A device for manually locking the inserted line draw device to prevent premature retraction

Abstract

A fluid transfer device for needleless delivery of a probe to a patient's vasculature, the device including an introducer body and an actuator. The actuator is linearly displaceable along at least a portion of the introducer body, the actuator operably coupled to the probe to advance and retract the probe based on a direction of displacement of the actuator. The device also includes a connector member positioned proximate a distal end portion of the introducer body and configured to releasably connect to at least one surface of the access connector. The device also includes a locking member configured to prevent decoupling of the connector member from the access connector when the actuator is advanced to a first position and to allow decoupling of the connector member when the actuator is retracted along the introducer body to a second position.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application Serial No. 63 / 325,987, filed March 31, 2022, entitled “Device for Manually Locking an Inserted Line Draw Device to Prevent Premature Retraction,” the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] FIELD OF THEINVENTION The present disclosure relates generally to fluid transfer devices and associated assemblies, systems, and methods for use in blood collection via existing vascular access devices (VADs), such as peripheral intravenous catheters (PIVCs). Specifically, the fluid transfer devices of the present disclosure are configured to prevent premature backout and / or removal of the device.

[0003] 2. Description of Related Art Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient. Catheters may also be used to withdraw blood from a patient.

[0004] A common type of catheter is the over-the-needle peripheral intravenous ("IV") catheter ("PIVC"). Over-the-needle catheters may be mounted on an introducer needle having a sharp distal tip. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter and the bevel of the needle points up, away from the patient's skin surface. The catheter and introducer needle are typically inserted at a shallow angle through the skin and into the patient's vasculature. To confirm that the introducer needle and / or catheter are properly placed within the blood vessel, the practitioner will typically confirm that there is a "flashback" of blood in the flashback chamber of the catheter assembly. Once needle placement is confirmed, the practitioner may temporarily block flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawals or fluid injections.

[0005] Blood withdrawal using peripheral venous catheters can be difficult for several reasons, especially when the catheter is indwelling for a day or more. For example, if a catheter remains inserted in a patient for an extended period of time, the catheter or vein may become susceptible to stenosis, collapse, kinking, blockage by debris (e.g., fibrin or platelet clumps), and adhesion of the catheter tip to the vasculature. For this reason, catheters are often used to obtain blood samples at the time of catheter placement, but are less often used to obtain blood samples during the catheter indwelling period.

[0006] Accordingly, fluid transfer devices have been developed to collect blood samples through an existing PIVC. Such "line draw" fluid transfer devices include a flexible probe that is attached to the PIVC and advanced through the PIVC and into the blood vessel beyond the catheter tip to collect a blood sample. After blood collection, the fluid transfer device is removed from the PIVC and discarded. One example of such a fluid transfer device is known as PIVO™ from Velano Vascular, Inc. Additionally, U.S. Pat. No. 11,090,461 also discloses such a device, which is incorporated herein by reference in its entirety. FIG. 1 of the present application illustrates a fluid transfer device 200 similar to that shown and described in U.S. Pat. No. 11,090,461. The fluid transfer device 200 includes an introducer 210, a connector member 240, a secondary catheter 265, and an actuator 270. The introducer 210 includes a proximal end portion 211 and a distal end portion 212, with the connector member 240 disposed adjacent to the distal end portion 212. Secondary catheter 265 includes a proximal end portion 266 that is coupled to and / or includes a coupler 269. Coupler 269 is configured to physically and fluidly couple secondary catheter 265 to any suitable device, such as, for example, a fluid reservoir, a fluid source, a syringe, a vacuum vessel holder (e.g., having a sheathed needle or configured to be coupled to a sheathed needle), a pump, etc.

[0007] A user may manipulate the fluid transfer device 200 to couple the connector member 240 to a catheter adapter, for example, of an integrated intravenous catheter. For example, the user may apply sufficient force to pivot the first and second clip arms of the connector member 240 so that a portion of the catheter adapter may be inserted into a space defined between the arms of the connector member 240 and a distal introducer portion 242 extending distally from the introducer portion 210. The user may then linearly displace the actuator 270 distally along the introducer portion 210 to advance the flexible probe through the distal introducer portion 242. The user may also linearly displace the actuator 270 proximally along the introducer portion to retract the flexible probe.

[0008] Typically, the flexible probe is retracted into the fluid transfer device 200 after blood collection, at which point the connector member 240 may be disconnected from the catheter adapter by squeezing the proximal clip portion to release the "alligator clip" distal connection of the connector member 240 from the adapter. In some cases, however, the user may disconnect the connector member 240 from the catheter adapter and retract the distal introduction portion 242 while the probe is still advanced at least beyond the distal introduction portion 242 into the catheter adapter. Such premature retraction and / or removal of the fluid transfer device 200 from the catheter adapter may result in undesirable exposure to blood or other bodily fluids and / or damage to the probe.

[0009] The subject matter claimed herein is not limited to embodiments that solve any disadvantages, nor does it operate exclusively in the environments described above. Rather, this background is only provided to illustrate one example technology area in which some embodiments described herein may be practiced. Summary of the Invention

[0010] According to one aspect of the disclosure, a fluid transfer device for delivering a probe to a patient's vasculature is provided. The fluid transfer device includes an introducer body, a distal introducer portion positioned at a distal end portion of the introducer body and configured to penetrate an access connector of a vascular access device, and an actuator, the actuator being linearly displaceable along at least a portion of the introducer body, the actuator being operably coupled to the probe to advance and retract the probe through the distal introducer portion based on a direction of displacement of the actuator. The fluid transfer device also includes a connector member positioned proximate the distal introducer portion and configured to releasably connect to at least one surface of the access connector, the connector member including a pair of opposing distal clip portions and a pair of opposing proximal clip portions. Additionally, the fluid transfer device includes a locking member, the locking member being linearly displaceable along at least a portion of the introducer body and configured to block actuation of at least one of the pair of opposing proximal clip portions when the actuator is at least partially displaced toward a first position and to allow actuation of at least one of the pair of opposing proximal clip portions when the actuator is at least partially displaced toward a second position.

[0011] In some embodiments, the locking member includes a single locking arm member configured to block actuation of a single one of a pair of opposing proximal clip portions of the connector member.

[0012] In some embodiments, a single locking arm member extends distally from a base portion, the base portion being configured to be slidable along at least a portion of the introducer body.

[0013] In some embodiments, the locking member includes a pair of opposing arm members configured to block actuation of a pair of opposing proximal clip portions of the connector member.

[0014] In some embodiments, a pair of opposing arm members extend distally from a base portion, the base portion being configured to be slidable along at least a portion of the introducer body.

[0015] In some embodiments, the actuator is releasably engagable with the base portion.

[0016] In some embodiments, the locking member includes a biasing member configured to bias the locking member in one direction.

[0017] In some embodiments, the fluid transfer device further includes a retention tab configured to retain the locking member proximally away from the connector member.

[0018] In some embodiments, the retention tab is configured to be displaced by the actuator upon contact with the actuator, the displacement of the retention tab causing an distal displacement of the locking member towards the second position under the force of the biasing member.

[0019] In some embodiments, the locking member includes at least one arm member and an elongated tether portion extending proximally from the at least one arm member, the at least one arm member configured to block actuation of at least one of a pair of opposing proximal clip portions of the connector member.

[0020] In some embodiments, the actuator is configured to releasably engage at least a portion of the elongate tether portion.

[0021] In some embodiments, the locking member is manually displaceable by a user.

[0022] According to another aspect of the present disclosure, a fluid transfer device for needleless delivery of a probe to a patient's vasculature is disclosed. The fluid transfer device includes an introducer body having a distal end portion and a proximal end portion, and an actuator, the actuator being linearly displaceable along at least a portion of the introducer body, the actuator being operably coupled to the probe to advance and retract the probe based on a direction of displacement of the actuator. The fluid transfer device also includes a connector member positioned proximate the distal end portion of the introducer body and configured to releasably connect to at least one surface of the access connector, and a locking member, the locking member configured to prevent decoupling of the connector member from the access connector when the actuator is advanced along the introducer body to a first position and to allow decoupling of the connector member when the actuator is retracted along the introducer body to a second position.

[0023] In some embodiments, the locking member includes a single locking arm member, the single locking arm member configured to block actuation of the connector member.

[0024] In some embodiments, the locking member includes a pair of opposing arm members configured to block actuation of the connector member.

[0025] In some embodiments, the locking member includes at least one arm member and an elongated tether portion extending proximally from the at least one arm member, the at least one arm member configured to block actuation of the connector member.

[0026] In some embodiments, the actuator is configured to releasably engage at least a portion of the elongate tether portion.

[0027] According to another aspect of the present disclosure, a fluid transfer device for needleless delivery of a probe to a patient's vasculature is disclosed. The fluid transfer device includes an introducer body having a distal end portion and a proximal end portion, and an actuator, the actuator being linearly displaceable along at least a portion of the introducer body, the actuator being operably coupled to the probe to advance and retract the probe based on a direction of displacement of the actuator. The fluid transfer device also includes a connector member positioned proximate the distal end portion of the introducer body and configured to releasably connect to at least one surface of the access connector, and a locking member, the locking member including at least one arm member and an elongated tether portion extending proximally from the at least one arm member, the at least one arm member being configured to selectively block actuation of the connector member based on a position of the actuator along the introducer body.

[0028] In some embodiments, the actuator is configured for releasable engagement with at least a portion of the elongate tether portion.

[0029] In some embodiments, the connector member includes a pair of opposing distal clip portions and a pair of opposing proximal clip portions, and at least one arm member of the locking member is configured to block actuation of at least one of the pair of opposing proximal clip portions.

[0030] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory, and are not intended to limit the invention as claimed. It is to be understood that the various embodiments are not limited to the arrangement and instrumentality shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief description of the drawings]

[0031] Example embodiments will be detailed and explained with additional specificity and detail through the use of the accompanying drawings.

[0032] [Figure 1] FIG. 1 is a perspective view of a prior art fluid transfer device. [Diagram 2] FIG. 2 is a top view of a fluid transfer device in a first configuration according to an embodiment of the present disclosure. [Diagram 3] FIG. 3 is a top view of the fluid transfer device of FIG. 2 in a second configuration. [Figure 4] FIG. 4 is a top view of the fluid transfer device of FIG. 2 in a third configuration. [Diagram 5] FIG. 5 is a top view of a locking member for use with the fluid transfer device of FIG. [Figure 6] FIG. 6 is an end view of the locking member of FIG. [Figure 7] FIG. 7 is a top view of a fluid transfer device in a first and second configuration according to another embodiment of the present disclosure. [Figure 8] FIG. 8 is a top view of a fluid transfer device in a first configuration according to another embodiment of the present disclosure. [Figure 9] FIG. 9 is a top view of the fluid transfer device of FIG. 8 in a second configuration. [Figure 10] FIG. 10 is a top view of the fluid transfer device of FIG. 8 in a third configuration. [Figure 11] FIG. 11 is an end view of a locking member for use with the fluid transfer device of FIG. [Figure 12] FIG. 12 is a top view of a fluid transfer device in a first configuration according to another embodiment of the present disclosure. [Figure 13] FIG. 13 is a top view of the fluid transfer device of FIG. 12 in a second configuration. [Figure 14] FIG. 14 is a top view of the fluid transfer device of FIG. 12 in a third configuration. [Figure 15] 15 is a top view of a locking member for use with the fluid transfer device of FIG. 12. FIG. [Figure 16] FIG. 16 is a top view of a fluid transfer device in a first configuration according to another embodiment of the present disclosure. [Figure 17] FIG. 17 is a top view of the fluid transfer device of FIG. 16 in a second configuration. [Figure 18] FIG. 18 is a top view of the fluid transfer device of FIG. 16 in a third configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Description of the embodiments The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives will, however, remain readily apparent to those skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present disclosure.

[0034] For purposes of the following description, the terms "top," "bottom," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and derivatives thereof, shall refer to the invention as oriented in the drawings. It should be understood, however, that the invention may contemplate various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0035] In this disclosure, the distal end of a component or device means the end furthest from the user's hand when the component or device is in the use position, i.e., when a user is holding the fluid transfer device in preparation for or during use, and the proximal end means the end closest to the user's hand. Similarly, in this application, the terms "distal" and "distaly" mean in the direction toward the connector portion of the fluid transfer device, and the terms "proximally" and "proximally" mean in the direction opposite to the direction of the connector.

[0036] Although not shown or described here, the fluid transfer devices described below may be utilized to draw blood from any suitable vascular access device, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD CATHENA™ Catheter System, the BD VENFLON™ ProSafely Shielded IV Catheter System, the BD NEOFLON™ IV Cannula System, the BD INSYTE™ AUTOGUARD™ BC Shielded IV Catheter System, or other suitable vascular access device.

[0037] 2-4, a fluid transfer device 10 according to an embodiment of the present disclosure is shown. The fluid transfer device 10 includes an introducer body 12 and an actuator 14. The actuator 14 is configured to be linearly displaceable by a user along a track or other feature of the introducer body 12 between a proximal end portion 18 and a distal end portion 16 of the introducer body 12. The actuator 14 is operatively coupled to an elongated flexible probe 26 to advance and retract the probe 26 through a distal introducer portion 24 disposed near the distal end portion 16 of the introducer body 12. That is, displacement of the actuator 14 in a first direction advances the probe 26 through the distal introducer portion 24 such that the probe 26 can enter the vasculature of a patient when the fluid transfer device 10 is coupled to a vascular access device. Conversely, displacement of the actuator 14 in a second, opposite direction retracts the probe 26 through the distal introducer portion 24, ultimately removing the probe 26 from the patient's vasculature.

[0038] In some embodiments, the probe 26 is configured as a guidewire (e.g., a nickel titanium wire). However, in other embodiments, the probe 26 may be configured as any flexible member or instrument that can be advanced through a catheter, such as, for example, a tube, a secondary catheter, one or more sensors, an obturator, or any combination thereof. Additionally, in some embodiments, the distal introducer portion 24 is configured as a blunt plastic cannula that can be used with a needleless connector of a vascular access device. However, in other embodiments, the distal introducer portion 24 may be configured as a male luer connector and / or a needleless connector (NFC), a needle access connector (PRN), a luer access port (or female luer), or a needle or cannula that can access a septum, such as, for example, a BD NEXIVA™ needle septum.

[0039] The fluid transfer device 10 also includes a connector member 20 configured to selectively couple the fluid transfer device 10 to a needleless access connector, for example, of an adapter coupled to a vascular access device. The connector member 20 is configured as an alligator clip type connector and has opposing distal clip portions 21A, 21B that allow for securing the fluid device 10 to a surface of the needleless access connector. The pair of proximal clip portions 22A, 22B are sized and configured to be pinched or otherwise manipulated by a user. Manipulation of the proximal clip portions 22A, 22B pivots the distal clip portions 21A, 21B away from one another, resulting in the distal clip portions 21A, 21B being released from engagement with the needleless access connector. In some embodiments, the proximal clip portions 22A, 22B may include textured surfaces and / or indicators to provide an indication to a user regarding the functionality of the connector member 20.

[0040] Fluid transfer device 10 further includes a locking member 28. As shown in Figures 2-6, locking member 28 includes a locking arm 30 extending distally from a base portion 32 that is configured to both secure locking member 28 to, for example, a track extending along introducer body 12, and to permit selective longitudinal movement of the locking member along introducer body 12.

[0041] 2, when the actuator 14 is in a first position substantially adjacent the proximal end portion 18 of the introducer body 12, the probe 26 is retracted into the distal introducer portion 24 and introducer body 12. Additionally, when the actuator 14 is in the first position, the locking member 28 is in a "disengaged" position along the introducer body 12 and the locking arm 30 is disposed proximally away from the connector member 20. In this position, the proximal clip portions 22A, 22B of the connector member 20 are pinched together to allow the distal clip portions 21A, 21B to be released from engagement with the needleless access connector, thereby allowing the fluid transfer device 10 to be removed from engagement with the needleless access connector.

[0042] Conversely, with reference to Figure 3, when the actuator 14 is manipulated toward a second position at or near the distal end portion 16 of the introducer body 12, the probe 26 is advanced through (and distally beyond) the distal introducer portion 24. In addition, advancement of the actuator 14 also advances the locking member 28 distally. When the actuator 14 is in its distal-most position along the introducer body 12, the locking arm 30 of the locking member 28 is configured to be positioned substantially below at least one of the proximal clip portions 22A, 22B, and the locking arm 30 is sized and configured to substantially limit inward movement of at least one of the proximal clip portions 22A, 22B when pinched. By limiting / blocking the inward movement of one or more of the proximal clip portions 22A, 22B, the user is unable to release the distal clip portions 21A, 21B from engagement with the needleless access connector and therefore is unable to remove the fluid transfer device 10 from the needleless access connector when the flexible probe 26 is in the advanced position shown in FIG. 3.

[0043] In some embodiments, the actuator 14 and at least the base portion 32 of the locking member 28 may be configured to engage or otherwise couple to one another upon contact between the actuator 14 and the locking member 28. For example, the actuator 14 and the locking member 28 may couple by mechanical interference, a magnetic connector, or any other suitable coupling means. In such embodiments, when the actuator 14 is manipulated proximally toward the first position to retract the flexible probe 26, the locking member 28 is simultaneously pulled proximally away from the connector member 20, as shown in FIG. 4. In this retracted position, the locking arms 30 are positioned away from the connector member 20 to again permit inward movement of the proximal clip portions 22A, 22B, thereby allowing the distal clip portions 21A, 21B to be released from engagement with the needleless access connector, thus allowing removal of the fluid transfer device 10 from the needleless access connector when the flexible probe 26 is at or near the retracted position. In this manner, premature removal of the fluid transfer device 10 from the needleless access connector may be substantially avoided.

[0044] In other embodiments, the actuator 14 and the locking member 28 may not be configured to engage or interlock upon contact between the actuator 14 and the locking member 28. In such embodiments, the user may be required to manually retract the locking member 28 in a proximal direction after the actuator 14 is returned to the first (i.e., most proximal) position to retract the probe 26. Additionally and / or alternatively, in some embodiments, the locking member 28 may be manually displaced by the user toward the connector 20 prior to distal displacement of the actuator 14 to advance the probe 26 from the distal introduction portion 24. In such embodiments, the locking member 28 is configured to prevent premature removal of the fluid transfer device 10 from the needleless access connector as the probe 26 is being advanced.

[0045] 7, a fluid transfer device 40 according to another aspect of the present disclosure is shown. The fluid transfer device 40 includes an introducer body 42 and an actuator 44. The actuator 44 is configured to be linearly displaceable by a user along a track or other feature of the introducer body 42 between a proximal end portion 48 and a distal end portion 46 of the introducer body 42. The actuator 44 is operatively coupled to an elongated flexible probe 56 for selectively advancing and retracting the probe 56 through a distal introducer portion 54 disposed near the distal end portion 46 of the introducer body 42. Although not shown in FIG. 7, it should be understood that displacement of the actuator 44 in a first direction advances the probe 56 through the distal introducer portion 54 such that the probe 56 can enter the vasculature of a patient when the fluid transfer device 40 is coupled to a vascular access device. Conversely, displacement of the actuator 54 in a second, opposite direction retracts the probe 56 through the distal introducer portion 54 and removes the probe 56 from the patient's vasculature.

[0046] The fluid transfer device 40 also includes a connector member 50 configured to selectively couple the fluid transfer device 40 to a needleless access connector, for example, of an adapter coupled to a vascular access device. The connector member 50 is configured as an alligator clip type connector and has opposing distal clip portions 51A, 51B that allow for securing the fluid device 40 to a surface of the needleless access connector. The pair of proximal clip portions 52A, 52B are sized and configured to be pinched or otherwise manipulated by a user. Manipulation of the proximal clip portions 52A, 52B pivots the distal clip portions 51A, 51B away from one another, thereby releasing the distal clip portions 51A, 51B from engagement with the needleless access connector.

[0047] The fluid transfer device 40 further includes a locking member 58. The locking member 58 is operably coupled to a biasing member 60 (e.g., a spring) configured to selectively bias the locking member 58 in a distal direction.

[0048] 7, when the actuator 44 is in a first position substantially adjacent the proximal end portion 48 of the introducer body 42, the probe 56 is retracted into the distal introducer portion 54 and the introducer body 42. Furthermore, when the actuator 44 is in the first position, the locking member 58 is in a "disengaged" position along the introducer body 42, where the locking member 58 is held by the retention tabs 62 such that the biasing member 60 is in a compressed state to hold the locking member 58 away from the connector member 50. In this position, the proximal clip portions 52A, 52B of the connector member 50 can be pinched such that the distal clip portions 51A, 51B can be released from engagement with the needleless access connector, and thus the fluid transfer device 40 can be removed from engagement with the needleless access connector.

[0049] On the other hand, when the actuator 44 is manually slid toward a second position at or near the distal end portion 46 of the introducer body 42, the probe 56 is advanced through (and distally beyond) the distal introducer portion 54. In addition, advancement of the actuator 44 also acts to release the engagement between the retention tab 62 and the locking member 58. Such release of the locking member 58 results in the biasing member 60 urging the locking member 58 in a distal direction toward the connector member 50. Thus, when the actuator 44 is moved along the introducer body 42 toward its distal-most position to advance the probe 56, the locking member 58 and biasing member 60 (annotated as 58' and 60', respectively, in FIG. 7) are configured to position the locking member 58 substantially below at least one of the proximal clip portions 52A, 52B to substantially limit inward movement of at least one of the proximal clip portions 52A, 52B when pinched. By limiting / blocking the inward movement of one or more of the proximal clip portions 52A, 52B, the user cannot release the distal clip portions 51A, 51B from engagement with the needleless access connector and therefore cannot remove the fluid transfer device 40 from the needleless access connector when the flexible probe 56 is in the advanced position.

[0050] 8-10, there is illustrated a fluid transfer device 70 according to another embodiment of the present disclosure. While the fluid transfer device 10 shown and described above with respect to Figures 2-4 includes a locking member having only a single arm member configured to block actuation of a single proximal clip portion of the connector member, the fluid transfer device 70 includes a locking member having a pair of arm members configured to block actuation of both proximal clip portions, as will be described in further detail herein.

[0051] The fluid transfer device 70 includes an introducer body 72 and an actuator 74. The actuator 74 is configured to be linearly displaceable by a user along a track or other feature of the introducer body 72 between a proximal end portion 78 and a distal end portion 76 of the introducer body 72. The actuator 74 is operatively coupled to an elongated flexible probe 86 to advance and retract the probe 86 through a distal introducer portion 84 disposed near the distal end portion 76 of the introducer body 72. Thus, displacement of the actuator 74 in a first direction advances the probe 86 through the distal introducer portion 84 such that, when the fluid transfer device 70 is coupled to a vascular access device, the probe 86 can enter the patient's vasculature. Conversely, displacement of the actuator 74 in a second, opposite direction retracts the probe 86 through the distal introducer portion 84 and removes the probe 86 from the patient's vasculature.

[0052] The fluid transfer device 70 includes a connector member 80 configured to selectively couple the fluid transfer device 70 to a needleless access connector, for example, of an adapter coupled to a vascular access device. The connector member 80 is configured as an alligator clip type connector and has opposing distal clip portions 81A, 81B capable of securing the fluid device 70 to a surface of the needleless access connector. The pair of proximal clip portions 82A, 82B are sized and configured to be pinched or otherwise manipulated by a user. Pinching the proximal clip portions 82A, 82B pivots the distal clip portions 81A, 81B away from one another, thereby releasing the distal clip portions 81A, 81B from engagement with the needleless access connector.

[0053] Fluid transfer device 70 further includes a locking member 88. As shown in Figures 8-11, locking member 88 includes a pair of opposing locking arms 90A, 90B extending distally from a base portion 92. With reference to Figure 11, a coupling member 94 also extends from base portion 92 to allow both fixation of locking member 88 to, for example, a track extending along introducer body 72 and selective longitudinal movement of locking member 88 along introducer body 72.

[0054] 8, when the actuator 74 is in a first position substantially adjacent the proximal end portion 78 of the introducer body 72, the probe 86 is retracted into the distal introducer portion 844 and the introducer body 72. Additionally, when the actuator 74 is in the first position, the locking member 88 is in a "disengaged" position along the introducer body 72 and a pair of opposing locking arms 90A, 90B are disposed proximally away from the connector member 80. In this position, the proximal clip portions 82A, 82B of the connector member 80 can be pinched to allow the distal clip portions 81A, 81B to be released from engagement with the needleless access connector, thus allowing the fluid transfer device 70 to be removed from engagement with the needleless access connector.

[0055] 9, when the actuator 74 is manipulated toward a second position at or near the distal end portion 76 of the introducer body 72, the probe 86 is advanced through (and distally beyond) the distal introducer portion 84. Additionally, advancement of the actuator 74 also advances the locking member 88 in a distal direction. When the actuator 74 is in its distal-most position along the introducer body 72, the pair of opposing locking arms 90A, 90B of the locking member 88 are configured to be positioned substantially below the respective proximal clip portions 82A, 82B, with the opposing locking arms 90A, 90B having a size and configuration that substantially limits inward movement of at least one of the proximal clip portions 82A, 82B when sandwiched. By limiting / blocking the inward movement of one or more of the proximal clip portions 82A, 82B, the user cannot release the distal clip portions 81A, 81B from engagement with the needleless access connector and therefore cannot remove the fluid transfer device 70 from the needleless access connector when the flexible probe 86 is in the advanced position shown in FIG. 9.

[0056] In some embodiments, the actuator 74 and at least a base portion 92 of the locking member 88 may be configured to engage or couple with one another upon contact between the actuator 74 and the locking member 88. For example, the actuator 74 and the locking member 88 may couple by mechanical interference, a magnetic connector, or any other suitable coupling means. In such embodiments, when the actuator 74 is slid proximally toward the first position to retract the flexible probe 86, the locking member 88 is simultaneously pulled proximally away from the connector member 80, as shown in FIG. 10. In this retracted position, the opposing locking arms 90A, 90B are positioned away from the connector member 80 to again allow inward movement of the proximal clip portions 82A, 82B, thereby allowing the distal clip portions 81A, 81B to be released from engagement with the needleless access connector, and thus the fluid transfer device 70 to be removed from the needleless access connector when the flexible probe 86 is at or near the retracted position. In this manner, premature removal of the fluid transfer device 70 from the needleless access connector may be prevented.

[0057] 12-14, a fluid transfer device 100 according to another embodiment of the present disclosure is illustrated. The fluid transfer device 100 includes an introducer body 102 and an actuator 104. The actuator 104 is configured to be linearly displaceable by a user along a track or other feature of the introducer body 102 between a proximal end portion 108 and a distal end portion 106 of the introducer body 102. The actuator 104 is operably coupled to an elongated flexible probe 116 to advance and retract the probe 116 through a distal introducer portion 114 disposed near the distal end portion 106 of the introducer body 102. In other words, displacement of the actuator 104 in a first direction advances the probe 116 through the distal introducer portion 114 such that the probe 116 can enter the vascular system of a patient when the fluid transfer device 100 is coupled to a vascular access device. Meanwhile, a second, opposite displacement of the actuator 104 retracts the probe 116 through the distal introducer portion 114, ultimately removing the probe 116 from the patient's vasculature.

[0058] The fluid transfer device 100 also includes a connector member 110 configured to selectively couple the fluid transfer device 100 to a needleless access connector, for example, of an adapter coupled to a vascular access device. The connector member 110 is configured as an alligator clip type connector and has opposing distal clip portions 111A, 1111B that allow for securing the fluid device 100 to a surface of the needleless access connector. The pair of proximal clip portions 112A, 112B are sized and configured to be clamped by a user. Manipulation of the proximal clip portions 112A, 112B pivots the distal clip portions 111A, 1111B away from one another, resulting in the disengagement of the distal clip portions 111A, 111B from the needleless access connector.

[0059] Fluid transfer device 100 further includes a locking member 118. As shown in Figures 12-15, locking member 118 comprises a locking arm 120 extending distally from a base portion 122 that is configured to both secure locking member 118, for example to a track extending along introducer body 102, and to permit selective longitudinal movement of the locking member along introducer body 102. Although only a single locking arm 120 is shown in Figures 12-15, it should be understood that a pair of opposing locking arms may be utilized, similar to those shown and described with respect to Figures 8-11.

[0060] Locking member 118 also includes an elongated tether portion 124 and a proximal tether member 126. As will be described in more detail below, tether portion 124 and proximal tether member 126 act to control the timing of retraction of locking arm 120 away from connector member 110 during simultaneous retraction of actuator 104.

[0061] 12, when the actuator 104 is in a first position substantially adjacent the proximal end portion 108 of the introducer body 102, the probe 116 is retracted into the distal introducer portion 114 and the introducer body 102. Additionally, when the actuator 104 is in the first position, the locking member 118 is in a "disengaged" position along the introducer body 102 and the locking arm 120 is disposed proximally away from the connector member 110. In this position, the proximal clip portions 112A, 112B of the connector member 110 can be pinched, allowing the distal clip portions 111A, 111B to be released from engagement with the needleless access connector, thus allowing the fluid transfer device 100 to be removed from engagement with the needleless access connector.

[0062] 13, when actuator 104 is manually slid toward a second position at or near distal end portion 106 of introducer body 102, probe 116 is advanced through (and beyond) distal introducer portion 114. Because actuator 104 is configured to contact at least base portion 122 of locking member 118 to slide locking member 118 distally as actuator 104 is slid toward distal end portion 106, advancement of actuator 104 in this manner also advances locking member 118 distally. Such movement of base portion 122 and arm member 120 also results in corresponding distal movement of elongated tether portion 124 and proximal tether member 126, as shown in FIG.

[0063] When the actuator 104 is in its distal-most position along the introducer body 102, the locking arm 120 of the locking member 118 is configured to be positioned substantially beneath at least one of the proximal clip portions 112A, 112B, and the locking arm 120 is sized and configured to substantially limit inward movement of at least one of the proximal clip portions 112A, 112B when pinched. By limiting / blocking the inward movement of one or more of the proximal clip portions 112A, 112B, a user cannot release the distal clip portions 111A, 111B from engagement with the needleless access connector and therefore cannot remove the fluid transfer device 100 from the needleless access connector when the flexible probe 116 is in the advanced position shown in FIG.

[0064] 12-14, when the actuator 104 is manipulated proximally toward the first position to retract the flexible probe 116, the locking member 118 is not immediately pulled proximally away from the connector member 110. Instead, the actuator 104 shifts the length of the elongated tether portion 124 until it contacts the proximal tether portion 126, at which point the locking member 118 also begins to retract proximally away from the connector member 110. In this manner, the elongated tether portion 124 acts to time the disengagement of the locking member 118 from its position below the connector member 110, further ensuring that the proximal clip portions 112A, 112B cannot be pinched to remove the fluid transfer device 100 before the flexible probe 116 is sufficiently retracted. The length of the elongated tether portion 124 can be varied and / or optimized based on the desired engagement / disengagement of the locking member 118 with respect to the connector member 110. For example, if the elongated tether portion 124 is only slightly shorter than the introducer body 102, the locking member 118 will remain "engaged" beneath the connector member 110 until the actuator 104 has nearly reached its full proximal retraction point of the introducer body 102, thereby ensuring that the flexible probe 116 is fully (or nearly) retracted before the connector member 110 functions.

[0065] 14 shows both the actuator 104 and the locking member 118 in a fully retracted position after use of the fluid transfer device. In this retracted position, the locking arms 120 are positioned away from the connector member 110 to again allow inward movement of the proximal clip portions 112A, 112B, thereby allowing the distal clip portions 111A, 111B to be released from engagement with the needleless access connector, and thus allowing removal of the fluid transfer device 100 from the needleless access connector when the flexible probe 116 is at or near the retracted position. In this manner, premature removal of the fluid transfer device 100 from the needleless access connector may be prevented.

[0066] 16-18, a fluid transfer device 130 according to another embodiment of the present disclosure is illustrated. The fluid transfer device 130 includes an introducer body 132 and an actuator 134. The actuator 134 is configured to be linearly displaceable by a user along a track or other feature of the introducer body 132 between a proximal end portion 138 and a distal end portion 136 of the introducer body 132. The actuator 134 is operably coupled to an elongated flexible probe 146 to advance and retract the probe 146 through a distal introducer portion 144 disposed adjacent the distal end portion 136 of the introducer body 132.

[0067] The fluid transfer device 130 also includes a connector member 140 configured to selectively couple the fluid transfer device 130 to a needleless access connector, for example, of an adapter coupled to a vascular access device. The connector member 140 is configured as an alligator clip type connector and has opposing distal clip portions 141A, 141B that allow for securing the fluid device 130 to a surface of the needleless access connector. The pair of proximal clip portions 142A, 142B are sized and configured to be clamped by a user. Such clamping of the proximal clip portions 142A, 142B causes the distal clip portions 141A, 141B to pivot away from one another, thereby releasing the distal clip portions 141A, 141B from engagement with the needleless access connector.

[0068] Fluid transfer device 130 further includes a locking member 148. Locking member 148 includes at least one locking arm 150 extending distally from a base portion 152 that is configured to both secure locking member 148, for example to a track extending along introducer body 132, and to permit selective longitudinal movement of the locking member along introducer body 132. Although only a single locking arm 150 is shown in Figures 16-18, it should be understood that a pair of opposing locking arms may be utilized, similar to those shown and described with respect to Figures 8-11.

[0069] Locking member 148 also includes an elongated tether portion 154 and a proximal tether member 156. In the embodiment shown in Figures 16-18, elongated tether portion 154 extends substantially the length of elongated body 132. As will be explained in further detail below, tether portion 154 and proximal tether member 156 act to control the timing of advancement and retraction of locking arm 150 relative to and away from connector member 140 during simultaneous movement of the actuator.

[0070] 16, when the actuator 134 is in a first position substantially adjacent the proximal end portion 138 of the introducer body 132, the probe 146 is retracted into the distal introducer portion 144 and introducer body 132. Additionally, when the actuator 144 is in the first position, the locking member 148 is in a "disengaged" position along the introducer body 132 and the locking arm 150 is disposed proximally away from the connector member 140. In this position, the proximal clip portions 142A, 142B of the connector member 140 are pinched together to release the distal clip portions 141A, 141B from engagement with the needleless access connector, thus allowing removal of the fluid transfer device 130 from engagement with the needleless access connector.

[0071] 17, when actuator 134 is manually slid toward a second position at or near distal end portion 136 of introducer body 132, probe 146 is advanced through (and beyond) distal introducer portion 144. Advancement of actuator 134 in this manner advances locking member 148 in a distal direction, with actuator 134 configured to have a slight engagement with elongated tether portion 154 and / or proximal tether member 156 to slide simultaneously as actuator 134 is slid toward distal end portion 136. It should be appreciated that the engagement between actuator 134 and one or more portions of locking member 148 may be any suitable releasable engagement, such as, for example, an interference engagement, a mechanical engagement, a magnetic engagement, etc.

[0072] When the actuator 134 is initially moved along the introducer body 132 towards the distal end portion 136, engagement between the actuator 134 and the locking member 148 causes the locking arm 150 to move to a position substantially below at least one of the proximal clip portions 142A, 142B, the locking arm 150 being sized and configured to substantially limit inward movement of at least one of the proximal clip portions 142A, 142B when pinched. By limiting / blocking inward movement of one or more of the proximal clip portions 142A, 142B, a user is unable to release the distal clip portions 141A, 141B from engagement with the needleless access connector when the flexible probe 146 is advanced through the distal introducer portion 144, as shown in FIG. 17, and therefore is unable to remove the fluid transfer device 130 from the needleless access connector.

[0073] 18, after locking member 148 is in its "engaged" position below connector member 140, actuator 134 may continue to be moved distally to advance probe 146 past distal introducer portion 144 and into the patient's vasculature. Additionally, although not shown, when actuator 134 is moved proximally toward the first position to retract flexible probe 146, locking member 148 is not immediately pulled proximally away from connector member 140. Instead, actuator 134 traverses the length of elongated tether portion 154 until it contacts proximal tether portion 156, at which point locking member 148 also begins to retract proximally away from connector member 140. In this manner, the elongated tether portion 154 acts to time the disengagement of the locking member 148 from its position below the connector member 140, ensuring that the proximal clip portions 142A, 142 cannot be pinched to remove the fluid transfer device 130 before the flexible probe 146 has been sufficiently retracted. The length of the elongated tether portion 154 can be varied and / or optimized based on the desired engagement / disengagement of the locking member 148 to the connector member 140. For example, in the embodiment shown in Figures 16-18, the elongated tether portion 154 is only slightly shorter than the introducer body 132, allowing the locking member 148 to remain in a "locked" position below the connector member 140 until the actuator 134 has approximately reached its full proximal retraction point on the introducer body 132, thereby ensuring that the flexible probe 146 is fully (or nearly fully) retracted before the connector member 140 functions to release the fluid transfer device 130 from the needleless access connector.

[0074] All examples and conditional expressions incorporated herein are intended for educational purposes to help the reader understand the concepts contributed by the inventor to further develop the present invention and the art, and are not to be construed as being limited to such specifically incorporated examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made therein without departing from the spirit and scope of the present invention.

Claims

1. 1. A fluid transfer device for delivery of a probe to a patient's vascular system, said fluid transfer device comprising: Introduction body, a terminal introducer portion positioned at a distal end portion of the introducer body and configured to penetrate an access connector of a vascular access device; an actuator, the actuator being linearly displaceable along at least a portion of the introducer body, the actuator being operably coupled to the probe to advance and retract the probe through the distal introducer portion based on a direction of displacement of the actuator; a connector member positioned proximate the distal introducer portion and configured to releasably connect to at least one surface of the access connector, the connector member comprising a pair of opposing distal clip portions and a pair of opposing proximal clip portions; and a locking member, the locking member being linearly displaceable along at least a portion of the introducer body and configured to prevent actuation of at least one of the pair of opposing proximal clip portions when the actuator is at least partially displaced toward a first position and to allow actuation of at least one of the pair of opposing proximal clip portions when the actuator is at least partially displaced toward a second position; A fluid transfer device comprising:

2. 2. The fluid transfer device of claim 1, wherein the locking member comprises a single locking arm member configured to block actuation of a single one of the pair of opposing proximal clip portions of the connector member.

3. The fluid transfer device of claim 2 , wherein the single locking arm member extends distally from a base portion, the base portion being configured to be slidable along at least a portion of the introducer body.

4. 2. The fluid transfer device of claim 1, wherein the locking member comprises a pair of opposing arm members configured to block actuation of the pair of opposing proximal clip portions of the connector member.

5. The fluid transfer device of claim 4 , wherein the pair of opposing arm members extend distally from a base portion, the base portion being configured to be slidable along at least a portion of the introducer body.

6. The fluid transfer device of claim 5 , wherein the actuator is releasably engagable with the base portion.

7. The fluid transfer device of claim 1 , wherein the locking member comprises a biasing member configured to bias the locking member in one direction.

8. The fluid transfer device of claim 7 , further comprising a retention tab, said retention tab configured to retain said locking member proximally away from said connector member.

9. 9. The fluid transfer device of claim 8, wherein the retention tab is configured to be displaced by the actuator upon contact with the actuator, the displacement of the retention tab resulting in distal displacement of the locking member toward the second position under the force of the biasing member.

10. 2. The fluid transfer device of claim 1, wherein the locking member comprises at least one arm member and an elongated tether portion extending proximally from the at least one arm member, the at least one arm member configured to block actuation of at least one of the pair of opposing proximal clip portions of the connector member.

11. The fluid transfer device of claim 10 , wherein the actuator is configured to releasably engage at least a portion of the elongated tether portion.

12. The fluid transfer device of claim 1 , wherein the locking member is manually displaceable by a user.

13. 1. A fluid transfer device for needle-free delivery of a probe to a patient's vascular system, the fluid transfer device comprising: an introducer body having a distal end portion and a proximal end portion; an actuator, the actuator being linearly displaceable along at least a portion of the introducer body, the actuator being operably coupled to the probe to advance and retract the probe based on a direction of displacement of the actuator; a connector member positioned proximate the distal end portion of the introducer body and configured for releasable connection to at least one surface of an access connector; and a locking member configured to prevent disengagement of the connector member from the access connector when the actuator is advanced along the introducer body to a first position and to allow disengagement of the connector member when the actuator is retracted along the introducer body to a second position; A fluid transfer device comprising:

14. The fluid transfer device of claim 13 , wherein the locking member comprises a single locking arm member, the single locking arm member configured to block actuation of the connector member.

15. The fluid transfer device of claim 13 , wherein the locking member comprises a pair of opposing arm members, the pair of opposing arm members configured to block actuation of the connector member.

16. 14. The fluid transfer device of claim 13, wherein the locking member comprises at least one arm member and an elongated tether portion extending proximally from the at least one arm member, the at least one arm member configured to block actuation of the connector member.

17. The fluid transfer device of claim 16 , wherein the actuator is configured to releasably engage at least a portion of the elongated tether portion.

18. 1. A fluid transfer device for needle-free delivery of a probe to a patient's vascular system, the fluid transfer device comprising: an introducer body having a distal end portion and a proximal end portion; an actuator, the actuator being linearly displaceable along at least a portion of the introducer body, the actuator being operably coupled to the probe to advance and retract the probe based on a direction of displacement of the actuator; a connector member positioned adjacent a distal end portion of the introducer body and configured for releasable connection to at least one surface of an access connector; and a locking member comprising at least one arm member and an elongated tether portion extending proximally from the at least one arm member, the at least one arm member configured to selectively block actuation of the connector member based on a position of the actuator along the introducer body; A fluid transfer device comprising:

19. The fluid transfer device of claim 18 , wherein the actuator is configured to releasably engage at least a portion of the elongated tether portion.

20. 20. The fluid transfer device of claim 18, wherein the connector member comprises a pair of opposing distal clip portions and a pair of opposing proximal clip portions, and wherein the at least one arm member of the locking member is configured to block actuation of at least one of the pair of opposing proximal clip portions.

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