Catheter extension set and related methods

Abstract

A catheter extension set includes a distal end including a luer adapter configured to couple to a catheter adapter, a proximal end including a blood collection device, and an extension tube extending between the distal end and the proximal end. The catheter extension set can increase flow resistance, which can reduce the risk of hemolysis when there is a high pressure differential within the catheter extension set. The catheter extension set can decrease flow resistance after the pressure differential within the catheter extension set is reduced, which can facilitate faster blood collection.

Description

Technical Field

[0001] This application relates to the field of medical devices, and in particular to catheter extension kits and related methods. Background Technology

[0002] Catheters are commonly used to deliver fluids into a patient's vascular system. For example, catheters can be used to infuse saline solutions, various medications, or total parenteral nutrition. Catheters can also be used to draw blood from a patient.

[0003] The catheter may comprise a needle-type peripheral intravenous (“IV”) catheter. In this case, the catheter may be mounted on a guide needle with a sharp distal tip. The catheter and guide needle may be assembled such that the distal tip of the guide needle extends beyond the distal tip of the catheter, with the bevel of the needle facing upwards away from the patient’s skin. The catheter and guide needle are typically inserted into the patient’s vascular system through the skin at a shallow angle.

[0004] To verify proper placement of the guide needle and / or catheter in the blood vessel, clinicians typically confirm the presence of a "flashback" of blood in the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily block flow in the vascular system 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 blood samples, a blood collection container can be used. This container may contain a syringe or test tube with a rubber stopper 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. Commonly used blood collection containers are available from Becton Dickinson & Company. Blood collection tube.

[0006] The blood collection container can be connected to the catheter. When the blood collection container is connected to the catheter, the pressure in the vein is higher than the pressure in the blood collection container, which pushes blood into the blood collection container, thereby filling the blood collection container with blood. As the blood collection container fills, the vacuum inside the blood collection container decreases until the pressure in the blood collection container equals the pressure in the vein, and the blood flow stops.

[0007] Unfortunately, when blood is aspirated into the blood collection container, the high initial pressure differential between the vein and the container causes red blood cells to be under high shear stress and prone to hemolysis. Hemolysis can lead to the spoilage and disposal of the blood sample. The high initial pressure differential can also cause catheter tip collapse, vein collapse, or other complications that prevent or limit blood filling of the blood collection container. As the blood collection container fills, the pressure differential between the vein and the container decreases, and the filling of the blood collection tube slows down significantly.

[0008] The subject matter claimed herein is not limited to solutions to any drawbacks or embodiments that operate only in environments such as those described above. Rather, this background is provided merely to illustrate an exemplary technical field in which certain implementations described herein can be practiced. Summary of the Invention

[0009] This disclosure generally relates to an extension kit for a vascular access device, and related devices, systems, and methods. In some embodiments, a vascular access system may include an extension kit coupled to the vascular access device. In some embodiments, the vascular access device may include a catheter, a needle, or another device suitable for blood collection.

[0010] In some embodiments, during blood collection, the extension kit may help regulate flow resistance within the vascular access system based on pressure conditions within the system. More specifically, in some embodiments, the extension kit may be responsive and may help regulate flow resistance within the vascular access system as the pressure difference between the patient's vein and the blood collection container coupled to the vascular access system changes during blood collection. In some embodiments, the extension kit may reduce the risk of hemolysis. In some embodiments, the extension kit may simultaneously reduce the risk of hemolysis and reduce blood collection time during the blood extraction process. In some embodiments, the extension kit may also reduce the risk of collapse of the vein and / or vascular access device.

[0011] In some embodiments, in response to a higher pressure differential, such as when the blood collection container is first connected to the vascular access system, the extension kit may help increase flow resistance within the vascular access system to distribute the pressure differential and reduce shear stress on the red blood cells. In some embodiments, when the blood collection container is filled with blood, the vacuum within the fluid passage of the vascular access system may decrease, and the pressure differential may decrease. Therefore, in some embodiments, to shorten blood collection time, the extension kit may help reduce flow resistance within the vascular access system while still maintaining the shear stress on the blood cells below a threshold level.

[0012] In some embodiments, the extension kit may be configured to connect to a catheter assembly and may be referred to as a catheter extension kit. In some embodiments, the extension kit may include a distal end, which may include a Luer adapter configured to connect to a catheter adapter or another suitable vascular access device. In some embodiments, the extension kit may include a proximal end, which may include a blood collection device. 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-sealed blood collection tube, a small sample collection device, or any other container configured to collect blood from a patient via a pressure differential. In some embodiments, the blood collection device may include a needle assembly, which may include a needle configured to receive the blood collection container. In these and other embodiments, the blood collection container may include a vacuum-sealed blood collection tube.

[0013] In some embodiments, the extension kit may include an extension tube that extends between a distal end and a proximal end of the extension kit. In some embodiments, the extension kit may include a clamp that is disposed on the extension tube. In some embodiments, the clamp may be configured to move between a clamped position and an unclamped position. In some embodiments, in response to the clamp being in the clamped position, the clamp may impede or reduce fluid flow through the extension tube.

[0014] In some embodiments, the Luer adapter may be a first Luer adapter. In some embodiments, the blood collection device may include a second Luer adapter. In some embodiments, the extension kit may include a third Luer adapter, which may be coupled to the second Luer adapter. In some embodiments, the extension tube may include a distal end and a proximal end. In some embodiments, the distal end of the extension tube may be integrated with the first Luer adapter. In some embodiments, the proximal end of the extension tube may be integrated with the third Luer adapter. In other embodiments, the proximal end of the extension tube may be integrated with the blood collection device.

[0015] In some embodiments, the extension tube may comprise an absorbent material or an indicator tube. In some embodiments, the inner surface of the extension tube may comprise an absorbent material or an indicator tube. In some embodiments, the absorbent material and / or the indicator tube may comprise one or more markers. In some embodiments, blood within the extension tube may be configured to flow toward the absorbent material or through the indicator tube. In some embodiments, in response to the blood reaching or saturating a specific marker, a clinician may alter the flow resistance within the vascular access system via the extension kit. In some embodiments, to reduce flow resistance within the vascular access system, a clinician may remove the extension kit from the vascular access system, move the clamp to the non-clamped position, or perform another action to reduce flow resistance, as may be further described in this disclosure.

[0016] In some embodiments, the extension kit may include one or more extension tubes. In some embodiments, the extension tube may be a first extension tube. In some embodiments, the extension kit may include a second extension tube. In some embodiments, the flow resistance of the first extension tube may be greater than the flow resistance of the second extension tube. For example, the first extension tube may be longer than the second extension tube. Additionally or alternatively, in some embodiments, the inner diameter of the first extension tube may be smaller than the inner diameter of the second extension tube. In some embodiments, the flow resistance of the first extension tube may be equal to the flow resistance of the second extension tube. In some embodiments, the second extension tube may comprise any combination of length and inner diameter such that the flow resistance of the second extension tube is equal to or less than the flow resistance of the first extension tube.

[0017] In some embodiments, the first extension tube and the second extension tube may extend between the distal end and the proximal end of the extension kit. In some embodiments, the clamp may be disposed on the second extension tube. In some embodiments, the second extension tube may extend through the clamp. In some embodiments, the second extension tube may contain the absorbent material or the indicator tube. In some embodiments, blood within the second extension tube may be configured to flow toward the absorbent material or flow through the indicator tube.

[0018] In some embodiments, the first extension tube may be disposed within the second extension tube. In some embodiments, in response to the clamp being in the clamped position, blood can flow through the first extension tube, and blood flow between the outer surface of the first extension tube and the inner surface of the second extension tube can be reduced or stopped. In some embodiments, to reduce or stop flow resistance within the vascular access system after the blood collection container is partially filled and the pressure differential has decreased, the clinician may move the clamp to the unclamped position to increase the flow rate, taking into account the decreased pressure differential.

[0019] In some embodiments, the second extension tube may include a distal end and a proximal end. In some embodiments, the distal ends of the first extension tube and the second extension tube may be integrated with the first Luer adapter. In some embodiments, the proximal ends of the first extension tube and the second extension tube may be integrated with the third Luer adapter.

[0020] In some embodiments, in response to the second Luer adapter being tightened relative to the third Luer adapter, a first fluid passage through the first extension tube can be opened, and a second fluid passage through the second extension tube can be closed. In some embodiments, in response to the second Luer adapter being loosened relative to the third Luer adapter, a first fluid passage through the first extension tube can be opened, and a second fluid passage through the second extension tube can be opened. In some embodiments, to reduce flow resistance within the vascular access system after the blood collection container has been partially filled and the pressure differential has decreased, a clinician can loosen the second Luer adapter relative to the third Luer adapter or move the second Luer adapter from a tightened position to a loosened position. As a result, in these and other embodiments, the flow rate can be increased.

[0021] In some embodiments, the extension kit may include a pressure-sensitive valve within it. In some embodiments, the pressure-sensitive valve may be disposed within the second extension tube. In some embodiments, the pressure-sensitive valve may be disposed in a portion of the fluid passage of the extension kit distal to the first and second extension tubes. In some embodiments, the fluid passage of the extension kit may extend through both the proximal and distal ends of the extension kit. In some embodiments, the fluid passage of the extension kit may include a first fluid passage of the first extension tube and / or a second fluid passage of the second extension tube. In some embodiments, the pressure-sensitive valve may be disposed at the junction of the first and second fluid passages.

[0022] In some embodiments, the pressure-sensitive valve may open relative to the first extension tube and close relative to the second extension tube in response to a first predetermined pressure difference within the extension kit. In some embodiments, the pressure-sensitive valve may close relative to the first extension tube and open relative to the second extension tube in response to a second predetermined pressure difference within the extension kit. In some embodiments, the first predetermined pressure difference may be greater than the second predetermined pressure difference. In some embodiments, the first predetermined pressure difference and the second predetermined pressure difference may correspond to the pressure difference between the patient's vein and the blood collection container connected to the vascular access system.

[0023] In some embodiments, a blood collection method or method of collecting a blood sample may include inserting a catheter of a catheter system into a patient's vascular system. In some embodiments, the catheter system may include a catheter assembly, which may include a catheter adapter and the catheter. In some embodiments, the catheter may be secured within the catheter adapter and may extend distally from the catheter adapter.

[0024] In some embodiments, the blood collection method may include coupling the extension kit to the catheter adapter. In some embodiments, the blood collection method may include blocking blood flow through the second extension tube. In some embodiments, after inserting a catheter of the catheter system into the patient's vascular system, coupling the catheter extension kit to the catheter adapter, and blocking blood flow through the second extension tube, the blood collection method may include coupling a blood collection container to the blood collection device or the third Luer adapter. In some embodiments, in response to coupling the blood collection container to the blood collection device or the third Luer adapter, the blood collection container may begin to fill with blood. In some embodiments, in response to the blood collection container being partially filled with blood, the blood collection method may include opening the second extension tube to allow increased blood flow through the second extension tube.

[0025] In some embodiments, the second extension tube may extend through the clamp. In these embodiments, blocking blood flow through the second extension tube may include moving the clamp to the clamped position, and opening the second extension tube may include moving the clamp to the unclamped position. In some embodiments, blocking blood flow through the second extension tube may include tightening the second Luer adapter relative to the third Luer adapter. In some embodiments, opening the second extension tube may include loosening the second Luer adapter relative to the third Luer adapter.

[0026] In some embodiments, the extension kit may include a roller clamp. In some embodiments, the roller clamp may include a roller movable within a track. In some embodiments, the first and second extension tubes may extend substantially perpendicular to the track through the roller clamp. In some embodiments, when blood flow through the second extension tube is obstructed, the roller may be positioned in a first position close to the second extension tube. In some embodiments, opening the second extension tube may involve moving the roller along the track away from the second extension tube and toward the first extension tube.

[0027] In some embodiments, the distal end of the extension kit may include a three-way stopcock valve, which may include a first port, a second port, and a third port. In some embodiments, the first extension tube may be connected to the first port, the second extension tube may be connected to the second port, and the third port may include a first Luer adapter configured to be connected to the catheter adapter. In some embodiments, blocking blood flow through the second extension tube may include rotating the three-way stopcock valve to a first position. In some embodiments, opening the second extension tube may include rotating the three-way stopcock valve to a second position.

[0028] It should be understood that the foregoing general description and the following detailed description are illustrative and explanatory, and do not limit the invention as claimed. 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 embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description should not be construed as restrictive. Attached Figure Description

[0029] Exemplary embodiments will be described and explained in further detail with reference to the accompanying drawings, wherein:

[0030] Figure 1A This is a top perspective view of an exemplary extension kit according to certain embodiments;

[0031] Figure 1B for Figure 1A Cross-sectional view of the extended kit according to certain embodiments;

[0032] Figure 1C for Figure 1A Upper perspective view of an extension kit coupled to an exemplary catheter assembly according to certain embodiments;

[0033] Figure 2AThis is a top perspective view of another exemplary extended kit according to certain embodiments;

[0034] Figure 2B for Figure 2A Cross-sectional view of the extended kit according to certain embodiments;

[0035] Figure 2C for Figure 2A According to certain embodiments, the connection to Figure 1C Upper perspective view of the extension kit of the catheter assembly;

[0036] Figure 3A This is a top perspective view of another exemplary extended kit according to certain embodiments;

[0037] Figure 3B for Figure 3A A cross-sectional view of an extension kit, according to certain embodiments, connected to another exemplary catheter assembly;

[0038] Figure 3C for Figure 3A According to certain embodiments, the connection to Figure 3B Upper perspective view of the extension kit of the catheter assembly;

[0039] Figure 4A This is a top perspective view of another exemplary extended kit according to certain embodiments;

[0040] Figure 4B for Figure 4A According to certain embodiments, the connection to Figure 3B Upper perspective view of the extension kit of the catheter assembly;

[0041] Figure 4C for Figure 4A According to certain embodiments, the connection to Figure 3B A cross-sectional view of the extension kit of the conduit assembly;

[0042] Figure 5A for Figure 3A A schematic diagram of an extension kit according to certain embodiments, showing an exemplary clamp in a clamped position before blood enters the extension kit;

[0043] Figure 5B for Figure 3A A schematic diagram of an extension kit according to certain embodiments, showing blood flowing through an exemplary first extension tube under a high initial pressure differential;

[0044] Figure 5C for Figure 3A A schematic diagram of an extension kit according to certain embodiments, showing a clamp being removed or not clamped in response to a low pressure differential;

[0045] Figure 6A A cross-sectional view of an exemplary second Luer adapter and an exemplary third Luer adapter prior to being coupled together, according to certain embodiments;

[0046] Figure 6B for Figure 6A A cross-sectional view of a second Luer adapter and a third Luer adapter according to certain embodiments, showing the second Luer adapter tightened relative to the third Luer adapter;

[0047] Figure 6C for Figure 6A A cross-sectional view of a second Luer adapter and a third Luer adapter according to certain embodiments, showing the second Luer adapter relaxed relative to the third Luer adapter;

[0048] Figure 7A According to certain embodiments, it can be used with Figure 3A extension kits or Figure 4A Upper perspective view of an exemplary roller clamp used in conjunction with the extension kit;

[0049] Figure 7B for Figure 7A A cross-sectional view of a roller clamp according to certain embodiments, showing an exemplary roller in an exemplary first position;

[0050] Figure 7C for Figure 7B A cross-sectional view of a roller clamp according to certain embodiments, showing a roller in an exemplary second position;

[0051] Figure 8 According to certain embodiments, linked to Figure 3B A cross-sectional view of another exemplary extension kit of the conduit assembly;

[0052] Figure 9A According to certain embodiments, linked to Figure 3B Upper perspective view of another exemplary extension kit of the conduit assembly;

[0053] Figure 9B for Figure 9A An enlarged upper perspective view of a portion of an extension kit according to certain embodiments;

[0054] Figure 9C for Figure 9A Cross-sectional view of the extended kit according to certain embodiments;

[0055] Figure 9D for Figure 9AA cross-sectional view of an extension kit according to certain embodiments, showing another exemplary first extension tube disposed within an exemplary second extension tube and the clamped second extension tube;

[0056] Figure 9E for Figure 9A A cross-sectional view of an extension kit according to certain embodiments, showing a first extension tube disposed within the second extension tube;

[0057] Figure 10A A cross-sectional view of a portion of another exemplary first extension tube according to certain embodiments, showing an exemplary absorbent material prior to blood entering the first extension tube;

[0058] Figure 10B for Figure 10A A cross-sectional view of a portion of a first extension tube according to certain embodiments, showing the absorbent material in response to blood flowing through the first extension tube at a high initial pressure differential;

[0059] Figure 11A A cross-sectional view of a portion of another exemplary first extension tube according to certain embodiments, showing an exemplary indicator tube before blood enters the first extension tube;

[0060] Figure 11B for Figure 11A A cross-sectional view of a portion of a first extension tube according to certain embodiments, showing the indicator tube in response to blood flowing through the first extension tube at a high initial pressure differential;

[0061] Figure 12A This is a cross-sectional view of an exemplary joint between an exemplary first extension tube and an exemplary second extension tube according to certain embodiments, showing the joint before blood enters the joint;

[0062] Figure 12B for Figure 12A A cross-sectional view of a joint according to certain embodiments, showing the joint in response to blood flowing through it under a high initial pressure differential;

[0063] Figure 12C for Figure 12A A cross-sectional view of the joint according to certain embodiments, showing the joint in response to blood flowing through it at a low pressure difference compared to the high initial pressure difference;

[0064] Figure 13 According to certain embodiments, linked to Figure 3B A partial cross-sectional view of another exemplary extension kit of the conduit assembly;

[0065] Figure 14A A top perspective view of an exemplary catheter system according to certain embodiments; and

[0066] Figure 14B This is a top perspective view of another exemplary catheter system according to certain embodiments. Detailed Implementation

[0067] Now for reference Figure 1A-1C In some embodiments, the extension kit 10 may include a distal end 12, which may include a Luer adapter 14 configured to connect to a catheter adapter or another suitable vascular access device. In some embodiments, the extension kit 10 may include a proximal end 16, which may include a blood collection device 18. In some embodiments, the blood collection device 18 may include or correspond to a blood collection container. In some embodiments, the blood collection container may include a syringe, a vacuum-sealed blood collection tube, a small sample collection device, or any other container configured to collect blood from a patient via a pressure differential.

[0068] In some embodiments, the blood collection device 18 may include a needle assembly 19, which may include a needle 20 configured to receive a blood collection container. In these and other embodiments, the blood collection container may include a vacuum-sealed blood collection tube. In some embodiments, the blood collection container removes all or part of the air, so that the pressure inside the blood collection container is lower than ambient pressure.

[0069] In some embodiments, the needle assembly 19 may include one or more threads configured to engage with a retainer 22, which may be generally cylindrical and configured to hold a blood collection container. In some embodiments, the retainer 22 may be integrally formed with the needle assembly 19, or may be engaged to the needle assembly 19 via adhesive or another suitable method. In some embodiments, the retainer 22 may surround the needle 20. In some embodiments, the needle assembly 19 and the retainer 22 may include or correspond to a Luer lock access device, for example, available from Becton Dickinson. LUER-LOK TM Access device ( LUER-LOK TM(ACCESS DEVICE). In some embodiments, retainer 22 may comprise or correspond to blood collection tube retainer 127 as described in U.S. Patent Application No. 62 / 928,69, filed October 30, 2019, entitled “BLOOD COLLECTIONSYSTEM WITH USER-ADJUSTED PRESSURE MANAGEMENT AND RELATED METHODS”, which is incorporated herein by reference in its entirety.

[0070] In some embodiments, the Luer adapter 14 may be a first Luer adapter 14. In some embodiments, the extension kit 10 may include a second Luer adapter 24. In some embodiments, the blood collection device 18 may include a second Luer adapter 24. In some embodiments, the needle 20 may be integrated with the second Luer adapter 24. In some embodiments, the proximal end of the needle 20 may be enclosed within an elastomeric sheath 26. In some embodiments, the elastomeric sheath 26 may include an open distal end 28 and a closed proximal end 30. In some embodiments, in response to the blood collection container pushing the elastomeric sheath 26 distally, the needle 20 may pierce the elastomeric sheath 26, and the needle 20 may be inserted into the cavity of the blood collection container.

[0071] In some embodiments, the extension kit 10 may include an extension tube 32 that extends between the distal end 12 and the proximal end 16 of the extension kit 10. In some embodiments, the extension tube 32 may be rigid or semi-rigid, which may reduce the possibility of kinking.

[0072] In some embodiments, the extension kit 10 may include a third Luer adapter 34, which may be coupled to the second Luer adapter 24. In some embodiments, the extension tube 32 may include a distal end 36 and a proximal end 38. In some embodiments, the distal end 36 may be coupled to or integrated with the first Luer adapter 14. In some embodiments, the proximal end of the extension tube 32 may be coupled to or integrated with the third Luer adapter 34. In other embodiments, the proximal end of the extension tube 32 may be coupled to or integrated with the blood collection device 18.

[0073] In some embodiments, the extension kit 10 can act as, for example... Figure 1CThe catheter system or another vascular access system shown is a flow resistant device in its fluid passage. In some embodiments, the catheter system may include a catheter assembly 37, which may include a catheter adapter 39 and a catheter 40. In some embodiments, the catheter 40 may be secured within the catheter adapter 39 and may extend distally from the catheter adapter 39. In some embodiments, the catheter adapter 39 may include a distal end 42, a proximal end 44, and a lumen extending through the distal end 42 and the proximal end 44. In some embodiments, a guide needle 45 may extend through the catheter 40 from a needle sheath.

[0074] In some embodiments, the extension kit 10 can be coupled to the catheter assembly 37 in any number of suitable ways. In some embodiments, the catheter assembly 37 can be integrated. More specifically, in some embodiments, another extension tube 46 can extend from the side port 48 of the catheter adapter 39. In some embodiments, the proximal end of the other extension tube 46 can include a fourth Luer adapter 50, which can be coupled to the first Luer adapter 14. In some embodiments, the catheter assembly 37 can be straight and / or the first Luer adapter 14 can be coupled to the proximal end 44 of the catheter adapter 39. In some embodiments, one or more of the first Luer adapter 14, the second Luer adapter 24, the third Luer adapter 34, and the fourth Luer adapter 50 can include a sliding or threaded or clamp-type male Luer adapter, a sliding or threaded female Luer adapter, a needleless connector, a blunt cannula, or another suitable access device.

[0075] In some embodiments, catheter assembly 37 may comprise or correspond to any suitable catheter assembly, such as BDNEXIVA. TM Closed IV catheter system, BD CATHENA TM Catheter system, BD VENFLON TM Supported safety shield IV (BD VENFLON) TM Pro safely Shielded IV) catheter system, BD NEOFLON TM IV sleeve system, BDINSYTE TM AUTOGUARD TM A BC-shielded IV catheter system, or another suitable catheter assembly. In some embodiments, catheter 40 may comprise a peripheral intravenous catheter (PIVC), a peripherally inserted central catheter (PICC), or a midline catheter.

[0076] In some embodiments, the fluid access pathway of the catheter system may include one or more of the following: catheter 40, catheter adapter 39, another extension tube 46, a fourth Luer adapter 50, a first Luer adapter 14, an extension tube 32, a third Luer adapter 34, a second Luer adapter 24, and a blood collection device 18. In some embodiments, the extension kit 10 may reduce the blood flow rate within the fluid access pathway of the catheter system, which in turn may reduce the shear rate for hemolysis management. In some embodiments, the catheter assembly 37 may be replaced by another type of vascular access device, such as a venipuncture device, a disposable infusion set, a blood collection access device, or a blood collection container.

[0077] Blood cells experience shear stress as they flow through a fluid pathway. The maximum shear stress occurs along the wall of the fluid pathway, or wall shear stress. Wall shear stress on blood cells is considered a major source of mechanical damage. For cylindrical fluid pathways, wall shear stress is typically expressed as:

[0078]

[0079] Where Δp is the pressure drop along a path with length L and inner radius r. k is the contraction exponent.

[0080] To fill a given volume V of the collection tube at a flow rate Q, the required time can be easily estimated as follows:

[0081]

[0082] Where μ is the dynamic viscosity of the fluid. Hemolysis is generally associated with wall shear stress and the time that blood cells are exposed to wall shear stress. According to the literature, the hemolysis index is widely considered to be a function that can be applied as follows:

[0083] HI(%)=A*t a *τ β

[0084] Where A, α, and β are coefficients.

[0085] In principle, the hemolysis index is related to the pressure gradient and the characteristic dimensions of the cross-section:

[0086]

[0087] In some embodiments, the length of the extension tube 32 may be selected based on one or more of the following: a particular catheter specification and / or length, a particular catheter assembly construction, or clinical setup. In some embodiments, the extension tube 32 may comprise a length L from the first Luer adapter 14 to the second Luer adapter 24. In some embodiments, the extension tube 32 may comprise an inner diameter D.

[0088] The Poiseuille equation can be used to analyze fluid flow in an extension tube with a tubular fluid passage passing through it:

[0089]

[0090] Where ΔP represents the change in pressure gradient across the length of the extension tube, D and L are the inner diameter and length of the tubular fluid passage through the extension tube, respectively, and μ is the viscosity of the fluid. For fluid resistance. An extension tube may contain or correspond to extension tube 32. Since μ is the viscosity of the fluid rather than part of the extension tube geometry, a geometry factor G is defined. f So that R f (fluid resistance) is in

[0091] In some embodiments, the extension tube 32 may have multiple segments with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), thus the geometric factors are:

[0092]

[0093] In some embodiments, the extension tube 32 may have an inner diameter that varies along the length of the extension tube, and therefore the geometric factor is:

[0094]

[0095] In some embodiments, the extension tube 32 may have a non-circular cross-section. In this case, the geometric factors can be determined by measuring the fluid rate (Q) at a given pressure (ΔP) with a fluid of known viscosity (μ).

[0096]

[0097] You can choose G f Values ​​are set to reduce the maximum shear stress to equal to or less than 21G for each catheter specification. UTLRATOUCH TM The maximum shear stress of the button blood collection kit (available from Becton Dickinson & Company), which was previously considered the gold standard for blood aspiration. In some embodiments, when using an 18G catheter, G... f It can be equal to or greater than 3.83E+06(1 / in) 3 This can reduce wall shear stress and thus reduce hemolysis. In some embodiments, when using a 20G (gauge) catheter, G... f It can be equal to or greater than 3.27E+06(1 / in)3 This can reduce wall shear stress and thus reduce hemolysis. In some embodiments, when using a 22G catheter, G... f It can be equal to or greater than 3.33E+06(1 / in) 3 This can reduce wall shear stress and thus reduce hemolysis. In some embodiments, when using a 24G catheter, G... f It can be equal to or greater than 1.50E+07(1 / in) 3 This can reduce wall shear stress and thus reduce hemolysis. In some embodiments, G f It can include another value. In some embodiments, G can be selected. f The value is set to reduce the maximum shear stress to equal or less than 25G for each catheter specification. ULTRATOUC TM Maximum shear stress of the button blood collection kit (available from Becton Dickinson & Company).

[0098] In some embodiments, when using an 18G catheter, G f It can be equal to 3.83E+06(1 / in) 3 Adding or subtracting 10%, 25%, 50%, or 75% can reduce wall shear stress and thus reduce hemolysis. In some embodiments, when using a 20G catheter, G... f It can be equal to 3.27E+06(1 / in) 3 Adding or subtracting 10%, 25%, 50%, or 75% can reduce wall shear stress and thus reduce hemolysis. In some embodiments, when using a 22G catheter, G... f It can be equal to 3.33E+06(1 / in) 3 Adding or subtracting 10%, 25%, 50%, or 75% can reduce wall shear stress and thus reduce hemolysis. In some embodiments, when using a 24G catheter, G... f It can be equal to 1.50E+07(1 / in) 3 Adding or subtracting 10%, 25%, 50%, or 75% can reduce wall shear stress and thus reduce hemolysis. In some embodiments, G f Another value may be included, which can be selected based on the catheter's specifications. In some embodiments, for 22G to 18G catheters, G can be... f Choose the same value.

[0099] In some embodiments, the fluid pathway of the catheter system (which may include one or more of a needle assembly 19, an extension tube 32, and a catheter assembly 37 (which may include another extension tube 46)) may encompass the entire blood collection pathway through which blood flows during blood collection. The system geometry factor G of the fluid pathway of the catheter system can be determined in a manner similar to that described earlier. fs In some embodiments, the system geometry factor G fs It can be equal to or greater than 7.34E+06 (1 / in3). In some embodiments, G fs It may contain another value. In some embodiments, the system geometry factor G fs It can be 7.34E+06 (1 / in3) plus or minus 10%, plus or minus 25%, plus or minus 50%, or plus or minus 75%. In some embodiments, G fs It may include another value, which may be selected based on the specifications of the catheter.

[0100] Now for reference Figure 2A-2C The diagram illustrates an extension kit 52 according to certain embodiments. In some embodiments, the extension kit 52 may be compatible with one or more of the included features and / or operations. Figure 1A-1C The extension kit 10 is similar to or identical to the extension tube 32. In some embodiments, the proximal end of the extension tube 32 may be integrated with the blood collection device 18. In some embodiments, the extension kit 52 may include a clamp 54 disposed on the extension tube 32. In some embodiments, the clamp 54 may be configured to move between a clamped position and an unclamped position or between a larger clamped position and a smaller clamped position. In some embodiments, in response to the clamp 54 being in the clamped position, the clamp 54 may prevent or reduce fluid flow through the extension tube 32.

[0101] In some embodiments, clinicians can adjust the flow resistance within the catheter system by manually altering the fluid characteristics of the catheter system using clamp 54. In some embodiments, in response to clamp 54 being in the clamped position, the flow resistance within the catheter system can be increased and the blood flow through extension tube 32 can be reduced. In these embodiments, the risk of hemolysis can be reduced. In some embodiments, to reduce the flow resistance within the catheter system after the blood collection container is nearly full, clinicians can move the clamp to a non-clamped position, which allows for faster blood collection while reducing the risk of hemolysis.

[0102] In some embodiments, clamp 54 may include a sliding clamp that may include a gradually narrowing slot. In these and other embodiments, extension tube 32 may be flexible and compliant. In some embodiments, a clinician can adjust the inner diameter of extension tube 32 by adjusting the depth of extension tube 32 within the slot of the sliding clamp. The clinician can then adjust the flow resistance within extension kit 52. In some embodiments, clamp 54 may include a roller clamp, a sliding clamp, a compression clamp, or another suitable type of clamp.

[0103] Now for reference Figures 3A-3C The diagram illustrates an extension kit 56 according to certain embodiments. In some embodiments, the extension kit 56 may be compatible with one or more of the included features and / or operations. Figure 1A-1C The extension kit 10 and / or extension kit 52 are similar to or identical to each other. In some embodiments, extension kit 56 may include one or more extension tubes. In some embodiments, extension tube 32 may include or correspond to a first extension tube 58 of extension kit 56. In some embodiments, extension kit 56 may include a second extension tube 60.

[0104] It should be understood that in some embodiments, any suitable first lumen can replace the first extension tube 58 and / or any suitable second lumen can replace the second extension tube 60. Therefore, in some embodiments, a particular extension kit may not include the first extension tube 58 and / or the second extension tube 60, but may instead include the first lumen and / or the second lumen. In some embodiments, the first and second lumens may be disposed in a single multi-lumen extension tube or any other suitable structure. In some embodiments, the distal end of the single multi-lumen extension tube may be coupled to or integrated with the first Luer adapter 14. In some embodiments, the proximal end of the single multi-lumen extension tube may be coupled to or integrated with the third Luer adapter 34. In some embodiments, the proximal end of the single multi-lumen extension tube may be coupled to or integrated with the blood collection device 18.

[0105] In some embodiments, the flow resistance of the first extension tube 58 may be greater than the flow resistance of the second extension tube 60. For example, as Figures 3A-3C As shown, the first extension tube 58 may be longer than the second extension tube 60. Additionally or alternatively, in some embodiments, the inner diameter of the first extension tube 58 may be smaller than the inner diameter of the second extension tube 60, for example... Figures 4A-4C As shown in the diagram. In some embodiments, the flow resistance of the first extension tube 58 may be equal to the flow resistance of the second extension tube 60. In some embodiments, the second extension tube 60 may comprise any combination of length and inner diameter such that the flow resistance of the second extension tube 60 is equal to or less than the flow resistance of the first extension tube 58.

[0106] In some embodiments, the first extension tube 58 and the second extension tube 60 may extend between the distal end 12 and the proximal end 16 of the extension kit 56. In some embodiments, the proximal end 16 of the extension kit may include a blood collection device 18 or a third Luer connector 34. In some embodiments, a clamp 54 may be disposed on the second extension tube 60. In some embodiments, the second extension tube 60 may extend through the clamp 54.

[0107] In some embodiments, the second extension tube 60 may include a distal end 62 and a proximal end 64. In some embodiments, the distal end 66 of the first extension tube 58 and the distal end 62 of the second extension tube 60 may be integrated with the first Luer adapter 14, for example, as shown in the image. Figure 3B As shown in the diagram. In some embodiments, the proximal end 68 of the first extension tube 58 and the proximal end 64 of the second extension tube 60 may be integrated with the third Luer adapter 34, or one or more components, such as a short tube, may be present between the proximal ends 64, 68 and the third Luer adapter 34. In some embodiments, the proximal end 68 of the first extension tube 58 and the proximal end 64 of the second extension tube 60 may be integrated with the blood collection device 18.

[0108] In some embodiments, in response to clamp 54 being in the clamped position, flow resistance may increase as blood can flow through the first extension tube 58. In some embodiments, in response to clamp 54 being in the clamped position, blood flow through the second extension tube 60 may be reduced or absent. In some embodiments, to reduce flow resistance after the blood collection container has been partially filled and the pressure differential has decreased, the clinician may move clamp 54 to a non-clamped position, which may allow for faster blood collection. Figure 3B-3C An exemplary blood collection container 69 is shown in the figure.

[0109] Now for reference Figures 4A-4C The diagram illustrates an extension kit 70 according to certain embodiments. In some embodiments, the extension kit 70 may be similar to or identical to one or more of the following in terms of one or more of the included features and / or operations: Figure 1A-1C Extension kit 10 Figure 2A-2C Extension kit 52, and Figures 3A-3C Extension kit 56. In some embodiments, the inner diameter of the first extension tube 58 may be smaller than the inner diameter of the second extension tube 60. In some embodiments, the first extension tube 58 and the second extension tube 60 may have the same length.

[0110] Now for reference Figures 5A-5CThis diagram illustrates an extension kit having multiple extension tubes according to certain embodiments. The extension kit may, for example, correspond to extension kit 56 or extension kit 70. In some embodiments, such as... Figure 5A As shown, clamp 54 can be in a clamped position before blood enters the extension kit. In some embodiments, such as Figure 5B As shown, in response to the second extension tube 60 being clamped, blood can flow through the first extension tube 58. In some embodiments, such as Figure 5C As shown, in response to the clamp being removed, not clamped, or clamped less, increased blood can flow through the second extension tube 60, which can increase the total amount of blood flowing through the extension kit.

[0111] Now for reference Figures 6A-6C This illustrates a portion of an extension kit 72 according to certain embodiments. In some embodiments, the extension kit 72 may be similar to or identical to one or more of the following in terms of one or more of the included features and / or operations: Figure 1A-1C Extension kit 10 Figure 2A-2C Extension kit 52 Figures 3A-3C Extension kit 56, and Figures 4A-4C Extension kit 70.

[0112] In some embodiments, in response to the second Luer adapter 24 being tightened relative to the third Luer adapter 34, the first fluid passage 74 through the first extension tube 58 can be opened, and the second fluid passage 76 through the second extension tube 60 can be closed. In some embodiments, in response to the second Luer adapter 24 being loosened relative to the third Luer adapter 34, the first fluid passage 74 through the first extension tube 58 can be opened, and the second fluid passage 76 through the second extension tube 60 can be opened. In some embodiments, to reduce flow resistance within the extension kit 72 after the blood collection container has been partially filled and the pressure differential has decreased, the clinician can loosen the second Luer adapter 24 relative to the third Luer adapter 34 or move the second Luer adapter 24 from a tightened position to a loosened position. In some embodiments, the second Luer adapter 24 and the third Luer adapter 34 may contain corresponding threads, and the second Luer adapter 24 may be unthreaded relative to the third Luer adapter 34 to allow the second Luer adapter 24 to move from a tightened position to a loosened position.

[0113] In some embodiments, the extension kit 72 may include a third extension tube 78, which may be integrated with a third Luer adapter 34. In some embodiments, the third Luer adapter 34 may include one or more openings 80, each opening 80 being in fluid communication with a particular extension tube. In some embodiments, the openings 80 in fluid communication with the first extension tube 58 may remain open in response to the second Luer adapter 24 being in a relaxed or tightened position relative to the third Luer adapter 34.

[0114] In some embodiments, when the second Luer adapter 24 is in the retracted position relative to the third Luer adapter 34, the opening 80 in fluid communication with the second extension tube 60 and / or the third extension tube 78 can be blocked by the second Luer adapter 24, for example as... Figure 6B As shown in the diagram. In some embodiments, in response to the second Luer adapter 24 being in a relaxed position relative to the third Luer adapter 34, the opening 80 in fluid communication with the second extension tube 60 and / or the third extension tube 78 may be unblocked, for example, as shown in the diagram. Figure 6C As shown in the figure. In these embodiments, the second Luer adapter 24 may be spaced apart from the opening 80 which is in fluid communication with the second extension tube 60 and / or the third extension tube 78.

[0115] Now for reference Figures 7A-7C This illustrates a portion of an extension kit 82 according to certain embodiments. In some embodiments, the extension kit 82 may be similar to or identical to one or more of the following in terms of one or more of the included features and / or operations: Figure 1A-1C Extension kit 10 Figure 2A-2C Extension kit 52 Figures 3A-3C Extension kit 56 Figures 4A-4C Extension kit 70, and Figures 6A-6C Extension kit 72.

[0116] In some embodiments, the extension kit 82 may include a roller clamp 84. In some embodiments, the roller clamp 84 may include a roller 86 movable within a track 88. In some embodiments, the first extension tube 58 and the second extension tube 60 may extend substantially perpendicular to the track 88 through the roller clamp 84. In some embodiments, when blood flow through the second extension tube 60 is obstructed, the roller 86 may be positioned in a first location proximate to the second extension tube 60, such as, for example... Figure 7B As shown, the second extension tube 60 can be squeezed. In some embodiments, opening the second extension tube 60 may involve moving the roller 86 along the track 88 away from the second extension tube 60 and toward the first extension tube 58. In some embodiments, when blood flow through the first extension tube 58 is blocked, the roller 86 may be positioned in a second position close to the first extension tube 58, such as, for example... Figure 7C As shown in the figure, the first extension tube 58 can be squeezed.

[0117] Now for reference Figure 8 The diagram illustrates an extension kit 90 according to certain embodiments. In some embodiments, the extension kit 90 may be similar to or identical to one or more of the following in terms of one or more of the included features and / or operations: Figure 1A-1C Extension kit 10 Figure 2A-2C Extension kit 52 Figures 3A-3C Extension kit 56 Figures 4A-4C Extension kit 70 Figures 6A-6C Extension kit 72, and Figures 7A-7C Extension kit 82.

[0118] In some embodiments, the distal end 12 of the extension kit 90 may include a three-way stopcock valve 92, which may include a first port 94, a second port 96, and a third port 98. In some embodiments, a first extension tube 58 may be connected to the first port 94, a second extension tube 60 may be connected to the second port 96, and the third port 98 may include a first Luer adapter 14 configured to connect to the catheter adapter 39. In some embodiments, blocking blood flow through the second extension tube 60 may include rotating the three-way stopcock valve 92 to a first position. In some embodiments, opening the second extension tube 60 may include rotating the three-way stopcock valve 92 to a second position.

[0119] Now for reference Figures 9A-9E The diagram illustrates an extension kit 100 according to certain embodiments. In some embodiments, the extension kit 100 may be similar to or identical to one or more of the following in terms of one or more of the included features and / or operations: Figure 1A-1C Extension kit 10 Figure 2A-2C Extension kit 52 Figures 3A-3C Extension kit 56 Figures 4A-4C Extension kit 70 Figures 6A-6C Extension kit 72 Figures 7A-7C Extension kit 82, and Figure 8 Extension kit 90.

[0120] In some embodiments, the first extension tube 58 may be disposed within the second extension tube 60. In some embodiments, in response to the clamp 54 being in the clamped position, blood can flow through the first extension tube 58, and the blood flow between the outer surface of the first extension tube 58 and the inner surface of the second extension tube 60 may be reduced, for example... Figure 9DAs shown in the diagram. In some embodiments, to increase flow resistance within the catheter system after the blood collection container 69 has been partially filled and the pressure differential has decreased, the clinician can move the clamp 54 to a non-clamped position to allow blood to flow between the outer surface of the first extension tube 58 and the inner surface of the second extension tube 60, such as, for example... Figure 9E As shown in the figure. In some embodiments, the first extension tube 58 may be longer than the second extension tube 60 and / or the inner diameter of the first extension tube 58 may be smaller than the inner diameter of the second extension tube 60.

[0121] In some embodiments, the first extension tube 58 may be configured to collapse under a different pressure differential than the second extension tube 60. In some embodiments, the second extension tube 60 may have a lower stiffness than the first extension tube 58. In some embodiments, the second extension tube 60 may be configured to collapse under a lower pressure differential than the first extension tube 58. In some embodiments, at a lower pressure differential, the second extension tube 60 may contact the first extension tube 58 to reduce or stop blood flow between the outer surface of the first extension tube 58 and the inner surface of the second extension tube 60. In some embodiments, in response to the blood collection container 18 being partially filled with blood, blood flow between the outer surface of the first extension tube 58 and the inner surface of the second extension tube 60 may be increased.

[0122] Now for reference Figures 10A-10B In some embodiments, the inner surface of the first extension tube 58 may comprise an absorbent material 104. In some embodiments, blood within the first extension tube 58 may be configured to flow into and approach the absorbent material 104. In some embodiments, in response to blood reaching or saturating a specific portion of the absorbent material 104 (e.g., ...), ... Figure 10B (As shown) or to the point of saturating the entire absorbent material 104, clinicians can alter the flow resistance via a specific extension kit. In some embodiments, the specific extension kit may be similar to or identical to one or more of the following in relation to one or more of the included features and / or operations: Figure 1A-1C Extension kit 10 Figure 2A-2C Extension kit 52 Figures 3A-3C Extension kit 56 Figures 4A-4C Extension kit 70 Figures 6A-6C Extension kit 72 Figures 7A-7C Extension kit 82, and Figure 8 Extension kit 90.

[0123] In some embodiments, the first fluid passage 74 through the first extension tube 58 may be narrowed, for example, by an island 106 that may be disposed within the first fluid passage 74, near the absorbent material 104. In some embodiments, blood may flow around the island 106 in a distal to proximal direction, such as, for example... Figure 10B As shown in the image.

[0124] Now for reference Figure 11A-11B In some embodiments, the first extension tube 58 may include an indicator passage or tube 108, which may include a first end and a second end connected to a main portion of a first fluid passage 74 of the first extension tube 58. In some embodiments, blood within the first extension tube 58 may be configured to flow through the indicator tube 108, which may have a smaller diameter than the main portion of the first fluid passage 74.

[0125] In some embodiments, the indicator tube 108 may include one or more markers 110, which may include a channel or tubing configured to collect blood. In some embodiments, the markers 110 may provide a visual indicator to a clinician. In some embodiments, in response to blood reaching a specific marker 110 (e.g., Figure 11B As shown in the diagram (or all markings 110), clinicians can alter flow resistance via a specific extension kit. In some embodiments, the specific extension kit may be similar to or identical to one or more of the following in relation to one or more of the included features and / or operations: Figure 1A-1C Extension kit 10 Figure 2A-2C Extension kit 52 Figures 3A-3C Extension kit 56 Figures 4A-4C Extension kit 70 Figures 6A-6C Extension kit 72 Figures 7A-7C Extension kit 82, and Figure 8 Extension kit 90.

[0126] Now for reference Figures 12A-12C In some embodiments, the first extension tube 58 and the second extension tube 60 may engage at the joint 112. In some embodiments, the joint 112 may be located in the first Luer adapter 14, proximal to the first Luer adapter 14, or at another location within a particular extension kit. In some embodiments, the particular extension kit may be similar to or identical to one or more of the following in relation to one or more of the included features and / or operations: Figure 1A-1C Extension kit 10 Figure 2A-2C Extension kit 52 Figures 3A-3C Extension kit 56 Figures 4A-4C Extension kit 70 Figures 6A-6C Extension kit 72 Figures 7A-7C Extension kit 82, and Figure 8 Extension kit 90.

[0127] In some embodiments, a particular extension kit may include a pressure-sensitive valve 114. In some embodiments, the pressure-sensitive valve 114 may be located at the junction of the first fluid passage 74 and the second fluid passage 76. In some embodiments, the pressure-sensitive valve 114 may be located in the second extension tube 60. In some embodiments, the pressure-sensitive valve 114 may be located in a distal portion of the fluid passage of the particular extension kit in the first extension tube 58 and the second extension tube 60. In some embodiments, the fluid passage of the particular extension kit may extend through the proximal end 16 and the distal end 12. In some embodiments, the fluid passage of the particular extension kit may include the first fluid passage 74 and / or the second fluid passage 76.

[0128] In some embodiments, pressure-sensitive valve 114 may open relative to first extension tube 58 and close relative to second extension tube 60 in response to a first predetermined pressure difference within a particular extension kit. In some embodiments, pressure-sensitive valve 114 may remain open relative to first extension tube 58 and remain open relative to second extension tube 60 in response to a second predetermined pressure difference within a particular extension kit. In some embodiments, the first predetermined pressure difference may be greater than the second predetermined pressure difference. In some embodiments, the first and second predetermined pressure differences may correspond to the pressure difference between a patient's vein and a blood collection container coupled to a particular extension kit. In some embodiments, pressure-sensitive valve 114 may comprise any suitable type of pressure-sensitive valve. In some embodiments, the inner surface of a particular extension kit may include one or more grooves adjacent to the pressure-sensitive valve. In some embodiments, the grooves may allow blood to bypass pressure-sensitive valve 114 and flow into the first extension tube 58 instead of the second extension tube 60.

[0129] In some embodiments, a blood collection method or method of collecting a blood sample may include inserting a catheter of a catheter system into a patient's vascular system. In some embodiments, the catheter system may include a catheter assembly, which may include a catheter adapter and a catheter. In some embodiments, the catheter may be secured within the catheter adapter and may extend distally from the catheter adapter.

[0130] Now for reference Figure 13 In some embodiments, the pressure-sensitive valve 116 may be disposed within a second extension tube 60, which may be shorter than the first extension tube 58 and / or have an inner diameter larger than the first extension tube 58. In some embodiments, the pressure-sensitive valve 116 may include, for example... Figure 13The duckbill valve shown, or another suitable type of pressure-sensitive valve. For example, pressure-sensitive valve 116 may comprise a spring-loaded plunger or ball. In some embodiments, the second extension tube 60 may be more compliant than the first extension tube 58, and therefore can close at a lower pressure differential than the first extension tube 58.

[0131] In some embodiments, pressure valve 116 may close and prevent blood flow through the second extension tube 60 in response to a first predetermined pressure difference within a particular extension kit. In some embodiments, pressure valve 116 may open in response to a second predetermined pressure difference within a particular extension kit. In some embodiments, the first predetermined pressure difference may be greater than the second predetermined pressure difference. In some embodiments, the particular extension kit may be similar to or identical to one or more of the following in relation to one or more of the included features and / or operations: Figure 1A-1C Extension kit 10 Figure 2A-2C Extension kit 52 Figures 3A-3C Extension kit 56 Figures 4A-4C Extension kit 70 Figures 6A-6C Extension kit 72 Figures 7A-7C Extension kit 82, and Figure 8 Extension kit 90.

[0132] Now for reference Figure 14A The image illustrates a catheter system 118 according to certain embodiments. In some embodiments, the catheter system 118 may include an extension kit 120 that may be integrated with the catheter assembly 37. More specifically, in some embodiments, the distal end 12 of the extension kit 120 may be integrated with an adapter 122 of the catheter assembly 37, such as, for example... Figure 14A As shown in the diagram, or integrated with the catheter adapter 39 itself. In these and other embodiments, the extension kit 120 may not be removable from the catheter system 118. In some embodiments, the distal end of the first extension tube 58 or the distal end of the extension tube 32 may be integrated with the adapter 122 or the catheter adapter 39. In some embodiments, the adapter 122 may include a Y-adapter, a T-adapter, or another suitable adapter.

[0133] In some embodiments, the first extension tube 58 and / or the second extension tube 60 (see, for example, Figures 4-9) may be integrated into the side port 48. In some embodiments, the other extension tube 46 may be similar to or identical to the first extension tube 58 in terms of one or more of the included features and / or operations. In some embodiments, the extension kit 120 may be similar to or identical to one or more of the following in terms of one or more of the included features and / or operations: Figure 1A-1C Extension kit 10 Figure 2A-2C Extension kit 52 Figures 3A-3C Extension kit 56 Figures 4A-4C Extension kit 70 Figures 6A-6C Extension kit 72 Figures 7A-7C Extension kit 82, and Figure 8 Extension kit 90. In some embodiments, extension kit 120 may be similar to or the same as one or more of the following extension kits in terms of one or more of the included features and / or operations: extension kits of Figures 9-13.

[0134] Now for reference Figure 14B The image illustrates a catheter system 124 according to certain embodiments. In some embodiments, the catheter system 124 may include an extension kit 126, which may be coupled to or integrated with an instrument delivery device 127, the instrument delivery device 127 which can deliver probes, catheters, or guidewires (e.g., via specific catheter assemblies) through a particular catheter assembly. Figure 14A (as shown in the figure). In some embodiments, the first extension tube 58 and / or the second extension tube 60 (see, for example, Figures 4-9) may be integrated into the instrument delivery device 127.

[0135] In some embodiments, the extension kit 126 may be similar to or the same as one or more of the following in relation to one or more of the included features and / or operations: Figure 1A-1C Extension kit 10 Figure 2A-2C Extension kit 52 Figures 3A-3C Extension kit 56 Figures 4A-4C Extension kit 70 Figures 6A-6C Extension kit 72 Figures 7A-7C Extension kit 82, and Figure 8 Extension kit 90. In some embodiments, extension kit 126 may be similar to or the same as one or more of the following extension kits in terms of one or more of the included features and / or operations: extension kits of Figures 9-13.

[0136] In some embodiments, the instrument delivery device 127 may include any suitable instrument delivery device. In some embodiments, the device delivery device 127 is further described in the following documents: U.S. Patent Application No. 16 / 037,246, filed July 17, 2018, entitled “Extension housing a probe or intravenous catheter”; U.S. Patent Application No. 16 / 388,650, filed April 18, 2019, entitled “Instrument delivery device having an arcatory element”; U.S. Patent Application No. 16 / 037,319, filed July 18, 2018, entitled “Multi-diameter catheter and associated devices and methods”; and U.S. Patent Application No. 16 / 037,319, filed July 3, 2019, entitled “Delivery device for a vascular access device”. U.S. Patent Application No. 16 / 502,541 entitled “VASCULAR ACCESS INSTRUMENT”; U.S. Patent Application No. 16 / 691,217 entitled “SYRINGE-BASED DELIVERY DEVICE FOR A VASCULAR ACCESS INSTRUMENT”, filed November 21, 2019; U.S. Patent Application No. 62 / 794,437 entitled “CATHETER DELIVERY DEVICE AND RELATED SYSTEMS AND METHODS”, filed January 18, 2019; and U.S. Patent Application No. 62 / 794,437 entitled “CATHETER DELIVERY DEVICE AND RELATED SYSTEMS AND METHODS”, filed April 5, 2019; and U.S. Patent Application No. 5 / 4 / 2019 entitled “VASCULAR ACCESS INSTRUMENT HAVING A FLUID PERMEABLE STRUCTURE AND RELATED DEVICES”. The U.S. Patent Application No. 62 / 830,286, entitled “ANDMETHODS”, is incorporated herein by reference in its entirety.

[0137] All examples and conditional language cited herein are intended for pedagogical purposes to aid the reader's understanding of the invention and the concepts contributed by the inventors to advance the art, and should be interpreted as not being limited to such specifically enumerated 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 catheter extension set, comprising: a distal end including a luer adapter configured to be coupled to a catheter adapter; and a proximal end including a blood collection device; and an extension tube extending between the distal end and the proximal end, the extension tube defining a fluid pathway from the distal end to the proximal end; wherein, in the fluid pathway defining a lumen of the extension tube, an inner surface of the extension tube includes an absorbent material having a plurality of indicia or includes an indicator tube having a plurality of indicia to provide a visual indicator to a clinician whereby to vary a flow resistance, wherein blood in the fluid pathway of the extension tube flows proximate to the absorbent material or proximate to the indicator tube.

2. The catheter extension set of claim 1, further comprising a clamp disposed on the extension tube, wherein the clamp is configured to move between a clamped position and an unclamped position.

3. The catheter extension set of claim 1, wherein, the luer adapter is a first luer adapter, wherein the blood collection device includes a second luer adapter, the catheter extension set further comprising a third luer adapter coupled to the second luer adapter, wherein the extension tube includes a distal end and a proximal end, wherein the distal end of the extension tube is integrated with the first luer adapter, wherein the proximal end of the extension tube is integrated with the third luer adapter.

4. The catheter extension set of claim 1, wherein, the extension tube includes a distal end and a proximal end, wherein the distal end of the extension tube is integrated with the luer adapter, wherein the proximal end of the extension tube is integrated with the blood collection device.

5. A catheter extension set, comprising: a distal end including a luer adapter configured to be coupled to a catheter adapter; a proximal end including a blood collection device; a first extension tube extending between the distal end and the proximal end, wherein the first extension tube is rigid or semi-rigid to reduce a likelihood of kinking; and a second extension tube extending between the distal end and the proximal end; wherein the first extension tube defines a fluid pathway extending between the distal end and the proximal end, an inner surface of the first extension tube includes an absorbent material having a plurality of indicia or includes an indicator tube having a plurality of indicia to provide a visual indicator to a clinician whereby to vary a flow resistance, wherein blood in the fluid pathway of the first extension tube flows proximate to the absorbent material or proximate to the indicator tube.

6. The catheter extension set of claim 5, further comprising a clamp, wherein the second extension tube extends through the clamp, wherein the clamp is configured to move between a clamped position and an unclamped position.

7. The catheter extension set of claim 6, wherein, the first extension tube is longer than the second extension tube.

8. The catheter extension set of claim 6, wherein, an inner diameter of the first extension tube is smaller than an inner diameter of the second extension tube.

9. The catheter extension set of claim 6, wherein, the first extension tube is disposed within the second extension tube, wherein in response to the clamp being in the clamped position, blood flows through the first extension tube and blood flows between an outer surface of the first extension tube and an inner surface of the second extension tube.

10. The catheter extension set of claim 5, wherein, The luer adapter is a first luer adapter, wherein the blood collection device includes a second luer adapter, the catheter extension set further includes a third luer adapter coupled to the second luer adapter, wherein the first extension tube includes a distal end and a proximal end, wherein the second extension tube includes a distal end and a proximal end, wherein the distal end of the first extension tube and the distal end of the second extension tube are both integrated with the first luer adapter, wherein the proximal end of the first extension tube and the proximal end of the second extension tube are both integrated with the third luer adapter, wherein in response to the second luer adapter being tightened relative to the third luer adapter, a first fluid passageway through the first extension tube is opened and a second fluid passageway through the second extension tube is closed, wherein in response to the second luer adapter being loosened relative to the third luer adapter, the first fluid passageway through the first extension tube is opened and the second fluid passageway through the second extension tube is opened.

11. The catheter extension set of claim 5, further comprising a pressure sensitive valve within a fluid passageway of the catheter extension set distal to the first extension tube and the second extension tube, wherein in response to a first predetermined vacuum pressure level within the catheter extension set, the pressure sensitive valve is open relative to the first extension tube and closed relative to the second extension tube, wherein in response to a second predetermined vacuum pressure level within the catheter extension set, the pressure sensitive valve is closed relative to the first extension tube and open relative to the second extension tube, wherein the first predetermined vacuum pressure level is greater than the second predetermined vacuum pressure level.

12. The catheter extension set of claim 5, wherein, The second extension tube includes a pressure sensitive valve.

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