Two-way stop valve matched with ventilation syringe

Abstract

A blood collection system configured for connection to a tube stack that provides vascular access to a patient, the system including an access device coupled to the tube stack, where the access device includes a blood collection tube holder and a non-patient needle disposed at least partially within the blood collection tube holder. The system further includes a syringe, wherein the syringe includes a plunger rod, a stop, and a distal interface; and a cap assembly coupleable to the distal interface of the syringe. The cap assembly includes a cap body and a two-way valve, and wherein the two-way valve is in fluid communication with a vent chamber formed within the cap body.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 454,204, filed March 23, 2023, entitled “Bidirectional Stopper Valve that Mates to a Venting Syringe,” the entire disclosure of which is incorporated herein by reference.

[0003] BACKGROUND

[0004] Field of the Disclosure

[0005] The present disclosure relates generally to biological fluid collection devices. More specifically, the present disclosure relates to a cap assembly having a bidirectional stopper valve that mates to a biological fluid collection device, such as a venting syringe.

[0006] Description of Related Art

[0007] Blood sampling is a common health care procedure that involves the withdrawal of at least one drop of blood from a patient. Blood samples are often obtained from inpatient, home care, and emergency room patients by finger stick, heel stick, or venipuncture. Blood samples can also be obtained from a patient by venous or arterial line. Once blood samples are collected, they can be analyzed for medically useful information, including, for example, chemistry, hematology, and coagulation.

[0008] For blood withdrawal using an existing vascular access, a venous or arterial line can be coupled to, for example, a luer lock access device (LLAD) holder or a blood transfer device (BTD) holder, which are provided with a non-patient needle (NPN) therein. The holder is configured to receive a blood collection device (e.g., a BD Vacutainer® blood collection tube) so as to collect a blood sample from a patient via the venous or arterial line. The blood collection device is pressed into the holder such that the NPN pierces a rubber stopper of the blood collection tube, where a vacuum in the tube draws the blood sample into the blood collection device.

[0009] ​However, typical blood collection tubes are generally used to obtain larger amounts of blood samples, and can require the use of separate instruments to collect and dispense blood for testing and analysis purposes. Moreover, typical blood collection tubes are generally not configured to vent air bubbles and / or discard clotted blood samples prior to transporting the blood sample for testing or analysis.

[0010] The subject matter claimed herein is not limited to embodiments or implementations that solve any disadvantages or address a specific problem described above. Rather, the present background is provided merely for generally describing various examples while some implementations are described above. SUMMARY

[0011] According to an aspect of the present disclosure, a blood collection system configured for connection to a tube set providing vascular access for a patient includes a access device coupled to the tube set, wherein the access device includes a blood collection tube holder and a non-patient needle at least partially disposed within the blood collection tube holder, and a syringe, wherein the syringe includes a plunger rod, a stopper, and a distal interface. The blood collection system further includes a cap assembly couplable to the distal interface of the syringe, wherein the cap assembly includes a cap body and a bidirectional valve, and wherein the bidirectional valve is in fluid communication with a venting chamber formed within the cap body.

[0012] In some embodiments, at least a portion of the bidirectional valve is formed by at least a portion of the stopper member.

[0013] In some embodiments, at least a portion of the bidirectional valve is formed by at least a portion of the cap body.

[0014] In some embodiments, the stopper member is formed of a resilient material that is pierceable by the non-patient needle and self-sealable upon removal of the non-patient needle.

[0015] In some embodiments, the cap assembly further includes a top venting member couplable to the cap body, and wherein the top venting member is configured to at least partially retain the stopper member within the cap body.

[0016] In some embodiments, the top venting member includes a venting opening in fluid communication with the venting chamber formed within the cap body.

[0017] In some embodiments, the venting opening is configured to allow air to escape the venting chamber and prevent blood samples or other fluids from passing therethrough.

[0018] In some embodiments, the cap further includes a valve opening, the stopper member includes a deflectable portion, and the top vent member includes a notched portion.

[0019] In some embodiments, the valve opening, the deflectable portion, and the notched portion function to vent at least one of a bubble and a portion of a blood sample collected within the syringe into the vent chamber formed in the cap when the plunger rod of the syringe is depressed by a user.

[0020] In some embodiments, the distal interface of the syringe is configured as one of a luer lock interface and a luer slip interface.

[0021] In some embodiments, the cap includes a proximal interface coupling configured to removably engage with the distal interface of the syringe.

[0022] In some embodiments, the syringe is configured as an arterial blood gas (ABG) syringe.

[0023] In some embodiments, the access device is configured as a luer lock access device.

[0024] In some embodiments, an outer profile of at least a portion of the cap is configured to conform to an inner profile of at least a portion of the blood collection tube holder.

[0025] According to another aspect of the present disclosure, a cap assembly is disclosed that is couplable to a syringe for collecting a blood sample. The cap assembly includes a cap, a stopper member, and a top vent member couplable to the cap. The top vent member is configured to at least partially retain the stopper member within the cap, and a vent chamber is formed within the cap assembly between the cap and the top vent member.

[0026] In some embodiments, the cap includes a valve opening, the stopper member includes a deflectable portion, and the top vent member includes a notched portion.

[0027] In some embodiments, the valve opening, the deflectable portion, and the notched portion function to vent at least one of a bubble and a portion of a blood sample collected within the syringe into the vent chamber when a plunger rod of a syringe coupled to the cap assembly is depressed by a user.

[0028] In some embodiments, the stopper member is formed of a resilient material that is pierceable by a non-patient needle of an access device and is self-sealable upon removal of the non-patient needle of the access device.

[0029] In some embodiments, the top vent member includes a center sized and configured to accommodate the non-patient needle of the access device such that the non-patient needle can pierce the stop member.

[0030] In some embodiments, the top vent member includes a vent opening in fluid communication with the vent chamber.

[0031] In some embodiments, an outer profile of at least a portion of the cap is configured to conform to an inner profile of at least a portion of a blood collection tube holder.

[0032] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application claimed. It should be understood that various embodiments are not limited to the arrangements and instrumentalities shown in the attached drawings. It should also be understood that the embodiments can be combined or other embodiments utilized, and structural changes can be made without departing from the scope of the various embodiments of the present disclosure, unless so claimed. Accordingly, the following detailed description is not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF DRAWINGS

[0033] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following description of various embodiments of the disclosure taken together with the accompanying drawings, wherein:

[0034] FIG. 1 is a perspective view of a blood collection system according to an aspect of the present disclosure;

[0035] FIG. 2 is a perspective view of a blood collection device and cap assembly according to an aspect of the present disclosure;

[0036] FIG. 3 is a partial cross-sectional view of a blood collection system of FIG. 1 ; and

[0037] FIG. 4 is a cross-sectional perspective view of a cap assembly according to an aspect of the present disclosure.

[0038] Corresponding reference characters indicate the corresponding parts throughout the several views. The examples set forth herein demonstrate exemplary embodiments of the disclosure and are not to be interpreted as limiting the scope of the disclosure in any way. DETAILED DESCRIPTION

[0039] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for practicing the present invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the present invention.

[0040] For the purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives will refer to the present invention as oriented in the accompanying drawings. However, it should be understood that the present invention may employ various alternative variations, unless expressly specified to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0041] In the present disclosure, the distal end of a component or the distal end of a device (e.g., a syringe) means the end farthest from the hand of a user when the component or the device is in the use position (i.e., when the user holds the syringe in preparation or during use), and the proximal end of a component or the proximal end of a device (e.g., a syringe) means the end closest to the hand of a user when the component or the device is in the use position (i.e., when the user holds the syringe in preparation or during use). Similarly, in the present application, the terms "in the distal direction" and "distally" refer to the direction farthest from the hand of a user when in use, and the terms "in the proximal direction" and "proximally" refer to the direction close to the hand of a user when in use.

[0042] refer to FIG. 1 , FIG. 1 A blood collection system 10 is shown according to one aspect of the present disclosure. The blood collection system 10 includes a tubing set 19 that provides vascular access to a patient via, for example, a catheter. FIG. 1 In the illustrated embodiment, the tubing set 19 is coupled to a three-way valve 24, wherein one branch of the three-way valve 24 is coupled to an access device 11, such as a Luer lock access device (LLAD). The access device 11 comprises a tube holder 12 and a Luer connector interface 13. The three-way valve 24 can be selectively actuated to fluidically couple the access device 11 to the tubing set 19, thereby enabling blood to be collected into a suitable container. Although the access device 11 is shown as a Luer lock access device (LLAD), it should be understood that the access device 11 can be any suitable access device, such as a blood transfer 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 coupled to the tubing set 19 via any suitable interface or coupling.

[0043] 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 noted above, blood collection tubes such as BD Vacutainer® and the like are not typically configured for the purpose of venting air bubbles and / or discarding clotted blood samples prior to delivery of the blood sample for testing or analysis. Accordingly, the blood collection system 10 according to embodiments of the present disclosure utilizes a syringe 14 coupled to a cap assembly 30. As will be described in further detail below, the syringe 14 and cap assembly 30 are configured to enable blood collection via the access device 11 while simultaneously purging air and / or clotted blood samples prior to delivery of the sample for testing or analysis.

[0044] Referring to FIG. 1 and FIG. 2 , the syringe 14 includes a stopper 16 and a plunger rod 22. In some embodiments, the syringe 14 can be configured as an arterial blood gas (ABG) vented syringe, which is similar to a BD Vacutainer® and the like, can enable blood to be drawn into the syringe 14 by patient blood pressure alone. In other embodiments, the syringe 14 can be configured as a standard syringe, such that blood or other fluid is drawn into the syringe 14 by manual proximal movement of the plunger rod 22 and stopper 16 by a user. The syringe 14 includes a distal interface 15, which can be configured as any suitable interface, such as a luer lock interface, a luer slip interface, or the like.

[0045] As shown in FIG. 2 and FIG. 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. One or more outer diameters and an overall exterior profile of the cap body 32 are configured to be substantially similar to the outer diameters and overall exterior profile of the cap and stopper components of conventional blood collection tubes (e.g., BD Vacutainer® ) used with access devices 11. In this manner, the cap assembly 30 is configured to securely (but detachably) fit within the distal end portion of the holder 12, thereby allowing the cap assembly 30 to facilitate blood collection into the syringe 14 via the access device 11 with the cap assembly 30 in proper alignment with the non-patient needle (NPN) 17 of the access device 11.

[0046] In particular, referring to FIG. 3Prior to collecting blood via access device 11, a user inserts syringe 14 and coupled cap assembly 30 into holder 12 of access device 11. Distal movement of syringe 14 and cap assembly 30 within the holder causes stopper member 34 of cap assembly 30 to compress sheath 18 disposed on NPN 17, thereby exposing the tip of NPN 17 such that stopper member 34 is pierced by NPN 17 to provide a fluid path from tube set 19 (shown in FIG. 1 FIG. 11) into syringe 14 via access device 11. Stopper member 34 can be formed of any suitable material capable of resealing after being pierced by NPN 17, such as an elastomeric material, more particularly a thermoplastic elastomer.

[0047] After cap assembly 30 is sufficiently pierced by NPN 17 (as shown in FIG. 3 FIG. 11), blood can be collected or drawn into syringe 14 via any suitable method. For example, in the case where syringe 14 is configured as an ABG syringe, blood can be drawn into syringe 14 via only the patient’s blood pressure. Alternatively, in the case where syringe 14 is a standard syringe, a blood sample can be drawn into syringe 14 by a user manually moving plunger rod 22 and stopper 16 proximally. Once the desired blood sample is collected within syringe 14, syringe 14 and cap assembly 30 can be withdrawn from holder 12, thereby removing NPN 17 from stopper member 34, which self-seals to prevent blood leakage and / or air infiltration into syringe 14.

[0048] Next, reference is made to FIG. 4 , FIG. 4 FIG. 11, which illustrates various features of cap assembly 30. As described above, cap assembly 30 includes cap body 32. Proximal interface coupling 36 extends from cap body 32 to provide selective coupling with, for example, distal interface 15 of syringe 14. Thus, proximal interface coupling 36 can be configured for threaded engagement with a luer lock interface, press-fit engagement with a luer slip interface, etc.

[0049] Further, as described above, cap assembly 30 includes stopper member 34 formed of rubber and elastomeric materials, etc. Stopper member 34 is at least partially retained within cap assembly 30 by top vent member 38. Top vent member 38 can be formed of any suitable material, such as a polymer or plastic material, and can be formed of the same or different material as that of cap body 32. Further, top vent member 38 can be retained within cap body 32 by any suitable method, such as a press-fit, snap-fit, threaded fit, etc. Top vent member 38 includes central cavity 39, which is sized and configured to accommodate NPN 17 and sheath 18 of access device 11 such that NPN 17 is able to pierce stopper member 34 during use.

[0050] A passageway 42 is formed within the cap 32 proximate the stop member 34. The passageway 42 is configured to accommodate at least a terminal portion of the NPN 17 during the blood collection procedure, and the passageway 42 enables the blood sample to flow through the proximal interface coupling 36 into the syringe 14. In some embodiments, the coupling between the proximal interface coupling 36 and the distal interface 15 of the syringe 14 can allow for automatic mixing of the blood sample as it enters the syringe 14.

[0051] Still referring to FIG. 4 , the cap 32 also includes a valve opening 44 at a location proximate the stop member 34. In the vicinity of the valve opening 44, the top vent member 38 includes a notched portion 45, and the stop member 34 includes a deflectable portion 46 that is positioned between the valve opening 44 of the cap 32 and the notched portion 45 of the top vent member 48.

[0052] The interrelationship between the valve opening 44, the deflectable portion 46, and the notched portion 45 enables the stop member 34 to operate as a bidirectional stop valve, thereby enabling venting of the syringe 14 after the blood collection procedure. That is, after the blood sample has been collected into the syringe 14, the syringe 14 and cap assembly 30 can be removed from the holder 12, thereby causing the NPN 17 to be withdrawn from the stop member 34 and causing the stop member 34 to self-seal at the puncture location of the NPN 17.

[0053] With the syringe 14 and cap assembly 30 removed from the holder 12, the user can purge the syringe 14 of air bubbles and a small amount of clotted blood sample 47 that is located at or near the luer connector of the syringe 14. To initiate such purging, the user typically holds the syringe 14 and cap assembly 30 in a substantially upright position, with the cap assembly 30 disposed upright above the syringe 14, thereby allowing any air bubbles in the collected sample to rise toward the distal interface 15 of the syringe 14. The user then depresses the plunger rod 22 to force the air bubbles and / or a portion of the collected blood sample 47 through the passageway 42 and into the valve opening 44 of the cap 32. Fluid pressure forces the air bubbles and / or a portion of the collected blood sample 47 past the deflectable portion 46 of the stop member 34, thereby enabling the air bubbles and / or a portion of the collected blood sample 47 to enter a venting chamber 48 formed within the cap assembly 30. Purging any air bubbles and / or clotted sample 47 in this manner improves the stability of the collected blood sample within the syringe 14 prior to testing and / or analysis.

[0054] As FIG. 4 shown, the top vent member 38 can also include a vent opening 40 formed therein, where the vent opening 40 allows air 49 to pass therethrough during purging of air bubbles from the sample collected within the syringe 14. While the vent opening 40 is shown as being formed in the top vent member 38, it is contemplated that the vent opening 40 could be formed in the deflectable portion 46 of the stop member 34. FIG. 4A vent plug or vent filter can be provided at or near the location of the vent opening 40, although not shown, and it is understood that the vent plug or vent filter can be configured to allow air to pass therethrough until completely wetted by, for example, a portion of the blood sample, while preventing the blood sample from passing therethrough. In some embodiments, the vent plug or vent filter comprises a hydrophobic filter. Thus, when the vent chamber 48 is filled with a portion of the collected blood sample, the vent opening 40 is effectively plugged, thereby preventing leakage of the blood sample from the cap assembly 30 via the vent opening 40.

[0055] In some embodiments, the cap body 32 and / or the top vent member 38 of the cap assembly 30 can be formed of a substantially transparent or translucent material, thereby enabling a user to visually confirm that a portion of the blood sample is collected in the vent chamber 48.

[0056] In addition to draining the sample of air bubbles and clots after blood collection, the cap body 32 can also serve as a closure for the syringe 14 to prevent leakage of blood and / or ingress of air during transport and / or prior to testing and analysis. When testing and analysis of the blood sample within the syringe 14 is required, the cap body 32 can be removed from the syringe 14 and placed separately in an appropriate medical waste container.

[0057] While this disclosure has been described as having exemplary designs, the disclosure can be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and fall within the limits of the appended claims.

Claims

1. A blood collection system configured for connection to a tube set providing vascular access for a patient, the blood collection system comprising: an access device coupled to the tube set, wherein the access device includes a blood collection tube holder and a non-patient needle at least partially disposed within the blood collection tube holder; a syringe, wherein the syringe includes a plunger rod, a stopper, and a distal interface; and a cap assembly couplable to the distal interface of the syringe, wherein the cap assembly includes a cap body and a bidirectional valve, and wherein the bidirectional valve is in fluid communication with a vent chamber formed within the cap body.

2. The blood collection system of 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 of claim 1, wherein, At least a portion of the bidirectional valve is formed by at least a portion of a stop member.

4. The blood collection system of claim 3, wherein, The stop member is formed of a resilient material that is pierceable by the non-patient needle and self-sealable upon removal of the non-patient needle.

5. The blood collection system of claim 3, wherein, The cap assembly further includes a top vent member couplable to the cap body, and wherein the top vent member is configured to at least partially retain the stop member within the cap body.

6. The blood collection system of claim 5, wherein, The top vent member includes a vent opening in fluid communication with the vent chamber formed within the cap body.

7. The blood collection system of claim 6, wherein, The vent opening is configured to allow air to escape the vent chamber and prevent a blood sample or other fluid from passing therethrough.

8. The blood collection system of claim 5, wherein, The cap body further includes a valve opening, the stop member includes a deflectable portion, and the top vent member includes a notched portion.

9. The blood collection system of claim 8, wherein, The valve opening, the deflectable portion, and the notched portion function to vent at least one of an air bubble and a portion of a blood sample collected within the syringe into the vent chamber formed in the cap body when the plunger rod of the syringe is depressed by a user.

10. The blood collection system of claim 1, wherein, The distal interface of the syringe is configured as one of a luer lock interface and a luer slip interface.

11. The blood collection system of claim 10, wherein, The cap body includes a proximal interface coupling configured for removable engagement with the distal interface of the syringe.

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

13. The blood collection system of claim 1, wherein, The access device is configured as a luer lock access device.

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

15. A cap assembly couplable to a syringe for collecting a blood sample, the cap assembly comprising: a cap body; a stop member; and a top vent member couplable to the cap body, wherein the top vent member is configured to at least partially retain the stop member within the cap body, and wherein a vent chamber is formed within the cap assembly between the cap body and the top vent member.

16. The cap assembly of claim 15, wherein, The cap body includes a valve opening, the stop member includes a deflectable portion, and the top vent member includes a notched portion.

17. The cap assembly of claim 16, wherein, When a plunger rod of a syringe coupled to the cap assembly is depressed by a user, the valve opening, the deflectable portion, and the notched portion function to vent at least one of an air bubble and a portion of a blood sample collected within the syringe into the vent chamber.

18. The cap assembly of claim 15, wherein, The stop member is formed of a resilient material that is pierceable by a non-patient needle of an access device and is self-sealable upon removal of the non-patient needle of the access device.

19. The cap assembly of claim 18, wherein, The top vent member includes a center sized and configured to accommodate the non-patient needle of the access device such that the non-patient needle can pierce the stop member.

20. The cap assembly of claim 15, wherein, The top vent member includes a vent opening in fluid communication with the vent chamber.

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