Blood oxygenator

Abstract

An oxygenator is disclosed that includes a housing defining an interior with improved gas exchange fluid channels and / or heat exchange fluid channels. In some examples, the oxygenator includes gas exchange fluid channels for sequentially passing gas from a gas exchange fluid inlet, through one or more layers of gas exchange fibers extending in a first direction, through one or more layers of gas exchange fibers extending in a second direction, and out of a gas exchange fluid outlet. In some examples, the oxygenator includes a partition between the gas exchange chamber and the gas and heat exchange chamber that divides the interior. In some examples, the housing includes an isolation fluid barrier chamber configured to be filled with a flow of heat exchange fluid from the heat exchange fluid inlet to provide an isolation barrier between the outflow end of the gas exchange fiber and the gas exchange fluid outlet.

Description

Technical Field

[0001] This disclosure relates to extracorporeal blood regulation devices, such as blood oxygenators. More specifically, this disclosure relates to blood oxygenators with improved fluid flow paths therethrough, their construction, and uses. Background Technology

[0002] Blood perfusion typically requires the use of one or more pumps in an extracorporeal circuit interconnected with the patient's vascular system to pump blood through the patient's blood vessels. The extracorporeal circuit typically includes an oxygenator, such as a hollow fiber blood oxygenator, for exchanging oxygen (O2) and carbon dioxide (CO2) in the extracorporeal circuit from the patient's blood. Cardiopulmonary bypass surgery typically requires a perfusion system that temporarily stops the heart from beating by replacing the function of the heart and lungs to create a static surgical field. This isolation allows for surgical correction of vascular stenosis, valvular disease, congenital heart defects, and other medical procedures. In a perfusion system used for cardiopulmonary bypass surgery, an extracorporeal blood circuit is established, which includes at least one pump and an oxygenation device to replace the function of the heart and lungs.

[0003] More specifically, in a cardiopulmonary bypass procedure, deoxygenated blood, i.e., venous blood, is transferred from a large vein entering the heart or other veins in the body (e.g., the femoral vein) via gravity drainage or vacuum aspiration and through venous lines in an extracorporeal circuit. The venous blood is pumped to an oxygenator, which provides oxygen transfer to the blood. Oxygen is introduced into the blood via transmembrane transfer, or, less commonly, via bubbling oxygen into the blood. Simultaneously, carbon dioxide is removed across the membrane. The oxygenated blood is filtered and then returned to the patient's aorta, femoral artery, or other arteries through arterial lines.

[0004] Currently available oxygenators have many drawbacks. For example, there is a ongoing need to improve the efficiency of oxygen exchange from the gas exchange fibers to the blood passing through the oxygenator. Additionally, during use, water vapor condensation can occur within the gas exchange fibers, leading to a gradual decline in gas exchange performance. Therefore, there is a continued need for alternative oxygenator designs that can improve efficiency, reduce vapor condensation, or otherwise enhance oxygenator performance. Summary of the Invention

[0005] This disclosure provides design, materials, manufacturing methods, and alternative usage options for blood oxygenators.

[0006] A first example is an oxygenator comprising a housing defining an inner chamber. A plurality of gas exchange fibers are disposed within the inner chamber. The plurality of gas exchange fibers includes one or more layers of gas exchange fibers extending in a first direction and one or more layers of gas exchange fibers extending in a second direction. The second direction is generally orthogonal to the first direction. The oxygenator also includes a gas exchange fluid inlet and a gas exchange fluid outlet. A gas exchange fluid passage is configured to allow gas to pass through the plurality of gas exchange fibers to oxygenate the blood in the inner chamber. The gas exchange fluid passage sequentially extends from the gas exchange fluid inlet, through one or more layers of gas exchange fibers extending in the first direction, through one or more layers of gas exchange fibers extending in the second direction, and exits at the gas exchange fluid outlet.

[0007] As an alternative or supplement to any of the examples in this document, in another example, the housing includes a first side, a second side opposite to the first side, a third side extending between the first and second sides, and a fourth side extending between the first and second sides and opposite to the third side. Gas exchange fluid passages are formed through one or more layers of gas exchange fibers extending in a first direction from the fourth side to the third side, and then gas exchange fluid passages are formed through one or more layers of gas exchange fibers extending in a second direction from the first side to the second side.

[0008] As an alternative or supplement to any of the examples in this document, the first velocity of the gas exchange fluid flowing through one or more gas exchange fibers extending in a first direction from the fourth side to the third side is greater than the second velocity of the gas exchange fluid flowing through one or more gas exchange fibers extending in a second direction from the first side to the second side.

[0009] As an alternative or supplement to any of the examples in this article, the first speed is 1.25 times or more the speed of the second speed.

[0010] As an alternative or supplement to any of the examples in this document, in another example, the oxygenator includes a gas exchange fluid passage defined within the housing between a gas outlet end of one or more layers of gas exchange fibers extending in a first direction and a gas inlet end of one or more layers of gas exchange fibers extending in a second direction.

[0011] As an alternative or supplement to any of the examples in this document, in another example, the inner chamber is a gas exchange chamber, and the housing includes a second inner chamber that is a gas and heat exchange chamber, wherein the gas and heat exchange chamber includes a plurality of gas exchange fibers disposed within the gas and heat exchange chamber and a plurality of heat exchange fibers disposed within the gas and heat exchange chamber.

[0012] As an alternative or supplement to any of the examples in this article, in another example, the oxygenator includes a partition located between the gas exchange chamber and the gas and heat exchange chamber.

[0013] As an alternative or supplement to any of the examples in this document, in another example, the housing includes a blood inlet in fluid communication with a gas and heat exchange chamber and a blood outlet in fluid communication with a gas exchange chamber.

[0014] As an alternative or supplement to any of the examples in this article, in another example, the blood flow path is sequentially from the blood inlet, through the gas and heat exchange chamber, through the gas exchange chamber, and out of the blood outlet.

[0015] As an alternative or supplement to any of the examples in this document, in another example, a plurality of heat exchange fibers in the gas and heat exchange chamber are arranged along a first direction, and a plurality of gas exchange fibers in the gas and heat exchange chamber are arranged along a second direction.

[0016] As an alternative or supplement to any of the examples in this document, in another example, the housing includes a first side, a second side opposite to the first side, a third side extending between the first and second sides, and a fourth side extending between the first and second sides and opposite to the third side. Gas exchange fluid passages are formed through one or more layers of gas exchange fibers extending in a first direction from the fourth side to the third side, and then gas exchange fluid passages are formed through one or more layers of gas exchange fibers extending in a second direction from the first side to the second side.

[0017] As an alternative or supplement to any of the examples in this article, in another example, the second side includes an isolation fluid barrier chamber configured to be filled with a flowing heat exchange fluid.

[0018] As an alternative or supplement to any of the examples in this article, in another example, the housing includes a heat exchange fluid port in fluid communication with an isolation fluid barrier chamber.

[0019] As an alternative or supplement to any of the examples in this article, in another example, both the heat exchange fluid port and the gas exchange fluid outlet are located on the second side of the housing.

[0020] As an alternative or supplement to any of the examples in this document, in another example, the isolation fluid barrier chamber is located between the outlet end of one or more layers of gas exchange fibers extending in a second direction on the second side and the exterior of the second side of the housing.

[0021] Another example is an oxygenator comprising a housing defining an interior. The interior includes a gas exchange chamber and a gas and heat exchange chamber. A partition is located between the gas exchange chamber and the gas and heat exchange chamber. Multiple gas exchange fibers are disposed within the gas exchange chamber. Multiple gas exchange fibers are disposed within the gas and heat exchange chamber. Multiple heat exchange fibers are disposed within the gas and heat exchange chamber.

[0022] As an alternative or supplement to any of the examples in this document, in another example, the plurality of gas exchange fibers disposed in the gas exchange chamber include one or more layers of gas exchange fibers extending in a first direction and one or more layers of gas exchange fibers extending in a second direction. The second direction may be substantially orthogonal to the first direction.

[0023] As an alternative or supplement to any of the examples in this document, in another example, a gas exchange fluid channel for oxygenating blood in a gas exchange chamber by passing gas through a plurality of gas exchange fibers in a gas exchange chamber passes sequentially through one or more gas exchange fibers extending in a first direction, and subsequently through one or more gas exchange fibers extending in a second direction.

[0024] As an alternative or supplement to any of the examples in this article, in another example, the first velocity of the gas exchange fluid flowing through one or more layers of gas exchange fibers extending in a first direction is greater than the second velocity of the gas exchange fluid flowing through one or more layers of gas exchange fibers extending in a second direction.

[0025] As an alternative or supplement to any of the examples in this document, in another example, the oxygenator includes a gas exchange fluid passage defined within the housing between a gas outlet end of one or more layers of gas exchange fibers extending in a first direction and a gas inlet end of one or more layers of gas exchange fibers extending in a second direction.

[0026] As an alternative or supplement to any of the examples in this document, in another example, the plurality of heat exchange fibers arranged in the gas and heat exchange chamber comprises one or more layers of heat exchange fibers extending in a first direction, and the plurality of gas exchange fibers arranged in the gas and heat exchange chamber comprises one or more layers of gas exchange fibers extending in a second direction. The second direction may be substantially orthogonal to the first direction.

[0027] Another example is an oxygenator comprising a housing having a first side, a second side opposite to the first side, a third side extending between the first and second sides, and a fourth side extending between the first and second sides and opposite to the third side. The housing defines an interior. A plurality of gas exchange fibers are disposed within the interior of the housing. The plurality of gas exchange fibers extend between the first and second sides, wherein gas flows out of the plurality of gas exchange fibers along the second side. A plurality of heat exchange fibers are disposed within the interior of the housing. The oxygenator includes a gas exchange fluid inlet and a gas exchange fluid outlet in fluid communication with the plurality of gas exchange fibers. The oxygenator also includes a heat exchange fluid inlet and a heat exchange fluid outlet in fluid communication with the heat exchange fibers. The second side of the housing includes an isolation fluid barrier chamber configured to be filled with a flow of heat exchange fluid from the heat exchange fluid inlet.

[0028] As an alternative or supplement to any of the examples in this article, in another example, an isolation fluid barrier is fluidly arranged between the heat exchange fluid inlet and the inflow end of a plurality of heat exchange fibers.

[0029] As an alternative or supplement to any of the examples in this article, in another example, the inflow ends of a plurality of heat exchange fibers are positioned along a fourth side, wherein the plurality of heat exchange fibers extend between the fourth side and the third side.

[0030] Another example is an oxygenator comprising a housing defining an interior. A plurality of gas exchange fibers are disposed within the interior. The plurality of gas exchange fibers includes one or more layers of gas exchange fibers extending in a first direction and one or more layers of gas exchange fibers extending in a second direction. The second direction is generally orthogonal to the first direction. The oxygenator also includes a gas exchange fluid inlet and a gas exchange fluid outlet. A gas exchange fluid passage is configured to allow gas to pass through the plurality of gas exchange fibers to oxygenate blood within the housing. The gas exchange fluid passage extends from the gas exchange fluid inlet, through the plurality of gas exchange fibers, and then exits at the gas exchange fluid outlet. A first velocity of the gas exchange fluid flowing through the one or more layers of gas exchange fibers extending in the first direction is greater than a second velocity of the gas exchange fluid flowing through the one or more layers of gas exchange fibers extending in the second direction.

[0031] As an alternative or supplement to any of the examples in this article, in another example, the first speed is 1.25 times or more the speed of the second speed.

[0032] The foregoing overview of some embodiments is not intended to describe every disclosed embodiment or implementation of this disclosure. The following figures and detailed description illustrate some of these embodiments in more detail. Attached Figure Description

[0033] This disclosure can be more fully understood by referring to the following detailed description in conjunction with the accompanying drawings, in which: Figure 1 This is a perspective top view of an exemplary blood oxygenator; Figure 2 yes Figure 1 A perspective bottom view of a blood oxygenator; Figure 3 yes Figure 1 Exploded view of a blood oxygenator; Figure 4 This is a perspective view taken from the first side to the second side of the blood oxygenator through a cross-section of the blood oxygenator; Figure 5 This is a perspective view taken from the third to the fourth side of the blood oxygenator through a cross-section of the blood oxygenator; Figure 6 This is a perspective top view of the blood oxygenator, with the top panel removed to view the interior of the blood oxygenator; Figure 7 This is a perspective top view of the blood oxygenator, with the top and side panels removed to view the internal chamber of the blood oxygenator; Figure 8 This is a cross-sectional view of the first gas and heat exchange chamber of the blood oxygenator, showing the flow paths of the gas exchange fluid and the heat exchange fluid through it; Figure 9 This is a perspective view of a fiber mat comprising a heat exchange fluid fiber layer extending in a first direction, which is arranged together with a gas exchange fiber layer extending in a second direction for use as a gas and heat exchange chamber. Figure 10 This is a perspective bottom view of the blood oxygenator, with the bottom panel removed to view the internal chamber; Figure 11 This is a perspective bottom view of the blood oxygenator, with the bottom and side panels removed to view the internal chamber of the blood oxygenator; Figure 12 This is a cross-sectional view of the second gas exchange chamber of the blood oxygenator, showing the flow path of the gas exchange fluid therethrough; and Figure 13 This is a perspective view of a fiber mat comprising a gas exchange fluid fiber layer extending in a first direction, which is arranged together with a gas exchange fiber layer extending in a second direction for use in a gas exchange chamber.

[0034] While this disclosure may have various modifications and alternatives, its details are shown by way of example in the figures and will be described in detail. However, it should be understood that this disclosure is not intended to be limited to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0035] The following definitions shall apply unless otherwise defined in the claims or elsewhere in this specification.

[0036] In this document, it is assumed that all numerical values ​​are modified by the term “approximately”, whether explicitly stated or not. The term “approximately” generally refers to a range of quantities that a person skilled in the art would consider equivalent to (i.e., having the same function or result) the value stated. In many instances, the term “approximately” may include the number of significant figures rounded to the nearest nearest digit.

[0037] The range of numbers expressed by the endpoints includes all quantities within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0038] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural indicators unless otherwise expressly stated. As used in this specification and the appended claims, the term “or” is generally used to include the meaning of “and / or” unless otherwise expressly stated.

[0039] The terms “top,” “up,” “above,” and “upward,” and their variations, used throughout this disclosure, are for descriptive purposes only and are intended to refer only to relative directions (i.e., directions to be distinguished from another direction), and should not be construed as referring to absolute directions. Similarly, the terms “bottom,” “down,” “below,” and “downward,” and their variations, used throughout this disclosure, are for descriptive purposes only and are intended only to refer to relative directions that are at least substantially opposite to the directions indicated by one or more of the terms “top,” “up,” “above,” and “upward,” and their variations.

[0040] For clarity, certain identifying numerical designations (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish the various described and / or claimed features. It should be understood that the numerical designations are not intended to be limiting but are merely exemplary. In some embodiments, for the sake of brevity and clarity, previously used numerical designations may be modified and adapted. That is, a feature identified as a “first” element may later be referred to as a “second” element, a “third” element, etc., or may be omitted entirely, and / or different features may be referred to as a “first” element. The meaning and / or name in each instance will be clear to a skilled practitioner.

[0041] The terms "integral" and "single" generally refer to one or more elements made or composed of a single structure or basic unit / component. Integral and / or single element shall exclude structures and / or features formed by assembling or otherwise connecting multiple discrete structures or elements together.

[0042] As used in this document, the term "in sequence" means that components, paths, steps, events, etc. are arranged in the order listed, but does not exclude additional components, paths, steps, events, etc. before, between, or after any listed components, steps, events, etc., unless it is explicitly stated that the explicitly listed components, paths, steps, events, etc. are arranged directly in sequence.

[0043] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Furthermore, when a specific feature, structure, and / or characteristic is described in connection with an embodiment, it should be understood that these features, structures, and / or characteristics may also be used in conjunction with other embodiments, whether explicitly described or not, unless otherwise expressly stated.

[0044] It should be noted that, for ease of understanding, certain features of this disclosure may be described in the singular, even if such features may be plural or repeated within the disclosed embodiments. Unless otherwise expressly stated, each instance of a feature may include and / or be covered by a single disclosure. For example, unless otherwise expressly stated, references to some features may equally refer to all instances and quantities other than one of the features stated. Therefore, it should be understood that, unless expressly stated to the contrary, the following statements are equally applicable to any and / or all of the more than one component present in the device.

[0045] The following detailed description should be read with reference to the figures, in which similar structures in different figures are numbered the same. The illustrative embodiments are depicted not necessarily to scale and are not intended to limit the scope of this disclosure.

[0046] Figure 1 This is a perspective top view of an oxygenator 2 used to regulate blood in an extracorporeal circuit (e.g., an extracorporeal life support (ECLS) system), and Figure 2 This is a perspective bottom view of the oxygenator 2. The oxygenator 2 may include a housing 10 having a top 20 and a bottom 30 opposite to the top 20. The oxygenator 2 may include a plurality of sides extending around the periphery of the housing 10 between the top 20 and the bottom 30. For example, the housing 10 may include a first side 21, a second side 22 opposite to the first side 21, a third side 23, and a fourth side 24 opposite to the third side 23. The third side 23 and the fourth side 24 may extend between the first side 21 and the second side 22. Thus, the first side 21 may be adjacent to the third side 23 and the fourth side 24, the second side 22 may be adjacent to the third side 23 and the fourth side 24, the third side 23 may be adjacent to the first side 21 and the second side 22, and the fourth side 24 may be adjacent to the first side 21 and the second side 22. The housing 10 may also include a connector 18 configured to connect the oxygenator 2 to a component of an ECLS, a blood perfusion system, or other medical system. For example, connector 18 can be used to connect oxygenator 2 (such as via a dedicated bracket) to a column or rod of a blood perfusion system.

[0047] The housing 10 may be a rigid housing and / or the housing 10 may be made of a substantially rigid material. In some instances, the housing 10 may be formed of a plurality of panels (e.g., polymer panels) assembled together to surround the interior of the housing 10. For example, the housing 10 may include a top panel 40 disposed on the top 20 of the housing 10 and a bottom panel 50 disposed on the bottom 30 of the housing 10. The top panel 40 may define the upper outer surface of the housing 10, and / or the bottom panel 50 may define the lower outer surface of the housing 10.

[0048] Additionally, the housing 10 may include: a first side panel 41 defining a first side 21 of the housing 10, disposed on or otherwise extending along the first side 21 of the housing 10; a second side panel 42 (collectively referred to herein as a second inner side panel 42a and a second outer side panel 42b), defining a second side 22 of the housing 10, disposed on or otherwise extending along the second side 22 of the housing 10; a third side panel 43 defining a third side 23 of the housing 10, disposed on or otherwise extending along the third side 23 of the housing 10; and / or a fourth side panel 44 defining a fourth side 24 of the housing 10, disposed on or otherwise extending along the fourth side 24 of the housing 10. In some embodiments, each of the panels may be formed separately and then assembled to form the housing 10. In other instances, one or more of the panels may be formed together with one or more of the panels, and then assembled with one or more additional panels to form housing 10. Other arrangements and configurations for constructing housing 10 are also conceivable.

[0049] The housing 10 may include a blood inlet 12 in fluid communication with the interior of the housing 10 to allow deoxygenated venous blood to flow from the patient into the oxygenator 2, and the housing 10 may include a blood outlet 14 in fluid communication with the interior of the housing 10 to allow oxygenated arterial blood to flow from the oxygenator to the patient. During use of the oxygenator 2, a blood inlet conduit (not shown) may be connected to the blood inlet 12, and / or a blood outlet conduit (not shown) may be connected to the blood outlet 14. In some instances, the blood inlet 12 may extend from the top 20 of the housing 10, such as from the top panel 40 of the housing 10. In some instances, the blood outlet 14 may extend from the bottom 30 of the housing 10, such as from the bottom panel 50 of the housing 10. Other arrangements and configurations of the blood inlet 12 and the blood outlet 14 are also contemplated.

[0050] The housing 10 may include a gas inlet 52 in fluid communication with a gas exchange structure (e.g., a gas exchange fiber pad or segment) within the housing 10, and the housing 10 may include a gas outlet 54 in fluid communication with the gas exchange structure within the housing 10. For example, the gas inlet 52 may be in fluid communication with the lumens of a plurality of gas exchange fibers to provide a gas (e.g., oxygen) to oxygenate blood passing through the oxygenator 2, while the gas outlet 54 may be in fluid communication with the lumens of a plurality of gas exchange fibers to remove gases (e.g., carbon dioxide) carried from the blood. In some instances, the gas inlet 52 may extend from a fourth side 24 of the housing 10, such as from a fourth side panel 44 of the housing 10. In some instances, the gas outlet 54 may extend from a second side 22, such as from a second side inner panel 42a of the housing 10. Thus, in some instances, the gas inlet 52 and the gas outlet 54 may extend from adjacent sides of the housing 10. Other arrangements and configurations of the blood inlet 12 and the blood outlet 14 are also contemplated.

[0051] The housing 10 may include a first heat exchange fluid port 62 in fluid communication with a heat exchange structure (e.g., a heat exchange fiber pad or segment) within the housing 10, which may be referred to as a heat exchange fluid inlet in some instances. The housing 10 may also include a second heat exchange fluid port 64 in fluid communication with a heat exchange structure within the housing 10, which may be referred to as a heat exchange fluid outlet in some instances. For example, when the heat exchange fluid port 62 is used as a heat exchange fluid inlet, it may be in fluid communication with the cavities of multiple heat exchange fibers to provide heat exchange fluid (e.g., water or other liquid) to heat / cool blood passing through the oxygenator 2. When used as a heat exchange fluid outlet, the heat exchange fluid port 64 may be in fluid communication with the cavities of multiple heat exchange fibers to remove heat exchange fluid (e.g., water or other liquid) from the oxygenator 2. In other instances, the direction of heat exchange fluid flow through the oxygenator 2 (e.g., through multiple heat exchange fibers) may be reversed, such that the second heat exchange fluid port 64 serves as a heat exchange fluid inlet and the first heat exchange fluid port 62 serves as a heat exchange fluid outlet. In some instances, the first heat exchange fluid port 62 (e.g., a heat exchange fluid inlet) may extend from a second side 22 of the housing 10, such as from a second-side outer panel 42b of the housing 10. In some instances, the second heat exchange fluid port 64 (e.g., a heat exchange fluid outlet) may extend from a third side 23, such as from a third-side panel 43 of the housing 10. Thus, in some instances, the first heat exchange fluid port 62 and the second heat exchange fluid port 64 may extend from adjacent sides of the housing 10. Other arrangements and configurations of the heat exchange fluid ports 62, 64 are also contemplated.

[0052] In some instances, housing 10 may include one or more additional auxiliary ports. For example, housing 10 may include an auxiliary port 56 extending from top panel 40, a first auxiliary port 58a extending from bottom panel 50, a second auxiliary port 58b extending from bottom panel 50, and / or a third auxiliary port 58c extending from bottom panel 50. In some instances, the first auxiliary port 58a may be referred to as a cardiac arrest port, configured to return blood to the patient's heart chambers. In some instances, the second auxiliary port 58b may be referred to as a temperature control port, connectable to a temperature probe to measure the temperature of blood passing through oxygenator 2. In some instances, the third auxiliary port 58c may be referred to as a purge port outlet. In some instances, auxiliary port 56 may be referred to as a purge port inlet. The purge port inlet and purge port outlet may be configured to jointly purge air bubbles within oxygenator 2. More or fewer ports, their uses, and their arrangement and configuration are also contemplated.

[0053] Figure 3 This is an exploded view of the housing 10 of the oxygenator 2, wherein the top panel 40, bottom panel 50, first side panel 41, second inner side panel 42a, second outer side panel 42b, third side panel 43, and fourth side panel 44 are separated from each other. Figure 3 As shown, the interior of the housing 10 may include partitions or baffles 38 to divide the interior of the housing 10 into a plurality of chambers or compartments. The baffles 38 may extend across the interior of the housing 10 between a first side 21 and a second side 22, and may extend across the interior of the housing 10 between a third side 23 and a fourth side 24, to divide the interior of the housing 10 into an upper chamber or upper compartment defined between the top panel 40 and the upper surface of the baffles 38, and a lower chamber or lower compartment defined between the bottom panel 50 and the lower surface of the baffles 38. As will be further described herein, the baffles 38 may be provided with perforations such that the baffles 38 include a plurality of orifices or openings extending from the upper surface of the baffles 38 through the baffles 38 to the lower surface of the baffles 38 to allow blood to flow from the upper chamber through the baffles 38 to the lower chamber.

[0054] Figure 4 This is a perspective view taken through a cross-section of the oxygenator 2, from the first side 21 to the second side 22. Figure 5 This is a perspective view taken from the third side 23 to the fourth side of the oxygenator 2 through the cross section of the oxygenator 2. Figure 4 The cross section is perpendicular to Figure 5 The cross-section is cut off. For example... Figure 4 and Figure 5 As shown, the partition 38 can divide the interior 32 of the housing 10 into a first or upper chamber 34 and a second or lower chamber 36. Figure 4 and Figure 5As can be seen, the first chamber 34 can be defined between the top panel 40 and the upper surface of the partition 38, while the second chamber 36 can be defined between the bottom panel 50 and the lower surface of the partition 38. Figure 4 As shown, the partition 38 may include opposing first and second lateral edges that extend to, are connected to, interlock with, or otherwise engage with the first and second side panels 41 and 42, respectively. Figure 5 As shown, the partition 38 may include opposing third and fourth lateral edges that extend to, connect with, interlock with, or otherwise engage with the third and fourth side panels 43 and 44, respectively. As described above, the partition 38 may be provided with holes such that it includes a plurality of orifices or openings 39 extending from the upper surface of the partition 38 through the partition 38 to the lower surface of the partition 38 to allow blood to flow from the first chamber 34 through the partition 38 to the second chamber 36.

[0055] Blood inlet 12 may be in fluid communication (e.g., direct fluid communication) with first chamber 34 to guide blood into first chamber 34. Blood outlet 14 may be in fluid communication (e.g., direct fluid communication) with second chamber 36 to collect blood flowing out of second chamber 36. Thus, blood may sequentially flow from blood inlet 12 into first chamber 34, then through multiple orifices or openings 39 of partition 38 into second chamber 36, and then exit second chamber 36 through blood outlet 14. In other words, the blood flow path may be sequentially defined as from blood inlet 12, through first chamber 34, through or via partition 38 (e.g., via multiple orifices or openings 39), through second chamber 36, and exiting blood outlet 14.

[0056] will with Figures 6 to 8 Further discussion of the first chamber 34 is described in relation to this. Figure 6 This is a perspective top view of the housing 10 of the oxygenator 2, with the top panel 40 removed to view the upper first chamber 34 of the interior 32 of the oxygenator 2. Figure 7 This is a perspective top view of the housing 10 of the oxygenator 2, with the top panel 40 and the third side panel 43 removed to view the first chamber 34 and the lower second chamber 36 of the interior 32 of the oxygenator 2. Figure 8 This is a cross-sectional view through the first chamber 34 of the oxygenator 2 (hereinafter referred to as the gas and heat exchange chamber), showing the flow paths of the gas exchange fluid and the heat exchange fluid therethrough.

[0057] The gas and heat exchange chamber 34 may be configured to provide both gas exchange (e.g., oxygen) with blood flowing through it and heat exchange between a heat exchange fluid (e.g., water) and blood flowing through it. For example, the gas and heat exchange chamber 34 may include a plurality of heat exchange fibers and a plurality of gas exchange fibers arranged as fibers in the gas and heat exchange section of the chamber. When blood flows through the gas and heat exchange chamber 34, it may flow around the plurality of heat exchange fibers and the plurality of gas exchange fibers. Figure 9 The diagram shows one possible arrangement of the gas and heat exchange sections of the fiber.

[0058] like Figure 9 As shown, the gas and heat exchange fiber segment 100 may include a plurality of heat exchange fibers 112 and a plurality of gas exchange fibers 122. In some embodiments, the plurality of heat exchange fibers 112 may be arranged in one or more, or more, heat exchange fiber layers 110, and / or the plurality of gas exchange fibers 122 may be arranged in one or more, or more, gas exchange fiber layers 120. For example, the heat exchange fiber layers 110 may alternate with the gas exchange fiber layers 120 along the thickness dimension of the gas and heat exchange fiber segment 100. For example, the plurality of heat exchange fibers 112 in each heat exchange fiber layer 110 in the gas and heat exchange chamber 34 may be arranged along a first direction, and the plurality of gas exchange fibers 122 in each gas exchange fiber layer 120 in the gas and heat exchange chamber 34 may be arranged along a second direction. In some embodiments, the first direction may be substantially orthogonal to or perpendicular to the second direction. Thus, the plurality of heat exchange fibers 112 may be arranged substantially perpendicular to the plurality of gas exchange fibers 122 in the gas and heat exchange chamber 34. In some instances, the first direction may form an angle between approximately 60 and 90 degrees or between approximately 75 and 90 degrees with the second direction.

[0059] Heat exchange fibers 112 may extend in a first direction between the fourth side 24 and the third side 23 of the housing 10 within the gas and heat exchange chamber 34. For example, the inflow end of the heat exchange fibers 112 may be encapsulated in a potting compound near the fourth side panel 44, while the outflow end of the heat exchange fibers 112 may be encapsulated in a potting compound near the third side panel 43. In the case of reverse flow, the end of the heat exchange fibers 112 at the third side panel 43 may be considered as the inflow end of the heat exchange fibers 112, and the end of the heat exchange fibers 112 at the fourth side panel 44 may be considered as the outflow end of the heat exchange fibers 112.

[0060] Gas exchange fiber 122 may extend in a second direction between a first side 21 and a second side 22 of housing 10 within gas and heat exchange chamber 34. For example, the inlet end of gas exchange fiber 122 may be encapsulated in a potting compound near the first side panel 41, while the outlet end of gas exchange fiber 122 may be encapsulated in a potting compound near the second side panel (e.g., the second inner side panel 42a).

[0061] Return to Figure 8 The flow path of the heat exchange fluid (e.g., water) will be further described. The heat exchange fluid enters the oxygenator 2 through a first heat exchange fluid port 62 (i.e., heat exchange fluid inlet) arranged on the second side 22 of the housing 10. The heat exchange fluid then enters an isolation barrier chamber 70 extending along the second side 22 of the housing 10. The heat exchange fluid flows through the isolation barrier chamber 70 into a heat exchange fluid passage 72 defined along the second side 22, and subsequently into a heat exchange fluid passage 74 defined along the fourth side 24. The heat exchange fluid passage 74 may extend a considerable length of the fourth side 24 to allow the heat exchange fluid to reach the inflow ends of a plurality of heat exchange fluid fibers arranged in the gas and heat exchange chamber 34. Then, as Figure 8 As shown, the heat exchange fluid can pass through the heat exchange fiber 112 from the fourth side 24 to the third side 23 in a first direction. Then, the heat exchange fluid can flow out from the outlet end of the heat exchange fiber at the third side 23 and leave the oxygenator 2 (e.g., the gas and heat exchange chamber 34 of the housing 10 of the oxygenator 2) through the second heat exchange fluid port 64 (i.e., the heat exchange fluid outlet) extending from the third side 23.

[0062] In an alternative arrangement where the direction of the heat exchange fluid is reversed, the heat exchange fluid can enter the oxygenator 2 through the second heat exchange fluid port 64 (i.e., the heat exchange fluid inlet) and flow into the inlet end of the heat exchange fibers at the third side 23. Then, the heat exchange fluid can flow along... Figure 8 The heat exchange fluid flows from the third side 23 through the heat exchange fiber 112 to the fourth side 24 in the opposite direction to the first direction shown, and exits from the outlet end of the heat exchange fiber at the fourth side 24. The heat exchange fluid can then flow through the heat exchange fluid passage 74 defined along the fourth side 24 and enter the isolation barrier chamber 70 via the heat exchange fluid passage 72 defined along the second side 22. The heat exchange fluid can then exit the oxygenator 2 through the first heat exchange fluid port 62 (i.e., the heat exchange fluid outlet) extending from the second side 22.

[0063] The isolation barrier chamber 70 may be a space defined between the second side inner panel 42a and the second side outer panel 42b. For example, the outward-facing surface of the second side inner panel 42a may be spaced apart from the inward-facing surface of the second side outer panel 42b to define the isolation barrier chamber 70 between them. The isolation barrier chamber 70 may extend across a large portion of the second side 22 of the housing 10, and in some embodiments, the isolation barrier chamber 70 may extend across substantially the entire second side 22 of the housing 10. Figure 11 As shown, the isolation barrier chamber 70 extends substantially the entire height of the second side 22 between the top and bottom sides of the housing 10, such that the isolation barrier chamber 70 is arranged outside the first chamber 34 and the second chamber 36. The isolation barrier chamber 70 may be in fluid communication with a heat exchange fluid passage 72, such that fluid leaving the isolation barrier chamber 70 enters (e.g., directly enters) the heat exchange fluid passage 72, or, in the case of reverse flow, fluid leaving the heat exchange fluid passage 72 enters (e.g., directly enters) the isolation barrier chamber 70. In some instances, the heat exchange fluid passage 72 may be integrally formed in the second side outer panel 42b, or the heat exchange fluid passage 72 may be formed separately. The heat exchange fluid passage 72 may be fluidly coupled to (e.g., in fluid communication with) a heat exchange fluid passage 74. In some instances, the heat exchange fluid passage 74 may be integrally formed in the fourth side panel 44, or the heat exchange fluid passage 74 may be formed separately. The heat exchange fluid passage 74 may extend across a large portion of the fourth side 24 of the housing 10 (e.g., across a large portion of the length of the fourth side panel 44), and in some instances, the heat exchange fluid passage 74 may extend across substantially the entire fourth side 24 of the housing 10 (e.g., across substantially the entire length of the fourth side panel 44). Thus, the heat exchange fluid passages 72 and 74 may guide heat exchange fluid around the periphery of the housing 10 from the second side 22 of the housing 10 to the adjacent fourth side 24, or, in the case of reverse flow, from the fourth side 24 to the second side 22. For example, the heat exchange fluid passages 72 and 74 may guide heat exchange fluid around the periphery of the housing 10 from the first heat exchange fluid port 62 (extending from the second side 22) to the inflow end of the heat exchange fibers 112 arranged along the fourth side 24 of the housing 10 in the gas and heat exchange chamber 34. In the case of reverse flow, heat exchange fluid passages 72 and 74 can guide heat exchange fluid from the outlet end of heat exchange fiber 112 arranged along the fourth side 24 of housing 10 in gas and heat exchange chamber 34 to the first heat exchange fluid port 62 (extending from the second side 22) around the periphery of housing 10.

[0064] Figure 8 The diagram also illustrates the flow path of gas exchange fluid (e.g., oxygen or oxygenated gas) through gas exchange fibers 122 in the gas and heat exchange chamber 34. Figure 8As shown, the gas exchange fluid can flow from the first side 21 to the second side 22 along a second direction. The second direction can be substantially orthogonal to or perpendicular to the first direction. Therefore, the flow path of the gas exchange fluid through the gas and heat exchange chamber 34 can be substantially orthogonal to or perpendicular to the flow path of the heat exchange fluid through the gas and heat exchange chamber 34. The gas exchange fluid can then flow out from the outlet end of the gas exchange fiber 122 at the second side 22 and exit the oxygenator 2 (e.g., exit the gas and heat exchange chamber 34 of the housing 10 of the oxygenator 2) through the gas exchange fluid outlet 54 extending from the second side 22. The flow path of the gas exchange fluid before reaching the gas and heat exchange chamber 34 (e.g., before the inlet end of the gas exchange fiber 122 entering the gas and heat exchange chamber 34) will be further described herein.

[0065] will with Figures 10 to 12 Further discussion of the second chamber 36 is described in connection with this. Figure 10 This is a perspective bottom view of the housing 10 of the oxygenator 2, with the bottom panel 50 removed to view the second chamber 36 of the interior 32 of the oxygenator 2. Figure 11 This is a perspective bottom view of the housing 10 of the oxygenator 2, with the bottom panel 50 and the second side panels (e.g., the second inner side panel 42a and the second outer side panel 42b) removed to view the first chamber 34 and the second chamber 36 of the interior 32 of the oxygenator 2. Figure 12 This is a cross-sectional view through the second chamber 36 of the oxygenator 2 (hereinafter referred to as the gas exchange chamber), showing the flow path of the gas exchange fluid therethrough.

[0066] The gas exchange chamber 36 may be configured to provide additional gas exchange between a gas exchange fluid (e.g., oxygen) and blood flowing through the gas exchange chamber 36. For example, the gas exchange chamber 36 may include a plurality of gas exchange fibers arranged as gas exchange sections of fibers within the gas exchange chamber 36. As blood flows through the gas exchange chamber 36, the blood may flow around the plurality of gas exchange fibers. Figure 13 The image shows one possible arrangement of the gas exchange section of the fiber.

[0067] like Figure 13As shown, the gas exchange fiber segment 200 may include a first plurality of gas exchange fibers 212 and a second plurality of gas exchange fibers 222. In some embodiments, the first plurality of gas exchange fibers 212 may be arranged in one or more first gas exchange fiber layers 210, and / or the second plurality of gas exchange fibers 222 may be arranged in one or more second gas exchange fiber layers 220. For example, the first gas exchange fiber layers 210 and the second gas exchange fiber layers 220 may alternate along the thickness dimension of the gas exchange fiber segment 200. For example, the first plurality of gas exchange fibers 212 in each first gas exchange fiber layer 210 in the gas exchange chamber 36 may be arranged along a first direction, and the second plurality of gas exchange fibers 222 in each second gas exchange fiber layer 220 in the gas exchange chamber 36 may be arranged along a second direction. In some embodiments, the first direction may be substantially orthogonal to or perpendicular to the second direction. Thus, the first plurality of gas exchange fibers 212 may be arranged substantially perpendicular to the second plurality of gas exchange fibers 222 in the gas exchange chamber 36. In some instances, the first direction may form an angle between approximately 60 and 90 degrees or between approximately 75 and 90 degrees with the second direction.

[0068] The first plurality of gas exchange fibers 212 may extend in a first direction between the fourth side 24 and the third side 23 of the housing 10 within the gas exchange chamber 36. For example, the inflow end of the first plurality of gas exchange fibers 212 may be encapsulated in a potting compound near the fourth side panel 44, while the outflow end of the first plurality of gas exchange fibers 212 may be encapsulated in a potting compound near the third side panel 43.

[0069] The second plurality of gas exchange fibers 222 may extend in the gas exchange chamber 36 between the first side 21 and the second side 22 of the housing 10 in a second direction. For example, the inlet end of the second plurality of gas exchange fibers 222 may be encapsulated in a potting compound near the first side panel 41, while the outlet end of the second plurality of gas exchange fibers 222 may be encapsulated in a potting compound near the second side panel (e.g., the second inner side panel 42a).

[0070] The orientation or direction of the second plurality of gas exchange fibers 222 in the gas exchange chamber 36 may be the same as that of the gas exchange fibers 122 in the gas and heat exchange chamber 34. In other words, the second plurality of gas exchange fibers 222 in the gas exchange chamber 36 may be arranged parallel to or at least substantially parallel to the gas exchange fibers 122 in the gas and heat exchange chamber 34, wherein the inflow ends of both the second plurality of gas exchange fibers 222 in the gas exchange chamber 36 and the gas exchange fibers 122 in the gas and heat exchange chamber 34 are encapsulated in a potting compound near the first side 21, and wherein the outflow ends of both the second plurality of gas exchange fibers 222 in the gas exchange chamber 36 and the gas exchange fibers 122 in the gas and heat exchange chamber 34 are encapsulated in a potting compound near the second side 22.

[0071] Return to Figure 12 The flow path of the gas exchange fluid (e.g., oxygen or oxygenated gas) will be further described. The gas exchange fluid enters the oxygenator 2 through a gas exchange fluid inlet 52 arranged on the fourth side 24 of the housing 10. The gas exchange fluid then flows into the inlet ends of the first plurality of gas exchange fibers 212 arranged in the gas exchange chamber 36. Then, as... Figure 12 As shown, gas exchange fluid can pass through the first plurality of gas exchange fibers 212 from the fourth side 24 to the third side 23 in a first direction. Then, the gas exchange fluid can flow out from the outlet end of the first plurality of gas exchange fibers 212 at the third side 23 into a gas exchange fluid passage 82 extending along the third side 23.

[0072] Gas exchange fluid passage 82 may be fluidly connected to (e.g., in fluid communication with) gas exchange fluid passage 84 extending along the first side 21. In some instances, gas exchange fluid passage 82 may be integrally formed in the third side panel 43, or gas exchange fluid passage 82 may be formed separately. In some instances, gas exchange fluid passage 84 may be integrally formed in the first side panel 41, or gas exchange fluid passage 84 may be formed separately. Thus, gas exchange fluid passages 82 and 84 may guide gas exchange fluid around the periphery of the housing 10 from the third side 23 of the housing 10 to the adjacent first side 21. For example, gas exchange fluid passages 82 and 84 may guide gas exchange fluid from the outlet ends of the first plurality of gas exchange fibers 212 in the gas exchange chamber 36 around the periphery of the housing 10 to the inlet ends of the second plurality of gas exchange fibers 222 in the gas exchange chamber 36.

[0073] Then, as Figure 12 As shown, the gas exchange fluid (e.g., oxygen or oxygenated gas) can flow from the first side 21 to the second side 22 along a second direction. The second direction can be substantially orthogonal to or perpendicular to the first direction. Therefore, the flow channels of the gas exchange fluid through the first plurality of gas exchange fibers 212 in the gas exchange chamber 36 can be substantially orthogonal to or perpendicular to the flow channels of the gas exchange fluid through the second plurality of gas exchange fibers 222 in the gas exchange chamber 36. Thus, the gas exchange fluid can sequentially pass through the first plurality of gas exchange fibers 212 along the first direction and then through the second plurality of gas exchange fibers 222 along the second direction to improve the efficiency of O2 and CO2 gas exchange between the gas exchange fluid and the blood. The gas exchange fluid can then flow out from the outlet end of the second plurality of gas exchange fibers 222 at the second side 22 and exit the oxygenator 2 (e.g., exit the gas exchange chamber 36 of the housing 10 of the oxygenator 2) through the gas exchange fluid outlet 54 extending from the second side 22.

[0074] Furthermore, gas exchange fluid passages 82 and 84 can guide gas exchange fluid from the outflow ends of the first plurality of gas exchange fibers 212 in the gas exchange chamber 36 around the periphery of the housing 10 to the inflow ends of the gas exchange fibers 122 in the gas and heat exchange chamber 34. Therefore, gas exchange fluid passages 82 and 84 can be in fluid communication with the inflow ends of both the gas exchange fibers 122 in the gas and heat exchange chamber 34 and the second plurality of gas exchange fibers 222 in the gas exchange chamber 36. In other words, gas exchange fluid exiting the gas exchange fluid passage 84 at the first side 21 can be dispersed or distributed between the inflow ends of the gas exchange fibers 122 in the gas and heat exchange chamber 34 and the inflow ends of the second plurality of gas exchange fibers 222 in the gas exchange chamber 36. Therefore, gas exchange fluid can pass through the first plurality of gas exchange fibers 212 in the gas exchange chamber 36 in the first direction before passing through the gas exchange fibers 122 in the gas and heat exchange chamber 34 in the second direction.

[0075] The sequential flow path of the gas exchange fluid through oxygenator 2 improves gas exchange between the gas exchange fluid and the blood, and provides other beneficial effects. For example... Figure 12 As shown, the gas exchange fluid can pass through the first plurality of gas exchange fibers 212 in the gas exchange chamber 36 from the fourth side 24 to the third side 23 in a first direction at a first velocity, but then, as Figure 8 and Figure 12 As shown, when the gas exchange fluid flows from the first side 21 to the second side 22 along the second direction, a certain amount of gas exchange fluid is distributed through the first plurality of gas exchange fibers 212 to the second plurality of gas exchange fibers 222 in the gas exchange chamber 36 and the plurality of gas exchange fibers 122 in the gas and heat exchange chamber 34. Since the sum of the amounts of the second plurality of gas exchange fibers 222 in the gas exchange chamber 36 and the plurality of gas exchange fibers 122 in the gas and heat exchange chamber 34 (or at least the sum of their internal cross-sectional areas) is greater than the amount of the first plurality of gas exchange fibers 212 in the gas exchange chamber 36 (or at least the sum of their internal cross-sectional areas), the velocity of the gas exchange fluid flowing along the second direction decreases. Therefore, the sequential flow path of the gas exchange fluid through the oxygenator 2 results in a velocity greater than the velocity of the gas exchange fluid flowing across the housing 10 from the fourth side 24 to the third side 23 along the first direction than the velocity of the gas exchange fluid flowing across the housing 10 from the first side 21 to the second side 22 along the second direction.

[0076] In some instances, the velocity of the gas exchange fluid flowing across the housing 10 from the fourth side 24 to the third side 23 in the first direction is 20% or more greater than the velocity of the gas exchange fluid flowing across the housing 10 from the first side 21 to the second side 22 in the second direction. In some instances, the velocity of the gas exchange fluid flowing across the housing 10 from the fourth side 24 to the third side 23 in the first direction is 25% or more greater than the velocity of the gas exchange fluid flowing across the housing 10 from the first side 21 to the second side 22 in the second direction. In some instances, the velocity of the gas exchange fluid flowing across the housing 10 from the fourth side 24 to the third side 23 in the first direction is 30% or more greater than the velocity of the gas exchange fluid flowing across the housing 10 from the first side 21 to the second side 22 in the second direction. In some instances, the velocity of the gas exchange fluid flowing across the housing 10 from the fourth side 24 to the third side 23 in the first direction is 50% or more greater than the velocity of the gas exchange fluid flowing across the housing 10 from the first side 21 to the second side 22 in the second direction.

[0077] In some instances, the first velocity of the gas exchange fluid in the first direction may be about 1.2 times or more than the second velocity of the gas exchange fluid in the second direction. In some instances, the first velocity of the gas exchange fluid in the first direction may be about 1.25 times or more than the second velocity of the gas exchange fluid in the second direction. In some instances, the first velocity of the gas exchange fluid in the first direction may be about 1.3 times or more than the second velocity of the gas exchange fluid in the second direction. In some instances, the first velocity of the gas exchange fluid in the first direction may be about 1.5 times or more than the second velocity of the gas exchange fluid in the second direction. In some instances, the first velocity of the gas exchange fluid in the first direction may be about 2 times or more than the second velocity of the gas exchange fluid in the second direction. Depending on the amount, size, and arrangement of the gas exchange fibers, the ratio of the first velocity of the gas exchange fluid in the first direction to the second velocity of the gas exchange fluid in the second direction may be, for example, 1.2:1 or greater, 1.25:1 or greater, 1.3:1 or greater, 1.4:1 or greater, 1.5:1 or greater, 1.75:1 or greater, 2:1 or greater, 2.25:1 or greater, or 2.5:1 or greater.

[0078] In other words, since a certain amount of gas exchange fluid is then distributed through the first plurality of gas exchange fibers 212 to the second plurality of gas exchange fibers 222 in the gas exchange chamber 36 and the plurality of gas exchange fibers 122 in the gas and heat exchange chamber 34, therefore, as Figure 12 The flow velocity of the gas exchange fluid through the first plurality of gas exchange fibers 212 in the gas exchange chamber 36, as shown, when the gas exchange fluid flows from the fourth side 24 to the third side 23 along the first direction, may be greater than that shown. Figure 8 and Figure 12The flow rate of the gas exchange fluid as shown is as follows: when the gas exchange fluid flows from the first side 21 to the second side 22 in the second direction, the gas exchange fluid passes through the second plurality of gas exchange fibers 222 in the gas exchange chamber 36 and the plurality of gas exchange fibers 122 in the gas and heat exchange chamber 34.

[0079] The isolation barrier chamber 70 of the housing 10 of the oxygenator 2 provides additional benefits. For example, the isolation barrier chamber 70, arranged between the outlet of the gas exchange fluid outlet 54 and the outlet ends of the plurality of gas exchange fibers 122 in the gas and heat exchange chamber 34 and the second plurality of gas exchange fibers 222 in the gas exchange chamber 36, can reduce or eliminate vapor condensation that might otherwise form in the oxygenator 2 near the gas exchange fluid outlet 54. Thus, the heat exchange fluid flowing through the oxygenator 2 can both act as an expansion barrier to reduce or eliminate vapor condensation near the gas exchange fluid outlet 54 and provide heating and / or cooling to the blood flowing through the oxygenator 2.

[0080] It should be understood that this disclosure is illustrative in many respects only. Changes may be made to the details, particularly in terms of shape, size, and arrangement of steps, without departing from the scope of this disclosure. To the extent appropriate, this may include using any feature of one exemplary embodiment in other embodiments. Of course, the scope of this disclosure is defined by the language expressed in the appended claims.

Claims

1. An oxygenator, comprising: A housing that defines an internal chamber; The interior chamber contains a plurality of gas exchange fibers; the plurality of gas exchange fibers include one or more layers of gas exchange fibers extending in a first direction and one or more layers of gas exchange fibers extending in a second direction, the second direction being generally orthogonal to the first direction; Gas exchange fluid inlet; Gas exchange fluid outlet; as well as A gas exchange fluid channel for passing gas through the plurality of gas exchange fibers to oxygenate the blood in the interior chamber, the gas exchange fluid channel sequentially extending from the gas exchange fluid inlet, through one or more layers of gas exchange fibers extending in a first direction, through one or more layers of gas exchange fibers extending in a second direction, and exiting the gas exchange fluid outlet.

2. The oxygenator according to claim 1, wherein, The housing includes a first side, a second side opposite to the first side, a third side extending between the first side and the second side, and a fourth side extending between the first side and the second side and opposite to the third side; and The gas exchange fluid channel is provided by one or more layers of gas exchange fibers extending in a first direction from the fourth side to the third side, and then the gas exchange fluid channel is provided by one or more layers of gas exchange fibers extending in a second direction from the first side to the second side.

3. The oxygenator according to claim 2, wherein, The first velocity of the gas exchange fluid flowing through one or more layers of gas exchange fibers extending in the first direction from the fourth side to the third side is greater than the second velocity of the gas exchange fluid flowing through one or more layers of gas exchange fibers extending in the second direction from the first side to the second side.

4. The oxygenator according to claim 3, wherein, The first speed is 1.25 times or more the speed of the second speed.

5. The oxygenator according to claim 1 further includes a gas exchange fluid passage defined in the housing between a gas outlet end of one or more gas exchange fibers extending in the first direction and a gas inlet end of one or more gas exchange fibers extending in the second direction.

6. The oxygenator according to claim 1, wherein, The inner chamber is a gas exchange chamber, and the shell includes a second inner chamber, which is a gas and heat exchange chamber, wherein the gas and heat exchange chamber includes a plurality of gas exchange fibers and a plurality of heat exchange fibers located within the gas and heat exchange chamber.

7. The oxygenator according to claim 6 further includes a partition located between the gas exchange chamber and the gas and heat exchange chamber.

8. The oxygenator according to claim 6, wherein, The housing includes a blood inlet in fluid communication with the gas and heat exchange chamber and a blood outlet in fluid communication with the gas exchange chamber.

9. The oxygenator according to claim 8, wherein, The blood flow path proceeds sequentially from the blood inlet, through the gas and heat exchange chamber, through the gas exchange chamber, and out of the blood outlet.

10. The oxygenator according to claim 6, wherein, The plurality of heat exchange fibers in the gas and heat exchange chamber are arranged along the first direction, and the plurality of gas exchange fibers in the gas and heat exchange chamber are arranged along the second direction.

11. The oxygenator according to claim 1, wherein, The housing includes a first side, a second side opposite to the first side, a third side extending between the first side and the second side, and a fourth side extending between the first side and the second side and opposite to the third side; The gas exchange fluid channel is formed by one or more layers of gas exchange fibers extending in the first direction from the fourth side to the third side, and then the gas exchange fluid channel is formed by one or more layers of gas exchange fibers extending in the second direction from the first side to the second side; and The second side includes an isolation fluid barrier chamber configured to be filled with a flowing heat exchange fluid.

12. The oxygenator according to claim 11, wherein, The housing includes a heat exchange fluid port that is in fluid communication with the isolation fluid barrier chamber.

13. The oxygenator according to claim 12, wherein, Both the heat exchange fluid port and the gas exchange fluid outlet are located on the second side of the housing.

14. The oxygenator according to claim 11, wherein, The isolation fluid barrier chamber is positioned between the outlet of one or more layers of gas exchange fibers extending along the second direction on the second side and the exterior of the second side of the housing.

15. An oxygenator, comprising: A housing defining an interior, the interior including a gas exchange chamber and a gas and heat exchange chamber. A partition between the gas exchange chamber and the gas and heat exchange chamber; Multiple gas exchange fibers within the gas exchange chamber; Multiple gas exchange fibers within the gas and heat exchange chamber; and Multiple heat exchange fibers are arranged in the gas and heat exchange chamber.

16. The oxygenator according to claim 15, wherein, The gas exchange chamber contains multiple gas exchange fibers, including: One or more layers of gas exchange fibers extending in the first direction; and One or more layers of gas exchange fibers extending in the second direction, The second direction is generally orthogonal to the first direction.

17. The oxygenator according to claim 16, wherein, Gas exchange fluid channels for oxygenating blood in the gas exchange chamber by passing gas through a plurality of gas exchange fibers in the gas exchange chamber pass sequentially through one or more gas exchange fibers extending in the first direction, and subsequently through one or more gas exchange fibers extending in the second direction.

18. The oxygenator according to claim 17, wherein, The first velocity of the gas exchange fluid flowing through one or more gas exchange fibers extending in the first direction is greater than the second velocity of the gas exchange fluid flowing through one or more gas exchange fibers extending in the second direction.

19. The oxygenator of claim 17 further includes a gas exchange fluid passage defined in the housing between a gas outlet end of one or more gas exchange fibers extending in the first direction and a gas inlet end of one or more gas exchange fibers extending in the second direction.

20. The oxygenator according to claim 16, wherein: The plurality of heat exchange fibers arranged in the gas and heat exchange chamber include one or more layers of heat exchange fibers extending in the first direction; and The plurality of gas exchange fibers arranged in the gas and heat exchange chamber comprise one or more layers of gas exchange fibers extending in the second direction.

21. An oxygenator, comprising: A housing, the housing including a first side, a second side opposite to the first side, a third side extending between the first side and the second side, and a fourth side extending between the first side and the second side and opposite to the third side, the housing defining an interior; A plurality of gas exchange fibers are located inside the housing, the plurality of gas exchange fibers extending between a first side and a second side, wherein gas flows out from the plurality of gas exchange fibers along the second side; Multiple heat exchange fibers are located inside the housing; A gas exchange fluid inlet that is in fluid communication with the plurality of gas exchange fibers; A gas exchange fluid outlet that is in fluid communication with the plurality of gas exchange fibers; A heat exchange fluid inlet that is in fluid communication with the heat exchange fiber; as well as The heat exchange fluid outlet is in fluid communication with the heat exchange fiber; The second side includes an isolation fluid barrier chamber configured to be filled with a flow of heat exchange fluid from the heat exchange fluid inlet.

22. The oxygenator according to claim 21, wherein, The isolation fluid barrier is fluidly arranged between the heat exchange fluid inlet and the inflow end of the plurality of heat exchange fibers.

23. The oxygenator according to claim 21, wherein, The inflow ends of the plurality of heat exchange fibers are positioned along the fourth side, wherein the plurality of heat exchange fibers extend between the fourth side and the third side.

24. An oxygenator, comprising: A housing that defines an interior; The interior contains a plurality of gas exchange fibers; the plurality of gas exchange fibers include one or more layers of gas exchange fibers extending in a first direction and one or more layers of gas exchange fibers extending in a second direction, the second direction being generally orthogonal to the first direction; Gas exchange fluid inlet; Gas exchange fluid outlet; as well as A gas exchange fluid channel for allowing gas to flow from the gas exchange fluid inlet to the gas exchange fluid outlet, through the plurality of gas exchange fibers, to oxygenate the blood inside the housing; Wherein, the first velocity of the gas exchange fluid flowing through the one or more gas exchange fibers extending in the first direction is greater than the second velocity of the gas exchange fluid flowing through the one or more gas exchange fibers extending in the second direction.

25. The oxygenator according to claim 24, wherein, The first speed is 1.25 times or more the speed of the second speed.

Images