Arterial blood gas injector

Abstract

An arterial blood module includes an arterial blood sampling element defining a collection chamber, and an arterial blood module removably connectable to a portion of the arterial blood sampling element. The arterial blood module includes a hub, a needle extending from the hub, and a safety shield engaged with a portion of the hub and switchable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield. The arterial blood module also includes an exhaust chamber where the exhaust is in fluid communication with the hub body to expel bubbles from a collected blood sample within the collection chamber of the arterial blood sampling element.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 328,960, filed on April 8, 2022, and entitled “Arterial Blood Gas Syringe,” the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] Background of the Invention Technical Field

[0004] The present disclosure relates generally to arterial blood sampling systems.

[0005] More particularly, the present disclosure relates to an arterial blood sampling system including an arterial blood sampling element suitable for radial artery puncture and an arterial blood module.

[0006] Description of Related Technology

[0007] Arterial blood sampling syringes are used to extract and collect arterial blood samples from patients. Once the blood sample is collected, it is subjected to diagnostic analysis, primarily for blood gases, and often also for electrolytes, metabolites, and other elements indicative of the patient's condition. Various types of syringes have been designed to collect arterial blood samples, and these syringes primarily include elements from hypodermic syringes, i.e., a plastic or glass syringe barrel, a sealing elastomeric stopper with or without a vent, and a plunger rod.

[0008] Conventional arterial blood collection syringes typically use conventional hypodermic needles with safety shields that need to be broken off or slid over the needle after the blood collection procedure. During the blood collection procedure, such safety shields are often in sight, obscuring the doctor's field of vision during this delicate procedure.

[0009] Conventional arterial blood sampling 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.

[0010] Conventional arterial blood sampling syringes that include anticoagulants are typically loaded with the anticoagulant within the syringe, thus requiring the user to tumble or shake the collected sample to ensure adequate mixing with the anticoagulant.

[0011] Arterial blood modules that can be removably connected to an arterial blood sampling element have been contemplated. For example, U.S. Application No. 17 / 272,767, published as U.S. Application Publication No. 2021 / 0315498, which is incorporated herein by reference in its entirety, discloses an arterial blood module that can be removably connected to an arterial blood sampling element. Summary of the invention

[0012] The present disclosure provides an arterial blood module that can be detachably connected to an arterial blood sampling element. The arterial blood module includes a housing, a needle, a cap that can be detachably fixed to the needle, a mixing chamber, and a safety shield, the safety shield being engaged with a portion of the housing and being capable of switching from a first shield position to a second shield position, in which a portion of the needle is exposed and in which the needle is shielded by a portion of the safety shield. In one embodiment, the present disclosure includes an arterial blood sampling system, the arterial blood sampling system including an arterial blood sampling element and an arterial blood module, the arterial blood sampling element defining a collection chamber, the arterial blood module being detachably connected to a portion of the arterial blood sampling element. Additionally and / or alternatively, the arterial blood module according to the present disclosure may not be provided with a mixing chamber.

[0013] In an exemplary embodiment, the arterial blood sampling system of the present disclosure provides a novel blood sampling device for collecting arterial blood samples using a radial puncture technique. In other embodiments, the arterial blood sampling system according to various aspects of the present disclosure can be used to collect arterial blood samples from the brachial artery. The system of the present disclosure provides an efficient system that simplifies and reduces the number of workflow steps and enables one-handed device operation that allows more efficient arterial blood gas (ABG) collection procedures. The arterial blood module of the present disclosure includes ergonomic touch points, a push-button safety shield, automatic anticoagulant mixing, and an integrated exhaust cap for exhausting bubbles after the collection procedure (if necessary).

[0014] According to an embodiment of the present invention, an arterial blood sampling system includes an arterial blood sampling element and an arterial blood module, wherein the arterial blood sampling element defines a collection chamber; the arterial blood module can be detachably connected to a portion of the arterial blood sampling element, and the arterial blood module includes: a shell having a first end and a second end; a needle extending from the first end; a cap that can be detachably fixed to the needle; a mixing chamber adjacent to the second end; and a safety shield that engages with a portion of the shell and can be switched from a first shield position to a second shield position, in which a portion of the needle is exposed and in which the needle is shielded by a portion of the safety shield.

[0015] In one configuration, the safety shield includes a shield assembly and an actuator that is capable of switching from a first actuator position to a second actuator position, in which the actuator engages a portion of the shield assembly to lock the shield assembly in the first shield position, and in which the actuator releases the shield assembly and the safety shield automatically moves to the second shield position. In another configuration, the actuator includes a button. In yet another configuration, the shield assembly includes a telescopic shield. In one configuration, the shield assembly includes: a fixed outer shield; an intermediate movable shield in communication with the fixed outer shield, wherein the intermediate movable shield moves relative to the fixed outer shield; and an inner movable shield in communication with the intermediate movable shield, wherein the inner movable shield moves relative to the intermediate movable shield. In another configuration, when the safety shield is in the first shield position, the inner movable shield is nested within the intermediate movable shield, and the intermediate movable shield is nested within the fixed outer shield. In yet another configuration, when the safety shield is in the second shield position, the inner movable shield extends from the intermediate movable shield, and the intermediate 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 also includes a sample stabilizer disposed in the flow channel between the first end of the housing and the mixing chamber. In yet another configuration, the arterial blood sampling system includes: a material including pores, the material being disposed in the flow channel between the first end of the housing and the mixing chamber; and a dry anticoagulant powder located in the pores of the material. In one configuration, the blood sample dissolves the dry anticoagulant powder and mixes with the dry anticoagulant powder while passing through the material. In another configuration, the material is an open cell foam. In yet another configuration, the sample stabilizer is the dry anticoagulant powder. In one configuration, the housing of the arterial blood module defines an exhaust chamber. In another configuration, the arterial blood module further includes an exhaust plug that allows air to pass through the exhaust plug and prevents the blood sample from passing through the exhaust plug, wherein a portion of the exhaust plug is in communication with the exhaust chamber. In yet another configuration, the arterial blood module further includes a first valve, and wherein, when the arterial blood module is connected to the arterial blood sampling element, the blood sample enters the collection chamber of the arterial blood sampling element via the needle and the first valve. In one configuration, the first valve allows the blood sample to flow from the arterial blood module to the collection chamber of the arterial blood sampling element. In another configuration, the first valve blocks the blood sample from returning from the collection chamber of the arterial blood sampling element to the arterial blood module.In yet another configuration, the arterial blood module further comprises a second valve, and wherein, when the arterial blood module is connected to the arterial blood sampling element, a portion of the air and blood sample contained in the collection chamber of the arterial blood sampling element enters the exhaust chamber via the second valve. In one configuration, air flows out of the arterial blood module via the exhaust plug. In another configuration, the arterial blood module comprises a first finger grip portion. In yet another configuration, the arterial blood module comprises a second finger grip portion, wherein the first finger grip portion is opposite to the second finger grip portion. In one configuration, the needle comprises thin-wall needle technology. In another configuration, the arterial blood sampling element comprises a plunger rod assembly, which comprises a stopper and a plunger rod.

[0016] According to another embodiment of the present 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 that can be removably fixed to the needle; a mixing chamber adjacent to the second end; and a safety shield that engages with a portion of the housing and can be switched from a first shield position to a second shield position, in which a portion of the needle is exposed, and in which the needle is shielded by a portion of the safety shield.

[0017] In one configuration, the arterial blood module is removably connectable to a portion of an arterial blood collection element. In another configuration, the arterial blood collection element defines a collection chamber.

[0018] According to another aspect of the present disclosure, an arterial blood sampling system is disclosed, the arterial blood sampling system including an arterial blood sampling element and an arterial blood module, the arterial blood sampling element defining a collection chamber, the arterial blood module being removably connectable to a portion of the arterial blood sampling element. The arterial blood module may include a hub body, a needle extending from the hub body, and a safety shield, the safety shield engaging with a portion of the hub body and being able to switch from a first shield position to a second shield position, in which a portion of the needle is exposed, and in which the needle is shielded by a portion of the safety shield. The arterial blood module may also include an exhaust chamber, wherein the exhaust chamber is in fluid communication with the hub body to exhaust bubbles from the collected blood sample in the collection chamber.

[0019] In some embodiments, the arterial blood module further comprises an actuator capable of switching from a first actuator position to a second actuator position, wherein the second actuator position releases the safety shield to the second shield position.

[0020] In some embodiments, the actuator comprises a button.

[0021] In some embodiments, the safety shield comprises a telescoping shield.

[0022] In some embodiments, the exhaust chamber is formed within the actuator.

[0023] In some embodiments, the hub of the arterial blood module defines the exhaust chamber.

[0024] In some embodiments, the arterial blood module further comprises a vent plug that allows air to pass through the vent plug and prevents the blood sample from passing through the vent plug, wherein a portion of the vent plug is in communication with the vent chamber.

[0025] In some embodiments, the needle and the safety shield are selectively removable from the hub.

[0026] In some embodiments, the needle and the safety shield can be removed from the hub only when the safety shield is in the second shield position.

[0027] In some embodiments, the actuator includes an actuator stem and a stopcock.

[0028] In some embodiments, the arterial blood sampling module further comprises an eccentric needle holder having a needle bearing portion, an exhaust chamber portion, and a rotatable rod portion, wherein the needle bearing portion is coupled to the needle and is in fluid communication with the needle.

[0029] In some embodiments, the arterial blood sampling module further comprises an insert located at a distal end of the interior portion of the safety shield to seal the opening in the safety shield when in the second shield position wherein the needle is shielded by a portion of the safety shield.

[0030] According to another aspect of the present disclosure, an arterial blood module is disclosed, which includes a hub body, a needle extending from the hub body, a safety shield, and an exhaust chamber, wherein the safety shield is engaged with a portion of the hub body and can be switched from a first shield position to a second shield position, in which a portion of the needle is exposed and the needle is shielded by a portion of the safety shield, wherein the exhaust chamber is in fluid communication with the hub body to exhaust bubbles from a collected blood sample in the collection chamber.

[0031] In some embodiments, the arterial blood module can be removably connected to a portion of the arterial blood sampling element.

[0032] In some embodiments, the arterial blood module can be connected to a portion of the arterial blood collection element via a threaded Luer connection.

[0033] In some embodiments, the arterial blood module further comprises an actuator capable of switching from a first actuator position to a second actuator position, wherein the second actuator position releases the safety shield to the second shield position.

[0034] In some embodiments, the exhaust chamber is formed within the actuator.

[0035] In some embodiments, the actuator comprises a button.

[0036] In some embodiments, the actuator includes an actuator stem and a stopcock.

[0037] In some embodiments, the hub of the arterial blood module defines the exhaust chamber.

[0038] In some embodiments, the arterial blood module further comprises a vent plug that allows air to pass through the vent plug and prevents the blood sample from passing through the vent plug, wherein a portion of the vent plug is in communication with the vent chamber.

[0039] It should be understood that the foregoing general description and the following detailed description are examples and illustrative, and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and mechanisms shown in the accompanying drawings. It should also be understood that, unless so claimed, the various embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention. Therefore, the following detailed description is not intended to be limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The above and other features and advantages of the present disclosure and the manner in which they are achieved will become more apparent, and the present disclosure itself will be better understood, by referring to the following description of embodiments of the present disclosure taken in conjunction with the accompanying drawings, in which:

[0041] Figure 1 is a perspective view of an arterial blood sampling system according to an embodiment of the present invention.

[0042] Figure 2 is a perspective view of an arterial blood module with a cap secured to a needle according to an embodiment of the present invention.

[0043] Figure 3 is a perspective view of an arterial blood module with the cap removed from the needle in accordance with an embodiment of the present invention.

[0044] Figure 4 is a perspective view of an arterial blood sampling system in which air bubbles are exhausted from the system according to an embodiment of the present invention.

[0045] Figure 5 is a perspective view of a first step of using the system of the present disclosure, according to an embodiment of the present invention.

[0046] Figure 6is a perspective view of a second step of using the system of the present disclosure according to an embodiment of the present invention.

[0047] Figure 7 is a perspective view of a third step of using the system of the present disclosure according to an embodiment of the present invention.

[0048] Figure 8 is a perspective view of a fourth step of using the system of the present disclosure according to an embodiment of the present invention.

[0049] Fig. 9 is a perspective view of a fifth step of using the system of the present disclosure according to an embodiment of the present invention.

[0050] Fig.10 is a first schematic diagram of an arterial blood sampling system according to an embodiment of the present invention.

[0051] Fig.11 is a second schematic diagram of the arterial blood sampling system according to an embodiment of the present invention.

[0052] Fig.12 is a third schematic diagram of the arterial blood sampling system according to an embodiment of the present invention.

[0053] 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 an embodiment of the present invention.

[0054] Fig.14 is a cross-sectional view of a portion of an arterial blood module with the safety shield in a second shield position according to an embodiment of the present invention.

[0055] Fig.15 is a cross-sectional view of a portion of an arterial blood module with a safety shield in a first shield position according to another embodiment of the present invention.

[0056] Fig.16 is a cross-sectional view of a portion of an arterial blood module with the safety shield in a second shield position according to another embodiment of the present invention.

[0057] Fig.17 is a cross-sectional view of a portion of an arterial blood module with a safety shield in a first shield position according to another embodiment of the present invention.

[0058] Fig.18 is a cross-sectional view of a portion of an arterial blood module with the safety shield in a second shield position according to another embodiment of the present invention.

[0059] Fig.19 is a perspective view of an open-cell foam material according to an embodiment of the present invention.

[0060] Fig. 20 is a microscopic view of the microstructure of an open-cell foam material having dry anticoagulant powder distributed throughout its microstructure in accordance with an embodiment of the present invention.

[0061] Fig.21 is a perspective view of an arterial blood module according to another aspect of the present invention.

[0062] Fig. 22 Is in the first configuration Fig.21 Cross-sectional view of the arterial blood module.

[0063] Fig.23 It is in the second configuration Fig.21 Cross-sectional view of the arterial blood module.

[0064] Fig.24 It is in the third configuration Fig.21 Cross-sectional view of the arterial blood module.

[0065] Fig.25 is a perspective view of an arterial blood module according to another aspect of the present invention.

[0066] Fig.26 Is in the first configuration Fig.25 Cross-sectional view of the arterial blood module.

[0067] Fig. 27 It is in the second configuration Fig.25 Cross-sectional view of the arterial blood module.

[0068] Fig.28 is a cross-sectional view of an arterial blood module according to another aspect of the present invention in a first configuration.

[0069] Fig.29 It is in the second configuration Fig.28 Cross-sectional view of the arterial blood module.

[0070] Fig.30 is a perspective view of an arterial blood module for an arterial blood gas injector according to another aspect of the present invention.

[0071] Fig.31 Is in the first configuration Fig.30 Cross-sectional view of the arterial blood module.

[0072] Fig.32 Is in the first configuration Fig.30 Another cross-sectional view of the arterial blood module.

[0073] Fig.33 It is in the second configuration Fig.30 Cross-sectional view of the arterial blood module.

[0074] Fig.34 It is in the third configuration Fig.30 Cross-sectional view of the arterial blood module.

[0075] Fig.35 It is in the fourth configuration Fig.30 Cross-sectional view of the arterial blood module.

[0076] Fig.36 It is in the fifth configuration Fig.30 Cross-sectional view of the arterial blood module.

[0077] Fig.37 is a perspective view of an arterial blood module for an arterial blood gas injector according to another aspect of the present invention.

[0078] Fig.38 Is in the first configuration Fig.37 Partial side view of the arterial blood module.

[0079] Fig.39 Is in the first configuration Fig.37 A partial schematic diagram of the arterial blood module.

[0080] Fig.40 It is in the second configuration Fig.37 A partial schematic diagram of the arterial blood module.

[0081] Fig.41 is a perspective view of an arterial blood module for an arterial blood gas injector according to another aspect of the present invention in a first configuration.

[0082] Fig.42 It is in the second configuration Fig.41 A stereogram of the arterial blood module.

[0083] Fig.43 Is in the first configuration Fig.41 A partial cross-sectional view of the arterial blood module.

[0084] Fig.44 It is in the second configuration Fig.41 Cross-sectional view of the arterial blood module.

[0085] Fig.45 is a perspective view of an arterial blood module for an arterial blood gas injector according to another aspect of the present invention in a first configuration.

[0086] Fig.46 It is in the second configuration Fig.45 A stereogram of the arterial blood module.

[0087] Fig.47 Is in the first configuration Fig.45Cross-sectional view of the arterial blood module.

[0088] Fig.48 It is in the second configuration Fig.45 A partial cross-sectional view of the arterial blood module.

[0089] Fig.49 Is in the first configuration Fig.45 A partial cross-sectional view of the arterial blood module.

[0090] Fig.50 is in the second configuration with Fig.45 End view of the eccentric needle holder used with the arterial blood module.

[0091] Fig.51 is in the first configuration with Fig.45 End view of the eccentric needle holder used with the arterial blood module.

[0092] Fig.52 is a partial cross-sectional view of an arterial blood module for an arterial blood gas injector according to another aspect of the present invention in a first configuration.

[0093] Fig.53 It is in the second configuration Fig.52 A partial cross-sectional view of the arterial blood module.

[0094] Fig.54 is a partial cross-sectional view of an arterial blood module for an arterial blood gas injector according to another aspect of the present invention in a first configuration.

[0095] Fig.55 It is in the second configuration Fig.54 A partial cross-sectional view of the arterial blood module.

[0096] Fig.56 yes Fig.54 Exploded view of the arterial blood module.

[0097] Fig.57 yes Fig.54 Another exploded view of the arterial blood module.

[0098] Fig.58 is a partial cross-sectional view of an arterial blood module for an arterial blood gas injector according to another aspect of the present invention in a first configuration.

[0099] Fig.59 It is in the second configuration Fig.58 A partial cross-sectional view of the arterial blood module.

[0100] Fig.60is a partial cross-sectional view of a safety shield assembly for use with an arterial blood module for an arterial blood gas injector according to another aspect of the present invention in a first configuration.

[0101] Fig.61 It is in the second configuration Fig.60 A partial cross-sectional view of a safety shield assembly.

[0102] 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 injector according to another aspect of the present invention in a first configuration.

[0103] Fig.63 It is in the second configuration Fig.62 A partial cross-sectional view of a safety shield assembly.

[0104] Fig.64 is a perspective view of an arterial blood module and an arterial blood gas syringe according to another aspect of the present invention in a first configuration.

[0105] Fig.65 yes Fig.64 Side view of the arterial blood module.

[0106] Fig.66 yes Fig.64 A stereogram of the arterial blood module.

[0107] Fig.67 It is in the second configuration Fig.64 A stereoscopic view of an arterial blood module and an arterial blood gas syringe.

[0108] Fig.68 Is in the first configuration Fig.64 A partial cross-sectional view of the arterial blood module.

[0109] Fig.69 It is in the second configuration Fig.64 A partial cross-sectional view of the arterial blood module.

[0110] Fig.70 is a perspective view of an arterial blood module and an arterial blood gas syringe according to another aspect of the present invention in a first configuration.

[0111] Fig.71 yes Fig.70 Side view of the arterial blood module.

[0112] Fig.72 yes Fig.70 A stereogram of the arterial blood module.

[0113] Fig.73 It is in the second configuration Fig.70A stereoscopic view of an arterial blood module and an arterial blood gas syringe.

[0114] Fig.74 Is in the first configuration Fig.70 A partial cross-sectional view of the arterial blood module.

[0115] Fig.75 It is in the second configuration Fig.70 A partial cross-sectional view of the arterial blood module.

[0116] Fig.76 is with Fig.70 A perspective view of an actuator used with the arterial blood module.

[0117] Fig.77 is with Fig.70 Another perspective view of an actuator used with the arterial blood module.

[0118] Fig.78 is a perspective view of an arterial blood module and an arterial blood gas syringe according to another aspect of the present invention in a first configuration.

[0119] Fig.79 yes Fig.78 Side view of the arterial blood module.

[0120] Fig.80 yes Fig.78 A stereogram of the arterial blood module.

[0121] Fig.81 It is in the second configuration Fig.78 A stereoscopic view of an arterial blood module and an arterial blood gas syringe.

[0122] Fig.82 Is in the first configuration Fig.78 A partial cross-sectional view of the arterial blood module.

[0123] Fig.83 It is in the second configuration Fig.78 A partial cross-sectional view of the arterial blood module.

[0124] Fig.84 is with Fig.78 A perspective view of the stem actuator and stopcock used with the arterial blood module.

[0125] Corresponding reference numerals indicate corresponding parts throughout the several views.The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and these exemplifications are not to be construed as limiting the scope of the disclosure in any way. DETAILED DESCRIPTION

[0126] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for implementing the present invention. However, various modifications, equivalents, variations and substitutes will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents and substitutes are intended to fall within the spirit and scope of the present invention.

[0127] Hereinafter, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the present invention as oriented in the accompanying drawings. However, it should be understood that the present invention may adopt various alternative variations unless expressly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0128] The present disclosure provides an arterial blood module that can be detachably connected to an arterial blood sampling element. The arterial blood module includes a housing, a needle, a cap that can be detachably fixed to the needle, a mixing chamber, and a safety shield that engages with a portion of the housing and can be switched from a first shield position to a second shield position, in which a portion of the needle is exposed, and in which the needle is shielded by a portion of the safety shield. In one embodiment, the present disclosure includes an arterial blood sampling system, the arterial blood sampling system including an arterial blood sampling element and an arterial blood module, the arterial blood sampling element defining a collection chamber, and the arterial blood module being detachably connected to a portion of the arterial blood sampling element.

[0129] In an exemplary embodiment, the arterial blood sampling system of the present disclosure provides a novel blood sampling device that uses a radial puncture technique to collect arterial blood samples. The system of the present disclosure provides an efficient system that simplifies and reduces the number of workflow steps and enables one-handed device operation that allows for a more efficient arterial blood gas (ABG) collection procedure. The arterial blood module of the present disclosure includes ergonomic touch points, a push-button safety shield, automatic anticoagulant mixing, and an integrated exhaust cap for venting bubbles after the collection procedure (if necessary).

[0130] Figures 1 to 20 An exemplary embodiment of an arterial blood sampling system 10 of the present disclosure is shown, which is adapted to receive a biological fluid sample, such as an arterial blood sample 12. In one embodiment, the arterial blood sampling system 10 of the present disclosure includes an arterial blood sampling element 14 and an arterial blood module 16 that is detachably connectable to a portion of the arterial blood sampling element 14.

[0131] Reference Figure 1 as well as Figures 4 to 12 In one embodiment, the arterial blood sampling 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 sampling element 14 includes a plunger rod assembly 22 having a stopper 24 and a plunger rod 26. In one embodiment, the arterial blood sampling element 14 is a conventional arterial blood gas syringe assembly, such as a Luer lock arterial blood gas syringe assembly or a Luer slip arterial blood gas syringe assembly. The arterial blood module 16 of the present disclosure can be compatible with any conventional arterial blood sampling element or arterial blood gas syringe assembly.

[0132] When the system 10 of the present disclosure is used to remove arterial blood, the arterial pressure of the blood is greater than the normal atmospheric or ambient pressure within the collection chamber 20 of the arterial blood sampling element 14, and therefore, when the needle 32 of the arterial blood module 16 is inserted into the artery, the arterial blood sample 12 will flow from the patient through the arterial blood module 16 to the collection chamber 20 of the arterial blood sampling element 14, as described in more detail below. In this manner, the system 10 of the present disclosure is self-filling due to the arterial blood pressure and the venting of the arterial blood gas syringe stopper.

[0133] Reference Figures 1 to 20 In one embodiment, the arterial blood module 16 of the present disclosure is removably connectable to a portion of the arterial blood sampling 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 extending from the first end 46 to the second end 48.

[0134] In an exemplary embodiment, the arterial blood module 16 of the present disclosure can be removably connected to a portion of the arterial blood collection element 14 through conventional methods and structures. For example, in one embodiment, the arterial blood module 16 of the present disclosure can be removably connected to a portion of the arterial blood collection element 14 through a standard Luer connection.

[0135] Advantageously, the arterial blood module 16 of the present disclosure allows for automatic mixing with a sample stabilizer 39. For example, in one embodiment, a mixing chamber 36 is provided to be in fluid communication with a flow channel 37. The mixing chamber 36 and the sample stabilizer 39 are positioned so that a biological fluid sample such as an arterial blood sample 12 will first pass through the sample stabilizer 39, then the blood sample 12 and the sample stabilizer 39 pass through the mixing chamber 36, and then the sample 12 with the sample stabilizer 39 appropriately mixed therein flows into the collection chamber 20 of the arterial blood sampling element 14. In this manner, the blood sample 12 can be mixed with a sample stabilizer 39 (such as an anticoagulant or other additive) disposed within the arterial blood module 16 before passing through the mixing chamber 36 to appropriately mix the sample stabilizer 39 within the blood sample 12, and then the stabilized sample is received and stored in the collection chamber 20 of the arterial blood sampling element 14.

[0136] In one embodiment, a sample stabilizer 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 stabilizer 39. For example, the arterial blood module 16 includes a mixing chamber 36 that allows the blood sample 12 to be passively mixed with an anticoagulant or another additive, such as a blood stabilizer, as the blood sample 12 flows through the mixing chamber 36.

[0137] The sample stabilizer may be an anticoagulant or a substance designed to preserve specific elements in the blood, such as, for example, RNA, protein analytes, or other elements. In one embodiment, the sample stabilizer 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 stabilizer 39 may be disposed in other areas within the housing 30 of the arterial blood module 16.

[0138] Reference Figures 19 to 20 In one embodiment, the arterial blood module 16 includes a material 40 having pores 42, and a dry anticoagulant powder 44, which is disposed in the flow channel 37 between the first end 46 of the housing 30 and the mixing chamber 36, and the dry anticoagulant powder is located in the pores 42 of the material 40. In this way, the arterial blood module 16 can include a dry anticoagulant, such as heparin or EDTA, deposited on or in a portion of the arterial blood module 16. In one embodiment, the material 40 is an open-cell foam that contains a dry anticoagulant dispersed within the cells of the open-cell foam to improve the effectiveness of flow mixing and anticoagulant uptake. In one embodiment, the sample stabilizer 39 is a dry anticoagulant powder 44.

[0139] In one embodiment, the open-cell foam may be treated with an anticoagulant to form a dry anticoagulant powder finely distributed in the pores of the open-cell foam. When 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 distributed throughout the internal pore structure of the open-cell foam. In this manner, the sample 12 dissolves and mixes with the dry anticoagulant powder 44 while passing through the material 40 or the open-cell foam.

[0140] The open-cell foam may be a soft, deformable open-cell foam that is inert to blood, for example a melamine foam (such as available from BASF) The open-cell foam may be a flexible, hydrophilic open-cell foam that is substantially heat-resistant and resistant to organic solvents. In one embodiment, the foam may include a sponge material.

[0141] Anticoagulants or other additives may be introduced into open cell foams by immersing the foam in a liquid solution of the additive and water and subsequently evaporating the water to form a dry additive powder finely distributed throughout the internal structure of the foam.

[0142] The arterial blood module 16 includes a mixing chamber 36 that allows the blood sample 12 to be passively mixed with an anticoagulant or another additive, such as a 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.

[0143] The interior portion of the mixing chamber 36 may have any suitable structure or form as long as the structure or form provides 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 .

[0144] The mixing chamber 36 receives the sample 12 and the sample stabilizer 39 therein and achieves dispersive mixing of the sample stabilizer 39 within the sample 12. The mixing chamber 36 achieves dispersive mixing of the sample stabilizer 39 within the sample 12 and prevents very high sample stabilizer concentrations in any portion of the blood sample 12. This prevents underdosing of the sample stabilizer 39 in any portion of the blood sample 12. The mixing chamber 36 achieves dispersive mixing of the sample stabilizer 39 within the sample 12, so that approximately equal amounts and / or equal concentrations of the sample stabilizer 39 are dissolved in the entire blood sample 12, for example, approximately equal amounts and / or equal concentrations of the sample stabilizer 39 are dissolved in the blood sample 12 from the front portion of the blood sample 12 to the rear portion of the blood sample 12.

[0145] Reference Figures 1 to 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 wall needle technology. For example, the thin wall needle technology of the present disclosure provides a small gauge needle while still maintaining a high flow rate, thereby achieving a fast fill time and exposing the patient to a shorter uncomfortable procedure.

[0146] Reference Figures 1 to 20 In one embodiment, the arterial blood module 16 includes a safety cap 34 that can be removably secured to the needle 32. The safety cap 34 ensures that the needle 32 is completely covered and shielded before any collection procedure begins. Before using the arterial blood module 16, the user can remove the safety cap 34 from the arterial blood module 16.

[0147] Reference Figures 1 to 20 In one embodiment, the arterial blood module 16 includes a safety shield 38 that engages a portion of the housing 30 and is capable of being moved from a first shield position ( Figure 3 ) Switch to the second shield position ( Fig.14 , Fig.16 and Fig.18 ), in which a portion of the needle 32 is exposed, and in which a portion of the safety shield 38 is shielded by the needle 32 in the second shield position.

[0148] 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 can be moved from a first actuator position ( Fig.13 , Fig.15 and Fig.17 ) to the second actuator position ( Fig.14 , Fig.16 and Fig.18 ), in which the actuator 52 engages a portion of the shield assembly 50 to lock the shield assembly 50 in the first shield position ( Figure 3 ), in which the actuator 52 releases the shield assembly 50, and the safety shield 38 automatically moves to the second shield position ( Fig.14 , Fig.16 and Fig.18). In an exemplary embodiment, the actuator 52 includes a button. In this way, the integrated push-button safety shield 38 of the present disclosure provides a device that can be activated one-handedly by simply pressing a button after the collection procedure is completed, while not obstructing the view of the medical staff during the procedure. In this way, 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 an exemplary embodiment, when the actuator 52 of the safety shield 38 is activated, the spring 59 applies a force to a portion of the shield assembly 50 to automatically move the safety shield 38 to a second shield position in which the needle 32 is shielded by a portion of the safety shield 38.

[0149] Reference Figures 13 to 18 In an exemplary embodiment, the shield assembly 50 includes a telescopic shield. For example, referring to Figure 13 to Figure 14 In an exemplary embodiment, the shield assembly 50 includes: a fixed outer shield 54; an intermediate movable shield 56 connected to the fixed outer shield 54, wherein the intermediate movable shield 56 moves relative to the fixed outer shield 54; and an inner movable shield 58 connected to the intermediate movable shield 56, wherein the inner movable shield 58 moves relative to the intermediate movable shield 56.

[0150] Reference Fig.13 In one embodiment, when the safety shield 38 is in the first shield position, the inner movable shield 58 is nested within the intermediate movable shield 56 , and the intermediate movable shield 56 is nested within the fixed outer shield 54 .

[0151] Reference Fig.14 In one embodiment, when the safety shield 38 is in the second shield position, the inner movable shield 58 extends from the middle movable shield 56 , and the middle movable shield 56 extends from the fixed outer shield 54 .

[0152] In an exemplary embodiment, when the actuator 52 of the safety shield 38 is activated, the spring 59 applies a force to a portion of the shield assembly 50 to automatically move the safety shield 38 to the second shield position in which the needle 32 is shielded by a portion of the safety shield 38. Fig.13 In the first position, the spring 59 is disposed in a compressed position within the inner shield 58. Fig.14 When the actuator 52 of the safety shield 38 is activated, the spring 59 is able to apply a stored force on a portion of the internal shield 58 to automatically move the telescopic shields 54, 56, 58 to a second shield position in which the needle 32 is shielded by a portion of the shield assembly 50.

[0153] Figures 15 to 18Other exemplary embodiments are shown. Figure 15 to Figure 16 The illustrated embodiment includes Figure 13 to Figure 14 Similar components of the illustrated embodiment are identified by a reference numeral followed by the letter A. Figure 17 to Figure 18 The embodiment shown in also includes Figure 13 to Figure 14 , and similar components are indicated by reference numerals followed by the letter B. For simplicity, these similar components and the use of arterial blood module 16A ( Figure 15 to Figure 16 ) and arterial blood module 16B ( Figure 17 to Figure 18 ) will not be combined with Figure 15 to Figure 16 and Figure 17 to Figure 18 Advantageously, the arterial blood module 16 of the present disclosure allows for an integrated vent system that allows for the removal of trapped bubbles by simply venting the trapped bubbles into a vent chamber 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.

[0154] 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 through the vent plug and prevents the blood sample 12 from passing through the vent plug, wherein a portion of the vent plug 62 is in communication with the vent chamber 60. In this manner, any air bubbles contained within the arterial blood sampling element 14 can be discharged from the vent plug 62 through the vent chamber 60 to be discharged to the outside of the system 10. The structure of the arterial blood module 16, the vent chamber 60, and the vent plug 62 allows air to pass through the arterial blood module 16 while preventing the blood sample 12 from passing through the arterial blood module 16, and may include a hydrophobic filter.

[0155] Reference Figures 10 to 12 In one embodiment, the arterial blood module 16 includes a first valve 64. In an exemplary embodiment, when the arterial blood module 16 is connected to the arterial blood sampling element 14, the blood sample 12 enters the collection chamber 20 of the arterial blood sampling element 14 via the needle 32 and the first valve 64. The first valve 64 allows the blood sample 12 to enter the collection chamber 20 of the arterial blood sampling element 14 from the arterial blood module 16. The first valve 64 blocks the blood sample 12 from returning from the collection chamber 20 of the arterial blood sampling element 14 to the arterial blood module 16. In one embodiment, the first valve 64 is a one-way valve.

[0156] In one embodiment, the arterial blood module 16 includes a second valve 66. In an exemplary embodiment, when the arterial blood module 16 is connected to the arterial blood sampling element 14, a portion of the air and blood sample 12 contained in the collection chamber 20 of the arterial blood sampling element 14 enters the exhaust chamber 60 via the second valve 66. In one embodiment, the second valve 66 is a one-way valve.

[0157] Advantageously, the arterial blood module 16 of the present disclosure provides an ergonomic design with designated touch points to facilitate accurate and easy manipulation of the arterial blood module 16 during a collection procedure. For example, in one exemplary embodiment, referring to Figures 1 to 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, wherein the first finger grip portion 90 is disposed opposite to the second finger grip portion 92.

[0158] Reference Figures 5 to 9 , the use of the arterial blood sampling system 10 of the present disclosure having the arterial blood module 16 and the arterial blood sampling element 14 will now be described.

[0159] Reference Figure 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 begins. Figure 5 As shown, before using the arterial blood module 16 , the user may remove the safety cap 34 by pulling the safety cap 34 away from the arterial blood module 16 .

[0160] Reference Figure 6 , the needle 32 of the system 10 is inserted into the patient's artery 70. As described above, the arterial blood sampling element 14 of the arterial blood sampling system 10 is self-filled due to arterial blood pressure and the exhaust arterial blood gas syringe stopper. As described above, when the blood sample 12 is automatically moved from the patient's artery 70 to the collection chamber 20 of the arterial blood sampling element 14 via the arterial blood module 16, the arterial blood sample 12 is automatically mixed with the sample stabilizer 39.

[0161] Reference Figure 7 , the needle 32 is then removed from the patient's artery 70 and the safety shield 38 is activated by pressing the actuator 52, which automatically shields the needle 32 with the safety shield 38. In this way, the safety shield 38 is locked into the shield position that safely covers the needle 32 so that the arterial blood module 16 can be safely handled and disposed of.

[0162] Reference Figure 8, and then vertically orient the arterial blood collection system 10 with the safety shielded needle 32 pointing in an upward configuration. Next, as described above, the user can push the plunger rod 26 of the arterial blood collection element 14 to expel any trapped air bubbles from the collection chamber 20 of the arterial blood collection element 14 and from the arterial blood module 16 via the vent chamber 60 and the vent plug 62.

[0163] Reference Fig. 9 , the arterial blood module 16 is then removed from the arterial blood sampling element 14. In this way, the arterial blood module 16 can be safely disposed of, and the arterial blood sampling element 14 can be docked with the arterial blood gas analysis instrument 80 for sample transfer and analysis.

[0164] The present disclosure provides an arterial blood module that can be detachably connected to an arterial blood sampling element. The arterial blood module includes a housing, a needle, a cap that can be detachably fixed to the needle, a mixing chamber, and a safety shield that engages with a portion of the housing and can be switched from a first shield position to a second shield position, in which a portion of the needle is exposed, and in which the needle is shielded by a portion of the safety shield. In one embodiment, the present disclosure includes an arterial blood sampling system, the arterial blood sampling system including an arterial blood sampling element and an arterial blood module, the arterial blood sampling element defining a collection chamber, and the arterial blood module being detachably connected to a portion of the arterial blood sampling element.

[0165] In an exemplary embodiment, the arterial blood sampling system of the present disclosure provides a novel blood sampling device for collecting arterial blood samples using a radial puncture technique. The system of the present disclosure provides an efficient system that simplifies and reduces the number of workflow steps and enables one-handed device operation that allows for a more efficient arterial blood gas (ABG) collection procedure. The arterial blood module of the present disclosure includes ergonomic touch points, a push-button safety shield, automatic anticoagulant mixing, and an integrated exhaust cap for venting bubbles after the collection procedure (if necessary).

[0166] 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 .

[0167] Now refer to Figure 21 to Figure 24, an arterial blood module 100 according to aspects of the present disclosure is shown. The arterial blood module 100 includes a hub body 102 having a proximal coupling interface 104, wherein the proximal coupling interface 104 is configured to removably couple the arterial blood module 100 to an arterial blood sampling element (such as, for example, the arterial blood sampling element 14 described above). The arterial blood module 100 also includes a safety shield 108 that can be selectively deployed by a user to cover the needle 110. As will be described in further detail below, the deployment of the safety shield 108 is initiated by an actuator 106 housed within the hub body 102.

[0168] Fig. 22 The arterial blood module 100 is shown in a first configuration in which the safety shield 108 is in an undeployed position such that the needle 110 is at least partially exposed. In the first configuration, the safety shield 108 can be releasably secured to the hub body 102 via an interface between a 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 communicates with an actuator aperture 107 formed in the hub body 102, wherein the actuator 106 is slidable within the actuator aperture 107 in a direction that is generally transverse to the direction of the slot 112 and, therefore, generally transverse to the deployment direction of the safety shield 108. Therefore, when the actuator 106 is pressed, the base portion of the actuator 106 contacts the proximal portion of the safety shield 108, thereby disengaging the stop portion 116 of the safety shield 108 from the protruding portion 109 of the hub body 102, so that the safety shield 108 is telescopically deployed above the needle 110 by the elastic force applied by the spring 118, as shown in FIG. Fig.23 shown.

[0169] Refer again Fig. 22 , when the safety shield 108 is in the undeployed position (i.e., 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, wherein the needle assembly body 115 has a flow channel 113 passing through the needle assembly body, wherein the flow channel 113 is in fluid communication with the needle 110. Although not shown, the flow channel 113 can be in communication with, for example, a sample stabilizer. In this configuration, a blood sample can flow through the needle 110, the flow channel 113, and around the actuator 106 toward the opening 105, where the sample can be drawn into, for example, an arterial blood sampling element coupled to the proximal coupling interface 104.

[0170] Conversely, when the actuator 106 is depressed to deploy the safety shield 108 (eg, Fig.23105 ), the fluid passage between the opening 105 and the flow channel 113 is also disconnected, thereby preventing the flow of fluid between the needle 110 and the opening 105. More specifically, the pressing of the actuator 106 within the actuator hole 107 aligns the orifice 120 formed in the actuator 106 with the opening 105. The orifice 120 is in fluid communication with an exhaust chamber 122 formed in the actuator 106. The actuator 106 may also include an exhaust plug in communication with the exhaust chamber 122, which allows air to pass through the exhaust plug while preventing the blood sample from passing through the exhaust plug. In some embodiments, the exhaust plug may include a hydrophobic filter. In this way, any bubbles contained in the arterial blood sampling element coupled to the arterial blood module 100 can be discharged to the outside of the system through the exhaust chamber 122 and discharged from the exhaust plug formed as a part of the actuator 106.

[0171] In addition, refer to Fig.24 , arterial blood module 100 is also configured such that needle assembly body 115, safety shield 108, and needle 110 are removably coupled to hub body 102. For example, needle assembly body 115 may include a threaded interface 114 that can be coupled to a corresponding threaded interface on hub body 102. In this manner, needle assembly body 115, safety shield 108, and needle 110 may be removed together after use and discarded into an appropriate sharps container, while hub body 102 may remain coupled to the arterial blood sampling element for air bubble removal, transport, etc.

[0172] However, although needle assembly body 115, safety shield 108, and needle 110 are removably coupled to hub body 102, these components are prevented from being removed from hub body 102 when safety shield 108 is in the undeployed position (i.e., when needle 110 is not protected by safety shield 108). Fig. 22 As shown, the engagement between the detent portion 116 of the safety shield 108 and the protruding portion 109 of the hub body 102 within the slot 112 not only holds the safety shield 108 in the undeployed position, but also serves to prevent the safety shield 108 (and the needle assembly body 115) from rotating relative to the hub body 102. Therefore, in order to remove the needle assembly body 115 and the needle 110 for proper disposal, the user must first deploy the safety shield 108 by depressing the actuator 106, thereby separating the detent portion 116 of the safety shield 108 from the protruding portion 109 of the hub body 102, so that the needle assembly body 115 can rotate relative to the hub body 102, as shown in FIG. Fig.23 shown.

[0173] Next, refer to Figure 25 to Figure 27, an arterial blood module 150 according to another aspect of the present disclosure is shown. The arterial blood module 150 includes a twist-off safety shield assembly 154 that is removably connected to a hub body 152, wherein the hub body 152 is capable of being coupled to, for example, an arterial blood collection element 14 via a threaded Luer coupling. The twist-off safety shield assembly 154 may also be threadedly coupled to the hub body 152, but removal of the twist-off safety shield assembly 154 may require a rotational direction opposite to the rotational direction of the interface between the hub body 152 and the arterial blood collection element 14 (e.g., left-hand threads) to avoid undesired disengagement of the hub body 152 from the arterial blood collection element 14 when the twist-off safety shield assembly 154 is removed.

[0174] like Fig.26 and Fig. 27 As shown, the safety shield assembly 154 includes a telescopic safety shield, a needle 155 and a spring 156, which is used to bias the various components of the telescopic safety shield toward the deployed position, as shown in FIG. Fig. 27 As shown. The retractable safety shield can be deployed by any suitable method (such as a button, twist, etc.). In addition, an interface portion 157 is provided on the distal end of the safety shield assembly 154, wherein the interface portion 157 is configured to be detachably engaged with the hub body 152 and provide a fluid communication path between the hub body 152 and the needle 155.

[0175] Hub 152 includes a first check valve 162, a second check valve 160, and a vent chamber 158. Vent chamber 158 may include a vent plug in communication with vent chamber 158 that allows air to pass through the vent plug while preventing blood sample from passing through the vent plug. In some embodiments, the vent plug may include a hydrophobic filter.

[0176] When the safety shield assembly 154 is coupled to the hub body 152, as shown Fig.26 As shown, the needle 155 is fluidly coupled to the arterial blood sampling element 14, wherein the first check valve 162 is opened to allow fluid to pass through the first check valve. However, when the safety shield assembly 154 is disengaged from the hub body 152, as shown in FIG. Fig. 27 As shown, the first check valve 162 can be closed to prevent blood leakage and minimize air exposure. The safety shield assembly 154 can then be discarded in an appropriate sharps container.

[0177] In addition, Fig. 27In the illustrated configuration, the plunger rod (not shown) of the arterial blood sampling element 14 can be depressed to cause any air bubbles contained within the arterial blood sampling element 14 to be vented through the second check valve 160 and into the exhaust chamber 158, wherein the exhaust chamber 158 is also sized and configured to accommodate a small amount of clotted blood sample from near the Luer tip. As described above, when the safety shield assembly 154 is disengaged, the first check valve 162 is substantially sealed to prevent blood leakage and minimize air exposure.

[0178] By enabling the safety shield assembly 154 to be easily detached from the hub 152, the needle 155 is removed prior to transport and sample analysis, thereby minimizing the risk of needle sticks and / or improper handling. In addition, removing the safety shield assembly 154 also reduces the overall size of the device, which can be beneficial during transport and analysis.

[0179] Next, refer to Fig.28 and Fig.29 , an arterial blood module 170 according to another aspect of the present disclosure is shown. Figure 25 to Figure 27 Arterial blood module 150 is depicted, arterial blood module 170 includes a twist-off safety shield assembly 174 that is removably coupled to hub 172, wherein hub 172 is capable of being coupled to, for example, an arterial blood collection element (not shown) via a threaded Luer coupling. Twist-off safety shield assembly 174 may also be threadedly coupled to hub 172, but removal of twist-off safety shield assembly 174 may require a rotational direction opposite to the rotational direction of the interface between hub 172 and the arterial blood collection element (e.g., left-hand threads).

[0180] like Fig.28 and Fig.29 As shown in part, the safety shield assembly 174 includes a telescopic safety shield, a needle 175, and a spring 176 for biasing the various components of the telescopic safety shield toward the deployed position. The telescopic safety shield can be deployed by any suitable method (such as a button, twist, etc.). In addition, an interface portion 177 is disposed on the distal end of the safety shield assembly 174, wherein the interface portion 177 is configured to removably engage with the hub body 172 and provide a fluid communication path between the hub body 172 and the needle 175. The interface portion 177 also includes a distal protrusion 186, which is sized and configured to extend within (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 protrusion 186 is configured to provide a fluid channel between the needle 175 and the hub body 172.

[0181] The hub body 172 also includes a normally closed ball valve 182, wherein the ball valve 182 is biased to a normally closed position by a spring 184. Fig.28 As shown, when the safety shield assembly 174 is coupled to the hub body 172, the distal protrusion 186 acts on the spring 184, thereby opening the ball valve 182 to allow blood to flow from the needle 175 to the hub body 172. However, when the safety shield assembly 174 is disengaged from the hub body 172, the distal protrusion 186 no longer acts on the spring 184, thereby allowing the spring 184 to close the ball valve 182 to prevent blood from flowing out of the opening 188 of the hub body 172.

[0182] Still refer to Fig.28 and Fig.29 , the hub body 172 also includes a check valve 180 and an exhaust chamber 178. The exhaust chamber 178 may include an exhaust plug in communication with the exhaust chamber 178, the exhaust plug allowing air to pass through the exhaust plug while preventing the blood sample from passing through the exhaust plug. In some embodiments, the exhaust plug may include a hydrophobic filter. When the safety shield assembly 174 is detached from the hub body 172, as shown Fig.29 As shown, ball valve 182 is closed to prevent blood leakage and minimize air exposure. In addition, the plunger rod (not shown) of the arterial blood sampling element can be depressed to allow any air bubbles contained within the arterial blood sampling element to be exhausted through check valve 180 and into exhaust chamber 178, wherein exhaust chamber 178 is also sized and configured to accommodate a small amount of clotted blood sample from near the Luer end.

[0183] Now refer to Figure 30 to Figure 36 , shows an arterial blood gas syringe assembly 200 and related components according to another aspect of the present disclosure. Fig.30 As shown, the arterial blood gas syringe assembly 200 includes a syringe body 216, a concave plunger stop 214, and a venting plunger 212. The distal end of the syringe body 216 is configured to have, for example, a Luer connector.

[0184] Coupled to the distal end of the syringe body 216 is the arterial blood module 202, wherein the arterial blood module 202 includes an integrated mixing portion 206 and a safety shield 208 and a vent cap portion 204. The vent cap portion 204 is configured to be removably coupled to the syringe body 216 via, for example, a Luer connection, and the integrated mixing portion 206 and the safety shield 208 are configured to be removably coupled to the vent cap portion 204.

[0185] Reference Fig.31, the mixing part 206 includes a needle 210 extending distally from the mixing part and filters 218, 220 located in the mixing chamber. Although not shown, it is understood that a sample stabilizer can be provided in the mixing chamber of the mixing part 206. The safety shield 208 is configured to be coupled to the mixing part 206 and can be telescopically deployed by any appropriate method (such as a button, twisting, etc.). The exhaust cap part 204 includes a one-way valve 222, an exhaust chamber 224 and a proximal coupling part 226, wherein the proximal coupling part 226 is configured to allow the exhaust cap part 204 to be attached to the syringe body 216. The exhaust chamber 224 may include an exhaust plug or a filter communicated with the exhaust chamber 224, which allows air to pass through the exhaust plug or the filter while preventing a blood sample from passing through the exhaust plug or the filter. In some embodiments, the exhaust plug or the filter may include a hydrophobic filter.

[0186] Next, refer to Figure 32 to Figure 36 , shows the steps of using the arterial blood gas syringe assembly 200 according to aspects of the present disclosure. First, as Fig.32 As shown, with the safety shield 208 in the undeployed position, blood is drawn into the syringe body 216 through the needle 210 via, for example, arterial pressure. The blood sample passes through the mixing portion 206 and the one-way valve 222 of the exhaust cap portion 204, thereby providing a stable blood sample in the syringe body 216. Then, as shown in FIG. Fig.33 As shown, the safety shield 208 is deployed to substantially cover the needle 210. With the needle 210 protected by the safety shield 208, the integrated mixing portion 206, the safety shield 208, and the needle 210 are removed together from the vent cap portion 204 so that the mixing portion 206, the safety shield 208, and the needle 210 can be disposed of in an appropriate sharps container, such as Fig.34 shown.

[0187] Next, refer to Fig.35 , the syringe body 216 can be maintained in a vertical position to move any bubbles within the sample to rise toward the distal end, and the plunger rod 212 (eg Fig.30 The vent cap portion 204 is shown in Figure 204. The one-way valve 222 of the vent cap portion 204 generally prevents blood from leaking out of the vent cap portion 204 during this venting step. Then, referring 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 within the syringe body 216 can be transported for analysis.

[0188] Now refer to Figures 37 to 40, an arterial blood module 250 according to another aspect of the present disclosure is shown. Fig.37 As shown, the arterial blood module 250 is configured to be coupled to, for example, the arterial blood sampling element 14 via a threaded Luer coupling or a similar interface. The arterial blood module 250 includes a body 252, a safety shield 254 (e.g., a telescopic shield), and a needle 256. In addition, a rotatable stopcock 260 is disposed within the proximal portion of the body 252, wherein the rotatable stopcock 260 is configured to be partially rotated by an actuator 258, which is at least partially disposed outside the body 252. Fig.38 As shown, a proximal connector 261 is disposed on the body 252, wherein the proximal connector 261 is configured to be detachably coupled to, for example, a Luer connector of the arterial blood collection element 14. A passage 262 passes through the proximal connector 261 to provide a fluid passage between the rotatable stopcock 260 and the arterial blood collection element 14.

[0189] Reference Fig.39 When the rotatable stopcock 260 is in the first configuration (i.e., the actuator 258 is not depressed), the blood sample is configured to pass through the channel 264 in the rotatable stopcock 260 to reach the arterial blood sampling element 14 from the needle 256 and the passage 262 to collect the blood sample. However, after the desired blood sample is collected in the arterial blood sampling element 14, the actuator 258 can be depressed to partially rotate the rotatable stopcock 260 so that the channel 264 is angularly offset from the needle 256 and the passage 262, as shown in FIG. Fig.40 Alternatively, a second opening (not shown) in the rotatable stopcock 260 may be aligned with the passageway 262. The user may then vertically orient the arterial blood sampling element 14 and the attached arterial blood module 250 and depress the plunger rod of the arterial blood sampling element 14 to vent the air bubbles and coagulated sample volume from the arterial blood sampling element 14 into the vent chamber 265 within 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 will allow air to pass through the vent plug until wet, at which point the vent plug will seal to prevent further passage of air and blood.

[0190] Next, Figure 42 to Figure 44 An arterial blood module 300 according to another aspect of the present disclosure is shown. The arterial blood module 300 includes a safety shield assembly 304 coupled to a hub body 302, wherein the hub body 302 has a proximal coupling interface 310 that can be coupled to, for example, an arterial blood sampling element 14 via a threaded Luer coupling. The safety shield assembly 304 may include, for example, a telescoping safety shield and a spring (not shown) for biasing various components of the telescoping safety shield toward a deployed position, such as Fig.42 and Fig.44In addition, the needle 306 is disposed in fluid communication with the hub body 302 , wherein the safety shield assembly 304 is configured to selectively cover the needle 306 .

[0191] Arterial blood module 300 also includes a rotary valve 315 that is operably coupled to lever member 308. When lever member 308 is in a first position (eg, Fig.41 and Fig.43 ), the rotary valve 315 is in a first configuration such that the needle 306 and the passage 314 are in fluid communication with each other, thereby allowing the blood sample to flow from the needle 306 to the arterial blood sampling element 14 via the rotary valve 315 and the passage 314 .

[0192] In contrast, when the lever member 308 is in the second position (eg, Fig.42 and Fig.44 306 and passage 314 are no longer in fluid communication. Instead, in the second configuration, the rotary valve 315 fluidly couples the passage 314 to a conduit 313 leading to a vent chamber 312 within the hub body 302. In this configuration, the user can depress the plunger rod of the arterial blood sampling element 14 to vent bubbles and coagulated sample volume from the arterial blood sampling 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 will allow air to pass through the vent plug until it is wet, at which time the vent plug will seal to prevent further passage of air and blood.

[0193] In addition, 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 the first position (e.g., Fig.41 and Fig.43 ), the rod member 308 does not contact any portion of the latch member 309, thereby allowing the latch member 309 to maintain the safety shield assembly 304 in the undeployed position near the male portion 311 of the hub body 302, so that the needle 306 remains exposed. However, the rod member 308 is then moved to the second position (as shown). Fig.42 and Fig.44 ), a portion of the rod member 308 contacts the latch member 309, thereby causing the latch member 309 to pivot so as to release the safety shield assembly 304 to the deployed position, thereby substantially covering the needle 306.

[0194] Now refer to Figures 45 to 51, an arterial blood module 350 according to another aspect of the present disclosure. The arterial blood module 350 includes a safety shield assembly 354 coupled to a hub body 352, wherein the hub body 352 has a proximal coupling interface 353, which can be coupled to, for example, an arterial blood sampling element 14 through a threaded Luer coupling. The safety shield assembly 354 may include, for example, a telescopic safety shield and a spring 355, which is used to bias the various components of the telescopic safety shield toward the deployed position, such as Fig.45 and Fig.47 In addition, the needle 356 is configured to be selectively in fluid communication with the hub body 352 , wherein the safety shield assembly 354 is configured to selectively cover the needle 356 .

[0195] Arterial blood module 350 also includes an eccentric needle holder 358 having a needle bearing portion 364, a venting chamber portion 366, and a rotatable shaft portion 360. Fig.50 and Fig.51 As shown, the needle bearing portion 364, the exhaust chamber portion 366 and the rotatable shaft portion 360 are configured to rotate eccentrically about a pivot point 368 within the hub body 352. Fig.46 , Fig.48 and Fig.50 In the first configuration shown, the rotatable shaft portion 360 is in a first position, so that the first conduit 365 of the needle-bearing portion 364 is fluidly connected to the fluid passage 362 leading to the proximal coupling interface 353, thereby allowing the blood sample to enter the arterial blood collection element 14 through the needle 356, the first conduit 365 and the fluid passage 362.

[0196] However, when the rotatable rod portion 360 is moved to the second position, as shown in FIG. Fig.45 , Fig.47 , Fig.49 and Fig.51 As shown, the needle 356 and the first conduit 365 of the needle bearing portion 364 are moved out of fluid communication with the fluid passage 362. Instead, the second conduit 367 is moved into fluid communication with the fluid passage, wherein the second conduit 367 leads to the vent chamber portion 366 of the eccentric needle holder 360. In this configuration, the user can depress the plunger rod of the arterial blood sampling element 14 to vent bubbles and coagulated sample volume from the arterial blood sampling 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 can include a vent plug that will allow air to pass through the vent plug until wet, at which time the vent plug will seal to prevent further passage of air and blood.

[0197] like Fig.47As shown, when the needle bearing 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. Therefore, the rotation of the eccentric needle support 358 can also play a role in locking the retraction of the telescopic needle shield assembly 354, thereby preventing the exposure of the needle 356.

[0198] Now refer to Fig.52 and Fig.53 , an arterial blood module 370 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 an active shield function. Therefore, the purpose and function of the common components between the arterial blood module 370 and the arterial blood module 350 will not be repeated here.

[0199] like Fig.52 and Fig.53 As shown, at least a portion of the safety shield assembly 354 includes a hook member 372 formed at a proximal end thereof, wherein the hook member 372 is sized and configured to engage with a corresponding latch member 374 formed on a distal portion of the exhaust chamber portion 366 of the eccentric needle holder 358. Thus, when the eccentric needle holder 358 is in the first position (e.g., Fig.52 and Fig.53 356 is exposed. However, when the eccentric needle holder 358 is rotated to the second position (not shown), the latch member 374 will disengage from the hook member 372, thereby releasing the safety shield assembly 354, so that the safety shield assembly 354 is deployed to generally cover the needle 356. With this configuration, the rotation of the eccentric needle holder 358 can simultaneously disconnect the needle 356 from the fluid communication with the arterial blood collection element 14 and deploy the safety shield assembly 354.

[0200] Next, refer to Figure 54 to Figure 57 , an arterial blood module 400 is shown according to another aspect of the present disclosure. The arterial blood module 400 is configured to move from a blood drawing configuration to a venting configuration via a simple button actuation.

[0201] The arterial blood module 400 includes a hub body 402 having a proximal coupling interface 404, wherein the proximal coupling interface 404 is configured to removably couple the arterial blood module 400 to an arterial blood collection element, such as, for example, the arterial blood collection element 14 described above. Although not shown, it should be understood that the arterial blood module 400 may also include a safety shield that can be selectively deployed by the user to cover the needle.

[0202] Reference Fig.54, showing an arterial blood module 400 in which a button-type actuator 406 is in a first position. The actuator 406 is configured to slide within a hole 407 of a housing 420, wherein the actuator 406 has a first passage 410 and a second passage 411 that are offset but in fluid communication with each other, such as Fig.54 and Fig.55 In the first position, the actuator 406 is positioned so that the first passage 410 is aligned with the first opening 413 of the hub body 402 and the central conduit 408, wherein the central conduit 408 is configured to be in fluid communication with a needle (not shown) of the arterial blood module 400. The first passage 410 also has a second opening 405 formed near the proximal coupling interface 404. Therefore, in this first position, a blood sample can pass from the needle through the actuator 406 to the arterial blood sampling element coupled to the proximal coupling interface 404.

[0203] On the contrary, refer to Fig.55 , when the actuator 406 is depressed and moved to the second position, the first opening 413 is blocked, thereby preventing fluid communication with the central conduit 408 (and thereby the needle). Instead, the second passage 411 of the actuator 406 is aligned with the second opening 405, and the first passage 410 is positioned to be in fluid communication with a third opening 414 leading to a vent chamber 412 formed in the hub body 402. Thus, in this second position, the user can depress the plunger rod of an arterial blood sampling element (not shown) to vent air bubbles and coagulated sample volume from the arterial blood sampling element into the vent chamber 412. Although not shown, it should be understood that one end of the vent chamber 412 can include a vent plug that will allow air to pass through the vent plug until wet, at which time the vent plug will seal to prevent further passage of air and blood.

[0204] like Fig.56 and Fig.57 As shown, the actuator 406 can incorporate a plurality of O-ring type seals 424 to prevent air and / or blood from leaking from the holes 407. The seals 424 can be formed of any suitable material, such as, for example, TPE. In addition, a plug 422 can be provided in one end of the actuator 406 to simplify molding of the actuator 406 having interconnected passages formed therethrough.

[0205] Next, refer to Fig.58 and Fig.59, shows a gravity-based "locking valve" configured to prevent blood from flowing into the chamber when the arterial blood module 450 is pointed downward (i.e., the needle 454 is pointed downward). As shown, the arterial blood module 450 includes a housing 452, a needle 454, and a safety shield 456 that can be selectively deployed by a spring 458. A base 460 is also provided, wherein the base 460 is configured to allow fluid communication between the needle 454 and an arterial blood sampling element coupled to the arterial blood module 450.

[0206] The arterial blood module 450 also includes a moving ball 462 that is movably disposed between the base 460 and a passage 465 that is fluidly coupled to the needle 454. Fig.58 As shown, when the arterial blood module 450 is held in a vertical position (ie, with the needle 454 pointing upward), the ball 462 naturally moves away from the base 464 near the passage 465, thereby allowing fluid to flow from the base 460 to the needle 454. Fig.59 When arterial blood module 450 is inverted to remain in the downward position, gravity guides ball 462 into base 464, thereby blocking blood from entering passage 465 when the device is actuated with needle 454 pointing downward. However, safety shield 456 can be deployed to generally cover needle 454 regardless of the position of needle 454.

[0207] Now refer to Fig.60 and Fig.61 , shows a safety shield assembly 500 according to another aspect of the present disclosure. The safety shield assembly 500 includes a telescoping needle shield including 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 are used to generally surround a needle 506 coupled to, for example, an arterial blood module.

[0208] The safety shield assembly 500 also includes an insert 510 disposed at or near the distal end of the inner portion of the inner telescoping member 505. Fig.61 As shown, insert 510 includes a slot 512. Slot 512 can be configured to be Fig.60 ) allows the needle 506 to pass through the slot, but when the needle 506 is surrounded by the safety shield assembly (as shown Fig.61 The insert 510 may be formed of any suitable material, such as an elastic material or a foam material, for example.

[0209] When the safety shield is actuated to close, the insert 510 moves along the needle 506, thereby wiping the outer surface of the needle 506 as the inner telescopic member 505 moves to its end. Then, once beyond the distal end of the needle 506, the groove 512 of the needle 510 is generally closed, thereby preventing blood from splashing out of the safety shield assembly 500.

[0210] Next, refer to Fig.62 and Fig.63 , showing a safety shield assembly 520 according to another aspect of the present disclosure. Similar to the above reference Fig.60 and Fig.61 The safety shield assembly 500 described herein includes a telescoping needle shield including 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, the outer telescoping member 522, the intermediate telescoping member 524, and the inner telescoping member 525 are used to generally surround a needle 526 coupled to, for example, an arterial blood module.

[0211] The safety shield assembly 520 also includes an insert 530 disposed at or near the distal end of the inner portion of the inner telescoping member 525. The insert 530 may include a living hinge to allow the insert 530 to clamp or close when pressed against the inner 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 be in a first configuration (e.g., Fig.62 ) allows the needle 526 to pass through the insert, but when the needle 526 is substantially surrounded by the safety shield assembly (as shown Fig.63 When the safety shield is actuated to close, the insert 530 moves along the needle 526, thereby wiping the outer surface of the needle 526 as the inner telescopic member 525 moves to its end point. Then, once beyond the distal end of the needle 526, the force exerted on the insert 530 by the spring 528 causes the insert to pivot about the living hinge to be generally closed at its distal end, thereby preventing blood from splattering out of the safety shield assembly 520.

[0212] Now refer to Figure 64 to Figure 69 , an arterial blood module 550 according to another aspect of the present disclosure is shown. As with the various arterial blood modules described above, the arterial blood module 550 is configured to be coupled to an arterial blood sampling element 14 having a plunger 22 and a stopper 24, for example, for collecting and dispensing blood samples.

[0213] The arterial blood module 550 includes a hub 552 having a proximal coupling interface 562, wherein the proximal coupling interface 562 is configured to removably couple the arterial blood module 550 to an arterial blood sampling element (such as, for example, the arterial blood sampling element 14 described above). The arterial blood module 550 also includes a safety shield 554 that can be selectively deployed by a user to cover the needle 556. As will be described in further detail below, the deployment of the safety shield 554 is initiated by an actuator 560 housed within the hub 552.

[0214] Figure 64 to Figure 66 Arterial blood module 550 is shown in a first configuration, wherein safety shield 554 is in an undeployed position such that needle 556 is at least partially exposed. Fig.68 As shown, the safety shield 554 can be releasably fixed to the hub body 552 via the interface between the protrusion 557 of the hub body 552 and the detent portion 555 of the safety shield 554. The proximal portion of the safety shield 554 including the detent portion 555 is configured to be received in the slot 563 of the hub body 552. The slot 563 is in communication with the actuator hole 559 formed in the hub body 552, wherein the actuator 560 can slide in the actuator hole 559 in a direction that is generally transverse to the direction of the slot 563 and thus generally transverse to the deployment direction 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, thereby disengaging the stop portion 555 of the safety shield 554 from the protruding portion 557 of the hub body 552, so 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. Fig.67 shown.

[0215] Refer again Fig.68 , when the safety shield 554 is in the undeployed position (i.e., 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 through the hub body 552, wherein the flow channel 570 is in fluid communication with the needle 556. Although not shown, the flow channel 570 can be in communication with a sample stabilizer, for example, located within a portion of the hub body 552. In this configuration, a blood sample can flow through the needle 556, the flow channel 570, and around the actuator 560 to the opening 568, where the sample can be drawn into, for example, an arterial blood sampling element coupled to the proximal coupling interface 562. A radial seal circumferentially disposed about the actuator 560 can be used to provide a fluid-tight passage between the flow channel 570 and the opening 568.

[0216] On the contrary, refer to Fig.69, when the actuator 560 is pressed to deploy the safety shield 554, the fluid passage between the opening 568 and the flow channel 570 is also disconnected, thereby preventing the fluid flow between the needle 556 and the opening 568. More specifically, the pressing of the actuator 560 within the actuator hole 559 aligns the orifice 566 formed in the actuator 560 with the opening 568. The orifice 566 is in fluid communication with the exhaust chamber 561 formed in the actuator 560. The actuator 560 may also include an exhaust plug in communication with the exhaust chamber 561, the exhaust plug allowing air to pass through the exhaust plug while preventing the blood sample from passing through the exhaust plug. In some embodiments, the exhaust plug may include a hydrophobic filter. In this way, any bubbles contained in the arterial blood sampling element coupled to the arterial blood module 550 can be discharged to the outside of the system through the exhaust chamber 561 and discharged from the exhaust plug formed as a part of the actuator 560.

[0217] Although not specifically shown, it should be understood that the hub 552 and safety shield 554 can be configured such that the safety shield 554 is generally locked in place when deployed, thereby preventing undesirable or accidental exposure of the needle 556. After the blood draw and bubble degassing procedure, the entire arterial blood module 550 can be separated from the arterial blood sampling element 14, and the entire arterial blood module 550 can be disposed of in an appropriate sharps container.

[0218] Next, refer to Figure 70 to Figure 77 , showing various aspects of an arterial blood module 600 according to another aspect of the present disclosure. As with the above-described arterial blood module, the arterial blood module 600 is configured to be coupled to an arterial blood sampling element 14 for collecting and dispensing a blood sample, for example, the arterial blood sampling element having a plunger 22 and a stopper 24, such as Fig.70 shown.

[0219] The arterial blood module 600 includes a hub body 602 having a proximal coupling interface 611, wherein the proximal coupling interface 611 is configured to removably couple the arterial blood module 600 to an arterial blood sampling element (such as, for example, the arterial blood sampling element 14 described above). The arterial blood module 600 also includes a safety shield 604 that can be selectively deployed by a user to cover the needle 606. As will be described in further detail below, the deployment of the safety shield 604 is initiated by an actuator 610 housed within the hub body 602.

[0220] Figure 70 to Figure 72 Arterial blood module 600 is shown in a first configuration, wherein safety shield 604 is in an undeployed position such that needle 606 is at least partially exposed. Fig.74As shown, the safety shield 604 can be releasably fixed to the hub body 602 via the interface between the protrusion 625 of the hub body 602 and the stop portion 621 of the safety shield 604. The proximal portion of the safety shield 604 including the stop portion 621 is configured to be received in the slot 613 of the hub body 602. The slot 613 is in communication with the actuator hole 609 formed in the hub body 602, wherein the actuator 610 can slide in the actuator hole 609 in a direction that is generally transverse to the direction of the slot 613 and thus generally transverse to the deployment direction 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, thereby disengaging the stop portion 621 of the safety shield 604 from the protruding portion 625 of the hub body 602, so 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. Fig.73 shown.

[0221] like Fig.74 As shown, when the safety shield 604 is in the undeployed position (i.e., the needle 606 is exposed), the arterial blood module 600 is configured to provide a fluid path between the needle 606 and an opening 620 in communication with the proximal coupling interface 611. More specifically, the arterial blood module 600 includes a flow channel 625 through the hub body 602, wherein the flow channel 625 is in fluid communication with the needle 606. Although not shown, the flow channel 625 can be in communication with a sample stabilizer, for example, located within a portion of the hub body 602. In this configuration, a blood sample can flow through the needle 606, through the flow channel 625, through the first channel 622 formed through the actuator 610, and through the opening 620, where the sample can be drawn into, for example, an arterial blood sampling element coupled to the proximal coupling interface 611.

[0222] However, referring to Fig.75 When the actuator 610 is depressed to deploy the safety shield 604, the first channel 622 is fluidly disconnected 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 within the actuator hole 609 aligns a second channel 623, which is generally L-shaped, formed in the actuator 560 with the opening 620. The second channel 623 is in fluid communication with the second opening 624, which is fluidly coupled to the exhaust chamber 612 formed in the hub body 602. Figure 71 to Figure 73As shown, the vent plug 614 is arranged to communicate with the vent chamber 612, and the vent plug allows air to pass through the vent plug until it is completely wetted, while preventing the blood sample from passing through the vent plug. In some embodiments, the vent plug 614 may include a hydrophobic filter. In this way, any bubbles contained in the arterial blood sampling element coupled to the arterial blood module 600 can be discharged to the outside of the system through the vent chamber 612 integrally formed in the hub body 602, and discharged from the vent plug 614.

[0223] Although not specifically shown, it is understood that the hub 602 and safety shield 604 can be configured such that the safety shield 604 is generally locked in place when deployed, thereby preventing undesirable or accidental exposure of the needle 606. After the blood draw and bubble degassing procedure, the entire arterial blood module 600 can be separated from the arterial blood sampling element 14, and the entire arterial blood module 600 can be disposed of in an appropriate sharps container.

[0224] Now refer to Figures 78 to 84 , an arterial blood module 650 according to another aspect of the present disclosure is shown. Like the above-mentioned arterial blood module, the arterial blood module 650 is configured to be coupled to an arterial blood sampling element 14 for collecting and dispensing blood samples, for example, the arterial blood sampling element having a plunger 22 and a stopper 24, such as Fig.78 shown.

[0225] The arterial blood module 650 includes a hub body 652 having a proximal coupling interface 661, wherein the proximal coupling interface 661 is configured to removably couple the arterial blood module 650 to an arterial blood sampling element (such as, for example, the arterial blood sampling element 14 described above). The arterial blood module 650 also includes a safety shield 654 that can be selectively deployed by a user to cover the needle 656. As will be described in further detail below, the deployment of the safety shield 654 is initiated by rotation of a stopcock 664 that is at least partially housed within the hub body 652.

[0226] Figures 78 to 80 Arterial blood module 650 is shown in a first configuration, wherein safety shield 654 is in an undeployed position such that needle 656 is at least partially exposed. In this first configuration, safety shield 654 can be releasably secured to hub body 652 via an interface between at least one of stem actuator 660 and stopcock 664, stem actuator 660 being coupled to stopcock 664. When stem actuator 660 is actuated to rotate stopcock 664, safety shield 654 can also be released to telescopically deploy safety shield 654 over needle 656 by a spring force exerted by spring 658, as shown in FIG. Fig.81 shown.

[0227] Reference Fig.82, when the safety shield 654 is in the undeployed position (i.e., the needle 656 is exposed), the arterial blood module 650 is configured to provide a fluid path between the needle 656 and an opening 672 in communication with the proximal coupling interface 661. More specifically, the arterial blood module 650 includes a flow channel 674 through the hub body 652, wherein the flow channel 674 is in fluid communication with the needle 656. Although not shown, the flow channel 674 can be in communication with a sample stabilizer, for example, located within a portion of the hub body 652. In this configuration, the stem actuator 660 and the stopcock 664 are in a first position so that a blood sample can flow through the needle 656, through the flow channel 674, through a first channel 675 formed through the stopcock 664, and through the opening 672, where the sample can be drawn into, for example, an arterial blood sampling element coupled to the proximal coupling interface 661.

[0228] On the contrary, refer to Fig.83 , when the rod actuator 660 is pressed to provide, for example, a 90° rotation of the stopcock 664, not only can the safety shield 654 be deployed, but the first channel 675 is fluidly disconnected from the flow channel 674, thereby preventing fluid flow between the needle 656 and the opening 672. Instead, the rotation of the stopcock 664 aligns the second channel 676 formed in the stopcock 664 with the opening 672, while also aligning the first channel 675 with the second opening 670. The second opening 670 is fluidly coupled to the exhaust chamber 662 formed in the hub body 652. As shown in 79 to 86, the exhaust plug 665 is configured to communicate with the exhaust chamber 662, which allows air to pass through the exhaust plug until it is fully wetted while preventing the blood sample from passing through the exhaust plug. In some embodiments, the exhaust plug 665 may include a hydrophobic filter. In this way, any bubbles contained within the arterial blood sampling element coupled to the arterial blood module 650 can be discharged to the outside of the system through the exhaust chamber 662 integrally formed in the hub body 602 and discharged from the exhaust plug 614, and the exhaust chamber 662 can accommodate a small amount of coagulated blood sample in the exhaust chamber.

[0229] Although not specifically shown, it is understood that the hub 652 and safety shield 654 can be configured such that the safety shield 654 is generally locked in place when deployed, thereby preventing undesirable or accidental exposure of the needle 656. After the blood draw and bubble degassing procedure, the entire arterial blood module 650 can be separated from the arterial blood sampling element 14, and the entire arterial blood module 650 can be disposed of in an appropriate sharps container.

[0230] Although the present disclosure has been described as having an exemplary design, the present disclosure may be further modified within the spirit and scope of the present disclosure. Therefore, the present application is intended to cover any variation, use or adaptation of the present disclosure using its general principles. In addition, the present application is intended to cover these deviations from the present disclosure within the known or customary practices in the field to which the present disclosure belongs, and these deviations fall within the limitations of the appended claims.

Claims

1. An arterial blood sampling system, comprising: an arterial blood sampling element, the arterial blood sampling element defining a collection chamber; as well as An arterial blood module, the arterial blood module being detachably connectable to a portion of the arterial blood sampling element, the arterial blood module comprising: Hub body; a needle extending from the hub; a safety shield engaged with a portion of the hub and capable of transitioning from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield; and An exhaust chamber is provided, wherein the exhaust chamber is in fluid communication with the hub to exhaust air bubbles from the collected blood sample within the collection chamber.

2. The arterial blood sampling system according to claim 1, wherein: The arterial blood module also includes an actuator that is transitionable from a first actuator position to a second actuator position, wherein the second actuator position releases the safety shield to the second shield position.

3. The arterial blood sampling system according to claim 2, wherein: The actuator includes a button.

4. The arterial blood sampling system according to claim 2, wherein: The safety shield comprises a telescopic shield.

5. The arterial blood sampling system according to claim 2, wherein: The exhaust chamber is formed in the actuator.

6. The arterial blood sampling system according to claim 1, wherein: The hub of the arterial blood module defines the exhaust chamber.

7. The arterial blood sampling system according to claim 1, wherein: The arterial blood module further includes a vent plug that allows air to pass through the vent plug and prevents a blood sample from passing through the vent plug, wherein a portion of the vent plug is in communication with the vent chamber.

8. The arterial blood sampling system according to claim 1, wherein: The needle and the safety shield are selectively removable from the hub.

9. The arterial blood sampling system according to claim 8, wherein: The needle and the safety shield can be removed from the hub only when the safety shield is in the second shield position.

10. The arterial blood sampling system according to claim 1, wherein: The actuator includes an actuator stem and a stopcock.

11. The arterial blood sampling system according to claim 1, wherein: The arterial blood sampling module also includes an eccentric needle holder including a needle bearing portion, an exhaust chamber portion, and a rotatable rod portion, wherein the needle bearing portion is coupled to the needle and is in fluid communication with the needle.

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

13. An arterial blood module, comprising: Hub body; a needle extending from the hub; a safety shield engaged with a portion of the hub and capable of transitioning from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield; as well as An exhaust chamber is provided, wherein the exhaust chamber is in fluid communication with the hub to exhaust air bubbles from the collected blood sample within the collection chamber.

14. The arterial blood module according to claim 13, wherein: The arterial blood module is removably connectable to a portion of the arterial blood sampling element.

15. The arterial blood module according to claim 14, wherein: The arterial blood module is connectable to a portion of the arterial blood sampling element via a threaded Luer connection.

16. The arterial blood module of claim 13, further comprising an actuator that is switchable from a first actuator position to a second actuator position, wherein: The second actuator position releases the safety shield to the second shield position.

17. The arterial blood module according to claim 16, wherein: The exhaust chamber is formed in the actuator.

18. The arterial blood module according to claim 16, wherein: The actuator includes a button.

19. The arterial blood module according to claim 16, wherein: The actuator includes an actuator stem and a stopcock.

20. The arterial blood module according to claim 13, wherein: The hub of the arterial blood module defines the exhaust chamber.

21. The arterial blood module of claim 13, further comprising a vent plug that allows air to pass through the vent plug and prevents a blood sample from passing through the vent plug, wherein A portion of the exhaust plug communicates with the exhaust chamber.

Images