Delivery device for probe with asymmetric tip

Abstract

The invention relates to a delivery device for a probe with an asymmetric tip. 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, and entitled “Delivery Device for Probe with Asymmetric Tip,” the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to device delivery devices for use with intravenous (IV) catheters and, more particularly, to delivery devices for use with probes having asymmetric tips. Background Art

[0004] Vascular access devices (VADs) are used in the medical field to access a patient's peripheral vascular system for the purpose of infusion therapy and / or blood withdrawal. Common types of VADs include over-the-needle peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. Catheters are typically provided as part of a catheter assembly that also includes a catheter hub or adapter, and other connectors or extensions that provide connection of external devices to the catheter assembly.

[0005] It can be appreciated that catheters can be indwelling in patients for a short time (a few days), a medium time (a few weeks) or a long time (a few months to a few years), and when indwelling IV catheters remain in the patient's vascular system, they are likely to be blocked. Once the IV catheter device is blocked, it may be impossible to use the IV catheter device for infusion or blood drawing. In this case, the IV catheter device can be replaced. However, replacing the IV catheter device is burdensome to the patient and increases the cost. In order to address these problems, an instrument delivery device capable of advancing a probe and inserting the probe into the indwelling IV catheter has been developed, wherein the probe is used to reposition the distal end of the IV catheter relative to the blockage. For example, some instrument delivery devices can use an asymmetric probe that can be inserted through the catheter and adjacent to the distal opening of the catheter, and the probe is configured with a shaped portion that can lift, advance, retract or rotate the distal end of the IV catheter, thereby repositioning the catheter in the patient's vascular system. This repositioning can move the intravenous catheter relative to the wall or other anatomical structures of the vascular system and relative to any obstacles (e.g., thrombus / blockage) that may form. By repositioning the catheter, the probe extends catheter patency, including facilitating blood sampling through long-indwelling catheters.

[0006] While such asymmetric probes are effective in repositioning IV catheters relative to the walls or other anatomical structures of the vasculature and relative to any obstructions that may form, it should be recognized that the shaped portions of these probes may cause difficulty in introducing them into an IV catheter. For example, asymmetric probes having a V-shaped tip have been shown to be effective in moving the catheter tip away from the wall of a vein to facilitate successful blood draws, but the geometry of the V-shaped tip makes it easy for the probe to become stuck when it is advanced into the catheter. As an example, the V-shaped tip may become stuck by a metal wedge included on a catheter hub or adapter from which the catheter extends. The V-shaped tip may also become stuck by another obstruction, either at a location along the length of the catheter tubing or within the housing of the instrument delivery device.

[0007] It would therefore be desirable to provide a probe delivery device that can be used with an indwelling IV catheter that allows a clinician to advance an asymmetric probe into and through the indwelling IV catheter while reducing or eliminating the possibility of the probe becoming caught on an obstruction in the catheter assembly. Summary of the invention

[0008] The present invention provides a probe delivery device for advancing an asymmetric probe into a vascular access device. The probe delivery device includes an outer shell and a connector, the outer shell defines an internal volume and has a proximal end and a distal end; the connector is positioned at the distal end of the outer shell and is configured to cooperate with the access connector of the vascular access device. The probe delivery device also includes a shield assembly, the shield assembly includes a shield sleeve and a shield pusher, the shield sleeve is longitudinally arranged in the internal volume and can move in 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 the shield pusher has a shield handle, which is configured to slide along the outer surface of the outer shell. The probe delivery device also includes a probe assembly, the probe assembly including a probe and a probe pusher, the probe being positioned within the shield sleeve and being movable within the shield sleeve, the probe having a distal end and a proximal end, the probe pusher being coupled to the proximal end of the probe, the probe pusher having a probe handle, the probe handle being configured to slide along the outer surface of the outer shell. The shield pusher is configured to move relative to the outer shell, wherein distal movement of the shield pusher moves the shield sleeve from a first sleeve position to a second sleeve position, wherein the distal end of the shield sleeve is disposed within the outer shell, and wherein the distal end of the shield sleeve is disposed outside the distal end of the outer shell and the connector. The probe pusher is configured to move relative to the outer shell, wherein distal movement of the probe pusher moves the probe from a first probe position to a second probe position, wherein the distal end of the probe is disposed within the outer shell, and wherein the distal end of the probe is disposed outside the distal end of the outer shell and the connector.

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

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

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

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

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

[0014] In some embodiments, the probe advancer 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 so that distal movement or rotation of the probe handle causes corresponding distal movement or rotation of the probe.

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

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

[0018] In some embodiments, the probe delivery device further includes a fluid flow preventing seal positioned within or adjacent to the connector and configured to prevent fluid transfer between the vascular access device and the interior volume of the outer housing.

[0019] In some embodiments, the shield pusher and the probe pusher include an integral pusher assembly, and wherein each of the proximal end of the shield sleeve and the proximal end of the probe is coupled to the pusher assembly, and wherein the pusher assembly is configured to move relative to the outer shell, wherein distal movement of the pusher 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 also includes a locking mechanism positioned on the connector, which locks the pusher assembly to the connector, and wherein, when the pusher assembly is locked with the connector, the outer shell is capable of rotating relative to the pusher assembly, wherein when the probe is in the second probe position, rotation of the outer shell causes the probe to rotate within the catheter, allowing the outer shell to rotate.

[0021] In some embodiments, the distal end of the probe includes a shaped portion for enabling the distal end of the catheter to be repositioned when 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 forms a curve at body temperature.

[0023] In some embodiments, the shield sleeve comprises a rigid sleeve or a flexible sleeve.

[0024] A system for performing a blood draw is also provided herein. The system includes a vascular access device, the vascular access device including: a catheter adapter having a proximal end and a distal end and defining a lumen in the catheter adapter; a catheter extending distally from the catheter adapter, the catheter 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 shield sleeve is in the second sleeve position, the distal end of the shield sleeve is disposed 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 comprises an extension set 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 set. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a side view of a catheter assembly and an associated probe delivery device that may be used therewith 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 of claim 1, 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 of claim 1, wherein the probe delivery device is in a second configuration;

[0032] Figure 5 The embodiment described herein is shown Figure 1 An isolated view of an asymmetric probe included in a probe delivery device;

[0033] Figure 6 is a side view of a catheter assembly and an associated probe delivery device usable therewith according to another embodiment described herein;

[0034] Figure 7 yes Figure 6 A side cross-sectional view of a probe delivery device of FIG. 1 , wherein the probe delivery device is in a first configuration; and

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

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

[0037] Hereinafter, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the present invention as oriented in the accompanying drawings. However, it should be understood that the present invention may adopt various alternative variations unless expressly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0038] As used in this specification, the words "proximal" and "distal" refer to the direction closer to and away from the user who brings the device into contact with the patient, respectively. Thus, for example, the end of the device that first contacts the patient's body would be the distal end, and the opposite end of the device that is manipulated by the user would be the proximal end of the device.

[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" refers to any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of only A; or one or more of only B; or one or more of only 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 one or more of all of A, B, and C.

[0041] Reference now Figures 1 to 5 , shown is a non-limiting embodiment of a catheter system 10 that includes a vascular access device in the form of a catheter assembly 12 and an associated instrument delivery device 14, wherein the instrument delivery device 14 is configured to facilitate delivery of an instrument (e.g., an instrument that may be desired when drawing blood from a patient) 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 an (optional) 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® 100 commercially available from Becton, Dickinson and Company. TM Catheter System. As known to those skilled in the art, catheter 24 may be implemented as a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter, and 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 appreciated that the catheter connector 20 can include stabilizing features (e.g., wings) thereon that assist in maintaining the catheter connector 20 in a suitable position on the patient's skin. The catheter connector 20 includes a proximal port having a proximal coupler 26 and a distal port having a distal coupler 28, and defines at least one lumen 30 ( Figure 2 ), the at least one lumen extending through couplers 26 and 28 or otherwise in fluid communication with these couplers. Proximal coupler 26 and / or distal coupler 28 may be, for example, a male Luer lock or a female Luer lock and / or any other suitable coupler, wherein Figures 1 to 5The non-limiting embodiment in FIG. 2 shows that the proximal coupler 26 is a female Luer connector and the distal coupler 28 is a male Luer connector. The proximal coupler 26 can be physically and fluidically coupled to the instrument delivery device 14 to enable the introduction of the probe into the catheter and subsequent blood draw, as will be explained in further detail below. The distal coupler 28 can be physically and fluidically coupled to the catheter hub 16 so 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 a side port 32. The side port 32 defines a lumen 34 that is fluidly connected to the lumen 30 between the distal coupler 28 and the proximal coupler 26. Therefore, the side port 32 may provide access to the lumen 30 between the distal coupler 28 and the proximal coupler 26, which in turn may provide access to the catheter hub 16 (and the catheter 24) coupled to the distal coupler 28. In some embodiments, the arrangement of the side port 32 may form, for example, a Y-shaped connector or a T-shaped connector for the catheter connector 20. As noted previously, it should be appreciated that the extension kit 18 may include an extension tube 22 that is connected to the side port 32 and is fluidly connected to the lumen 34 of the side port 32. In some embodiments, the side port 32 and / or the extension tube 22 may be and / or may form at least a portion of a fluid line that may be used to transport fluid, remove fluid, flush fluid, etc.

[0044] like Figure 2 As shown, according to some aspects or embodiments, the catheter hub 16 can 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 the 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 instrument delivery device 14 of the system can be operated to introduce an instrument into the catheter assembly 12 and the patient's vasculature. In some embodiments, as described below, the instrument delivery device 14 can include a probe delivery device ("probe delivery device 14") that introduces a probe 40 through the catheter hub 16 and into the indwelling catheter 24. In some embodiments, the probe 40 can be an asymmetric probe with a curved or shaped distal end that is configured to reposition the distal end or tip 42 of the catheter 24 while the catheter 24 remains inserted into the patient's vasculature, thereby moving the tip 42 of the catheter relative to the wall or other anatomical structure of the vasculature and relative to any obstructions (e.g., thrombi / blockages) that may have formed, and provide for subsequent blood draw.

[0046] like Figure 1 and Figures 3 to 5 As shown, according to a non-limiting embodiment, the probe 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 as to move a portion of the probe 40 from a first position or a retracted position ( Figure 3 ) to a second position or advanced position outside the housing 44 ( Figure 4 ), so that its distal end can enter the catheter assembly 12, and the shield sleeve 54 can also be moved from the first position ( Figure 3 ) moves to a second position outside the housing 44 ( Figure 4 ), wherein the shield sleeve 54 prevents the shaped portion at the distal end of the probe 40 from becoming stuck or trapped within the catheter assembly (or within the housing 44) when advancing from its first position to its second position.

[0047] The housing 44 of the blood drawing device 14 may be an elongated member having a proximal end 58 and a distal end 60 and defining an interior 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 interior volume 62. The housing 44 may include one or more features or surface finishes on an outer surface thereof that may be arranged to enhance the ergonomics of the blood drawing device 14, which in some cases may allow a user to manipulate the blood drawing device 14 with one hand (i.e., one-handed use).

[0048] The connector 46 of the blood drawing device 14 is disposed at the distal end 60 of the housing 44, wherein the connector 46 provides for reversible coupling of the blood drawing device 14 to the catheter assembly 12, for example via Figure 1 26. The connector 46 is illustrated as a male Luer connector that mates with a female Luer connector of the proximal coupler 26 on the catheter connector 20, wherein the male Luer connector of the connector 46 has an elongated member 64 surrounded by a rotation sleeve 66. The rotation sleeve 66 can be rotated to thread the male Luer connector into engagement with the female Luer connector of the proximal coupler 26. However, it should be understood that alternative embodiments of the probe delivery device 14 may include another type of connector 46 that secures the probe delivery device 14 to the catheter assembly 12, including a Luer slip connection, a clamp, a passivated plastic sleeve, a passivated metal sleeve, a hybrid Luer (e.g., with a sleeve), a friction fit, etc.

[0049] As described above, the shield assembly 48 of the blood drawing device 14 includes a shield pusher 52 and a shield sleeve 54. The shield sleeve 54 is positioned within the internal volume 62 of the housing 44 and extends substantially along the length of the housing 44. The shield sleeve 54 is configured as an elongated tubular member having a distal end 68 and a proximal end 70, and defining a shield lumen 72 therein. The shield sleeve 54 can be formed of any rigid or flexible material as long as the material is hard enough to resist buckling. In a non-limiting embodiment, the shield sleeve 54 is formed of a material that provides anti-buckling, such as polyethylene, polypropylene, nylon, polyurethane, polyimide, etc. In some embodiments, the distal end 68 of the shield sleeve 54 may include a fenestration (not shown) formed therein, which allows a higher flow rate of blood drawing (or transfusion) through the catheter assembly 12 (and the delivery device 14).

[0050] The shroud pusher 52 includes a first portion 74 and a second portion 76. The first portion 74 is movably disposed along an outer surface 78 of the housing 44, and the second portion 76 is movably disposed within the interior volume 62 of the housing 44. In some embodiments, the shroud pusher 52 and the housing 44 are arranged such that a connecting portion (not shown) of the shroud pusher 52 that joins the first portion 74 and the second portion 76 is seated within a recess 80 formed in the upper surface 78 of the housing 44, the recess 80 generally extending 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 joined together, movement of the first portion 74 along the outer surface 78 of the housing 44 results in corresponding movement of the second portion 76 within the interior 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 so 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 interior volume 62 of the housing 44 and includes an attachment member 82 (e.g., a base or opening) by 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. Because the shield sleeve 54 is retained by the attachment member 82 of the second portion 76, movement of the shield pusher 52 relative to the housing 44 causes corresponding movement of the shield sleeve 54 relative to the housing 44. In this manner, the distal end 68 of the shield sleeve 54 can be selectively moved out of or back into the interior volume 62 of the housing 44 as desired, such as when the distal end 68 of the shield sleeve 54 is pushed out of the housing 44 when the probe 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 probe delivery device 14 includes a probe pusher 56 and a probe 40. The probe 40 may be configured as a wire formed of metal or other suitable material, wherein the wire has a diameter that provides for positioning of the wire within the catheter 24. The probe 40 is positioned within the lumen 72 of the shield sleeve 54, and as described in further detail below, the probe 40 may be moved relative to the shield sleeve 54 via operation of the probe pusher 56 such that the distal end 84 of the probe 40 may be pushed out from the distal end 68 of the shield sleeve 54.

[0054] As noted above, according to aspects of the present disclosure, the probe 40 can be configured as an asymmetric probe having a curved or shaped distal end 84 that is configured to reposition the distal end 42 of the catheter 24 when the probe 40 is advanced into the catheter 24 and / or rotated within the catheter. Figure 5 An example of how the probe 40 may be configured to cause such repositioning is provided. Figure 5 8, the probe 40 is shown having a distal end 84, a shaped portion 86, and a proximal end 88. The shaped portion 86 should be interpreted as a length of the probe 40 positioned at or toward the distal end 84, the shape of the shaped portion deviating from the longitudinal axis of the proximal end 88, and the shaped portion generally maintains the shape when the distal end 84 is positioned near or at the distal end 42 of the catheter 24. In the illustrated embodiment, the shaped portion 86 is in the form of a V-shaped length of the 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 the probe 40. In other embodiments, it should be appreciated that the shaped portion 86 may instead be configured to have an inverted V-shape or a curved W-shape according to other non-limiting examples.

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

[0056] Similar to the shroud pusher 52, the probe pusher 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 interior volume 62 of the housing 44. In some embodiments, the arrangement of the probe pusher 56 and the housing 44 is such that a connecting portion (not shown) of the probe pusher 56 that joins the first portion 90 and the second portion 92 is seated within a recess 80 formed in the outer surface 78 of the housing 44, the recess 80 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 joined together, movement of the first portion 90 along the outer surface 78 of the housing 44 causes corresponding movement of the second portion 92 within the interior 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 that generally surrounds the housing 44 and contacts the outer surface 78 of the housing. The handle 90 can be engaged by a user so 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 distal to the shield handle 74.

[0058] like Figure 3 and Figure 4As shown, a second portion 92 of the probe pusher 56 is movably disposed within the interior volume 62 of the housing 44 and is configured such that at least a portion of the second portion is positioned adjacent to or around the shield sleeve 54. According to aspects of the present disclosure, the second portion 92 includes a coupling element 94 thereon that is configured to interact with the probe 40 such that movement of the probe pusher 56 relative to the housing 44 causes corresponding movement of the probe 40 relative to the housing 44. In an exemplary embodiment, the coupling element 94 may be provided as an annular or other shaped member positioned around the shield sleeve 54 and configured as a magnetic element (i.e., formed of a magnetic material or including a magnet thereon) that interacts with a magnetic element 96 located on the proximal end of the probe 40 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 of or back into the internal volume 62 of the shell 44 as desired, such as when the probe delivery device 14 is already coupled to the catheter assembly 12 to push the distal end 84 of the probe 40 out of the shell 44 and it is desired to advance the probe 40 into the catheter 24.

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

[0060] According to aspects of the present disclosure, in addition to the probe pusher 56 being able to move 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 to move the distal end of the catheter away from the vein wall, thrombus, or other potential features on the vein that prevent successful blood draw. In particular, 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 to rotate the probe 40 and its asymmetric tip in a desired angular direction. Depending on the embodiment, the handle 90 may be rotatable in only one direction, or may be rotatable in two directions (to rotate the probe tip back and forth).

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

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

[0063] In use of the probe delivery device 14 and when the probe delivery device is connected to the catheter assembly 12, the operator can push the shield pusher 52 distally along the housing 44. Pushing the shield pusher 52 causes the shield sleeve 54 to be advanced within the housing 44, and in some embodiments, the shield pusher 52 can be advanced distally until the shield sleeve 54 has moved forward past the wedge 36 of the catheter hub 16 or another known obstacle. Because the probe pusher 56 is located proximate to the shield pusher 52, pushing the shield pusher 52 distally along the housing 44 also causes the probe pusher 56 to be advanced distally along the housing 44, wherein pushing the probe pusher 56 causes the probe 40 to be advanced distally within the housing 44 and the shield sleeve 54. When the shield pusher 52 is moved distally to its desired position, the operator can continue to push the probe pusher 56 distally along the housing 44 to advance the probe 40 further 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 area of ​​the tip 42 of the catheter. Once there, the probe pusher 56 can be rotated about the housing 44 to move the asymmetric tip (i.e., the shaped portion 86) of the probe 40, wherein the probe pusher 56 is rotated unidirectionally to rotate the tip in a consistent angular direction, or bidirectionally to rotate the tip 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 prevent successful blood draw.

[0064] 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 probe delivery device 14 of EMBODIMENT 2 differs in that the separate shroud pusher 52 and probe pusher 56 of the device are replaced by a single integrated pusher assembly 112 that performs the functions of both the shroud pusher 52 and the probe pusher 56 .

[0065] Similar to the above description, the integrated pusher 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 in the interior volume 62 of the housing 44. The first portion 114 of the pusher assembly 112 can be configured as a handle (hereinafter referred to as "handle 114") positioned on the housing 44. In some embodiments, the handle 114 can be configured as an annular member that generally surrounds the housing 44 and contacts the outer surface of the housing. The handle 114 can be engaged by a user so 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 pusher assembly 112 is movably disposed within the interior volume 62 of the housing 44 and includes an attachment member 118 (e.g., a base) by which both the shroud sleeve 54 and the probe 40 can be secured to the pusher assembly 112, wherein 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 retained by the attachment member 118 of the second portion 116, movement of the pusher 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 shield sleeve 54 and the distal end 84 of the probe 40 can be selectively moved out of or back into the internal volume 62 of the shell 44 as desired, such as when the distal end 84 of the shield sleeve 54 and the distal end 84 of the probe 40 are pushed out of the shell 44 when the probe delivery device 110 is already coupled to the catheter assembly 12 and it is desired to advance the probe 40 into the catheter 24.

[0066] According to various aspects of the present 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, so as to achieve rotation of the probe 40 and repositioning of the distal end 42 of the catheter 24, so as to keep the distal end of the catheter away from the vein wall, thrombus or other potential features on the vein that 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 be engaged with the pusher assembly 112 after the pusher assembly 112 has been advanced distally along the housing 44 and engaged with the connector 46. When the pusher assembly 112 is separated from the connector 46, the locking mechanism 120 can be in a locked state that prevents the housing 44 (relative to the connector 46) from rotating. When the pusher assembly 112 is in contact / engagement with the connector 46, the handle 114 of the pusher assembly 112 actuates the locking mechanism 120 to its unlocked state, wherein the pusher assembly 112 and the housing 44 are thereby rotatable. In this manner, with the pusher assembly 112 advanced distally to its second position, the probe 40 can be rotated to reposition the asymmetric tip (shaped portion 86) of the probe in a desired angular orientation, thereby also repositioning the distal end 42 of the catheter 24.

[0067] In use Figures 6 to 8 When inserting and attaching the probe delivery device to a catheter assembly, the operator can push the integrated pusher assembly 112 distally along the housing 44. Pushing the pusher assembly 112 causes the shield sleeve 54 and the probe 40 to be advanced within the housing 44, and in some embodiments, the pusher assembly 112 can be advanced distally until the shield sleeve 54 and the 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 the probe 40 (and the shield sleeve 54) is advanced adjacent the distal end 42 of the indwelling catheter 24. When the pusher assembly 112 is moved distally to its desired position, the pusher assembly 112 / housing 44 can be rotated to move the asymmetric tip (also referred to as the distal end) 84 of the probe 40, with the probe pusher 56 being rotated unidirectionally to rotate the tip 84 in a consistent angular direction, or bidirectionally to rotate the tip 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 of the vein that would prevent successful blood withdrawal.

[0068] According to additional aspects of the present disclosure, Figures 1 to 5 and Figures 6 to 8In any of the delivery devices 14, 110 of the present invention, the probe delivery device 14, 110 coupled to the catheter assembly 12 and the probe 40 in its second position (i.e., the shaped portion 86 of the probe 40 adjacent to the distal end 42 of the catheter 24) can be used to reposition the tip 42 of the catheter to perform blood drawing. When providing blood drawing, an extension kit or a blood collection device can be connected at the proximal end of the delivery device 14, 110. In some embodiments, the extension kit includes a secondary conduit 124, which is placed in fluid communication with the shield sleeve 54, wherein the shield sleeve 54 provides a fluid flow path between the catheter assembly 12 and the secondary conduit 124. The distal end 126 of the secondary conduit 124 can be fixed to the second portion 76 of the shield pusher 52 (or the second portion 116 of the pusher assembly 112) so as to align with the shield sleeve 54. In some embodiments, the secondary conduit 124 can be secured to the second portion 76 via attachment members 82, 118, which can be openings aligned with the shield sleeve 54. The proximal end 128 of the secondary conduit 124 can 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 syringe, can be connected to enable blood drawing to be performed.

[0069] Advantageously, aspects of the present disclosure thus 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 shield sleeve in which the probe is positioned, wherein each shield sleeve and the probe are configured to be advanced into the catheter assembly. The shield sleeve can prevent the probe from getting stuck on a wedge of the catheter hub and / or another obstruction in the catheter assembly or the delivery device.

[0070] Although the present disclosure has been described in detail based on what are currently considered to be the most practical and preferred embodiments or aspects for the purpose of illustration, it should be understood that such detail is only for that purpose, and the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, the present 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 the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A probe delivery device, the probe delivery device being used to advance an asymmetric probe into a vascular access device, the probe delivery device comprising: an outer housing defining an interior volume and having a proximal end and a distal end; a connector positioned at the distal end of the outer housing and configured to mate with an access connector of the vascular access device; A shield assembly, the shield assembly comprising: a shroud sleeve longitudinally disposed within the interior volume and movable therein, the shroud sleeve having a distal end and a proximal end; and a shroud pusher coupled to the proximal end of the shroud sleeve, the shroud pusher having a shroud handle configured to slide along an outer surface of the outer shell; and A probe assembly, the probe assembly comprising: a probe positioned within and movable within the shield sleeve, the probe 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 an outer surface of the outer shell; wherein the shroud pusher is configured to move relative to the outer housing, wherein distal movement of the shroud pusher moves the shroud sleeve from a first sleeve position, wherein the distal end of the shroud sleeve is disposed within the outer housing, to a second sleeve position, wherein the distal end of the shroud sleeve is disposed outside of the distal end of the outer housing and the connector; and Wherein, the probe pusher is configured to move relative to the outer shell, wherein distal movement of the probe pusher moves the probe from a first probe position, wherein the distal end of the probe is disposed within the outer shell to a second probe position, wherein the distal end of the probe is disposed outside the distal end of the outer shell and the connector.

2. The probe delivery device according to claim 1, wherein: The shield handle is positioned on the outer housing proximate the probe handle, and wherein distal movement of the shield handle causes corresponding distal movement of the probe handle.

3. The probe delivery device according to claim 1, wherein: The shield handle is movable distally along the outer housing a first distance, and wherein the probe handle is movable distally along the outer housing a second distance greater than the first distance.

4. The probe delivery device according to claim 1, wherein: When the shield 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 shield sleeve such that the distal end of the probe is positioned outside of the shield sleeve.

5. The probe delivery device according to claim 1, wherein: The probe handle is configured to rotate relative to the outer housing when the probe is in the second probe position, wherein rotation of the probe handle rotates the probe within the catheter when the probe is in the second probe position.

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

7. The probe delivery device according to claim 1, wherein: The probe advancer 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, wherein: 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 so 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, wherein: The outer housing includes a plurality of markings thereon including at least a first marking that indicates when the shield handle has been advanced distally along the outer housing a first distance.

10. The probe delivery device according to claim 9, wherein: The plurality of markings includes at least one additional marking that indicates when the probe handle has been advanced distally along the outer housing the second distance or is proximate to the second distance.

11. The probe delivery device of claim 1 , further comprising a fluid flow preventing seal positioned within or near the connector and configured to prevent fluid transfer between the vascular access device and the interior volume of the outer housing.

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

13. The probe delivery device of claim 12, further comprising a locking mechanism positioned on the connector, the locking mechanism locking the pusher assembly to the connector, and wherein: The outer housing is rotatable relative to the pusher assembly when the pusher assembly is locked with the connector, wherein rotation of the outer housing to rotate the probe within the catheter will allow the outer housing to rotate when the probe is in the second probe position.

14. The probe delivery device according to claim 1, wherein: The distal end of the probe includes a shaped portion for allowing the distal end of a catheter to be repositioned when the probe is selectively extended into the catheter.

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

16. The probe delivery device according to claim 1, wherein: The shield sleeve includes a rigid sleeve or a flexible sleeve.

17. A system for performing a blood draw, the system comprising: A 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, the catheter having a proximal end and a distal end; and The probe delivery device according to claim 1; Wherein, when the probe is in the second probe position, the distal end of the probe is arranged adjacent to the distal end of the catheter.

18. The system of claim 17, wherein: 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 shield sleeve is in the second sleeve position, the distal end of the shield sleeve is disposed distal to the wedge.

19. The system of claim 18, wherein: 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 of claim 17, further comprising an extension kit including a secondary conduit and 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 conduit.

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