Hemoshield device and related systems and methods

Abstract

A hemoshield 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 insert into a proximal end of a catheter hub to form a tight fluid seal. The hemoshield device may include a proximal end, which 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 hemoshield device may include an extension tube. A distal end of the extension tube may be fixed within the tapered male luer, and a proximal end of the extension tube may be fixed within the adapter. The extension tube may include a fluid pathway extending from the distal connector to the adapter.

Description

HEMOSHIELD DEVICE AND RELATED SYSTEMS AND METHODSBACKGROUND

[0001] Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient. Catheters may also be used for withdrawing blood from the patient.

[0002] A common type of catheter device includes an over-the-needle intravenous (“IV”) catheter. As its name implies, the catheter that is over-the-needle may be mounted over an introducer needle having a sharp distal tip. A catheter assembly may include a catheter hub, the catheter extending distally from the catheter hub, and the introducer needle extending through the catheter. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with a bevel of the needle facing up away from skin of the patient. The catheter and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.

[0003] In order to verify proper placement of the introducer needle and / or the catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the clinician may temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.

[0004] For blood withdrawal or collecting a blood sample from a patient, a blood collection container may be used. The blood collection container may include a syringe or a test tube with a rubber stopper at one end. In some instances, the blood collection container has had all or a portionof the air removed from the test tube so pressure within the blood collection container is lower than ambient pressure. Such a blood collection container is often referred to as an internal vacuum or a vacuum tube. A commonly used blood collection container is a BD VACUTAINER® blood collection tube, available from Becton Dickinson & Company.

[0005] The blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter inserted into a blood vessel, a pressure in the blood vessel is higher than a pressure in the blood collection container, which pushes blood through a fluid pathway within the catheter into the blood collection container, thus filling the blood collection container with blood. A vacuum within the blood collection container decreases as the blood collection container fills, until the pressure in the blood collection container equalizes with the pressure in the blood vessel, and the flow of blood stops.

[0006] Unfortunately, as blood is drawn through the fluid pathway, the blood is subject to shear and other stresses that often result in hemolysis (e.g., shear-induced hemolysis). The risk of hemolysis is higher for larger volume blood collection containers and for arterial blood draws since the pressure differential at the start of the blood draw may be higher compared to smaller volume blood draws or venous draws.

[0007] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced.SUMMARY

[0008] The present disclosure generally relates to a hemoshield device for reducing hemolysis in a catheter system, as well as related devices, systems, and methods. In some embodiments, the catheter system may include the hemoshield device coupled to a vascular access device. In some embodiments, the vascular access device may include a catheter, a needle, or another device suitable for blood collection.

[0009] In some embodiments, the hemoshield device may include one or more features for reducing shear stress on blood cells as blood travels proximally through a fluid pathway, thereby reducing a risk of hemolysis. In some embodiments, the features may be configured to reduce shear stress that could otherwise be induced by abrupt changes in geometry. Accordingly, a risk of hemolysis may be decreased in connection with reduction of shear stress.

[0010] In some embodiments, the hemoshield device may include a distal end, which may include a distal connector. In some embodiments, the distal connector may include a tapered male luer configured to insert into a proximal end of a catheter hub to form a tight fluid seal. In some embodiments, the hemoshield device may include a proximal end, which 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.

[0011] In some embodiments, the hemoshield 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 hemoshield device may include the fluid pathway extending from the distal connector to the adapter.

[0012] In some embodiments, the distal connector may further include a collar, which may be configured to couple the distal connector to the proximal end of the 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, which may help drive blood into the hemoshield device without exposure to sharp corners that could increase a risk of hemolysis. In some embodiments, the distal end of the tapered male luer may have a diameter, and the funnel may extend across an entirety of the diameter of the distal end of the tapered male luer.

[0013] In some embodiments, the distal connector may include a proximally-extending flange within the tapered male luer and inserted into the distal end of the extension tube. In some embodiments, the funnel may include an aperture. In some embodiments, a diameter of the aperture may be equal to or approximately equal to a diameter of a portion of the fluid pathway extending through the proximally-extending flange.

[0014] In some embodiments, the funnel may include an outer diameter. In some embodiments, the outer diameter of the funnel may be greater than an outer diameter of the proximally-extending flange. In some embodiments, the outer diameter of the funnel may be greater than an outer diameter of the distal end of the extension tube. In some embodiments, the fluid pathway may extend through the funnel and / or the proximally-extending flange. In some embodiments, the funnel, the proximally-extending flange, and the fluid pathway may be aligned with a 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 the distal end of the extension tube and the proximal end of the extension tube. In some embodiments, the inner surface of the extension tube may include a chamfer, which maybe positioned at the distal end of the extension tube. In some embodiments, the extension tube may include a fillet, which may be proximate and / or proximal to the chamfer. In some embodiments, the chamber and / or the fillet of the extension tube may be annular. In some embodiments, the fillet and / or the chamfer of the extension tube may prevent blood exposure to sharp corners when blood flows proximally through the fluid pathway.

[0016] In some embodiments, an inner surface of the distal end of the tapered male luer may include a tapered portion. In some embodiments, a diameter of the tapered portion of the distal end of the tapered male luer may be greater than or equal to a diameter of a lumen of the catheter hub proximate to the tapered portion. In some embodiments, the tapered portion of the tapered male luer may prevent blood exposure to sharp comers when blood flows proximally through the fluid pathway.

[0017] In some embodiments, the distal end of the extension tube may have an inner diameter at the chamfer. In some embodiments, an entirety of the tapered male luer lumen of the tapered male luer distal to the chamfer may have a diameter greater than the inner diameter at the chamfer, which may reduce a risk of hemolysis when blood flows proximally through the fluid pathway. In some embodiments, the entirety of the tapered male luer lumen of the tapered male luer distal to the chamfer may have a uniform diameter.

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

[0019] In some embodiments, one or more portions of the fluid pathway may include a change in geometry that include one or more particular features for reducing the rate of change. In further detail, in some embodiments, one or more of the fillet, the chamfer, the funnel, or the tapered portion may reduce a rate of change of geometry of the fluid pathway.

[0020] In some embodiments, a hemoshield device for reducing hemolysis in a catheter system may include a distal end, which may include a distal connector. In some embodiments, the distal connector may include a tapered male luer configured to insert into a proximal end of a catheter hub to form a tight fluid seal. In some embodiments, the hemoshield device may include a proximal end, which may include an adapter configured to receive a blood collection device.

[0021] In some embodiments, the adapter may include a pocket. 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 pocket 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, a diameter of the proximal end of the channel may be equal to or less than a diameter of the non-patient cannula lumen proximate the channel, which may prevent blood exposure to sharp comers when blood flows proximally through the fluid pathway.

[0022] In some embodiments, the hemoshield device may include an extension tube, which may include 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. In some embodiments, the distal end of the extension tube may be fixed within the distal connector. In some embodiments, the proximal end of the extension tube may be fixed within the pocket. In some embodiments, thefluid pathway may extend from the distal connector to the adapter through the extension tube, the channel, and the non-patient cannula.

[0023] In some embodiments, the channel may include a chamfer. In some embodiments, the distal end of the channel may include the chamfer. In some embodiments, the chamfer of the channel may be annular. In some embodiments, a diameter of the channel at the chamfer may be greater than or equal to a diameter of the extension tube lumen, which may prevent blood exposure to sharp comers when blood flows proximally through the fluid pathway. In some embodiments, the distal end of the channel may be proximate 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 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 a proximal direction. In these and other embodiments, a diameter of the channel at the proximal end may be less than or equal to an inner diameter of the distal end of the non-patient cannula, which may prevent blood exposure to sharp corners when blood flows proximally through the fluid pathway.

[0025] It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0026] The objects and features of the present invention will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only typical embodiments of the invention and are, therefore, not to be considered limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0027] Figure 1 is a cross-sectional view of an example catheter system having an example hemoshield device, in accordance with some embodiments;

[0028] Figure 2 is a cross-sectional view of a portion of the catheter system, in accordance with some embodiments;

[0029] Figure 3 is a cross-sectional view of an example distal connector coupled to an example catheter assembly, in accordance with some embodiments;

[0030] Figure 4 is a cross-sectional view of an example proximal end of an example hemoshield device, in accordance with some embodiments;

[0031] Figure 5 is a cross-sectional view of another proximal end of the hemoshield device, according to some embodiments;

[0032] Figure 6 is a cross-sectional view of another proximal end of the hemoshield device, according to some embodiments; and

[0033] Figure 7 is a cross-sectional view of another proximal end of the hemoshield device, according to some embodiments.DESCRIPTION OF EMBODIMENTS

[0034] For clarity it is to be understood that the word “proximal” refers to a direction relatively closer to a clinician using the device to be described in the present disclosure, while the word “distal” refers to a direction relatively further from the clinician. For example, the end of a catheter placed within the body of a patient is considered a distal end of the catheter, while the catheter end remaining outside the body is a proximal end of the catheter. Also, the words “including,” “has,” and “having,” as used in the present disclosure, including the claims, shall have the same meaning as the word “comprising.”

[0035] Referring to Figure 1, a 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 hemoshield device 30 for reducing hemolysis in blood as the blood 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, an evacuated blood collection tube (such as, for example, a BD VACUTAINER® blood collection tube, available from Becton Dickinson & Company), a small sample collection device, or any other suitable container configured to contain blood from a patient. In some embodiments, the catheter 22 may include an over-the-needle intravenous catheter through which an introducer needle having a sharp distal tip may extend. In some embodiments, the catheter 22 may include an arterial catheter, a peripheral intravenous catheter, a peripherally-inserted central catheter, a midline catheter, or another type of catheter that may be used to collect blood from vasculature of a patient.

[0037] In some embodiments, the hemoshield 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, thecatheter hub 24, and the hemoshield device 30 may define a fluid pathway through which blood may be transferred from a patient to the 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 fluidically connect the distal connector 40 to the adapter 60.

[0038] In some embodiments, the adapter 60 may be configured to receive the blood collection device. In further detail, in some embodiments, the adapter 60 may include a receptacle 61 for receipt of a particular blood collection container, such as, for example, an evacuated blood collection tube. In some embodiments, the adapter 60 may include a non-patient cannula 62 having a distal end 63 housed within an adapter lumen 73 and a proximal end 64 external to the adapter lumen 73. In some embodiments, the non-patient cannula 62 may include a sheath 66, which 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 puncture the sheath and / or a rubber seal of the blood collection device.

[0039] Referring now to Figure 2, in some embodiments, a distal end of the hemoshield device 30 may include the distal connector 40, which may include a tapered male luer 41. The term “tapered male luer” as used in the present disclosure includes a male luer having a tapered exterior so as to form a seal with the proximal end 27 of the catheter hub 24, for example. In some embodiments, the tapered male luer 41 may be formed substantially in the shape of a plug and configured to insert 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 would not be able to exit the proximal end 27 of the catheter hub 24 between an inner wall of the catheter hub 24 and an outer wall of the tapered male luer 41. In some embodiments, the tapered male luer 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 the tapered male luer 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 tapered male luer 41 may extend from a 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 threaded to the catheter hub 24.

[0041] In some embodiments, the tapered male luer 41 may include a tapered male luer lumen 48. In some embodiments, a distal end 81 of an extension tube 80 may be secured or fixed within the tapered male luer lumen 48 of the tapered male luer 41. In some embodiments, the distal end 81 of the extension tube 80 and the tapered male luer 41 may be coupled together through an interference fit, a snap fit, a bonding, an ultrasonic welding, or any other suitable attachment. In some embodiments, the extension tube 80 and the tapered male luer 41 may be monolithically formed as a single unit.

[0042] In some embodiments, the tapered male luer 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 help facilitate a snug fit of the tapered male luer 41 into the catheter hub 24. In some embodiments, the shoulder 47 may help prevent the tapered male luer 41 from being inserted too far into the catheter hub 24.

[0043] In some embodiments, the distal connector 40 may include a proximally-extending flange 46 within the tapered male luer 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 on the proximally-extending flange 46. In some embodiments, the proximally-extending flange 46 may include an outer diameter slightly larger than an inner diameter of the extension tube 80 such that the proximally-extending flange 46 and the extension tube 80 are engaged in an interference fit. In some embodiments, a proximal end of the proximally-extending flange 46 may be tapered distally such that the portion of the extension tube 80 proximal to the proximally-extending flange 46 has a greater volume than it does in such embodiments in which the proximally-extending flange 46 is not tapered.

[0044] In some embodiments, the hemoshield device 30 may include a funnel 50, which may be disposed at the distal end 42 of the 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 50 may extend across all or substantially all of the outer diameter of the distal end 42 of the tapered male luer 41. In some embodiments, the funnel 50 may be distal to the shoulder 47. In some embodiments, the outer diameter of the distal end 42 of the tapered male luer 41 may be approximately equal to a diameter of the catheter hub lumen 25 at a location corresponding to a location of the distal end 42 of the tapered male luer 41 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 rests against the tapered or stepped surface of the inner wall of the catheter hub 24). In some embodiments, a diameter of the tapered male luer 41 may be smallest at the outer diameter of the distal end 42 of the tapered male luer 41.

[0045] In some embodiments, the funnel 50 may include a conical shape or a truncated conical shape. In some embodiments, an aperture 51 may be at a proximal end and / or a center of the funnel 50. In some embodiments, the aperture 51 may include a fillet 53. In some embodiments, the aperture 61 may extend through the proximally-extending flange 46. In some embodiments, adiameter of the aperture 61 may be constant or generally constant along a length of the aperture61.

[0046] In some embodiments, the funnel 50 may have a distal opening 52 at its distal end. In some embodiments, the distal opening 52 may have a diameter that is greater than the diameter of the aperture 61 and an outer diameter of the proximally-extending flange 46. In some embodiments, the diameter of the distal opening 52 may be greater than an outer diameter and / or an inner diameter of the distal end 81 of the extension tube 80.

[0047] Referring now to Figure 3, a distal connector 83 is illustrated according to some embodiments. In some embodiments, the distal connector may be similar or identical to the distal connector 40 of Figures 1-2 in terms of one or more features and / or operation. In some embodiments, the distal connector 83 may include a tapered male luer 41 configured to insert 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 tapered male luer lumen 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 of the extension tube 80 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 luer 41 (e.g., within the catheter hub 24) may include a tapered portion 58.

[0050] In some embodiments, the distal fillet 56 may be proximate and proximal to the distal chamfer 54. In some embodiments, the distal fillet 56 may operate to further smooth edges of the distal chamfer 54 to further reduce hemolysis. In some embodiments, the tapered portion 58 of the tapered male luer 41 may be positioned at the distal end 42 of the tapered male luer 41. In some embodiments (as illustrated, for example, in Figure 2), the distal end 81 of the extension tube 80 may be located proximal to the distal end 42 of the tapered male luer 41.

[0051] In some embodiments, the tapered portion 58 may provide a smooth transition in the fluid pathway from the catheter hub lumen 25 to the tapered male luer lumen 48. In some embodiments, the tapered portion 58 may include a funnel, a taper, a chamfer, a fillet, or another feature capable of providing a smooth geometric transition between portions of the fluid pathway. In some embodiments, a diameter of the tapered portion 58 may be greater than or equal to a diameter of the catheter hub lumen 25 proximate to the tapered portion 58, which may provide the smooth transition in the fluid pathway from the catheter hub lumen 25 to the tapered male luer lumen 48. In some embodiments, an inner diameter of a distal-most surface of tapered male luer 41 may be greater than or equal to a diameter of the catheter hub lumen 25 proximate to the distal-most surface of tapered male luer 41, which may provide the smooth transition in the fluid pathway from the catheter hub lumen 25 to the tapered male luer lumen 48. Referring now to Figures 2-3, in some embodiments, one or more of the funnel 50, the fillet 53, the distal chamfer 54, the distal fillet 56, and the tapered portion 58 may be annular, thereby providing a smooth geometric transition around a circumference of the fluid pathway.

[0052] The term “fillet” as used in the present disclosure may include a rounded surface, which may extend annularly. In some embodiments, a fillet may include a convex surface at the intersection of two surfaces, which may be created by machining using a fillet edge tool or a similarrounded tool. The term “chamfer” as used in the present disclosure may include a flat surface, illustrated in cross-section (see Figure 3, for example), that is sloped or angled and which may extend annularly.

[0053] Referring now to Figure 4, in some embodiments, a proximal end of the hemoshield 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, which may be configured to pierce the blood collection device. In some embodiments, a distal portion 71 of the adapter 60 may include a pocket 70 for receiving a proximal end 82 of the extension tube 80. Although space is illustrated between the extension tube 80 and the pocket 70 in Figures 4-7, in some embodiments, the space may be reduced or eliminated such that the extension tube 80 fits snugly within the pocket 70. In some embodiments, the proximal end of the extension tube may be secured or fixed within the pocket 70.

[0054] 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. As illustrated, for example, in Figure 4, the fluid pathway may extend through the extension tube 80, the channel 67, and the non-patient cannula 62 (as well as through the distal connector 40, the catheter hub 24, and the catheter 22, as illustrated in Figure 1).

[0055] In some embodiments, there may be one or more transition regions in the fluid pathway in 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. As illustrated, for example, inFigure 4, in some instances, the transition regions may include sharp comers, and when blood is exposed to the sharp corners, this may increase the hemolysis risk due to the added shear stress.

[0056] Referring now to Figures 5-7, in some embodiments, one or more features may be added to the transition regions in the fluid pathway in order to decrease the risk of hemolysis. For example, in some embodiments, a diameter of the proximal end 68 of the channel 67 may be equal to or less than an inner diameter of the non-patient cannula lumen 65 proximate the channel 67. In some embodiments, this may be accomplished with the non-patient cannula 62 having a thin annular wall. In some embodiments, an annular wall of the non-patient cannula 62 may be embedded within a portion of the adapter 60 such that an inner surface of the annular wall of the non-patient cannula lumen 65 is aligned with the channel 67.

[0057] In some embodiments, as illustrated, for example, in Figure 6, 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 an inward taper in a proximal direction. For instance, the inner surface of the non-patient canula may be extruded or machined (or otherwise formed) at the distal end in such a manner so as to provide the non-patient cannula chamfer. In some embodiments, the non-patient cannula chamfer 74 may be annular. In some embodiments, as shown in Figure 7, the channel 67 itself may be tapered inwardly in a 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 proximate 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.

[0058] As illustrated, for example, in Figures 5-6, the fluid pathway in the adapter 60 may include a distal chamfer 76 and / or a distal fillet 77. As illustrated, for example, in Figures 5-6, in some embodiments, the distal chamfer 76 and / or the distal fillet 77 may be formed in the channel 67. Insome embodiments, the distal chamfer 76 and / or the distal fdlet 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 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] Referring now to Figures 1-7, in some embodiments, the extension tube 80 may include a distal end 81 that is fixed within the distal connector 40, and the extension tube 80 may include a proximal end 82 that is 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 pathway of the catheter system 20. In some embodiments, the fluid pathway may extend from the distal connector 40 to the adapter 60 through the extension tube 80. In some embodiments, the fluid pathway 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 pathway may extend through various features as discussed in the present disclosure, such as through the funnel 50 and / or the proximally- extending flange 46 of the distal connector 40, and though the channel 67 and non-patient cannula 62 of the adapter 60. In some embodiments, the fluid pathway (and optionally other features, such as the flange and the funnel) may be aligned with a central axis of the catheter system 20 or a portion thereof (e.g., a central axis of the distal connector 40, a central axis of the adapter 60, and / or a central axis of the extension tube 80).

[0060] In some embodiments, the catheter system 20 may include features within the fluid pathway (e g., geometric features of interior surfaces of the various lumens that form portions of the fluid pathway, and interactions between different segments of the fluid pathway) that are configured to reduce hemolysis as blood travels proximally through the fluid pathway to be collected. For example, one or more of a funnel, chamfer, fillet, tapered portion, or other smoothgeometric feature discussed in the present disclosure may be positioned to reduce hemolysis that could otherwise occur as a result of contact between the blood and sharp or rough portions at component transitions within the fluid pathway. In some embodiments, the interaction of multiple such features (e.g., a chamfer and a fdlet proximate to each other, and / or a distal feature combined with a proximal feature downstream) may reduce the risk of hemolysis beyond what could be achieved with only a single feature on its own.

[0061] It is understood that, in some embodiments, the extension tube 80 may be any form of tube suitable for providing a fluid pathway between the distal connector 40 and the adapter 60. In particular, the extension tube 80 may include an extension set, a compact connector, a rigid cannula, and / or any other suitable tube.

[0062] All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.

Claims

CLAIMSWhat is claimed is:

1. A hemoshield device for reducing hemolysis in a catheter system, the hemoshield device comprising: a distal end comprising a distal connector, wherein the distal connector comprises a tapered male luer configured to insert into a proximal end of a catheter hub to form a tight fluid seal; a proximal end comprising an adapter configured to receive a blood collection device, wherein the adapter comprises a non-patient cannula configured to pierce the blood collection device; an extension tube comprising a distal end and a proximal end, wherein the distal end of the extension tube is fixed within the tapered male luer, wherein the proximal end of the extension tube is fixed within the adapter; and a fluid pathway extending from the distal connector to the adapter through the extension tube.

2. The hemoshield device of claim 1, wherein the distal connector further comprises a collar configured to couple the distal connector to the proximal end of the catheter hub.

3. The hemoshield device of claim 1, wherein a distal end of the tapered male luer comprises a funnel.

4. The hemoshield device of claim 3, wherein the distal end of the tapered male luer comprises a diameter, wherein the funnel extends across an entirety of the diameter of the distal end of the tapered male luer.

5. The hemoshield device of claim 4, wherein the distal connector further comprises a proximally-extending flange within the tapered male luer and inserted into the distal end of the extension tube.

6. The hemoshield device of claim 5, wherein the funnel comprises an aperture, wherein a diameter of the aperture is equal to a diameter of a portion of the fluid pathway extending through the proximally-extending flange.

7. The hemoshield device of claim 5, wherein an outer diameter of the funnel is greater than an outer diameter of the proximally-extending flange and an outer diameter of the distal end of the extension tube.

8. The hemoshield device of claim 5, wherein the fluid pathway extends through the funnel and the proximally-extending flange.

9. The hemoshield device of claim 8, wherein the funnel, the proximally-extending flange, and the fluid pathway are aligned with a central axis of the distal connector.

10. The hemoshield device of claim 1, wherein the extension tube further comprises an extension tube lumen and an inner surface forming the extension tube lumen, wherein the extension tube lumen extends through the distal end of the extension tube and the proximal end of the extension tube, wherein the inner surface of the extension tube comprises a chamfer.

11. The hemoshield device of claim 10, wherein the extension tube comprises a fdlet proximate and proximal to the chamfer.

12. The hemoshield device of claim 10, wherein an inner surface of the distal end of the tapered male luer comprises a tapered portion.

13. The hemoshield device of claim 12, wherein a diameter of the tapered portion of the distal end of the tapered male luer is greater than or equal to a diameter of a lumen of the catheter hub proximate to the tapered portion.

14. The hemoshield device of claim 10, wherein the chamfer is annular.

15. A hemoshield device for reducing hemolysis in a catheter system, the hemoshield device comprising: a distal end comprising a distal connector, wherein the distal connector comprises a tapered male luer configured to insert into a proximal end of a catheter hub to form a tight fluid seal; a proximal end comprising an adapter configured to receive a blood collection device, wherein the adapter comprises a pocket, a non-patient cannula configured to pierce the blood collection device, and a channel extending between the pocket and the non-patient cannula, wherein the channel comprises a distal end and a proximal end, wherein the non-patient cannula comprises a non-patient cannula lumen, wherein a diameter of the proximal end of the channel is equal to or less than a diameter of the non-patient cannula lumen proximate the channel; an extension tube comprising 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, wherein the proximal end of the extension tube is fixed within the pocket; and a fluid pathway extending from the distal connector to the adapter through the extension tube, the channel, and the non-patient cannula.

16. The hemoshield device of claim 15, wherein the distal end of the channel comprises a chamfer, wherein the chamfer is annular.

17. The hemoshield device of claim 16, wherein a diameter of the channel at the chamfer is greater than a diameter of the extension tube lumen, wherein the distal end of the channel is proximate the proximal end of the extension tube.

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

19. The hemoshield device of claim 18, wherein the channel is tapered in a proximal direction.

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