Biological fluid collection system and stabilization assembly

Abstract

A biological fluid collection system (10) is disclosed that includes a collection module (14) for collecting a small amount of a blood sample and transferring a portion of the sample into a device or instrument for analyzing the sample, such as a point-of-care or near-patient test device including a blood collection device for collecting and transferring venous and arterial blood samples.

Description

[0001] Description of the case

[0002] This patent application is a divisional patent application.

[0003] The original application of this divisional patent application (i.e., the parent case, firm file number IIM210459) is a patent application with an international application date of August 16, 2019, an international application number of PCT / US2019 / 046854, a Chinese national application number of 201980064609.6, and a subject name of "Biological Fluid Collection System and Stabilization Component".

[0004] Cross-references to related applications

[0005] This application claims priority to U.S. Provisional Application Serial No. 62 / 719,166, filed on August 17, 2018, entitled “Biological Fluid Collection System and Stabilization Assembly,” the entire disclosure of which is incorporated herein by reference. Technical Field

[0006] The present disclosure relates generally to biological fluid collection systems. More specifically, the present disclosure relates to a collection module for collecting a small blood sample and dispensing a portion of the sample into a device for analyzing the sample (e.g., a point-of-care or near-patient testing device), and a blood collection device for collecting an arterial blood sample to be delivered to a blood gas analyzer. Background Art

[0007] There is a need for a device capable of collecting micro-samples, such as less than 1.0 ml, for analysis for patient point-of-care and blood gas analysis applications. Current devices require routine sample collection and subsequent use of large syringes or pipettes to transfer small blood samples to a point-of-care box or instrument receiving port. This open system approach increases the risk of blood exposure to personnel performing the test and increases the collection of excess sample required for prescribed testing procedures.

[0008] Therefore, it is desirable to have a blood sample collection and dispensing tool for point-of-care blood gas analysis applications that incorporates conventional automated blood draws and includes novel controlled sample transfer capabilities while minimizing exposure risk.

[0009] There is also a need to reduce the number of workflow steps in arterial blood gas collection procedures. Summary of the invention

[0010] The present invention discloses a biological fluid collection system, which includes a collection module for collecting a small blood sample and distributing a portion of the sample to a device for analyzing the sample, such as a point-of-care or near-patient testing device, such as a blood collection device for collecting venous and arterial blood samples.

[0011] According to one embodiment of the present invention, a biological fluid collection system includes a collection module suitable for receiving a sample, the collection module including: a shell having an inlet port and an outlet port, the inlet port and the outlet port being fluidically connected; a cannula; a mixing chamber arranged between the inlet port and the outlet port; and a collection chamber arranged between the mixing chamber and the outlet port, the collection chamber including an actuating portion, wherein the actuating portion is capable of switching between a first position and a second position, in the first position, the sample is capable of being contained in the collection chamber, and in the second position, a portion of the sample is discharged from the collection chamber; and a safety shield, which is engaged with a portion of the shell and is capable of switching from a first position to a second position, in the first position, a portion of the cannula is exposed, and in the second position, the cannula is shielded by at least a portion of the safety shield.

[0012] According to another embodiment of the present invention, a biological fluid collection system includes: a collection module, which is suitable for receiving a sample, the collection module includes: a shell having an inlet port and an outlet port, the inlet port and the outlet port being fluidically connected; a cannula; a mixing chamber arranged between the inlet port and the outlet port; and a collection chamber arranged between the mixing chamber and the outlet port, the collection chamber including an actuating portion, wherein the actuating portion is capable of switching between a first position and a second position, in the first position, the sample is capable of being contained in the collection chamber, and in the second position, a portion of the sample is discharged from the collection chamber; and a tube holder and a wing group connected to the tube holder, wherein a portion of the collection module is capable of engaging with a portion of the tube holder.

[0013] According to another embodiment of the present invention, a fluid collection box configured for use with a needle holder for collecting a fluid sample includes: a tubular member having a proximal end, an open distal end and a side wall extending between the proximal end and the distal end, which defines an inner chamber having an internal storage portion; a pierceable closure member connected to the open distal end of the tubular member, the closure member being configured to cooperate with the side wall of the tubular member to sealingly close the open distal end; a plunger rod assembly, which includes a stopper and a plunger rod removably connected to each other by an interengagement arrangement, wherein the interengagement arrangement is configured to enable the plunger rod to apply a distally directed force to the stopper and to enable the plunger rod to be removed from the stopper and the tubular member when the proximally directed force is applied; and a shieldable needle device.

[0014] The device of the present disclosure has the following advantages over conventional arterial blood gas (ABG) collection kits: (1) an ergonomic design with designated touch points; (2) thin-wall needle technology that allows for small gauge needles while still maintaining high flow rates, resulting in fast fill times; (3) a push-button safety shield that can be activated one-handedly after collection with a simple button press while not obstructing the user's view during the procedure; (4) an integrated vent / vent cap capability that allows trapped air bubbles to be removed during filling or after collection with a simple vent; and (5) the use of a safety sleeve with a guard and button that prevents accidental activation of the safety shield during transport of the device. 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, through the following description of embodiments of the present disclosure with reference to the accompanying drawings, in which:

[0016] Figure 1 is a perspective view of a biological fluid collection system according to one embodiment of the present invention.

[0017] Figure 2 is a cross-sectional side elevation view of a collection module with a cap according to one embodiment of the present invention.

[0018] Figure 3 is a cross-sectional side elevation view of a collection module according to one embodiment of the present invention, wherein the deformable portion is in an initial position.

[0019] Figure 4 is a cross-sectional side elevation view of a biological fluid collection system according to one embodiment of the present invention, with the lock in a locked position.

[0020] Figure 5 is a cross-sectional side elevation view of a biological fluid collection system according to one embodiment of the present invention, with the lock in an unlocked position.

[0021] Figure 6 is a cross-sectional perspective view of a collection module according to one embodiment of the present invention, wherein the deformable portion is in an initial position adjacent to a point-of-care testing device.

[0022] Figure 7 is a cross-sectional perspective view of a collection module according to one embodiment of the present invention, wherein the deformable portion is in a deformed position adjacent to a point-of-care testing device.

[0023] Figure 8 is a perspective view of a collection module according to an embodiment of the present invention.

[0024] Fig. 9is an exploded perspective view of a needle assembly with a hinged safety shield according to one embodiment of the present invention.

[0025] Fig.10 is in the retracted position Fig. 9 Assembly perspective view of the needle assembly.

[0026] Fig.11 yes Fig.10 Cross-sectional side view of the needle assembly.

[0027] Fig.12 is in extended position Fig.10 A stereoscopic view of the needle assembly.

[0028] Fig.13 is a perspective view of a biological fluid collection system according to another embodiment of the present invention.

[0029] Fig.14 is a perspective view of a biological fluid collection device inserted into a tube holder in accordance with one embodiment of the present invention.

[0030] Fig.15 is a perspective view of a fluid collection system according to another embodiment of the present invention.

[0031] Fig.16 is a perspective view of components of a fluid collection assembly according to one embodiment of the present invention.

[0032] Fig.17 is a perspective view of a fluid collection assembly according to one embodiment of the present invention.

[0033] Fig.18 According to one embodiment of the present invention Fig.16 A partial cross-sectional side view of a similar fluid collection cassette.

[0034] Fig.19 According to an embodiment of the present invention, during the insertion of the fluid collection cassette into the holder, Fig.18 A cross-sectional side view of a fluid collection assembly is shown.

[0035] Fig. 20 According to an embodiment of the present invention, during the insertion of the fluid collection cassette into the holder, Fig.17 A cross-sectional side perspective view of a fluid collection assembly is shown.

[0036] Fig.21 According to an embodiment of the present invention, after filling with the fluid treatment additive and before collecting the fluid sample, as Fig.17 A cross-sectional side perspective view of a fluid collection assembly is shown.

[0037] Fig. 22According to one embodiment of the invention, after filling with the fluid treatment additive and during removal of the plunger rod, Fig.19 A cross-sectional side view of a fluid collection assembly is shown.

[0038] Fig.23 is a perspective view of a fluid collection assembly during fluid collection according to one embodiment of the present invention.

[0039] Fig.24 According to one embodiment of the present invention, when the collection of the fluid sample is completed, as Fig.23 A cross-sectional side view of a fluid collection assembly is shown.

[0040] Fig.25 is a plan view of a fluid collection box according to an embodiment of the present invention, showing the stirring direction after collecting the fluid sample.

[0041] Fig.26 is a cross-sectional side view of a fluid collection cassette according to one embodiment of the present invention, illustrating the mixing dynamics after collecting a fluid sample.

[0042] Fig. 27 is a perspective side view of a fluid collection cassette with a Luer adapter ready for shipping and testing according to one embodiment of the present invention.

[0043] Fig.28 is a perspective view of a blood collection kit according to the present invention.

[0044] Fig.29 is a side plan view of the blood collection set showing the outer shield in a retracted position.

[0045] Fig.30 is a side plan view of a blood collection set showing the outer shield in an extended position.

[0046] Corresponding reference numerals indicate corresponding parts throughout the several views.The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications should not be construed as limiting the scope of the disclosure in any way. DETAILED DESCRIPTION

[0047] The following description is provided to enable those skilled in the art to make and use the described embodiments to implement the present invention. However, various modifications, equivalents, variations and substitutes are still 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.

[0048] For the purposes of the following 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 take 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 illustrative embodiments of the present invention. Therefore, specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0049] The present disclosure provides a biological fluid collection system, which includes a power source for a collection module that receives a sample and provides flow-through blood stabilization technology and precise sample dispensing capabilities for point-of-care and near-patient testing applications. The collection module of the present disclosure is capable of achieving distributed mixing of a sample stabilizer in a blood sample and dispensing the stabilized sample in a controlled manner. In this manner, the biological fluid collection system of the present disclosure enables blood microsample management, such as passive mixing and controlled dispensing with a sample stabilizer, for point-of-care and near-patient testing applications.

[0050] Advantageously, the biological fluid collection system of the present disclosure provides a consistent blood sample management tool for point-of-care and near-patient testing applications, automated blood draw, passive mixing technology, and controlled small sample dispensing capabilities for point-of-care cassettes and standard Luer interfaces with near-patient testing receiving ports.

[0051] Figure 1-8 An exemplary embodiment of a biological fluid collection system 10 of the present disclosure is shown, which is suitable for receiving a biological fluid sample, such as a blood sample 12. In one embodiment, the biological fluid collection system 10 of the present disclosure includes a collection module 14 adapted to receive the blood sample 12 and a power source 16 removably connected to the collection module 14. The power source of the present disclosure provides a user-activated vacuum source for drawing the biological fluid sample within the collection module 14. In one embodiment, a portion of the collection module 14 includes a cannula 17 for obtaining the blood sample 12 from a patient into the collection module 14.

[0052] refer to Figure 1-8 In one embodiment, the collection module 14 of the present disclosure is suitable for receiving a biological fluid sample, such as a blood sample 12, and includes a housing 20, a mixing chamber 22, a sample stabilizer 24, a collection chamber 26, a closure 28 and a cap 30.

[0053] In one embodiment, housing 20 of collection module 14 includes an inlet port 32 and an outlet port 34. Inlet port 32 and outlet port 34 are in fluid communication via a passage 36 extending therebetween.

[0054] The mixing chamber 22 and the collection chamber 26 are arranged to be in fluid communication with the channel 36. The mixing chamber 22 and the collection chamber 26 are positioned so that the biological fluid sample (e.g., blood sample 12) introduced into the inlet port 32 of the collection module 14 will first pass through the sample stabilizer 24, then the blood sample 12 and the sample stabilizer 24 pass through the mixing chamber 22, and then the sample 12 properly mixed with the sample stabilizer 24 flows into the collection chamber 26 before reaching the outlet port 34 of the collection module 14. In this way, the blood sample 12 can be mixed with the sample stabilizer 24, such as an anticoagulant or other additives, disposed in the collection module 14 before passing through the mixing chamber 22 for proper mixing of the sample stabilizer 24 in the blood sample 12, and then the stabilized sample is received and stored in the collection chamber 26.

[0055] In one embodiment, the sample stabilizer 24 is disposed between the inlet port 32 and the mixing chamber 22. The collection module 14 of the present disclosure provides passive and rapid mixing of the blood sample 12 with the sample stabilizer 24. For example, the collection module 14 includes a mixing chamber 22 that allows passive mixing of the blood sample 12 with an anticoagulant or another additive (e.g., a blood stabilizer) as the blood sample 12 flows through the mixing chamber 22.

[0056] The sample stabilizer can be an anticoagulant, or a substance designed to preserve specific elements in the blood, such as RNA, protein analytes, or other elements. In one embodiment, the sample stabilizer 24 is disposed between the inlet port 32 and the mixing chamber 22. In other embodiments, the sample stabilizer 24 can be disposed in other areas within the housing 20 of the collection module 14.

[0057] refer to Figure 2 and Figure 3 In one embodiment, the collection module 14 includes a material 40 with pores 42 disposed between the inlet port 32 and the mixing chamber 22 and a dry anticoagulant powder within the pores 42 of the material 40. In this manner, the collection module 14 can include a dry anticoagulant, such as heparin or EDTA, deposited on or within a portion of the collection module 14. In one embodiment, the material 40 is an open-cell foam that contains the dry anticoagulant dispersed in the pores of the open-cell foam to promote the effects of flow-through mixing and anticoagulant absorption. In one embodiment, the sample stabilizer 24 is a dry anticoagulant powder.

[0058] 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. When the blood sample 12 enters the collection module 14, 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 as it passes through the material 40 or the open-cell foam.

[0059] The open-cell foam may be a soft, deformable open-cell foam that is inert to blood, such as a melamine foam, such as Basotect available from BASF. ® The 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 heat-resistant and resistant to organic solvents. In one embodiment, the foam may include a sponge material.

[0060] Anticoagulants or other additives may be introduced into open cell foams by soaking the foam in a liquid solution of the additive and water and then evaporating the water to form a dry additive powder that is finely distributed throughout the internal structure of the foam.

[0061] The collection module 14 includes a mixing chamber 22 that allows passive mixing of the blood sample 12 with an anticoagulant or another additive (eg, a blood stabilizer) as the blood sample 12 flows through the mixing chamber 22. In one embodiment, the mixing chamber 22 is disposed between an inlet port 32 and an outlet port 34.

[0062] The interior portion of the mixing chamber 22 may have any suitable structure or form so long as it provides for mixing of the blood sample 12 with the anticoagulant or another additive as the blood sample 12 passes through the passage 36 of the collection module 14 .

[0063] The mixing chamber 22 receives the sample 12 and the sample stabilizer 24 therein, and achieves distributed mixing of the sample stabilizer 24 within the sample 12. The mixing chamber 22 achieves distributed mixing of the sample stabilizer 24 within the sample 12, and prevents the sample stabilizer concentration in any portion of the blood sample 12 from being very high. This prevents insufficient dosing of the sample stabilizer 24 in any portion of the blood sample 12. The mixing chamber 22 achieves distributed mixing of the sample stabilizer 24 within the sample 12, so that approximately equal amounts and / or concentrations of the sample stabilizer 24 are dissolved in the entire blood sample 12, for example, approximately equal amounts and / or concentrations of the sample stabilizer 24 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.

[0064] In one embodiment, the collection module 14 includes a collection chamber 26 disposed between the mixing chamber 22 and the outlet port 34. The collection chamber 26 includes an actuation portion 61. In one embodiment, the actuation portion 61 is capable of being in a first position ( Figure 2 , 3 and 6) with the second position ( Figure 7 ), in which the sample 12 can be contained in the collection chamber 26 and in which a portion of the sample 12 is discharged from the collection chamber 26.

[0065] In one embodiment, the actuating portion 61 of the collection chamber 26 includes a first deformable portion 62, a second deformable portion 64, and a rigid wall portion 66 ( Figure 8 In one embodiment, the first deformable portion 62 is located on a first side 70 of the collection chamber 26 and the second deformable portion 64 is located on a second side 72 of the collection chamber 26. In one embodiment, the second side 72 of the collection chamber 26 is opposite to the first side 70 of the collection chamber 26.

[0066] In one embodiment, the first deformable portion 62 and the second deformable portion 64 are capable of transitioning between an initial position in which the sample 12 is contained within the collection chamber 26 and a deformed position in which a portion of the sample 12 is expelled from the collection chamber 26. The first deformable portion 62 and the second deformable portion 64 are squeezed simultaneously to transition from the initial position to the deformed position.

[0067] Advantageously, by having a first deformable portion 62 and a second deformable portion 64 that can be squeezed simultaneously, the collection module 14 of the present disclosure is able to dispense more sample 12 from the collection chamber 26 and the outlet port 34. In addition, in one embodiment, by having a first deformable portion 62 on a first side 70 and a second deformable portion 64 on an opposite second side 72, the collection module 14 of the present disclosure has a symmetrical design and provides a smooth straight fluid path chamber that promotes fluid adherence flow characteristics. The smooth straight fluid path chamber of the collection module 14 has no significant geometric steps in diameter, and the smooth fluid path inhibits the formation of cavitation or bubbles.

[0068] After passing through the mixing chamber 22, the stabilized sample is directed to the collection chamber 26. The collection chamber 26 can be of any suitable shape and size to store a sufficient amount of blood required for the desired test, such as 500 microliters or less. In one embodiment, the collection chamber 26 is defined by a portion of the housing 20 in conjunction with a first deformable portion 62, a second deformable portion 64, and a rigid wall portion 66.

[0069] The first deformable portion 62 and the second deformable portion 64 can be made of any material that is flexible, deformable, and capable of providing a fluid-tight seal with the housing 20. In some embodiments, the first deformable portion 62 and the second deformable portion 64 can be made of natural or synthetic rubber and other suitable elastomeric materials. The first deformable portion 62 and the second deformable portion 64 are fixedly connected to a portion of the housing 20 so that the first deformable portion 62 and the second deformable portion 64 can be transformed between an initial position and a deformed position, in which the sample 12 is contained in the collection chamber 26, and in which a portion of the sample 12 is discharged from the collection chamber 26.

[0070] In another embodiment, the actuation portion 61 of the collection chamber 26 may include an activation member such that applying an inward pressure on the resilient portion of the actuation portion 61 forces the sample to be dispensed from the collection chamber 26. In this manner, the sample can be transferred to a device for analyzing the sample, such as a point-of-care testing device, such as a cartridge tester, or via a port, while minimizing exposure of the sample. In certain configurations, the activation member may at least partially define the collection chamber 26, alternatively, the activation member may be a separate element capable of engaging with the collection chamber 26, such as a plunger, button, slider, etc. Activation members, such as those described in U.S. patent application Ser. No. 15 / 065,022, filed on Mar. 9, 2016, entitled “Biological Fluid Micro-Sample Management Device,” the entire disclosure of which is expressly incorporated herein by reference, may also be used in conjunction with the present invention. In other embodiments, the actuating portion 61 of the collection chamber 26 may include an actuating portion and / or an actuating portion of a deformable portion described in U.S. patent application serial number 62 / 634,960, entitled “Biological Fluid Collection Device and Collection Module,” filed on February 26, 2018, the entire disclosure of which is expressly incorporated herein by reference.

[0071] In one embodiment, the collection module 14 includes a cap 30 that is removably attached to and protectively covers the outlet port 34. In one embodiment, the cap 30 includes a vent plug 80 that allows air to pass through and prevents the sample 12 from passing through.

[0072] The configuration of the cap 30 and the vent plug 80 allows air to pass through the cap 30 while preventing the blood sample 12 from passing through the cap 30, and may include a hydrophobic filter. The vent plug 80 has a selected air passage resistance that can be used to finely control the filling rate of the channel 36 and / or the collection chamber 26 of the collection module 14. By changing the porosity of the plug, the speed of air flowing out of the cap 30 can be controlled, thereby controlling the speed of the blood sample flowing into the collection module 14.

[0073] In one embodiment, the collection module 14 includes a closure 28 that engages the inlet port 32 of the collection module 14 to seal the passage 36. The closure 28 protectively covers the inlet port 32. The closure 28 allows the blood sample 12 to be introduced into the passage 36 of the housing 20 and may include a pierceable self-sealing plug 82 having an outer shield 84, such as Hemogard available from Becton, Dickinson and Company. TM cap.

[0074] In one embodiment, a portion of the collection module 14 includes a cannula 17 for obtaining a blood sample 12 from a patient into the collection module 14. In such an embodiment, the collection module 14 includes a first removable protective cap 90 and a safety shield 92.

[0075] Figure 1 and Figure 9-12 An exemplary hinged safety shield assembly embodiment of the present disclosure is depicted. The needle assembly 5000 generally includes a needle structure 32c2 coupled to a hub 58c2, and a safety shield 64c2 coupled to the hub 58c2 and adapted to safely shield the needle structure or cannula 17 after use of the device. In one embodiment, the needle assembly 5000 may incorporate features of other known needle assemblies having hinged safety shields, such as those disclosed in U.S. Patent Publication No. 2005 / 0187493, the entire disclosure of which is incorporated herein by reference.

[0076] Needle structure 32c2 may include a patient needle portion or cannula 17. Cannula 17 represents the patient end of needle structure 32c2 and may be beveled to define a puncture tip for puncturing the patient's skin and entering the patient's vasculature.

[0077] The hub 58c2 can include a front hub portion 5010 and a rear hub portion 5012, and can support a needle structure 32c2 therethrough. In one embodiment, the sleeve 17 can be integral with the front hub portion 5010, and the central lumen 5006 can be integral with the rear hub portion 5012. The front hub portion 5010 and the rear hub portion 5012 are configured to engage in a matching manner. The front hub portion 5010 can include a protrusion 5014, such as a raised annular ring, for engaging a corresponding recess 5016 integral with the rear hub portion 5012. In another embodiment, the front hub portion 5010 and the rear hub portion 5012 can be coupled together via an adhesive or welding. Once assembled, the hub 58c2 defines a flashback indicator 60c2 therein.

[0078] The hub 58c2 may also include a collar 5018 for surrounding at least a portion of the safety shield 64c2. In one embodiment, the front hub portion 5010 includes a first collar portion 5022 and the rear hub portion 5012 includes a second collar portion 5024. The first collar portion 5022 may include a generally c-shaped area 5028 for accommodating an attachment bearing 5026 of the safety shield 64c2. The attachment bearing 5026 may be integral with the safety shield 64c2. The attachment bearing 5026 may also be integral with a portion of the hub 58c2, such as the first collar portion 5022 and / or the second collar portion 5024. Alternatively, the attachment bearing 5026 may be provided separately and subsequently assembled with the safety shield 64c2 and / or the hub 58c2. The first collar portion 5022 may include a protrusion 5034 for engaging a corresponding recess 5036 integral with the second collar portion 5024. Thus, in one embodiment, engagement of the front hub portion 5010 with the rear hub portion 5012 also engages the first collar portion 5022 with the second collar portion 5024. In another embodiment, the collar 5018 is substantially located on the top surface of the hub 58c2 to allow the safety shield 64c2 to also be connected to the top surface of the hub 58c2.

[0079] refer to Figure 1 and 9 As described herein, a protective cap 90 may be provided over the patient needle portion or cannula 17 prior to use.

[0080] During use, the protective cap 90 can be removed from the cannula 17, thereby exposing the cannula 17 for use. The cannula 17 can then be engaged with a patient to collect a blood sample. After use, the safety shield 92 is used to protectively cover and shield the cannula 17, thereby preventing accidental needle stick injuries.

[0081] Needle assembly 5000 can be converted from a retracted position, in which cannula 17 is unshielded for patient access, to an extended position, in which cannula 17 is safely shielded from exposure.

[0082] In some embodiments, the present disclosure provides a biological fluid collection system 10 that includes a power source 16 for a collection module 14 that receives a sample 12 and provides flow-through blood stabilization technology and precision sample dispensing functionality for point-of-care and near-patient testing applications. The power source of the present disclosure allows a user to activate a vacuum source.

[0083] In one embodiment, the power source 16 comprises a spring-loaded device for automatically aspirating the blood sample 12 within the collection module 14. The spring-loaded power source utilizes a user-activated spring-powered piston to create a vacuum at the distal end of the collection module 14. In such an embodiment, by controlling the stiffness and stroke length of the spring, a predictable vacuum can be applied to the fluid path of the collection module 14 to produce a given blood flow rate as the blood fills the collection module 14. A predictable flow rate is important for mixing structures.

[0084] refer to Figure 4-5 In an exemplary embodiment, the power source 16 is removably connectable to the collection module 14, and the power source 16 generates a vacuum that draws the sample 12 within the collection chamber 26. In one embodiment, the power source 16 includes a barrel 110, a piston 112, a spring 114, an activation button 116, and a lock. In one embodiment, the piston 112 includes an O-ring 150 that provides static friction with the inner surface of the sidewall 126 of the barrel 110.

[0085] Optionally, the power source 16 may include a lock that can be switched between a locked position, in which the lock locks the piston 112 in the first piston position and maintains the spring 114 in the compressed position, and an unlocked position, in which the piston 112 is unlocked and the spring 114 is allowed to drive the piston 112 to the second piston position, thereby generating a vacuum that draws the sample into the collection chamber 26. Optionally, activation of the activation member may move the lock to the unlocked position.

[0086] The barrel 110 is in communication with the collection chamber 26 of the collection module 14. The barrel 110 defines an interior 120 and includes a first end 122, a second end 124, and a sidewall 126 therebetween. The barrel 110 is removably connected to a portion of the collection module 14. For example, in one embodiment, the barrel 110 is removably connected to the cap 30 of the collection module 14 so that the vacuum generated by the power source 16 can draw the sample 12 within the collection chamber 26 of the collection module 14. As discussed above, the cap 30 includes a vent plug 80 that allows air to pass through and prevents the sample 12 from passing through. In this way, the vacuum generated within the barrel 110 of the power source 16 is in communication with the collection chamber 26 of the collection module 14 so that the vacuum generated by the power source 16 can draw the sample 12 within the collection chamber 26 of the collection module 14.

[0087] The piston 112 is slidably disposed within the interior 120 of the cylinder 110. The piston 112 is sized relative to the interior 120 of the cylinder 110 to provide a sealing engagement with the sidewall 126 of the cylinder 110. The piston 112 is capable of being in a first piston position ( Figure 4 ) and the second piston position ( Figure 5 ), in a first piston position, the piston 112 is a first distance from the first end 122 of the cylinder 110, and in a second piston position, the piston 112 is a second distance from the first end 122 of the cylinder 110, and the second distance is greater than the first distance.

[0088] refer to Figure 4-5 , the spring 114 is disposed between the first end 122 of the cylinder 110 and the piston 112. In one embodiment, the activation button 116 is disposed on a portion of the cylinder 110.

[0089] The power source 16 also includes a lock in communication with the spring 114 and the activation button 116. The lock is switchable between a locked position and an unlocked position, in which the lock locks the piston 112 in the first piston position ( Figure 4 ) and maintains the spring 114 in the compressed position. In the unlocked position, the piston 112 is unlocked and the spring 114 is allowed to drive the piston 112 to the second piston position ( Figure 5 ), thereby creating a vacuum that pulls the sample 12 into the collection chamber 26 of the collection module 14. In one embodiment, actuation of the activation button 116 moves the lock to the unlocked position.

[0090] Advantageously, the collection module and power source of the present disclosure can be engaged with many different sources through which biological fluids such as blood samples 12 pass. For example, in some embodiments, the collection module and power source of the present disclosure can be engaged with a conventional tube holder. In other embodiments, the user-activated power source of the present disclosure enables the user to be directly connected to a Luer line, such as an IV catheter, a wing set, a PICC or a similar device. In other embodiments, if the collection module and power source are used with HemoLuer, the user can connect the collection module and power source to a Luer piece (by removing the HemoLuer) or a conventional tube holder (using the HemoLuer as an interface). Advantageously, the system of the present disclosure also allows direct Luer access without the use of a LLAD (Luer Line Access Device) or any other holder.

[0091] In one embodiment, a portion of the collection module 14 includes a cannula 17 for obtaining a blood sample 12 from a patient into the collection module 14. In such an embodiment, the collection module 14 includes a first removable protective cap 90 and a safety shield 92. In such an embodiment, the cannula 17 can be engaged with the patient and then the power source 16 is used to create a vacuum that draws the sample 12 into the collection chamber 26.

[0092] In one embodiment, the blood sample 12 is drawn into the channel 36 of the housing 20 of the collection module 14 by vacuum suction created in the barrel. In one embodiment, the blood sample 12 fills the entire channel 36 so that when the blood sample 12 enters the collection module 14, the blood sample 12 passes through the open-cell foam, such as material 40, and is exposed to the anticoagulant powder throughout the internal pore 42 structure of the open-cell foam. In this way, the sample 12 dissolves the dry anticoagulant powder and mixes with the dry anticoagulant powder as it passes through the material 40 or the open-cell foam. Next, the mixing chamber 22 receives the sample 12 and the sample stabilizer 24 therein and achieves distributed mixing of the sample stabilizer 24 within the sample 12. After passing through the mixing chamber 22, the stabilized sample is directed to the collection chamber 26. The collection chamber 26 can be of any suitable shape and size to store a sufficient amount of blood required for the desired test, such as 500 microliters or less. In one embodiment, when the channel 36, mixing chamber 22, and collection chamber 26 of the collection module 14 are completely filled, the cap 30 stops the collection of the blood sample 12. The vent plug 80 of the cap 30 allows air to pass through the cap 30 while preventing the blood sample 12 from passing through the cap 30 and entering the barrel 110 of the power source 16.

[0093] In one embodiment, once sample collection is complete, the power source 16 is separated from the collection module 14. Once the collection module 14 is separated from the power source 16, the cap 30 can then be removed from the collection module 14, exposing the outlet port 34 of the housing 20 of the collection module 14. Removal can be achieved by a user grasping an outer portion of the cap 30 and pulling the cap 30 out of the housing 20. After the cap 30 is removed, the blood sample 12 is retained within the channel 36 of the housing 20, such as the collection chamber 26, by capillary action.

[0094] The blood sample 12 can then be dispensed from the collection module 14 by activation of the actuation portion 61. In one embodiment, the actuation portion 61 includes a first deformable portion 62 and a second deformable portion 64. For example, the first deformable portion 62 and the second deformable portion 64 are capable of transitioning between an initial position, in which the sample 12 is contained within the collection chamber 26, and a deformed position, in which a portion of the sample 12 is discharged from the collection chamber 26 and the outlet port 34. The first deformable portion 62 and the second deformable portion 64 are squeezed simultaneously to transition from the initial position to the deformed position. In this manner, the blood sample 12 can be transferred to a device for analyzing the sample, such as a point-of-care testing device 105 ( Figure 6 ), cartridge testers, or near-patient testing devices while minimizing exposure of medical personnel to blood samples.

[0095] Advantageously, by having the first deformable portion 62 and the second deformable portion 64 that can be squeezed simultaneously, the collection module 14 of the present disclosure is able to dispense more sample 12 from the collection chamber 26 and the outlet port 34. Furthermore, in one embodiment, by having the first deformable portion 62 on a first side 70 and the second deformable portion 64 on an opposing second side 72, the collection module 14 of the present disclosure has a symmetrical design and provides a smooth straight fluid path chamber that promotes fluid adherent flow characteristics.

[0096] The present disclosure provides a biological fluid collection system 10 that includes a power source 16 for a collection module 14 that receives a sample 12 and provides flow-through blood stabilization technology and precision sample dispensing functionality for point-of-care and near-patient testing applications. The power source of the present disclosure allows a user to activate a vacuum source.

[0097] The power source 16 of the present disclosure may include a power system according to other power systems described in U.S. patent application serial number 62 / 658,737, entitled “Biological Fluid Collection System,” filed on April 17, 2018, the entire disclosure of which is expressly incorporated herein by reference.

[0098] As described herein, the present disclosure provides a biological fluid collection system including a power source for a collection module that receives a sample and provides flow-through blood stabilization technology and precision sample dispensing functionality for point-of-care and near-patient testing applications. The power source of the present disclosure provides a user-activated vacuum source for aspirating a biological fluid sample within the collection module.

[0099] The collection module of the present disclosure is capable of achieving distributed mixing of a sample stabilizer in a blood sample and dispensing the stabilized sample in a controlled manner. In this manner, the biofluid collection system of the present disclosure enables blood microsample management, such as passive mixing with a sample stabilizer and controlled dispensing, for point-of-care and near-patient testing applications.

[0100] Advantageously, the biological fluid collection system of the present disclosure provides a consistent blood sample management tool for point-of-care and near-patient testing applications, automated blood draw, passive mixing technology, and controlled small sample dispensing capabilities for point-of-care cassettes and standard Luer interfaces with near-patient testing receiving ports.

[0101] refer to Figure 13-14 In one embodiment, the biological fluid collection device 10 of the present disclosure is suitable for receiving a biological fluid sample, such as a blood sample 12, and includes a collection module 14 and an outer housing 16a removably connected to the collection module 14. In one embodiment, the collection module 14 is connected to the outer housing 16a, and the collection module 14 is disposed in the outer housing 16a. Figure 13-14 The outer shell 16a may be a blood collection tube containing a vacuum, such as a Vacutainer available from Becton, Dickinson and Company. ® Blood collection tube.

[0102] In one embodiment, the collection module 14 is disposed within the outer housing 16a and is compatible with a tube holder 102 having a cannula and wing set 104. In use, the needle cannula of the tube holder 102 is inserted through the inlet port 32 into the passage 36 of the housing 20 of the collection module 14, such as through the pierceable self-sealing plug 82 of the closure 28. The biological fluid collection device 10 including the combined collection module 14 and outer housing 16a can be inserted into a conventional tube holder 102 having a cannula through which a biological fluid, such as a blood sample 12, is passed.

[0103] The blood sample 12 is drawn from the conventional tube holder 102 into the channel 36 of the housing 20 of the collection module 14 by suction of the vacuum contained in the outer shell 16a. In one embodiment, the blood sample 12 fills the entire channel 36 so that when the blood sample 12 enters the collection module 14, the blood sample 12 passes through the open-cell foam, such as material 40, and is exposed to the anticoagulant powder 44 distributed throughout the internal pore 42 structure of the open-cell foam. In this way, the sample 12 dissolves and mixes with the dry anticoagulant powder 44 as it passes through the material 40 or open-cell foam. Next, the mixing chamber 22 receives the sample 12 and the sample stabilizer 24 therein and achieves distributed mixing of the sample stabilizer 24 within the sample 12. After passing through the mixing chamber 22, the stabilized sample is directed to the collection chamber 26. The collection chamber 26 can be of any suitable shape and size to store a sufficient amount of blood required for the desired test, such as 500 microliters or less. In one embodiment, when the channel 36, mixing chamber 22, and collection chamber 26 of the collection module 14 are completely filled, the cap 30 stops the collection of the blood sample 12. The vent plug 80 of the cap 30 allows air to pass through the cap 30 while preventing the blood sample 12 from passing through the cap 30 and entering the outer shell 16.

[0104] In one embodiment, once sample collection is complete, the outer housing 16a including the collection module 14 is separated from the tube holder 102, and then the outer housing 16a is separated from the collection module 14 by removing the closure 28 from the outer housing 16a while it is still attached to the collection module 14. Removal of the closure 28 may be accomplished by a user grasping the outer shield 84 of the closure 28 and the outer housing 16a and pulling or twisting them in opposite directions.

[0105] Once the collection module 14 is separated from the outer shell 16a, the cap 30 can then be removed from the collection module 14, exposing the outlet port 34 of the housing 20 of the collection module 14. Removal can be achieved by a user grasping the outer portion of the cap 30 and pulling the cap 30 from the housing 20. After removing the cap 30, the blood sample 12 is retained within the channel 36 of the housing 20, such as the collection chamber 26, by capillary action. In one embodiment, alternatively, the cap 30 can be removed when the collection module 14 is removed from the outer shell 16. In this configuration, the cap 30 is constrained within the outer shell 16. In one embodiment, the cap 30 can be engaged with the outer shell 16 so that the outer shell 16 and the cap 30 are removed in a single step.

[0106] The blood sample 12 can then be dispensed from the collection module 14 by activating the first deformable portion 62 and the second deformable portion 64. For example, the first deformable portion 62 and the second deformable portion 64 can be transformed between an initial position, in which the sample 12 is contained within the collection chamber 26, and a deformed position, in which a portion of the sample 12 is expelled from the collection chamber 26 and the outlet port 34. The first deformable portion 62 and the second deformable portion 64 are squeezed simultaneously to transform from the initial position to the deformed position. In this manner, the blood sample 12 can be transferred to a device for analyzing the sample, such as a point-of-care testing device 105 ( Figure 6 ), cartridge testers or near-patient testing devices while minimizing exposure of medical personnel to blood samples.

[0107] The present disclosure includes a blood collection device for collecting arterial blood samples using a radial puncture technique. The present disclosure simplifies and reduces the number of workflow steps, which is very important in arterial blood gas (ABG) collection procedures. The proposed device includes automatic anticoagulant mixing and an integrated exhaust for venting bubbles during collection.

[0108] Existing ABG syringes typically use a conventional hypodermic needle with a safety shield that needs to be snapped onto or slid onto the needle after blood collection. This safety shield is typically in sight during the blood collection procedure, thereby obstructing the physician's field of vision during such a delicate procedure. Conventional ABG syringes also typically have a separate vent cap that requires the needle to be removed before the cap is attached to the syringe to expel trapped air bubbles from the collected sample. Anticoagulant is typically contained within the ABG syringe, requiring the user to roll or shake the collected sample to ensure adequate mixing with the anticoagulant. The device of the present invention has the following advantages over conventional ABG collection kits: (1) an ergonomic design with designated touch points; (2) thin-walled needle technology (BD Ultratouch) that allows the use of small gauge needles while still maintaining high flow rates, thereby reducing fill time and exposing the patient to a potentially painful procedure; (3) a push-button safety shield that can be activated one-handedly after collection with a simple button press while not obstructing the user's view during the procedure; (4) an integrated vent / vent cap capability that allows trapped air bubbles to be removed during filling or after collection by simple venting; and (5) the use of a safety sleeve with a guard and button that prevents accidental activation of the safety shield during transport of the device.

[0109] In another concept of the present disclosure, referring to Figure 15-27, the fluid collection assembly 10b generally includes a needle assembly 11b, a first needle shield 60b, a tube holder 13b, and a fluid collection cassette 20b. According to one embodiment, the fluid collection assembly 10b may include an arterial blood collection assembly. Although described herein in terms of an arterial blood collection cassette 20b intended for use with a needle assembly 11b, the cassette 20b of the present disclosure may be used with or may be combined with other medical devices, such as other medical device assemblies that include piercing elements or allow attachment to a catheter or arterial line.

[0110] In an exemplary embodiment, the major components of the fluid collection cassette 20b include a plunger assembly 30b having a removable plunger rod 31b and a stopper 32b in slidable communication with the tubular member 21b and the closure 40b.

[0111] refer to Figure 15-18 In an exemplary embodiment, the fluid collection box 20b includes an elongated hollow cylindrical tubular member 21b having a proximal end 23b, an open distal end 22b, and a sidewall 25b extending between the proximal end 23b and the distal end 22b, which defines an inner chamber 26b having an internal storage portion 28b. The sidewall 25b of the tube 21b defines an inner surface 27b for slidably receiving the plunger assembly 30b. An annular flange 24b is disposed at the proximal end 23b of the tubular member 21b and extends from the inner surface 27b into the chamber 26b, partially closing the proximal end 23b of the tubular member 21b.

[0112] Tubular member 21b can be made of one or more of the following representative materials: polypropylene, polyethylene, polyethylene terephthalate (PET), polystyrene, polycarbonate, cellulose, glass products or their combinations. More expensive plastics, such as polytetrafluoroethylene and other fluorinated polymers, can also be used. In addition to the above-mentioned materials, the examples of other suitable materials include polyolefins, polyamides, polyesters, silicones, polyurethanes, epoxy resins, acrylic resins, polyacrylates, polysulfones, polymethacrylates, PEEK, polyimides and fluoropolymers, such as PTFE Teflon , FEP Teflon , Tefzel , polyvinylidene fluoride, PVDF and perfluoroalkoxy resins. An exemplary glass product is PYREX (can be purchased from Corning Glass of Corning, New York). According to embodiments of the present invention, ceramic collecting devices can be used. Cellulose products such as paper and reinforced paper containers can also be used to form collecting devices according to the present invention.

[0113] refer to Figure 15-18In an exemplary embodiment, the fluid collection box 20b also includes a plunger assembly 30b slidably received in the chamber 26b defined by the side wall 25b of the tube 21b. The plunger assembly 30b includes a plug 32b and a removable plunger rod 31b. The plug 32b is slidably positioned in fluid-tight engagement with the inner surface 27b and is capable of sliding distally and proximally along the longitudinal axis 29b. The plug 32b and the plunger rod 31b are removably associated with each other by an interengagement arrangement 90b. The interengagement arrangement 90b is configured to enable the plunger rod 31b to apply a distally directed force to the plug 32b, and to enable the plunger rod 31b to removably move when a proximally directed force is applied (e.g., Fig. 22 32b and the tubular member 21b). In other words, the plug 32b and the plunger rod 31b are not mechanically fixed to each other, but are merely arranged in a removable contact arrangement, which only allows the plunger rod 31b to apply force to the plug 32b in the distal direction. The proximal end of the removable plunger rod 31b may include a thumb flange 33b, which the user can use to apply force to push the entire plunger assembly 30b distally, or pull to remove the plunger rod 31b from the tubular member 21b.

[0114] refer to Figure 15-18 In an exemplary embodiment, the plug 32b includes a distal side 34b and a proximal side 35b. The diameter of the plug 32b is approximately equal to or slightly smaller than the inner diameter "a" of the tube 21b, but larger than the inner diameter "b" of the annular flange 24b. The plug 32b is slidably in contact with the inner surface 27b of the tube 21b and provides a fluid-tight seal between the plunger assembly 30b and the inner surface 27b of the tube 21b, so that the sample can be retained in the internal reservoir 28b formed in the chamber 26b between the distal end 22b of the tube 21b and the distal side 34b of the plug 32b, thereby preventing the sample from leaking from the proximal end 23b of the tube 21b.

[0115] The plug 32b is a low resistance plug and is therefore designed to have a relatively low frictional resistance to movement inside the tube 21b when compared to similar components in prior art arterial blood gas syringes, such that the presence of fluid pressure (e.g., arterial blood pressure) in the internal reservoir 28b will cause the plug 32b to slide / travel in the proximal direction toward the proximal end 23b of the tube 21b until the proximal side 35b of the plug 32b contacts the annular flange 24b, thereby limiting the proximal movement of the plug 32b. The frictional resistance of the plug can be reduced by a combination of plug sealing profile design and / or component material selection. A first sealing ring 36b and a second sealing ring 37b extend around the outer circumferential surface of the plug 32b near the distal side 34b and the proximal side 35b, respectively, to form a primary seal and a secondary seal with the inner surface 27b of the tube 21b. Compared to a plug seal profile in which the entire outer circumferential surface is in contact with the inner surface 27b, this plug seal profile design reduces the amount of contact between the plug 32b and the inner surface 27b, thereby reducing the frictional resistance to the movement of the plug 32b. As an alternative to the plug seal profile design or in combination with the plug seal profile design, the plug 32b is preferably made of an elastomeric material such as natural rubber, synthetic rubber, thermoplastic elastomer and a combination thereof, which is formulated or synthesized to be self-lubricating or have relatively low frictional resistance. The plug 32b can also be made of a combination of elastomers, which includes a harder inner rubber core and a soft outer layer of self-lubricating polymeric material. The self-lubricating polymeric material has a lubricant, such as silicone oil, incorporated into the polymeric material (an example of which is Epilor).

[0116] Prior to use, the plunger rod 31b contacts the proximal side 35b of the stopper 32b so that the plunger rod 31b can only apply forces applied in the distal direction. The mutual engagement arrangement 90b may include a convex member extending from the distal end of the plunger rod 31b, such as a tapered finger 39b, which is configured to cooperate with a corresponding concave member in the proximal side 35b of the stopper 32b, such as a tapered recess 45b. It is understood that the tapered finger 39b and the tapered recess 45b illustrate an example of the mutual engagement arrangement 90b, and other mutual engagement arrangements may be used to removably connect the plunger rod 31b and the stopper 32b. For example, the mutual engagement arrangement 90b may be designed so that the distal end of the plunger rod 31b includes a concave member configured to cooperate with a corresponding convex member extending from the proximal side 35b of the stopper 32b.

[0117] refer to Figure 20-22 If a fluid passage exists in the distal end 22b of the tube 21b, for example, application of force by a user to the thumb flange 33b causes the plunger rod 31b to transmit the applied force to move the stopper 32b in the distal direction, thereby forcing the fluid to flow out of the blood collection cassette. However, pulling the plunger rod 31b in the proximal direction, such as Fig. 22As shown by the "P" in FIG. 3 , no force will be applied to the plug 32b. The tapered fingers 39b will simply retract out of contact with the recess 45b, so that when the plunger rod 31b is removed from the tubular member 21b, the plug 32b will remain stationary in the tube 21b.

[0118] The plunger rod 31b is ideally made of a suitable polymeric material and can be manufactured by injection molding using a suitable polymeric material known in the art. Within the scope of the present invention, the plunger rod and the stopper are formed separately or integrally from the same material or different materials (e.g., in two-color molding), or are formed separately from the same or different materials and are connected together by mechanical means, adhesives, ultrasonic welding, heat sealing or other suitable means.

[0119] refer to Figure 15-18 In an exemplary embodiment, a pierceable closure 40b is connected to the open distal end 22b of the tubular member 21b. The closure 40b is configured to cooperate with the side wall 25b of the tubular member 21b to seal the open distal end 22b, thereby forming a liquid-impermeable seal to contain a fluid sample. The closure 40b includes an outer end 41b and an inner end 42b, which is structured to be at least partially received in the tubular member 21b. The portion of the closure 40b adjacent to the open distal end 22b of the tube 21b defines a maximum outer diameter exceeding the inner diameter "a" of the tube 21b. The inherent elasticity of the closure 40b can ensure a sealing engagement with the inner surface 27b of the wall 25b of the tube 21b. The portion of the closure 40b extending downward from the inner end 42b can be tapered from a small diameter approximately equal to or slightly less than the inner diameter "a" of the tube 21b to a large diameter greater than the inner diameter "a" of the tube 21b adjacent to the distal end 22b. Thus, the inner end 42b of the closure 40b can be pushed into a portion of the tube 21b adjacent the distal open end 22b. The closure 40b is such that it can be pierced by a needle 50b or other cannula to introduce a biological specimen into the tubular member 21b. According to one embodiment, the closure 40b is resealable. Fig.19 As shown, the closure member 40b can also be formed to define a cavity 43b extending into the inner end 42b. The size of the cavity 43b can be set to receive at least one corresponding mixing fin 44b, which extends distally from the distal side 34b of the plug 32b. Alternatively, there can be a plurality of cavities and corresponding mixing fins. Suitable materials for the closure member 40b include, for example, elastomers, such as silicone rubber, natural rubber, styrene butadiene rubber, ethylene-propylene copolymers and polychloroprene, thermoplastic elastomers, etc.

[0120] According to one embodiment, the fluid collection box 20b may contain additional additives required for a specific testing procedure, such as anticoagulants, coagulants, stabilizing additives, etc. Fig.1970b in FIG. Such additives may be sprayed onto the inner surface 27b of the tube 21b or may be located within the internal storage portion 28b. The anticoagulant may include hirudin, a hirudin derivative, a chelating agent, or a chelating agent derivative. Specific anticoagulants include citrate, ethylenediaminetetraacetic acid (EDTA), heparin, CPAD, CTAD, CPDA-1, CP2D, potassium oxalate, sodium fluoride, or ACD. The anticoagulant may be used in liquid form to improve incorporation, thereby enhancing the effect of the anticoagulant when collecting arterial blood. The liquid form may be an emulsion, solution, or dispersion of the anticoagulant in a suitable carrier. Other known arterial blood sample collection methods use an arterial blood gas syringe that is pre-loaded with an anticoagulant in solid form, such as heparin powder in a syringe barrel, during manufacture, in order to maximize the shelf life of the syringe. The use of an anticoagulant in solid form may result in a reduced effect of the anticoagulant because it is difficult to incorporate powdered heparin into a blood sample during arterial blood collection due to lack of stirring.

[0121] The combination of the cavity 43b in the inner end 42b of the closure member 40b and the mixing fins 44b extending from the distal surface 34b of the plug 32b provides an asymmetric surface at each end of the fluid reservoir 28b. Figure 25-26 , when rolling box 20b by rotating box 20b around longitudinal axis in the direction of arrows w and x, cavity 43b and mixing fins 44b produce eddy currents, which promote the thorough mixing of the contents of fluid storage portion 28b. This is particularly useful when there is no air (head space) in the fluid storage portion of the collection container. Turning this device upside down is not helpful for mixing contents, especially if the component densities are similar. Vessels with cylindrical internal fluid storage portions, such as vials, insulin pen boxes and syringes, usually have flat inner surfaces at the top and bottom of the fluid storage portion. Therefore, when these containers are rolled, turbulence is hardly produced.

[0122] refer to Figure 15-22, shows an embodiment of a fluid collection system, the fluid collection system comprising a needle assembly 11b and a retainer 13b. The needle assembly 11b comprises a needle cannula 50b, the needle cannula 50b having a sharp proximal end 51b, a sharp distal end 52b and a lumen 53b extending between the proximal end 51b and the distal end 52b. The needle assembly 11b also comprises a hub 54b, the hub 54b having a proximal end 55b, a distal end 56b and a passage extending between the proximal end 55b and the distal end 56b. The portion of the needle cannula 50b extending between the proximal end 51b and the distal end 52b is securely mounted in the passage of the hub 54b. Therefore, the sharp proximal end 51b of the needle cannula 50b protrudes proximally beyond the hub 54b, and the sharp distal end of the needle cannula protrudes distally beyond the hub 54b. An outer surface area of ​​the hub 54b near the proximal end 55b of the hub 54b may be formed with a mounting structure, such as an array of external threads, at least one annular groove or at least one annular rib. According to an embodiment of the present disclosure, the mounting structure enables the needle hub 54b to be fixedly connected to the holder 13b, which is configured to slidably receive the blood collection box 20b. Fig.19 As shown, the needle assembly 11b may further include a multi-sample sleeve 57b, which is mounted on the proximal portion of the needle cannula 50b and fixed to the proximal end 55b of the hub 54b. When the hub 54b of the needle assembly 11b is mounted to the holder 13b, the proximal portions of the needle cannula 50b and the multi-sample sleeve 57b protrude into the holder 13b.

[0123] refer to Figure 15-22 In an exemplary embodiment, the needle assembly 11b includes a first needle shield 60b and a second needle shield 61b. The first needle shield 60b covers the distal end 52b of the cannula 50b, while the second needle shield 61b covers the proximal end 51b of the cannula 50b. The first needle shield 60b includes an indicator tip 62b at the distal end, which is activated by the presence of a fluid handling material 70b (e.g., a liquid anticoagulant).

[0124] The assembly of the fluid collection cassette 20b is accomplished by slidably inserting the stopper 32b into the chamber 26b via the distal end 22b of the tubular member 21b. The fluid handling material 70b (e.g., liquid anticoagulant heparin) is then added to the fluid reservoir 28b before sealing the distal end 22b by inserting the closure 40b. The plunger rod 31b is then inserted through the annular flange 24b at the proximal end 23b of the tube 21b until the tapered fingers 39b engage the recess 45b. The assembly can then be packaged for subsequent use.

[0125] In a method of use according to one embodiment of the present invention, the second needle shield 61b is removed from the needle assembly 11b and the holder 13b, and the needle assembly 11b and the holder 13b are connected for fluid collection, such as for arterial blood collection. Figure 19-21As shown, a fluid collection box 20b (e.g., a blood collection box) according to one embodiment of the present invention is inserted into the proximal end of the retainer 13b until the sharp proximal end 51b of the needle 50b penetrates the closure 40b and the lumen 53b is in fluid communication with the fluid processing material 70b (e.g., liquid heparin anticoagulant) located in the fluid storage portion 28b.

[0126] The user then grasps the retainer 13b, anchors the fingers around the annular flange 15b extending outwardly on the retainer 13b, and presses the thumb flange 33b downwardly in the distal direction "D" with sufficient force, such as Fig.21 As shown, until the distal side of the plug 32b contacts the inner end 42b of the closure member 40b, and the internal mixing fins 44b cooperate with the recesses 45b, and the proximal end 51b of the sleeve 50b is received in the cavity 43b of the plug 32b, as shown in FIG. Fig. 22 This action causes the fluid treatment material 70b within the fluid collection box 20b to flow from the fluid reservoir 28b, through the proximal end 51b, into the lumen 53b of the cannula 50b, and into the first needle shield 60b. When excess fluid treatment material is discharged from the distal end 52b of the needle 50b, the indicator tip 62b will activate and change color when it comes into contact with the excess fluid treatment material to provide a visual confirmation to the user that any dead space within the fluid reservoir 28b or the lumen 53b of the needle 50b is filled with fluid treatment material 70b. Then, as shown in FIG. Fig. 22 As shown, the plunger rod 31b can be separated from the stopper 32b by pulling the plunger rod 31b in the proximal direction (indicated by arrow P). The remaining volume (10-20μl) of the fluid treatment material 70b present in the dead space should be at a concentration that can provide sufficient treatment, such as providing sufficient anticoagulant function to prevent clotting of the arterial blood sample when it is collected.

[0127] The purpose of filling assembly 10b with fluid treatment material is to remove any ambient air so that the partial pressure of oxygen, for example in an arterial blood sample, is not affected by the ambient air. Assembly 10b should preferably have a low dead space to keep the residual volume of fluid treatment material low, thereby minimizing the dilution effect of the fluid treatment material on the fluid sample.

[0128] The fluid collection method according to one embodiment of the present invention enables the use of a one-handed technique similar to current clinical practice in a fluid collection procedure using a low-resistance rubber stopper moved by arterial pressure or an arterial blood collection procedure. The first needle shield 60b is removed from the needle assembly 11b. The user grasps the assembly 10b with one hand, such as Fig.23As shown, the distal end 52b is inserted into a fluid source, such as an artery of a patient. When arterial blood is removed using the present invention, blood at arterial pressure (greater than normal atmospheric or ambient pressure) will then flow through the lumen 53b of the cannula 50b into the fluid reservoir 28b and force the plug 32b to slide in the proximal direction until the proximal side 35b of the plug contacts the annular flange 24b, thereby defining the completion of the collection volume of the blood sample, as shown in FIG. Fig.24 The sliding movement of the rubber stopper 32b allows the fluid handling material 70b and the collected arterial blood to mix during the collection process, as shown in 47b.

[0129] The fluid or blood collection cassette 20b is then removed from the multiple sample needle assembly 11b and the holder 13b. The distal end 52b can then be removed from the fluid source or artery. The removed cassette 20b can then be rolled between the palms of the user in a plane perpendicular to the longitudinal axis 29b to further mix the fluid sample with the fluid processing material 70b (e.g., heparin), such as Figure 25-26 As the box 20b is rolled in the directions indicated by arrows w, x, y and z, the inner end 42b of the closure 40b and the asymmetric fin surface of the distal side 34b of the plug 32b generate vortices. The fluid collection box 20b containing the fluid sample is now ready to be transported to a laboratory, for example, for arterial blood gas analysis.

[0130] According to one embodiment, Fig. 27 The luer adapter 80b shown can then be inserted through the closure 40b of the cassette 20b to provide the cassette with an interface connection that is compatible with the blood gas analyzer. A range of different luer adapters can be provided to allow the fluid collection cassette 20b to be connected to all different types of testing devices and / or all different types of blood gas analyzer interfaces. The luer adapter 80b can also be supplied with a luer tip cap (not shown) to seal the fluid collection cassette 20b when the luer adapter 80b is connected.

[0131] refer to Fig.15 and 28 -30, in one embodiment, the device may further include a shieldable needle device 12. For example, referring to Fig.15 and 28 -30, the fluid collection assembly 10b, 10c may include a shieldable needle device 12c.

[0132] In an exemplary embodiment, the shieldable needle device 12c may include a flexible tube 14c extending from the needle device 12c, a fixture 16c mounted to the flexible tube 14c, a needle cannula 20c, a hub 30c, and an outer shield 50c. In some embodiments, the fixture 16c may be connected to a receptacle (not shown) for a blood collection procedure, as is known in the art.

[0133] In one embodiment, the needle cannula 20c includes a proximal end and an opposite distal end, and a lumen 26c extends through the needle cannula 20c from the proximal end to the distal end. The distal end of the needle cannula 20c is beveled to define a sharp puncture tip 28c, such as an intravenous puncture tip. The puncture tip 28c is provided for insertion into a patient's blood vessel, such as a vein, and is therefore designed to provide ease of insertion and minimal discomfort during venipuncture. A removable protective cover (not shown) can be positioned on the distal end of the needle cannula 20c for protecting the puncture tip 28c prior to use of the blood collection kit 10c.

[0134] The shieldable needle device 12c also includes a hub 30c. The hub 30 is a unitary structure, ideally molded from a thermoplastic material. The needle cannula 20c is located within and supported by the internal passage of the hub 30c, and the distal end of the needle cannula 20c extends from the distal end of the hub 30c. Ideally, the needle cannula 20c and the hub 30c are separately provided parts that are fixedly attached and secured by a suitable medical grade adhesive or the like. The proximal end of the hub 30c is adapted to be connected to the flexible tube 14c of the blood collection kit 10c. The hub 30c also includes a first protrusion 40c extending outwardly from the outer surface at a position adjacent to the proximal end of the hub 30c. In this way, when the shieldable needle device 12c is assembled with the tube 14c in the blood collection kit 10c, the user's fingers can contact the flexible protrusion 40c.

[0135] The shieldable needle device 12c also includes a hollow outer shield 50c. The outer shield 50c also includes a second protrusion 62c extending outwardly from a top portion of the housing 50c. The second protrusion 62c includes an inclined surface having a protrusion thereon for providing frictional engagement with a user's thumb.

[0136] The outer shield 50c is movable between a retracted position, in which the first projection 40c is exposed from the proximal end of the outer shield 50c and the piercing tip 28c is exposed from the distal end of the outer shield 50c, and an extended position, in which the piercing tip 28c and the distal end of the needle cannula 20c are covered by the outer shield 50c.

[0137] The first and second protrusions 40c, 62c are configured such that opposing forces applied to the first and second protrusions 40c, 62c cause the outer shield 50c to move from the retracted position to the extended position in the direction of arrow 100c toward the distal end of the needle cannula 20c. The protrusions on the first and second protrusions 40c, 62c provide frictional engagement with the user's fingers and thumb, respectively, to facilitate moving the outer shield 50c from the retracted position to the extended position.

[0138] The outer shield 50c can further include a pair of stabilizing members in the form of wings 68c extending laterally from opposite sides of the outer shield 50c, providing the blood collection set 10c as a butterfly-shaped wing assembly. The wings 68c assist in positioning and placing the shieldable needle device 12c and the blood collection set 10c during a blood collection procedure and are adapted to lie flat on a patient's skin surface during a blood collection procedure. Likewise, the wings 68c can be constructed of a flexible material such that at least one, and preferably both, of the wings 68c can be bent toward each other and placed together between the user's fingers to assist in positioning and placing the shieldable needle device 12c during venipuncture.

[0139] The shieldable needle device 12c can be substantially Fig.15 and 28 The blood collection kit 10c is packaged in the condition shown. In particular, the blood collection kit 10c is provided with an assembled needle device 12c and includes a flexible tube 14c extending from the needle device 12c and connected to a fixture 16c. Before use, the blood collection kit 10c is removed from its packaging. After the blood collection kit 10c is removed from its packaging, it can be assembled with other suitable medical devices for use. The fixture 16c can then be connected to a suitable receptacle, such as a non-patient needle assembly and needle holder, for providing fluid communication with the lumen 26c through the needle cannula 20c.

[0140] To prepare for use of the blood collection kit 10c, the user grasps the blood collection kit 10c at the shieldable needle device 12c and removes a protective cover (not shown) to expose the puncture tip 28c of the needle cannula 20c. The medical professional can then push the puncture tip 28c at the distal end of the needle cannula 20c into the patient's target blood vessel. During this positioning process, at least one of the wings 68c can be bent inwardly toward the other wing with the user's fingers to facilitate positioning and placement of the shieldable needle device 12c. When the procedure is complete, such as when all desired samples have been aspirated, the needle cannula 20c is withdrawn from the patient. After the needle cannula 20c is removed from the patient, activation of the safety feature of the shieldable needle device 12c is complete.

[0141] Although the present disclosure is described as having an exemplary design, the present disclosure can be further modified within the spirit and scope of the present disclosure. Therefore, the present application is intended to cover any changes, uses or adaptations of the present disclosure using its general principles. In addition, the present application is intended to cover deviations based on the present disclosure within the scope of practice known or customary in the field to which the present disclosure belongs and within the limits of the appended claims.

Claims

1. A biological fluid collection system, comprising: A collection module, which is suitable for receiving a sample, the collection module comprising: a housing having an inlet port and an outlet port, the inlet port and the outlet port being in fluid communication; Casing; and a mixing chamber disposed between the inlet port and the outlet port; and a collection chamber disposed between the mixing chamber and the outlet port, the collection chamber comprising an actuation portion, wherein the actuation portion comprises a first deformable portion located on a first side of the collection chamber and a second deformable portion located on a second side of the collection chamber opposite to the first side, wherein the first deformable portion and the second deformable portion are capable of transitioning between a first position in which a sample can be contained within the collection chamber and a second position in which a portion of the sample is expelled from the collection chamber; and a safety shield engaged with a portion of the housing and capable of transitioning from a first shield position in which a portion of the sleeve is exposed to a second shield position in which the sleeve is shielded by at least a portion of the safety shield; Wherein, after the safety shield has been switched from the first shield position to the second shield position, the first deformable portion and the second deformable portion are deflectable from the first position to the second position.

2. The biological fluid collection system of claim 1, wherein: The safety shield is pivotally engaged with a portion of the housing. 3 . The biological fluid collection system of claim 1 , further comprising a top cap disposed on at least a portion of the outlet port.

4. The biological fluid collection system of claim 1, wherein: The mixing chamber also includes a sample stabilizer disposed therein.

5. The biological fluid collection system of claim 4, wherein: The mixing chamber also includes an open-cell foam having pores, and the sample stabilizer is disposed within the pores of the open-cell foam.

6. The biological fluid collection system of claim 5, wherein: The open-cell foam is a melamine foam.

7. The biological fluid collection system of claim 1, wherein: A sample is drawn from the patient through the cannula and into the mixing chamber where it is passively mixed with a sample stabilizer and then into the collection chamber.

8. The biological fluid collection system of claim 7, wherein: The mixing chamber includes an open-cell melamine foam, and the sample stabilizer is disposed within pores of the open-cell melamine foam, and the sample is passively mixed with the sample stabilizer as the sample passes through the open-cell melamine foam.

9. The biological fluid collection system of claim 1 , further comprising a tube holder and a wing assembly in communication with the tube holder, wherein: A portion of the collection module is engageable with a portion of the tube holder.

10. The biological fluid collection system of claim 1, further comprising a top cap disposed over at least a portion of the outlet port, the top cap comprising a vent plug therein, the vent plug allowing air to pass therethrough and preventing sample from passing therethrough.

11. The biological fluid collection system of claim 10, further comprising a power source capable of being removably connected to the top end cap at the outlet port of the collection module, the power source being configured to generate a vacuum that draws the sample into the collection chamber; wherein, The power source comprises: a barrel attached to the top cap, a piston movable in the cylinder, a spring configured to move the piston within the cylinder, a lock that is switchable between a locked position in which the lock locks the piston in a first piston position and maintains the spring in a compressed position, and an unlocked position in which the piston is unlocked and the spring is allowed to drive the piston to a second piston position, and an activation button configured to transition the lock between the locked position and the unlocked position, Wherein, movement of the piston from the first position to the second position generates a vacuum, which draws the sample into the collection chamber, while the vent plug prevents the sample from being discharged from the top end cap.

Images