Probe delivery device and system for performing blood drawing

Abstract

The utility model relates to a probe delivery device and a system for performing blood drawing. Provided herein is a probe delivery device for advancing a probe into a vascular access device. The probe conveying device comprises an outer shell, a connector, a shield assembly and a probe assembly. And a shroud assembly including a shroud sleeve movable within the interior volume of the outer housing, the shroud advancing an appliance shroud handle, and a shroud pusher coupled to a proximal end of the shroud sleeve, the shroud handle is configured to slide along an outer surface of the outer housing to move the shroud sleeve distally from a first sleeve position to a second sleeve position. The probe assembly includes a probe movable within the shield sleeve and a probe pusher coupled to a proximal end of the probe, the probe pusher having a probe handle configured to slide along an outer surface of the outer housing to move the probe distally from a first probe position to a second probe position.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 584,797, filed on September 22, 2023, entitled “DeliveryDevice for Probe with Asymmetric Tip,” the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to instrument delivery devices for use with intravenous (IV) catheters, and more specifically, to delivery devices for probes having asymmetrical tips. Background Technology

[0004] Vascular access devices (VADs) are used in the medical field to connect to a patient's peripheral vascular system for intravenous therapy and / or blood draws. Common types of VADs include peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. Catheters are typically supplied as part of a catheter assembly that also includes a catheter hub or adapter, as well as other connectors or extensions providing connections to external devices within the catheter assembly.

[0005] It is recognized that catheters can remain in a patient's body for short periods (days), moderate periods (weeks), or long periods (months to years), and while indwelling IV catheters remain within a patient's vascular system, they are likely to become blocked. Once an IV catheter device is blocked, it may become impossible to use the IV catheter device for infusion or blood draw. In this case, the IV catheter device can be replaced. However, replacing an IV catheter device is burdensome for the patient and increases costs. To address these issues, device delivery devices have been developed that can advance and insert a probe into an indwelling IV catheter, where the probe is used to reposition the distal end of the IV catheter relative to the blockage. For example, some device delivery devices may employ an asymmetric probe that passes through the catheter insertion and is adjacent to the distal opening of the catheter, and the probe is configured with a shaping portion that can lift, advance, retract, or rotate the distal end of the IV catheter, thereby repositioning the catheter within the patient's vascular system. This repositioning can move the venous catheter relative to the walls of the vascular system or other anatomical structures and relative to any obstacles that may form (e.g., thrombi / blockages). By repositioning the catheter, the probe extends catheter patency, including facilitating the collection of blood samples through catheters that have been left in place for extended periods.

[0006] While such asymmetric probes are effective in repositioning IV catheters relative to the walls or other anatomical structures of the vascular system and relative to any obstructions that may form, it should be recognized that the shaped portions of these probes can lead to difficulties in their insertion into the IV catheter. For example, asymmetric probes with V-shaped tips have been shown to be effective in removing the catheter tip from the vein wall to facilitate successful blood draw, but the geometry of the V-shaped tip makes the probe prone to jamming when being advanced into the catheter. As an example, the V-shaped tip may be jammed by a metal wedge included on a catheter hub or adapter from which the catheter extends. The V-shaped tip may also be jammed by another obstruction, whether located along the length of the catheter fitting or within the housing of the device delivery device.

[0007] Therefore, it is desirable to provide a probe delivery device that can be used with an indwelling IV catheter, which allows clinicians to advance an asymmetric probe into and through the indwelling IV catheter while reducing or eliminating the possibility of the probe getting stuck in obstructions in the catheter assembly. Utility Model Content

[0008] This document provides a probe delivery device for advancing an asymmetric probe into a vascular access device. The probe delivery device includes a housing and a connector. The housing defines an internal volume and has a proximal end and a distal end. The connector is positioned at the distal end of the housing and configured to mate with a access connector of the vascular access device. The probe delivery device also includes a shield assembly comprising a shield sleeve and a shield pusher. The shield sleeve is longitudinally arranged within the internal volume and movable within the internal volume. The shield sleeve has a distal end and a proximal end. The shield pusher is coupled to the proximal end of the shield sleeve and has a shield handle configured to slide along an outer surface of the housing. The probe delivery device further includes a probe assembly comprising a probe and a probe pusher. The probe is positioned within and movable within the housing sleeve. The probe has a distal end and a proximal end. The probe pusher is coupled to the proximal end of the probe and has a probe handle configured to slide along the outer surface of the housing. The housing pusher is configured to move relative to the housing, wherein distal movement of the housing pusher moves the housing sleeve from a first sleeve position to a second sleeve position. In the first sleeve position, the distal end of the housing sleeve is disposed within the housing. In the second sleeve position, the distal end of the housing sleeve is disposed outside the distal end of the housing and the connector. The probe pusher is configured to move relative to the housing, wherein distal movement of the probe pusher moves the probe from a first probe position to a second probe position. In the first probe position, the distal end of the probe is disposed within the housing. In the second probe position, the distal end of the probe is disposed outside the distal end of the housing and the connector.

[0009] In some embodiments, the shield handle is positioned on the housing near the probe handle, and wherein distal movement of the shield handle causes a corresponding distal movement of the probe handle.

[0010] In some embodiments, the shield handle is movable a first distance distally along the housing, and the probe handle is movable a second distance distally along the housing greater than the first distance.

[0011] In some embodiments, when the protective sleeve is in the second sleeve position and the probe is in the second probe position, the distal end of the probe extends further distally from the distal end of the protective sleeve, such that the distal end of the probe is positioned outside the protective sleeve.

[0012] In some embodiments, the probe handle is configured to rotate relative to the housing when the probe is in the second probe position, wherein when the probe is in the second probe position, the rotation of the probe handle causes the probe to rotate within the catheter.

[0013] In some embodiments, the probe handle is configured to rotate in a unidirectional or bidirectional manner.

[0014] In some embodiments, the probe pusher includes a coupling element that engages the probe handle with the proximal end of the probe.

[0015] In some embodiments, each of the proximal end of the probe and the coupling element includes a magnet or magnetic material to magnetically couple the probe to the coupling element such that distal movement or rotation of the probe handle causes corresponding distal movement or rotation of the probe.

[0016] In some embodiments, the housing includes a plurality of markings thereon, including at least a first marking that indicates when the guard handle has been advanced a first distance distally along the housing.

[0017] In some embodiments, the plurality of markings includes at least one additional marking that indicates when the probe handle has advanced a second distance or is close to the second distance along the housing.

[0018] In some embodiments, the probe delivery device further includes a seal to prevent fluid flow, the seal being located within or near the connector and configured to prevent fluid transfer between the vascular access device and the internal volume of the housing.

[0019] In some embodiments, the shield thruster and the probe thruster include an integral thruster assembly, wherein each of the proximal end of the shield sleeve and the proximal end of the probe is coupled to the thruster assembly, and wherein the thruster assembly is configured to move relative to the housing, wherein distal movement of the thruster assembly moves the probe and the shield sleeve from their respective first positions to their respective second positions.

[0020] In some embodiments, the probe delivery device further includes a locking mechanism positioned on the connector, the locking mechanism locking the thruster assembly to the connector, and wherein, when the thruster assembly is locked to the connector, the housing is rotatable relative to the thruster assembly, wherein, when the probe is in the second probe position, rotation of the housing causes the probe to rotate within the conduit, which in turn allows the housing to rotate.

[0021] In some embodiments, the distal end of the probe includes a shaping portion for repositioning the distal end of the catheter as the probe is selectively extended into the catheter.

[0022] In some embodiments, the shaped portion is formed of a shape memory material that is straight at ambient room temperature and bends at body temperature.

[0023] In some embodiments, the protective sleeve includes a rigid sleeve or a flexible sleeve.

[0024] This document also provides a system for performing blood draws. The system includes a vascular access device comprising: a catheter adapter having a proximal end and a distal end and defining a lumen therein; and a catheter extending distally from the catheter adapter, having a proximal end and a distal end. The system also includes a probe delivery device, wherein, when the probe is in a second probe position, the distal end of the probe is disposed adjacent to the distal end of the catheter.

[0025] In some embodiments, the catheter adapter includes a wedge positioned within the lumen adjacent to the distal end of the catheter adapter, the wedge being configured to secure the proximal end of the catheter to the catheter adapter, and wherein, when the protective sleeve is in a second sleeve position, the distal end of the protective sleeve is located distal to the wedge.

[0026] In some embodiments, the probe delivery device is configured to advance the probe such that the distal end of the probe is adjacent to the distal end of the catheter.

[0027] In some embodiments, the system further includes an extension kit coupled to the proximal end of the shield sleeve, wherein the shield sleeve provides a fluid flow path between the vascular access device and the extension kit. Attached Figure Description

[0028] Figure 1 This is a side view of a catheter assembly and an associated probe delivery device that can be used with it, according to embodiments described herein;

[0029] Figure 2 yes Figure 1 A side cross-sectional view of the catheter assembly taken along line 2-2;

[0030] Figure 3 yes Figure 1 A side cross-sectional view of a probe delivery device, wherein the probe delivery device is in a first configuration;

[0031] Figure 4 yes Figure 1 A side cross-sectional view of a probe delivery device, wherein the probe delivery device is in a second configuration;

[0032] Figure 5 An embodiment according to the description herein is shown. Figure 1 A separate view of the asymmetric probes included in the probe delivery device;

[0033] Figure 6 This is a side view of a catheter assembly and an associated probe delivery device that can be used with it, according to another embodiment described herein;

[0034] Figure 7 yes Figure 6 A side cross-sectional view of a probe delivery device, wherein the probe delivery device is in a first configuration; and

[0035] Figure 8 yes Figure 6 A side cross-sectional view of the probe delivery device, wherein the probe delivery device is in the second configuration. Detailed Implementation

[0036] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for carrying out the present invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all such modifications, equivalents, variations, and substitutions are intended to fall within the spirit and scope of the present invention.

[0037] 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 embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0038] As used in this specification, the terms "proximal" and "distal" refer to the direction closer to the user who brings the device into contact with the patient and the direction further away from the user, 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 operated by the user will be the proximal end.

[0039] The terms “first”, “second”, etc., are not intended to refer to any particular order or sequence, but rather to different conditions, attributes, or elements.

[0040] 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 only one or more of A; or only one or more of B; or only one or more of C; 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 all or one or more of A, B, and C.

[0041] Now for reference Figures 1 to 5 The diagram illustrates a non-limiting embodiment of a catheter system 10, which includes a vascular access device in the form of a catheter assembly 12 and an associated device delivery device 14, wherein the device delivery device 14 is configured to facilitate the delivery of a device (e.g., a device that may be desired during patient blood collection) into an indwelling catheter of the catheter assembly 12. According to a non-limiting embodiment, the catheter assembly 12 includes a catheter hub 16 and an (optional) extension kit 18, which includes a catheter connector 20 and (optional) an extension tube 22. The catheter hub 16 receives a catheter 24 and is coupled to the catheter connector 20. In one aspect or embodiment, the catheter hub 16 is an AccuCath commercially available from Becton, Dickinson and Company. TM Catheter system. As is known to those skilled in the art, catheter 24 may be a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter, and catheter 24 may be made of any suitable material and may have any useful length.

[0042] The catheter connector 20 is configured to contact the patient's skin surface at or near the insertion site of the catheter 24. Although not shown, it should be understood that the catheter connector 20 may include stabilizing features (e.g., wings) that assist in holding the catheter connector 20 in proper position on the patient's skin. The catheter connector 20 includes a proximal port with a proximal coupler 26 and a distal port with a distal coupler 28, and defines at least one lumen 30. Figure 2 The at least one lumen extends through or is otherwise in fluid communication with couplers 26 and 28. Proximal coupler 26 and / or distal coupler 28 may be, for example, a male or female Luer lock and / or any other suitable coupler, wherein... Figures 1 to 5A non-limiting embodiment of the diagram shows a proximal coupler 26 as a female Luer connector and a distal coupler 28 as a male Luer connector. The proximal coupler 26 can be physically and fluidly coupled to the instrument delivery device 14 to enable the insertion of a probe into the catheter and subsequent blood draw, as will be explained in further detail below. The distal coupler 28 can be physically and fluidly coupled to the catheter hub 16 such that the lumen 30 of the catheter connector 20 is at least selectively in fluid communication with the catheter 24.

[0043] The catheter connector 20 may also include and / or define one or more additional ports, such as side ports 32. Side ports 32 define a lumen 34 in fluid communication with a lumen 30 located between the distal coupler 28 and the proximal coupler 26. Thus, side ports 32 can provide access to the lumen 30 between the distal coupler 28 and the proximal coupler 26, and can further provide access to the catheter hub 16 (and catheter 24) coupled to the distal coupler 28. In some embodiments, the arrangement of the side ports 32 may allow the catheter connector 20 to form, for example, a Y-connector or a T-connector. As previously noted, it should be appreciated that the extension kit 18 may include an extension tube 22 connected to the side port 32 and in fluid communication with the lumen 34 of the side port 32. In some embodiments, the side ports 32 and / or the extension tube 22 may be and / or form at least part of a fluid line that can be used for delivering fluid, removing fluid, flushing fluid, etc.

[0044] like Figure 2 As shown, according to some aspects or embodiments, the catheter hub 16 may include a metallic wedge 36 positioned within a lumen 38 formed through the catheter hub 16. The wedge 36 is positioned within the lumen 38 and at the distal end of the catheter hub 16, such that the wedge 36 can be seated within the lumen 38. The wedge 36 is configured to receive the proximal end of a catheter 24, such that the catheter 24 is secured to the wedge 36, thereby anchoring the catheter 24 to the catheter hub 16.

[0045] The system's device delivery device 14 can be operated to introduce a device into the catheter assembly 12 and the patient's vascular system. In some embodiments, as described below, the device delivery device 14 may include a probe delivery device that introduces a probe 40 through the catheter hub 16 and into the indwelling catheter 24. In some embodiments, the probe 40 may be an asymmetric probe with a curved or shaped distal end, configured to reposition the distal end or tip 42 of the catheter 24 while the catheter 24 is retained within the patient's vascular system, thereby moving the tip 42 of the catheter relative to the walls or other anatomical structures of the vascular system and relative to any obstructions that may have formed (e.g., thrombi / blockages), and providing subsequent blood draw.

[0046] like Figure 1 and Figures 3 to 5 As shown, according to a non-limiting embodiment, the instrument delivery device 14 includes at least a housing 44, a connector 46, a shield assembly 48, and a probe assembly 50, wherein the shield assembly 48 includes a shield pusher 52 and a shield sleeve 54, and the probe assembly 50 includes a probe pusher 56 and a probe 40. As will be described in further detail below, the probe 40 is movable within the housing 44 so that a portion of the probe 40 is either in a first position or a retracted position within the housing 44. Figure 3 Advance to the second position or propulsion position outside the housing 44. Figure 4 This allows its distal end to enter the catheter assembly 12, while the protective sleeve 54 can also be positioned from the first position within the housing 44. Figure 3 ) Move to the second position outside the housing 44 ( Figure 4 The protective sleeve 54 prevents the shaped portion at the distal end of the probe 40 from being jammed or stuck in the catheter assembly (or housing 44) when it is advanced from its first position to its second position.

[0047] The housing 44 of the instrument delivery device 14 may be an elongated member having a proximal end 58 and a distal end 60 and defining an internal volume 62. In some embodiments, the housing 44 may be formed from a pair of housing portions arranged side-by-side and coupled together to define the internal volume 62. The housing 44 may include one or more features or surface finishes on its outer surface, which may be arranged to improve the ergonomics of the instrument delivery device 14, and in some cases, this may allow a user to operate the instrument delivery device 14 with one hand (i.e., single-handed use).

[0048] The connector 46 of the instrument delivery device 14 is located at the distal end 60 of the housing 44, wherein the connector 46 provides reversible coupling between the instrument delivery device 14 and the catheter assembly 12, for example via... Figure 1 The reversible coupling of the proximal coupler 26 is shown. Connector 46 is illustrated as a male Luer connector that mates with the female Luer connector of the proximal coupler 26 on the catheter connector 20, wherein the male Luer connector of connector 46 has an elongated member 64 surrounded by a rotating sleeve 66. The rotating sleeve 66 is rotatable to thread the male Luer connector onto the female Luer connector of the proximal coupler 26. However, it should be understood that alternative embodiments of the instrument delivery device 14 may include another type of connector 46 for securing the instrument delivery device 14 to the catheter assembly 12, including Luer sliding connections, clips, passivated plastic sleeves, passivated metal sleeves, hybrid Luer elements (e.g., having sleeves), friction mating elements, etc.

[0049] As described above, the shroud assembly 48 of the instrument delivery device 14 includes a shroud thruster 52 and a shroud sleeve 54. The shroud sleeve 54 is positioned within an internal volume 62 of the housing 44 and extends generally along the length of the housing 44. The shroud sleeve 54 is configured as an elongated tubular member having a distal end 68 and a proximal end 70, and defining a shroud lumen 72 therein. The shroud sleeve 54 can be formed of any rigid or flexible material, provided that the material is sufficiently rigid to resist buckling. In a non-limiting embodiment, the shroud sleeve 54 is formed of a material that provides buckling resistance, such as polyethylene, polypropylene, nylon, polyurethane, polyimide, etc. In some embodiments, the distal end 68 of the shroud sleeve 54 may include openings (not shown) formed therein that allow for higher flow rates of blood aspiration (or transfusion) through the catheter assembly 12 (and the instrument delivery device 14).

[0050] The shield thruster 52 includes a first portion 74 and a second portion 76. The first portion 74 is movably disposed along the outer surface 78 of the housing 44, and the second portion 76 is movably disposed within the internal volume 62 of the housing 44. In some embodiments, the arrangement of the shield thruster 52 and the housing 44 is such that the connecting portion (not shown) of the first portion 74 and the second portion 76 of the shield thruster 52 is disposed within a recess 80 formed in the outer surface 78 of the housing 44, and the recess 80 generally extends between the proximal end 58 and the distal end 60 of the housing 44. When the first portion 74 and the second portion 76 are engaged, movement of the first portion 74 along the outer surface 78 of the housing 44 causes a corresponding movement of the second portion 76 within the internal volume 62.

[0051] like Figure 3 and Figure 4 As shown, the first portion 74 of the shield pusher 52 can be configured as a (shield) handle (hereinafter referred to as "handle 74") positioned on the housing 44. In some embodiments, the handle 74 can be configured as an annular member that generally surrounds the housing 44 and contacts the outer surface 78 of the housing. The handle 74 can be engaged by a user such that the handle can be pushed distally along the outer surface 78 of the housing 44 and relative to the outer surface of the housing.

[0052] like Figure 3 and Figure 4As shown, the second portion 76 is movably disposed within the internal volume 62 of the housing 44 and includes an attachment member 82 (e.g., a base or opening) through which the shield sleeve 54 can be secured to the shield pusher 52, wherein the attachment member 82 is configured to clamp or retain the proximal end 70 of the shield sleeve 54. Since the shield sleeve 54 is held by the attachment member 82 of the second portion 76, movement of the shield pusher 52 relative to the housing 44 causes a corresponding movement of the shield sleeve 54 relative to the housing 44. In this way, the distal end 68 of the shield sleeve 54 can be selectively moved out or back into the internal volume 62 of the housing 44 as desired, such as pushing the distal end 68 of the shield sleeve 54 out of the housing 44 when the instrument delivery device 14 has been coupled to the catheter assembly 12, and it is desired to advance the probe 40 into the catheter 24.

[0053] As noted above, the probe assembly 50 of the instrument delivery device 14 includes a probe pusher 56 and a probe 40. The probe 40 may be configured as a lead wire formed of metal or other suitable material, wherein the lead wire has a diameter that provides positioning of the lead wire within the conduit 24. The probe 40 is positioned within the lumen 72 of the sheath sleeve 54, and as described in further detail below, the probe 40 may be moved relative to the sheath sleeve 54 via operation of the probe pusher 56, such that the distal end 84 of the probe 40 may be extended from the distal end 68 of the sheath sleeve 54.

[0054] As noted above, according to various aspects of this disclosure, probe 40 can be configured as an asymmetric probe having a curved or shaped distal end 84, which is configured to reposition the distal end 42 of catheter 24 when probe 40 is advanced into and / or rotated within catheter 24. Figure 5 Examples of how probe 40 can be configured to induce this repositioning are provided. Figure 5 In the illustration, probe 40 is shown having a distal end 84, a shaping portion 86, and a proximal end 88. The shaping portion 86 should be interpreted as a length of probe 40 positioned at or toward the distal end 84, the shape of which deviates from the longitudinal axis of the proximal end 88, and which generally retains this shape when the distal end 84 is positioned near or at the distal end 42 of the catheter 24. In the illustrated embodiment, the shaping portion 86 is in the form of a V-shaped length of probe 40 positioned between the proximal end 88 and the distal end 84, wherein the V-shaped length is adjacent to the distal end 84 of probe 40. In other embodiments, it should be appreciated that, according to other non-limiting examples, the shaping portion 86 may alternatively be configured to have an inverted V-shape or a curved W-shape.

[0055] In some embodiments, the shaping portion 86 may bend, flatten, or otherwise adjust its shape as it is advanced through the conduit 24, and when positioned at or near the distal end 42 of the conduit 24, it may substantially maintain its shape, thereby acting on the distal end 42 of the conduit 24 to reposition the distal end. As described above, when the probe 40 is advanced, the shape of the probe 40 will necessarily need to adapt to the boundaries of the conduit 24. However, even with this adaptation, the shaping portion 86 is configured to substantially maintain its shape relative to the distal end 84 and the proximal end 88. In other embodiments, it will be appreciated that the shaping portion 86 may be formed of a shape memory material that is straight at ambient room temperature and bends at body temperature.

[0056] Similar to the shield thruster 52, the probe thruster 56 is also formed to include a first portion 90 and a second portion 92. The first portion 90 is movably disposed along the outer surface 78 of the housing 44, and the second portion 92 is movably disposed within the internal volume 62 of the housing 44. In some embodiments, the arrangement of the probe thruster 56 and the housing 44 is such that the connecting portion (not shown) of the probe thruster 56, which combines the first portion 90 and the second portion 92, is disposed within a recess 80 formed in the outer surface 78 of the housing 44, extending generally between the proximal end 58 and the distal end 60 of the housing 44. When the first portion 90 and the second portion 92 are engaged, movement of the first portion 90 along the outer surface 78 of the housing 44 causes a corresponding movement of the second portion 92 within the internal volume 62.

[0057] like Figure 3 and Figure 4 As shown, the first portion 90 of the probe pusher 56 can be configured as a (probe) handle (hereinafter referred to as "handle 90") positioned on the housing 44. In some embodiments, the handle 90 can be configured as an annular member generally surrounding the housing 44 and contacting the outer surface 78 of the housing. The handle 90 can be engaged by a user such that the handle can be pushed distally along the outer surface 78 of the housing 44 and relative to the outer surface of the housing, wherein the probe handle 90 is positioned distally to the housing handle 74.

[0058] like Figure 3 and Figure 4As shown, a second portion 92 of the probe thruster 56 is movably disposed within the internal volume 62 of the housing 44 and configured such that at least a portion of the second portion is positioned adjacent to or around the shroud sleeve 54. According to aspects of this disclosure, the second portion 92 includes a coupling element 94 configured to interact with the probe 40 such that movement of the probe thruster 56 relative to the housing 44 causes a corresponding movement of the probe 40 relative to the housing 44. In an exemplary embodiment, the coupling element 94 may be configured as an annular or other shaped member positioned around the shroud sleeve 54 and configured to interact with a magnetic element 96 located at the proximal end of the probe 40 (i.e., formed of or including a magnet thereon) such that the coupling element 94 is magnetically coupled to the probe 40. In this way, the distal end 84 of the probe 40 can be selectively moved out or back into the internal volume 62 of the housing 44 as desired, such as pushing the distal end 84 of the probe 40 out of the housing 44 when the instrument delivery device 14 has been coupled to the catheter assembly 12, and advancing the probe 40 into the catheter 24.

[0059] With the instrument delivery device 14 configured as described above (i.e., with the shroud pusher 52 close to the probe pusher 56 on the housing 44), the distal advancement of the shroud pusher 52 along the housing 44 will cause the probe pusher 56 to correspondingly advance distally along the housing 44, such that both the shroud sleeve 54 and the probe 40 advance together relative to the housing 44. Additionally, when desired, after the shroud pusher 52 has reached the desired position along the housing 44, the probe pusher 56 can be further advanced distally along the housing 44, such that while the shroud sleeve 54 remains in position, the probe 40 can be further advanced distally, i.e., the probe handle 90 can move distally along the housing 44 by a distance (a second distance) greater than the (first) distance that the shroud handle 74 can move distally along the housing 44. Therefore, the distal end of the probe 40 can extend distally from the distal end 68 of the shroud sleeve 54, such that the distal end 84 of the probe 40 is positioned outside the shroud sleeve 54.

[0060] According to various aspects of this disclosure, in addition to being movable along the housing 44, the probe pusher 56 is also configured to rotate relative to the housing 44 to provide rotation of the probe 40 and repositioning of the distal end 42 of the catheter 24 away from the vein wall, thrombus, or other potential features on the vein that could prevent successful blood draw. Specifically, as the probe pusher 56 is advanced distally and the probe 40 is in its second position, the probe handle 90 can be rotated relative to the housing 44, wherein the magnetic coupling between the probe pusher 56 (i.e., the coupling element 94 of the probe pusher) and the proximal end 88 of the probe 40 transmits the rotation of the probe handle 90 to the probe 40, causing the probe 40 and its asymmetrical tip to rotate in a desired angular direction. According to embodiments, the handle 90 may be able to rotate in only one direction, or it may be able to rotate in both directions (causing the probe tip to rotate back and forth).

[0061] According to some aspects of this disclosure, and as Figure 1As shown, housing 44 may include one or more position marks on the housing indicating the positioning of the shield sleeve 54 and / or probe 40 relative to components of catheter assembly 12. According to a non-limiting embodiment, a first position mark 98 may be provided on housing 44 as a marker (such as a colored area, text, or symbol). The first position mark 98 may be provided on the top surface of housing 44 (or around the entire outer surface of housing) and may indicate to the operator when the shield sleeve 54 has been advanced distally to its second position, such that the shield sleeve 54 extends into or distally passes through the wedge 36 (in catheter hub 16). With the shield pusher 52 aligned with the first position mark 98 on housing 44, the shield sleeve 54 will be in the second position, where the distal end 68 of the shield sleeve extends into or distally passes through the wedge 36, thereby ensuring that probe 40 will not become stuck on the wedge 36. One or more second position marks 100 may also be provided on the housing 44 as markers (such as colored areas, text, or symbols). The second position marks 100 may be located on the top surface of the housing 44 (or around the entire outer surface of the housing) and may indicate to the operator when the probe 40 has been advanced distally to or has reached its second position, such that the probe 40 is positioned near or at the distal end 42 of the catheter 24. In some embodiments, the second position marks 100 may indicate when the distal end 84 of the probe 40 is within 2 inches, 1.25 inches, 1.0 inch, or at the distal end 42 of the catheter 23. When the probe advancer 56 is aligned with one of the second position marks 100 on the housing 44, the probe 40 will be located at or near its second position, such that the distal end 84 of the probe is positioned on / near the distal end 42 of the catheter 24, enabling the distal end 42 of the catheter 24 to be positioned away from the vein wall or thrombus / blockage.

[0062] According to the additional aspects of this disclosure, and as Figure 3 and Figure 4As shown, the instrument delivery device 14 may include a flow-preventing diaphragm or sealing member 102 to prevent unwanted fluid transfer between the catheter assembly 12 and the instrument delivery device 14. That is, the flow-preventing sealing member 102 may be provided within or near the connector 46 of the instrument delivery device 14, configured to prevent unwanted fluid transfer between the catheter assembly 12 and the internal volume 62 of the housing 44. In some embodiments, the sealing member 102 is formed within the connector 46 (i.e., within its lumen). According to one embodiment, the sealing member 102 may be formed of a flexible, elastic material and includes an opening 104 formed therein through which the sheath sleeve 54 passes. Based on the size of the opening 104, a seal is formed between the sealing member 102 and the sheath sleeve 54 as the sheath sleeve and probe are advanced through the opening 104 and as the sheath sleeve 54 and probe 40 move to a second position. In some embodiments, a lubricant (e.g., a silicone-based lubricant) may be added to the opening 104 of the sealing member 102 or the outer surface of the protective sleeve 54 to reduce friction between the protective sleeve 54 and the sealing member 102.

[0063] In use of the instrument delivery device 14 and when connecting the probe delivery device to the catheter assembly 12, the operator can push the shield pusher 52 distally along the housing 44. Pushing the shield pusher 52 advances the shield sleeve 54 within the housing 44, and in some embodiments, the shield pusher 52 can be pushed distally until the shield sleeve 54 has moved forward past the wedge 36 of the catheter hub 16 or another known obstacle. Since the probe pusher 56 is positioned close to the shield pusher 52, pushing the shield pusher 52 distally along the housing 44 also pushes the probe pusher 56 distally along the housing 44, wherein pushing the probe pusher 56 pushes the probe 40 distally within the housing 44 and the shield sleeve 54. When the shield pusher 52 has moved distally to its desired position, the operator can continue to push the probe pusher 56 distally along the housing 44 to further advance the probe 40 through the shield sleeve 54 and further into the catheter 24. The probe pusher 56 can be advanced distally until the probe 40 reaches the region of the catheter tip 42. Once there, the probe pusher 56 can be rotated about the housing 44 to move the asymmetrical tip of the probe 40 (i.e., the shaped portion 86), wherein the probe pusher 56 rotates unidirectionally to rotate the tip in a consistent angular direction, or rotates bidirectionally to rotate the tip back and forth. Both movements can move the catheter tip 42 away from the vein wall, thrombus, or other potential features on the vein that could prevent successful blood draw.

[0064] For reference Figures 6 to 8 These figures illustrate a probe delivery device 110 according to another embodiment of the present disclosure. Figures 6 to 8The probe delivery device 110 and Figures 1 to 5 The difference with the instrument delivery device 14 is that the separate shield thruster 52 and probe thruster 56 of the device are replaced by a single integrated thruster assembly 112 that performs the functions of both shield thruster 52 and probe thruster 56.

[0065] Similar to the description above, the integrated thruster assembly 112 may include a first portion 114 and a second portion 116, wherein the first portion 114 is movably disposed along the outer surface 78 of the housing 44, and the second portion 116 is movably disposed within the internal volume 62 of the housing 44. The first portion 114 of the thruster assembly 112 may be configured as a handle (hereinafter referred to as "handle 114") positioned on the housing 44. In some embodiments, the handle 114 may be configured as an annular member generally surrounding the housing 44 and contacting the outer surface of the housing. The handle 114 may be engaged by a user such that the handle can be pushed distally along the outer surface 78 of the housing 44 and relative to the outer surface of the housing. The second portion 116 of the thruster assembly 112 is movably disposed within the internal volume 62 of the housing 44 and includes an attachment member 118 (e.g., a base), through which the shroud sleeve 54 and the probe 40 can be secured to the thruster assembly 112. The attachment member 118 is configured to clamp or retain the proximal ends of the shroud sleeve 54 and the probe 40. Because the shroud sleeve 54 and the probe 40 are held by the attachment member 118 of the second portion 116, movement of the thruster assembly 112 relative to the housing 44 causes corresponding movement of the shroud sleeve 54 and the probe 40 relative to the housing 44. In this way, the distal end 68 of the sheath sleeve 54 and the distal end 84 of the probe 40 can be selectively moved out or back into the internal volume 62 of the housing 44 as desired, such as when the probe delivery device 110 has been coupled to the catheter assembly 12, the distal end 84 of the sheath sleeve 54 and the distal end 84 of the probe 40 are pushed out of the housing 44, and the probe 40 is desired to be pushed into the catheter 24.

[0066] According to various aspects of this disclosure, in addition to the ability of the pusher assembly 112 to move along the housing 44, the pusher assembly 112 is also configured to provide rotation between the housing 44 and the pusher assembly 112 to allow rotation of the probe 40 and repositioning of the distal end 42 of the catheter 24 away from the vein wall, thrombus, or other potential features on the vein that could prevent successful blood draw. As shown, the connector 46 of the probe delivery device 110 includes a locking mechanism 120 positioned on the proximal surface of the connector, which can engage the pusher assembly 112 after it has been advanced distally along the housing 44 and engaged with the connector 46. When the pusher assembly 112 is disengaged from the connector 46, the locking mechanism 120 can be in a locked state that prevents rotation of the housing 44 (relative to the connector 46). When the pusher assembly 112 contacts / engages with the connector 46, the handle 114 of the pusher assembly 112 actuates the locking mechanism 120 to its unlocked state, thereby making the pusher assembly 112 and the housing 44 rotatable. In this way, when the pusher assembly 112 is advanced distally to its second position, the probe 40 can be rotated to reposition the asymmetrical end (formed portion 86) of the probe in the desired angular direction, thereby also repositioning the distal end 42 of the conduit 24.

[0067] In use Figures 6 to 8 When delivering the probe and when connecting it to the catheter assembly, the operator can push the integrated thruster assembly 112 distally along the housing 44. Pushing the thruster assembly 112 advances the shroud sleeve 54 and probe 40 within the housing 44, and in some embodiments, the thruster assembly 112 can be pushed distally until the shroud sleeve 54 and probe 40 have moved forward past the wedge 36 of the catheter hub 16 or another known obstruction, and until the distal end 84 of probe 40 (and the shroud sleeve 54) is advanced to the distal end 42 adjacent to the indwelling catheter 24. As the thruster assembly 112 is moved distally to its desired position, the thruster assembly 112 / housing 44 can be rotated to move the asymmetrical end (also referred to as the distal end) 84 of probe 40, wherein the probe thruster 56 rotates unidirectionally to rotate the end 84 in a consistent angular direction, or rotates bidirectionally to rotate the end 84 back and forth. Both of these movements can move the tip 42 of the catheter away from the vein wall, thrombus, or other potential features on the vein that could prevent successful blood draw.

[0068] According to additional aspects of this disclosure, in Figures 1 to 5 The instrument delivery device 14 and Figures 6 to 8In any of the probe delivery devices 110, blood aspiration can be performed by repositioning the catheter tip 42 using an instrument delivery device 14 coupled to the catheter assembly 12, a probe delivery device 110, and a probe 40 located in a second position thereon (i.e., using a shaped portion 86 of the distal end 42 of the probe 40 adjacent to the catheter 42). When providing blood aspiration, an extension kit or blood collection device can be connected at the proximal end of the instrument delivery device 14 or the probe delivery device 110. In some embodiments, the extension kit includes a secondary catheter 124 positioned in fluid communication with a shield sleeve 54, wherein the shield sleeve 54 provides a fluid flow path between the catheter assembly 12 and the secondary catheter 124. The distal end 126 of the secondary catheter 124 can be secured to a second portion 76 of the shield pusher 52 (or a second portion 116 of the pusher assembly 112) for alignment with the shield sleeve 54. In some embodiments, the secondary catheter 124 may be secured to the second portion 76 via attachment members 82, 118, which may be an opening aligned with the sheath sleeve 54. The proximal end 128 of the secondary catheter 124 may include a connector 130 (e.g., a Luer connector) on the proximal end, to which a blood collection device (not shown), such as a vacuum injector, can be connected to enable blood collection.

[0069] Advantageously, aspects of this disclosure thereby provide a probe delivery device that can be used with a catheter assembly having a catheter hub and an indwelling IV catheter, wherein the probe delivery device allows a clinician to advance an asymmetric probe into and through the indwelling IV catheter while reducing or eliminating the possibility of the probe getting stuck on an obstruction in the catheter assembly. The probe delivery device includes a sheath sleeve in which the probe is positioned, wherein each sheath sleeve and the probe are configured to be advanced into the catheter assembly. The sheath sleeve can prevent the probe from getting stuck on a wedge-shaped part of the catheter hub and / or another obstruction in the catheter assembly or delivery device.

[0070] Although this disclosure has been described in detail based on embodiments or aspects currently considered to be most practical and preferred for illustrative purposes, it should be understood that such detail 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 probe delivery device, characterized in that, The probe delivery device is used to advance an asymmetric probe into a vascular access device, and the probe delivery device includes: An outer casing that defines an internal volume and has a proximal end and a distal end; A connector, located at the distal end of the housing and configured to mate with the access connector of the vascular access device; The shield assembly includes: A protective sleeve, the protective sleeve being longitudinally arranged within the internal volume and movable within the internal volume, the protective sleeve having a distal end and a proximal end; and A shield thruster coupled to the proximal end of the shield sleeve, the shield thruster having a shield handle configured to slide along the outer surface of the housing; and The probe assembly includes: A probe, positioned within the protective sleeve and movable within the protective sleeve, having a distal end and a proximal end; and A probe pusher coupled to the proximal end of the probe, the probe pusher having a probe handle configured to slide along the outer surface of the housing; The shield thruster is configured to move relative to the outer housing, wherein the distal movement of the shield thruster moves the shield sleeve from a first sleeve position to a second sleeve position. In the first sleeve position, the distal end of the shield sleeve is disposed within the outer housing; in the second sleeve position, the distal end of the shield sleeve is disposed outside the distal end of the outer housing and the connector. The probe pusher is configured to move relative to the housing, wherein the distal movement of the probe pusher moves the probe from a first probe position to a second probe position. In the first probe position, the distal end of the probe is disposed within the housing, and in the second probe position, the distal end of the probe is disposed outside the distal end of the housing and the connector.

2. The probe delivery device according to claim 1, characterized in that, The shield handle is positioned on the housing near the probe handle, and wherein distal movement of the shield handle causes a corresponding distal movement of the probe handle.

3. The probe delivery device according to claim 1, characterized in that, The shield handle is capable of moving a first distance along the outer shell to the distal side, and wherein the probe handle is capable of moving a second distance along the outer shell to the distal side greater than the first distance.

4. The probe delivery device according to claim 1, characterized in that, When the protective sleeve is in the second sleeve position and the probe is in the second probe position, the distal end of the probe extends further distally from the distal end of the protective sleeve, so that the distal end of the probe is positioned outside the protective sleeve.

5. The probe delivery device according to claim 1, characterized in that, The probe handle is configured to rotate relative to the housing when the probe is in the second probe position, wherein when the probe is in the second probe position, the rotation of the probe handle causes the probe to rotate within the conduit.

6. The probe delivery device according to claim 5, characterized in that, The probe handle is configured to rotate in a unidirectional or bidirectional manner.

7. The probe delivery device according to claim 1, characterized in that, The probe pusher includes a coupling element that engages the probe handle with the proximal end of the probe.

8. The probe delivery device according to claim 7, characterized in that, Each of the proximal end of the probe and the coupling element includes a magnet or magnetic material to magnetically couple the probe to the coupling element such that distal movement or rotation of the probe handle causes corresponding distal movement or rotation of the probe.

9. The probe delivery device according to claim 1, characterized in that, The housing includes a plurality of markings, including at least a first marking that indicates when the shield handle has been advanced a first distance distally along the housing.

10. The probe delivery device according to claim 9, characterized in that, The plurality of markings includes at least one additional marking that indicates when the probe handle has advanced a second distance or is close to the second distance along the housing.

11. The probe delivery device according to claim 1, characterized in that, The probe delivery device also includes a seal to prevent fluid flow, the seal being located within or near the connector and configured to prevent fluid transfer between the vascular access device and the internal volume of the housing.

12. The probe delivery device according to claim 1, characterized in that, The shield thruster and the probe thruster include an integral thruster assembly, wherein each of the proximal end of the shield sleeve and the proximal end of the probe is coupled to the thruster assembly, and wherein the thruster assembly is configured to move relative to the housing, wherein distal movement of the thruster assembly moves the probe and the shield sleeve from their respective first positions to their respective second positions.

13. The probe delivery device according to claim 12, characterized in that, The probe delivery device further includes a locking mechanism positioned on the connector, the locking mechanism locking the thruster assembly to the connector, and wherein, when the thruster assembly is locked to the connector, the housing is rotatable relative to the thruster assembly, wherein, when the probe is in the second probe position, the rotation of the housing causes the probe to rotate within the conduit.

14. The probe delivery device according to claim 1, characterized in that, The distal end of the probe includes a shaping portion for repositioning the distal end of the catheter as the probe is selectively extended into the catheter.

15. The probe delivery device according to claim 14, characterized in that, The shaped portion is formed from a shape memory material that is straight at ambient room temperature and bends at body temperature.

16. The probe delivery device according to claim 1, characterized in that, The protective sleeve includes a rigid sleeve or a flexible sleeve.

17. A system for performing blood draws, characterized in that, The system includes: Vascular access device, the vascular access device comprising: A catheter hub having a proximal end and a distal end and defining a lumen therein; A catheter, extending distally from the catheter hub, having a proximal end and a distal end; and The probe delivery device according to claim 1; Wherein, when the probe is in the position of the second probe, the distal end of the probe is positioned adjacent to the distal end of the catheter.

18. The system according to claim 17, characterized in that, The catheter hub includes a wedge positioned within the lumen adjacent to the distal end of the catheter hub, the wedge being configured to secure the proximal end of the catheter to the catheter hub, and wherein, with the shroud sleeve in the second sleeve position, the distal end of the shroud sleeve is located distal to the wedge.

19. The system according to claim 18, characterized in that, The probe delivery device is configured to advance the probe such that the distal end of the probe is adjacent to the distal end of the catheter.

20. The system according to claim 17, characterized in that, The system also includes an extension kit that includes a secondary catheter and is coupled to the proximal end of the shield sleeve, wherein the shield sleeve provides a fluid flow path between the vascular access device and the secondary catheter.

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