RU2772191C1 - Biological fluid collection system and stabilisation unit - Google Patents

Abstract

FIELD: conveying.

SUBSTANCE: group of inventions relates to systems for collecting biological fluid. Proposed is a variant of a biological fluid collection system containing a collection module configured to receive a sample. The collection module therein comprises: a body with an inlet port and an outlet port. The inlet port and the outlet port are in fluid communication. The collection module also comprises a cannula, a mixing chamber located between the inlet port and the outlet port, and a collection chamber located between the mixing chamber and the outlet port, wherein the collection chamber includes an activating part containing a first deformable part and a second deformable part, configured to be compressed simultaneously, and a rigid wall part located between said parts. The first and second deformable parts therein are made of a flexible deformable material capable of providing a fluid-impermeable seal with the body, and are configured to switch between a first position, wherein the sample can be contained in the collection chamber, and a second position, wherein part of the sample is removed from the collection chamber. The collection module also comprises a protective apparatus interacting with part of the body and configured to switch from a first position, wherein part of the cannula is open, to a second position, wherein the cannula is protected by at least part of the protective apparatus. Additionally proposed is a second variant of the biological fluid collection system.

EFFECT: increase in the accuracy and reliability of collection, as well as simplification of the working process.

18 cl, 30 dwg

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 62/719,166, filed August 17, 2018, and entitled "Biological Fluid Collection System and Stabilization Assembly", the entire content of which included in this application by reference.

STATE OF THE ART TO which THE INVENTION RELATES

1. Technical field

[0002] 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 sample analysis device, such as a bedside or near patient testing device, and a blood collection device for collecting arterial blood samples. to be fed into the blood gas analyzer.

2. Description of the prior art

[0003] There is a need for a device that allows taking a microsample, for example, less than 1.0 milliliters, from a sample taken for analysis, for applications near the patient's bedside and for blood gas analysis. Current devices require conventional sampling and then the use of a large syringe or pipette to transfer a small sample of blood into the receiving port of a cartridge or bedside instrument. This open system approach results in an increased risk for testing personnel to expose the blood to external influences, as well as in the collection of a larger sample than is required for the specified testing procedure.

[0004] Thus, it is desirable to have a blood sample collection and distribution tool for bedside blood gas applications that incorporates conventional automatic blood draw and provides a new possibility for controlled sample transfer while minimizing the risk of external tampering.

[0005] Also, there is a need to reduce the number of workflow steps in an arterial blood gas collection procedure.

SUMMARY OF THE INVENTION

[0006] A biological fluid collection system is disclosed, including a collection module for collecting a small blood sample and dispensing a portion of the sample into a sample analysis device, such as a bedside or near patient testing device, such as collection devices. blood for collecting samples of venous and arterial blood.

[0007] According to one embodiment of the present invention, the biological fluid collection system includes a collection module configured to receive a sample, the collection module including a housing having an inlet port and an outlet port, the inlet port and the outlet port being in communication fluid medium; cannula a mixing chamber located between the inlet port and the outlet port; and a collection chamber positioned between the mixing chamber and the outlet port, the collection chamber including an activating portion, the activating portion being translatable between a first position in which a sample can be contained in the collection chamber and a second position in which a portion of the sample is removed from the chamber. collection; and a protective device cooperating with the housing part and being translated from the first position, in which the cannula part is exposed, to the second position, in which the cannula is protected by at least part of the protective device.

[0008] According to another embodiment of the present invention, the biological fluid collection system includes a collection module configured to receive a sample, the collection module including a housing having an inlet port and an outlet port, the inlet port and the outlet port being connected by fluid medium; cannula a mixing chamber located between the inlet port and the outlet port; and a collection chamber positioned between the mixing chamber and the outlet port, the collection chamber including an activating portion, the activating portion being translatable between a first position in which a sample can be contained in the collection chamber and a second position in which a portion of the sample is removed from the chamber. collection; and a tubular holder and a wing device associated with the tubular holder, and the collection module part is cooperating with the part of the tubular holder.

[0009] According to another embodiment of the present invention, a fluid collection cartridge configured to be used with a fluid sample collection needle holder includes a tubular member having a proximal end, an open distal end, and a side wall extending between the proximal end and a distal end defining an inner chamber having an inner reservoir; a pierceable lid associated with the open distal end of the tubular, the lid being configured to engage with a side wall of the tubular to seal said open distal end; a piston rod assembly including a stopper and a piston rod releasably connected to each other by means of an interlocking arrangement, wherein said interlocking arrangement is configured to allow the piston rod to apply a distally directed force to the stopper and to allow the piston rod to be removed from the stopper and from the tubular element after application of a proximal directed force; and a protected needle device.

[0010] The device of the present disclosure has the following advantages over conventional arterial blood gas (ABG) collection kits: (1) ergonomic design with defined touch points; (2) thin-walled needle technology, which allows the use of a small needle size while maintaining a high flow rate resulting in a short filling time; (3) a push button safety device that can be activated with one hand by simply pressing the button after collection and does not block the user's field of vision during the procedure; (4) built-in vent/air-vent cap capability that allows entrapped air bubbles to be removed by simple removal during filling or after collection; and (5) uses a protective sleeve with protection and a push button that prevents accidental activation of the protective device during transport of the device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The above and other features and advantages of this disclosure and the manner in which they are provided will become more apparent, and the disclosure thereof will be more intelligible, with reference to the following description of embodiments of the disclosure, used in conjunction with the accompanying drawings, in which:

[0012] FIG. 1 is a perspective view of a biological fluid collection system according to another embodiment of the present invention.

[0013] FIG. 2 is a sectional side view of a capped collection module according to one embodiment of the present invention.

[0014] FIG. 3 is a sectional side view of a collection module with a deformable portion in a rest position, according to one embodiment of the present invention.

[0015] FIG. 4 is a sectional side view of a biological fluid collection system with the lock in the locked position according to one embodiment of the present invention.

[0016] FIG. 5 is a sectional side view of a biological fluid collection system with the lock in the unlocked position according to one embodiment of the present invention.

[0017] FIG. 6 is a sectional perspective view of a collection module with a deformable portion in rest position adjacent to a bedside testing device, according to one embodiment of the present invention.

[0018] FIG. 7 is a sectional perspective view of a collection module with a deformable portion in a deformed position adjacent to a bedside testing device, according to one embodiment of the present invention.

[0019] FIG. 8 is a perspective view of an acquisition module according to one embodiment of the present invention.

[0020] FIG. 9 is an exploded perspective view of a needle block having a hinged guard according to one embodiment of the present invention.

[0021] FIG. 10 is an assembled perspective view of the needle block of FIG. 9 in the retracted position.

[0022] FIG. 11 is a sectional side view of the needle block of FIG. ten.

[0023] FIG. 12 is a perspective view of the needle block of FIG. 10 in the extended position.

[0024] FIG. 13 is a perspective view of a biological fluid collection system according to another embodiment of the present invention.

[0025] FIG. 14 is a perspective view of a biological fluid collection device inserted into a tubular holder, according to one embodiment of the present invention.

[0026] FIG. 15 is a perspective view of a fluid collection system according to another embodiment of the present invention.

[0027] FIG. 16 is a perspective view of the components of a fluid collection unit according to one embodiment of the present invention.

[0028] FIG. 17 is a perspective view of the components of a fluid collection unit according to one embodiment of the present invention.

[0029] FIG. 18 is a partially sectioned side view of a fluid collection cartridge similar to the cartridge shown in FIG. 16 according to one embodiment of the present invention.

[0030] FIG. 19 is a sectional side view of the fluid collection unit shown in FIG. 18 during insertion of the fluid collection cartridge into the holder according to one embodiment of the present invention.

[0031] FIG. 20 is a sectional side perspective view of the fluid collection unit shown in FIG. 17 during insertion of the fluid collection cartridge into the holder according to one embodiment of the present invention.

[0032] FIG. 21 is a sectional side perspective view of the fluid collection unit shown in FIG. 17 after administration of a fluid treatment additive and before fluid sampling, in accordance with one embodiment of the present invention.

[0033] FIG. 22 is a sectional side view of the fluid collection unit shown in FIG. 19 after injection of a fluid treatment additive and during removal of a piston rod in accordance with one embodiment of the present invention.

[0034] FIG. 23 is a perspective view of a fluid collection unit during fluid collection according to one embodiment of the present invention.

[0035] FIG. 24 is a sectional side view of the fluid collection unit shown in FIG. 23 upon completion of a fluid sample collection according to one embodiment of the present invention.

[0036] FIG. 25 is a top view of a fluid collection cartridge showing the direction of agitation after collection of a fluid sample according to one embodiment of the present invention.

[0037] FIG. 26 is a sectional side view of a fluid collection cartridge showing mixing dynamics after collection of a fluid sample according to one embodiment of the present invention.

[0038] FIG. 27 is a perspective side view of a luer-lock fluid collection cartridge in preparation for shipping and testing in accordance with one embodiment of the present invention.

[0039] FIG. 28 is a perspective view of a blood collection device according to the present invention.

[0040] FIG. 29 is a side view of the blood collection device showing the outer guard in the retracted position.

[0041] FIG. 30 is a side view of the blood collection device showing the outer guard in an extended position.

[0042] The respective reference numbers indicate the respective parts in the individual views. The examples provided herein show illustrative embodiments of the disclosure, and such examples should not be construed as limiting the scope of the disclosure in any way.

DETAILED DESCRIPTION

[0043] The following description is provided to enable those skilled in the art to make and use the described embodiments provided for practicing the present invention. Various modifications, equivalents, changes, and alternatives, however, will immediately become apparent to those skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0044] For the purposes of the description below, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "higher", "lower", "transverse", "longitudinal" , and their derivatives should relate to the invention as it is oriented in the drawings. However, it should be understood that the present invention may contemplate various alternatives, except where expressly stated otherwise. It should also be understood that the specific devices shown in the accompanying drawings and described in the following description are merely illustrative embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed here should not be considered a limitation.

[0045] The present disclosure provides a biological fluid collection system that includes a power source for a collection module that receives a sample and provides flow blood stabilization technology and an accurate sample distribution function for bedside and near patient testing applications. . The collection module of the present disclosure is configured to perform distributed mixing of a sample stabilizer with a blood sample and distribute the stabilized sample in a controlled manner. Thus, the biological fluid collection system of the present disclosure provides micro-blood sample management, such as passive mixing with sample stabilizer and controlled distribution, for bedside and patient-proximity testing applications.

[0046] Preferably, the biological fluid collection system of the present disclosure provides a consistent blood sample management tool for bedside and near patient testing applications, automatic blood collection, passive mixing technology, and controlled small sample distribution capabilities for cartridge interfaces. and standard Luer interfaces directly at the bedside with receiving ports for testing in close proximity to the patient.

[0047] FIG. 1-8 show exemplary embodiments of a biological fluid collection system 10 of the present disclosure that is configured to receive 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 that is configured to receive a blood sample 12 and a power source 16 that is removably connectable to the collection module 14. The power source of the present disclosure provides a user-activated vacuum source to draw a biological fluid sample into collection module 14 . In one embodiment, part of the collection module 14 includes a cannula 17 for obtaining a blood sample 12 from a patient to the collection module 14.

[0048] With reference to FIG. 1-8, in one embodiment, the collection module 14 of the present disclosure is configured to receive a biological fluid sample, such as a blood sample 12, and includes a housing 20, a mixing chamber 22, a sample stabilizer 24, a collection chamber 26, a lid 28, and cap 30.

[0049] 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 fluidly connected through a passage 36 extending therebetween.

[0050] The mixing chamber 22 and the collection chamber 26 are in fluid communication with the passageway 36. The mixing chamber 22 and the collection chamber 26 are positioned such that a biological fluid sample, such as a blood sample 12, is 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 with the sample stabilizer 24, properly mixed in it, flows into the collection chamber 26 before reaching the outlet port 34 of the collection module 14 . Thus, the blood sample 12 can be mixed with a sample stabilizer 24 such as an anticoagulant or other additive provided inside the collection module 14 before passing through the mixing chamber 22 to properly mix the sample stabilizer 24 with the blood sample 12, and then the stabilized sample is received and stored inside the collection chamber 26 .

[0051] In one embodiment, the sample stabilizer 24 is located between the inlet port 32 and the mixing chamber 22. Collection module 14 of the present disclosure provides passive and rapid mixing of blood sample 12 with sample stabilizer 24 . For example, collection module 14 includes a mixing chamber 22 that allows for passive mixing of blood sample 12 with an anticoagulant or other additive, such as a blood stabilizer, as blood sample 12 flows through mixing chamber 22.

[0052] The sample stabilizer may be an anticoagulant or a substance configured to retain a particular element in the blood, such as, for example, RNA, a protein analyte, or another element. In one embodiment, sample stabilizer 24 is located between inlet port 32 and mixing chamber 22. In other embodiments, the sample stabilizer 24 may be located in other areas within the housing 20 of the collection module 14.

[0053] With reference to FIG. 2 and 3, in one embodiment, the collection module 14 includes a material 40 including pores 42, which is located between the inlet port 32 and the mixing chamber 22, and dry anticoagulant powder, which is inside the pores 42 of the material 40. Thus, collection module 14 may include a dry anticoagulant such as heparin or EDTA located on or within a portion of collection module 14. In one embodiment, material 40 is an open cell foam that contains a dry anticoagulant dispersed within the voids of the open cell foam to increase flow mixing efficiency and anticoagulant uptake. In one embodiment, the sample stabilizer 24 is a dry anticoagulant powder.

[0054] 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 available throughout the internal porous structure of the open cell foam. Thus, sample 12 dissolves and mixes with dry anticoagulant powder as it passes through material 40 or open cell foam.

[0055] The open cell foam may be a soft, deformable open cell foam that is inert to blood, such as melamine foam such as Basotect® foam available from BASF, or may be composed of a melamine formaldehyde copolymer and sodium bisulfite. The open cell foam may also be a flexible, hydrophilic open cell foam that is substantially resistant to heat and organic solvents. In one embodiment, the foam material may include a sponge material.

[0056] An anticoagulant or other additive may be incorporated into the open cell foam by impregnating the foam with a liquid solution of the additive and water and then evaporating the water to form a dry powder of the additive finely distributed throughout the internal structure of the foam.

[0057] The collection module 14 includes a mixing chamber 22 that allows the blood sample 12 to be passively mixed with an anticoagulant or other additive, such as a blood stabilizer, as the blood sample 12 flows through the mixing chamber 22. In one embodiment, mixing chamber 22 is located between inlet port 32 and outlet port 34.

[0058] The interior of the mixing chamber 22 may be of any suitable structure or shape, as long as it allows the blood sample 12 to be mixed with an anticoagulant or other additive as the blood sample 12 passes through the passage 36 of the collection module 14.

[0059] Mixing chamber 22 receives sample 12 and sample stabilizer 24 and distributes mixing of sample stabilizer 24 with sample 12. Mixing chamber 22 distributes mixing of sample stabilizer 24 with sample 12 and prevents very high concentration of sample stabilizer in any part of blood sample 12. This prevents underdosing of sample stabilizer 24 in any part of the blood sample 12 . Mixing chamber 22 distributes mixing of sample stabilizer 24 with sample 12 such that approximately the same amount and/or concentration of sample stabilizer 24 dissolves throughout blood sample 12, e.g., approximately the same amount and/or concentration of sample stabilizer 24 dissolves in sample 12 blood from the front of the blood sample 12 to the back of the blood sample 12.

[0060] In one embodiment, the collection module 14 includes a collection chamber 26 that is located between the mixing chamber 22 and the outlet port 34. The collection chamber 26 includes an activation portion 61. In one embodiment, the activation portion 61 is transferable between a first position (FIGS. 2, 3 and 6) in which the blood sample 12 can be contained in the collection chamber 26, and a second position (FIG. 7) in which a portion of the blood sample 12 is removed from the collection chamber 26.

[0061] In one embodiment, the activating portion 61 of the collection chamber 26 includes a first deformable portion 62, a second deformable portion 64, and a rigid wall portion 66 (FIG. 8) that is between the first deformable portion 62 and the second deformable portion 64 In one embodiment, the first deformable portion 62 is located on the first side 70 of the collection chamber 26, and the second deformable portion 64 is located on the second side 72 of the collection chamber 26. In one embodiment, the second side 72 of the collection chamber 26 is opposite the first side 70 of the collection chamber 26.

[0062] In one embodiment, the first deformable portion 62 and the second deformable portion 64 are translatable between the initial position in which the sample 12 is contained in the collection chamber 26 and the deformed position in which the sample 12 is removed from the collection chamber 26. The first deformable portion 62 and the second deformable portion 64 are simultaneously compressed to move them from the initial position to the deformed position.

[0063] Preferably, by having a first deformable portion 62 and a second deformable portion 64 that can be simultaneously compressed, the collection module 14 of the present disclosure is configured to dispense more sample 12 from the collection chamber 26 and the outlet port 34. Additionally, in one embodiment, by having the first deformable portion 62 on the first side 70 and the second deformable portion 64 on the second side 72, the collection module 14 of the present disclosure is symmetrically constructed and provides a chamber with a smooth, straight fluid path that maintains the fluid sticking flow characteristics. The collection module 14's smooth, straight fluid path chamber does not have significant geometric differences in diameter, and the smooth fluid path prevents air pockets or bubbles from forming.

[0064] After passing through the mixing chamber 22, the stabilized sample is sent to the collection chamber 26 . The collection chamber 26 may be of any suitable shape and size to store a sufficient volume of blood required for the required testing, eg 500 μl or less. In one embodiment, the collection chamber 26 is defined by a body part 20 in combination with a first deformable part 62, a second deformable part 64, and a rigid wall part 66.

[0065] The first deformable portion 62 and the second deformable portion 64 may be made from any material that is flexible, deformable, and capable of providing a fluid-tight seal to the housing 20. In some embodiments, the first deformable portion 62 and the second deformable portion 64 can be made from natural or synthetic rubber and other suitable elastomeric materials. The first deformable part 62 and the second deformable part 64 are attached to the body part 20 so that the first deformable part 62 and the second deformable part 64 are translatable between the initial position in which the sample 12 is contained in the collection chamber 26 and the deformed position in which the part sample 12 is removed from collection chamber 26 .

[0066] In another embodiment, the activation portion 61 of the collection chamber 26 may include an activation member such that applying inward pressure to the resilient portion of the activation portion 61 causes the sample to be dispensed from the collection chamber 26 . Thus, the sample can be transferred to a sample analysis device, such as a bedside testing device such as a cartridge tester, or can be transferred through a port while minimizing impact on the sample. In some configurations, the activation element may at least partially define the collection chamber 26, alternatively, the activation element may be a separate element interacting with the collection chamber 26, such as a piston, push button, slider, or the like. An activation element, such as the activation element described in U.S. Patent Application No. 15/065,022, filed March 9, 2016, and entitled "Biological Fluid Micro-Sample Management Device", the entire content of which is included in this application by reference, may also be used in conjunction with the present invention. In other embodiments, activation portion 61 of collection chamber 26 may comprise activation portions corresponding to the activation portions and/or deformable portions described in U.S. Patent Application No. 62/634,960, filed Feb. Module” (“Collection Device and Biological Fluid Collection Module”), the entire content of which is incorporated into this application by reference.

[0067] In one embodiment, collection module 14 includes a cap 30 that is removably attachable to outlet port 34 and that covers outlet port 34 for protection. In one embodiment, cap 30 includes an air-vent plug 80 that allows air to pass through and prevents sample 12 from passing through.

[0068] The design of cap 30 and vent-air plug 80 allows air to pass through cap 30 while preventing blood sample 12 from passing through cap 30 and may include a hydrophobic filter. The vent-air plug 80 has a selected resistance to the passage of air, which can be used to precisely control the filling rate of the passage 36 and/or the collection chamber 26 of the collection module 14. By varying the porosity of the plug, the rate of air flow exiting the cap 30 and thus the rate of blood sample flow into the collection module 14 can be controlled.

[0069] In one embodiment, collection module 14 includes a cover 28 that cooperates with inlet port 32 of collection module 14 to seal passage 36. Cover 28 covers inlet port 32 for protection. Cap 28 allows introduction of blood sample 12 into passage 36 of housing 20 and may include a pierceable self-sealing stopper 82 with an external safety device 84 such as a Hemogard™ cap available from Becton, Dickinson and Company.

[0070] In one embodiment, part of the collection module 14 includes a cannula 17 for obtaining a blood sample 12 from a patient to the collection module 14. In such embodiments, collection module 14 includes a first removable protective cap 90 and a protective device 92.

[0071] FIG. 1 and 9-12 show an exemplary embodiment of the hinged guard assembly of the present disclosure. The needle assembly 5000 generally includes a needle structure 32c2 associated with the hub 58c2 and a guard 64c2 coupled to the hub 58c2 and configured to protect the needle structure or cannula 17 after use of the device. In one embodiment, the needle block 5000 may include elements of other known needle blocks having hinged guards, such as the needle blocks disclosed in US Patent Publication No. 2005/0187493, the entire contents of which are incorporated herein by reference.

[0072] The needle structure 32c2 may include a patient needle portion or cannula 17. Cannula 17 represents the patient end of the needle structure 32c2 and may be bevelled to define a piercing tip for piercing the patient's skin and providing access to the patient's vasculature.

[0073] The sleeve 58c2 may include a front sleeve portion 5010 and a rear sleeve portion 5012 and is configured to support the needle structure 32c2 therewith. In one embodiment, the cannula 17 may be integral with the front portion 5010 of the sleeve, while the central lumen 5006 may be integral with the rear portion 5012 of the sleeve. The front part 5010 of the sleeve and the rear part 5012 of the sleeve are made with the possibility of pair interaction. The front portion 5010 of the sleeve may include a protrusion 5014, such as a raised sectorial ring, for engagement with a corresponding recess 5016 that is integral with the rear portion 5012 of the sleeve. In another embodiment, the front part 5010 of the sleeve and the rear part 5012 of the sleeve may be joined together by adhesive or welding. After assembly, the sleeve 58c2 determines the blood occurrence indicator 60c2.

[0074] Sleeve 58c2 may further include a lug 5018 to surround at least a portion of guard 64c2. In one embodiment, the front sleeve portion 5010 includes a first lug portion 5022 and the rear sleeve portion 5012 includes a second lug portion 5024. The first lug portion 5022 may include a generally c-shaped area 5028 to accommodate the attachment support 5026 of the security device 64c2. Mounting support 5026 can be integral with the protective device 64c2. The mounting support 5026 may also be integral with a portion of the sleeve 58c2, such as the first lug portion 5022 and/or the second lug portion 5024. Alternatively, mounting support 5026 may be provided separately and then assembled with guard 64c2 and/or bushing 58c2. The first lug part 5022 may include a protrusion 5034 for engagement with a corresponding recess 5036 that is integral with the second lug part 5024. Accordingly, in one embodiment, the engagement of the front sleeve portion 5010 with the rear sleeve portion 5012 also enables the first lug portion 5022 to interact with the second lug portion 5024. In another embodiment, lug 5018 may be located substantially on the top surface of sleeve 58c2, which allows the protective device 64c2 to be connected to the top surface of sleeve 58c2 in a similar manner.

[0075] With reference to FIG. 1 and 9, as described herein, a protective cap 90 may be provided over the patient's needle portion or cannula 17 prior to use.

[0076] During use, the protective cap 90 can be removed from the cannula 17, whereby the cannula 17 is exposed for use. The cannula 17 may then interact with the patient to collect a blood sample. After use, the guard 92 is used to close and cover the cannula 17 for protection, whereby accidental needle-stick injuries are prevented.

[0077] The needle block 5000 can be moved from a retracted position, in which the cannula 17 is not closed to allow access to the patient, to an extended position, in which the cannula 17 is protected from impact.

[0078] 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 blood stabilization technology and an accurate sample distribution function for direct testing applications. at the patient's bedside and in close proximity to the patient. The energy source of the present disclosure makes it possible to provide a user-activated vacuum source.

[0079] In one embodiment, power source 16 includes a spring-loaded device for automatically drawing blood sample 12 into collection module 14. The spring-loaded power source uses a user-activated, spring-driven piston to create a vacuum at the distal end of the collection module 14. In such an embodiment, by controlling the stiffness and travel distance of the spring, a predictable vacuum can be applied in the fluid path of the collection module 14 to provide a given blood flow rate as it fills the collection module 14. Predictable flow rates are important to mixing design.

[0080] With reference to FIG. 4-5, in one exemplary embodiment, power source 16 is removably coupled to collection module 14 and power source 16 creates a vacuum that draws sample 12 into collection chamber 26. In one embodiment, the power source 16 includes a cup 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 engages with the inner surface of the side wall 126 of the cup 110.

[0081] Optionally, the power source 16 may include a lock that is translatable between a locked position, in which the lock locks the piston 112 in the first piston position and holds the spring 114 in a compressed position, and an unlocked position, in which the piston 112 is not locked, and the spring 114 may move the piston 112 to the second piston position whereby a vacuum is created which draws the sample into the collection chamber 26 . Optionally, activation of the activation element may move the lock to the unlocked position.

[0082] The cup 110 is connected to the collection chamber 26 of the collection module 14. Cup 110 defines an interior 120 and includes a first end 122, a second end 124, and a side wall 126 therebetween. Cup 110 is removably connected to part of the collection module 14. For example, in one embodiment, beaker 110 is removably connected to cap 30 of collection module 14 such that the vacuum created by power source 16 can draw sample 12 into collection chamber 26 of collection module 14. As described above, the cap 30 includes an air-vent plug 80 that allows air to pass through and prevents the sample 12 from passing through. so that the vacuum created by the energy source 16 can draw the sample 12 into the collection chamber 26 of the collection module 14 .

[0083] Piston 112 is slidably positioned within interior 120 of cup 110. Piston 112 is sized relative to interior 120 of cup 110 to seal engagement with side wall 126 of cup 110. Piston 112 is translatable between a first piston position (FIG. 4), in which the piston 112 is at a first distance from the first end 122 of the cup 110, and the second position of the piston (Fig. 5), in which the piston 112 is at a second distance from the first end 122 of the cup 110, and the second distance is greater than the first distance.

[0084] With reference to FIG. 4-5, spring 114 is located between first end 122 of cup 110 and piston 112. In one embodiment, activation button 116 is located on a portion of cup 110.

[0085] Power source 16 also includes a lock that is associated with spring 114 and activation button 116. The lock is translatable between a locked position in which the lock locks piston 112 in the first piston position (FIG. 4) and holds spring 114 in compression. position, and an unlocked position in which piston 112 is not locked and spring 114 can move piston 112 to a second piston position (FIG. 5) whereby a vacuum is created that draws sample 12 into collection chamber 26 of collection module 14. In one embodiment, activation of the activation button 116 moves the lock to the unlocked position.

[0086] Preferably, the collection module and energy source of the present disclosure can interact with many different sources through which the biological fluid passes, such as sample 12 blood. For example, in some embodiments, the collection module and power source of the present disclosure may interact with a conventional tubular holder. In other embodiments, the user-activated energy source of the present disclosure allows the user to directly connect to a Luer line, such as an IV catheter, vane device, PICC, or similar device. In other embodiments, if the collection module and energy source are used with the HemoLuer, the user may connect the collection module and energy source to either a Luer-lock tube holder (by removing the HemoLuer) or a conventional tube holder (using the HemoLuer as an interface). Preferably, the system of the present disclosure also allows direct Luer access without the use of a Luer Line Access Device (LLAD) or any other holder.

[0087] In one embodiment, part of the collection module 14 includes a cannula 17 for obtaining a blood sample 12 from a patient to the collection module 14. In such embodiments, the collection module 14 includes a first removable protective cap 90 and a protective device 92. In such embodiments, the cannula 17 may interact with the patient and then the power source 16 may be used to create a vacuum that draws the sample 12 into collection chamber 26.

[0088] In one embodiment, the blood sample 12 is drawn into the passage 36 of the housing 20 of the collection module 14 by the draft of the vacuum created in the beaker. In one embodiment, the blood sample 12 fills the entire passageway 36 such that when the blood sample 12 enters the collection module 14, the blood sample 12 passes through an open cell foam material, such as material 40, and is exposed to an anticoagulant powder available throughout the internal pore structure 42 of the open cell foam. Thus, sample 12 dissolves and mixes with dry anticoagulant powder as it passes through material 40 or open cell foam. Then, the mixing chamber 22 receives the sample 12 and the sample stabilizer 24 and performs distributed mixing of the sample stabilizer 24 with the sample 12. After passing through the mixing chamber 22, the stabilized sample is sent to the collection chamber 26. The collection chamber 26 may be of any suitable shape and size to store a sufficient volume of blood required for the required testing, eg 500 μl or less. In one embodiment, the cap 30 stops the collection of the blood sample 12 when the passage 36, the mixing chamber 22, and the collection chamber 26 of the collection module 14 are completely filled. The air-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 into the beaker 110 of the energy source 16.

[0089] In one embodiment, after completion of the sample collection, the energy source 16 is separated from the collection module 14. After separating the collection module 14 from the energy source 16, the cap 30 can be removed from the collection module 14 and the outlet port 34 of the housing 20 of the collection module 14 can be exposed. Removal can be accomplished by the user grasping the outside of the cap 30 and pulling the cap 30 off the body 20. The blood sample 12 is retained in the passage 36 of the body 20, such as the collection chamber 26, by capillary action after removal of the cap 30.

[0090] The blood sample 12 may then be dispensed from the collection module 14 by activating the activation portion 61. In one embodiment, the activation 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 may be translatable between a home position in which sample 12 is contained in collection chamber 26 and a deformed position in which a portion of sample 12 is removed from collection chamber 26 and outlet port 34. First deformable portion 62 and second deformable portion 64 are simultaneously compressed to their transfer from the initial position to the deformed position. Thus, the blood sample 12 can be transferred to a sample analysis device, such as a bedside test device 105 (FIG. 6), a cartridge tester, or a near patient test device, while minimizing the impact of the healthcare worker. for a blood sample.

[0091] Preferably, by having a first deformable portion 62 and a second deformable portion 64 that can be simultaneously compressed, the collection module 14 of the present disclosure is configured to dispense more sample 12 from the collection chamber 26 and the outlet port 34. Additionally, in one embodiment, by having a first deformable portion 62 on the first side 70 and a second deformable portion 64 on the opposite second side 72, the collection module 14 of the present disclosure is symmetrically constructed and provides a chamber with a smooth, straight fluid path that maintains the fluid adherence flow characteristics.

[0092] 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 blood stabilization technology and an accurate sample distribution function for bedside and in-patient testing applications. close proximity to the patient. The energy source of the present disclosure makes it possible to provide a user-activated vacuum source.

[0093] The energy source 16 of the present disclosure may contain energy systems corresponding to other energy systems described in US patent application No. 62/658,737, filed April 17, 2018 and entitled "Biological Fluid Collection System" ("Biological Fluid Collection System" ), the full content of which is incorporated into this application by reference.

[0094] As described herein, the present disclosure provides a biological fluid collection system that includes a power source for a collection module that receives a sample and provides flow blood stabilization technology and an accurate sample distribution function for near-bedside and in-patient testing applications. close proximity to the patient. The power source of the present disclosure provides a user-activated vacuum source for drawing a biological fluid sample into a collection module.

[0095] The collection module of the present disclosure is configured to perform distributed mixing of a sample stabilizer with a blood sample and distribute the stabilized sample in a controlled manner. Thus, the biological fluid collection system of the present disclosure provides micro-blood sample management, such as passive mixing with sample stabilizer and controlled distribution, for bedside and patient-proximity testing applications.

[0096] Preferably, the biological fluid collection system of the present disclosure provides a consistent blood sample management tool for bedside and near patient testing applications, automatic blood collection, passive mixing technology, and controlled small sample distribution capabilities for cartridge interfaces. and standard Luer interfaces directly at the bedside with receiving ports for testing in close proximity to the patient.

[0097] With reference to FIG. 13-14, in one embodiment, the biological fluid collection device 10 of the present disclosure is configured to receive a biological fluid sample, such as a blood sample 12, and includes a collection module 14 and an outer housing 16a that is removably connectable to the module 14. collection. In one embodiment, in the case of an acquisition module 14 coupled to an outer housing 16a, the acquisition module 14 is located in the outer housing 16a as shown in FIG. 13-14. The outer housing 16a may be a vacuum-containing blood collection tube, such as the Vacutainer® blood collection tube available from Becton, Dickinson and Company.

[0098] In one embodiment, the collection module 14 is located in the outer housing 16a and is compatible with a tubular holder 102 having a cannula and a wing device 104. In use, the needle cannula of the tubular holder 102 is inserted into the passage 36 of the housing 20 of the collection module 14 through the inlet port 32, for example, through a pierceable self-sealing stopper 82 of cap 28. The biological fluid collection device 10, including the combined collection module 14 and outer housing 16a, can be inserted into a conventional tubular holder 102 having a cannula through which the biological fluid passes, for example, sample 12 blood.

[0099] The blood sample 12 is drawn into the passage 36 of the housing 20 of the collection module 14 from the conventional tubular holder 102 by means of a vacuum pull contained in the outer housing 16a. In one embodiment, blood sample 12 fills the entire passageway 36 such that blood sample 12 enters collection module 14, blood sample 12 passes through an open cell foam material such as material 40 and is exposed to anticoagulant powder 44 available throughout the entire structure of internal pores 42 of open-cell foam. Thus, sample 12 dissolves and mixes with dry anticoagulant powder 44 as it passes through material 40 or open cell foam. Then, the mixing chamber 22 receives the sample 12 and the sample stabilizer 24 and performs distributed mixing of the sample stabilizer 24 with the sample 12. After passing through the mixing chamber 22, the stabilized sample is sent to the collection chamber 26. The collection chamber 26 may be of any suitable shape and size to store a sufficient volume of blood required for the required testing, eg 500 μl or less. In one embodiment, the cap 30 stops the collection of the blood sample 12 when the passage 36, the mixing chamber 22, and the collection chamber 26 of the collection module 14 are completely filled. The air-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 into the outer housing 16.

[00100] In one embodiment, after completion of the sample collection, the outer housing 16a, including the collection module 14, is separated from the tubular holder 102, and then the outer housing 16a is separated from the collection module 14 by removing the cover 28, which is still attached to collection module 14, from the outer housing 16a. Removal of the lid 28 can be accomplished by the user grasping both the outer guard 84 of the lid 28 and the outer housing 16a and pulling or twisting them in opposite directions.

[00101] After separating the collection module 14 from the outer housing 16a, the cap 30 may be removed from the collection module 14 and the outlet port 34 of the collection module 14 housing 20 may be exposed. Removal can be accomplished by a user grasping the outside of cap 30 and pulling cap 30 off body 20. Blood sample 12 is retained in passage 36 of body 20, such as collection chamber 26, by capillary action after removal of cap 30. In one embodiment, alternatively, removal of cap 30 may occur after removal of collection module 14 from outer housing 16. In this configuration, cap 30 is secured within outer housing 16. In one embodiment, cap 30 may cooperate with outer housing 16 such that outer housing 16 and cap 30 could be removed in one go.

[00102] The blood sample 12 can then be dispensed from the collection module 14 by activating the first deformable part 62 and the second deformable part 64. For example, the first deformable part 62 and the second deformable part 64 are transferable between the initial position in which the sample 12 is contained in the chamber 26 collection, and a deformed position in which part of the sample 12 is removed from the collection chamber 26 and the outlet port 34. The first deformable part 62 and the second deformable part 64 are simultaneously compressed to transfer them from their original position to the deformed position. Thus, the blood sample 12 can be transferred to a sample analysis device, such as a bedside test device 105 (FIG. 6), a cartridge tester, or a near patient test device, while minimizing the impact of the healthcare worker. for a blood sample.

[00103] The present disclosure includes blood collection devices for collecting arterial blood samples using radial puncture technology. The present disclosure streamlines and reduces the number of steps in the workflow, which is very important in the procedure for collecting arterial blood gases (Arterial Blood Gas - ABG). The proposed device includes automatic mixing with anticoagulant and built-in air venting to remove air bubbles during collection.

[00104] Existing ABG syringes typically use conventional hypodermic needles with a guard that must snap or slide over the needle after blood has been collected. Such protective devices are often in line of sight during a blood collection procedure and thus obscure the field of view of clinicians during this sensitive procedure. Conventional ABG syringes also often have a separate air-venting cap which requires removal of the needle before attaching the cap to remove trapped air bubbles from the sample taken. The anticoagulant is typically loaded into an ABG syringe, which requires the user to rotate or shake the sample to ensure complete mixing with the anticoagulant. The device of the present disclosure has the following advantages over conventional arterial blood gas (ABG) collection kits: (1) ergonomic design with defined touch points; (2) thin-walled needle technology (BD Ultratouch), which allows the use of a small needle size while maintaining a high flow rate resulting in short filling times and shorter patient exposure for potentially painful procedures; (3) a push button safety device that can be activated with one hand by simply pressing the button after collection and does not block the user's field of vision during the procedure; (4) built-in vent/air-vent cap capability that allows entrapped air bubbles to be removed by simple removal during filling or after collection; and (5) uses a protective sleeve with protection and a push button that prevents accidental activation of the protective device during transport of the device.

[00105] According to another idea of the present disclosure, with reference to FIG. 15-27, the fluid collection unit 10b generally includes a needle assembly 11b, a first needle guard 60b, a tubular holder 13b, and a fluid collection cartridge 20b. According to one embodiment, the fluid collection unit 10b may comprise an arterial blood collection unit. While an arterial blood collection cartridge 20b for use with a needle assembly 11b is described herein, the cartridge 20b of the present disclosure may be used with or may include other medical devices, such as another medical device assembly that includes a piercing element. or allows attachment to a catheter or arterial lines.

[00106] In an exemplary embodiment, the main components of the fluid collection cartridge 20b include a piston assembly 30b having a removable piston rod 31b and a stopper 32b in slidable engagement with the tubular member 21b, and a cap 40b.

[00107] With reference to FIG. 15-18, in one illustrative embodiment, the fluid collection cartridge 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 defining an inner chamber 26b having an inner reservoir 28b. The side wall 25b of the tube 21b defines an inner surface 27b for sliding the piston block 30b. An annular flange 24b is provided at the proximal end 23b of the tubular 21b and extends from the inner surface 27b into the chamber 26b, partially covering the proximal end 23b of the tubular 21b.

[00108] The tubular element 21b may be made from one or more of the following representative materials: polypropylene, polyethylene, polyethylene terephthalate (polyethylene terephthalate - PET), polystyrene, polycarbonate, cellulose, glass products, or combinations thereof. More expensive plastics such as polytetrafluoroethylene and other fluorinated polymers can also be used. In addition to the materials mentioned above, examples of other suitable materials include polyolefins, polyamides, polyesters, siloxanes, polyurethanes, epoxy compounds, acrylics, polyacrylates, polysulfones, polymethacrylates, PEEK, polyimides, and fluoropolymers such as PTFE Teflon®, FEP Teflon ®, Tefzel®, PVDF, PVDF, and perfluoroalkoxy resins. One exemplary glass product is PYREX® (commercially available from Corning Glass, Corning, New York). Ceramic collection devices may be used in accordance with embodiments of the present invention. Cellulosic products such as paper and reinforced paper containers can also be used to form the collection devices of the present disclosure.

[00109] With reference to FIG. 15-18, in one exemplary embodiment, the fluid collection cartridge 20b also includes a piston assembly 30b slidably received within a chamber 26b defined by a side wall 25b of tube 21b. The piston block 30b includes a stopper 32b and a removable piston rod 31b. Stopper 32b is slidably in fluid-tight engagement with inner surface 27b and is slidable distally and proximally along longitudinal axis 29b. The stopper 32b and the piston rod 31b are removably connected to each other by an interlocking arrangement 90b. The interlocking arrangement 90b is configured to allow the piston rod 31b to apply a distally directed force to the stopper 32b and to allow the piston rod 31b to be removed from the stopper 32b and from the tubular member 21b upon application of a proximally directed force, shown as "P" in FIG. 22. In other words, stopper 32b and piston rod 31b are not mechanically attached to each other, but are simply located in a releasable contact arrangement that allows piston rod 31b to apply force to stopper 32b only in a distal direction. The proximal end of the removable piston rod 31b may include a thumb flange 33b which the user can use to apply force to distally push the entire piston assembly 30b, or which the user can pull to remove the piston rod 31b from the tubular member 21b.

[00110] With reference to FIG. 15-18, in one illustrative embodiment, the stopper 32b includes a distal face 34b and a proximal face 35b. The diameter of the stopper 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 stopper 32b is in sliding contact with the inner surface 27b of the tube 21b and provides a fluid-tight seal between the piston block 30b and the inner surface 27b of the tube 21b so that the sample can be held within the internal reservoir 28b formed within the chamber 26b between the distal end 22b of the tube 21b and the distal face 34b of the stopper 32b, thereby preventing the sample from flowing out of the proximal end 23b of the tube 21b.

[00111] Stopper 32b is a low resistance stopper and is substantially configured to have a relatively low frictional resistance to movement within tube 21b compared to similar prior art arterial blood gas collection syringe components such that the presence of fluid pressure, such as arterial pressure blood, in the inner reservoir 28b will cause the stopper 32b to slide/move in a proximal direction towards the proximal end 23b of the tube 21b until the proximal face 35b of the stopper 32b contacts the annular flange 24b by which the proximal movement of the stopper 32b is limited . The frictional resistance of the stopper can be reduced either through the design of the sealing profile of the stopper or the choice of component materials, or through a combination of the above. The first sealing ring 36b and the second sealing ring 37b extend around the outer circumferential surface of the stopper 32b near the distal face 34b and the proximal face 35b, respectively, to form a primary and secondary seal with the inner surface 27b of the tube 21b. This design of the stopper sealing profile reduces the amount of contact between the stopper 32b and the inner surface 27b, thereby reducing frictional resistance to movement of the stopper 32b compared to a stopper sealing profile in which the entire outer circumferential surface is in contact with the inner surface 27b. Alternatively, or in combination with the sealing profile design of the stopper, stopper 32b may preferably be made from an elastomeric material such as natural rubber, synthetic rubber, thermoplastic elastomers, and combinations thereof, which are capable of being self-lubricating or having relatively low frictional resistance. Stop 32b can also be made from a combination of elastomers that 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, embedded in the polymeric material, an example of which is Epilor.

[00112] Prior to use, the piston rod 31b contacts the proximal face 35b of the stopper 32b such that the piston rod 31b can only apply force in the distal direction. The interlocking arrangement 90b may include a male element, such as a tapered pin 39b, extending from the distal end of the piston rod 31b, which is configured to mate with a corresponding female element, such as a tapered recess 45b in the proximal face 35b of the stopper 32b. It can be understood that the tapered pin 39b and the tapered recess 45b show one example of an interlocking arrangement 90b, and that other interlocking arrangements may be used to releasably connect the piston rod 31b to the stopper 32b. For example, the interlocking arrangement 90b may be configured such that the distal end of the piston rod 31b includes a female member configured to mate with a corresponding male member extending from the proximal face 35b of stopper 32b.

[00113] With reference to FIG. 20-22, the application of a force, for example by a user, to the thumb flange 33b causes the piston rod 31b to transmit the applied force to move the stopper 32b distally, which would force the fluids out of the blood collection cartridge if the distal end 22b of the tube 21b, there was a fluid passage. However, pulling the piston rod 31b in the proximal direction, as shown by "P" in FIG. 22 will not apply any force to stop 32b. The tapered pin 39b will simply disengage from the recess 45b and thus the stopper 32b will remain stationary in the tube 21b while the piston rod 31b is removed from the tubular member 21b.

[00114] The piston rod 31b is desirably made from a suitable polymeric material, and can be made by injection molding using a suitable polymeric material known in the art. The scope of the present invention includes piston rods and stoppers that are formed separately or integrally formed from the same materials or different materials, for example, by two-color molding, or formed separately from the same or different materials and joined together by mechanical means, adhesive, ultrasonic welding , heat sealing, or other suitable means.

[00115] With reference to FIG. 15-18, in one exemplary embodiment, pierce cap 40b is associated with open distal end 22b of tubular 21b. The lid 40b is configured to cooperate with the side wall 25b of the tubular member 21b to seal the open distal end 22b to form a liquid-tight seal to contain the fluid sample. Cap 40b includes an outer end 41b and an inner end 42b configured to be at least partially received within the tubular member 21b. The parts of the cap 40b adjacent to the open distal end 22b of the tube 21b define a maximum outside diameter that is larger than the inside diameter "a" of the tube 21b. The inherent resilience of the cap 40b can provide a sealing engagement with the inner surface 27b of the wall 25b of the tube 21b. Portions of cap 40b extending downward from inner end 42b may be tapered from a smaller diameter that is approximately equal to or slightly smaller than the inner diameter "a" of tube 21b to a larger diameter that is greater than the inner diameter "a" of tube 21b adjacent the distal end. 22b. Thus, the inner end 42b of the cap 40b can be pushed into the part of the tube 21b adjacent to the distal open end 22b. The cap 40b is such that it can be pierced with a needle 50b or other cannula to introduce a biological sample into the tubular member 21b. According to one embodiment, cover 40b is resealable. The lid 40b may also be configured to define the cavity 43b shown in FIG. 19 continuing into the inner end 42b. The cavity 43b may be configured to receive at least a corresponding mixing rib 44b extending distally from the distal face 34b of the stopper 32b. Alternatively, a plurality of cavities and corresponding mixing ribs may be present. Suitable materials for the cap 40b include, for example, elastomers such as silicone rubber, natural rubber, styrene butadiene rubber, ethylene-propylene copolymers and polychloroprene, thermoplastic elastomers, and the like.

[00116] According to one embodiment, the fluid collection cartridge 20b may contain additional additives required for specific testing procedures, such as anticoagulants, clotting agents, stabilizing additives, and the like, shown at 70b in FIG. 19. Such additives may be sprayed on the inner surface 27b of the tube 21b or located in the inner reservoir 28b. Anticoagulants may include hirudins, hirudin derivatives, chelating agents, or derivatives of chelating agents. 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 the administration and hence the effectiveness of the anticoagulant after arterial blood collection. The liquid form may be an emulsion, solution, or dispersion of the anticoagulant in a suitable vehicle. Other known arterial blood sample collection methods use an arterial blood gas syringe that is preloaded with a solid form of an anticoagulant, such as heparin powder, after manufacture to maximize syringe life. The use of a solid form of anticoagulant may cause a decrease in the effectiveness of the anticoagulant, since the introduction of powdered heparin into the blood sample is difficult due to insufficient mixing during the arterial blood collection procedure.

[00117] The combination of cavity 43b at inner end 42b of lid 40b and mixing rib 44b extending from distal face 34b of stopper 32b provides asymmetric surfaces at each end of inner reservoir 28b. With reference to FIG. 25-26, when the cartridge 20b is rotated by rotating the cartridge about its longitudinal axis in the direction of the arrows w and x, the cavity 43b and the mixing rib 44b create vortices that promote complete mixing of the contents of the fluid reservoir 28b. This is especially useful in cases where there is no air (headspace) in the collection vessel's fluid reservoir. Tipping such devices upside down does little to stir the contents, especially if the components are similar in density. Vessels with cylindrical internal fluid reservoirs, such as test tubes, insulin pens, and syringes, typically have smooth interior surfaces at the top and bottom of the fluid reservoir. Thus, little turbulence is created by the rotation of these vessels.

[00118] With reference to FIG. 15-22, an embodiment of a fluid collection system is shown including a needle block 11b and a holder 13b. The needle block 11b includes a 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 block 11b further includes a 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 portions of the needle cannula 50b extending between the proximal end 51b and the distal end 52b are securely seated in the passage of the sleeve 54b. Thus, the sharp proximal end 51b of the needle cannula 50b protrudes proximally from the sleeve 54b, and the sharp distal end of the needle cannula protrudes distally from the sleeve 54b. The outer surface regions of the sleeve 54b near the proximal end 55b of the sleeve 54b may be formed by mounting structures such as an array of external threads, at least one annular groove, or at least one annular rib. The mounting structure allows the sleeve 54b to be fixed in the holder 13b, which is configured to slidably receive the fluid collection cartridge 20b according to one embodiment of the present disclosure. The needle block 11b may further include the multi-sampling sleeve 57b shown in FIG. 19 mounted over the proximal portion of the needle cannula 50b and attached to the proximal end 55b of the sleeve 54b. The proximal portions of the needle cannula 50b and the multisampling sleeve 57b protrude into the holder 13b when the sleeve 54b of the needle block 11b is installed in the holder 13b.

[00119] With reference to FIG. 15-22, in an exemplary embodiment, the needle assembly 11b includes a first needle guard 60b and a second needle guard 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 guard 60b includes, at its distal end, an index tip 62b that is activated in the presence of a fluid treatment material 70b, such as a liquid anticoagulant.

[00120] Assembly of the fluid collection cartridge 20b is accomplished by sliding the stopper 32b into the chamber 26b through the distal end 22b of the tubular member 21b. Fluid treatment material 70b, such as liquid anticoagulant heparin, is then added to inner reservoir 28b before sealing distal end 22b by inserting cap 40b. The piston rod 31b is then inserted through the annular flange 24b at the proximal end 23b of the tube 21b until the conical pin 39b is mated with the recess 45b. The assembled device can then be packaged for further use.

[00121] In the method of use according to one embodiment of the present invention, the second needle guard 61b is removed from the needle block 11b and holder 13b connected to collect a fluid, such as to collect arterial blood. A fluid collection cartridge 20b according to one embodiment of the present invention, such as a blood collection cartridge, is then inserted into the proximal end of the holder 13b as shown in FIG. 19-21 until the sharp proximal end 51b of the needle 50b penetrates the cap 40b and the lumen 53b is in fluid communication with a fluid treatment material 70b, such as liquid anticoagulant heparin, located in the fluid reservoir 28b. .

[00122] The user then grasps holder 13b, hooks fingers around the outwardly extending annular flange 15b on holder 13b, and presses down on thumb flange 33b with sufficient force in the distal direction "D" shown in FIG. 21 until the distal face of the stopper 32b contacts the inner end 42b of the cap 40b, the inner mixing rib 44b will mate with the recess 45b and the proximal end 51b of the cannula 50b will fit into the cavity 43b of the stopper 32b as shown in FIG. . 22. This action causes the fluid treatment material 70b within the fluid collection cartridge 20b to flow from the fluid reservoir 28b through the proximal end 51b into the lumen 53b and into the first needle shield 60b. Index tip 62b will activate and change color upon contact with excess fluid treatment material as it is pushed out of distal end 52b of needle 50b, providing visual confirmation to the user that any "dead space" in fluid reservoir 28b or lumen 53b of needle 50b is filled with fluid treatment material 70b. The piston rod 31b can then be separated from the stopper 32b by pulling the piston rod 31b in the proximal direction (indicated by arrow P) as shown in FIG. 22. The residual volume (10-20 μl) of fluid treatment material 70b that is present in the "dead space" should be at a concentration sufficient to allow treatment, for example, to provide sufficient anticoagulant function to prevent arterial blood sample from clotting after collection.

[00123] The purpose of filling block 10b with fluid treatment material is to remove any atmospheric air so that atmospheric air does not affect the partial pressure of oxygen, such as oxygen in an arterial blood sample. The block 10b should preferably have a low "dead space" to keep the residual volume of the fluid treatment material at a low level, to minimize the effect of dilution of the fluid treatment material by the fluid sample.

[00124] The fluid collection method according to one embodiment of this invention allows for one-handed technology similar to current clinical practice in fluid collection or arterial blood collection using a low resistance rubber stopper that moved by blood pressure. The first needle guard 60b is removed from the needle block 11b. The user grabs block 10b as shown in FIG. 23 with one hand and inserts the distal end 52b into a fluid source such as a patient's artery. When using the present invention to collect arterial blood, blood at arterial pressure (which is greater than normal atmospheric pressure or external pressure) will then flow through the lumen 53b of the cannula 50b into the fluid reservoir 28b and cause the stopper 32b to slide in the proximal direction until the proximal the stopper face 35b will not contact the annular flange 24b, which will determine the filling of the blood collection volume, as shown in FIG. 24. The sliding movement of the rubber stopper 32b allows mixing of the fluid treatment material 70b and the collected arterial blood, as shown at 47b, during the collection process.

[00125] The fluid or blood collection cartridge 20b is then removed from the multiple needle block 11b and holder 13b. The distal end 52b may then be removed from the fluid source or artery. The detached cartridge 20b can then be rotated between the palms of the user in a plane perpendicular to the longitudinal axis 29b to further mix the fluid sample with a fluid treatment material 70b such as heparin, as shown in FIG. 25-26. The asymmetrical finned surfaces of the inner end 42b of the cap 40b and the distal face 34b of the stopper 32b create a swirl when the cartridge 20b is rotated in the directions indicated by the arrows w, x, y, and z. The fluid collection cartridge 20b containing the fluid sample is now ready to be transported to the laboratory, for example for arterial blood gas analysis.

[00126] According to one embodiment, the luer adapter 80b shown in FIG. 27 may then be inserted through cap 40b of cartridge 20b to provide an interface connection for the cartridge that is compatible with a blood gas analyzer. A number of different Luer lock adapters may be provided to connect the fluid collection cartridge 20b to all different types of test equipment and/or all different types of blood gas analyzer interfaces. The Luer lock 80b may also be provided with a Luer lock end cap (not shown) to seal the fluid collection cartridge 20b when the Luer lock 80b is attached.

[00127] With reference to FIG. 15 and 28-30, in one embodiment, the device may also include a secure needle device 12. For example, with reference to FIG. 15 and 28-30, the fluid collection unit 10b, 10c may include a guarded needle device 12c.

[00128] In one exemplary embodiment, the needle device 12c to be protected may include a flexible tube 14c extending from the needle device 12c, a fastening device 16c mounted on the flexible tube 14c, a needle cannula 20c, a sleeve 30c, and an outer guard 50c. In some embodiments, the attachment device 16c is connectable to a receptacle (not shown) for use in blood collection procedures known in the art.

[00129] In one embodiment, the needle cannula 20c includes a proximal end and an opposite distal end, with the lumen 26c extending through the needle cannula 20c from the proximal end to the distal end. The distal end of the needle cannula 20c is bevelled to define a sharp piercing tip 28c, such as an intravenous piercing tip. The piercing tip 28c is configured to be inserted into a patient's blood vessel, such as a vein, and is therefore configured to provide ease of insertion and minimal discomfort during venipuncture. A removable protective cap (not shown) may be placed over the distal end of the needle cannula 20c to protect it from the piercing tip 28c prior to using the blood collection set 10c.

[00130] The guarded needle assembly 12c further includes a hub 30c. Sleeve 30c is a single structure, desirably molded from a thermoplastic material. The needle cannula 20c is positioned in and supported by the internal passageway of the sleeve 30c, with the distal end of the needle cannula 20c extending from the distal end of the sleeve 30c. Desirably, the needle cannula 20c and the sleeve 30c are separate parts that are fixedly connected and fixed with an appropriate medical grade adhesive or the like. The proximal end of the sleeve 30c is configured to connect to the flexible tube 14c of the blood collection set 10c. Sleeve 30c further includes a first tab 40c extending outwardly from the outer surface at a location adjacent the proximal end of sleeve 30c. Thus, the flexible tab 40c is accessible to the user's finger when the protected needle device 12c is assembled with the tube 14c into the blood collection set 10c.

[00131] The guarded needle device 12c further includes a hollow outer guard 50c. The outer guard 50c further includes a second tab 62c extending outwardly from the top of the body 50c. The second tab 62c includes an inclined surface having protrusions to provide frictional engagement with the user's thumb.

[00132] The outer guard 50c is a movable retracted position in which the first tab 40c is extended from the proximal end of the outer guard 50c and the piercing tip 28c is exposed from the distal end of the outer guard 50c, and an extended position in which the piercing tip 28c and the distal the end of the needle cannula 20c is covered with an external protective device 50c.

[00133] The first tab 40c and the second tab 62c are configured such that opposing forces applied to the first tab 40c and the second tab 62c cause the outer guard 50c to move toward the distal end of the needle cannula 20c in the direction of the arrow 100c from the retracted position. to the extended position. The protrusions on the first tab 40c and the second tab 62c, respectively, provide frictional engagement with the user's finger and thumb, respectively, to facilitate movement of the outer guard 50c from a retracted position to an extended position.

[00134] The outer guard 50c may further include a pair of wing-shaped stabilizers 68c extending transversely from the outer guard 50c in opposite directions to give the blood collection set 10c the appearance of a block with butterfly wings. Wings 68c assist in positioning and placement of the protected needle assembly 12c and blood collection set 10c during a blood collection procedure and are configured to lie flat on the patient's skin surface during a blood collection procedure. As such, the wings 68c may be made of a flexible material such that at least one, and preferably both, wings 68c may be bent towards each other and brought together between the user's fingers to assist in the positioning and placement of the needle device 12c during venipuncture.

[00135] The protected needle assembly 12c may be packaged substantially in the state shown in FIG. 15 and 28. In particular, the blood collection set 10c is provided with a needle device 12c assembled and including a flexible tube 14c extending from the needle device 12c and connected to the attachment device 16c. Before use, the 10c blood collection set is removed from its packaging. Once the 10c blood collection set has been removed from its packaging, it can be assembled with other appropriate medical equipment for use. The attachment device 16c may then be connected to an appropriate receptacle, such as a needle block other than the patient's needle block, and a needle holder to provide fluid communication with the lumen 26c through the needle cannula 20c.

[00136] To prepare the blood collection set 10c for use, the user grasps the blood collection set 10c by the protected needle assembly 12c and removes a protective cover (not shown) to expose the piercing tip 28c of the needle cannula 20c. The healthcare professional may then insert the piercing tip 28c at the distal end of the needle cannula 20c into the patient's target blood vessel. During such positioning, at least one of the wings 68c can be bent inwardly towards the other wing by the user's fingers to facilitate positioning and placement of the protected needle device 12c. After completion of the procedure, for example, after collecting all the necessary samples, the needle cannula 20c is removed from the patient. After removing the needle cannula 20c from the patient, the security feature of the protected needle device 12c is activated.

[00137] While the present disclosure has been described as having illustrative constructions, the present disclosure may be further modified within the spirit and scope of the present disclosure. Thus, this application is intended to cover any variations, uses, or adaptations of the present disclosure using its general principles. Additionally, this application is intended to cover those departures from the present disclosure that are within the known or accepted practice of the art to which the present disclosure pertains and that are within the scope of the appended claims.

Claims (31)

1. A biological fluid collection system, comprising: a collection module configured to receive a sample, the collection module comprising: a body having an inlet port and an outlet port, the inlet port and the outlet port being in fluid communication; cannula a mixing chamber located between the inlet port and the outlet port; and collection chamber located between the mixing chamber and the outlet port, and the collection chamber includes an activating part containing the first deformable part and the second deformable part, which are made with the possibility of simultaneous compression, and a rigid wall part located between them, the first and second deformable the parts are made of a flexible, deformable material capable of providing a fluid-tight seal with the housing and are configured to transition between a first position in which the sample can be contained in the collection chamber and a second position in which a portion of the sample is removed from the collection chamber; and a protective device that interacts with a part of the housing and is configured to move from the first position, in which part of the cannula is open, to the second position, in which the cannula is protected by at least part of the protective device. 2. The biological fluid collection system of claim. 1, in which the protective device pivotally interacts with the body part. 3. The biological fluid collection system of claim 1, further comprising an end cap positioned over at least a portion of the outlet port. 4. The biological fluid collection system of claim 1, wherein the mixing chamber further comprises a sample stabilizer disposed therein. 5. The biological fluid collection system of claim 4, wherein the mixing chamber further comprises an open cell foam having pores and a sample stabilizer located within the pores of the open cell foam. 6. The biological fluid collection system of claim 5, wherein the open cell foam is melamine foam. 7. The biological fluid collection system of claim 1, wherein the sample is drawn from the patient through the cannula into the mixing chamber, wherein the sample is passively mixed with the sample stabilizer before entering the collection chamber. 8. The biological fluid collection system of claim 7 wherein the mixing chamber includes open cell melamine foam and the sample stabilizer is located in the pores of the open cell melamine foam and the sample passively mixes with the sample stabilizer as it passes through the foam. open cell melamine. 9. The biological fluid collection system of claim 1, wherein the activating portion is movable between a first position and a second position after the protective device is moved from the first position to the second position. 10. A biological fluid collection system, comprising: a collection module configured to receive a sample, the collection module comprising: a body having an inlet port and an outlet port, the inlet port and the outlet port being in fluid communication; cannula a mixing chamber located between the inlet port and the outlet port; and collection chamber located between the mixing chamber and the outlet port, and the collection chamber includes an activating part containing the first deformable part and the second deformable part, which are made with the possibility of simultaneous compression, and a rigid wall part located between them, the first and second deformable the parts are made of a flexible, deformable material capable of providing a fluid-tight seal with the housing and are configured to transition between a first position in which the sample can be contained in the collection chamber and a second position in which a portion of the sample is removed from the collection chamber; and a tubular holder and a wing device associated with the tubular holder, moreover, a part of the collection module is configured to interact with a part of the tubular holder. 11. The biological fluid collection system of claim 10, wherein the protective device pivotally engages with a housing portion. 12. The biological fluid collection system of claim 10, further comprising an end cap positioned over at least a portion of the outlet port. 13. The biological fluid collection system of claim 10, wherein the mixing chamber further comprises a sample stabilizer disposed therein. 14. The biological fluid collection system of claim 13, wherein the mixing chamber further comprises open cell foam having pores and the sample stabilizer is located within the pores of the open cell foam. 15. The biological fluid collection system of claim 10, wherein the open cell foam is melamine foam. 16. The biological fluid collection system of claim 10, wherein the sample is drawn from the patient through the cannula into the mixing chamber, wherein the sample is passively mixed with the sample stabilizer before entering the collection chamber. 17. The biological fluid collection system of claim 16 wherein the mixing chamber includes open cell melamine foam and the sample stabilizer is located in the pores of the open cell melamine foam and the sample passively mixes with the sample stabilizer as it passes through the foam. open cell melamine. 18. The biological fluid collection system of claim 10, wherein the activating portion is movable between a first position and a second position after the protective device is moved from the first position to the second position.

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