Systems and methods for maintaining organ viability

Abstract

The system (400) includes a fluid supply (414), a pressure regulator (418), a pressure valve (420), and a vent assembly (422). The fluid supply is fluidly coupled to an outlet tube (416), which is configured to be fluidly coupled to at least a portion of the organ environment (404). The pressure regulator is configured to supply fluid to the organ (402) in the organ environment via the outlet tube. The supplied fluid is at a pressure range above ambient to maintain the organ in an expanded position. The pressure valve is fluidly coupled to the outlet tube and inhibits an increase in fluid pressure above a threshold. The vent assembly removes excess fluid from the organ environment and includes a vent tube disposed within the organ environment and a vent valve disposed outside the organ environment. In another system, a fluidic condenser may be provided, where the pressure controller supplies a fluid (e.g., ambient air) to the fluidic condenser through the fluidic valve, which condenses the fluid (e.g., removes gases so that the supplied fluid is primarily oxygen).

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 234,563, filed August 18, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to the field of maintaining viability of organs during transport or storage. [Background technology]

[0003] For organs prepared for transport, it is desirable to maintain the viability and health of the organ while it is being transported. One technique is static cryopreservation, where the organ is placed in a cooler and surrounded by ice to maintain the organ's temperature. However, this technique can result in various pressure changes that can lead to hypoinflation or hyperinflation of the organ or organ cavity, which can lead to organ damage. These pressure changes can be due to leakage within the organ or changes in pressure outside the organ. Organ damage can lead to poor patient outcomes, premature death, and organ non-viability. Summary of the Invention [Means for solving the problem]

[0004] One embodiment relates to a system. The system includes a fluid supply, a pressure regulator, and a pressure valve. The fluid supply is configured to contain a volume of fluid and is fluidly coupled to an outlet tube. The outlet tube is configured to be coupled to at least a portion of an organ environment. The organ environment is configured to hold an organ. The pressure regulator is coupled to the outlet tube and configured to maintain a fluid pressure of fluid provided from the outlet tube to the organ environment. The provided fluid is in a pressure range to maintain the organ in an expanded position. The pressure valve is fluidly coupled to the outlet tube and configured to inhibit an increase in fluid pressure above a threshold. In some embodiments, the system includes a vent assembly configured to remove excess fluid from the transport container. The vent assembly includes a vent tube and / or a vent valve disposed within the organ environment and an outlet disposed outside the organ environment.

[0005] One embodiment relates to a method. The method includes providing a system including a fluid supply, an outlet tube, and a pressure regulator. The fluid supply is configured to contain a volume of fluid. The outlet tube is configured to be fluidly coupled to the fluid supply. The pressure regulator is coupled to the outlet tube. A pressure valve is coupled to the outlet tube. The method includes disposing at least a portion of an organ within an organ environment and fluidly coupling a first end of the outlet tube to at least a portion of the organ environment. The pressure regulator is adjusted to supply fluid to the organ through the outlet tube at a fluid pressure range to maintain the organ in an expanded position. In some embodiments, the method includes providing a system further including a vent assembly. The vent assembly includes a vent tube and / or a vent valve disposed into the organ environment and an outlet disposed outside the organ environment.

[0006] Another embodiment relates to a system. The system includes a controller, a fluid supply, a condenser, and a fluid supply line. The fluid supply is coupled to the controller and configured to contain a volume of fluid. The condenser is coupled to the controller and fluidly coupled to the fluid supply. The controller operates a fluid supply to the condenser, which condenses the fluid. The fluid supply line is fluidly coupled to the condenser at a first end and fluidly coupled to at least a portion of the organ environment at a distal end. In some embodiments, the system may include a pressure valve and a pressure regulator. The pressure valve is fluidly coupled to the fluid supply line and configured to inhibit an increase in fluid pressure above a threshold. The pressure regulator is fluidly coupled to the fluid supply line and configured to maintain a fluid pressure of fluid supplied from the fluid supply line to the organ environment at a fluid pressure above ambient to maintain the organ in an expanded position.

[0007] The present disclosure will become more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which like reference numerals refer to like elements unless otherwise noted. [Brief description of the drawings]

[0008] [Figure 1] FIG. 1 is a schematic diagram of an exemplary system according to one embodiment.

[0009] [Diagram 2] FIG. 2 is a perspective view of the system according to one embodiment.

[0010] [Diagram 3] FIG. 3 is a schematic diagram of the system according to one embodiment.

[0011] [Figure 4] FIG. 4 is a schematic diagram of the system according to one embodiment.

[0012] [Diagram 5] FIG. 5 is a flow chart illustrating a process for maintaining organ viability, according to one embodiment.

[0013] [Figure 6] FIG. 6 is a schematic diagram of an exemplary system according to one embodiment.

[0014] [Figure 7] FIG. 7 is a schematic diagram of an example of the system of FIG.

[0015] [Figure 8] FIG. 8 is a schematic diagram of an example of the system of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Reference is made to the accompanying drawings throughout the following detailed description. In the drawings, like numerals generally refer to like elements unless the context dictates otherwise. The exemplary implementations described in the detailed description, drawings, and claims are not meant to be limiting. Other implementations can be utilized and other changes can be made without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described and illustrated herein, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are expressly contemplated and made a part of this disclosure.

[0017] Detailed Description The embodiments described herein relate generally to systems and methods for maintaining the viability of an organ during transport and / or storage, and more particularly to providing fluid at an ideal pressure range to at least a portion of an organ to maintain proper pressure in the organ during transport or storage. As used herein, "organ" can refer to an entire organ or a portion of an organ, such as a lobe of a lung.

[0018] Organs or parts of organs used for transplantation, educational purposes, research, or testing transplant viability are often transported from the site of removal to the intended use of the organ or part. One example is ex vivo lung perfusion, where a lung or part of a lung is perfused outside the body and monitored to determine if it is suitable for use in transplantation. Typically, organs are stored in static refrigeration during transport, e.g., packed in a cooler containing ice. A preservation solution may be used, and the organ's vasculature and other openings (e.g., airways in the lungs) may be clamped or cannulated. There are no active measures to maintain physiological or other desired pressures. In some cases, some organ procurement personnel do not initially inflate the organ during organ procurement. Organs may be transported by ground or air. During ground transport, organs may be underinflated due to possible leakage of the organ or part of it. During air transport, organs may be 1) underinflated due to leakage, or 2) overinflated due to pressure changes during transport. Hyperinflation and / or hypoinflation can lead to increased edema, microvascular damage, impaired gas exchange, tissue damage upon restoration of blood flow to the organ, and potentially reducing or eliminating the viability of the organ or parts thereof during transport. In some cases, damage to the organ can have deleterious consequences for the organ recipient.

[0019] In contrast, the systems and methods for maintaining viability described herein, including inflating the organ at an ideal pressure range, may provide one or more advantages, including: (1) regulating the internal pressure of an organ or portion thereof to limit over- and under-inflation; (2) inflating the organ at a pressure higher than ambient during transport; (3) providing a disposable system that reduces the likelihood of introducing bacteria or other infectious agents from previous use; (4) preventing organ deflation; and (5) providing compensation for operator differences in handling the organ.

[0020] Referring to FIG. 1, a system 100 according to some embodiments is shown. The system 100 is used to maintain viability and prevent damage to an organ (e.g., lung, kidney, liver, etc.) during transportation. In some embodiments, the system 100 is used to maintain viability and prevent damage to at least a portion of an organ (e.g., lung lobe, etc.) during transportation. The system 100 generally provides a fluid (e.g., gas, liquid, air, oxygen, air / oxygen mixture, etc.) to the organ or at least a portion of an organ (e.g., lung lobe, etc.) to help maintain viability of the organ or at least a portion of the organ. The system 100 can include an organ 102. In some embodiments, the organ 102 can be an organ extracted from a human patient, such as a lung. In some embodiments, the organ 102 can be a non-human organ (e.g., a 3D printed organ, a grafted organ, a synthetic organ, a xeno organ, etc.). In some embodiments, the system 100 may include only a portion of the organ 102 (eg, a lung lobe, a liver lobe, a vascular section, a gastrointestinal section).

[0021] The organ 102 is disposed within an organ environment 104. In some embodiments, the organ environment 104 is sterile. The organ environment 104 includes at least one organ bag 106 (e.g., a lung bag, etc.). In some embodiments, the organ bag 106 is sterile. The organ bag 106 is configured to receive and store the organ 102 for transport, where the organ 102 may be stored within the organ bag 106 to prevent contaminants (e.g., bacteria, viruses, etc.) from interacting with and potentially damaging the organ 102. The organ bag 106 may be formed from plastic and may be treated (e.g., chemically treated, steam treated, radiation treated, etc.) to remove possible contaminants and bacteria prior to placing the organ 102 within the organ bag 106. In some embodiments, the organ bag 106 receives an organ stabilizing fluid L1 (e.g., electrolyte preservation solution, low potassium dextran, intracellular preservation solution, pharmacological agents, biological agents, etc.). The organ stabilizing fluid L1 is configured to preserve the organ 102 while the organ 102 is stored in the organ bag 106. In some embodiments, the organ bag 106 containing the organ 102 and the organ stabilizing fluid L1 is disposed in at least a second organ bag 108. In some embodiments, the second organ bag 108 is sterile. The second organ bag 108 may be structurally identical to the organ bag 106. In some embodiments, the second organ bag 108 containing the organ 102 and the organ stabilizing fluid L1 is disposed in at least a third organ bag 110, which may be structurally identical to the organ bag 106 and / or the second organ bag 108. In some embodiments, the third organ bag 110 is sterile. Having multiple organ bags may provide the advantage of redundancy in that if one of the organ bags 106, 108, or 110 fails (e.g., is punctured or ruptured), the other organ bags 106, 108, and / or 110 can still prevent fluid leakage and / or maintain the organ environment around the organ 102. Additionally, multiple organ bags 106, 108, 110 can also inhibit heat transfer from the organ 102.In some embodiments, bags 106, 108, and / or 110 may be replaced by other containers, such as boxes.

[0022] The system 100 includes an organ environment manifold 112. The organ environment manifold 112 is configured to seal the organ bag 106 from the outside environment and prevent fluid from leaking within the organ environment 104. In some embodiments, the organ environment manifold 112 is configured to seal the organ bag 106. In some embodiments, the organ environment manifold 112 is configured to seal the organ bag 106 and the second organ bag 108. In some embodiments, the organ environment manifold 112 is configured to seal the organ bag 106, the second organ bag 108, and the third organ bag 110. The organ environment manifold 112 facilitates regulation of pressure within the organ bag 106, as described herein. In some embodiments, the organ environment manifold 112 may be incorporated into the first organ bag 106. In some embodiments, the organ environment manifold 112 may be incorporated into the second organ bag 108. In some embodiments, the organ environment manifold 112 may be incorporated into the third organ bag 110. In some embodiments, an organ environment manifold 112 may be incorporated into a combination of a first organ bag 106 and a second organ bag 108. In some embodiments, an organ environment manifold 112 may be incorporated into a combination of a first organ bag 106, a second organ bag 108, and a third organ bag 110. In some embodiments, an organ environment manifold is not present.

[0023] The system 100 includes a fluid supply 114. The fluid supply 114 is configured to store a volume of fluid. In some embodiments, the fluid supply 114 is a compressed gas tank. In some embodiments, the fluid supply 114 may be a gas condenser. In some embodiments, the gas stored by the fluid supply 114 may be air, oxygen, nitrogen, or a combination thereof. In some embodiments, the fluid supply 114 stores a gas that is comprised of approximately (e.g., within 5%) 50% oxygen and approximately 50% air. In some embodiments, the fluid supply 114 stores a gas that is comprised of approximately 40%-60% oxygen and the remaining gas (40%-60%) air. In some embodiments, the fluid supply 114 stores a gas that is comprised of approximately 25% oxygen and approximately 75% air. In some embodiments, the fluid supply 114 stores a gas that is comprised of approximately 75% oxygen and approximately 25% air. In some embodiments, the fluid supply 114 stores a gas comprised of 100% oxygen. In some embodiments, the fluid supply 114 stores a pharmacological agent in combination with the gas. In some embodiments, the system 100 may include a fluid supply 114 configured to store a liquid (e.g., compressed liquid, saline, electrolyte preservation solution, low potassium preservation solution, synthetic blood, blood substitutes, perfluorocarbons, etc.). In some embodiments, the system 100 may include multiple fluid supplies, such as a first fluid supply configured to store a gas (e.g., air for maintaining pressure in the airways of the lungs) and a second fluid supply configured to store a liquid (e.g., liquid for maintaining pressure in the vasculature of the lungs).

[0024] The system 100 includes an outlet tube 116. The outlet tube 116 is configured to receive fluid from the fluid supply 114. In some embodiments, the outlet tube 116 may be a conduit (e.g., a pipe, a tube, a hose, etc.). The outlet tube 116 may also be fluidly coupled to the fluid supply 114. The outlet tube 116 may also be coupled (e.g., attached, secured, affixed, glued, fluidly, electrically, etc.) to the fluid supply 114. The outlet tube 116 is fluidly coupled to the organ 102 at a distal end. The outlet tube 116 may be coupled to the organ at a distal end. In some embodiments, the outlet tube is fluidly coupled to an organ connector that is fluidly coupled to the organ. Specifically, the outlet tube 116 is fluidly coupled to the fluid supply 114 at one end, extends from the fluid supply 114 through the organ environment manifold 112, and is fluidly coupled to the organ 102. As the outlet tube 116 extends through the organ environment manifold 112, the organ environment manifold 112 is configured to seal the space around an outer portion of the outlet tube 116 to prevent leakage of fluid from within the organ bag 106. The organ environment manifold 112 may utilize seals (e.g., gaskets, elastomeric rubber seals, etc.) to prevent leakage from within the organ bag 106. In some embodiments, the system 100 includes multiple fluid supplies, each of which may have a separate outlet tube, and the fluid supplies may be fluidly coupled to different portions of the organ, such as the airway and vasculature. Each fluid supply may operate substantially similarly to the fluid supply 114, such as each fluid supply having its own outlet tube, pressure regulator, pressure valve, etc.

[0025] In some embodiments where the fluid in the fluid supply 114 is a liquid, the fluid supply 114 may include a container for containing the liquid. In such embodiments, a pump (not shown), e.g., a rotary pump, a positive displacement pump, an axial pump, etc., may be fluidly coupled to the fluid supply 114 and receives the fluid from the fluid supply 114. The pump is configured to pressurize the fluid received from the fluid supply 114 and facilitate flow of the pressurized fluid to the outlet tube 116. In some embodiments, the pump can be replaced by the fluid supply 114 and / or a pressure regulator as described herein. In some embodiments, the pump pressurizes the fluid in a range of about 3 mmHg to about 50 mmHg (e.g., 2.85 mmHg, 3 mmHg, 5 mmHg, 10 mmHg, 15 mmHg, 20 mmHg, 25 mmHg, 30 mmHg, 35 mmHg, 40 mmHg, 45 mmHg, 50 mmHg, 52.5 mmHg, etc.). As used herein, the range of X to Y includes X, Y, values ​​between X and Y, values ​​approximately equal to X, and values ​​approximately equal to Y. In some embodiments, a return line may be provided from the organ bag 106 to the fluid supply to allow for recirculation of fluid from the organ bag 106 to the fluid supply 114. In some embodiments, the pump pressurizes the fluid at the vascular pressure of the organ. In some embodiments, the pump is configured to pressurize the fluid to the organ in a range of about 3 mmHg to about 20 mmHg if the organ is a lung. In some embodiments, the pump is configured to pressurize the fluid to the organ in a range of about 10 mmHg to about 20 mmHg if the organ is a kidney. In some embodiments, the pump is configured to pressurize the fluid to the organ in a range of about 3 mmHg to about 50 mmHg if the organ is a liver.

[0026] The outlet tube 116 is configured to supply fluid from the fluid supply 114 to the organ 102. In some embodiments, the fluid facilitates expansion of the organ 102 while stored in transit. Additionally, the fluid can maintain oxygenation to the organ 102, maintain hydration to the organ 102, and continue to supply nutrients, pharmacological agents, or biological agents to the organ 102. In embodiments in which the fluid includes a gas, the fluid supplied by the outlet tube 116 from the fluid supply 114 to the organ 102 can be pressurized within a range of about 8 cmH2O to about 20 cmH2O (e.g., 7.6 cmH2O, 8 cmH2O, 10 cmH2O, 12 cmH2O, 14 cmH2O, 16 cmH2O, 18 cmH2O, 20 cmH2O, 21 cmH2O, etc.) above ambient pressure (hereinafter "above ambient"). In some embodiments, the fluid can be pressurized within a range of about 12 cmH2O to about 15 cmH2O above ambient pressure.

[0027] In some embodiments, the system 100 includes a pressure regulator 118. The pressure regulator 118 is fluidly coupled to the outlet tube 116. In some embodiments, the pressure regulator 118 is directly coupled to the fluid supply 114 (e.g., a gas supply). The pressure regulator 118 is configured to supply fluid to the organ 102 via the outlet tube 116. In some embodiments, the pressure regulator 118 may be a valve (e.g., a positive end-expiratory pressure (PEEP) valve, a check valve, a pressure relief valve, a fast response valve, etc.). In some embodiments, the pressure regulator 118 may be an operated valve (e.g., a gate valve, a pinch valve, a ball valve, a butterfly valve, a solenoid valve, a pneumatic valve, etc.) that may be controlled by an external device. Specifically, the pressure regulator 118 is configured to be set to a constant pressure threshold and to supply fluid from the fluid supply 114 to the outlet tube 116 at the pressure threshold. For example, the pressure regulator 118 may be set to a certain pressure threshold to facilitate fluid flow from the fluid supply 114 to the outlet tube 116 at the pressure threshold. In some embodiments, the pressure regulator 118 may facilitate fluid flow at a pressure greater than the pressure threshold. In some embodiments, the pressure threshold at which the pressure regulator 118 may be set is within a range of about 8 cmH2O to about 14 cmH2O (e.g., 7.6 cmH2O, 8 cmH2O, 10 cmH2O, 12 cmH2O, 14 cmH2O, 14.7 cmH2O, etc.) above ambient. In an exemplary embodiment, when the pressure regulator 118 is set to a pressure threshold of 12 cmH2O, the fluid delivered from the pressure regulator 118 to the outlet tube 116 has a pressure of at least 12 cmH2O.

[0028] The fluid then flows from the pressure regulator 118 into the outlet tube 116 towards the organ 102. A pressure valve 120 is fluidly coupled to the outlet tube 116. In some embodiments, the pressure valve 120 is fluidly coupled to the outlet tube between the organ bag 106 and the pressure regulator 118. The pressure valve 120 is configured to counteract the rise in fluid pressure between the pressure regulator 118 and the pressure valve 120 by opening the pressure valve 120 to release a portion of the fluid communicated from the fluid supply 114 when the pressure rises above a pressure threshold. In some embodiments, the pressure valve 120 is configured to counteract the rise in pressure in the fluid by opening the pressure valve 120 and releasing a portion of the fluid in the outlet tube 116. In some embodiments, the pressure valve 120 is configured to counteract the rise in pressure in the fluid by opening the pressure valve 120 and releasing a portion of the fluid in the organ 102 via the outlet tube 116. The pressure valve threshold may be in the range of approximately 14 cmH2O to 20 cmH2O (e.g., 13.3 cmH2O, 14 cmH2O, 16 cmH2O, 18 cmH2O, 20 cmH2O, 21 cmH2O, etc.) above ambient. In operation, as fluid flows in the outlet tube 116 towards the pressure valve 120, the fluid pressure may increase due to the pressure of the surrounding environment. When the fluid reaches the pressure valve 120, the pressure valve 120 may be forced open due to the increase in pressure on the fluid exceeding the pressure threshold. When the pressure of the fluid falls below the pressure threshold, the pressure valve 120 closes to prevent further outflow of the fluid. In an exemplary embodiment, the pressure valve 120 may be set to a pressure threshold of approximately 15 cmH2O. The environment may cause the fluid pressure in the outlet tube 116 to increase and become higher than 15 cmH2O (e.g., 17 cmH2O, etc.). As fluid flows through the pressure valve 120, the pressure valve 120 is opened by excess pressure, allowing some of the fluid to be expelled through the pressure valve 120 to the environment. When the fluid pressure drops to 15 cmH2O, the pressure valve 120 closes. The fluid then flows through the outlet tube 116 to the organ 102. In some embodiments, the pressure within the organ 102 may be greater than the pressure valve threshold.This may force the pressure valve 120 to open to relieve excess pressure so that the pressure within the organ 102 drops to the pressure valve threshold. In some embodiments, the pressure within the organ 102 drops below the pressure valve threshold.

[0029] In some embodiments, as the organ 102 receives fluid, pressure increases within the organ environment 104. The organ 102 may also have physical damage that may result in leakage of fluid causing fluid to leave the organ 102 and enter the organ environment 104. Because the organ bag 106 is sealed within the organ environment 104, pressure increases within the organ environment 104 and may lead to damage to the organ. To regulate the pressure within the organ environment 104, in some embodiments, the system 100 includes a vent assembly 122. The vent assembly 122 includes a vent tube 124. The vent tube 124 extends through the organ environment manifold 112 and is disposed within the organ bag 106. The vent tube 124 is configured to facilitate the flow of fluid within the organ bag 106 to the environment. Specifically, the vent assembly 122 includes a vent valve 126. The vent valve 126 is fluidly coupled to the vent tube 124 and configured to receive fluid from the organ environment via the vent tube 124. The vent valve 126 is set to a pressure threshold within a range of approximately 1 cmH2O to 5 cmH2O (e.g., 0.95 cmH2O, 1 cmH2O, 2 cmH2O, 3 cmH2O, 4 cmH2O, 5 cmH2O, 5.25 cmH2O, etc.). In some embodiments, the vent valve 126 may be set to a low pressure threshold to keep the organ inflated. In operation, when the fluid exceeds the pressure threshold set for the vent valve 126, the vent valve 126 is forced open by the fluid.

[0030] FIG. 2 is a perspective view of a system 200 according to one embodiment. The system 200 includes an outlet tube 216 and a pressure regulator 218. The pressure regulator 218 is substantially identical to the pressure regulator 118. The system 200 further includes a pressure gauge 219. The pressure gauge 219 is configured to measure the pressure of the fluid in the outlet tube and display the pressure in the outlet tube 216. In some embodiments, the pressure gauge 219 may be a digital pressure gauge. The pressure gauge 219 is configured to verify that the pressure of the fluid in the outlet tube 216 is within a range of about 8 cmH2O to about 14 cmH2O (e.g., 7.6 cmH2O, 8 cmH2O, 10 cmH2O, 12 cmH2O, 14 cmH2O, 14.7 cmH2O, etc.) higher than ambient. For example, if the pressure regulator 218 is defective and not delivering pressurized fluid, the pressure gauge 219 may read a pressure less than about 8 cmH2O. System 200 includes a pressure valve 220 and a vent assembly 222. Vent assembly 222 includes a vent tube 224 and a vent valve 226. Vent assembly 222, including pressure regulator 218, pressure valve 220, and vent tube 224 and vent valve 226, are substantially identical to vent assembly 122, including pressure regulator 118, pressure valve 120, and vent tube 124 and vent valve 126, respectively, and therefore will not be described in further detail herein.

[0031] The outlet tube 216 of the system 200 is configured to receive fluid from a fluid supply (not shown). In some embodiments, the outlet tube 216 receives the fluid once it has passed through a pressure regulator 218. The outlet tube 216 extends from the fluid supply to and is coupled to an organ connector assembly 228. Specifically, the organ connector assembly 228 is fluidly coupled to the outlet tube 216 at a distal end.

[0032] The organ connector assembly 228 is configured to provide fluid to an organ within the organ environment. In some embodiments, the organ connector assembly 228 is configured to provide fluid to the transport container 104 such that the fluid surrounds the organ. The organ connector assembly 228 includes an organ connector tube 230. The organ connector tube 230 is coupled to the outlet tube 216 and configured to receive fluid from the outlet tube 216. In some embodiments, the organ connector tube 230 is coupled to the outlet tube 216 to prevent leakage of fluid. In some embodiments, the organ connector tube 230 may include a seal disposed between the organ connector tube 230 and the outlet tube 216 to prevent leakage of fluid. The organ connector assembly 228 includes an organ connector 232. The organ connector 232 is coupled to the organ connector tube 230 at one end and receives fluid from the organ connector tube 230. At another end, the organ connector 232 is coupled to an organ (not shown). In some embodiments, the organ connector 232 is coupled to an inlet of the organ. In some embodiments, the organ connector 232 may be a needle. In some embodiments, the organ connector 232 may be a flexible catheter. In operation, the organ connector 232 receives fluid from the organ connector tube 230 and supplies fluid to the organ to inflate, oxygenate, and / or hydrate the organ. In some embodiments, the organ connector 232 is coupled to the trachea. In some embodiments, the organ connector 232 is coupled to a mainstem bronchus.

[0033] 3, a schematic diagram of a system 300 is depicted. The system 300 includes an organ 302 disposed with an organ stabilizing fluid L3 and an organ environment 304 including at least one organ bag 306. In some embodiments, the organ environment 304 may include a second organ bag 308. In some embodiments, the organ environment 304 may include a third organ bag 310. The system 300 includes an organ environment manifold 312. The organ 302, the organ stabilizing fluid L3, the organ environment 304, the organ bag 306, the second organ bag 308, the third organ bag 310, and the organ environment manifold 312 may be substantially identical to the organ 102, the organ stabilizing fluid L1, the organ environment 104, the organ bag 106, the second organ bag 108, the third organ bag 110, and the organ environment manifold 112, respectively, and therefore will not be described in further detail herein.

[0034] The system 300 includes a transport container 313. The transport container 313 is configured to receive the organ environment 304 including the organ 302 and to protect the organ environment 304 and the organ 302 from external damage. In some embodiments, the transport container 313 is a cooler configured to maintain the temperature of the organ, as described herein. In some embodiments, the transport container 313 is the organ environment 304. The shipping container 313 can have an interior length in the range of approximately 12 inches (30.48 cm) to 24 inches (60.96 cm) (e.g., 11.4 inches (28.956 cm), 12 inches (30.48 cm), 13 inches (33.02 cm), 14 inches (35.56 cm), 15 inches (38.10 cm), 16 inches (40.64 cm), 17 inches (43.18 cm), 18 inches (45.72 cm), 19 inches (48.26 cm), 20 inches (50.80 cm), 21 inches (53.34 cm), 22 inches (55.88 cm), 23 inches (58.42 cm), 24 inches (60.96 cm), 24.7 inches (62.738 cm), etc.). The shipping container 313 can have an interior width in the range of approximately 10 inches (25.4 cm) to 16 inches (40.64 cm) (e.g., 9.6 inches (24.384 cm), 10 inches (25.4 cm), 11 inches (27.94 cm), 12 inches (30.48 cm), 13 inches (33.02 cm), 14 inches (35.56 cm), 15 inches (38.1 cm), 16.8 inches (42.672 cm), etc.). In some embodiments, the transport container 313 can have a depth in the range of about 10 inches (25.4 cm) to 16 inches (40.64 cm) (e.g., 9.2 inches (23.368 cm), 10 inches (25.4 cm), 11 inches (27.94 cm), 12 inches (30.48 cm), 13 inches (33.02 cm), 14 inches (35.56 cm), 15 inches (38.1 cm), 16 inches (40.64 cm), 16.6 inches (42.164 cm), etc.).

[0035] System 300 includes a fluid supply 314, an outlet tube 316, a pressure regulator 318, a pressure gauge 319, a pressure valve 320, and a vent assembly 322 including a vent tube 324 and a vent valve 326. Vent assembly 322 including fluid supply 314, outlet tube 316, pressure regulator 318, pressure valve 320, and vent tube 324 and vent valve 326 may be substantially identical to vent assembly 122 including fluid supply 114, outlet tube 116, pressure regulator 118, pressure gauge 219, pressure valve 120, and vent tube 124 and vent valve 126, respectively, and therefore will not be described in further detail herein. In some embodiments, vent valve 126 may be a filter to maintain sterility.

[0036] The system 300 includes a temperature adjustment unit 327 (e.g., ice, dry ice, cooling fluid, phase change material, etc.). The temperature adjustment unit 327 is configured to cool the organ to a temperature range within a range of about 0°C to about 10°C (e.g., -0.05°C, 0°C, 1°C, 2°C, 3°C, 4°C, 5°C, 6°C, 7°C, 8°C, 9°C, 10°C, 12.5°C, etc.). Here, the temperature adjustment unit 327 cools the organ so as to reduce metabolism in the organ during transportation and inhibit cell death.

[0037] The system 300 includes an organ connector assembly 328. The organ connector assembly includes an organ connector tube 330 and an organ connector 332. The organ connector assembly 328 including the organ connector tube 330 and the organ connector 332 is substantially identical to the organ connector assembly 228 including the organ connector tube 230 and the organ connector 232, respectively, and therefore will not be described in further detail herein.

[0038] 4, a schematic diagram of a system 400 is depicted. The system 400 includes an organ 402 disposed with an organ stabilizing fluid L4 and an organ environment 404 including at least one organ bag 406. In some embodiments, the organ environment 404 may include a second organ bag 408. In some embodiments, the organ environment 404 may include a third organ bag 410. The system 400 includes an organ environment manifold 412, a transport container 413, an outlet tube 416, a pressure regulator 418, a pressure valve 420, and an organ connector assembly 428 including a vent tube 424, a vent filter 425 and a vent valve 426, a temperature regulator 427, and an organ connector tube 430 and an organ connector 432. The organ 402, organ stabilizing fluid L4, organ environment 404, organ bag 406, second organ bag 408, third organ bag 410, organ environment manifold 412, transport container 413, and organ connector assembly 428 including organ connector tube 430 and organ connector 432 are substantially identical to organ connector assembly 228 including organ 102, organ stabilizing fluid L1, organ environment 104, organ bag 106, second organ bag 108, third organ bag 110, organ environment manifold 112, transport container 313, and organ connector tube 230 and organ connector 232, respectively, and therefore will not be described in further detail herein.

[0039] The system 400 includes a fluid supply 414. The fluid supply 414 is substantially identical to the fluid supply 114 in that it is configured to store fluid and supply the fluid to the organ via an outlet tube 416. In some embodiments, the fluid supply 414 is housed within a transport container 413. Specifically, the fluid supply 414 is housed within a temperature regulation unit 427 such that the fluid within the fluid supply 414 may be cooled before flowing to the organ 402. This allows for additional cooling of the organ 402 which may increase the survivability of the organ 402 during transport.

[0040] Additionally, the system 400 includes a controller 434 (e.g., control circuitry, programmable logic board, drivers, etc.). The pressure regulator 418 and pressure gauge 419 are electrically or communicatively coupled to the controller 434. The controller 434 is configured to control the pressure regulator 418 to maintain the fluid pressure at a fluid pressure value within a range of about 8 cmH2O to about 20 cmH2O (e.g., 7.6 cmH2O, 8 cmH2O, 10 cmH2O, 12 cmH2O, 14 cmH2O, 16 cmH2O, 18 cmH2O, 20 cmH2O, 21 cmH2O, etc.) above ambient. In some embodiments where the fluid includes a liquid, the controller 434 may be configured to control a pump to control the supply and pressure of the liquid delivered to the organ.

[0041] The controller 434 includes a processing circuit 435. The processing circuit 435 includes a processor 436 and a memory 438. The processor 436 may include a microprocessor, an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or the like, or a combination thereof. The memory 438 may include, but is not limited to, an electronic, optical, magnetic, or any other storage device or transmission device capable of providing program instructions to the processor, ASIC, FPGA, or the like. This memory 438 may include memory chips, an electrically erasable programmable read-only memory (EEPROM), an erasable programmable read only memory (EPROM), a flash memory, or any other suitable memory from which the controller 434 can read instructions. The instructions may include code in any suitable programming language. The memory 438 may include various modules that include instructions configured to be executed by the processor 436. In some embodiments, the memory 438 includes pressure ranges for various fluids that may be stored in the fluid supply 414. In some embodiments, the memory 438 includes a temperature range.

[0042] In operation, the controller 434, via the processor 436, electrically sends commands to the pressure gauge 419 to perform measurements and obtain fluid pressure values. The pressure gauge 419 receives the commands, obtains the fluid pressure values, and sends the fluid pressure values ​​to the controller 434. The controller 434, via the processor 436, receives the fluid pressure values ​​and stores the fluid pressure values ​​in the memory 438. The controller 434, via the processor 436, retrieves the pressure range of the fluid in the fluid supply tube 416 and the fluid pressure value from the memory 438 and compares the fluid pressure value to the pressure range. In some embodiments, the controller 434 determines that the fluid pressure value is greater than the upper limit of the pressure range. The controller 434 then adjusts the pressure regulator 418 so that the pressure of the fluid is reduced, and the pressure valve 420 vents the excess pressure so that the pressure of the fluid can be maintained within the pressure range. In some embodiments, the controller 434 may determine that the pressure value of the fluid is within the pressure range and not adjust the pressure regulator 418. In some embodiments, the controller 434 may determine that the fluid pressure value is below the lower limit of the pressure range and adjusts the pressure regulator 418 to allow more fluid to flow from the fluid supply 414 to increase the fluid pressure.

[0043] In some embodiments, the controller 434 may include a global positioning system sensor 440 (e.g., a Global Positioning System (GPS), a route information sensor, etc.) (hereinafter, a “GPS sensor”). The GPS sensor 440 is configured to sense the location of the system 400. In some embodiments, the GPS sensor 440 is configured to determine a geographic location of the system 400. In some embodiments, the GPS sensor 440 may determine precise longitude and latitude coordinates of the system 400. In some embodiments, the controller 434 includes an antenna 442 (e.g., a receiver, a transponder, etc.). In some embodiments, the system 400 includes a remote server 446. Here, the antenna 442 is wirelessly connected to the remote server 446 via a wireless path 444. The remote server 446 is configured to receive the location of the system 400. In operation, the controller 434 activates the GPS sensor 440 via the processor 436. The GPS sensor 440 detects the location of the system 400 and transmits the location to the processor 436. The processor 436 transmits the location to an antenna 442. The antenna 442 transmits the location over wireless path 444 to a remote server 446. The remote server 446 receives the location of the system 400. In some embodiments, the remote server 446 may have a display that displays the location of the system 400 to a user. In some embodiments, the remote server 446 may transmit the location to one or more user devices (e.g., a cell phone, a tablet, a remote server, etc.).

[0044] In some embodiments, the controller 434 includes communication capabilities that allow for one-way or two-way communication with at least one other device. For example, the controller 434 can report information such as the status (e.g., pressure and temperature) of the system 400 or the organ 402 to another device using any suitable method, such as cellular communication, Wireless Fidelity (Wi-Fi), or Bluetooth. The information can be relayed to the device using an intermediate device, such as a server. In some embodiments, the device can be used to send commands or instructions, such as instructions to change the temperature or pressure, to the controller. In this manner, the status of the system 400, and more specifically, the status of the organ 402, can be monitored and / or controlled during transport. The system 400 can include a computer interface for monitoring and / or regulating the status of the organ 402, such as using a laptop or mobile device, such as a cell phone or tablet. In some embodiments, the system 400 is configured to turn off certain radio transmissions (e.g., cellular, etc.) above a certain speed (e.g., 130 mph) and resume when the speed of the device drops below a certain speed in order to comply with restrictions on radio transmissions during flight.

[0045] Referring to FIG. 5, a flow chart illustrating a method 500 of maintaining viability of an organ is shown, according to one embodiment. In operation 502, a system for maintaining viability of an organ is provided. The system includes a fluid supply configured to store a volume of fluid, an outlet tube configured to be fluidly coupled to the fluid supply, a pressure regulator fluidly coupled to the outlet tube, a pressure valve fluidly coupled to the outlet tube, and a vent assembly including a vent tube configured to be disposed within the organ environment and a vent valve configured to be disposed outside the organ environment. In some embodiments, the system may include a pressure gauge fluidly coupled to the outlet tube. In some embodiments, the system may include systems 100, 200, 300, 400, or any other system described herein.

[0046] At 504, at least a portion of an organ is placed within the organ environment. In some embodiments, the organ environment can include at least one organ bag containing an organ stabilization medium. In some embodiments, the organ environment can include multiple organ bags. At 506, a first end of an outlet tube of the system is fluidly coupled to at least a portion of the organ. In some embodiments, the outlet tube can be connected to an organ connector assembly that is fluidly coupled to at least a portion of the organ.

[0047] At 508, a second end of the outlet tube is fluidly coupled to a fluid supply. At 510, a pressure regulator is adjusted to facilitate fluid flow from the fluid supply to at least a portion of the organ. Specifically, the pressure regulator is set to a predetermined pressure threshold, and is configured to facilitate fluid flow from the outlet tube to the environment when the fluid in the outlet tube exceeds the pressure threshold. In some embodiments, the pressure of the fluid in the outlet tube after the pressure regulator may increase due to the surrounding environment. Here, a pressure valve included in the system facilitates the removal of excess fluid to stabilize the pressure in the outlet tube.

[0048] In some embodiments, the method 500 also includes, at 512, disposing a vent assembly within the organ environment. The vent assembly is configured to stabilize fluid pressure within the organ environment. Specifically, the vent assembly can include a vent tube disposed within the organ environment. Further, the vent assembly can include a vent valve fluidly coupled to the vent tube and configured to release excess fluid within the organ environment to the surrounding environment via the vent tube.

[0049] 6-8, a schematic diagram of a system 600 is depicted. The system 600 includes an organ 602 disposed within an organ stabilizing fluid L5 and an organ environment 606 including at least one organ bag 606. In some embodiments, the organ environment 606 includes one or more organ bags 606. The organ environment system 606 includes a transport container 608. The transport container 608, at least one organ bag 606, organ stabilizing fluid L5, organ environment 604, and organ 602 are substantially identical to the transport container 313, at least one organ bag 102, organ stabilizing fluid L1, organ environment 104, and organ 102, and therefore will not be described in further detail.

[0050] System 600 includes a controller 610 (e.g., control circuitry, programmable logic board, drivers, etc.). Controller 610 may be coupled to transport vessel 608. Controller 610 is substantially identical to controller 434. Controller 610 is coupled to fluid capacitor 612, pressure gauge 614, pressure controller 616, fluid input line 618, vent supply line 620, fluid valve 622, and vent valve 624. Pressure gauge 614 is substantially identical to pressure gauge 219 and will not be described in further detail. In some embodiments, fluid capacitor 612 is similar to fluid supply 114 when fluid supply 114 is a gas capacitor.

[0051] In operation, the pressure controller 616 is operated to supply fluid to the organ 602. The pressure controller 616 operates the fluid valve 622 to allow fluid from the surrounding atmosphere (e.g., ambient air, oxygen, etc.) to flow through the fluid valve 622 to the fluid condenser 612. As a result, the pressure controller 616 can control the pressure of the fluid surrounding the organ 602. The fluid condenser 612 (e.g., oxygen condenser, gas condenser, etc.) condenses the fluid (e.g., removes nitrogen, removes carbon dioxide, removes neon, removes hydrogen, etc.) and supplies the condensed fluid to the fluid input line 618. In an exemplary embodiment, the fluid condenser 612 receives fluid from the fluid valve 624 and filters the nitrogen so that the fluid is primarily oxygen. In some embodiments, the fluid condenser 612 can combine the fluid flowing through the fluid valve 622 with fluid from a fluid supply (e.g., fluid supply 114, fluid supply 214, fluid supply 314, fluid supply 414, etc.). Fluid flows into the organ 602 through a fluid supply line 618 to maintain the organ 602 in a desired state (e.g., inflated, etc.) Once the organ 602 is maintained in the desired state, excess fluid flows through a vent supply line 620 and through a vent valve 624 to atmosphere.

[0052] As used herein, terms such as "coupled" mean that two components are joined directly or indirectly to one another. Such joining may be fixed (e.g., permanent) or movable (e.g., removable or releasable). Such joining may be achieved where the two components, or the two components and any additional intermediate components, are integrally formed with one another as a single unit, where the two components, or the two components and any additional intermediate components, are attached to one another.

[0053] As used herein, terms such as "fluidly coupled" mean that a pathway is formed between two components or objects, with or without intervening components or objects, through which a fluid, such as air, gas, or liquid, can flow.

[0054] It is important to note that the construction and arrangement of the various systems shown in the various exemplary implementations are merely illustrative and not limiting in features. It is desired that all changes and modifications that fall within the spirit and / or scope of the described implementations be protected. It is understood that some features may not be essential and implementations lacking various features may also be contemplated as being within the scope of the present disclosure, the scope of which is defined by the following claims. When the term "a portion" is used, an item may include a portion and / or the entire item, unless specifically stated to the contrary.

[0055] Additionally, the terms "or" and "or" are used in their inclusive (not exclusive) sense in the context of a list of elements, so that when used to connect a list of elements, the terms "or" and "or" refer to one, more than one, or all of the elements in the list. Conjunctions such as "at least one of X, Y, and Z" are understood in conjunction with the context as being generally used to convey that an item, term, etc., can be either X, Y, Z, X and Y, X and Z, Y and Z, or X and Y and Z (i.e., any combination of X, Y, and Z), unless otherwise indicated. Thus, such conjunctions do not generally imply that an embodiment requires that at least one X, at least one Y, and at least one Z are present, unless otherwise indicated.

[0056] Additionally, use of ranges of values ​​herein (e.g., W1-W2, etc.) includes the maximum and minimum values ​​thereof (e.g., W1-W2 includes W1 and W2, etc.) unless otherwise indicated. Additionally, ranges of values ​​(e.g., W1-W2, etc.) do not necessarily include intermediate values ​​within the range of values ​​(e.g., W1-W2 may include only W1 and W2, etc.) unless otherwise indicated.

Claims

1. 1. A system comprising: a fluid supply configured to contain a volume of fluid, the fluid supply fluidly coupled to an outlet conduit, the outlet conduit configured to be fluidly coupled to at least a portion of an organ environment configured to hold an organ; a pressure regulator fluidly coupled to the outlet conduit, the pressure regulator configured to maintain a fluid pressure of the fluid delivered from the outlet conduit to the organ environment in an above-ambient fluid pressure range so as to maintain the organ in an expanded position; a pressure valve fluidly coupled to the outlet conduit and configured to inhibit an increase in fluid pressure above a threshold.

2. 10. The system of claim 1, further comprising a vent assembly comprising a vent tube disposed within the organ environment and a vent valve disposed outside the organ environment, the vent assembly configured to remove excess fluid from the organ environment.

3. The fluid is about 12 cmH ２ O ~ about 15cmH ２ 0. Have fluid pressure in the range above ambient 10. The system of claim 1, wherein the gas is a gas.

4. The system of claim 1 , further comprising a pressure gauge fluidly coupled to the outlet conduit and configured to measure the fluid pressure within the outlet conduit.

5. The system of claim 1 , wherein the organ is a lung.

6. 10. The system of claim 1, further comprising an organ connector fluidly coupled to a distal end of the outlet tube and configured to be fluidly coupled to an inlet of the organ environment.

7. 10. The system of claim 1, wherein the organ environment comprises at least one organ bag including an organ stabilization medium disposed within the organ bag and configured to receive the organ therein.

8. a controller, receiving a fluid pressure value related to the fluid pressure; adjusting the pressure regulator to maintain the fluid pressure at the fluid pressure value; storing the fluid pressure value in a memory located within the controller; The system of claim 1 , further comprising a controller configured to:

9. The system of claim 8 , wherein the controller further comprises a global position system configured to determine a geographic location of the system and an antenna configured to transmit the geographic location to a remote server.

10. The system of claim 8 , wherein the controller further comprises a communications module for sending information regarding the state of the system to a device remote server.

11. The system of claim 10 , wherein the communication module is capable of receiving commands from the device remote server to adjust a temperature condition of the system or a pressure condition of the system.

12. 1. A method comprising: providing a system, a fluid supply configured to store a volume of fluid; an outlet conduit configured to be fluidly coupled to a fluid supply; a pressure regulator fluidly coupled to the outlet conduit; a pressure valve fluidly coupled to the outlet conduit; providing a system comprising: placing at least a portion of the organ within the organ environment; fluidly coupling a first end of the outlet tube to the organ environment; fluidly coupling a second end of the outlet tube to the fluid supply; and adjusting the pressure regulator to supply the fluid through the outlet conduit to the organ in an above-ambient pressure range so as to maintain at least a portion of the organ in an expanded position.

13. The method of claim 12 , wherein the system further comprises a pressure gauge fluidly coupled to the outlet conduit and configured to measure fluid pressure within the outlet conduit.

14. The system further includes a vent assembly including a vent tube disposed within the organ environment and a vent valve disposed outside the organ environment; The method comprises: measuring, with the pressure gauge, a value of fluid pressure in the outlet pipe when the fluid flows from the fluid supply to the organ; stabilizing the fluid pressure in the outlet conduit with the pressure valve; 14. The method of claim 13, further comprising stabilizing the fluid pressure within the organ environment with the vent assembly.

15. 13. The method of claim 12, wherein the system further comprises a vent assembly comprising a vent tube disposed within the organ environment and a vent valve disposed outside the organ environment.

16. 1. A system comprising: a controller; a fluid supply coupled to the controller and configured to contain a volume of fluid; a condenser coupled to the controller and fluidly coupled to the fluid supply, the controller operating the fluid supply to supply fluid to the condenser, the condenser condensing the fluid; a fluid supply line fluidly coupled at a first end to the capacitor and fluidly coupled at a distal end to at least a portion of the organ environment, the fluid supply line configured to supply fluid to the organ environment.

17. a pressure valve fluidly coupled to the fluid supply line to inhibit an increase in fluid pressure above a threshold; 17. The system of claim 16, further comprising a pressure regulator fluidly coupled to the fluid supply line, the pressure regulator configured to maintain a fluid pressure of fluid being supplied from the fluid supply line to the organ environment in an above-ambient fluid pressure range to maintain the organ in an expanded position.

18. 17. The system of claim 16, wherein the controller further comprises a global positioning system configured to determine a geographic location of the system and an antenna configured to transmit the geographic location to a remote server.

19. The controller further comprises: receiving a fluid pressure value related to the fluid pressure; adjusting the pressure regulator to maintain the fluid pressure at the fluid pressure value; 20. The system of claim 17, wherein the controller is configured to store the fluid pressure value in a memory located within the controller.

20. 17. The system of claim 16, wherein the condenser condenses the fluid by removing gases such that the fluid provided from the condenser is primarily oxygen.

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