Valve with sampling port and purge port

The valve design addresses hemolysis and clotting risks in extracorporeal systems by using a tapered sidewall and movable element for a fluid-tight seal, ensuring safe and efficient fluid flow and sterilization in extracorporeal blood circulation systems.

JP2026511551APending Publication Date: 2026-04-14MAQUET CARDIOPULMONARY GMBH
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
MAQUET CARDIOPULMONARY GMBH
Filing Date
2024-03-14
Publication Date
2026-04-14

AI Technical Summary

Technical Problem

Conventional valves used in extracorporeal blood circulation systems pose risks such as hemolysis and blood clotting due to structural obstacles and inadequate sterilization of purge ports, leading to adverse effects on patients.

Method used

A valve design with a tapered sidewall and movable valve element that forms a fluid-tight seal in the closed position, allowing for smooth fluid flow in the open position, and incorporating features like a threaded connection and angled access ports to prevent blood damage and clotting.

Benefits of technology

The design minimizes hemolysis and clotting risks by providing a seamless fluid path and ensuring thorough sterilization, enhancing safety in extracorporeal blood circulation systems.

✦ Generated by Eureka AI based on patent content.

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Abstract

A valve used in an extracorporeal blood circulation system includes a valve port extending at an angle from the main lumen and defining the valve lumen, an access port extending at an angle from the valve lumen and defining an access lumen that is in fluid communication with the valve lumen, and a valve element positioned within the valve port. The valve element is movable between a closed position and an open position. In the closed position, the valve element engages with the side wall of the valve lumen to prevent fluid from flowing through the access lumen, and in the open position, the valve element retracts relative to the closed position to allow fluid to flow through the valve lumen into the access lumen.
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Description

Technical Field

[0001] Background of the Disclosure Field of the Disclosure The present disclosure relates to valves for controlling fluid flow, and more particularly to valves having sampling ports and / or purge ports.

Background Art

[0002] Description of Related Art Extracorporeal blood circulation is an important element of modern medicine. Using various types of extracorporeal blood circulation systems, such as extracorporeal membrane oxygenation (ECMO) devices, cardiopulmonary devices, cardiopulmonary bypass devices, pump-assisted lung protection devices, and dialysis devices, etc., it is possible to provide cardiac assistance and / or respiratory assistance to patients whose own heart and / or lungs are unable to maintain life. When installing such a system, when connecting such a system to a patient, and during the operation of such a system, access to the fluid circuit of the system may be necessary or desirable to perform various functions. For example, it is necessary to discharge air from the fluid circuit so as not to inject air into the patient. In some cases, it may be necessary or desirable to collect blood from the fluid circuit for analysis. These functions and other functions are realized through an openable and closable valve that enables selective access to the fluid circuit.

[0003] Conventional valves can provide the necessary access to fluid circuits, but they also have inherent drawbacks that can pose risks to patients. Specifically, the structure of conventional valves includes obstacles that the blood flowing through the valve may collide with. Conventional valves involve increased hemolysis due to edges / corners resulting from the integration of the port into the blood flow pathway. Conventional valves also involve an increased risk of blood clotting due to "dead zones" in the blood pathway where blood accumulates when the valve is closed ("normal" state). Furthermore, conventional purge ports include purge ports that are press-fitted into the housing. Therefore, sterilization gases cannot reach the stopcock or portion of the purge port that will be exposed to blood in subsequent processes. Such effects can cause red blood cells to rupture, leading to conditions such as hemolysis. In addition, obstacles in conventional valves can cause undesirable blood clotting within the valve.

[0004] Summary of Disclosure [Overview of the Initiative] [Means for solving the problem]

[0005] In view of the above, there is a need for a valve used in an extracorporeal circulation system that enables sampling, purging, and similar functions while eliminating adverse effects on the blood. Accordingly, embodiments of the present disclosure relate to a valve used in an extracorporeal blood circulation system. The valve includes a valve port defining a valve lumen, an access port defining an access lumen extending at an angle from the valve lumen and in fluid communication with the valve lumen, and a valve element positioned within the valve port. The valve element is movable between a closed position and an open position. In the closed position, the valve element engages with the side wall of the valve lumen to prevent fluid from flowing through the access lumen, and in the open position, the valve element retracts relative to the closed position to allow fluid to flow through the valve lumen into the access lumen.

[0006] In some embodiments, the valve port has a tapered sidewall that narrows toward the main lumen, and the valve element includes a tapered pin configured to seal against the tapered sidewall in the closed position.

[0007] In some embodiments, the tapered sidewall has a taper angle in the range of 3° to 15°.

[0008] In some embodiments, the tapered sidewall functions as a stopper to prevent the tapered pin from protruding into the main lumen.

[0009] In some embodiments, when the valve element is in the closed position, the distal end of the valve element is substantially coplanar with the inner wall of the main flow channel component to which the valve can be fluid-connected.

[0010] In some embodiments, the valve element includes a knob for adjusting the valve element between a closed position and an open position.

[0011] In some embodiments, the valve port includes a threaded portion, and the proximal end of the valve element is threaded to engage with the threaded portion of the valve port.

[0012] In some embodiments, the threaded portion includes a threaded insert connected to the valve port.

[0013] In some embodiments, the valve port extends at an angle of about 90° from the main flow path component to which the valve can be fluid-connected.

[0014] In some embodiments, the access port extends from the valve port at an angle ranging from approximately 30° to approximately 90°.

[0015] In some embodiments, the access port includes a Luer connector. In some embodiments, the valve is located within the valve port and further includes a seal to prevent fluid flow between the valve element and the side wall of the valve port.

[0016] In some embodiments, the extracorporeal blood circulation system is selected from the group consisting of an ECMO device, a cardiopulmonary device, a cardiopulmonary bypass device, a pump-assisted lung protection device, and a dialysis device.

[0017] Other embodiments of the present disclosure relate to an extracorporeal blood circulation system including a flow path component and a valve. The valve includes a main flow path component defining a longitudinal axis and a main lumen extending parallel to the longitudinal axis; a valve port defining a valve lumen extending at an angle from the main lumen and in fluid communication with the main lumen; an access port defining an access lumen extending at an angle from the valve lumen and in fluid communication with the valve lumen; and a valve element disposed within the valve port. The valve element is movable between a closed position and an open position. In the closed position, the valve element engages with the side wall of the valve lumen to prevent fluid from flowing from the main lumen through the access lumen; in the open position, the valve element retracts relative to the closed position to allow fluid to flow from the main lumen through the valve lumen to the access lumen. The main flow path component is disposed within the flow path of the flow path component.

[0018] In some embodiments, the flow path component includes at least one of an oxygen supplier and a heat exchanger.

[0019] In some embodiments, the valve port has a tapered sidewall that narrows toward the main lumen, and the valve element includes a tapered pin configured to seal against the tapered sidewall in the closed position.

[0020] In some embodiments, the tapered sidewall has a taper angle in the range of 3° to 15°.

[0021] In some embodiments, the tapered sidewall functions as a stopper to prevent the tapered pin from protruding into the main lumen.

[0022] In some embodiments, when the valve element is in the closed position, the distal end of the valve element is substantially flush with the inner wall of the main flow path component.

[0023] In some embodiments, the valve element includes a knob for adjusting the valve element between a closed position and an open position.

[0024] In some embodiments, the valve port includes a threaded portion, and the proximal end of the valve element is threaded to engage with the threaded portion of the valve port.

[0025] In some embodiments, the threaded portion includes a threaded insert connected to the valve port.

[0026] In some embodiments, the valve port extends at an angle of about 90° from the main flow path component.

[0027] In some embodiments, the access port extends at an angle in the range of about 30° to about 90° from the valve port.

[0028] In some embodiments, the access port includes a Luer fitting. In some embodiments, the valve is disposed within the valve port and further includes a seal for preventing fluid flow between the valve element and the sidewall of the valve port.

[0029] In some embodiments, the extracorporeal blood circulation system is selected from the group consisting of an ECMO device, a cardiopulmonary device, a cardiopulmonary bypass device, a pumpless lung protection device, and a dialysis device.

[0030] In another embodiment, a valve used in an extracorporeal blood circulation system includes a valve port defining a valve lumen that communicates fluid with a main lumen, and a valve element positioned within the valve port. The valve element defines a flow channel and is configured to be movable between a closed position and an open position. In the closed position, the valve element engages with the side wall of the valve lumen to prevent fluid from flowing through the access lumen, and in the open position, the valve element retracts relative to the closed position to allow fluid to flow through the valve lumen into the access lumen. The valve further includes an access port formed at the proximal end of the valve element, defining an access lumen that communicates fluid with the valve lumen.

[0031] In another embodiment, the access port includes a Luer lock. In another embodiment, the flow channel extends from the distal end of the valve element to the proximal end of the valve element.

[0032] In another embodiment, the valve port has a tapered sidewall that narrows toward the main lumen, and the valve element includes a tapered pin configured to seal against the tapered sidewall in the closed position.

[0033] In another embodiment, the tapered sidewall has a taper angle in the range of 3° to 15°. In another embodiment, the tapered sidewall functions as a stopper to prevent the tapered pin from protruding into the main flow channel component to which the valve can be fluid-connected.

[0034] In another embodiment, when the valve element is in the closed position, the distal end of the valve element is substantially coplanar with the inner wall of the main flow channel component to which the valve can be fluid-connected.

[0035] In another embodiment, a seal is placed inside the valve port to prevent fluid flow between the valve element and the side wall of the valve port.

[0036] In another embodiment, the extracorporeal blood circulation system is selected from the group consisting of an ECMO device, a cardiopulmonary device, a cardiopulmonary bypass device, a pump-assisted lung protection device, and a dialysis device.

[0037] Further details and advantages of the various non-limiting embodiments described in detail herein will become apparent by considering the following detailed descriptions of the various non-limiting embodiments in conjunction with the accompanying drawings. [Brief explanation of the drawing]

[0038] [Figure 1] This is a perspective view of a valve according to one embodiment of the present disclosure. [Figure 2] This is a cross-sectional view taken along line AA when the valve in Figure 1 is in the open position. [Figure 3] This is a cross-sectional view taken along line AA when the valve in Figure 1 is in the closed position. [Figure 4] This is a cross-sectional view taken along line AA when the valve in Figure 1 is in the open position. [Figure 5] This is a perspective view of an oxygen supply assembly according to one embodiment of the present disclosure. [Figure 6] This is a perspective view of a valve according to one embodiment of the present disclosure when it is in the closed position. [Figure 7] Figure 6 is a perspective view of the valve when it is in the open position. [Figure 8] This is a cross-sectional view of the valve in Figure 6 when it is in the closed position. [Figure 9] This is a cross-sectional view of the valve in Figure 6 when it is in the open position. [Modes for carrying out the invention]

[0039] With reference to drawings in which similar reference symbols refer to similar parts, this disclosure generally relates to extracorporeal circulation systems and fluid heating pump assemblies used in such extracorporeal circulation systems.

[0040] Detailed explanation For the purposes of the following description, the terms “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “upper surface,” “bottom surface,” “lateral,” “longitudinal,” and their derivatives shall be in relation to the members of the disclosure as oriented in the drawings. Since the disclosed embodiments may have various alternative orientations, spatial or directional terms such as “left,” “right,” “inside,” “outside,” “top,” and “bottom” should not be interpreted restrictively.

[0041] In this specification, the singular forms of "a," "an," and "the" shall be considered to include the plural form unless the context clearly indicates otherwise.

[0042] All numerical values ​​used in this specification and in the claims should be understood to always be modified by the term “approximately.” The terms “approximately,” “about,” and “substantially” mean a range of ±10% of the stated value.

[0043] As used herein, the term “at least one” is synonymous with “one or more.” For example, the expression “at least one of A, B, and C” means any one of A, B, and C, or any combination of two or more of A, B, and C. For example, “at least one of A, B, and C” includes one or more A's, or one or more B's, or one or more C's, or one or more A's and one or more B's, or one or more A's and one or more C's, or one or more B's and one or more C's, or one or more of all A's, B's, and C's. Similarly, as used herein, the term “at least two” is synonymous with “two or more.” For example, the expression “at least two of D, E, and F” means any combination of two or more of D, E, and F. For example, “at least two of D, E, and F” includes one or more Ds and one or more Es, or one or more Ds and one or more Fs, or one or more Es and one or more Fs, or all one or more of D, E, and F.

[0044] Furthermore, the specific apparatus and processes shown in the accompanying drawings and described in the following specification should be understood as merely examples of the present disclosure. Accordingly, the specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0045] Terms such as "first" and "second" do not refer to a specific order or chronological sequence, but rather to different conditions, characteristics, or elements.

[0046] The term "at least" is synonymous with "greater than or equal to." The term "not greater than" is synonymous with "less than or equal to."

[0047] This disclosure should be understood to allow for alternative modifications and sequences of procedures unless otherwise stated. Furthermore, the specific apparatus and processes shown in the accompanying drawings and described in the following specification should be understood to be merely examples of this disclosure. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0048] Referring to Figures 1-4, this disclosure relates to a valve 100 for controlling fluid flow and, in particular, enabling fluid sampling and / or purging. The valve 100 can be used in any fluid flow system, but is particularly suited for use in extracorporeal blood circulation systems such as ECMO machines, cardiopulmonary bypass machines, cardiopulmonary bypass machines, pump-assisted lung protection devices, and dialysis machines. The valve 100 includes a main flow path component 110 through which the fluid flows. The main flow path component 110 defines a longitudinal axis 112 extending from a first end 120 of the main flow path component 110 to a second end 122 of the main flow path component 110. The main lumen 114, defined by the inner wall 124 of the main flow path component 110, extends parallel to the longitudinal axis 112. When in use, the fluid can flow through the main lumen 114 generally along the direction of the longitudinal axis 112 between the first end 120 and the second end 122 or in the reverse direction. In some embodiments, the flow through the main flow channel component 110 is bidirectional. That is, the first end 120 can function as an inlet and / or outlet, and similarly, the second end 122 can function as an inlet and / or outlet. Thus, the valve 100 may be installed in the fluid flow system in either direction with respect to the direction of fluid flow. Each of the first end 120 and the second end 122 of the main flow channel component 110 may include connectors such as Luer locks, bayonet connectors, or slip joints suitable for connection to adjacent components in the system.

[0049] Valve 100 further includes a valve port 130 extending from the main flow channel component 110. The valve port 130 has an inner wall 132 defining a valve lumen 134 that extends parallel to the valve shaft 136. When valve 100 is in the open position, the valve lumen 134 is in fluid communication with the main lumen 114 of the main flow channel component 110. The angle θ between the longitudinal axis 112 and the valve shaft 136 may be approximately 90°. It is also conceivable that the valve shaft 136 may be at a different angle than 90°. A valve element 140 is positioned within the valve lumen 134 and configured to move parallel to the valve shaft 136. The valve element 140 may be a pin having a tapered distal end 142. The inner wall 132 of the valve port 130 may be tapered so that the valve lumen 134 is frustoconical. The tapered shape of the inner wall 132 is complementary to the shape of the tapered distal end 142 of the valve element 140. As a result, when the valve element 140 is in the closed position shown in Figure 3, the engagement between the inner wall 132 and the distal end 142 forms a substantially fluid-tight seal.

[0050] The valve 100 further includes an access port 150 extending from a valve port 130, which is a flow path component. As described later, the access port 150 may be used to take or add a fluid sample from the main lumen 114 and / or to purge the main lumen 114. The access port 150 defines an access lumen 152 extending along an access axis 154. When the valve 100 is in the open position, the access lumen 152 is in fluid communication with the valve lumen 134. The access axis 154 may extend from the valve axis 136 at an angle β. The angle β is in the range of about 20° to 70°, and in some embodiments, about 45°. In another example, the angle β is in the range of about 30° to 90°. The access port 150 may include fittings 156, such as Luer fittings, for connection to other components, such as syringes.

[0051] The valve element 140 is movable between two states: a closed position as shown in Figure 3 and an open position as shown in Figures 2 and 4. As previously mentioned, in the closed position, the valve element 140 forms a substantially liquid-tight seal with the inner wall 132 of the valve port 130. Specifically, the tapered distal end 142 of the valve element 140 engages with the complementary taper of the inner wall 132 to form a substantially liquid-tight interface. In some embodiments, the taper angles of the valve element 140 and the inner wall 132 may be in the range of about 1° to about 15°. In another example, the taper angles of the valve element 140 and the inner wall 132 may be 3° to 15°. In the closed position, the valve element 140 extends over the opening 158 between the valve lumen 134 and the access lumen 152, thereby preventing fluid from flowing from the main lumen 114 into the valve lumen 134 and ultimately into the access lumen 152. Furthermore, in the closed position, the end face 144 of the valve element 140 is substantially coplanar with the side wall 124 of the main flow channel component 110, providing a smooth transition surface for the fluid to flow through the main lumen 114. The taper of the inner wall 132 can function as a stopper or limit to prevent the valve member 140 from protruding significantly beyond the side wall 124 of the main flow channel component 110 into the main lumen 114. The flat, smooth transition surface between the side wall 124 of the main flow channel component 110 and the end face 144 does not have any protruding edges that could cause undesirable coagulation of the fluid (e.g., blood) flowing through the main lumen 114 and / or impart any impact that could result in conditions such as hemolysis.

[0052] To sample or purge using valve 100, the valve element 140 is moved from the closed position shown in Figure 3 to the open position shown in Figures 2 and 4. In the open position, the end face 144 of the valve element 140 retracts from the side wall 124 of the main lumen 114, allowing fluid to flow into the valve lumen 134. By separating the end face 144 from the side wall 124, the fluid can flow from the main lumen 114 into the valve lumen 134, through the opening 158, and finally into the access lumen 152. When the valve element 140 retracts to this position, there is no longer a liquid-tight engagement between the tapered distal end 142 and the inner wall 132, so fluid may flow between the inner wall 132 and the valve element 140. To prevent this, one or more seals 160 (e.g., O-rings) are placed around the valve element 140.

[0053] Referring again to Figures 1 to 4, the valve element 140 may be screwed into the valve port 130. This allows the valve element 140 to be moved along the valve axis 134 (i.e., parallel to the valve axis 134) by rotating it. Specifically, rotating the valve element 140 in one direction moves it from the open position (see Figures 2 and 4) to the closed position (see Figure 3), while rotating the valve element 140 in the opposite direction moves it from the closed position to the open position. The valve element 140 may include a knob 148 to facilitate manual rotation of the valve element 140 by a clinician.

[0054] The valve element 140 may include a male threaded portion 146 located proximal to the distal end 142. The male threaded portion 146 engages with a complementary female threaded portion 172 of the valve port 130. Specifically, the female threaded portion 172 may be provided on a threaded insert 170 disposed within the valve port 130. The threaded insert 170 may be connected to the valve port 130 by press-fitting, snap-fitting, adhesive, welding, etc. In addition to allowing rotation of the valve element 140, the threaded insert 170 can also hold the seal 160 in place within the valve port 130. The valve element 140 may be moved by a spring of a magnetic actuator, an electric actuator, or a pneumatic actuator.

[0055] To collect a sample of the fluid in the main lumen 114, as described above, the clinician connects a syringe (or other collection device) to the fitting 156 of the outlet port 150 and moves the valve element 140 to the open position (see Figures 2 and 4). This causes the fluid in the main lumen 114 to flow into the access lumen 152. The clinician then draws the fluid into a collection device connected to the access port 150 and returns the valve element 140 to the closed position (see Figure 3).

[0056] To purge valve 100 and connected fluid components, the clinician connects a syringe (or other collection device) to fitting 156 of outlet port 150 and moves valve element 140 to the open position (see Figures 2 and 4). This allows air in the main lumen 114 to flow into the access lumen 152. The clinician then aspirates the air into a collection device connected to access port 150, and once all air has been removed, returns valve element 140 to the closed position (see Figure 3).

[0057] Referring to Figure 5, the valve 100 of this disclosure may be attached to or integrated with another flow path component 200 of the extracorporeal circulation system 300 (e.g., an oxygen supply unit, a heat exchanger, etc.). In the illustrated embodiment, the main flow path component 110 is located inside the flow path of the flow path component 200, and the access port 150 and at least the knob 148 of the valve element 140 protrude from the flow path component 200. This allows a clinician to operate the knob 148 to take a fluid sample from the flow path component and / or purge the flow path component 200 via the access port 150.

[0058] With reference to Figures 6-9, a valve 300 is shown and described in another non-limiting embodiment or aspect of the present disclosure. Similar to the valve 100 described above, the valve 300 can be fluidly connected to the main flow channel component 110. The valve 300 includes a valve port 330 extending from the main flow channel component 110. The valve port 330 has an inner wall 332 defining a valve lumen 334 extending parallel to the valve axis 336. When the valve 300 is in the open position, the valve lumen 334 is in fluid communication with the main lumen of the main flow channel component 110. A valve element 340 is positioned within the valve lumen 334 and configured to move parallel to the valve axis 336. The valve element 340 may be a pin having a tapered distal end 342. The inner wall 332 of the valve port 330 may be tapered so that the valve lumen 334 is frustoconical. The taper of the inner wall 332 is complementary to the shape of the tapered distal end 342 of the valve element 340. As a result, when the valve element 340 is in the closed position shown in Figure 6, the engagement between the inner wall 332 and the distal end 342 forms a substantially liquid-tight seal.

[0059] The valve 300 may include an access port 350 formed integrally with the valve element 340. The access port 350 may be located at the proximal end of the valve element 340. In one example, the access port 350 is the male portion of a Luer lock.

[0060] The valve element 340 is movable between two states: a closed position as shown in Figures 6 and 8, and an open position as shown in Figures 7 and 9. As previously mentioned, in the closed position, the valve element 340 forms a substantially liquid-tight seal with the inner wall 332 of the valve port 330. In particular, the tapered distal end 342 of the valve element 340 engages with the complementary taper of the inner wall 332 to form a substantially liquid-tight interface. In some embodiments, the taper angles of the valve element 340 and the inner wall 332 may be in the range of about 1° to about 15°. In another example, the taper angles of the valve element 340 and the inner wall 332 may be 3° to 15°. In the closed position, the valve element 340 extends over the opening 358 between the valve lumen 334 and the main flow channel component 110, thereby preventing fluid from flowing from the main flow channel component 110 into the valve lumen 334 and ultimately into the access port 350. Furthermore, in the closed position, the end face 344 of the valve element 340 is substantially coplanar with the side wall 124 of the main flow channel component 110, providing a smooth transition surface for the fluid to flow through the main flow channel component 110. The taper of the inner wall 332 can function as a stopper or limit to prevent the valve member 340 from protruding significantly beyond the side wall 124 of the main flow channel component 110 into the main flow channel component 110. The flat, smooth transition surface between the side wall 124 of the main flow channel component 110 and the end face 344 does not have any protruding edges that could cause undesirable coagulation of the fluid (e.g., blood) flowing through the main flow channel component 110 and / or impart any impact that could result in conditions such as hemolysis.

[0061] In one non-limiting embodiment or aspect of the present disclosure, the valve element 340 may define a flow channel 360 extending from an opening at the distal end 342 of the valve element 340 to an opposing opening at the proximal end of the valve element 340. When the valve element 340 is in the open position, a flow path is established between the main flow channel component 110 and the access port 350 because the opening defined at the distal end 342 of the valve element 340 is not coplanar with or in contact with the inner wall 332 of the valve port 330.

[0062] Referring again to Figures 6-9, the valve element 340 may be screwed into the valve port 330. This allows the valve element 340 to be moved along the valve axis 336 (i.e., parallel to the valve axis 336) by rotating it. Specifically, rotating the valve element 340 in one direction moves it from the open position (see Figures 7 and 9) to the closed position (see Figures 6 and 8), while rotating the valve element 340 in the opposite direction moves it from the closed position to the open position.

[0063] The valve element 340 may include a male threaded portion 346 located proximal to the distal end 342. The male threaded portion 346 engages with a complementary female threaded portion 372 of the valve port 330. Specifically, the female threaded portion 372 may be provided on a threaded insert 370 positioned within the valve port 330. The threaded insert 370 may be connected to the valve port 330 by press-fitting, snap-fitting, adhesive, welding, etc. In addition to allowing rotation of the valve element 340, the threaded insert 370 can also hold the seal in place within the valve port 330. The valve element 340 may be moved by a spring of a magnetic actuator, an electric actuator, or a pneumatic actuator.

[0064] While various examples of the disclosure have been provided in the foregoing description of this specification, those skilled in the art can modify and change these examples without departing from the scope and spirit of the disclosure. For example, it should be understood that the features of the various embodiments described herein are applicable to other embodiments described herein. Accordingly, the foregoing description is illustrative and not restrictive. The foregoing disclosure is defined by the appended claims, and all modifications to the disclosure that fall within the meaning and scope of the equivalents of the claims should be encompassed within that scope.

Claims

1. A valve used in an extracorporeal blood circulation system, The valve port defines the valve lumen, An access port that extends at a certain angle from the valve lumen and defines an access lumen that is in fluid communication with the valve lumen, The valve element is disposed within the valve port and is movable between a closed position and an open position, In the closed position, the valve element engages with the side wall of the valve lumen to prevent fluid from flowing through the access lumen. In the open position, the valve element retracts relative to the closed position, allowing fluid to flow through the valve lumen into the access lumen.

2. The valve port has a tapered side wall that narrows in the direction toward the main lumen, The valve according to claim 1, wherein the valve element includes a tapered pin configured to seal against the tapered side wall in the closed position.

3. The valve according to claim 2, wherein the tapered side wall has a taper angle in the range of 3° to 15°.

4. The valve according to claim 2, wherein the tapered side wall functions as a stopper to prevent the tapered pin from protruding into the main lumen.

5. The valve according to claim 1, wherein when the valve element is in the closed position, the distal end of the valve element is substantially coplanar with the inner wall of a main flow channel component to which the valve can be fluid-connected.

6. The valve according to claim 1, wherein the valve element includes a knob for adjusting the valve element between the closed position and the open position.

7. The valve port includes a threaded portion, The valve according to claim 1, wherein the proximal end of the valve element is threaded to engage with the threaded portion of the valve port.

8. The valve according to claim 7, wherein the threaded portion includes a threaded insert connected to the valve port.

9. The valve according to claim 1, wherein the valve port extends at an angle of about 90° from a main flow path component to which the valve can be fluid-connected.

10. The valve according to claim 1, wherein the access port extends from the valve port at an angle in the range of approximately 30° to approximately 90°.

11. The valve according to claim 1, wherein the access port includes a Luer fitting.

12. The valve according to claim 1, further comprising a seal disposed within the valve port for preventing fluid flow between the valve element and the side wall of the valve port.

13. The valve according to claim 1, wherein the extracorporeal blood circulation system is selected from the group consisting of an ECMO device, a cardiopulmonary device, a cardiopulmonary bypass device, a pump-assisted lung protection device, and a dialysis device.

14. An extracorporeal blood circulation system, Flow channel components, Equipped with a valve, The aforementioned valve is A main flow channel component that defines a longitudinal axis and a main lumen extending parallel to the longitudinal axis, A valve port defines a valve lumen that extends at a certain angle from the main lumen and is in fluid communication with the main lumen, An access port that extends at a certain angle from the valve lumen and defines an access lumen that is in fluid communication with the valve lumen, The valve element is disposed within the valve port and is movable between a closed position and an open position, In the closed position, the valve element engages with the side wall of the valve lumen to prevent fluid from flowing from the main lumen through the access lumen. In the open position, the valve element retracts relative to the closed position, allowing fluid to flow from the main lumen through the valve lumen to the access lumen. The system wherein the main flow channel component is located within the flow channel of the flow channel component.

15. The system according to claim 14, wherein the flow path component includes at least one of an oxygen supplier and a heat exchanger.

16. The valve port has a tapered side wall that narrows in the direction toward the main lumen, The system according to claim 14, wherein the valve element includes a tapered pin configured to seal against the tapered sidewall in the closed position.

17. The system according to claim 16, wherein the tapered sidewall has a taper angle in the range of 3° to 15°.

18. The system according to claim 16, wherein the tapered side wall functions as a stopper to prevent the tapered pin from protruding into the main lumen.

19. The system according to claim 14, wherein when the valve element is in the closed position, the distal end of the valve element is substantially coplanar with the inner wall of the main flow channel component.

20. The system according to claim 14, wherein the valve element includes a knob for adjusting the valve element between the closed position and the open position.

21. The valve port includes a threaded portion, The system according to claim 14, wherein the proximal end of the valve element is threaded to engage with the threaded portion of the valve port.

22. The system according to claim 21, wherein the threaded portion includes a threaded insert connected to the valve port.

23. The system according to claim 14, wherein the valve port extends at an angle of approximately 90° from the main flow path component.

24. The system according to claim 14, wherein the access port extends from the valve port at an angle in the range of approximately 30° to approximately 90°.

25. The system according to claim 14, wherein the access port includes a Luer connector.

26. The system according to claim 14, wherein the valve is disposed within the valve port and further includes a seal for preventing fluid flow between the valve element and the side wall of the valve port.

27. The extracorporeal blood circulation system is selected from the group consisting of an ECMO device, a cardiopulmonary device, a cardiopulmonary bypass device, a pump-assisted lung protection device, and a dialysis device, as described in claim 14.

28. A valve used in an extracorporeal blood circulation system, A valve port is defined which defines a valve lumen that is in fluid communication with the main lumen, Includes a valve element disposed within the valve port, The valve element defines a flow channel and is configured to be movable between a closed position and an open position. In the closed position, the valve element engages with the side wall of the valve lumen to prevent fluid from flowing through the access lumen. In the open position, the valve element retracts relative to the closed position to allow fluid to flow through the valve lumen into the access lumen. The valve is configured to define a flow channel and is movable between a closed position and an open position. A valve further comprising an access port formed at the proximal end of the valve element, defining an access lumen that is in fluid communication with the valve lumen.

29. The valve according to claim 28, wherein the access port includes a Luer lock.

30. The valve according to claim 28, wherein the flow channel extends from the distal end of the valve element to the proximal end of the valve element.

31. The valve port has a tapered side wall that narrows in the direction toward the main lumen, The valve according to claim 28, wherein the valve element includes a tapered pin configured to seal against the tapered side wall in the closed position.

32. The valve according to claim 31, wherein the tapered side wall has a taper angle in the range of 3° to 15°.

33. The valve according to claim 31, wherein the tapered side wall functions as a stopper to prevent the tapered pin from protruding into a main flow channel component to which the valve can be connected to fluid.

34. The valve according to claim 28, wherein when the valve element is in the closed position, the distal end of the valve element is substantially coplanar with the inner wall of a main flow channel component to which the valve can be fluid-connected.

35. The valve according to claim 28, further comprising a seal disposed within the valve port for preventing fluid flow between the valve element and the side wall of the valve port.

36. The valve according to claim 28, wherein the extracorporeal blood circulation system is selected from the group consisting of an ECMO device, a cardiopulmonary device, a cardiopulmonary bypass device, a pump-assisted lung protection device, and a dialysis device.