Biological fluid collection devices and method for making such devices.

Abstract

A biological fluid collection device designed to extract blood using an "atmospheric balanced vacuum" to ensure that the blood is exposed to the oxygen levels of the atmospheric partial pressure sample and the carbon dioxide partial pressure, as found in standard arterial blood gas syringes, resulting in blood gas sample stabilization during collection and a longer shelf life than vacuum, reducing the rate of gas permeation through the plastic tubing. The biological fluid collection device comprises a collection module to receive a biological fluid sample, an evacuated container having an open end and a closed end in which the evacuated container contains the collection module, and a closure to close the open end of the evacuated container. The evacuated container comprises a gas composition that is substantially equal to the gas composition of the atmosphere outside the evacuated container.A method for forming the atmospheric balance vacuum collection device is also provided.

Description

1 / 19 “BIOLOGICAL FLUID COLLECTION DEVICES AND METHOD FOR MAKING SUCH DEVICES” CROSS-REFERENCE TO RELATED REQUESTS

[0001] This application claims priority and the benefit of U.S. Provisional Application Serial No. 62 / 684,800, filed June 14, 2018, entitled “ATMOSPHERIC-BALANCED VACUUM FOR BLOOD GAS SAMPLE STABILIZATION WITH AN EVACUATED CONTAINER,” the full disclosure of which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION Field of Invention

[0002] The invention relates generally to a collection device and a method for making an atmospheric balance fluid collection device for collecting a biological fluid sample and, more particularly, to a blood sample collection device integrated with an evacuated blood collection tube for use in connection with blood gas analysis and even more particularly to a blood sample collection device designed to extract blood using an “atmospheric balance vacuum” to ensure that the blood is exposed to the sample’s partial pressure atmospheric oxygen and partial pressure carbon dioxide levels as found in a standard arterial blood gas (ABG) syringe, resulting in the stabilization of the blood gas sample during collection.

[0003] A 1mL-3mL syringe-based platform is commonly accepted for laboratory blood gas testing. Current blood gas devices fall into two categories based on the filling methods employed: (1) user-assisted plunger and (2) ventilated arterial pressure-assisted. These syringe configurations typically require the user to follow a protocol involving air purging, buffering / sealing, and anticoagulant mixing steps to ensure that the quality of the blood sample is not compromised for analysis in Petition 870250112089, dated 05 / 12 / 2025, page 23 / 42 2 / 19 Diagnostic instruments. In addition to the complicated multi-step workflow, conventional blood collection syringes significantly increase the safety risk of blood exposure during the air purge and tamponade procedure.

[0004] A recent blood collection device for collecting small blood samples and dispensing a portion of the sample into a device intended or designed to analyze the sample, such as a point-of-care or patient-facing testing device, is disclosed in U.S. Patent Number 9,649,061, the entirety of which is incorporated herein by reference. The blood sample collection device disclosed herein is integrated within an evacuated container, such as a BD Vacutainer® blood collection tube, owned by Becton, Dickinson and Company, the assignees of the present invention. The use of this device enables the collection and dispensing of blood samples for point-of-care applications that incorporate conventional automated blood collection and includes a novel controlled sample dispensing capability, minimizing the risk of exposure.When blood fills a conventional Vacutainer® tube, the dissolved gas composition bound to hemoglobin in the blood (O2, N2, CO2) is exposed to a gas mixture in the tube, where each respective component of the gas mixture has its own partial pressure. The total pressure in the tube is the sum of the partial pressures of each individual gas (Ptube = PO2 + PCO2 + PN2), as demonstrated by Dalton's law of partial pressures. This fundamental property of gases dictates a vacuum pressure in the traditional tube of 300 mmHg (39996.7 N / m2), respectively. In comparison, the atmospheric gas composition typically has a partial pressure of oxygen of 160 mmHg (21331.6 N / m2) at atmospheric pressure, 760 mmHg (101325 N / m2) (at sea level). This standard vacuum process creates an environment that exposes the blood to a greater partial pressure gradient (ΔP) for oxygen and carbon dioxide in a conventional Vacutainer® tube compared to a syringe, which can then lead to gas splitting. Petition 870250112089, dated 05 / 12 / 2025, page 24 / 42 3 / 19 blood. As a result, gases can escape from the solution (blood), as determined by the balance between the undissolved gas in the vacuum tube and the gas dissolved in the blood.

[0005] There is a need in the art for an atmospherically balanced vacuum tube architecture that reduces gas polarization in the blood and allows for stable blood gas levels during vacuum blood collection using conventional blood collection sets. There is also a need in the art for an atmospherically balanced vacuum tube architecture that provides a superior vacuum shelf life by reducing the rate of gas permeation through the plastic tubing. There is a further need in the art for a conventional atmospherically balanced specimen collection container, such as an evacuated blood collection tube, that provides a superior vacuum shelf life by reducing the rate of gas permeation through the plastic material. SUMMARY OF THE INVENTION

[0006] The main benefits of the arterial blood atmospheric gas balance (ABG) vacuum tube of the present disclosure are the reduction in blood collection workflow steps and blood exposure associated with conventional syringe blood collection sets (ABG). The device of the present disclosure provides a simplified user workflow as it uses a vacuum extraction method to uniformly mix the anticoagulant in a fixed maximum blood sample that is free of air. A buffer element is located in a fixed position in a tip cap. This buffer element is air-permeable and liquid-impermeable to allow air to be purged as the device fills and subsequently seals upon contact with blood.This atmospheric balance vacuum design of the present disclosure allows the removal of a dispensing component from the evacuated tube, enabling a controlled sample dispenser for a cartridge. Petition 870250112089, dated 05 / 12 / 2025, page 25 / 42 4 / 19 Diagnostic instrument or aspiration by / through a probe in a blood gas diagnostic port.

[0007] According to one aspect, the invention comprises a biological fluid collection device comprising a collection module for receiving a biological fluid sample, an evacuated container having an open end and a closed end wherein the evacuated container contains the collection module, and a closure for closing the open end of the evacuated container. The evacuated container comprises a gas composition that is substantially the same as the gas composition of the atmosphere outside the evacuated container.

[0008] The gas composition inside the evacuated container comprises oxygen, nitrogen, and carbon dioxide. The oxygen in the gas composition located inside the evacuated container has a partial pressure that is substantially equal to the partial pressure of atmospheric oxygen outside the evacuated container. The carbon dioxide in the gas composition located inside the evacuated container may also have a partial pressure that is substantially equal to the partial pressure of atmospheric carbon dioxide outside the evacuated container.

[0009] According to one embodiment, the gas composition may comprise approximately 55% oxygen, approximately 43% nitrogen, and approximately 0.1% carbon dioxide. The evacuated container may have a total pressure of 300 mmHg (39996.7 N / m2), and the oxygen within the gas composition in the evacuated container may have a partial pressure of approximately 160 mmHg (21331.6 N / m2). According to another embodiment, the evacuated container may have a total pressure of 300 mmHg (39996.7 N / m2), and the carbon dioxide within the gas composition in the evacuated container may have a partial pressure of approximately 0.3 mmHg (39.99 N / m2). According to yet another embodiment, the evacuated container may have a total pressure of 300 mmHg (39996.7 N / m2), and the oxygen within the gas composition in the evacuated container may have a pressure Petition 870250112089, dated 05 / 12 / 2025, page 26 / 42 5 / 19 partial pressure of approximately 160 mmHg (21331.6 N / m2) and the carbon dioxide within the gas composition in the evacuated container may have a partial pressure of approximately 0.3 mmHg (39.99 N / m2). The total atmospheric air pressure outside the evacuated container may be approximately 760 mmHg (101325 N / m2) (dependent on temperature and altitude), and the oxygen within the gas composition of the outside air has a partial pressure of approximately 160 mmHg (21331.6 N / m2), and the carbon dioxide within the gas composition of the outside air has a partial pressure of approximately 0.3 mmHg (39.99 N / m2).

[0010] The collection module may include a first end having a sample introduction opening, a second end having a sample dispensing opening, a passage extending between the sample introduction opening and the sample dispensing opening, and a porous plug covering the second end of the housing. The closure is configured to close the sample introduction opening in the collection module, and the closure may comprise a pierceable self-sealing stop. The porous plug may be designed to allow air to pass from the passage of the collection module while preventing the biological fluid sample from passing through it.

[0011] According to another aspect, the invention comprises a biological fluid collection device comprising a collection module for receiving a biological fluid sample, an evacuated container containing the collection module therein, and a closure for closing an open end of the evacuated container, wherein the evacuated container comprises a gas composition having an enriched oxygen content having a partial pressure substantially equal to or greater than a partial pressure of oxygen in air at atmospheric pressure of 760 mmHg (101325 N / m2) outside the evacuated container. In another configuration, different altitudes may be accounted for whereby a variant of air pressure lower than 760 mmHg (101325 N / m2) may be used. Petition 870250112089, dated 05 / 12 / 2025, page 27 / 42 6 / 19

[0012] The evacuated container may have a pressure of approximately 300 mmHg (39996.7 N / m2) and the partial pressure of oxygen inside the evacuated container is approximately 160 mmHg (21331.6 N / m2). The gas composition may include carbon dioxide and nitrogen, and the partial pressure of carbon dioxide inside the evacuated container may be approximately 0.3 mmHg (39.99 N / m2) and the nitrogen inside the evacuated container may be approximately 140 mmHg (18665.1 N / m2).

[0013] According to one embodiment, the evacuated container has a pressure of approximately 300 mmHg (39996.7 N / m2) and the partial pressure of oxygen inside the evacuated container is greater than 160 mmHg (21331.6 N / m2). The gas composition may comprise approximately 55% oxygen. The gas composition may also comprise approximately 43% nitrogen and approximately 0.1% carbon dioxide.

[0014] According to yet another aspect, a method of making an atmospheric balanced fluid collection device comprises providing a container having an open end and a closed end defining a chamber, which draws a vacuum within the container to remove most of the gas from within the chamber, purging back from the chamber with a gas composition that is proportional to equalize a gas composition of the atmosphere outside the evacuated container, wherein the purging back from the chamber is conducted until a predetermined vacuum pressure is reached within the container and closing the open end of the container.

[0015] The predetermined partial pressure inside the container is 300 mmHg (39996.7 N / m2) and the gas composition comprises approximately 55% oxygen having a partial pressure of approximately 160 mmHg (21331.6 N / m2).

[0016] The method further comprises placing a fluid collection module inside the container, wherein the fluid collection module comprises a first end having a sample introduction opening, a Petition 870250112089, dated 05 / 12 / 2025, page 28 / 42 7 / 19 second end having a sample dispensing opening, a passage extending between the sample introduction opening and the sample dispensing opening, and a porous plug covering the second end of the housing. The porous plug is adapted to allow air to pass from the collection module passage while preventing the biological fluid sample from passing through it. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The above-mentioned features and advantages of this disclosure, and the manner of obtaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken together with the accompanying drawings, wherein:

[0018] Fig. 1 is a front perspective view of a biological fluid collection device having a collection module disposed within an external housing, according to one aspect of the present disclosure;

[0019] Fig. 2 is a partial cross-sectional side view of the biological fluid collection device of Fig. 1, according to an aspect of the present disclosure;

[0020] Figs. 3A-3B are enlarged partial cross-sectional side views of Figs. 1 and 2 showing the porous plug closing the liquid collection chamber, according to an aspect of the present disclosure;

[0021] Figs. 4A-4B are schematic diagrams illustrating the vacuum polarization of gases in blood using a standard vacuum process in a conventional Vacutainer® tube, according to principles known in the art;

[0022] Figs. 5A-5D are schematic diagrams illustrating the evacuated tube and the method of forming the atmospheric balanced evacuated tube, according to the present disclosure; Petition 870250112089, dated 05 / 12 / 2025, page 29 / 42 8 / 19

[0023] Fig. 6 is a schematic diagram illustrating the principles of vacuum tube service life, according to one aspect of the present disclosure;

[0024] Figs. 7A-7B are perspective views of the blood gas sample distribution in test devices according to aspects of the present disclosure;

[0025] Fig. 8 is a graph showing the tube pressure as a function of time for a tube filled with oxygen according to the disclosed invention, as well as for an unfilled tube;

[0026] Fig. 9 is a graph showing the percentage loss of extraction volume as a function of time of a 10 mL 16X125 tube filled with oxygen according to the disclosed invention, as well as an unfilled 10 mL 16X125 tube;

[0027] Fig. 10 is a graph showing the percentage loss of extraction volume as a function of time of a 10 mL 16X100 tube filled with oxygen according to the disclosed invention, as well as an unfilled 10 mL 16X100 tube;

[0028] Fig. 11 is a graph showing the percentage loss of extraction volume as a function of time of a 5 mL 13X100 tube filled with oxygen according to the disclosed invention, as well as an unfilled 5 mL 13X100 tube;

[0029] Fig. 12 is a graph showing the percentage loss of extraction volume as a function of time of a 2 mL 13X75 tube filled with oxygen according to the disclosed invention, as well as an unfilled 2 mL 13X75 tube; and

[0030] Fig. 13 is a graph showing the percentage loss of extraction volume as a function of time of a 1 mL 13X75 tube filled with oxygen according to the disclosed invention, as well as an unfilled 1 mL 13X75 tube. Petition 870250112089, dated 05 / 12 / 2025, p. 30 / 42 9 / 19

[0031] The corresponding reference characters indicate the corresponding parts in the various visualizations. The examples set forth in this document illustrate exemplary embodiments of the disclosure and such examples should not be construed as limiting the scope of the disclosure in any way. DESCRIPTION OF THE INVENTION

[0032] The following description is provided to enable those skilled in the art to make and use the contemplated embodiments described for carrying out the invention. Various modifications, equivalents, variations and alternatives, however, will remain readily apparent to those skilled in the art. Any and all modifications, variations, equivalents and alternatives are intended to fall within the scope and reach of the present invention.

[0033] For the purposes of the following description, the terms top, bottom, right, left, vertical, horizontal, upper, lower, side, longitudinal and their derivatives shall be related to the invention as directed in the figures. However, it should be understood that the invention may assume alternative variations and sequences of steps, except where expressly specified otherwise. It should also be understood that the specific devices and processes illustrated in the accompanying drawings, and described in the descriptive report below, are simply exemplary embodiments of the invention. Therefore, specific dimensions and other physical characteristics related to the embodiments disclosed in this document should not be considered limiting.

[0034] With reference to Figs. 1-2, which show a biological fluid collection device, generally indicated as 1, having a collection module 10 disposed within an external housing or evacuated container 34 according to an aspect of the present disclosure. The collection module 10 is adapted to receive a biological fluid sample, such as a blood sample, and includes a housing 12, a lid 14, a mixing chamber 16, Petition 870250112089, dated 05 / 12 / 2025, pages 31 / 42 10 / 19 a retention chamber 18, a cover 26, as shown in Fig. 2, and an activation member 22.

[0035] In one embodiment, the container 12 includes a first end 24, a second end 26, and a passage 28 extending between them and providing fluid communication between the first end 24 and the second end 26 of the container 12. The passage 28 has a sample introduction opening 30 at the first end 24 of the container 12 and a sample dispensing opening 32 at the second end 26 of the container 12. The mixing chamber 16 and the holding chamber 18 are provided in fluid communication with the passage 28. The mixing chamber 16 and the holding chamber 18 are positioned so that a biological fluid sample, such as a blood sample, introduced into the sample introduction opening 30 of the passage 28 first passes through the mixing chamber 16 and subsequently passes into the holding chamber 18 before reaching the sample dispensing opening 32 of the passage 28.In this way, the blood sample can be mixed with an anticoagulant or other additive supplied within the mixing chamber 16 before the stabilized sample is received and stored within the holding chamber 18.

[0036] The mixing chamber 16 allows passive mixing of the blood sample with an anticoagulant or other additive, such as a blood stabilizer, as the blood sample flows through passage 28. The inner portion of the mixing chamber 16 may have any suitable structure or shape, provided it provides mixing of the blood sample with an anticoagulant or other additive as the blood sample passes through passage 28. The mixing chamber 16 may include a dry anticoagulant, such as heparin or EDTA, deposited on or within the mixing chamber 16. The mixing chamber 16 may, for example, include an open-cell foam containing dry anticoagulant dispersed within the Petition 870250112089, dated 05 / 12 / 2025, pages 32 / 42 11 / 19 open-cell foam cells to promote effective mixing flow and anticoagulant absorption.

[0037] After passing through the mixing chamber 16, the blood sample can be directed to the holding chamber 18. The holding chamber 18 can assume any suitable shape and size to hold a sufficient volume of blood needed for the desired test, for example, 500 μL or less. In the embodiment shown in Figs. 1 and 2, the holding chamber 18 is defined by a portion of the container 12 in combination with an elastic sleeve 40 fastened over the outside of the housing 12. The elastic sleeve 40 can be made of any material that is flexible, deformable and capable of providing a fluid-tight seal with the housing 12, including, but not limited to, natural or synthetic rubber and other suitable elastomeric materials.

[0038] With continuous reference to Figs. 1 and 2 and with further reference to Figs. 3A and 3B, a porous or vented plug 44 is disposed at the second end 26 of the housing 12 and obstructs the sample dispensing opening 32 of the passage. The construction of the vented plug 44 allows air to pass through it and out of the collection module 10, while preventing the blood sample from passing through it and may include a hydrophobic filter. The vented plug 44 has selected air passage resistance which can be used to precisely control the filling rate of the passage 28. By varying the porosity of the plug, the speed of airflow out of the plug 44 and therefore the speed of blood sample flow into the collection module 10 can be controlled. If the speed of blood sample flow into the collection module 10 is too fast, hemolysis may occur.If the blood sample flow rate in collection module 10 is too slow, the sample collection time may be excessive.

[0039] A closure 14 is engaged with the first end 24 of the container 12 to seal the passage 28. The closure 14 allows the introduction of a blood sample into the passage 28 of the housing 12 and can Petition 870250112089, dated 05 / 12 / 2025, pages 33 / 42 12 / 19 include a self-sealing, pierceable stopper 36 with an outer shield 38, such as a Hemogard™ cap commercially available from Becton, Dickinson and Company. The closure 14 also attaches to the outer housing or evacuated container 34. It may be appreciated that the evacuated container 34 can be any well-known vacuum-containing blood collection tube, such as a Vacutainer® blood collection tube commercially available from Becton, Dickinson and Company.

[0040] Reference is now made to Figs. 4A-4B, which schematically illustrate the vacuum polarization of blood gases using a standard vacuum process in an evacuated container of conventional or prior art 134, such as a Vacutainer® container, according to principles known in the art. When blood fills a conventional evacuated container 134, the dissolved and hemoglobin-bound gas composition in the blood (O2, N2, CO2) is exposed to a gas mixture in the tube, where each respective component of the gas mixture has its own partial pressure. The total pressure (P) in the container 134 is the sum of the partial pressures (P) of each individual gas (Ptube = PO2 + PCO2 + PN2), as demonstrated by Dalton's law of partial pressures.This fundamental property of gases dictates that a traditional vacuum tube pressure of 300 mmHg (39996.7 N / m2) using an atmospheric gas composition (21% O2, 0.04% CO2, and 78% N2) will result in partial pressures of 63, 12, and 237 mmHg, respectively. In comparison, the atmospheric gas composition typically has a partial pressure of oxygen of 160 mmHg (21331.6 N / m2) at atmospheric pressure, 760 mmHg (101325 N / m2) (at sea level). As indicated by graph 160, as shown in Fig. 4B, the standard vacuum process creates an environment that exposes the blood to a greater partial pressure gradient (ΔP) for oxygen and carbon dioxide in a conventional evacuated container 134 compared to a syringe; this can lead to bias in the blood gas analysis. Henry's law states that the amount of dissolved gas is proportional to its partial pressure in the gas phase. This is the balance constant. Petition 870250112089, dated 05 / 12 / 2025, pages 34 / 42 Figure 13 / 19 shows that the partial pressure of blood gases is directly proportional to the partial pressure of the gas in the tube. As a result, the gases in the conventional container 134, as discussed above and shown in Fig. 4A, will exit the solution (blood) as determined by the balance between the undissolved gas in the evacuated container and the gas dissolved in the blood.

[0041] Reference is now made to Figs. 5A-5D, which schematically illustrate the atmospheric balanced liquid evacuated container 34 and the method of preparing the atmospheric balanced evacuated tube 34 according to the present disclosure, wherein the evacuated container 34, which contains the collection module 10, comprises a gas composition that is substantially equal to the gas composition of the atmosphere outside the evacuated container 34. The proposed device balances the fundamental partial pressure composition of oxygen, O2, and carbon dioxide, CO2, within the vacuum chamber with that of atmospheric conditions to provide a blood gas sample equivalent to a standard blood gas ABG syringe (current standard of care).This was accomplished by developing a vacuum assembly procedure in which a high vacuum is drawn and then oxygen O2 and carbon dioxide CO2 are added to fill the chamber until the desired final vacuum level and partial pressures of O2 and CO2 are reached. This process is discussed in more detail below in relation to Fig. 5C.

[0042] The device and method presently disclosed results in the collection of blood samples in a vacuum chamber or evacuated container 34, where the blood is exposed to the same levels of atmospheric partial pressure of oxygen (PO2) and partial pressure of carbon dioxide (PCO2) found in an arterial blood gas syringe, which exposes the blood sample to normal atmospheric air and its respective PO2 and PCO2 levels, as shown in the graph of Fig. 4B. With continuous reference to Fig. 5C, the method for obtaining the atmospheric balanced container 34 of the present disclosure is achieved starting with a container (step 1, 50) that is at atmospheric pressure, 760 mmHg (101325 N / m2), comprising a Petition 870250112089, dated 05 / 12 / 2025, pp. 35 / 42 14 / 19 composition of approximately 21% oxygen, O2 and 79% nitrogen, N2 having a partial pressure of nitrogen, PN2 of approximately 160 mmHg (21331.6 N / m2) and a partial pressure of oxygen, PO2 of approximately 600 mmHg (7993.4 N / m2). Then, a high vacuum (step 2, 52) is drawn from inside the tube where most of the gas is removed from chamber 135 so that the tube has a total pressure of approximately 20 mmHg (2666.45 N / m2) and the tube composition is approximately 21% oxygen, O2 having a partial pressure of PO2 of approximately 37 mmHg and approximately 79% nitrogen, N2, having a partial pressure of PN2 of approximately 140 mmHg (18665.1 N / m2).In a final step (step 3, 54) purge the tube back with a deliberately proportional gas composition of O2, N2 and CO2 until the desired vacuum level of approximately 300 mmHg (39996.7 N / m2) is reached, which coincides with the atmospheric partial pressures of O2 and CO2, forming the atmospheric balanced evacuated tube 34, as shown in Fig. 5B, wherein the tube composition is approximately 55% oxygen (or approximately 53.5% O2 and 0.1% CO2) and 43% nitrogen, and the partial pressure of oxygen, PO2 is approximately 160 mmHg (21331.6 N / m2), the partial pressure of nitrogen, PN2 is approximately 140 mmHg (18665.1 N / m2), and the partial pressure of carbon dioxide, CO2 is approximately 0.3 mmHg (39.99 N / m2). It can be seen that the tube can be purged so that the partial pressure of oxygen inside the evacuated container is greater than 160 mmHg (21331.6 N / m2).

[0043] The evacuated container 34 of the present disclosure having a total pressure of 300 mmHg (39996.7 N / m2), shown in Fig. 5B, differs from the conventional evacuated container 134, shown in Figs. 4A and 5A, having a total pressure of 300 mmHg (39996.7 N / m2) and a partial pressure of nitrogen PN2 of 234 mmHg and a partial pressure of oxygen PO2 of 63 mmHg. As illustrated in graph 60, shown in Fig. 5D, the gradient ΔP of partial pressure of oxygen O2 between the evacuated container 34 of the invention, Petition 870250112089, dated 05 / 12 / 2025, pages 36 / 42 15 / 19, in which gas enrichment was performed, and a syringe are substantially similar.

[0044] The architecture of the partial pressure vacuum tube with atmospheric balance PO2 and PCO2 allows stable blood gas levels during vacuum blood extraction using conventional blood collection sets based on typical evacuated container systems.

[0045] The vacuum lifetime loss in prior art evacuated vessels 134 is due to gas permeation through the plastic tube, which is driven by the atmospheric and vacuum partial pressure gradient in the plastic barrier as illustrated in Fig. 6. Nitrogen contributes the least to vacuum loss, as the permeation factor for oxygen is an order of magnitude higher in polyethylene terephthalate (PET), a plastic primarily used in typical evacuated tubes. An atmospheric balance vacuum tube architecture provides superior vacuum lifetime because the balanced PO2 and PCO2 gradients are not susceptible to gas permeation. This is because, by design, there is no difference in PO2 and PCO2 pressures inside and outside the prior art vessel 134.For example, when the total atmospheric air pressure outside the evacuated container is 760 mmHg (101325 N / m2), the oxygen within the gas composition of the outside air has a partial pressure of approximately 160 mmHg (21331.6 N / m2) and the carbon dioxide within the gas composition of the outside air has a partial pressure of approximately 0.3 mmHg (39.99 N / m2). In the balanced atmospheric evacuated tube 34 of this disclosure, the oxygen within the gas composition inside the tube also has a partial pressure of approximately 160 mmHg (21331.6 N / m2) and the carbon dioxide within the gas composition inside the tube has a partial pressure of approximately 0.3 mmHg (39.99 N / m2). Since the partial pressure of oxygen, PO2, and carbon dioxide, PCO2, are equal inside and outside the tube (homeostasis), there is no pressure exchange and no resulting vacuum loss from O2 and of CO2. This is significant because oxygen, O2, and carbon dioxide, CO2, constitute more than 50% of the pressure of. Petition 870250112089, dated 05 / 12 / 2025, pp. 37 / 42 16 / 19 total vacuum in the evacuated container with atmospheric balance 34 of this disclosure, when the vacuum level is at 300 mmHg (39996.7 N / m2). The difference in partial pressure of nitrogen, N2 inside and outside the tube can be significantly different, i.e., the partial pressure of nitrogen PN2 inside the tube is approximately 140 mmHg (18665.1 N / m2) and the partial pressure of nitrogen PN2 inside the atmosphere outside the tube is approximately 593 mmHg (79060.2 N / m2). This difference in partial pressure can result in a slight increase in vacuum pressure inside the tube due to nitrogen permeation of N2 into the tube because nitrogen has approximately 10X lower permeability compared to oxygen. It is noted in this document that atmospheric balance compositions, as described in this document, can be useful for increasing the lifespan of any conventional specimen collection container.For example, this atmospheric balance technique can be useful for extending the service life of plastic blood collection containers, including any type of evacuated tube. Although this application has particular applicability to arterial blood gas applications, the atmospheric balance methodologies described in this document can be used for any evacuated plastic container.

[0046] It can be appreciated that patients exposed to hyperoxia conditions for a prolonged period may experience a higher than normal partial pressure of oxygen, which can exceed 500 mmHg (666661.2 N / m2). Under these conditions, the gas is forced to dissolve in an unbound state in the blood plasma, while a smaller portion is still bound to hemoglobin. During blood gas analysis, these samples may exhibit higher polarization levels within typical 15-minute rotation times, as oxygen in the plasma has a high rate of dissolution gas exchange combined with the partial pressure gradient when blood is exposed to the atmosphere. Hyperoxia (relative to atmospheric PO2 and PCO2) PO2 and PCO2 levels can be used in vacuum tube architecture to further improve blood gas stability for a product of Petition 870250112089, dated 05 / 12 / 2025, pages 38 / 42 17 / 19 oxygen therapy that is not susceptible to extreme biases. This is feasible for ABG blood gas applications, as the device design does not have a high enough surface area needed to positively bias blood gas levels. This would never be possible in a classic ABG syringe.

[0047] Furthermore, as shown in Figs. 7A and 7B, the device of the present invention provides improvement in the reduction or substantial elimination of air contamination in blood sampling procedures through the use of a predefined volume of blood so that after removal of the collection module 10 from the evacuated tube, the sample can be consistently administered by aspiration to a point-of-care (PoC) cartridge 70, Fig. 7A or other ABG diagnostic instrument ports 80, Fig. 7B.

[0048] Fig. 8 shows a 180° graph of the change in tube pressure (e.g., vacuum loss) over time for a tube filled with O2 and an unfilled tube 184. As shown, the data predict that the 52% O2 tube filled 182 will advantageously increase in pressure much more slowly than the unfilled tube 184. During the test, evacuated blood collection tubes were tested to verify the results. One group was prepared by removing the air and then filling with oxygen gas until the gas mixture inside the tube was 52% oxygen. The other group was prepared by removing the air, but the air mixture was not adjusted from atmospheric air (e.g., 21% O2). The pressure inside the two devices was compared at specific intervals over a 10-month period. The experimental data, represented as points on the 180° graph, show that the performance corresponds to a mathematical model.Consequently, the inventors discovered that filling tube 182 with a relatively high percentage of O2 improves its lifespan by decreasing the overall permeability rate through tube 182. Petition 870250112089, dated 05 / 12 / 2025, pp. 39 / 42 18 / 19

[0049] Figs. 9-13 further illustrate the improved lifespan for tubes of different sizes (e.g., 16X125 10 mL, 16X100 10 mL, 13X100 5 mL, 13X75 2 mL, and 13X75 1 mL, respectively) provided by the disclosed concept. More specifically, if a healthcare professional, for example, a doctor or nurse, selects a tube to collect a blood sample and that tube indicates it can collect a predetermined amount of blood (e.g., a 10 mL tube), that professional will expect the tube to fill with 10 mL of blood, and if the tube collects only 1 or 5 mL of blood, that will not be acceptable. It is generally known that tubes that are still able to extract 20% of the volume they extracted when first evacuated can still be used. However, once a tube extracts less than 80% of its initial volume, it is not considered usable by professionals who collect samples.

[0050] Figs. 9-13 illustrate different graphs 190,200,210,220,230 of extraction volume as a function of time due to the permeability of the tube being tested. As shown in each of the graphs, the O2-filled tubes 192,202,212,222,232 take significantly longer to reach a limit (e.g., a critical limit of 20% 196,206,216,226,236 where the tube can still extract 20% of the volume it extracted when it was first evacuated, referred to in this document as service life) than the unfilled counterpart tubes 194,204,214,224,234. As a result, this corresponds to a significantly improved service life for the O2-filled tubes 192,202,212,222,232.Specifically, when a container is one of the following: 16X125 tube of 10 mL 192, 16X100 tube of 10 mL 202, 13X100 tube of 5 mL 212, 13X75 tube of 2 mL 222, and 13X75 tube of 1 mL 232, the container has a shelf life of at least 45 months, 40 months, 27 months, 27 months, and 30 months, respectively, and preferably at least 52 months, 45 months, 32 months, 32 months, and 34 months, respectively. Furthermore, it will be appreciated that in each of the examples represented, for example, Figs. 9-13, the shelf life was found to be... Petition 870250112089, dated 05 / 12 / 2025, pp. 40 / 42 19 / 19 of the tubes 192, 202, 212, 222, and 232 filled with O2 increased by a factor of at least 1.5 as a result of being purged back, some having their service lives increased by a factor of at least 1.8. That is, the service life of the containers is at least 1.5 times greater, sometimes 1.8 times greater, than it would be without the back purge.

[0051] It can be appreciated that an alternative system configuration to the POC architecture is using multiple evacuated tubes that are assembled using the atmospheric vacuum method for blood gas applications that may require a larger blood volume. It can also be appreciated that a version with a highly enriched O2 and CO2 gas composition can be used for alternative applications where the sample is much more susceptible to bias in blood gas analysis using conventional blood gas collection syringes. It is also contemplated in this document that the gas composition may alternatively include approximately 1% argon, as well as other residual gases.

[0052] Although this disclosure has been described as having exemplary designs, the present disclosure may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses or adaptations of the disclosure using its general principles. In addition, this application is intended to cover such deviations from the present disclosure that are known or customarily practiced in the art to which this disclosure belongs and that fall within the limits of the appended claims. Petition 870250112089, dated 05 / 12 / 2025, pp. 41 / 42

Claims

1 / 5 CLAIMS 1. Biological fluid collection device (1), characterized in that it comprises: a collection module (10) for receiving a biological fluid sample; an evacuated container (34) having an open end and a closed end, said evacuated container (34) containing the collection module (10) therein; and a closure (14) for closing the open end of the evacuated container (34), wherein the evacuated container (34) comprises a gas composition with a selected partial pressure of a directed gas that is equal to the partial pressure of the directed gas of the atmosphere outside the evacuated container (34).

2. Biological liquid collection device (1), according to claim 1, characterized in that the evacuated container (34) comprises a gas composition with selected partial pressures of directed gases that are equal to the partial pressures of directed gas of the atmosphere outside the evacuated container (34).

3. Biological fluid collection device (1), according to claim 1, characterized in that the gas composition inside the evacuated container (34) comprises oxygen, nitrogen and carbon dioxide.

4. Biological fluid collection device (1), according to claim 3, characterized in that the oxygen in the gas composition located inside the evacuated container (34) has a partial pressure that is equal to the partial pressure of atmospheric oxygen outside the evacuated container (34).

5. Biological liquid collection device (1), according to claim 3, characterized in that the carbon dioxide in the gas composition located inside the evacuated container (34) has a partial pressure that is equal to the partial pressure of atmospheric carbon dioxide outside the evacuated container (34).

6. Biological fluid collection device (1), according to claim 3, characterized in that the gas composition comprises 55% oxygen, 43% nitrogen and 0.1% carbon dioxide.

7. Biological fluid collection device (1), according to claim 6, characterized in that the evacuated container (34) has a total pressure of 300 mmHg (39996.7 N / m2) and in that the oxygen within the gas composition in the evacuated container (34) has a partial pressure of 160 mmHg (21331.6 N / m2).

8. Biological fluid collection device (1), according to claim 7, characterized in that the evacuated container (34) has a total pressure of 300 mmHg (39996.7 N / m2) and in that the carbon dioxide within the gas composition in the evacuated container (34) has a partial pressure of 0.3 mmHg (39.99 N / m2).

9. Biological fluid collection device (1), according to claim 8, characterized in that the oxygen within the gas composition of the atmosphere has a partial pressure of 160 mmHg (21331.6 N / m2) and the carbon dioxide within the gas composition of the atmosphere has a partial pressure of 0.3 mmHg (39.99 N / m2).

10. Biological fluid collection device (1), according to claim 1, characterized in that the collection module (10) includes a first end having a sample introduction opening (30), a second end having a sample distribution opening (32), a passage (28) extending between the sample introduction opening (30) and the sample distribution opening (32), and a covering over the second end.

11. Biological fluid collection device (1), according to claim 10, characterized in that the closure (14) is configured to close the sample introduction opening (30) in the collection module (10) Petition 870250112089, dated 05 / 12 / 2025, page 19 / 42 3 / 5 and in that the closure (14) comprises a self-sealing pierceable stop (36).

12. Biological fluid collection device (1), according to claim 10, characterized in that the porous plug (44) is adapted to allow air to pass through the passage (28) of the collection module (10), while preventing the biological fluid sample from passing through it.

13. Biological fluid collection device (1), according to claim 1, characterized in that, when the evacuated container (34) is one of a 10 mL 16X125 tube, a 10 mL 16X100 tube, a 5 mL 13X100 tube, a 2 mL 13X75 tube and a 1 mL 13X75 tube, the evacuated container (34) has a service life of at least 45 months, 40 months, 27 months, 27 months and 30 months, respectively.

14. Biological fluid collection device (1) characterized in that it comprises: a collection module (10) for receiving a biological fluid sample; an evacuated container (34) containing the collection module (10) therein; and a closure (14) for closing an open end of the evacuated container (34), wherein the evacuated container (34) comprises a gas composition having oxygen with a partial pressure equal to or greater than the partial pressure of oxygen in air at atmospheric pressure of 760 mmHg (101325 N / m2) outside the evacuated container (34).

15. Biological fluid collection device (1), according to claim 14, characterized in that the evacuated container (34) has a pressure of 300 mmHg (39996.7 N / m2) and in that the partial pressure of oxygen inside the evacuated container (34) is 160 mmHg (21331.6 N / m2).

16. Biological fluid collection device (1), according to claim 15, characterized in that the gas composition includes Petition 870250112089, dated 05 / 12 / 2025, page 20 / 42 4 / 5 carbon dioxide and nitrogen and in that the partial pressure of carbon dioxide inside the evacuated container (34) is 0.3 mmHg (39.99 N / m2) and the nitrogen inside the evacuated container (34) is 140 mmHg (18665.1 N / m2).

17. Biological fluid collection device (1), according to claim 14, characterized in that the evacuated container (34) has a pressure of 300 mmHg (39996.7 N / m2) and in that the partial pressure of oxygen inside the evacuated container (34) is greater than 160 mmHg (21331.6 N / m2).

18. Biological fluid collection device (1), according to claim 14, characterized in that the gas composition comprises 55% oxygen.

19. Biological fluid collection device (1), according to claim 18, characterized in that the gas composition further comprises 43% nitrogen and 0.1% carbon dioxide.

20. Biological fluid collection device (1), according to claim 14, characterized in that, when the evacuated container (34) is one of a 10 mL 16X125 tube, a 10 mL 16X100 tube, a 5 mL 13X100 tube, a 2 mL 13X75 tube and a 1 mL 13X75 tube, the evacuated container (34) has a service life of at least 45 months, 40 months, 27 months, 27 months and 30 months, respectively.

21. Method for making an atmospheric balanced fluid collection device defined according to any of the preceding claims, characterized in that it comprises: providing a container having an open end and a closed end, said container defining a chamber; drawing a vacuum within the container to remove at least some gas from within the chamber; back purging the chamber with a gas composition that is equal to a gas composition of the atmosphere outside the evacuated container (34), in Petition 870250112089, dated 12 / 05 / 2025, page 21 / 42 5 / 5, whereby the back purging of the chamber is conducted until a predetermined vacuum pressure is reached within the container; and closing the open end of the container.

22. Method according to claim 21, characterized in that the predetermined vacuum pressure inside the container is 300 mmHg (39996.7 N / m2) and the gas composition comprises 55% oxygen having a partial pressure of 160 mmHg (21331.6 N / m2).

23. Method according to claim 21, characterized in that it further includes placing a fluid collection module (10) inside the container, wherein the fluid collection module (10) comprises a first end having a sample introduction opening (30), a second end having a sample distribution opening (32), a passage (28) extending between the sample introduction opening (30) and the sample distribution opening, and a porous plug (44) covering the second end, said porous plug (44) being adapted to allow air to pass from the passage (28) of the collection module (10) while preventing the biological liquid sample from passing through it.

24. Method according to claim 21, characterized in that the service life of the container is increased by a factor of at least 1.5 as a result of the back purge.

25. Method according to claim 24, characterized in that the service life of the container is increased by a factor of at least 1.8 as a result of the back purge.

26. Method according to claim 21, characterized in that, when the container is one of a 10 mL 16X125 tube, a 10 mL 16X100 tube, a 5 mL 13X100 tube, a 2 mL 13X75 tube, and a 1 mL 13X75 tube, the container has a shelf life of at least 45 months, 40 months, 27 months, 27 months, and 30 months, respectively. Petition 870250112089, dated 05 / 12 / 2025, p. 22 / 42

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