Blood collection system and blood collection tube holder

Abstract

The present disclosure relates to a blood collection system and a blood collection tube holder. The blood collection system includes a needle configured to receive a vacuum blood collection tube, an adapter configured to couple to a catheter assembly, and a flow regulator disposed between the needle and the adapter and configured to regulate flow through a fluid passageway extending between the needle and the adapter. The flow regulator can be adjusted to reduce an inner diameter of a portion of the fluid passageway extending through the flow regulator. The reduced blood flow resulting from the reduction in the inner diameter and restriction of the fluid passageway can reduce the risk of hemolysis. The reduced blood flow can also reduce the risk of vein and / or catheter collapse.

Description

Technical Field

[0001] This disclosure relates to medical devices, and more particularly, to a blood collection system with user-adjustable pressure management, as well as related apparatus and methods. Background Technology

[0002] Intravenous catheters are commonly used for various infusion therapies. For example, they can be used to administer infusion fluids such as saline solution, various medications, and total parenteral nutrition. Intravenous catheters can also be used to draw blood from patients.

[0003] Common types of intravenous catheters include peripherally inserted intravenous catheters (“PIVCs”), peripherally inserted central catheters (“PICCs”), and midline catheters. Intravenous catheters can include “needle-mounted” catheters, which can be mounted on a needle with a sharp distal tip. The sharp distal tip is used to puncture the patient’s skin and vascular system. Insertion of the intravenous catheter into the vascular system can be performed after the needle has punctured the vascular system. The needle and intravenous catheter are typically inserted into the patient’s vascular system through the skin at a shallow angle, with the bevel of the needle facing upwards and away from the patient’s skin.

[0004] To verify that the guide needle and / or intravenous catheter are correctly positioned within the vascular system, the user typically needs to confirm that a flashback of blood is present and visible to the user. In some cases, the guide needle may include a notch positioned distal to the guide needle, and in response to the distal end of the guide needle being positioned within the vascular system, blood can flow proximally through the needle lumen, exit the needle lumen through the notch, and then travel proximally between the outer surface of the guide needle and the inner surface of the intravenous catheter.

[0005] Therefore, when the intravenous catheter is at least partially transparent, the user can see a small amount of blood "flashback," confirming that the intravenous catheter is placed within the vascular system. The presence of vascular system ingress indicators (such as flashbacks) can aid in successful intravenous catheter placement. Once the guide needle has been confirmed to be in place within the vascular system, the user can temporarily block flow in the vascular system and withdraw the guide needle, leaving the intravenous catheter in place for subsequent blood draws and / or fluid infusions.

[0006] Vacuum blood collection tubes are used for blood collection. A vacuum blood collection tube consists of a test tube with a rubber stopper at one end. All or part of the air has been removed from the test tube, so the pressure inside the vacuum blood collection tube is lower than ambient pressure. This type of vacuum blood collection tube is often called an internal vacuum tube or a vacuum tube. A commonly used vacuum blood collection tube is the VACUTAINER vacuum blood collection tube, which is available from Beckton Dickinson.

[0007] To collect a blood sample from a patient, the user first inserts a needle or intravenous catheter into the patient's vein. An adapter connects to the needle or intravenous catheter. The adapter includes an additional needle that punctures the rubber stopper of the vacuum blood collection tube. When the rubber stopper is punctured, the pressure in the vein is higher than the pressure in the vacuum blood collection tube, which pushes blood into the tube, filling it with blood. As the tube fills, the vacuum decreases until the pressure inside the tube equals the pressure in the vein, at which point blood flow stops.

[0008] Unfortunately, when blood is drawn into the vacuum blood collection tube, the red blood cells are under high shear stress and prone to hemolysis due to the high initial pressure difference between the vein and the tube. Hemolysis can lead to the rejection and disposal of the blood sample. The high initial pressure difference can also cause catheter tip collapse, vein collapse, or other complications that prevent or limit blood from filling the vacuum blood collection tube.

[0009] The subject matter claimed herein is not limited to solutions to any drawbacks or embodiments that operate only in environments such as those described above. Rather, this background art merely illustrates an example technical field in which some of the embodiments described herein can be practiced. Summary of the Invention

[0010] This disclosure generally relates to a blood collection system with user-adjustable pressure management, and related apparatus and methods. In some embodiments, the blood collection system may include a needle for receiving a vacuum blood collection tube. In some embodiments, the blood collection system may include a blood collection tube receiver that may surround the needle. In some embodiments, the blood collection system may include an adapter for coupling to a catheter assembly. In some embodiments, the blood collection system may include a flow regulator disposed between the needle and the adapter. In some embodiments, the flow regulator may be used to regulate the flow rate through a fluid passage of the blood collection system that may extend between the needle and the adapter.

[0011] In some embodiments, an adapter may be coupled to a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter, the catheter adapter including a distal end, a proximal end, and an inner lumen extending through the distal end and the proximal end of the catheter adapter. In some embodiments, the catheter assembly may include a catheter extending distally from the distal end of the catheter adapter. In some embodiments, the catheter may be inserted into a patient's vein.

[0012] In some embodiments, the flow regulator can be adjusted to reduce the inner diameter of the portion of the fluid passage extending through the flow regulator, such that the inner diameter of said portion is smaller than the inner diameter of the catheter. In some embodiments, after adjusting the flow regulator to reduce the inner diameter of said portion of the fluid passage, a needle can be inserted into the vacuum blood collection tube. In some embodiments, when the vacuum blood collection tube is coupled to a blood collection system, blood can flow more slowly than in other cases due to the reduced inner diameter and the restriction of the fluid passage. When the vacuum blood collection tube is coupled to a blood collection system, the high pressure difference between the vacuum blood collection tube and the vein typically creates a risk of hemolysis. However, in some embodiments, the reduced blood flow due to the reduced inner diameter and the restriction of the fluid passage can reduce the risk of hemolysis. In some embodiments, the reduced blood flow can also reduce the risk of vein and / or catheter collapse.

[0013] In some embodiments, as the vacuum blood collection tube fills with blood, the vacuum within the tube decreases, and the pressure difference between the tube and the vein decreases. In some embodiments, the reduced pressure difference may cause the tube to fill more slowly over time. In some embodiments, in response to the partial filling of the tube, a flow regulator may be adjusted to increase the extension of the fluid passage through its inner diameter, thereby increasing blood flow and accelerating blood collection. In some embodiments, the extension of the fluid passage through the flow regulator may be increased to a diameter greater than the inner diameter of the catheter when a needle is inserted into the tube. In some embodiments, the extension of the fluid passage through the flow regulator may be increased to a diameter equal to (or greater than) the inner diameter of the catheter.

[0014] In some embodiments, the flow regulator may include a rotating element. In some embodiments, in response to the rotating element being in a first position, a portion of the fluid passage of the blood collection system may extend through the rotating element. In some embodiments, in response to the rotating element rotating from the first position to a second position, the diameter of the portion of the fluid passage extending through the rotating element may change. In some embodiments, the rotating element may include one or more orifices for alignment with the fluid passage of the blood collection system. In some embodiments, each orifice may have a different diameter.

[0015] In some embodiments, the rotating element may include a curved slot extending through the rotating element. In some embodiments, the entire curved slot may be used for alignment with the fluid passage of a blood collection system. In some embodiments, the width of the curved slot may increase continuously, such that the fluid flow rate through the rotating element changes continuously as the rotating element rotates.

[0016] In some embodiments, the flow regulator may include a stop valve, a squeeze valve, or a slide valve. In some embodiments, the slide valve may include a housing and a body slidable relative to the housing between a first position and a second position. In some embodiments, the housing may include a first end, a second end, and an inner cavity extending through the first end and the second end. In some embodiments, the first end of the housing may include an opening. In some embodiments, the outer surface of the body may include one or more channels. In some embodiments, in response to the body being in the first position, blood flows through the gap between the outer surface of the body and the housing and through the opening. In some embodiments, in response to the housing being in the second position, blood flows through at least one channel and through the opening, but may not flow through the gap.

[0017] In some embodiments, the blood collection system may include a tubing that extends between an adapter and a needle. In some embodiments, the flow regulator may include a clamp disposed on the tubing. In some embodiments, the clamp on the tubing may include a roller clamp or a sliding clamp. In some embodiments, the inner surface of the tubing may include one or more ribs that may extend substantially parallel to the longitudinal axis of the tubing.

[0018] In some embodiments, the sliding clamp may include a housing, the housing including a slot. In some embodiments, the sliding clamp may include a body extending through the slot. In some embodiments, the body may slide relative to the housing between a first position and a second position. In some embodiments, the bottom of the body may include a first surface, a second surface, and a third surface disposed between the first and second surfaces. In some embodiments, the first and second surfaces may be substantially parallel to the longitudinal axis of the pipe. In some embodiments, the third surface may be at an angle relative to the longitudinal axis of the pipe. In some embodiments, the second surface may be closer to the pipe than the first surface.

[0019] In some embodiments, the sliding clamp may include a roller pin disposed between the body and the fitting. In some embodiments, in response to the body being in a first position, the roller pin may contact a first surface and the fitting. In some embodiments, in response to the body sliding from the first position to a second position, the roller pin moves along a third surface from the first surface to the second surface, reducing the fluid flow rate through the fitting.

[0020] In some embodiments, a specific blood collection tube holder may include one or more of the following: a needle for receiving a vacuum collection tube; a cavity; a fitting disposed within the cavity and in fluid communication with the needle; a button disposed within the cavity; and a spring. In some embodiments, the button may include an opening extending through the button. In some embodiments, the button may include a rib proximate to the opening. In some embodiments, the fitting may extend through the opening.

[0021] In some embodiments, a spring may be disposed between the button and the wall of the cavity. In some embodiments, the spring may bias a rib against the tube to compress it. In some embodiments, the tube may not be compressed in response to pressing the button and compressing the spring.

[0022] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and functions shown in the accompanying drawings. It should also be understood that these embodiments may be combined, other embodiments may be utilized, and structural changes may be made (unless so claimed). Therefore, the following detailed description should not be considered limiting. Attached Figure Description

[0023] With the use of the accompanying drawings, exemplary embodiments will be described and illustrated with additional features and details, wherein:

[0024] Figure 1A This is a top perspective view of an exemplary blood collection system according to some embodiments.

[0025] Figure 1B This is a cross-sectional view of a blood collection system according to some embodiments, showing an exemplary rotating element in a first position.

[0026] Figure 1C This is a cross-sectional view of a blood collection system according to some embodiments, showing an exemplary rotating element in a second position.

[0027] Figure 1D This is a top perspective view of a rotating element according to some embodiments.

[0028] Figure 1E This is a top perspective view of another rotating element according to some embodiments.

[0029] Figure 1F This is a cross-sectional view of a rotating element according to some embodiments.

[0030] Figure 2A This is a top perspective view of a blood collection system according to some embodiments, showing an exemplary roller clamp.

[0031] Figure 2B This is a cross-sectional view of a roller clamp according to some embodiments.

[0032] Figure 2C This is a top perspective view of an exemplary pipe fitting according to some embodiments.

[0033] Figure 3A This is a cross-sectional view of an exemplary slide valve according to some embodiments, showing the body of the slide valve in a first position.

[0034] Figure 3B This is a top perspective view of a slide valve according to some embodiments, showing the body of the slide valve in a first position.

[0035] Figure 3C This is a cross-sectional view of a slide valve according to some embodiments, showing the body of the slide valve in a second position.

[0036] Figure 3D This is a top perspective view of a slide valve according to some embodiments, showing the body of the slide valve in a second position.

[0037] Figure 3E This is a top perspective view of a slide valve according to some embodiments.

[0038] Figure 4A This is a top perspective view of a blood collection system according to some embodiments, showing an exemplary sliding clamp.

[0039] Figure 4B This is a cross-sectional view of a sliding clamp in a first position according to some embodiments.

[0040] Figure 4C This is a cross-sectional view of a sliding clamp in a second position according to some embodiments.

[0041] Figure 5A This is a top perspective view of a blood collection system according to some embodiments, which shows an exemplary stopcock valve.

[0042] Figure 5B This is a cross-sectional view of a plug valve in a first position according to some embodiments.

[0043] Figure 5C This is a cross-sectional view of a plug valve in the second position according to some embodiments.

[0044] Figure 5D This is a cross-sectional view of a plug valve according to some embodiments.

[0045] Figure 6A This is a top perspective view of a blood collection system according to some embodiments, showing an exemplary pinch clamp.

[0046] Figure 6B This is a cross-sectional view of a clamping fixture in a first position according to some embodiments.

[0047] Figure 6C This is a cross-sectional view of a clamping fixture in a second position according to some embodiments.

[0048] Figure 6D This is a cross-sectional view of a clamping fixture according to some embodiments.

[0049] Figure 7A This is a top perspective view of another blood collection system according to some embodiments.

[0050] Figure 7B This is a cross-sectional view of another blood collection system according to some embodiments.

[0051] Figure 8A This is a top perspective view of another blood collection system according to some embodiments.

[0052] Figure 8B This is a lower perspective view of an exemplary blood collection tube holder according to some embodiments.

[0053] Figure 8C This is a side view of a blood collection tube holder according to some embodiments.

[0054] Figure 8D This is another side view of a blood collection tube holder according to some embodiments.

[0055] Figure 8E According to some embodiments, the blood collection tube holder is along Figure 8C Sectional view of line 8E-8E.

[0056] Figure 8F According to some embodiments, the blood collection tube holder is along Figure 8D The sectional view along line 8F-8F shows an exemplary button in the first position.

[0057] Figure 8G According to some embodiments, the blood collection tube holder is along Figure 8D The sectional view along line 8F-8F shows the button in the second position.

[0058] Figure 8H This is a top perspective view of a button according to some embodiments.

[0059] Figure 8I This is a lower perspective view of an example body of a blood collection holder according to some embodiments.

[0060] Figure 8JThis is a lower perspective view of an exemplary tube and an exemplary pin connected to the tube according to some embodiments. Detailed Implementation

[0061] Now for reference Figure 1A-1D In some embodiments, the blood collection system 10 may include a needle 12 for receiving a vacuum blood collection tube. In some embodiments, the blood collection system 10 may include a blood collection tube receiver 14 that may surround the needle 12. In some embodiments, the blood collection system 10 may include an adapter 16 for coupling to a catheter assembly 18. In some embodiments, the blood collection system 10 may include a flow regulator 20 disposed between the needle 12 and the adapter 16. In some embodiments, the flow regulator 20 may be used to regulate the flow rate through a fluid passage 22 of the blood collection system 10 that may extend between the needle 12 and the adapter 16.

[0062] In some embodiments, adapter 16 may be coupled to catheter assembly 18. In some embodiments, adapter 16 may include a Luer adapter, which may include a Luer lock or a Luer slide connector. In some embodiments, the Luer adapter may include a male Luer connector or a female Luer connector. In some embodiments, catheter assembly 18 may include catheter adapter 24, which may include a distal end 26, a proximal end 28, and an inner lumen 30 extending through the distal end 26 and the proximal end 28 of catheter adapter 24. In some embodiments, catheter assembly 18 may include a catheter 32 extending distally from the distal end 26 of catheter adapter 24. In some embodiments, catheter 32 may be inserted into a patient's vein. In some embodiments, in response to coupling of adapter 16 to catheter adapter 24, a diaphragm 33 disposed within the inner lumen 30 may be punctured.

[0063] In some embodiments, catheter 32 may include a PIVC, such as BD NEXIVA. TM Closed intravenous catheter system, BDCATHENA TM Catheter system, BD VENFLON TM Pro Safety Shielded Intravenous Catheter System, BD NEOFLON TM Intravenous catheterization system, BD INSYTE TM AUTOGUARD TMA BC-shielded intravenous catheter system or other suitable peripheral intravenous catheter system. In some embodiments, catheter 32 may include a PICC or a midline catheter. In some embodiments, adapter 16 may be coupled to catheter adapter 24 in any number of suitable ways. For example, adapter 16 may be coupled to the distal end 26 of catheter adapter 24. As another example, adapter 16 may be coupled to an extension tube extending outward from catheter adapter 24.

[0064] In some embodiments, a first fitting 34 may extend between an adapter 16 and a flow regulator 20, and a second fitting 36 may extend between the flow regulator 20 and another adapter 38, which may be used for coupling to a needle assembly 40 including a needle 12. In some embodiments, the first fitting 34 and / or the second fitting 36 may increase flexibility and reduce the risk of interference with the insertion site of the catheter 32 into the patient. In some embodiments, the first fitting 34 and / or the second fitting 36 may be coupled to and / or integrated with the flow regulator 20.

[0065] In some embodiments, the flow regulator 20 can be adjusted to reduce the inner diameter of the portion of the fluid passage 22 extending through the flow regulator 20, such that the inner diameter of said portion is smaller than the inner diameter of the conduit 32. In some embodiments, after adjusting the flow regulator 20 to reduce the inner diameter of said portion of the fluid passage 22, the needle 12 can be inserted into a vacuum blood collection tube, which can be evacuated so that the pressure inside the vacuum blood collection tube is lower than ambient pressure or atmospheric pressure.

[0066] In some embodiments, when the vacuum blood collection tube is connected to the blood collection system 10 via the insertion needle 12, blood can flow more slowly than in other cases due to the reduced inner diameter and the restriction of the fluid passage. Typically, the high pressure difference between the vacuum blood collection tube and the vein when connected to the blood collection system poses a risk of hemolysis. However, in some embodiments, the reduced blood flow due to the reduced inner diameter and the restriction of the fluid passage 22 can reduce the risk of hemolysis. In some embodiments, the reduced blood flow can also reduce the risk of vein and / or catheter 32 collapse.

[0067] In some embodiments, as the vacuum blood collection tube is filled with blood, the vacuum within the vacuum blood collection tube decreases, and the pressure difference between the vacuum blood collection tube and the vein decreases. In some embodiments, the reduced pressure difference may cause the vacuum blood collection tube to fill more slowly over time. In some embodiments, in response to the vacuum blood collection tube being partially filled with blood, the flow regulator 20 may be adjusted to increase the extension of the fluid passage 22 through the inner diameter of the flow regulator 20, thereby increasing the blood flow rate and accelerating blood collection. In some embodiments, when the needle 12 is inserted into the vacuum blood collection tube, the extension of the fluid passage 22 through the inner diameter of the flow regulator 20 may be increased to be greater than the inner diameter of the catheter 32. In some embodiments, the extension of the fluid passage 22 through the inner diameter of the flow regulator 20 may be increased to be equal to (or greater than) the inner diameter of the catheter 32.

[0068] In some embodiments, the flow regulator 20 may include a rotating element 42. In some embodiments, in response to the rotating element 42 being in a first position, a portion of the fluid passage 22 of the blood collection system 10 may extend through the rotating element 42. Figure 1B An example of a first position is shown. In some embodiments, in response to the rotation of the rotating element 42 from the first position to the second position, the diameter of the extension of the fluid passage 22 through said portion of the rotating element 42 can be changed. Figure 1C An example of the second position is shown in the diagram. In some embodiments, the rotating element 42 may include one or more holes 44 for alignment with the fluid passage 22 of the blood collection system 10. In some embodiments, each hole 44 may have a different diameter and / or size.

[0069] In some embodiments, when the rotating element 42 is in a first position, the first orifice 44a can be aligned with the fluid passage 22, and when the rotating element 42 is in a second position, the second orifice 44b can be aligned with the fluid passage 22. In some embodiments, the first orifice 44a can be smaller than the second orifice 44b and smaller than the inner diameter of the conduit 32. In some embodiments, the size or inner diameter of the second orifice 44b can be between the first orifice 44a and the conduit 32. In some embodiments, the size or inner diameter of the second orifice 44b can be equal to the conduit 32.

[0070] In some embodiments, the rotating element 42 may be in a first position before or immediately after connecting the vacuum blood collection tube to the blood collection system 10. In some embodiments, in response to the vacuum blood collection tube being partially filled with blood, the user may rotate the rotating element 42 to a second position. In some embodiments, the first position may correspond to a closed or partially restricted state. In some embodiments, the second position may be advantageous for a higher flow rate compared to the first position.

[0071] In some embodiments, the rotating element 42 may be rotatable relative to the body 46 of the flow regulator 20, the body including a distal component 48 and / or a proximal component 50. In some embodiments, the rotating element 42 may be coupled to the distal component 48 and / or the proximal component 50 via a pin 52. In some embodiments, the pin 52 may extend through the distal component 48, the rotating element 42, and / or the proximal component 50. In some embodiments, the rotating element 42 may rotate about the pin 52. In some embodiments, the rotating element 42 may be coupled to the distal component 48 and / or the proximal component 50 in any number of suitable manners.

[0072] In some embodiments, the needle assembly 40 may include a Luer adapter, which may include a Luer lock or a Luer slide connector. In some embodiments, the Luer adapter may include a male Luer connector or a female Luer connector. In some embodiments, the needle 12 may extend proximally from the Luer adapter. In some embodiments, the needle assembly 40 may include one or more threads for coupling to a blood collection tube receiver 14, which is typically cylindrical.

[0073] In some embodiments, the elastomeric sheath 54 may be coupled to the needle assembly 40. In some embodiments, the proximal end 56 of the needle 12 may be enclosed within the elastomeric sheath 54. In some embodiments, the elastomeric sheath 54 may include an open distal end 58 and a closed proximal end 60. In some embodiments, in response to the distal pushing of the vacuum blood collection tube into the elastomeric sheath 54, the needle 12 may pierce the elastomeric sheath 54 and may be inserted into the cavity of the vacuum blood collection tube.

[0074] In some embodiments, the rotating element 42 may include one or more markings. In some embodiments, each marking may indicate a catheter specification size, such as 18g, 20g, 22g, or 24g. In some embodiments, the distal component 48 or the proximal component 50 may include another marking for alignment with the markings on the rotating element 42. In some embodiments, when the catheter 32 in use is a specific specification size, the user may align the specific marking on the rotating element 42 indicating the specific specification size with other markings. In some embodiments, in response to the alignment of the specific marking on the rotating element 42 with other markings, a specific orifice 44 may be aligned with the fluid passage 22. In some embodiments, the specific orifice 44 may include an inner diameter smaller than the specific specification size.

[0075] Now for reference Figure 1E In some embodiments, the rotating element 61 may include a curved slot 62 extending through the rotating element 61. In some embodiments, the rotating element 61 may be relative to one or more of the included features and / or operations. Figure 1A-1D The rotating element 42 discussed is similar or identical. In some embodiments, the entire curved slot 62 may be configured to align with the fluid passage 22 of the blood collection system 10 by causing the rotating element 61 to rotate. In some embodiments, the inner diameter or width of the curved slot 62 may be continuously increased, thereby causing the fluid flow rate through the rotating element 61 to continuously change as the rotating element 61 rotates.

[0076] In some embodiments, the rotating element 61 may be in a first position before or immediately after connecting the vacuum blood collection tube to the blood collection system 10. In some embodiments, in response to the vacuum blood collection tube being partially filled with blood, the user may rotate the rotating element 61 to a second position. In some embodiments, when the rotating element 61 is in the first position, a portion of the curved slot 62 having a first inner diameter may be aligned with the fluid passage 22. In some embodiments, when the rotating element 61 is in the second position, another portion of the curved slot 62 having a second inner diameter may be aligned with the fluid passage 22. In some embodiments, the second inner diameter may be larger than the first inner diameter. In some embodiments, the first position may correspond to a closed or partially restricted state. In some embodiments, the second position may be advantageous for a higher flow rate relative to the first position.

[0077] Now for reference Figure 1F In some embodiments, the blood collection system 10 may not include the first fitting 34 and / or the second fitting 36. In some embodiments, the adapter 16 and / or another adapter 38 may be integrally formed with the flow regulator 20.

[0078] Now for reference Figure 2A-2B In some embodiments, the blood collection system 10 may include a tube 64 that extends between the adapter 16 and the needle 12. In some embodiments, the tube 64 may be elastically deformable. In some embodiments, the flow regulator 20 may include a clamp disposed on the tube 64. In some embodiments, the clamp on the tube 64 may include a roller clamp 66. In some embodiments, the roller clamp 66 may include any suitable roller clamp known in the art.

[0079] In some embodiments, the roller clamp 66 may include a generally rigid elongated frame 68, a generally cylindrical roller 70, and a section of tubing 64 disposed within the frame. In some embodiments, the roller track 72 or the frame 68 may be inclined. In some embodiments, the flow rate through the tubing 64 can be controlled by moving the generally cylindrical roller 70 along the roller track 72 and above the tubing 64, thereby selectively compressing the tubing 64 to achieve a desired flow rate.

[0080] In some embodiments, the generally cylindrical roller 70 may be in a closed or partially restricted state before or immediately after the vacuum blood collection tube is connected to the blood collection system 10. In some embodiments, in response to the vacuum blood collection tube being partially filled with blood, the user can move the generally cylindrical roller 70 from the closed or partially restricted state to a high-flow state.

[0081] Now for reference Figure 2C In some embodiments, the inner surface of the fitting 64 may include one or more ribs 74 or protrusions that may extend substantially parallel to the longitudinal axis of the fitting 64. In some embodiments, the ribs 74 may prevent complete blockage of the fitting 64. In some embodiments, the ribs 74 may maintain a minimum flow rate through the fitting 64 even when the fitting 64 is clamped or locked. In some embodiments, the ribs 74 may extend through a portion of the fitting 64 disposed within the flow regulator 20. In some embodiments, the ribs 74 may extend along all or a portion of the fitting 64.

[0082] Now for reference Figures 3A-3E In some embodiments, the flow regulator 20 may include a slide valve 76. In some embodiments, the slide valve 76 may include a housing 78 and a body 80 slidable relative to the housing 78 in a first position and a second position. In some embodiments, the housing 78 may include a slot 82, and the body 80 may extend through the slot 82 for gripping by a user.

[0083] In some embodiments, the housing 78 may include a first end 84, a second end 86, and an inner cavity 88 extending through the first end 84 and the second end 86. In some embodiments, the first end 84 of the housing 78 may include an opening 90. In some embodiments, as shown, the first end 84 may be located proximal to the second end 86, and the body 80 may be moved proximal to close the opening 90. In some embodiments, the first end 84 may be located distal to the second end 86, and the body 80 may be moved distally to close the opening 90.

[0084] In some embodiments, the outer surface of the body 80 may include one or more channels 92. In some embodiments, in response to the body 80 being in a first position, such as in Figure 3C As shown, blood can flow through the gap 94 between the outer surface of the body 80 and the housing 78 and through the opening 90. In some embodiments, in response to the housing 78 being in a second position, for example in Figure 3A As shown, blood can flow through at least one channel 92 and through an opening 90, but may not flow through a gap 94.

[0085] In some embodiments, the body 80 may be in a first position before or immediately after the vacuum blood collection tube is connected to the blood collection system 10. In some embodiments, in response to the vacuum blood collection tube being partially filled with blood, the user may move the body 80 from the first position to a second position. In some embodiments, the first position may correspond to a closed or partially restricted state. In some embodiments, the second position may be advantageous for a higher flow rate relative to the first position.

[0086] Now for reference Figure 3E In some embodiments, the blood collection system 10 may not include the first fitting 34 and / or the second fitting 36. In some embodiments, the adapter 16 and / or another adapter 38 may be integrally formed with the flow regulator 20.

[0087] Now for reference Figures 4A-4C In some embodiments, the flow regulator 20 may include a slide valve 76. In some embodiments, the blood collection system 10 may include a fitting 64 that extends between the adapter 16 and the needle 12. In some embodiments, the flow regulator 20 may include a clamp disposed on the fitting 64. In some embodiments, the clamp located on the fitting 64 may include a sliding clamp 96.

[0088] In some embodiments, the sliding clamp 96 may include a housing 98, which may include a slot 100. In some embodiments, the sliding clamp 96 may include a body 102 that may extend through the slot 100. In some embodiments, the body 80 may be capable of, for example, positioning relative to the housing 98. Figure 4B The first position shown and, for example Figure 4C The body 80 slides between the second positions shown. In some embodiments, the bottom of the body 80 may include a first surface 104, a second surface 106, and a third surface 108 disposed between the first surface 104 and the second surface 106. In some embodiments, the first surface 104 and the second surface 106 may be planar and / or substantially parallel to the longitudinal axis of the tube 64. In some embodiments, the third surface 108 may be at an angle relative to the longitudinal axis of the tube 64. In some embodiments, the second surface 106 may be closer to the tube 64 than the first surface 104.

[0089] In some embodiments, the sliding clamp 96 may include a roller pin 110 disposed between the body 102 and the pipe 64. In some embodiments, in response to the body 102 being in a first position, the roller pin 110 may contact the first surface 104 and the pipe 64. In some embodiments, in response to the body 102 sliding from the first position to a second position, the roller pin 110 moves or rolls along a third surface 108 from the first surface 104 to the second surface 106 and reduces the fluid flow through the pipe 64. In some embodiments, a fourth surface 112 or a stop surface may be disposed at the end of the body 102 and may prevent the roller pin 110 from rolling beyond the end of the body 102.

[0090] In some embodiments, the body 102 may be in a first position before or immediately after connecting the vacuum blood collection tube to the blood collection system 10. In some embodiments, in response to the vacuum blood collection tube being partially filled with blood, the user may move the body 102 from the first position to a second position. In some embodiments, the first position may correspond to a closed or partially restricted state. In some embodiments, the second position may be advantageous for a higher flow rate relative to the first position.

[0091] Now for reference Figures 5A-5C In some embodiments, the flow regulator 20 may include a stopcock valve 114. In some embodiments, the stopcock valve 114 may be in a first position before or immediately after the vacuum blood collection tube is connected to the blood collection system 10. In some embodiments, in response to the vacuum blood collection tube being partially filled with blood, the user may turn the stopcock valve 114 from, for example, the position of the vacuum blood collection tube. Figure 5BThe first position shown is moved to, for example, in Figure 5C The second position is shown in the figure. In some embodiments, the first position may correspond to a closed or partially restricted state. In some embodiments, the second position may be advantageous for a higher flow rate compared to the first position.

[0092] In some embodiments, in response to rotation of the stopcock valve 114 from a first position to a second position, the diameter of the portion of the fluid passage 22 extending through the stopcock valve 114 may change. In some embodiments, the stopcock valve 114 may include one or more pairs of orifices 116 for alignment with the fluid passage 22 of the blood collection system 10. In some embodiments, the first and second orifices of the pairs of orifices 116 may be positioned to directly cross each other. In some embodiments, each orifice of the pairs of orifices 44 may have a different diameter and / or size.

[0093] In some embodiments, when the stopcock valve 114 is in the first position, the first pair of orifices 116a can be aligned with the fluid passage 22, and when the stopcock valve 114 is in the second position, the second pair of orifices 116b can be aligned with the fluid passage 22. In some embodiments, the first pair of orifices 116a can be smaller than the second pair of orifices 116b and smaller than the inner diameter of the conduit 32.

[0094] Now for reference Figure 5D In some embodiments, the blood collection system 10 may not include the first fitting 34 and / or the second fitting 36. In some embodiments, the adapter 16 and / or another adapter 38 may be integrally formed with the flow regulator 20.

[0095] Now for reference Figures 6A-6C In some embodiments, the flow regulator 20 may include a pinch valve 118. In some embodiments, the pinch valve 118 may include a body 120 through which a fluid passage 22 may extend. In some embodiments, a first end of the pinch valve 118 may be connected to a first fitting 34 and / or a second end of the pinch valve 118 may be connected to a second fitting 36. In some embodiments, the pinch valve 118 may be elastically deformable.

[0096] In some embodiments, the fluid passage 22 may be closed or partially restricted in response to a user squeezing the body 120. In some embodiments, the user may squeeze the body 120 before or immediately after connecting the vacuum blood collection tube to the blood collection system 10. In some embodiments, in response to the vacuum blood collection tube being partially filled with blood, the user may squeeze the body 120 less frequently or cease squeezing it altogether, and the flow rate through the fluid passage 22 may increase.

[0097] Now for reference Figure 6D In some embodiments, the blood collection system 10 may not include the first fitting 34 and / or the second fitting 36. In some embodiments, the adapter 16 and / or another adapter 38 may be integrally formed with the flow regulator 20.

[0098] Reference Figures 7A to 7B The illustration shows a blood collection system 122 according to some embodiments. In some embodiments, the blood collection system 122 may be compatible with, in relation to, one or more of the included features and / or operations. Figure 1A-6D The blood collection system 10 discussed is similar or identical. As mentioned, in some embodiments, adapter 16 can be coupled to catheter adapter 24 in any number of suitable ways. Figures 7A to 7B An adapter 16 is shown, which is coupled to an extension tube 124 extending outwardly from the catheter adapter 24. In some embodiments, the adapter 16 may include a blunt cannula that can be inserted into a needleless connector 126. Although the flow regulator 20 includes Figures 7A-7B Regarding the pinch valve 118, it should be understood that, in some embodiments, any flow regulator 20 of this disclosure can be used in the blood collection system 122. In some embodiments, the first fitting 34 or fitting 64 may extend proximally from the adapter 16 to provide improved flexibility.

[0099] Now for reference Figures 8A to 8J In some embodiments, the blood collection tube holder 127 may include one or more of the following: a needle 12 for receiving a vacuum collection tube; a cavity 128 of the body 129; a fitting 130 disposed within the cavity 128 and in fluid communication with the needle 12; a button 132 disposed within the cavity 128; and one or more springs 134. In some embodiments, the button 132 may include an opening 136 extending through the button 132. In some embodiments, the button 132 may include a rib 138 adjacent to the opening 136. In some embodiments, the fitting 130 may extend through the opening 136. In some embodiments, the body 129 may include a blood collection tube receiver 14.

[0100] In some embodiments, a spring 134 may be disposed between the button 132 and the wall 140 of the cavity 128. In some embodiments, the spring 134 may bias the rib 138 against the tube 130 to compress the tube 130. In some embodiments, the spring 134 and the tube 130 may be compressed in response to pressing the button 132. In some embodiments, when the tube 130 is compressed, the fluid passage 22 may be closed or partially restricted. In some embodiments, a user may press the button 132 in response to the vacuum blood collection tube being partially filled with blood. In some embodiments, the distal end of the body 129 may include a Luer adapter.

[0101] All examples and conditional language described herein are intended for educational purposes to help the reader understand the invention and the inventors' concepts for further development of the prior art, and should be interpreted as not being limited to these specifically described examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of the invention.

Claims

1. A blood collection system, characterized by, The blood collection system comprises: a needle configured to receive a vacuum blood collection tube; an adapter configured to couple to a catheter assembly; a tube extending between the adapter and the needle, wherein an inner surface of the tube includes a plurality of ribs extending substantially parallel to a longitudinal axis of the tube; and a flow regulator disposed between the needle and the adapter and configured to regulate flow through a fluid pathway extending between the needle and the adapter; wherein the flow regulator includes a spool comprising: a housing including a first end, a second end, and an internal cavity extending through the first end and the second end, wherein the first end of the housing includes an opening, a body axially slidable within the housing between the first end and the second end, wherein an outer surface of the body includes a plurality of channels, wherein the body is slidable between a first position in which fluid is configured to flow through a gap between the outer surface of the body and the housing and through the opening and a second position in which fluid is configured to flow through at least one of the plurality of channels and through the opening but not through the gap.

2. The blood collection system of claim 1, wherein, The blood collection system further comprises a blood collection tube receiver, wherein the blood collection tube receiver surrounds the needle.

3. The blood collection system of claim 1, wherein, The blood collection system further comprises the catheter assembly, wherein the catheter assembly comprises: a catheter adapter including a distal end, a proximal end, and an internal cavity extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; and a catheter extending distally from the distal end of the catheter adapter. The blood collection system further comprises a catheter assembly, wherein the catheter assembly comprises: a catheter adapter including a distal end, a proximal end, and an internal cavity extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; and a catheter extending distally from the distal end of the catheter adapter.

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