Oxygenator swap valves and method of using the same

Abstract

An extracorporeal oxygenation circuit includes a first valve, a second valve, a first oxygenator, and a second oxygenator. The first oxygenator and the second oxygenator being fluidically coupled between the first valve and the second valve. The first valve is configured to receive a first flow of fluid and a second flow of fluid, each of which contain blood. The first flow of fluid is received from a patient. The second valve is configured to receive the first flow of fluid and the second flow of fluid, and convey the first flow of fluid to the patient. The extracorporeal oxygenation circuit is configured to transition between a first state in which the first oxygenator oxygenates the first flow of fluid and the second oxygenator oxygenates the second flow of fluid, and a second state in which the second oxygenator oxygenates the first flow of fluid.

Description

OXYGENATOR SWAP VALVES AND METHOD OF USING THE SAMECROSS-REFERENCE TO RELATED APPLICATIONS|0001| This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 666,997, filed on Inly 2, 2024, entitled “Oxygenator Swap Valve,” the disclosure of which is hereby incorporated by reference as if set forth in its entirety herein.BACKGROUND(0002] This disclosure relates to extracorporeal oxygenation of a patient’s blood supply, and in particular, to blood oxygenators and valves for use in extracorporeal oxygenation of a patient’s blood supply.|0003| Extracorporeal oxygenator circuits are used to replace the functions of the lungs and usually the heart when a patient’s lungs cannot sufficiently oxygenate the blood. In order to oxygenate the blood, an extracorporeal oxygenator circuit includes a conduit to carry blood from the patient to a gas exchanger, oxygenator, that is exterior to the patient. The blood passing through the oxygenator allows the discharge of carbon dioxide (CO2) from the blood and the enrichment of the blood by oxygen that is supplied to the oxygenator in the form of a sweep gas. The blood is then returned to the patient via a return conduit allowing the oxygenated blood to perfuse the patient’s body via the patient’ s natural circulatory system. The flow of blood through the extracorporeal circuit can be driven by an external blood pump or naturally by the patient’s heart.10004] As can be appreciated, there may be situations where degradation of performance, obstruction of flow, or defects in an oxygenator can result in a need to replace the oxygenator in the extracorporeal circuit. Replacement of oxygenators in an Extracorporeal Membrane Oxygenation (ECMO) system relies on the skill of clinicians and the circumstances of the system configuration. Generally, a myriad of steps are required to successfully swap an oxygenator and several factors can impact the success of the procedure, all of which must be satisfied to avoid serious consequences on the health of the patient. Additionally, time management becomes a serious issue due to impacts on blood temperature and quality of the bleeding of air from the blood circulating within the system.SUMMARY(0005] In some embodiments, an extracorporeal oxygenation circuit includes a first valve, a second valve, a first oxygenator, and a second oxygenator. The first oxygenator and the second oxygenator being fluidically coupled between the first valve and the second valve. The first valve is configured to receive a first flow of fluid and a second flow of fluid, each of which contain blood. The first flow of fluid is received from a patient. The second valve is configured to receive the first flow of fluid and the second flow of fluid, and convey the first flow of fluid to the patient. The extracorporeal oxygenation circuit is configured to transition between a first state in which the first oxygenator oxygenates the first flow of fluid and the second oxygenator oxygenates the second flow of fluid, and a second state in which the second oxygenator oxygenates the first flow of fluid.BRIEF DESCRIPTION OF THE DRAWINGS(0006] For a fuller understanding of the nature and desired objects of the present disclosure, reference is made to the following detailed description taken in conjunction with the accompanying drawing figures wherein like reference characters denote corresponding parts throughout the several views.

[0007] FIG. 1 is a schematic view of an extracorporeal support system according to an aspect of the disclosure.(0008] FIG. 2 is a schematic view of a portion of the extracorporeal support system of FIG. 1.

[0009] FIG. 3 is a perspective view of a portion of the extracorporeal support system of FIG. 1.

[0010] FIG. 4 is a perspective view of an extracorporeal circuit of the extracorporeal support system of FIG. 1 in accordance with the disclosure.(0011] FIG. 5 is a perspective view of a valve of the extracorporeal circuit of FIG. 4 in accordance with the disclosure.

[0012] FIG. 6 is an exploded perspective view of the valve of FIG. 5.

[0013] FIG. 7A is a cross-sectional view of the valve of FIG. 5 illustrating the valve in a first position.

[0014] FIG. 7B is a cross-sectional view of the valve of FIG. 5 illustrating the valve in a second position.

[0015] FIG. 8 is a perspective view of the extracorporeal circuit of FIG. 4 including two valves of FIG. 5, showing each of the two valves in the first position.

[0016] FIG. 9 is a perspective view of the extracorporeal circuit of FIG. 8, showing each of the two valves in the second position.

[0017] FIG. 10A is a perspective view of another embodiment of an extracorporeal circuit suitable for use, for example, in the extracorporeal support system of FIG. 1 in accordance with the disclosure; the extracorporeal circuit having two valves of FIG. 4, with each of the two valves shown in the first position.

[9018] FIG. 10B is a perspective view of the extracorporeal circuit of FIG. 10A, showing each of the two valves in the second position.]0(H9] FIG. 11A is an exploded perspective view of another embodiment of a valve suitable for use, for example, in the extracorporeal circuit of FIG. 4 in accordance with the disclosure.

[0020] FIG. 1 IB is a perspective view of the valve of FIG. 11 A shown in a first position.

[0021] FIG. 11C is a perspective view of the valve of FIG. 11 A shown in a second position.

[0022] FIG. 12A is a plan view of the valve of FIG. 11 A shown in the first position.

[0023] FIG. 12B is a plan view of the valve of FIG. 11A shown in the second position.

[0024] FIG. 13 A is an exploded perspective view of another embodiment of a valve suitable for use, for example, in the extracorporeal circuit of FIG. 4 in accordance with the disclosure.

[0025] FIG. 13B is a perspective view of the valve of FIG. 13A shown in a first position.

[0026] FIG. 13C is a perspective view of the valve of FIG. 13A shown in a second position;

[0027] FIG. 14A is a plan view of the valve of FIG. 13A shown in the first position.

[0028] FIG. 14B is a plan view of the valve of FIG. 13A shown in the second position.

[0029] FIG. 15A is an exploded perspective view of another embodiment of a valve suitable for use, for example, in the extracorporeal circuit of FIG. 4 in accordance with the disclosure.

[0030] FIG. 15B is a perspective view of the valve of FIG. 15A shown in a first position.

[0031] FIG. 15C is a perspective view of the valve of FIG. 15A shown in a second position.

[0032] FIG. 16A is a plan view of the valve of FIG. 15A shown in the first position.

[0033] FIG. 16B is a plan view of the valve of FIG. 15A shown in the second position.|0034[ FIG. 17A is an elevation view of the valve of FIG. 5 illustrating a position locking mechanism in accordance with the disclosure.

[0035] FIG. 17B is a cross-sectional elevation view of the valve of FIG. 17A showing the valve in a first position.

[0036] FIG. 17C is a cross-sectional elevation view of the valve of FIG. 17A showing the valve in a second position.

[0037] FIG. 18A is a perspective view of the valve of FIG. 5 shown in the first position and selectively engaging first detents.

[0038] FIG. 18B is a perspective view of the valve of FIG. 5 shown in the second position and selectively engaging second detents.

[0039] FIG. 19 is an exploded perspective view of another embodiment of a valve suitable for use, for example, in the extracorporeal circuit of FIG. 4 in accordance with the disclosure.

[0040] FIG. 20 is a perspective view of the valve of FIG. 19 shown in a first position.10041] FIG. 21A is a perspective view of the valve of FIG. 19 shown in a second position.

[0042] FIG. 21B is a perspective, hidden line view of the valve of FIG. 19 shown in the second position.

[0043] FIG. 22 is a perspective, hidden line view of another embodiment of a valve suitable for use, for example, in the extracorporeal circuit of FIG. 4 in accordance with the disclosure; the valve being shown in a first position.

[0044] FIG. 23 is a perspective, hidden line view of the valve of FIG. 22 shown in a second position.

[0045] FIG. 24 is a perspective view of another embodiment of a valve suitable for use, for example, in the extracorporeal circuit of FIG. 4 in accordance with the disclosure; the valve being shown in a first position.

[0046] FIG. 25 A is a perspective, hidden line view of the valve of FIG. 24 shown in a first position.

[0047] FIG. 25B is a perspective, hidden line view of the valve of FIG. 24 shown in a second position.

[0048] FIG. 26 is an elevation, hidden line view of the valve of FIG. 24.

[0049] FIGS. 27A and 27B are schematic views of an aspect of the valve of FIG. 5 illustrating fluid path(s) through the valve when the valve is in a first position and a second position, respectively.

[0050] FIGS. 28A and 28B are schematic views of an aspect of the extracorporeal circuit of FIG. 4, having two valves of FIG. 5, and illustrating fluid path(s) of the extracorporeal circuit when each valve is in a first position and a second position, respectively.

[0051] FIGS. 29A and 29B are cross-sectional views of another embodiment of a valve suitable for use, for example, in the extracorporeal circuit of FIG. 4 in accordance with the disclosure; the valve being shown in a first position and a second position, respectively.DETAILED DESCRIPTION

[0052] Embodiments described herein relate to blood oxygenators and valves used, for example, in extracorporeal oxygenation of a patient’s blood supply. In some embodiments, an extracorporeal oxygenation circuit includes a first valve, a second valve, a first oxygenator, and a second oxygenator. The first oxygenator and the second oxygenator being fluidically coupled between the first valve and the second valve. The first valve is configured to receive a first flow of fluid and a second flow of fluid, each of which contain blood. The first flow of fluid is received from a patient. The second valve is configured to receive the first flow of fluid and the second flow of fluid, and convey the first flow of fluid to the patient. The extracorporeal oxygenation circuit is configured to transition between a first state in which the first oxygenator oxygenates the first flow of fluid and the second oxygenator oxygenates the second flow of fluid, and a second state in which the second oxygenator oxygenates the first flow of fluid.[00531 In some embodiments, an extracorporeal oxygenation circuit includes a first valve, a second valve, a first oxygenator fluidically coupled between the first valve and the second valve, and a second oxygenator fluidically coupled between the first valve and the second valve. The first valve is configured to receive a first flow of fluid and a second flow of fluid. The first flow of fluid and the second flow of fluid contain blood. The first flow of fluid isreceived from a patient. The second valve is configured to receive the first flow of fluid and the second flow of fluid, and to convey the first flow of fluid to the patient. The extracorporeal oxygenation circuit has a first state in which (i) the first valve is configured to convey the first flow of fluid to the first oxygenator and the second flow of fluid to the second oxygenator and (ii) the second valve is configured to covey the first flow of fluid, having been oxygenated by the first oxygenator, to the patient and the second flow of fluid, having been oxygenated by the second oxygenator, to the first valve. The extracorporeal oxygenation circuit further has a second state in which the first valve conveys the first flow of fluid to the second oxygenator and the second valve coveys the first flow of fluid, having been oxygenated by the second oxygenator, from the second oxygenator to the patient.(0054] In some embodiments, an extracorporeal oxygenation circuit includes a first valve including a valve body defining a first aperture and a second aperture, and a valve stem slidably supported within the first valve body, the valve stem defining a channel extending through the valve stem, wherein the valve stem is transitionable between a first position, where the channel is in fluid communication with the first aperture, and a second position, where the channel is in fluid communication with the second aperture, wherein one of the first aperture or the channel is configured to receive fluid from a fluid source, a second valve including a valve body defining a first aperture and a second aperture, and a valve stem slidably supported within the valve body of the second valve, the valve stem of the second valve defining a channel extending through the valve stem of the second valve, wherein the valve stem of the second valve is transitionable between a first position, where the channel of the second valve is in fluid communication with the first aperture of the valve body of the second valve, and a second position, where the channel of the second valve is in fluid communication with the second aperture of the valve body of the second valve, wherein one of the first aperture of the second valve or the channel of the second valve is configured to return fluid to the fluid source, a first oxygenator fluidly coupling one of the first aperture of the first valve or the channel of the first valve receiving fluid from the fluid source to the opposite one of the first aperture of the second valve or the channel of the second valve returning fluid to the fluid source, and a second oxygenator fluidly coupling the second aperture of the valve body of the first valve to the second aperture of the valve body of the second valve.10055] In some embodiments, a method includes conveying, via a first valve, a first flow of blood to a first oxygenator and a second flow of blood to a second oxygenator while the first valve is in a first state. The first flow of blood is received from a patient. The first flow of bloodis conveyed to the patient via a second valve while the second valve is in a first state, where the first flow of blood has been oxygenated by the first oxygenator. Each of the first valve and the second valve is transitioned from the first state to a second state. While the first valve and the second valve are in the second state, the method further includes conveying the first flow of blood to the patient, where the first flow of blood has been oxygenated by the second oxygenator.

[0056] In some embodiments, a method of using such systems and / or devices includes transitioning two valves from a first state to a second state. The first valve in the first state directs a flow of blood from a patient through a single inlet of the first valve and to a first outlet of the first valve and a first oxygenator fluidically coupled thereto. The first oxygenator is further fluidically coupled to a first inlet of the second valve in the first state. When in the first state, the second valve fluidically connects the first inlet to a single outlet of the second valve which is fluidically coupled to the patient. When the first valve and the second valve are both transitioned to the second state, the first valve directs the flow of blood from the single inlet of the first valve to the second outlet of the first valve which is fluidically coupled to a second oxygenator. The second oxygenator is further fluidically coupled to a second inlet of the second valve. When in the second state, the second valve fluidically connects the second inlet to the single outlet of the second valve. In some instances, the first valve and the second valve are transitioned from the first state to the second state essentially simultaneously. In some embodiments, the first valve and the second valve can be the same or substantially identical and arranged in mirrored configuration. In some embodiments, the first valve and the second valve can be part of or included in a valve assembly or the like and can be transitioned between states by a single actuator (or multiple actuators collectively controlled so as to act as a single actuator).

[0057] As used herein, the singular form “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.10058] Unless specifically stated or obvious from context, as used herein, the term “about” is understood as within a range of normal tolerance in the art, for example within 2 standard deviations of the mean. “About” can be understood as within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise clear from context, all numerical values provided herein are modified by the term about.

[0059] As used herein, the terms “parallel” or “substantially parallel” mean a relative angle as between two objects (if extended to theoretical intersection), such as elongated objects and including reference lines, that is from 0° to 5°, or from 0° to 3°, or from 0° to 2°, or from 0° to 1°, or from 0° to 0.5°, or from 0° to 0.25°, or from 0° to 0.1°, inclusive of the recited values.

[0060] As used herein, the terms “perpendicular” or “substantially perpendicular” mean a relative angle as between two objects (if extended to theoretical intersection), such as elongated objects and including reference lines, that is from 88° to 92°, or from 89° to 91°, or from 89.99° to 90.1°, or that is 90.0°, inclusive of the recited values.|0061[ As used in the specification and claims, the terms “comprises,” “comprising,” “containing,” “having,” and the like can have the meaning ascribed to them in U.S. patent law and can mean “includes,” “including,” and the like.

[0062] Unless specifically stated or obvious from context, the term “or,” as used herein, is understood to be inclusive.|0063] The terms “proximal” and “distal” can refer to the position of a portion of a device relative to the remainder of the device or the opposing end as it appears in the drawing. The proximal end can be used to refer to the end manipulated by the user. The distal end can be used to refer to the end of the device that is inserted and advanced and is furthest away from the user. As will be appreciated by those skilled in the art, the use of proximal and distal could change in another context (e.g., the anatomical context in which proximal and distal use the patient as reference, or where the entry point is distal from the user).

[0064] Ranges provided herein are understood to be shorthand for all of the values within the range. For example, a range of 1 to 50 is understood to include any number, combination of numbers, or sub-range from the group consisting 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 (as well as fractions thereof unless the context clearly dictates otherwise).

[0065] Method steps described herein may be designated by alphabetical letters, Roman numerals, Arabic numerals, or equivalents thereof. Steps in the method can be performed consecutively, concurrently, or out of order Further at least a portion of the step can be performed prior to, during, or after another step.

[0066] Aspects of the disclosure provide methods, systems, and apparatus for oxygenating blood. Aspects of the disclosure can utilize a high flow of CO2-rich sweep gas. Such aspectsavoid the technical challenges of regulating small flow rates of oxygen-rich sweep gas posed by the low neonatal blood flow rate.

[0067] As will be appreciated, the apparatus, systems, and methods described herein allow a simple one step (two if valves are not connected) process for switching from a primary to a secondary oxygenator. The apparatus, systems, and methods described herein allow the extracorporeal circuit to remain closed during an oxygenator swap reducing the risk of air introduction or contamination. The apparatus, systems, and methods described herein allow for an oxygenator swap to be done quickly enough that a patient does not need to have another source of blood oxygenation such as functioning lungs. The apparatus, systems, and methods described herein allow for an oxygenator swap to be done without high risk wet to wet or underwater connections necessary to prevent air from being introduced in an open system. The apparatus, systems, and methods described herein allow for blood to be circulated, conditioned and air removed from a secondary oxygenator in an extracorporeal circuit without a blood pump for the patient circuit. The apparatus, systems, and methods described herein allow for the same sweep gas flow to be used for the conditioning of the secondary oxygenator as being used for the primary oxygenator. Although generally described with reference to systems for providing extracorporeal support to a neonate, the disclosure is not so limited. It is envisioned that the systems, methods, and apparatus described herein can be utilized with any extracorporeal system without departing from the scope of the disclosure.(0068] Referring now to the drawings, FIGS. 1-3 illustrate a system for providing extracorporeal support to a patient in accordance with the disclosure and generally identified by reference numeral 10. As can be appreciated, the system 10 can be any extracorporeal support system, and the patient may be any type of patient, human or otherwise, without departing from the scope of the disclosure. In one non-limiting embodiment, the system 10 is configured to provide extracorporeal support to a neonate. According to one aspect of the disclosure, the system 10 may be configured to provide a system environment that is similar to an environment the neonate would experience in utero. Viability of a neonate that is removed from the uterine environment (e.g., due to preterm birth) and that is, for example, between about 22 weeks to about 24 weeks gestation, may be increased by placing the neonate in system 10.

[0069] According to an aspect of the disclosure, the system environment may be configured to perform at least one or more of the following: (1) limit exposure of the neonate to light; (2) limit exposure of the neonate to sound; (3) maintain the neonate submerged within a liquidenvironment; (4) maintain the neonate within a desired temperature range; or (5) any combination thereof. The system 10 also permits neonatal activities (e.g., neonatal breathing movements, neonatal swallowing of fluid) necessary for organ growth and development.|0070| The system 10 may be configured to treat neonates (e.g., less than 37 weeks estimated gestational age, particularly 28 to 32 weeks estimated gestational age), and extreme premature neonates (about 23 to 28 weeks estimated gestational age). The gestation periods are provided for humans, though corresponding preterm neonates of other animals may be used. In a particular embodiment, the neonate has no underlying congenital disease. The term or preterm neonate may have limited capacity for pulmonary gas exchange, for example, due to pulmonary hypoplasia or a congenital anomaly affecting lung development, such as congenital diaphragmatic hernia. In a particular aspect, the subject may be a preterm or term neonate awaiting lung transplantation, for example, due to congenital pulmonary disease (e.g., bronchoalveolar dysplasia, surfactant protein B deficiency, and the like). Such transplantation surgeries are currently rarely performed in the United States. However, the number of transplantation surgeries may be increased with the more stable method for pulmonary support provided by the embodiments disclosed herein. The neonate 5 may also be a candidate for ex utero intrapartum treatment (EXIT) delivery, including patients with severe airway lesions and a long-expected course before definitive resection. The neonate 5 may also be a neonatal surgical or fetoscopic procedure patient, particularly with preterm labor precipitating early delivery. According to one aspect of the disclosure, the system 10 may be configured such that the neonate 5 is maintained in the system 10 for as long as needed (for example, for days, weeks or months, until the neonate 5 is capable of life without the system 10). The system 10 should be operable to maintain the neonate 5 for at least 7 days, at least 14 days, at least 21 days, at least 28 days, at least 35 days, at least 42 days, at least 49 days, or at least 56 days.

[0071] The system 10 includes a neonatal chamber 20 configured to house a neonate 5, a physiologic saline solution (PSS) circuit configured to provide a flow (e g., a constant flow) of PSS through the neonatal chamber 20, and an oxygenation circuit 200 configured to remove carbon dioxide from the neonate’s blood and supply gas (e g., oxygen) to the neonate’s blood. In some embodiments, the system 10 includes or is in communication with one or more gas sources such as a wall gas source, one or more tanks of gas, and / or any other suitable gas source or storage system. Gas inputs into the system 10 can include oxygen gas (02), CO2, nitrogen gas (N2), and / or any other suitable gas. In some embodiments, air is optionally input into the system 10. The system 10 can further include and / or can be in communication with a gasblender or other suitable mixing device configured to mix one or more gases from one or more gas sources. Accordingly, a desired gas or a desired mixture of gas can be delivered to the system 10 and / or the oxygenator(s) of the oxygenation circuit 200 thereof, as described in further detail herein.

[0072] The system 10 is configured to maintain the neonate 5 in the neonatal chamber 20 immersed in PSS. The system 10 is further configured such that the oxygenation circuit 200 provides adequate gas exchange for the neonate 5 to sustain life. In this way, the system 10 provides an environment similar to an intrauterine environment to facilitate continued growth and development of the neonate 5. The system 10 may include a cart or similar device (not shown) that facilitates monitoring, caring for, and transporting the neonate 5 within a medical facility.

[0073] According to an aspect of this disclosure, the system 10 may be as described in U.S. Patent No. 11,471,351, filed on June 13, 2019, entitled “System and Method configured to Provide Extracorporeal Support for Premature Fetus,” the disclosure of which is hereby incorporated by reference as if set forth in its entirety herein. Another system contemplated for use is described in PCT application number PCT / US2022 / 043509, filed on September 14, 2022, titled “Systems and Methods for Oxygenating Blood, Passive Oxygenation Circuits, and Neonatal Extracorporeal Support Systems,” the disclosure of which is hereby incorporated by reference as if set forth in its entirety herein.

[0074] The oxygenation circuit 200 can be connected with the neonate 5 in a venous / venous arrangement. Alternatively, the oxygenation circuit 200 may be connected with the neonate 5 in an arterial / venous arrangement. Cannulas may be placed in the great neck vessels (e.g., carotid jugular) of the neonate 5 to connect the circulatory system of the neonate 5 to one or more oxygenators. The placement in the great neck vessels may avoid issues of vasospasm and cannula instability in umbilical vessels. An external portion of the cannulas may be fitted with a sleeve (e.g., to permit increased tension of the stabilizing sutures). The sleeve may be made of silicone and may be, for example, about 1 to about 10 cm in length, particularly about 3 to about 5 cm in length. The cannulas may be sutured to the neonate 5 (for example via the fitted sleeve) to secure the cannulas to the neck of the neonate 5.

[0075] In some embodiments, the oxygenation circuit 200 may be connected to the neonate 5 via the neonate’s umbilical cord. In such an arrangement, cannulas may be sutured into the veins and arteries of the umbilical cord. It will be appreciated that other connectionarrangements may be utilized. Examples of non-suturing devices are described in U.S. Patent Application Publication No. 2021 / 0338270, filed on April 28, 2021, the entire content of which is hereby incorporated by reference herein.|0076| With additional reference to FIG. 4, the oxygenation circuit 200 may include a first oxygenator 203 and a second oxygenator 303 that, as will be described in further detail hereinbelow, cooperate to define a primary oxygenator (the first oxygenator 203) and a secondary oxygenator (the second oxygenator 303) of the oxygenation circuit 200. The first oxygenator 203 and the second oxygenator 303 used alone or in any combination, provide gas exchange functionality, particularly of oxygen (to) and carbon dioxide (from), to the neonate 5. It is envisioned that one or both of the first oxygenator 203 and / or the second oxygenator 303 may be at least temporarily connected (and optionally removably connected) to the neonate 5 and / or other components of the oxygenation circuit 200 and the system 10. The oxygenation system 200 is connected with the neonate 5 via two or more fluid lines and includes at least a source line 201 (e.g., a conduit, flow path, tubing, etc.) and a return line 205 (e.g., a conduit, flow path, tubing, etc.). Blood flows from the neonate 5 through the source line 201 to the oxygenation circuit 200. The blood then flows through the oxygenation circuit 200, is oxygenated by the first and / or second oxygenator, and returns to the neonate 5 via the return line 205.

[0077] The oxygenation circuit 200 further includes a secondary loop (also referred to as a priming loop, circulation loop, secondary path, etc.). For example, the oxygenation system 200 is connected to a circulation line 305 (e.g., a conduit, flow path, tubing, etc.) forming a part of a circulation loop or secondary pathway 301 for fluid flow through the oxygenation circuit 200. In some embodiments, the circulation loop or secondary pathway 301 can allow the circulation of a fluid through one or more oxygenators to condition the fluid (or components of the system) prior to being placed in communication with the patient. In some instances, blood, blood substitute, and / or any suitable crystalloid fluid can be circulated through the circulation loop 301 in parallel with the blood being circulated therethrough. Such an arrangement can allow for the conditioning of the fluid and / or the removal of air in the circuit while, for example, the patient’s blood is flowing through the oxygenation circuit 200 for oxygenation. In some instances, it may be desirable to provide a relatively high flow rate or relatively vigorous circulation of fluid through the circulation loop 301 to facilitate and / or ensure the removal of air from an oxygenator connected thereto. In such instances, it may be desirable to circulate a crystalloid solution (e.g., plasmalyte) through the circulation loop 301 to avoid damage thatmay be caused to blood or a blood substitute due to the high or vigorous circulation. The circulation loop 301 can also include a pump 306 that can be used to convey, facilitate, or circulate liquid within the secondary path or circulation loop 301.

[0078] As will be described in further detail hereinbelow, one or both of the first oxygenator 203 and / or the second oxygenator 303 is configured to be shut off, sequestered, isolated, disconnected, decoupled, detached, and / or replaced while the oxygenation circuit 200 is operational. If one of the first oxygenator 203 or the second oxygenator 303 is damaged or has surpassed its expected life cycle, the oxygenation circuit 200 can be configurable to bypass or otherwise isolate one of the first oxygenator 203 or the second oxygenator 303, at least temporarily, allowing the first oxygenator 203 or the second oxygenator 303, respectively, to be replaced without interruption of blood flow.

[0079] As will be described in greater detail below, the system 10 disclosed herein is designed to rely on the neonate’s heart for blood flow circulation and, accordingly, does not comprise an external mechanical pump (i.e., external to the neonate’s heart). Alternatively, the system 10 may optionally include one or more pumps configured to circulate the blood or boost, support, and / or supplement the circulation of blood performed by the patient’s heart. Although generally described with respect to neonatal systems, the disclosure is not so limited. It is envisioned that the system 10, or any of the components thereof, may be used in any extracorporeal system or fluid system without departing from the scope of the disclosure.

[0080] With continued reference to FIG. 4, the extracorporeal circuit 200 allows for the circulation of blood in a second, new circuit without breaking sterile seals and the near instant change from the first, or original oxygenator 203 to a secondary oxygenator 303 without the need for stopping the flow using one or more valve assemblies, valves, and / or valve structures. For example, the oxygenation circuit 200 includes a first, or primary oxygenator 203 and a second, or secondary oxygenator 303 connected to the patient cannulas 201 and 205 by valves 100 (or by a valve assembly having any number of valves). The valves 100, in the first state or position (FIG. 7A), allow the blood from the patient (neonate 5) to pass through the primary oxygenator 203 and back to the patient. Simultaneously, it allows fluid to be circulated through the secondary oxygenator 303 without interfering with a primary circuit (e.g., for conditioning). When the valves 100 (or a valve assembly including the valves 100) are moved or transitioned to their second state or position (FIG. 7B), the blood passing through the patient cannulas 201, 205 is routed through the secondary oxygenator 303 and the primary oxygenator 203 and conditioning loop are sealed off.(0081] Turning to FIGS. 5, 6, 7 A, and 7B, the valves 100a, 100b enable the transition between the two states of the oxygenation circuit 200. In one non-limiting embodiment, each valve 100a, 100b is substantially similar to one another, and therefore, only one of the valves will be described in detail herein in the interest of brevity. The valve 100 includes at least two components, the valve body 101 and the valve stem 110. The valve stem 110 moves through the valve body 101 effecting a seal between the stem 110 and the body 101. FIG. 6 shows an exploded view of the valve 100 and FIGS. 7A and 7B illustrate cross-sections of the valve 100 in its first (FIG. 7A) and second positions (FIG. 7B). The body 101 of the valve 100 has a cavity 106 through it that allows the stem 110 to move from position A (FIG. 7A) to position B (FIG. 7B). For example, the valve stem 110 can be movable along a longitudinal axis of the valve body 101 to transition the valve 100 between position A and position B. The fit between an exterior of the valve stem exterior and the body cavity 106 is such that a liquid seal is affected between the body 101 and the stem 110. The stem 110 has two channels 104 and 105 (e.g., internal flow paths) that have connections to circuit conduits at one end. It is envisioned that these connections can be hose barbs, adhesive connections, welded, molded in place, or combinations thereof without departing from the scope of the disclosure. The body 101 has corresponding channels 113 and 114 (e.g., flow paths) that also have connections to circuit conduits on one side. These connections can be hose barbs, adhesive connections, welded, molded in place, or combinations thereof without departing from the scope of the disclosure. In some embodiments, the connections can correspond to inlets or outlets of the valve 100. For example, the valve 100 can include a first inlet 102 corresponding to channel 104 (or through which the channel 104 extends), a second inlet 103 corresponding to channel 105 (or through which the channel 105 extends), a first outlet 111 corresponding to channel 113 (or through which the channel 113 extends), and a fourth outlet 112 corresponding to channel 114 (or through which the channel 114 extends).

[0082] As shown in at least FIG. 7A, when the stem 110 is in position A the channels 104 and 113 are aligned. As such, flow is allowed / enabled between the channels 104 and 113 when the stem 110 is in position A. Further, the channels 105 and 114 are aligned when the stem 110 is in position A. This allows fluid to pass through the valve 100 through two independent paths. In some embodiments, the channel 104 is misaligned with the channel 114. As such, fluid flow from the channel 104 may be limited or prevented from flowing to the channel 114. Similarly, the channel 105 is misaligned with the channel 113. As such, fluid flow from the channel 105 may be limited or prevented from flowing to the channel 113. When the stem 110 is moved toor otherwise in position B (FIG. 7B), the channels 105 and 113 (e.g., flow paths) are blocked such that flow through the channel 105 is limited or prevented and flow through the channel 113 is limited or prevented. Rather, flow is allowed / enabled between channel 104 and 114 when the stem 110 is in position B (FIG. 7B). Thus, by changing the position of the stem 110, the flow from channel 104 is rerouted from channel 113 to channel 114. It is understood that the fluid flow paths through the valve can be in either direction without departing from the scope of the disclosure.

[0083] The valve 100, in the first position (FIG. 7A), enables the blood from the patient (neonate 5) to pass through a first inlet (e.g., the channel 104) of the valve 100 to a first outlet (e.g., the channel 113), to the primary oxygenator 203 and back to the patient. In such embodiments, the primary oxygenator 203 is configured to oxygenate the blood received from the first outlet (e.g., the channel 113) of the valve 100 and deliver the oxygenated blood to the patient through a second valve 100 (or second valve or portion of a valve assembly). In some embodiments, simultaneously with the oxygenation of the blood through the primary path including the primary oxygenator 203, the valve 100 positioned in position A allows fluid to be circulated through the secondary oxygenator 303 (e.g., via aligned ones of the channels 105, 114) for conditioning (e.g., without interfering with or disrupting the primary path). When the valve 100 is moved to the second position (FIG. 7B), the blood passing through the patient cannulas 201, 205 can be routed through the secondary oxygenator 303 (e.g., based on alignment between the channel 104 and the channel 114 in the second position) and limited or prevented from flowing to the primary oxygenator 203 (e.g., based on the misalignment between the channel 104 and the channel 113).

[0084] In one non-limiting embodiment, the flow channels defined by aligned channels 104, 113, 105, and / or 114 extend through the valve 100. Put differently, the valve stem 110 can include at least one channel extending therethrough to fluidically couple the channel 104 to the channel 113, the channel 105 to the channel 114, or the channel 104 to the channel 114. In some embodiments, the channels in the valve stem 110 extend in a direction substantially perpendicular to a longitudinal direction of the valve stem 110. In alternative embodiments, the channels in the valve stem 110 include at least one curved segment (as described in detail in connection with at least FIGS. 11 A-13C). The flow channels have only one junction point each that must align to make the flow path. This allows for simplified fabrication of very smooth channels with the potential for post assembly polishing to ensure minimizing any discontinuity. As can be appreciated, alternate designs with two junction points per channel arealso viable embodiments. In embodiments, the valve body 101 and stem 110 are made of transparent materials to allow visualization of the flow path (and appropriate removal of air during fluid priming of path 105-114). This allows inspection of the path for any indications of blood clothing or restricted flow. Potential transparent materials contemplated as within the scope of the disclosure include polymethyl methacrylate, polycarbonate, polyethylene terephthalate, polyethylene terephthalate glycol, polyvinyl chloride, cyclic olefin copolymer, polyethylene, polypropylene, fluorinated ethylene propylene, styrene methyl methacrylate, styrene acrylonitrile resin, polystyrene, ABS (acrylonitrile, butadiene and styrene mixture), perfluoroalkoxy, polyether ether ketone, poly sulfone, glass, or combinations of these or other materials. It is envisioned that in embodiments, the body 101 is transparent but the stem 110 is not, the stem 110 is transparent but the body 101 is not, or neither the stem 110 nor the body 101 is transparent to allow for an effective seal between the parts. It is contemplated that the parts could be made of any of the plastics described hereinabove above, stainless steel, polyvinylidene difluoride, Teflon PTFE, nylon, or other materials or combinations thereof without departing from the scope of the disclosure.

[0085] Continuing with FIGS. 5, 6, 7A, and 7B, a button cap 120 is attached to the stem 110 to allow easy activation of the valve 100. In embodiments, the valve 100 is constructed in a pair with a shared button to allow both valves 100 to be changed from one state to another with one action. It is envisioned that the pair of valves 100 may be constructed as a unitary component or may be discrete components mechanically coupled to one another (e.g., for example, mechanical linkage, electromechanical, and combinations thereof).

[0086] In one non-limiting embodiment, the stem 110 cross section, perpendicular to the direction of travel is round. In alternate embodiments, the cross section is square, rectangular, triangular, pentangular, hexagonal or non-symmetric such as a parallelogram or a non-regular cross section, or combinations thereof.

[0087] With reference to FIGS. 8 and 9, in application, two valves 100a and 100b are utilized to complete the oxygenation circuit or oxygenator swap circuit 200. The valves 100a and 100b can be included in or can collectively form a valve assembly (with any other suitable components such as conduit(s), actuator(s), and / or the like). In initial use, the circuit 200 is constructed with the blood conduit from the patient 201 to the inlet of one of the channels (e.g., the channel 104 of FIGS. 7A and 7B) of the pre-oxygenator valvelOOa. The connected channel (e.g., the channel 113) in position A (FIGS. 7A and 27A) is connected or otherwise fluidically coupled to the primary oxygenator 203 blood inlet. The blood outlet of the primary oxygenator203 is connected to the inlet of one of the channels (e.g., the channel 113 of FIGS. 7 A and 7B) of the post-oxygenator valve 100b. Further, the outlet of one of the channels (e.g., the channel104) in position A is fluidically coupled to the conduit 205 returning to the patient. Blood is circulated through the primary oxygenator 203 by the patient’s heart or via a blood pump (not shown) on line 201. Sweep gas is pushed through the gas side of oxygenator 203 supplying oxygen to the blood and removing carbon dioxide. The appropriate mixture and flow rate of sweep gas is supplied to result in the desired blood gas saturations.

[0088] The outlet of one of the channels (e.g., the channel 114) of the pre-oxygenator valve 100a is connected to the blood inlet of the secondary oxygenator 303. The blood outlet of the secondary oxygenator 303 is connected to the inlet of one of the channels (e.g., the channel 114) in the post-oxygenator valve 100b. The outlet of one of the channels (e.g., the channel105) of the post-oxygenator valve 100b is connected to the inlet of one of the channels (e.g., the channel 105) of the pre-oxygenator valve 100a completing a secondary path or conditioning loop 301. A pump 306 can be used to convey, facilitate, or circulate liquid within the secondary path 301 through the valves 100 and the secondary oxygenator 303. In some embodiments, the loop can also be used to heat any fluid within the loop by warming a section of the secondary path 301 around a heat source (e g., a blood warmer or a heating element 60, such as a heated bath), as shown in FIG. 2. In one embodiment, the secondary path is prefilled with plasmalyte either at initial installation or prior to an oxygenator exchange. The conduit 305 can also contain ports and connectors to allow the introduction of blood, condoning chemicals, removals of liquids or the escape of gases.

[0089] When it is determined by clinicians that the primary oxygenator 203 needs to be replaced, the secondary path 301 is filled with blood from the patient or compatible donor blood. If the secondary path 301 is prefilled with liquid such as a mixture of electrolytes and water (e.g., plasmalyte), the blood displaces the liquid replacing it in the secondary path 301. This is done via valves and fittings (not shown) on the secondary path 301. Once the secondary path 301 is filled with blood, the blood is circulated through the secondary oxygenator 303. Sweep gas of appropriate composition is pumped through the secondary oxygenator 303 until the blood gas saturations effectively match those in the line returning to the patient 205. Simultaneously, the blood temperature and other parameters can be adjusted in the secondary path 301.

[0090] Once the blood in the secondary path 301 matches the blood in the primary path, the system is ready for transition. The circulating pump 306 is deactivated or turned off andboth valves 100 are transitioned from position A (FIGS. 7A, 27A, and 28A) to position B (FIGS. 7B, 27B, and 28B). This action disconnects the flow from patient conduit 201 and return conduit 205 from the primary oxygenator 203 and connects the conduits 201, 205 to the secondary oxygenator 303 via a conduit system (e.g., the conduits 302 and 304). The action also disconnects the secondary path 301 from the secondary oxygenator 303 and isolates the secondary path 301 completing the transition from the blood circulating through the primary oxygenator 203 to circulating through the secondary oxygenator 303. In such embodiments, the primary oxygenator 203 can be isolated, separated, sequestered, fluidically decoupled, etc. from the secondary path 301 and / or conduit systems 202, 204 (e.g., without disrupting the flow of blood through the secondary oxygenator 303 and to the patient).[0091 J In some embodiments, the valves 100a, 100b have different valve bodies (e.g., the valves 100a, 100b in FIGS. 8 and 9). Turning to FIGS. 10A and 10B, in an alternative embodiment, the two valves 100a, 100b are integrated into one body or connected so that one action or actuation transitions both valves. Put differently, the two valve 100a, 100b may be integrated with one another or otherwise coupled such that actuation of the valve 100a to transition the valve 100a to a different position causes a subsequent actuation of the valve 100b to transition the valve 100b to a different position. This is shown in the initial position shown in FIG. 10A where the valve 400 is a dual valve with one actuator (e.g., button, press tab, etc.). The primary flow path is from the patient in conduit 201, through one portion of the valve 400 to the primary oxygenator 203 blood inlet via conduit 302. Out of the primary oxygenator 203 via the conduit system 204 to the primary outlet channel through the valve 400 and back to the patient via conduit 205. The secondary path in the initial position carries the blood from the secondary inlet channel in the valve 400 to the secondary oxygenator 303 via conduit 302 and back to the secondary outlet channel through the valve 400 via conduit 304. Once through the valve 400, the blood is carried through the secondary path via conduit 305 where it can be heated through a pump and back to the valve 400 secondary channel input via conduit 301. FIG. 10B illustrates the circuits after valve 400 transition where the blood flow path is now from the patient via conduit 201 to the secondary input of the valve 400, then to the secondary oxygenator 303 blood input via conduit 302. After leaving the secondary oxygenator 303, the blood goes to the valve 400 outlet channel and then back to the patient via conduit 205.

[0092] Turning to FIGS. 11A-11C, 12A, and 12B, as an alternative embodiment, a rotary valve configuration is shown and described. FIG. 11 A shows an exploded hidden line view of a rotary valve 700 with valve body 701 and valve stem 702. The assembled valve is shown inFIG. 1 IB in the initial position (FIG. 12A, position A). The blood connection from the patient is made to primary inlet port 703 on the pre-oxygenator valve 700a. The blood would pass through the stem 702 through curved channel 710 to the primary outlet port 704 and then to the primary oxygenator blood inlet port. After the primary oxygenator 203, the blood passes to the port 704 on the post-oxygenator valve 700b, through channel 710 out port 703 on the postoxygenator valve 700b, and back to the patient. The secondary oxygenator blood inlet is connected to port 706 in the pre-oxygenator valve 700a and the secondary oxygenator blood outlet is connected to port 706 on the post-oxygenator valve 700b. The secondary oxygenator conditioning loop is connected between the ports 705 on the pre- and post-oxygenator valves allowing the circulation through the secondary oxygenator 303 to flow through channel 711 in the stem 702.

[0093] To affect the swap, the stems 702 of both the inlet valve and outlet valve 700a, 700b are rotated (e.g., about a longitudinal axis of the valve body 701) to align channel 710 with the port connected to the secondary oxygenator 303 (FIG. 12B, position B). In this position, the inlet port 703 is connected to the secondary port 706 via channel 710 in the stem 702. The other ports 704 and 705 are blocked isolating the primary oxygenator 203 and the conditioning loop. In the rotary valve, the channels 710 and 711 internal to the stem 702 need to be curved to make the proper connections. This can make fabrication more difficult but as the channel paths can be shaped as sections of circular arcs, the stem 702 can be molded or the channels formed with conventional processing.

[0094] Turning to FIGS. 13A-13C, 14A, and 14B, another embodiment of a rotary valve configuration is illustrated and generally identified by reference numeral 800. FIG. 13A shows an exploded hidden line view of the rotary valve 800 with valve body 801 and valve stem 802. The assembled valve 800 is shown in FIG. 13B in the initial position (FIG. 14A, position A). The blood connection from the patient is made to primary inlet port 803 on the pre-oxygenator valve 800a. The blood would pass through the stem 802 through channel 810 to the primary outlet port 804 and then to the primary oxygenator blood inlet port. After the primary oxygenator 203, the blood passes to the port 804 on the post-oxygenator valve 800b, through channel 810 out port 803 on the post-oxygenator valve 800b, and back to the patient. The secondary oxygenator blood inlet is connected to port 806 in the pre-oxygenator valve 800a and the secondary oxygenator blood outlet is connected to port 806 on the post-oxygenator valve 800b. The secondary oxygenator conditioning loop is connected between the ports 805on the pre- and post-oxygenator valves allowing the circulation through the secondary oxygenator 303 to flow through channel 811 in the stem 802.

[0095] To affect the swap, the stems 802 of both the inlet valve and outlet valve 800a, 800b are rotated to align channel 810 with the port connected to the secondary oxygenator 303 (FIG. 14B, position B). In this position, the inlet port 803 is connected to the secondary port 806 via channel 810 in the stem 802. The other ports 804 and 805 are blocked, isolating the primary oxygenator 203 and the conditioning loop.

[0096] The channel for the blood from and to the patient can be straight allowing simple secondary refining of the channel through the stem and body minimizing the surface roughness. As can be appreciated, since the tubing connection rotates with the stem, there is only one joint that has to line up with valve change of position. This minimizes any potential perturbations in the flow path wall reducing the chance for sites that could promote clotting. The channel 811 internal to the stem 802 needs to be curved to make the proper connections. This can make fabrication more difficult but as the channel path can be shaped as section of circular arcs, the stem 802 can be molded or the channels formed with conventional processing.

[0097] With reference to FIGS. 15A-15C, 16A, and 16B, another embodiment of a rotary valve is illustrated and generally identified by reference numeral 900. FIG. 15A shows an exploded hidden line view of the rotary valve 900 with valve body 901 and valve stem 902. The assembled valve is shown in FIG. 15B in the initial position (position A). The blood connection from the patient is made to primary inlet port 903 on the pre-oxygenator valve 900a. The blood would pass through the stem 902 through channel 910 to the primary outlet port 906 and then to the primary oxygenator blood inlet port. After the primary oxygenator 203, the blood passes to the port 906 on the post-oxygenator valve 900b, through channel 910 out port 903 on the post-oxygenator valve 900b, and back to the patient. The secondary oxygenator blood inlet is connected to port 904 in the pre-oxygenator valve 900a and the secondary oxygenator blood outlet is connected to port 904 on the post-oxygenator valve 900b. The secondary oxygenator conditioning loop is connected between the ports 905 on the pre- and post-oxygenator valves allowing the circulation through the secondary oxygenator to flow through channel 911 in the stem 902.

[0098] To affect the swap, the stems 902 of both the inlet valve and outlet valve 900a, 900b are rotated to align channel 910 with the port connected to the secondary oxygenator 303 (FIG. 16B, position B). In this position, the inlet port 903 is connected to the secondary port 904 viachannel 910 in the stem 902. The other ports 906 and 905 are blocked isolating the primary oxygenator 203 and the conditioning loop.

[0099] In this embodiment, since the tubing connection rotates with the stem, there is only one joint that has to line up with valve change of position. As can be appreciated, this minimizes any potential perturbations in the flow path wall reducing the chance for sites that could promote clotting. The channel 911 internal to the stem 902 needs to be curved to make the proper connections. This can make fabrication more difficult but as the channel path can be shaped as section of circular arcs, the stem 902 can be molded or the channels formed with conventional processing without departing from the scope of the disclosure.

[0100] It is envisioned that the rotary valve embodiments can integrate the pre-oxygenator and the post oxygenator valves into single units requiring only one action to change both valves between their positions. This can be done by stacking the valves so that the stems are connected and rotate as one unit. It can also be done by offsetting the stems and mechanically coupling them by gear, chain, or linkage without departing from the scope of the disclosure.

[0101] Turning to FIGS. 17A-17C, it is envisioned that the valves described hereinabove may have a lock, an interlock, or position locking mechanism that prevents inadvertent movement and maintains the proper alignment between the valve body 101 and valve stem 110. For example, the lock can be configured to secure the valve 100 in a position to control the flow of blood from the patient through one or the other of the valve outlets. In one nonlimiting embodiment, the interlock is a pin 108 that is biased by a biasing element 109. The pin108 is contained in a passage through the side of the valve body 101 and the biasing element109 biases the pin tip into a recess 118 in the valve stem 110. The relative positions of the components are shown in FIG. 17A by hidden lines and in FIGS. 17B and 17C in section views. In the initial position of the valve 100, the valve stem 110 is held in position by the pin 108 being biased into recess 118 in the valve stem 110. The conical pointed end of the pin 108 mates with the shape of the recess 118 to hold the valve stem 110 position. Although generally described as defining a conical pointed end or conical frustum, it is envisioned that the end of the pin 108 may define any suitable profile, such as planar, arcuate, domed, and combinations thereof without departing from the scope of the disclosure.

[0102] In some embodiments, the lock is configured to transition between an engaged (e.g., locked) configuration and a disengaged (e.g., unlocked) configuration. When the lock is in the disengaged configuration (e.g., when a change in the valve stem 110 position is desired) thevalve is configured to or otherwise free to transition between position A and position B. In some embodiments, a user can pull on the external end of the pin 108 compressing the biasing element 109 and withdrawing the pin 108 from the recess 118 in the valve stem 110 (FIG. 17C) to move the lock to the disengaged position. The valve stem 110 is then free to move to the second position. When the lock is in the engaged configuration, the valve is limited or prevented from transitioning between position A and position B). In some embodiments, a user can release the pin 108 such that the pin 108 can be biased into recess 119 in the valve stem 110 holding the valve stem 110 in place (e.g., position B). The described mechanism accurately holds the valve stem 110 in the desired positions within the valve body 101 in both positions and prevents the accidental movement and misalignment of the two parts. Although generally described as utilizing a pin and recess, or detent mechanism, the disclosure is not so limited. It is envisioned that any suitable locking mechanism may be utilized, and in embodiments, a portion of one or more ports or lines may act as the detent mechanism.

[0103] The same mechanism can be employed in the rotary valve configurations through the rotary valve housings or via the ends of the rotary stems away from the axis of rotation.

[0104] With reference to FIGS. 18A and 18B, one or more of the connections or hose barbs coupling the fluid lines to the channels of the body 101 may define a barbell shaped profile having an annular groove interposed between a pair of flanges that is slidably retained within a slot 136 defined in the body 101. The annular groove selectively engages detents 137, 138, 139, or other suitable features (e g., for example, crenellations, protuberances, notches, and combinations thereof) defined within the body 101 adject to or within the slot 136 to selectively retain the stem 110 in one or more predefined positions relative to the body 101. In one nonlimiting embodiment, the body 101 defines a first detent 137, a second detent 138, and a third detent 139, although it is envisioned that any number of detents may be utilized without departing from the scope of the disclosure. The first, second, and third detents 137, 138, 139 are arranged in spaced apart relation to one another along a length of the slot 136. In embodiments, the spacing between each detent 137, 138, 139 corresponds to a spacing between the connections and / or channels 104, 105. In this manner, when the stem 110 of the valve 100 is placed in the first position, portion(s) of the valve stem 110 (e g., the inlet(s) or the outlet(s)) engage a respective one of the first detent 137 and the second detent 138 (FIG. 18A). When the stem 110 is placed in the second position, the connections engage a respective one of the second detent 138 and the third detent 139 (FIG. 18B). It is envisioned that the body 101 may be formed from a resilient material that is configured to deflect or otherwise deform as theannular groove engages and disengages the detents 137, 138, 139 during translation of the annular groove within the slot 136 of the body 101. It is contemplated that the detents may be used in conjunction with or in lieu of the locking mechanism described hereinabove.|0105| With reference to FIGS. 19-21B, another embodiment of a valve is illustrated in accordance with the disclosure and generally identified by reference numeral 1000. The valve 1000 is substantially similar to the valve 100, and therefore, only the differences therebetween will be described in detail herein in the interest of brevity.

[0106] As can be appreciated, it may be necessary to access or otherwise replace the first oxygenator 203 while blood is flowing through the second oxygenator 303. It is envisioned that access to the first oxygenator 203 may be provided by a valve having a third port, and therefore, a third fluid path when placed in position B (or second state). In this manner, the flow path of the first oxygenator 203 is accessible when the valve is in position B, enabling replacement of the first oxygenator 203 and fluid circulated through the replacement first oxygenator 203 while the blood from the patient circulates through the second oxygenator 303.[01071 The valve 1000 includes at least two components, the valve body 1001 and the valve stem 1010. The valve stem 1010 moves through the valve body 1001 effecting a seal between the stem 1010 and the body 1001. The body 1001 of the valve 1000 has a cavity 1006 through it that allows the stem 1010 to move between position A (FIG. 20) and position B (FIG. 21 A). The fit between an exterior of the stem 1010 and the body cavity 1006 is such that a liquid seal is affected between the body 1001 and the stem 1010. The stem 1010 has two internal paths 1004 and 1005 that have connections to circuit conduits at one end. It is envisioned that these connections can be hose barbs, adhesive connections, welded, molded in place, or combinations thereof without departing from the scope of the disclosure. The body 1001 has three fluid paths 1013, 1014, and 1015 that also have connections to circuit conduits on one side. These connections can be hose barbs, adhesive connections, welded, molded in place, or combinations thereof without departing from the scope of the disclosure. With stem 1010 in position A (FIG. 20) the fluid paths 1004 and 1013 are aligned, the fluid paths 1005 and 1014 are aligned, and the fluid path 1015 is blocked and no flow is allowed through it. This allows fluid to pass through the valve 1000 through two independent paths. When the stem 1010 is moved to position B (FIGS. 21 A and 21B), the fluid paths 1004 and 1014 are aligned, the fluid paths 1005 and 1015 are aligned, and the fluid path 1013 is blocked and no flow is allowed through it. The flow allowed is between fluid paths 1004 and 1014 and fluid paths 1005 and 1015. Thus, by changing the position of the stem 1010, the flow from fluidpath 1004 is reroutedfrom fluid path 1013 to fluid path 1014 and the flow from fluid path 1005 is rerouted from fluid path 1014 to fluid path 1015. It is understood that the fluid flow paths through the valve can be in either direction without departing from the scope of the disclosure.

[0108] Although the stem 1010 is generally described as having two fluid paths 1004, 1005 and the body 1001 is generally described as having three fluid paths 1013, 1014, 1015, the scope of the disclosure is not so limited. With reference to FIGS. 22 and 23, it is envisioned that a valve 1100 may include a body 1101 having two internal flow paths 1113 and 1114 and a stem 1110 having three internal flow paths 1104, 1105, and 1107. With the stem 1110 in position A (FIG. 22), the fluid paths 1105 and 1113 are aligned, the fluid paths 1107 and 1114 are aligned, and the fluid path 1104 is blocked and no flow is allowed through it. With the stem 1110 in position B (FIG. 23), the fluid paths 1104 and 1113 are aligned, the fluid paths 1105 and 1114 are aligned, and the fluid path 1107 is blocked and no flow is allowed through it. As can be appreciated, the valve 1100 is substantially similar to the valve 100, and therefore, only the differences therebetween are described hereinabove in the interest of brevity.

[0109] Turning to FIGS. 24, 25A, 25B, and 26, another embodiment of a valve is illustrated and generally identified by reference numeral 1200. The valve 1200 is substantially similar to the valve 800 and therefore only the differences therebetween will be described hereinbelow in the interest of brevity. The valve 1200 is a rotary valve with multiple straight channels in the valve stem. The valve includes a body 1201 with a rotating stem 1211 disposed within that can rotate between a first position A (FIGS. 24 and 25A) and a second position B (FIG. 25B). In position A the inlet channel 1203 within body port 1202 is connected with straight channel 1213 within stem port 1212. Also in position A, the channel 1215 in the stem port 1214 is connected to channel 1205 withing the body port 1204. This allows blood from the patient or neonate 5 to flow through 1203 into 1213 and then to the primary or first oxygenator 203. In position B, the inlet channel 1203 in body port 1202 is connected to channel 1215 within stem port 1214 and then to the secondary or second oxygenator 303 Channels 1205 and 1213 are blocked off when the valve 1200 is in position B. The channel input openings 1216, 1217 on the stem 1211 are on the same plane perpendicular to the valve axis of rotation. This allows the two openings to align with the same channel in the valve body 1201. The channel 1202 in the body 1201 is elliptical in cross section where it meets the stem 1211 to match the shape of the stem channel openings 1216, 1217 (FIG. 26), although it is envisioned that the channel 1203 may define any profile without departing from the scope of the disclosure. In embodiments, the channels 1213, 1215 through the valve stem 1211 are straight but do not lie in a commonplane perpendicular to the axis of rotation to prevent them from interconnecting. In embodiments, the channel for the blood from and to the patient can be straight allowing simple secondary refining of the channel through the stem and body minimizing the surface roughness.|0110| FIGS. 29A and 29B show a valve 1300 suitable for use, for example, in the extracorporeal circuit 200 shown in FIG. 4, according to another embodiment. One or more portions or aspects of the valve 1300 can be similar to or substantially the same as the valve 100 described above with reference to FIGS. 7A and 7B. Accordingly, such similar portions of aspects of the valve 1300 are identified for context but are not described in further detail herein. For example, as shown, the valve 1300 includes valve body 1301 and a valve stem 1310. The valve stem 1310 moves through a body cavity 1306 of the valve body 1301 effecting a seal between the valve stem 1310 and the valve body 1301, as described above with reference to the valve 100 of FIGS. 7A and 7B.[0.111] The valve 1300 shown in FIGS. 29A and 29B can differ from the valve 100 shown in FIGS. 7A and 7B in the arrangement of one or more inlets, outlets, channels, and / or flow paths of the valve 1300. For example, the valve 1300 includes connectors 1302, 1311, and 1312 (e.g., connectors, couplers, ports, barbs, etc ). The connector 1302 at least partially defines or is in communication with a channel 1304 (or flow path), the connector 1311 at least partially defines or is in communication with a channel 1313 (or flow path), and the connector 1312 at least partially defines or is in communication with a channel 1314 (or flow path). In some implementations, the connectors 1302, 1311, and 1312 can be and / or can function as, for example, an inlet or an outlet of the valve 1300, as described in further detail herein.

[0112] FIG. 29 A shows the valve 1300 in a first state in which the connector 1302 is in communication with the connector 1313. Similarly stated, the channel 1304 corresponding to the connector 1302 is fluidically connected to the channel 1313 corresponding to the connector 1311. FIG. 29B shows the valve 1300 in a second state in which the connector 1302 is in communication with the connector 1312. Similarly stated, the channel 1304 corresponding to the connector 1302 is fluidically connected to the channel 1314 corresponding to the connector 1314.

[0113] As described in detail above, the valve 1300 can be used in an extracorporeal circuit such as, for example, a circuit similar to or substantially the same as the extracorporeal circuit 200 shown in FIG. 4. In some embodiments, the circuit includes two of the valves 1300 having the same configurations but being arranged with mirrored or opposite flow directions. Forexample, the circuit can include a first valve 1300 thatis arranged such that the connector 1302 is an inlet configured to receive a flow of blood from a fluid source or patient, the connector 1311 is a first outlet fluidically coupled to an inlet of a first oxygenator, and the connector 1312 is a second outlet fluidically coupled to an inlet of a second oxygenator. The second valve 1300 can be arranged such that the connector 1311 is a first inlet fluidically coupled to an outlet of the first oxygenator, the connector 1312 is a second inlet fluidically coupled to an outlet of the second oxygenator, and the connector 1302 is an outlet configured to convey a return flow of blood to the fluid source or patient. Accordingly, as described in detail above, the valves 1300 can be actuated or transitioned (e g., substantially simultaneously) between the first state and the second state to transition a flow of blood from the fluid source or patient to one of the first oxygenator or the second oxygenator, and then return the flow of blood (now oxygenated) back to the fluid source or patient. In some instances, the first oxygenator or the second oxygenator that is not in communication with the inlet (connector 1302) of the first valve and the outlet (connector 1302) of the second valve can be primed by and / or can receive a flow of fluid within a priming circuit or secondary circuit between the first valve and the second valve. In this manner, the valves 1300 (or a valve assembly including the valves 1300) can be transitioned between the first state and the second state to swap or switch oxygenator used to oxygenate the flow of blood that is returned to the fluid source or patient, as described in detail above with respect to other embodiments.

[0114] It is envisioned that this disclosure encompasses any and all methods, processes, devices, systems, kits, products, materials, compositions and / or uses shown and / or described expressly or by implication in the information provided herewith, including but not limited to features that may be apparent and / or understood by those of skill in the art.

[0115] It should be understood that reversing the flow directions through the valves has no impact on the structure or functionality of the embodiments disclosed herein and is an alternative embodiment unless expressly stated otherwise.10116] It should be understood that the valves, oxygenators, and connecting tubing can be supplied pre-connected, sterile, and sealed during manufacturing.

[0117] In any or all embodiments, the line connections between the valve ports can be hose barbs, solvent bonds, molded in place connections, and / or any other suitable connection.

[0118] In any or all embodiments, the channels through the valve can be coated with a non- thrombotic or anti-thrombotic coating.

[0119] In any or all embodiments, the condition of the blood in the second oxygenator can be conditioned by routing the sweep gas exiting the primary oxygenator to the secondary oxygenator sweep gas input thus nearly matching the gas composition and flow conditions between the oxygenators without requiring additional flow control equipment.

[0120] In any or all embodiments, the blood from the patient may be routed through a blood pump before reaching the pre-oxygenator valve.

[0121] In any or all embodiments, the secondary oxygenator can be filled with plasmalyte or a similar fluid from the initiation of the use of the circuit.1 122] Any of the embodiments, apparatus, systems, and / or methods described herein may include any or all (and any combinations thereof):(a) A fluid valve assembly that connects a first port with a second port and a third port with a fourth port in a first position and the first port with the fourth port and blocks the second and third ports in a second position.(b) A fluid valve assembly as in (a) with fluid channels with uniform cross-sectional area from fluid entrance to exits.(c) A fluid valve assembly as in (a) with fluid channels of straight path from fluid entrance to exit.(d) A fluid valve assembly as in (a) with fluid channels with straight or tangent path from fluid entrance to exit.(e) A fluid valve assembly as in (a) with a rotating or sliding stem with at least one fluid conduit connection integrated with the valve stem.(f) A fluid valve assembly as in (a) with fluid channels in the stem that are arcs with uniform radius.(g) A fluid valve assembly as in (a) with locking feature that needs to be manipulated to allow the valve stem position to be changed.(h) A pair of fluid valve assemblies as in (a)-(f) that are mechanically connected such that they change states simultaneously.(i) A pair of valves as in (a), (b), or (c) that are mechanically connected such that they change states with a pre-determined offset in time.(j) An extracorporeal oxygenation circuit supplied with a replacement oxygenator incorporated in the circuit during manufacturing.(k) An extracorporeal oxygenation circuit with a replacement oxygenator included in the circuit but fluidically isolated from the primary circuit during manufacturing.(l) An extracorporeal oxygenation circuit with a valve with two channels within the stem that are not interconnected, each of which can connect to one of the valve ports.(m) An extracorporeal oxygenation circuit with a secondary oxygenator in which the sweep gas outlet of the primary oxygenator is connected to the sweep gas inlet of the secondary oxygenator to allow the same sweep gas to be used in both.(n) A valve as in (a) with a third channel in the valve stem and port in the valve body that connects with the first body port when the valve is in the second position.

[0123] Although certain embodiments have been described using specific terms, such description is for illustrative purposes only, and it is to be understood that changes and variations may be made without departing from the spirit or scope of the following claims.

[0124] The specific terminology used herein is for the purpose of describing particular embodiments and / or features or components thereof and is not intended to be limiting. While various schematics, embodiments, and / or implementations have been described above, it should be understood that they have been presented by way of example only, and not limitation. Various modifications, changes, and / or variations in form and / or detail may be made without departing from the scope and / or spirit of the disclosure and / or without altering the function and / or advantages thereof unless expressly stated otherwise. Likewise, while embodiments (and / or features, components, configurations, aspects, etc. thereof) may be described above in the context of certain implementations, it should be understood that such implementations are presented by way of example only, and not limitation. Any of the embodiments (and / or features, components, configurations, aspects, etc. thereof) can be used in, and / or adapted for use in, other implementations unless expressly stated otherwise. Functionally equivalent embodiments, implementations, and / or methods, in addition to those described herein, will be apparent to those skilled in the art from the foregoing descriptions and are intended to fall within the scope and / or spirit of the disclosure.[0125[ Where schematics, embodiments, and / or implementations described above indicate certain components arranged in certain orientations, configurations, or positions, the arrangement of components may be modified. Although various embodiments have been described as having particular features, configurations, and / or combinations of components, other embodiments are possible having a combination of any features, configurations, and / or components from any of embodiments described herein, except mutually exclusive combinations. The embodiments described herein can include various combinations and / orsub-combinations of the functions, components, configurations, and / or features of the different embodiments described.

[0126] The specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can be different from the embodiments shown, while still providing the functions as described herein. More specifically, the size and shape of the various components can be specifically selected for a desired or intended usage. Thus, it should be understood that the size, shape, and / or arrangement of the embodiments and / or components thereof can be adapted for a given use unless the context explicitly states otherwise.

[0127] Where methods described above indicate certain events, steps, and / or procedures occurring in certain order, the ordering of certain events, steps, and / or procedures may be modified. Additionally, certain of the events, steps, and / or procedures may be performed concurrently in a parallel process, when possible, as well as performed sequentially as described above. While methods have been described as having particular steps and / or combinations of steps, other methods are possible having a combination of any steps from any of methods described herein, except mutually exclusive combinations and / or unless the context clearly states otherwise.INCORPORATION BY REFERENCE

[0128] The entire content of all patents, published patent applications, and other references cited herein are hereby expressly incorporated herein in their entireties by reference. In particular, U.S. Patent Nos. 10,864,131, 10,751,238, and 11,471,351 further describe extracorporeal systems and International Publication No. WO 2020 / 210275 further describes oxygenators, each suitable for combination with the apparatus, systems, and methods as described herein.

Claims

What is claimed is:

1. An extracorporeal oxygenation circuit, comprising: a first valve configured to receive a first fluid and a second fluid, the first fluid being received from a patient and containing blood; a second valve configured to receive the first fluid and the second fluid, the second valve configured to convey the first fluid to the patient; a first oxygenator fluidically coupled between the first valve and the second valve; and a second oxygenator fluidically coupled between the first valve and the second valve, the extracorporeal oxygenation circuit having a first state in which the first oxygenator is configured to oxygenate the first fluid and the second oxygenator is configured to oxygenate the second fluid, the extracorporeal oxygenation circuit having a second state in which the second oxygenator is configured to oxygenate the first fluid.

2. The extracorporeal oxygenation circuit of claim 1, wherein the first valve and the second valve are in a first state when the extracorporeal oxygenation circuit is in the first state and are in a second state when the extracorporeal oxygenation circuit is in the second state.

3. The extracorporeal oxygenation circuit of claim 1, further comprising: an actuation system configured to actuate the first valve and the second valve to transition the extracorporeal oxygenation circuit between the first state and the second state.

4. The extracorporeal oxygenation circuit of claim 3, wherein the actuation system is configured to actuate the first valve and the second valve substantially simultaneously.

5. The extracorporeal oxygenation circuit of claim 1, wherein the second valve includes a first outlet fluidically coupled the patient and a second outlet fluidically coupled to a pump of the extracorporeal oxygenation circuit.

6. The extracorporeal oxygenation circuit of claim 5, wherein the first valve includes a first inlet fluidically coupled to the patient and a second inlet fluidically coupled to the pump.

7. The extracorporeal oxygenation circuit of claim 6, wherein when the extracorporeal oxygenation circuit is in the first state, the first oxygenator is in fluid communication with thefirst inlet of the first valve and the first outlet of the second valve and the second oxygenator is in fluid communication with the second inlet of the first valve and the second outlet of the second valve.

8. The extracorporeal oxygenation circuit of claim 7, wherein when the extracorporeal oxygenation circuit is in the second state, the second oxygenator is in fluid communication with the first inlet of the first valve and the first outlet of the second valve.

9. An extracorporeal oxygenation circuit, comprising: a first valve configured to receive a first fluid and a second fluid, the first fluid being received from a patient and containing blood; a second valve configured to receive the first fluid and the second fluid; a first oxygenator fluidically coupled between the first valve and the second valve; and a second oxygenator fluidically coupled between the first valve and the second valve, the extracorporeal oxygenation circuit having a first state in which (i) the first valve is configured to convey the first fluid to the first oxygenator and the second fluid to the second oxygenator and (ii) the second valve is configured to convey the first fluid to the patient and the second fluid to the first valve, wherein the first fluid is oxygenated by the first oxygenator, and the extracorporeal oxygenation circuit having a second state in which the first valve conveys the first fluid to the second oxygenator and the second valve conveys the first fluid from the second oxygenator to the patient, wherein the first fluid is oxygenated by the second oxygenator.

10. The extracorporeal oxygenation circuit of claim 9, further comprising: a gas source configured to provide a sweep gas to each of the first oxygenator and the second oxygenator.

11. The extracorporeal oxygenation circuit of claim 10, wherein the sweep gas includes at least one of O2, CO2, and N2.

12. The extracorporeal oxygenation circuit of claim 9, wherein the second fluid comprises at least one of patient blood, donor blood, electrolytes, water, or a crystalloid solution.

13. The extracorporeal oxygenation circuit of claim 9, further comprising: an actuation system configured to actuate the first valve and the second valve to transition the extracorporeal oxygenation circuit between the first state and the second state.

14. The extracorporeal oxygenation circuit of claim 13, wherein the actuation system is configured to actuate the first valve and the second valve substantially simultaneously.

15. The extracorporeal oxygenation circuit of claim 9, further comprising: a pump configured to facilitate a flow of the second fluid from the second valve to the first valve.

16. The extracorporeal oxygenation circuit of claim 15, wherein when the extracorporeal circuit is in the first state, the pump is configured to circulate the second fluid through the second oxygenator to at least one of condition the second fluid or remove air from the second oxygenator prior to the extracorporeal circuit being transitioned to the second state.

17. The extracorporeal oxygenation circuit of claim 16, wherein the first valve includes a first inlet fluidically coupled to the patient and a second inlet fluidically coupled to the pump, and the second valve includes a first outlet fluidically coupled the patient and a second outlet fluidically coupled to the pump.

18. The extracorporeal oxygenation circuit of claim 17, wherein when the extracorporeal oxygenation circuit is in the first state, the first oxygenator is in fluid communication with the first inlet of the first valve and the first outlet of the second valve and the second oxygenator is in fluid communication with the second inlet of the first valve and the second outlet of the second valve.

19. The extracorporeal oxygenation circuit of claim 18, wherein when the extracorporeal oxygenation circuit is in the second state, the second oxygenator is in fluid communication with the first inlet of the first valve and the first outlet of the second valve.

20. A method, comprising: conveying, via a first valve, a first flow of blood to a first oxygenator and a second flow of blood to a second oxygenator while the first valve is in a first state, the first flow of blood being received from a patient; conveying, via a second valve, the first flow of blood to the patient while the second valve is in a first state, wherein the first flow of blood is oxygenated by the first oxygenator; transitioning each of the first valve and the second valve from the first state to a second state; and conveying, while the second valve is in the second state, the first flow of blood to the patient, wherein the first flow of blood is oxygenated by the second oxygenator.

21. The method of claim 20, wherein the second flow of blood is stopped when the first valve and the second valve are in the second state.

22. The method of claim 20, wherein the transitioning of each of the first valve and the second valve from the first state to a second state includes actuating each of the first valve and the second valve such that the first valve and the second valve transition from the first state to the second state substantially simultaneously.

23. The method of claim 20, wherein the first valve includes a first inlet configured to receive the first flow of blood and a second inlet configured to receive the second flow of blood, and the second valve includes a first outlet configured to convey the first flow of blood after the first flow of blood has been oxygenated and a second outlet configured to convey the second flow of blood after the second flow of blood has been oxygenated.

24. The method of claim 23, further comprising: conveying, via the second outlet of the second valve, the second flow of blood to the first valve while the first valve and the second valve are in the first state.

25. The method of claim 23, wherein the second outlet of the second valve is fluidically coupled to a pump, the method further comprising: pumping, while the first valve and the second valve are in the first state, the second flow of blood from the second outlet of the second valve to the second inlet of the first valve.

26. The method of claim 20, further comprising: conveying a sweep gas from at least one gas source to each of the first oxygenator and the second oxygenator.

27. The method of claim 26, wherein the sweep gas includes at least one of O2, CO2, and N2.

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