Catheters with dedicated blood collection ports and related methods

Abstract

A catheter assembly can include a catheter adapter having a distal end including an intravenous catheter, a proximal end configured to receive a needle assembly, and an internal lumen extending between the distal and proximal ends. The catheter assembly can include an extension tube, which can include a first lumen and a second lumen. The first and second lumens can be in fluid communication with the internal lumen at a first end of the extension tube, the second end of the extension tube having an infusion port in fluid communication with the first lumen and a blood collection port in fluid communication with the second lumen. An extension kit for a catheter assembly can include a first lumen coupled to the infusion port and a second lumen coupled to the blood collection port. The second lumen can include a flow resistance optimized to reduce hemolysis during blood collection.

Description

Background Art

[0001] Catheters are commonly used to infuse 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.

[0002] The catheter can be an over-the-needle peripheral intravenous ("IV") catheter. In this case, the catheter can be mounted on an introducer needle having a sharp distal tip. The catheter and introducer needle can be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel of the needle facing away from the patient's skin. The catheter and introducer needle are typically inserted through the skin at a shallow angle into the patient's vasculature.

[0003] To verify proper placement of the introducer needle and / or catheter in the blood vessel, the clinician typically confirms the presence of a "flash" of blood in the flashback chamber of the catheter assembly. Once needle placement has been confirmed, the clinician can temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood draws or infusions.

[0004] Blood samples are typically collected from a patient via an IV catheter. A syringe and needle can be used to collect blood samples from a patient's IV catheter. Alternatively, a drained blood collection tube can be used. These devices are typically connected to a catheter adapter for an IV catheter, allowing the device to draw blood from the patient via the IV catheter set. In some cases, the blood collection device enters the catheter adapter housing directly, such as via a Y-port or other access point. In other cases, the catheter adapter housing includes an extension tube with an access port, which is in fluid communication with the inner lumen of the catheter adapter housing. These various access points provide fluid pathways through which any type of fluid can be moved into or withdrawn from the catheter adapter of an IV catheter. As a result of this complex design, clinicians must carefully control the flow rate of shear-sensitive fluids through these various access points. If clinicians fail to maintain a safe flow rate when withdrawing or infusing shear-sensitive fluids, the fluid could be damaged. For example, red blood cells are highly susceptible to hemolysis due to the high shear stress during blood withdrawal or infusion via an IV catheter. Hemolysis can result in the blood sample being rejected and discarded. High flow rates may also create high pressure differentials that can lead to catheter tip collapse, vessel collapse, or other complications that prevent or limit blood collection.

[0005] The claimed subject matter 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 merely provided to illustrate one exemplary technology area where some implementations described herein may be practiced. Summary of the Invention

[0006] The present disclosure generally relates to an extension set for a vascular access device and related devices, systems, and methods. In some embodiments, a vascular access system can include an extension set coupled to a catheter adapter having an intravenous catheter and a needle assembly for accessing a vascular system.

[0007] In some embodiments, the extension kit includes an integrated peripheral intravenous catheter with a dedicated blood collection port. The blood collection port is connected to an optimized fluid path that is constructed to minimize the possibility of hemolysis. In some embodiments, in the present disclosure, optimization can mean designed to improve. By constructing the optimized fluid path to have a fluid or flow resistance and / or flow rate that matches or is compatible with the maximum shear stress of a typical blood collection needle kit. Thus, blood collected through the optimized fluid path is substantially or completely free from solution. In many cases, the optimized fluid or flow resistance depends on the size of the catheter. In some cases, the optimized fluid or flow resistance of the dedicated blood collection port results in a flow rate that is undesirable and / or incompatible for infusing non-shear sensitive fluids. Therefore, various embodiments of the present disclosure include dedicated blood collection and infusion ports. Therefore, the features of the present disclosure achieve easy operation, such that there is no need to locate the optimal fluid resistance or flow rate for blood collection.

[0008] In some embodiments, an extension kit is provided that includes a single extension tube connected to a catheter adapter, wherein the single extension tube includes a first lumen optimized for blood collection and a second lumen optimized for infusion, wherein the flow resistance of the first lumen is greater than the flow resistance of the second lumen. Thus, the clinician is prevented from drawing blood through the first lumen at a flow rate that causes hemolysis. The first lumen is connected to the blood collection port, and the second lumen is connected to the infusion port. The flow resistance of the first lumen and the second lumen is optimized by selecting the catheter or lumen specifications of the corresponding lumens. In some cases, the first lumen (i.e., the lumen connected to the blood collection port and optimized for blood collection) includes a cross-sectional area that is smaller than the second lumen (i.e., the lumen connected to the infusion port and optimized for infusion).

[0009] In some embodiments, an extension kit is provided, comprising a first extension tube and a second extension tube coupled to a catheter adapter, wherein the first extension tube comprises a lumen optimized for blood collection and the second extension tube comprises a lumen optimized for infusion, wherein the first extension tube is coupled to a blood collection port and the second extension tube is coupled to an infusion port.

[0010] In some embodiments, an extension kit is provided, comprising a y-port coupled to a catheter adapter via a first extension tube, wherein the y-port comprises an infusion port having a flow resistance optimized for infusion, and wherein the y-port further comprises a Luer adapter for selectively receiving a second extension tube having a blood collection port, wherein the second extension tube comprises a flow resistance optimized for blood collection.

[0011] In some embodiments, the extension kit of the present disclosure is provided as an integral component of a catheter assembly. In other embodiments, the extension kit of the present disclosure is provided as a separate unit that is configured to be selectively attached to a catheter assembly, such as a catheter adapter of an intravenous catheter assembly, such that the lumen of the extension kit is in fluid communication with the internal lumen of the catheter adapter.

[0012] It should be understood that the above summary and the following detailed description are merely examples and are illustrative and do not limit the present disclosure protected by the claims. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that the 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 present disclosure, unless protected by the claims. Therefore, the following detailed description is not to be understood in a limiting sense. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The exemplary embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0014] Figure 1A is a top view of a catheter assembly according to a representative embodiment of the present disclosure, the catheter assembly including an extension kit having a dual-lumen extension tube, wherein one lumen is optimized for blood collection;

[0015] Figure 1B is a cross-sectional view of a dual-lumen extension tube according to a representative embodiment of the present disclosure, wherein one of the lumens is optimized for blood collection;

[0016] Figure 1C is a cross-sectional view of a dual-lumen extension tube according to a representative embodiment of the present disclosure, wherein one of the lumens is optimized for blood collection;

[0017] Figure 1D is a cross-sectional view of a dual-lumen extension tube according to a representative embodiment of the present disclosure, wherein one of the lumens is optimized for blood collection;

[0018] Figure 2is a top view of a catheter assembly according to a representative embodiment of the present disclosure, the catheter assembly including an extension kit having two extension tubes, wherein one of the extension tubes is optimized for blood collection;

[0019] Figure 3 is a top view of a catheter assembly according to a representative embodiment of the present disclosure, the catheter assembly including an extension kit having a y-shaped port (including an infusion port), and further including an extension tube having a blood collection port, wherein the extension tube is optimized for blood collection; and

[0020] Figure 4 is a top view of a catheter assembly according to a representative embodiment of the present disclosure, the catheter assembly including an extension having a nonlinear portion configured to increase flow resistance within the catheter assembly to distribute pressure differentials and thereby reduce shear stress of a fluid flowing through the catheter assembly. DETAILED DESCRIPTION

[0021] Referring now to Fig. 1, there is shown a catheter assembly 100. The catheter assembly 100 is shown as a peripheral intravenous catheter, however, as will be readily appreciated by those skilled in the art, various aspects of the present disclosure can be implemented in various other types of intravenous catheters and catheter assemblies. For example, various aspects of the present disclosure can be combined with BD NEXIVA™ closed IV catheter system, BD CATHENA™ catheter system, BD VENFLON™ professional safety protection IV catheter system, BD NEOFLON™ IV intubation system, BD INSYTE™ AUTOGUARD™ BC protection IV catheter system or another suitable catheter assembly, or otherwise implemented. In certain embodiments, the catheter assembly 100 can include a peripheral intravenous catheter (PIVC), a peripherally inserted central catheter (PICC), or a midline catheter. The catheter assembly 100 includes a catheter adapter 120 having a distal end 122 comprising a catheter 130. The catheter assembly 100 also includes a proximal end 124 configured to receive a needle assembly 140 having an introducer needle 142 that passes through the catheter adapter 120 and the catheter 130, thereby exposing a sharp distal tip 144 of the introducer needle 142 prior to catheter insertion. The catheter adapter 120 also includes an internal lumen in fluid communication with the catheter 30. The various materials for the catheter adapter 120, the catheter 130, and the needle assembly 140 are well known in the art.

[0022] The catheter assembly 100 also includes an extension tube 150 having a first end 152 coupled to the catheter adapter 120 and a second end 154 having an infusion port 160 and a blood collection port 170. In some embodiments, the extension tube 150 is a multi-lumen tube having a first lumen 156 in fluid communication with the infusion port 160 and a second lumen 158 in fluid communication with the blood collection port 170. In some embodiments, the infusion port 160 and the blood collection port 170 comprise a y-shaped port 180, wherein the ports 160 and 170 are two legs of the y-shaped port. In some embodiments, the y-shaped port 180 comprises a Luer adapter configured to selectively receive the infusion port 160 and the blood collection port 170 as separate units. In other cases, at least one of the infusion port 160 and the blood collection port 170 is an integral component of the y-shaped port 180.

[0023] First lumen 156 and second lumen 158 comprise separate fluid pathways along the length of extension tube 150, wherein the separate fluid pathways converge within the interior lumen of catheter adapter 120. In some embodiments, extension tube 50 further comprises a clamp 151 that can be selectively engaged to control fluid flow through first lumen 156 and / or second lumen 158.

[0024] The first lumen 156 and the second lumen 158 each include a fluid or flow resistance, which is a function of the diameter of the fluid path, the cross-sectional area of ​​the corresponding fluid path, and / or the length of the extension tube 150. In certain embodiments, the flow resistance of the first lumen 156 and / or the second lumen 158 is optimized to serve as the flow resistance of the catheter assembly 100. For example, the flow resistance of the first lumen 156 can be optimized for infusion, and the flow resistance of the second lumen 158 can be optimized for blood collection, wherein the optimization for blood collection minimizes hemolysis. In certain embodiments, the flow resistance of the second lumen is greater than the flow resistance of the first lumen. In certain embodiments, the flow resistance of the second lumen is optimized to reduce hemolysis, and the flow resistance of the first lumen is less than the flow resistance of the second lumen.

[0025] Blood cells are subject to shear stress as they flow through a fluid path. Within a fluid path, the maximum shear stress occurs along the walls of the fluid path and is referred to as "wall shear stress." Wall shear stress on blood cells is believed to be the primary source of mechanical damage to blood cells, which often leads to hemolysis. For a cylindrical fluid path, wall shear stress is typically expressed as:

[0026]

[0027] where ΔP is the pressure drop along a path of length L and inner radius r. k is the contraction exponent.

[0028] To fill a certain volume of collection tube V at a flow rate Q, the time required can be simply estimated by the following formula:

[0029]

[0030] Where μ is the dynamic viscosity of the fluid. Hemolysis is typically associated with both the wall shear stress and the time the blood cells are exposed to the wall shear stress. According to the literature, it is widely believed that the hemolysis index can be approximated according to the following formula:

[0031]

[0032] where A, α, and β are coefficients.

[0033] In principle, the hemolysis index is related to the pressure gradient and the characteristic cross-sectional dimensions.

[0034]

[0035] In some embodiments, the length of the extension tube 150 can be selected based on one or more of the following: the specifications of a particular lumen of the extension tube, a particular catheter assembly configuration, or a clinical setting. In some embodiments, the extension tube 150 can have a length (L) from a first end 152 to a second end 154. In some embodiments, the flow resistance of the lumen of the extension tube 150 can be optimized to reduce wall shear stress and corresponding hemolysis experienced by red blood cells flowing therethrough. For example, in some embodiments, the lumen of the extension tube 150 includes an inner diameter (D) selected such that D 4 / L provides a lumen volume equal to or less than 0.27E-06 cubic inches, equal to or less than 2.77E-06 cubic inches, equal to or less than 3.24E-07 cubic inches, equal to or less than 3.20E-07 cubic inches, or equal to or less than 6.73E-08 cubic inches, thereby reducing wall shear stress to reduce hemolysis. In some embodiments, D 4 / L can be another value.

[0036] Now refer to Figures 1B to 1D In some embodiments, the extension tube 150 comprises a single multi-lumen tube having a first lumen 156 and a second lumen 158, wherein the cross-sectional area of ​​the first lumen 156 is greater than the cross-sectional area of ​​the second lumen 158. In some embodiments, the first lumen 156 and the second lumen 158 are divided or separated by an inner wall 155 of the extension tube 150. In some embodiments, the second lumen 158 is located within the first lumen 156, wherein the first lumen 156 and the second lumen 158 are separated by a sidewall 157 that defines the second lumen 158. In some embodiments, the sidewall 157 is concentrically positioned within the first lumen 156, as shown. Figure 1CIn some embodiments, the side wall 157 is a portion of the inner wall 155, so that the second lumen is located within the first lumen 156 and contacts the inner wall surface of the first lumen 156, as shown in FIG. Figure 1D One of ordinary skill in the art will appreciate that the first lumen 156 and the second lumen 158 may include other shapes, configurations, and cross-sectional areas that can be compatible for use with the features of the present disclosure.

[0037] Now refer to Figure 2 , a catheter assembly 200 is shown. The catheter assembly 200 can include any catheter system or suitable catheter assembly disclosed herein. The catheter assembly 200 can also include any other elements or features of any catheter assembly disclosed herein that are compatible with the illustrated embodiment.

[0038] Catheter assembly 200 includes a first extension tube 250a having a first end 152a coupled to catheter adapter 220 and a second end 254a having an infusion port 270. Catheter assembly 200 also includes a second extension tube 250b having a first end 152b coupled to catheter adapter 220 and a second end 254b having a blood collection port 260. First extension tube 250a includes a first lumen 256 having a flow resistance optimized for an infusion procedure. Second extension tube 250b includes a second lumen 258 having a flow resistance optimized for blood collection, wherein the flow resistance of second lumen 258 reduces, eliminates, or otherwise prevents hemolysis during blood draw. First lumen 256 and second lumen 258 comprise separate fluid pathways along their respective extension tubes 250a and 250b, wherein the separate fluid pathways converge within the interior lumen of catheter adapter 220. In some embodiments, at least one of the first extension tube 250a and the second extension tube 250b further includes a clamp 251 that can be selectively engaged to control fluid flow through the first lumen 256 and / or the second lumen 258 .

[0039] The first lumen 256 and the second lumen 258 each include a flow resistance, as discussed above. In some embodiments, the second extension tube 250b includes a flow resistance that is optimized to reduce the wall shear stress experienced by red blood cells during blood collection via the blood collection port 260. Thus, the catheter assembly 200 includes an extension tube 250b that is dedicated to blood collection. In some embodiments, the length of the extension tube 250b can be selected based on one or more of the following: the specifications of a particular lumen of the extension tube, a particular catheter assembly configuration, or a clinical setting. In some embodiments, the extension tube 250b can have a length (L) from the first end 254b to the second end 152b. In some embodiments, the flow resistance of the lumen of the extension tube 250b can be optimized to reduce the wall shear stress and corresponding hemolysis experienced by red blood cells flowing therethrough. For example, in some embodiments, the lumen of the extension tube 250b includes an inner diameter (D) that is selected such that D 4 / L provides a lumen volume equal to or less than 0.27E-06 cubic inches, equal to or less than 2.77E-06 cubic inches, equal to or less than 3.24E-07 cubic inches, equal to or less than 3.20E-07 cubic inches, or equal to or less than 6.73E-08 cubic inches, which can reduce wall shear stress to reduce hemolysis. In some embodiments, D 4 / L can be another value.

[0040] Now refer to Figure 3 , showing a catheter assembly 300. The catheter assembly 300 can include any catheter system or suitable catheter assembly disclosed herein. The catheter assembly 200 can also include any other elements or features of any catheter assembly disclosed herein that are compatible with the illustrated embodiment.

[0041] The catheter assembly 300 includes a first extension tube 350a having a first end 352a coupled to the catheter adapter 320 and a second end 354a having an infusion port 360. In some embodiments, according to one or more embodiments provided herein, the infusion port 360 includes a y-shaped port 380. The first extension tube 350a includes a flow resistance optimized for infusing fluids. Thus, in some embodiments, the flow resistance of the first extension tube 350a is minimal. In some embodiments, the infusion port 360 is selectively coupled to a Luer adapter of the y-shaped port 380. In other embodiments, the infusion port 360 is an integral component of the y-shaped port 380. In some embodiments, the flow resistance of the first extension tube 350a is equal to the flow resistance of the y-shaped port 380 and the infusion port 360.

[0042] The catheter assembly 300 also includes a second extension tube 350b having a first end 352b coupled to the y-port 380 and a second end 354b having a blood collection port 370. The second extension tube 350b includes a flow resistance optimized for collecting a blood sample, wherein the flow resistance minimizes wall shear stress and reduces, limits, or eliminates hemolysis.

[0043] In some embodiments, the second extension tube 350b selectively couples to a Luer adapter of the Y-port 380, allowing the second extension tube 350b to be exchanged for another extension tube having an optimized flow resistance. In some embodiments, the specifications of the second extension tube 350b are selected to match the flow resistance of the catheter 330, wherein the second extension tube 350b can be replaced with a desired specification to optimize the flow resistance of the blood collection port 370 and the entire catheter assembly. In some embodiments, the flow resistance of the first extension tube 350a is less than the flow resistance of the catheter 330 and less than the flow resistance of the second extension tube 350b.

[0044] Various or any of the catheter assemblies disclosed herein may include additional features and elements configured to reduce shear stress on red blood cells during blood sample collection. Non-limiting examples of such additional features and elements are disclosed in U.S. Provisional Application Serial No. 62 / 965,674, filed on January 24, 2020, entitled "BLOOD COLLECTION ADAPTER AND RELATED DEVICES TO REDUCE HEMOLYSIS," which is incorporated herein in its entirety. For example, in some embodiments, the second extension tube 450b of the catheter assembly 400 may include a nonlinear portion, such as a spiral, coil, S-shape, or another suitable nonlinear shape. The nonlinear portion may help increase flow resistance within the catheter assembly, distributing pressure differentials and thereby reducing shear stress on red blood cells. In some embodiments, fluid flowing through the nonlinear portion 451 is prevented from flowing in a straight line or linear pattern. In some embodiments, the nonlinear portion 451 may increase the length of the fluid path of the second extension tube 450b, thereby increasing flow resistance and reducing blood flow within the catheter assembly. Therefore, these embodiments may further reduce the risk of hemolysis during blood collection.

[0045] In some embodiments, the extension tube of the present disclosure can be provided as a separate and distinct catheter extension kit from the catheter adapter of the other components of the catheter assembly. For example, in some embodiments, the extension tube of the present disclosure is selectively coupled to the catheter adapter via a slip-fit ​​or Luer adapter. Thus, the present disclosure also includes catheter extension kits according to the various features and elements described above in conjunction with the various embodiments.

[0046] All examples and conditional language described herein are intended for teaching purposes to help readers understand the present disclosure and the concepts contributed by the inventors to advance the art, and are to be construed as being limited to such specific examples and conditions. Although the embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and modifications may be made thereto without departing from the spirit and scope of the present disclosure.

Claims

1. A catheter assembly, characterized in that: The catheter assembly comprises: a catheter adapter having a distal end including an intravenous catheter, a proximal end configured to receive a needle assembly, and an internal lumen extending between the distal and proximal ends; and an extension tube comprising a first lumen and a second lumen, the first lumen and the second lumen being in fluid communication with the internal lumen at a first end of the extension tube, the second end of the extension tube having an infusion port in fluid communication with the first lumen and a blood collection port in fluid communication with the second lumen; The second flow resistance of the second lumen is greater than the first flow resistance of the first lumen, and the second flow resistance minimizes wall shear stress on red blood cells during blood collection.

2. The catheter assembly according to claim 1, wherein The cross-sectional area of ​​the first lumen is greater than the cross-sectional area of ​​the second lumen.

3. The catheter assembly according to claim 1, wherein The extension tube is composed of a single tube including the first lumen and the second lumen.

4. The catheter assembly according to claim 3, wherein The single tube is a multi-lumen tube.

5. The catheter assembly according to claim 4, wherein The second lumen is located within the first lumen.

6. The catheter assembly according to claim 4, wherein The first lumen is located within the second lumen.

7. The catheter assembly according to claim 4, wherein The first lumen and the second lumen are separated by an inner wall of the single tube.

8. The catheter assembly according to claim 7, wherein The inner wall is a side wall of the first lumen or the second lumen.

9. The catheter assembly according to claim 1, wherein The infusion port and the blood collection port are y-shaped ports.

10. The catheter assembly according to claim 1, wherein The extension tube includes: a first extension tube including the first lumen and the blood collection port; and a second extension tube including the second lumen and the infusion port.

11. The catheter assembly according to claim 1, wherein The first end of the extension tube is coupled to the catheter adapter via an extension tube having a single lumen.

12. The catheter assembly according to claim 1, wherein The second flow resistance is configured to minimize hemolysis.

13. A catheter assembly kit, characterized in that: The catheter assembly kit includes: a catheter adapter having a distal end including an intravenous catheter, a proximal end configured to receive a needle assembly, and an internal lumen extending between the distal and proximal ends; a first elongated tube comprising a first end in fluid communication with the interior lumen and a second end positioned opposite the first end; a y-port coupled to the second end of the first extension tube, the y-port comprising an infusion port and further comprising a Luer adapter; and a second extension tube coupled to the Luer adapter and comprising a blood collection port, The second flow resistance of the second extension tube is greater than the first flow resistance of the first extension tube, and the second flow resistance minimizes the wall shear stress on red blood cells during blood collection.

14. The catheter assembly kit according to claim 13, wherein: The second flow resistance is configured to minimize hemolysis.

15. The catheter assembly kit of claim 13, wherein: The infusion port is coupled to the y-port via a second luer adapter.

16. The catheter assembly kit of claim 13, wherein: The maximum flow rate through the second extension tube is less than the maximum flow rate through the first extension tube and less than the maximum flow rate through the infusion port.

17. A catheter extension kit, characterized in that: The catheter extension kit includes an extension tube having a first end, a second end, and a first lumen and a second lumen extending therebetween, the first end being configured to be coupled to a catheter adapter of a catheter assembly, and the second end having an infusion port in fluid communication with the first lumen and a blood collection port in fluid communication with the second lumen, wherein a second flow resistance of the second lumen is greater than a first flow resistance of the first lumen, and wherein the second flow resistance minimizes wall shear stress on red blood cells during blood collection.

18. The catheter extension kit according to claim 17, wherein: The extension tube includes: a first extension tube including the first lumen and the infusion port; and a second extension tube including the second lumen and the blood collection port.

Images