Pressure-Based Medical Devices and Methods

Abstract

A pressure-based vascular localization system including a pressure-based vascular localization device coupled to a needle or catheter. The pressure-based vascular localization device may include a proximal end having an air-permeable membrane and a first chamber and a second chamber. The first chamber may be separated from the second chamber by an interior wall. Each of the first chamber and the second chamber includes a proximal opening and a chamber opening having a pressure-activated valve disposed therein. The pressure-based vascular localization device may further include an air-permeable membrane configured to cover the proximal openings of the first chamber and the second chamber. Each of the chambers includes a window that allows a user to observe the contents of each chamber. A method of identifying a blood vessel includes visually inspecting each chamber for the presence or absence of blood.

Description

[Background technology]

[0001] Determining the identity of a vessel that has just been accessed can be difficult. Current methods either use an open-ended needle that the clinician must determine by blood color, texture, and spurt distance, or use a device that indicates blood flow flashback. Open-ended needles are unhygienic, while devices that indicate flashback do not allow the clinician to detect the color or texture of the blood flow. Accurately identifying whether a vessel is an artery or a vein is important when placing medical devices during patient treatment. Being able to quickly and accurately identify a vessel would be beneficial to the clinician and the patient. Disclosed herein is a pressure-based vessel detector system and method of use that addresses the above. Summary of the Invention

[0002] Disclosed herein is a medical device, according to some embodiments, that includes (i) a third chamber including a fluid port, (ii) a first chamber fluidly coupled to the third chamber via a first valve, and (iii) a second chamber fluidly coupled to the third chamber via a second valve. The first valve is configured to transition from a normally closed state to an open state in response to a first pressure across the first valve, and the second valve is configured to transition from a normally closed state to an open state in response to a second pressure across the second valve, the second pressure being different from the first pressure, and the fluid port is configured to receive bodily fluid from a patient. In some embodiments, the bodily fluid is blood.

[0003] In some embodiments, the fluid port is configured to mate with a vascular access device, and in some embodiments, the fluid port comprises a Luer lock connector. In some embodiments, the first pressure is defined according to the patient's venous pressure, and in some embodiments, the first pressure is about 4 mmHg to 40 mmHg (about 533 Pa to 5333 Pa).

[0004] In some embodiments, the second pressure is defined according to the patient's arterial pressure, and in some embodiments, the second pressure is greater than about 40 mmHg (about 5333 Pa). In some embodiments, the first valve includes a first partition extending across an opening between the first chamber and the third chamber, and the second valve includes a second partition extending across an opening between the second chamber and the third chamber.

[0005] In some embodiments, the first chamber includes a first vent configured to define an atmospheric pressure in the first chamber and the second chamber includes a second vent configured to define an atmospheric pressure in the second chamber, hi some embodiments, the first and second vents include hydrophobic membranes configured to prevent the passage of liquid therethrough.

[0006] In some embodiments, the first chamber includes a first outer wall having a first window, and the second chamber includes a second outer wall having a second window. In some embodiments, the device further includes a device body, the device body including a first outer wall, a second outer wall, and an inner wall disposed between the first chamber and the second chamber.

[0007] In some embodiments, the first outer wall and the second outer wall define a cylindrical periphery of the device body. In some embodiments, during use, fluid communication between the patient's vein and the fluid port causes blood to flow into the first chamber, and blood in the first chamber is visible through the first window.

[0008] In some embodiments, during use, fluid communication between the patient's artery and the fluid port causes blood to flow into the second chamber, and blood in the second chamber is visible through the second window.

[0009] Also disclosed herein is a method of identifying a blood vessel, according to some embodiments, the method including: (i) inserting a needle into a target area of ​​a patient, the needle being coupled to a medical device including a first chamber and a second chamber; (ii) visually inspecting the first chamber and the second chamber for the presence of blood therein; and (iii) determining a position of the tip of the needle relative to the blood vessel as a result of visually inspecting the first chamber and the second chamber.

[0010] In some embodiments of the method, visually inspecting the first and second chambers includes observing that no blood is present in the first and second chambers, and determining the position of the tip of the needle includes determining that the tip of the needle is disposed outside the blood vessel.

[0011] In some embodiments of the method, visually inspecting the first chamber and the second chamber includes observing the presence of blood in the first chamber and the absence of blood in the second chamber, and determining the position of the tip of the needle includes (i) determining that the tip of the needle is disposed within a blood vessel and (ii) determining that the vessel is a vein.

[0012] In some embodiments of the method, visually inspecting the first chamber and the second chamber includes observing the presence of blood in the first chamber and the second chamber, and determining the position of the tip of the needle includes (i) determining that the tip of the needle is disposed within a blood vessel and (ii) determining that the blood vessel is an artery.

[0013] Also disclosed herein is a method of manufacturing a vascular localization system, according to some embodiments, the method includes forming a device body of a pressure-based vascular localization device, the device body comprising: (i) a first chamber including an open proximal end and a first chamber opening at a distal end of the first chamber; (ii) a second chamber having an open proximal end and a second chamber opening at a distal end of the second chamber, the second chamber separated from the first chamber; and (iii) a third chamber disposed at a distal end of the device body, the third chamber in fluid communication with the first chamber opening and the second chamber opening. The method further includes (i) placing a first septum valve across the first chamber opening, the first septum valve defining a first valve pressure value; (ii) placing a second septum valve across the second chamber opening, the second septum valve defining a second valve pressure value; (iii) placing an air permeable membrane across the open proximal ends of the first and second chambers; and (iv) attaching a tip member to the device body at a distal end.

[0014] In some embodiments of the method, the second valve pressure value is at least two times greater than the first valve pressure value. In some embodiments, the method of manufacture further comprises packaging the pressure-based vascular localization device together with the one or more needles in a package.

[0015] In some embodiments, the method of manufacture further comprises sterilizing the pressure-based vascular localization device together with the one or more needles in the package.

[0016] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts.

[0017] A more particular description of the present disclosure will be made by reference to certain embodiments that are illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. Exemplary embodiments of the invention will be described with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0018] [Figure 1] 1 is a perspective view illustrating a pressure-based vascular localization system, according to some embodiments. [Figure 2A] 2 is a perspective view illustrating a pressure-based vascular localization device of the system of FIG. 1 in accordance with some embodiments. [Figure 2B] 1 is a side cross-sectional view illustrating a pressure-based vascular localization device, according to some embodiments. [Figure 2C] 1 is an exploded side cross-sectional view illustrating a pressure-based vascular localization device, according to some embodiments. [Figure 3A] 1 is a plan view illustrating a distal end of a pressure-based vascular localization device, according to some embodiments. [Figure 3B] 1 is a plan view illustrating a proximal end of a pressure-based vascular localization device, according to some embodiments. [Figure 4A] 1A-1D are various perspective views of a pressure-based vessel localization system illustrating an exemplary method of identifying a vessel, according to some embodiments. [Figure 4B] 1A-1D are various perspective views of a pressure-based vessel localization system illustrating an exemplary method of identifying a vessel, according to some embodiments. [Figure 4C] 1A-1D are various perspective views of a pressure-based vessel localization system illustrating an exemplary method of identifying a vessel, according to some embodiments. [Diagram 5] 1 is a flowchart illustrating an exemplary method for identifying a blood vessel, according to some embodiments. [Figure 6] 4 is a flow chart illustrating an exemplary method of manufacturing a pressure-based vascular localization system, in accordance with some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0020] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[0021] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a pressure-based vascular locating device disclosed herein includes a portion of the pressure-based vascular locating device that is intended to be near a clinician when the pressure-based vascular locating device is used on a patient. Similarly, for example, a "proximal length" of a pressure-based vascular locating device includes a length of a needle that is intended to be near a clinician when the pressure-based vascular locating device is used on a patient. For example, a "proximal end" of a pressure-based vascular locating device includes an end of the pressure-based vascular locating device that is intended to be near a clinician when the pressure-based vascular locating device is used on a patient. A proximal portion, proximal end portion, or proximal length of a pressure-based vascular locating device can include the proximal end of the pressure-based vascular locating device, but a proximal portion, proximal end portion, or proximal length of a proximal portion need not include the proximal end of the pressure-based vascular locating device. That is, unless otherwise indicated by context, a proximal portion, proximal end portion, or proximal length of a pressure-based vascular localization device is not a terminal portion or length of the pressure-based vascular localization device.

[0022] With respect to "distal," for example, a "distal portion" or "distal end portion" of a pressure-based vascular locating device disclosed herein includes a portion of a pressure-based vascular locator apparatus that is intended to be near or within a patient when the pressure-based vascular locating device is used with a patient. Similarly, for example, a "distal length" of a pressure-based vascular locating device includes a length of the pressure-based vascular locating device that is intended to be near or within a patient when the pressure-based vascular locating device is used with a patient. For example, a "distal end" of a pressure-based vascular locating device includes an end of the pressure-based vascular locating device that is intended to be near or within a patient when the pressure-based vascular locating device is used with a patient. A distal portion, distal end portion, or distal length of a pressure-based vascular locating device can include the distal end of the pressure-based vascular locating device, but a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the pressure-based vascular locating device. That is, unless otherwise indicated by context, a distal portion, distal end portion, or distal length of a pressure-based vascular localization device is not a terminal portion or terminal length of the pressure-based vascular localization device.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. FIG. 1 illustrates a perspective view of a pressure-based vascular localization system 100, according to some embodiments. The pressure-based vascular localization system (system) 100 includes a pressure-based vascular localization device (device) 120 removably coupled to a vascular access device, such as a needle 102. The device 120 is generally configured to determine when a tip of the needle 102 is disposed within a blood vessel 106. The position of the tip of the needle 102 is controlled by a user, thereby allowing the user to determine the location of the blood vessel 106. The device 120 is also generally configured to identify a blood vessel, for example, to determine whether the blood vessel is a vein or an artery. More specifically, the device 120 is configured to identify a blood vessel based on a pressure within the blood vessel. In use, a clinician can access a blood vessel 106 via the vascular access device 102, the blood vessel 106 being one of a vein 110 or an artery 108, and accessing the blood vessel 106 establishes fluid communication between the blood vessel 106 and the device 120.

[0024] The device 120 includes a first chamber 140 and a second chamber 150. During use, a user can access a blood vessel 106 via the needle 102. The user can then determine the identity of the blood vessel 106 as an artery 108 or as a vein 110 based on observing the blood in the first chamber 140 and / or second chamber 150, as described in more detail herein.

[0025] Device 120 is shown and described herein as being utilized in determining the position of a vascular device relative to a patient's vasculature, but may also be utilized in determining the position of any tubular device relative to any anatomical element within a patient as determined based on pressure.

[0026] 2A is a detailed view of the device 120. The device 120 can include a body 122 defining a first chamber 140 and a second chamber 150. In some embodiments, the first chamber 140 can be separated from the second chamber 150 by a common interior wall 148. The interior wall 148 can be configured to allow the first chamber 140 to be independent of the second chamber 150. The device 120 can include a distal end 124 having a tip 126 configured to receive the needle 102 thereon. The tip 126 includes a tip opening 128. In some embodiments, the tip 126 can include a luer lock connector 127. The device 120 can include a proximal end 130, where the first chamber 140 includes a proximal opening 144 and the second chamber 150 includes a proximal opening 154. In some embodiments, the proximal openings 144 / 154 can be covered by a membrane 132.

[0027] 2B shows a side cross-sectional view of the device 120, according to some embodiments. The device 120 further includes a third chamber 160 in fluid communication with the tip opening 128, which defines a fluid port of the third chamber 160. The first chamber 140 and the second chamber 150 are in fluid communication with the third chamber 160. In some embodiments, blood (or other bodily fluid) may be received through the tip opening 128, enter the third chamber 160, and further into the first chamber 140 and / or the second chamber 150. In some embodiments, the distal end 124 of the body 122 may include the first chamber opening 142 and the second chamber opening 152. The first chamber opening 142 defines fluid communication between the third chamber 160 and the first chamber 140, and the second chamber opening 152 defines fluid communication between the third chamber 160 and the second chamber 150.

[0028] The body 122 defines a first outer wall 140A of the first chamber 140 and a second outer wall 150A of the second chamber 150. The first outer wall 140A can be formed from a transparent material (or at least a translucent material) such that the first outer wall 140A includes a window 140B that allows visual observation of the contents of the first chamber 140 (e.g., air or blood). Similarly, the second outer wall 150A can be formed from a transparent material (or at least a translucent material) such that the second outer wall 150A includes a second window 150B that allows visual observation of the contents of the second chamber 150 (e.g., air or blood). The first outer wall 140A and the second outer wall 150A can define a cylindrical periphery of the device body 122.

[0029] 2C shows an exploded view of the device 120, according to some embodiments. Shown are (i) a first chamber opening 142 that defines fluid communication between the first chamber 140 and the third chamber 160, and (ii) a second chamber opening 152 that defines fluid communication between the second chamber 150 and the third chamber 160. The first chamber opening 142 includes a first valve 146, and the second chamber opening 152 includes a second valve 156. In some embodiments, the first valve 146 and the second valve 156 may each include a slit-containing diaphragm. The first valve 146 and the second valve 156 may be normally closed. Each of the first valve 146 and the second valve 156 can be configured to transition from a normally closed configuration to an open configuration in response to pressure exerted across the respective valve. The device 120 further includes a tip member 123 that can be coupled to the body 122 during manufacture, the tip member 123 including a luer lock connector 127 , the tip member 123 partially defining a third chamber 160 .

[0030] 3A shows an end view of a first chamber opening 142 and a second chamber opening 152, according to some embodiments. Shown is a first valve 146 disposed within the first chamber opening 142 and a second valve 156 disposed within the second chamber opening 152. The first chamber opening 142 and the second chamber opening 152 can be configured in any shape, including circular, square, triangular, pentagonal, etc. The first valve 146 and the second valve 156 can be constructed from any suitable septum material, such as, for example, silicone, rubber, thermoplastic elastomer, or synthetic polymer. The first valve 146 includes a first slit 146A and the second valve 156 includes a second slit 156A.

[0031] In some embodiments, the first valve 146 may define a first valve pressure value and the second valve 156 may define a second valve pressure value. The first valve pressure value is the pressure that needs to be exerted on the first valve 146 to transition the first valve 146 from a closed configuration to an open configuration. In some embodiments, the second valve pressure value is the pressure that needs to be exerted on the second valve 156 to transition the second valve 156 from a closed configuration to an open configuration. In some embodiments, the type of material, material thickness, slit geometry, slit length, etc. of the first valve 146 and second valve 156 may contribute to the first valve pressure value and the second valve pressure value. In some embodiments, the second valve pressure value may be greater than the first valve pressure value. In some embodiments, the second valve pressure value may be at least two times greater than the first valve pressure value.

[0032] In some embodiments, the first valve pressure value may be defined as a function of venous pressure (i.e., pressure in a vein), such that (i) when the pressure exerted on the first valve 146 (i.e., pressure in the third chamber 160) exceeds the venous pressure, the first valve 146 transitions from a closed configuration to an open configuration, and (ii) when the pressure exerted on the first valve 146 is below the venous pressure, the first valve 146 remains in the closed configuration. Similarly, in some embodiments, the second valve pressure value may be defined as a function of arterial pressure (i.e., pressure in an artery), such that (i) when the pressure exerted on the second valve 156 (i.e., pressure in the third chamber 160) exceeds the arterial pressure, the second valve 156 transitions from a closed configuration to an open configuration, and (ii) when the pressure exerted on the second valve 156 is below the venous pressure, the second valve 156 remains in the closed configuration.

[0033] In some embodiments, the second valve pressure value may be greater than about 40 mmHg (about 5333 Pa) and the first valve pressure value may be less than about 40 mmHg (about 5333 Pa), or between about 4 mmHg and 40 mmHg (about 533 Pa). For example, when the pressure in the third chamber 160 is equal to 10 mmHg (1333 Pa), the first valve 146 may transition from a closed configuration to an open configuration, while the second valve 156 remains in the closed configuration. Similarly, when the pressure in the third chamber 160 is equal to 50 mmHg (6666 Pa), the first valve 146 and the second valve 156 may transition from a closed configuration to an open configuration.

[0034] Thus, if the pressure in the third chamber 160 is greater than the first valve pressure value but less than the second valve pressure value, any fluid (e.g., blood) in the third chamber 160 will flow into the first chamber 140, which will be visible through the first window 140B. Similarly, if the pressure in the third chamber 160 is greater than both the second valve pressure value and the first valve pressure value, any fluid in the third chamber 160 will also flow into the second chamber 150, which will be visible through the second window 150B.

[0035] 3B shows a plan view of the membrane 132, according to some embodiments. The membrane 132 is configured to be air permeable, form a vent, and define atmospheric pressure within each of the first chamber 140 and the second chamber 150. In some embodiments, the membrane 132 may also be configured to prevent liquids (e.g., blood) from exiting the first chamber 140 or the second chamber 150. In some embodiments, the membrane 132 may be constructed from a synthetic polymer, including polytetrafluoroethylene and the like. The membrane 132 may be hydrophobic.

[0036] 4A-4C show various cross-sectional side views of the device 120 depicting an exemplary method of detecting and / or identifying a blood vessel 106, according to some embodiments. As shown in FIG. 4A, the pressure-based blood vessel localization system 100 can be assembled to access the blood vessel 106. In some embodiments, the needle 102 can be coupled to the device 120. The needle 102 is inserted into the target area 104 toward the blood vessel 106 (i.e., the vein 110 or the artery 108). The needle tip is disposed below the skin surface but not inside either the vein 110 or the artery 108. As a result, the third chamber 160 does not contain any blood, and neither the first chamber 140 nor the second chamber 150 contains any blood. Thus, the absence of blood is visible through both the first window 140B and the second window 150B. Thus, the user can determine that the needle 102 is not inserted into the vein 110 or the artery 108.

[0037] FIG. 4B shows the needle 102 inserted into the vein 110. Thus, blood from the vein 110 travels along the needle 102 into the third chamber 160, and the blood disposed in the third chamber 160 defines a venous pressure in the third chamber 160. The venous pressure in the third chamber 160 causes the first valve 146 to transition from a closed configuration to an open configuration, allowing blood to pass from the third chamber 160 into the first chamber 140. The pressure in the third chamber 160 is less than the second valve pressure value, so that the second valve 156 remains closed, preventing blood from entering the second chamber 150. Thus, the presence of blood is visible through the first window 140B, and the absence of blood is visible through the second window 150B. Thus, the user can determine that the needle 102 is inserted into the vein 110.

[0038] FIG. 4C shows the needle 102 inserted into the artery 108. Thus, blood from the artery 108 travels along the needle 102 into the third chamber 160, and the blood disposed in the third chamber 160 defines an arterial pressure in the third chamber 160. The arterial pressure in the third chamber 160 causes the first valve 146 to transition from a closed configuration to an open configuration, allowing blood to pass from the third chamber 160 to the first chamber 140. The arterial pressure in the third chamber 160 also causes the second valve 156 to transition from a closed configuration to an open configuration, allowing blood to pass from the third chamber 160 into the second chamber 150. Thus, the presence of blood is visible through the first window 140B and the second window 150B. Thus, the user can determine that the needle 102 is inserted into the artery 108.

[0039] 5 illustrates a flowchart of an example method 500 for identifying a blood vessel, according to some embodiments. The method 500 may include all or any subset of the following steps, actions, or processes. The method 500 may include inserting a needle into a target area of ​​a patient (block 510), the needle being coupled to a pressure-based blood vessel localization device including a first chamber and a second chamber. The method 500 may further include visually inspecting the first chamber and the second chamber (block 520) and determining a position of the tip of the needle relative to the blood vessel as a result of visually inspecting the first chamber and the second chamber (block 530).

[0040] In some embodiments of method 500, visually inspecting the first and second chambers may include observing that no blood is present in the first and second chambers (block 521). As a result of observing that no blood is present in the first and second chambers, method 500 may include determining that the tip of the needle is disposed outside of the blood vessel (block 531).

[0041] In some embodiments of method 500, visually inspecting the first and second chambers can include observing the presence of blood in the first chamber and the absence of blood in the second chamber (block 522). As a result of observing the presence of blood in the first chamber and the absence of blood in the second chamber, method 500 can include (i) determining that the tip of the needle is disposed in a blood vessel and (ii) determining that the blood vessel is a vein (block 532).

[0042] In some embodiments of method 500, visually inspecting the first and second chambers can include observing the presence of blood in the first and second chambers (block 523). As a result of observing the presence of blood in the first and second chambers, method 500 can include (i) determining that the tip of the needle is disposed in a blood vessel and (ii) determining that the blood vessel is an artery (block 533).

[0043] FIG. 6 shows a flow chart of an exemplary method 600 of manufacturing a pressure-based vascular localization system. The method 600 may include all or any subset of the following steps, actions, or processes. The method 600 may include forming a device body of a pressure-based vascular localization device (block 610), the device body comprising: (i) a first chamber including an open proximal end and a first chamber opening at a distal end of the first chamber; (ii) a second chamber having an open proximal end and a second chamber opening at a distal end of the second chamber, the second chamber being separated from the first chamber; and (iii) a third chamber disposed at a distal end of the device body, the third chamber being in fluid communication with the first chamber opening and the second chamber opening. In some embodiments, forming the device body includes injection molding, 3D printing, or extruding the device body. In some embodiments, the device body is formed from a polymer, aluminum, or the like.

[0044] The method 600 may further include placing a first diaphragm valve across the first chamber opening (block 620), the first diaphragm valve defining a first valve pressure value. The method 600 may further include placing a second diaphragm valve across the second chamber opening (block 630), the second diaphragm valve defining a second valve pressure value. In some embodiments of the present manufacturing methods, the second valve pressure value is at least two times greater than the first valve pressure value.

[0045] The method 600 may further include placing an air permeable membrane (block 640), where placing the air permeable membrane includes placing an air permeable membrane across the open proximal ends of the first chamber and the second chamber.

[0046] The method 600 may further include attaching a tip member to the device body at a distal end of the device body (block 650). The method 600 may further include packaging the pressure-based vascular localization device (block 660), where packaging the pressure-based vascular localization device includes enclosing the pressure-based vascular localization device in a package along with the one or more needles.

[0047] The method 600 may further include sterilizing the pressure-based vascular locating device (block 670). In some embodiments, sterilizing the pressure-based vascular locating device includes sterilizing one or more needles together with the pressure-based vascular locating device in the packaging.

[0048] Although some specific embodiments have been disclosed herein, and those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and are likewise encompassed in the broader aspects. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. A medical device comprising: a third chamber including a fluid port; a first chamber fluidly coupled to the third chamber via a first valve; a second chamber fluidly coupled to the third chamber via a second valve; Equipped with the first valve is configured to transition from a normally closed state to an open state in response to a first pressure across the first valve; the second valve is configured to transition from a normally closed state to an open state in response to a second pressure across the second valve, the second pressure being different from the first pressure; The medical device, wherein the fluid port is configured to receive bodily fluids from a patient.

2. The device of claim 1 , wherein the bodily fluid is blood.

3. The device of claim 1 , wherein the fluid port is configured to couple with a vascular access device.

4. The device of claim 1 , wherein the fluid port comprises a luer lock connector.

5. 4. The device according to claim 1, wherein the first pressure is determined in response to the patient's venous pressure.

6. 6. The device of claim 1, wherein the first pressure is between 4 mmHg and 40 mmHg (533 Pa and 5333 Pa).

7. 4. The device according to claim 1, wherein the second pressure is determined according to the arterial pressure of the patient.

8. 4. The device of claim 1, wherein the second pressure is greater than 40 mmHg (5333 Pa).

9. 4. A device according to any one of claims 1 to 3, the first valve includes a first septum extending across an opening between the first chamber and the third chamber; The device, wherein the second valve includes a second septum extending across an opening between the second chamber and the third chamber.

10. 4. A device according to any one of claims 1 to 3, the first chamber includes a first vent configured to define atmospheric pressure within the first chamber; The device, wherein the second chamber includes a second vent configured to define atmospheric pressure within the second chamber.

11. 11. The device of claim 10, wherein the first and second vents include a hydrophobic membrane configured to prevent the passage of liquid therethrough.

12. 4. A device according to any one of claims 1 to 3, the first chamber includes a first outer wall having a first window; The device, wherein the second chamber includes a second outer wall having a second window.

13. The device of claim 12 further comprises a device body, the device body comprising: the first outer wall; the second outer wall; an inner wall disposed between the first chamber and the second chamber; Devices that include:

14. 14. The device of claim 13, wherein the first and second outer walls define a cylindrical periphery of the device body.

15. 13. The device of claim 12, wherein, in use, fluid communication between the patient's vein and the fluid port causes blood to flow into the first chamber, the blood in the first chamber being visible through the first window.

16. 13. The device of claim 12, wherein, during use, fluid communication between the patient's artery and the fluid port causes blood to flow into the second chamber, the blood in the second chamber being visible through the second window.

17. 1. A method for manufacturing a vascular localization system, comprising: forming a device body of a pressure-based vascular localization device, the device body comprising: a first chamber having an open proximal end and a first chamber opening at a distal end of the first chamber; a second chamber having an open proximal end and a second chamber opening at a distal end of the second chamber, the second chamber being separated from the first chamber via an interior wall; a third chamber disposed at a distal end of the device body, the third chamber in fluid communication with the first chamber opening and the second chamber opening; placing a first diaphragm valve across the first chamber opening, the first diaphragm valve defining a first valve pressure value; placing a second diaphragm valve across the second chamber opening, the second diaphragm valve defining a second valve pressure value; placing an air permeable membrane across the open proximal ends of the first and second chambers; attaching a tip member to the device body at the distal end; A method comprising:

18. 18. The method of claim 17, wherein the second valve pressure value is at least two times greater than the first valve pressure value.

19. 20. The method of claim 17, further comprising packaging the pressure-based vascular localization device together with one or more needles in a package.

20. 20. The method of claim 19, further comprising sterilizing the pressure-based vascular localization device along with one or more needles in the package.

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