BLOOD COLLECTION ADAPTER AND RELATED DEVICES FOR REDUCING HEMOLYSIS - Patent application

Abstract

The adapter may include a distal end configured to couple to a catheter assembly. The adapter may include a proximal end including a proximal connector configured to couple to a blood collection device. The adapter may include a fluid pathway disposed between the distal end and the proximal end, the fluid pathway including a nonlinear portion. The nonlinear portion may form a coil shape, an S-shape, or another suitable shape.

Description

[Technical field]

[0001] Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids, such as saline, various medications, and total parenteral nutrition, into a patient. Catheters may also be used to withdraw blood from a patient. [Background technology]

[0002] A common type of catheter is the over-needle peripheral intravenous ("IV") catheter. As the name suggests, an over-needle catheter may be mounted over an introducer needle with a sharp distal tip. The catheter assembly may include a catheter hub, with the catheter extending distally from the catheter hub and the introducer needle extending through the catheter. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the needle bevel pointing away from the patient's skin. The catheter and introducer needle are typically inserted at a shallow angle through the skin into the patient's vascular system.

[0003] To verify proper placement of the introducer needle and / or catheter within the blood vessel, the clinician will typically confirm that there is a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician may temporarily occlude flow within the vasculature and remove the needle, leaving the catheter in place for subsequent blood collection or infusion.

[0004] A blood collection container may be used for drawing blood or collecting a blood sample from a patient. The blood collection container may include a syringe. Alternatively, the blood collection container may include a test tube with a rubber stopper at one end. In some cases, all or part of the air is removed from the test tube so that the pressure inside the test tube is lower than the ambient pressure. Such blood collection containers are often referred to as internal vacuum or vacuum tubes. A commonly used blood collection container is the VACUTAINER® blood collection tube available from Becton Dickinson & Company.

[0005] A blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is greater than the pressure in the blood collection container, forcing blood into the blood collection container, causing the blood collection container to fill with blood. The vacuum in the blood collection container decreases as the blood collection container fills, until the pressure in the blood collection container equals the pressure in the vein and blood flow stops.

[0006] Unfortunately, when blood is drawn into the blood collection container, red blood cells are in a state of high shear stress and are prone to hemolysis due to the high initial pressure difference between the vein and the blood collection container. Hemolysis can result in the rejection and discarding of the blood sample. The high initial pressure difference may also result in the collapse of the catheter tip, the collapse of the vein, or other complications that prevent or restrict blood from filling the blood collection container. As the blood collection container fills, the pressure difference between the vein and the blood collection container decreases, and blood filling of the blood collection container slows significantly.

[0007] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0008] The present disclosure relates generally to an adapter configured to reduce the likelihood of hemolysis during blood collection using a vascular access device, as well as related blood collection sets, systems, and methods. In some embodiments, the adapter may include a distal end that may be configured to couple to a catheter assembly. In some embodiments, the adapter may include a proximal end that may include a proximal connector configured to couple to a blood collection device. In some embodiments, the adapter may include a fluid pathway disposed between the distal end and the proximal end, the fluid pathway including a nonlinear portion.

[0009] In some embodiments, the nonlinear portion may form a coil shape, an S-shape, or another suitable shape. In some embodiments, the nonlinear portion may extend through the tube. In some embodiments, the adapter may include a lumen that may extend through a distal end of the adapter and a proximal end of the adapter. In some embodiments, the tube may be disposed within the lumen. In some embodiments, the adapter may include an intermediate portion disposed between the distal end and the proximal end. In some embodiments, the intermediate portion may surround the tube.

[0010] In some embodiments, the distal connector may include a male luer thread connector, a male luer slip connector, a blunt cannula, or another suitable connector. In some embodiments, the proximal connector may include a female luer connector. In some embodiments, the proximal end may be coupled to a blood collection device. For example, the proximal end may be integrated with the blood collection device or monolithically formed with the blood collection device as a single unit. As another example, the proximal end may include a female luer connector that may be coupled with a male luer connector of a blood collection device.

[0011] In some embodiments, the blood collection device may include a syringe. In some embodiments, the blood collection device may include a needle configured to pierce a seal of the evacuated blood collection tube. In these and other embodiments, the blood collection device may include a cylindrical holder that may extend around the needle and be configured to receive the evacuated blood collection tube.

[0012] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive. It is to be understood that the various embodiments are not limited to the arrangements and instrumentalities shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the present invention, unless so claimed. Therefore, the following detailed description should not be taken in a limiting sense. [Brief description of the drawings]

[0013] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings.

[0014] [Figure 1A] FIG. 1A is a top perspective view of an exemplary adapter, according to some embodiments. [Figure 1B] FIG. 1B is a cross-sectional view of the adapter of FIG. 1A according to some embodiments. [Figure 2A] FIG. 2A is a top perspective view of the adapter of FIG. 1A integrated with an exemplary blood collection device, according to some embodiments. [Figure 2B] 2B is a cross-sectional view of the adapter of FIG. 1A integrated with the blood collection device of FIG. 2A according to some embodiments. [Figure 2C] FIG. 2C is a top perspective view of the adapter of FIG. 1A integrated with another exemplary blood collection device, according to some embodiments. [Figure 2D] FIG. 2D is a top perspective view of the adapter of FIG. 1A integrated with another exemplary blood collection device, according to some embodiments. [Figure 3A] FIG. 3A is a top perspective view of another exemplary adapter, according to some embodiments. [Figure 3B]FIG. 3B is a cross-sectional view of the adapter of FIG. 3A according to some embodiments. [Figure 4A] FIG. 4A is a top perspective view of another exemplary adapter, according to some embodiments. [Figure 4B] FIG. 4B is a cross-sectional view of the adapter of FIG. 4A according to some embodiments. [Diagram 5] FIG. 5 is a cross-sectional view of another exemplary adapter, according to some embodiments. [Figure 6A] FIG. 6A is an exploded view of another exemplary adapter, according to some embodiments. [Figure 6B] FIG. 6B is a cross-sectional view of an exemplary outer component, according to some embodiments. [Figure 6C] FIG. 6C is a cross-sectional view of the adapter of FIG. 6A according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] 1A-1B, an adapter 10 is shown, according to some embodiments. In some embodiments, the adapter 10 may be configured to reduce the possibility of hemolysis during blood draw using a vascular access device. In some embodiments, the vascular access device may include a catheter assembly. In some embodiments, the adapter 10 may include a distal end 12, which may include a distal connector 14 configured to couple to the catheter assembly. In some embodiments, the distal connector 14 may include a male luer thread connector, as shown in FIG. 1A-1B, or another suitable connector.

[0016] In some embodiments, the catheter assembly may also include a catheter hub, which may include a distal end, a proximal end, and a lumen extending through the distal and proximal ends. In some embodiments, the catheter assembly may include a catheter that may be secured within the catheter hub and extend distally from the distal end of the catheter hub. In some embodiments, the catheter may include a peripheral intravenous catheter (PIVC), a peripherally inserted central catheter (PICC), or a midline catheter.

[0017] In some embodiments, the catheter assembly may include or correspond to any suitable catheter assembly. In some embodiments, the catheter assembly may be integrated and include an extension tube that may extend from and be integrated with a side port of the catheter hub. A non-limiting example of an integrated catheter assembly is the BD NEXIVA™ Closed IV Catheter System available from Becton Dickinson and Company of Franklin Lakes, New Jersey. In some embodiments, the proximal end of the extension tube may be coupled to another adapter, such as, for example, a Y adapter. In some embodiments, the adapter 10 may be configured to couple to other adapters.

[0018] In some embodiments, the catheter assembly may not be integrated and may not include an extension tube. In these and other embodiments, the adapter 10 may be configured to couple to the proximal end of a catheter hub or another suitable portion of a catheter assembly. In some embodiments, the adapter 10 may be coupled directly to a catheter adapter, eliminating the extension tube and providing a compact catheter system.

[0019] In some embodiments, the adapter 10 may include a proximal end 16 that may include a proximal connector 18 configured to couple to a blood collection device. In some embodiments, the proximal connector 18 may include a female luer connector or another suitable connector. In some embodiments, the adapter 10 may include a fluid pathway 20 disposed between the distal end 12 and the proximal end 16. In some embodiments, fluid in the fluid pathway 20 may flow through the distal end 12 and / or the proximal end 16. In some embodiments, fluid in the fluid pathway 20 may flow through the proximal end 16 in response to an opening of a septum 21 disposed within the proximal end 16. In some embodiments, the septum 21 may open in response to coupling a blood collection device to the proximal end 16 of the adapter 10. In some embodiments, the septum 21 may include any suitable septum and may differ from the septum 21 shown. In some embodiments, the septum 21 may include an accordion-style septum 21 that may open when compressed distally.

[0020] In some embodiments, the fluid path 20 may include a nonlinear section 22. Blood cells may experience shear stress as they flow through the fluid path 20. The maximum shear stress is along the wall or wall shear stress of the blood cells. The wall shear stress of the blood cells is considered the primary source of mechanical damage to the blood cells. In some embodiments, the nonlinear section may facilitate an increase in flow resistance within the vascular access system to distribute pressure differentials and reduce the shear stress experienced by the red blood cells.

[0021] In some embodiments, the nonlinear portion 22 may form a coil shape, an S shape, or another suitable shape. As shown in FIGS. 1A-1B, in some embodiments, the nonlinear portion 22 may include a coil shape that may include a spiral. In some embodiments, the fluid flowing through the nonlinear portion may not flow in a straight line. In some embodiments, the nonlinear portion 22 may increase the length of the fluid path 20 through the adapter 10, thereby increasing the fluid resistance within the adapter 10 and decreasing blood flow. In these embodiments, the risk of hemolysis during blood collection may be reduced.

[0022] In some embodiments, the length of the fluid pathway 20 of the adapter 10 may be selected based on one or more of the gauge and / or length of the catheter, the configuration of the catheter assembly configuration, or the clinical setup. In some embodiments, the fluid pathway 20 may include a length L. In some embodiments, the length L may extend from a distal end of the fluid pathway 20 to a proximal end of the fluid pathway 20. As an example, the length L may extend from a distal end 24 of the fluid pathway 20 to a proximal end 26 of the fluid pathway 20. As another example, the length L may extend from a distal end of the tube 28 to a proximal end of the tube 28. In some embodiments, the length L may correspond to the length or the entire length of the adapter 10. In some embodiments, the fluid pathway 20 may extend along the entire length of the adapter 10 from a distal-most portion of the adapter 10 to a proximal-most portion of the adapter 10. In some embodiments, the fluid pathway 20 may include an inner diameter D. In some embodiments, the inner diameter D may be constant along the length L.

[0023] The flow of fluid within the fluid path 20, which may be tubular, can be analyzed using Poiseuille's equation.

[0024]

number

[0025] where ΔP is the change in pressure gradient over the length of fluid path 20, D and L are the inner diameter and length of fluid path 20, respectively, μ is the viscosity of the fluid, and Rf=128μL / (πD^4) is the fluid resistance. Since μ is the viscosity of the fluid and is not part of the geometry of the extension tube, the geometry factor Gf is defined such that Rf (the fluid resistance) is Rf=(128μ / π)Gf, where Gf=L / D^4.

[0026] In some embodiments, the fluid pathway 20 may have multiple sections having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), with geometric factors being:

[0027]

number

[0028] In some embodiments, the fluid path 20 may have an inner diameter that varies over the length of the fluid path 20, with geometric factors being:

[0029]

number

[0030] In some embodiments, the fluid path 20 may have a non-circular cross-section or may have a complex inner diameter profile. The geometric coefficients can then be determined by measuring the flow rate (Q) at a particular pressure (ΔP) using a fluid of known viscosity (μ).

[0031]

number

[0032] The Gf value of the fluid path 20 may be selected to reduce the maximum shear stress of each catheter gauge to be the same as or less than the maximum shear stress of the BD 21G VACUTAINER® UltraTouch™ push button blood collection set (available from Becton, Dickinson & Company, Franklin Lakes, NJ), previously considered the gold standard for blood collection. In some embodiments, Gf may be 3.83E+06 (1 / cubic inch) or more when an 18G catheter is used, which may reduce wall shear stress to reduce hemolysis. In some embodiments, Gf may be 3.27E+06 (1 / cubic inch) or more when a 20G catheter is used, which may reduce wall shear stress to reduce hemolysis. In some embodiments, Gf may be 3.33E+06 (1 / cubic inch) or more when a 22G catheter is used, which may reduce wall shear stress to reduce hemolysis. In some embodiments, Gf may be 1.50E+07 (1 / in3) or greater when using a 24G catheter, which may reduce wall shear stress to reduce hemolysis. In some embodiments, Gf may include other values. In some embodiments, the Gf value of the fluid path may be selected to reduce the maximum shear stress of each catheter gauge to be the same as or less than the maximum shear stress of the BD 25G VACUTAINER® UltraTouch™ Push Button Blood Collection Set (available from Becton, Dickinson & Company, Franklin Lakes, NJ).

[0033] In some embodiments, when using an 18G catheter, Gf may be equal to 3.83E+06 (1 / cubic inch) plus or minus 10%, plus or minus 25%, plus or minus 50%, or plus or minus 75%, which may reduce wall shear stress to reduce hemolysis. In some embodiments, when using a 20G catheter, Gf may be equal to 3.27E+06 (1 / cubic inch) plus or minus 10%, plus or minus 25%, plus or minus 50%, or plus or minus 75%, which may reduce wall shear stress to reduce hemolysis. In some embodiments, when using a 22G catheter, Gf may be equal to 3.33E+06 (1 / cubic inch) plus or minus 10%, plus or minus 25%, plus or minus 50%, or plus or minus 75%, which may reduce wall shear stress to reduce hemolysis. In some embodiments, when using a 24G catheter, Gf may be equal to 1.50E+07 (1 / cubic inch) plus or minus 10%, plus or minus 25%, plus or minus 50%, or plus or minus 75%, which reduces wall shear stress to reduce hemolysis. In some embodiments, Gf may include different values ​​that may be selected based on the gauge of the catheter. In some embodiments, Gf values ​​may be selected to be the same for 22G-18G catheters.

[0034] In some embodiments, the nonlinear portion 22 may reduce the risk of hemolysis while simultaneously promoting a compact adapter 10. In some embodiments, the nonlinear portion 22 may extend through the tube 28, the groove 56 (see, e.g., FIGS. 6A-6C), or another suitable structure. In some embodiments, the distal end of the tube 28 and / or the proximal end of the tube 28 may be secured within the adapter 10 at a variety of suitable locations.

[0035] In some embodiments, the adapter 10 may include a lumen 30 that may extend through the distal end 12 of the adapter 10 and the proximal end 16 of the adapter 10. In some embodiments, the tube 28 may be disposed within the lumen 30. In some embodiments, the adapter 10 may include an intermediate portion 32 disposed between the distal end 12 and the proximal end 16. In some embodiments, the intermediate portion 32 may surround the tube 28. In some embodiments, the adapter 10 may accommodate the tube 28, with openings in the adapter 10 only at the distal end 12 and the proximal end 16.

[0036] 2A-2D , in some embodiments, the proximal end 16 may be coupled to a blood collection device 34. For example, the proximal end 16 may be integral with the blood collection device 34 or may be monolithically formed with the blood collection device 34 as a single unit. As another example, the proximal end 16 may include a female luer connector that may be coupled with a male luer connector of the blood collection device 34.

[0037] 2A, in some embodiments, the blood collection device 34 may include a needle assembly 36 that may include a needle 38 configured to receive a blood collection container. In these and other embodiments, the blood collection container may include an evacuated blood collection tube. In some embodiments, the blood collection container may have all or a portion of the air removed such that the pressure within the blood collection container is less than ambient pressure.

[0038] In some embodiments, the needle assembly 36 may include one or more threads that may be configured to couple to the holder 40, which may be generally cylindrical and configured to hold a blood collection container. In some embodiments, the holder 40 may be integrally formed with the needle assembly 36 or may be coupled to the needle assembly 36 via bonding or another suitable method. In some embodiments, the holder 40 may surround the needle 38. In some embodiments, the needle assembly 36 and the holder 40 may include or correspond to a luer lock access device, such as, for example, a VACUTAINER® LUER-LOK™ access device available from Becton, Dickinson & Company, Franklin Lakes, New Jersey. In some embodiments, the distal end of the needle assembly 36 may include a male luer connector that is compatible with the proximal connector 18.

[0039] In some embodiments, the proximal end of needle 38 may be encased within an elastomeric sheath 42. In some embodiments, elastomeric sheath 42 may include an open distal end and a closed proximal end. In some embodiments, in response to blood collection container 34 pushing elastomeric sheath 26 distally, needle 38 may penetrate elastomeric sheath 42 and needle 38 may insert into a cavity of the blood collection container.

[0040] In some embodiments, the fluid path of the vascular access system, which may include one or more of the needle assembly 36, the adapter 10, and the catheter assembly 37 (which may include an extension tube), may include the entire blood collection path through which blood flows during blood collection. The system geometric factor Gfs of the fluid path of the blood collection system may be determined in a similar manner as described above. In some embodiments, the system geometric factor Gfs may be equal to or greater than 7.34E+06 (1 / cubic inch). In some embodiments, Gfs may include other values. In some embodiments, the system geometric factor Gfs may be 7.34E+06 (1 / cubic inch) plus or minus 10%, plus or minus 25%, plus or minus 50%, or plus or minus 75%. In some embodiments, Gfs may include other values ​​that may be selected based on the gauge and / or length of the catheter. In some embodiments, the inner diameter of the adapter 10 may be equal to or greater than the minimum inner diameter of the remaining portion of the complete blood collection path for blood collection.

[0041] As illustrated in FIG. 2C, in some embodiments, blood collection device 34 may include a syringe 35 that may include a depressible plunger.

[0042] As shown in FIG. 2D, in some embodiments, blood collection device 34 may include a needle assembly 36 that may not include a holder 40.

[0043] 3A-3B, an adapter 44 is shown, according to some embodiments. In some embodiments, the adapter 44 may be similar or identical to the adapter 10 of FIGS. 1A-2D in one or more included features and / or operation. In some embodiments, the distal connector 14 of the adapter 10 may include a blunt cannula 46 that may be inserted into a portion of a catheter assembly, and / or one or more arms 48 that may clip onto a portion of a catheter assembly.

[0044] 4A-4B, an adapter 48 is shown, according to some embodiments. In some embodiments, the adapter 48 may be similar or identical to the adapter 10 of FIGS. 1A-2D and / or the adapter 44 of FIGS. 3A-3B in terms of one or more included features and / or operations. In some embodiments, the distal connector 14 of the adapter 10 may include a male luer slip connector 50.

[0045] 5, an adapter 52 is shown, according to some embodiments. In some embodiments, the adapter 52 may be similar or identical with respect to one or more included features and / or operations to one or more of the adapter 10 of FIGS. 1A-2D, the adapter 44 of FIGS. 3A-3B, and the adapter 48 of FIGS. 4A-4B. In some embodiments, the nonlinear portion 22 may form an S-shape 54, or another suitable shape.

[0046] 6A-6C, an adapter 55 is shown, according to some embodiments. In some embodiments, adapter 55 may be similar or identical with respect to one or more included features and / or operations to one or more of adapter 10 of FIGS. 1A-2D, adapter 44 of FIGS. 3A-3B, and adapter 48 of FIGS. 4A-4B, and adapter 52 of FIG. 5. For example, adapter 55 may be coupled to blood collection device 34 (see, e.g., FIGS. 2A-2D).

[0047] In some embodiments, the nonlinear portion 22 of the fluid pathway 20 may include a channel or groove 56. In some embodiments, the groove 56 may be disposed on an outer surface of an inner component 58, which may be coupled to an outer component 60. In some embodiments, the groove 56 may include a coil or helical shape. In some embodiments, the groove 56 may be adjacent to an inner surface of the outer component 60, which may close the groove 56 such that fluid flowing through the groove 56 does not escape the groove 56 except at the distal and proximal ends of the groove 56.

[0048] In some embodiments, contact between the inner component 58 and the outer component 60 may form a seal between the inner component 58 and the outer component 60. In some embodiments, the outer surface of the inner component 58 may include a seal element 61, which may include silicone, rubber, plastic, or another suitable material. In some embodiments, the seal element 61 may include a coil or helical shape and may be offset from the groove 56 in a distal-proximal direction. In some embodiments, the seal element 61 may prevent fluid from escaping the groove 56 except at the distal and proximal ends of the groove 56.

[0049] In some embodiments, the outer diameter of the inner component 58 may be about equal to or slightly smaller than the inner diameter of the outer component 60 such that the inner component 58 fits within the outer component 60. In some embodiments, the inner surface of the outer component 60 may be generally cylindrical and the outer surface of the inner component 58 may be generally cylindrical. In some embodiments, the inner component 58 and the outer component 60 may be concentric. In some embodiments, the inner component 58 and the outer component 60 may be integrally formed or monolithically formed as a single unit.

[0050] In some embodiments, the outer component 60 may include a distal end 12 which may include the distal connector 14 of FIG. 1, 3, or 4, or another suitable connector. In some embodiments, the inner component 58 may include a proximal end 16 which may include a proximal connector 18, such as a female Luer connector, or another suitable connector.

[0051] In some embodiments, the proximal end of groove 56 may include a hole 62 that may fluidly connect groove 56 to an opening 63 in proximal end 16. Similarly, in some embodiments, the distal end of groove 56 may include a hole that may fluidly connect groove 56 to an opening 64 in distal end 12.

[0052] All examples and conditional language described herein are intended for educational purposes to aid in understanding the concepts provided by the inventor to promote the invention and technology, and should be construed as not being limited to the specifically recited examples and conditions. Although the embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations can be made to the specification without departing from the spirit and scope of the disclosed embodiments.

Claims

1. a distal end having a distal luer connector configured to couple to a catheter assembly; a proximal end having a proximal luer connector configured to couple to a blood collection device; an intermediate section disposed between the distal end and the proximal end, the intermediate section connecting the distal luer connector to the proximal luer connector, the intermediate section being integrally formed with the distal luer connector and the proximal luer connector to provide a single, integral adapter body with a lumen extending through the distal end, the intermediate section, and the proximal end; a tube disposed within the lumen within the intermediate portion, the tube defining a fluid pathway disposed between the distal end and the proximal end, the fluid pathway including a non-linear portion, where fluid flowing through the non-linear portion cannot flow in a straight line, the non-linear portion configured to increase a length of the fluid pathway between the distal end and the proximal end as compared to a linear fluid pathway; Equipped with an adapter.

2. The adapter of claim 1 , wherein the nonlinear portion forms a coil shape.

3. The adapter of claim 1 , wherein the nonlinear portion forms an S-shape.

4. The adapter of claim 1 , wherein the distal luer connector comprises a male luer threaded connector.

5. The adapter of claim 1 , wherein the distal luer connector comprises a male luer slip connector.

6. The adapter of claim 1 , wherein the distal luer connector comprises a blunt cannula.

7. The adapter of claim 1 , wherein the proximal luer connector comprises a female luer connector.

8. A blood collection device; An adapter, a distal end having a distal luer connector configured to couple to a catheter assembly; a proximal end having a proximal luer connector coupled to the blood collection device; an intermediate section disposed between the distal end and the proximal end, the intermediate section connecting the distal luer connector to the proximal luer connector, the intermediate section being integrally formed with the distal luer connector and the proximal luer connector to provide a single, integral adapter body with a lumen extending through the distal end, the intermediate section, and the proximal end; a tube disposed within the lumen within the intermediate portion, the tube defining a fluid pathway disposed between the distal end and the proximal end, the fluid pathway including a non-linear portion, the non-linear portion configured such that a length of the non-linear portion is greater than a minimum distance between the distal end and the proximal end; an adapter comprising: A blood collection set comprising:

9. The blood collection set of claim 8 , wherein the blood collection device comprises a syringe.

10. The blood collection set of claim 8 , wherein the blood collection device comprises a needle configured to pierce a seal of an evacuated blood collection tube.

11. The blood collection set of claim 10 , wherein the blood collection device further comprises a cylindrical holder extending around the needle.

12. The blood collection set of claim 8 , wherein the nonlinear portion forms a coil shape.

13. The blood collection set of claim 8 , wherein the non-linear portion forms an S-shape.

14. The blood collection set of claim 8 , wherein the distal luer connector comprises a male luer threaded connector.

15. The blood collection set of claim 8 , wherein the distal luer connector comprises a male luer slip connector.

16. The blood collection set of claim 8 , wherein said distal luer connector comprises a blunt cannula.

17. The blood collection set of claim 8, wherein the proximal luer connector comprises a female luer connector.

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