TRANSFER TRAY AND PRIMING CART FOR NEONATAL CANNULATION AND ASSOCIATED METHODS - Patent application

Abstract

A priming cart, transfer tray, priming circuit, blood circuit, and related methods are disclosed. A transfer tray for receiving a neonate has a body and a movable support assembly. The body has a first portion for receiving a neonate chamber assembly with a neonate therein and a second portion for receiving a blood circuit. The blood circuit includes an oxygenator, a first conduit for transferring blood from the neonate to the oxygenator, and a second conduit for transferring blood from the oxygenator to the neonate. The movable support assembly is secured to the body of the transfer tray and configured to receive the blood circuit. When the neonate is placed on the first portion and in fluid communication with the blood circuit, the transfer tray is movable from a first position on a first surface to a second position on a second surface.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 180,819, filed April 28, 2021, the contents of which are incorporated herein by reference.

[0002] The present disclosure relates to neonatal care, and more particularly to systems and methods relating to improving extrauterine survival rates in preterm newborns. [Background technology]

[0003] Extremely preterm infants are a leading cause of infant morbidity and mortality in the United States. Preterm birth can result from any of a number of medical causes. Extreme respiratory insufficiency is a common and challenging problem associated with extremely preterm infants, as gas exchange is impaired due to structural and functional lung immaturity. Despite medical advances in the field, preterm infants, especially those born before 28 weeks of gestation, have a high incidence of chronic lung disease and other complications due to organ immaturity. Summary of the Invention [Means for solving the problem]

[0004] The above-mentioned needs are met by various aspects of the disclosed priming cart, transfer tray, priming circuit, blood circuit, and related methods. According to one aspect of the disclosure, a transfer tray for receiving a neonate can have a body and a movable support assembly secured to the body of the transfer tray. The body can have a first portion configured to receive a neonate chamber assembly on an upper surface thereof, the neonate chamber assembly being configured to receive the neonate therein, and a second portion configured to receive a blood circuit. The blood circuit can have an oxygenator, a first conduit for transporting blood from the neonate to the oxygenator, and a second conduit for transporting blood from the oxygenator to the neonate. The first conduit can have an arterial end configured to be in fluid communication with an artery of the neonate's umbilical cord, and the second conduit can have a venous end configured to be in fluid communication with a vein of the neonate's umbilical cord. The movable support assembly is secured to the body of the transfer tray and configured to receive the blood circuit thereon. When the neonate is positioned in the first portion and in fluid communication with the blood circuit, the transfer tray may be movable from a first position in which the transfer tray is positioned on a first surface to a second position in which the transfer tray is positioned on a second surface different from the first surface.

[0005] Optionally, the first surface may include a priming cart and the second surface may include an incubator.

[0006] Optionally, the transfer tray may have a support member configured to receive the neonatal chamber assembly thereon, the support member spacing the neonatal chamber assembly from the transfer tray at a first height.

[0007] Optionally, the support member is adjustable between a first height and a second height different from the first height, the first and second heights being measured between the transfer tray and the fetus chamber assembly.

[0008] Optionally, the transfer tray may include a plurality of support members.

[0009] Optionally, said body portion may define a receiver thereon configured to receive and hold a first volume of liquid.

[0010] Optionally, the support assembly may have a support attached to the support assembly, the support configured to receive at least one sensor from the group consisting of an oxygen sensor, a flow meter, a temperature sensor, a pressure sensor, and an air bubble sensor.

[0011] Optionally, the support may be movable relative to the support assembly.

[0012] Optionally, the support assembly may include an oxygenator holder that removably receives the oxygenator.

[0013] Optionally, the oxygenator holder may be movable relative to the support assembly.

[0014] Optionally, the support assembly may have first and second pressure sensors disposed on it, the first pressure sensor configured to measure pressure in the first conduit and the second pressure sensor configured to measure pressure in the second conduit.

[0015] Optionally, the first and second pressure sensors may be movable along a perpendicular axis relative to the transfer tray in directions towards and away from the transfer tray.

[0016] Optionally, the newborn may be positioned in a first plane spaced from the transport tray along the vertical axis, and the first and second pressure sensors are configured to be moved into the first plane.

[0017] Optionally, the transfer tray has a retaining member provided on the main body portion, the retaining member configured to perform at least one of aligning the transfer tray with at least one of the first plane and the second plane, and preventing sliding movement of the transfer tray relative to at least one of the first plane and the second plane.

[0018] According to another aspect of the disclosure, a priming device for priming a plurality of conduits of an external support system and connecting a neonate to the external support system may include a surface configured to movably receive the neonate, a blood circuit for connecting to the neonate, a priming circuit, a heater, and a pump. The blood circuit may include an oxygenator, a first conduit for transporting blood from the neonate to the oxygenator, and a second conduit for transporting blood from the oxygenator to the neonate, the first conduit having an arterial end and the second conduit having a venous end. The priming circuit may include a source of priming fluid and a priming conduit in fluid communication with the blood circuit for transporting priming fluid from the priming fluid source to the blood circuit. The priming fluid may be configured to be heated. The pump may be configured to pump the priming fluid from the priming fluid source through the priming conduit to the blood circuit. The arterial and venous ends of the blood circuit are sized and configured to be disconnected from the priming conduit of the priming circuit and connected to the neonate's umbilical cord, such that the arterial end is in fluid communication with an artery of the umbilical cord and the venous end is in fluid communication with a vein of the umbilical cord. When the blood circuit is connected to the umbilical cord, a fluid connection is established between the arterial and venous ends through the neonate, thereby allowing blood to move from the blood circuit to the umbilical cord and allowing the neonate's blood to move from the umbilical cord into the blood circuit.

[0019] Optionally, the priming device may be a mobile cart configured to move from a first location to a second location different from the first location.

[0020] Optionally, at least one wheel may be included, said priming device being capable of translating along said wheel.

[0021] Optionally, the priming device may have an upper portion including the surface configured to receive the neonate, a lower portion spaced from the upper portion along a vertical axis, and a central portion disposed between the upper portion and the lower portion.

[0022] Optionally, the priming device can be configured to have a first height and a second height greater than the first height, the first and second heights being measured along a vertical axis between the upper and lower portions, and the priming device being movable between the first height and the second height.

[0023] Optionally, the priming device may have at least one weight sensor on the surface, the at least one weight sensor configured to detect a weight of the newborn received on the surface.

[0024] Optionally, the priming device may include an oxygen sensor configured to measure oxygen concentration in at least one of the neonate, the priming circuit, and the blood circuit.

[0025] Optionally, the priming device may include a temperature sensor configured to measure a temperature of fluid in at least one of the priming circuit and the blood circuit.

[0026] Optionally, the priming device may include a pressure sensor configured to measure fluid pressure within at least one of the priming circuit, the blood circuit, and the neonate.

[0027] Optionally, the priming device may have a first pressure sensor configured to measure pressure in the first conduit of the blood circuit and a second pressure sensor configured to measure pressure in the second conduit of the blood circuit, the first and second pressure sensors being movable to be positioned on a plane on which the neonate is placed.

[0028] Optionally, the priming device may include a gas tank configured to receive a predetermined gas mixture, and the oxygenator is configured to receive the predetermined gas mixture from the gas tank.

[0029] Optionally, the priming device is configured to receive the predetermined gas mixture from the gas tank and to control delivery of the gas to the oxygenator.

[0030] Optionally, the priming device may include a power source configured to provide power to the priming device.

[0031] Optionally, the power source may include a battery.

[0032] Optionally, the priming fluid may include human blood.

[0033] Optionally, the priming fluid may include a crystalloid fluid.

[0034] Optionally, the priming circuit may be connectable to a replacement oxygenator different from the oxygenator in the blood circuit and configured to transfer the priming fluid to the replacement oxygenator.

[0035] Optionally, the priming circuit can be configured to removably connect to the blood circuit via a connection assembly having a blood circuit connector configured to receive the blood circuit, a priming circuit connector configured to receive the priming circuit, and a chamber defined between the blood circuit connector and the priming circuit connector, the chamber configured to be in fluid communication with the blood circuit and the priming circuit when the blood circuit and the priming circuit are connected to the blood circuit connector and the priming circuit connector, respectively.

[0036] According to another aspect of the present disclosure, a connection assembly for removably connecting a first conduit to a second conduit includes a body having a first end and a second end axially spaced from the first end, a first connector configured to receive the first conduit at the first end of the body, a second connector configured to receive the second conduit at the second end of the body, and a carriage configured to move along the body between an unlocked position and a locked position, the carriage moving axially in a first direction toward the first end and a second connector opposite the first direction. The device can include a carriage that is movable in a second direction toward the end, an elastic member configured to apply a force to the carriage to move the carriage in either of the first or second directions, and a deformable release arm having a first position and a second position, wherein when in the first position, the deformable release arm prevents the carriage from being moved relative to the main body by the elastic member, and when in the second position, the deformable release arm is disposed in a position that allows the carriage to be moved by the elastic member.

[0037] The carriage may be configured, when moved from the unlocked position to the locked position, to move one of the first conduit and the second conduit towards and contact the other of the first conduit and the second conduit, such that the first conduit and the second conduit are in liquid communication with each other and a liquid-tight seal is formed between the first conduit and the first connector and between the second conduit and the second connector.

[0038] Optionally, the resilient member may be a spring.

[0039] Optionally, when the carriage is in the unlocked position, the spring is in tension and exerts a biasing force on the carriage in a direction towards the locked position.

[0040] Optionally, the deformable release arm may include a protrusion extending therefrom, the body defining a shoulder against which the protrusion contacts, the protrusion configured to disengage from the shoulder when the deformable release arm is moved from the first position to the second position.

[0041] Optionally, the deformable release arm is movable from the first position to the second position by contacting a release member on a manifold, the manifold being configured to slidably receive the connection assembly.

[0042] Optionally, when the connection assembly is in an unlocked configuration, the first conduit is receivable within the first connector but a fluid-tight seal is not formed with the first connector, and when the connection assembly is in a locked configuration, the first conduit is receivable within the first connector and a fluid-tight seal is formed with the first connector.

[0043] Optionally, the first conduit can be included in a blood circuit configured to be connected to a neonate and the second conduit can be included in a priming circuit configured to receive priming fluid, wherein when the connection assembly is in a locked configuration, the blood circuit is in fluid communication with the priming circuit and the priming fluid is freely movable between the blood circuit and the priming circuit.

[0044] According to another aspect of the present disclosure, a method of cannulating the umbilical cord of a newborn infant on a priming device is disclosed, the priming device may have a blood circuit having an arterial end, a venous end opposite the arterial end, a blood conduit extending between the arterial end and the venous end, and an oxygenator disposed in continuity with the blood conduit between the arterial end and the venous end. The priming device can include a priming circuit having a first end, a second end opposite the first end, and a priming conduit extending between the first end and the second end, the first end of the priming conduit configured to be releasably connected to the arterial end of the blood conduit and the second end of the priming conduit configured to be releasably connected to the venous end of the blood conduit, such that the blood conduit is in fluid communication with the priming conduit and the blood circuit and the priming circuit are configured to receive priming fluid.

[0045] The method may include placing a neonate on an upper surface of the priming device, calculating a weight of the neonate via a weight sensor on an upper surface of the priming device, connecting the arterial end of the blood conduit to an artery in an umbilical cord of the neonate, and connecting the venous end of the blood conduit to a vein in an umbilical cord of the neonate. When at least one of the arterial and venous ends of the blood conduit is connected to the umbilical cord, the blood circuit may not be in fluid communication with the priming circuit.

[0046] Optionally, the method includes calculating the weight of the newborn by placing a scale on the floor with an assistant standing on it. Prior to the cannulation procedure, the scale's tare weight is measured with the assistant standing on it. During cannulation, the assistant lifts the patient out of the chamber (to fill the umbilical vein with blood to aid in cannulation) and a weight measurement is collected.

[0047] According to another aspect of the disclosure, a method of priming a blood circuit with a priming fluid is disclosed. The blood circuit is configured to be connected to a neonate and may have a first end, a second end opposite the first end, a blood conduit extending between the first end and the second end, and an oxygenator disposed in series with the blood conduit. The method includes the steps of connecting the first end of the blood circuit to a first end of the priming circuit such that the blood circuit and the priming circuit are in fluid communication with each other, connecting the second end of the blood circuit to a second end of the priming circuit, the second end of the priming circuit being spaced from the first end of the priming circuit and the priming circuit extending between the first end and the second end, receiving the priming fluid from a priming fluid source into the priming conduit, and pumping the priming fluid into the priming conduit. the steps of: actuating movement of the priming fluid in the priming conduit to the blood conduit by pumping the priming fluid towards the connected blood circuit via a pump; receiving the priming fluid in the blood conduit, and then discharging the priming fluid from the blood conduit into the priming conduit, the priming fluid passing through the blood conduit and the oxygenator before being discharged into the priming conduit; and heating the priming fluid by contacting a heater with the priming conduit.

[0048] Optionally, the priming fluid is pumped through the priming conduit towards one of the first and second ends, into the respective connected first and second ends of the blood conduit, and out of the blood conduit into the priming conduit at the other of the first and second ends of the priming conduit.

[0049] Optionally, the pumping may be actuated by a peristaltic pump configured in operative contact with the priming conduit.

[0050] Optionally, said pumping may be actuated by a centrifugal pump configured in operative contact with said priming conduit.

[0051] Optionally, the method may include transferring the priming fluid from a priming fluid source to the priming conduit through a supply line connecting the priming fluid source to the priming conduit.

[0052] Optionally, the method may include introducing gas into the oxygenator at a gas inlet, at least a portion of the gas being introduced into the priming liquid as the priming liquid moves through the oxygenator.

[0053] Optionally, the method may include measuring a temperature of the priming fluid in at least one of the priming conduit and the blood conduit.

[0054] Optionally, the method may comprise providing a signal to the heater to increase or decrease heat based on the measured temperature.

[0055] Optionally, the priming fluid may include at least one of the neonatal plasma, the non-neonatal human plasma, and artificial plasma.

[0056] Optionally, the priming fluid may be a first priming fluid, and the method may include introducing a second priming fluid into the priming conduit from a second priming fluid source.

[0057] Optionally, the first priming fluid may comprise a crystalloid fluid and the second priming fluid may comprise human blood.

[0058] According to another aspect of the disclosure, a method of priming an oxygenator for use with a blood circuit connected to a neonate includes the steps of connecting a liquid inlet of the oxygenator to a first end of a priming conduit; connecting a liquid outlet of the oxygenator to a second end of the priming conduit opposite the first end, thereby defining a circuit through the priming conduit and the oxygenator; and introducing a priming fluid through the priming conduit and into one of the liquid inlet and liquid outlet of the oxygenator, wherein the priming fluid travels through the oxygenator and exits the other of the liquid inlet and liquid outlet of the oxygenator back into the priming conduit.

[0059] Optionally, the method may include heating the priming fluid to a predetermined temperature and measuring the temperature of the priming fluid.

[0060] Optionally, the method may include introducing gas from a controlled gas source into a gas inlet of the oxygenator, passing the gas through the oxygenator, and exhausting the gas through a gas outlet of the oxygenator.

[0061] Optionally, the priming fluid is a first priming fluid, and the method may further comprise introducing a second priming fluid.

[0062] Optionally, the first priming fluid may be different from the second priming fluid.

[0063] According to another aspect of the present disclosure, a method for replacing an oxygenator in a blood circuit is disclosed. The blood circuit may have an arterial end and a venous end opposite to the arterial end, and may further have an oxygenator disposed in continuity with a blood conduit between the arterial end and the venous end, a first portion of the blood conduit between the arterial end and the oxygenator, and a second portion of the blood conduit between the oxygenator and the venous end. The oxygenator may have a liquid inlet for receiving neonatal blood from the first portion of the blood conduit and introducing it into the oxygenator, a liquid outlet for discharging neonatal blood from the oxygenator and introducing it into the second portion of the blood conduit, a gas inlet for receiving gas and introducing it into the oxygenator, and a gas outlet for discharging gas from the oxygenator.The disclosed method includes the steps of connecting the bypass to the blood circuit by placing a first end of the bypass in fluid communication with the first portion of the blood conduit and placing a second end of the bypass in fluid communication with the second portion of the blood conduit, the bypass defining a lumen between the first and second ends, the lumen configured to receive the neonatal blood from the blood conduit at the first end and to discharge the neonatal blood from the second end to the blood conduit; and distributing the neonatal blood through the bypass such that the neonatal blood is introduced from the first portion of the blood conduit to the first end of the bypass, travels through the bypass, and is discharged from the second end of the bypass to the second portion of the blood conduit without traveling through the oxygenator. the transferring step includes the steps of: moving the neonate's blood through a blood conduit, the step including preventing transfer of the neonate's blood to the oxygenator; disconnecting the oxygenator from the blood conduit such that the oxygenator is not in liquid communication with the blood conduit; connecting a replacement oxygenator to the blood conduit, whereby the first portion of the blood conduit is in liquid communication with a liquid inlet of the replacement oxygenator and the second portion of the blood conduit is in liquid communication with a liquid outlet of the replacement oxygenator; transferring the neonate's blood from the arterial end of the blood conduit through the replacement oxygenator toward the venous end of the blood conduit; and disconnecting the bypass from the blood conduit such that the bypass is not in liquid communication with the blood conduit.

[0064] Optionally, the method may include disconnecting a gas conduit from the gas inlet of the oxygenator and connecting the gas conduit to a gas inlet of the replacement oxygenator, whereby gas from a gas source is configured to transfer to the replacement oxygenator. [Brief description of the drawings]

[0065] The present application will be better understood when read in conjunction with the accompanying drawings, in which there is shown, for the purpose of illustrating the inventive subject matter, exemplary aspects of that subject matter; however, the inventive subject matter disclosed herein is not limited to the specific methods, apparatus, and systems disclosed. [Figure 1] FIG. 1 shows a perspective view of a priming cart having a transfer tray and a neonatal chamber assembly according to one embodiment of the present disclosure. [Diagram 2] FIG. 2 shows a perspective view of the priming cart of FIG. 1 according to one embodiment of the present disclosure. [Diagram 3] FIG. 3 shows another perspective view of the priming cart of FIG. [Figure 4] FIG. 4 shows a perspective view of a priming circuit according to one embodiment of the present disclosure. [Diagram 5] FIG. 5 shows a front perspective view of a priming cart with a priming circuit connected thereto, according to one embodiment of the present disclosure. [Figure 6] FIG. 6 shows a perspective view of a blood circuit according to one embodiment of the present disclosure. [Figure 7] FIG. 7 shows a priming cart with a priming circuit connected thereto, a transfer tray on the cart, and a blood circuit connected to the priming circuit, according to one embodiment of the present disclosure. [Figure 8] FIG. 8 shows a front perspective view of a connection interface between a blood circuit and a priming circuit according to one embodiment of the present disclosure. [Figure 9] FIG. 9 shows a flow diagram of a method for connecting a blood circuit to a priming circuit according to one embodiment of the present disclosure. [Figure 10] FIG. 10 illustrates a perspective view of a connection assembly according to one embodiment of the present disclosure. [Figure 11] FIG. 11 shows another perspective view of the connection assembly of FIG. 10 with the cover removed. [Figure 12] FIG. 12 shows an exploded perspective view of a connection assembly according to another embodiment of the present disclosure. [Figure 13]FIG. 13 shows another exploded perspective view of the connection assembly of FIG. 12 with the cover removed. [Figure 14A] FIG. 14A shows a cross-sectional side view of a connection assembly in a partially connected state according to one embodiment of the present disclosure. [Figure 14B] FIG. 14B illustrates a cross-sectional side view of a connection assembly in a fully connected state according to one embodiment of the present disclosure. [Figure 14C] FIG. 14C shows a cross-sectional side view of a blood circuit connector in a connection assembly according to one embodiment of the present disclosure. [Figure 15] FIG. 15 shows a perspective view of a manifold that receives a connection assembly according to one embodiment of the present disclosure. [Figure 16] FIG. 16 shows a perspective view of the manifold of FIG. 15 with a connection assembly attached, according to one embodiment of the present disclosure. [Figure 17A] FIG. 17A shows a connection assembly in a first position relative to a manifold according to one embodiment of the present disclosure. [Figure 17B] FIG. 17B shows the connection assembly and manifold of FIG. 17A with the connection assembly in a second position relative to the manifold. [Figure 17C] FIG. 17C shows the connection assembly and manifold of FIG. 17A with the connection assembly in a third position relative to the manifold. [Figure 18] FIG. 18 shows a perspective view of a cradle that receives a manifold and a connection assembly according to one embodiment of the present disclosure. [Figure 19] FIG. 19 shows a perspective view of a transfer tray according to one embodiment of the present disclosure with the neonate chamber assembly for placing the neonate and blood circuit components on the transfer tray. [Figure 20] FIG. 20 shows a perspective view of the transfer tray of FIG. [Figure 21] FIG. 21 shows another perspective view of the transfer tray of FIG. [Figure 22] FIG. 22 illustrates a portion of the transfer tray of FIG. 19 with a support assembly according to one embodiment of the present disclosure. [Diagram 23] FIG. 23 illustrates a perspective view of a portion of a transfer tray according to one embodiment of the present disclosure, along with a support assembly and a blood circuit connected to the transfer tray. [Figure 24] FIG. 24 illustrates another perspective view of a portion of a transfer tray according to one embodiment of the present disclosure, along with a support assembly and a blood circuit connected to the transfer tray. [Diagram 25] FIG. 25 is a perspective view of a blood circuit with an exchange oxygenator. [Figure 26] FIG. 26 shows a flow diagram of a method for priming a replacement oxygenator and replacing an oxygenator in a blood circuit according to one embodiment of the present disclosure. [Figure 27] FIG. 27 shows a plan view of the drape of FIG. [Figure 28] FIG. 28 shows a treatment flow diagram according to one embodiment of the present invention.

[0066] Aspects of the present disclosure will now be described in detail with reference to the drawings, in which like reference numbers refer to like elements throughout unless otherwise specified. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0067] Apparatus and methods are disclosed for cannulating a newborn after removal from the mother's uterus. If a newborn needs to be removed prematurely from the uterus, the newborn may require additional time for development, preferably in a natural, uterus-like environment. For purposes of this disclosure, "newborn" may include newborns removed prematurely from the uterus as well as full-term infants that require additional time for development in a uterus-like environment. The terms "newborn" and "infant," or "fetonate," may be used interchangeably throughout this disclosure.

[0068] Developing a system that can support normal neonatal growth and organ maturation even for a few weeks could significantly reduce morbidity and mortality in extremely preterm infants and improve the quality of life of survivors. Existing mechanisms for supporting preterm neonates have drawbacks. Existing attempts to provide adequate oxygenation to neonates in animal models are limited by circulatory overload and cardiac failure. Known systems suffer from unacceptable complications such as circulatory failure and contamination. Thus, systems and methods for providing extracorporeal support for preterm neonates or neonates (preterm or full-term) with insufficient vital respiratory gas exchange due to various conditions / disorders could improve survival rates.

[0069] After a newborn is removed from the mother's uterus by Caesarean section or vaginal delivery, it can be connected to an external support system that provides the newborn with the necessary nutrients and maintains a uterus-like physical environment within which the newborn can develop. In such an external support system, the newborn is connected to an extracorporeal blood, oxygenation, and / or filtration circuit that provides the newborn with nutrients, removes waste products, and maintains desired levels of oxygen and body temperature. Portions of the above systems can be connected to the newborn via one or more blood vessels in the newborn's umbilical cord. After the newborn is removed from the uterus, one or more blood vessels in the umbilical cord can be cannulated and placed in fluid communication with one or more of the above external circulatory systems, which are described in more detail throughout this application.

[0070] When the newborn is first removed from the uterus, it needs to be placed in a suitable environment so that it can be connected to external systems. This environment is advantageously in close proximity to the uterus so that the newborn can be housed therein immediately after removal from the uterus, thereby reducing the time the newborn is exposed to the extrauterine environment. The newborn's umbilical vessels are then cannulated and connected to one or more external systems. After cannulation, the newborn is transferred to the main console and maintained therein for the duration of its development. The main console may be or may include an incubator portion configured to provide favorable environmental parameters (e.g., temperature, light, etc.) for the desired newborn development. It is advantageous to perform the cannulation and related procedures as quickly as possible after the newborn is removed from the uterus. In certain embodiments, the clinician cannulates the umbilical vessels for the device within about 10 minutes, or within about 5 minutes, or within about 3 minutes, or within about 2 minutes of removal from the uterus. However, the main console may be located an undesirable distance from the uterus, for example, outside the operating room where the neonate is removed, or may be bulky, cumbersome, and difficult to operate in close proximity to the uterus. In some cases, the main console may include various wiring connections to the medical facility, such as gas lines and electrical wiring. Therefore, it may not be practical to place the main console in a sterile field. A longer time may be required to transfer the neonate directly from the uterus to the main console. This situation is undesirable because the longer the transfer takes, the more delays there will be in the cannulation of the umbilical cord. Long delays are undesirable because the longer the neonate is outside the uterus-like environment and not connected to an external oxygen supply and / or nutrition system, the greater the risk of long-term injury, delayed development, or neonatal death.

[0071] Thus, disclosed herein are systems and methods for receiving a neonate from the uterus that allow for timely cannulation of the umbilical cord vessels, placement of the neonate in a uterus-like environment, and eventual transfer to a main console. Also disclosed are devices and methods for preparing the necessary components for cannulation and for properly activating one or more external support systems.

[0072] Certain terminology is used herein for convenience and not for limitation. The words "axial," "vertical," "transverse," "leftward," "rightward," "upper," "lower," "longitudinal," "lateral," and "rotational" designate directions in the drawings to which reference is made. The term "substantially" is intended to mean to the extent or majority, but not necessarily the entirety, of what is specified. This term includes the above words, derivatives thereof, and words of similar import.

[0073] As used herein, the term "plurality" means one or more. The singular forms "a," "an," and "the" include plural references, and a reference to a particular value includes at least that particular value unless the context clearly indicates that a reference to that value is not included. Thus, for example, reference to a "certain material" refers to at least one of that material and equivalents thereof known to those of skill in the art.

[0074] Priming Cart Referring to FIG. 1, a cart 1000 for receiving a neonate and preparing the components of the external system is illustrated. The cart 1000 performs at least one of the following functions: providing a platform for priming the blood circuit, allowing a clinician to prepare the cannula for use, supporting the neonate chamber assembly during the cannulation procedure, and / or allowing the neonate patient in the neonate chamber assembly to be transferred to a console (not shown in FIG. 1). The cart 1000 can receive a transfer tray 1100, which itself can receive a neonate chamber assembly 10. The neonate chamber assembly 10 may be substantially similar to or identical to one or more neonate chamber assemblies 10 described elsewhere in this application, unless otherwise specified. The neonate is placed in the neonate chamber assembly 10 after removal from the uterus. The neonate's umbilical cord can be measured by ultrasound prior to delivery. The measurement of the neonate's umbilical cord is used to determine the size of the cannula. The neonate's umbilical cord can then be cannulated and the neonate connected to the blood circuit 1200 (described below) so that blood flows from the neonate into the blood circuit 1200 and back through the blood circuit 1200 to the neonate. After the neonate's umbilical cord is connected to the blood circuit 1200, the neonate can be transferred to the main console (not shown). The neonate can be maintained within the neonate chamber assembly 10 while being transferred to the main console. In some embodiments, the entire tray 1100 carrying the neonate chamber assembly 10 can be moved from the cart 1000 to the main console. The cart 1000 can be selectively moved between different positions. For example, moving the cart 1000 to a desired proximity to the uterus allows for a sterile and rapid transfer of the neonate from the uterus to the cart 1000. Moving the cart 1000 to a desired proximity to the main console facilitates the transfer of the neonate to the main console.

[0075] The cart 1000 may also include systems and components for preparing a blood circuit 1200 (one embodiment is shown in FIG. 6) for connection to the neonate. Such preparation includes priming components of the blood circuit 1200, such as tubing, oxygenators, and sensors, with an appropriate priming fluid, which is described in more detail below. Embodiments of the cart 1000 and tray 1100 are described in more detail below.

[0076] 1-3, the cart 1000 includes an upper portion 1004, a lower portion 1030 spaced apart from the upper portion 1004, and a central portion 1018 disposed between the upper portion 1004 and the lower portion 1030. The upper portion 1004 serves as a tabletop for the cart 1000 and is configured to receive a newborn thereon. The lower portion 1030 serves as a structural base for the cart 1000 to keep the cart 1000 sturdy and upright. For purposes of this disclosure, the cart 1000 and tray 1100 embodiments are described with reference to a vertical axis 1001, a longitudinal axis 1002, and a horizontal axis 1003, each of which is orthogonal to both of the other two axes of the vertical axis 1001, the longitudinal axis 1002, and the horizontal axis 1003. The vertical axis 1001 can be defined as parallel to the direction of gravity.

[0077] The top 1004 can define a top surface 1006 thereon (shown in FIGS. 2 and 3). In some embodiments, the top surface 1006 can be substantially planar in a plane defined by the longitudinal axis 1002 and the lateral axis 1003. It should be understood that in some embodiments, the top surface 1006 can alternatively be angled relative to the longitudinal axis 1002 and / or the lateral axis 1003. The top surface 1006 can receive a neonate thereon on the cart 1000. In some embodiments, the neonate can be disposed in the neonate chamber assembly 10 (see FIG. 1). In some embodiments, a tray 1100 (shown in FIG. 1) can be removably disposed on the top 1004 of the cart 1000. The tray 1100 can be in contact with the top surface 1006 or alternatively can be disposed adjacent to the top surface 1006 and spaced from the top surface 1006 by one or more components disposed along the vertical axis 1001.

[0078] The cart 1000 may include one or more sensors configured to measure and / or calculate characteristics of the newborn. The cart 1000 may include a support 1008 attached to a scale having a weight sensor for measuring the weight of the newborn. The support 1008 may rest on a scale structure in the top 1004. It is understood that the support may be the weight sensor itself that constitutes the scale. It is also understood that the weight sensor that constitutes the scale may be calibrated to accurately detect and measure the weight of the newborn. It is further understood that the weight sensor that constitutes the scale may detect and measure the weight and then transmit the detected measurements to a processor (not shown), which is configured to perform algorithmic processing to determine the weight of the newborn based at least in part on the measurements detected by the scale. The scale may be located on or within the top 1004 of the cart. The support 1008 may be located adjacent to, defined on, and / or extend from the top surface 1006 along a vertical axis 1001 in a direction away from the cart 1000. In some embodiments, the cart 1000 may include multiple supports 1008. As shown in the exemplary embodiment of FIGS. 1-3, the cart 1000 may include six supports 1008, although it should be understood that another suitable number of supports may be utilized, such as 1, 2, ...12, or another number of supports 1008. In embodiments in which the scale includes multiple weight sensors, the processor may receive detected readings from one or more of the multiple weight sensors and calculate the weight of the newborn based on the detected readings. The calculated weight of the newborn may be displayed on the cart 1000 (e.g., displayed on the display 1016 shown in FIG. 2 and described in more detail below) and / or electronically transmitted to a display component (not shown) separate from the cart 1000.

[0079] The upper portion 1004 is spaced apart from the lower portion 1030 along the vertical axis 1001. The central portion 1018 is located between the upper portion 1004 and the lower portion 1030. It should be understood that the central portion 1018 functions as a structural frame and should have sufficient size and strength to support the upper portion 1004 and any components disposed thereon (e.g., the tray 1100, the neonatal chamber assembly 10, etc.). The central portion 1018 can be configured to receive one or more components associated with the cart 1000, the tray 1100, or the blood circuit 1200 on or within the central portion, as described below.

[0080] The central portion 1018 can be adjusted in size based on the desired application. Typically, the cart 1000 defines a height 1001a measured along a vertical axis 1001 from a surface (shown in FIG. 2) on which the cart is placed. The height 1001a of the cart 1000 is adjustable to accommodate the steps of the neonate removal, cannulation, and transfer procedure, and to complement the respective height of the individual using the cart 1000 and to allow the top surface of the cart 1006 to match the work surface of a console (not shown). In some embodiments, the top portion 1004 can include a height adjustment assembly 1020 configured to change the height of the cart 1000. The height 1001a can be adjusted by moving the top portion 1004 along the vertical axis 1001 relative to the bottom portion 10030. The height 1001a increases when the top portion 1004 is moved away from the bottom portion 1030 and decreases when the top portion 1004 is moved toward the bottom portion 1030. As the height 1001a increases, the central portion 1018 also increases in size measured along the vertical axis 1001, and as the height 1001a decreases, the central portion 1018 decreases in size.

[0081] The height adjustment assembly 1020 can be manually actuated to selectively increase or decrease the height 1001a by an actuation foot pedal 1028. A user of the cart 1000 can raise or lower the upper portion 1004 relative to the lower portion 1030. The height adjustment assembly 1020 can include a movement actuator to move the upper portion 1004 relative to the lower portion 1030 and an input device 1028 to actuate the movement actuator. In some embodiments, the input device 1028 includes electronic components, and a user can actuate the height adjustment assembly 1020 by electronic instructions that are processed by a computing device and transmitted to the height adjustment assembly 1020. Suitable input devices 1028 include push buttons, levers, switches, and / or the like, and the height adjustment assembly 1020 may include multiple input devices 1028 to allow multiple users to operate the height adjustment assembly 1020 and / or to operate the height adjustment assembly 1020 from different locations on the cart 1000.

[0082] The movement actuators may include any suitable assembly for moving a connected component. Exemplary movement actuators include motors, magnetic field trackers, piezoelectric components, pneumatic cylinders, hydraulic cylinders, and / or the like. For example, in some embodiments, as shown in FIGS. 1-3, the height adjustment assembly 1020 may include an electronic linear actuator. The cart 1000 may include one, two, three, four, or more input devices 1028, which are shown in FIGS. 1-3 as pedals that can be operated by a user's feet. In use, a user may step on one or more pedals to raise (i.e., move along the vertical axis 1001 away from the lower portion 1030) the upper portion 1004 to increase the height 1001a, or to lower (i.e., move along the vertical axis 1001 towards the lower portion 1030) the upper portion 1004 to decrease the height 1001a, or to selectively raise and lower. In some embodiments, one or more of the plurality of input devices 1028 may be actuated to increase the height 1001 a while one or more other of the plurality of input devices 1028 may be actuated to decrease the height 1001 a. The central portion 1018 may also increase or decrease as the height 1001 a increases or decreases.

[0083] The lower portion 1030 serves as a structural base and support for the cart 1000. The lower portion 1030 can contact a surface on which the cart 1000 stands. The lower portion 1030 can be designed to be selectively movable (i.e., along the longitudinal direction 1002 and the lateral direction 1003) relative to the surface on which the cart 1000 stands, and to be fixed along the longitudinal direction 1002 and the lateral direction 1003. In some embodiments, the lower portion 1030 can include multiple movable components, such as wheels or casters 1032. The wheels 1032 are defined on or coupled to the lower portion 1030 and extend along a vertical axis 1001 toward the surface on which the cart 1000 stands. 1-3 show an exemplary embodiment having four wheels 1032, it is understood that the cart 1000 may include any suitable number of wheels 1032, such as two, three, four, eight, or another suitable number of wheels 1032. The wheels 1032 are switchable between locked and unlocked positions to selectively prevent and allow rolling motion. When the wheels 1032 are unlocked, the cart 1000 can easily translate in the longitudinal direction 1002 and / or the lateral direction 1003 along the surface on which the cart stands by the rolling motion of the wheels 1032. When the wheels 1032 are locked, the rolling motion of each wheel is prevented, reducing the translational mobility of the cart 1000 in the longitudinal direction 1002 and the lateral direction 1003. Locking the wheels 1032 is advantageous when transporting and securing the neonate to the cart 1000, when preparing the components of the blood circuit 1200, when transporting the transport tray to the console, and / or when cannulating the neonate on the cart 1000. By preventing translational movement of the cart 1000, the likelihood of human error due to unintended movement of the cart 1000 and / or components secured or disposed thereon is reduced when the cart 1000 is kept stationary. Additionally, it is advantageous to unlock the wheels 1032 to allow translational movement of the cart 1000 so that the cart 1000 can be easily moved from a first location to a second location.In some cases, the first location is an operating room where the neonate is removed from the uterus, placed on the cart 1000, cannulated, and connected to the blood circuit 1200. The second location is in proximity to the main console where the neonate is transferred from the cart 1000. It is understood that additional components to facilitate movement of the cart 1000 are contemplated, such as a handle (not shown) that can be grasped by a user, to facilitate guidance when moving the cart 1000 between locations.

[0084] The cart 1000 can be designed and configured to receive and hold thereon various components associated with umbilical cannulation of a neonate. Components such as a power source 1036, a gas tank 1040, a flow control device 1050, a heater 1048, and / or a pump 1052 (shown in FIGS. 2 and 3 and described in detail below) can be held in the top 1004, bottom 1030, center portion 1018, or one or more of the above portions of the cart 1000. The power source 1036 is configured to provide power to one or more components of the cart 1000, such as the heater 1048, the pump 1052, one or more displays 1016, the height adjustment assembly 1020, or other components on the cart 1000. In some embodiments, the power source 1036 includes a battery. In this or other embodiments, the battery's state of charge, battery life, or other attributes may be displayed on one or more displays 1016. 2 and 3, at least some of the above components may be located in the lower portion 1030 and the middle portion 1018. It is understood that the components must be properly stored to enable their intended function and must be properly secured to prevent unintended movement of the components and damage during use of the cart 1000.

[0085] Priming Circuit When a neonate is removed from the uterus, as described above, the neonate must be cannulated and connected to an external circulatory system, forming a circulatory circuit that moves blood from the neonate through one or more components designed to give the blood desired properties and then returns it to the neonate. Before connecting the neonate to such a system, the circuit and components must be primed to have the desired properties for the neonate's desired physiological development. Components (e.g., blood circuit 1200, described in detail below) must be primed to receive a desired priming liquid having the desired composition, concentration, temperature, pressure, and other parameters. Described herein are systems and methods for priming components that are connected to a neonate.

[0086] The cart 1000 includes a priming circuit 1300 configured to prime the blood circuit 1200, which is connected to the neonate after priming. With reference to FIG. 4, the priming circuit 1300 includes a priming conduit 1302 configured to receive a priming fluid and transport the priming fluid to a connected circuit (e.g., the blood circuit 1200) through its interior. The priming conduit 1302 may be a tube and may have a circular, oval, or differently shaped cross section. The priming conduit 1302 must be configured to receive a fluid therein and to hold and transport the fluid. The priming conduit 1302 extends between a first end 1308 and a second end 1312, defining a conduit length between the first end 1308 and the second end 1312. The conduit length includes the entire priming conduit 1302, including the priming conduit portion. The priming conduit 1302 may comprise silicone, thermoplastic elastomer, fluoropolymer, and / or other suitable polymers or materials. In some exemplary embodiments, the priming conduit 1302 may comprise Tygon polymer tubing. It is understood that the selected material should be biocompatible and acceptable for use with blood components. The selected material should be suitable for receiving liquid and transferring heat to the liquid flowing therethrough. The selected material should also have the desired gas exchange (or gas exchange blocking) properties to facilitate gas transfer to and from the liquid in the priming conduit 1302 and / or to block gas transfer to maintain a desired gas concentration in the liquid in the priming conduit 1302. The selected material should also be suitable for heat transfer so that the priming liquid is heated. In some embodiments, the priming conduit 1302 can include one or more coatings on its surface to facilitate the flow of fluid therethrough and / or neonatal development, such as an anticoagulant or antithrombotic coating, an antimicrobial coating, a hydrophobic coating, and / or the like.The thickness of the walls defining the priming conduit 1302 should be sufficient to allow effective heat transfer therethrough.

[0087] The priming conduit 1302 can include a portion configured to receive heat and transfer the received heat to the priming fluid in the priming conduit 1302. The heating portion 1336 (shown in FIGS. 4 and 5) can be configured to be disposed adjacent to the heater 1048 (see FIG. 5) such that heat from the heater 1048 can be transferred thereto. As shown in the exemplary embodiment of FIG. 5, the heating portion 1336 can be wrapped around the heater 1048. The heating portion 1336 can be wrapped around the heater 1048 over multiple turns. It will be appreciated that the more times the heating portion 1336 contacts the heater 1048, the greater the amount of heat transferred from the heater 1048 to the heating portion 1336 due to the greater surface area between the heating portion 1336 and the heater 1048. Although the heating portion 1336 is shown as a coil wrapped around the heater 1048, other embodiments are envisioned in which the heating portion 1336 is disposed differently relative to the heater 1048. The heating portion 1336 may be a uniform portion integrated into the priming conduit 1302. In some embodiments, the heating portion 1336 may be separable from the remainder of the priming conduit 1302 or connectable to the priming conduit 1302.

[0088] The priming conduit 1302 includes a pump portion 1338 configured to receive priming fluid and contact a pump 1052 (see FIG. 5 ), which causes movement of the priming fluid through the priming conduit 1302. The pump portion 1338 may be a uniform portion integral to the priming conduit 1302, or alternatively, in some embodiments, the pump portion 1338 may be separable from the remainder of the priming conduit 1302 and connectable to the priming conduit 1302. In some embodiments, the priming conduit 1302 includes a pump portion 1338 connectable to a heating portion 1336 and positionable in fluid communication with the heating portion 1336.

[0089] In some embodiments, the priming conduit 1302 can be constructed of the same materials, dimensions, and densities throughout. For example, the pump portion 1338 can be constructed of similar or identical properties and dimensions as the heating portion 1336. Alternatively, in some embodiments, the priming conduit 1302 can vary in materials, dimensions, and / or densities along its length. For example, the heating portion 1336 can be constructed of a different material, or a material of a different composition, than the pump portion 1338 and / or other portions of the priming conduit 1302. The heating portion 1336 can be constructed of one or more materials that are more suitable for heat transfer than materials used in other portions of the priming conduit 1302.

[0090] The priming conduit 1302 may have a constant wall thickness throughout between the first end 1308 and the second end 1312. Alternatively, the priming conduit 1302 may have a wall thickness that varies along its length. In some embodiments, the heating portion 1336 may have a different wall thickness than another portion of the priming conduit 1302, such as the pump portion 1338. In some exemplary embodiments, the priming conduit 1302 may have an inner diameter of about 3 / 16 inch and an outer diameter of about 5 / 16 inch. In that case, the wall thickness of the exemplary priming conduit 1302 may be about 1 / 16 inch. In some embodiments, the wall thickness of the heating portion 1336 may be less than the wall thickness of one or more of the remaining portions of the priming conduit 1302. A smaller wall thickness may increase the efficiency and / or rate of heat transfer from the heater 1048 to the priming fluid flowing through the heating portion 1336. However, in some circumstances, a thinner wall thickness in the heating portion 1336 may not be preferred in other portions of the priming conduit 1302. For example, such thinner walls may result in undesirable stresses on the material of the priming conduit 1302, such as stresses on the pump portion 1338 of the priming conduit 1302 by the pump 1052 as priming fluid is pumped through the priming conduit 1302. Thus, in some embodiments, it may be preferred to have different wall thicknesses in different portions of the priming conduit 1302. For example, in some embodiments, the wall thickness of the priming conduit 1302 in the heating portion 1336 may be less than the wall thickness of the priming conduit 1302 in the pump portion 1338. The relatively thicker wall thickness in the pump portion 1338 may allow the priming conduit 1302 to be more resistant to stresses on the priming conduit 1302 due to the action of the pump 1052 during operation.

[0091] As discussed above, the priming conduit 1302 defines a length between the first end 1308 and the second end 1312. The length of the priming conduit 1302 can include the sum of the lengths of each portion of the conduit. For example, the overall length of the priming conduit 1302 includes the sum of the lengths of the heating portion 1336 and the pump portion 1338. In some embodiments, the heating portion 1336 may comprise a greater percentage of the length of the conduit than the pump portion 1338. In some specific embodiments, the heating portion 1336 may be longer than the pump portion 1338 by a factor of between 1 and 2, between 2 and 3, between 3 and 4, between 4 and 5, between 5 and 6, or another preferred factor. In some embodiments, the lengths of the heating portion 1336 and the pump portion 1338 may be approximately equal. In some embodiments, the length of the pump portion 1338 may be greater than the length of the heating portion 1336, for example, by a factor of between 1 and 2, a factor of between 2 and 3, a factor of between 3 and 4, a factor of between 4 and 5, a factor of between 5 and 6, or another preferred factor. In some exemplary embodiments, the priming conduit 1302 may be up to 2000 mm in length between the first end 1308 and the second end 1312. It should be understood that the specific length of the priming conduit 1302 will depend on the application, the components utilized (e.g., heater 1048, etc.), and the desired placement of the priming conduit 1302.

[0092] The priming circuit 1300 is configured to receive priming fluid from a priming fluid source 1331 and transfer the priming fluid through the priming circuit 1300 to any of the connected components (e.g., the blood circuit 1200 and the oxygenator 800, as described in detail below). The priming fluid may include blood components from the neonate, the neonate's mother, or a donor, and may include plasma. In some embodiments, the priming fluid may include another suitable liquid that can be used to provide sufficient water, electrolytes, and calories to the neonate. It is understood that the selected priming fluid should be biocompatible with neonates and preferably exhibit similar properties to a physiological plasma composition, e.g., with similar concentrations of electrolytes, osmolality, and pH. In some embodiments, the priming fluid may include a crystalloid fluid. An exemplary suitable priming fluid may include an intravenous product known as PlasmaLyte (or Plasma-Lyte), which exhibits the desirable properties described above. It is understood that the priming fluid may include a combination of different suitable fluids, and the present disclosure is not limited to the use of a particular priming fluid. For example, in some embodiments, the priming fluid used can include a combination of a crystalloid fluid (e.g., PlasmaLyte) and albumin. In some embodiments, the priming fluid can include blood, e.g., adult human blood. In some embodiments, two priming fluids are used, a first priming fluid including a crystalloid and a second priming fluid including human blood. The human blood can be treated, e.g., by washing, irradiating, and / or removing platelets, prior to use as a priming fluid. In one particular embodiment, the first priming fluid can be PlasmaLyte. In the same or alternative embodiment, the second priming fluid can be human type O negative blood.

[0093] Priming fluid is introduced into the priming circuit 1300 from a source 1331 connectable to the priming circuit 1300. With continued reference to FIG. 5, the source 1331 may include a bag configured to receive and hold a desired volume of priming fluid (not shown). A supply line 1330 extends between the source 1331 and the priming circuit 1300. The supply line 1330 may be a tube, hose, or other suitable conduit for transporting priming fluid. The supply line 1330 is in fluid communication with a priming conduit 1302, whereby priming fluid moves or can move from the source 1331 to the supply line 1330. At its other end, the supply line 1330 may be placed in fluid communication with the priming conduit 1302, whereby priming fluid in the supply line 1330 is permitted to flow into the priming conduit 1302. In some embodiments, the priming conduit 1302 can include a supply connector 1328 coupled between the priming conduit 1302 and the supply line 1330 and configured to receive the supply line 1330 in fluid communication with the interior of the priming conduit 1302. The supply connector 1328 can include a movable valve, a luer connector, a stopcock, a resealable membrane, a capped opening, or other suitable connector commonly utilized in the medical field. The supply connector 1328 can be selectively opened and closed to allow and prevent the flow of priming fluid into the priming conduit 1302. Thus, priming fluid can be introduced from a source 1331 via the supply line 1330 into the priming conduit 1302 of the priming circuit 1300. When a desired volume of priming fluid has been introduced into the priming conduit 1302 (e.g., when the entire priming conduit 1302 between the first end 1308 and the second end 1312 is filled with priming fluid), the supply connector 1328 is actuated to block further flow of priming fluid from the supply line 1330 into the priming conduit 1302 (i.e., disconnecting the supply source 1331 and the supply line 1330 from fluid communication with the priming conduit 1302).The priming fluid within the priming conduit 1302 can be moved through the priming circuit 1300 .

[0094] After the priming fluid is received into and travels through the priming circuit 1300 for a desired sufficient time, at least a portion of the priming fluid is removed or drained from the priming circuit 1300. A waste line 1334 can be connected to the priming conduit 1302. A waste connector 1332 is defined on the priming conduit 1302 and configured to couple the priming conduit 1302 and the waste line 1334 and to receive the waste line 1334 in fluid communication with the interior of the priming conduit 1302. The waste connector 1332 can be selectively actuated to open or close a flow path between the priming conduit 1302 and the waste line 1334; when the waste connector 1332 is open, the waste line 1334 is in fluid communication with the priming conduit 1302, and when the waste connector 1332 is closed, the waste line 1334 is not in fluid communication with the priming conduit 1302. The waste connector 1332 can include a movable valve, a luer connector, a stopcock, a resealable membrane, a capped opening, or other suitable connector commonly utilized in the medical field. The waste line 1334 extends from the waste connector 1332 to a waste receptacle 1335. The waste receptacle 1335 can be a bottle, a bag, a drain, or other suitable container or location for receiving liquid medical waste.

[0095] When both the waste connector 1332 and the supply connector 1328 are in their respective closed positions, the flow of priming fluid between the priming conduit 1302 and each of the waste line 1334 and the supply line 1330 is prevented. In this state, priming fluid can move through the priming circuit 1300 (specifically, along the priming conduit 1302 between the first end 1308 and the second end 1312). One or more physical or chemical changes can occur to the priming fluid in the priming conduit 1302. In some embodiments, the priming fluid can receive heat from a heat source (e.g., heater 1048). As shown in FIG. 5 and described above, the heating portion 1304 of the priming conduit 1302 is configured to receive heat from the heater 1048. The heater 1048 can be connected to the cart 1000. As shown in FIG. 5, the heater 1048 can be located in the central portion 1018. However, it is understood that the heater 1048 may alternatively be located in the upper portion 1004, the lower portion 1030, or partially in two adjacent portions of the cart 1000. In some embodiments, multiple heaters 1048 may be utilized, with each of the multiple heaters 1048 positioned to contact a predetermined portion of the priming circuit 1300. The priming fluid located in the heated portion 1304 of the priming conduit 1302 may receive heat by conduction through the wall of the priming conduit 1302 that contacts the heater 1048 at the heated portion 1304. It is understood that other mechanisms for heating the priming fluid may be utilized, such as convection from a remote heating source.

[0096] The priming fluid can be moved through the priming circuit via one or more pumping mechanisms. With continued reference to FIG. 5, the pump 1052 is connected to or disposed adjacent to the priming conduit 1302 to move the priming fluid through the priming conduit 1302. The pump 1052 may be fixed to the cart 1000. As shown in FIG. 5, the pump 1052 may be disposed in the central portion 1018. However, it is understood that the pump 1052 may alternatively be disposed in the upper portion 1004, the lower portion 1030, or across two adjacent portions. In some embodiments, the cart 1000 can include multiple pumps 1052, each of the multiple pumps 1052 configured to move the priming fluid through the priming circuit 1300 and / or another conduit (e.g., the blood circuit 1200) connected to the cart 1000. The pump 1052 may be a positive displacement pump. Examples of suitable pumps include peristaltic pumps, centrifugal pumps, gear pumps, progressive cavity pumps, rotary pumps, diaphragm pumps, impeller pumps, or other suitable pumps. In some embodiments shown in the illustrative figures (e.g., FIG. 5 ), the pump 1052 may be a peristaltic pump configured to contact the priming conduit 1302 and move priming fluid therein toward either the first end 1308 or the second end 1312. As described above, the priming conduit 1302 may include a pump portion 1338 configured for contact by the pump 1052. The pump portion 1338 has advantageous physical and structural parameters for withstanding the stresses associated with peristaltic pumps.

[0097] The priming circuit 1300 is configured to introduce priming fluid to one or more components in the circuit to prime those components prior to use. In some embodiments, the blood circuit 1200 needs to be primed with a priming fluid configured or maintained to have desired physical and chemical properties before it is connected to the neonate via umbilical cannulation. In some embodiments, it may be desirable to maintain the temperature of the priming fluid circulated within the priming circuit 1300. As described above, heat can be applied by the heater 1048 to at least a portion of the priming conduit 1302 and thus the priming fluid therein. The priming circuit 1300 can include a temperature sensor 1324 (see FIGS. 4 and 5) configured to detect and measure the temperature of the priming fluid within the priming conduit 1302. The temperature sensor 1324 can include or be connectable to a computing device having a processor (not shown) for receiving and recording the temperature of the priming fluid. In some embodiments, the heater 1048 can be controlled to apply a higher or lower temperature to the priming conduit 1302 to increase or decrease the temperature of the priming fluid. The heater 1048 can be controlled based on the temperature of the priming fluid measured by the temperature sensor 1324. If the temperature sensor 1324 detects that the temperature of the priming fluid is below a predetermined threshold, the temperature sensor 1324 (or a connected computing device) can control the heater 1048 to apply more heat to the priming conduit 1302, and if the temperature sensor 1324 detects that the temperature of the priming fluid exceeds a different predetermined threshold, the temperature sensor 1324 (or a connected computing device) can control the heater 1048 to apply less heat to the priming conduit 1302.

[0098] The priming circuit 1300 can be located on or attached to the cart 1000. The priming circuit 1300 can be designed in an integrated manner with the cart 1000 such that the priming circuit 1300 moves with the cart 1000 when the cart 1000 is moved between locations. In some embodiments, the source 1331, the waste 1335, or both, can be fixed to the cart 1000 such that the source 1331 and / or the waste 1335 are movable with the cart 1000. Alternatively, the priming circuit 1300 can be removably connected to the source 1331 and / or the waste 1335, either or both of which are separable from and independent of the cart 1000.

[0099] The priming circuit 1300 may include one or more connectors to facilitate a releasable connection between the priming circuit 1300 and one or more connectable components (e.g., blood circuit 1200). Referring again to FIG. 4, the priming circuit 1300 may include a first end connector 1316 disposed at, on, or adjacent to a first end 1308 of the circuit. The first end connector 1316 is configured to releasably place the connectable component in fluid communication with the interior of the priming conduit 1302 of the cannula. As described below, in some embodiments, the first end connector 1316 may be releasably connected to a corresponding component of the blood circuit 1200. In some embodiments, the priming circuit 1300 may include multiple first end connectors 1316, such as, for example, two, three, four, or another suitable number of first end connectors 1316. The one or more first end connectors 1316 can include a movable valve, a luer connector, a stopcock, a resealable membrane, a capped opening, or other suitable connectors commonly used in the medical field. In some embodiments, the one or more first end connectors 1316 are connectable with a corresponding connector of another component (e.g., blood circuit 1200) via a connecting device, connecting assembly, or adapter, such as connecting assembly 1500, described in detail below.

[0100] The priming circuit 1300 can include a second end connector 1320 disposed at, on, or adjacent to the second end 1312 of the circuit. The second end connector 1320 is configured to removably place a connectable component in fluid communication with the interior of the priming conduit 1302 of the cannula. As described below, in some embodiments, the second end connector 1320 can be removably connected to a corresponding component of the blood circuit 1200. The second end connector can include a movable valve, a luer connector, a stopcock, a resealable membrane, a capped opening, or other suitable connectors commonly utilized in the medical field. In some embodiments, the second end connector 1320 can be connected to a corresponding connector of another component (e.g., the blood circuit 1200) via a connecting device, a connecting assembly, or an adapter, such as the connecting assembly 1500 described in detail below. The second end connector 1320 can be of similar or identical dimensions or arrangement to the one or more of the first end connectors 1316. In some embodiments, the second end connector 1320 may be arranged and / or sized differently from the one or more of the first end connectors 1316. Such differences are due to the different complementary connectors that the first end connector 1316 and the second end connector 1320 are designed to connect to. In some embodiments, the different dimensions and / or arrangement or orientation can prevent accidental mix-up of the connectors when making the described connections, thereby reducing user errors and ensuring connection of the first end connector 1316 to the desired complementary connector and the second end connector 1320 to the complementary connector. The dimensions, arrangement, and / or orientation between the first end connector 1316 and the second end connector 1320 may be different depending on the structure or arrangement of the respective components to be connected so as not to allow connection between incorrect components.In some embodiments, the priming circuit 1300 can include multiple second end connectors 1320, such as, for example, 2, 3, 4, or another suitable number of second end connectors 1320.

[0101] blood circuit The priming circuit 1300 is designed to be removably connected to the blood circuit 1200 for priming the blood circuit 1200 with a priming fluid having desired properties prior to connecting the blood circuit 1200 to the neonate via umbilical cannulation. Turning to FIG. 6, the exemplary blood circuit 1200 is shown having a first end 1208 and a second end 1212 opposite the first end 1208. A blood conduit 1202 extends between the first end 1208 and the second end 1212. The blood conduit 1202 is configured to receive a fluid therein, such as a priming fluid from the priming circuit 1300 or neonatal blood from the neonate.

[0102] The blood conduit 1202 comprises silicone, thermoplastic elastomer, fluoropolymer, and / or other suitable polymers or materials. In some exemplary embodiments, the blood conduit 1202 comprises polymer tubing under the trade name Tygon. It is understood that the material selected should be biocompatible and meet the requirements for use with blood and plasma components. The material selected should have the desired gas exchange properties to promote gas transfer to and from the liquid in the blood conduit 1202 and / or impede gas transfer to maintain a desired gas concentration in the liquid in the blood conduit 1202. In some embodiments, the blood conduit 1202 comprises the same or similar material and exhibits the same or similar properties as the priming conduit 1302. In some embodiments, the blood conduit 1202 comprises one or more coatings thereon, such as an anticoagulant coating, an antithrombogenic coating, an antithrombogenic coating, an antimicrobial coating, a hydrophobic coating, and / or the like to promote the flow of liquid therethrough and / or neonatal development.

[0103] The blood circuit 1200 can include a gas exchange mechanism such as an oxygenator 800. The oxygenator 800 is configured to introduce oxygen into the liquid flowing therethrough, e.g., priming fluid or neonatal blood. The oxygenator 800 can be designed to remove one or more gases from the liquid flowing therethrough while supplying one or more gases to the liquid. It is understood that the oxygenator 800 and / or other components of the blood circuit 1200 are adjusted to accommodate the desired range of different gases that can be present in or introduced into the priming fluid or neonatal blood. It is further understood that the blood circuit 1200 can include multiple oxygenators 800 arranged in series and / or parallel to each other. A variety of suitable oxygenator designs can be utilized and the disclosure is not limited to a particular type of oxygenator. As shown in FIG. 6, the oxygenator 800 includes a liquid inlet 804 through which the liquid (e.g., priming fluid or neonatal blood) flowing through the blood conduit 1202 can enter the oxygenator 800. Liquid entering the oxygenator 800 can flow through one or more flow paths (not shown) within the oxygenator and exit the oxygenator at liquid outlet 808, through which liquid travels from the oxygenator to the blood conduit 1202. In some embodiments, the liquid inlet 804 and liquid outlet 808 can be reversed in function based on the flow of liquid. For example, if liquid flows from the first end 1208 of the blood conduit 1202 toward the second end 1212 of the blood conduit 1202, liquid enters the oxygenator 800 at liquid inlet 804 and exits the oxygenator at liquid outlet 808; however, if liquid flows in the opposite direction from the second end 1212 toward the first end 1208, liquid enters the oxygenator 800 at liquid outlet 808 and exits the oxygenator at liquid inlet 804. As such, it should be understood that the terminology is not intended to limit the function of the oxygenator 800 or blood circuit 1200, and liquid inlet 804 and liquid outlet 808 are defined as such for ease of reference only. In some embodiments, ports can be incorporated into the oxygenator on the blood inlet or blood outlet side to allow for connection of a pressure sensor to sense blood pressure on one or both sides of the gas exchange medium.

[0104] The oxygenator 800 can receive one or more gases at a gas inlet 812. A sweep gas can be passed through the gas inlet 812. The sweep gas can be introduced in a desired direction 801 from the inlet 804 to the outlet 808. The sweep gas can remove ambient air from the oxygenator 800. The sweep gas can include about 0% to about 100% O2. The sweep gas can include about 0% to about 50% CO2. The sweep gas can include about 0% to about 100% N2. In one particular embodiment, the sweep includes oxygen, carbon dioxide, and nitrogen. In this or another embodiment, the sweep gas can pass through the oxygenator 800 at a flow rate of about 30 mL / min to about 40 mL / min. The flow rate of the sweep gas can be adjusted with a system monitor (not shown). The sweep gas can regulate the gas levels in the blood delivered to the neonate. In one aspect, oxygen is absorbed into the neonate's blood and carbon dioxide is removed. The composition of the sweep gas can be adjusted to achieve desired levels of blood oxygen saturation and carbon dioxide saturation in the neonate's blood or in the neonate's expired breath. In some embodiments, it is desirable to have about 2% to about 5% CO2 in the expired gas.

[0105] Gas entering the oxygenator 800 can be introduced into the liquid flowing through the oxygenator 800. Gas removed from the liquid as it passes through the oxygenator 800 can be removed from the oxygenator 800 via the gas outlet 816. The gas inlet 812 is connected to a gas source via appropriate gas conduits and flow control elements. In some embodiments, the gas source includes a portable tank 1040 (see, e.g., FIGS. 2 and 3). In some embodiments, the gas inlet is connected to a valve, faucet, spout, or flow control device (1050). The gas source includes a predetermined and / or premixed preferred gas composition. In some embodiments, the gas tank 1040 includes gas concentrations including about 6 percent oxygen gas and about 5 percent carbon dioxide gas to provide the desired partial pressures of oxygen and carbon dioxide. It is understood that other suitable concentration ratios are available and can be varied based on the desired values ​​depending on the individual blood values ​​of the newborn. In some exemplary embodiments, the gas flow rate can be provided at about 200 standard cubic meters per minute (SCCM) and the blood flow rate can be maintained at about 85 mL / min. The specific flow rates of gas and / or blood can be varied by the flow controller 1050, and other flow rates are also contemplated. The gas outlet 816 may be connected to another portable tank (not shown) or a vent (not shown). In some embodiments, the gas outlet 816 is open to the environment.

[0106] The oxygenator 800 may be disposed in line with the blood conduit 1202 so as to separate the blood conduit 1202 into at least two portions. A first blood conduit portion 1204 may extend between a first end 1208 of the blood conduit 1202 and a liquid inlet 804 of the oxygenator 800. A second blood conduit portion 1206 may extend between a liquid outlet 808 of the oxygenator 800 and a second end 1212 of the blood conduit 1202. In operation, liquid passing through the blood conduit 1202 may travel from the first portion 1204 toward the second portion 1206, or alternatively, from the second portion 1206 toward the first portion 1204. For purposes of this disclosure, the first portion 1204 may be referred to as the arterial portion of the blood circuit 1200, while the second portion 1206 may be referred to as the venous portion of the blood circuit 1200, although it will be understood that such terms and functions may be reversed. For example, the first portion 1204 may be a venous portion and the second portion 1206 may be an arterial portion. It should be understood that in such a reversed arrangement, the liquid inlet 804 of the oxygenator 800 is connected to the second portion 1206 and the liquid outlet 808 is connected to the first portion 1204.

[0107] 6 , the first portion 1204 of the blood conduit 1202 may be designed to be connected to an artery (not shown) of the umbilical cord of a newborn. The first portion 1204 may include a first end connector 1216 (alternatively referred to as an arterial connector 1216) at a first end 1208. The arterial connector 1216 may include a cannula configured to be connected to a blood vessel (e.g., the umbilical cord artery) of the newborn. The arterial connector 1216 may be sized depending on the desired use and may have a predetermined length, diameter, gauge size, connectors, retention members, and other preferred or required components for insertion of the cannula into the blood vessel and retention of the cannula within the blood vessel after cannulation.

[0108] In some aspects, the first end 1208 includes a plurality of arterial connectors 1216, each of which is configured to connect to a separate blood vessel in the neonate's umbilical cord. As shown in the exemplary embodiment of FIG. 6, the blood circuit 1200 may include two arterial connectors 1216 at the first end 1208. In other embodiments, the blood circuit 1200 includes one, two, three, four, or other suitable number of arterial connectors 1216 at the first end 1208. The first portion 1204 of the blood conduit 1202 may be sized according to a preferred size of cannula, for example, a 7 French, 8 French, or 9 French size. The inner diameter in such aspects ranges from about 1 / 32 inch to about 1 inch, between about 1 / 16 inch to about 0.5 inch, or other suitable range. In some exemplary embodiments, the inner diameter is about 0.133 inch. The outer diameter may be between about 2 / 16 inches and about 1.5 inches, between about 4 / 16 inches and about 1 inch, or other suitable range. In some exemplary embodiments, the outer diameter is about 5 / 16 inches. In some aspects, the first portion 1204 includes a larger cannula size, such as 14 French, 15 French, 16 French, or other suitable size. The inner diameter of at least a portion of the first portion 1204 may be in the range of about 1 / 16 inches to about 1 inch, between about 2 / 16 inches to about 1 / 2 inch, or other suitable range. In some exemplary embodiments, the inner diameter is about 3 / 16 inches. The outer diameter may be in the range of about 2 / 16 inches to about 1.25 inches, between about 4 / 16 inches to about 1 inch, or other suitable range. In some exemplary embodiments, the outer diameter is about 5 / 16 inches.

[0109] The first portion 1204 may include one or more access ports 1224 that provide access to the interior of the blood conduit 1202. In some embodiments, liquid is drawn from the interior of the blood conduit 1202 via the one or more access ports 1224. Additionally or alternatively, one or more liquids, solids, or solution mixtures may be introduced into the blood conduit 1202 via the one or more access ports 1224 (e.g., heparin, nutrients, and / or the like). In some embodiments, one or more sensors (described in more detail below) for measuring parameters of the priming fluid and / or neonatal blood in the blood circuit 1200 are measured via the one or more access ports 1224. The one or more access ports 1224 may be connectable to a syringe and / or a separate tubing line. The one or more access ports 1224 may be selectively open or closed to respectively allow or prevent liquid communication with the interior of the blood conduit 1202 through the access ports 1224. The one or more access ports 1224 may include a movable valve, a luer connector, a stopcock, a resealable membrane, a capped opening, or other suitable connector commonly used in the medical field.

[0110] The second portion 1206 of the blood conduit 1202 may be designed to be connected to a neonatal umbilical vein (not shown). The second portion 1206 may include a second end connector 1220 (alternatively referred to as a venous connector 1220) at the second end 1212. The second end connector 1220 may include a cannula configured to be connected to a neonatal blood vessel (e.g., an umbilical vein). The second end connector 1220 may be dimensioned depending on the desired application and may have a predetermined length, diameter, gauge size, connectors, retention members, and other preferred or required components for insertion of the cannula into the blood vessel and retention of the cannula within the blood vessel after cannulation. With continued reference to FIG. 6, the second portion 1206 includes a single second end connector 1220. However, it should be understood that the illustrated embodiment is not limiting and other aspects of the blood circuit 1200 include multiple venous connectors 1220, such as two, three, four, or other suitable number of venous connectors 1220.

[0111] The second portion 1206 of the blood conduit 1202 may be sized according to a cannula that is a preferred size, for example, 14 French, 15 French, 16 French, or other suitable size. In some embodiments, the second portion 1206 has a cannula that is larger than the cannula of the first portion 1204. The inner diameter of at least a portion of the first portion 1204 is in the range of about 1 / 16 inch to about 1 inch, between about 2 / 16 inch to about 1 / 2 inch, or other suitable range. In some exemplary embodiments, the inner diameter is about 3 / 16 inch. The outer diameter may be in the range of about 2 / 16 inch to about 1.25 inch, between about 4 / 16 inch to about 1 inch, or other suitable range. In some exemplary embodiments, the outer diameter is about 5 / 16 inch. Alternatively, the second portion 1206 includes a relatively smaller cannula, for example, a 7 French, 8 French, or 9 French size cannula, or other suitable size. The inner diameter in such embodiments may range from about 1 / 16 inch to about 1 inch, between about 2 / 16 inch to about 0.5 inch, or other suitable range. In some exemplary embodiments, the inner diameter is about 0.133 inch. The outer diameter may be between about 2 / 16 inch to about 1.5 inch, between about 4 / 16 inch to about 1 inch, or other suitable range. In some exemplary embodiments, the outer diameter is about 5 / 16 inch.

[0112] The second portion 1206 may include one or more access ports 1224. Unless otherwise noted, the one or more access ports 1224 are substantially similar to or the same as the one or more access ports 1224 described above in connection with the first portion 1204. It should be understood that the terminology for the first end connector 1216 and the second end connector 1220 depends on the particular use and operation of the blood circuit 1200. For example, if fluid flows from the first end 1208 toward the second end 1212, the first end connector 1216 is an arterial connector and the second end connector 1220 is a venous connector, whereas, conversely, if fluid flows in a direction from the second end 1212 toward the first end 1208, the first end connector 1216 is referred to as a venous connector and the second end connector 1220 is referred to as an arterial connector.

[0113] Connection between blood circuit and priming circuit and priming process Prior to connecting the blood circuit 1200 to the neonate, it may be advantageous to prime the blood circuit 1200. Priming may include introducing one or more liquids into the blood circuit 1200. This is advantageous to immediately provide the neonate with a desired priming fluid, which may include nutrients and / or blood thinners. The priming process may also serve to adjust the physical and / or chemical parameters of the priming fluid introduced into the blood circuit 1200. Adjustable parameters include the temperature, pressure, pH, osmolality, composition, gas saturation, and other properties of the priming fluid. Ensuring that the priming fluid introduced to the neonate has the desired parameters may reduce changes in injury to the neonate due to excessively hot or cold priming fluid or inappropriate concentrations of gases that are not optimal for the neonate's development. Priming the blood circuit 1200 may also serve to remove undesirable particulates or gases from the priming circuit 1300 prior to connecting the priming circuit 1300 to the neonate. For example, a priming fluid may be introduced into the blood circuit 1200 to displace and remove from the bloodstream any trapped air bubbles that may enter the neonate's bloodstream if not removed prior to cannulation. This step also serves to flush out any particulates, debris, or other unwanted components within the blood circuit 1200. In general, the purpose of priming the blood circuit 1200 prior to connecting it to the neonate is to ensure that when the neonate is cannulated and placed in fluid communication with the blood circuit 1200, the neonate will be in an optimal environment that is as close as possible to the physiological conditions of the natural womb.

[0114] To prime the blood circuit 1200, the blood circuit 1200 may be connected to a priming circuit 1300. With reference to Figures 7 and 8, exemplary connections are illustrated showing the blood circuit 1200 in fluid communication with the priming circuit 1300. The priming circuit 1300 is secured to the cart 1000 and operatively connected to or located adjacent to the pump 1052 and heater 1048, as described above. A priming source 1331 and a waste 1335 can be connected to the priming circuit 1300. The blood circuit 1200 is illustrated on the cart 1000 (shown on the tray 1100, which is described further below).

[0115] FIG. 8 shows details of the connection interface between the blood circuit 1200 and the priming circuit 1300. The blood conduit 1202 and the priming conduit 1302 may be connected to each other via a connection assembly 1500 and may be disposed in a connection cradle 1580 (described further below). The first end 1208 of the blood circuit 1200 may be connected to the first end 1308 of the priming circuit 1300. Similarly, the second end 1212 of the blood circuit 1200 may be connected to the second end 1312 of the priming circuit 1300. The first end connector 1216 of the blood circuit 1200 may be resealably connected to the first end connector 1316 of the priming circuit 1300. The second end connector 1220 of the blood circuit 1200 may be resealably connected to the second end connector 1320 of the priming circuit 1300. In embodiments in which the blood circuit 1200 includes a plurality of first end connectors 1216, the priming circuit 1300 includes a corresponding same number of first end connectors 1316, where each of the first end connectors 1216 of the blood circuit 1200 is connectable to a different first end connector 1316 of the priming circuit. Similarly, in embodiments in which the blood circuit 1200 includes a plurality of second end connectors 1220, the priming circuit 1300 includes a corresponding same number of second end connectors 1320, where each of the second end connectors 1220 of the blood circuit 1200 is connectable to a different second end connector 1320 of the priming circuit.

[0116] When a first end 1208 of the blood circuit 1200 is connected to a first end 1308 of the priming circuit 1300 and a second end 1212 of the blood circuit 1200 is connected to a second end 1312 of the priming circuit 1300, a loop circuit is established that includes both the priming circuit 1300 and the blood circuit 1200. That is, the priming circuit 1300 is in fluid communication with the blood circuit 1200, and fluid (e.g., priming fluid) can be circulated throughout the priming circuit 1300, transferred from the priming circuit 1300 to the blood circuit 1200, circulated throughout the blood circuit 1200, and returned to the priming circuit 1300. This arrangement allows the blood circuit 1300 to be primed with a desired priming fluid. Components operably connected to and in fluid communication with the blood circuit 1200 and / or the priming circuit 1300 may also be primed in this arrangement (e.g., oxygenator 800). A sweep gas may be introduced during priming of the blood circuit 1200.

[0117] An exemplary priming method 1700 is shown in the flow diagram of Figure 9. Prior to commencing priming of the blood circuit 1200 and its components, and as shown in step 1704, the blood circuit 1200 can be connected to the prime circuit 1300 to form an interconnected loop circuit between the prime circuit 1300 and the blood circuit 1200 described above.

[0118] During operation, the priming circuit 1300 may receive priming fluid from a priming fluid source 1331. In step 1708, the priming fluid source 1331 is connected to the priming circuit 1300 to begin the priming process. Alternatively, if the priming fluid source 1331 is already connected, priming fluid is introduced into the priming fluid source 1331 to prime. The priming fluid may travel from the source 1331 along the supply line 1330 and through the supply connector 1328 into the priming conduit 1302. The supply connector 1328 should be in an open configuration at this time to allow priming fluid to flow through the supply connector 1328 into the priming conduit 1302. If the supply connector 1328 is in a closed configuration, the supply connector 1328 may be moved to an open configuration during this step.

[0119] At step 1712, priming fluid flows through the priming circuit 1300. A pump 1052 operably connected to the priming circuit 1300 can be actuated to move priming fluid through the priming conduit 1302 toward the blood circuit 1200. Actuation of the pump 1052 can cause an increase in pressure in the priming conduit 1302 that moves fluid (including priming fluid or air) in the priming conduit 1302 along the priming conduit 1302 in a desired direction. In some embodiments, the pump 1052 is configured to move the priming fluid toward the first end 1308 of the priming conduit 1302 such that the priming fluid is discharged from one or more first end connectors 1316 to one or more connected first end connectors 1216 of the first end 1208 of the blood conduit 1202. In such embodiments, actuation of the pump 1052 causes the priming fluid to continue to flow through the blood circuit 1200 from the first end 1208 toward the second end 1212, then through one or more second end connectors 1220, out the second end 1212, and back to the priming circuit 1300 through one or more connected second end connectors 1320 of the second end 1312 of the priming conduit 1302. In some embodiments, the pump 1052 is configured to cause movement of the priming fluid in the opposite direction. In such embodiments, the pump 1052 is configured to move the priming fluid toward the second end 1312 of the priming conduit 1302 such that the priming fluid is discharged from the one or more second end connectors 1320 into one or more connected second end connectors 1220 of the blood conduit 1202. In such an embodiment, operation of the pump 1052 causes the priming fluid to continue to flow through the blood circuit 1200 from the second end 1212 toward the first end 1208, then out the first end 1208 through one or more first end connectors 1216, and back to the priming circuit 1300 through one or more connected first end connectors 1316 at the first end 1308 of the priming conduit 1302.In some embodiments, liquid is circulated back to the source container 1331 to trap any air bubbles within the source container 1331 .

[0120] During the priming step, while the priming fluid is circulating through the priming circuit 1300 and blood circuit 1200, parameters of the priming fluid can be adjusted until a desired target or threshold value is reached. In some embodiments, the temperature of the priming fluid is raised to a predetermined threshold and then maintained within a desired predetermined temperature range, as shown in step 1720. The temperature of the priming fluid can be monitored by temperature sensor 1324, as described above. The priming fluid can be heated by heater 1048 to raise the temperature. Heater 1048 can be adjusted to increase or decrease heat output to increase or decrease, respectively, the heat applied to the priming fluid. In some embodiments, the desired temperature range is similar to a physiological uterine temperature, for example, in the range between about 35 degrees Celsius and about 40 degrees Celsius, more specifically, in the range between about 36 degrees Celsius and about 38 degrees Celsius. Other suitable temperature thresholds are also envisioned.

[0121] In some embodiments, the pump 1052 is reversible so that the priming fluid can be pumped in either direction. In some exemplary embodiments, the priming fluid travels from the priming source 1331 to the priming conduit 1302 and toward the second portion 1206 of the blood conduit 1200, which corresponds to the venous connection of the blood circuit 1200. In this manner, the priming fluid receives heat from the heater 1048 and travels into the blood circuit 1200 while being heated, and as the priming fluid travels through the blood circuit 1200 and back into the priming circuit 1300, the priming fluid gradually loses heat. After the priming step, when the primed blood circuit 1200 is disconnected from the priming circuit 1300, the warmest blood is adjacent the second end 1206 (i.e., the venous connector). Thus, when the second end 1206 is connected to the umbilical cord (i.e., to the umbilical cord vein), the umbilical cord vein will receive the warmest blood from the blood circuit 1200, which is advantageous for minimizing the risk of venous spasms that may result due to undesirably low blood temperature.

[0122] When a desired amount of priming fluid has been introduced into the priming circuit 1300, the priming fluid source 1331 may be removed from fluid communication from the priming circuit 1300. This can be done by moving the supply connector 1328 to a closed configuration, preventing the flow of fluid from the supply line 1330 to the priming conduit 1302. In some embodiments, the desired priming fluid is substantially equal to the total volume of the priming circuit 1300 and the blood circuit 1200. In some embodiments, the desired volume of priming fluid is greater than the total volume of the priming circuit 1300 and the blood circuit 1200, such that a portion of the desired volume of priming fluid is removed from the loop circuit formed by the connected priming circuit 1300 and the blood circuit 1200. This allows any unwanted fluid or particulates within the priming circuit 1300, the blood circuit 1200, or any connected components to be flushed from the connected priming circuit 1300 and the blood circuit 1200. In step 1720, a portion of the priming fluid may be flushed from the priming circuit 1300. To flush a portion of the priming fluid, the waste connector 1332 is moved to an open configuration that allows flow of priming fluid from the priming conduit 1302 to a connected waste line 1334. From there, the priming fluid may travel toward and enter the waste receptacle 1335. Once the desired amount of priming fluid has been removed from the priming conduit 1302, the waste connector 1328 is moved to a closed position to prevent further flow of priming fluid therethrough to the waste line 1334. The priming fluid may be replaced with blood.

[0123] Once the initial priming fluid is replaced with blood, the dissolved gas concentration of the priming fluid can also be adjusted. As the priming fluid moves through the oxygenator 800, one or more gases are introduced into the priming fluid while one or more gases are removed therefrom via the oxygenator, as shown in step 1724. In some embodiments, the sweep flow rate and composition through the oxygenator 800 controls the partial pressures of oxygen and carbon dioxide gases in the blood. The goal of the gas exchange is to provide the priming fluid with partial pressures of gases that approximate those in a naturally occurring physiological environment (e.g., when a newborn is in utero). In some embodiments, the desired target range for the partial pressure of oxygen gas in the priming fluid is between about 30 mmHg and about 50 mmHg, more specifically between about 35 mmHg and about 40 mmHg. The partial pressure of carbon dioxide gas in the priming fluid is between about 30 mmHg and about 50 mmHg, more specifically between about 35 mmHg and about 40 mmHg. Nitrogen gas may also be added or removed to achieve balance. The gas exchange process may further aid in reaching and maintaining a target pH concentration of the priming solution. In some embodiments, the preferred pH range of the priming solution is between about 7 and about 8, more specifically between about 7.2 and about 7.6. In some exemplary embodiments, the target pH range is between about 7.35 and about 7.4. The gases utilized may be supplied from the console or stored in a gas tank 1040 with the desired concentration of gas prepared therein. The concentrations of oxygen, carbon dioxide, and nitrogen gases may be altered to alter the physiological blood values ​​that correspond to the neonatal blood gas concentrations.

[0124] In some embodiments, multiple priming solutions are used. That is, the priming circuit 1300 and / or the blood circuit 1200 may first be primed as described above with a first priming solution, and then the priming circuit 1300 and / or the blood circuit 1200 may be primed with a second priming solution. The first and second priming solutions may be the same, or the first and second priming solutions may be different or have different components therein. In some specific embodiments, the first priming solution includes a synthetic solution (e.g., a crystalloid solution including desired electrolytes, such as PlasmaLyte), and the second priming solution includes conditioned donor blood. When multiple priming solutions are used, the multiple priming solutions are connected to and introduced into the priming circuit 1300. In some embodiments, the first priming solution is first introduced into the priming solution source 1331, and then the second priming solution is introduced into the priming solution source 1331. In an alternative embodiment, each priming fluid is disposed in its own respective priming fluid source 1331, and each priming fluid source 1331 is selectively positioned in or out of fluid communication with the priming conduit 1302 such that a desired, predetermined amount of each of the first and second priming fluids is introduced into the priming circuit 1300 in a desired sequence.

[0125] Once the blood circuit 1200 and other desired components are sufficiently primed, the blood circuit 1200 can be disconnected from the priming circuit 1300 in step 1728. After the blood circuit 1200 is primed and disconnected from the priming circuit 1300, the blood circuit 1200 is connected to the neonate by cannulating the umbilical cord blood vessels.

[0126] It is understood that additional steps in the priming process are contemplated, and that the above list of steps is exemplary and not limiting. Unless otherwise noted, the above steps may be performed in any order relative to one another. For example, the priming fluid may be heated before, during, or after oxygen addition, or any combination. In some aspects, a portion of the priming fluid is heated at the same time that another portion of the priming fluid is oxygenated. One or more of the above steps may be performed multiple times, may be repeated sequentially, or may be repeated with other steps between repetitions. One or more of the above steps may be performed simultaneously in some embodiments.

[0127] Connection Assembly As briefly mentioned above, the priming circuit 1300 may be removably connected to the blood circuit 1200 via a connection assembly 1500 (shown generally in FIG. 8). The connection assembly 1500 serves to provide an interface between the respective ends 1202 and 1302 of the blood and priming conduits to place the blood circuit 1200 in fluid communication with the priming circuit 1300 such that priming fluid can circulate between the priming circuit 1300 and the blood circuit 1200. A first end 1208 of the blood conduit 1202 can be connected to a first end 1308 of the priming conduit 1302, and a second end 1212 of the blood conduit 1202 can be connected to a second end 1312 of the priming conduit 1302. In some embodiments, the connection assembly 1500 removably engages one or more first end connectors 1216 with respective one or more first end connectors 1316 (see, e.g., FIG. 8). Similarly, the connection assembly 1500 releasably engages one or more second end connectors 1220 with respective one or more second end connectors 1320. The connection assembly 1500 is actuated based on the relative positioning of one or more components therein (discussed in more detail below). The mating and unmating of the connectors of the priming circuit 1300 and the blood circuit 1200 may be spring-loaded or otherwise biased or pre-tensioned so that the connection is not permanent and is not established over time. That is, the interface between the priming circuit 1300 and the blood circuit 1200 may be disconnected so that the respective connectors do not contact each other until a desired time (e.g., immediately prior to the priming step). This may protect the connection components during shipping, sterilization, and / or storage, reducing the risk of compromising the integrity of the components.

[0128] 10-13, an exemplary embodiment of a connection assembly 1500 is illustrated. It is understood that other suitable connection mechanisms can be utilized to connect the priming circuit 1300 and the blood circuit 1200, and similar systems can be operated without the disclosed connection assembly 1500. The connection assembly 1500 includes a body portion 1504 including at least two connectors thereon for receiving the priming conduit 1302 and the blood conduit 1202 and forming an engagement between the blood conduit 1202 and the priming conduit 1302. The connection assembly 1500 may include a cover 1518 configured to at least partially enclose the body portion 1504 and the connectors to protect the components of the connection assembly 1500 from debris and / or damage. The components of the connection assembly 1500, as well as the respective connectors from the blood conduit 1202 and the priming conduit 1302, may also be protected from a non-sterile environment during use. The cover 1518 may be opaque or transparent. The cover 1518 may be movable between a closed configuration in which the cover 1518 contacts the body portion 1504 and prevents access to components defined or attached to the body portion 1504, and an open configuration in which the cover 1518 is spaced from the body portion 1504 to allow a user to access components on or within the body portion 1504. In some embodiments, the cover 1518 is completely separated from the body portion 1504 when moved to the open configuration, or alternatively, in other embodiments, the cover 1518 remains attached to the body portion 1504 (e.g., via a hinged connection) when moved to the open configuration.

[0129] 11-13, the blood circuit connector 1512 is disposed on or attached to the body portion 1504. The blood circuit connector 1512 is configured to receive the blood conduit 1202 thereon and be in fluid communication with the blood circuit 1200. The priming circuit connector 1508 is disposed on or attached to the body portion 1504 and is spaced apart from the blood circuit connector 1512 along the axial direction 1501. The priming circuit connector 1508 is configured to receive the priming conduit 1302 thereon and be in fluid communication with the priming circuit 1300. When the blood conduit 1202 is fully engaged with the blood circuit connector 1512 and the priming conduit 1302 is fully engaged with the priming circuit connector 1508, a fluid flow path can be established between the priming conduit 1302 and the blood conduit 1202.

[0130] In some embodiments, the priming circuit connector 1508 and the blood circuit connector 1512 are disposed on a carriage member 1520 disposed on or within the body portion 1504. The priming circuit connector 1508 may be spaced apart from the blood circuit connector 1512 along the axial direction 1501. A chamber 1528 may be defined within the carriage 1520 between the priming circuit connector 1508 and the blood circuit connector 1512 (labeled in FIGS. 12, 14A, 14B). The chamber 1528 may receive a priming fluid therein when the priming circuit 1300 is connected to the blood circuit 1200. The chamber 1528 may define a flow path between the priming conduit 1302 and the blood conduit 1202.

[0131] In some embodiments, the connection assembly 1500 is configured to have multiple connection states or configurations. In a fully connected configuration, the blood circuit 1200 and the priming circuit 1300 are in fluid communication with each other and are connected via a fluid flow path extending through the chamber 1528 between the priming circuit connector 1508 and the blood circuit connector 1512. In the fully connected configuration, the chamber 1528 is substantially sealed such that priming fluid can only travel from the priming conduit 1302 to the chamber 1528 and from the chamber 1528 to the blood conduit 1202 or vice versa. That is, in the fully connected configuration, the chamber 1528 and the liquid flow path extending therethrough are sealed (i.e., there are no leaks between the priming conduit 1302 and the priming circuit connector 1508 or between the blood conduit 1202 and the blood circuit connector 1512) so that substantially all of the liquid entering the chamber 1528 from one of the priming conduit 1302 and the blood conduit 1202 moves to the other of the priming conduit 1302 and the blood conduit 1202.

[0132] In the partially connected configuration, the blood circuit 1200 and the priming circuit 1300 may be in fluid communication with each other and may be connected via a fluid flow path extending through the chamber 1528, but the connection need not be fluid-tight. In some embodiments, in the partially connected configuration, the blood conduit 1202 contacts the blood circuit connector 1512, but a gap is defined between the blood conduit 1202 and the blood circuit connector 1512. Such an arrangement allows the blood circuit connector 1512 and the blood conduit 1202 to be axially aligned to facilitate movement to the fully connected configuration while maintaining separation of the connection points. Maintaining separation of the connections helps prevent damage to the connector components and can reduce the risk of contamination or bacterial growth. In the partially connected configuration, the blood conduit 1202 and the priming conduit 1302 are positioned relative to each other such that they can be easily moved to the fully connected configuration without a user spending excessive time aligning the components (compared to a fully disconnected configuration in which the priming conduit 1302 is completely disconnected from the priming circuit connector 1508, the blood conduit 1202 is completely disconnected from the blood circuit connector 1512, or both).

[0133] To transition from the partially connected configuration to the fully connected configuration, a portion of the connection assembly 1500 can be moved along the axial direction 1501 such that a fluid-tight connection is established between the priming conduit 1302 and the priming circuit connector 1508, between the blood conduit 1202 and the blood circuit connector 1512, or both. With reference to FIGS. 10-13, the carriage member 1520 can be movable relative to the body portion 1504 along the axial direction 1501. The body portion can define a recess 1540 configured to receive the carriage 1520 therein. The carriage 1520 can have a first position within the recess 1540 relative to the body portion 1504 (see, e.g., FIG. 14A) and a second position within the recess 1540 axially spaced from the first position along the axial direction 1501 (see, e.g., FIG. 14B). When the priming conduit 1302 is connected to the priming circuit connector 1508, the blood conduit 1202 is connected to the blood circuit connector 1512, and the carriage 1520 is in a first position, the connection assembly 1500 is in a partially connected configuration. When the priming conduit 1302 is connected to the priming circuit connector 1508, the blood conduit 1202 is connected to the blood circuit connector 1512, and the carriage 1520 is in a second position, the connection assembly 1500 is in a fully connected configuration.

[0134] The carriage 1520 can be moved between a first position and a second position by applying a force along the axial direction 1501 to the carriage 1520. In some embodiments, the carriage 1520 is moved from the first position to the second position by an actuator 1532. The actuator 1532 can be configured to apply a force to the carriage 1520 to slidably move the carriage 1520 along the axial direction 1501 relative to the body portion 1504. In some embodiments, the actuator 1532 includes a resilient spring. The resilient spring can apply a tension force to the carriage 1520 to move the carriage 1520. Alternatively, the resilient spring can apply a compression force to the carriage 1520. In some embodiments, the actuator 1524 includes a deformable member configured to be disposed in contact with the carriage 1520 and biased in a direction to cause movement of the carriage 1520 along the axial direction 1501. In the exemplary embodiment illustrated in FIGS. 10-14B, the connection assembly 1500 is shown having a spring actuator 1532 that is held in tension between the body portion 1504 and the carriage 1520. In such an embodiment, the spring actuator 1532 may apply a tensile force to the carriage 1520 to pull the carriage 1520 along the axial direction 1501 relative to the body portion 1504 and transition the connection assembly 1500 from a partially connected configuration to a fully connected configuration. With specific reference to FIGS. 14A and 14B, the connection assembly 1500 is shown in a partially connected configuration in FIG. 14A and in a fully connected configuration in FIG. 14B. In FIG. 14A, the end connector of the blood conduit 1202 (which may be either the first end connector 1216 or the second end connector 1220) is axially aligned with and partially inserted into the blood circuit connector 1512. However, because the end connector is not fully inserted into the blood circuit connector 1512, a fluid-tight seal is not established between the blood conduit 1202 and the chamber 1528 in this configuration.As shown in FIG. 14B, when the spring actuator 1532 moves the carriage 1520 along the axial direction 1501 toward the blood conduit 1202, the end connector of the blood conduit 1202 (e.g., the first end connector 1216 or the second end connector 1220) is axially aligned with the blood circuit connector 1512 and is fully inserted into the blood circuit connector 1512. When the end connector is fully inserted into the blood circuit connector 1512, a fluid-tight seal is established between the end connector and the blood circuit connector 1512 and the blood conduit 1202 is in fluid communication with the chamber 1528. The connection assembly 1500 is in a fully connected configuration. Although the priming conduit 1302 is not shown in FIGS. 14A and 14B, it is understood that the priming conduit 1302 must be fully connected to the priming circuit connector 1508 as described above in order for the connection to be established and for the connection assembly 1500 to be in the fully connected configuration. In the fully connected configuration, a fluid-tight seal is defined between the priming conduit 1302 and the chamber 1528 and between the blood conduit 1202 and the chamber 1528 .

[0135] 14C, an exemplary blood circuit connector 1512 is illustrated that may be utilized with one or more embodiments of the connection assembly 1500 disclosed herein. The blood circuit connector 1512 may define an opening 1513 configured to receive a blood conduit 1202 therein (e.g., the first end connector 1216 or the second end connector 1220). A channel 1514 is defined in the blood circuit connector 1512 extending from the opening 1513 along the axial direction 1501 toward the chamber 1528. The channel 1514 may be in fluid communication with the chamber 1528. The blood circuit connector 1512 may define a constriction 1515 therein disposed between the opening 1513 and the chamber 1528. The channel 1514 may be tapered along at least a portion of its length along the axial direction 1501 such that a cross-sectional dimension of the channel 1514 decreases between the opening 1513 and the constriction 1515. The channel 1514 has a first diameter D1 adjacent the opening 1513 and a second diameter D2 adjacent the constriction 1515. In some embodiments, the first diameter D1 is greater than the second diameter D2. It should be understood that the first diameter D1 should be sized such that an appropriate end connector of the blood conduit 1202 may be inserted therethrough into the channel 1514. In operation, when the blood conduit 1202 is not within the channel 1514, the connection assembly 1500 may be in a fully disconnected configuration, i.e., neither a fully connected configuration nor a partially connected configuration. When a portion of the blood conduit 1202 is within the channel 1514 but is spaced from and does not contact the constriction 1515, the connection assembly 1500 may be in a partially connected configuration. The connection assembly 1500 may be in a fully connected configuration when a portion of the blood conduit 1202 is within the channel 1514 and in contact with the constriction 1515. As the blood conduit 1202 moves further within the channel 1514 along the axial direction 1501 toward the constriction 1515, the blood conduit 1202 may contact the call of the channel 1514 as the channel 1514 tapers.Contact between the walls of the channel 1514 and the blood conduit 1202 can define a fluid-tight seal such that liquid can be transferred from the chamber 1528 into the blood conduit 1202 without flowing around the blood conduit 1202 and leaking out of the opening 1513 of the blood circuit connector 1512.

[0136] The connection assembly 1500 is configured to be actuated between a partially connected configuration and a fully connected configuration by the actuator 1532 moving the carriage 1520 within the recess 1540 of the body portion 1504. For purposes of this disclosure, when the carriage 1520 is in a first position, the connection assembly 1500 is in a partially connected configuration, and when the carriage 1520 is in a second position, the connection assembly 1500 is in a fully connected configuration, although it is understood that such terminology is reversed in other embodiments. In some aspects, the carriage 1520 is biased toward movement toward the second position. In such embodiments, the carriage 1520 is physically restrained in its first position from moving toward its second position. It should be understood that the restraining mechanism should be sufficient to apply the force necessary to counteract the biasing force being applied to the carriage 1520 by the actuator 1532. To move the carriage 1520 to the second position, the restraining mechanism is removed or reduced such that the force applied by the actuator 1532 is sufficient to move the carriage 1520 to the second position. Referring again to FIG. 13, the actuator 1532 is a spring 1532 operably coupled to the carriage 1520 and the body portion 1504. The spring 1532 can apply a tension force to the carriage 1520 to bias the carriage 1520 to move along the axial direction 1501 within the recess 1540 toward the blood circuit 1200. The carriage 1520 can include a retention and release mechanism 1536. The retention mechanism 1536 can hold the carriage 1520 in its first position. The retention mechanism 1536 is designed to counter the biasing force being applied by the spring 1532. The retention mechanism 1536 may be any suitable retention device configured to counteract and exert a force at least as strong as the biasing force exerted by the spring 1532. In some embodiments, the retention mechanism 1536 includes a flexible arm 1537 extending from the carriage 1520. The flexible arm 1537 may be configured to deflect in at least one direction perpendicular to the axial direction 1501. The flexible arm 1537 may have a protrusion 1538 defined thereon.The protrusion 1538 may be configured to releasably contact a corresponding retaining surface. As shown in FIG. 13 , the body portion 1504 may define a shoulder 1544 thereon configured to receive the protrusion 1538. When the carriage 1520 is in the first position, the spring 1532 may be tensioned and may apply a biasing force to the carriage 1520 toward the second position. In the first position, the protrusion 1538 may contact the shoulder 1544 of the body portion 1504. The protrusion 1538 may be axially aligned with the shoulder 1544 along the axial direction 1501. Because the biasing force applied by the spring 1532 is not sufficient to overcome the engagement between the protrusion 1538 and the shoulder 1544, the carriage 1520 is retained in the first position despite the biasing force applied by the spring 1532. To move the carriage 1520 from the first position to the second position, the retention mechanism 1536 can be actuated to no longer impede or to impede less the biasing force exerted by the spring 1532. The protrusion 1538 can be moved out of axial alignment with the shoulder 1544 by deflecting the flexible arm 1537 along a direction offset from the axial direction 1501. When the protrusion 1538 is not in contact with the shoulder 1544, the biasing force exerted by the spring 1532 can move the carriage 1520 along the axial direction 1501 to the second position. In some embodiments, the retention mechanism 1536 includes a plurality of flexible arms 1537, protrusions 1538, and respective shoulders 1544.

[0137] The retention feature 1536 is released by a user by moving one or more projections 1538 out of axial alignment with one or more respective shoulders 1544. In some embodiments, the retention feature 1536 is released by movement of the connection assembly 1500 and / or engagement relative to or with other components of the connection assembly 1500. With reference to FIGS. 15 and 16, a manifold 1560 configured to receive one or more connection assemblies 1500 thereon is illustrated. The manifold 1560 is configured to hold the connection assemblies 1500 during a priming process. In some embodiments, the manifold 1560 is used to transition each connection assembly 1500 from a partially connected configuration to a fully connected configuration (e.g., by causing movement of the carriage 1520 from a first position to a second position). The manifold 1560 includes a receiving surface 1564 configured to receive each connection assembly 1500 thereon. One or more retention channels 1566 may be defined on the receiving surface 1564 for contacting the attached connection assembly 1500 and releasably securing the connection assembly 1500 to the manifold 1560 .

[0138] In some embodiments, relative movement of the connection assembly 1500 along the receiving surface 1564, as well as contact between the connection assembly 1500 and the retention channel 1566, can release the retention feature 1536 described above to cause movement of the carriage 1520. In some embodiments, the manifold 1560 can include one or more fingers 1568 defined thereon and configured to operatively contact the retention feature 1536 on the connection assembly 1500. The fingers 1568 are positioned such that when the connection assembly 1500 is secured to the receiving surface 1564 within the one or more retention channels 1566, the fingers 1568 move the protrusion 1538 out of axial alignment with the shoulder 1544. As described above, when the protrusion 1538 is not axially aligned with the shoulder 1544, the carriage 1520 is moved to the second position by a force applied to the carriage 1520 by the spring 1532 (or by other suitable actuator).

[0139] An exemplary release process is shown in Figures 17A, 17B, and 17C. In Figure 17A, the connection assembly 1500 is shown received on the receiving surface 1564 of the manifold 1560 along the axial direction 1501. The protrusion 1538 is shown axially aligned with the shoulder 1544, thus retaining the carriage 1520 in its first position. The finger 1568 is spaced from the protrusion 1538. In Figure 17B, the connection assembly 1500 has been moved further along the axial direction 1501 toward the finger 1568, where the finger 1568 can contact the protrusion 1538. As the connection assembly 1500 continues to move in the same direction, contact between the finger 1568 and the protrusion 1538 can deflect the flexible arm 1537 (shown in FIG. 13 and described above) away from the axial direction 1501, causing the protrusion 1538 attached to the flexible arm 1537 to move out of axial alignment with the shoulder 1544 on the body portion 1504. In FIG. 17C, the flexible arm 1537 is deflected and the protrusion 1538 is moved out of axial alignment with the shoulder 1544 by the finger 1568 on the manifold 1560. Without the engagement between the protrusion 1538 and the shoulder 1544 counteracting the biasing force exerted by the spring 1532, the spring 1532 can cause the carriage 1520 to move to a second position within the recess 1540 of the body portion 1504. When the carriage 1520 is in its second position, the connection assembly 1500 is in a fully connected configuration, as described above. At this point, the priming process can begin to move priming fluid between the priming circuit 1300 and the blood circuit 1200. Although Figures 17A-17C do not show the priming conduit 1302 connected in order to provide a better view of the other described components, it is understood that such a connection should be established prior to beginning the priming process.

[0140] The cart 1000 may include multiple connection assemblies 1500 such that each connector on the blood circuit 1200 is connected to each connector on the priming circuit 1300. In some exemplary embodiments, each of the one or more first end connectors 1216 and second end connectors 1220 of the blood conduit 1202 is received in, on, or adjacent to a blood circuit connector 1512 of a separate connection assembly 1500. Similarly, each of the one or more first end connectors 1316 and second end connectors 1320 of the priming conduit 1302 is received in, on, or adjacent to a priming circuit connector 1508 of a respective separate connection assembly 1500.

[0141] Each connection assembly 1500 may include a connector specific to the component being connected to the connection assembly 1500. In some embodiments, the first end connector 1316 of the priming conduit 1302 is different from the second end connector 1320. Thus, one connection assembly 1500 utilized with the first end 1308 of the priming conduit 1302 has a different priming circuit connector 1508 than another connection assembly 1500 utilized with the second end 1312 of the priming conduit 1302. It is understood that the connectors should be complementary to any components they are designed to mate with. In the exemplary embodiment illustrated in Figures 12 and 13, two different priming circuit connectors 1508 are shown, with exemplary priming circuit connector 1508a referring to a priming circuit connector for use with the first end 1308 of the priming conduit 1302 and exemplary priming circuit connector 1508b referring to a priming circuit connector for use with the second end 1312 of the priming conduit 1302. It is understood that other suitable connector designs are envisioned. Although two priming circuit connectors 1508a and 1508b are illustrated in Figures 12 and 13, it is understood that each connection assembly 1500 may include a single priming circuit connector, and that the priming circuit connectors are interchangeable depending on which end of the priming conduit 1302 is connected to a particular connection assembly 1500. The blood circuit connector 1512 may also differ depending on which portion of the blood conduit 1202 is connected. In some embodiments, the blood circuit connector 1512 for use with the first end connector 1216 has a smaller cross-sectional dimension than the blood circuit connector 1512 for use with the second end connector 1220. For example, the first and second diameters D1 and D2 shown in FIG. 14C are smaller in the blood circuit connector 1512 configured to receive the first end connector 1216 of the blood conduit 1202 than the first and second diameters D1 and D2, respectively, of the blood circuit connector 1512 configured to receive the second end connector 1220 of the blood conduit 1202.

[0142] In some embodiments, it is advantageous to utilize connection assemblies 1500 that cannot be connected to an incorrect conduit. If all connection assemblies 1500 were completely interchangeable, the risk of user error would be increased in that a connector of a blood conduit 1202 could be inadvertently connected to a connector of a priming conduit 1302. To ensure that only proper connections are made, each connection assembly 1500 may be arranged, or have components arranged therein, in such a way that only desired connections are made, while incorrect connections cannot be successfully made. For example, in some embodiments, one or more connection assemblies 1500 intended to be used to connect first ends 1208 and 1308 of blood conduits 1202 and priming conduits 1302, respectively, include blood circuit and priming circuit connectors 1512 and 1508 that only allow proper engagement with the correct first ends 1208 and 1308, and do not allow proper connection with, for example, the second end 1212 of the blood conduit 1202 or the second end 1312 of the priming conduit 1302. Conversely, one or more connection assemblies 1500 intended to be used to connect the second ends 1212 and 1312 of the blood conduit 1202 and the priming conduit 1302, respectively, include blood circuit and priming circuit connectors 1512 and 1508 that only allow proper engagement with the correct second ends 1212 and 1312, and do not allow proper connection, for example, with the first end 1208 of the blood conduit 1202 or the first end 1308 of the priming conduit 1302.

[0143] 18, the manifold 1560 can be removably held within a cradle 1580. The cradle 1580 can include an internal receiver 1584 configured to receive the manifold 1560 (and any accessory connection assemblies 1500) therein. The receiver 1584 is configured to receive and hold fluid therein, for example, if priming fluid leaks from the priming conduit 1302, the blood conduit 1202, and / or the connection assemblies 1500. The cradle 1580 can be removably connected to a cart 1000, for example, the top 1004 of the cart 1000 (see, for example, FIGS. 1-3 and 8).

[0144] Draping Procedure 7 and 27, a drape 2700 can be placed between the transfer tray 1100 and the cart 1000. The drape 2700 can provide a barrier between the sterile and non-sterile components during use of the system. The drape 2700 can provide a thermal barrier between the transfer tray 1100 and the cart 1000. The drape 2702 can include a cutout 2702 for the weight sensor 1008. The drape 2702 can include a cutout 2704 for the docking cradle 1580. The cutout 2704 can be an elongated slit in the drape 2702 such that a flap extends from the top surface of the cart 1000 into the space between the docking cradle 1580 and the cart 1000. The drape 2700 can include a window 2706 such that the display 1016 is viewable through the window 2706 when the drape 2702 is on the cart 1000. The window 2706 can be a transparent film that allows light to pass through while maintaining sterility. The drape 2700 can be removably coupled to the cart 1000. The connection cradle 1580 helps secure the drape 2700 to the cart 1000.

[0145] Transfer Tray The blood circuit 1200 may be retained on the cart 1000 when the blood circuit 1200 is connected to the priming circuit 1300 and primed, and when the blood circuit 1200 is connected to or connected to a neonate. When the neonate is transferred from the cart 1000 to the main console, the blood circuit 1200 is transferred with the neonate (and, for example, with the neonate chamber assembly 10). To facilitate the transfer of multiple components with the neonate, it is advantageous to utilize a transfer tray 1100 designed to receive and hold thereon the neonate, the neonate chamber assembly 10, the blood circuit 1200, and / or other components. With reference to Figures 19-21, a tray 1100 for receiving the neonate chamber assembly 10 including the neonate 1 therein is illustrated. The tray 1100 includes a body portion 1104 defining an upper surface 1108 and a lower surface 1112 opposite the upper surface 1108 and spaced from the upper surface 1108 along a vertical axis 1001. As shown in FIG. 19, the neonatal chamber assembly 10 is disposed on the body portion 1104, for example, on or adjacent to the top surface 1108. In some embodiments, the top surface 1108 is dimensioned such that the tray 1100 is configured to receive a volume of liquid thereon on the top surface 1108 without the liquid flowing or spilling from the tray 1100. As such, the top surface 1108 defines one or more receptacles, depressions, or grooves 1109 (labeled in FIG. 20) on the body portion 1104 configured to receive a volume of liquid therein. Such an arrangement allows for the capture of spilled liquid in the event that priming fluid, neonatal blood, or neonatal chamber assembly fluid unexpectedly leaks from the blood circuit 1200 and / or neonatal chamber assembly 10. In some embodiments, the body portion 1104 of the tray 1100 is dimensioned such that any liquid that overflows from one or more of the receptacles 1109 is directed to a desired location relative to the tray 1100, such as a designated gutter or waste source (not shown). Such an arrangement is advantageous in the event that the tray 1100 overflows, to prevent liquid from contacting electronic components that may be damaged by the liquid.

[0146] The neonate 1 can be introduced into the neonate chamber assembly 10 before or after the neonate chamber assembly 10 is placed in the tray 1100. The neonate chamber assembly 10 can be placed on a first portion 1116 of the tray 1100. The tray 1100 may include a second portion 1120 offset from the first portion 1116 along the longitudinal axis 1002 and / or along the transverse axis 1003. In some embodiments, a portion of the first portion 1116 overlaps a portion of the second portion 1120. For purposes of this disclosure, the first portion 1116 generally refers to a portion of the tray 1100 configured to receive the neonate 1 and / or neonate chamber assembly 10 thereon, and the second portion 1120 generally refers to a portion of the tray 1100 configured to receive a support assembly 1150 for securing the blood circuit 1200 thereon (described in more detail below). In some particular embodiments, the first portion 1116 may include one or more receptacles 1109, the second portion 1120 may include one or more receptacles 1109, and the one or more receptacles 1109 of the first portion 1116 may be isolated from the one or more receptacles 1109 of the second portion 1120 such that liquid received in the one or more receptacles 1109 of the first portion 1116 is not mixed with liquid received in the one or more receptacles 1109 of the second portion 1120.

[0147] The tray 1100 can be received on the cart 1000 (see FIG. 1), for example, on the top surface 1006 of the top 1004. The bottom surface 1112 of the tray 1100 can be configured to contact at least a portion of the top 1004 of the cart 1000. In some embodiments, as shown in FIG. 21, the tray 1100 includes a retaining structure 1132 configured to retain the tray 1100 on the cart 1000 to facilitate a desired alignment between the tray 1100 and the cart 1000 and / or to prevent inadvertent movement of the tray 1100 relative to the cart 1000. The retaining structure 1132 can include a notch configured to receive a protrusion of a complementary retaining structure 1010 (labeled in FIG. 2) on the cart 1000. The retaining structure 1010 on the cart 1000 can be adjacent to or can include a weight sensor 1008. Additionally or alternatively, the retaining structures 1132 of the tray 1100 may be protrusions receivable within complementary notches or grooves defined on the cart 1000. In some embodiments, the retaining structures 1132 of the tray 1100 are constructed from a material having a higher coefficient of friction than the material of the body of the tray 1100 such that when the tray 1100 is placed on the cart 1000, contact between the retaining structures 1132 and the cart 1000 along the vertical axis 1001 prevents relative sliding between the tray 1100 and the cart 1000 along the longitudinal axis 1002 and / or the lateral axis 1003. In such embodiments, the complementary retaining structures 1010 on the cart 1000 are constructed from such a material having a higher coefficient of friction in addition to or in place of the retaining structures 1132 on the tray 1100. In some embodiments, the tray 1100 includes a plurality of retaining structures 1132 on the lower surface 1112. Thus, the cart 1000 may include a plurality of corresponding retaining structures 1010 thereon. It will be appreciated that the respective arrangements of the retaining structures 1132 of the tray 1100 and the retaining structures 1010 of the cart 1000 may be arranged to allow for a desired orientation and alignment of the tray 1100 relative to the cart 1000.

[0148] In some embodiments, the neonatal chamber assembly 10 is placed directly on the top surface 1108 of the tray 1100. It should be understood that the body portion 1104 (and particularly the first portion 1116) should be sized and shaped to be compatible for receiving and securing the neonatal chamber assembly 10. In some embodiments, as shown for example in FIG. 19, the tray 1100 includes a support member 1124 configured to receive the neonatal chamber assembly 10 thereon. The support member 1124 can be secured to the body portion 1104 of the tray 1100 via known mechanisms such as fasteners, clips, welding, friction or wedge fits, or other suitable securing mechanisms. The support member 1124 may be separable and removable from the tray 1100, or the support member 1124 may be replaceable with another mechanism (not shown) that is part of the console. In some embodiments, the tray 1100 is formed with the support member 1124 as an integral part of the one-piece tray 1100.

[0149] In some embodiments, the support member 1124 has a height 1128 measured along the vertical axis 1001 from the top surface 1108 along the support member 1124. The height 1128 of the support member 1124 may be adjustable to allow the support member 1124 to be shortened or removed when the newborn chamber assembly 10 is secured to a support mechanism (not shown) that is part of the console. Alternatively, the height 1128 of the support member 1124 may be adjustable based on a desired distance between the body portion 1104 of the tray 1100 and the newborn chamber assembly 10 or the newborn 1. In some embodiments, the support member 1124 includes a releasable retention mechanism (not shown) configured to releasably secure to the newborn chamber assembly 10 to prevent inadvertent separation of the newborn chamber assembly 10 from the support member 1124. In some embodiments, the support member 1124 is shaped or dimensioned such that a portion of the support member 1124 is received in a complementary notch or groove (not shown) on the neonatal chamber assembly 10, or, additionally or alternatively, the support member 1124 defines such a notch or groove configured to receive a complementary protrusion defined on the neonatal chamber assembly 10.

[0150] In some aspects, the tray 1100 is configured to receive multiple support members 1124, such as two, three, four, five, six, seven, or more support members 1124. In some specific embodiments disclosed herein, the tray 1100 includes four support members 1124. Each of the support members 1124 is disposed on the body portion 1104 such that, together, all of the support members 1124 can receive the neonatal chamber assembly 10 thereon and hold the neonatal chamber assembly 10 in a stable and secure manner relative to the remainder of the tray 1100. The support members 1124 can be removably coupled to the tray 1100. The tray 1100 can include a receiver 1103 adapted to receive a portion of the support member 1124. The receiver 1103 can include a side wall 1105 and a top wall 1107 that define a recess for receiving a portion of the support member 1124. The receiver 1103 may include a pin 1111 adapted to be received within a recess in the support member 1124. The pin 1111 may be a spring loaded pin that is movable relative to the receiver 1103 such that a foot of the support member 1124 can slide horizontally within a recess defined by the receiver 1103. The neonatal chamber assembly 10 may be coupled to the support assembly 1150 such that the neonatal chamber assembly 10 may be supported without the use of the support member 1124. The support member 1124 may be individually removable from the neonatal chamber assembly 10. The neonatal chamber assembly 10 may be cantilevered from the support assembly 1150.

[0151] In some embodiments, the tray 1100 includes a preferred color, pattern, or other visual scheme to provide a contrasting background to facilitate identifying, isolating, and visualizing the neonate within the neonate chamber assembly 10 when the tray 100 is placed within the main console.

[0152] The tray 1100 may include a gantry or support assembly 1150 for receiving, holding, and / or manipulating one or more components of the blood circuit 1200. The support assembly 1150 is disposed on the second portion 1120 of the tray 1100. With continued reference to FIGS. 19-21 and further reference to FIG. 22, the support assembly 1150 includes a base 1154 that allows the support assembly 1150 to be attached to the tray 1100. The base 1154 may be a unitary, uniform part of the tray 1100, or the base 1154 may alternatively be a separable part. The base 1154 is attached to the tray 1100 via known connection mechanisms, such as fasteners, clips, welds, friction or wedge fits, or other suitable fastening mechanisms. The base 1154 may receive posts 1158 therein or thereon. The post 1158 may be secured to the tray 1100 via the base 1154 and may extend from the base 1154, at least in part, along a vertical axis 1001 away from the tray 1100. The post 1158 may be movable relative to the base 1154 and the tray 1100. The post 1158 may be movable along the vertical axis 1101 toward or away from the base 1154. In some embodiments, the post 1158 is rotatable about the vertical axis 1001 (or about another axis parallel to the vertical axis 1001). The support assembly 1150 may be configured to selectively permit or prevent translation and / or rotation of the post 1158 relative to the base 1154. A retainer 1190 may be disposed on the base 1154 and / or on the post 1158 and may be actuated to selectively permit and prevent movement of the post 1158. In some aspects, the retention device 1190 is a knob 1190 that can be rotated in a first direction to secure the post 1158 relative to the base 1154 to prevent movement of the post 1158, and can be rotated in a second direction opposite the first direction to allow movement of the post 1158. This disclosure is not limited to the particular retention device utilized, and other contemplated embodiments of the support assembly 1150 include other suitable retention mechanisms, such as clips, pins, ties, or other fasteners.In some embodiments, the posts 1158 are rigidly fixed relative to the base 1154 such that the posts 1158 do not move relative to the base 1154. In some embodiments, the posts 1158 are integrated with the base 1154 as part of the integral support assembly 1150.

[0153] A movable support 1162 is disposed on the post 1158. The support 1162 is configured to receive at least a portion of the blood circuit 1200 thereon. The support 1162 may include or receive one or more attachment members 1164 thereon configured to removably attach a portion of the blood circuit 1200 to the support 1162. The one or more attachment members 1164 may include clips, tethers, tube conduits or channels, tie-downs, grooves or notches, or other suitable components configured to hold a portion of the blood circuit 1200 on the support 1162 without damaging the blood circuit 1200 and without interfering with the desired operation of the blood circuit 1200 or its associated components. The support 1162 may be movable relative to the tray 1100 along the post 1158. The support 1162 may be translatable along the vertical axis 1001 toward and away from the tray 1100. The support 1162 may be rotatable about the post 1158 (i.e., about the vertical axis 1001 or about an axis parallel to the vertical axis 1001). In some embodiments, the support 1162 is rotatable up to 360 degrees about the post 1158. Translation and / or rotation of the support 1162 allows for adjustment of the blood circuit 1200 relative to the neonatal chamber assembly 10 and / or the priming circuit 1300. The maneuverability of the support 1162 can also allow for unhindered or less hindered access to components on the tray 1100 that would be difficult to access if movement of the support 1162 was not permitted. For example, the support 1162 may be in a first position while the neonate is being cannulated to provide additional space for a user to cannulate the neonate, and in a second position translationally and / or rotationally offset from the first position after the neonate is cannulated and fluid flow through the blood circuit 1200 and neonate is established. Other positions of the support 1162 are also envisioned, for example, during priming of the blood circuit 1200 (as described above) or during replacement and / or priming of the oxygenator 800 (as further described below).Another retention device 1190 may be disposed on the post 1158, the support 1162, or both to selectively allow translational and / or rotational movement of the support 1162 relative to the post 1158. The retention device 1190 may be any suitable retention mechanism as described above.

[0154] The support assembly 1150 may be configured to receive and / or hold thereon one or more sensors configured to monitor, measure, record, and / or transmit information related to various parameters of the blood circuit 1200, the priming fluid, the neonatal blood, the neonate, the environment within the neonatal chamber assembly 10, and / or the environment surrounding the tray 1100 and / or cart 1000. Blood may be moved through the blood circuit 1200 by the neonate's heart, and thus the one or more sensors may monitor the performance of the neonate's heart. The sensors may include temperature sensors, flow meters, pressure sensors, gas saturation sensors, light sensors, air bubble sensors, liquid composition sensors, meconium sensors, and other sensors for detecting desired parameters related to the development of the neonate. One or more of the sensors are configured to communicate with a controller and processor (not shown) that may receive and record measurements, perform calculations related to the received measurements, and / or transmit signals or instructions based on the received data to other components of the tray 1100, cart 1000, blood circuit 1200, priming circuit 1300, or another system to which it is physically or wirelessly connected. With continuing reference to Figure 22 and with further reference to Figures 23 and 24, one or more sensors are carried on the support 1162. As shown in the exemplary embodiment of Figure 23 and the alternative exemplary embodiment of Figure 24, a blood gas saturation sensor or flow sensor 1180 is disposed on the support 1162 and configured to measure one or more gas saturations of the liquid flowing through the blood conduit 1202. The gas saturation sensor 1180 may be configured to measure the saturation of oxygen gas in the liquid flowing through the blood conduit 1202.In some embodiments, multiple gas sensors 1180 are positioned to measure gas saturation along various portions of the blood circuit 1200, for example, a first gas saturation sensor positioned on the first blood conduit portion 1204 to measure oxygen saturation in liquid flowing toward the oxygenator 800 before oxygenation, and a second gas saturation sensor 1180 positioned on the second blood conduit portion 1206 to measure oxygen saturation in liquid flowing away from the oxygenator 800 after oxygenation. The one or more gas saturation sensors 1180 may be non-invasive such that the one or more gas saturation sensors 1180 can operate without being inserted into or otherwise penetrating the blood conduit 1202. For example, the one or more gas saturation sensors 1180 are designed to be positioned adjacent to the blood conduit 1202.

[0155] One or more flow sensors 1181 may be disposed on the support 1162 and configured to detect parameters of the flow of liquid and / or gas through the blood conduit 1202. The one or more flow sensors 1181 may be configured to detect the flow rate of the liquid as well as other characteristics such as viscosity, turbulence, composition, etc. In some embodiments, the one or more flow sensors 1181 are configured to detect and / or quantify the presence of air bubbles within the liquid flowing through the blood conduit 1202. Detection of air bubbles preferably allows for identification and removal of air bubbles to reduce the risk of injury to the neonate.

[0156] One or more pressure transducers or sensors 1182 may be disposed on or adjacent to the support 1162 configured to measure fluid pressure within the blood conduit 1202. In some aspects, the one or more pressure sensors 1182 are configured to measure pressure within the neonatal blood vessels. In some specific embodiments, the one or more pressure sensors 1182 are configured to measure arterial pressure. In the exemplary aspects of FIGS. 23 and 24, two separate pressure sensors 1182 are illustrated. One of the two pressure sensors 1182 may be configured to detect a pressure measurement within the first blood conduit portion 1204, and the other of the two pressure sensors 1182 may be configured to detect a pressure measurement within the second blood conduit portion 1206.

[0157] In some embodiments, it is preferred that the position of the pressure sensor 1182 relative to the tray 1100 can be adjusted based on the respective position of the neonate 1. The pressure sensor 1182 may be configured to move along the vertical axis 1001 toward or away from the tray 1100 based on the position of the neonate 1. The height of the pressure sensor 1182 (measured along the vertical axis 1001 between the top surface 1108 of the tray 1100 and the pressure sensor 1182) may be adjusted to correspond to the sternal axis of the neonate. This is advantageous to allow approximating the mean arterial pressure of the neonate. In some embodiments, the neonate 1 can be moved relative to the pressure sensor 1182, for example, by adjusting the height 1128 of the neonate chamber assembly 10 by adjusting the height of the support member 1124. In preferred embodiments, the pressure sensor 1182 can be moved relative to the neonate 1. The pressure sensor 1182 can be moved by moving one or more components of the support assembly 1150. In some embodiments, the support 1162 can be moved along the support 1158 toward or away from the tray 1100 so that the pressure sensor 1182 is positioned in substantially the same plane as the neonate 1, specifically the neonate's heart, defined by the longitudinal axis 1002 and the lateral axis 1003.

[0158] In some more preferred embodiments, the pressure sensor 1182 is movable along the vertical axis 1001 relative to the support 1162 without requiring movement of the support 1162 itself. Referring again to FIG. 22, a pressure sensor holder 1170 is operably connected to the support assembly 1150, for example to the support 1162. The pressure sensor holder 1170 is configured to receive one or more pressure sensors 1182, such as two pressure sensors 1182 in some disclosed embodiments. The multiple pressure sensors 1182 may all be disposed within the same plane defined by the longitudinal axis 1002 and the lateral axis 1003. The pressure sensor holder 1170 may be configured to be slidably movable along the longitudinal axis 1001 relative to the tray 1100. In some embodiments, the pressure sensor holder 1170 is slidably movable relative to the support 1162. 22, for example, a rail 1174 may be disposed on the support 1162 along which the pressure sensor holder 1170 may be moved. It is understood that other suitable arrangements that allow the multiple pressure sensors 1182 to be moved along the vertical axis 1001 may be envisioned. One or more retaining devices 1190 may be disposed on the support assembly 1150, on the support 1162, on the pressure sensor holder 1170, and / or on the rail 1174 configured to selectively permit and prevent translational movement of the pressure sensor holder 1170 (and the pressure sensors 1182 thereon). The one or more retaining devices 1190 may be one or more of the different types of suitable retaining devices 1190 described above.

[0159] In some embodiments, the support assembly 1150 is configured to receive and hold the oxygenator 800 thereon. With reference to FIGS. 22-24, an oxygenator holder 1166 may be disposed on the support assembly 1150. The oxygenator holder 1166 is configured to removably secure the oxygenator 800. In some embodiments, the oxygenator holder 1166 may be disposed on the support 1162 and may be movable relative to the tray 1100 when the support 1162 is moved. In other embodiments, the oxygenator holder 1166 may be secured to the post 1158 and may be separate from the support 1162. The oxygenator holder 1166 may be translatable along the post 1158 toward and away from the tray 1100 along the vertical axis 1001. The oxygenator holder 1166 may be rotatable about the post 1158. In some embodiments, a holder 1190 may be disposed on the support assembly 1150 and configured to selectively permit or prevent translation and / or rotation of the oxygenator holder 1166. The holder 1190 may be any one of the suitable holders described above. In some embodiments, one of the previously disclosed holders 1190 configured to permit or prevent translation and / or rotation of one or more of the other disclosed components of the support assembly 1150 (e.g., the strut 1158, the support 1162, and / or the pressure sensor holder 1170) may be additionally configured to permit or prevent translation and / or rotation of the oxygenator holder 1166. In use, the oxygenator 800 may be moved relative to the remainder of the blood circuit 1200 and relative to the tray 1100 and / or other components of the support assembly 1150. The oxygenator 800 may be moved by rotating or translating the oxygenator holder 1166 with the oxygenator 800 therein. For example, while the neonate is being cannulated, the oxygenator 800 can be moved to a first position to allow the user inserting the cannula unhindered access to the neonate 1 on the tray 1100 and other components of the blood circuit 1200.After the cannula is inserted, the oxygenator 800 may be moved to a second position that is translationally and / or rotationally offset from the first position such that the oxygenator 800 is disposed in a desired orientation and placement relative to the blood circuit 1200. In some embodiments, when the oxygenator 800 is being primed and prepared for use (or when a replacement oxygenator is being primed and prepared for use), the oxygenator 800 may similarly be moved to the first position and then moved to the second position upon completion of the priming process (as described below).

[0160] In some embodiments, the support assembly 1150 is configured to hold the above-mentioned components such that the formation of air bubbles within those components is minimized. For example, the connectors (e.g., one or more access ports 1224) associated with the above-mentioned blood circuit 1200 are arranged on the support assembly 1150 in a substantially vertical orientation (i.e., substantially perpendicular to the vertical axis 1001) to facilitate removal of trapped air within those components. Because trapped air is less dense than the liquid within the blood circuit 1200, it will be displaced by the liquid within the blood circuit 1200 as the liquid acts due to gravity, and thus the trapped air will be located above the liquid within each component (along the vertical axis 1001, relative to the ground). By arranging the connectors vertically, the trapped air is more accessible and can be more easily removed via one or more connectors.

[0161] Replacing and priming the oxygen supply In some embodiments, the oxygenator 800 configured for use with the blood circuit 1200 as described above needs to be replaced with another oxygenator. This is due to damage or clogging of the oxygenator 800 over time. In some cases, after the blood circuit 1200 is connected to a neonate and the neonate's blood is circulated through the blood circuit 1200, the oxygenator 800 needs to be replaced with a replacement oxygenator 800a. In such cases, it is preferable to maintain as much of the circulatory function of the blood circuit 1200 as possible while the oxygenator replacement is being performed. If the blood circuit 1200 is disconnected from the neonate or blood flow through the blood circuit 1200 stops, it may be detrimental to the neonate. Therefore, it is advantageous to replace the oxygenator as quickly as possible without stopping the flow of blood through the blood circuit 1200 and the neonate.

[0162] The introduction of another oxygenator into the blood circuit 1200 requires that the new oxygenator be prepared, primed, and conditioned. In some embodiments, similar components that can be used to prime the blood circuit 1200 as described above can also be used to prime the new oxygenator. The new oxygenator can be primed before the first oxygenator 800 is removed from the blood circuit 1200. Referring to FIG. 25, the replacement oxygenator 800a is connected to the priming circuit 1300 of the cart 1000. The priming circuit 1300 in such an embodiment is substantially similar or the same as the embodiments of the priming circuit 1300 described elsewhere in this application, and the components of the cart 1000 and the oxygenator 800 are substantially the same as those previously described, unless otherwise noted.

[0163] FIG. 25 shows a replacement oxygenator 800a having a liquid inlet 804a, a liquid outlet 808a, a gas inlet 812a, and a gas outlet 820a. The replacement oxygenator 800a and its components may be substantially similar to the embodiments of the oxygenator 800 and its components described throughout this disclosure. The gas conduit 820 is configured to connect the gas inlet 812a to a gas source, such as a gas tank 1040 (labeled in FIGS. 2 and 3) or another suitable gas source, such as a valve, faucet, or spout (not shown). The replacement oxygenator 800a is received and held to the cart 1000 on the replacement oxygenator holder 1166a. The replacement oxygenator holder 1166a is removably connectable to the cart 1000, for example, to the top 1004.

[0164] 27 is a flow diagram illustrating an exemplary method 1800 of priming a replacement oxygenator 800a and replacing an oxygenator 800 with a primed replacement oxygenator 800a. In step 1804, the replacement oxygenator 800a is placed on the cart 1000 and connected to the priming circuit 1300. It is understood that the priming step can be performed elsewhere, but with integrated components on the cart 1000 related to the blood circuit 1200 and the priming circuit 1300 for use in priming the original oxygenator 800, it is advantageous to utilize the same system already in place for priming the replacement oxygenator 800a. The replacement oxygenator 800a can be secured to the cart 1000 in any suitable manner, such as via the replacement oxygenator holder 1166a. One of the first end 1308 and the second end 1312 of the priming conduit 1302 may be connected to the liquid inlet 804a of the exchange oxygen supply 800a. The other of the first end 1308 and the second end 1312 of the priming conduit 1302 may be connected to the liquid outlet 808a. The priming conduit 1302 may be substantially similar to the priming conduit 1302 described above. The connections between the priming conduit 1302 and the liquid inlet 804a and the liquid outlet 808a may include barbed tube connectors. It is understood that other suitable connections are envisioned.

[0165] In step 1808, priming fluid is introduced into the priming conduit 1302. As previously described, priming fluid may be transferred from a priming fluid source 1331 via a priming fluid supply line 1330. Excess priming fluid may be transferred from the priming conduit 1302 to a waste receptacle 1335 via a waste line 1334.

[0166] At step 1812, the priming fluid in the priming conduit 1302 may be circulated through the priming conduit 1302 towards the replacement oxygen supply 800a. The priming fluid may be moved into the replacement oxygen supply 800a at the fluid inlet 804a, through the replacement oxygen supply 800a and out the fluid outlet 808a. The priming fluid may then be returned to the priming conduit 1302. The movement of the priming fluid may be caused by operation of the pump 1052, and the priming fluid may be heated by the heater 1048, as described elsewhere in this application.

[0167] After the replacement oxygenator 800a is sufficiently primed, the original oxygenator 800 may be removed and replaced from the blood circuit 1200 connected to the neonate. Before removing the oxygenator 800 from the blood circuit 1200, it may be preferable to maintain blood flow through the blood circuit 1200 even though blood is not passing through the oxygenator 800. Referring to FIG. 26, in step 1816, a bypass 830 may be introduced and connected to the blood circuit 1200, and in step 1820, blood flowing through the blood conduit 1202 may be temporarily diverted around the oxygenator 800. The bypass 830 may be a tube or conduit similar in composition and / or material to the blood conduit 1202. At one end thereof, the bypass 830 is configured to be connected to the blood conduit 1202 upstream of the oxygenator 800 (i.e., at the first portion 1204 of the blood conduit 1202, between the first end 1208 and the liquid inlet 804). At its other end, the bypass 830 is configured to be connected to the blood conduit 1202 downstream of the oxygenator 800 (i.e., at the second portion 1206 of the blood conduit 1202, between the liquid outlet 808 and the second end 1212 of the blood conduit 1202). When connected, the bypass 830 should be in fluid communication with the blood conduit 1202 such that the neonate's blood flowing from the first end 1208 towards the oxygenator 800 is received by the bypass 830 from the first portion 1204 of the blood conduit 1202, travels through the bypass 830, and is discharged from the bypass 830 into the second portion 1206 of the blood conduit 1202. In this manner, blood flow can continue from the neonate through the blood circuit 1200 and back to the neonate while the oxygenator 800 is being replaced. The bypass 830 should include dimensions and materials that substantially match the flow resistance of the oxygenator, such that the parameters of the fluid flowing through the blood circuit 1200 when the bypass 830 is connected are similar to the parameters of the fluid flowing through the blood circuit 1200 when the oxygenator 800 is connected.

[0168] 26, in step 1820, the oxygenator 800 connected to the blood circuit 1200 can be removed from communication with the blood conduit 1202. This can be accomplished by clamping a portion of the blood conduit 1202 at a first portion 1204 (e.g., adjacent the liquid inlet 804) and clamping a portion of the blood conduit 1202 at a second portion 1206 (e.g., adjacent the liquid outlet 808). It will be appreciated that other mechanisms can be utilized to inhibit blood flow through the oxygenator 800 in the blood circuit 1200. Step 1820 can be performed after the bypass 830 is connected to the blood conduit 1202. The oxygenator 800 can then be isolated from the blood conduit 1202, for example, by severing the portions of the blood conduit 1202 adjacent the liquid inlet 804 and the liquid outlet 808. Similarly, the gas conduit 820 connected to the gas inlet 812 can be disconnected from the oxygenator 800. Any other conduits can be disconnected from the oxygenator 800 as well (e.g., additional gas conduit 820 connected to gas outlet 816). The oxygenator 800 can be removed from the oxygenator holder 1166 on the support assembly 1150.

[0169] In step 1824, the primed replacement oxygenator 800a can be introduced into the oxygenator holder 1166 or elsewhere on the support assembly 1150. A blood conduit 1202 can be connected to the replacement oxygenator 800a. For example, a first portion 1204 of the blood conduit 1202 can be connected to a liquid inlet 804a and a second portion 1206 of the blood conduit 1202 can be connected to a liquid outlet 808a. The connections can be made via any known mechanism, such as, for example, via a barbed connector between the conduits or tubes. One or more gas conduits 820 can be connected to the gas inlet 812a and / or the gas outlet 816a.

[0170] In step 1828, blood flow can be introduced through the replacement oxygenator 800a after the replacement oxygenator 800a is connected to the blood circuit 1200 in place of the original oxygenator 800. Any clamps or other blocking devices introduced in step 1820 can be removed such that the neonate's blood flows from the neonate into the blood conduit 1202 at the first end 1208, through the first portion 1204 into the replacement oxygenator 800a, through the second portion 1206, and back from the blood conduit 1202 at the second end 1212 to the neonate. The bypass 830 can be removed from fluid communication with the blood conduit 1202 and removed from the blood circuit 1200.

[0171] Referring to FIG. 28, a method of operating the system is shown. Step 2802 includes preparing for treatment. Step 2802 can include providing power to the cart 1000, the neonatal chamber assembly 10, and the blood circuit 1200. The oxygenator 800 can be connected to provide gas (e.g., wall gas or gas tank 1040). An ultrasound can be performed while the neonate is in utero to measure the diameter of the umbilical cord blood vessels and determine the appropriate cannula size. The priming circuit 1300 can prime the blood circuit 1200 during step 2802. The priming circuit 1300 can prime the blood circuit 1200 while the transfer tray 1100 is on the cart 1000. The transfer tray 1100 can be placed on the cart 1000 before the neonate is introduced to the neonatal chamber assembly 10.

[0172] Step 2804 may include performing a cesarean section on the mother with an ultrasound-induced paralytic administered to the newborn prior to delivery to prevent the newborn from taking its first breath. Although step 2804 is described in the context of a cesarean section, vaginal delivery may also be used with the methods and systems described herein. The umbilical cord may be cut and the newborn transferred to the partially filled, warmed saline in the newborn chamber assembly 10. The newborn's umbilical cord may be cannulated to connect the newborn to the blood circuit 1200 so that blood flows from the newborn into the blood circuit 1200 and back through the blood circuit 1200 to the newborn. The lid of the newborn chamber assembly 10 may then be closed and locked to the base. Additional saline may then be added to the newborn chamber assembly 10.

[0173] Step 2806 includes moving the transfer tray 1100 onto the cart 1000. The sensors (pressure, temperature, meconium detector, blood detector) coupled to the neonatal chamber assembly 10 can begin sending signals to another device or computer. An ultrasound examination can be performed while the neonatal is in the neonatal chamber assembly 10. The cart 1000 can then be transported to the neonatal intensive care unit.

[0174] Step 2808 may include reviewing vital signs, fetal growth assessment, and camera imaging of the neonate. A blood sample may be taken from the blood circuit 1200 during step 2808. The blood sample may be taken without opening the neonate chamber assembly 10. The system may be periodically calibrated during step 2808 via the gas analyzer and pressure sensor.

[0175] At step 2810, a clinical decision can be made to release the neonate from the neonate chamber assembly 10 to standard of care. The lid of the neonate chamber assembly 10 can be unlocked and removed from the base. Excess saline can be removed from the neonate chamber assembly 10. The umbilical cord can be clamped and cut. The neonate can then receive standard of care.

[0176] While the systems and methods have been described with reference to various embodiments in various figures, it will be understood by those skilled in the art that modifications may be made to the embodiments without departing from the broad inventive concept thereof. It is understood, therefore, that the disclosure is not limited to the particular embodiments disclosed, but is intended to cover modifications within the spirit and scope of the disclosure as defined by the appended claims.

[0177] When values ​​are expressed as approximations by use of the antecedent "about," it is understood that the particular value forms another embodiment. In general, the use of the term "about" indicates an approximation that may vary depending on the desired properties sought to be obtained by the disclosed subject matter and should be interpreted based on its function in the particular context in which it is used, as one of ordinary skill in the art would be able to interpret it as such. In some cases, the number of significant figures used for a particular value may be one non-limiting way of determining the scope of the term "about." In other cases, the scale used in a series of values ​​may be used to determine the intended range in which the term "about" may be used for each value. When present, all ranges are inclusive and combinable. That is, reference to values ​​set forth in a range includes each value within that range.

[0178] Throughout this specification, words are to be given their ordinary meaning as understood by those of ordinary skill in the relevant art. However, to avoid doubt, the meaning of certain terms has been specifically defined or clarified.

[0179] For clarity, it should be understood that certain features of the invention described herein in the context of separate embodiments may also be provided in combination in a single embodiment. That is, unless clearly incompatible or expressly excluded, each embodiment is deemed combinable with any other embodiment(s), and such combinations are deemed to be separate embodiments. Conversely, various features of the invention that are described for brevity in the context of a single embodiment may also be provided separately or in any subcombination. Finally, while an embodiment may be described as part of a series of steps or as part of a more general structure, it is also contemplated that each said step is an independent embodiment in itself and may be combined with others.

[0180] It should be understood that the steps of the exemplary methods described herein do not necessarily have to be performed in the order described, and that the order of steps of such methods is merely exemplary. Similarly, additional steps may be included in such methods, and certain steps may be omitted or combined, in methods consistent with various embodiments of the present invention. Although elements included in the following method claims, if any, are described in a particular order with corresponding labeling, they are not necessarily intended to be limited to being performed in that particular order, unless the claim description otherwise implies a particular order for performing some or all of those elements.

Claims

1. A transfer tray for receiving a newborn baby, comprising: A main body portion, a first portion configured to receive a neonate chamber assembly on an upper surface thereof, the neonate chamber assembly configured to receive the neonate therein; a second part configured to receive a blood circuit, the blood circuit having an oxygenator; and a first conduit for transporting blood from the neonate to the oxygenator; a second conduit for transporting blood from the oxygenator to the neonate; and having the first conduit having an arterial end configured to be in fluid communication with an artery of the neonate's umbilical cord; the second conduit having a venous end configured to be in fluid communication with an umbilical cord vein of the newborn. The main body portion, a movable support assembly secured to the body portion of the transfer tray and configured to receive the blood circuit thereon; having when the neonate is disposed in the first portion and in fluid communication with the blood circuit, the transfer tray is movable from a first position in which the transfer tray is disposed on a first surface to a second position in which the transfer tray is disposed on a second surface different from the first surface. Transfer tray.

2. 2. The transfer tray of claim 1, wherein the first surface comprises a priming cart and the second surface comprises an incubator.

3. 3. The transfer tray according to claim 1 or 2, further comprising: a support member configured to receive the neonatal chamber assembly thereon; the support member spaces the neonate chamber assembly from the transfer tray at a first height. Transfer tray.

4. 4. The transfer tray of claim 3, wherein the support members are adjustable between a first height and a second height different from the first height; The first and second heights are measured between the transfer tray and the fetal chamber assembly.

5. 4. The transfer tray of claim 3, wherein the transfer tray comprises a plurality of support members.

6. 3. The transfer tray of claim 1 or 2, wherein the body portion defines a receptacle thereon configured to receive and hold a first volume of liquid.

7. 3. The transfer tray of claim 1 or 2, wherein the support assembly has a support attached thereto, the support configured to receive at least one sensor from the group consisting of an oxygen sensor, a flow meter, a temperature sensor, a pressure sensor, and an air bubble sensor.

8. 8. The transfer tray of claim 7, wherein the support is movable relative to the support assembly.

9. 3. The transfer tray of claim 1 or 2, wherein the support assembly includes an oxygenator holder for removably receiving the oxygenator.

10. 10. The transfer tray of claim 9, wherein the oxygenator holder is movable relative to the support assembly.

11. 3. The transfer tray according to claim 1 or 2, further comprising: at least one pressure sensor disposed on the support assembly; the at least one pressure sensor configured to measure pressure in the first conduit. Transfer tray.

12. The transfer tray of claim 11, wherein the at least one pressure sensor is movable toward and away from the transfer tray along a perpendicular axis relative to the transfer tray.

13. 12. The transport tray of claim 11, wherein the newborn is positioned in a first plane spaced from the transport tray along the vertical axis, and the at least one pressure sensor is configured to be moved into the first plane.

14. 3. The transfer tray according to claim 1, further comprising a holding member provided on the body of the transfer tray, the holding member comprising: aligning the transfer tray with at least one of the first plane and the second plane; and preventing sliding movement of the transfer tray relative to at least one of the first planar surface and the second planar surface; and configured to perform at least one of the following: Transfer tray.

15. 1. A priming device for priming a plurality of conduits of an external support system and connecting a neonate to the external support system, comprising: a surface configured to movably receive the neonate; A blood circuit connected to the neonate, An oxygen supply; a first conduit for transporting blood from the neonate to the oxygenator; a second conduit for transporting blood from the oxygenator to the neonate; and having the first conduit having an arterial end; the second conduit having a venous end. The blood circuit; a priming circuit having a priming fluid source and a priming conduit in fluid communication with the blood circuit for transporting priming fluid from the priming fluid source to the blood circuit; a heater configured to heat the priming fluid; a pump configured to pump the priming fluid from the priming fluid source through the priming conduit and into the blood circuit; having the arterial end and the venous end of the blood circuit are sized and configured to be disconnected from the priming conduit of the priming circuit and connected to an umbilical cord of the neonate, such that the arterial end is in fluid communication with an artery of the umbilical cord and the venous end is in fluid communication with a vein of the umbilical cord; when the blood circuit is connected to the umbilical cord, a fluid connection is established between the arterial end and the venous end through the neonate, thereby allowing blood to pass from the blood circuit to the umbilical cord and allowing blood of the neonate to pass from the umbilical cord into the blood circuit. Priming device.

16. 16. The priming device of claim 15, wherein the priming device is a mobile cart configured to move from a first location to a second location different from the first location.

17. The priming device according to claim 15 or 16, further comprising: an upper portion including the surface configured to receive the neonate; a lower portion spaced from the upper portion along a vertical axis; a central portion disposed between the upper portion and the lower portion; A priming device comprising:

18. 18. The priming device of claim 17, wherein the priming device is configured to have a first height and a second height greater than the first height; the first and second heights are measured along a vertical axis between the upper and lower portions; The priming device is movable between the first height and the second height. Priming device.

19. The priming device according to claim 15 or 16, further comprising: A priming device comprising at least one weight sensor configured to detect a weight of the newborn received on the surface.

20. The priming device according to claim 15 or 16, further comprising: A priming device having an oxygen sensor configured to measure an oxygen concentration in at least one of the neonate, the priming circuit, and the blood circuit.

21. The priming device according to claim 15 or 16, further comprising: A priming device having a temperature sensor configured to measure a fluid temperature in at least one of the priming circuit and the blood circuit.

22. The priming device according to claim 15 or 16, further comprising: A priming device having a pressure sensor configured to measure fluid pressure within at least one of the priming circuit, the blood circuit, and the neonate.

23. 23. The priming device of claim 22, a first pressure sensor configured to measure a pressure in the first conduit of the blood circuit; a second pressure sensor configured to measure pressure in the second conduit of the blood circuit; having the first and second pressure sensors are movable to be positioned on a plane on which the neonate is placed; Priming device.

24. The priming device according to claim 15 or 16, further comprising: a gas tank configured to receive a predetermined gas mixture; The oxygen supply is configured to receive the predetermined gas mixture from the gas tank.

25. The priming device according to claim 15 or 16, further comprising: A priming device having a power source configured to provide power to the priming device.

26. 26. The priming device of claim 25, wherein the power source comprises a battery.

27. 17. The priming device according to claim 15 or 16, wherein the priming fluid comprises human blood.

28. 17. The priming device of claim 15 or 16, wherein the priming fluid comprises a crystalloid fluid.

29. 17. The priming device according to claim 15 or 16, wherein the priming circuit is connectable to a replacement oxygen supplier different from the oxygen supplier in the blood circuit, and is configured to move the priming liquid to the replacement oxygen supplier.

30. 17. The priming device according to claim 15 or 16, wherein the priming circuit is configured to be removably connected to the blood circuit via a connection assembly, the connection assembly comprising: a blood circuit connector configured to receive the blood circuit; a priming circuit connector configured to receive the priming circuit; a chamber defined between the blood circuit connector and the priming circuit connector, the chamber configured to be in fluid communication with the blood circuit and the priming circuit when the blood circuit and the priming circuit are connected to the blood circuit connector and the priming circuit connector, respectively; A priming device comprising:

31. 1. A connection assembly for releasably connecting a first conduit to a second conduit, comprising: a body having a first end and a second end axially spaced from the first end; a first connector configured to receive the first conduit at the first end of the body; a second connector configured to receive the second conduit at the second end of the body; and a carriage configured to move along the body between an unlocked position and a locked position, the carriage being movable along the axial direction in a first direction toward the first end and a second direction toward a second end opposite the first direction; a resilient member configured to apply a force to the carriage to cause the carriage to move in either of the first and second directions; a deformable release arm having a first position and a second position, the deformable release arm being disposed in a position that prevents the carriage from being moved relative to the body by the resilient member when in the first position and allows the carriage to be moved by the resilient member when in the second position; having the carriage is configured, when moved from the unlocked position to the locked position, to move one of the first conduit and the second conduit towards and into contact with the other of the first conduit and the second conduit, such that the first conduit and the second conduit are in liquid communication with each other and a liquid-tight seal is formed between the first conduit and the first connector and between the second conduit and the second connector. Connection assembly.

32. 32. The connection assembly of claim 31, wherein the resilient member is a spring.

33. 33. The connection assembly of claim 32, wherein when the carriage is in the unlocked position, the spring is in tension and exerts a biasing force on the carriage in a direction toward the locked position.

34. A connection assembly according to any one of claims 31 to 33, the deformable release arm includes a projection extending therefrom; the body portion defines a shoulder against which the projection contacts; the protrusion is configured to disengage from the shoulder when the deformable release arm is moved from the first position to the second position. Connection assembly.

35. 34. A connection assembly as claimed in any one of claims 31 to 33, wherein the deformable release arm is movable from the first position to the second position by contacting a release member on a manifold, the manifold being configured to slidably receive the connection assembly.

36. A connection assembly according to any one of claims 31 to 33, when the connection assembly is in an unlocked configuration, the first conduit is received within the first connector but does not form a fluid-tight seal with the first connector; when the connection assembly is in a locked configuration, the first conduit is received within the first connector and a fluid-tight seal is formed with the first connector. Connection assembly.

37. A connection assembly according to any one of claims 31 to 33, the first conduit is included in a blood circuit configured to be connected to a neonate; the second conduit being included in a priming circuit configured to receive a priming fluid; A connection assembly, wherein when the connection assembly is in a locked configuration, the blood circuit is in fluid communication with the priming circuit and the priming fluid is freely movable between the blood circuit and the priming circuit.

38. 1. A method of cannulating the umbilical cord of a newborn baby on a priming device, the priming device comprising: A blood circuit comprising: An arterial end portion; a venous end opposite the arterial end; a blood conduit extending between said arterial end and said venous end; an oxygenator disposed in continuity with the blood conduit between the arterial end and the venous end; The blood circuit has The priming device further comprises a priming circuit, A first end; a second end opposite the first end; and a priming conduit extending between said first end and said second end; The priming circuit includes: the first end of the priming conduit is configured to be releasably connected to the arterial end of the blood conduit and the second end of the priming conduit is configured to be releasably connected to the venous end of the blood conduit, whereby the blood conduit is in fluid communication with the priming conduit and the blood circuit and the priming circuit are configured to receive a priming fluid; This method is placing a neonate on an upper surface of the priming device; connecting the arterial end of the blood conduit to an artery in the neonate's umbilical cord; connecting the venous end of the blood conduit to a vein in the neonate's umbilical cord; having When at least one of the arterial end and the venous end of the blood conduit is connected to the umbilical cord, the blood circuit is not in fluid communication with the priming circuit. method.

39. 1. A method of priming with a priming solution a blood circuit adapted to be connected to a neonate, the blood circuit comprising: A first end; a second end opposite the first end; and a blood conduit extending between the first end and the second end; an oxygenator disposed in series with said blood conduit; and the method further comprising: connecting the first end of the blood circuit to a first end of the priming circuit such that the blood circuit and the priming circuit are in fluid communication with each other; connecting the second end of the blood circuit to a second end of the priming circuit, the second end of the priming circuit being spaced from the first end of the priming circuit, the priming circuit extending between the first end and the second end; receiving the priming fluid from a priming fluid source into the priming conduit; actuating movement of the priming fluid in the priming conduit to the blood conduit by pumping the priming fluid toward the connected blood circuit with a pump; after receiving the priming fluid into the blood conduit, draining the priming fluid from the blood conduit into the priming conduit, the priming fluid passing through the blood conduit and the oxygenator before being drained into the priming conduit; heating the priming fluid by contacting a heater with the priming conduit; The method comprising:

40. 40. The method of claim 39, the priming fluid is pumped through the priming conduit toward one of the first end and the second end and into the connected first end and second end, respectively, of the blood conduit; The method of claim 1, wherein the priming fluid is discharged from the blood conduit into the priming conduit at the other of the first end and the second end of the priming conduit.

41. 41. The method of claim 39 or 40, wherein the pumping is actuated by a peristaltic pump configured in operative contact with the priming conduit.

42. 41. The method of claim 39 or 40, further comprising: The method includes transferring the priming fluid from a priming fluid source to the priming conduit through a supply line connecting the priming fluid source to the priming conduit.

43. 41. The method of claim 39 or 40, further comprising: introducing gas into the oxygenator at a gas inlet; A method wherein at least a portion of the gas is introduced into the priming fluid as it travels through the oxygenator.

44. 41. The method of claim 39 or 40, further comprising: The method comprising measuring a temperature of the priming fluid in at least one of the priming conduit and the blood conduit.

45. 45. The method of claim 44, further comprising: providing a signal to the heater to increase or decrease heat based on the measured temperature.

46. 41. The method of claim 39 or 40, wherein the priming fluid comprises at least one of the neonatal plasma, the non-neonatal human plasma, and artificial plasma.

47. 41. The method of claim 39 or 40, wherein the priming solution is a first priming solution, the method further comprising: The method includes introducing a second priming fluid from a second priming fluid source into the priming conduit.

48. 48. The method of claim 47, wherein the first priming fluid comprises a crystalloid fluid and the second priming fluid comprises human blood.

49. 1. A method of priming an oxygenator for use with a blood circuit connected to a neonate, comprising: connecting a liquid inlet of the oxygenator to a first end of a priming conduit; connecting a liquid outlet of the oxygenator to a second end of the priming conduit opposite the first end, thereby defining a circuit through the priming conduit and the oxygenator; introducing a priming fluid through the priming conduit into one of the liquid inlet and the liquid outlet of the oxygenator, the priming fluid traveling through the oxygenator and exiting the other of the liquid inlet and the liquid outlet of the oxygenator back to the priming conduit; The method comprising:

50. 50. The method of claim 49, further comprising: heating the priming fluid to a predetermined temperature; measuring the temperature of the priming fluid; The method comprising:

51. 51. The method of claim 49 or 50, further comprising: introducing gas from a gas source into a gas inlet of the oxygenator; passing the gas through the oxygenator; discharging the gas through a gas outlet of the oxygenator; The method comprising:

52. 51. The method of claim 49 or 50, wherein the priming solution is a first priming solution, the method further comprising: The method includes introducing a second priming fluid.

53. 53. The method of claim 52, wherein the first priming fluid is different from the second priming fluid.

54. 1. A method for replacing an oxygenator in a blood circuit, comprising: The blood circuit includes: An arterial end portion; a venous end opposite the arterial end; an oxygenator disposed in continuity with the blood conduit between the arterial end and the venous end; a first portion of the blood conduit between the arterial end and the oxygenator; a second portion of the blood conduit between the oxygenator and the venous end; and The oxygen supplier includes: a fluid inlet for receiving neonatal blood from the first portion of the blood conduit and introducing the blood into the oxygenator; a fluid outlet for draining the neonate's blood from the oxygenator and introducing it into the second portion of the blood conduit; a gas inlet for receiving and introducing gas into the oxygenator; a gas outlet for discharging gas from the oxygen supply; and This method is including a bypass in the blood circuit by placing a first end of the bypass in fluid communication with the first portion of the blood conduit and a second end of the bypass in fluid communication with a second portion of the blood conduit, the bypass defining a lumen between the first end and the second end, the lumen configured to receive the neonatal blood from the blood conduit at the first end and to discharge the neonatal blood from the second end to the blood conduit; moving the neonate's blood through a bypass such that the neonate's blood is introduced from the first portion of the blood conduit into the first end of the bypass, travels through the bypass, and exits from the second end of the bypass to the second portion of the blood conduit without traveling through the oxygenator, the step including preventing the neonate's blood from traveling to the oxygenator; disconnecting the oxygenator from the blood conduit such that the oxygenator is not in fluid communication with the blood conduit; connecting a replacement oxygenator to the blood conduit, whereby the first portion of the blood conduit is in fluid communication with a liquid inlet of the replacement oxygenator and the second portion of the blood conduit is in fluid communication with a liquid outlet of the replacement oxygenator; moving the neonate's blood from the arterial end of the blood conduit through the replacement oxygenator toward the venous end of the blood conduit; disconnecting the bypass from the blood conduit such that the bypass is not in fluid communication with the blood conduit. The method comprising:

55. 55. The method of claim 54, further comprising: disconnecting a gas conduit from the gas inlet of the oxygenator; connecting the gas conduit to a gas inlet of the replacement oxygenator, whereby gas from a gas source is configured to travel to the replacement oxygenator; The method comprising:

56. The transfer tray of claim 1 or 2, further comprising: at least one pressure sensor disposed on the support assembly; the at least one pressure sensor configured to measure pressure in the second conduit. Transfer tray.

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