Vacuum tube receiver for aspirating blood through a peripheral intravenous catheter

Abstract

A vacuum tube receiver, the vacuum tube receiver comprising: a housing having a proximal end and a distal end and forming a hollow interior, the proximal end forming a proximal opening for receiving a vacuum tube into the hollow interior, the distal end forming an adapter for coupling the vacuum tube receiver to an intravenous system; and a spike extending proximally into the hollow interior, the spike including an opening and forming a blood flow path.

Description

Technical Field

[0001] The present disclosure relates to the field of medical devices. More particularly, the present disclosure relates to a vacuum tube receiver for aspirating blood through a peripheral intravenous catheter. Background Art

[0002] Vacuum tubes, such as BD Vacutainer tubes sold by Becton Dickinson, are commonly used to draw blood from patients. Figure 1 An example of a common vacuum tube 110 and a corresponding vacuum tube receiver 120 is provided. The vacuum tube 110 includes a diaphragm 111 that maintains a vacuum and a cap 112. The vacuum tube receiver 120 includes a housing 121 having a hollow interior 121a and a proximal opening 122 that permits the vacuum tube 110 to be inserted into the interior 121a. A spike 123 surrounded by a shield 123a is located within the interior 121a and extends proximally such that the spike will pierce the diaphragm 111 of the vacuum tube 110. The vacuum tube receiver 120 may also include an adapter 124 at its distal end through which the vacuum tube receiver is connected to an intravenous (IV) system (e.g., via tubing). When the vacuum tube 110 is inserted into the interior 121a such that the spike 123 pierces the diaphragm 111, the vacuum within the vacuum tube 110 will cause blood to flow into the vacuum tube 110.

[0003] Typically, vacuum tubes are used with a dedicated blood collection kit, such as Figure 2 the blood collection kit 200 shown. The blood collection kit 200 includes a vacuum tube receiver 120 and a needle assembly 210 that are fluidly connected via tubing 220. The needle assembly 210 includes a needle adapter 211 and a needle 212. When a patient does not have an intravenous catheter (e.g., when a patient goes to a physician's office to have blood drawn), the blood collection kit 200 is typically used. In other words, the needle 212 must be inserted into the patient's blood vessel for a sufficient length of time to draw blood. For this reason, the needle 212 is typically formed of rigid metal with an upward bevel. In the blood collection kit 200, the length of the tubing 220 can also be selected to provide optimal blood flow characteristics. In short, since the blood collection kit 200 is designed specifically for drawing blood, its characteristics can be adjusted to fill the vacuum tube as quickly as possible while minimizing the risk of hemolysis or other blood cell damage.

[0004] Vacuum tubes are also commonly used to draw blood via a peripheral IV catheter (PIVC), such as Figure 3The PIVC 300 shown. The PIVC 300 includes a catheter adapter 310 and a needle adapter 320. A catheter 311 extends from the catheter adapter, and a needle 321 extends from the needle adapter. The needle 321 is used to insert the catheter 311 into a patient's vasculature, but is then withdrawn so that only the catheter 311 remains in the vasculature. The PIVC 300 typically includes a tubing 330 with one or more adapters 340 that allow various devices (such as a vacuum tube receiver 120) to be connected to the PIVC 300.

[0005] Using a vacuum tube to draw blood from a PIVC creates various problems that do not occur when using a dedicated blood collection kit. For example, unlike the rigid metal needle 212 of the blood collection kit 200, the catheter 311 of the PIVC 300 is typically formed of a flexible plastic, which increases the likelihood that the distally-facing catheter opening may be positioned against the vein wall, thereby restricting blood flow. Additionally, because the diameter of the catheter 311 must be large enough to accommodate the needle 321, the catheter 311 will occlude a larger portion of the vein than the needle 212. Furthermore, since the PIVC 300 is designed to be used with many different systems, it cannot be tailored to provide ideal blood flow characteristics to the vacuum tube. As a result, when a vacuum tube is connected, a significant pressure drop may occur within the vein, which increases the likelihood of hemolysis or other blood cell damage and may even cause the vein to collapse.

[0006] The subject matter claimed herein is not limited to solving any disadvantages only in environments such as those described above or to embodiments that operate only in environments such as those described above. Rather, this background is provided only to illustrate an example technical field in which some of the embodiments described herein may be practiced. Summary of the Invention

[0007] The present disclosure generally relates to a vacuum tube receiver that can be used when drawing blood from a patient. More particularly, in some embodiments, the present disclosure relates to a vacuum tube receiver adapted to be used with a peripheral IV catheter (PIVC).

[0008] In some embodiments, the vacuum tube receiver may include a housing having a proximal end and a distal end and forming a hollow interior. In some embodiments, the proximal end forms a proximal opening for receiving a vacuum tube into the hollow interior. In some embodiments, the distal end forms an adapter for coupling the vacuum tube receiver to an intravascular system. In some embodiments, the vacuum tube receiver includes a spike extending proximally into the hollow interior. In some embodiments, the spike includes an opening and forms a blood flow path.

[0009] In some embodiments, the opening is an elongated opening having a constant width. In some embodiments, the opening is an elongated opening that includes a proximal portion having a width that increases distally, and a distal portion. In some embodiments, the distal portion has a constant width. In some embodiments, the constant width of the distal portion matches the maximum width of the proximal portion.

[0010] In some embodiments, the vacuum tube receiver can include an insertion depth control member that includes a stop member. In some embodiments, the insertion depth control member is coupled to the housing and is configured to move between a retracted position and an inserted position. In some embodiments, when the insertion depth control member is in the inserted position, the stop member limits the insertion of the vacuum tube into the hollow interior such that at least an initial length of the proximal portion extends beyond a septum of the vacuum tube positioned adjacent to the stop member, but prevents the distal portion from extending beyond the septum. In some embodiments, the inserted position is a first inserted position where the stop member only causes the initial length of the proximal portion to extend beyond the septum. In some embodiments, the insertion depth control member is further configured to move between a second inserted position. In some embodiments, when the insertion depth control member is in the second inserted position, the stop member causes an additional length of the proximal portion to extend beyond the septum of the vacuum tube positioned against the stop member, but prevents the distal portion from extending beyond the septum.

[0011] In some embodiments, the spike further includes a second opening that is distally spaced from the opening. In some embodiments, the vacuum tube receiver includes an insertion depth control member that includes a stop member. In some embodiments, the insertion depth control member is coupled to the housing and is configured to move between a retracted position and an inserted position. In some embodiments, when the insertion depth control member is in the inserted position, the stop member limits the insertion of the vacuum tube into the hollow interior such that only the opening of the spike extends beyond the septum of the vacuum tube. In some embodiments, when the insertion depth control member is in the retracted position, the stop member does not limit the insertion of the vacuum tube into the hollow interior such that both the opening and the second opening of the spike extend beyond the septum of the vacuum tube.

[0012] In some embodiments, the vacuum tube receiver includes a flow control member having a shaft inserted into the distal end of the spike and a head located above the distal end of the spike. In some embodiments, the head forms a channel through which blood flows into the spike. In some embodiments, the head is formed of a flexible material such that when the spike pierces the vacuum tube, the head can flex proximally above the distal end of the spike. In some embodiments, when the head flexes proximally, the effective size of the channel is reduced, thereby restricting the flow of blood into the spike.

[0013] In some embodiments, the blood flow path formed by the spike portion is the primary blood flow path. In some embodiments, the vacuum tube receiver includes a secondary blood flow path. In some embodiments, the vacuum tube receiver further includes a plug configured to move from an initial position where the plug blocks the secondary blood flow path to a subsequent position where the plug does not block the secondary blood flow path. In some embodiments, the primary blood flow path is configured to move the plug from the initial position to the subsequent position. In some embodiments, the vacuum tube receiver includes a second spike portion that forms the secondary blood flow path.

[0014] In some embodiments, the vacuum tube receiver includes a vacuum tube having a diaphragm that forms a vacuum seal at the distal end of the vacuum tube and one or more additional diaphragms spaced proximally from the diaphragm. In some embodiments, each additional diaphragm forms a vacuum seal within the vacuum tube. In some embodiments, when the vacuum tube is inserted into the hollow interior of the housing, the length of the spike portion is sufficient to pass through the diaphragm and each of the one or more additional diaphragms.

[0015] In some embodiments, the spike portion extends proximally into the hollow interior a first distance. In some embodiments, the vacuum tube receiver includes a second spike portion that extends proximally into the hollow interior a second distance. In some embodiments, the first distance is greater than the second distance. In some embodiments, the second spike portion also forms a blood flow path.

[0016] In some embodiments, the vacuum tube receiver includes a housing having a proximal end and a distal end and forming a hollow interior. In some embodiments, the proximal end forms a proximal opening for receiving the vacuum tube into the hollow interior. In some embodiments, the distal end forms an adapter for coupling the vacuum tube receiver to an intravenous system. In some embodiments, the vacuum tube receiver includes a first spike portion that extends proximally into the hollow interior. In some embodiments, the first spike portion forms a first blood flow path. In some embodiments, the vacuum tube receiver includes a second spike portion that extends proximally into the hollow interior. In some embodiments, the second spike portion forms a second blood flow path.

[0017] In some embodiments, the first spike portion extends proximally into the hollow interior a first distance and the second spike portion extends proximally into the hollow interior a second distance. In some embodiments, the first distance is greater than the second distance. In some embodiments, the vacuum tube receiver includes a plug configured to move from an initial position where the plug blocks the second blood flow path to a subsequent position where the plug does not block the second blood flow path. In some embodiments, the first spike portion includes an opening that causes a vacuum pressure within the first blood flow path to pull the plug from the initial position to the subsequent position.

[0018] In some embodiments, the vacuum tube receiver includes a housing having a proximal end and a distal end and forming a hollow interior. In some embodiments, the proximal end forms a proximal opening for receiving a vacuum tube into the hollow interior. In some embodiments, the distal end forms an adapter for coupling the vacuum tube receiver to an intravenous system. In some embodiments, the vacuum tube receiver includes a spike extending proximally into the hollow interior. In some embodiments, the spike includes an elongate opening extending along an outer surface of the spike. In some embodiments, the elongate opening has a proximal portion and a distal portion.

[0019] In some embodiments, the vacuum tube receiver includes an insertion depth control member including a stop member. In some embodiments, the insertion depth control member is coupled to the housing and is configured to move between a retracted position and an inserted position. In some embodiments, when the insertion depth control member is in the inserted position, the stop member restricts insertion of the vacuum tube into the hollow interior such that the distal portion of the slotted opening does not extend beyond the diaphragm of the vacuum tube.

[0020] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the drawings. It should also be understood that the embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Accordingly, the following detailed description should not be considered limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The example embodiments will be described and illustrated with additional features and details by using the drawings, in which:

[0022] Figure 1 A prior art vacuum tube and vacuum tube receiver are shown;

[0023] Figure 2 A prior art dedicated blood collection kit is shown;

[0024] Figure 3 A prior art PIVC is shown;

[0025] Figure 4 A vacuum tube receiver configured according to some embodiments is shown;

[0026] Figures 4A to 4C It is shown how the vacuum tube receiver Figure 4 can be used to control flow or regulate pressure when blood is collected in the vacuum tube;

[0027] Figures 5A-5DShows another vacuum tube receiver configured according to some embodiments;

[0028] Figure 6 、 6A and 6B show another vacuum tube receiver configured according to some embodiments;

[0029] Figure 7 Shows another vacuum tube receiver configured according to some embodiments;

[0030] Figure 8 Shows another vacuum tube receiver and corresponding vacuum tube configured according to some embodiments;

[0031] Figure 9 、 9A and 9B show another vacuum tube receiver configured according to some embodiments; and

[0032] Figure 10A and 10B Shows another vacuum tube receiver configured according to some embodiments. Detailed Description

[0033] As used in this disclosure, the term "distal" refers to the portion of a needle or catheter assembly or its components that is relatively farther from the user, and the term "proximal" refers to the portion of a needle or catheter assembly or its components that is relatively closer to the user. As used in this disclosure, the term "user" may refer to a clinician, doctor, nurse, or any other care provider, and may include support staff.

[0034] Figure 4 Shows a vacuum tube receiver 400 configured according to one or more embodiments of the present disclosure. Figures 4A-4C Examples of how the vacuum tube receiver 400 can be used are provided. The vacuum tube receiver 400 includes a housing 401 having a hollow interior 401a and a proximal opening 402 through which a vacuum tube, such as vacuum tube 110, can be inserted. The vacuum tube receiver 400 further includes an adapter 403 through which the vacuum tube receiver 400 can be connected to a PIVC, such as PIVC 300, or to another IV system. Although the adapter 403 is depicted as a Luer lock adapter, any other type of adapter can be used on the vacuum tube receiver 400. The vacuum tube receiver 400 further includes a spike 410 that is typically surrounded by a shield 404.

[0035] To enable the user to control the flow rate and / or pressure during blood collection, the spike portion 410 has an elongated opening 411 (which may be in the form of a slot through the outer surface of the spike portion 410). More particularly, the elongated opening 411 includes a proximal portion 411a positioned toward the proximal end 410a of the spike portion 410 and a distal portion 411b extending distally along the length of the spike portion 410. In some embodiments, the proximal portion 411a and the distal portion 411b may have the same constant width. In other embodiments, such as Figure 4 shown, the proximal portion 411a may have a width that increases distally, while the distal portion 411b may have a constant width that matches the maximum width of the proximal portion 411a. In other words, the width of the elongated opening 411 is initially small, but gradually increases along the proximal portion 411a until it reaches and remains at its maximum width along the distal portion 411b. However, in some embodiments, the width of the elongated opening 411 may also increase along the distal portion 411b. Thus, at least a portion of the elongated opening 411 may be configured to have a width that increases distally.

[0036] Figures 4A-4C Illustrated how the elongated opening 411 enables the user to control the flow rate of blood entering the vacuum tube 110 and / or the pressure downstream of the vacuum tube 110 during blood drawing. In Figure 4A , the user has inserted the vacuum tube 110 into the vacuum tube receiver 400 such that the spike portion 410 pierces the shield 404 and the septum 111. As shown, at this minimum insertion level, the vacuum tube 110 is inserted only far enough so that the initial length of the proximal portion 411a extends beyond the septum 111. Thus, the effective hydraulic diameter will be small, thereby minimizing the surge of blood flowing into the vacuum tube 110 and / or preventing a sharp pressure drop within the patient's vasculature. The effective hydraulic diameter can be minimized by configuring the proximal portion 411a to have an increasing width distally, but there will still be a small initial effective hydraulic diameter when the proximal portion 411a is configured to have a constant width.

[0037] Figure 4B Illustrated that the user has inserted the vacuum tube 110 such that all of the proximal portion 411a is positioned beyond the septum 111, but the distal portion 111b is still blocked by the septum 111. At this intermediate insertion level, the effective hydraulic diameter will increase only due to the insertion depth of the elongated opening 411. Additionally, by configuring the proximal portion 411a to have an increasing width distally, the increase in the effective hydraulic diameter will be more gradual. Figure 4C Illustrated that the user has inserted the vacuum tube 110 such that most (or all) of the distal portion 111b extends beyond the septum 111. At this maximum insertion level, the effective hydraulic diameter will be maximized.

[0038] Figures 4A-4C can represent different positions where a vacuum tube can be inserted when drawing blood from a specific type of IV system. For example, when drawing blood from a PIVC, the user can insert the vacuum tube 100 only to the Figure 4A position shown, or insert it to the Figure 4B position shown, but when drawing blood from a dedicated blood collection kit, the user can insert the vacuum tube 100 to the Figure 4C position shown. Additionally or alternatively, Figures 4A-4C can represent a series of positions during a single blood draw. For example, when drawing blood through a PIVC, the user can intentionally insert the vacuum tube 100 gradually from the Figure 4A position shown to the Figure 4B position shown, so that when drawing blood from the PIVC, the flow rate gradually increases and the pressure difference between the vacuum tube 110 and the patient's vasculature decreases correspondingly. Similarly, when drawing blood through a dedicated blood collection kit, the user can intentionally insert the vacuum tube 100 gradually from the Figure 4A position shown to the Figure 4C position shown.

[0039] Figures 5A-5D Illustrates a vacuum tube receiver 500 configured in accordance with one or more embodiments of the present disclosure. The vacuum tube receiver 500 can be similar to the vacuum tube receiver 400, but includes an insertion depth control member 520. The insertion depth control member 520 can include a stop member 521 and an actuating member 522. The stop member 521 can be positioned adjacent to the distal side wall 401b of the housing 401 and can be configured to slide or otherwise move into the hollow interior 401a of the housing 401 when the insertion depth control member 520 is in the inserted position. Conversely, when the insertion depth control member 520 is in the retracted position, the stop member 521 can be withdrawn from the hollow interior 401a. The actuating member 522 can be positioned outside the housing 401 (or at least accessible from the outside of the housing 401) to allow the user to selectively position the insertion depth control member 520 in the retracted position and the inserted position.

[0040] Figure 5A and 5B Illustrates the vacuum tube receiver 500 when the insertion depth control member 520 is in the retracted position. As shown, the actuating member 522 is spaced apart from the housing 401 such that the stop member 521 is withdrawn from the hollow interior 401a. As Figure 5B shown, since the stop member 521 is not positioned within the hollow interior 401a, the vacuum tube 110 can be inserted into the vacuum tube receiver 500 until it contacts the distal side wall 401b. In embodiments where the vacuum tube receiver 500 includes a spike portion 410,Figure 5B may correspond to Figure 4C Thus, when the vacuum tube receiver 500 is used to draw blood from a dedicated blood collection kit, the insertion depth control member 520 may be in the retracted position to allow the vacuum tube 110 to be inserted to the maximum level.

[0041] Relatively,[ Figure 5C and 5D FIG. shows the vacuum tube receiver 500 when the insertion depth control member 520 is in the inserted position. As shown, the actuating member 522 is positioned against (or near) the housing 401 such that the stop member 521 is inserted into the hollow interior 401a. As Figure 5D shown, the cap 112 of the vacuum tube 110 will contact the stop member 521, thereby restricting the distance that the vacuum tube 110 can be inserted into the vacuum tube receiver 500. In an embodiment where the vacuum tube receiver 500 includes a spike portion 410, Figure 5D may correspond to Figure 4A or Figure 4B Thus, when the vacuum tube receiver 500 is to be used to draw blood from a PIVC, the insertion depth control member 520 may be in the inserted position to prevent the vacuum tube 110 from being inserted beyond the minimum level or the intermediate level.

[0042] In some embodiments, the insertion depth control member 520 may be configured to limit the insertion of the vacuum tube 100 to other depths. For example, the stop member 521 may include multiple surfaces corresponding to the insertion levels shown in Figure 4A and 4B As just one example, when the actuating member 522 is in the first position, the first surface of the stop member 521 may allow insertion to the intermediate level shown in Figure 4B and when the actuating member 522 is in the second position, the second surface of the stop member 521 may allow insertion to the minimum level shown in Figure 4C In such an embodiment, the user may actuate the insertion depth control member 520 to a specific level based on the characteristics of the PIVC or other IV system. For example, due to the specifications, length, position, etc. of the PIVC, inserting the vacuum tube 110 to the intermediate level shown in Figure 4B instead of the minimum level shown in Figure 4A may be optimal.

[0043] In some embodiments, the user can adjust the insertion depth control member 520 during blood draw. For example, when using a PIVC, the user can initially place the insertion depth control member 520 in the insertion position to prevent the vacuum tube 110 from being inserted beyond the minimum level. Then, once blood flow has started and the pressure differential has decreased to an appropriate level, the user can shift the insertion depth control member 520 to the intermediate position or the withdrawn position so that the vacuum tube 110 can be inserted further, which will in turn increase the blood flow rate to minimize the collection time.

[0044] Figure 6 , 6A Figures 6A and 6B illustrate a vacuum tube receiver 600 configured in accordance with one or more embodiments of the present disclosure. The vacuum tube receiver 600 is similar to the vacuum tube receiver 400 but incorporates a spike 610. The spike 610 includes a proximal opening 611 positioned at the proximal end of the spike 610 and a distal opening 612 spaced from the proximal opening 611. As Figure 6A shown, the vacuum tube 110 can be inserted into the vacuum tube receiver 600 to the minimum level, which will cause the proximal opening 611 to be positioned beyond the septum 111 and the distal opening 612 not to be positioned beyond the septum 111. In contrast, Figure 6B illustrates that the vacuum tube 110 has been inserted to the maximum level, which causes both the proximal opening 611 and the distal opening 612 to be positioned beyond the septum 111.

[0045] When using the vacuum tube receiver 600 to draw blood through a PIVC, the vacuum tube 110 can be inserted to the Figure 6A lowest level shown to minimize the flow rate and prevent a sharp drop in pressure in the patient's vasculature. In some embodiments, the vacuum tube receiver 600 may also include an insertion depth control member 520 to enable the user to prevent the vacuum tube 110 from being inserted beyond this minimum level. Similarly, when the vacuum tube receiver 600 is used to draw blood through a dedicated blood collection kit, the vacuum tube 110 can be inserted to the Figure 6B maximum level shown. Moreover, in some embodiments, when using the vacuum tube receiver 600 to draw blood through a PIVC, the user can first insert the vacuum tube 110 to the minimum level and then, after the pressure differential has decreased, insert the vacuum tube 110 to the maximum level to increase the flow rate and reduce the collection time.

[0046] Figure 7Shows a vacuum tube receiver 700 configured in accordance with one or more embodiments of the present disclosure. The vacuum tube receiver 700 is similar to the vacuum tube receiver 400, but employs two spike portions 710a, 710b. As shown, the spike portion 710a extends further proximally than the spike portion 710b. Thus, when the vacuum tube 110 is inserted into the vacuum tube receiver 700, the spike portion 710a will first pierce the septum 111, thereby allowing blood to initially flow only through the spike portion 710a. Then, when the vacuum tube 110 is further inserted into the vacuum tube receiver 700, the spike portion 710b will pierce the septum 111, thereby allowing blood to flow through both the spike portion 710a and the spike portion 710b. In some embodiments, the specification of the spike portion 710a may be larger than the specification of the spike portion 710b to minimize the initial flow rate of blood. Alternatively, the opening or inner diameter of the spike portion 710a may be smaller than the opening or inner diameter of the spike portion 710b to minimize the initial flow. In any case, the use of the spike portions 710a and 710b ensures that the initial flow rate and pressure drop can be controlled while maintaining the ability to obtain higher flow rates subsequently. In some embodiments, the vacuum tube receiver 700 may include an insertion depth control member 520 that can be used to prevent the spike portion 710b from passing beyond the septum 111 when the vacuum tube receiver 700 is used for blood drawing through a PIVC.

[0047] Figure 8Shows a vacuum tube receiver 800 and a corresponding vacuum tube 850 configured according to one or more embodiments of the present disclosure. The vacuum tube receiver 800 is similar to the vacuum tube receiver 400, but includes a longer spike portion 810. The vacuum tube 850 includes a diaphragm 851, which may be similar to the diaphragm 111, but also includes additional diaphragms 852a - 852c spaced apart within the vacuum tube 850 to create a plurality of vacuum pocket portions 853a - 853d. When the vacuum tube 850 is inserted into the vacuum tube receiver 800, the spike portion 810 will first pierce the diaphragm 851, allowing blood to flow into the vacuum pocket portion 853a. Since the volume of the vacuum pocket portion 853a is relatively small compared to the overall volume of the vacuum tube 850, a smaller pressure drop will occur once the spike portion 810 penetrates the diaphragm 851 than would occur if the vacuum tube 850 included only the diaphragm 851. As the vacuum tube 850 is further inserted, the spike portion 810 will sequentially pierce the diaphragms 852a and 852b. Again, due to the small volumes of the vacuum pocket portions 853b and 853c, a smaller pressure drop will occur again. Finally, the spike portion 810 will pass through the diaphragm 852c, causing blood to flow into the vacuum pocket portion 853d. Although the volume of the vacuum pocket portion 853d is larger than that of the other vacuum pocket portions, due to the spike portion 810 passing through the vacuum pocket portions 853a - 853c, the pressure difference will gradually decrease, so there will be no sharp drop in pressure. Although the shown vacuum tube 850 has three additional diaphragms, in some embodiments, the vacuum tube 850 may have one additional diaphragm, two additional diaphragms, or more than three additional diaphragms.

[0048] Figure 9 Shows a vacuum tube receiver 900 configured according to one or more embodiments of the present disclosure. The vacuum tube receiver 900 is similar to the vacuum tube receiver 400, but after blood begins to flow through the main flow path, a plug 911 is employed to provide a secondary flow path. As shown, the vacuum tube receiver 900 includes a first spike portion 910a that defines the main flow path and a second spike portion 910b that defines the secondary flow path. The plug 911 is received within a channel 912 and is initially positioned within the secondary flow path such that no blood will initially flow through the spike portion 910b. The channel 912 is connected to the main flow path through an opening 912a in the spike portion 910a.

[0049] As Figure 9A shown, when the vacuum tube 110 is inserted into the vacuum tube receiver 900, the spike portions 910a and 910b will pierce the diaphragm 111, allowing blood to flow into the vacuum tube 110. With the plug 911 in its initial position, the flow of blood will be restricted to the main flow path through the spike portion 910a. However, due to the vacuum within the vacuum tube 110, the plug 911 will be pulled towards the opening 912a and will eventually reach Figure 9Bto the position shown, thereby opening a second flow path through the spike portion 910b. The plug 911 and / or the channel 912 can be configured to impede movement of the plug 911 toward the opening 912a, so that when the septum 111 is pierced, the secondary flow path is not immediately opened. This can minimize the pressure drop compared to the case where both flow paths are immediately opened. In some embodiments, the secondary flow path can be established using only the spike portion 910a. Such an embodiment would be substantially the same as Figure 9 that shown, except that the secondary flow path would connect back to the spike portion 910a instead of forming a separate spike portion 910b.

[0050] FIG. 10 shows a vacuum tube receiver 1000 configured in accordance with one or more embodiments of the present disclosure. The vacuum tube receiver 1000 is similar to the vacuum tube receiver 400, but employs a flow control member 1020 inserted into the distal end of the spike portion 1010. The flow control member 1020 is configured to minimize the pressure drop and flow that initially occur when the vacuum tube 110 is inserted into the vacuum tube receiver 1000, while also allowing the flow to increase, thereby minimizing the collection time.

[0051] Figure 10A A detailed view of the flow control member 1020 is provided. As shown, the flow control member 1020 includes a shaft 1021 inserted into the distal end of the spike portion 1010 such that the head 1022 is located above the distal opening of the spike portion 1010. The head 1022 has a mushroom shape with a concave proximal-facing surface 1022a and a convex distal-facing surface 1022b. The edge of the head 1022 includes alternating extension portions 1023 and channels 1024. The extension portions 1023 can be positioned against the inner wall surrounding the spike portion 1010 such that blood flows through the channels 1024 into the spike portion 1010.

[0052] When the spike portion 1010 is initially inserted into the vacuum tube 110, the vacuum will pull the flow control member 1020 in the proximal direction. Due to its mushroom shape, the head 1022 will flex proximally, thereby reducing the effective size of the channels 1024, which limits the flow of blood and minimizes the pressure drop that occurs in the patient's vasculature. As the pressure differential gradually decreases, the vacuum force acting on the flow control member 1020 will likewise decrease. This decrease in the vacuum force will allow the head 1022 to return to its normal shape, which increases the effective size of the channels 1024, thereby increasing the flow of blood. Thus, the flow control member 1020 minimizes the initial pressure drop without sacrificing subsequent flow.

[0053] All of the examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the invention and the concepts that the inventors used to further the art, and are to be construed as not being limited to such specifically recited examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made thereto without departing from the spirit and scope of the invention. It should be understood that the embodiments can be combined.

Claims

1. A vacuum tube receiver, characterized in that, The vacuum tube receiver includes: a housing having a proximal end and a distal end and forming a hollow interior, the proximal end forming a proximal opening for receiving a vacuum tube into the hollow interior, and the distal end forming an adapter for coupling the vacuum tube receiver to an intravenous system; a spike extending proximally into the hollow interior, the spike including an opening and forming a blood flow path; and an insertion depth control member including a stop member, the insertion depth control member being coupled to the housing and configured to move between a retracted position and an inserted position, wherein when the insertion depth control member is in the inserted position, the stop member limits insertion of the vacuum tube into the hollow interior, wherein the stop member is positioned adjacent to the distal wall of the housing and is configured to move into the hollow interior of the housing when the insertion depth control member is in the inserted position and to be withdrawn from the hollow interior when the insertion depth control member is in the retracted position.

2. The vacuum tube receiver according to claim 1, characterized in that, The opening of the spike is an elongated opening having a constant width.

3. The vacuum tube receiver according to claim 1, characterized in that, The opening of the spike is an elongated opening including a proximal portion having a width increasing distally and a distal portion.

4. The vacuum tube receiver according to claim 3, wherein, The distal portion has a constant width matching the maximum width of the proximal portion.

5. The vacuum tube receiver according to claim 1, characterized in that, When the insertion depth control member is in the inserted position, the stop member causes at least an initial length of the proximal portion to extend beyond a diaphragm of the vacuum tube positioned against the stop member, but prevents the distal portion from extending beyond the diaphragm.

6. The vacuum tube receiver according to claim 5, characterized in that, The inserted position is a first inserted position in which the stop member causes only an initial length of the proximal portion to extend beyond the diaphragm, and wherein the insertion depth control member is further configured to move between the first inserted position and a second inserted position, wherein when the insertion depth control member is in the second inserted position, the stop member causes an additional length of the proximal portion to extend beyond the diaphragm of the vacuum tube positioned against the stop member, but prevents the distal portion from extending beyond the diaphragm.

7. The vacuum tube receiver according to claim 1, characterized in that, The spike further includes a second opening spaced distally from the opening of the spike.

8. The vacuum tube receiver according to claim 7, characterized in that, When the insertion depth control member is in the inserted position, the stop member limits insertion of the vacuum tube into the hollow interior such that only the opening of the spike extends beyond the diaphragm of the vacuum tube, and when the insertion depth control member is in the retracted position, the stop member does not limit insertion of the vacuum tube into the hollow interior such that both the opening of the spike and the second opening extend beyond the diaphragm of the vacuum tube.

9. The vacuum tube receiver according to claim 1, characterized in that, The vacuum tube receiver further includes: a flow control member having a shaft inserted into the distal end of the spike and a head located above the distal end of the spike, the head forming a channel through which blood flows to enter the spike.

10. The vacuum tube receiver according to claim 9, characterized in that, The head is formed of a flexible material such that when the spike portion pierces the vacuum tube, the head is capable of flexing in a proximal direction above the distal end of the spike portion, wherein as the head flexes in the proximal direction, the effective size of the channel decreases, thereby restricting blood flow into the spike portion.

11. The vacuum tube receiver according to claim 1, wherein, The blood flow path formed by the spike portion is the primary blood flow path, and the vacuum tube receiver further comprises: a secondary blood flow path; and a plug configured to move from an initial position in which the plug blocks the secondary blood flow path to a subsequent position in which the plug does not block the secondary blood flow path, wherein the primary blood flow path is configured to cause the plug to move from the initial position to the subsequent position.

12. The vacuum tube receiver according to claim 11, wherein The vacuum tube receiver further comprises: a second spike portion forming the secondary blood flow path.

13. The vacuum tube receiver according to claim 1, characterized in that, The vacuum tube receiver further comprises: a vacuum tube having a diaphragm forming a vacuum seal at the distal end of the vacuum tube and one or more additional diaphragms spaced proximally from the diaphragm, each of the additional diaphragms forming a vacuum seal within the vacuum tube; wherein when the vacuum tube is inserted into the hollow interior of the housing, the length of the spike portion is sufficient to penetrate each of the diaphragm and the one or more additional diaphragms.

14. The vacuum tube receiver according to claim 1, characterized in that, The spike portion extends proximally into the hollow interior by a first distance, and the vacuum tube receiver further comprises: a second spike portion extending proximally into the hollow interior by a second distance, the first distance being greater than the second distance, and the second spike portion also forming a blood flow path.

15. A vacuum tube receiver, characterized in that, The vacuum tube receiver comprises: a housing having a proximal end and a distal end and forming a hollow interior, the proximal end forming a proximal opening for receiving a vacuum tube into the hollow interior, and the distal end forming an adapter for coupling the vacuum tube receiver to an intravenous system; a first spike portion extending proximally into the hollow interior, the first spike portion forming a first blood flow path; a second spike portion extending proximally into the hollow interior, the second spike portion forming a second blood flow path; and an insertion depth control member including a stop member, the insertion depth control member being coupled to the housing and configured to move between a retracted position and an inserted position, wherein when the insertion depth control member is in the inserted position, the stop member restricts insertion of the vacuum tube into the hollow interior, wherein the stop member is positioned adjacent to the distal wall of the housing and is configured to move into the hollow interior of the housing when the insertion depth control member is in the inserted position and to be withdrawn from the hollow interior when the insertion depth control member is in the retracted position, wherein the vacuum tube receiver further comprises: A plug configured to move from an initial position where the plug blocks the second blood flow path to a subsequent position where the plug does not block the second blood flow path, wherein the first spike includes an opening that creates a vacuum pressure inside the first blood flow path to pull the plug from the initial position to the subsequent position.

16. A vacuum tube receiver, characterized in that, The vacuum tube receiver includes: A housing having a proximal end and a distal end and forming a hollow interior, the proximal end forming a proximal opening to receive a vacuum tube into the hollow interior, the distal end forming an adapter for coupling the vacuum tube receiver to an intravenous system; A spike extending proximally into the hollow interior, the spike including an elongate opening extending along an outer surface of the spike, the elongate opening having a proximal portion and a distal portion; and An insertion depth control member including a stop member, the insertion depth control member being coupled to the housing and configured to move between a retracted position and an inserted position, wherein when the insertion depth control member is in the inserted position, the stop member limits insertion of the vacuum tube into the hollow interior such that the distal portion of the elongate opening of the slotted spike does not extend beyond the septum of the vacuum tube. Wherein the stop member is positioned adjacent to the distal sidewall of the housing and is configured to move into the hollow interior of the housing when the insertion depth control member is in the inserted position and to be withdrawn from the hollow interior when the insertion depth control member is in the retracted position.

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