Adapter, related system, and method for facilitating blood collection and injection.

Abstract

An adapter configured to couple to a catheter assembly. The adapter may include a first proximal port, a second proximal port, and a distal port. An infusion fluid pathway may extend between the first proximal port and the distal port. A blood withdrawal fluid pathway may extend between the second proximal port and the distal port. The adapter may include a one-way septum disposed in the first proximal port and configured to open to allow fluid to flow distally with a pressure differential across the one-way septum. The one-way septum is disposed in the infusion pathway. The adapter may include a two-way septum disposed in the second proximal port. The two-way septum may be disposed in the blood withdrawal fluid pathway.

Description

Technical Field

[0001] Cross-Reference to Related Applications This application claims priority to U.S. Provisional Application Serial No. 63 / 139,621, filed January 20, 2021, entitled "Adapter for Facilitating Blood Collection and Injection, Related Systems, and Methods", the entire disclosure of which is hereby incorporated by reference in its entirety. Background Art

[0002] Background Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids such as normal saline, various medicaments, and total parenteral nutrition into a patient. Catheters may also be used to withdraw blood from a patient. After collection, blood samples may be analyzed to determine a patient's physiological and biochemical conditions, such as disease, mineral content, drug efficacy, and organ function.

[0003] A common type of catheter is a peripheral intravenous catheter ("PIVC"), which is an "over-the-needle" catheter. As the name suggests, an over-the-needle PIVC may be mounted over an introducer needle having a sharp distal tip. The PIVC and the introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle oriented away from the patient's skin. The PIVC and the introducer needle are inserted through the skin into the patient's vasculature as an assembly at a shallow angle.

[0004] An integrated PIVC includes a PIVC connected to an extension set. The extension set typically includes an extension tube that is integrated at one end to the catheter hub and includes an adapter, such as a Y-adapter, connected at the other end. The adapter may include one or more access ports (e.g., luer connectors).

[0005] An integrated PIVC may be used to collect blood. More specifically, after the integrated PIVC is inserted into the patient's vascular system, blood may flow into the expansion set and adapter. To facilitate this blood flow, a vent plug is usually connected to at least one of the access ports, allowing air to escape from the extension tube as blood flows into it. A blood collection device may also be connected to the adapter. As blood fills the adapter, the operator may begin blood collection. [Overview of the Initiative] [Problems that the invention aims to solve]

[0006] There are several challenges to blood collection using PIVCs. For example, blood samples may be requested by the practitioner at various points during the course of treatment, but PIVCs can be unreliable for collecting blood after the initial insertion. Also, even using a PIVC temporarily for blood extraction can hinder a rapid transition to infusion. More specifically, a fluid is injected through the adapter to flush out blood from the extension tube after blood extraction. This flushing process tends to be time-consuming and inefficient because it is difficult to completely flush out residual blood from within the adapter and access port. Residual blood can increase the risk of bloodstream infection, especially when certain access ports are used for blood extraction and infusion into the patient's vascular system.

[0007] The subject matter claimed herein is not limited to embodiments that solve any particular defect, nor does it operate only in the environment described above. Rather, this background is provided merely to illustrate an example of the technical field in which some of the embodiments described herein may be implemented.

[0008] overview This disclosure relates, as a whole, to devices, systems, and methods for facilitating automated fluid infusion and blood withdrawal from a catheter. Some embodiments of this disclosure may provide different fluid pathways for withdrawing blood and for infusing fluid through an extension set. In some embodiments, the adapter may be configured to allow infusion to flow unidirectionally through one of the different fluid pathways. In some embodiments, the adapter may be configured to allow blood to flow bidirectionally through another of the different fluid pathways. In this way, some embodiments may allow the fluid to be injected into the patient's vascular system with reduced risk of blood contamination from previous blood collection. Furthermore, in some embodiments, blood may be automatically collected from the patient's vascular system for a diagnostic procedure and then reinjected after the diagnostic procedure.

[0009] In some embodiments, the catheter system may include a catheter hub, which may include a terminal end and a proximal end. In some embodiments, the catheter system may include a catheter, which may extend from the terminal end of the catheter hub. In some embodiments, the catheter may include a PIVC, a peripherally inserted central catheter, or a midline catheter. In some embodiments, the catheter system may include an adapter, which may be in fluid communication with the catheter hub and the catheter. In some embodiments, the adapter may include a first proximal port, a second proximal port, and a terminal port. In some embodiments, an infusion fluid path may extend through the first proximal port and the terminal port. In some embodiments, a blood withdrawal fluid path may extend through the second proximal port and the terminal port.

[0010] In some embodiments, the catheter system may include a one-way septum, which may be located at a first proximal port and configured to open, allowing fluid to flow terminally across the one-way septum due to a pressure difference. In some embodiments, the one-way septum is located within the infusion fluid path. In some embodiments, the catheter system may include a two-way septum located at a second proximal port. In some embodiments, the two-way septum may be located within the blood withdrawal fluid path.

[0011] In some embodiments, the catheter system may include an extension tube. In some embodiments, the extension tube may include a terminal end connected to a catheter hub and a proximal end connected to a terminal port of an adapter. In some embodiments, the first proximal port may be aligned with the terminal port, and the injectable fluid path may be straight. In some embodiments, the second proximal port may include a lateral port located between the first proximal port and the terminal port.

[0012] In some embodiments, the catheter system may include an infusion module. In some embodiments, the infusion module may include a first extension tube configured to direct fluid terminally through an infusion fluid pathway for injection into the patient's vascular system. In some embodiments, the catheter system may include a diagnostic module. In some embodiments, the diagnostic module may include a second extension tube configured to direct blood proximally from the patient's vascular system through a blood withdrawal fluid pathway. In some embodiments, the terminal end of the first extension tube may be coupled to a first proximal port, and the terminal end of the second extension tube may be coupled to a second proximal port.

[0013] In some embodiments, the infusion module may include at least one of a pump and / or a gravity-based device for directing the fluid through the infusion fluid path toward the terminal. In some embodiments, the diagnostic module may be configured to apply a pressure difference across a bidirectional septum to open the bidirectional septum and direct the blood through the blood extraction fluid path toward the proximal end. In some embodiments, the diagnostic module may include a pump for pushing the fluid through the blood extraction fluid path toward the terminal in order to reinject the blood into the patient's vascular system. In some embodiments, the diagnostic module may include at least one sensor for performing diagnostic tests on the blood.

[0014] In some embodiments, the catheter system may include a saline lavage device. In some embodiments, the pump may be configured to reintroduce blood to the end through the catheter via the saline lavage device. In some embodiments, the saline lavage device may be integrated into a diagnostic module. In some embodiments, the saline lavage device is independent of the diagnostic module.

[0015] In some embodiments, the method for facilitating fluid injection and blood extraction may include priming an adapter. In some embodiments, the method may include injecting a first fluid into the patient's vascular system by directing a first fluid terminally through an injection path. In some embodiments, the method may include drawing blood proximal through a blood extraction fluid path and directing the blood to a blood collection reservoir. In some embodiments, the method may include performing an analysis of the blood in the blood collection reservoir. In some embodiments, after the analysis, the method may include pushing a second fluid terminally through at least one of the blood collection reservoir and the blood extraction fluid path to reinject the blood into the patient's vascular system.

[0016] In some embodiments, directing the first fluid toward the terminal may include using the flow of the first fluid to open a one-way septum located in the first proximal port. In some embodiments, in response to opening the one-way septum using the flow of the first fluid, the two-way septum may remain closed. In some embodiments, in response to pushing the second fluid toward the terminal through at least one of the blood collection reservoir and blood extraction fluid pathway to reinject blood into the patient's vascular system, the one-way septum may remain closed.

[0017] Embodiment of the Invention The general description above and the detailed description below are illustrative and descriptive, and should not be understood as limiting the invention as described in the claims. It should be understood that the various embodiments are not limited to the arrangements and apparatus shown in the drawings. Furthermore, embodiments may be combined, or other embodiments may be utilized, and structural modifications may be made without departing from the scope of the various embodiments of the invention, unless otherwise claimed. Therefore, the detailed description below should not be taken as restrictive.

[0018] Brief explanation of the drawing Exemplary embodiments are described and illustrated in more specific and detail through the use of the accompanying drawings. [Brief explanation of the drawing]

[0019] [Figure 1] Figure 1 shows exemplary catheter systems for facilitating fluid injection and blood withdrawal according to several embodiments. [Figure 2] Figure 2 shows a catheter system for facilitating fluid injection and blood withdrawal according to several embodiments. [Figure 3] Figure 3 is a cross-sectional view of an adapter including a one-way septum and a two-way septum according to several embodiments. [Figure 4A]FIG. 4A is a cross-sectional view of the adapter of FIG. 3 showing an initial primed state of the adapter, according to some embodiments. [Figure 4B] FIG. 4B is a cross-sectional view of the adapter of FIG. 3 showing a blood withdrawal state, according to some embodiments. [Figure 4C] FIG. 4C is a cross-sectional view of the adapter of FIG. 3 showing a blood re-infusion state, according to some embodiments. [Figure 4D] FIG. 4D is a cross-sectional view of the adapter of FIG. 3 showing an infusion state, according to some embodiments. DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0020] Description of Embodiments Prior art catheter systems do not provide for rapid transition between blood withdrawal use and infusion use. Infusion or blood withdrawal through prior art adapters can result in fluid mixing, and the fluid may travel in an incorrect direction for the purpose of infusion or blood collection. Simply attaching a needleless connector to each access port of the adapter may not solve the problem. In fact, needleless connectors create a fluid path that is open in both directions.

[0021] Referring now to FIGS. 1-2, a catheter system 10 according to some embodiments may facilitate infusion of fluid and withdrawal of blood from a catheter in fluid communication with a patient's vasculature. Some embodiments of the catheter system 10 may provide a method for consistently and reliably performing infusion and blood withdrawal for diagnostic purposes. In some embodiments, in response to blood withdrawal and analysis for diagnostic purposes, at least a portion of the blood may be returned to the patient's vasculature with a small volume saline flush, and the line may be returned to a primary state for pump-based infusion.

[0022] In some embodiments, the catheter system 10 may include an adapter 12, such as a Y-adapter, to provide a separate, dedicated fluid pathway for drawing blood and injecting fluid into the patient's vascular system. For example, the adapter 12 may include a septum configured to direct the flow of fluid or injection through one pathway in one direction (into the patient) and direct the blood through another pathway to flow in either of two directions (outside the patient and / or inside the patient). In this way, some embodiments may allow the catheter to be used for both drawing and injecting blood, thereby reducing the risk of contamination from prior blood sampling.

[0023] As shown in Figure 1, in some embodiments, the catheter system 10 may include an infusion module 14, a diagnostic module 16, and an adapter 12. In some embodiments, the infusion module 14 may receive an infusion agent from an infusion dosing set 18, such as saline solution, drugs, parenteral nutritional supplements, and / or other suitable fluids. In some embodiments, the infusion dosing set 18 may include an electronic infusion device, such as a pump 20, a gravity reservoir, or other suitable infusion device known to those skilled in the art. Some embodiments of the infusion module 14 may include a first extension tube 22 for directing the fluid or infusion toward terminal direction 24 through a first fluid pathway 26 for infusion into the patient's vascular system. The first fluid pathway 26 may be referred to in this disclosure as the “infusion pathway”. The terminal end of the first extension tube 22 may be coupled to the adapter 12, for example, by press-fitting or by any other suitable method or device.

[0024] In some embodiments, the diagnostic module 16 may be located next to or near the infusion module 14. In some embodiments, the diagnostic module 16 may include a blood collection reservoir 28 for collecting blood drawn from the patient's vascular system via a second fluid pathway 30. The second fluid pathway 30 may be referred to herein as the “blood extraction fluid pathway” and may be used to reintroduce the drawn blood into the patient's vascular system. In some embodiments, the saline wash device may include a saline wash reservoir 32, which may communicate with the diagnostic module 16 to facilitate the reinfusion of the collected blood into the patient's vascular system, as will be discussed in more detail below.

[0025] In some embodiments, the saline irrigation reservoir 32 may be suspended above the diagnostic module 16 in a conventional setup so that saline or other fluid is directed into the diagnostic module 16 by gravity. In some embodiments, the diagnostic module 16 may be a self-supporting device including the saline irrigation reservoir 32. In these embodiments and other embodiments, a pump may apply positive pressure to the saline or other fluid to direct the fluid flow toward the end 24 through the second fluid path 30. In some embodiments, the diagnostic module 16 and the infusion module 14 may communicate with a shared control device 34 to control the inflow and outflow of their respective fluids into the patient's vascular system.

[0026] In some embodiments, the diagnostic module 16 may include a second extension tube 36 configured to direct blood in a proximal direction 38 away from the patient's vascular system through a second fluid pathway 30. In some embodiments, the terminal end of the second extension tube 36 may be coupled to an adapter 12. In some embodiments, the saline irrigation reservoir 32 may also communicate with the second extension tube 36 to reinject the blood in the terminal direction 24 into the patient's vascular system.

[0027] In some embodiments, the adapter 12 may include an injection section 40, which may include a blood extraction section 42 that includes at least a portion of the first fluid path 26 and at least a portion of the second fluid path 30. In some embodiments, the end 44 of the first extension tube 22 may be connected to the injection section 40, and the end 46 of the second extension tube 36 may be connected to the blood extraction section 42.

[0028] In some embodiments, the catheter system 10 may further include a third extension tube 48. In some embodiments, the terminal end 50 of the third extension tube 48 may be connected to a catheter hub 52. In some embodiments, the catheter hub 52 may include a catheter 54 extending from its terminal end 56. In some embodiments, the catheter 54 may be in fluid communication with the patient's vascular system. In some embodiments, the catheter 74 may include a PIVC, a peripherally inserted central catheter, or a midline catheter.

[0029] In some embodiments, the diagnostic module 16 may include a vacuum pump or other suitable device for applying negative pressure to the proximal end 90 of the second extension tube 36. In response to the operation of the vacuum pump or other such device, the diagnostic module 16 may direct blood through the second fluid path 30 in the proximal direction 38. In some embodiments, the diagnostic module 16 may be configured to collect blood from the patient's vascular system. In some embodiments, the blood may be collected in a blood collection reservoir 28. In some embodiments, the blood collection reservoir 28 may include or correspond to a testing compartment for collecting and testing the blood. In some embodiments of the testing compartment, one or more sensors 62 may be included for performing one or more of a variety of diagnostic tests on the collected blood.

[0030] In some embodiments, the diagnostic module 16 may include a pump 63 which is operably coupled to a blood collection reservoir 28 and / or a saline wash reservoir 32 to push saline and / or blood terminally 24 through a second fluid pathway 30. In some embodiments, the pump 20 may include a positive pressure pump. In some embodiments, in response to the operation of the pump 20, saline or another suitable fluid may be forced from the saline wash reservoir 32 through the second fluid pathway 30. Thus, some embodiments may utilize the positive pressure applied to saline or other fluid to push blood terminally 24 through the second fluid pathway 30 and reinject the blood into the patient's vascular system.

[0031] As shown in Figure 1, in some embodiments, the infusion module 14 may be coupled to the diagnostic module 16. As shown in Figure 1, in some embodiments, the saline irrigation reservoir may be freestanding or located in a separate container from the diagnostic module 16. In other embodiments, as shown in Figure 2, the saline irrigation reservoir 32 may be incorporated into or located within the diagnostic module 16.

[0032] Referring now to Figure 3, in some embodiments, the one-way septum 64 may be located within the injection section 40. In some embodiments, the one-way septum 64 may be a low-pressure one-way septum configured to automatically open in response to fluid flow in the terminal direction 24. In some embodiments, the one-way septum 64 may be configured to open in response to a small cracking pressure applied, for example, by the pump 20 or gravity-based injection. In some embodiments, the one-way septum 64 may not be reversible, and therefore, the application of vacuum or a decrease in applied pressure may close the one-way septum 64 to provide a fluid-tight seal.

[0033] In some embodiments, a bidirectional septum 66 may be located within the blood extraction portion 42. In some embodiments, the bidirectional septum 66 may include a passive septum configured to automatically open in response to blood flow in the proximal direction 38 through the second fluid path 30.

[0034] In some embodiments, the bidirectional septum 66 may have a uniform cracking pressure in both the proximal direction 38 and the terminal direction 24. In some embodiments, the bidirectional septum 66 may be tuned to a symmetrical activation pressure in either the terminal direction 24 or the proximal direction 38. In other embodiments, the bidirectional septum 66 may be tuned to an asymmetrical cracking pressure. For example, the bidirectional septum 66 may open in the proximal direction 38 for blood withdrawal in response to a pressure difference across the bidirectional septum, but the bidirectional septum may not open in the terminal direction 24 for blood reinfusion in response to an opposite pressure difference of the same magnitude as the pressure difference.

[0035] In some embodiments, the two-way septum 66 may have sufficient strength to remain closed during pressure-based injection through the injection section 40. Furthermore, some embodiments of the two-way septum 66 may be sealed and closed in the absence of direct application of negative or positive pressure. In this way, some embodiments of the two-way septum 66 may seal the blood extraction section 42 to prevent any saline, drug, or other fluid injected through the first fluid pathway 26 from flowing back up the blood extraction section 42 beyond the position of the two-way septum 66 and being inadvertently delivered to the patient.

[0036] During or after blood extraction, in some embodiments, negative pressure or pumping force may be applied to the proximal end 90 of the second extension tube 36. In some embodiments, as described above, this may trigger the unidirectional septum 64 to close and the bidirectional septum 66 to open, allowing blood extraction with low force. In some embodiments, negative pressure may trigger the bidirectional septum 66 to open, allowing blood to move proximal 38 to reach the diagnostic module 16. Importantly, in some embodiments, the pressure applied to the proximal end 90 of the second extension tube 36 may be gentle enough so as not to cause hemolysis as the blood passes through the second fluid path 30.

[0037] In some embodiments, following blood withdrawal to the diagnostic module 16 and completion of the diagnostic examination, the bidirectional septum 66 may allow blood to passively flow through the bidirectional septum 66 toward the terminal 24 for reinjection into the patient's vascular system. In this way, some embodiments of the catheter system 10 may reduce the possibility of blood clotting or contamination after the examination. In some embodiments, blood may be reinjected by pushing a small amount of saline or other suitable fluid toward the terminal 24 through a second fluid pathway 30. In some embodiments, positive pressure, for example, applied by a pump, may push saline or other suitable fluid through the second fluid pathway 30 for reinjection into the patient's vascular system.

[0038] In some embodiments, the two-way septum 66 may be configured to automatically open in response to the extrusion of saline solution toward the terminal direction 24. In some embodiments, the amount of pressure used to reinject blood through the second fluid path 30 may be less than the amount of pressure used to inject fluid through the first fluid path 26. In some embodiments, the injection section 40 may be locked to prevent the flow of fluid through it. In some embodiments, this may contribute to a fluid lock state in which the fluid may be naturally directed toward the patient's vascular system rather than flowing backward or moving toward the proximal direction 38 and returning to the injection section 40.

[0039] In some embodiments, the adapter 12 may be positioned relatively close to the patient to reduce the amount of blood required to draw blood for diagnostic procedures. Similarly, an adapter 12 positioned close to the patient may reduce the amount of saline or other suitable lavage fluid required to reinject blood into the patient's vascular system.

[0040] In some embodiments, the first proximal port 68 may be aligned with the terminal port 69, and the first fluid path 26 may be straight. In some embodiments, the second proximal port 71 may include a lateral port located between the first proximal port 68 and the terminal port 69, which may facilitate the removal of blood from the adapter 12 after blood extraction. However, in some embodiments, the first fluid path 26 and the one-way septum 64 may be located between the second proximal port 71 and the terminal port 69, and the second fluid path 30 and the two-way septum 66 may be located between the first proximal port 58 and the terminal port 69.

[0041] Referring here to Figure 4A, in some embodiments, a method for facilitating fluid injection and blood extraction according to some embodiments may include priming the adapter 12, which may include a blood extraction portion 42 and an injection portion 40. As shown, for example, both the one-way septum 64 and the two-way septum 66 may be closed so that fluid does not flow during the priming procedure.

[0042] Figure 4A shows the injection section 40 and blood extraction section 42, respectively, filled with priming fluid, according to several embodiments. In some embodiments, this priming fluid may be retained within the injection section 40 and blood extraction section 42 by, for example, a one-way septum 64 and a two-way septum 66. In some embodiments, the priming fluid may be further retained within the adapter 12 by acting on a pinch clamp (not shown) or other suitable clamp connected to a third extension tube 48.

[0043] Referring now to Figure 4B, in some embodiments the method may include drawing blood from the patient's vascular system in the proximal direction 38 through the blood drawout portion 42. In some embodiments, as shown, the one-way septum 64 is closed, while the two-way septum 66 is open to allow blood drawout.

[0044] In some embodiments, the blood extraction portion 42 may include a second fluid path 30 for directing blood to a blood collection reservoir 28. In some embodiments, negative pressure or vacuum may be applied to the second fluid path 30 to cause blood to flow in the proximal direction 38. In some embodiments, negative pressure may form a fluid-tight seal at the unidirectional septum 64 of the injection portion 40.

[0045] In some embodiments, the bidirectional septum 66 may be configured to move passively between a closed position 70 and an open position 72. In some embodiments of the closed position 70, the bidirectional septum 66 may block the second fluid path 30, while in the open position 72, the bidirectional septum 66 may not block the second fluid path 30.

[0046] In some embodiments, the two-way septum 66 may include a first flexible portion 74 and a second flexible portion 76. In some embodiments, the first flexible portion 74 and the second flexible portion 76 may be configured to deform in the proximal direction 38 in response to blood flow in that direction. In some embodiments, the first flexible portion 74 and the second flexible portion 76 may be further configured to deform in the terminal direction 24 in response to the intrusion of saline or another suitable fluid in that direction. In some embodiments, the intrusion of saline or fluid may be used to direct blood flow in the terminal direction 24 to reinject blood into the patient's vascular system.

[0047] Referring here to Figure 4C, in some embodiments the method may include performing an analysis of the blood in the blood collection reservoir 28. In some embodiments the method may include pushing a second fluid toward the terminal direction 24 through the blood collection reservoir 28, the blood extraction section 42 and / or the second fluid path 30, thereby reinjecting the blood into the patient's vascular system after analysis.

[0048] Next, referring to Figure 4D, in some embodiments, the method may allow the blood sample to be collected through a fluid path different from the fluid path that may subsequently be used to inject the fluid. Importantly, this allows the injection portion 40 of the adapter 12 to be pre-primed and also allows the blood sample to be collected while the injection portion 40 remains primed.

[0049] During the injection procedure, in some embodiments, the one-way septum 64 may be open, while the two-way septum 66 may be closed. For example, the injectable agent or first fluid may be directed terminally 24 through the injection section 40. In some embodiments, directing the injectable agent terminally 24 through the injection section 40 may cause the one-way septum 64 located thereto to open automatically. In some embodiments, the first fluid pathway 26 is opened in this way so that the injectable agent may be injected into the patient's vascular system through the injection section 40 and the first fluid pathway 26.

[0050] Some embodiments of the one-way septum 64 may include an elastic element having a slit through it. In some embodiments, the slit may form a first elastic portion 41a and a second elastic portion 41b. In some embodiments, each of the first elastic portion 41a and the second elastic portion 41b may be configured to flex in the terminal direction 24. This may cause some embodiments of the one-way septum 64 to open in response to fluid flow in the terminal direction 24 and to automatically provide a fluid-tight seal in response to the cessation of fluid flow.

[0051] All embodiments and conditional statements incorporated herein are intended for educational purposes to help the reader understand the concepts to which the inventors have contributed to further the invention and the art, and are construed as not being limited to such specifically incorporated embodiments 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 without departing from the spirit and scope of the invention.

Claims

1. It is a catheter system, A catheter hub having a terminal end and a proximal end, A catheter extending from the terminal end of the catheter hub, An adapter that communicates fluidly with the catheter hub and the catheter, wherein the adapter comprises a first proximal port, a second proximal port, and a terminal port, the infusion fluid path extending through the first proximal port and the terminal port, and the blood withdrawal fluid path extending through the second proximal port and the terminal port, A one-way septum, positioned at the first proximal port and configured to be open to allow fluid to flow in the terminal direction due to a pressure difference across the one-way septum, thereby forming a fluid-tight seal, wherein the one-way septum is positioned within the injection fluid path, and A two-way septum located at the second proximal port, wherein the two-way septum is located within the blood extraction fluid path, and is a passive septum configured to automatically open in response to a proximal flow of blood through the blood extraction fluid path, and is configured to allow the blood to flow in the proximal direction when negative pressure or vacuum is applied to the blood extraction fluid path. A catheter system equipped with the following features.

2. The catheter system according to claim 1, further comprising an extension tube, the extension tube comprising a terminal end connected to the catheter hub and a proximal end connected to the terminal port of the adapter.

3. The catheter system according to claim 1, wherein the first proximal port is aligned with the terminal port and the injection fluid path is straight.

4. The catheter system according to claim 3, wherein the second proximal port comprises a lateral port positioned between the first proximal port and the terminal port.

5. An infusion module comprising a first extension tube configured to direct fluid toward the terminal side through an infusion fluid pathway for injection into the patient's vascular system, and A diagnostic module comprising a second extension tube configured to direct blood proximal to a patient's vascular system through a blood extraction fluid pathway, The catheter system according to claim 1, further comprising:

6. The catheter system according to claim 5, wherein the terminal end of the first extension tube is connected to the first proximal port, and the terminal end of the second extension tube is connected to the second proximal port.

7. The catheter system according to claim 5, wherein the injection module comprises at least one pump and gravity-based device for directing the fluid through the injection fluid path toward the terminal.

8. The catheter system according to claim 5, wherein the diagnostic module is configured to apply a pressure difference across the two-way septum to open the two-way septum and direct blood toward the proximal end through the blood extraction fluid pathway.

9. The catheter system according to claim 8, wherein the diagnostic module further comprises a pump for pushing fluid through the blood extraction fluid path toward the terminal in order to reinject the blood into the patient's vascular system.

10. The catheter system according to claim 9, wherein the diagnostic module further comprises at least one sensor for performing the diagnostic test of the blood.

11. The catheter system according to claim 9, further comprising a saline wash device, wherein the pump is configured to transport blood through the saline wash device into the blood extraction fluid path and reintroduce it to the end through the catheter.

12. The catheter system according to claim 11, wherein the saline solution washing device is incorporated into the diagnostic module.

13. The catheter system according to claim 11, wherein the saline solution washing device is independent of the diagnostic module.

14. An adapter configured to be coupled to a catheter assembly, wherein the adapter is First base port, The second base port, and A terminal port, wherein an injection fluid path extends between the first proximal port and the terminal port, and a blood withdrawal fluid path extends between the second proximal port and the terminal port, A one-way septum located at the first proximal port and configured to be open to allow fluid to flow toward the terminal due to a pressure difference across the one-way septum, thereby forming a fluid-tight seal, wherein the one-way septum is located within the injection fluid path, and A two-way septum located at the second proximal port, wherein the two-way septum is located within the blood extraction fluid path, and is a passive septum configured to automatically open in response to a proximal flow of blood through the blood extraction fluid path, and is configured to allow the blood to flow in the proximal direction when negative pressure or vacuum is applied to the blood extraction fluid path, An adapter equipped with [the following features].

15. The adapter according to claim 14, wherein the first base port is aligned with the terminal port and the injection fluid path is straight.

16. The adapter according to claim 15, wherein the second base port comprises a side port positioned between the first base port and the end port.

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