Arterial blood collection system and arterial blood module

Abstract

An arterial blood collection system includes an arterial blood collection element defining a collection chamber and an arterial blood module removably connectable to a portion of the arterial blood collection element, the arterial blood module including: a housing having a first end and a second end; a needle extending from the first end; a cap removably securable on the needle; a mixing chamber adjacent to the second end; and a safety shield engaged with a portion of the housing, the safety shield being 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 present disclosure also includes an arterial blood module. The present disclosure simplifies and reduces the number of workflow steps and enables single-handed device operation, which allows for a more efficient arterial blood gas collection procedure.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application Serial No. 62 / 727,869, filed on September 6, 2018, entitled “ARTERIAL BLOOD GAS COLLECTION SYSTEM,” the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure generally relates to arterial blood collection systems.

[0004] More particularly, the present disclosure relates to an arterial blood collection system including an arterial blood collection element suitable for radial artery puncture and an arterial blood module. Background Art

[0005] Arterial blood collection syringes are used to draw and collect arterial blood samples from a patient. Once the blood sample is collected, it is analyzed for diagnostics, primarily blood gases, and often electrolytes, metabolites, and other components indicative of the patient's condition. Various types of syringes have been designed for collecting arterial blood samples, which primarily include the components from a hypodermic syringe (i.e., a plastic or glass syringe barrel), a sealing elastomeric stopper with or without a vent, and a plunger rod.

[0006] Conventional arterial blood collection syringes typically use a conventional hypodermic needle with a safety shield that needs to be snapped on or slid over the needle after the blood collection procedure. During the blood collection procedure, this safety shield is typically in sight, obscuring the physician's view during this delicate procedure.

[0007] Conventional arterial blood collection syringes also have a separate vent cap that requires removal of the needle to expel trapped air bubbles from the collected sample before attaching the cap to the syringe.

[0008] Conventional arterial blood collection syringes that include anticoagulants typically contain the anticoagulant within the syringe, thereby requiring the user to roll or shake the collected sample to ensure adequate mixing with the anticoagulant. Summary of the invention

[0009] The present disclosure provides an arterial blood module that can be removably connected to an arterial blood collection element. The arterial blood module includes a housing, a needle, a cap that can be removably 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 collection system that includes an arterial blood collection element that defines a collection chamber and an arterial blood module that can be removably connected to a portion of the arterial blood collection element.

[0010] In an exemplary embodiment, the arterial blood collection system of the present disclosure provides a novel blood collection 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, which allows for a more efficient arterial blood gas (ABG) collection procedure. The arterial blood module of the present disclosure includes ergonomic contact points, a push-button safety shield, automatic anticoagulant mixing, and an integrated vent cap for expelling air bubbles after the collection procedure if necessary.

[0011] According to an embodiment of the present invention, an arterial blood collection system includes: an arterial blood collection element defining a collection chamber; and an arterial blood module removably connected to a portion of the arterial blood collection element, the arterial blood module including: a housing having a first end and a second end; a needle extending from the first end; a cap removably fixable on the needle; a mixing chamber adjacent to the second end; and a safety shield engaged with a portion of the housing, the safety shield being 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.

[0012] In one configuration, the safety shield includes a shield assembly and an actuator capable of switching from a first actuator position to a second actuator position, wherein in the first actuator position, the actuator engages a portion of the shield assembly to lock the shield assembly in the first shield position, and in the second actuator position, the actuator releases the shield assembly and the safety shield automatically moves to the second shield position. In another configuration, the actuator includes a push button. In yet another configuration, the shield assembly includes a telescopic shield. In one configuration, the shield assembly includes: a fixed outer shield; a movable intermediate shield, which is in communication with the fixed outer shield, wherein the movable intermediate shield moves relative to the fixed outer shield; and a movable inner shield, which is in communication with the movable intermediate shield, wherein the movable inner shield moves relative to the movable intermediate shield. In another configuration, when the safety shield is in the first shield position, the movable inner shield is nested inside the movable intermediate shield, and the movable intermediate shield is nested inside the fixed outer shield. In yet another configuration, when the safety shield is in the second shield position, the movable inner shield extends from the movable middle shield, and the movable middle 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 collection system includes: a material containing pores 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 and mixes with the dry anticoagulant powder while passing through the material. In another configuration, the material is an open-cell foam. In another configuration, the sample stabilizer is a dry anticoagulant powder. In one configuration, the housing of the arterial blood module defines a vent cavity. In another configuration, the arterial blood module also includes a vent plug that allows air to pass therethrough but prevents blood sample from passing therethrough, wherein a portion of the vent plug is in communication with the vent cavity. In yet another configuration, the arterial blood module further comprises a first valve, and wherein, in a case where the arterial blood module is connected to the arterial blood collection element, the blood sample enters the collection chamber of the arterial blood collection 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 collection element. In another configuration, the first valve prevents the blood sample from returning from the collection chamber of the arterial blood collection element to the arterial blood module. In yet another configuration, the arterial blood module further comprises a second valve, and wherein, in a case where the arterial blood module is connected to the arterial blood collection element, air and a portion of the blood sample contained in the collection chamber of the arterial blood collection element enter the ventilation cavity via the second valve. In one configuration, the air exits the arterial blood module via the ventilation plug. In another configuration, the arterial blood module comprises a first finger grip portion.In yet another configuration, the arterial blood module includes a second finger grip portion, wherein the first finger grip portion is opposite the second finger grip portion. In one configuration, the needle includes thin wall needle technology. In another configuration, the arterial blood collection element includes a plunger rod assembly, the plunger rod assembly including a stopper and a plunger rod.

[0013] 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 engaged with a portion of the housing, the safety shield being able to 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.

[0014] In one configuration, the arterial blood module is removably connectable to a portion of the arterial blood collection element. In another configuration, the arterial blood collection element defines a collection chamber. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The above and other features and advantages of the present disclosure and the manner of achieving them will become more apparent and the present disclosure itself will be better understood by referring to the following description of the embodiments of the present disclosure in conjunction with the accompanying drawings, in which:

[0016] Figure 1 is a perspective view of an arterial blood collection system according to an embodiment of the present invention.

[0017] Figure 2 is a perspective view of an arterial blood module according to an embodiment of the present invention, with a cap secured to a needle.

[0018] 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.

[0019] Figure 4 is a perspective view of an arterial blood collection system according to an embodiment of the present invention, wherein air bubbles are being expelled from the system.

[0020] 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.

[0021] Figure 6 is a perspective view of a second step of using the system of the present disclosure, according to an embodiment of the present invention.

[0022] 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.

[0023] Figure 8is a perspective view of a fourth step of using the system of the present disclosure, according to an embodiment of the present invention.

[0024] 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.

[0025] Fig.10 is a first schematic diagram of an arterial blood collection system according to an embodiment of the present invention.

[0026] Fig.11 is a second schematic diagram of an arterial blood collection system according to an embodiment of the present invention.

[0027] Fig.12 is a third schematic diagram of an arterial blood collection system according to an embodiment of the present invention.

[0028] Fig.13 is a cross-sectional view of a portion of an arterial blood module according to an embodiment of the present invention with the safety shield in a first shield position.

[0029] Fig.14 is a cross-sectional view of a portion of an arterial blood module according to an embodiment of the present invention with the safety shield in a second shield position.

[0030] Fig.15 is a cross-sectional view of a portion of an arterial blood module according to another embodiment of the present invention, wherein the safety shield is in a first shield position.

[0031] Fig.16 is a cross-sectional view of a portion of an arterial blood module according to another embodiment of the present invention, wherein the safety shield is in a second shield position.

[0032] Fig.17 is a cross-sectional view of a portion of an arterial blood module according to another embodiment of the present invention, wherein the safety shield is in a first shield position.

[0033] Fig.18 is a cross-sectional view of a portion of an arterial blood module according to another embodiment of the present invention, wherein the safety shield is in a second shield position.

[0034] Fig.19 is a perspective view of an open-cell foam material according to an embodiment of the present invention.

[0035] 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.

[0036] Corresponding reference characters indicate corresponding parts throughout the several views.The examples set out herein illustrate exemplary embodiments of the disclosure, and these examples should not be construed as limiting the scope of the disclosure in any way. DETAILED DESCRIPTION

[0037] The following description is provided to enable those skilled in the art to make and use the described embodiments envisioned for implementing the present invention. However, various modifications, equivalents, variations and substitutions remain apparent to those skilled in the art. Any and all of these modifications, variations, equivalents and substitutions are intended to fall within the spirit and scope of the present invention.

[0038] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "side", "longitudinal" and their derivatives shall relate to the present invention as it is oriented in the accompanying drawings. However, it should be understood that the present invention may adopt various alternative variations unless expressly indicated 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, specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0039] The present disclosure provides an arterial blood module that can be removably connected to an arterial blood collection element. The arterial blood module includes a housing, a needle, a cap that can be removably fixed to the needle, a mixing chamber, and a safety shield engaged with a portion of the housing, the safety shield being able to 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 collection system, which includes an arterial blood collection element defining a collection chamber and an arterial blood module that can be removably connected to a portion of the arterial blood collection element.

[0040] In an exemplary embodiment, the arterial blood collection system of the present disclosure provides a novel blood collection 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, which allows for a more efficient arterial blood gas (ABG) collection procedure. The arterial blood module of the present disclosure includes ergonomic contact points, a push-button safety shield, automatic anticoagulant mixing, and an integrated vent cap for expelling air bubbles after the collection procedure if necessary.

[0041] Figure 1-20 shows an exemplary embodiment of an arterial blood collection system 10 of the present disclosure, which is suitable for receiving a biological fluid sample, such as an arterial blood sample 12. In one embodiment, the arterial blood collection system 10 of the present disclosure includes an arterial blood collection element 14 and an arterial blood module 16, which is removably connectable to a portion of the arterial blood collection element 14.

[0042] Reference Figure 1 and Figure 4-12 In one embodiment, the arterial blood collection element 14 of the present disclosure is adapted to receive a biological fluid sample, such as an arterial blood sample 12, and defines a collection chamber 20. In an exemplary embodiment, the arterial blood collection element 14 includes a plunger rod assembly 22 having a stopper 24 and a plunger rod 26. In one embodiment, the arterial blood collection element 14 is a conventional arterial blood gas syringe assembly, such as a Luer lock or Luer-slip arterial blood gas syringe assembly. The arterial blood module 16 of the present disclosure may be compatible with any conventional arterial blood collection element or arterial blood gas syringe assembly.

[0043] When the system 10 of the present disclosure is used to remove arterial blood, the blood at the arterial pressure is greater than the normal atmospheric or ambient pressure within the collection chamber 20 of the arterial blood collection 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's body through the arterial blood module 16 to the collection chamber 20 of the arterial blood collection 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 vented arterial blood gas syringe stopper.

[0044] like Figure 1-2 0, in one embodiment, the arterial blood module 16 of the present disclosure is removably connectable to a portion of the arterial blood collection element 14 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.

[0045] In an exemplary embodiment, the arterial blood module 16 of the present disclosure is removably connectable to a portion of the arterial blood collection element 14 by conventional methods and structures. For example, in one embodiment, the arterial blood module 16 of the present disclosure is removably connectable to a portion of the arterial blood collection element 14 via a standard Luer connector.

[0046] 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 disposed in fluid communication with the flow channel 37. The mixing chamber 36 and the sample stabilizer 39 are positioned so that a biological fluid sample (e.g., 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 flows into the collection chamber 20 of the arterial blood collection element 14 together with the appropriate sample stabilizer 39 appropriately mixed therein. In this way, the blood sample 12 can be mixed with a sample stabilizer 39 (e.g., an anticoagulant or other additive) disposed in the arterial blood module 16 before passing through the mixing chamber 36, so that the sample stabilizer 39 is appropriately mixed within the blood sample 12, and then the stabilized sample is received and stored in the collection chamber 20 of the arterial blood collection element 14.

[0047] 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. 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 (e.g., a blood stabilizer) as the blood sample 12 flows through the mixing chamber 36.

[0048] The sample stabilizer can be an anticoagulant, or a substance designed to preserve specific components in the blood, such as RNA, protein analytes, or other components. 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 can be disposed in other areas within the housing 30 of the arterial blood module 16.

[0049] Reference Figure 19-2 0, in one embodiment, the arterial blood module 16 includes a material 40 including pores 42 and a dry anticoagulant powder 44 located within the pores 42 of the material 40, the material 40 being disposed within the flow channel 37, between the first end 46 of the housing 30 and the mixing chamber 36. In this manner, the arterial blood module 16 can include a dry anticoagulant, such as heparin or EDTA, deposited on or within a portion of the arterial blood module 16. In one embodiment, the material 40 is an open-cell foam containing a dry anticoagulant dispersed within the open cells of the open-cell foam to promote circulation mixing and effectiveness of anticoagulant absorption. In one embodiment, the sample stabilizer 39 is a dry anticoagulant powder 44.

[0050] In one embodiment, the open cell foam may be treated with an anticoagulant to form a dry anticoagulant powder finely distributed throughout the pores of the open cell foam. As the blood sample 12 enters the arterial blood module 16, the blood sample 12 passes through the open cell foam and is exposed to the anticoagulant powder available throughout the internal pore structure of the open cell foam. In this manner, the blood sample 12 dissolves and mixes with the dry anticoagulant powder 44 while passing through the material 40 or the open cell foam.

[0051] The open-cell foam may be a soft, deformable open-cell foam that is inert to blood, for example, a melamine foam, such as Basotect® foam commercially available from BASF, or the open-cell foam may be composed of a formaldehyde-melamine-sodium bisulfite copolymer. The open-cell foam may also be a flexible, hydrophilic open-cell foam that is substantially resistant to heat and organic solvents. In one embodiment, the open-cell foam may include a sponge material.

[0052] Anticoagulants or other additives may be introduced into the open cell foam by soaking the open cell 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.

[0053] 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 (e.g., 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.

[0054] The interior portion of the mixing chamber 36 may have any suitable structure or form so long as it 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 .

[0055] The mixing chamber 36 receives the blood sample 12 and the sample stabilizer 39 therein, and achieves distributed mixing of the sample stabilizer 39 within the blood sample 12. The mixing chamber 36 achieves distributed mixing of the sample stabilizer 39 within the blood sample 12 and prevents a very high sample stabilizer concentration from occurring in any portion of the blood sample 12. This prevents insufficient dosing of the sample stabilizer 39 in any portion of the blood sample 12. The mixing chamber 36 achieves distributed mixing of the sample stabilizer 39 within the blood sample 12, so that substantially equal amounts and / or equal concentrations of the sample stabilizer 39 are dissolved in the entire blood sample 12, for example, substantially equal amounts and / or equal concentrations of the sample stabilizer 39 are dissolved into the blood sample 12 from the front portion of the blood sample 12 to the rear portion of the blood sample 12.

[0056] Reference Figure 1-2 0, 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 a 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, resulting in a fast fill time and a shorter exposure of the patient to uncomfortable procedures.

[0057] Reference Figure 1-2 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.

[0058] Reference Figure 1-2 0, in one embodiment, the arterial blood module 16 includes a safety shield 38 that engages a portion of the housing 30 and can be moved from a first shield position ( Figure 3 ) to the second shroud position ( Fig.14 , 16 and 18), in the first shield position, a portion of the needle 32 is exposed, and in the second shield position, the needle 32 is shielded by a portion of the safety shield 38.

[0059] 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 , 15 and 17) to the second actuator position ( Fig.14 , 16 and 18), in the first actuator position, 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 the second actuator position, the actuator 52 releases the shield assembly 50 and the safety shield 38 automatically moves to the second shield position ( Fig.14 , 16and 18). In one exemplary embodiment, the actuator 52 includes a push button. In this manner, the integrated push button safety shield 38 of the present disclosure provides a device that can be activated with one hand by simply pushing a button after the collection procedure is completed, while not obstructing the view of the medical staff during the collection procedure. In this manner, the safety shield 38 of the arterial blood module 16 of the present disclosure allows for automatic shielding of the needle 32 after use. For example, in one exemplary embodiment, upon activation of the actuator 52 of the safety shield 38, the spring 59 applies a force on 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.

[0060] Reference Figure 13-18 In an exemplary embodiment, the shield assembly 50 includes a telescoping shield. For example, referring to Figure 13-14 In an exemplary embodiment, the shield assembly 50 includes: a fixed outer shield 54; a movable intermediate shield 56, which is connected to the fixed outer shield 54, wherein the movable intermediate shield 56 moves relative to the fixed outer shield 54; and a movable inner shield 58, which is connected to the movable intermediate shield 56, wherein the movable inner shield 58 moves relative to the movable intermediate shield 56.

[0061] Reference Fig.13 In one embodiment, when the safety shield 38 is in the first shield position, the movable inner shield 58 is nested inside the movable middle shield 56 , and the movable middle shield 56 is nested inside the fixed outer shield 54 .

[0062] Reference Fig.14 In one embodiment, when the safety shield 38 is in the second shield position, the movable inner shield 58 extends from the movable middle shield 56 , and the movable middle shield 56 extends from the fixed outer shield 54 .

[0063] In an exemplary embodiment, upon activation of the actuator 52 of the safety shield 38, the spring 59 exerts a force on a portion of the shield assembly 50 to automatically move the safety shield 38 to a second 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 movable 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 to a portion of the movable inner shield 58 to automatically move the fixed outer shield 54, the movable intermediate shield 56, and the movable inner shield 58 to a second shield position in which the needle 32 is shielded by a portion of the shield assembly 50.

[0064] Figure 15-18 Other exemplary embodiments are shown. Figure 15-16The illustrated embodiment includes Figure 13-14 Similar components of the illustrated embodiment are identified by a reference numeral followed by the letter A. Figure 17-18 The illustrated embodiment also includes Figure 13-14 Similar components of the embodiment shown are shown, and similar components are indicated by a reference numeral followed by the letter B. For the sake of brevity, these similar components and the use of arterial blood module 16A ( Figure 15-16 ) and arterial blood module 16B ( Figure 17-18 ) will no longer be combined with Figure 15-16 and Figure 17-18 The embodiments shown are discussed in their entirety.

[0065] Advantageously, the arterial blood module 16 of the present disclosure allows for an integrated venting system that allows for removal of air bubbles by simply expelling trapped air bubbles into a venting compartment inside the arterial blood module 16. For example, in an exemplary embodiment, the arterial blood module 16 includes a venting lumen 60, a venting plug 62, a first valve 64, and a second valve 66.

[0066] In one embodiment, the housing 30 of the arterial blood module 16 defines a vent cavity 60. In an exemplary embodiment, the arterial blood module 16 includes a vent plug 62 that allows air to pass therethrough but prevents the blood sample 12 from passing therethrough, wherein a portion of the vent plug 62 is in communication with the vent cavity 60. In this manner, any air bubbles contained within the arterial blood collection element 14 can be expelled to the exterior of the system 10 through the vent cavity 60 and out of the vent plug 62. The configuration of the arterial blood module 16, the vent cavity 60, and the vent plug 62 allows air to pass through the arterial blood module 16 but prevents the blood sample 12 from passing through the arterial blood module 16, and may include a hydrophobic filter.

[0067] Reference Figure 10-12 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 collection element 14, the blood sample 12 enters the collection chamber 20 of the arterial blood collection element 14 via the needle 32 and the first valve 64. The first valve 64 allows the blood sample 12 to flow from the arterial blood module 16 to the collection chamber 20 of the arterial blood collection element 14. The first valve 64 prevents the blood sample 12 from returning from the collection chamber 20 of the arterial blood collection element 14 to the arterial blood module 16. In one embodiment, the first valve 64 is a one-way valve.

[0068] 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 collection element 14, a portion of the air and blood sample 12 contained in the collection chamber 20 of the arterial blood collection element 14 enters the venting lumen 60 via the second valve 66. In one embodiment, the second valve 66 is a one-way valve.

[0069] 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 Figure 1-2 0, 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.

[0070] Reference Figure 5-9 , the use of the arterial blood collection system 10 of the present disclosure having the arterial blood module 16 and the arterial blood collection element 14 will now be described.

[0071] 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. Before using the arterial blood module 16, the user can remove the safety cap 34 by pulling the safety cap 34 away from the arterial blood module 16, such as Figure 5 shown.

[0072] Reference Figure 6 , the needle 32 of the system 10 is inserted into the patient's artery 70. As described above, the arterial blood collection element 14 of the arterial blood collection system 10 is self-filled due to the arterial blood pressure and the vented arterial blood gas syringe stopper. As described above, as the blood sample 12 automatically travels from the patient's artery 70 to the collection chamber 20 of the arterial blood collection element 14 via the arterial blood module 16, the arterial blood sample 12 is automatically mixed with the sample stabilizer 39.

[0073] 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 in the shielding position that safely covers the needle 32 so that the arterial blood module 16 can be safely handled and disposed of.

[0074] Reference Figure 8, and then orient the arterial blood collection system 10 vertically by pointing the safety shield needle 32 in an upward configuration. Next, 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 out of the arterial blood module 16 via the vent lumen 60 and vent plug 62, as described in detail above.

[0075] Reference Fig. 9 , the arterial blood module 16 is then removed from the arterial blood collection element 14. In this manner, the arterial blood module 16 can be safely disposed of, and the arterial blood collection element 14 can be docked with the arterial blood gas analyzer 80 for sample transfer and analysis.

[0076] The present disclosure provides an arterial blood module that can be removably connected to an arterial blood collection element. The arterial blood module includes a housing, a needle, a cap that can be removably fixed to the needle, a mixing chamber, and a safety shield engaged with a portion of the housing, the safety shield 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. In one embodiment, the present disclosure includes an arterial blood collection system that includes an arterial blood collection element that defines a collection chamber and an arterial blood module that can be removably connected to a portion of the arterial blood collection element.

[0077] In an exemplary embodiment, the arterial blood collection system of the present disclosure provides a novel blood collection 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, which allows for a more efficient arterial blood gas (ABG) collection procedure. The arterial blood module of the present disclosure includes ergonomic contact points, a push-button safety shield, automatic anticoagulant mixing, and an integrated vent cap for expelling air bubbles after the collection procedure if necessary.

[0078] 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 .

[0079] 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 the overall principles of the present disclosure. In addition, the present application is intended to cover deviations from the present disclosure that fall within known or customary practices in the field to which the present disclosure belongs and within the limitations of the appended claims.

Claims

1. An arterial blood collection system, comprising: an arterial blood collection element defining a collection chamber; as well as an arterial blood module removably connectable to a portion of the arterial blood collection element, the arterial blood module comprising: a housing having a first end and a second end; a needle extending from the first end, wherein the housing defines a vent lumen in communication with a fluid flow path defined between the needle and the arterial blood collection element, wherein the vent lumen is configured to expel air bubbles out of the arterial blood module; a first one-way valve located in the fluid flow path, wherein the first one-way valve allows a blood sample to flow from the arterial blood module to the collection chamber of the arterial blood collection element; a second one-way valve, wherein, when the arterial blood module is connected to the arterial blood collection element, the second one-way valve allows air contained in the collection chamber of the arterial blood collection element and a portion of the blood sample to enter the vent lumen; a cap removably securable on the needle; a mixing chamber adjacent the second end; and A safety shield is engaged with a portion of the housing, the safety shield being transitionable 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.

2. The arterial blood collection system according to claim 1, characterized in that: The safety shield comprises: a shroud assembly; and An actuator capable of switching from a first actuator position, in which the actuator engages a portion of the guard assembly to lock the guard assembly in the first guard position, to a second actuator position, in which the actuator releases the guard assembly and the safety guard automatically moves to the second guard position.

3. The arterial blood collection system according to claim 2, characterized in that: The actuator includes a push button.

4. The arterial blood collection system according to claim 2, characterized in that: The shield assembly includes a telescoping shield.

5. The arterial blood collection system according to claim 2, characterized in that: The shield assembly comprises: Fixing the outer shield; a movable intermediate shield in communication with the fixed outer shield, wherein the movable intermediate shield moves relative to the fixed outer shield; and A movable inner shield is in communication with the movable middle shield, wherein the movable inner shield moves relative to the movable middle shield.

6. The arterial blood collection system according to claim 5, characterized in that: When the safety shield is located at the first shield position, the movable inner shield is nested inside the movable middle shield, and the movable middle shield is nested inside the fixed outer shield.

7. The arterial blood collection system according to claim 5, characterized in that: When the safety shield is located at the second shield position, the movable inner shield extends from the movable middle shield, and the movable middle shield extends from the fixed outer shield.

8. The arterial blood collection system according to claim 1, characterized in that: The housing of the arterial blood module defines a flow passage from the first end to the second end.

9. The arterial blood collection system according to claim 8, characterized in that: The arterial blood module also includes a sample stabilizer disposed within the flow channel between the first end of the housing and the mixing chamber.

10. The arterial blood collection system of claim 9, further comprising: a material comprising pores, the material disposed within the flow passage between the first end of the housing and the mixing chamber; and A dry anticoagulant powder is located within the pores of the material.

11. The arterial blood collection system according to claim 10, characterized in that: The blood sample dissolves and mixes with the dry anticoagulant powder as it passes through the material.

12. The arterial blood collection system according to claim 10, characterized in that: The material is an open cell foam.

13. The arterial blood collection system according to claim 10, characterized in that: The sample stabilizer is a dry anticoagulant powder.

14. The arterial blood collection system according to claim 1, characterized in that: The arterial blood module further includes a vent plug that allows air to pass therethrough but prevents the blood sample from passing therethrough, wherein a portion of the vent plug communicates with the vent lumen.

15. The arterial blood collection system according to claim 1, characterized in that: The first one-way valve prevents the blood sample from returning from the collection chamber of the arterial blood collection element to the arterial blood module.

16. The arterial blood collection system according to claim 14, characterized in that: Air exits the arterial blood module via the vent plug.

17. The arterial blood collection system according to claim 1, characterized in that: The arterial blood module includes a first finger grip portion.

18. The arterial blood collection system according to claim 17, characterized in that: The arterial blood module includes a second finger grip portion, wherein the first finger grip portion is opposite the second finger grip portion.

19. The arterial blood collection system according to claim 1, characterized in that: The needle comprises thin wall needle technology.

20. The arterial blood collection system according to claim 1, characterized in that: The arterial blood collection element includes a plunger rod assembly, and the plunger rod assembly includes a stopper and a plunger rod.

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