Blood collection system with automatic pressure management and related methods

Abstract

A blood collection system may include a needle assembly comprising a needle configured to receive a vacuum-sealed blood collection tube. The blood collection system may include a tubing member comprising a distal end and a proximal end. The proximal end may be coupled to the needle assembly. The tubing member may include a first flow channel and a second flow channel. The first flow channel may be configured to collapse under a lower pressure differential than the second flow channel.

Description

Background Technology

[0001] Intravenous catheters are commonly used for a variety of infusion therapies. For example, they can be used to infuse fluids such as saline solutions, various medications, and total parenteral nutrition. Intravenous catheters can also be used to draw blood from patients.

[0002] Common types of intravenous catheters include peripherally inserted intravenous catheters (“PIVCs”), peripherally inserted central catheters (“PICCs”), and midline catheters. Intravenous catheters can include “needle-feed” 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. Intravenous catheter insertion 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 at a shallow angle through the skin, with the bevel of the needle facing upwards and away from the patient’s skin.

[0003] To verify proper placement of the insertion needle and / or intravenous catheter within the vascular system, the user typically confirms a blood flash, which is visible to the user. In some cases, the insertion needle may include a notch positioned distal to the insertion needle, and in response to the distal tip of the insertion 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 insertion needle and the inner surface of the intravenous catheter.

[0004] Therefore, when the intravenous catheter is at least partially transparent, the user can see a small amount of blood “flash” to confirm its placement within the vascular system. The presence of a vascular system entry indicator (such as a flash) facilitates successful placement of the intravenous catheter. Once the insertion needle is confirmed to be in place within the vascular system, the user can temporarily block flow in the vascular system and withdraw the insertion needle, leaving the intravenous catheter in place for future blood draws and / or fluid infusions.

[0005] For blood draws, vacuum-sealed blood collection tubes can be used. A vacuum-sealed blood collection tube includes a test tube with a rubber stopper at one end. All or part of the air in the vacuum-sealed blood collection tube has been removed from the test tube, so the pressure inside the tube is lower than ambient pressure. This type of vacuum-sealed blood collection tube is often referred to as an internal vacuum or vacuum tube. A commonly used vacuum-sealed blood collection tube is available from Becton Dickinson & Company. Blood collection tube.

[0006] To collect blood samples from a patient, an adapter is attached to a needle or intravenous catheter. The adapter includes an additional needle that penetrates the rubber stopper of a vacuum-sealed blood collection tube. When the rubber stopper is pierced, the pressure in the vein is higher than the pressure in the vacuum-sealed blood collection tube, which pushes blood into the tube, filling it with blood. The vacuum in the tube decreases as it fills until the pressure inside the tube equalizes with the pressure in the vein, at which point blood flow stops.

[0007] Disadvantageously, when blood is drawn into a vacuum-sealed blood collection tube, the red blood cells are under high shear stress due to the high initial pressure differential between the vein and the tube, making them prone to hemolysis. Hemolysis can lead to blood sample rejection and disposal. The high initial pressure differential can also cause catheter tip collapse, vein collapse, or other complications, preventing or limiting blood filling of the vacuum-sealed blood collection tube.

[0008] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an example technical field in which some of the implementations described herein can be practiced. Summary of the Invention

[0009] This disclosure generally relates to a blood collection system with automatic pressure management, and related apparatus and methods. In some embodiments, the blood collection system may provide a fluid path between a catheter and a vacuum-sealed blood collection tube, the fluid path having an inner diameter responsive to a pressure differential between the vacuum-sealed blood collection tube and a patient's vein. In some embodiments, a pressure differential peak may occur in response to the connection of the vacuum-sealed blood collection tube to the blood collection system. In some embodiments, in response to the pressure differential peak, a portion of the inner diameter of the fluid path may be reduced, which may increase the fluid resistance of the fluid path and slow blood flow into the blood collection system. In some embodiments, the reduction in blood flow may reduce the risk of hemolysis. In some embodiments, the reduction in blood flow may also reduce the risk of venous and / or catheter collapse.

[0010] In some embodiments, when a vacuum-sealed blood collection tube is filled with blood, the vacuum within the tube can be reduced, and the pressure differential between the tube and the vein can be decreased. In some embodiments, the reduced pressure differential can lead to an increase in the inner diameter of the fluid path portion, which reduces fluid resistance and increases the flow rate of blood into the blood collection system. Therefore, despite the reduced pressure differential, the vacuum-sealed blood collection tube can still be filled rapidly.

[0011] In some embodiments, the blood collection system may include a needle assembly that includes a needle configured to receive a vacuum-sealed blood collection tube. In some embodiments, the blood collection device may include a blood collection tube retainer that may be coupled to and surround the needle assembly. In some embodiments, the blood collection system may include a tubing that may include a distal end and a proximal end. In some embodiments, the proximal end may be coupled to the needle assembly. In some embodiments, the tubing may include a first flow channel and a second flow channel. In some embodiments, the fluid path of the blood collection system may include a first flow channel and a second flow channel.

[0012] In some embodiments, the first flow channel may be configured to collapse at a lower pressure differential than the second flow channel. In some embodiments, the first flow channel may collapse in response to a peak pressure differential between the vacuumed blood collection tube and the patient's vein. In some embodiments, the second flow channel does not collapse in response to a peak pressure differential. In some embodiments, because the second flow channel remains open but the first flow channel collapses, the inner diameter may decrease, but the fluid path may remain open. In some embodiments, the first flow channel may open when the vacuumed blood collection tube is filled with blood, allowing for an increased blood flow rate.

[0013] In some embodiments, the fluid resistance of the first flow channel may be less than that of the second flow channel. In these embodiments, the fluid resistance of the first flow channel may be less than that of the second flow channel because the size or diameter of the first flow channel may be larger than that of the second flow channel. In some embodiments, the first flow channel may be formed by a first wall and a shared wall, which may be shared between the first and second flow channels. In some embodiments, the second flow channel may be formed by a second wall and a shared wall. In some embodiments, the first wall may include a lower hardness than the second wall. In some embodiments, the second flow channel may include an inner bore. In some embodiments, the inner bore may extend from the distal end of the fitting to the proximal end of the fitting.

[0014] In some embodiments, the blood collection system may include a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending through the distal and proximal ends of the catheter adapter. In some embodiments, the distal end of the fitting may be coupled to 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 blood collection system may include a convex Luer adapter coupled to the distal end of the fitting and a concave Luer adapter coupled to the proximal end of the fitting. In some embodiments, the catheter assembly may be replaced by a needle assembly that may be coupled to the distal end of the fitting.

[0015] In some embodiments, the blood collection system may include an outer tube and an inner tube. In some embodiments, the inner diameter of the outer tube may be larger than the outer and inner diameters of the inner tube. In some embodiments, the blood collection system may include a first flow channel and a second flow channel. In some embodiments, the second flow channel may extend between the outer and inner tubes. In some embodiments, the second flow channel may extend through the inner tube. In some embodiments, the second flow channel may be configured to collapse under a different pressure differential than the second flow channel.

[0016] In some embodiments, the outer fitting may have a lower stiffness than the inner fitting. In some embodiments, another first flow channel may be configured to collapse under a lower pressure differential than another second flow channel. In some embodiments, at a lower pressure differential, the outer fitting may contact the inner fitting to close at least a portion of the other first flow channel.

[0017] In some embodiments, the outer fitting may have greater rigidity than the inner fitting. In these and other embodiments, a second flow channel may be configured to collapse at a lower pressure differential than the first flow channel. In some embodiments, the distal end of the inner fitting may include a duckbill valve.

[0018] In some embodiments, the blood collection system may include another fitting that may include no more than one flow channel. In some embodiments, the inner surface of the other fitting may include one or more ribs or one or more grooves. In some embodiments, the grooves may close in response to a peak in the pressure differential, and the flow channel may remain open. In some embodiments, the grooves may be configured to close when the pressure differential reaches a predetermined level. In some embodiments, the ribs may extend along the length of the other fitting and may be spaced substantially evenly around the circumference of the inner surface. In some embodiments, the grooves may extend outward from a generally cylindrical portion of the fluid channel. In some embodiments, the generally cylindrical portion of the fluid channel may remain open in response to a peak in the pressure differential and when the pressure differential reaches a predetermined level.

[0019] It should be understood that the foregoing general description and the following detailed description are illustrative and exemplary, and not intended to limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that these 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 required. Therefore, the following detailed description is not restrictive. Attached Figure Description

[0020] The exemplary embodiments will be described and explained in additional specific detail using the accompanying drawings, wherein:

[0021] Figure 1A This is a top perspective view of an exemplary blood collection system according to some embodiments;

[0022] Figure 1B It is according to some embodiments along Figure 1A Cross-sectional view of line 1B-1B;

[0023] Figure 1C This is an enlarged cross-section of an example pipe fitting according to some embodiments;

[0024] Figure 1D According to some embodiments Figure 1A A cross-sectional view of a blood collection system;

[0025] Figure 2A It is according to some embodiments along Figure 1A Another cross-sectional view of line 1B-1B;

[0026] Figure 2B This is an enlarged cross-sectional view of another example pipe fitting according to some embodiments;

[0027] Figure 2C According to some embodiments Figure 1A Another cross-sectional view of the blood collection system;

[0028] Figure 2D According to some embodiments Figure 1A Another cross-sectional view of the blood collection system shows an exemplary flow channel with a closed end;

[0029] Figure 3A It is according to some embodiments along Figure 1A Another cross-sectional view of line 1B-1B;

[0030] Figure 3B This is an enlarged cross-sectional view of another example pipe fitting according to some embodiments;

[0031] Figure 3C According to some embodiments Figure 1A Another cross-sectional view of the blood collection system;

[0032] Figure 3D According to some embodiments Figure 1A Another cross-sectional view of the blood collection system shows an example vacuumed blood collection tube connected to the blood collection system;

[0033] Figure 3E According to some embodiments Figure 1A Another cross-sectional view of the blood collection system;

[0034] Figure 4A It is according to some embodiments along Figure 1A Another cross-sectional view of line 1B-1B;

[0035] Figure 4B This is an enlarged cross-section of another example pipe fitting according to some embodiments;

[0036] Figure 4C According to some embodiments Figure 1A Another cross-sectional view of the blood collection system;

[0037] Figure 4D According to some embodiments Figure 1A Another cross-sectional view of the blood collection system shows the blood collection tube connected to the blood collection system and subjected to vacuum.

[0038] Figure 5A It is according to some embodiments along Figure 1A Another cross-sectional view of line 1B-1B;

[0039] Figure 5B According to some embodiments Figure 1A Another cross-sectional view of the blood collection system;

[0040] Figure 6A This is a cross-sectional view of another example pipe fitting under a first differential pressure according to some embodiments;

[0041] Figure 6B According to some embodiments Figure 6A A cross-sectional view of the pipe fitting under a second pressure differential higher than the first pressure differential;

[0042] Figure 7A This is a cross-sectional view of another example pipe fitting under a first differential pressure according to some embodiments;

[0043] Figure 7B According to some embodiments Figure 7A A cross-sectional view of the pipe fitting under a second pressure differential higher than the first pressure differential;

[0044] Figure 8A This is a cross-sectional view of another example pipe fitting under a first differential pressure according to some embodiments;

[0045] Figure 8B According to some embodiments Figure 8A A cross-sectional view of the pipe fitting under a second pressure differential higher than the first pressure differential;

[0046] Figure 9A This is a cross-sectional view of another example pipe fitting under a first differential pressure according to some embodiments;

[0047] Figure 9B According to some embodiments Figure 9A A cross-sectional view of the pipe fitting under a second pressure differential higher than the first pressure differential;

[0048] Figure 10A This is a cross-sectional view of another example pipe fitting under a first differential pressure according to some embodiments;

[0049] Figure 10B According to some embodiments Figure 10A A cross-sectional view of the pipe fitting under a second pressure differential higher than the first pressure differential;

[0050] Figure 11A This is a cross-sectional view of another example pipe fitting under a first differential pressure according to some embodiments;

[0051] Figure 11B According to some embodiments Figure 11A A cross-sectional view of the pipe fitting under a second pressure differential higher than the first pressure differential;

[0052] Figure 12A According to some embodiments Figure 1A Another cross-sectional view of the blood collection system;

[0053] Figure 12B According to some embodiments Figure 12A Another cross-sectional view of the blood collection system shows the blood collection tube connected to the blood collection system and subjected to vacuum.

[0054] Figure 12C This is a cross-sectional view of another example pipe fitting under a first differential pressure according to some embodiments;

[0055] Figure 12D According to some embodiments Figure 12C A cross-sectional view of the pipe fitting under a second pressure differential higher than the first pressure differential;

[0056] Figure 13A This is a cross-sectional view of another blood collection system according to some embodiments;

[0057] Figure 13B According to some embodiments Figure 13A Another cross-sectional view of the blood collection system shows the blood collection tube connected to the blood collection system and subjected to vacuum.

[0058] Figure 14 According to some embodiments Figure 13A A cross-sectional view of a blood collection system;

[0059] Figure 15A According to some embodiments Figure 13A A cross-sectional view of the blood collection system under the first pressure differential;

[0060] Figure 15B According to some embodiments Figure 15A A cross-sectional view of a blood collection system under a second pressure differential higher than the first pressure differential;

[0061] Figure 16A According to some embodiments Figure 13A A cross-sectional view of the blood collection system under the first pressure differential;

[0062] Figure 16B According to some embodiments Figure 16A A cross-sectional view of a blood collection system under a second pressure differential higher than the first pressure differential; and

[0063] Figure 17 According to some embodiments Figure 13A A cross-sectional view of the blood collection system. Detailed Implementation

[0064] Now for reference Figure 1A-1D In some embodiments, the blood collection system 10 may provide a fluid path between the catheter 12 and a vacuum-sealed blood collection tube, the fluid path having an inner diameter responsive to the pressure differential between the vacuum-sealed blood collection tube and the patient's vein. In some embodiments, a pressure differential peak may occur in response to the connection of the vacuum-sealed blood collection tube to the blood collection system 10. In some embodiments, in response to the pressure differential peak, a portion of the inner diameter of the fluid path may be reduced, which may increase the fluid resistance of the fluid path and slow blood flow into the blood collection system 10. In some embodiments, the reduction in blood flow may reduce the risk of hemolysis. In some embodiments, the reduction in blood flow may also reduce the risk of venous and / or catheter collapse.

[0065] In some embodiments, the vacuum-sealed blood collection tube may be evacuated such that the pressure inside the vacuum-sealed blood collection tube is lower than ambient or atmospheric pressure. In some embodiments, the vacuum-sealed blood collection tube may include any suitable vacuum-sealed blood collection tube. In some embodiments, when the vacuum-sealed blood collection tube is filled with blood, the vacuum inside the vacuum-sealed blood collection tube may be reduced, and the pressure differential between the vacuum-sealed blood collection tube and the vein may be reduced. In some embodiments, the reduced pressure differential may result in an increase in the inner diameter of the fluid path portion, which may reduce fluid resistance and increase the flow rate of blood into the blood collection system 10. Therefore, despite the reduced pressure differential, the vacuum-sealed blood collection tube can still be filled rapidly.

[0066] In some embodiments, the blood collection system 10 may include a needle assembly 14, which may include a needle 16 configured to receive a vacuum-sealed blood collection tube (see, for example...). Figure 3DIn some embodiments, the needle assembly 14 may include one or more threads configured to engage with a blood collection tube retainer 18 (which may be generally cylindrical). In some embodiments, the blood collection tube retainer 18 may surround the needle 16. In some embodiments, the needle assembly 14 may include a Luer lock access device, for example, available from Becton Dickinson & Company. LUER-LOK TM Access device.

[0067] In some embodiments, the pin assembly 14 may include a Luer adapter 20, which may include a Luer lock or a Luer slide connector. In some embodiments, the Luer adapter 20 may include a convex Luer connector or a concave Luer connector. In some embodiments, the pin 16 may extend proximally from the Luer adapter 20.

[0068] In some embodiments, the blood collection system 10 may include a fitting 22, which may include a distal end 24 and a proximal end 26. In some embodiments, the proximal end 26 may be coupled to a needle assembly 14, such as a Luer adapter 20 of the needle assembly 14. In some embodiments, the fitting 22 may include a first flow channel 28 and a second flow channel 30. In some embodiments, the fluid path of the blood collection system 10 may include the first flow channel 28 and the second flow channel 30. In some embodiments, the fitting 22 may be made of urethane (including polyurethane), rubber, polyvinyl chloride (PVC), silicone, polyethylene (low-density and high-density), nylon, fluoropolymers, polypropylene, acrylonitrile-butadiene-styrene (ABS), polycarbonate, acrylic acid, and / or the like.

[0069] In some embodiments, the first flow channel 28 may be configured to collapse at a lower pressure differential than the second flow channel 30. In some embodiments, collapse may include partial or complete blockage of the particular flow channel due to failure or collapse of the surrounding wall forming the particular flow channel. In some embodiments, the first flow channel 28 may collapse in response to a peak pressure differential between the vacuumed blood collection tube and the patient's vein. In some embodiments, the first flow channel may be partially or completely blocked when the first flow channel 28 collapses. In some embodiments, the second flow channel 30 may not collapse in response to a peak pressure differential, and the diameter of the second flow channel 30 may remain the same. In other embodiments, the second flow channel 30 may partially collapse in response to a peak pressure differential. In other embodiments, the second flow channel 30 may collapse less than the first flow channel 28 in response to a peak pressure differential. In some embodiments, because the second flow channel 30 remains open, but the first flow channel collapses, the inner diameter of this portion of the fluid path may decrease, but the fluid path may remain open. In some embodiments, when the vacuum-sealed blood collection tube is filled with blood and the pressure differential decreases, the first flow channel 28 can be opened to allow an increase in the blood flow rate.

[0070] In some embodiments, the fluid resistance of the first flow channel 28 may be less than the fluid resistance of the second flow channel. In these embodiments, since the size or diameter of the first flow channel 28 may be larger than the size or diameter of the second flow channel 30, the fluid resistance of the first flow channel 28 may be less than the fluid resistance of the second flow channel 30.

[0071] In some embodiments, the first flow channel 28 may be formed by a first wall 32 and a shared wall 34, which may be shared between the first flow channel 28 and the second flow channel 30. In some embodiments, the shared wall 34 may include any portion of a fitting 22 disposed between the first flow channel 28 and the second flow channel 30. In some embodiments, the second flow channel 30 may be formed by a second wall 36 and the shared wall 34. In some embodiments, the first wall 32 may have a lower hardness than the second wall 36 and / or the shared wall 34.

[0072] In some embodiments, the second flow channel 30 may include an inner aperture, for example, such as Figure 1B-1DAs shown. In some embodiments, the inner bore may extend from the distal end 24 of the tube 22 to the proximal end 26 of the tube 22. In some embodiments, the inner bore may extend along a large portion of the length of the tube 22 from the distal end 24 of the tube 22 to the proximal end 26 of the tube 22. In some embodiments, the inner bore may extend along a portion of the length of the tube 22 from the distal end 24 of the tube 22 to the proximal end 26 of the tube 22. In some embodiments, the first flow channel 28 may include a generally circular shape, with a shared wall 34 projecting inward toward the center of the circle to form a generally C-shape. In some embodiments, the shared wall 34 may be convex, extending toward the central portion of the first flow channel 28.

[0073] In some embodiments, the blood collection system 10 may include a catheter assembly 40. In some embodiments, the catheter assembly 40 may include a catheter adapter 42, which may include a distal end 44, a proximal end 46, and a lumen 48 extending through the distal end 44 and the proximal end 46 of the catheter adapter 42. In some embodiments, the distal end 24 of the fitting 22 may be coupled to the catheter adapter 42. In some embodiments, the catheter assembly 40 may include a catheter 12 extending distally from the distal end 44 of the catheter adapter 42. In some embodiments, the catheter assembly 40 may be replaced by a needle assembly coupled to the distal end 24 of the fitting 22.

[0074] In some embodiments, the blood collection system 10 may include a Luer adapter 50 coupled to the distal end 24 of the fitting 22 and / or a Luer adapter 52 coupled to the proximal end 26 of the fitting 22. In some embodiments, the Luer adapter 50 and / or the Luer adapter 52 may include a Luer lock or a Luer slide connector. In some embodiments, the Luer adapter 50 and / or the Luer adapter 52 may include a convex Luer connector or a concave Luer connector. In some embodiments, the proximal end 26 of the fitting 22 may be integrated with the Luer adapter 20 and / or the needle assembly 14.

[0075] In some embodiments, the catheter assembly 40 may include a PIVC, such as BD NEXIVA. TM Closed IV catheter system, BD CATHENA TM Catheter system, BD VENFLON TM Pro Safety Shielded IV Catheter System, BD NEOFLON TM IV casing system, BD INSYTE TM AUTOGUARD TMA BC-shielded IV catheter system or another suitable peripheral intravenous catheter system. In some embodiments, catheter assembly 40 may include a PICC or a midline catheter. In some embodiments, Luer adapter 50 may be coupled to catheter adapter 42 in any suitable manner. For example, Luer adapter 50 may be coupled to the distal end 44 of catheter adapter 42. As another example, Luer adapter 50 may be coupled to an extension tube extending outward from catheter adapter 42.

[0076] In some embodiments, the elastomeric sheath 54 may be coupled to the needle assembly 14. In some embodiments, the proximal end 56 of the needle 16 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 a vacuum-sealed blood collection tube pushing the elastomeric sheath 54 distally, the needle 16 may pierce the elastomeric sheath 54 and may be inserted into the lumen of the vacuum-sealed blood collection tube.

[0077] Now for reference Figure 2A-2D In some embodiments, the shapes of the first flow channel 28 and / or the second flow channel 30 may vary. In some embodiments, the first flow channel 28 may be formed by a first wall 32 and a shared wall 34, for example as... Figure 2B As shown. In some embodiments, the second flow channel 30 may be formed by a second wall 36 and a shared wall 34, for example as Figure 2B As shown. In some embodiments, the first wall 32 may have a lower hardness than the second wall 36 and / or the shared wall. In some embodiments, the shared wall 34 may protrude relative to the first flow channel 28. In some embodiments, the first flow channel 28 and the second flow channel 30 may together form a generally circular shape. In some embodiments, one or more of the first wall 32, the shared wall 34, and the second wall 36 may be generally smooth.

[0078] In some embodiments, such as Figure 2D As shown, the second flow channel 30 may be isolated from the fluid path of the blood collection system 10 and may contain air, which may help to cause the first flow channel 28 to collapse or reduce in size in response to a peak in the pressure differential. In these embodiments, each end of the second flow channel 30 may be closed or sealed.

[0079] Now for reference Figures 3A-4DIn some embodiments, the blood collection system 10 may include an outer tube 62 and an inner tube 64. In some embodiments, the inner diameter of the outer tube 62 may be larger than both the inner and outer diameters of the inner tube 64. In some embodiments, the outer tube 62 may include a first flow channel 66, and the inner tube 64 may include a second flow channel 68. In some embodiments, the first flow channel 66 may extend between the outer tube 62 and the inner tube 64. In some embodiments, the second flow channel 68 may extend through the inner tube 64, and the first flow channel 66 may extend through the outer tube 62. In some embodiments, the first flow channel 66 and the outer tube 62 may be configured to collapse under a different pressure differential than the second flow channel 68 and the inner tube 64.

[0080] Now for reference Figures 3A-3E In some embodiments, the outer tube 62 may include a lower stiffness than the inner tube 64. In some embodiments, the first flow channel 66 and the outer tube 62 may be configured to collapse under a lower pressure differential than the second flow channel 68 and the inner tube 64. In some embodiments, at a lower pressure differential, the outer tube 62 may contact the inner tube 64 to close at least a portion of the first flow channel 66. In some embodiments, the first flow channel 66 and the outer tube 62 may collapse in response to connecting a vacuum-sealed blood collection tube to the blood collection system 10, for example, as... Figure 3D As shown.

[0081] In some embodiments, the first flow channel 66 can be opened in response to the vacuuming of the blood collection tube being partially filled with blood. In some embodiments, the diameter of the second flow channel 68 may remain the same or substantially the same before and after connecting the vacuumed blood collection tube to the blood collection system 10. In some embodiments, the diameter of the second flow channel 68 may remain the same before and after connecting the partially filled, vacuumed blood collection tube.

[0082] In some embodiments, the inner fitting 64 may not be connected to the outer fitting 62. In some embodiments, the inner fitting 64 may be connected to the outer fitting 62. In some embodiments, a portion of the inner fitting 64 may be embedded in the outer fitting 62. In some embodiments, the inner fitting 64 may be secured within the outer fitting 62 by a portion of a specific adapter, for example, as... Figure 3E As shown. In some embodiments, the second flow channel 68 may be isolated from the fluid path of the blood collection system 10 and may contain air, similar to, for example... Figure 2D In some embodiments, the proximal ends of the inner fitting 64 and / or the outer fitting 62 may be integrated with the Luer adapter 20 and / or the pin assembly 14.

[0083] Now for reference Figures 4A-4DIn some embodiments, the outer tube 62 may have greater rigidity than the inner tube 64. In some embodiments, the second flow channel 68 and the inner tube 64 may be configured to collapse under a lower pressure differential than the first flow channel 66 and the outer tube 62. In some embodiments, the second flow channel 68 and the inner tube 64 may collapse in response to connecting a vacuum-sealed blood collection tube to the blood collection system 10, for example, as... Figure 4D As shown. In some embodiments, in response to a vacuum-sealed blood collection tube being partially filled with blood, a second flow channel 68 may open. In some embodiments, the diameter of the first flow channel 66 may remain the same before and after connecting the vacuum-sealed blood collection tube to the blood collection system 10. In some embodiments, the diameter of the first flow channel 66 may remain the same before and after connecting the partially filled, vacuum-sealed blood collection tube. In some embodiments, the second flow channel 68 may be isolated from the fluid path of the blood collection system 10 and may contain air, similar to, for example... Figure 2D .

[0084] Now for reference Figure 12A-12B In some embodiments, the distal end of the inner fitting 64 may include a duckbill valve 70. In these and other embodiments, the outer fitting 62 may have greater rigidity than the inner fitting 64. In some embodiments, the second flow channel 68 and the inner fitting 64 may collapse in response to connecting a vacuum-sealed blood collection tube to the blood collection system 10, for example, as... Figure 12B and 12D As shown. In some embodiments, the duckbill valve 70 can close in response to the collapse of the second flow channel 68 and the internal tubing. In some embodiments, the duckbill valve 70 and the second flow channel 68 can open in response to the vacuuming of the blood collection tube being partially filled with blood, for example as... Figure 12C As shown.

[0085] Return to reference Figures 5A-5B In some embodiments, the fitting 22 may include no more than one flow channel 71 extending through the fitting 22. In some embodiments, the inner surface of the fitting 22 may include one or more ribs 72, for example, as shown in the figure. Figures 5A-5B As shown. In some embodiments, the ribs 72 may extend along the length of the fitting 22 and / or may be spaced substantially uniformly around the circumference of the inner surface of the fitting 22. In some embodiments, the ribs 72 may maintain a minimum flow rate through the fitting 22, even when the fitting 22 collapses. In some embodiments, refer to Figures 3A-4D The outer fitting 62 and / or inner fitting 64 discussed in section 12 may include ribs 72.

[0086] Now for reference Figure 6A-8BIn some embodiments, the inner surface of the fitting 22 may include one or more grooves 74, for example, as Figure 6A-8B As shown. In some embodiments, fitting 22 may include a flow channel 71. In some embodiments, slots 74 may extend along the length of fitting 22 and / or may be spaced substantially uniformly around the circumference of the inner surface of fitting 22. In some embodiments, the inner surface of fitting 22 may include one slot, two slots, three slots, four slots, or more than four slots, depending on, for example, the desired flow rate variation.

[0087] In some embodiments, in response to a peak in the pressure differential, fitting 22 may collapse, causing slot 74 to close and flow passage 71 to remain open. For example, fitting 22 may collapse in response to connecting a vacuum-sealed blood collection tube to the blood collection system 10. In some embodiments, slot 74 may extend outward from a generally cylindrical portion 76 of flow passage 71. In some embodiments, the generally cylindrical portion 76 of the fluid passage may remain open in response to a peak in the pressure differential and a predetermined pressure differential level. In some embodiments, slot 74 may reopen in response to the vacuum-sealed blood collection tube being partially filled with blood.

[0088] Now for reference Figures 9A-9B The fitting 22 may include a generally hourglass shape, such that its middle portion has a smaller outer and inner diameter than either side. In some embodiments, in response to a peak pressure differential and a predetermined pressure differential level, the fitting 22 may collapse, causing the middle portion to close and forming two flow channels 78, 80, for example, as shown below. Figure 9B As shown. In some embodiments, the blood collection tube, in response to vacuuming, is partially filled with blood, and the middle section can be reopened.

[0089] Now for reference Figures 10A-10B The cross-section of the inner lumen of fitting 22 may include a generally hourglass shape, such that the middle portion of the inner lumen has a smaller diameter than the two sides of the inner lumen. In some embodiments, in response to a peak pressure differential and a predetermined pressure differential level, fitting 22 may collapse, closing the middle portion and forming one or more flow channels. For example, in response to a peak pressure differential and a predetermined pressure differential level, fitting 22 may collapse, closing the middle portion and forming two flow channels 78, 80, for example... Figure 10B As shown. In some embodiments, the blood collection tube, in response to vacuuming, is partially filled with blood, and the middle section can be reopened.

[0090] Now for reference Figure 11A-11BAccording to some embodiments, a first flow channel 28 and a second flow channel 30 are shown. In some embodiments, the first flow channel 28 may be configured to collapse under a lower pressure differential than the second flow channel 30. In some embodiments, the first flow channel 28 may collapse in response to a peak pressure differential between a vacuumed blood collection tube and a patient's vein. In some embodiments, the first flow channel 28 may be partially or completely blocked when it collapses. In some embodiments, the first flow channel 28 may be elongated compared to the second flow channel 30 and have a narrowing inner diameter along its entire length, which may facilitate the collapse of the first flow channel 28. In some embodiments, the second flow channel 30 may be generally circular or other suitable shape.

[0091] Now for reference Figures 13A-13B In some embodiments, the blood collection system 82 may include a housing 84. In some embodiments, the blood collection system 82 may be similar to or equivalent to the referenced features and / or operational aspects in one or more of the included features and / or operational aspects. Figure 1A-12D The discussed blood collection system 10. In some embodiments, housing 84 may include a distal end 86 and a proximal end 88. In some embodiments, housing 84 may correspond to a tubing. In some embodiments, distal end 86 may include a Luer adapter 87 and / or proximal end 88 may include a Luer adapter 89. In some embodiments, Luer adapter 87 and / or Luer adapter 89 may include a Luer lock or a Luer slide connector. In some embodiments, Luer adapter 87 and / or Luer adapter 89 may include a convex Luer connector or a concave Luer connector. In some embodiments, proximal end 88 may be integrated with Luer adapter 20 and / or needle assembly 14.

[0092] In some embodiments, the blood collection system 82 may include a fitting 90, which may include a distal end 92 and a proximal end 94. In some embodiments, the fitting 90 may be similar to or equivalent to the following regarding one or more of the included features and / or operations: Figure 1A-2C The fitting 22 discussed in 5A-11B. In some embodiments, the distal end 92 and / or proximal end 94 may be coupled to the housing 84. In some embodiments, the housing 84 may include a higher rigidity than the fitting 90. In some embodiments, in response to a peak pressure differential and a predetermined pressure differential level, the flow passage 96 extending through the fitting 90 may collapse, for example, as... Figure 13B As shown. In some embodiments, the flow channel 96 may be closed or restricted in response to the collapse of the fitting 90. In some embodiments, the flow channel 96 may reopen in response to the blood collection tube being partially filled with blood after being evacuated.

[0093] Now for reference Figure 14In some embodiments, a diaphragm 98 may be disposed within a housing 84. In some embodiments, a flow channel or opening 100 may extend through the diaphragm 98. In some embodiments, the diaphragm 98 may be annular. In some embodiments, the diameter of the opening 100 may be manually adjustable by a user. In some embodiments, the diaphragm 98 may be attached to a nut, which may be screwed into the housing 84. In some embodiments, the nut may be rotated relative to the housing 82 to increase or decrease the diameter of the opening 100 extending through the diaphragm 98.

[0094] Now for reference Figure 15A-16B In some embodiments, the diaphragm 98 within the housing 84 can be partially pressurized by means of nitrogen or another compressible gas. In some embodiments, in response to a peak in the pressure differential, the opening 100 can narrow or close due to the presence of nitrogen or other gas and the expansion of the diaphragm 98. In some embodiments, the inner surface of the diaphragm 98 may include two opposing arcuate shapes or another suitable shape. Figures 15A-15B As shown, in some embodiments, the diaphragm 98 may not contact the housing 84 along its entire length. In some embodiments, the diaphragm 98 may be coupled to the housing 84 at a first point and a second point, and the area between the first point and the second point may be spaced apart from the housing 84. In some embodiments, this area may be arc-shaped or other suitable shape. Figures 16A-16B As shown, in some embodiments, the diaphragm 98 may contact the housing 84 along the entire length of the diaphragm 98.

[0095] Now for reference Figure 17 In some embodiments, the fitting 90 may include a shape that promotes the Coanda effect. In some embodiments, the fitting 90 may include a first branch 102, which may be generally straight or parallel to the longitudinal axis of the blood collection system 82. In some embodiments, blood within the first branch 102 may be configured to flow in a distal to proximal direction. In some embodiments, a second branch 104 may extend from the first branch 102. In some embodiments, a portion of the second branch 104 near the first branch 102 may include a counter-branch, wherein blood is configured to flow in a proximal to distal direction. In some embodiments, the distal end of the first branch 102 may extend through the distal end 86 of the housing 84 and / or be coupled to a Luer adapter 87. In some embodiments, the proximal end of the first branch 102 and / or the proximal end of the second branch 104 may be coupled to the proximal end 88 of the housing 84 and / or a Luer adapter 89.

[0096] In some embodiments, in response to a high pressure differential or a peak pressure differential, blood traveling from catheter assembly 40 through fitting 90 can largely bypass the second branch 104. In some embodiments, in response to a high pressure differential or a peak pressure differential, a large portion of the blood traveling from catheter assembly 40 through fitting 90 can largely bypass the second branch 104 and can flow through the first branch 102. In some embodiments, as the pressure differential decreases, more blood can flow through the second branch 104, thereby reducing the overall flow resistance.

[0097] All examples and conditional language described herein are for educational purposes, to help the reader understand the invention and the concepts contributed by the inventors to expand the field, and are to be construed as not being limited to these specifically listed 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 comprising: A needle assembly comprising a needle configured to receive a vacuum-sealed blood collection tube; A tubing comprising a distal end and a proximal end, wherein the proximal end is coupled to the needle assembly, wherein the tubing includes a first flow channel and a second flow channel, wherein the first flow channel is configured to collapse under a lower pressure differential than the second flow channel during blood collection. Wherein, the first flow channel is in fluid communication with the second flow channel at the proximal end of the pipe fitting, and wherein the first flow channel is in fluid communication with the second flow channel at the distal end of the pipe fitting.

2. The blood collection system according to claim 1, wherein, The fluid resistance of the first flow channel is less than that of the second flow channel.

3. The blood collection system according to claim 2, wherein, The first flow channel is formed by a first wall and a shared wall, wherein the second flow channel is formed by a second wall and the shared wall, wherein the first wall has a lower hardness than the second wall.

4. The blood collection system according to claim 3, wherein, The second flow channel includes an inner hole extending from the distal end of the fitting to the proximal end of the fitting.

5. The blood collection system of claim 1, further comprising a blood collection tube retainer coupled to the needle assembly, wherein, The blood collection tube holder surrounds the needle.

6. The blood collection system of claim 1, further comprising a catheter assembly, wherein, The catheter assembly includes: A catheter adapter includes a distal end, a proximal end, and a lumen extending through the distal end and the proximal end of the catheter adapter, wherein the distal end of the fitting is coupled to the catheter adapter; and A catheter extending distally from the distal end of the catheter adapter.

7. The blood collection system of claim 1, further comprising a convex Luer adapter connected to the distal end of the tube and a concave Luer adapter connected to the proximal end of the tube.

8. The blood collection system according to claim 1, wherein, The pipe fitting includes an outer pipe fitting and an inner pipe fitting disposed within the outer pipe fitting, wherein the inner diameter of the outer pipe fitting is larger than the outer diameter of the inner pipe fitting, wherein the first flow channel extends between the outer pipe fitting and the inner pipe fitting, and wherein the second flow channel extends through the inner pipe fitting.

9. The blood collection system according to claim 8, wherein, The outer fitting has a lower hardness than the inner fitting, and wherein, under the lower pressure differential, the outer fitting contacts the inner fitting to close at least a portion of the first flow channel.

10. The blood collection system according to claim 8, wherein, The distal end of the inner fitting includes a duckbill valve.

11. The blood collection system of claim 8, further comprising a blood collection tube retainer coupled to the needle assembly, wherein, The blood collection tube holder surrounds the needle.

12. The blood collection system of claim 8, further comprising a catheter assembly, wherein, The catheter assembly includes: A catheter adapter includes a distal end, a proximal end, and a lumen extending through the distal end and the proximal end of the catheter adapter, wherein the distal end of the fitting is coupled to the catheter adapter; and A catheter extending distally from the distal end of the catheter adapter.

13. The blood collection system of claim 8, further comprising a convex Luer adapter coupled to the distal end of the tube and a concave Luer adapter coupled to the proximal end of the tube.

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