BLOOD SAMPLING DEVICE AND ASSOCIATED SYSTEMS AND METHODS

Abstract

A blood collection device for reducing hemolysis in a peripheral intravenous catheter system may include a distal end. The distal end of the blood collection device may include a male Luer adapter, which may include a distal opening. The blood collection device may include a cannula in fluid communication with the male Luer adapter. The cannula may include a distal end and a sharp proximal tip. The blood collection device may include an elongated neck disposed between the male Luer adapter and the sharp proximal tip. The blood collection device may include a fluid pathway extending from the distal opening through the sharp proximal tip. The diameter of the fluid pathway may be constant. The overall length of the fluid pathway is represented by L, and the diameter of the fluid pathway is represented by D, where D 4 / L may be equal to or less than a predetermined value.

Description

[Technical Field]

[0001] The present invention relates to a catheter system and a blood collection device.

[0002] This application claims priority to U.S. Provisional Application No. 63 / 065,785, entitled "Blood Collection Device and Related Systems and Methods," filed August 14, 2020, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0003] Catheters are commonly used to infuse fluids into a patient's vascular system. For example, catheters may be used to infuse saline, various medications, or total parenteral nutrition. Catheters may also be used to withdraw blood from a patient.

[0004] The catheter may include an over-the-needle peripheral intravenous ("IV") catheter. In this case, the catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and introducer needle may be assembled so 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 into the patient's vascular system at a shallow angle from the skin.

[0005] To verify proper placement of the introducer needle and / or catheter within the vessel, the clinician typically confirms the presence of a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can remove the needle and leave the catheter in place for future blood draws or transfusions.

[0006] Blood collection containers can be used to draw blood or collect blood samples from patients. Blood collection containers can include syringes or test tubes with rubber stoppers at one end. Additionally, blood collection containers can remove all or part of the air from the test tube so that the pressure inside the blood collection container is lower than ambient pressure. Such blood collection containers are often referred to as internally evacuated or vacuum tubes. A commonly used blood collection container is the BD VACUTAINER® tube, available from Becton Dickinson & Company, Franklin Lakes, New Jersey.

[0007] A blood collection container can 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.

[0008] Unfortunately, as blood is drawn into the collection container, red blood cells are subject to high shear stress and are susceptible to hemolysis due to the high initial pressure difference between the vein and the collection container. Hemolysis can result in the rejection and disposal of the blood sample. High initial pressure differences can also lead to complications such as catheter tip collapse, vein collapse, and preventing or limiting the filling of the collection container.

[0009] 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

[0010] FIELD OF THE DISCLOSURE The present disclosure relates generally to blood collection devices and related systems and methods. In some embodiments, a peripheral intravenous catheter system can reduce the risk of mechanical hemolysis during blood collection from a patient's vasculature. In some embodiments, the peripheral intravenous catheter system can include a peripheral intravenous catheter and a female luer adapter coupled to the peripheral intravenous catheter.

[0011] In some embodiments, a peripheral intravenous catheter system may include a blood collection device that may include a distal end. In some embodiments, the distal end of the blood collection device may include a male Luer adapter that may be coupled to a male Luer adapter, which may be coupled to a female Luer adapter. In some embodiments, the male Luer adapter may include a distal opening. In some embodiments, the blood collection device may include a cannula in fluid communication with the male Luer adapter. In some embodiments, the cannula may include a distal end and a sharp proximal tip. In some embodiments, the blood collection device may include an elongated neck disposed between the male Luer adapter and the sharp proximal tip. In some embodiments, the blood collection device may include a fluid path extending from the distal opening through the sharp proximal tip.

[0012] In some embodiments, the peripheral intravenous catheter is 22G to 18G (inclusive) and the total length of the fluid pathway is 2 inches. In some embodiments, the peripheral intravenous catheter is 24G and the total length of the fluid pathway is 5.4 inches. In some embodiments, the total length of the fluid pathway is between 2 inches and 5.4 inches.

[0013] In some embodiments, the diameter of the fluid pathway is constant, the total length of the fluid pathway is represented by L, and the diameter of the fluid pathway is represented by D. In some embodiments, the diameter of the fluid pathway may be larger than the minimum inner diameter of the peripheral intravenous catheter. In some embodiments, D 4 / L is less than or equal to a predetermined value that may be based on the gauge of the peripheral intravenous catheter.

[0014] In some embodiments, the gauge of the peripheral intravenous catheter is 24G and 4 / L is 5.8E-08 cubic inches or less. In some embodiments, the gauge of the peripheral intravenous catheter is 22G, and 4 / L is 1.6E-07 cubic inches or less. In some embodiments, the gauge of the peripheral intravenous catheter is 20G, and 4 / L is 3.1E-07 cubic inches or less. In some embodiments, the gauge of the peripheral intravenous catheter is 18G, and 4 / L is 5.8E-08 cubic inches or less.

[0015] In some embodiments, the male Luer adapter of the blood collection device may include a collar. In some embodiments, the outer diameter of the collar may be larger than the outer diameter of the elongate neck. In some embodiments, the blood collection device may include a holder configured to receive a blood collection tube. In some embodiments, the holder may include a cylindrical body. In some embodiments, the sharp proximal tip is disposed at the center of the cylindrical body. In some embodiments, the outer diameter of the holder may be larger than the outer diameter of the elongate neck. In some embodiments, the elongate neck may be disposed between the holder and the collar. In some embodiments, the distal end of the cannula may be integrated into the elongate neck. In some embodiments, the blood collection device may be gauge-specific or configured for use with a particular gauge of catheter. In some embodiments, the blood collection device may be configured for use with a single gauge of catheter or with multiple gauges of catheter. In some embodiments, D may be equal to or greater than the inner diameter of the catheter.

[0016] In some embodiments, the blood collection device may include another female Luer adapter disposed at the proximal end of the elongate neck. In some embodiments, the distal end of the holder may include another male Luer adapter. In some embodiments, the other female Luer adapter may be coupled to the other male Luer adapter.

[0017] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality 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 is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0018] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1A] FIG. 1A is a top perspective view of a prior art blood collection device. [Figure 1B] FIG. 1B is a cross-sectional view of a prior art blood collection device. [Figure 2A] FIG. 2A is a top perspective view of an exemplary blood collection device, according to some embodiments. [Figure 2B] FIG. 2B is a cross-sectional view of a blood collection device, according to some embodiments. [Figure 2C] FIG. 2C is a top perspective view of a portion of an exemplary blood collection device, according to some embodiments. [Figure 2D] FIG. 2D is a cross-sectional view of a portion coupled to the remainder of a blood collection device, according to some embodiments. [Figure 3A] FIG. 3A is a top perspective view of an exemplary peripheral intravenous catheter system, according to some embodiments. [Figure 3B] FIG. 3B is a cross-sectional view of a peripheral intravenous catheter system showing an exemplary needle assembly detached, according to some embodiments. [Figure 4A]FIG. 4A is a bar graph showing the average maximum shear ratio and average blood collection rate ratio of exemplary blood collection devices compared to best-in-class prior art blood collection devices, according to some embodiments, each of which includes a fluid path having a total length represented by L. [Figure 4B] FIG. 4B is a bar graph showing the sum of maximum shear ratios and sum of blood collection rate ratios of exemplary blood collection devices compared to best-in-class prior art blood collection devices, according to some embodiments, each including a fluid path having a total length represented by L. [Figure 4C] FIG. 4C is a bar graph showing the average maximum shear ratio and average blood collection rate ratio of exemplary blood collection devices compared to best-in-class prior art blood collection devices, according to some embodiments, each of which includes a fluid path having a total length represented by L. DETAILED DESCRIPTION OF THE INVENTION

[0019] 1A-1B, a prior art blood collection device 10 is shown. The prior art blood collection device 10 may correspond to a BD Vacutainer® LUER-LOK® access device available from Becton Dickinson & Company of Franklin Lakes, New Jersey. The prior art blood collection device 10 is typically used during blood collection via an extension set of a catheter assembly inserted into a patient's vascular system. The prior art blood collection device 10 is configured to receive a blood collection container, such as a BD Vacutainer® tube. The prior art blood collection device 10 includes a cannula 12 configured to flash a rubber stopper on the BD Vacutainer® tube in response to the BD Vacutainer® tube being inserted into the prior art blood collection device 10.

[0020] 2A-2B, a blood collection device 20 is shown, according to some embodiments. In some embodiments, the blood collection device 20 may include a distal end 22 and a proximal end 24. In some embodiments, the distal end 22 of the blood collection device 20 may include a male Luer adapter 26, which may include a distal opening 28. In some embodiments, the blood collection device 20 may include a cannula 30 in fluid communication with the male Luer adapter 26. In some embodiments, the cannula 30 may include a distal end 32 and a sharp proximal tip 34. In some embodiments, the cannula 30 may be comprised of a metal or another suitable material configured to punctuate a seal of a blood collection container, such as a blood collection tube. In some embodiments, in response to insertion of an elastomeric sheath 31 and a blood collection container inserted into the blood collection device 20, the sharp proximal tip 34 may puncture the elastomeric sheath 31, which may be distally compressed by the blood collection container.

[0021] In some embodiments, the blood collection device 20 may include an elongated neck 35 disposed between the male luer adapter 26 and the sharp proximal tip 34. In some embodiments, the blood collection device 20 may include a fluid pathway 36 extending from the distal opening 28 through the sharp proximal tip 34. In some embodiments, the diameter 37 of the fluid pathway 36 is constant. In some embodiments, the overall length 38 of the fluid pathway 36 is represented by L, and the diameter 37 of the fluid pathway 36 is represented by D, as will be discussed in more detail below.

[0022] In some embodiments, the male Luer adapter 26 of the blood collection device 20 may include a collar 39 that may extend around the protrusion 40 of the male Luer adapter 26. In some embodiments, the distal opening 28 may be located within the distal-most portion of the protrusion 40. In some embodiments, the inner surface of the collar 39 may be threaded to form a Luer lock fit with a corresponding female Luer adapter. In other embodiments, the inner surface of the collar 39 may be smooth to form a slip fit with a corresponding female Luer adapter. In some embodiments, the fluid pathway 36 may be formed entirely by the cannula 30, which may extend through the collar 39 and form the protrusion 40 and the distal opening 28.

[0023] In some embodiments, the outer diameter of collar 39 may be larger than the outer diameter of elongated neck 35. In some embodiments, blood collection device 20 may include a holder 41 configured to receive a blood collection container, such as a blood collection tube. In some embodiments, holder 41 may include a cylindrical body 42. In some embodiments, sharp proximal tip 34 may be disposed at the center of cylindrical body 42 to facilitate puncturing a seal of the blood collection container in response to insertion of the blood collection container within proximal opening 44 of cylindrical body 42.

[0024] In some embodiments, the outer diameter of cylindrical body 42 may be larger than the outer diameter of elongated neck 35. In some embodiments, elongated neck 35 may be disposed between holder 41 and collar 39. In some embodiments, distal end 32 of cannula 30 may be integrally secured within elongated neck 35. In some embodiments, elastomeric sheath 21 may be bonded to the inner surface of holder 41.

[0025] 2C-2D, in some embodiments, blood collection device 20 may include a female Luer adapter 46 disposed at the proximal end of elongated neck 35. In some embodiments, the distal end of holder 41 may include another male Luer adapter 48. In some embodiments, female Luer adapter 46 may be coupled to male Luer adapter 48. Thus, in some embodiments, blood collection device 20 may include extension 50, which a user may couple to holder 41 to provide elongated neck 35 and increased L, which may reduce the risk of hemolysis. In these and other embodiments, D may correspond to the inner diameter of cannula 30. In some embodiments, the inner diameter of elongated neck 35 may be equal to D along all or a portion of elongated neck 35. In some embodiments, male Luer adapter 48 may be similar or identical to male Luer adapter 26 with respect to one or more features and / or operation.

[0026] 3A-3B, a peripheral intravenous catheter system 52 is shown, according to some embodiments. In some embodiments, the peripheral intravenous catheter system 52 may include a peripheral intravenous catheter 54 and a female luer adapter 56 coupled to the peripheral intravenous catheter 54. In some embodiments, the peripheral intravenous catheter system 52 may include a blood collection device 20 that may reduce the risk of hemolysis.

[0027] In some embodiments, the peripheral intravenous catheter system 52 may include a catheter adapter 58, which may include a distal end 60, a proximal end 62, and a lumen 64 extending through the distal end 60 of the catheter adapter 58 and the proximal end 62 of the catheter adapter 58. In some embodiments, the peripheral intravenous catheter 54 may extend distally from the distal end 60 of the catheter adapter 58.

[0028] In some embodiments, the male Luer adapter 26 of the blood collection device 20 may be coupled to the female Luer adapter 56. In some embodiments, the location of the peripheral intravenous catheter system 52 and / or the female Luer adapter 56 may vary. In some embodiments, the peripheral intravenous catheter system 52 may include an extension tube 66, which may include a distal end integrated with a side port 68 of the catheter adapter 58 and a proximal end integrated with the female Luer adapter 56. In some embodiments, the side port 68 may be disposed between the distal end 60 and the proximal end 62 of the catheter adapter 58 and in fluid communication with the lumen 64. In some embodiments, the proximal end 62 of the catheter adapter 58 may include the female Luer adapter 56, and the blood collection device 20 may be coupled to the proximal end 62 of the catheter adapter 58.

[0029] In some embodiments, the septum 70 may be disposed within the lumen 64 of the catheter adapter 58. In some embodiments, the introducer needle 72 of the needle assembly 74 may extend through the septum 70 and the peripheral intravenous catheter 54 when the peripheral intravenous catheter system 52 is inserted into the patient's vasculature. In some embodiments, the needle assembly 74 may be detached from the peripheral intravenous catheter system 52 in response to the peripheral intravenous catheter 54 being inserted into the vasculature. In some embodiments, the introducer needle 72 may include a sharp distal tip 76 and extend from a needle hub 78 of the needle assembly 74, which may be coupled to the proximal end 62 of the catheter adapter 58.

[0030] Typically, the maximum shear stress during blood collection via a peripheral intravenous catheter 54 is much higher than the maximum shear stress during blood collection using another type of catheter. In some embodiments, the overall length of the fluid pathway 36 is between 2 inches and 5.4 inches, which may reduce the maximum shear stress during blood collection. In some embodiments, the gauge of the peripheral intravenous catheter 54 is between 22G and 18G, and the overall length of the fluid pathway 36 may be approximately 2 inches. In some embodiments, by increasing the overall length of the fluid pathway 36 from 1 inch (as in the prior art blood collection device 10 of FIGS. 1A-1B) to approximately 2 inches for a peripheral intravenous catheter 54 that is 22G to 18G (inclusive), the maximum shear stress during blood collection was reduced an unexpected amount.

[0031] In some embodiments, the gauge of the peripheral intravenous catheter may be 24G and the total length of the fluid pathway 36 may be approximately 5.4 inches. In some embodiments, increasing the total length of the fluid pathway 36 from 1 inch (as in the prior art blood collection device 10 of FIGS. 1A-1B) to approximately 5.4 inches for a 24G peripheral intravenous catheter 54 reduced the maximum shear stress during blood collection by an unexpected amount.

[0032] In some embodiments, the diameter of the fluid pathway 36 may be larger than the minimum inner diameter of the peripheral intravenous catheter 54. 4 / L is less than or equal to a predetermined value that may be based on the gauge of the peripheral intravenous catheter 54. In some embodiments, the predetermined value may correspond to a value determined to be at low risk of hemolysis. In some embodiments, the gauge of the peripheral intravenous catheter is 24G, and D 4 / L is 5.8E-08 cubic inches or less. In some embodiments, the gauge of the peripheral intravenous catheter is 22G, and 4 / L is 1.6E-07 cubic inches or less. In some embodiments, the gauge of the peripheral intravenous catheter is 20G, and 4 / L is 3.1E-07 cubic inches or less. In some embodiments, the gauge of the peripheral intravenous catheter is 18G, and 4 / L is 5.8E-08 cubic inches or less.

[0033] Referring now to FIG. 4A, a bar graph shows the maximum shear ratio and blood collection rate ratio for blood collection device 20 compared to a best-in-class prior art blood collection device, i.e., a 21G BD Vacutainer® ULTRATOUCH™ push-button blood collection set (referred to as the "21G UT w BC set" or "UT"). In some embodiments, the gauge of the peripheral intravenous catheter may be 24G, and the total length of fluid path 36 may be approximately 5.4 inches. In some embodiments, increasing the total length of fluid path 36 from 1 inch (as in prior art blood collection device 10 of FIGS. 1A-1B) to approximately 5.4 inches for a 24G peripheral intravenous catheter 54 reduced the maximum shear stress ratio during blood collection by an unexpected amount. In some embodiments, increasing the overall length of the fluid path 36 (see FIG. 2) from 1 inch (as in the prior art blood collection device 10 of FIGS. 1A-1B) to approximately 2 inches in an 18G-22G peripheral intravenous catheter 54 (see FIG. 3) unexpectedly reduced the maximum shear stress to UT ratio during blood collection.

[0034] In some embodiments, when the peripheral intravenous catheter 54 is 18G or 20G, matching the maximum shear stress results in a blood draw rate that is the same as the UT. In some embodiments, when the peripheral intravenous catheter 54 is 22G, the blood draw rate may be slightly slower than the UT, and when the peripheral intravenous catheter 54 is 24G, matching the maximum shear results in a blood draw rate that is significantly lower than the UT. Referring now to FIG. 4A, a bar graph shows the maximum shear ratio and blood draw rate ratio of the blood collection device 20 compared to a best-in-class prior art blood collection device, namely, the 21G BD Vacutainer® ULTRATOUCH™ push-button blood collection set (referred to as the "21G UT w BC set" or "UT"). Results are illustrated for blood collection devices 20 with D equal to 0.024 inches and 0.017 inches. Results are illustrated for blood collection devices 20 with L equal to 1 inch, 1.6 inches, and 1.44 inches.

[0035] In some embodiments, with a 24G peripheral intravenous catheter 54, if D of the fluid path 36 is reduced to 0.017 inches, L of the fluid path 36 can be significantly reduced to 1.44 inches, which may be just larger than the minimum inner diameter of the tip of the peripheral intravenous catheter 54. In some embodiments, if D is larger than the minimum inner diameter of the tip and D 4 As long as the volume per liter is maintained at 5.8E-8 cubic inches, the maximum shear stress in blood draws using a 24G peripheral intravenous catheter 54 matches that of the UT. Similarly, in some embodiments, using a 22G to 18G (inclusive) peripheral intravenous catheter 54, the L of the fluid path 36 can be significantly reduced to 1.6 inches to match the maximum shear stress of the UT. However, in some embodiments, the draw rate is only one-third that of the UT, as shown in FIG. 4B.

[0036] Referring now to FIG. 4A , a bar graph shows the maximum shear ratio and blood collection rate ratio of blood collection device 20 compared to a best-in-class prior art blood collection device, namely, the 21G BD Vacutainer® ULTRATOUCH™ push-button blood collection set (referred to as the “21G UT w BC set” or “UT”). Results are illustrated for blood collection devices 20 having D equal to 0.024 inches, 0.017 inches, 0.036 inches, 0.029 inches, and 0.023 inches. Results are illustrated for blood collection devices 20 having L equal to 1 inch, 1.44 inches, 2.92 inches, 2.25 inches, and 1.73 inches. In some embodiments, different geometries of blood collection device 20 may be used for different catheter gauges.

[0037] In some embodiments, the limiting factor for blood withdrawal rate when matching the maximum shear stress to UT is the minimum inner diameter within the peripheral intravenous catheter system, which may be the minimum inner diameter of the tip of the peripheral intravenous catheter 54. For a peripheral intravenous catheter 54 that is 20G or 18G, the blood withdrawal rate can be increased by increasing the D of the fluid path 36. In some embodiments, the blood withdrawal rate can be increased by increasing the D greater than the minimum inner diameter of the peripheral intravenous catheter system. In some embodiments, the D 4 By increasing L while maintaining / L below a predetermined or critical value, the maximum shear stress can be reduced to match or be below the UT. In some embodiments, if the peripheral intravenous catheter 54 is 22G, L can be reduced from 2 inches to 1.73 inches when matching the maximum shear of the UT by decreasing D to be just larger than the smallest inner diameter of the tip.

[0038] In some embodiments, a method of manufacturing a peripheral intravenous catheter system can include selecting a target maximum shear stress, such as that of UT. 4 The method may include reducing the current maximum shear stress in the peripheral intravenous catheter system by increasing L while maintaining / L at or below a predetermined value.

[0039] All examples and conditional language set forth herein are intended for educational purposes to aid the reader in understanding the present disclosure and concepts provided by the inventors to further the present technology, and should be construed as not being limited to such specifically recited examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations can be made thereto without departing from the spirit and scope of the disclosed embodiments.

Claims

1. 1. A peripheral intravenous catheter system for reducing the risk of hemolysis, comprising: a peripheral intravenous catheter; a female luer adapter coupled to the peripheral intravenous catheter; 1. A blood collection device comprising: a distal end including a male luer adapter coupled to the female luer adapter, the male luer adapter having a distal opening; a cannula in fluid communication with the male luer adapter, the cannula having a distal end and a sharp proximal tip; an elongated neck disposed between the male luer adapter and the sharp proximal tip; a fluid path extending from the distal opening through the sharp proximal tip, the fluid path having a constant diameter, the fluid path having a diameter greater than a minimum inner diameter of the peripheral intravenous catheter, the total length of the fluid path being represented by L and the diameter of the fluid path being represented by D; The peripheral intravenous catheter comprises: (i) a 20 gauge (G) catheter; 4 a catheter with a diameter of 3.1E-07 cubic inches or less; and (ii) an 18 gauge (G) catheter; 4 Catheters with a length of 5.8E-08 cubic inches or less a fluid path, which is at least one of a blood collection device comprising: A catheter system comprising:

2. 10. The catheter system of claim 1, wherein the peripheral intravenous catheter is 22G to 18G and the total length of the fluid path is 2 inches.

3. The catheter system of claim 1 , wherein the male luer adapter includes a collar, the collar having an outer diameter greater than an outer diameter of the elongate neck.

4. 4. The catheter system of claim 3, wherein the blood collection device further comprises a holder configured to receive a blood collection tube, the holder comprising a cylindrical body, and the sharp proximal tip is disposed at a center of the cylindrical body.

5. The catheter system of claim 4 , wherein the holder has an outer diameter greater than an outer diameter of the elongate neck, and the elongate neck is disposed between the holder and the collar.

6. The catheter system of claim 1 , wherein the distal end of the cannula is integrated into the elongate neck.

7. 5. The catheter system of claim 4, wherein the blood collection device further comprises another female luer adapter disposed at a proximal end of the elongate neck, and the distal end of the holder comprises another male luer adapter, the another female luer adapter being coupled to the another male luer adapter.

8. 1. A blood collection device for reducing the risk of hemolysis in a peripheral intravenous catheter system, comprising: a distal end comprising a male luer adapter, said male luer adapter comprising a distal opening; a cannula in fluid communication with the male luer adapter, the cannula having a distal end and a sharp proximal tip; an elongated neck disposed between the male luer adapter and the sharp proximal tip; a fluid pathway extending from the distal opening through the sharp proximal tip, the fluid pathway having a constant diameter; the total length of the fluid path is represented by L, the diameter of the fluid path is represented by D, the blood collection device is gauge specific; the blood collection device is gauge specific; (i) a 20 gauge (G) catheter; 4 a catheter with a diameter of 3.1E-07 cubic inches or less; and (ii) an 18 gauge (G) catheter; 4 Catheters with a length of 5.8E-08 cubic inches or less a fluid path configured for use with at least one of A blood collection device comprising:

9. 9. The blood collection device of claim 8, wherein the total length of the fluid path is between 2 inches and 5.4 inches.

10. The blood collection device of claim 8 , wherein D is equal to or greater than the inner diameter of the catheter.

11. 11. The blood collection device of claim 10, further comprising a holder configured to receive a blood collection tube, the holder comprising a cylindrical body, the sharp proximal tip being disposed at the center of the cylindrical body.

12. The blood collection device of claim 11 , wherein the holder has an outer diameter greater than the elongate neck outer diameter.

13. The blood collection device of claim 11 , wherein the distal end of the cannula is integrated into the elongate neck.

14. 12. The blood collection device of claim 11, wherein the blood collection device further comprises another female luer adapter disposed at the proximal end of the elongate neck, and the distal end of the holder comprises another male luer adapter, the another female luer adapter being coupled to the another male luer adapter.

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