Vented point-of-care blood sample collection and delivery device

Abstract

A biological fluid collection device adapted to collect a sample is provided. The biological fluid collection device includes a collection module comprising a housing including an inlet port and an outlet port in fluid communication, a distal connector, a tip portion configured to dispense drops of the sample, a mixing chamber disposed between the inlet port and the outlet port, and a collection chamber disposed between the mixing chamber and the outlet port, wherein a portion of the collection chamber is actuatable to force a portion of the sample out therefrom. The biological fluid collection device also includes a vent cap removably connected with the tip portion and configured to allow air to pass therethrough while preventing the sample from passing therethrough. With the vent cap connected to the tip portion, an interior volume of the collection module including the mixing chamber and the collection chamber is at atmospheric pressure.

Description

Attorney Docket No. 09846-2600911 (P-30229.WO01)VENTED POINT-OF-CARE BLOOD SAMPLE COLLECTION AND DELIVERY DEVICECROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Patent Application No. 63 / 771,418, entitled “Vented Point-of-Care Blood Sample Collection and Delivery Device” filed March 13, 2025, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present disclosure relates generally to a biological fluid collection device. More particularly, the present disclosure relates to a vented point-of-care blood sample collection and delivery device for collecting a small sample of blood and dispensing a portion of the sample into a device for analyzing the sample, such as a point-of-care or a near-patient testing device.Background of the Invention

[0003] Recent developments in the point-of-care blood sampling market have led to the emergence of technologies designed to collect a small, point-of-care blood sample. Existing devices for such small, point-of-care blood sample collection sample typically utilize a vacuum tube pressure and existing vacuum tube-based blood collection accessory devices, such as a luer-lock access device (LLAD), connected to a venipuncture or other vascular access device (VAD). While such devices bring significant value and improvements to POC blood sample collection and dispensing to cartridge or direct instrumentation diagnostic systems, it is recognized that such vacuum tube driven systems have potential drawbacks associated therewith. As one example, the vacuum tube configuration of existing devices is more complex than devices not requiring a vacuum. As another example, the vacuum tube configuration of existing devices is limited for use with needle-based LLAD type systems, making it difficult to incorporate the device into other VAD systems. As yet another example, the vacuum tube configuration of existing devices limits options with regard to the size and shape thereof, as the devices are constrained to fit within a standard vacuum tube. Finally, the vacuum tube configuration of existing device can potentially result in hemolysis of the sample due to the vacuum pressure used to collect the sample.6BL0225.DOCX 1Attorney Docket No. 09846-2600911 (P-30229.WO01)

[0004] Accordingly, a need exists for small, point-of-care blood sample collection devices that address the drawbacks described above. The devices would utilize venous or arterial to atmospheric pressure differential to fill the blood collection sample volume, while providing a clinically acceptable fill time given the small sample volume required. The devices would also provide more flexible integration options, allowing for use thereof with various VAD systems.SUMMARY OF THE INVENTION

[0005] Provided herein is a biological fluid collection device adapted to collect a sample. The biological fluid collection device comprises a collection module including a housing having a distal end and a proximal end, with the housing including an inlet port at the distal end and an outlet port at the proximal end, wherein the inlet port and the outlet port are in fluid communication. The collection module also includes a distal connector provided at the distal end, a tip portion provided at the proximal end in fluid communication with the outlet port and configured to dispense drops of the sample, a mixing chamber disposed between the inlet port and the outlet port, and a collection chamber disposed between the mixing chamber and the outlet port, wherein a portion of the collection chamber is actuatable to force a portion of the sample out therefrom. The biological fluid collection device also comprises a vent cap removably connected with the tip portion, the vent cap including a venting plug configured to allow air to pass therethrough and prevent the sample from passing therethrough. With the vent cap connected to the tip portion, an interior volume of the collection module including the mixing chamber and the collection chamber, is at atmospheric pressure.

[0006] In some embodiments, the distal connector comprises a threaded male luer connector including an elongated member and a collar formed about the elongated member, the collar having a threaded inner surface.

[0007] In some embodiments, the distal connector comprises a slip luer connector including an elongated member.

[0008] In some embodiments, the distal connector comprises a closure including a pierceable self-sealing stopper and an outer shield.

[0009] In some embodiments, the distal connector comprises a septum retained within the inlet port and configured to receive a cannula therein and an engagement feature configured to couple the collection module to an external connector.

[0010] In some embodiments, the biological fluid collection device further includes a distal cap attachable to the distal connector to cover the inlet port.6BL0225.DOCX 2Attorney Docket No. 09846-2600911 (P-30229.WO01)

[0011] In some embodiments, the tip portion comprises a tapered elongated member in fluid communication with the outlet port and an external thread provided at a base of tapered the elongated member, the external thread configured to mate with the vent cap to secure the vent cap to the tip portion.

[0012] In some embodiments, the vent cap comprises a cap body including a connector formed at a distal end of the cap body and configured to engage the tip portion and an internal channel extending through the cap body, with the venting plug positioned within the internal channel.

[0013] In some embodiments, the collection module includes a sample stabilizer disposed between the inlet port and the mixing chamber.

[0014] In some embodiments, the collection module includes a one-way valve positioned between the inlet port and the outlet port, the one-way valve configured to allow a flow therethrough in a proximal direction but prevent a flow therethrough in a distal direction, so as to prevent the sample from leaking back out through the inlet port.

[0015] In some embodiments, the sample stabilizer comprises a dry anticoagulant powder, and wherein the sample dissolves and mixes with the dry anticoagulant powder.

[0016] In some embodiments, the dry anticoagulant powder is retained within pores of an open cell foam.

[0017] In some embodiments, the collection chamber comprises a first deformable portion and a second deformable portion that are transitionable between an initial position in which the sample is contained within the collection chamber and a deformed position in which a portion of the sample is expelled from the collection chamber and out through the tip portion.

[0018] In some embodiments, the collection chamber is configured to hold 500 pl or less of the sample.

[0019] Also provided is a method for collecting a sample of a biological fluid and dispensing a portion of the sample. The method includes fluidly connecting the biological fluid collection device to a catheter assembly, directly collecting the sample in the collection module, with the sample caused to flow into the collection module responsive to a venous-to-atmospheric pressure differential, removing the vent cap from the collection module upon collection of the sample, and actuating the collection module to cause a portion of the sample contained in the collection chamber to be expelled therefrom and out through the tip portion.

[0020] In some embodiments, the method also includes attaching a distal cap to the distal connector upon collection of the sample, the distal cap configured to cover the inlet port and provide for controlled dispensing of the portion of the sample out through the tip portion. 6BL0225.DOCX 3Attorney Docket No. 09846-2600911 (P-30229.WO01)

[0021] In some embodiments, the method also includes dispensing the portion of the sample out through the tip portion and directly onto a point-of-care testing device, a cartridge tester, or a near patient testing device.

[0022] In some embodiments, actuating the collection module comprises squeezing a first deformable portion and a second deformable portion of the collection chamber to transition the first deformable portion and the second deformable portion from an initial position in which the sample is contained within the collection chamber to a deformed position in which the portion of the sample is expelled from the collection chamber and out through the tip portion.

[0023] In some embodiments, the distal connector comprises one of a threaded luer connector, a slip luer connector, a closure including a pierceable self-sealing stopper and an outer shield, or a septum and associated engagement feature.

[0024] In some embodiments, in fluidly connecting the biological fluid collection device to the catheter assembly, the distal connector is coupled directly to a proximal connector of the catheter assembly.

[0025] In some embodiments, in fluidly connecting the biological fluid collection device to the catheter assembly, the distal connector is coupled to a blood draw device coupled to the catheter assembly and in fluid communication therewith, the blood draw device comprising a catheter tube, a housing having a proximal end portion and a distal end portion, with the distal end portion coupleable to the access port and the housing defining an inner volume configured to movably receive the catheter tube, and an advancement member configured to move relative to the housing to move the catheter tube between a first position, in which the catheter tube is disposed within the housing, and a second position in which a distal end of the catheter tube is disposed beyond the distal end portion of the housing and past a distal tip of the arterial catheter, wherein the biological fluid collection device is positioned proximal to the housing and in fluid communication with the catheter tube, to directly collect the sample through the catheter tube.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1 is a perspective view of a biological fluid collection device including a collection module and a vent cap, in accordance with an aspect of the disclosure;

[0027] FIG. 2 illustrates the biological fluid collection device of FIG. 1 with the vent cap removed from the collection module;

[0028] FIG. 3 is a cross-sectional view of the biological fluid collection device of FIG. 1 ;

[0029] FIG. 4 is a cross-sectional view of the biological fluid collection device of FIG. 1, with a sample drawn into the collection module;6BL0225.DOCX 4Attorney Docket No. 09846-2600911 (P-30229.WO01)

[0030] FIG. 5 is a cross-sectional view of the biological fluid collection device of FIG. 1, with a distal luer cap attached to the collection module;

[0031] FIG. 6 is a cross-sectional view of the biological fluid collection device of FIG. 1, with the vent cap removed from the collection module and with a deformable portion in an initial position;

[0032] FIG. 7 is a cross-sectional view of the biological fluid collection device of FIG. 1, with the vent cap removed from the collection module and with a deformable portion in a deformed position;

[0033] FIG. 8 is a perspective view of the biological fluid collection device of FIG. 1 connected to a catheter assembly, in accordance with an aspect of the disclosure;

[0034] FIGS. 9-13 illustrate various steps of an operational sequence of using the biological fluid collection device for collecting a biological sample and dispensing the sample to a point-of-care testing device, in accordance with an aspect of the disclosure;

[0035] FIG. 14 is a perspective view of a biological fluid collection device, in accordance with another aspect of the disclosure;

[0036] FIG. 15 is a perspective view of a biological fluid collection device, in accordance with another aspect of the disclosure;

[0037] FIG. 16 is a perspective view of a biological fluid collection device, in accordance with another aspect of the disclosure; and

[0038] FIG. 17 is a perspective view of a vascular access system that includes a biological fluid collection device, in accordance with an aspect of the disclosure.DESCRIPTION OF THE INVENTION

[0039] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0040] As used in this specification, the words "proximal" and "distal" refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device (e.g., the end of the device being manipulated by the user) would be the proximal end of the device.6BL0225.DOCX 5Attorney Docket No. 09846-2600911 (P-30229.WO01)

[0041] Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, are not to be considered as limiting as the invention can assume various alternative orientations.

[0042] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention.

[0043] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0044] As used herein, “at least one of’ is synonymous with “one or more of’. For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.

[0045] The present disclosure is directed to a vented point-of-care blood sample collection and delivery device for collecting a small sample of blood and dispensing a portion of the sample into a device for analyzing the sample, such as a point-of-care or a near-patient testing device.

[0046] FIGS. 1-7 illustrate an exemplary embodiment of a biological fluid collection device 10 according to an aspect of the present disclosure. The biological fluid collection device 10 is adapted to receive a biological fluid sample, such as a blood sample 12, and includes a collection module 14 and a vent cap 16 that is removably connectable to the collection module 14.

[0047] In one embodiment, and as best shown in FIGS. 3-7, the collection module 14 of the present disclosure is adapted to receive a biological fluid sample, such as a blood sample 12, and includes a housing 20, a mixing chamber 22, a sample stabilizer 24, a collection chamber 26, a distal connector 28, and a proximal dispensing tip 30 - with it recognized that distal connector 28 and proximal dispensing tip 30 may be formed integrally with the housing 20, so as to be considered to form part of housing 20.6BL0225.DOCX 6Attorney Docket No. 09846-2600911 (P-30229.WO01)

[0048] In one embodiment, the housing 20 of the collection module 14 includes an inlet port 32 provided in / at the distal connector 28 and an outlet port 34 provided in / at the proximal dispensing tip 30. In one embodiment, the inlet port 32 and the outlet port 34 are in fluid communication via a passageway 36 extending therebetween.

[0049] The mixing chamber 22 and the collection chamber 26 are provided in fluid communication via the passageway 36. The mixing chamber 22 and the collection chamber 26 are positioned such that a biological fluid sample, such as a blood sample 12, introduced into the inlet port 32 of the collection module 14 will first pass through a sample stabilizer 24, then the blood sample 12 and the sample stabilizer 24 pass through the mixing chamber 22, and subsequently the sample 12 with the sample stabilizer 24 properly mixed therein flow into the collection chamber 26, prior to reaching the outlet port 34 of the collection module 14. In this way, the blood sample 12 may be mixed with a sample stabilizer 24, such as an anticoagulant or other additive, provided within the collection module 14, before passing through the mixing chamber 22 for proper mixing of the sample stabilizer 24 within the blood sample 12, and then the stabilized sample is received and stored within the collection chamber 26.

[0050] In one embodiment, a sample stabilizer 24 is disposed between the inlet port 32 and the mixing chamber 22. The collection module 14 of the present disclosure provides passive and fast mixing of a blood sample 12 with the sample stabilizer 24. For example, the collection module 14 includes a mixing chamber 22 that allows for passive mixing of the blood sample 12 with an anticoagulant or another additive, such as a blood stabilizer, as the blood sample 12 flows through the mixing chamber 22.

[0051] The sample stabilizer can be an anticoagulant, or a substance designed to preserve a specific element within the blood such as, for example, RNA, protein analyte, or other element. In one embodiment, the sample stabilizer 24 is disposed between the inlet port 32 and the mixing chamber 22. In other embodiments, the sample stabilizer 24 may be disposed in other areas within the housing 20 of the collection module 14.

[0052] In one embodiment, the sample stabilizer 24 comprises a dry anticoagulant powder (e.g., Heparin or EDTA, as non-limiting examples) that is retained within pores of an open cell foam 38, with the open cell foam 38 disposed between the inlet port 32 and the mixing chamber 22. The dry anticoagulant powder may be dispersed within the cells of the open cell foam 38 to promote the effectiveness of the flow-through mixing and anticoagulant uptake. As the blood sample 12 enters the collection module 14, the blood sample 12 passes through the open cell foam 38 and is exposed to the anticoagulant powder available throughout the internal pore6BL0225.DOCX 7Attorney Docket No. 09846-2600911 (P-30229.WO01)structure of the open cell foam 38. In this manner, the sample 12 dissolves and mixes with the dry anticoagulant powder while passing through the open cell foam 38.

[0053] The open cell foam 38 may be a soft deformable open cell foam that is inert to blood, for example, a melamine foam, such as Basotect® foam commercially available from BASF, or may consist of a formaldehyde-melamine-sodium bisulfite copolymer. The open cell foam 38 may also be a flexible, hydrophilic open cell foam that is substantially resistant to heat and organic solvents. In one embodiment, the foam may include a sponge material.

[0054] The anticoagulant or other additive may be introduced into the open cell foam 38 by soaking the foam in a liquid solution of the additive and water and subsequently evaporating the water forming a dry additive powder finely distributed throughout the internal structure of the foam 38.

[0055] The collection module 14 includes a mixing chamber 22 that allows for passive mixing of the blood sample 12 with an anticoagulant or another additive, such as a blood stabilizer, as the blood sample 12 flows through the mixing chamber 22. In one embodiment, the mixing chamber 22 is disposed between the inlet port 32 and the outlet port 34. The internal portion of the mixing chamber 22 may have any suitable structure or form as long as it provides for the mixing of the blood sample 12 with an anticoagulant or another additive as the blood sample 12 passes through the passageway 36 of the collection module 14. In one embodiment, the mixing chamber 22 includes curved walls extending between an inlet end and an outlet end thereof.

[0056] The mixing chamber 22 receives the sample 12 and the sample stabilizer 24 therein and effectuates distributed mixing of the sample stabilizer 24 within the sample 12. The mixing chamber 22 effectuates distributed mixing of the sample stabilizer 24 within the sample 12 and prevents a very high sample stabilizer concentration in any portion of the blood sample 12. This prevents underdosing of the sample stabilizer 24 in any portion of the blood sample 12. The mixing chamber 22 effectuates distributed mixing of the sample stabilizer 24 within the sample 12 so that an approximately equal amount and / or concentration of the sample stabilizer 24 is dissolved throughout the blood sample 12, e.g., an approximately equal amount and / or concentration of the sample stabilizer 24 is dissolved into the blood sample 12 from a front portion of the blood sample 12 to a rear portion of the blood sample 12.

[0057] In one embodiment, the collection module 14 includes a collection chamber 26 that is disposed between the mixing chamber 22 and the outlet port 34. After passing through the mixing chamber 22, the stabilized sample is directed to the collection chamber 26. The collection chamber 26 may take any suitable shape and size to store a sufficient volume of 6BL0225.DOCX 8Attorney Docket No. 09846-2600911 (P-30229.WO01)blood necessary for the desired testing, for example 500 pl or less. In one embodiment, the collection chamber 26 is defined by a first deformable portion 40, a second deformable portion 42, and a rigid wall portion 44 (FIGS. 1 and 2) that is between the first deformable portion 40 and the second deformable portion 42, with the rigid wall portion 44 optionally being a portion of the housing 20. In one embodiment, the first deformable portion 40 is located on a first side of the collection chamber 26 and the second deformable portion 42 is located on a second side of the collection chamber 26, so as to be on opposite sides of the collection chamber 26.

[0058] The first deformable portion 40 and the second deformable portion 42 may be made of any material that is flexible, deformable, and capable of providing a fluid tight seal with the housing 20. In some embodiments, the first deformable portion 40 and the second deformable portion 42 may be made of natural or synthetic rubber, and other suitable elastomeric materials.

[0059] The first deformable portion 40 and the second deformable portion 42 are secured to a portion of the housing 20 such that the first deformable portion 40 and the second deformable portion 42 are transitionable between an initial position (FIGS. 3-6) in which the sample 12 is contained within the collection chamber 26 and a deformed position (FIG. 7) in which a portion of the sample 12 is expelled from the collection chamber 26. The first deformable portion 40 and the second deformable portion 42 are simultaneously squeezed to transition from the initial position (FIGS. 3-6) to the deformed position (FIG. 7).

[0060] Advantageously, by having a first deformable portion 40 and a second deformable portion 42 that can be simultaneously squeezed, a collection module 14 of the present disclosure is able to dispense more sample 12 out of the collection chamber 26 and the outlet port 34. Furthermore, in one embodiment, by having a first deformable portion 40 on a first side and a second deformable portion 42 on an opposite second side, a collection module 14 of the present disclosure has a symmetrical design and provides a smooth straight fluid path chamber that encourages fluid attachment flow characteristics. The smooth straight fluid path chamber of the collection module 14 is without significant geometric steps in diameter and the smooth fluid pathway inhibits the formation of air pockets or bubbles.

[0061] While the collection chamber 26 is shown and described herein as including a first deformable portion 40, a second deformable portion 42, and a rigid wall portion 44, it is recognized that the collection chamber 26 could have other suitable constructions, such as described in US Patent 11,193,862, assigned to Becton Dickinson and Company, which is incorporated herein in its entirety. As one non-limiting example, the collection chamber 26 could include a rigid wall chamber that receives the sample 12, a deformable portion including air, and a one-way valve disposed between the rigid wall chamber and the deformable portion.6BL0225.DOCX 9Attorney Docket No. 09846-2600911 (P-30229.WO01)The deformable portion may be an air bladder filled with air or viscous fluid to displace a sample out of the collection chamber 26. The deformable portion would be transitionable between an initial position in which the sample 12 is contained within the rigid wall chamber and a deformed position in which a portion of the sample 12 is expelled from the rigid wall chamber. The one-way valve prevents the sample 12 from moving from the rigid wall chamber to the deformable portion and allows air to move from the deformable portion to the rigid wall chamber to expel the sample 12 from the rigid wall chamber.

[0062] Referring still to FIGS. 1-7, and with reference now also to FIG. 9, the distal connector 28 is provided at a distal end of the housing 20, with the connector 28 providing for reversible coupling of the collection module 14 to a catheter assembly 50 or other blood draw device. In one embodiment, the distal connector 28 may comprise a threaded male luer connector 28a configured to mate with a female luer connector 52 provided on the catheter assembly 50 or other blood draw device. The male luer connector 28a may include an elongated member 54 having a collar 56 formed thereabout, which may be a spin collar according to some embodiments. The elongated member 54 can have a length that is sufficient to mate with the female luer connector 52 (and / or a needle-free connector positioned therein) and place the collection module 14 in fluid communication with the catheter assembly 50 or other blood draw device. The rotating collar 56 may be rotated to threadingly engage the male luer connector 28a to the catheter assembly 50 or other blood draw device.

[0063] In some embodiments, collection module 14 may further include a distal luer cap 58 (FIGS. 1, 2 and 5-7) that may be positioned over the male luer connector 28a after collection of a blood sample within collection module 14. The distal luer cap 58 may engage the elongated member 54 to close the inlet port 32, thereby preventing distal blood leakage out through the inlet port 32. The distal luer cap 58 may also improve proximal sample dispensing out from proximal dispensing tip 30.

[0064] In some embodiments, in place of (or in addition to) a distal luer cap 58 to close the inlet port 32 to prevent distal blood leakage out from the inlet port 32 after acquisition of a blood sample, the collection module 14 may include an optional one-way valve (e.g., a duckbill or disk valve, as non-limiting examples) that allows a flow of blood through inlet port 32 and into collection module 14, but prevents distal blood leakage back out from the inlet port 32 after acquisition of a blood sample. FIGS. 3-7 illustrate collection module 14 including a one-way valve 59 therein (shown in phantom). In one embodiment, the one-way valve 59 is positioned just distal to the sample stabilizer 24. Inclusion of the one-way valve 59 allows the6BL0225.DOCX 10Attorney Docket No. 09846-2600911 (P-30229.WO01)blood sample to be dispensed from outlet port 34 without spilling / leaking out from the inlet port 32, without the need for a separate distal luer cap 58.

[0065] The proximal tip portion 30 is provided at a proximal end of the housing 20, with the tip portion 30 providing for dispensing of a blood sample out therefrom in a controlled manner. The tip portion 30 comprises an elongated member 60 and a connection feature 62 provided at a base of the elongated member 60. The elongated member 60 may have a tapered configuration, and is formed as a hollow member, with the elongated member 60 in fluid communication with the outlet port 34. The connection feature 62 may comprise an external thread provided at base of elongated member 60 and may be configured to provide for attachment and removal of the vent cap 16 from the proximal tip portion 30.

[0066] According to aspects of the disclosure, the removable vent cap 16 of biological fluid collection device 10 is configured so as to be removably attachable to the proximal dispensing tip 30 of collection module 14. The vent cap 16 protectively covers the outlet port 34 of dispensing tip 30, while allowing for venting of the collection module 14. The vent cap 16 may comprise a cap body 64 that includes a connector 66 and a venting plug 68.

[0067] The connector 66 is formed at a distal end of the cap body 64 and enables selective attachment and removal of the vent cap 16 from the collection module 14. In some embodiments, the connector 66 may comprise a collar 70 with a thread formed on an inner surface thereof, with the threaded collar 70 configured to engage the connection feature 62 (i.e., external thread) provided on the proximal tip portion 30.

[0068] The venting plug 68 may be positioned within an internal channel 72 of the cap body 64 and is configured to allow air to pass therethrough but prevent the sample 12 from passing therethrough. In some embodiments, the venting plug 68 may comprise a hydrophobic filter that has a selected air passing resistance. By varying the porosity of the plug 68, the velocity of the air flow out of the vent cap 16, and thus the velocity of the blood sample flow into the collection module 14, may be controlled.

[0069] In some embodiments, the cap body 64 may further include one or more gripping features 74 formed thereon that aid in removal of the vent cap 16 from the collection module 14. The gripping features 74 may comprise a plurality of elongated tabs or extensions that may be pinched / grasped by a user to provide for twisting and pulling of the vent cap 16 off from the collection module 14.

[0070] Inclusion of the vent cap 16 in biological fluid collection device 10 provides for collection of a blood sample within collection module 14 using a venous- (or arterial) to atmospheric pressure differential. This is as compared to existing biological fluid collection 6BL0225.DOCX 11Attorney Docket No. 09846-2600911 (P-30229.WO01)devices that use / require a vacuum pressure to fill the blood collection sample volume thereof. Although filling the blood collection sample volume in the collection module 14 using a venous- (or arterial) to atmospheric pressure differential (provided by vent cap 16) increases the volume fill time (based on the reduced pressure differential, as compared to a vacuum), the biological fluid collection device 10 is simplified compared to vacuum-based devices, provides more flexible integration options, and provides a clinically acceptable fill-time given the small sample volume collected.

[0071] Referring to FIGS. 8-13, use of the biological fluid collection device 10 will now be described. In use, the distal connector 28 of biological fluid collection device 10 is coupled with a proximal connector 52 of a catheter assembly 50.

[0072] Upon connection of biological fluid collection device 10 with catheter assembly 50, the collection module 14 is placed in fluid communication with the catheter assembly 50, allowing for the blood sample 12 to be pulled into the passageway 36 of the housing 20 of the collection module 14 - with the blood sample 12 pulled into the passageway 36 via a venous-(or arterial) to atmospheric pressure differential that is present. In one embodiment, the blood sample 12 fills the entire passageway 36 such that, as the blood sample 12 enters the collection module 14, the blood sample 12 passes through the open cell foam 38 and the sample stabilizer 24 (i.e., anticoagulant powder) contained therein. In this manner, the sample 12 dissolves and mixes with the sample stabilizer 24 while passing through the open cell foam 38.

[0073] Next, the mixing chamber 22 receives the sample 12 and the sample stabilizer 24 therein and effectuates distributed mixing of the sample stabilizer 24 within the sample 12. After passing through the mixing chamber 22, the stabilized sample is directed to the collection chamber 26. The collection chamber 26 may take any suitable shape and size to store a sufficient volume of blood necessary for the desired testing, for example 500 pl or less. In one embodiment, the vent cap 16 stops the collection of the blood sample 12 when the passageway 36, the mixing chamber 22, and the collection chamber 26 of the collection module 14 has been fully filled. The venting plug 68 of the vent cap 16 allows air to pass through the vent cap 16 while preventing the blood sample 12 from passing through the vent cap 16 and exiting the collection module 14.

[0074] In one embodiment, once sample collection is complete, the collection module 14 is separated from the catheter assembly 50 (FIG. 9) by disconnecting the distal connector 28 from proximal connector 52, and then a distal luer cap 58 is attached to the distal connector 28 (FIG.10). Attachment of the distal luer cap 58 to the distal connector 28 closes the inlet port 32 and prevents distal blood leakage out through the inlet port 32 of distal connector 28. In another 6BL0225.DOCX 12Attorney Docket No. 09846-2600911 (P-30229.WO01)embodiment, and as described previously, a one-way valve 59 (FIGS. 3-7) may be included in collection module 14 rather than distal luer cap 58, to close the inlet port 32 and prevent distal blood leakage out through the inlet port 32 of distal connector 28.

[0075] Once the collection module 14 is disconnected from the catheter assembly 50 and the distal luer cap 58 is attached to the distal connector 28, the vent cap 16 may then be removed from the collection module 14 (FIG. 11) exposing the outlet port 34 of the proximal tip portion 30 of the collection module 14. Removal may be accomplished by the user grasping gripping features 74 of the vent cap 16 and twisting and pulling the vent cap 16 from the housing 20. The blood sample 12 is held within the passageway 36 of the housing 20, e.g., the collection chamber 26, by capillary action after removal of the vent cap 16.

[0076] In some embodiments, the blood sample 12 may then be dispensed from the collection module 14 by activation of the first deformable portion 40 and the second deformable portion 42. For example, the first deformable portion 40 and the second deformable portion 42 are transitionable between an initial position (FIGS. 3-6 and 12) in which the sample 12 is contained within the collection chamber 26 and a deformed position (FIGS. 7 and 13) in which a portion of the sample 12 is expelled from the collection chamber 26 and the outlet port 34. The first deformable portion 40 and the second deformable portion 42 are simultaneously squeezed to transition from the initial position (FIGS. 3-6 and 12) to the deformed position (FIGS. 7 and 13). In this manner, the blood sample 12 may be transferred to a device intended to analyze the sample, e.g., such as a point-of-care testing device 80 (FIGS. 13 and 14), a cartridge tester, or a near patient testing device, while minimizing the exposure of the medical practitioner to the blood sample.

[0077] FIGS. 14-16 illustrate other exemplary embodiments of a biological fluid collection device 10 of the present disclosure. The biological fluid collection devices 10 illustrated in FIGS. 14-16 include similar components to the biological fluid collection device 10 illustrated in FIGS. 1-7, and thus for the sake of brevity, these similar components will not all be discussed in conjunction with the embodiments described here below. However, in the biological fluid collection devices 10 illustrated in FIGS. 14-16, the distal connector 28 of the collection module 14 may differ from the male luer connector 28a shown in FIGS. 1-7.

[0078] Referring first to the embodiment of FIG. 14, distal connector 28 comprises a slip luer connector 28b. The slip luer connector 28b includes a tapered elongated protrusion 82 that is configured to mate with a female luer connector or needle-free connector provided at the proximal end of a catheter assembly 50 (FIG. 8), with engagement of the slip luer connector6BL0225.DOCX 13Attorney Docket No. 09846-2600911 (P-30229.WO01)28b and the female luer connector or needle-free connector fluidly connecting the collection module 14 to the catheter assembly 50.

[0079] Referring next to the embodiment of FIG. 15, distal connector 28 comprises a connector 28c that includes a distal septum 84 and an engagement feature 86. According to aspects of the disclosure, the distal septum 84 may comprise a split septum or other suitable septum that may be retained within the inlet port 32 of the collection module 14, with the distal septum 84 configured to receive therein a proximal cannula (e.g., blunted cannula or needle cannula) of the catheter assembly 50 (FIG. 8). The engagement feature 86 may comprise a threaded connector (e.g., threaded external surface) or other suitably configured connector configured to mate with the proximal connector 52 of the catheter assembly 50, to provide additional securing between the collection module 14 and the catheter assembly 50.

[0080] For either of the distal connector embodiments shown in FIGS. 14 or 15, i.e., for the slip luer connector 28b or connector 28c, a distal luer cap 58 such as shown in FIGS. 1 and 2 may be attached to the distal connector 28b, 28c to close the inlet port 32 and prevent distal blood leakage out through the inlet port 32 of the distal connector. Alternatively, and as described previously, a one-way valve 59 may be included in collection module 14 rather than distal luer cap 58, to close the inlet port 32 and prevent distal blood leakage out through the inlet port 32 of the distal connector.

[0081] Referring finally to the embodiment of FIG. 16, distal connector 28 comprises a closure 28d that is engaged with the inlet port 32 of the collection module 14 to cover the inlet port 32 and seal the passageway 36. The closure 28d may include a pierceable self-sealing stopper 88 with an outer shield 90 such as a Hemogard™ cap commercially available from Becton, Dickinson and Company. In order to mechanically and fluidly couple the biological fluid collection device 10 to a catheter assembly 50 (FIG. 8), a needle cannula forming part of a proximal connector of the catheter assembly 50 may be inserted through the pierceable selfsealing stopper 88 of closure 28d and into the passageway 36 of the housing 20 of the collection module 14.

[0082] While biological fluid collection device 10 is shown and described above as being directly connected to a catheter assembly 50 for collecting of a blood sample therefrom (e.g., FIG. 8), it is recognized that the biological fluid collection device 10 could instead be connected to other vascular access devices or systems.

[0083] Referring to FIG. 17, shown is a non-limiting embodiment of a vascular access system 100 for facilitating improved arterial line blood collection. Vascular access system 100 may include a catheter assembly 102 having a catheter adapter 104 and associated catheter 106.6BL0225.DOCX 14Attorney Docket No. 09846-2600911 (P-30229.WO01)In some non-limiting embodiments or aspects, the catheter assembly 102 may comprise an integrated catheter assembly that further includes a fluid conduit 108 extending from a side port 110 of the catheter adapter 104 and a connector 112 (e.g., t-connector or y-connector, for example) coupled to a proximal end of the fluid conduit 108, with a needleless access connector 114 coupled to the proximal end of connector 112.

[0084] Arterial access system 10 further includes a blood draw device 116 (alternatively, “line draw device”) that may be operated to obtain a blood sample from the patient. As shown in FIG. 17, according to a non-limiting embodiment, the blood draw device 116 includes at least a housing 118, a coupling device 120, a catheter tube 122, and an advancement member 124. The catheter tube 122 is moveable within the housing 118 so as to provide for advancement of a portion of the catheter tube 122 from a first or retracted position inside the housing 118 to a second or advanced position outside of the housing 118, such that a distal end thereof may be routed into the catheter assembly 102. Once a portion of the catheter tube 122 has been routed into the catheter assembly 102 and out past the distal tip of indwelling catheter 106, the catheter tube 122 may enable collection of a blood sample.

[0085] As further shown in FIG. 17, blood collection device 116 includes an extension tube 126 provided at a proximal end of the housing 118. According to embodiments of the disclosure, a proximal end portion of the extension tube 126 is coupled to and / or otherwise includes a coupler 128 configured to mate with a biological fluid collection device, such as the biological fluid collection device 10 of FIGS. 1-7, to collect a blood sample for subsequent analysis, such as a point-of-care analysis of the sample.

[0086] According to some embodiments, the coupler 128 may be configured as a luer connection (i.e., a female luer connection) configured to mate with a corresponding luer connection (i.e., a male luer connection) of the collection device, such as distal connector 28 / 28a of the collection module 14. The coupler 128 physically and fluidically couples the extension tube 126 to the biological fluid collection device 10, with the biological fluid collection device 10 pulling a blood sample into the collection module 14 via a venous- (or arterial) to atmospheric pressure differential that is present due to the structure of biological fluid collection device 10, as described in detail above.

[0087] Beneficially, embodiments of the disclosure thus provide a vented point-of-care blood sample collection and delivery device for collecting a small sample of blood and dispensing a portion of the sample into a device for analyzing the sample, such as a point-of-care or a near-patient testing device. The device utilized a venous- (or arterial) to atmospheric6BL0225.DOCX 15Attorney Docket No. 09846-2600911 (P-30229.WO01)pressure differential to fill the blood collection sample volume, while providing a clinically acceptable fill time given the small sample volume required.

[0088] Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.6BL0225.DOCX 16

Claims

Attorney Docket No. 09846-2600911 (P-30229.WOOl)THE INVENTION CLAIMED IS1. A biological fluid collection device adapted to collect a sample, the biological fluid collection device comprising:a collection module comprising:a housing having a distal end and a proximal end, with the housing including an inlet port at the distal end and an outlet port at the proximal end, wherein the inlet port and the outlet port are in fluid communication;a distal connector provided at the distal end;a tip portion provided at the proximal end, the tip portion in fluid communication with the outlet port and configured to dispense drops of the sample;a mixing chamber disposed between the inlet port and the outlet port; anda collection chamber disposed between the mixing chamber and the outlet port, wherein a portion of the collection chamber is actuatable to force a portion of the sample out therefrom; anda vent cap removably connected with the tip portion, the vent cap comprising a venting plug configured to allow air to pass therethrough and prevent the sample from passing therethrough;wherein with the vent cap connected to the tip portion, an interior volume of the collection module including the mixing chamber and the collection chamber, is at atmospheric pressure.

2. The biological fluid collection device of claim 1, wherein the distal connector comprises a threaded male luer connector including an elongated member and a collar formed about the elongated member, the collar having a threaded inner surface.

3. The biological fluid collection device of claim 1, wherein the distal connector comprises a slip luer connector including an elongated member.

4. The biological fluid collection device of claim 1, wherein the distal connector comprises a closure including a pierceable self-sealing stopper and an outer shield.6BL0225.DOCX 17Attorney Docket No. 09846-2600911 (P-30229.WOOl)5. The biological fluid collection device of claim 1, wherein the distal connector comprises:a septum retained within the inlet port, the septum configured to receive a cannula therein; andan engagement feature configured to couple the collection module to an external connector.

6. The biological fluid collection device of claim 1, further comprising a distal cap attachable to the distal connector to cover the inlet port.

7. The biological fluid collection device of claim 1, wherein the tip portion comprises:a tapered elongated member in fluid communication with the outlet port; and an external thread provided at a base of tapered the elongated member, the external thread configured to mate with the vent cap to secure the vent cap to the tip portion.

8. The biological fluid collection device of claim 1, wherein the vent cap comprises a cap body including:a connector formed at a distal end of the cap body and configured to engage the tip portion; andan internal channel extending through the cap body, with the venting plug positioned within the internal channel.

9. The biological fluid collection device of claim 1, wherein the collection module includes a sample stabilizer disposed between the inlet port and the mixing chamber.

10. The biological fluid collection device of claim 9, further comprising a one-way valve positioned between the inlet port and the inlet port, the one-way valve configured to allow a flow therethrough in a proximal direction but prevent a flow therethrough in a distal direction, so as to prevent the sample from leaking back out through the inlet port.

11. The biological fluid collection device of claim 9, wherein the sample stabilizer comprises a dry anticoagulant powder, and wherein the sample dissolves and mixes with the dry anticoagulant powder.6BL0225.DOCX 18Attorney Docket No. 09846-2600911 (P-30229.WO01)12. The biological fluid collection device of claim 11, wherein the dry anticoagulant powder is retained within pores of an open cell foam.

13. The biological fluid collection device of claim 1, wherein the collection chamber comprises a first deformable portion and a second deformable portion that are transitionable between an initial position in which the sample is contained within the collection chamber and a deformed position in which a portion of the sample is expelled from the collection chamber and out through the tip portion.

14. The biological fluid collection device of claim 1, wherein the collection chamber is configured to hold 500 pl or less of the sample.

15. A method for collecting a sample of a biological fluid and dispensing a portion of the sample, the method comprising:fluidly connecting the biological fluid collection device of claim 1 to a catheter assembly;directly collecting the sample in the collection module, with the sample caused to flow into the collection module responsive to a venous-to-atmospheric pressure differential;removing the vent cap from the collection module upon collection of the sample; andactuating the collection module to cause a portion of the sample contained in the collection chamber to be expelled therefrom and out through the tip portion.

16. The method of claim 15, further comprising attaching a distal cap to the distal connector upon collection of the sample, the distal cap configured to cover the inlet port and provide for controlled dispensing of the portion of the sample out through the tip portion.

17. The method of claim 15, further comprising dispensing the portion of the sample out through the tip portion and directly onto a point-of-care testing device, a cartridge tester, or a near patient testing device.

18. The method of claim 15, wherein actuating the collection module comprises squeezing a first deformable portion and a second deformable portion of the 6BL0225.DOCX 19Attorney Docket No. 09846-2600911 (P-30229.WO01)collection chamber to transition the first deformable portion and the second deformable portion from an initial position in which the sample is contained within the collection chamber to a deformed position in which the portion of the sample is expelled from the collection chamber and out through the tip portion.

19. The method of claim 15, wherein the distal connector comprises one of a threaded luer connector, a slip luer connector, a closure including a pierceable self-sealing stopper and an outer shield, or a septum and associated engagement feature.

20. The method of claim 15, wherein in fluidly connecting the biological fluid collection device to the catheter assembly, the distal connector is coupled to a blood draw device coupled to the catheter assembly and in fluid communication therewith, the blood draw device comprising:a catheter tube;a housing having a proximal end portion and a distal end portion, the distal end portion coupleable to the access port, the housing defining an inner volume configured to movably receive the catheter tube; andan advancement member configured to move relative to the housing to move the catheter tube between a first position, in which the catheter tube is disposed within the housing, and a second position in which a distal end of the catheter tube is disposed beyond the distal end portion of the housing and past a distal tip of the arterial catheter;wherein the biological fluid collection device is positioned proximal to the housing and in fluid communication with the catheter tube, to directly collect the sample through the catheter tube.6BL0225.DOCX 20

Images