portion 215 of the internal volume 213 defined by the housing 218.

[0068] like Figure 10 As shown, the conduit 260 has a proximal portion 261 and a distal portion 262 and defines an inner lumen 263. The proximal portion 261 of the conduit 260 is coupled to a second portion 275 of the main propulsion member 270. In this way, the main propulsion member 270 can be moved relative to the housing 218 to move the conduit 260 between a first position in which the conduit 260 is disposed within the housing 218 (e.g., the entire conduit 260 is disposed within the housing 218 or within the housing 218 and the locking member 240), and in the second position, when the locking member 240 is coupled to the VAD 310, the distal portion of the conduit 260 is at least partially disposed distal to the locking member 240 and distal to the distal end of the indwelling conduit 312 (see [link to VAD]). Figure 1 The location of the distal portion 262 is as described in further detail herein. The distal portion 262 may have any suitable shape, size and / or configuration and may define at least one opening in fluid communication with the lumen 263.

[0069] The connecting tube 265 has a proximal portion 266 and a distal portion 267 and defines an inner cavity 268. A portion of the connecting tube 265 is disposed within and extends through an opening 217 of the housing 218 (e.g., defined by a notch 223 of the first housing member 220 and a notch 233 of the second housing member 230). Thus, the proximal portion 266 is at least partially disposed outside the housing 218, and the distal portion 267 is at least partially disposed within a second portion 215 of the inner volume 213 defined by the housing 218. As described above, the connecting fitting 265 can move within the opening 217 between a first position and a second position to selectively clamp a portion of the connecting fitting 265, compress a portion of the connecting fitting 265, kink a portion of the connecting fitting 265, bend a portion of the connecting fitting 265, and / or otherwise deform a portion of the connecting fitting 265, which in turn blocks the inner cavity 268 of the connecting fitting 265, compresses the inner cavity 268 of the connecting fitting 265, kinks the inner cavity 268 of the connecting fitting 265, closes the inner cavity 268 of the connecting fitting 265, seals the inner cavity 268 of the connecting fitting 265, etc. For example, the first position can be associated with and / or aligned with a first portion of the opening 217, the circumference and / or diameter of which is larger than the circumference and / or diameter of a second portion of the opening 217 associated with and / or aligned with the second position. Therefore, the user can manipulate the connecting fitting 265 to block the inner cavity 268 of the connecting fitting 265, thereby limiting, constraining and / or substantially preventing fluid from passing through it.

[0070] like Figure 10As shown, the proximal portion 266 of the connecting tube 265 is coupled to and / or includes the connector 269. The connector 269 is configured to physically and fluidly connect the connecting tube 265 to any suitable device, such as a fluid reservoir, fluid source, syringe, vacuum container holder (e.g., a vacuum container holder having a sheathed needle or configured to be coupled to a sheathed needle), pump, etc. The distal portion 267 of the connecting tube 265 is at least partially disposed within a second portion 215 of the internal volume 213 defined by the housing 218 and is coupled to a second portion 275 of the main propulsion member 270. In some embodiments, the connecting tube 265 may have a larger diameter than the conduit 260, such that when the conduit 260 and the connecting tube 265 are coupled to the second portion 275 of the main propulsion member 270, the proximal portion 261 of the conduit 260 is at least partially disposed within the lumen 268 defined by the connecting tube 265. In some embodiments, this arrangement can, for example, reduce and / or substantially prevent leakage associated with fluid flow between conduit 260 and connecting fitting 265. In some embodiments, this arrangement can also limit, reduce, and / or substantially prevent hemolysis of a volume of blood when it flows through conduit 260 and connecting fitting 265. In this way, when connector 269 is coupled to a fluid reservoir, fluid source, syringe, vacuum container, pump, etc., connecting fitting 265 establishes fluid communication between the reservoir, fluid source, pump, etc., and conduit 260.

[0071] like Figure 10 As further shown, the support tube 280 is positioned in the blood-drawing device 200 away from the secondary propulsion member 290. The support tube 280 has a proximal portion 281 and a distal portion 282, and defines an inner lumen 283. The proximal portion 281 of the support tube 280 is coupled to a second portion 295 of the secondary propulsion member 290. In this way, the secondary propulsion member 290 can be moved relative to the housing 218 to move the support tube 280 between a first position in which the support tube 280 is disposed within the housing 218 (e.g., the entire support tube 280 is disposed within the housing 218 or within the housing 218 and the locking member 240), and in the second position, when the locking member 240 is coupled to the VAD 310, the distal portion of the support tube 280 is positioned distal to the locking member 240 and distal to the distal end of the indwelling catheter 312, as described in further detail herein. The distal portion 282 may have any suitable shape, size and / or configuration, and may define at least one opening in fluid communication with the lumen 283.

[0072] According to embodiments of this disclosure, the diameter of the support fitting 280 is larger than the diameter of the catheter 260 (i.e., the inner diameter of the lumen 283 is larger than the outer diameter of the catheter 260). Therefore, when the catheter is moved to the second position, the distal portion 262 of the catheter 260 can be at least partially disposed within the lumen 283 defined by the support fitting 280, i.e., the support fitting 280 is coaxially positioned around the catheter 260. During operation of the blood collection device 200, the support fitting 280 facilitates guiding the catheter 260 to the second catheter position (beyond the tip of the indwelling catheter 312), wherein the support fitting 280 prevents the catheter 260 from kinking as the catheter 260 is advanced distally through the VAD 310 and into the patient's vascular system.

[0073] According to an exemplary embodiment, in order to advance catheter 260 from a first catheter position to a second catheter position, support fitting 280 is made of a flexible material with anti-kink properties. Such material may include shape memory alloys, such as nitinol as a non-limiting example. When support fitting 280 is formed of an anti-kink material, as support fitting 280 is advanced from the first fitting position to the second fitting position, support fitting 280 is able to guide itself through VAD 310 (and indwelling catheter 312), even if indwelling catheter 312 has a bend where it enters the vein from the skin surface. With support fitting 280 advanced to the second fitting position without any kink, catheter 260 can then be moved to its second catheter position, where catheter 260 is advanced through support fitting 280, and because support fitting 280 is coaxially arranged around catheter 260, support fitting 280 prevents catheter 260 from kinking as it is advanced through support fitting.

[0074] In some embodiments, such as Figure 10 As shown, the support fitting 280 may include graduations 286 thereon that allow clinicians or other users to estimate the position of the support fitting 280 relative to the distal end of the indwelling catheter 312 as the support fitting 280 is moved to its second fitting position. In other words, the graduations 286 on the support fitting 280 allow the user to determine when the support fitting 280 is placed within the vascular system (and relative to the indwelling catheter 312) at the desired position from which fresh blood can be drawn. The graduations 286 are visible through the housing 218 of the guide tube 210 to provide this position determination.

[0075] During operation of the blood-drawing device 200, each of the main propulsion member 270 and the secondary propulsion member 290 of the blood-drawing device 200 is movable along the length of the housing 218 to allow the blood-drawing device 200 to switch between its first configuration and a second configuration, in which the conduit 260 is in a first conduit position and the support tube 280 is in a first tube position, and in the second configuration, the conduit 260 is in a second conduit position and the support tube 280 is in a second tube position. The main propulsion member 270 and the secondary propulsion member 290 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the main propulsion member 270 and the secondary propulsion member 290 may have a size and shape associated with and / or at least partially based on the size and / or shape of the housing 218.

[0076] Now for reference Figure 11A and Figure 11B as well as Figure 12A and Figure 12B The configuration of the main propulsion member 270 and the auxiliary propulsion member 290, as well as their positioning within the housing 218, are shown and described in more detail.

[0077] like Figure 11A and Figure 12A As shown, the main propulsion member 270 includes a first portion 271, a second portion 275, and a wall 277 extending between the first portion and the second portion. As described above, the first portion 271 of the main propulsion member 270 is at least partially disposed within a first portion 214 of the internal volume 213 defined by the housing 218, and the second portion 275 of the main propulsion member 270 is disposed within a second portion 215 of the internal volume 213. The first portion 271 of the main propulsion member 270 includes an engaging member 272. The main propulsion member 270 is arranged such that the engaging member 272 is disposed outside the housing 218, while the remaining portion of the first portion 271 is located within the first portion 214 of the internal volume 213 defined by the housing 218. Thus, the engaging member 272 can be engaged and / or manipulated by a user (e.g., using the user's thumb or other finger) to move the main propulsion member 270 relative to the housing 218. In some embodiments, the engagement member 272 may include a set of ridges and / or any suitable surface finish, which may, for example, increase the ergonomics of the main propulsion member 270 and / or the blood-drawing device 200.

[0078] The engaging member 272 includes a protrusion 273 disposed at or near the proximal portion of the engaging member 272. The protrusion 273 can be any suitable protrusion, track, ridge, bulge, projection, knob, roller, slider, etc., extending from the surface of the engaging member 272. The protrusion 273 is configured to selectively engage the top surface 235 of the second housing member 230 of the housing 218. More specifically, as the main propulsion member 270 moves along the length of the housing 218, the protrusion 273 contacts ribs 236 formed by the second housing member 230 and moves along each successive rib, wherein the interaction between the protrusion 273 and the ribs 236 causes vibration of the main propulsion member 270.

[0079] The second portion 275 of the main propulsion member 270 includes an opening 276 formed therein, which can be used to insert / engage the conduit 260 to secure the proximal end 261 of the conduit 260 to the main propulsion member 270.

[0080] like Figure 11B and Figure 12B As shown, the secondary propulsion member 290 includes a first portion 291, a second portion 295, and a wall 297 extending between the first portion and the second portion. As described above, the first portion 291 of the secondary propulsion member 290 is at least partially disposed within a first portion 214 of the internal volume 213 defined by the housing 218, and the second portion 295 of the secondary propulsion member 290 is disposed within a second portion 215 of the internal volume 213. The first portion 291 of the secondary propulsion member 290 includes an engaging member 292. The arrangement of the secondary propulsion member 290 is such that the engaging member 292 is disposed outside the housing 218, while the remaining portion of the first portion 291 is located within the first portion 214 of the internal volume 213 defined by the housing 218. Thus, the engaging member 292 can be engaged and / or manipulated by a user (e.g., using the user's thumb or other finger) to move the secondary propulsion member 290 relative to the housing 218. In some embodiments, the engagement member 292 may include a set of ridges and / or any suitable surface finish, which may, for example, increase the ergonomics of the secondary propulsion member 290 and / or the blood-drawing device 200.

[0081] The engaging member 292 includes a protrusion 293 disposed at or near the proximal portion of the engaging member 292. The protrusion 293 can be any suitable protrusion, track, ridge, bulge, projection, knob, roller, slider, etc., extending from the surface of the engaging member 292. The protrusion 293 is configured to selectively engage the top surface 235 of the second housing member 230 of the housing 218. More specifically, as the secondary propulsion member 290 moves along the length of the housing 218, the protrusion 293 contacts ribs 236 formed by the second housing member 230 and moves along each successive rib, wherein the interaction between the protrusion 293 and the ribs 236 causes vibration of the secondary propulsion member 290.

[0082] The second portion 295 of the secondary propulsion member 290 includes an opening 296 formed therein, through which a support tube 280 can be inserted / engaged to secure the proximal end 281 of the support tube 280 to the secondary propulsion member 290. Furthermore, the opening 296 allows the conduit 260 to be advanced through the secondary propulsion member 290 as the conduit 260 moves from a first conduit position to a second conduit position.

[0083] like Figure 3 and Figure 10 As shown, in some embodiments of this disclosure, one or more catheter support inserts 300 (or more generally, "support inserts") may optionally be included in the guide 210 and positioned along the length of the catheter 260 between the proximal and distal ends. Figure 3 and Figure 10 As shown, two support inserts 300 are positioned along the length of the catheter 260. However, it should be understood that fewer or more support inserts 300 may be provided in the guide, including only a single support insert 300 positioned on the catheter 260, or two, three, five or more support inserts 300 possibly positioned along the length of the catheter 260. In the case of providing multiple support inserts 300, these support inserts 300 may be spaced equidistantly along the catheter 260.

[0084] The support inserts 300 of the guide 210 are positioned within the housing 218 (i.e., within the second portion 215 of the internal volume 213), between the main propulsion member 270 and the secondary propulsion member 290. The conduit 260 passes through the channels or openings 302 of each support insert 300 to reduce the unsupported length of the conduit 260, thereby effectively increasing the resistance that the conduit 260 can withstand before bending or kinking. That is, the force required to bend / kink the conduit 260 is inversely proportional to the square of its effective length. Therefore, as the effective length of the conduit 260 increases, the force required to bend / kink the conduit 260 decreases, making the conduit easier to bend / kink. The support insert 300 supports the conduit 260, thereby shortening the effective length of the conduit 260, increasing the force required to bend / kink the conduit 260, and reducing the tendency of the conduit 260 to bend / kink within the housing 218. That is, the support insert 300 divides the unsupported length of the conduit 260 into smaller portions that are more resistant to bending, kinking, flexing, and / or deformation.

[0085] According to embodiments of this disclosure, the cross-sectional shape of each support insert 300 may be at least partially based on the cross-sectional shape of the second portion 215 of the internal volume 213 defined by the guide 210, such as a circular cross-sectional shape. In this way, when the support insert 300 moves relative to the guide 210, the inner surface 223 of the first member 220 ( Figure 4 ) and the inner surface 233 of the second component 230 Figure 5 The support insert 300 can support and / or guide the support insert 300, as explained in further detail below. The support insert 300 includes an opening 302 formed therethrough, such as an opening formed at its center point, the opening 302 being sized and shaped to allow the conduit 260 to pass freely through it while being contained within it, thereby preventing excessive movement of the conduit 260 within the opening 302. In some embodiments, as a non-limiting example, the support insert 300 may be formed of an easily manufactured moldable material, wherein the support insert 300 is formed of a polymeric material that can be injection molded.

[0086] Now for reference Figures 13 to 16 And continue to refer to Figures 1 to 12B This illustrates a change in the blood-drawing device 200 from a first configuration to a second configuration. The blood-drawing device 200 can be in the first configuration before use and can be switched from the first configuration to the second configuration by a user (e.g., a doctor, internist, nurse, technician, venipuncturist, etc.) to position at least the distal portion 262 of the catheter 260 in a distal position relative to the housing 218 (e.g., positioned in the indwelling catheter 312). Figure 1 (inside the distal end of the catheter / through the distal end of the indwelling catheter).

[0087] First refer to Figure 13When the catheter 260 is positioned in a first catheter location within the housing 218 and the support tube 280 is positioned in a first tube location within the housing 218, the blood-drawing device 200 is shown in a first configuration. In some embodiments, when the catheter and support tube are in their respective first positions, substantially the entire catheter 260 and support tube are disposed within the housing 218. In such embodiments, the housing 218 may include a seal (as described above) that can substantially seal the distal portion 212 of the housing 210 to isolate the catheter 260 and support tube 280 within a second portion 215 of the internal volume 213. In other embodiments, the catheter 260 and support tube 280 are disposed within the housing 210 and locking member 240 when in their respective first positions.

[0088] With the blood-drawing device 200 in its first configuration, the main propulsion member 270 is positioned toward the proximal portion 211 of the guide 210, and the secondary propulsion member 290 is positioned slightly centrally within the guide 210. The proximal portion 261 of the catheter 260 is connected to the second portion 275 of the main propulsion member 270, and the catheter 260 extends through the second portion 215 of the internal volume 213 of the guide 210 and through the catheter support insert 300 (e.g., Figures 13 to 16 The two support inserts (300) shown have a channel 285 for each catheter support insert, wherein the distal portion 262 of the catheter 260 is positioned within the support insert 280. The proximal portion 281 of the support insert is coupled to a second portion 295 of the secondary propulsion member 290, and the support insert 280 extends through a second portion 215 of the internal volume 213 of the guide 210 to be received within the lumen of the connector 216 and / or the lumen 255 of the locking member 240.

[0089] With the blood-drawing device 200 in its first configuration, the catheter support inserts 300 are positioned in their initial pre-use position, for example, equidistantly spaced along the unsupported portions of the catheter 260 (extending from the second portion 275 of the main propeller 270 to the second portion 295 of the auxiliary propeller 290). In some embodiments (not shown), these catheter support inserts are formed on the inner surface of the guide housing (i.e., the inner surface 223 of the first housing member 220). Raised protrusions project inward from the inner surface 223 of the housing 218 and can be formed on this inner surface at positions corresponding to the pre-use position of the catheter support inserts 300.

[0090] To change the blood-drawing device 200 from the first configuration to the second configuration, the user first engages the engagement member 292 of the secondary propulsion member 290 to move the secondary propulsion member 290 relative to the housing 218. This, in turn, moves the support tube 280 from the first tube position (e.g., disposed within the housing 218) to the second tube position. In this way, the support tube 280 moves through the second portion 215 of the internal volume 213 and the lumen 255 of the locking member 240, and is advanced into and through the VAD 310 such that the distal end 282 of the support tube 280 extends out of the indwelling catheter 312 and into the patient's vein. As previously described, the support tube 280 is formed of an anti-kink material, such as a shape memory alloy (e.g., nitinol), which allows the support tube 280 to be advanced through the VAD 310 without concern for kinking.

[0091] After the secondary propulsion component 290 moves in the distal direction, the blood-drawing device 200 is considered to be in an intermediate configuration (e.g., Figure 14 As shown), the support tube 280 is in the second tube position (pushed through VAD 310), but the conduit 260 is still in the first conduit position (within the housing 218 of the guide 210).

[0092] When the blood-drawing device 200 is actuated to the intermediate configuration, the user can then engage the engagement member 272 of the main propulsion member 270 to move the main propulsion member 270 relative to the housing 218, thereby changing the blood-drawing device 200 from the intermediate configuration to the second configuration. Figure 15 As shown, the main propulsion member 270 is actuated distally along the housing 218 to move the catheter 260 from a first catheter position (e.g., disposed within the housing 218) toward a second catheter position. As the catheter 260 moves distally, it advances through the second portion 215 of the internal volume 213 and the lumen 255 of the locking member 240, and advances into and through the VAD 310, such that the distal end 282 of the catheter 260 extends out of the indwelling catheter 312 and out of the support fitting 280, and into the patient's vein. As described above, with the support fitting 280 already in its second fitting position, the catheter 260 can advance to the second catheter position as it is pushed distally through the support fitting 280 (which is coaxially positioned around the catheter) without concern about catheter kinking. Since the inner diameter of the inner cavity 283 of the support fitting 280 is only slightly larger than the outer diameter of the conduit 260, and due to the anti-kink properties of the support fitting 280, the support fitting 280 is used to guide the conduit 260 and prevent the conduit from kinking when the conduit is pushed distally to the second conduit position.

[0093] In some embodiments, when the main propulsion member 270 moves distally along the housing 218 to change the blood collection device 200 from an intermediate configuration to a second configuration, the main propulsion member 270 contacts the nearest-side catheter support insert 300a. As the main propulsion member 270 advances further distally, it pushes the nearest-side catheter support insert 300a distally. According to aspects of this disclosure, the pushing of the catheter support insert 300a by the main propulsion member 270 is sufficient to force the catheter support insert 300a past a raised protrusion on the housing 218 that holds the catheter support insert 300a in its pre-use position. Continued distal advancement of the main propulsion member 270 causes the nearest-side catheter support insert 300a to eventually contact the next catheter support insert 300b located on the catheter 260. When the nearest catheter support insert 300a contacts the next catheter support insert 300b and the main propulsion member 270 continues to advance, the main propulsion member 270 and the catheter support insert 300a push the next catheter support insert 300b in a distal direction (through its engagement with the raised protrusion). In some embodiments, when the blood-drawing device 200 reaches the second configuration, the catheter support inserts 300a, 300b may be moved to contact the second portion 295 of the auxiliary propulsion member 290, while in other embodiments, a gap may be maintained between the catheter support inserts 300a, 300b and the second portion 295 of the auxiliary propulsion member 290.

[0094] With the blood-drawing device 200 in its second configuration, the catheter 260 is thus moved to its second position, wherein the distal portion 262 of the catheter is located at a desired position relative to the distal end of the indwelling catheter 312, such as... Figure 16 As shown. In some cases, for example, the distal end 262 of catheter 260 may extend beyond the predetermined distal distance of indwelling catheter 312, such that the distal end 262 of catheter 260 is positioned within the vein beyond a predetermined distance from the distal surface of catheter 260 (e.g., in a location within the vein where there is substantially no debris (e.g., fibrin / blood clots) that would otherwise surround the distal portion of the PIVC).

[0095] In some embodiments, with catheter 260 in the second catheter position, the user can retract the support tube 280 from its second tube position before performing blood draw. That is, the user can push the secondary propulsion member 290 proximally along the housing 218 to retract the support tube 280 back into the indwelling catheter 312, thereby optimizing the conditions for blood draw.

[0096] With catheter 260 in the second catheter position (and support fitting 280 optionally retracted proximally), the user can establish fluid communication between catheter 260 and a fluid reservoir, fluid source, syringe, etc. With catheter 260 in fluid communication with the fluid reservoir and / or fluid source, the blood-drawing device 200 can then aspirate a volume of blood from a vein, at least in part, by positioning the distal surface of catheter 260 at a predetermined and / or desired distance beyond the distal end of indwelling catheter 312. In some cases, once the desired amount of blood has been collected and / or once the desired amount of medication has been delivered to the patient, the user can move the main propulsion member 270 proximally, for example, moving the main propulsion member 270 back to its proximal position, thereby moving catheter 260 back to the first position.

[0097] In this way, the blood-drawing device 200 can be operated to advance the catheter 260 into the indwelling catheter 312 while minimizing the possibility of the catheter 260 bending, twisting or deforming.

[0098] Now for reference Figures 17 to 19 It is recognized that some embodiments of the blood-drawing device 200 may further integrate one or more sensors and associated electronics / circuitets into the support tube 280 and the secondary propulsion member 290 to further facilitate the advancement of the catheter 260 into / through the VAD 310. That is, readings from the sensors may help determine whether it is appropriate to advance the catheter 260 to the second catheter position for blood drawing, or whether there is a problem with the indwelling catheter 312.

[0099] First refer to Figure 17 The support tube 280 is shown to include a sensor 320 which is incorporated into the distal portion 282 of the support tube 280, wherein the sensor 320 is embedded in the support tube 280 or formed on the outer surface of the support tube 280.

[0100] In one embodiment, sensor 320 may include a pressure sensor embedded in support fitting 280 and operable to assess line pressure within indwelling catheter 312 as support fitting 280 is advanced toward the second fitting position. The detection of pressure difference by sensor 320 may be used to indicate whether support fitting 280 has withdrawn from indwelling catheter 312, thereby allowing subsequent advancement of catheter 260, or may be used to indicate blockage of indwelling catheter 312 of VAD 310, thus indicating improper insertion of catheter 260.

[0101] In another embodiment, sensor 320 may include a near-infrared (NIR) sensor mounted externally to support fitting 280. This NIR sensor utilizes light transmission and absorption to measure various physiological parameters at the insertion site of the indwelling catheter 312. As sensor 320 extends from the indwelling catheter 312 and enters the patient's vein, it can indicate its position based on measured light transmission obliquely through the inner diameter of the support fitting (confirming blood flow into the support fitting 280). Conversely, if an obstruction of the indwelling catheter 312 is present, sensor 320 can determine the presence of such an obstruction based on measured light transmission obliquely through the inner diameter of the support fitting.

[0102] Now for reference Figure 18 The support fitting 280 is shown to include a flow sensor 320 incorporated in the distal portion 282 of the support fitting 280, wherein the flow sensor is housed in a split diaphragm 322 disposed at the distal end of the support fitting 280. The flow sensor 320 operates to detect changes in the flow rate of fluid entering the support fitting 280, thereby indicating a clinical condition in the VAD 310, such as partial blockage of the indwelling catheter 312 due to thrombus buildup. Due to the split diaphragm 322, the catheter 260 is still able to pass through the distal portion 282 of the support fitting 280.

[0103] exist Figure 17 and Figure 18 In any of these sensor embodiments, sensor 320 can be operatively communicated with electronic module 324 integrated in secondary propulsion member 290, such as Figure 19 As shown. That is, the secondary propulsion member 290 may include an electronic module 324 incorporated therein, which includes a communication module 326 operatively connected to the sensor 320 to receive signals from the sensor 320 regarding acquired operational data. The electronic module also includes: an integrated circuit 328 configured to process the signals received by the communication module 326; and an indicator 330 controlled by the integrated circuit 328 and configured to generate an audio or visual alarm in response to the acquired operational data. In this way, the electronic module 324 can communicate and indicate to the user the status of the VAD 310 (i.e., the indwelling catheter 312) and / or whether it is appropriate to advance the catheter 260 into / through the indwelling catheter 312 for blood collection, including when the support tube 280 and the catheter 260 have been advanced to the appropriate position within the vascular system. Figure 19 As further shown, a flexible clip 332 can be provided to secure the electronic module 324 to the secondary propulsion member 290.

[0104] Advantageously, embodiments of this disclosure relate to a blood-drawing device that advances an extension catheter into an indwelling catheter in a VAD while minimizing the possibility of catheter bending, kinking, or deformation. The blood-drawing device includes a support tube located within a guide housing, which can be advanced into the VAD before advancing the extension catheter. The support tube is made of a shape memory alloy or other suitable material with anti-kinking properties, allowing it to be initially advanced into the patient's vascular system without kinking. The catheter can then be subsequently advanced through the support tube, which guides the catheter and prevents kinking, thereby positioning the catheter in a suitable location within the patient's vascular system for blood collection.

[0105] Although this disclosure has been described in detail based on embodiments or aspects currently considered most practical and preferred for illustrative purposes, it should be understood that such detailed description is for that purpose only, and this disclosure is not limited to the disclosed embodiments or aspects. Rather, this disclosure is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that this 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. A blood-drawing device for advancing a catheter into an indwelling catheter of a vascular access device, characterized in that, The blood-drawing device includes: A guide, the guide including a housing having a proximal portion and a distal portion, wherein the housing defines an internal volume; A connecting member, the connecting member being positioned at the distal portion and capable of being connected to the vascular access device; A conduit, which is movably received within the internal volume; A support fitting is movably received within the internal volume and defines a fitting cavity therein, the fitting cavity being configured to receive the conduit, wherein the support fitting is formed of a flexible anti-kink material; A main propulsion member, movably coupled to the housing, and configured to move relative to the housing to move the catheter between a first catheter position and a second catheter position, wherein in the first catheter position the catheter is disposed within the guide or within the guide and the coupling member, and in the second catheter position the distal portion of the catheter is disposed outside the distal portion of the guide and enters or extends distally beyond the distal end of the indwelling catheter; and A secondary propulsion member is movably coupled to the housing, away from the primary propulsion member, and is configured to move relative to the housing to move the support tube between a first tube position and a second tube position. In the first tube position, the support tube is disposed within the guide or within the guide and the connecting member. In the second tube position, the distal portion of the support tube is disposed outside the distal portion of the guide and enters or extends distally beyond the distal end of the indwelling catheter. Wherein, when the support fitting is in the second fitting position and the conduit moves from the first conduit position to the second conduit position, the support fitting is arranged coaxially around a portion of the conduit to prevent the conduit from twisting when the conduit is advanced from the first conduit position to the second conduit position.

2. The blood draw device of claim 1, wherein, The support tube is formed of shape memory alloy.

3. The blood draw device of claim 2, wherein, The shape memory alloy includes nickel-titanium alloy.

4. The blood draw device of claim 1, wherein, The main propulsion member and the secondary propulsion member are arranged on the housing such that the conduit can only move from the first conduit position to the second conduit position by the main propulsion member along the housing distally after the support tube has moved from the first tube position to the second tube position by the secondary propulsion member moving distally along the housing.

5. The blood draw device of claim 1, wherein, The blood-drawing device further includes one or more catheter support inserts positioned within the internal volume and between the main propulsion member and the secondary propulsion member, each of the one or more catheter support inserts receiving the catheter to provide support for the length of the catheter extending between the main propulsion member and the secondary propulsion member.

6. The blood draw device of claim 5, wherein, For the corresponding catheter support insert closest to the main propulsion member among the one or more catheter support inserts, when the catheter is moved from the first catheter position to the second catheter position, the main propulsion member engages the catheter support insert during its movement, wherein the main propulsion member engages the catheter support insert and moves the catheter support insert relative to the housing.

7. The blood draw device of claim 5, wherein, The one or more catheter support inserts include a plurality of catheter support inserts spaced apart along the length of the catheter between the main propulsion member and the secondary propulsion member.

8. The blood draw device of claim 1, wherein, The support tube includes a sensor located at the distal end of the support tube and configured to acquire operational data as the support tube is advanced from the first tube position to the second tube position.

9. The blood draw device of claim 8, wherein, The sensor includes a pressure sensor configured to assess the tubing pressure within the indwelling conduit as the support fitting moves from the first fitting position to the second fitting position.

10. The blood draw device of claim 8, wherein, The sensor includes a near-infrared (NIR) sensor configured to provide positional data of the support fitting relative to the indwelling catheter and / or detect blockages within the indwelling catheter.

11. The blood draw device of claim 8, wherein, The sensor includes a flow sensor configured to detect the flow rate of fluid entering the indwelling catheter.

12. The blood draw device of claim 11, wherein, The flow sensor is housed in a split diaphragm valve located at the distal end of the support fitting, which allows the conduit to pass through when the conduit moves to the second conduit position.

13. The blood draw device of claim 8, wherein, The secondary propulsion component includes an electronic module integrated therein, the electronic module comprising: A communication module, operably connected to the sensor, for receiving signals from the sensor regarding the acquired operational data; An integrated circuit, configured to process the signal received by the communication module; and An indicator, controlled by the integrated circuit and configured to generate an audio or visual alarm in response to the acquired operational data.

14. The blood draw device of claim 1, wherein, The support tube includes scale markings thereon that indicate the length by which the support tube is advanced distally as it moves from the first tube position to the second tube position.

15. The blood draw device of claim 1, wherein, Each of the main propulsion component and the secondary propulsion component includes: The first part includes an engagement portion movable along the top surface of the housing; and The second part is located at least partially within the internal volume and is connected to the first part by a slot formed in the top surface of the housing; Wherein, for the main propulsion component, the second portion is connected to the proximal end of the conduit; and Specifically, for the secondary propulsion component, the second part is connected to the proximal end of the support tube.

16. The blood draw device of claim 15, wherein, Each of the main propulsion member and the secondary propulsion member slides within the slot formed in the top surface of the housing to move relative to the housing.

17. The blood draw device of claim 1, wherein, The connecting member includes a locking element, the locking element comprising: A connector configured to engage the distal portion of the housing; A first arm and a second arm, the first arm and the second arm being configured to engage with the vascular access device or an adapter disposed between the vascular access device and the locking member; and A blunt sleeve extending from the connector and disposed between the first arm and the second arm, the blunt sleeve being configured to engage with the vascular access device or the adapter; The inner lumen extends through the blunt sleeve and the connector, and the support tube and the conduit can be advanced distally through the inner lumen.

18. A blood draw device for advancing a catheter into a retention catheter of a vascular access device, comprising: The blood-drawing device includes: A guide, the guide including a housing having a proximal portion and a distal portion, wherein the housing defines an internal volume, and wherein the housing includes a slot formed therein; A main propulsion member, movably coupled to the housing, and configured to slide within the slot of the housing; A secondary propulsion member is movably coupled to the housing and configured to slide within the slot in the housing, the secondary propulsion member being positioned away from the primary propulsion member; A conduit, movably received within the internal volume, the conduit including a distal end and a proximal end, wherein the proximal end is fixed to the main propulsion member such that movement of the main propulsion member causes a corresponding movement of the conduit; and A support tube is movably received within the internal volume and defines a tube lumen therein, the tube lumen being configured to receive the conduit, the support tube including a distal end and a proximal end, wherein the proximal end of the support tube is fixed to the secondary propulsion member such that movement of the secondary propulsion member causes a corresponding movement of the support tube; Wherein, when each of the main propulsion member and the secondary propulsion member has moved to the corresponding farthest position on the housing, a portion of each of the conduit and the support tube is disposed outside the distal portion of the guide, wherein the conduit is advanced into and through the support tube to prevent the conduit from kinking as the conduit is advanced distally.

19. The blood draw device of claim 18, wherein, The support tube is formed of a shape memory alloy, which resists kinking when it is advanced distally into the indwelling catheter of the vascular access device by the movement of the secondary propulsion member.

20. The blood draw device of claim 18, wherein, The blood-drawing device further includes one or more catheter support inserts positioned within the internal volume and between the main propulsion member and the secondary propulsion member, each of the one or more catheter support inserts receiving the catheter to provide support for the length of the catheter extending between the main propulsion member and the secondary propulsion member.

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