Blood Culture Sample Collection System

Abstract

The blood culture sample collection system includes a container holder defining an opening, the container holder including a needle positioned within the opening, an adapter engaging the container holder, an access connector configured to connect to a vascular access device and in fluid communication with the needle of the container holder, and a collection container having a pre-advance position, an advanced position, and a post-collection position.

Description

[Technical Field]

[0001] The present disclosure relates to a blood culture sample collection system. [Background technology]

[0002] This application claims priority to U.S. Provisional Application No. 63 / 400,507, filed August 24, 2022, entitled "Blood Culture Sample Collection System," the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] When collecting blood specimens from indwelling vascular access devices such as peripheral intravenous catheters (PIVCs), central venous catheters (CVCs), or peripherally inserted central catheters (PICCs), the first 1–10 ml of blood is often wasted (i.e., discarded) to avoid contamination from fluid within the dead space of the vascular access pathway of such devices. While this additional step reduces contamination of the blood specimen, it can also be forgotten or performed improperly, potentially spoiling the blood specimen.

[0004] Blood cultures are often used as a tool to detect the presence of bacteria or fungi in a patient's blood sample, identify the type of bacteria or fungi present, and prescribe patient treatment. However, accidental contamination of blood samples is a common problem, resulting in false positives and often resulting in patients being prescribed unnecessary treatments, such as broad-spectrum antibiotics. To address this concern, some healthcare professionals cleanse the patient's skin before the blood collection procedure. While this reduces the false positive rate, it can still be significant (e.g., 3–5%), due to bacteria and / or fungi present in hair follicles. Therefore, some systems also reuse a small amount of blood collected initially, while others discard the initial (potentially contaminated) volume. However, these systems can be costly and time-consuming. Furthermore, these systems often rely on puncturing the patient's skin to collect the sample, which is uncomfortable for the patient.

[0005] Furthermore, needleless blood collection systems, such as Becton, Dickinson and Company's PIVO™, are intended to be used in conjunction with an intravenous catheter placed within a patient. These needleless blood collection systems can be configured to receive an evacuated tube such that when the evacuated tube is in fluid communication with the patient's vascular system via the needleless blood collection system, a pressure differential between the reservoir and the patient's vascular system can draw blood into the evacuated tube's reservoir. Because evacuated tubes are often not provided in a sterile state, there can be a risk of contamination each time the evacuated tube is coupled to a needleless blood collection system. Even if a healthcare provider disinfects the surface of the evacuated tube's resealable membrane (e.g., with an alcohol pad), the risk of contamination to the needleless blood collection system may be too high to use the evacuated tube as a waste tube collector before using the needleless blood collection system to collect a blood sample for blood culture.

[0006] To address the possibility of sample contamination due to contact with an unsterile evacuated tube, blood collection systems have been developed in which an evacuated tube configured to receive a discarded blood sample is held in a pre-advanced position within the LLAD via an adapter, thereby sterilizing both the evacuated tube and the LLAD together, thereby reducing the number of non-sterile steps and connections during the blood culture collection procedure. An example of such a system is shown and described in U.S. Patent Application Publication No. 2021 / 0196167, which is incorporated herein by reference in its entirety. However, while the system shown and described in U.S. Patent Application Publication No. 2021 / 0196167 addresses at least some of the risk of false-positive blood culture samples, it typically does not account for the risk of hemolysis in subsequent blood samples collected after the initial blood culture sample is drawn. A common problem with collecting blood from a patient using a vascular access device such as a PIVC is that as the blood is drawn into, for example, a blood collection tube, red blood cells are in a state of high shear stress and are therefore susceptible to hemolysis due to the high-pressure differential between the vein and the blood collection tube. Such hemolysis can result in the rejection and discarding of the blood sample. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent Application Publication No. 2021 / 0196167 [Patent Document 2] U.S. Patent Application Publication No. 2021 / 10186394 [Patent Document 3] U.S. Patent No. 11,090,461 Summary of the Invention [Means for solving the problem]

[0008] In one aspect or embodiment, a blood culture sample collection system includes: a container holder having a first end and a second end disposed opposite the first end, the container holder defining an opening and including a needle disposed within the opening; an adapter engaging the container holder; an access connector configured to connect to a vascular access device and in fluid communication with the needle of the container holder; and a collection container having the first end and the second end disposed opposite the first end. The collection container has a pre-advance position in which the first end of the collection container is spaced from the needle, the first end of the collection container is received within the opening of the container holder, and the collection container engages with the adapter, an advanced position in which the first end of the collection container is received within the opening of the container holder, the needle is in fluid communication with the collection container, and the collection container engages with the adapter, and a post-collection position in which the collection container is disposed outside the opening of the container holder.

[0009] The adapter can be engaged with the collection container and separated from the container holder when the collection container is in the post-collection position. The container holder can include an elastomeric sleeve surrounding the needle. The collection container can include a neck portion and a body, the neck portion increasing in diameter in a direction extending from the first end of the collection container to the second end of the collection container. The collection container can include a blood culture sample collection container, the collection container including a septum disposed at the first end of the collection container, and the needle pierces the septum when the collection container moves from the pre-advance position to the advance position. The access connector can include a Luer connector. The access connector can be connected to the container holder via a flexible tube. The access connector can be a compact connector having a fluid path configured to reduce the risk of hemolysis. The access connector can be directly connected to the container holder.

[0010] The adapter may be annular, and the adapter may include a first portion configured to be received within the opening of the container holder and a second portion configured to engage the second end of the container holder. The second portion of the adapter may have a larger diameter than the first portion of the adapter. More than half of the neck portion of the collection container may be received within the container holder when the collection container is in the advanced position.

[0011] The blood culture sample collection system may include a vascular access device including a passive diversion portion, where the vascular access device is in fluid communication with a needle. The blood culture sample collection system may include a vascular access device including an integrated catheter and a vented diversion chamber, where the vascular access device is in fluid communication with a needle. The blood culture sample collection system may include a vascular access device including an extension set and a vented diversion chamber, where the vascular access device is in fluid communication with a needle. The blood culture sample collection system may include a user-controlled active diversion mechanism. The blood culture sample collection system may include a blood collection device in fluid communication with a needle. The blood collection device may include a vented diversion chamber. [Brief explanation of the drawings]

[0012] The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings.

[0013] [Figure 1] FIG. 1 is a front view of a blood culture sample collection system according to one aspect or embodiment of the present application. [Figure 2] FIG. 2 is a perspective view of an access system connector according to a further aspect or embodiment of the present application. [Figure 3] FIG. 3 is a front view of a blood culture sample collection system according to a further aspect or embodiment showing a pre-travel position of the collection container. [Figure 4] FIG. 4 is a front view of a blood culture sample collection system according to a further aspect or embodiment showing the advanced position of the collection container. [Figure 5] FIG. 5 is a front view of a blood culture sample collection system according to a further aspect or embodiment showing the post-collection position of the collection container. [Figure 6]FIG. 6 is a front view of a blood culture sample collection system according to a further aspect or embodiment. [Figure 7] FIG. 7 is a front view of a blood culture sample collection system according to a further aspect or embodiment. [Figure 8] FIG. 8 is a front view of a blood culture sample collection system according to a further aspect or embodiment. [Figure 9] FIG. 9 is a front view of a blood culture sample collection system according to a further aspect or embodiment. [Figure 10] FIG. 10 is a front view of a blood culture sample collection system according to a further aspect or embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0014] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations presented herein illustrate exemplary embodiments of the present disclosure, and such illustrations should not be construed as limiting the scope of the present disclosure in any way.

[0015] Spatial or directional terms such as "left," "right," "inner," "outer," "above," "below," etc. should not be considered limiting as the present invention may assume various alternative orientations.

[0016] For purposes of explanation hereinafter, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "sideways," "vertical," and derivatives thereof, shall refer to the invention as oriented in the drawings. However, it will be understood that the invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings, and described in the following specification, are simply exemplary embodiments of the invention.

[0017] Unless otherwise indicated, all ranges or ratios disclosed herein should be understood to encompass the starting and ending values, and any and all subranges or subratios therein. For example, a specified range or ratio of "1 to 10" should be considered to include any and all subranges or subratios between (and including) the minimum value of 1 and the maximum value of 10; i.e., all subranges or subratios begin with a minimum value of 1 or greater and end with a maximum value of 10 or less.

[0018] The terms "first," "second," and the like are not intended to refer to any particular order or chronology, but rather to different conditions, characteristics, or elements.

[0019] As used herein, "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more As alone, or one or more Bs alone, or one or more Cs alone, or one or more As and one or more Bs, or one or more As and one or more Cs, or one or more Bs and one or more Cs, or all one or more of A, B, and C.

[0020] 1-5 , in one aspect or embodiment, a blood culture sample collection system 10 includes a container holder 12, an adapter 14, an access connector 16, and a collection container 18. The container holder 12 has a first end 20 and a second end 22 disposed opposite the first end 20. The container holder 12 defines an opening 24 and includes a needle 26 disposed within the opening 24. The adapter 14 engages with the container holder 12. In some aspects or embodiments, the adapter 14 is at least partially received by the opening 24 of the container holder 12. The access connector 16 is in fluid communication with the needle 26 of the container holder 12, as described in more detail below, and the access connector 16 is configured to connect to a vascular access device. The collection container 18 has a first end 28 and a second end 30 disposed opposite the first end 28. As shown in Figures 3-5, the collection container 18 has a pre-advance position (Figure 3), an advanced position (Figure 4), and a post-collection position (Figure 5). In the pre-advance position, the first end 28 of the collection container 18 is spaced from the needle 26, the first end 28 of the collection container 18 is received within the opening 24 of the container holder 12, and the collection container 18 is engaged with the adapter 14. In the advanced position, the first end 28 of the collection container 18 is received within the opening 24 of the container holder 12, the needle 26 is in fluid communication with the collection container 18, and the collection container 18 is engaged with the adapter 14. In the post-collection position, the collection container 18 is positioned outside the opening 24 of the container holder 12. The blood culture sample collection system 10 is configured to be assembled and sterilized with the collection container 18 in the pre-advance position, thereby eliminating a connection step and reducing the risk of sample contamination. As shown in FIG. 5, in one aspect or embodiment, the adapter 14 engages the collection container 18 and is separated from the container holder 12 when the collection container 18 is in the post-collection position.

[0021] In some aspects or embodiments, the container holder 12 is an access device such as the BD Vacutainer® Luer-Lok™ access device, commercially available from Becton, Dickinson and Co. The container holder 12 includes an elastomeric sleeve 32 that surrounds the needle 26, the elastomeric sleeve 32 being configured to retract when the needle 26 penetrates the collection container 18 and then return to its original position to seal the needle 26. The needle 26 extends from the first end 20 of the container holder 12 into the opening 24.

[0022] In some aspects or embodiments, the collection container 18 includes a neck portion 34 and a body 36, with the neck portion 34 increasing in diameter in a direction extending from the first end 28 of the collection container 18 to the second end 30 of the collection container 18. In one aspect or embodiment, the collection container 18 is a blood culture sample collection container, such as a BD BACTEC™ blood culture specimen collection container, commercially available from Becton, Dickinson and Co. The collection container 18 may include a septum 38 disposed at the first end 28 of the collection container 18, and the needle 26 pierces the septum 38 when the collection container 18 moves from the pre-advance position to the advanced position. Although other suitable arrangements may be utilized, more than half of the neck portion 34 of the collection container 18 is received within the container holder 12 when the collection container is in the advanced position.

[0023] Referring to FIG. 1 , in one aspect or embodiment, the access connector 16 includes a luer connector, and the access connector 16 is connected to the container holder via a flexible tubing 40. The access connector 16 may be a threaded luer or slip luer, a threaded luer lock with a collar, a blunt plastic cannula, a male luer with a clip, a PRN access cannula, or any other suitable configuration. The flexible tubing 40 is configured to have a fluid resistance optimized for blood collection. The flexible tubing 40 may be directly secured or molded to the container holder 12, or may be connected to the container holder 12 via an appropriate connector.

[0024] 2-5 , in one aspect or embodiment, the access connector 16 is a compact connector 42 having a fluid path configured to reduce the risk of hemolysis. The access connector 16 is directly connected to the vessel holder 12 via a Luer connection or any other suitable connection configuration. In some aspects or embodiments, the access connector 16 and / or the flexible tubing include one of the flow path geometries shown and described in U.S. Patent Application Publication No. 2009 / 0129994, the entirety of which is incorporated herein by reference. In some aspects or embodiments, the vessel holder 12 is directly coupled to the access connector 16 and does not include the flexible tubing 40 or the compact connector 42.

[0025] Referring again to FIGS. 3-5 , in one aspect or embodiment, the adapter 14 is annular and includes a first portion 60 configured to be received within the opening 24 of the container holder 12 and a second portion 62 configured to engage with the second end 22 of the container holder 12. The second portion 62 of the adapter 14 has a larger diameter than the first portion 60 of the adapter 14. The second portion 62 of the adapter 14 engages with a flange 64 extending radially outward from the second end 22 of the container holder 12. The first portion 60 of the adapter is removably connected to the container holder 12 by a press or interference fit. The adapter 14 may be formed from a plastic or elastomeric material. As shown in FIG. 3 , the adapter 14 is configured to receive and engage the neck portion 34 of the collection container 18 when the collection container 18 is in the pre-advance position. In one aspect or embodiment, the adapter 14 is configured to form a seal to maintain sterility within the opening 24 of the container holder 12 when the collection container 18 is in the pre-advance position.

[0026] The collection container 18 is moved from the pre-advance position to the advanced position by axially moving the collection container 18 relative to the container holder 12 such that the neck portion 34 of the collection container 18 is moved further within the opening 24 of the container holder 12 and the needle 26 pierces the septum 38, placing the needle 26 in fluid communication with the collection container 18, as shown in Figure 4. The collection container 18 is moved from the advanced position to the post-collection position by axially moving the collection container 18 away from the container holder 12, as shown in Figure 5. Due to the tapered neck portion 34 of the collection container 18, the adapter 14 is pushed onto the neck portion 34 of the collection container 18 such that the adapter 14 is removed from the container holder 12 when the collection container 18 is moved to the post-collection position.

[0027] Referring to FIG. 6, in one aspect or embodiment, the blood culture sample collection system 10 further includes and is utilized with a vascular access device 70 including a passive diversion portion 72. The vascular access device 70 is in fluid communication with the needle 26. The vascular access device 70 shown in FIG. 6 is a Kurin® blood culture collection set. The passive diversion portion 72 is configured to provide visual confirmation of proper needle placement and to act as a flash chamber for capturing a predetermined volume of blood to minimize contamination of the blood culture sample. The vascular access device 70 includes a butterfly needle 74 for performing a standard venipuncture procedure.

[0028] 7 , in one aspect or embodiment, blood culture sample collection system 10 further includes a vascular access device 80 including an integrated catheter 82 and a vent flow chamber 84, and is utilized with vascular access device 80 in fluid communication with needle 26. Vent flow chamber 84 includes a vent plug 86 and is configured to passively accept a shunt volume to minimize blood culture sample contamination. Access connector 16 of blood culture sample device 10 connects to a needleless connector 88 of integrated catheter 82.

[0029] 8 , in one aspect or embodiment, the blood culture sample collection system 10 further includes a vascular access device 90 including an extension set 92 and a vent flow chamber 94, and is utilized with the vascular access device 90 in fluid communication with the needle 26. The access connector 16 of the blood culture sample collection system 10 is connected to a distal access port 96 of the vascular access device 90. The vent flow chamber 94 includes a vent plug 98 and is configured to passively accept a shunt volume to minimize blood culture sample contamination. The vascular access device 90 may include a conventional needle cannula or a catheter.

[0030] 9, in one aspect or embodiment, the blood culture sample collection system 10 further includes and is utilized with a user-controlled active flow diversion mechanism 100. As shown in FIG. 9, the user-controlled active flow diversion mechanism 100 is a Steripath® blood diversion system commercially available from Magnolia Medical Technologies. The user-controlled active flow diversion mechanism 100 is configured to divert and isolate a predetermined volume of blood to minimize blood culture sample contamination.

[0031] 10 , in one aspect or embodiment, the blood culture sample collection system 10 further includes and is utilized with a blood collection device 110 in fluid communication with the needle 26. The blood collection device 110 may be a PIVO™ blood collection device commercially available from Velano Vascular. In one embodiment, the blood collection device 110 is the same as or similar to the blood collection device shown in U.S. Patent No. 6,223,999, the entirety of which is incorporated herein by reference. The access connector 16 of the blood culture sample collection system 10 is connected to a connector of a fluid pathway 112 of the blood collection device 110. In some aspects or embodiments, the fluid pathway 112 includes a vent flow chamber 114. The vent flow chamber 114 can be automatically or manually vented after the blood collection device 110 is advanced into the patient's vascular system.

[0032] The blood culture sample collection system 10 is configured to enable blood culture sample collection from any existing vascular access device. The blood culture sample collection system 10 is configured to reduce the risk of blood culture sample contamination by providing all of the system's components in a sterile package, including the collection container. The blood culture sample collection system 10 is configured to support a vascular access device with a shunt volume that eliminates the need for waste samples. The blood culture sample collection system 10 is configured to improve workflow by reducing the number of steps to obtain a blood culture sample and reducing the number of connections and disconnections, thereby reducing the potential for contamination during blood draw. The blood culture sample collection system 10 is also configured to provide a system for evacuated tube blood collection immediately after blood culture sample collection, which minimizes hemolysis.

[0033] While the present invention has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is for that purpose only, and that the present invention is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. 1. A blood culture sample collection system comprising: a vessel holder having a first end and a second end disposed opposite the first end, the vessel holder defining an opening and including a needle disposed within the opening; an adapter that engages with the container holder; an access connector in fluid communication with the needle of the vessel holder, the access connector configured to be connected to a vascular access device; a collection container having a first end and a second end disposed opposite the first end; and the collection container comprises: a pre-advance position in which the first end of the collection container is spaced from the needle, the first end of the collection container is received within the opening of the container holder, and the collection container engages an adapter; and an advanced position in which the first end of the collection container is received within the opening of the container holder, the needle is in fluid communication with the collection container, and the collection container is engaged with an adapter; a post-collection position in which the collection container is positioned outside the opening of the container holder.

2. The system of claim 1 , wherein the adapter is engaged with the collection container and is disengaged from the container holder when the collection container is in a post-collection position.

3. The system of claim 1 , wherein the vial holder includes an elastomeric sleeve surrounding the needle.

4. 10. The system of claim 1, wherein the collection container may include a neck portion and a body, the neck portion increasing in diameter in a direction extending from the first end of the collection container to the second end of the collection container.

5. 2. The system of claim 1, wherein the collection container comprises a blood culture sample collection container, the collection container comprising a septum disposed at the first end of the collection container, and the needle pierces the septum when the collection container moves from the pre-advance position to the advanced position.

6. The system of claim 1 , wherein the access connector comprises a luer connector.

7. The system of claim 6 , wherein the access connector is connected to the vessel holder via a flexible tube.

8. The system of claim 1 , wherein the access connector comprises a compact connector having a fluid path configured to reduce the risk of hemolysis.

9. The system of claim 8 , wherein the access connector is directly connected to the vessel holder.

10. 2. The system of claim 1, wherein the adapter is annular and includes a first portion configured to be received within the opening of the vessel holder and a second portion configured to engage with the second end of the vessel holder.

11. The system of claim 10 , wherein the second portion of the adapter has a larger diameter than the first portion of the adapter.

12. The system of claim 4 , wherein more than half of the neck portion of the collection canister is received within the canister holder when the collection canister is in the advanced position.

13. The system of claim 1 , further comprising a vascular access device including a passive shunt portion, the vascular access device in fluid communication with the needle.

14. The system of claim 1 , further comprising a vascular access device including an integrated catheter and ventilator flow chamber, said vascular access device in fluid communication with said needle.

15. The system of claim 1 , further comprising a vascular access device including an extension set and a ventilator flow chamber, the vascular access device in fluid communication with the needle.

16. The system of claim 1 further comprising a user-controlled active flow shunting mechanism.

17. The system of claim 1 , further comprising a blood collection device in fluid communication with the needle.

18. 20. The system of claim 17, further comprising a vent airflow chamber.

Images