Blood protection devices and related systems and methods

Abstract

A blood protection device for reducing hemolysis in a catheter system 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

Background Technology

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

[0002] A common type of catheter device includes a needle-type intravenous (“IV”) catheter. As the name suggests, a needle-type catheter is mounted on a guide needle with a sharp distal tip. The catheter assembly may include a catheter hub, from which the catheter extends distally, and through which the guide needle extends. 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 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 small angle.

[0003] To verify proper placement of the guide needle and / or catheter in the blood vessel, clinicians typically confirm the presence of blood "backflow" in the reflux chamber of the catheter assembly. Once needle placement is confirmed, clinicians may temporarily block flow in the vascular system and remove the needle, leaving the catheter in place for future blood draws or fluid infusions.

[0004] Blood collection containers are used to draw blood from patients or collect blood samples. These containers may include syringes or test tubes with rubber stoppers at one end. In some cases, all or part of the air has been removed from the test tube, so the pressure inside the container is lower than ambient pressure. Such containers are often referred to as internal vacuum or vacuum tubes. A commonly used blood collection container is the BD VACUTAINER. Blood collection tubes are available from Beckton Dickinson.

[0005] The blood collection container can be connected to a catheter. When the blood collection container is connected to the catheter inserted into a blood vessel, the pressure in the blood vessel is higher than the pressure in the blood collection container. This forces blood through the fluid path within the catheter into the blood collection container, thus filling the container with blood. The vacuum inside the blood collection container decreases as it fills until the pressure inside the container equals the pressure in the blood vessel, and blood flow stops.

[0006] Unfortunately, when blood is drawn through a fluid path, it is subjected to shear and other stresses, which often leads to hemolysis (e.g., shear-induced hemolysis). The risk of hemolysis is higher for larger blood collection containers and arterial blood draws because the pressure differential at the start of blood draws may be higher than that for smaller blood draws or venous draws.

[0007] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in the aforementioned environment. Rather, this background is provided merely to illustrate an exemplary technical field in which some of the embodiments described herein can be practiced. Summary of the Invention

[0008] This 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.

[0009] In some embodiments, a blood protection device may include one or more features configured to reduce shear stress on blood cells as blood travels proximally along a fluid path, thereby reducing the risk of hemolysis. In some embodiments, these features may be configured to reduce shear stress that could otherwise be caused by abrupt changes in geometry. Therefore, the risk of hemolysis can be reduced as shear stress decreases.

[0010] 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 lug configured to insert into the proximal end of the 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 puncture the blood collection device.

[0011] 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 secured within a tapered lug. In some embodiments, the proximal end of the extension tube may be secured within an adapter. In some embodiments, the blood protection device may include a fluid path extending from the distal connector to the adapter.

[0012] In some embodiments, the distal connector may further include a collar configured to connect the distal connector to the proximal end of the catheter hub. In some embodiments, the tapered male lug may include a distal end and a proximal end. In some embodiments, the distal end of the tapered male lug may include a funnel portion that facilitates the diversion of blood into a blood protection device without exposing blood to sharp corners that may increase the risk of hemolysis. In some embodiments, the distal end of the tapered male lug may have a diameter, and the funnel portion may extend over the entire diameter of the distal end of the tapered male lug.

[0013] In some embodiments, the distal connector may include a proximal flange located within a tapered lug and inserted into the distal end of an extension tube. In some embodiments, the funnel portion may include an orifice. In some embodiments, the diameter of the orifice may be equal to or approximately equal to the diameter of a portion of the fluid path extending through the proximal flange.

[0014] In some embodiments, the funnel portion may include an outer diameter. In some embodiments, the outer diameter of the funnel portion may be larger than the outer diameter of the proximal flange. In some embodiments, the outer diameter of the funnel portion may be larger 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 proximal flange. In some embodiments, the funnel portion, the proximal flange, and the fluid path may be aligned with the central axis of the distal connector.

[0015] In some embodiments, the extension tube may include an extension tube lumen and an inner surface forming the extension tube lumen. In some embodiments, the extension tube lumen may extend through a distal end and a proximal end of the extension tube. In some embodiments, the inner surface of the extension tube may include a chamfer located at the distal end of the extension tube. In some embodiments, the extension tube may include a fillet proximal to and / or near the chamfer. In some embodiments, the chamfer and / or fillet of the extension tube may be annular. In some embodiments, the fillet and / or chamfer of the extension tube may prevent blood from being exposed to sharp corners as blood flows proximally through the fluid path.

[0016] 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 at 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 as blood flows proximally through the fluid path.

[0017] In some embodiments, the distal end of the extension tube may have an inner diameter at the chamfer. In some embodiments, the entire conical lumen of the distal conical Luer may have a diameter larger than the inner diameter at the chamfer, which reduces the risk of hemolysis when blood flows proximally through the fluid path. In some embodiments, the entire conical lumen of the distal conical Luer may have a uniform diameter.

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

[0019] In some embodiments, one or more portions of the fluid path may include geometrical variations, which include one or more specific features for reducing the rate of change. More specifically, in some embodiments, one or more of rounded corners, chamfers, funnel-shaped portions, or tapered portions may reduce the rate of change of the fluid path's geometry.

[0020] 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 lug configured to insert into the proximal end of the 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.

[0021] In some embodiments, the adapter may include a pouch-like portion. In some embodiments, the adapter may include a non-patient cannula configured to puncture a blood collection device. In some embodiments, the adapter may include a channel extending between the pouch-like 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 smaller than the diameter of the non-patient cannula lumen adjacent to the channel, which prevents blood from being exposed at sharp angles as blood flows proximally through the fluid path.

[0022] 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 extending through the distal and proximal ends of the extension tube. In some embodiments, the distal end of the extension tube may be secured within a distal connector. In some embodiments, the proximal end of the extension tube may be secured within a pouch. In some embodiments, a fluid path may extend from the distal connector to the adapter via the extension tube, a channel, and a non-patient cannula.

[0023] 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 lumen of the extension tube, which prevents blood from being exposed to sharp corners as 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.

[0024] In some embodiments, the non-patient cannula may include a distal end, a proximal end, and an inner surface forming the lumen of the non-patient cannula. 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 prevents blood from being exposed to sharp corners as blood flows proximally through the fluid path.

[0025] It should be understood that the foregoing general description and the following detailed description are illustrative and do not limit the invention as described in the claims. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that these embodiments may be combined or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention unless stated otherwise. Therefore, the following detailed description should not be considered limiting. Attached Figure Description

[0026] The object and features of the invention will become more apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. It should be understood that these drawings depict only exemplary embodiments of the invention and are therefore not intended to be considered as limiting its scope. The invention will be described and explained with additional features and details using the drawings, wherein:

[0027] Figure 1 A cross-sectional view of an exemplary catheter system having an exemplary blood protection device according to some embodiments;

[0028] Figure 2 A cross-sectional view of a portion of a catheter system according to some embodiments;

[0029] Figure 3 A cross-sectional view of an exemplary distal connector coupled to an exemplary catheter assembly according to some embodiments;

[0030] Figure 4 A cross-sectional view of an exemplary proximal end of an exemplary blood protection device according to some embodiments;

[0031] Figure 5 This is a cross-sectional view of another proximal end of a blood protection device according to some embodiments;

[0032] Figure 6 A cross-sectional view of another proximal end of a blood protection device according to some embodiments; and

[0033] Figure 7 This is a cross-sectional view of another proximal end of a blood protection device according to some embodiments. Detailed Implementation

[0034] For clarity, the term "proximal" should be understood as referring to the direction relatively closer to the clinician using the device described in this disclosure, while the term "distal" refers to the direction relatively farther from the clinician. For example, the tip of a catheter placed inside a patient is considered the distal tip of the catheter, while the tip of the catheter remaining outside the body is the proximal tip. Furthermore, the terms "comprising," "having," and "having" as used in this disclosure (including the claims) should have the same meaning as the term "including."

[0035] Reference 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 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 as it is transferred to a blood collection device.

[0036] 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 Beckton Dickinson), etc. The catheter 22 may be a blood collection tube, a small sample collection device, or any other suitable container configured to hold blood from a patient. In some embodiments, the catheter 22 may include a needle-type venous catheter with a guide needle having a sharp distal end that extends through the venous catheter. In some embodiments, the catheter 22 may 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 vascular system.

[0037] In some embodiments, the blood protection device 30 may 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 may define a fluid path through which blood is transferred from a patient to a blood collection device. In some embodiments, the distal connector 40 may be configured to connect to the catheter hub 24. In some embodiments, the extension tube 80 may be configured to fluidly connect the distal connector 40 to the adapter 60.

[0038] In some embodiments, the adapter 60 may be configured to receive a blood collection device. More specifically, in some embodiments, the adapter 60 may include a receiver 61 for receiving a specific blood collection container (e.g., a vacuum blood collection tube). In some embodiments, the adapter 60 may include a non-patient cannula 62 having a distal end 63 received within an adapter lumen 73 and a proximal end 64 outside the adapter lumen 73. In some embodiments, the non-patient cannula 62 may include a sheath 66 that may cover the proximal end 64 of the non-patient cannula 62. In some embodiments, the proximal end 64 of the non-patient cannula 62 may be configured to pierce the sheath and / or rubber seal of the blood collection device.

[0039] Now refer to Figure 2 In some embodiments, the distal end of the blood protection device 30 may include a distal connector 40, which may include a tapered male lug 41. As used herein, the term "tapered male lug" includes a male lug having a tapered outer shape to form a seal, for example, with the proximal end 27 of the catheter hub 24. In some embodiments, the tapered male lug 41 may be substantially formed in the shape of a plug and configured to fit tightly into the proximal end 27 of the catheter hub 24 to form a tight fluid seal, preventing blood or other fluids from escaping 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 tapered male lug 41. In some embodiments, the tapered male lug 41 may include a distal end 42 and a proximal end 43.

[0040] In some embodiments, the distal connector 40 may further include a collar 44 spaced apart from a tapered male lug 41, such that the collar 44 is configured to be positioned around the proximal end 27 of the conduit hub 24. In some embodiments, the collar 44 and / or the tapered male lug 41 may extend from the proximal sidewall 45 of the distal connector 40. In some embodiments, the collar 44 may be threaded to provide a more reliable connection between the distal connector 40 and the conduit hub 24. In some embodiments, the conduit hub 24 may also be threaded, such that the collar 44 can be threaded onto the conduit hub 24.

[0041] In some embodiments, the tapered male lug 41 may include a tapered male lug 48. In some embodiments, the distal end 81 of the extension tube 80 may be fastened or secured within the tapered male lug 48 of the tapered male lug 41. In some embodiments, the distal end 81 of the extension tube 80 and the tapered male lug 41 may be joined together by interference fit, snap-fit, adhesive bonding, ultrasonic welding, or any other suitable attachment method. In some embodiments, the extension tube 80 and the tapered male lug 41 may be integrally formed as a single unit.

[0042] In some embodiments, the tapered male lug 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 conduit hub 24. In some embodiments, the shoulder 47 may facilitate a tight fit of the tapered male lug 41 into the conduit hub 24. In some embodiments, the shoulder 47 may help prevent the tapered male lug 41 from being inserted too deeply into the conduit hub 24.

[0043] In some embodiments, the distal connector 40 may include a proximal flange 46 located within a tapered lug 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 proximal flange 46. In some embodiments, the proximal flange 46 may include an outer diameter slightly larger than the inner diameter of the extension tube 80, such that the proximal flange 46 and the extension tube 80 are interference-fitted. In some embodiments, the proximal end of the proximal flange 46 may be tapered distally, such that the portion of the extension tube 80 near the proximal flange 46 has a larger volume than the portion in embodiments where the proximal flange 46 is not tapered.

[0044] In some embodiments, the blood protection device 30 may include a funnel portion 50 disposed at the distal end 42 of a tapered male Luer 41. In some embodiments, the distal end 42 of the tapered male 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 tapered male Luer 41. In some embodiments, the funnel portion 50 may be distal to a shoulder 47. In some embodiments, when the tapered male Luer 41 is inserted into the catheter hub 24 (e.g., when the tapered male Luer 41 is fully inserted such that the shoulder 47 abuts against a tapered or stepped surface of the inner wall of the catheter hub 24), the outer diameter of the distal end 42 of the tapered male 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 tapered male Luer 41. In some embodiments, the diameter of the tapered male Luer 41 may be minimized at the outer diameter of the distal end 42 of the tapered male Luer 41.

[0045] In some embodiments, the funnel portion 50 may include a conical shape or a truncated conical shape. In some embodiments, the hole 51 may be located at the proximal end and / or center of the funnel portion 50. In some embodiments, the hole 51 may include a fillet 53. In some embodiments, the hole 51 may extend through a flange 46 extending proximally. In some embodiments, the diameter of the hole 51 may be constant or substantially constant along the length of the hole 51.

[0046] 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 orifice 61 and the outer diameter of the flange 46 extending proximally. In some embodiments, the diameter of the distal opening 52 may be greater than the outer diameter and / or inner diameter of the distal end 81 of the extension tube 80.

[0047] Now refer to Figure 3 According to some embodiments, a distal connector 83 is shown. In some embodiments, the distal connector may be compatible with one or more features and / or operations. Figures 1-2 The distal connector 40 is similar to or the same as the distal connector 40. In some embodiments, the distal connector 83 may include a tapered male lug 41 configured to insert into the proximal end 27 of the conduit hub 24. In some embodiments, the distal connector 83 may include an extension tube 80 fixed within the lumen 48 of the tapered male lug 48.

[0048] 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.

[0049] 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, which may be within the distal connector 83, may include a distal fillet 56. In some embodiments, the distal end 42 of the tapered male lug 41 (e.g., within the conduit hub 24) may include a tapered portion 58.

[0050] In some embodiments, the distal fillet 56 may be adjacent to and located proximal to the distal chamfer 54. In some embodiments, the distal fillet 56 may be operable to further smooth the edge of the distal chamfer 54 to further reduce hemolysis. In some embodiments, the tapered portion 58 of the tapered male Luer 41 may be located at the distal end 42 of the tapered male Luer 41. In some embodiments (e.g., as Figure 2 As shown), the distal end 81 of the extension tube 80 may be located near the distal end 42 of the tapered Luer 41.

[0051] In some embodiments, the tapered portion 58 may provide a smooth transition in the fluid path from the conduit hub lumen 25 to the tapered male Luer lumen 48. In some embodiments, the tapered portion 58 may include a funnel, a cone, a chamfer, a fillet, or other features that provide 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 conduit hub lumen 25 adjacent to the tapered portion 58, which may provide a smooth transition in the fluid path from the conduit hub lumen 25 to the tapered male Luer lumen 48. In some embodiments, the inner diameter of the distal surface of the tapered male Luer 41 may be greater than or equal to the diameter of the conduit hub lumen 25 adjacent to the distal surface of the tapered male Luer 41, which may provide a smooth transition in the fluid path from the conduit hub lumen 25 to the tapered male Luer lumen 48. Referring now to Figures 2 to 3 In some embodiments, one or more of the funnel portion 50, fillet 53, distal chamfer 54, distal fillet 56, and tapered portion 58 may be annular, thereby providing a smooth geometric transition around the circumference of the fluid path.

[0052] As used in this disclosure, the term "rounded corner" can include a circular surface that may extend in a ring shape. In some embodiments, a rounded corner can include a convex surface at the intersection of two surfaces, which can be produced by machining using a rounded edge tool or a similar rounding tool. As used in this disclosure, the term "chamfer" can include a flat surface shown in cross-section (e.g., see reference 1). Figure 3 The flat surface is inclined or angled, and the flat surface can extend in a ring shape.

[0053] Now refer 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, the non-patient cannula being configured to puncture the blood collection device. In some embodiments, the distal portion 71 of the adapter 60 may include a pouch 70 for receiving the proximal end 82 of the extension tube 80. Although in Figures 4 to 7 The diagram shows the space between the extension tube 80 and the pouch 70, but in some embodiments, this space may be reduced or eliminated so that the extension tube 80 fits snugly within the pouch 70. In some embodiments, the proximal end of the extension tube may be fastened or secured within the pouch 70.

[0054] In some embodiments, the channel 67 may extend between the pouch portion 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 4As shown, the fluid path extends through extension tube 80, channel 67, and non-patient cannula 62 (as well as through distal connector 40, catheter hub 24, and catheter 22, as shown). Figure 1 (As shown).

[0055] In some embodiments, there may be one or more transition regions in the fluid path from one component to another. For example, a transition region may exist between the proximal end 82 of the extension tube 80 disposed within the pouch 70 and the distal end 69 of the channel 67. As another example, another transition region may exist between the proximal end 68 of the channel 67 and the lumen 65 of the non-patient cannula. Figure 4 In some cases, the transition area may include sharp corners, and when blood is exposed to sharp corners, the risk of hemolysis may increase due to increased shear stress.

[0056] Now refer to Figures 5 to 7 In some embodiments, one or more features may be added to the transition region 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 smaller than the inner diameter of the non-patient cannula lumen 65 adjacent to the channel 67. In some embodiments, this may be achieved using 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.

[0057] In some embodiments, such as Figure 6 As shown, the distal end 63 of the non-patient cannula 62 may include an inner surface including a non-patient cannula chamfer 74, which may include a tapered portion pointing inward in a proximal direction. For example, the inner surface of the non-patient cannula may be extruded or machined (or otherwise formed) at the distal end to provide the non-patient cannula chamfer. In some embodiments, the non-patient cannula chamfer 74 may be annular. In some embodiments, such as Figure 7 As 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 smaller than the diameter of the non-patient cannula lumen 65 near the channel 67. In some embodiments, the diameter of the proximal end 68 of the channel 67 may be smaller than the diameter of the distal end 69 of the channel 67.

[0058] For example, such as Figures 5 to 6 As shown, the fluid path in adapter 60 may include a distal chamfer 76 and / or a distal fillet 77. For example, as Figures 5 to 6As shown, in some embodiments, a distal chamfer 76 and / or a 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 pouch portion 70. In some embodiments, the distal fillet 77 may be adjacent to and proximal to 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.

[0059] Now refer to Figures 1 to 7 In some embodiments, the extension tube 80 may include a distal end 81 secured within the distal connector 40, and a proximal end 82 secured within the adapter 60. In some embodiments, the extension tube 80 may include an extension tube lumen 84 forming part of a fluid path of the catheter system 20. In some embodiments, a fluid path may extend from the distal connector 40 to the adapter 60 via the extension tube 80. In some embodiments, the fluid path may include a catheter hub lumen 25, a tapered Luer lumen 48, an extension tube lumen 84, and an adapter lumen 73. In some embodiments, the fluid path may extend through various features discussed in this disclosure, such as through the funnel portion 50 of the distal connector 40 and / or the proximal 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 the flange and funnel portion) 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).

[0060] In some embodiments, the catheter system 20 may include features within the fluid path (e.g., geometric features of the internal surfaces of various lumens forming multiple portions of the fluid path, and interactions between different segments of the fluid path) configured to reduce hemolysis as blood travels proximally through the fluid path for collection. For example, one or more of the funnel-shaped portions, chamfers, fillets, tapered portions, or other smooth geometric features discussed in this disclosure may be positioned to reduce hemolysis that could otherwise occur due to contact between blood and sharp or rough portions at transitions within the fluid path. In some embodiments, the interaction of multiple such features (e.g., chamfers and fillets close to each other, and / or distal features combined with downstream proximal features) reduces the risk of hemolysis beyond what can be achieved with a single feature alone.

[0061] 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 sleeve, and / or any other suitable tube.

[0062] All examples and conditional language listed herein are intended as teaching aids to help readers understand the invention and the concepts contributed by the inventors to promote technological development, and should be understood as not being limited to such specifically listed examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of the invention.

Claims

1. A blood protection device for reducing hemolysis in a catheter system, characterized in that, The blood protection device includes: Includes a distal end of a distal connector, wherein the distal connector includes a tapered male lug that is configured to insert into the proximal end of the conduit hub to form a tight fluid seal; The proximal end includes an adapter configured to receive a blood collection device, wherein the adapter includes a non-patient cannula configured to puncture the blood collection device; An extension tube including a distal end and a proximal end, wherein the distal end of the extension tube is fixed within the tapered male lug, and wherein the proximal end of the extension tube is fixed within the adapter; and The fluid path extends from the distal connector to the adapter via the extension tube.

2. The blood protection device according to claim 1, characterized in that, The distal connector also includes a collar configured to engage the distal connector to the proximal end of the conduit hub.

3. The blood protection device according to claim 1, characterized in that, The distal end of the conical Luer includes a funnel-shaped portion.

4. The blood protection device according to claim 3, characterized in that, The distal end of the conical male lug includes a diameter, wherein the funnel portion extends over the entire diameter of the distal end of the conical male lug.

5. The blood protection device according to claim 4, characterized in that, The distal connector also includes a proximal flange located within the tapered lug and inserted into the distal end of the extension tube.

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

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

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

9. The blood protection device according to claim 8, characterized in that, The funnel portion, the proximal 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 and the proximal end 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, characterized in that, The extension tube includes a rounded corner close to and near the chamfer.

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

13. The blood protection device according to claim 12, characterized in that, The diameter of the tapered portion at the distal end of the tapered lumen is greater than or equal to the diameter of the inner cavity of the conduit hub near the tapered portion.

14. The blood protection device according to claim 10, characterized in that, The chamfer is circular.

15. A blood protection device for reducing hemolysis in a catheter system, characterized in that, The blood protection device includes: Includes a distal end of a distal connector, wherein the distal connector includes a tapered male lug that is configured to insert into the proximal end of the conduit hub to form a tight fluid seal; The proximal end includes an adapter configured to receive a blood collection device, wherein the adapter includes a pouch, a non-patient cannula configured to puncture the blood collection device, and a channel extending between the pouch and the non-patient cannula, wherein the channel includes a distal end and a proximal end, wherein the non-patient cannula includes a non-patient cannula lumen, and wherein the diameter of the proximal end of the channel is equal to or smaller 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 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-like portion; and A fluid path extends 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 larger than the diameter of the inner cavity of the extension tube, wherein the distal end of the channel is close to the proximal end of the extension tube.

18. The blood protection device according to claim 17, characterized in that, The non-patient cannula includes a distal end, a proximal end, and an inner surface forming the lumen of the non-patient cannula, 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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