Luer lock access devices and low volume sample collection and dispensing devices for use in point-of-care diagnostics

Abstract

A point-of-care blood collection and dispensing device for use with a Luer lock access device, the point-of-care blood collection and dispensing device includes a distal engagement portion and a sidewall portion, at least a portion of the distal engagement portion configured to engage a needle of the Luer lock access device, and at least a portion of the sidewall portion formed of a compressible flexible material. The device also includes a fluid chamber configured to hold a blood sample, the fluid chamber at least partially bounded by the distal engagement portion and the sidewall portion and may also include an opening, the opening sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed.

Description

[Technical field]

[0001] The present disclosure relates generally to a blood collection and dispensing device and associated assemblies, systems, and methods for use in blood collection via a peripheral intravenous catheter (PIVC), the blood collection and dispensing device being configured for use with a Luer lock access device coupled to a PIVC for point-of-care (PoC) diagnostics.

[0002] This application claims priority to U.S. Provisional Application No. 63 / 317,669, entitled "Miniature Sample Collection and Dispensing Device for Use with Luer Lock Access Devices and Point-of-Care Diagnostics," filed March 8, 2022, the entire disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0003] Catheters are commonly used to infuse fluids into a patient's vascular system. For example, catheters may be used to infuse saline, various medications, or total parenteral nutrition. In some instances, the catheter may be an over-the-needle peripheral intravenous catheter (PIVC).

[0004] In addition to infusion, PIVCs can also be used to withdraw blood from patients, although they are not typically designed and optimized for such purposes. Given the various challenges associated with blood extraction from a PIVC, fluid transfer devices have been developed to mitigate the possibility of catheter breakage, reduced blood flow due to debris accumulated on or within the catheter, and the like. One such device, the PIVO™ from Velano Vascular, Inc., is configured as a disposable device that is temporarily attached to a PIVC to collect a blood sample. Using an existing peripheral venous line as a conduit to the vasculature, the PIVO™ device advances a flexible internal flow tube through the PIVC, past the catheter tip, and into the vein to collect the blood sample. Once blood collection is complete, the flow tube is retracted and the device is detached from the PIVC and discarded.

[0005] When collecting blood using an existing vascular access, the PIVC may be coupled to a blood collection device, such as, for example, a BD Vacutainer® blood collection tube, to collect a blood sample from a patient via the PIVC. However, typical blood collection tubes are generally used to collect larger volumes of blood samples, requiring the use of separate instruments to collect and distribute smaller volumes of blood for testing purposes. Such multi-step and multi-component processes for collecting and distributing blood samples are not ideal for use with increasingly popular point-of-care (PoC) diagnostic tests that utilize portable testing systems that can rapidly provide results using small blood samples (e.g., glucose tests). Often, small blood samples for use with PoC testing systems are collected via finger pricks, but repeated finger pricks can be uncomfortable for patients. Therefore, it is desirable to utilize existing vascular access via the PIVC to collect small blood samples for efficient use with PoC testing systems.

[0006] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in certain environments such as those described above. Rather, this background is provided only to illustrate one example technology area in which some of the embodiments described herein may be practiced. Summary of the Invention

[0007] According to one aspect of the disclosure, a point-of-care blood collection and dispensing device for use with a Luer lock access device is provided, the device including a distal engagement portion, at least a portion of which is configured to engage a needle of the Luer lock access device, and a sidewall portion, at least a portion of which is formed of a compressible flexible material. The device may also include a fluid chamber configured to hold a blood sample, the fluid chamber at least partially bound by the distal engagement portion and the sidewall portion, and an opening, the opening sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed.

[0008] In some embodiments, the device further includes a stopper member, the stopper member configured to be pierced by a needle of a luer lock access device.

[0009] In some embodiments, the stop member is disposed within the distal engagement portion.

[0010] In some embodiments, the stop member is offset from a central axis of the point-of-care blood collection and dispensing device within the distal engagement portion.

[0011] In some embodiments, the opening is formed in the valve.

[0012] In some embodiments, the valve is a one-way valve.

[0013] In some embodiments, the one-way valve is disposed at a proximal end portion of the point-of-care blood collection and dispensing device opposite the distal engagement portion.

[0014] In some embodiments, the one-way valve is disposed within the distal engagement portion and is offset from a central axis of the point-of-care blood collection and dispensing device.

[0015] In some embodiments, the sidewall portion includes an indented portion configured to allow compression of the sidewall portion.

[0016] In some embodiments, at least a portion of the sidewall portion is formed from an elastomeric material.

[0017] In some embodiments, the device further includes a proximal vent portion disposed opposite the distal engagement portion, the proximal vent portion comprising a hydrophobic vent material.

[0018] According to another aspect of the disclosure, a small sample blood collection system for use with a point-of-care diagnostic testing device is provided, the system including a Luer lock access device having a Luer lock access hub configured to couple to an intermediate device for venous access to a patient, a needle fluidly coupled to the Luer lock access hub, and a holder configured to at least partially surround the needle and hold the blood collection device. The system also includes a point-of-care blood collection and dispensing device having a distal engagement portion, at least a portion of which is configured to engage the needle of the Luer lock access device, a sidewall portion, at least a portion of which is formed from a compressible flexible material, a fluid chamber configured to hold a blood sample, the fluid chamber at least partially bounded by the distal engagement portion and the sidewall portion, and an opening, the opening sized and configured to dispense a small volume of the blood sample held in the fluid chamber when the sidewall portion is compressed.

[0019] In some embodiments, the Luer lock access device further includes a sheath at least partially surrounding the needle.

[0020] In some embodiments, the point-of-care blood collection and dispensing device further includes a stopper member configured to be pierced by the needle of the Luer lock access device.

[0021] In some embodiments, the stopper member is offset from a central axis of the point-of-care blood collection and dispensing device within the distal engagement portion, and further, the needle of the Luer lock access device is correspondingly offset from the central axis of the Luer lock access device.

[0022] In some embodiments, the opening of the point-of-care blood collection and dispensing device is formed in a one-way valve.

[0023] In some embodiments, the one-way valve is disposed within a distal engagement portion of the point-of-care blood collection and dispensing device and is offset from a central axis of the point-of-care blood collection and dispensing device.

[0024] In some embodiments, at least a portion of the sidewall portion of the point-of-care blood collection and dispensing device is formed from an elastomeric material.

[0025] According to another aspect of the disclosure, a method of small blood sample collection and dispensing is provided, the method including providing a Luer lock access device having a Luer lock access hub configured to couple the Luer lock access device to an intermediate device for venous access to a patient, a needle fluidly coupled to the Luer lock access hub, and a holder configured to at least partially surround the needle and hold a blood collection device. The method also includes providing a point-of-care blood collection and dispensing device having a distal engagement portion, at least a portion of which is configured to engage the needle of the Luer lock access device, a sidewall portion, at least a portion of which is formed from a compressible flexible material, a fluid chamber configured to hold a blood sample, the fluid chamber at least partially bounded by the distal engagement portion and the sidewall portion, and an opening, the opening sized and configured to dispense a small blood sample held in the fluid chamber when the sidewall portion is compressed. The method also includes orienting the point-of-care blood collection and dispensing device distally toward the Luer lock access device such that a needle of the Luer lock access device pierces at least a portion of a distal engagement portion of the point-of-care blood collection and dispensing device, and collecting a blood sample within a fluid chamber of the point-of-care blood collection and dispensing device.

[0026] In some embodiments, the method also includes disengaging the point-of-care blood collection and dispensing device from the needle of the Luer lock access device, placing the point-of-care blood collection and dispensing device against a point-of-care diagnostic testing device, and compressing at least a portion of a sidewall portion of the point-of-care blood collection and dispensing device to dispense a portion of the blood sample collected in the fluid chamber into or onto the point-of-care diagnostic testing device.

[0027] It is to be understood that both the general description above and the detailed description that follows are exemplary and explanatory and are not restrictive of the claimed invention. It is to be understood that the various embodiments are not limited to the arrangements and instrumentalities shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and that 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]

[0028] Exemplary embodiments will be described and explained with additional specificity and detail through the use of accompanying drawings. [Figure 1] FIG. 1 is a side cross-sectional view of a luer lock access device according to an embodiment of the present disclosure. [Diagram 2] 2 is a side cross-sectional view of a blood collection and dispensing device for use with the luer lock access device of FIG. 1 according to an embodiment of the present disclosure. [Diagram 3] FIG. 3 is a side cross-sectional view of a blood collection and dispensing device according to another embodiment of the present disclosure. [Figure 4] FIG. 4 is a side cross-sectional view of a blood collection and dispensing device according to another embodiment of the present disclosure. [Diagram 5] FIG. 5 is a side cross-sectional view of a blood collection and dispensing device according to another embodiment of the present disclosure. [Figure 6] FIG. 6 is an isometric view of the blood collection and dispensing device of FIG. 5 used with a PoC test cartridge according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] 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. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present disclosure.

[0030] For purposes of description hereinafter, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal" and their derivatives refer to the invention as oriented in the drawings. It will be understood, however, that the invention may be subject to 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. As such, specific dimensions and other physical characteristics relating to aspects disclosed herein are not to be considered as limiting.

[0031] In this disclosure, a distal end of a component or device means the end furthest from a user's hand, and a proximal end means the end closest to the user's hand when the component or device is in the use position, i.e., when a user is holding the blood collection and dispensing device during preparation or use. Similarly, in this application, the terms "distally" and "distally" mean the direction toward the Luer lock access device, and the terms "proximal" and "proximally" mean the direction opposite to the direction of the Luer lock access device.

[0032] Although not shown or described herein, it will be understood that the blood collection and dispensing devices described below may be utilized to collect blood from any suitable catheter system, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD CATHENA™ Catheter System, the BD VENFLON™ Pro Safely Shielded IV Catheter System, the BD NEOFLON™ IV Cannula System, the BD INSYTE™ AUTOGUARD™ BC Shielded IV Catheter System, or another suitable catheter assembly.

[0033] 1, a luer lock access device 100 according to aspects of the present disclosure is shown. In some embodiments, the luer lock access device 100 may be coupled to a PIVC (not shown) via any suitable blood collection adapter or other intermediate device. As shown, the luer lock access device 100 is configured to receive a blood collection device, such as, for example, a BD VACUTAINER® blood collection tube. The luer lock access device 100 includes a luer lock hub 104. In some embodiments, the luer lock hub 104 may have internal threads (not shown) that allow a proximal coupling portion of a blood collection adapter or other device to engage the luer lock access device 100.

[0034] The Luer lock access device 100 further includes a needle 106 in fluid communication with the Luer lock hub 104 to allow fluid to pass from the blood draw adapter (or other device) to the blood draw device. The needle 106 may be substantially surrounded by a sheath 108 to protect against needlestick injury. The sheath 108 may be formed of rubber or any other suitable material. Additionally, the Luer lock access device 100 may include a holder 102 sized and configured to accommodate a blood draw device, such as, for example, a BD VACUTAINER® blood draw tube. In response to the blood draw device pushing the sheath 108 distally toward the Luer lock hub 104, the needle 106 may penetrate the sheath 108 and a sharp proximal tip of the needle 106 may be inserted into the blood draw device to receive a blood sample via the blood draw adapter or other intermediate device.

[0035] As mentioned above, the holder 102 of the Luer lock access device 100 may be sized and configured to accommodate a blood collection device, such as, for example, a BD VACUTAINER® blood collection tube. However, such blood collection devices are not typically utilized in conjunction with point-of-care (PoC) diagnostic testing devices, which require the use of a separate blood collection instrument to collect and dispense the small samples required by the PoC diagnostic testing devices.

[0036] Thus, according to an aspect of the disclosure, a PoC blood collection / dispensing device 200 is provided for use with the Luer lock access device 100, as shown in FIG. The PoC blood collection / dispensing device 200 includes a flexible sidewall portion 202, a distal introduction portion 204, and a proximal vent portion 210. The flexible sidewall portion 202 substantially encloses a fluid chamber 206 sized and configured to hold a small blood sample obtained via venous pressure through the Luer lock access device 100. The proximal vent portion 210 may include a hydrophobic vent material 208 that allows blood to be drawn into the fluid chamber by venous pressure alone.

[0037] 2, the distal introducer portion 204 includes a distal end 205. In some embodiments, the distal introducer portion 204 may include an angled radial surface 209 extending inwardly from the distal end 205, the angled radial surface 209 configured to contact the sheath 108 surrounding the needle 106 of the luer lock access device 100. When a user wishes to obtain a blood sample, the angled radial surface of the distal introducer portion 204 may be positioned over the proximal tip of the sheath 108 and the entire PoC blood collection / dispensing device 200 may be pushed proximally, thereby compressing the sheath 108 until it is punctured by the needle 106, as shown in FIG. 2. In this position, the fluid chamber 206 is fluidly coupled to the needle 106 such that a small amount of blood sample may be collected within the PoC blood collection / dispensing device 200.

[0038] After the desired blood sample is collected within the fluid chamber 206, the PoC blood collection / dispensing device 200 is moved proximally to decouple the distal introducer portion 204 from the sheath 108 and needle 106. The distal introducer portion 204 may include an opening 207 sized and configured such that surface tension alone is sufficient to retain the blood sample within the fluid chamber 206 prior to dispensing the sample, thereby eliminating the need for any valves or other closures associated with the distal introducer portion 204. Additionally, the inner diameter and / or shape of the distal introducer portion 204 may be configured to limit the volume and / or rate at which blood is dispensed therethrough, thereby ensuring that an appropriately small sample can be dispensed into the PoC diagnostic testing device in a controlled manner.

[0039] To dispense a blood sample from within the fluid chamber 206, the flexible sidewall portion 202 of the PoC blood collection / dispensing device 200 can be squeezed or otherwise compressed by a user to force a droplet of sample out of the opening 207 of the distal introduction portion 204. The flexible sidewall portion 202 may be formed of any suitable flexible material, such as, for example, a molded elastomeric material, and may have any suitable durometer and / or thickness to achieve the desired force required to flex the surface for controlled dispensing of blood from the distal introduction portion 204. Additionally, all or a portion of the flexible sidewall portion 202 may be formed of a translucent or transparent material to allow a user to visualize the sample contained therein. In some embodiments, at least a portion of the flexible sidewall portion 202 may include volumetric graduation markings thereon.

[0040] As mentioned above, the PoC blood collection / dispensing device 200 can be used with any suitable PoC diagnostic testing device including, for example, cartridges for systems such as the i-STAT handheld blood analyzer from Abbott, test strips for glucose monitors, etc. After dispensing a desired amount of blood sample into the PoC diagnostic testing device, the entire PoC blood collection / dispensing device 200 may be discarded in an appropriate medical waste container. Thus, the PoC blood collection / dispensing device 200 provides a simple and efficient solution for collecting and dispensing small blood samples using existing vascular access via a PIVC.

[0041] 3, there is shown a PoC blood collection / dispensing device 300 according to another embodiment of the present disclosure. Although not shown, similar to the PoC blood collection / dispensing device 200 described above with respect to FIGURE 2, the PoC blood collection / dispensing device 300 is configured to be usable with a Luer lock access device to collect small blood samples via existing vascular access.

[0042] The PoC blood collection / dispensing device 300 includes an at least partially compressible sidewall portion 302, a stopper member 304, and a valve member 306. The sidewall portion 302, the stopper member 304, and the valve member 306 define a fluid chamber 305 that is sized and configured to hold a small volume of the blood sample. Volumetric graduation markings 308 may be provided on at least a portion of the sidewall portion 302.

[0043] The stopper member 304 may be formed of any suitable material capable of engaging with the needle of a Luer lock access device, such as, for example, rubber. The valve member 306 may be selectively opened and closed by a user to control the collection of a blood sample within the PoC blood collection / dispensing device 300.

[0044] To initiate blood collection, a user may push the PoC blood collection / dispensing device 300 distally such that the stopper member 304 is fully penetrated by the needle of the Luer lock access device, thereby fluidly coupling the fluid chamber 305 with the Luer lock access device. The valve member 306 may then be opened to initiate blood collection via venous pressure, thus allowing blood to begin to fill the fluid chamber 305. Once a desired amount of blood has been collected within the fluid chamber 305, the valve member 306 may be closed and the stopper member 304 may be disengaged from the Luer lock access device.

[0045] To dispense a blood sample into the PoC diagnostic testing device, the valve member 306 may be opened and at least a portion of the sidewall portion 302 may be squeezed or otherwise compressed by a user, thereby forcing a small amount of the blood sample out of the fluid chamber 305 through the valve member 306. The valve member 306 may be configured to limit the volume and / or rate at which blood is dispensed therethrough. Additionally, at least the compressible region of the sidewall portion 302 may be formed of any suitable flexible material, such as, for example, a molded elastomeric material, and may have any suitable durometer and / or thickness to achieve the desired force required to flex a surface for controlled dispensing of blood from the valve member 306.

[0046] 4, there is shown a PoC blood collection / dispensing device 400 according to another aspect of the present disclosure. As shown, the PoC blood collection / dispensing device 400 is configured to be usable with the Luer lock access device 100 to collect a small blood sample via an existing vascular access.

[0047] PoC blood collection / dispensing device 400 includes a sidewall portion 402 having a recessed portion 403. Recessed portion 403 is configured to reduce the wall thickness of sidewall portion 402, thereby providing a compressible weak point in sidewall portion 402. In some embodiments, recessed portion 403 may extend entirely around sidewall portion 402. In other embodiments, recessed portion 403 may extend only partially around sidewall portion 402.

[0048] The PoC blood collection / dispensing device 400 further includes a stopper member 404 and a one-way valve member 406. The sidewall portion 402, the stopper member 404, and the one-way valve member 406 combine a fluid chamber 405 that is sized and configured to hold a blood sample. Although not shown in FIG. 4, volumetric graduation markings may be provided on at least a portion of the sidewall portion 402.

[0049] Stopper member 404 may be formed at least in part from any suitable material, such as rubber, capable of engaging a needle of a Luer lock access device. One-way valve member 406 includes an opening 407 that can open under a proximal fluid force to dispense a small blood sample at a desired rate.

[0050] To initiate blood collection, a user may push the PoC blood collection / dispensing device 400 distally such that at least a portion of the stopper member 404 is fully penetrated by the needle of the Luer lock access device 100, thereby fluidly coupling the fluid chamber 405 with the Luer lock access device 100. Once a desired amount of blood has been collected in the fluid chamber 405, the stopper member 404 may be disengaged from the Luer lock access device 100.

[0051] To dispense a blood sample into the PoC diagnostic testing device, the recessed portion 403 of the sidewall portion 402 may be squeezed or otherwise compressed by a user, thereby forcing a small amount of the blood sample out of the fluid chamber 305 through an opening 407 in the one-way valve member 406. The one-way valve member 406 may be configured to limit the volume and / or rate at which blood is dispensed therethrough. Additionally, at least the recessed portion 403 of the sidewall portion 402 may be formed of any suitable flexible material, such as, for example, a molded elastomeric material, and may have any suitable durometer and / or thickness to achieve the desired force required to flex a surface for controlled dispensing of blood from the one-way valve member 406.

[0052] Unlike the PoC blood collection / dispensing devices 200, 300 described above with respect to Figures 2 and 3, the PoC blood collection / dispensing device 400 may be configured to have a form factor similar to a conventional blood collection device, such as, for example, a BD VACUTAINER® blood collection tube, and thus, the PoC blood collection / dispensing device 400 may be sized and configured to fit securely within a holder of the Luer lock access device 100 when engaged with the needle of the Luer lock access device 100.

[0053] 5 and 6, a luer lock access device 500 and a PoC blood collection / dispensing device 550 are shown according to another embodiment of the present disclosure.

[0054] In some embodiments, the Luer lock access device 500 may be coupled to a PIVC (not shown) via any suitable blood draw adapter or other intermediate device. The Luer lock access device 500 includes a Luer lock hub 504. In some embodiments, the Luer lock hub 504 may have internal threads that allow a proximal coupling portion of a blood draw adapter or other device to engage the Luer lock access device 500. The Luer lock access device 500 further includes a needle 508 in fluid communication with the Luer lock hub 504 to allow fluid to pass from the blood draw adapter (or other device) to the blood draw device. Unlike the needle 106 shown and described above with respect to the Luer lock access device 100, the needle 508 is offset from the central axis of the Luer lock hub 504. Additionally, although not shown in FIG. 5, the needle 508 may be substantially surrounded by a sheath to protect against needlestick injuries. The sheath may be formed of rubber or any other suitable material. Luer lock access device 500 may also include a holder 502 sized and configured to accommodate a conventional blood collection device, such as, for example, a BD VACUTAINER® blood collection tube.

[0055] As shown in FIG. 5, the PoC blood collection / dispensing device 550 is configured to be usable with the Luer lock access device 500 to collect a small blood sample via an existing vascular access. The PoC blood collection / dispensing device 550 includes a flexible sidewall portion 556. At least a portion of the flexible sidewall portion 556 may be formed of any suitable flexible material, such as, for example, a molded elastomeric material, and may have any suitable durometer and / or thickness to achieve the desired force required to flex the surface for controlled dispensing of blood of the PoC blood collection / dispensing device 550. Alternatively, a portion of the flexible sidewall portion 556 may be thinned to allow compression by a user's finger and / or thumb. The thinned portion of the flexible sidewall portion 556 may have a finger / thumb print molded therein to provide a user with a visual and / or tactile indicator as to the location of the compressible portion. Additionally, all or a portion of the flexible sidewall portion 556 may be formed of a translucent or transparent material to allow a user to visualize the sample contained therein. In some embodiments, at least a portion of the flexible sidewall portion 556 may include volume graduation markings thereon.

[0056] The PoC blood collection / dispensing device 550 further includes a closed end 555 and a distal engagement portion 552. The distal engagement portion 552 includes both a stopper member 553 and a one-way valve member 554. The stopper member 553 and the one-way valve member 554 are each offset from a central axis of the PoC blood collection / dispensing device 550. Thus, unlike the PoC blood collection / dispensing device 400 described above with respect to FIG. 4, both the stopper member 553 and the one-way valve member 554 are disposed at a distal portion of the PoC blood collection / dispensing device 550.

[0057] The flexible sidewall portion 556, the distal engagement portion 552, and the closed end 555 combine a fluid chamber 551 that is sized and configured to hold a blood sample. Although not shown in FIGS. 5 and 6, volumetric graduation markings may be provided on at least a portion of the sidewall portion 556. The stopper member 553 may be formed at least in part of any suitable material, such as rubber, that can engage with the needle 508 of the luer lock access device 500. The one-way valve member 554 includes an opening that can open under a distal fluid force to dispense a small volume of the blood sample at a desired rate.

[0058] To initiate blood collection, a user may push the PoC blood collection / dispensing device 550 distally such that at least a portion of the offset stopper member 553 is fully pierced by a corresponding offset needle 508 of the Luer lock access device 500, thereby fluidly coupling the fluid chamber 551 with the Luer lock access device 500. Once a desired amount of blood has been collected in the fluid chamber 551, the stopper member 553 may be disengaged from the Luer lock access device 500.

[0059] 6, to dispense a blood sample into a PoC diagnostic testing device (e.g., cartridge 600), at least a portion of flexible sidewall portion 556 may be squeezed or otherwise compressed by a user, thereby forcing a small amount of the blood sample out of fluid chamber 551 through an opening in a one-way valve member 554 provided in distal engagement portion 552. One-way valve member 554 may be configured to limit the volume and / or rate at which blood is dispensed therethrough.

[0060] 4, the PoC blood collection / dispensing device 550 may be configured to have a form factor similar to that of a conventional blood collection device, such as, for example, a BD VACUTAINER® blood collection tube. As such, the PoC blood collection / dispensing device 550 may be sized and configured to fit securely within the holder 502 of the Luer lock access device 500 when engaged with the needle 508 of the Luer lock access device 500.

[0061] All examples and conditional language described herein are intended for educational purposes to help the reader understand the concepts provided by the inventor to promote the invention and technology, and should be interpreted as not being limited to the specifically recited 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 herein without departing from the spirit and scope of the present invention.

Claims

1. 1. A point-of-care blood collection and dispensing device for use with a Luer lock access device, comprising: a distal engagement portion, at least a portion of the distal engagement portion configured to engage a needle of the Luer lock access device; and a sidewall portion, at least a portion of which is formed from a compressible flexible material; and a fluid chamber configured to hold a blood sample, the fluid chamber being at least partially bounded by the distal engagement portion and the sidewall portion; an opening sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed; 1. A point-of-care blood collection and dispensing device comprising:

2. 10. The point-of-care blood collection and dispensing device of claim 1, further comprising a stopper member, the stopper member configured to be pierced by the needle of the Luer lock access device.

3. The point-of-care blood collection and dispensing device of claim 2 , wherein the stop member is disposed within the distal engagement portion.

4. The point-of-care blood collection and dispensing device of claim 2 , wherein the stop member is offset from a central axis of the point-of-care blood collection and dispensing device within the distal engagement portion.

5. The point-of-care blood collection and dispensing device of claim 1 , wherein the opening is formed in a valve.

6. 6. The point-of-care blood collection and dispensing device of claim 5, wherein the valve is a one-way valve.

7. 7. The point-of-care blood collection and dispensing device of claim 6, wherein the one-way valve is disposed at a proximal end portion of the point-of-care blood collection and dispensing device opposite the distal engagement portion.

8. 7. The point-of-care blood collection and dispensing device of claim 6, wherein the one-way valve is disposed within the distal engagement portion and offset from a central axis of the point-of-care blood collection and dispensing device.

9. 10. The point-of-care blood collection and dispensing device of claim 1, wherein the sidewall portion comprises a recessed portion configured to allow compression of the sidewall portion.

10. The point-of-care blood collection and dispensing device of claim 1 , wherein at least a portion of the sidewall portion is formed from an elastomeric material.

11. 10. The point-of-care blood collection and dispensing device of claim 1, further comprising a proximal vent portion disposed opposite the distal engagement portion, the proximal vent portion comprising a hydrophobic vent material.

12. 1. A low volume blood sample collection system for use in a point-of-care diagnostic testing device, comprising:

1. A luer lock access device comprising: a Luer lock access hub configured to couple the Luer lock access device to an intermediate device for venous access to a patient; a needle fluidly coupled to the luer lock access hub; and a holder at least partially surrounding the needle and configured to hold a blood collection device; The luer lock access device comprising:

1. A point-of-care blood collection and dispensing device comprising: a distal engagement portion, at least a portion of the distal engagement portion configured to engage the needle of the Luer lock access device; a sidewall portion, at least a portion of which is formed from a compressible flexible material; a fluid chamber configured to hold a blood sample, the fluid chamber being at least partially bounded by the distal engagement portion and the sidewall portion; and an opening sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed; said point-of-care blood collection and dispensing device comprising: A small volume blood sample collection system comprising:

13. 13. The small volume blood sample collection system of claim 12, wherein the luer lock access device further comprises a sheath at least partially surrounding the needle.

14. 13. The small volume blood sample collection system of claim 12, wherein the point-of-care blood collection and dispensing device further comprises a stopper member configured to be pierced by the needle of the Luer lock access device.

15. 15. The small volume blood sample collection system of claim 14, wherein the stopper member is offset from a central axis of the point-of-care blood collection and dispensing device within the distal engagement portion, and further wherein the needle of the Luer lock access device is correspondingly offset from a central axis of the Luer lock access device.

16. 13. The small volume sample collection system of claim 12, wherein the opening of the point-of-care blood collection and dispensing device is formed in a one-way valve.

17. 17. The small volume sample collection system of claim 16, wherein the one-way valve is disposed within the distal engagement portion of the point-of-care blood collection and dispensing device and is offset from a central axis of the point-of-care blood collection and dispensing device.

18. 13. The small volume sample collection system of claim 12, wherein at least a portion of the sidewall portion of the point-of-care blood collection and dispensing device is formed from an elastomeric material.

19. 1. A method for collecting and dispensing a small sample of blood, comprising: Providing a luer lock access device, a Luer lock access hub configured to couple the Luer lock access device to an intermediate device for venous access to a patient; a needle fluidly coupled to the luer lock access hub; and a holder at least partially surrounding the needle and configured to hold a blood collection device; and Providing a point-of-care blood collection and dispensing device, a distal engagement portion, at least a portion of the distal engagement portion configured to engage the needle of the Luer lock access device; a sidewall portion, at least a portion of which is formed from a compressible flexible material; a fluid chamber configured to hold a blood sample, the fluid chamber being at least partially bounded by the distal engagement portion and the sidewall portion; and an opening sized and configured to dispense a small volume of the blood sample held within the fluid chamber when the sidewall portion is compressed; and Equipped with directing the point-of-care blood collection and dispensing device distally toward the Luer lock access device such that the needle of the Luer lock access device pierces at least a portion of the distal engagement portion of the point-of-care blood collection and dispensing device; collecting a blood sample within the fluid chamber of the point-of-care blood collection and dispensing device.

20. removing the point-of-care blood collection and dispensing device from engagement with the needle of the Luer lock access device; placing said point-of-care blood collection and dispensing device relative to a point-of-care diagnostic testing device; and compressing at least a portion of the sidewall portion of the point-of-care blood collection and dispensing device to dispense a portion of the blood sample collected in the fluid chamber into or onto the point-of-care diagnostic testing device.

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