Blood withdrawal syringe with hemolysis protection

Abstract

A blood collection device can include a syringe having hemolysis protection. The syringe with hemolysis protection can be coupled to a catheter assembly and used to draw blood. The blood collection device can include a syringe that can include a distal end and a flow restrictor. The flow restrictor can include a distal end and a proximal end. The proximal end of the flow restrictor can be coupled to the distal end of the syringe such that hemolysis can be protected against.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 090,602, entitled “Blood-Drawing Injector with Hemolysis Protection,” filed October 12, 2020, the entire disclosure of which is incorporated herein by reference. Background Technology

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

[0004] The catheter may include a peripheral intravenous (“IV”) catheter. In this case, the catheter may be mounted on a guide needle with a sharp distal tip. The catheter and guide needle may be assembled such that the distal tip of the guide needle extends beyond the distal tip of the catheter, with the bevel of the needle facing upwards and away from the patient’s skin. The catheter and guide needle are typically inserted into the patient’s vascular system through the skin at a shallow angle.

[0005] To verify proper placement of the guide needle and / or catheter in the blood vessel, clinicians typically confirm the presence of a blood "flashback" in the flashback lumen of the catheter assembly. Once needle placement has been confirmed, the clinician can remove the guide needle, leaving the catheter in place for future fluid infusions.

[0006] Blood draws are not routinely performed via peripheral venous catheters, largely due to the risk of hemolysis associated with blood samples collected through these catheters. When blood draws are performed via a peripheral venous catheter, the commonly used blood collection container is the VACUTAINER, available from Becton Dickinson & Company. 注册商标 Blood collection tubes. In some cases, a syringe can be used instead. However, with VACUTAINER... 注册商标 In contrast, syringes did not show a reduction in the risk of hemolysis.

[0007] The disadvantage is that when blood is drawn into a syringe or VACUTAINER 注册商标 During this time, red blood cells are under high shear stress, and due to the intravenous infusion and the syringe or VACUTAINER... 注册商标 The high pressure difference between the two vessels makes hemolysis more likely. Hemolysis can lead to unqualified blood samples that must be discarded. The high pressure difference can also cause catheter tip collapse, vein collapse, or other complications.

[0008] The subject matter claimed herein is not limited to implementations that address all drawbacks 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 blood collection devices and related apparatuses, systems, and methods. In some embodiments, the blood collection system may include a catheter assembly that may include a catheter adapter and a catheter extending distally from the catheter adapter. In some embodiments, the blood collection system may include a blood collection device coupled to the catheter assembly. In some embodiments, the blood collection device may include a syringe that may include a distal end. In some embodiments, the blood collection device may include a flow restrictor that may include a distal end and a proximal end. In some embodiments, the proximal end of the flow restrictor may be coupled to the distal end of the syringe.

[0010] In some embodiments, the catheter assembly may include an extension tube. In some embodiments, the distal end of the extension tube may be integrated with a catheter adapter. In some embodiments, a blood collection device may be coupled to the proximal end of the extension tube.

[0011] In some embodiments, the distal end of the syringe may include a first Luer adapter. In some embodiments, the proximal end of the flow limiter may include a second Luer adapter coupled to the first Luer adapter. In some embodiments, the flow limiter may be integrally formed as a single unit. In these and other embodiments, the distal end of the flow limiter may include a third Luer adapter.

[0012] In some embodiments, the distal end of the current limiter may include a third Luer adapter. In these and other embodiments, the current limiter may include an extension tube disposed between the second and third Luer adapters. In these and other embodiments, the current limiter may include a first component integrally formed as a single unit and a second component integrally formed as a single unit. In some embodiments, the proximal end of the extension tube may be integrated within the first component. In some embodiments, the distal end of the extension tube may be integrated within the second component. In some embodiments, the first component may include a second Luer adapter. In some embodiments, the second component may include a third Luer adapter.

[0013] In some implementations, the geometric factor of the current limiter is G f In some implementations, G... f It can be 1.43E7 1 / in 3 ±30%. In some implementations, G fIt can be 3.70E6 1 / in 3 ±30%. In some implementations, G f It can be between 1.43E7 and 3.70E6. In some implementations, G f It can be 1.43E7 1 / in 3 ±10% or 3.70E6 1 / in 3 ±10%.

[0014] In some embodiments, the flow restrictor may include a fluid path extending through the flow restrictor. In some embodiments, the diameter of the fluid path may be uniform along its entire length. In these embodiments, the diameter is denoted by D, the length by L, and D... 4 / L can be 2.7E-7 or 7.0E-8.

[0015] It should be understood that, as requested, the foregoing overview and the following detailed description are illustrative and exemplary of the invention, and not restrictive. 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 the various embodiments can be combined or other embodiments can be utilized, and structural changes can be made (unless required). Therefore, the following detailed description should not be considered restrictive. Attached Figure Description

[0016] The exemplary embodiments will be described and explained with additional specificity and detail using the accompanying drawings, wherein:

[0017] Figure 1A This is a top-view perspective view of an example blood collection device including hemolysis protection according to some embodiments;

[0018] Figure 1B It is based on some implementation methods Figure 1A A cross-sectional view of a blood collection device;

[0019] Figure 2A This is a top view of another example blood collection device including hemolysis protection according to some embodiments;

[0020] Figure 2B It is based on some implementation methods Figure 2A A cross-sectional view of a blood collection device;

[0021] Figure 3 This is a top-view perspective view of an example blood collection system based on some implementation methods;

[0022] Figure 4This is a bar graph showing the blood collection rate using different catheter sizes and flow restrictors at different syringe extraction rates according to some embodiments;

[0023] Figure 5 This is a bar graph showing the maximum shear stress at different syringe extraction rates using different catheter sizes and flow restrictors, according to some embodiments; and

[0024] Figure 6 This is a diagram illustrating plasma free hemoglobin in catheter assemblies with and without flow restrictors according to some embodiments. Detailed Implementation

[0025] In some embodiments, the blood collection device 10 may include a syringe 12, which may include a distal end 14 and a proximal end 16. In some embodiments, the syringe 12 may include a sliding plunger 18 tightly fitted within a barrel or tube 20. In some embodiments, the sliding plunger 18 may be pulled proximally relative to the tube 20, thereby allowing the syringe 12 to draw in liquid—such as blood—through an orifice 22 at the distal end 14. In some embodiments, the sliding plunger 18 may be pushed distally relative to the tube 20, thereby allowing the syringe 12 to subsequently expel the liquid through the orifice 22. In some embodiments, the syringe 12 may be configured to contain between about 1 ml and 20 ml of liquid.

[0026] In some embodiments, the blood collection device 10 may include a flow restrictor 24, which may include a distal end 26 and a proximal end 28. In some embodiments, the proximal end 28 of the flow restrictor 24 may be coupled to the distal end 14 of the syringe 12. In some embodiments, the flow restrictor 24 may be detachably coupled to the distal end 14 of the syringe 12. In other embodiments, the flow restrictor 24 may be permanently coupled to the distal end 14 of the syringe 12.

[0027] In some embodiments, the distal end 14 of the syringe 12 may include a first Luer adapter 30. In some embodiments, the proximal end 16 of the flow restrictor 24 may include a second Luer adapter 32 coupled to the first Luer adapter 30. In some embodiments, the first Luer adapter 30 may include a convex Luer adapter that can be threadedly or slidably engaged with the second Luer adapter 32, which may include a concave Luer adapter. In some embodiments, the threaded connection between the first Luer adapter 30 and the second Luer adapter 32 prevents the syringe 12 from accidentally disengaging from the flow restrictor 24 during blood collection.

[0028] In some implementations, the current limiter 24 can be integrally formed as a single unit, for example, Figure 1A-1B As shown. In these and other embodiments, the distal end 26 of the flow restrictor 24 may include a third Luer adapter 34. In some embodiments, the third Luer adapter 34 may include a convex Luer adapter. In some embodiments, the distal end 26 of the flow restrictor 24 may be configured to connect to a catheter assembly that can be inserted into a patient's vascular system. In some embodiments, the sliding plunger 18 may be pulled proximally to draw blood from the patient's vascular system into the tube 20 of the syringe 12.

[0029] In some embodiments, the length of the flow restrictor 24 may be less than the length of the syringe 12 for ease of operation by the user. In some embodiments, the flow restrictor 24 may include a fluid path 36 extending through the flow restrictor 24. Typically, when blood flows in the fluid path, blood cells are subjected to shear stress. The maximum shear stress occurs along the blood cell wall, or wall shear stress. Wall shear stress on blood cells is considered a major cause of hemolysis and mechanical damage to blood cells.

[0030] In some embodiments, the flow limiter 24 can provide hemolysis protection. More specifically, the flow limiter 24 can limit the maximum blood collection rate, which in turn limits the maximum shear stress during blood collection and reduces hemolysis. In some embodiments, the flow limiter 24 can be configured to limit the maximum shear stress exposed to blood cells during syringe aspiration to a predetermined or target value.

[0031] The fluid flow in a flow restrictor with a tubular fluid path can be analyzed using the Poiseuille equation:

[0032]

[0033] Where P is the change in pressure gradient through the flow restrictor, D and L are the inner diameter and length of the fluid path 36 passing through the flow restrictor, respectively, and μ is the viscosity of the fluid. It is fluid resistance. Since μ is the viscosity of the fluid rather than part of the flow restrictor geometry, it defines the geometry factor G. f This makes R f (fluid resistance) is in In some implementations, the current limiter may include current limiter 24 or current limiter 38 (e.g., see...). Figure 2A-2B ).

[0034] In response to a fluid path 36 having multiple segments of various lengths (L1, L2, L3) and various inner diameters (D1, D2, D3), the fluid resistance is:

[0035]

[0036] In some implementations, the current limiter can be configured to limit G. f This limits hemolysis. For example, for flow limiter 24, G f It could be approximately 1.43E7 1 / in 3 In some implementations, for current limiter 24, G f It can be 1.43E7 1 / in 3 ±10% or 1.43E7 1 / in 3 ±30%.

[0037] In some embodiments, the inner diameter of the fluid path 36 may be consistent along the entire length of the fluid path 36. In some embodiments, D 4 / L is approximately 2.7E-7, which can reduce wall shear stress to reduce hemolysis when the flow restrictor 24 is used with a 20G catheter. In some embodiments, D 4 / L is approximately 7.0E-8, which can reduce wall shear stress to reduce hemolysis when the flow restrictor 24 is used with a 22G catheter.

[0038] Now refer to Figure 2A-2B In some embodiments, the blood collection device 10 may include a flow limiter 38. In some embodiments, the flow limiter 38 may be similar to or identical to the flow limiter 24 in one or more features and / or operations. In some embodiments, the flow limiter 38 may also be configured to limit G... f This limits hemolysis. For example, for flow limiter 38, G f It could be approximately 3.70E6 1 / in 3 In some implementations, for current limiter 38, G f It can be 3.70E6 1 / in 3 ±10% or 3.70E6 1 / in 3 ±30%. In some implementations, specific current limiters—such as, for example, current limiter 24 or current limiter 38—may have a G value between 1.43E7 and 3.70E6. f In some embodiments, the inner diameter of the fluid path 36 may vary along the length of the fluid path 36. In these and other embodiments, the flow restrictor 38 may include multiple sections formed by tubes with different inner diameters joined together, or a single tube whose inner diameter varies along its length.

[0039] In some embodiments, the distal end 26 of the current limiter 38 may include a third Luer adapter 34. In these and other embodiments, the current limiter 38 may include an extension tube 44 disposed between the second Luer adapter 32 and the third Luer adapter 34. In these and other embodiments, the current limiter 38 may include a first component 40 integrally formed as a single unit and / or a second component 42 integrally formed as a single unit. In some embodiments, the proximal end of the extension tube 44 may be integrated within the first component 40. In some embodiments, the distal end of the extension tube 44 may be integrated within the second component 42. In some embodiments, the first component 40 may include the second Luer adapter 32. In some embodiments, the second component 42 may include the third Luer adapter 34.

[0040] In some embodiments, the length of the flow restrictor 38 may be less than the length of the syringe 12 for ease of user operation. In some embodiments, the flow restrictor 38 may include a fluid path 36 extending through the flow restrictor 24. In some embodiments, the inner diameter of the fluid path 36 may be consistent along its entire length. In some embodiments, the inner diameter is denoted by D, the length by L, and D... 4 / L is 2.7E-7, which can reduce wall shear stress to reduce hemolysis when the flow restrictor 38 is used with a 20G catheter. In some embodiments, the inner diameter is represented by D, the length by L, and D 4 The / L is 7.0E-8, which can reduce wall shear stress to reduce hemolysis when the flow restrictor 38 is used with a 22G catheter.

[0041] Now refer to Figure 3 Such as current limiter 24 (for example, see Figure 1A-1B ) or current limiter 38 (for example, see Figure 2A-2B A flow restrictor can be coupled to catheter assembly 46. In some embodiments, catheter assembly 46 may include catheter adapter 48 and catheter 50 extending distally from catheter adapter 48. In some embodiments, catheter assembly 46 may include extension tube 52. In some embodiments, the distal end of extension tube 52 may be integrated with catheter adapter 48. In some embodiments, blood collection device 10 may be coupled to the proximal end of extension tube 52.

[0042] In some embodiments, the needle assembly 54 may be coupled to the catheter assembly 46. In some embodiments, the needle assembly 54 may include a needle hub 56 and a guide needle 58 secured within the needle hub 56. In some embodiments, the needle assembly 54 may be removed from the catheter assembly 46 in response to insertion of the catheter 50 into the patient's vascular system. In some embodiments, the proximal end of the extension tube 52 may be integrated with the side port 60 of the catheter adapter 48.

[0043] In some implementations, catheter assembly 46 may include or correspond to any suitable catheter assembly, such as, for example, BD NEXIVA. 商标 Closed intravenous catheter system, BD CATHENA 商标 Catheter system, BD VENFLON 商标 Professional and safe shielded intravenous catheter system, BD NEOFLON 商标 Intravenous catheterization system, BD INSYTE 商标 AUTOGUARD 商标 BC-shielded intravenous catheter system or other suitable catheter assembly. In some embodiments, catheter 50 may include a peripheral intravenous catheter (PIVC), a peripherally inserted central catheter (PICC), a midline catheter, or other suitable catheter.

[0044] In some embodiments, in response to insertion of catheter 50 into the vascular system, blood can flow proximally through a fluid path of catheter assembly 46, which may include one or more of the following: catheter 50, catheter adapter 48, extension tube 52, adapter 62, flow restrictor, and syringe 12.

[0045] Now refer to Figure 4 The bar graph illustrates blood collection rates using different catheter sizes and flow restrictors at different syringe aspiration rates, according to some embodiments. "Hemoshield1" refers to a first example flow restrictor coupled to the catheter assembly. Hemoshield1 may include a flow restrictor coupled to the catheter assembly. Figure 1A-1B Current limiter 24 or Figure 2A-2B The current limiter 38. In this example, Hemoshield 1's D 4 / L is approximately 7e-8, but the D 4 / L can also be changed. "Hemoshield 2" refers to another example flow restrictor connected to the catheter assembly. Hemoshield 2 may include connections to the catheter assembly. Figure 1A-1B Current limiter 24 or Figure 2A-2B The current limiter 38. In this example, the D of Hemoshield 2 4 / L is approximately 2.7e-8, but the D 4 / L can also be changed. "None" refers to the conduit assembly that is not connected to the flow limiter.

[0046] Without a flow restrictor, blood flow rate varies significantly with syringe withdrawal rate. However, by using flow restrictors (Hemoshield 1 and Hemoshield 2 in the experiment), the flow rate through the catheter during blood collection becomes independent of the syringe withdrawal rate. According to some implementations, this will greatly reduce variability in syringe withdrawal in a clinical setting.

[0047] Figure 5 This is a bar graph showing the maximum shear stress using different catheter sizes and flow restrictors at different syringe extraction rates according to some embodiments. Similarly, "Hemoshield 1" refers to a first example flow restrictor coupled to the catheter assembly. Hemoshield 1 may include a flow restrictor coupled to the catheter assembly. Figure 1A-1B Current limiter 24 or Figure 2A-2B The current limiter 38. In this example, Hemoshield 1's D 4 / L is approximately 7e-8, but the D 4 / L can also be changed. "Hemoshield 2" refers to another example flow restrictor connected to the catheter assembly. Hemoshield 2 may include connections to the catheter assembly. Figure 1A-1B Current limiter 24 or Figure 2A-2B The current limiter 38. In this example, the D of Hemoshield 2 4 / L is approximately 2.7e-8, but the D 4 / L can also be changed. “None” refers to a conduit assembly not connected to a flow limiter. “UT 21G” refers to a prior art conduit assembly with a 21G conduit.

[0048] The combined maximum shear stress for each catheter specification can be shown as [compared to the value of the catheter with...]. The ratio of the maximum shear stress of the UT21G catheter, previously considered the gold standard for blood aspiration, is used. Since shear stress can cause mechanical hemolysis, reducing the shear stress during catheter aspiration to the shear stress of UT21G reduces the risk of hemolysis. Data show that for 18G catheters, the risk of hemolysis is low when using a syringe to aspirate blood. However, the risk of hemolysis increases with increasing catheter size. For 20G catheters, the risk of hemolysis is moderate at lower syringe pull speeds, but increases at higher pull speeds. Using D... 4 With a flow limiter of 2.7e-7 / L, the maximum shear rate during catheter withdrawal is reduced to 21G UT for all tested syringe withdrawal rates. For 22G catheters, the risk of hemolysis is significant at higher withdrawal rates. For all tested syringe pull rates, D 4A flow restrictor with a shear rate of 7e-8 further reduced the shear rate to the gold standard. For 24G catheters, the tested flow restrictor was able to reduce the maximum shear stress by 2.5 to 3 times, depending on the syringe withdrawal rate.

[0049] Figure 6 This is an illustration of plasma free hemoglobin in catheter assemblies with and without flow restrictors according to some embodiments. "IAG" refers to the prior art catheter assembly, namely INSYTE™, available from Becton Dickinson & Company, Franklin Lake, New Jersey. 商标 AUTOGUARD™ 商标 BC-covered intravenous catheter. "IAG+H" refers to connections to, for example,... Figure 1A-1B Current limiter 24 or Figure 2A-2B The flow limiter 38 is a prior art catheter assembly. "UT" refers to another prior art catheter assembly. Hemoshield 1 was used in a hemolysis study using 24G IAG, where all samples were hemolyzed (measured by the presence of free hemoglobin in plasma) without the flow limiter. Using Hemoshield 1, hemolysis was reduced to a UT level of 21G.

[0050] All examples and conditional language described herein are intended for illustrative purposes to aid the reader's understanding of the invention and the inventive conception made by the inventors for further development of the art, and should be construed as not being limited to such specific examples and conditions. Although embodiments of this disclosure have been described in detail, it should be understood that various changes, substitutions, and modifications can be made therein without departing from the spirit and scope of this disclosure.

Claims

1. A blood collection device, characterized in that, The blood collection device includes: A syringe, comprising a distal end; and A flow restrictor includes a distal end, a proximal end, an inner diameter D, and a length L between the distal end and the proximal end, wherein the proximal end is coupled to the distal end of the syringe, and wherein the geometric factor of the flow restrictor is G. f It is indicated that G f = L / D 4 And wherein G f It is at least one of the following: i)1.43E7 1 / in 3 ±30%; ii)3.70E6 1 / in 3 ±30%; iii) at 1.43E7 1 / in 3 and 3.70E6 1 / in 3 between; iv)1.43E7 1 / in 3 ±10%; or v)3.70E6 1 / in 3 ±10%。 2. The blood collection device according to claim 1, characterized in that, The distal end of the current limiter is configured to connect to the conduit assembly.

3. The blood collection device according to claim 1, characterized in that, The distal end of the syringe includes a first Luer adapter, wherein the proximal end of the flow limiter includes a second Luer adapter coupled to the first Luer adapter.

4. The blood collection device according to claim 3, characterized in that, The overall terrain of the current limiter is divided into a single unit.

5. The blood collection device according to claim 4, characterized in that, The distal end of the current limiter includes a third Luer adapter.

6. The blood collection device according to claim 3, characterized in that, The distal end of the current limiter includes a third Luer adapter, wherein the current limiter further includes an extension tube disposed between the second Luer adapter and the third Luer adapter.

7. The blood collection device according to claim 6, characterized in that, The current limiter includes a first component and a second component that are integrally formed as a single unit, wherein the proximal end of the extension tube is integrated within the first component, wherein the distal end of the extension tube is integrated within the second component, wherein the first component includes a second Luer adapter, and wherein the second component includes the third Luer adapter.

8. The blood collection device according to claim 1, characterized in that, G f 1.43E7 1 / in 3 ±30%.

9. The blood collection device according to claim 1, characterized in that, G f 3.70E6 1 / in 3 ±30%.

10. The blood collection device according to claim 1, characterized in that, G f At 1.43E7 1 / in 3 With 3.70E6 1 / in 3 between.

11. The blood collection device according to claim 1, characterized in that, G f 1.43E7 1 / in 3 ±10%.

12. A blood collection system, characterized in that, The blood collection system includes: The catheter assembly includes: Conduit adapter; and A catheter extending distally from the catheter adapter; and A blood collection device according to claim 1, connected to the catheter assembly.

13. The blood collection system according to claim 12, characterized in that, The catheter assembly further includes an extension tube, wherein the distal end of the extension tube is integrated with the catheter adapter, and the blood collection device is connected to the proximal end of the extension tube.

14. The blood collection system according to claim 12, characterized in that, The distal end of the syringe includes a first Luer adapter, wherein the proximal end of the flow limiter includes a second Luer adapter coupled to the first Luer adapter.

15. The blood collection system according to claim 14, characterized in that, The overall terrain of the current limiter is divided into a single unit.

16. The blood collection system according to claim 15, characterized in that, The distal end of the current limiter includes a third Luer adapter.

17. The blood collection system according to claim 14, characterized in that, The distal end of the current limiter includes a third Luer adapter, wherein the current limiter further includes an extension tube disposed between the second Luer adapter and the third Luer adapter.

18. The blood collection system according to claim 17, characterized in that, The current limiter includes a first component and a second component that are integrally formed as a single unit, wherein the proximal end of the extension tube is integrated within the first component, wherein the distal end of the extension tube is integrated within the second component, wherein the first component includes a second Luer adapter, and wherein the second component includes the third Luer adapter.

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