Bidirectional stopper valve that can be attached to syringes with a discharge mechanism.

Abstract

A blood collection system configured to be connected to a set of tubes providing vascular access to a patient, wherein the system has an access device connected to the set of tubes, the access device having a blood collection tube holder and a non-patient needle at least partially located within the blood collection tube holder. A blood collection system further having a syringe, the syringe having a plunger rod, a stopper, and a distal interface, and a cap assembly that can be coupled to the distal interface of the syringe. The cap assembly has a cap body and a bidirectional valve, the bidirectional valve being in fluid communication with a discharge chamber formed within the cap body.

Description

Technical Field

[0001] The present disclosure generally relates to a biological fluid collection device. More specifically, the present disclosure relates to a cap assembly having a bi-directional stopper valve that can be attached to a biological fluid collection device such as a syringe having an ejection mechanism.

[0002] Cross-reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 454,204, filed on March 23, 2023, entitled "Bi-Directional Stopper Valve Attachable to a Syringe Having an Ejection Mechanism", the entire disclosure of which is incorporated herein by reference.

Background Art

[0003] Blood collection is a common medical procedure for collecting at least a drop of blood from a patient. Blood samples are typically collected from inpatients, home care patients, and emergency patients by finger prick, heel prick, or venipuncture. Blood samples may also be collected from a patient via a venous line or an arterial line. The collected blood sample may be analyzed to obtain medically useful information such as, for example, chemical composition, hematology, and coagulation ability.

[0004] In blood collection using an existing vascular access, a venous line or an arterial line may be connected to, for example, a Luer lock access device (LLAD) holder or a blood transfer device (BTD) holder equipped with a non-patient needle (NPN). The holder is configured to receive a blood collection device such as, for example, a BD VACUTAINER® blood collection tube, and collect a blood sample from a patient via a venous line or an arterial line. The blood collection device is pushed into the holder, and the non-patient needle is positioned to puncture the rubber stopper of the blood collection tube, and the vacuum in the tube sucks the blood sample into the blood collection device.

[0005] However, standard blood collection tubes are typically used to collect larger volumes of blood samples, and separate equipment may be required to collect and dispense blood for testing or analysis purposes. Furthermore, standard blood collection tubes are usually not designed to remove air bubbles or clots before transporting the blood for testing or analysis. [Overview of the project] [Problems that the invention aims to solve]

[0006] The subject matter claimed herein is not limited to embodiments that resolve any of the aforementioned shortcomings, or embodiments that operate only in the aforementioned environment. Rather, this background art is provided merely to illustrate an example of the technical area in which some of the embodiments described herein may be carried out. [Means for solving the problem]

[0007] According to one aspect of the present disclosure, a blood collection system is disclosed which is configured to be connected to a set of tubes that provide vascular access to a patient. The blood collection system includes an access device coupled to the set of tubes, the access device including a blood collection tube holder, a non-patient needle at least partially located within the blood collection tube holder, and a syringe, the syringe including a plunger rod, a stopper, and a distal interface. The blood collection system further includes a cap assembly connectable to the distal interface of the syringe, the cap assembly including a cap body and a bidirectional valve, the bidirectional valve being in fluid communication with a vent chamber formed within the cap body.

[0008] In some embodiments, at least a portion of the bidirectional valve is formed by at least a portion of the stopper member.

[0009] In some embodiments, at least a portion of the bidirectional valve is formed by at least a portion of the cap body.

[0010] In some embodiments, the stopper member is formed from an elastomer material that can be punctured by a non-patient needle and is self-sealing when the non-patient needle is removed.

[0011] In some embodiments, the cap assembly further includes an upper discharge member that can be coupled to the cap body, the upper discharge member being configured to hold at least partially a stopper member within the cap body.

[0012] In some embodiments, the upper discharge member includes a discharge opening that communicates with a discharge chamber formed within the cap body.

[0013] In some embodiments, the discharge opening is configured to allow air to be discharged from the discharge chamber, preventing blood samples or other fluids from passing through it.

[0014] In some embodiments, the cap body further includes a valve opening, the stopper member includes a deformable portion, and the upper discharge member includes a notch.

[0015] In some embodiments, the valve opening, elastic deformation portion, and notch portion serve to discharge some of the air bubbles and blood sample collected in the syringe into a discharge chamber formed in the cap body when the plunger rod of the syringe is pushed down by the user.

[0016] In some embodiments, the distal interface of the syringe is configured as either a Luer lock interface or a Luer slip interface.

[0017] In some embodiments, the cap body includes a proximal interface coupling configured to detachably engage with the distal interface of the syringe.

[0018] In some embodiments, the syringe is configured as an arterial blood gas (ABG) syringe.

[0019] In some embodiments, the access device is configured as a luer lock type access device.

[0020] In some embodiments, at least a part of the outer contour of the cap body is configured to fit at least a part of the inner contour of the blood collection tube holder.

[0021] According to another aspect of the present disclosure, a cap assembly connectable to a syringe for collecting a blood sample is disclosed. The cap assembly includes a cap body, a stopper member, and an upper discharge member coupled to the cap body. The upper discharge member is configured to hold at least partially the stopper member within the cap body, and a discharge chamber is formed between the cap body and the upper discharge member within the cap assembly.

[0022] In some embodiments, the cap body includes a valve opening, the stopper member includes an elastic deformation portion, and the upper discharge member includes a notch portion.

[0023] In some embodiments, the valve opening, the elastic deformation portion, and the notch portion serve to discharge at least one of the air bubbles and a part of the blood sample collected in the syringe connected to the cap assembly into the discharge chamber when the user presses the plunger rod of the syringe.

[0024] In some embodiments, the stopper member is formed of an elastomeric material that can be punctured by the non-patient needle of the access device and is self-sealing when the non-patient needle of the access device is removed.

[0025] In some embodiments, the upper discharge member includes a central portion sized and shaped to receive the non-patient needle of the access device such that the non-patient needle can puncture the stopper member.

[0026] In some embodiments, the upper discharge member includes a discharge opening in fluid communication with the discharge chamber.

[0027] In some embodiments, at least a portion of the outer contour of the cap body is configured to conform to at least a portion of the inner contour of the blood collection tube holder.

[0028] It should be understood that both the foregoing summary description and the following detailed description are exemplary and for purposes of explanation and are not restrictive of the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and instrumentalities shown in the drawings. Also, it should be understood that embodiments may be combined, or other embodiments may be used, and structural changes may be made without departing from the scope of the various embodiments of the present invention, unless so claimed. Accordingly, the following detailed description should not be construed in a limiting sense.

Brief Description of the Drawings

[0029] The above and other features and advantages of this specification, and the manner of achieving them, will become more apparent and the specification itself will be better understood by reference to the following description of the embodiments of this specification in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a perspective view of a blood collection system according to an aspect of the present disclosure. [Figure 2] FIG. 2 is a perspective view of a blood collection device and a cap assembly according to an aspect of the present disclosure. [Figure 3] FIG. 3 is a partial cross-sectional view of the blood collection system of FIG. 1. [Figure 4] FIG. 4 is a perspective cross-sectional view of a cap assembly according to an aspect of the present disclosure.

Mode for Carrying Out the Invention

[0030] Corresponding reference numerals indicate corresponding parts through some of the figures. The examples presented herein illustrate exemplary embodiments of the disclosure, and such examples should not be construed as limiting the scope of the disclosure in any way.

[0031] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutes will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutes are intended to fall within the spirit and scope of the invention.

[0032] Hereafter, for explanatory purposes, “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “horizontal,” “vertical,” and their derivatives shall be used in relation to the present invention as oriented in the drawings. However, it will be understood that the present invention may presuppose various alternative modifications unless otherwise explicitly specified. It should also be understood that the specific devices shown in the accompanying drawings and described below are merely exemplary embodiments of the present invention. Therefore, specific dimensions and other physical features relating to the embodiments disclosed herein should not be considered limiting.

[0033] In this specification, the distal end of a component or device (e.g., a syringe) means the end furthest from the user's hand when the component or device is in use, i.e., when the user is holding the syringe during preparation or use, and the proximal end means the end closest to the user's hand. Similarly, in this application, the terms “distal direction” and “distal” mean the direction furthest from the user's hand during use, and the terms “proximal direction” and “proximal” mean the direction closest to the user's hand during use.

[0034] Referring to Figure 1, a blood collection system 10 according to an aspect of the present disclosure is shown. The blood collection system 10 includes a tube set 19 that provides, for example, vascular access to a patient via a catheter. In the embodiment shown in Figure 1, the tube set 19 is connected to a three-way valve 24, one branch of which is connected to an access device 11, such as a Luer-lock access device (LLAD). The access device 11 includes a tube holder 12 and a Luer connector interface 13. The three-way valve 24 can be selectively actuated to fluidly couple the access device 11 and the tube set 19, enabling blood collection into a suitable container. Although shown as a Luer-lock access device (LLAD), it should be understood that the access device 11 is any suitable access device, such as a blood transport device (BTD). Additionally and / or alternatively, in some embodiments, the three-way valve 24 may not be used, and the access device 11 may be connected to the tube set 19 via a suitable interface or coupling.

[0035] The holder 12 of the access device 11 is sized and configured to receive a blood collection device, such as a BD VACUTAINER® blood collection tube. However, as mentioned above, blood collection tubes such as BD VACUTAINER® are not typically configured for the removal of air bubbles and / or the disposal of coagulated blood samples before delivery for testing or analysis. Therefore, the blood collection system 10 according to embodiments of the present disclosure utilizes a syringe 14 connected to a cap assembly 30. As will be described in more detail below, the syringe 14 and the cap assembly 30 are configured to enable blood collection via the access device 11 while simultaneously allowing for the removal of air and / or coagulated blood samples before supplying the sample for testing or analysis.

[0036] Referring to Figures 1 and 2, the syringe 14 includes a stopper 16 and a plunger rod 22. In some embodiments, the syringe 14 may be configured as a vented syringe for arterial blood gas (ABG). This allows blood to be drawn into the syringe 14 solely by the patient's blood pressure, similar to a vacuum blood collection tube such as BD VACUTAINER®. In other embodiments, the syringe 14 may be configured as a standard syringe, allowing blood or other fluids to be drawn into the syringe 14 by the user manually moving the plunger rod 22 and stopper 16 proximal. The syringe 14 is equipped with a distal interface 15, which may be configured as any suitable interface, such as a Luer lock interface or a Luer slip interface.

[0037] As shown in Figures 2 and 3, the cap assembly 30 is configured to be detachably coupled to the distal interface 15 of the syringe 14. The cap assembly 30 includes a cap body 32. The outer diameter and overall outline of the cap body 32 are configured to be substantially similar to the cap and stopper components of conventional blood collection tubes (e.g., BD VACUTAINER®) used with the access device 11. In this way, the cap assembly 30 is configured to fit securely (but detachably) to the distal end of the holder 12, facilitating blood collection into the syringe 14 via the access device 11, with the cap assembly 30 properly aligned with the non-patient needle (NPN) 17 of the access device 11.

[0038] Specifically, referring to Figure 3, before blood collection via the access device 11, the user inserts the cap assembly 30, connected to the syringe 14, into the holder 12 of the access device 11. Distal movement of the syringe 14 and cap assembly 30 within the holder causes the stopper member 34 of the cap assembly 30 to compress the protective cover 18 positioned on the non-patient needle 17, exposing the tip of the non-patient needle 17 so that the stopper member 34 is punctured by the non-patient needle 17, forming a fluid path from the tube set 19 (see Figure 1) through the access device 11 to the syringe 14. The stopper member 34 may be formed of any suitable material that can be resealed after puncture by the non-patient needle 17, such as an elastomer, more specifically a thermoplastic elastomer.

[0039] As shown in Figure 3, after the cap assembly 30 has been sufficiently punctured by the non-patient needle 17, blood can be collected or drawn into the syringe 14 by any appropriate method. For example, if the syringe 14 is configured as an ABG syringe, blood may be drawn into the syringe 14 solely by the patient's blood pressure. Alternatively, if the syringe 14 is a standard syringe, the user can draw a blood sample into the syringe 14 by manually displacing the plunger rod 22 and stopper 16 proximal. Once the required blood sample has been collected in the syringe 14, the syringe 14 and cap assembly 30 can be withdrawn from the holder 12, thereby disengaging the non-patient needle 17 from the stopper member 34, which self-seals to prevent blood leakage and air intrusion.

[0040] Next, referring to Figure 4, various features of the cap assembly 30 are shown. As previously mentioned, the cap assembly 30 includes the cap body 32. The proximal interface connector 36 extends from the cap body 32 and allows for selective coupling with, for example, the distal interface 15 of the syringe 14. Thus, the proximal interface connector 36 can be configured to accommodate screw engagement with a Luer lock interface, press-fit engagement with a Luer slip interface, and so on.

[0041] Furthermore, as described above, the cap assembly 30 includes a stopper member 34 made of, for example, rubber, elastomer material. The stopper member 34 is at least partially held within the cap assembly 30 by an upper discharge member 38. The upper discharge member 38 may be made of any suitable material, such as polymer or plastic material, and may be made of the same material as the cap body 32 or a different material. Furthermore, the upper discharge member 38 may be held within the cap body 32 by any suitable method, such as press-fit, snap-fit, or screw-in. The upper discharge member 38 has a central cavity 39, which is sized and shaped to accommodate the non-patient needle 17 and protective cover 18 of the access device 11, and the non-patient needle 17 can puncture the stopper member 34 during use.

[0042] A channel 42 is formed inside the cap body 32, located proximal to the stopper member 34. The channel 42 is configured to accommodate at least a portion of the tip of the non-patient needle 17 during blood collection, and the channel 42 allows the blood sample to flow into the syringe 14 through the proximal interface connector 36. In some embodiments, the connection between the proximal interface connector 36 and the distal interface 15 of the syringe 14 allows the blood sample to mix automatically as it enters the syringe 14.

[0043] Referring to Figure 4, the cap body 32 is further provided with a valve opening 44 located proximal to the stopper member 34. Near the valve opening 44, the upper discharge member 38 has a notch 45, while the stopper member 34 has an elastically deformable portion 46 between the valve opening 44 of the cap body 32 and the notch 45 of the upper discharge member 38.

[0044] Due to the interrelationship of the valve opening 44, the elastic deformation portion 46, and the notch portion 45, the stopper member 34 functions as a bidirectional stopper valve that allows the syringe 14 to be discharged after the blood collection procedure. That is, after the blood sample has been collected in the syringe 14, the syringe 14 and the cap assembly 30 can be removed from the holder 12, thereby withdrawing the non-patient needle 17 from the stopper member 34, and as a result the stopper member 34 self-seals at the puncture site of the non-patient needle 17.

[0045] When the syringe 14 and cap assembly 30 are removed from the holder 12, the user can remove air bubbles in the syringe 14 and a small amount of clotted blood sample 47 present near the Luer connector of the syringe 14. To initiate this discharge, the user typically holds the syringe 14 and cap assembly 30 in a nearly vertical position, positioning the cap assembly 30 directly above the syringe 14, thereby causing air bubbles in the collected sample to rise towards the distal interface 15 of the syringe 14. The user then pushes down the plunger rod 22 to push the air bubbles and / or a portion of the collected blood sample 47 through the channel 42 to the valve opening 44 of the cap body 32. The air bubbles and / or a portion of the collected blood sample 47 are then forced by fluid pressure to pass through the elastic deformation portion 46 of the stopper member 34, thereby allowing the air bubbles and / or a portion of the collected blood sample 47 to flow into the discharge chamber 48 formed within the cap assembly 30. By removing air bubbles and / or the collected blood sample 47 in this method, the stability of the collected blood sample in the syringe 14 before testing and / or analysis is improved.

[0046] As shown in Figure 4, the upper discharge member 38 may further include a discharge opening 40 formed inside it, which allows air 49 to pass through when discharging air bubbles from the sample collected in the syringe 14. Although not shown in Figure 4, it should be understood that a discharge plug or discharge filter may be provided at or near the location of the discharge opening 40. The discharge plug or discharge filter may be configured to prevent the passage of the blood sample until it is completely wet with a portion of the blood sample, while allowing air to pass through. In some embodiments, the discharge plug or discharge filter includes a hydrophobic filter. Thus, when the discharge chamber 48 is filled with a portion of the collected blood sample, the discharge opening 40 is effectively sealed, preventing leakage of the blood sample from the cap assembly 30 through the discharge opening 40.

[0047] In some embodiments, the cap body 32 and / or upper discharge member 38 of the cap assembly 30 may be formed of a substantially transparent or translucent material so that the user can visually confirm that a portion of the blood sample is being collected in the discharge chamber 48.

[0048] In addition to its function of expelling air bubbles and blood coagulation samples after blood collection, the cap body 32 can also function as a closure device for the syringe 14 to prevent blood leakage and / or air intrusion during transport and / or before testing and analysis. If testing and analysis of the blood sample in the syringe 14 is required, the cap body 32 can be removed from the syringe 14 and disposed of separately in an appropriate medical waste container.

[0049] While this disclosure has been described to have an exemplary structure, it is subject to further modification within its spirit and scope. Therefore, this application is intended to encompass any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover any deviations from this disclosure that fall within the scope of the appended claims, provided that such deviations are within the realm of known or customary practices in the relevant art.

Claims

1. A blood collection system configured to connect to a set of tubes that provide vascular access to a patient, An access device connected to the tube set, the access device comprising a blood collection tube holder and a non-patient needle at least partially disposed within the blood collection tube holder, A syringe having a plunger rod, a stopper, and a distal interface, A cap assembly connectable to the distal interface of the syringe, wherein the cap assembly comprises a cap body and a bidirectional valve, the bidirectional valve being in fluid communication with a discharge chamber formed within the cap body, A blood collection system equipped with the following features.

2. The blood collection system according to claim 1, wherein at least a portion of the bidirectional valve is formed by at least a portion of the cap body.

3. The blood collection system according to claim 1, wherein at least a portion of the bidirectional valve is formed by at least a portion of a stopper member.

4. The blood collection system according to claim 3, wherein the stopper member is formed from an elastomer material that can be punctured by the non-patient needle and is self-sealing when the non-patient needle is removed.

5. The cap assembly further comprises an upper discharge member that can be coupled to the cap body, The blood collection system according to claim 3, wherein the upper discharge member is configured to at least partially hold the stopper member within the cap body.

6. The blood collection system according to claim 5, wherein the upper discharge member has a discharge opening that is in fluid communication with the discharge chamber formed in the cap body.

7. The blood collection system according to claim 6, wherein the discharge opening is configured to allow air to be discharged from the discharge chamber and to prevent a blood sample or other fluid from passing through the discharge opening.

8. The blood collection system according to claim 5, wherein the cap body further has a valve opening, the stopper member has an elastically deformable portion, and the upper discharge member has a notch.

9. The blood collection system according to claim 8, wherein the valve opening, the elastically deformable portion, and the notch portion cause a portion of the air bubbles and blood sample collected in the syringe to be discharged into the discharge chamber formed in the cap body when the plunger rod of the syringe is pushed down by the user.

10. The blood collection system according to claim 1, wherein the distal interface of the syringe is configured as either a Luer lock interface or a Luer slip interface.

11. The blood collection system according to claim 10, wherein the cap body comprises a proximal interface coupling portion configured to be detachably engaged with the distal interface of the syringe.

12. The blood collection system according to claim 1, wherein the syringe is configured as an arterial blood gas (ABG) syringe.

13. The blood collection system according to claim 1, wherein the access device is configured as a Luer lock type access device.

14. The blood collection system according to claim 1, wherein the outer shape of at least a portion of the cap body is configured to conform to the inner shape of at least a portion of the blood collection tube holder.

15. A cap assembly that can be connected to a syringe for collecting blood samples, The cap body and Stopper member and An upper discharge member that can be attached to the cap body, Equipped with, The upper discharge member is configured to at least partially hold the stopper member within the cap body. A cap assembly in which a discharge chamber is formed between the cap body and the upper discharge member within the cap assembly.

16. The cap assembly according to claim 15, wherein the cap body has a valve opening, the stopper member has an elastically deformable portion, and the upper discharge member has a notch.

17. The cap assembly according to claim 16, wherein the valve opening, the elastically deformable portion, and the notch portion allow at least one of the air bubbles and a portion of the blood sample collected in the syringe connected to the cap assembly to be discharged to the discharge chamber when the plunger rod of the syringe is pushed down by the user.

18. The cap assembly according to claim 15, wherein the stopper member is puncturable by a non-patient needle of the access device and is formed from a self-sealing elastomer material when the non-patient needle of the access device is removed.

19. The cap assembly according to claim 18, wherein the upper discharge member has a central portion configured to have dimensions and shape that allow it to accommodate the non-patient needle of the access device so that the non-patient needle can puncture the stopper member.

20. The cap assembly according to claim 15, wherein the upper discharge member has a discharge opening that communicates fluidly with the discharge chamber.

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