Arterial Blood Gas Syringe

Abstract

An arterial blood module including an arterial blood collection element defining a collection chamber and an arterial blood module removably connectable to a portion of the arterial blood collection element, the arterial blood module including a hub body, a needle extending from the hub body, and a safety shield engageable with a portion of the hub body and transitionable from a first shielded position in which a portion of the needle is exposed to a second shielded position in which the needle is shielded by a portion of the safety shield, the arterial blood module also including a vent chamber in fluid communication with the hub body for venting air bubbles from a collected blood sample in the collection chamber of the arterial blood collection element.

Description

[Technical field]

[0001] The present disclosure relates generally to arterial blood collection systems.

[0002] More specifically, the present disclosure relates to an arterial blood collection system including an arterial blood collection element adapted for use with a radial artery stick and an arterial blood module. [Background technology]

[0003] This application claims priority to U.S. Provisional Application No. 63 / 328,960, entitled "Arterial Blood Gas Syringe," filed April 8, 2022, the entire disclosure of which is incorporated herein by reference in its entirety.

[0004] Arterial blood collection syringes are used to withdraw and collect arterial blood samples from a patient's body. Once collected, the blood sample undergoes diagnostic analysis, primarily for blood gases, and often electrolytes, metabolites, and other elements indicative of the patient's condition. Various types of syringes have been devised for collecting arterial blood samples, including primarily elements from hypodermic syringes, namely, a plastic or glass syringe barrel, a sealing elastomeric stopper with or without a vent, and a plunger rod.

[0005] Conventional arterial blood collection syringes typically use conventional hypodermic needles with a safety shield that must be snapped or slid over the needle following the blood collection procedure. Such safety guards are often in view during the blood collection procedure, thereby obscuring the physician's view during this delicate procedure.

[0006] Conventional arterial blood collection syringes also have a separate vent cap that requires the needle to be removed before the cap is attached to the syringe in order to expel trapped air bubbles from the collected sample.

[0007] Conventional arterial blood collection syringes that contain anticoagulants typically have the anticoagulant loaded within the syringe and therefore require the user to roll or shake the collected sample to ensure complete mixing with the anticoagulant.

[0008] Arterial blood modules that are removably connectable to an arterial blood collection element are contemplated. For example, U.S. Patent No. 5,399,633, published as U.S. Patent No. 5,399,633 and incorporated herein by reference in its entirety, discloses an arterial blood module that is removably connectable to an arterial blood collection element. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] U.S. Application Publication No. 2021 / 0315498 [Patent Document 2] U.S. Application Serial No. 17 / 272,767 Summary of the Invention [Means for solving the problem]

[0010] The present disclosure provides an arterial blood module removably connectable to an arterial blood collection element. The arterial blood module includes a housing, a needle, a cap removably securable over the needle, a mixing chamber, and a safety shield that engages a portion of the housing and is transitionable from a first shielded position in which a portion of the needle is exposed to a second shielded position in which the needle is shielded by a portion of the safety shield. In one embodiment, the present disclosure includes an arterial blood collection system including an arterial blood collection element defining a collection chamber and an arterial blood module removably connectable to a portion of the arterial blood collection element. Additionally and / or alternatively, an arterial blood module according to the present disclosure may be provided without a mixing chamber.

[0011] In an exemplary embodiment, the arterial blood collection system of the present disclosure provides a novel blood sampling device for collecting arterial blood samples using radial stick technology. In other embodiments, the arterial blood collection system according to aspects of the present disclosure may be used to collect arterial blood samples from the brachial artery. The system of the present disclosure provides an efficient system that streamlines and reduces the number of workflow steps, allowing for one-handed device operation that allows for a more efficient arterial blood gas (ABG) collection procedure. The arterial blood module of the present disclosure optionally includes ergonomic touch points, a push button safety shield, automatic anticoagulant mixing, and an integrated vent cap for venting air bubbles after the collection procedure.

[0012] According to an embodiment of the invention, an arterial blood collection system includes an arterial blood collection element defining a collection chamber, and an arterial blood module removably connectable to a portion of the arterial blood collection element, the arterial blood module comprising a housing having a first end and a second end, a needle extending from the first end, a cap removably securable over the needle, a mixing chamber adjacent the second end, and a safety shield engageable with a portion of the housing and transitionable from a first shielded position in which a portion of the needle is exposed to a second shielded position in which the needle is shielded by a portion of the safety shield.

[0013] In one configuration, the safety shield comprises a shield assembly and an actuator transitionable from a first actuator position where the actuator engages a portion of the shield assembly to lock the shield assembly in the first shield position to a second actuator position where the actuator releases the shield assembly and the safety shield automatically moves to the second shield position. In another configuration, the actuator comprises a push button. In yet another configuration, the shield assembly comprises a telescoping shield. In one configuration, the shield assembly comprises a fixed outer shield, an intermediate movable shield in communication with the fixed outer shield, the intermediate movable shield moving relative to the fixed outer shield, and an inner movable shield in communication with the intermediate movable shield, the inner movable shield moving relative to the intermediate movable shield. In another configuration, with the safety shield in the first shield position, the inner movable shield is nested inside the intermediate movable shield and the intermediate movable shield is nested inside the fixed outer shield. In yet another configuration, with the safety shield in the second shielding position, the inner movable shield extends from the middle movable shield, and the middle movable shield extends from the fixed outer shield. In one configuration, the housing of the arterial blood module defines a flow channel from the first end to the second end. In another configuration, the arterial blood module further comprises a sample stabilizer disposed in the flow path between the first end of the housing and the mixing chamber. In yet another configuration, the arterial blood collection system includes a material including pores disposed in the flow path between the first end of the housing and the mixing chamber, and a dry anticoagulant powder in the pores of the material. In one configuration, the blood sample dissolves and mixes with the dry anticoagulant powder as it passes through the material. In another configuration, the material is an open cell foam. In yet another configuration, the sample stabilizer is a dry anticoagulant powder. In one configuration, the housing of the arterial blood module defines a vent chamber. In another configuration, the arterial blood module further comprises a vent plug that allows air to pass therethrough and prevents the blood sample from passing therethrough, a portion of the vent plug in communication with the vent chamber.In yet another configuration, the arterial blood module further comprises a first valve, the arterial blood module is connected to the arterial blood collecting element, and the blood sample enters the collection chamber of the arterial blood collecting element via the needle and the first valve. In one configuration, the first valve allows the blood sample to pass from the arterial blood module to the collection chamber of the arterial blood collecting element. In another configuration, the first valve blocks the blood sample from returning from the collection chamber of the arterial blood collecting element to the arterial blood module. In yet another configuration, the arterial blood module further comprises a second valve, the arterial blood module is connected to the arterial blood collecting element, and air and a portion of the blood sample contained in the collection chamber of the arterial blood collecting element enter the vent chamber via the second valve. In one configuration, the air travels out of the arterial blood module via the vent plug. In another configuration, the arterial blood module includes a first finger grip portion. In yet another configuration, the arterial blood module includes a second finger grip portion, the first finger grip portion being opposite the second finger grip portion. In one configuration, the needle comprises thin walled needle technology. In another configuration, the arterial blood collection element comprises a plunger rod assembly including a stopper and a plunger rod.

[0014] According to another embodiment of the invention, an arterial blood module includes a housing having a first end and a second end, a needle extending from the first end, a cap removably securable over the needle, a mixing chamber adjacent the second end, and a safety shield engageable with a portion of the housing and transitionable from a first shielded position in which a portion of the needle is exposed to a second shielded position in which the needle is shielded by a portion of the safety shield.

[0015] In one configuration, the arterial blood module is removably connectable to a portion of the arterial blood collection element, hi another configuration, the arterial blood collection element defines a collection chamber.

[0016] According to another aspect of the present disclosure, an arterial blood collection system is disclosed that includes an arterial blood collection element defining a collection chamber and an arterial blood collection module removably connectable to a portion of the arterial blood collection element. The arterial blood module may include a hub body, a needle extending from the hub body, and a safety shield that engages a portion of the hub body and is transitionable from a first shielded position in which a portion of the needle is exposed to a second shielded position in which the needle is shielded by a portion of the safety shield. The arterial blood module may also include a vent chamber in fluid communication with the hub body to vent air bubbles from a collected blood sample in the collection chamber.

[0017] In some embodiments, the arterial blood module further includes an actuator transitionable from a first actuator position to a second actuator position, the second actuator position releasing the safety shield to the second shield position.

[0018] In some embodiments, the actuator includes a push button.

[0019] In some embodiments, the safety shield includes a telescoping shield.

[0020] In some embodiments, the vent chamber is formed in the actuator.

[0021] In some embodiments, the hub body of the arterial blood module defines a vent chamber.

[0022] In some embodiments, the arterial blood module further includes a vent plug that allows air to pass therethrough and prevents the blood sample from passing therethrough, a portion of the vent plug in communication with the vent chamber.

[0023] In some embodiments, the needle and safety shield are selectively removable from the hub body.

[0024] In some embodiments, the needle and safety shield are removable from the hub body only when the safety shield is in the second, shielded position.

[0025] In some embodiments, the actuator includes an actuator lever and a stopcock valve.

[0026] In some embodiments, the arterial blood collection module further includes an eccentric needle carrier having a needle carrying portion coupled to the needle and in fluid communication with the needle, a vent chamber portion, and a rotatable lever portion.

[0027] In some embodiments, the arterial blood collection module further includes an insert disposed at a distal end of the inner portion of the safety shield to seal the opening in the safety shield when the needle is in a second shielded position where it is shielded by a portion of the safety shield.

[0028] According to another aspect of the present disclosure, an arterial blood module is disclosed that includes a hub body, a needle extending from the hub body, a safety shield that engages a portion of the hub body and is transitionable from a first shielded position in which a portion of the needle is exposed to a second shielded position in which the needle is shielded by a portion of the safety shield, and a vent chamber in fluid communication with the hub body to vent air bubbles from a collected blood sample in the collection chamber.

[0029] In some embodiments, the arterial blood module is removably connectable to a portion of the arterial blood collection element.

[0030] In some embodiments, the arterial blood module is connectable to a portion of the arterial blood collection element via a threaded luer connection.

[0031] In some embodiments, the arterial blood module further includes an actuator transitionable from a first actuator position to a second actuator position, the second actuator position releasing the safety shield to the second shield position.

[0032] In some embodiments, the vent chamber is formed in the actuator.

[0033] In some embodiments, the actuator includes a push button.

[0034] In some embodiments, the actuator includes an actuator lever and a stopcock valve.

[0035] In some embodiments, the hub body of the arterial blood module defines a vent chamber.

[0036] In some embodiments, the arterial blood module further includes a vent plug that allows air to pass therethrough and prevents the blood sample from passing therethrough, a portion of the vent plug in communication with the vent chamber.

[0037] It is to be understood that both the foregoing general description and the following detailed description 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 present invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief description of the drawings]

[0038] The above and other features and advantages of the present disclosure, as well as the manner in which they are accomplished, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings, in which: [Figure 1]FIG. 1 is a perspective view of an arterial blood collection system according to one embodiment of the present invention. [Diagram 2] FIG. 2 is a perspective view of an arterial blood module having a cap secured over a needle, according to an embodiment of the present invention. [Diagram 3] FIG. 3 is a perspective view of an arterial blood module with the caps removed from the needles, according to one embodiment of the present invention. [Figure 4] FIG. 4 is a perspective view of an arterial blood collection system in which air bubbles are evacuated from the system, according to one embodiment of the present invention. [Diagram 5] FIG. 5 is a perspective view of a first step in using the system of the present disclosure, according to one embodiment of the present invention. [Figure 6] FIG. 6 is a perspective view of a second step of using the system of the present disclosure, according to one embodiment of the present invention. [Figure 7] FIG. 7 is a perspective view of a third step of using the system of the present disclosure, according to one embodiment of the present invention. [Figure 8] FIG. 8 is a perspective view of a fourth step of using the system of the present disclosure, according to one embodiment of the present invention. [Figure 9] FIG. 9 is a perspective view of a fifth step of using the system of the present disclosure, according to one embodiment of the present invention. [Figure 10] FIG. 10 is a first schematic diagram of an arterial blood collection system according to one embodiment of the present invention. [Figure 11] FIG. 11 is a second schematic diagram of an arterial blood collection system according to one embodiment of the present invention. [Figure 12] FIG. 12 is a third schematic diagram of an arterial blood collection system according to one embodiment of the present invention. [Figure 13] FIG. 13 is a cross-sectional view of a portion of an arterial blood module with a safety shield in a first shield position, according to one embodiment of the present invention. [Figure 14] FIG. 14 is a cross-sectional view of a portion of an arterial blood module with a safety shield in a second shield position, according to one embodiment of the present invention. [Figure 15]FIG. 15 is a cross-sectional view of a portion of an arterial blood module with a safety shield in a first shielding position according to another embodiment of the present invention. [Figure 16] FIG. 16 is a cross-sectional view of a portion of an arterial blood module with a safety shield in a second shield position, according to one embodiment of the present invention. [Figure 17] FIG. 17 is a cross-sectional view of a portion of an arterial blood module with a safety shield in a first shielding position according to another embodiment of the present invention. [Figure 18] FIG. 18 is a cross-sectional view of a portion of an arterial blood module with a safety shield in a second shield position, according to one embodiment of the present invention. [Figure 19] FIG. 19 is a perspective view of an open cell foam material according to one embodiment of the present invention. [Figure 20] FIG. 20 is a microscopic view of the microstructure of an open cell foam material having dry anticoagulant powder distributed throughout its microstructure, according to one embodiment of the present invention. [Figure 21] FIG. 21 is a perspective view of an arterial blood module according to another embodiment of the present invention. [Figure 22] FIG. 22 is a cross-sectional view of the arterial blood module of FIG. 21 in a first configuration. [Figure 23] FIG. 23 is a cross-sectional view of the arterial blood module of FIG. 21 in a second configuration. [Figure 24] FIG. 24 is a cross-sectional view of the arterial blood module of FIG. 21 in a third configuration. [Diagram 25] FIG. 25 is a perspective view of an arterial blood module according to another embodiment of the present invention. [Figure 26] FIG. 26 is a cross-sectional view of the arterial blood module of FIG. 25 in a first configuration. [Figure 27] FIG. 27 is a cross-sectional view of the arterial blood module of FIG. 25 in a second configuration. [Figure 28] FIG. 28 is a cross-sectional view of an arterial blood module according to another embodiment of the present invention in a first configuration. [Figure 29]FIG. 29 is a cross-sectional view of the arterial blood module of FIG. 28 in a second configuration. [Diagram 30] FIG. 30 is a perspective view of an arterial blood module for an arterial blood gas syringe according to another embodiment of the present invention. [Diagram 31] FIG. 31 is a cross-sectional view of the arterial blood module of FIG. 30 in a first configuration. [Diagram 32] FIG. 32 is another cross-sectional view of the arterial blood module of FIG. 30 in the first configuration. [Diagram 33] FIG. 33 is a cross-sectional view of the arterial blood module of FIG. 30 in a second configuration. [Diagram 34] FIG. 34 is a cross-sectional view of the arterial blood module of FIG. 30 in a third configuration. [Diagram 35] FIG. 35 is a cross-sectional view of the arterial blood module of FIG. 30 in a fourth configuration. [Diagram 36] FIG. 36 is a cross-sectional view of the arterial blood module of FIG. 30 in a fifth configuration. [Figure 37] FIG. 37 is a perspective view of an arterial blood module for an arterial blood gas syringe according to another embodiment of the present invention. [Figure 38] FIG. 38 is a partial side view of the arterial blood module of FIG. 37 in a first configuration. [Figure 39] FIG. 39 is a partial schematic diagram of the arterial blood module of FIG. 37 in a first configuration. [Diagram 40] FIG. 40 is a partial schematic diagram of the arterial blood module of FIG. 37 in a second configuration. [Diagram 41] FIG. 41 is a perspective view of an arterial blood module for an arterial blood gas syringe according to another embodiment of the invention in a first configuration. [Diagram 42] FIG. 42 is a perspective view of the arterial blood module of FIG. 41 in a second configuration. [Diagram 43] FIG. 43 is a partial cross-sectional view of the arterial blood module of FIG. 41 in a first configuration. [Diagram 44] FIG. 44 is a cross-sectional view of the arterial blood module of FIG. 41 in a second configuration. [Diagram 45] FIG. 45 is a perspective view of an arterial blood module for an arterial blood gas syringe according to another embodiment of the invention in a first configuration. [Figure 46] FIG. 46 is a perspective view of the arterial blood module of FIG. 45 in a second configuration. [Figure 47] FIG. 47 is a cross-sectional view of the arterial blood module of FIG. 45 in a first configuration. [Figure 48] FIG. 48 is a partial cross-sectional view of the arterial blood module of FIG. 45 in a second configuration. [Figure 49] FIG. 49 is a partial cross-sectional view of the arterial blood module of FIG. 45 in a first configuration. [Figure 50] FIG. 50 is an end view of an eccentric needle carrier for use with the arterial blood module of FIG. 45 in a second configuration. [Figure 51] FIG. 51 is an end view of an eccentric needle carrier for use with the arterial blood module of FIG. 45 in a first configuration. [Figure 52] FIG. 52 is a partial cross-sectional view of an arterial blood module for an arterial blood gas syringe according to another embodiment of the invention in a first configuration. [Diagram 53] FIG. 53 is a partial cross-sectional view of the arterial blood module of FIG. 52 in a second configuration. [Figure 54] FIG. 54 is a partial cross-sectional view of an arterial blood module for an arterial blood gas syringe according to another embodiment of the invention in a first configuration. [Figure 55] FIG. 55 is a partial cross-sectional view of the arterial blood module of FIG. 54 in a second configuration. [Figure 56] FIG. 56 is an exploded view of the arterial blood module of FIG. [Figure 57] FIG. 57 is another exploded view of the arterial blood module of FIG. [Figure 58] FIG. 58 is a partial cross-sectional view of an arterial blood module for an arterial blood gas syringe according to another embodiment of the invention in a first configuration. [Figure 59]FIG. 59 is a partial cross-sectional view of the arterial blood module of FIG. 58 in a second configuration. [Figure 60] FIG. 60 is a partial cross-sectional view of a safety shield assembly for use with an arterial blood module for an arterial blood gas syringe according to another embodiment of the invention in a first configuration. [Figure 61] FIG. 61 is a partial cross-sectional view of the safety shield assembly of FIG. 60 in a second configuration. [Figure 62] FIG. 62 is a partial cross-sectional view of a safety shield assembly for use with an arterial blood module for an arterial blood gas syringe according to another embodiment of the invention in a first configuration. [Figure 63] 63 is a partial cross-sectional view of the safety shield assembly of FIG. 62 in a second configuration. [Figure 64] FIG. 64 is a perspective view of an arterial blood module and arterial blood gas syringe according to another embodiment of the invention in a first configuration. [Figure 65] FIG. 65 is a side view of the arterial blood module of FIG. [Figure 66] FIG. 66 is a perspective view of the arterial blood module of FIG. 64. [Figure 67] FIG. 67 is a perspective view of the arterial blood module and arterial blood gas syringe of FIG. 64 in a second configuration. [Figure 68] FIG. 68 is a partial cross-sectional view of the arterial blood module of FIG. 64 in a first configuration. [Figure 69] FIG. 69 is a partial cross-sectional view of the arterial blood module of FIG. 64 in a second configuration. [Figure 70] FIG. 70 is a perspective view of an arterial blood module and arterial blood gas syringe according to another embodiment of the invention in a first configuration. [Figure 71] FIG. 71 is a side view of the arterial blood module of FIG. [Figure 72] FIG. 72 is a perspective view of the arterial blood module of FIG. [Figure 73]FIG. 73 is a perspective view of the arterial blood module and arterial blood gas syringe of FIG. 70 in a second configuration. [Figure 74] FIG. 74 is a partial cross-sectional view of the arterial blood module of FIG. 70 in a first configuration. [Figure 75] FIG. 75 is a partial cross-sectional view of the arterial blood module of FIG. 70 in a second configuration. [Figure 76] FIG. 76 is a perspective view of an actuator for use with the arterial blood module of FIG. [Figure 77] FIG. 77 is another perspective view of an actuator for use with the arterial blood module of FIG. [Figure 78] FIG. 78 is a perspective view of an arterial blood module and arterial blood gas syringe according to another embodiment of the invention in a first configuration. [Figure 79] FIG. 79 is a side view of the arterial blood module of FIG. [Figure 80] FIG. 80 is a perspective view of the arterial blood module of FIG. [Figure 81] FIG. 81 is a perspective view of the arterial blood module and arterial blood gas syringe of FIG. 78 in a second configuration. [Figure 82] FIG. 82 is a partial cross-sectional view of the arterial blood module of FIG. 78 in a first configuration. [Figure 83] FIG. 83 is a partial cross-sectional view of the arterial blood module of FIG. 78 in a second configuration. [Figure 84] FIG. 84 is a perspective view of a lever actuator and stopcock valve for use with the arterial blood module of FIG.

[0039] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations presented herein illustrate exemplary embodiments of the present disclosure, and such illustrations should not be construed as limiting the scope of the present disclosure in any way. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain 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 invention.

[0041] 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 the embodiments disclosed herein are not to be considered as limiting.

[0042] The present disclosure provides an arterial blood module removably connectable to an arterial blood collection element. The arterial blood module includes a housing, a needle, a cap removably securable over the needle, a mixing chamber, and a safety shield that engages a portion of the housing and is transitionable from a first shielded position in which a portion of the needle is exposed to a second shielded position in which the needle is shielded by a portion of the safety shield. In one embodiment, the present disclosure includes an arterial blood collection system including an arterial blood collection element defining a collection chamber and an arterial blood module removably connectable to a portion of the arterial blood collection element.

[0043] In an exemplary embodiment, the arterial blood collection system of the present disclosure provides a novel blood draw device for collecting arterial blood samples using radial stick technology. The system of the present disclosure provides an efficient system that streamlines and reduces the number of workflow steps, allowing for one-handed device operation that allows for a more efficient arterial blood gas (ABG) collection procedure. The arterial blood module of the present disclosure optionally includes ergonomic touch points, a push button safety shield, automatic anticoagulant mixing, and an integrated vent cap to evacuate air bubbles after the collection procedure.

[0044] 1-20 illustrate an exemplary embodiment of an arterial blood collection system 10 of the present disclosure adapted to receive a biological fluid sample, such as an arterial blood sample 12. In one embodiment, the arterial blood collection system 10 of the present disclosure includes an arterial blood collection element 14 and an arterial blood module 16 that is removably connectable to a portion of the arterial blood collection element 14.

[0045] 1 and 4-12, in one embodiment, the arterial blood collection element 14 of the present disclosure is adapted to receive a biological fluid sample, such as an arterial blood sample 12, and defines a collection chamber 20. In an exemplary embodiment, the arterial blood collection element 14 includes a plunger rod assembly 22 having a stopper 24 and a plunger rod 26. In one embodiment, the arterial blood collection element 14 is a conventional arterial blood gas syringe assembly, for example, either a Luer lock or a Luer slip arterial blood gas syringe assembly. The arterial blood module 16 of the present disclosure may be compatible with any conventional arterial blood collection element or arterial blood gas syringe assembly.

[0046] When the system 10 of the present disclosure is used to remove arterial blood, blood at arterial pressure is greater than normal atmospheric or ambient pressure in the collection chamber 20 of the arterial blood collecting element 14, and thus, upon insertion of the needle 32 of the arterial blood module 16 into an artery, the arterial blood sample 12 flows from the patient through the arterial blood module 16 to the collection chamber 20 of the arterial blood collecting element 14, as described in more detail below. In this manner, the system 10 of the present disclosure is self-priming due to the arterial blood pressure and the vented arterial blood gas syringe stopper.

[0047] 1-20, in one embodiment, an arterial blood module 16 of the present disclosure is removably connectable to a portion of an arterial blood collecting element 14 and includes a housing 30, a needle 32, a cap 34, a mixing chamber 36, a flow channel 37, a safety shield 38, and a sample stabilizer 39. In one embodiment, the housing 30 includes a first end 46 and a second end 48. In one embodiment, the housing 30 of the arterial blood module 16 defines a flow channel 37 that extends from the first end 46 to the second end 48.

[0048] In exemplary embodiments, the arterial blood module 16 of the present disclosure is removably connectable to a portion of the arterial blood collection element 14 via conventional methods and structures. For example, in one embodiment, the arterial blood module 16 of the present disclosure is removably connectable to a portion of the arterial blood collection element 14 via a standard Luer connection.

[0049] Advantageously, the arterial blood module 16 of the present disclosure allows for automatic mixing with a sample stabilizing agent 39. For example, in one embodiment, a mixing chamber 36 is provided in fluid communication with the flow channel 37. The mixing chamber 36 and the sample stabilizing agent 39 are arranged such that a biological fluid sample, such as an arterial blood sample 12, first passes through the sample stabilizing agent 39, then the blood sample 12 and the sample stabilizing agent 39 pass through the mixing chamber 36, and thereafter the sample 12, with the sample stabilizing agent 39 appropriately mixed therein, flows to the collection chamber 20 of the arterial blood collecting element 14. In this manner, the blood sample 12 may be mixed with the sample stabilizing agent 39, such as an anticoagulant or other additive, provided in the arterial blood module 16, before passing through the mixing chamber 36 to appropriately mix the sample stabilizing agent 39 within the blood sample 12, and the stabilized sample is then received and stored in the collection chamber 20 of the arterial blood collecting element 14.

[0050] In one embodiment, the sample stabilizing agent 39 is disposed within the flow channel 37 between the first end 46 of the housing 30 and the mixing chamber 36. The arterial blood module 16 of the present disclosure provides passive and rapid mixing of the blood sample 12 with the sample stabilizing agent 39. For example, the arterial blood module 16 includes a mixing chamber 36 that allows the blood sample 12 to be passively mixed with another additive, such as an anticoagulant or blood stabilizing agent, as the blood sample 12 flows through the mixing chamber 36.

[0051] The sample stabilization agent can be an anticoagulant or a substance designed to preserve certain components in the blood, such as RNA, protein analytes, or other components. In one embodiment, the sample stabilization agent 39 is disposed within the flow channel 37 between the first end 46 of the housing 30 and the mixing chamber 36. In other embodiments, the sample stabilization agent 39 can be disposed in other areas within the housing 30 of the arterial blood module 16.

[0052] 19-20, in one embodiment, the arterial blood module 16 includes a material 40 including pores 42 disposed within the flow channel 37 between the first end 46 of the housing 30 and the mixing chamber 36, and a dry anticoagulant powder 44 within the pores 42 of the material 40. In this manner, the arterial blood module 16 may include a dry anticoagulant, such as heparin or EDTA, deposited on or within a portion of the arterial blood module 16. In one embodiment, the material 40 is an open cell foam containing a dry anticoagulant dispersed within the bubbles of the open cell foam, facilitating the effects of flow-through mixing and anticoagulant uptake. In one embodiment, the sample stabilizing agent 39 is a dry anticoagulant powder 44.

[0053] In one embodiment, the open cell foam can be treated with an anticoagulant to form a dry anticoagulant powder that is finely dispersed throughout the pores of the open cell foam. As the blood sample 12 enters the arterial blood module 16, the blood sample 12 passes through the open cell foam and is exposed to the anticoagulant powder available throughout the internal pore structure of the open cell foam. In this manner, the blood sample 12 dissolves and mixes with the dry anticoagulant powder 44 while passing through the material 40, i.e., the open cell foam.

[0054] The open cell foam may be a blood inert, soft, deformable open cell foam, for example a melamine foam such as Basotect® foam commercially available from BASF, or may be comprised of a formaldehyde-melamine-sodium bisulfite copolymer. The open cell foam may also be a flexible, hydrophilic open cell foam that is substantially resistant to heat and organic solvents. In one embodiment, the foam may comprise a sponge material.

[0055] Anticoagulants or other additives may be introduced into the open cell foam by immersing the foam in a solution of the additive and water, followed by evaporation of the water to form a dry additive powder that is finely distributed throughout the internal structure of the foam.

[0056] The arterial blood module 16 includes a mixing chamber 36 that allows for passive mixing of the blood sample 12 with another additive, such as an anticoagulant or blood stabilizer, as the blood sample 12 flows through the mixing chamber 36. In one embodiment, the mixing chamber 36 is disposed between a first end 46 and a second end 48 of the housing 30 of the arterial blood module 16. In one embodiment, the mixing chamber 36 is adjacent to the second end 48.

[0057] The interior portion of the mixing chamber 36 may have any suitable structure or configuration, so long as it provides for mixing of the blood sample 12 with the anticoagulant or another additive as the blood sample 12 passes through the flow channel 37 of the arterial blood module 16.

[0058] The mixing chamber 36 receives the sample 12 and the sample stabilizer 39 therein and provides dispersive mixing of the sample stabilizer 39 within the sample 12. The mixing chamber 36 provides dispersive mixing of the sample stabilizer 39 within the sample 12 to prevent the sample stabilizer concentration from becoming too high in any one portion of the blood sample 12. This prevents the sample stabilizer 39 from being applied insufficiently in any one portion of the blood sample 12. The mixing chamber 36 provides dispersive mixing of the sample stabilizer 39 within the sample 12 such that an approximately equal amount and / or concentration of the sample stabilizer 39 is dissolved throughout the blood sample 12. For example, an approximately equal amount and / or concentration of the sample stabilizer 39 is dissolved in the blood sample 12 from the front to the back of the blood sample 12.

[0059] 1-20, in one embodiment, the arterial blood module 16 includes a needle 32 extending from a first end 46 of the housing 30. In an exemplary embodiment, the needle 32 includes thin walled needle technology. For example, the thin walled needle technology of the present disclosure provides a small gauge needle while maintaining a high flow rate resulting in fast fill times and reduced patient exposure to uncomfortable procedures.

[0060] 1-20 , in one embodiment, the arterial blood module 16 includes a safety cap 34 that is removably securable over the needle 32. The safety cap 34 ensures that the needle 32 is fully covered and shielded before any collection procedure is initiated. Prior to using the arterial blood module 16, a user may remove the safety cap 34 from the arterial blood module 16.

[0061] 1-20, in one embodiment, the arterial blood module 16 includes a safety shield 38 that engages a portion of the housing 30 and is transitionable from a first shielded position (FIG. 3) in which a portion of the needle 32 is exposed to a second shielded position (FIGS. 14, 16, and 18) in which a portion of the needle 32 is shielded by a portion of the safety shield 38.

[0062] Advantageously, the safety shield 38 of the arterial blood module 16 of the present disclosure allows for automatic shielding of the needle 32 after use. For example, in one exemplary embodiment, the safety shield 38 includes a shield assembly 50 and an actuator 52 that is transitionable from a first actuator position (FIGS. 13, 15, and 17) in which the actuator 52 engages a portion of the shield assembly 50 to lock the shield assembly 50 in the first shield position (FIG. 3) to a second actuator position (FIGS. 14, 16, and 18) in which the actuator 52 releases the shield assembly 50 and the safety shield 38 automatically moves to the second shield position (FIGS. 14, 16, and 18). In one exemplary embodiment, the actuator 52 comprises a push button. In this manner, the integrated push button safety shield 38 of the present disclosure provides a device that does not obscure the medical practitioner's view during the procedure while still being able to be actuated solely by simply pressing a button after the collection procedure is completed. In this manner, the safety shield 38 of the arterial blood module 16 of the present disclosure allows for automatic shielding of the needle 32 after use. For example, in one exemplary embodiment, upon actuation of the actuator 52 of the safety shield 38, the spring 59 exerts a force on a portion of the shield assembly 50 to automatically move the safety shield 38 to a second shielded position in which the needle 32 is shielded by a portion of the safety shield 38.

[0063] 13-18, in an exemplary embodiment, the shield assembly 50 includes a telescoping shield. For example, with reference to FIGS. 13-14, in one exemplary embodiment, the shield assembly 50 includes a fixed outer shield 54, an intermediate movable shield 56 in communication with the fixed outer shield 54, which moves relative to the fixed outer shield 54, and an inner movable shield 58 in communication with the intermediate movable shield 56, which moves relative to the intermediate movable shield 56.

[0064] Referring to FIG. 13, in one embodiment, with the safety shield 38 in the first shielding position, the inner movable shield 58 is nested inside the intermediate movable shield 56, which is nested inside the fixed outer shield 54.

[0065] 14, in one embodiment, with the safety shield 38 in the second shielding position, the inner movable shield 58 extends from the middle movable shield 56, which in turn extends from the fixed outer shield 54.

[0066] In one exemplary embodiment, upon actuation of the actuator 52 of the safety shield 38, the spring 59 exerts a force on a portion of the shield assembly 50 to automatically move the safety shield 38 to the second shielding position where the needle 32 is shielded by a portion of the safety shield 38. For example, with reference to FIG. 13, in the first position, the spring 59 is disposed within the inner shield 58 in a compressed position. With reference to FIG. 14, upon actuation of the actuator 52 of the safety shield 38, the spring 59 exerts a stored force on a portion of the inner shield 58 to automatically move the telescoping shields 54, 56, 58 to the second shielding position where the needle 32 is shielded by a portion of the shield assembly 50.

[0067] 15-18 show other exemplary embodiments. The embodiment shown in FIGS. 15-16 includes similar components to the embodiment shown in FIGS. 13-14, where the similar components are designated with the letter A after the reference number. The embodiment shown in FIGS. 17-18 also includes similar components to the embodiment shown in FIGS. 13-14, where the similar components are designated with the letter B after the reference number. For brevity, these similar components and similar steps of using the arterial blood module 16A (FIGS. 15-16) and the arterial blood module 16B (FIGS. 17-18) will not be described in full in conjunction with the embodiment shown in FIGS. 15-16 and 17-18. Advantageously, the arterial blood module 16 of the present disclosure allows for an integrated venting system that allows for the removal of trapped air bubbles by simply venting into a vent compartment within the arterial blood module 16. For example, in one exemplary embodiment, the arterial blood module 16 includes a vent chamber 60, a vent plug 62, a first valve 64, and a second valve 66.

[0068] In one embodiment, the housing 30 of the arterial blood module 16 defines a vent chamber 60. In an exemplary embodiment, the arterial blood module 16 includes a vent plug 62 that allows air to pass therethrough and prevents blood sample 12 from passing therethrough, with a portion of the vent plug 62 in communication with the vent chamber 60. In this manner, any air bubbles contained within the arterial blood collecting element 14 may be vented from outside the system 10 via the vent chamber 60 and out the vent plug 62. The structure of the arterial blood module 16, vent chamber 60, and vent plug 62 allows air to pass through the arterial blood module 16 while preventing blood sample 12 from passing therethrough, and may include a hydrophobic filter.

[0069] 10-12, in one embodiment, the arterial blood module 16 includes a first valve 64. In an exemplary embodiment, with the arterial blood module 16 connected to the arterial blood collecting element 14, the blood sample 12 enters the collection chamber 20 of the arterial blood collecting element 14 via the needle 32 and the first valve 64. The first valve 64 allows the blood sample 12 to pass from the arterial blood module 16 to the collection chamber 20 of the arterial blood collecting element 14. The first valve 64 blocks the blood sample 12 from the collection chamber 20 of the arterial blood collecting element 14 from returning to the arterial blood module 16. In one embodiment, the first valve 64 is a one-way valve.

[0070] In one embodiment, the arterial blood module 16 includes a second valve 66. In an exemplary embodiment, with the arterial blood module 16 connected to the arterial blood collecting element 14, air contained in the collection chamber 20 of the arterial blood collecting element 14 and a portion of the blood sample 12 enter the vent chamber 60 via the second valve 66. In one embodiment, the second valve 66 is a one-way valve.

[0071] Advantageously, the arterial blood module 16 of the present disclosure provides an ergonomic design with designated touch points to facilitate accurate and easy handling of the arterial blood module 16 during a collection procedure. For example, in one exemplary embodiment, and with reference to Figures 1-20, the arterial blood module 16 includes a first finger grip portion 90. In another exemplary embodiment, the arterial blood module 16 includes a second finger grip portion 92, with the first finger grip portion 90 disposed opposite the second finger grip portion 92.

[0072] 5-9, the use of the arterial blood collection system 10 of the present disclosure, having an arterial blood module 16 and an arterial blood collection element 14, will now be described.

[0073] 5, the safety cap 34 ensures that the needle 32 of the arterial blood module 16 is completely covered and shielded before any collection procedure is initiated. Prior to using the arterial blood module 16, a user can remove the safety cap 34 by pulling the safety cap 34 away from the arterial blood module 16, as shown in FIG.

[0074] 6, the needle 32 of the system 10 is inserted into the patient's artery 70. The arterial blood collection element 14 of the arterial blood sampling system 10 self-fills due to the arterial blood pressure and the vented arterial blood gas syringe stopper, as described above. The arterial blood sample 12 is automatically mixed with the sample stabilizer 39 as the blood sample 12 automatically moves from the patient's artery 70 through the arterial blood module 16 to the collection chamber 20 of the arterial blood collection element 14, as described above.

[0075] 7, the needle 32 is then removed from the patient's artery 70 and the safety shield 38 is actuated by pressing the actuator 52 which automatically shields the needle 32 with the safety shield 38. In this manner, the safety shield 38 is locked in a shielding position safely covering the needle 32 for safe handling and disposal of the arterial blood module 16.

[0076] 8, the arterial blood collection system 10 is oriented vertically with the safety shielded needle 32 in an upright configuration. The user can then press the plunger rod 26 of the arterial blood collection element 14 to expel trapped air bubbles from the collection chamber 20 of the arterial blood collection element 14 and out of the arterial blood module 16 via the vent chamber 60 and vent plug 62, as described above.

[0077] 9, the arterial blood module 16 is detached from the arterial blood collection element 14. In this manner, the arterial blood module 16 can be safely disposed of, and the arterial blood collection element 14 can be coupled to an arterial blood gas analysis instrument 80 for sample transfer and analysis.

[0078] The present disclosure provides an arterial blood module removably connectable to an arterial blood collection element. The arterial blood module includes a housing, a needle, a cap removably securable over the needle, a mixing chamber, and a safety shield that engages a portion of the housing and is transitionable from a first shielded position in which a portion of the needle is exposed to a second shielded position in which the needle is shielded by a portion of the safety shield. In one embodiment, the present disclosure includes an arterial blood collection system including an arterial blood collection element defining a collection chamber and an arterial blood module removably connectable to a portion of the arterial blood collection element.

[0079] In an exemplary embodiment, the arterial blood collection system of the present disclosure provides a novel blood draw device for collecting arterial blood samples using radial stick technology. The system of the present disclosure provides an efficient system that streamlines and reduces the number of workflow steps, allowing for one-handed device operation that allows for a more efficient arterial blood gas (ABG) collection procedure. The arterial blood module of the present disclosure optionally includes ergonomic touch points, a push button safety shield, automatic anticoagulant mixing, and an integrated vent cap to evacuate air bubbles after the collection procedure.

[0080] In an exemplary embodiment, the arterial blood module 16 of the present disclosure includes an open cell foam material 40. In other exemplary embodiments, the arterial blood collection element 14 may include an open cell foam material 40.

[0081] 21-24, an arterial blood module 100 according to an embodiment of the present disclosure is shown. The arterial blood module 100 includes a hub body 102 having a proximal coupling interface 104 configured to removably couple the arterial blood module 100 to an arterial blood collection element, such as, for example, the arterial blood collection element 14 described above. The arterial blood module 100 also includes a safety shield 108, which may be selectively deployed by a user to cover the needle 110. As described in further detail below, deployment of the safety shield 108 is initiated by an actuator 106 housed within the hub body 102.

[0082] 22 illustrates the arterial blood module 100 in a first configuration, with the safety shield 108 in an undeployed position such that the needle 110 is at least partially exposed. In this first configuration, the safety shield 108 may be releasably secured to the hub body 102 via an interface between the protruding portion 109 of the hub body 102 and a detent portion 116 of the safety shield 108. A proximal portion of the safety shield 108, including the detent portion 116, is configured to be received within a slot 112 of the hub body 102. The slot 112 is in communication with an actuator bore 107 formed in the hub body 102, and the actuator 106 is slidable within the actuator bore 107 in a direction substantially transverse to the direction of the slot 112, and thus substantially transverse to the direction of deployment of the safety shield 108. Thus, when the actuator 106 is depressed, the base portion of the actuator 106 contacts the proximal portion of the safety shield 108, disengaging the detent portion 116 of the safety shield 108 from the protruding portion 109 of the hub body 102 such that the safety shield 108 is telescopically deployed over the needle 110 by the spring force applied by the spring 118, as shown in FIG. 23.

[0083] 22, when the safety shield 108 is in the undeployed position (i.e., when the needle 110 is exposed), the arterial blood module 100 is configured to provide a fluid path between the needle 100 and an opening 105 in communication with the proximal coupling interface 104. More specifically, the arterial blood module 100 includes a needle assembly body 115 coupled to the needle 100, the needle assembly body 115 having a flow channel 113 therethrough, the flow channel 113 in fluid communication with the needle 110. Although not shown, the flow channel 113 may be in communication with, for example, a sample stabilizing agent. In this configuration, a blood sample may flow through the needle 110, the flow channel 113, and around the actuator 106 to the opening 105, where the sample may be drawn, for example, into an arterial blood collection element coupled to the proximal coupling interface 104.

[0084] Conversely, when the actuator 106 is depressed to deploy the safety shield 108 (as shown in FIG. 23 ), the fluid path between the opening 105 and the flow channel 113 is also severed, thereby stopping fluid flow between the needle 110 and the opening 105. More specifically, depression of the actuator 106 in the actuator bore 107 aligns an orifice 120 formed in the actuator 106 with the opening 105. The orifice 120 is in fluid communication with a vent chamber 122 formed in the actuator 106. The actuator 106 may also include a vent plug in communication with the vent chamber 122 that allows air to pass therethrough while preventing a blood sample from passing therethrough. In some embodiments, the vent plug may include a hydrophobic filter. In this manner, any air bubbles contained within the arterial blood collection element coupled to the arterial blood module 100 may be vented outside the system via the vent chamber 122 and out of a vent plug formed as part of the actuator 106.

[0085] 24, the arterial blood module 100 is also configured such that the needle assembly body 115, safety shield 108, and needle 110 are removably coupled to the hub body 102. For example, the needle assembly body 115 may include a threaded interface 114 that can mate with a corresponding threaded interface on the hub body 102. In this manner, the needle assembly body 115, safety shield 108, and needle 110 may be removed together after use and discarded in an appropriate sharps container, while the hub body 102 may remain coupled to the arterial blood collection element for evacuation of air bubbles, transport, etc.

[0086] However, although the needle assembly body 115, safety shield 108, and needle 110 are removably coupled to the hub body 102, removal of these components from the hub body 102 is prevented when the safety shield 108 is in the undeployed position (i.e., when the needle 110 is not protected by the safety shield 108). As shown in FIG. 22, the interface between the detent portion 116 of the safety shield 108 from the protruding portion 109 of the hub body 102 in the slot 112 not only retains the safety shield 108 in the undeployed position, but also acts to prevent rotation of the safety shield 108 (and thus the needle assembly body 115) relative to the hub body 102. Thus, to remove the needle assembly body 115 and needle 110 for proper disposal, the user must first deploy the safety shield 108 by depressing the actuator 106, thereby disengaging the detent portion 116 of the safety shield 108 from the protruding portion 109 of the hub body 102 and allowing rotation of the needle assembly body 115 relative to the hub body 102, as shown in FIG. 23.

[0087] 25-27, an arterial blood module 150 according to another embodiment of the present disclosure is shown. The arterial blood module 150 includes a twist-off safety shield assembly 154 removably coupled to a hub body 152, which is connectable to the arterial blood collection element 14, for example, via a threaded luer connection. The twist-off safety shield assembly 154 may also be threadably coupled to the hub body 152, but may require a rotational direction opposite to that of the interface between the hub body 152 and the arterial blood collection element 14 (e.g., left-handed threads) when the twist-off safety shield assembly 154 is removed.

[0088] 26 and 27, the safety shield assembly 154 includes a retractable safety shield, a needle 155, and a spring 156 for biasing each of the members of the retractable safety shield toward a deployed position, as shown in FIG 27. The retractable safety shield may be deployed by any suitable method, such as a push button, a twist, etc. Additionally, an interface portion 157 is provided at a distal end of the safety shield assembly 154, the interface portion 157 configured to removably engage the hub body 152 and provide a fluid communication path between the hub body 152 and the needle 155.

[0089] The hub body 152 includes a first check valve 162, a second check valve 160, and a vent chamber 158. The vent chamber 158 may also include a vent plug in communication with the vent chamber 158 that allows air to pass therethrough while preventing the blood sample from passing therethrough. In some embodiments, the vent plug may include a hydrophobic filter.

[0090] As shown in Fig. 26, when the safety shield assembly 154 is coupled to the hub body 152, the needle 155 is fluidly coupled to the arterial blood collection element 14 and the first check valve 162 is opened to allow fluid to pass therethrough. However, as shown in Fig. 27, when the safety shield assembly 154 is removed from the hub body 152, the first check valve 162 may be closed to prevent blood leakage and minimize air exposure. The safety shield assembly 154 may then be discarded in an appropriate sharps container.

[0091] 27, a plunger rod (not shown) of the arterial blood collecting element 14 can be depressed to expel any air bubbles contained within the arterial blood collecting element 14 through a second check valve 160 and into a vent chamber 158, which is also sized and configured to retain a small amount of clotted blood sample from near the luer tip. As mentioned above, the first check valve 162 is substantially sealed when the safety shield assembly 154 is removed to prevent blood leakage and minimize air exposure.

[0092] By allowing the safety shield assembly 154 to be easily removed from the hub body 152, the needle 155 may be removed prior to transport and sample analysis, thereby minimizing the risk of needle stick injury and / or improper disposal. Additionally, removal of the safety shield assembly 154 also reduces the overall size of the device, which may be beneficial during transport and analysis.

[0093] 28 and 29, an arterial blood module 170 according to another embodiment of the present disclosure is shown. Similar to the arterial blood module 150 described above with respect to FIGS. 25-27, the arterial blood module 170 includes a twist-off safety shield assembly 174 removably coupled to a hub body 172, which is connectable to an arterial blood collection element (not shown), for example, by a threaded luer connection. The twist-off safety shield assembly 174 may also be threadably coupled to the hub body 172, although removal of the twist-off safety shield assembly 174 may require a rotational direction opposite to the interface between the hub body 172 and the arterial blood collection element (e.g., left-handed threads).

[0094] As partially shown in FIGS. 28 and 29 , the safety shield assembly 174 includes a retractable safety shield, a needle 175, and a spring 176 for biasing each of the members of the retractable safety shield toward a deployed position. The retractable safety shield may be deployed by any suitable method, such as a push button, a twist, or the like. Additionally, an interface portion 177 is provided at a distal end of the safety shield assembly 174, the interface portion 177 configured to removably engage the hub body 172 and provide a fluid communication path between the hub body 172 and the needle 175. The interface portion 177 further includes a distal projection 186 that is dimensioned and configured to extend into (and partially beyond) an opening 188 formed in the hub body 172 when the safety shield assembly 174 is coupled to the hub body 172. The distal projection 186 is configured to provide a fluid path between the needle 175 and the hub body 172.

[0095] Hub body 172 also includes a normally closed ball valve 182 that is biased to a normally closed position by a spring 184. As shown in FIG. 28 , when safety shield assembly 174 is coupled to hub body 172, distal projection 186 acts against spring 184, thereby opening ball valve 182 and allowing blood to flow from needle 175 into hub body 172. However, when safety shield assembly 174 is removed from hub body 172, distal projection 186 no longer acts against spring 184, allowing spring 184 to close ball valve 182, thereby blocking blood flow from opening 188 in hub body 172.

[0096] 28 and 29, the hub body 172 further includes a check valve 180 and a vent chamber 178. The vent chamber 178 may also include a vent plug in communication with the vent chamber 178 that allows air to pass therethrough while preventing the blood sample from passing therethrough. In some embodiments, the vent plug may include a hydrophobic filter. As shown in FIG. 29, when the safety shield assembly 174 is removed from the hub body 172, the ball valve 182 is closed to prevent blood leakage and minimize air exposure. Additionally, a plunger rod (not shown) of the arterial blood collection element may be depressed to expel air bubbles contained within the arterial blood collection element through the check valve 180 and into the vent chamber 178, which is also sized and configured to retain a small amount of clotted blood sample from near the luer tip.

[0097] 30-36, an arterial blood gas syringe assembly 200 and associated components are shown in accordance with another embodiment of the present disclosure. As shown in FIG 30, arterial blood gas syringe assembly 200 includes a syringe body 216, a concave plunger stopper 214, and a vented plunger 212. The distal end of syringe body 216 is configured to have, for example, a Luer connector.

[0098] Coupled to the distal end of syringe body 216 is arterial blood module 202, which includes integral mixing portion 206 and safety shield 208, as well as vent cap portion 204. Vent cap portion 204 is configured to be removably coupleable to syringe body 216, e.g., via a Luer connection, while integral mixing portion 206 and safety shield 208 are configured to be removably coupleable to vent cap portion 204.

[0099] 31, the mixing portion 206 includes a needle 210 extending distally therefrom with filters 218, 220 disposed within the mixing chamber. Although not shown, it should be understood that a sample stabilizing agent may be provided within the mixing chamber of the mixing portion 206. The safety shield 208 is configured to be coupled to the mixing portion 206 and may be telescopically deployed by any suitable method, such as, for example, a push button, a twist, etc. The vent cap portion 204 includes a one-way valve 222, a vent chamber 224, and a proximal coupling portion 226, which is configured to allow the vent cap portion 204 to be attached to the syringe body 216. The vent chamber 224 may also include a vent plug in communication with the vent chamber 224 that allows air to pass therethrough while preventing the blood sample from passing therethrough. In some embodiments, the vent plug or filter may include a hydrophobic filter.

[0100] 32-36, steps of use of an arterial blood gas syringe assembly 200 according to an embodiment of the present disclosure are shown. First, as shown in FIG. 32, when the safety shield 208 is in an undeployed position, blood is drawn into the syringe body 216 via, for example, arterial pressure, through the needle 210. The blood sample passes through the mixing portion 206 and one-way valve 222 of the vent cap portion 204 to provide a stabilized blood sample within the syringe body 216. Next, as shown in FIG. 33, the safety shield 208 is deployed to substantially cover the needle 210. As shown in FIG. 34, with the needle 210 protected by the safety shield 208, the integrated mixing portion 206, safety shield 208, and needle 210 are removed together from the vent cap portion 204, allowing the mixing portion 206, safety shield 208, and needle 210 to be placed in an appropriate sharps container.

[0101] Next, with reference to FIG. 35, the syringe body 216 can be held in an upright position, allowing any air bubbles in the sample to rise toward the distal end, and the plunger rod 212 (shown in FIG. 30) can be depressed to move the recessed plunger stopper 214 distally, thereby expelling the air bubbles and a small amount of clotted blood sample into the vent chamber 224 of the vent cap portion 204. The one-way valve 222 of the vent cap portion 204 substantially prevents leakage of blood from the vent cap portion 204 during this venting step. Finally, with reference to FIG. 36, the vent cap portion 204 containing the clotted blood sample and / or air bubbles can be removed from the syringe body 216 and discarded in an appropriate container, and the remaining blood sample in the syringe body 216 can be delivered for analysis.

[0102] 37-40, an arterial blood module 250 according to another embodiment of the present disclosure is shown. As shown in FIG. 37, the arterial blood module 250 is configured to be coupled, for example, to the arterial blood collecting element 14 via a threaded luer coupling or similar interface. The arterial blood module 250 includes a body 252, a safety shield 254 (e.g., a retractable shield), and a needle 256. Further, a rotatable stopcock 260 is provided within a proximal end portion of the body 252, the rotatable stopcock 260 configured to be rotated in part by an actuator 258 disposed outside at least a portion of the body 252. As shown in FIG. 38, a proximal connector 261 is provided on the body 252, the proximal connector 261 configured to be removably coupled, for example, to a luer connector of the arterial blood collecting element 14. A passageway 262 passes through the proximal connector 261 to provide a fluid passageway between the rotatable stopcock 260 and the arterial blood collecting element 14.

[0103] 39, when the rotatable stopcock 260 is in the first configuration (i.e., actuator 258 is not depressed), a blood sample is configured to pass through channel 264 in the rotatable stopcock 260 and out of needle 256 and passageway 262 to the arterial blood collecting element 14 to collect the blood sample. However, after the desired blood sample has been collected in the arterial blood collecting element 14, actuator 258 can be depressed, thereby partially rotating rotatable stopcock 260 such that channel 264 is away from needle 256 and passageway 262, as shown in FIG. 40. Alternatively, a second opening (not shown) in rotatable stopcock 260 can be aligned with passageway 262. A user can then vertically orient the arterial blood collecting element 14 and attached arterial blood module 250 and depress the plunger rod of the arterial blood collecting element 14 to expel air bubbles and clotted bulk sample from the arterial blood collecting element 14 into a vent chamber 265 in the rotatable stopcock 260. Although not shown, it should be understood that one end of the vent chamber 265 may include a vent plug that allows air to pass therethrough until wetted, at which point the vent plug is sealed to prevent further passage of air and blood.

[0104] 42-44 next show an arterial blood module 300 according to another embodiment of the present disclosure. The arterial blood module 300 includes a safety shield assembly 304 coupled to a hub body 302, which has a proximal coupling interface 310 and is coupleable to the arterial blood collection element 14, for example, via a threaded luer coupling. The safety shield assembly 304 may include a retractable safety shield and a spring (not shown) for biasing each member of the retractable safety shield toward a deployed position, for example, as shown in FIGS. 42 and 44. Additionally, a needle 306 is provided in fluid communication with the hub body 302, and the safety shield assembly 304 is configured to selectively cover the needle 306.

[0105] The arterial blood module 300 further includes a rotary valve 315 operably coupled to the lever member 308. When the lever member 308 is in a first position (as shown in FIGS. 41 and 43 ), the rotary valve 315 is in a first configuration such that the needle 306 and the passageway 314 are in fluid communication with one another, thereby allowing a blood sample to flow from the needle 306 through the rotary valve 315 and the passageway 314 to the arterial blood collection element 14.

[0106] Conversely, when the lever member 308 is in a second position (as shown in FIGS. 42 and 44 ), the rotary valve 315 is in a second configuration such that the needle 306 and the passageway 314 are no longer in fluid communication. Rather, in the second configuration, the rotary valve 315 fluidly couples the passageway 314 to a conduit 313 that leads to a vent chamber 312 in the hub body 302. In such a configuration, a user can depress the plunger rod of the arterial blood collecting element 14 to expel air bubbles and clotted bulk sample from the arterial blood collecting element 14 into the vent chamber 312. Although not shown, it should be understood that one end of the vent chamber 312 may include a vent plug that allows air to pass therethrough until wetted, at which point the vent plug is sealed to prevent further passage of air and blood.

[0107] Additionally, the arterial blood module 300 may include a latch member 309 pivotally coupled to the hub body 302. The latch member 309 may be configured to selectively retain and release the safety shield assembly 304 based on the position of the lever member 308. That is, when the lever member 308 is in a first position (as shown in FIGS. 41 and 43), the lever member 308 does not contact any portion of the latch member 309, thereby allowing the latch member 309 to retain the safety shield assembly 304 in a non-deployed position adjacent the tab portion 311 of the hub body 302 such that the needle 306 remains exposed. However, the lever member 308 is then moved to a second position (as shown in FIGS. 42 and 44), where a portion of the lever member 308 contacts the latch member 309, causing the latch member 309 to pivot to release the safety shield assembly 304 to the deployed position, thus substantially covering the needle 306.

[0108] 45-51, an arterial blood module 350 according to another embodiment of the present disclosure is shown. The arterial blood module 350 includes a safety shield assembly 354 coupled to a hub body 352 having a proximal coupling interface 353 and is coupleable to the arterial blood collection element 14 via, for example, a threaded luer coupling. The safety shield assembly 354 may include a retractable safety shield and a spring 355 for biasing each member of the retractable safety shield toward a deployed position, for example, as shown in FIGS. 45 and 47. Additionally, a needle 356 is provided in selective fluid communication with the hub body 352, and the safety shield assembly 354 is configured to selectively cover the needle 356.

[0109] The arterial blood module 350 also includes an eccentric needle carrier 358 having a needle carrying portion 364, a vent chamber portion 366, and a rotatable lever portion 360. As shown in FIGS. 50 and 51 , the needle carrying portion 364, the vent chamber portion 366, and the rotatable lever portion 360 are configured to rotate eccentrically about a pivot point 368 within the hub body 352. For example, in a first configuration shown in FIGS. 46, 48, and 50, the rotatable lever portion 360 is in a first position such that a first conduit 365 of the needle carrying portion 364 is in fluid communication with a fluid passageway 362 leading to the proximal coupling interface 353, thereby allowing a blood sample to pass through the needle 356, the first conduit 365, and the fluid passageway 362 and into the arterial blood collection element 14.

[0110] However, as shown in FIGS. 45, 47, 49, and 51, when the rotatable lever portion 360 is moved to the second position, the needle 356 and the first conduit 365 of the needle carrying portion 364 are moved out of fluid communication with the fluid passageway 362. Instead, the second conduit 367 is moved into fluid communication with the fluid passageway, the second conduit 367 leading to the vent chamber portion 366 of the eccentric needle carrier 360. In such a configuration, a user can depress the plunger rod of the arterial blood collecting element 14 to expel air bubbles and clotted bulk sample from the arterial blood collecting element 14 into the vent chamber of the vent chamber portion 366. Although not shown, it should be understood that one end of the vent chamber portion 366 may include a vent plug that allows air to pass therethrough until wetted, at which point the vent plug is sealed to prevent further passage of air and blood.

[0111] 47, when the needle carrying portion 364 is rotated to the second position, the needle 354 moves off-center from the opening 357 formed in the distal end of the safety shield assembly 354. Thus, rotation of the eccentric needle carrier 358 can also act to lock out retraction of the retractable needle shield assembly 354, thereby preventing exposure to the needle 356.

[0112] 52 and 53, an arterial blood module 370 is shown according to another aspect of the present disclosure. The arterial blood module 370 is substantially similar to the arterial blood module 350 described above, but incorporates active shielding functionality. Accordingly, the purpose and function of common components between the arterial blood module 370 and the arterial blood module 350 will not be repeated herein.

[0113] As shown in FIGS. 52 and 53 , at least one portion of the safety shield assembly 354 includes a hook member 372 formed at its proximal end, the hook member 372 being sized to engage a corresponding latch member 374 formed at a distal portion of the vent chamber portion 366 of the eccentric needle carrier 358. Thus, when the eccentric needle carrier 358 is in a first position (as shown in FIGS. 52 and 53 ), the safety shield assembly 354 is held in an undeployed position such that the needle 356 is exposed. However, when the eccentric needle carrier 358 is rotated to a second position (not shown), the latch member 374 disengages from the hook member 372, thereby releasing the safety shield assembly 354 such that the safety shield assembly 354 deploys to substantially cover the needle 356. In this configuration, rotation of the eccentric needle carrier 358 may act to simultaneously disconnect the needle 356 from fluid communication with the arterial blood collection element 14 and deploy the safety shield assembly 354.

[0114] 54-57, an arterial blood module 400 according to another embodiment of the present disclosure is shown. The arterial blood module 400 is configured to move from a blood draw configuration to a vent configuration via simple push button actuation.

[0115] The arterial blood module 400 includes a hub body 402 having a proximal coupling interface 404 that is configured to removably couple the arterial blood module 400 to an arterial blood collection element, such as, for example, the above-described arterial blood collection element 14. Although not shown, it should be understood that the arterial blood module 400 may also include a safety shield that may be selectively deployed by a user to cover the needle.

[0116] 54, an arterial blood module 400 is shown with a push button actuator 406 in a first position. The actuator 406 is configured to be slidable within a bore 407 of the housing 420, as shown in FIGS. 54 and 55, and the actuator 406 has a first passageway 410 and a second passageway 411 that are offset but in fluid communication with each other. In the first position, the actuator 406 is disposed such that the first passageway 410 is aligned with a first opening 413 of the hub body 402 and a central conduit 408, and the central conduit 408 is configured to be in fluid communication with a needle (not shown) of the arterial blood module 400. The first passageway 410 also has a second opening 405 formed adjacent the proximal coupling interface 404. Thus, in this first position, a blood sample can pass from the needle through the actuator 406 to an arterial blood collection element coupled to the proximal coupling interface 404.

[0117] Conversely, referring to FIG. 55, when the actuator 406 is depressed and moved to the second position, the first opening 413 is blocked, thereby blocking fluid communication with the central conduit 408 (and thus the needle). Instead, the second passageway 411 of the actuator 406 is aligned with the second opening 405, and the first passageway 410 is positioned to be in fluid communication with a third opening 414 that leads to a vent chamber 412 formed in the hub body 402. Thus, in this second position, a user can depress the plunger rod of the arterial blood collection element (not shown) to vent air bubbles and clotted bulk sample from the arterial blood collection element into the vent chamber 412. Although not shown, it should be understood that one end of the vent chamber 412 may include a vent plug that allows air to pass therethrough until wetted, at which point the vent plug is sealed to prevent further passage of air and blood.

[0118] 56 and 57, the actuator 406 may incorporate a number of O-ring type seals 424 to prevent leakage of air and / or blood from the bore 407. The seals 424 may be formed of any suitable material, such as, for example, TPE. Additionally, a plug 422 may be provided at one end of the actuator 406 to allow for simplified molding of the actuator 406 having interconnected passages formed therethrough.

[0119] 58 and 59, a gravity-based "lock valve" is shown configured to prevent blood from flowing into the chamber when the arterial blood module 450 is oriented downward (i.e., the needle 454 is oriented downward). As shown, the arterial blood module 450 includes a housing 452, a needle 454, and a safety shield 456 that is selectively deployable by a spring 458. A base 460 is also provided with the base 460 configured to allow fluid communication between the needle 454 and an arterial blood collection element coupled to the arterial blood module 450.

[0120] The arterial blood module 450 also includes a movable ball 462 movably disposed between the base 460 and a passageway 465 fluidly coupled to the needle 454. As shown in FIG. 58, when the arterial blood module 450 is held in an upright position (i.e., when the needle 454 is oriented upward), the ball 462 naturally moves away from a seat 464 adjacent the passageway 465, thereby allowing fluid to flow from the base 460 to the needle 454. However, with reference to FIG. 59, when the arterial blood module 450 is inverted so that it is held in a downward position, gravity directs the ball 462 to the seat 464, thereby preventing the passage of blood into the passageway 465 when the device is actuated to orient the needle 454 downward. However, regardless of the position of the needle 454, the safety shield 456 may be deployed to substantially cover the needle 454.

[0121] 60 and 61, a safety shield assembly 500 according to another aspect of the present disclosure is shown. The safety shield assembly 500 includes a telescoping needle shield comprising at least an outer telescoping member 502, an intermediate telescoping member 504, and an inner telescoping member 505. When selectively biased by a spring 508, the outer telescoping member 502, the intermediate telescoping member 504, and the inner telescoping member 505 act to substantially surround a needle 506 coupled to, for example, an arterial blood module.

[0122] The safety shield assembly 500 also includes an insert 510 disposed at or near the distal end of the interior portion of the inner telescoping member 505. The insert 510 includes a slot 512, as shown in FIG. 61. The slot 512 may be configured to allow the needle 506 to pass therethrough in a first configuration (as shown in FIG. 60), but then substantially closes when the needle 506 is surrounded by the safety shield assembly (as shown in FIG. 61). The insert 510 may be formed of any suitable material, such as an elastomeric or foam material.

[0123] When the safety shield is actuated to close, the insert 510 moves along the needle 506, wiping the outer surface of the needle 506 as the inner telescoping member 505 moves to its distal end. Then, once past the distal tip of the needle 506, the slot 512 in the needle 510 substantially closes, thereby preventing blood from splashing out of the safety shield assembly 500.

[0124] 62 and 63, a safety shield assembly 520 is shown according to another aspect of the present disclosure. Similar to safety shield assembly 500 described above with respect to Figures 60 and 61, safety shield assembly 520 includes a telescoping needle shield comprising at least an outer telescoping member 522, an intermediate telescoping member 524, and an inner telescoping member 525. When selectively biased by a spring 528, outer telescoping member 522, intermediate telescoping member 524, and inner telescoping member 525 act to substantially surround a needle 526 coupled to, for example, an arterial blood module.

[0125] The safety shield assembly 520 also includes an insert 530 disposed at or near the distal end of the interior portion of the inner telescoping member 525. The insert 530 may include a living hinge, allowing the insert 530 to pinch or close when pressed against the interior distal end of the inner telescoping member 525, thereby substantially sealing the distal opening 532 of the inner telescoping member 525 when the safety shield assembly 520 is fully deployed. The insert 530 may be configured to allow the needle 526 to pass therethrough in a first configuration (as shown in FIG. 62), but then substantially close when the needle 526 is surrounded by the safety shield assembly (as shown in FIG. 63). When the safety shield is actuated to close, the insert 530 moves along the needle 526 and wipes the outer surface of the needle 526 as the inner telescoping member 525 moves to its distal end. Then, once over the distal tip of needle 526, the force exerted by spring 528 on insert 530 causes the insert to pivot about the living hinge and substantially close at the distal tip of the living hinge, thereby preventing blood from splashing out of safety shield assembly 520.

[0126] 64-69, an arterial blood module 550 according to another embodiment of the present disclosure is shown. Similar to the various arterial blood modules described above, the arterial blood module 550 is configured to be coupled to an arterial blood collection element 14 having, for example, a plunger 22 and a stopper 24 for collection and distribution of a blood sample.

[0127] The arterial blood module 550 includes a hub body 552 having a proximal coupling interface 562 configured to removably couple the arterial blood module 550 to an arterial blood collection element, such as, for example, the arterial blood collection element 14 described above. The arterial blood module 550 also includes a safety shield 554, which may be selectively deployed by a user to cover a needle 556. As described in further detail below, deployment of the safety shield 554 is initiated by an actuator 560 housed within the hub body 552.

[0128] 64-66 depict the arterial blood module 550 in a first configuration, with the safety shield 554 in an undeployed position such that the needle 556 is at least partially exposed. In this first configuration, the safety shield 554 may be releasably secured to the hub body 552 via an interface between a protruding portion 557 of the hub body 552 and a detent portion 555 of the safety shield 554, as shown in FIG. 68. A proximal portion of the safety shield 554, including the detent portion 555, is configured to be received within a slot 563 of the hub body 552. The slot 563 is in communication with an actuator bore 559 formed in the hub body 552, such that the actuator 560 is slidable within the actuator bore 559 in a direction substantially transverse to the direction of the slot 563 and, therefore, substantially transverse to the direction of deployment of the safety shield 554. Thus, when the actuator 560 is depressed, the base portion 565 of the actuator 560 contacts the proximal portion of the safety shield 554 and disengages the detent portion 555 of the safety shield 554 from the protruding portion 557 of the hub body 552 such that the safety shield 554 is telescopically deployed over the needle 556 by the spring force applied by the spring 558, as shown in FIG. 67.

[0129] Referring again to FIG. 68, when the safety shield 554 is in the undeployed position (i.e., when the needle 556 is exposed), the arterial blood module 550 is configured to provide a fluid path between the needle 556 and an opening 568 in communication with the proximal coupling interface 562. More specifically, the arterial blood module 550 includes a flow channel 570 passing through the hub body 552, the flow channel 570 in fluid communication with the needle 556. Although not shown, the flow channel 570 may be in communication with, for example, a sample stabilizer within a portion of the hub body 552. In this configuration, a blood sample may flow through the needle 556, the flow channel 570, and around the actuator 560 to the opening 568, where the sample may be drawn into, for example, an arterial blood collection element coupled to the proximal coupling interface 562. A radial seal provided circumferentially around the actuator 560 may act to provide a fluid-tight channel between the flow channel 570 and the opening 568.

[0130] Conversely, referring to FIG. 69, when the actuator 560 is depressed to deploy the safety shield 554, the fluid path between the opening 568 and the flow channel 570 is also severed, thereby stopping fluid flow between the needle 556 and the opening 568. More specifically, depression of the actuator 560 in the actuator bore 559 aligns an orifice 566 formed in the actuator 560 with the opening 568. The orifice 566 is in fluid communication with a vent chamber 561 formed in the actuator 560. The actuator 560 may also include a vent plug in communication with the vent chamber 561 that allows air to pass therethrough while preventing a blood sample from passing therethrough. In some embodiments, the vent plug may include a hydrophobic filter. In this manner, any air bubbles contained within the arterial blood collection element coupled to the arterial blood module 550 may be vented outside the system via the vent chamber 561 and out of a vent plug formed as part of the actuator 560.

[0131] Although not specifically shown, it is understood that hub body 552 and safety shield 554 may be configured such that, upon deployment, safety shield 554 is substantially locked in place, thereby preventing undesired or unintended exposure of needle 556. The entire arterial blood module 550 may be separated from arterial blood collection element 14 following the blood draw and bubble evacuation procedure, and the entire arterial blood module 550 may be placed in an appropriate sharps container.

[0132] 70-77, various embodiments of an arterial blood module 600 are shown according to another embodiment of the present disclosure. Similar to the arterial blood modules described above, the arterial blood module 600 is configured to be coupled to an arterial blood collection element 14 having a plunger 22 and a stopper 24 for collection and distribution of a blood sample, as shown, for example, in FIG.

[0133] The arterial blood module 600 includes a hub body 602 having a proximal coupling interface 611 configured to removably couple the arterial blood module 600 to an arterial blood collection element, such as, for example, the arterial blood collection element 14 described above. The arterial blood module 600 also includes a safety shield 604, which can be selectively deployed by a user to cover the needle 606. As described in further detail below, deployment of the safety shield 604 is initiated by an actuator 610 housed within the hub body 602.

[0134] 70-72 show the arterial blood module 600 in a first configuration, with the safety shield 604 in an undeployed position such that the needle 606 is at least partially exposed. In this first configuration, the safety shield 604 may be releasably secured to the hub body 602 via an interface between a protruding portion 625 of the hub body 602 and a detent portion 621 of the safety shield 604, as shown in FIG. 74. A proximal portion of the safety shield 604, including the detent portion 621, is configured to be received within a slot 613 of the hub body 602. The slot 613 is in communication with an actuator bore 609 formed in the hub body 602, and the actuator 610 is slidable within the actuator bore 609 in a direction substantially transverse to the direction of the slot 613, and thus substantially transverse to the direction of deployment of the safety shield 604. Thus, when the actuator 610 is depressed, the base portion 616 of the actuator 610 contacts the proximal portion of the safety shield 604 and disengages the detent portion 621 of the safety shield 604 from the protruding portion 625 of the hub body 602 such that the safety shield 604 is telescopically deployed over the needle 606 by the spring force applied by the spring 608, as shown in FIG. 73.

[0135] As shown in FIG. 74, when the safety shield 604 is in a non-deployed position (i.e., when the needle 606 is exposed), the arterial blood module 600 is configured to provide a fluid path between the needle 606 and the opening 620 in communication with the proximal coupling interface 611. More specifically, the arterial blood module 600 includes a flow channel 625 passing through the hub body 602, the flow channel 625 in fluid communication with the needle 606. Although not shown, the flow channel 625 may be in communication with, for example, a sample stabilizer within a portion of the hub body 602. In this configuration, a blood sample may flow through the needle 606, through the flow channel 625, through a first channel 622 formed through the actuator 610, through the opening 620, and the sample may be drawn into, for example, an arterial blood collection element coupled to the proximal coupling interface 611.

[0136] However, referring to FIG. 75, when the actuator 610 is depressed to deploy the safety shield 604, the first channel 622 is fluidly isolated from the opening 620 and the flow channel 625, thereby preventing fluid flow between the needle 606 and the opening 620. Instead, depression of the actuator 610 in the actuator bore 609 aligns a substantially L-shaped second channel 623 formed in the actuator 560 with the opening 620. The second channel 623 is in fluid communication with a secondary opening 624 that is fluidly coupled to a vent chamber 612 formed in the hub body 602. As shown in FIGS. 71-73, a vent plug 614 is provided in communication with the vent chamber 612 to prevent the blood sample from passing therethrough while allowing air to pass therethrough until completely wetted. In some embodiments, the vent plug 614 may include a hydrophobic filter. In this manner, any air bubbles contained within the arterial blood collection element coupled to the arterial blood module 600 can be vented out of the system via the vent chamber 612 integrally formed within the hub body 602 and out the vent plug 614.

[0137] Although not specifically shown, it is understood that the hub body 602 and safety shield 604 may be configured such that, upon deployment, the safety shield 604 is substantially locked in place, thereby preventing undesired or unintended exposure of the needle 606. The entire arterial blood module 600 may be separated from the arterial blood collection element 14 following the blood draw and bubble evacuation procedure, and the entire arterial blood module 600 may be placed in an appropriate sharps container.

[0138] 78-84, an arterial blood module 650 according to another embodiment of the present disclosure is shown. Similar to the arterial blood modules described above, the arterial blood module 650 is configured to be coupled to an arterial blood collection element 14 having a plunger 22 and a stopper 24 for collection and distribution of a blood sample, for example, as shown in FIG.

[0139] The arterial blood module 650 includes a hub body 652 having a proximal coupling interface 661 configured to removably couple the arterial blood module 650 to an arterial blood collection element, such as, for example, the arterial blood collection element 14 described above. The arterial blood module 650 also includes a safety shield 654, which may be selectively deployed by a user to cover a needle 656. As described in further detail below, deployment of the safety shield 654 is initiated by rotation of a stopcock valve 664 that is at least partially contained within the hub body 652.

[0140] 78-82 show the arterial blood module 650 in a first configuration, with the safety shield 654 in an undeployed position such that the needle 656 is at least partially exposed. In this first configuration, the safety shield 654 may be releasably secured to the hub body 652 via an interface between the lever actuator 660 and at least one of the stopcock valves 664 to which the lever actuator 660 is coupled. When the lever actuator 660 is actuated to rotate the stopcock valve 664, the safety shield 654 may also be released to telescopically deploy the safety shield 654 over the needle 656 via a spring force applied by the spring 658, as shown in FIG.

[0141] 82, when safety shield 654 is in a non-deployed position (i.e., needle 656 is exposed), arterial blood module 650 is configured to provide a fluid pathway between needle 656 and opening 672 in communication with proximal coupling interface 661. More specifically, arterial blood module 650 includes a flow channel 674 passing through hub body 652, flow channel 674 in fluid communication with needle 656. Although not shown, flow channel 674 may be in communication with, for example, a sample stabilizer within a portion of hub body 652. In this configuration, lever actuator 660 and stopcock valve 664 are in a first position such that a blood sample can flow through needle 656, through flow channel 674, through a first channel 675 formed through stopcock valve 664, through opening 672, and the sample may be drawn, for example, into an arterial blood collection element coupled to proximal coupling interface 661.

[0142] Conversely, referring to FIG. 83, when the lever actuator 660 is pressed to provide, for example, a 90° rotation of the stopcock valve 664, not only may the safety shield 654 be deployed, but the first channel 675 may be fluidly isolated from the flow channel 674, thereby preventing fluid flow between the needle 656 and the opening 672. Instead, the rotation of the stopcock valve 664 aligns the secondary channel 676 formed in the stopcock valve 664 with the opening 672, while aligning the first channel 675 with the secondary opening 670. The secondary opening 670 is fluidly coupled to the vent chamber 662 formed in the hub body 652. As shown in FIGS. 79-86, a vent plug 665 is provided in communication with the vent chamber 662 to prevent the blood sample from passing therethrough while allowing air to pass therethrough until completely wetted. In some embodiments, the vent plug 665 may include a hydrophobic filter. In this manner, any air bubbles contained within the arterial blood collection element coupled to the arterial blood module 650 can be vented out of the system through the vent chamber 662 and vent plug 614 integrally formed within the hub body 602, and the vent chamber 662 can retain a small amount of clotted blood sample therein.

[0143] Although not specifically shown, it is understood that the hub body 652 and the safety shield 654 may be configured such that, upon deployment, the safety shield 654 is substantially locked in place, thereby preventing undesired or unintended exposure of the needle 656. The entire arterial blood module 650 may be separated from the arterial blood collection element 14 following the blood draw and bubble evacuation procedure, and the entire arterial blood module 650 may be placed in an appropriate sharps container.

[0144] While the present disclosure has been described as having an exemplary structure, the disclosure can be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which the disclosure pertains and fall within the scope of the appended claims.

Claims

1. 1. An arterial blood collection system comprising: an arterial blood collection element defining a collection chamber; an arterial blood module removably connectable to a portion of the arterial blood collecting element, the arterial blood module comprising: The hub body, a needle extending from the hub body; a safety shield that engages a portion of the hub body and is transitionable from a first shielding position in which a portion of the needle is exposed to a second shielding position in which a portion of the safety shield shields the needle; a vent chamber in fluid communication with the hub body to vent air bubbles from the collected blood sample in the collection chamber; 1. An arterial blood collection system comprising:

2. 2. The arterial blood collection system of claim 1, wherein the arterial blood module further includes an actuator transitionable from a first actuator position to a second actuator position, the second actuator position releasing the safety shield to the second shield position.

3. The arterial blood collection system of claim 2 , wherein the actuator comprises a push button.

4. The arterial blood collection system of claim 2 , wherein the safety shield comprises a telescoping shield.

5. The arterial blood collection system of claim 2 , wherein the vent chamber is formed within the actuator.

6. The arterial blood collection system of claim 1 , wherein the hub body of the arterial blood module defines the vent chamber.

7. 2. The arterial blood collection system of claim 1, wherein the arterial blood module further comprises a vent plug that allows air to pass therethrough and prevents a blood sample from passing therethrough, a portion of the vent plug in communication with the vent chamber.

8. The arterial blood collection system of claim 1 , wherein the needle and the safety shield are selectively removable from the hub body.

9. 9. The arterial blood collection system of claim 8, wherein the needle and the safety shield are removable from the hub body only when the safety shield is in the second shielding position.

10. The arterial blood collection system of claim 1 , wherein the actuator includes an actuator lever and a stopcock valve.

11. 2. The arterial blood collection system of claim 1, wherein the arterial blood module further includes an eccentric needle carrier having a needle carrying portion coupled to the needle and in fluid communication with the needle, a vent chamber portion, and a rotatable lever portion.

12. 2. The arterial blood collection system of claim 1, further comprising an insert disposed at a distal end of an inner portion of the safety shield to seal an opening in the safety shield when the needle is in the second shielded position shielded by a portion of the safety shield.

13. An arterial blood module, comprising: The hub body, a needle extending from the hub body; a safety shield that engages a portion of the hub body and is transitionable from a first shielding position in which a portion of the needle is exposed to a second shielding position in which a portion of the safety shield shields the needle; a vent chamber in fluid communication with the hub body to vent air bubbles from the collected blood sample in the collection chamber.

14. The arterial blood module of claim 13 , wherein the arterial blood module is removably connectable to a portion of an arterial blood collecting element.

15. The arterial blood module of claim 14 , wherein the arterial blood module is connectable to a portion of the arterial blood collection element via a threaded luer connection.

16. The arterial blood module of claim 13 , further comprising an actuator transitionable from a first actuator position to a second actuator position, the second actuator position releasing the safety shield to the second shield position.

17. The arterial blood module of claim 16 , wherein the vent chamber is formed within the actuator.

18. The arterial blood module of claim 16 , wherein the actuator comprises a push button.

19. The arterial blood module of claim 16 , wherein the actuator includes an actuator lever and a stopcock valve.

20. The arterial blood module of claim 13 , wherein the hub body of the arterial blood module defines the vent chamber.

21. 14. The arterial blood module of claim 13, further comprising a vent plug that allows air to pass therethrough and prevents the blood sample from passing therethrough, a portion of the vent plug in communication with the vent chamber.

Images