Blood protection device

Abstract

The present disclosure relates to a blood protection device for reducing hemolysis in a catheter system, the blood protection device may include a distal end, which may include a distal connector. The distal connector may include a tapered male luer configured to be inserted into the proximal end of the catheter hub to form a tight fluid seal. The blood protection device may include a proximal end that may include an adapter configured to receive a blood collection device. The adapter may include a non-patient cannula configured to pierce the blood collection device. The blood protection device may include an extension tube. A distal end of the extension tube may be secured within the tapered male luer and a proximal end of the extension tube may be secured within the adapter. The extension tube may include a fluid path extending from the distal connector to the adapter.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical devices. In particular, the present disclosure relates to a blood protection device for reducing hemolysis in a catheter system. Background Art

[0002] Catheters are commonly used in various infusion therapies. For example, catheters can be used to infuse fluids into a patient, such as saline solutions, various drugs, and total parenteral nutrition. Catheters can also be used to draw blood from a patient.

[0003] One common type of catheter device includes an over-the-needle intravenous ("IV") catheter. As the name implies, an over-the-needle catheter can be mounted on a guide needle having a sharp distal end. The catheter assembly can include a catheter hub, with the catheter extending distally from the catheter hub and the guide needle extending through the catheter. The catheter and the guide needle can be assembled such that the distal end of the guide needle extends beyond the distal end of the catheter, and the bevel of the needle faces upward away from the patient's skin. The catheter and the guide needle are typically inserted through the skin into the patient's vasculature at a small angle.

[0004] To verify the correct placement of the guide needle and / or catheter in a blood vessel, a clinician typically confirms the presence of a "backflow" of blood in the return lumen of the catheter assembly. Once the placement of the needle is confirmed, the clinician can temporarily occlude the flow in the vasculature and remove the needle, leaving the catheter in place for future blood draws or fluid infusions.

[0005] To draw blood from a patient or collect a blood sample, a blood collection container can be used. The blood collection container can include a syringe or a test tube with a rubber stopper at one end. In some cases, the blood collection container has removed all or part of the air from the test tube, so the pressure inside the blood collection container is lower than the ambient pressure. Such a blood collection container is commonly referred to as an internal vacuum or vacuum tube. A commonly used blood collection container is the BD VACUTAINER blood collection tube, which is available from Becton Dickinson and Company.

[0006] The blood collection container can be connected to the catheter. When the blood collection container is coupled to a catheter inserted into a blood vessel, the pressure in the blood vessel is higher than the pressure in the blood collection container, which pushes the blood through the fluid path inside the catheter into the blood collection container, thereby filling the blood collection container with blood. The vacuum inside the blood collection container decreases as the blood collection container is filled, until the pressure inside the blood collection container is equal to the pressure inside the blood vessel and the blood flow stops.

[0007] Unfortunately, when blood is drawn through a fluid path, the blood is subjected to shear and other stresses, which typically results in hemolysis (e.g., shear-induced hemolysis). The risk of hemolysis is higher for larger volume blood collection containers and arterial blood draws because the pressure differential at the start of blood draw may be higher than that for smaller volume blood draws or venous draws.

[0008] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or operate only in the above-described environments. Rather, this background is provided only to illustrate an exemplary technical field in which some of the embodiments described herein may be practiced. Summary of the Utility Model

[0009] The present disclosure generally relates to a blood protection device for reducing hemolysis in a catheter system, and related devices, systems, and methods. In some embodiments, the catheter system may include a blood protection device coupled to a vascular access device. In some embodiments, the vascular access device may include a catheter, a needle, or other device suitable for blood collection.

[0010] In some embodiments, the blood protection device may include one or more features for reducing shear stress on blood cells as the blood travels proximally through a fluid path, thereby reducing the risk of hemolysis. In some embodiments, these features may be configured to reduce shear stress that might otherwise be caused by a sudden change in geometry. Accordingly, the risk of hemolysis may be reduced as the shear stress is reduced.

[0011] In some embodiments, the blood protection device may include a distal end that may include a distal connector. In some embodiments, the distal connector may include a tapered male Luer that is configured to be inserted into the proximal end of a catheter hub to form a tight fluid seal. In some embodiments, the blood protection device may include a proximal end that may include an adapter configured to receive a blood collection device. In some embodiments, the adapter may include a non-patient cannula configured to pierce the blood collection device.

[0012] In some embodiments, the blood protection device may include an extension tube having a distal end and a proximal end. In some embodiments, the distal end of the extension tube may be fixed within the tapered male Luer. In some embodiments, the proximal end of the extension tube may be fixed within the adapter. In some embodiments, the blood protection device may include a fluid path extending from the distal connector to the adapter.

[0013] In some embodiments, the distal connector may further include a collar that may be configured to connect the distal connector to the proximal end of a catheter hub. In some embodiments, the tapered male Luer may include a distal end and a proximal end. In some embodiments, the distal end of the tapered male Luer may include a funnel portion that may assist in driving blood into the blood protection device without exposing the blood to sharp corners that may increase the risk of hemolysis. In some embodiments, the distal end of the tapered male Luer may have a diameter, and the funnel portion may extend across the entire diameter of the distal end of the tapered male Luer.

[0014] In some embodiments, the distal connector may include a proximally extending flange located within the tapered male Luer and inserted into the distal end of the extension tube. In some embodiments, the funnel portion may include a hole. In some embodiments, the diameter of the hole may be equal to or approximately equal to the diameter of a portion of the fluid path extending through the proximally extending flange.

[0015] In some embodiments, the funnel portion may include an outer diameter. In some embodiments, the outer diameter of the funnel portion may be greater than the outer diameter of the proximally extending flange. In some embodiments, the outer diameter of the funnel portion may be greater than the outer diameter of the distal end of the extension tube. In some embodiments, the fluid path may extend through the funnel portion and / or the proximally extending flange. In some embodiments, the funnel portion, the proximally extending flange, and the fluid path may be aligned with the central axis of the distal connector.

[0016] In some embodiments, the extension tube may include an extension tube lumen and an inner surface that forms the extension tube lumen. In some embodiments, the extension tube lumen may extend through the distal end and the proximal end of the extension tube. In some embodiments, the inner surface of the extension tube may include a chamfer that may be located at the distal end of the extension tube. In some embodiments, the extension tube may include a rounded corner that may be adjacent to and / or proximal to the chamfer. In some embodiments, the chamfer and / or rounded corner of the extension tube may be annular. In some embodiments, the rounded corner and / or chamfer of the extension tube may prevent blood from being exposed to sharp corners when blood flows proximally through the fluid path.

[0017] In some embodiments, the inner surface of the distal end of the tapered male Luer may include a tapered portion. In some embodiments, the diameter of the tapered portion of the distal end of the tapered male Luer may be greater than or equal to the diameter of the lumen of the catheter hub adjacent to the tapered portion. In some embodiments, the tapered portion of the tapered male Luer may prevent blood from being exposed to sharp corners when blood flows proximally through the fluid path.

[0018] In some embodiments, the distal end of the extension tube may have an inner diameter at the chamfer. In some embodiments, the entire tapered male luer lumen distal to the chamfer may have a diameter greater than the inner diameter at the chamfer, which may reduce the risk of hemolysis when blood flows proximally through the fluid path. In some embodiments, the entire tapered male luer lumen distal to the chamfer may have a uniform diameter.

[0019] In some embodiments, the distal end of the extension tube may have an inner diameter at the rounded corner. In some embodiments, the entire tapered male luer lumen distal to the rounded corner may have a diameter greater than the inner diameter at the rounded corner, which may reduce the risk of hemolysis when blood flows proximally through the fluid path. In some embodiments, the entire tapered male luer lumen distal to the rounded corner may have a uniform diameter.

[0020] In some embodiments, one or more portions of the fluid path may include a change in geometry that includes one or more specific features for reducing the rate of change. More specifically, in some embodiments, one or more of a rounded corner, a chamfer, a funnel portion, or a tapered portion may reduce the rate of change of the geometry of the fluid path.

[0021] In some embodiments, a blood protection device for reducing hemolysis in a catheter system may include a distal end that may include a distal connector. In some embodiments, the distal connector may include a tapered male luer that is configured to be inserted into the proximal end of a catheter hub to form a tight fluid seal. In some embodiments, the blood protection device may include a proximal end that may include an adapter configured to receive a blood collection device.

[0022] In some embodiments, the adapter may include a pouch portion. In some embodiments, the adapter may include a non-patient cannula configured to pierce the blood collection device. In some embodiments, the adapter may include a channel extending between the pouch portion and the non-patient cannula. In some embodiments, the channel may include a distal end and a proximal end. In some embodiments, the non-patient cannula may include a non-patient cannula lumen. In some embodiments, the diameter of the proximal end of the channel may be equal to or less than the diameter of the non-patient cannula lumen near the channel, which may prevent blood from being exposed to sharp corners when blood flows proximally through the fluid path.

[0023] In some embodiments, the blood protection device may include an extension tube, which may include a distal end, a proximal end, and an extension tube lumen that extends through the distal end and the proximal end of the extension tube. In some embodiments, the distal end of the extension tube may be fixed within a distal connector. In some embodiments, the proximal end of the extension tube may be fixed within a pouch. In some embodiments, the fluid path may extend from the distal connector to the adapter through the extension tube, a channel, and a non-patient cannula.

[0024] In some embodiments, the channel may include a chamfer. In some embodiments, the distal end of the channel may include a chamfer. In some embodiments, the chamfer of the channel may be annular. In some embodiments, the diameter of the channel at the chamfer may be greater than or equal to the diameter of the extension tube lumen, which may prevent blood from being exposed to sharp corners when blood flows proximally through the fluid path. In some embodiments, the distal end of the channel may be close to the proximal end of the extension tube.

[0025] In some embodiments, the non-patient cannula may include a distal end, a proximal end, and an inner surface that forms a non-patient cannula lumen. In some embodiments, the inner surface at the distal end of the non-patient cannula may include a chamfer. In some embodiments, the chamfer of the non-patient cannula may be annular. In some embodiments, the channel may be tapered in the proximal direction. In these and other embodiments, the diameter of the channel at the proximal end may be less than or equal to the inner diameter of the distal end of the non-patient cannula, which may prevent blood from being exposed to sharp corners when blood flows proximally through the fluid path.

[0026] It should be understood that the foregoing general description and the following detailed description are both exemplary and explanatory and do not limit the utility model as claimed. It should be understood that the various embodiments are not limited to the arrangements and means shown in the 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 present utility model unless stated otherwise. Therefore, the following detailed description should not be considered restrictive. Description of the Drawings

[0027] In conjunction with the drawings, the objects and features of the present utility model will become more apparent from the following description and the appended claims. It should be understood that these drawings only depict typical embodiments of the present utility model and should not be considered as limiting its scope. The present utility model will be described and explained with additional features and details by using the drawings, wherein:

[0028] Figure 1 A cross-sectional view of an exemplary catheter system having an exemplary blood protection device according to some embodiments;

[0029] Figure 2Cross-sectional view of a portion of a catheter system according to some embodiments;

[0030] Figure 3 Cross-sectional view of an exemplary distal connector coupled to an exemplary catheter assembly according to some embodiments;

[0031] Figure 4 Cross-sectional view of an exemplary proximal end of an exemplary blood protection device according to some embodiments;

[0032] Figure 5 Cross-sectional view of another proximal end of a blood protection device according to some embodiments;

[0033] Figure 6 Cross-sectional view of another proximal end of a blood protection device according to some embodiments; and

[0034] Figure 7 Cross-sectional view of another proximal end of a blood protection device according to some embodiments. Detailed Description

[0035] For clarity, it should be understood that the term "proximal" refers to the direction relatively closer to the clinician using the device described in the present disclosure, and the term "distal" refers to the direction relatively farther from the clinician. For example, the end of a catheter placed within a patient is considered the distal end of the catheter, while the end of the catheter remaining outside the body is the proximal end of the catheter. Additionally, the terms "comprising," "having," and "including" as used in the present disclosure (including the claims) shall have the same meaning as the term "containing."

[0036] Referring to Figure 1 , the catheter system 20 may include a catheter 22 and a catheter hub 24. In some embodiments, the catheter hub 24 may include a catheter hub lumen 25, a distal end 26, and a proximal end 27. In some embodiments, the catheter system 20 may include a blood protection device 30 for reducing hemolysis in the blood when the blood is transferred to a blood collection device.

[0037] In some embodiments, the blood collection device may include or correspond to a blood collection container. In some embodiments, the blood collection container may include a syringe, a vacuum blood collection tube (e.g., BDVACUTAINER available from Becton, Dickinson and Company a blood collection tube), a small sample collection device, or any other suitable container configured to receive blood from a patient. In some embodiments, the catheter 22 can include an over-the-needle venous catheter through which a guide needle having a sharp distal end can extend. In some embodiments, the catheter 22 can include an arterial catheter, a peripheral venous catheter, a peripherally inserted central catheter, a midline catheter, or other types of catheters that can be used to collect blood from a patient's vasculature.

[0038] In some embodiments, the blood protection device 30 can include one or more of a distal connector 40, an adapter 60, and an extension tube 80. In some embodiments, the catheter 22, the catheter hub 24, and the blood protection device 30 can define a fluid path through which blood can be transferred from the patient to the blood collection device. In some embodiments, the distal connector 40 can be configured to connect to the catheter hub 24. In some embodiments, the extension tube 80 can be configured to fluidly connect the distal connector 40 to the adapter 60.

[0039] In some embodiments, the adapter 60 can be configured to receive a blood collection device. More specifically, in some embodiments, the adapter 60 can include a receptacle 61 for receiving a specific blood collection container (e.g., a vacuum blood collection tube). In some embodiments, the adapter 60 can include a non-patient cannula 62 having a distal end 63 received within the lumen 73 of the adapter and a proximal end 64 outside the lumen 73 of the adapter. In some embodiments, the non-patient cannula 62 can include a sheath 66 that can cover the proximal end 64 of the non-patient cannula 62. In some embodiments, the proximal end 64 of the non-patient cannula 62 can be configured to pierce the sheath and / or rubber seal of the blood collection device.

[0040] Now referring to Figure 2 , in some embodiments, the distal end of the blood protection device 30 can include a distal connector 40, and the distal connector can include a male luer taper 41. As used in this disclosure, the term "male luer taper" includes a male luer having a tapered exterior such that, for example, it forms a seal with the proximal end 27 of the catheter hub 24. In some embodiments, the male luer taper 41 can be substantially in the shape of a plug and is configured to be inserted into the proximal end 27 of the catheter hub 24 with a tight fit to form a tight fluid seal such that blood or other fluid cannot exit from the proximal end 27 of the catheter hub 24 between the inner wall of the catheter hub 24 and the outer wall of the male luer taper 41. In some embodiments, the male luer taper 41 can include a distal end 42 and a proximal end 43.

[0041] In some embodiments, the distal connector 40 may further include a collar 44 spaced apart from the male luer taper 41 such that the collar 44 is configured to be placed around the proximal end 27 of the catheter hub 24. In some embodiments, the collar 44 and / or the male luer taper 41 may extend from the proximal wall 45 of the distal connector 40. In some embodiments, the collar 44 may be threaded to provide a more secure connection between the distal connector 40 and the catheter hub 24. In some embodiments, the catheter hub 24 may also be threaded such that the collar 44 may be threadedly coupled to the catheter hub 24.

[0042] In some embodiments, the male luer taper 41 may include a male luer lumen 48. In some embodiments, the distal end 81 of the extension tube 80 may be fastened or secured within the male luer lumen 48 of the male luer taper 41. In some embodiments, the distal end 81 of the extension tube 80 and the male luer taper 41 may be joined together by an interference fit, snap fit, adhesive bonding, ultrasonic welding, or any other suitable attachment means. In some embodiments, the extension tube 80 and the male luer taper 41 may be integrally formed as a single unit.

[0043] In some embodiments, the male luer taper 41 may include a shoulder 47. In some embodiments, the shoulder 47 may include a tapered or stepped surface corresponding to a tapered or stepped surface of the inner wall of the catheter hub 24. In some embodiments, the shoulder 47 may assist in closely fitting the male luer taper 41 into the catheter hub 24. In some embodiments, the shoulder 47 may help prevent the male luer taper 41 from being inserted too deeply into the catheter hub 24.

[0044] In some embodiments, the distal connector 40 may include a proximally extending flange 46 located within the male luer taper 41 and inserted into the distal end 81 of the extension tube 80. In some embodiments, the distal end 81 of the extension tube 80 may be secured to the proximally extending flange 46. In some embodiments, the proximally extending flange 46 may include an outer diameter slightly larger than the inner diameter of the extension tube 80 such that the proximally extending flange 46 and the extension tube 80 engage in an interference fit. In some embodiments, the proximal end of the proximally extending flange 46 may be tapered distally such that the portion of the extension tube 80 adjacent to the proximally extending flange 46 has a greater volume than in embodiments where the proximally extending flange 46 is not tapered.

[0045] In some embodiments, the blood protection device 30 may include a funnel portion 50, and the funnel portion may be disposed at the distal end 42 of the male tapered Luer 41. In some embodiments, the distal end 42 of the male tapered Luer 41 may have an outer diameter, and the funnel portion 50 may extend over all or substantially all of the outer diameter of the distal end 42 of the male tapered Luer 41. In some embodiments, the funnel portion 50 may be distal to the shoulder 47. In some embodiments, when the male tapered Luer 41 is inserted into the catheter hub 24 (e.g., when the male tapered Luer 41 is fully inserted such that the shoulder 47 abuts against the tapered or stepped surface of the inner wall of the catheter hub 24), the outer diameter of the distal end 42 of the male tapered Luer 41 may be approximately equal to the diameter of the catheter hub lumen 25 at a position corresponding to the position of the distal end 42 of the male tapered Luer 41. In some embodiments, the diameter of the male tapered Luer 41 may be smallest at the outer diameter of the distal end 42 of the male tapered Luer 41.

[0046] In some embodiments, the funnel portion 50 may include a conical shape or a frustoconical shape. In some embodiments, the hole 51 may be located at the proximal end and / or the center of the funnel portion 50. In some embodiments, the hole 51 may include a rounded corner 53. In some embodiments, the hole 51 may extend through the proximally extending flange 46. In some embodiments, the diameter of the hole 51 may be constant or substantially constant along the length of the hole 51.

[0047] In some embodiments, the funnel portion 50 may have a distal opening 52 at its distal end. In some embodiments, the diameter of the distal opening 52 may be greater than the diameter of the hole 61 and the outer diameter of the proximally extending flange 46. In some embodiments, the diameter of the distal opening 52 may be greater than the outer diameter and / or the inner diameter of the distal end 81 of the extension tube 80.

[0048] Now referring Figure 3 , a distal connector 83 is shown according to some embodiments. In some embodiments, in one or more features and / or operational aspects, the distal connector may be similar or identical to Figure 1 - Figure 2 the distal connector 40. In some embodiments, the distal connector 83 may include a male tapered Luer 41 configured to be inserted into the proximal end 27 of the catheter hub 24. In some embodiments, the distal connector 83 may include an extension tube 80 fixed within the lumen 48 of the male tapered Luer.

[0049] In some embodiments, the extension tube 80 may further include an extension tube lumen 84 and an inner surface forming the extension tube lumen 84. In some embodiments, the extension tube lumen 84 may extend through the distal end 81 and the proximal end 82 of the extension tube 80.

[0050] In some embodiments, the distal end 81 of the extension tube 80 (e.g., within the distal connector 83) may include a distal chamfer 54. In some embodiments, the distal end 81 of the extension tube 80 within the distal connector 83 may include a distal fillet 56. In some embodiments, the distal end 42 of the male luer taper 41 (e.g., within the catheter hub 24) may include a tapered portion 58.

[0051] In some embodiments, the distal fillet 56 may be adjacent to and proximal to the distal chamfer 54. In some embodiments, the distal fillet 56 may operate to further smooth the edge of the distal chamfer 54 to further reduce hemolysis. In some embodiments, the tapered portion 58 of the male luer taper 41 may be located at the distal end 42 of the male luer taper 41. In some embodiments (e.g., as Figure 2 shown), the distal end 81 of the extension tube 80 may be proximal to the distal end 42 of the male luer taper 41.

[0052] In some embodiments, the tapered portion 58 may provide a smooth transition in the fluid path from the catheter hub lumen 25 to the male luer taper lumen 48. In some embodiments, the tapered portion 58 may include a funnel portion, a tapered portion, a chamfer, a fillet, or other features capable of providing a smooth geometric transition between multiple portions of the fluid path. In some embodiments, the diameter of the tapered portion 58 may be greater than or equal to the diameter of the catheter hub lumen 25 adjacent to the tapered portion 58, which may provide a smooth transition in the fluid path from the catheter hub lumen 25 to the male luer taper lumen 48. In some embodiments, the inner diameter of the farthest distal surface of the male luer taper 41 may be greater than or equal to the diameter of the catheter hub lumen 25 adjacent to the farthest distal surface of the male luer taper 41, which may provide a smooth transition in the fluid path from the catheter hub lumen 25 to the male luer taper lumen 48. Now referring to Figure 2 to Figure 3 , in some embodiments, one or more of the funnel portion 50, the fillet 53, the distal chamfer 54, the distal fillet 56, and the tapered portion 58 may be annular to provide a smooth geometric transition around the circumference of the fluid path.

[0053] The term "fillet" as used in the present disclosure may include a circular surface that may extend annularly. In some embodiments, the fillet may include a convex surface at the intersection of two surfaces, which may be produced by machining using a fillet edge tool or a similar rounding tool. The term "chamfer" as used in the present disclosure may include a flat surface shown in cross-section (e.g., referring to Figure 3 ), the flat surface is inclined or angled, and the flat surface may extend annularly.

[0054] Now referring to Figure 4, in some embodiments, the proximal end of the blood protection device 30 may include an adapter 60 configured to receive a blood collection device. In some embodiments, the adapter may include a non-patient cannula 62 having a distal end 63 and a proximal end, and the non-patient cannula may be configured to pierce the blood collection device. In some embodiments, the distal portion 71 of the adapter 60 may include a pocket 70 for receiving the proximal end 82 of the extension tube 80. Although the space between the extension tube 80 and the pocket 70 is shown in Figure 4 to Figure 7 , in some embodiments, this space may be reduced or eliminated such that the extension tube 80 fits tightly within the pocket 70. In some embodiments, the proximal end of the extension tube may be fastened or secured within the pocket 70.

[0055] In some embodiments, a channel 67 may extend between the pocket 70 and the non-patient cannula 62. In some embodiments, the channel 67 may include a proximal end 68 and a distal end 69. In some embodiments, the non-patient cannula 62 may include a non-patient cannula lumen 65. For example, as Figure 4 shown, a fluid path may extend through the extension tube 80, the channel 67, and the non-patient cannula 62 (and through the distal connector 40, the catheter hub 24, and the catheter 22, as Figure 1 shown).

[0056] In some embodiments, there may be one or more transition regions in the fluid path from one component to another. For example, there may be a transition region between the proximal end 82 of the extension tube 80 disposed within the pocket 70 and the distal end 69 of the channel 67. As another example, there may be another transition region between the proximal end 68 of the channel 67 and the non-patient cannula lumen 65. For example, Figure 4 in some cases, the transition region may include sharp corners, and when blood is exposed to the sharp corners, the risk of hemolysis may increase due to increased shear stress.

[0057] Now referring to Figure 5 to Figure 7 , in some embodiments, one or more features may be added to the transition regions of the fluid path to reduce the risk of hemolysis. For example, in some embodiments, the diameter of the proximal end 68 of the channel 67 may be equal to or less than the inner diameter of the non-patient cannula lumen 65 near the channel 67. In some embodiments, this may be achieved by a non-patient cannula 62 having a thin annular wall. In some embodiments, the annular wall of the non-patient cannula 62 may be embedded within a portion of the adapter 60 such that the inner surface of the annular wall of the non-patient cannula lumen 65 is aligned with the channel 67.

[0058] In some embodiments, as Figure 6As shown, the distal end 63 of the non-patient cannula 62 may include an inner surface that includes a non-patient cannula chamfer 74, which may include a tapered portion that tapers inward in the proximal direction. For example, the inner surface of the non-patient cannula may be extruded or machined (or otherwise formed) at the distal end in such a way as to provide the non-patient cannula chamfer. In some embodiments, the non-patient cannula chamfer 74 may be annular. In some embodiments, as Figure 7 shown, the channel 67 itself may be tapered inward in the proximal direction such that the diameter of the proximal end 68 of the channel 67 may be less than the diameter of the non-patient cannula lumen 65 adjacent to the channel 67. In some embodiments, the diameter of the proximal end 68 of the channel 67 may be less than the diameter of the distal end 69 of the channel 67.

[0059] For example, as Figure 5 to Figure 6 shown, the fluid path in the adapter 60 may include a distal chamfer 76 and / or a distal fillet 77. For example, as Figure 5 to Figure 6 shown, in some embodiments, the distal chamfer 76 and / or the distal fillet 77 may be formed in the channel 67. In some embodiments, the distal chamfer 76 and / or the distal fillet 77 may be formed in the proximal end 82 of the extension tube 80 disposed within the pocket 70. In some embodiments, the distal fillet 77 may be proximate to and proximal of the distal chamfer 76. In some embodiments, one or more of the distal chamfer 76, the distal fillet 77, and the channel 67 may be annular.

[0060] Now referring to Figure 1 to Figure 7 , in some embodiments, the extension tube 80 may include a distal end 81 fixed within the distal connector 40, and the extension tube 80 may include a proximal end 82 fixed within the adapter 60. In some embodiments, the extension tube 80 may include an extension tube lumen 84 that forms part of the fluid path of the catheter system 20. In some embodiments, the fluid path may extend through the extension tube 80 from the distal connector 40 to the adapter 60. In some embodiments, the fluid path may include the catheter hub lumen 25, the tapered male Luer lumen 48, the extension tube lumen 84, and the adapter lumen 73. In some embodiments, the fluid path may extend through the various features discussed in this disclosure, such as through the funnel portion 50 of the distal connector 40 and / or the proximally extending flange 46, and through the channel 67 and the non-patient cannula 62 of the adapter 60. In some embodiments, the fluid path (and optional other features, such as flanges and funnel portions) may be aligned with the central axis of the catheter system 20 or a portion thereof (e.g., the central axis of the distal connector 40, the central axis of the adapter 60, and / or the central axis of the extension tube 80).

[0061] In some embodiments, the catheter system 20 may include features within the fluid path (e.g., geometric features of the inner surfaces of the various lumens that form portions of the fluid path, and the interactions between different sections of the fluid path), which are configured to reduce hemolysis when blood travels proximally through the fluid path to be collected. For example, one or more of the funnel portions, chamfers, rounded corners, tapered sections, or other smooth geometric features discussed in the present disclosure may be positioned to reduce hemolysis that might otherwise occur due to blood contacting sharp or rough portions at component transitions within the fluid path. In some embodiments, the interaction of multiple such features (e.g., chamfers and rounded corners in proximity to each other, and / or distal features combined with proximal features downstream) may reduce the risk of hemolysis beyond what can be achieved by a single feature alone.

[0062] It should be understood that in some embodiments, the extension tube 80 may be any form of tube suitable for providing a fluid path between the distal connector 40 and the adapter 60. In particular, the extension tube 80 may include an extension kit, a compact connector, a rigid cannula, and / or any other suitable tube.

[0063] All of the examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the present utility model and the concepts contributed by the inventors to further the art and are to be construed as not being limited to such specifically recited examples and conditions. Although the embodiments of the present utility model 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 present utility model.

Claims

1. A blood protection device for reducing hemolysis in a catheter system, characterized in that, The blood protection device includes: A distal end portion including a distal connector, wherein the distal connector includes a tapered male Luer that is configured to be inserted into the proximal end portion of a catheter hub to form a tight fluid seal; A proximal end portion including an adapter configured to receive a blood collection device, wherein the adapter includes a non-patient cannula configured to pierce the blood collection device; An extension tube including a distal end portion and a proximal end portion, wherein the distal end portion of the extension tube is fixed within the tapered male Luer, and wherein the proximal end portion of the extension tube is fixed within the adapter; and A fluid path extending from the distal connector through the extension tube to the adapter.

2. The blood protection device according to claim 1, characterized in that, The distal connector further includes a collar configured to couple the distal connector to the proximal end portion of the catheter hub.

3. The blood protection device according to claim 1, wherein The distal end portion of the tapered male Luer includes a funnel portion.

4. The blood protection device according to claim 3, wherein, The distal end portion of the tapered male Luer includes a diameter, wherein the funnel portion extends across the entire diameter of the distal end portion of the tapered male Luer.

5. The blood protection device according to claim 4, characterized in that The distal connector further includes a proximally extending flange that is located within the tapered male Luer and inserts into the distal end portion of the extension tube.

6. The blood protection device according to claim 5, characterized in that, The funnel portion includes a hole, wherein the diameter of the hole is equal to the diameter of a portion of the fluid path that extends through the proximally extending flange.

7. The blood protection device according to claim 5, wherein The outer diameter of the funnel portion is greater than the outer diameter of the proximally extending flange and the outer diameter of the distal end portion of the extension tube.

8. The blood protection device according to claim 5, characterized in that, The fluid path extends through the funnel portion and the proximally extending flange.

9. The blood protection device according to claim 8, characterized in that, The funnel portion, the proximally extending flange, and the fluid path are aligned with the central axis of the distal connector.

10. The blood protection device according to claim 1, characterized in that, The extension tube further includes an extension tube lumen and an inner surface forming the extension tube lumen, wherein the extension tube lumen extends through the distal end portion and the proximal end portion of the extension tube, and wherein the inner surface of the extension tube includes a chamfer.

11. The blood protection device according to claim 10, wherein, The extension tube includes a rounded corner adjacent to and proximal to the chamfer.

12. The blood protection device according to claim 10, wherein The inner surface of the distal end portion of the tapered male Luer includes a tapered portion.

13. The blood protection device according to claim 12, characterized in that, The diameter of the tapered portion of the distal end portion of the tapered male Luer is greater than or equal to the diameter of the lumen of the catheter hub adjacent to the tapered portion.

14. The blood protection device according to claim 10, wherein The chamfer is annular.

15. A blood protection device, the blood protection device being used to reduce hemolysis in a catheter system, characterized in that, The blood protection device includes: A distal end portion including a distal connector, wherein the distal connector includes a tapered male Luer that is configured to be inserted into the proximal end portion of a catheter hub to form a tight fluid seal; A proximal end portion including an adapter configured to receive a blood collection device, wherein the adapter includes a bag portion, a non-patient cannula configured to pierce the blood collection device, and a channel extending between the bag portion and the non-patient cannula, wherein the channel includes a distal end portion and a proximal end portion, wherein the non-patient cannula includes a non-patient cannula lumen, and wherein the diameter of the proximal end portion of the channel is equal to or less than the diameter of the non-patient cannula lumen adjacent to the channel; An extension tube, the extension tube including a distal end, a proximal end, and an extension tube lumen extending through the distal end of the extension tube and the proximal end of the extension tube, wherein the distal end of the extension tube is fixed within the distal connector, and wherein the proximal end of the extension tube is fixed within the pouch; and A fluid path extending from the distal connector through the extension tube, the channel, and the non-patient cannula to the adapter.

16. The blood protection device according to claim 15, characterized in that, The distal end of the channel includes a chamfer, wherein the chamfer is annular.

17. The blood protection device according to claim 16, characterized in that, The diameter of the channel at the chamfer is greater than the diameter of the extension tube lumen, and the distal end of the channel is adjacent to the proximal end of the extension tube.

18. The blood protection device according to claim 17, wherein, The non-patient cannula includes a distal end, a proximal end, and an inner surface forming the non-patient cannula lumen, wherein the inner surface of the non-patient cannula includes a chamfer at the distal end of the non-patient cannula, and wherein the chamfer of the non-patient cannula is annular.

19. The blood protection device according to claim 18, characterized in that, The channel is tapered in the proximal direction.

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