Dual-chamber gas exchanger for respiratory support and its usage

Abstract

This relates to devices for extracorporeal membrane oxygenation, respiratory support, and cardiopulmonary support. [Solution] The apparatus of the present invention includes a dual-chamber gas exchanger configured to enhance flexibility and expandability for a wide range of clinical applications. The dual-chamber oxygen exchanger can be configured and used in various applications, such as a cardiopulmonary device for cardiopulmonary support during cardiopulmonary surgery, an extracorporeal membrane oxygenation (ECMO) circuit, and a respiratory support device for patients with pulmonary failure. The dual-chamber gas exchanger comprises two sweep gas channels and two gas exchange membrane bundles surrounded by a housing structure with various blood flow distribution and gas distribution mechanisms. The gas exchanger includes an outer housing, an intermediate housing, two gas exchange fiber bundles, a blood inlet, a blood outlet, two gas inlets, two gas outlets, two gas distribution chambers, and an optional heat exchanger.

Description

Technical Field

[0001] The present invention was made with government support under grant number HL118372 awarded by the National Institutes of Health. The government has certain rights in the invention.

[0002] This application claims the benefit of provisional patent application 62 / 545,512, filed on August 15, 2017, the entire disclosure of which is incorporated herein by reference.

[0003] The present invention generally relates to medical devices and methods. More particularly, the present invention relates to devices for extracorporeal membrane oxygenation, respiratory assistance, and cardiopulmonary assistance.

Background Art

[0004] The oxygenation of blood by artificial devices began in the 1930s. Early blood oxygenators, such as membrane blood oxygenators and bubble oxygenators, were based on exposing blood directly to oxygen or air. Direct contact between blood and oxygen is an effective way to exchange gases, but it also damages blood proteins and formed elements. Therefore, these early blood oxygenators could only be used for limited times, such as a few hours.

[0005] In other approaches, such as gas-permeable solid membranes, blood and sweep gas were separated to eliminate damage due to direct contact between blood and gas. Solid membranes were the basis of many design platforms but were hampered by manufacturing issues and thrombogenicity. Therefore, hollow fiber membranes emerged. Hollow fiber membranes enabled the design and construction of efficient and small blood oxygenators with low prime volume, an increased ratio of blood exchange surface area to blood volume, and reduced thrombogenicity. Many current blood oxygenators contain hollow fibers of microporous materials.

[0006] Many types of blood oxygen delivery devices based on hollow fiber membrane materials have been designed and developed. Oxygen delivery devices with hollow fiber membranes typically have a single chamber with one fiber bundle, characterized by the blood flow pathways within the fiber bundle. For example, there are four types of blood flow pathways: (1) longitudinal flow (axial flow) through the annular bundle, (2) circumferential flow around the annular bundle, (3) flow across the bundle with a substantially rectangular cross-section, and (4) radial flow through the annular bundle.

[0007] While membrane blood oxygenators based on the above principles are generally acceptable for cardiopulmonary bypass during open-heart surgery, they present several problems when used for respiratory support over extended periods (days to weeks). For example, typical hollow fiber membrane blood oxygenators have a large physical size with a relatively large blood contact surface area, a large prime volume, very limited long-term biocompatibility and durability, and limited flexibility for various clinical applications. Patients receiving respiratory support with these current blood oxygenators are often bedridden and have limited mobility due to the complexity and bulk of typical blood oxygenators caused by their inherent hemohydrodynamics. Further complications arise from non-uniform blood flow through the fiber membrane and the laminar boundary flow zone between blood cells and the fiber membrane.

[0008] Non-uniform blood distribution can cause numerous problems in hollow fiber membrane blood oxygenators, including hyperperfusion and hypoperfusion of blood within the flow path. Hyperperfusion offers no additional benefits compared to oxygen-saturated blood. However, hypoperfusion can be harmful to the patient. Hollow fiber membrane blood oxygenators use long flow paths to increase blood contact with a larger fiber membrane surface area, ensuring that all blood cells in the hypoperfused areas are adequately oxygenated. However, the large surface area and large prime volume of the gas exchange membrane reduce biocompatibility and wearability. Non-uniform blood flow can also cause excessive mechanical shear stress or stagnation in the oxygenator's blood flow pathway. These are major factors in blood activation and thrombus formation, consequently limiting long-term biocompatibility and durability.

[0009] In addition to these technical issues, typical hollow fiber membrane blood oxygen delivery systems lack flexibility for various clinical applications. Often, one device is designed for only one use, making them insufficient for some patients. In many cases, these oxygen delivery systems have limited ability to deliver oxygen while removing carbon dioxide for some patients. Furthermore, removing carbon dioxide requires a high sweep gas flow rate. Alternatively, because the sweep gas flow rate is limited (e.g., outpatient use), it is necessary to maintain a low blood flow rate. Low blood flow rates can lead to thrombus formation within the oxygen delivery system.

[0010] The requirements and availability of sweep gases vary across different clinical applications, including hospitals, outpatient clinics, and home environments. In particular, oxygen sources can present challenges in walking applications, such as requiring bulky oxygen tanks or large, heavy oxygen concentrators. Therefore, typical blood oxygen delivery systems can limit patient mobility and flexibility.

[0011] Removing carbon dioxide from an oxygen supply typically requires higher flow rates and a gas with very little carbon dioxide. Oxygen is a typical primary sweep gas for supplying oxygen and removing carbon dioxide. For example, with a 1:1 sweep gas flow rate and blood flow rate, only 5% of the oxygen (50cc / liter) is delivered to the circulating blood. However, to increase carbon dioxide removal, the sweep gas-to-blood flow rate ratio must exceed 1:1. Therefore, the proportion of oxygen utilized is far less than 5%, resulting in very low efficiency and high cost of oxygen supply. Even in acute situations with a flow rate of 5 liters / minute over 24 hours, a patient consumes 7,200 liters of oxygen, with less than 5% delivered to the patient. High-flow room air can also serve as a sufficient sweep gas for removing carbon dioxide. Current oxygen supply systems have limited adjustment capabilities, resulting in inaccurate control of oxygen supply and carbon dioxide removal.

[0012] Therefore, it is clear that an improved oxygen supply system is needed that efficiently utilizes swept gas for gas exchange. Such an oxygen supply system can be beneficial for a variety of applications and patients.

[0013] The background of the invention and related background patents include U.S. Patent Application Publication No. 2013 / 0296633; U.S. Patent No. 9320844; U.S. Patent No. 8709343; U.S. Patent No. 8529834; U.S. Patent No. 7871566; U.S. Patent No. 5270005; U.S. Patent No. 8795220; U.S. Patent No. 8545754; U.S. Patent No. 8518259; and U.S. Patent No. 6998093. [Overview of the project]

[0014] The apparatus of the present invention includes a gas exchanger configured to enhance flexibility and expandability for numerous clinical applications. The gas exchanger can be configured and used in a variety of applications, such as cardiopulmonary bypass machines for cardiopulmonary support during cardiopulmonary surgery, extracorporeal membrane oxygenation (ECMO) circuits, and respiratory support devices for patients with pulmonary failure. In some embodiments, a dual-chamber gas exchanger features two sweep gas channels. In other embodiments, two gas exchange membrane bundles are surrounded by a housing structure that provides two chambers that isolate the gas flow and provide continuous blood flow with various blood flow distributions and gas distribution mechanisms. In some embodiments, the gas exchanger includes an outer housing, an intermediate housing, two gas exchange fiber bundles, a blood inlet, a blood outlet, two gas inlets, two gas exhausts or outlets, two gas distribution chambers, and an optional heat exchanger. In certain embodiments, the gas exchanger can be configured to manipulate the concentration of the sweep gas exposed to the patient's blood to move oxygen and remove carbon dioxide, for example, by using a sweep gas that includes oxygen, mixed oxygen, and air, or other medical gases.

[0015] The present invention includes a compact dual-chamber gas exchanger having a low priming volume, a small gas exchange surface area, and the ability to break the boundary layer effect. The dual-chamber gas exchanger removes carbon dioxide while transporting oxygen. The dual-chamber gas exchanger includes an outer housing surrounding the internal components and host connector, a blood inlet, and an annular outer fiber bundle of hollow fiber membrane. The dual-chamber gas exchanger is configured for a wide range of applications, including cardiopulmonary bypass, extracorporeal membrane oxygenation (ECMO), integrated pump oxygenators, passive respiratory support devices (e.g., right ventricle-to-pulmonary artery configuration, or pulmonary artery-to-left atrium configuration), walking cardiopulmonary support, and respiratory support.

[0016] The outer fiber bundle is located in the center of the housing and further includes fibers, an upper potting, and a lower potting. The upper and lower pottings hold the fibers within the housing. In one embodiment, the outer fiber bundle includes a blood distributor configured as a helical spiral that wraps around the inner surface of the housing. The blood distributor is connected to a blood inlet near the upper or lower potting. The blood distributor is configured to release blood around the outer fiber bundle, creating a pressurized annular blood volume surrounding the outer fiber bundle, so that the blood flows axially through the gas exchange membrane of the outer fiber bundle.

[0017] In an alternative embodiment, the blood distributor of the dual-chamber gas exchanger includes a rectangular inlet or first gate opening on one side of the outer housing, extending from one end of the potting area to the other. The rectangular gate opening is typically a vertically oriented slot configured to discharge the blood entering through the blood inlet to the outer fiber bundle. The blood then generally flows circumferentially through the gas exchange membrane of the outer fiber bundle and typically exits through a second gate or outlet gate, as described below.

[0018] One embodiment of a dual-chamber gas exchanger further includes an annular inner fiber bundle of a hollow fiber membrane. The annular inner fiber bundle is concentrically arranged within the outer fiber bundle and further includes fibers, an upper potting, and a lower potting. The upper and lower potting of the annular inner fiber bundle hold the fibers in place within the housing.

[0019] Other embodiments of the dual-chamber gas exchanger further include an intermediate housing, typically formed as a cylindrical wall, configured to substantially separate the outer fiber bundle and the inner fiber bundle. Thus, the intermediate housing is generally located between the radially inner surface of the outer fiber bundle and the radially outer surface of the inner fiber bundle. An intermediate annular space is formed between the radially inner surface of the intermediate housing and the radially outer surface of the inner fiber bundle, providing an annular flow path around the inner fiber bundle and enabling a radially inner blood flow path through the inner fiber bundle. In other embodiments, the intermediate housing may be configured to provide circumferential or axial flow through the inner fiber bundle.

[0020] The dual-chamber gas exchanger further includes a narrow slot in the upper potting area, allowing blood to exit the outer fiber bundle and enter the intermediate annular space present between the intermediate housing wall and the outer annular surface of the inner fiber bundle. In other embodiments having a circumferential flow path through the outer fiber bundle, the dual-chamber gas exchanger includes a rectangular gate configured to allow blood flow from the outer fiber bundle into the intermediate annular space.

[0021] A dual-chamber gas exchanger includes components for transporting fluids, including a blood inlet, a blood outlet, and at least one gas inlet. The blood outlet is configured to collect oxygenated blood from the fibers and is coupled to a cannula into which the further oxygenated blood is returned to the patient. The blood outlet is typically located in a central position at the top of the housing and is fluidically coupled to the inner fiber bundle, such as the upper potting of the inner fiber bundle.

[0022] In one embodiment, at least one gas inlet, such as two gas inlets, is configured to provide a separate gas passage for a gas, such as oxygen and / or air, to enter the hollow fiber. The at least one gas inlet is located at the bottom of the housing. In one embodiment, the at least one gas inlet, together with the lower potting of two bundles of hollow fiber membrane, forms two separate gas chambers.

[0023] The two gas outlets are configured to provide gas passages for gases such as oxygen or air that escape from the hollow fibers. The gas outlets are generally located at the top of the housing and typically form two separate gas chambers with the upper potting of the two bundles of hollow fiber membranes.

[0024] In other embodiments, the blood gas exchanger includes a blood sample port or blood gas sensor configured to allow external sampling of blood within the blood gas exchanger. For example, the blood sample port may be fluidly connected to a blood inlet or blood outlet. The blood sample port may further include an oxygen saturation detector attached to the blood outlet and a temperature port attached to the blood outlet.

[0025] While each clinical scenario may have different considerations and requirements, there is a widespread demand for efficient, long-term biocompatible, long-term durable, and versatile blood exchangers. In other words, it is desirable to achieve the most efficient gas transfer using the minimum necessary fibrous membrane while minimizing blood trauma and maintaining long-term durability and reliability. Furthermore, it should be possible to accommodate various sweep gas sources to provide oxygen transfer, carbon dioxide removal, or both for a variety of clinical applications.

[0026] In a first embodiment, the present invention provides a blood oxygenator including a housing comprising a blood inlet, a blood outlet, a stripping gas inlet, an oxygenation gas inlet, and at least one gas outlet. An oxygenator fiber bundle is placed within the housing and configured so that blood flows through the blood flow region of the oxygenator fiber bundle in a predetermined path from the blood inlet to the blood outlet. The stripping gas inlet is configured to direct the flow of stripping gas through the stripping region of the oxygenator fiber bundle to at least one gas outlet. The oxygenation gas inlet is configured to direct the flow of oxygenation gas through the oxygenation region of the oxygenator fiber bundle to at least one gas outlet. The stripping gas region of the oxygenator fiber bundle is upstream of the oxygenation region of the oxygenator fiber bundle. The term “upstream” refers to the direction of blood flow such that the blood to be oxygenated is first exposed to the stripping gas in the stripping region and then exposed to the oxygenation gas in the oxygenation region of the fiber bundle.

[0027] In a first set of exemplary embodiments, the blood oxygen supply device of the present invention may have a cylindrical fiber bundle in which at least a portion of the blood flow pathway is radially inward or radially outward. In such embodiments, portions of the fiber bundle along the central axis are typically open to receive blood from the cylindrical fiber bundle or to provide an outlet or inlet plenum for distributing blood to the cylindrical fiber bundle. In yet another embodiment, the fiber bundle is cylindrical, and at least a portion of the blood flow pathway follows an annular pathway, and the bundle typically has a blood inlet or outlet plenum along the central axis of the fiber bundle. In yet another embodiment, at least a portion of the blood flow pathway may be unidirectional across the oxygen supply fiber bundle.

[0028] In certain examples, the fiber bundle of the oxygenator is cylindrical and has an outer portion of the blood flow path following an annular path and an inner portion of the blood flow path following a radially inward path. In these examples, the blood inlet typically supplies the outer portion of the fiber bundle, and the inner portion of the fiber bundle supplies the blood outlet. More specifically, the stripping region may be at least partially disposed in the outer portion of the blood flow path, and the oxygenation region may be at least partially disposed in the inner portion of the blood flow path where the blood inlet supplies the inner portion and the outer portion supplies the blood outlet. Alternatively, the stripping region may be at least partially disposed in the inner portion of the blood flow path, and the oxygenation region may be at least partially disposed in the outer portion of the blood flow path.

[0029] The blood oxygenator may further include a cylindrical wall separating the outer and inner portions of the cylindrical fiber bundle, and blood flows from the blood inlet through the axial opening of the housing to the outer portion of the fiber bundle, flows annularly through the outer portion of the fiber bundle, then through the axial opening of the cylindrical wall, and the blood flows radially inward through the inner portion of the fiber bundle and into a distribution ring surrounding an inner bundle that flows into an axial collection region along the central axis of the inner portion of the fiber bundle.

[0030] In other embodiments, the oxygenation fiber bundle of the blood oxygenator of the present invention has a cross-sectional area, the stripping region receiving stripping gas from the stripping gas inlet has an inlet area of between 20% and 80% of the cross-sectional area, and the oxygenation region receiving oxygenation gas from the oxygenation gas inlet has an inlet area of between 80% and 20% of the cross-sectional area.

[0031] In further embodiments, the blood oxygen supply unit may further comprise a manifold divider that divides and directs both (1) stripping gas from the stripping gas inlet to the stripping region of the oxygen supply unit fiber bundle and (2) oxygenated gas from the oxygenation gas inlet to the oxygenation region of the oxygen supply unit fiber bundle. The manifold divider may be positioned in a manifold that receives the stripping gas from the stripping gas inlet and the oxygenated gas from the oxygenation gas inlet, the manifold typically opening to the entire gas inlet side of the oxygenated fiber bundle, and the positioning of the manifold divider controls the inlet region of the stripping region that receives the stripping gas from the stripping gas inlet and the inlet region of the oxygenation region that receives the oxygenated gas from the oxygenation gas inlet. The manifold divider may be fixed or movable, in the latter case allowing adjustment of the relative area of ​​the stripping region and the oxygenation region of the fiber bundle during or between uses.

[0032] In further embodiments, the oxygenated fiber bundle of the blood oxygen supply may comprise an upper potting and a lower potting. The manifold may be located in a housing adjacent to one of the pottings, and a blood pump may be connected to the blood inlet. An oxygenated gas source may be connected to the oxygenated gas inlet, and a stripping gas source may be connected to the stripping gas inlet.

[0033] In a second aspect, the present invention provides a method for oxygenating blood. The blood oxygenator has (1) a housing having a blood inlet, a blood outlet, a stripping gas inlet, an oxygenation gas inlet, and at least one gas outlet, and (2) an oxygenator fiber bundle disposed within the housing. Blood flows through the blood inlet, the oxygenator fiber bundle, and the blood outlet. The stripping gas flows through the stripping gas inlet, and the oxygenation gas flows through the oxygenation gas inlet. The stripping gas flows through the stripping region of the oxygenator fiber bundle to at least one gas outlet, and the oxygenation gas flows through the oxygenation region of the oxygenator fiber bundle to at least one gas outlet. The stripping gas region of the oxygenator fiber bundle is located upstream of the oxygenation region of the oxygenator fiber bundle. This configuration achieves particularly efficient CO2 removal and oxygen uptake, and in particular can reduce the need for pure oxygen to perform both CO2 stripping and blood oxygenation.

[0034] In certain embodiments of the method of the present invention, blood may move through the stripping region of the oxygenator fiber bundle in an annular channel, and in other embodiments, blood may move through the oxidizing region of the oxygenator fiber bundle in a radially inward channel. In yet another embodiment, blood may move in a straight direction through the stripping region and the oxygenation region of the oxygenator fiber bundle. In some cases, blood may move through the oxygenator fiber bundle with a substantially uniform blood flow distribution. In other examples, the fiber bundle may have a cross-sectional area having an inlet area in which the stripping region receiving the stripping gas from the stripping gas inlet comprises 20% to 80% of the cross-sectional area, and an inlet area in which the oxygenation region receiving the oxygenation gas from the oxygenation gas inlet comprises 80% to 20% of the cross-sectional area. The method of the present invention may further include moving a manifold divider that directs a flowing stripping gas from a stripping gas inlet to the stripping region of an oxygen supply fiber bundle, and directs an oxygenated gas from an oxygenation gas inlet to the oxygenated region of an oxygen supply fiber bundle, in order to adjust the relative area of ​​the stripping region and the oxygenated region of the oxygenated fiber bundle. [Brief explanation of the drawing]

[0035] [Figure 1] This is a perspective view of a first embodiment of a dual-chamber gas exchanger equipped with circumferential-radial flow channels according to the principle of the present invention. [Figure 2] Figure 1 is a vertical cross-sectional view of a dual-chamber gas exchanger, which has a circumferential flow path design in the outer fiber bundle, a radial flow path in the inner fiber bundle, two gas inlets, and two gas exhaust ports. [Figure 3] Figures 1 and 2 show vertical cross-sectional views of the dual-chamber gas exchanger, illustrating the blood flow pathways within the blood distributor as well as the inner and outer fiber bundles. [Figure 4] Figures 1 to 3 show horizontal cross-sectional views of the dual-chamber gas exchanger, illustrating the circumferential blood flow path of the outer fiber bundle, from the distributor through gate 1 to the outer fiber bundle, and through gate 2 to the inner fiber bundle. [Figure 5] This is a perspective view of a dual-chamber gas exchanger with axial radial flow channels according to another embodiment of the present invention. [Figure 6] Figure 5 shows a vertical cross-sectional view of a dual-chamber gas exchanger, which features an axial flow path design in the outer fiber bundle, a radial flow path design in the inner fiber bundle, two gas inlets, and two gas exhaust ports. [Figure 7] Figure 5 shows a vertical cross-sectional view of the dual-chamber gas exchanger, illustrating the blood flow pathway. [Figure 8A] Figure 5 shows horizontal and partial cross-sectional views of the dual-chamber gas exchanger, illustrating the axial blood flow pathway of the outer fiber bundle, which continues from the spiral distributor through gate 1 to the outer fiber bundle, and then through gate 2 to the inner fiber bundle (left: upper cross-sectional view of the spiral vortex with blood flow through gate 1; right: transparent cross-sectional view of the axial blood flow pathway that enters the inner fiber bundle through gates 1 and 2 and exits the dual-chamber gas exchanger). [Figure 8B]Figure 5 shows horizontal and partial cross-sectional views of the dual-chamber gas exchanger, illustrating the axial blood flow pathway of the outer fiber bundle, which continues from the spiral distributor through gate 1 to the outer fiber bundle, and then through gate 2 to the inner fiber bundle (left: upper cross-sectional view of the spiral vortex with blood flow through gate 1; right: transparent cross-sectional view of the axial blood flow pathway that enters the inner fiber bundle through gates 1 and 2 and exits the dual-chamber gas exchanger). [Figure 9A] Horizontal and vertical cross-sectional views of examples of computational fluid dynamics modeling of blood flow fields in two embodiments of a dual-chamber gas exchanger (left: cross-sectional view of the embodiment in Figure 1 at 6 liters per minute, right: central cross-sectional view of the embodiment in Figure 5 at 6 liters per minute). [Figure 9B] Horizontal and vertical cross-sectional views of examples of computational fluid dynamics modeling of blood flow fields in two embodiments of a dual-chamber gas exchanger (left: cross-sectional view of the embodiment in Figure 1 at 6 liters per minute, right: central cross-sectional view of the embodiment in Figure 5 at 6 liters per minute). [Figure 10A] Horizontal and vertical cross-sectional views of computational fluid dynamics modeling of the oxygen transfer process and velocity vectors in two embodiments of a dual-chamber gas exchanger (left: cross-sectional view of the embodiment in Figure 1 at 6 liters per minute, right: central cross-sectional view of the embodiment in Figure 5 at 6 liters per minute). [Figure 10B] Horizontal and vertical cross-sectional views of computational fluid dynamics modeling of the oxygen transfer process and velocity vectors in two embodiments of a dual-chamber gas exchanger (left: cross-sectional view of the embodiment in Figure 1 at 6 liters per minute, right: central cross-sectional view of the embodiment in Figure 5 at 6 liters per minute). [Figure 11] This is a schematic diagram of a dual-chamber blood oxygen delivery system, showing various components used in cardiopulmonary bypass surgery. [Figure 12] This is a diagram of a dual-chamber gas exchanger for use as a removable integrated pump oxygenator (e.g., integrated pump oxygenator) according to another embodiment of the present invention. [Figure 13A]This is a diagram of a dual-chamber gas exchanger for use as a portable respiration and / or cardiopulmonary support according to another embodiment of the present invention ((A) harness configuration; (B) wheeled configuration). [Figure 13B] This is a diagram of a dual-chamber gas exchanger for use as a portable respiration and / or cardiopulmonary support according to another embodiment of the present invention ((A) harness configuration; (B) wheeled configuration). [Figure 14] This is a vertical cross-sectional view of a dual-chamber gas exchanger having a radial flow channel design in the outer fiber bundle and a circumferential flow channel in the inner fiber bundle, according to another embodiment of the present invention. [Figure 15] This is a vertical cross-sectional view of the dual-chamber gas exchanger of the embodiment shown in Figure 14, with arrows indicating the direction of blood flow. [Figure 16] This is a horizontal cross-sectional view of the outer and inner fiber bundles of a dual-chamber gas exchanger, similar to the one shown in Figure 14, showing the blood flow path within the spiral vortex. [Figure 17] This is a schematic vertical cross-section of a dual-chamber gas exchanger with radial blood flow through inner and outer annular chambers. [Figure 18] Figure 17 shows a vertical cross-sectional view of a dual-chamber gas exchanger according to an embodiment, with arrows indicating the radial blood flow pathways of the inner and outer fiber bundles. [Figure 19] This is a horizontal cross-sectional view of the helical vortex, outer fiber bundle, and inner fiber bundle of a dual-chamber gas exchanger, showing a blood flow path similar to that of the embodiment in Figure 17. [Figure 20] This is a vertical cross-sectional view of a dual-chamber gas exchanger having radial flow channels in an outer fiber bundle and axial flow channels in an inner fiber bundle, according to another embodiment of the present invention. [Figure 21] Figure 20 is a vertical cross-sectional view of a dual-chamber gas exchanger with arrows indicating the radial blood flow pathway of the outer fiber bundle, the axial blood flow pathway of the inner fiber bundle, two gas inlets, and two gas outlets. [Figure 22]This is a horizontal cross-sectional view of a helical vortex blood inlet in a dual-chamber gas exchanger, similar to that in Figure 20, with arrows indicating the blood flow pathways of the helical vortex and outer fiber bundles. [Figure 23A] Figure 23A shows a schematic diagram of an alternative gas flow path in a dual-chamber gas exchanger according to an alternative embodiment of the present invention, in which oxygen-rich sweep gas discharged from one of the inner or outer fiber bundles is mixed with air for use as a sweep gas in the other of the inner or outer fiber bundles. Each sweep gas is used separately for the inner and outer fiber bundles (Figure 23B). [Figure 23B] Figure 23A shows a schematic diagram of an alternative gas flow path in a dual-chamber gas exchanger according to an alternative embodiment of the present invention, in which oxygen-rich sweep gas discharged from one of the inner or outer fiber bundles is mixed with air for use as a sweep gas in the other of the inner or outer fiber bundles. Each sweep gas is used separately for the inner and outer fiber bundles (Figure 23B). [Figure 24] Another embodiment of the present invention shows blood and gas flow paths in a dual-chamber gas exchanger having a square fiber bundle and two gas inlets. [Figure 25] This shows blood and gas flow paths in another embodiment of dual-chamber gas exchange, which has regions within fiber bundles divided by a movable wall within a cylindrical gas inlet manifold. [Figure 26A] This is a vertical cross-sectional view of a dual-chamber gas exchanger with an alternative partition mechanism. [Figure 26B] This is a horizontal cross-sectional view of a variable partition mechanism similar to Figure 26A, which has a spiral vortex. [Modes for carrying out the invention]

[0036] Referring to Figures 1-22, the dual-chamber gas exchanger 100 is configured to be used in a variety of clinical applications by using two separate sweep gases (e.g., ventilation gases). For example, the dual-chamber gas exchanger 100 uses separate flow paths in separate chambers of the dual gas flow chamber 124, such as the first chamber 110 and the second chamber 113, to transfer oxygen to the blood and remove carbon dioxide from the blood. The dual-chamber gas exchanger 100 of this embodiment includes an outer housing 112, a blood distributor 114, an outer fiber bundle 116 of the hollow membrane, an intermediate housing 118, an inner fiber bundle 120 of the hollow membrane, an inner flow deflector 122, and a dual gas flow chamber 124. The dual-chamber gas exchanger 100 can be used in a variety of clinical scenarios. For example, it can be used in cardiopulmonary bypass during cardiac and thoracic surgery, extracorporeal membrane oxygenation (ECMO) for cardiopulmonary or respiratory support in a hospital, outpatient respiratory support from the intensive care unit (see Figure 13), and at the patient's home.

[0037] The outer housing 112 and the intermediate housing 118 surround the outer fiber bundle 116 and are configured to form various blood flow pathways in the outer fiber bundle 116 and the inner fiber bundle 120 (see Figures 2, 3, 4, 6, 7, 8A, 8B, 14, 15, 16, 17, 18, 19, 20, 21, and 22). For example, each blood flow pathway may be at least one of axial, circumferential, or radial flow paths. The inner flow deflector 122 is configured to deflect or guide blood flow from the inner fiber bundle 120 toward the blood outlet 144. The inner flow deflector 122 in this embodiment (see Figures 2, 3, 4, 6, 7, 8B, 14, 15, 17, 18, 20, and 21) has a general shape of a conical cylinder and is positioned substantially concentrically around the center of the inner fiber bundle 120.

[0038] The dual gas flow chamber 124 receives the sweep gas and distributes it to the fiber membranes of both the inner fiber bundle 120 and the outer fiber bundle 116 (Figures 2, 6, 14, 15, 17, 18, 20, 21, and 23). The sweep gas in this embodiment includes air, oxygen, a mixture of oxygen and air, or other ventilation gases. The intermediate housing 118 is configured to surround the inner fiber bundle 120 and allows blood to flow through the inner fiber bundle 120 (e.g., substantially radially, axially, and / or circumferentially). The inner fiber bundle 120 and the outer fiber bundle 116 include gas exchange membrane fibers, such as hollow membrane fibers, configured to transfer oxygen to the blood and remove carbon dioxide from the blood flowing through the membrane fibers. The inner fiber bundle 120 and the outer fiber bundle 116 can be in the form of annular fiber bundles (see Figures 2, 6, 14, 17, 20, and 23A and 23B) or in the form of a square consisting of multiple (e.g., thousands) gas-permeable hollow membrane fibers or membrane fibers (see Figure 24). The inner fiber bundle 120 and the outer fiber bundle 116 are generally centrally and concentrically arranged within the outer housing 112, and the intermediate housing 118 separates the inner fiber bundle 120 and the outer fiber bundle 116 as described above.

[0039] The hollow fiber membranes of the outer fiber bundle 116 and the inner fiber bundle 120 are coupled to an upper potting 117 and a lower potting 119 configured to allow fluid communication of sweep gases entering and leaving the hollow fiber membrane (for example, from a gas inlet 121 and / or from the hollow fiber membrane to gas outlets 123 such as gas outlets 1 and 2). Thus, the upper potting 117 is located at the top of the outer housing 112, and the lower potting 119 is located at the bottom of the outer housing 112. Furthermore, each of the inner fiber bundle 120 and the outer fiber bundle 116 is configured to be sealed to each other, including the upper potting 117 and the lower potting 119, to prevent undesirable flow paths of blood and / or sweep gases.

[0040] For example, the sweeping gas can be selected based on clinical application, such as using oxygen or an oxygen-rich gas to substantially transfer oxygen to the blood in the outer fiber bundle 116 and substantially remove carbon dioxide from the inner fiber bundle 120. Alternatively, air (e.g., atmospheric air) or a combination of air and oxygen may be used. The sweeping gas flows can be separated into channels (e.g., oxygen transfer and carbon dioxide removal) to control the flow rate and / or contents of each sweeping gas independently of the other sweeping gases.

[0041] Referring to Figures 1, 2, 5, 6, 14, 15, 17, 18, 20, 21, and 23, the dual-chamber gas exchanger 100 is further configured to control how many of the hollow membrane fibers come into contact with the swept gas. For example, one channel can be controlled to independently supply oxygen and / or air from another channel. Thus, the dual-chamber gas exchanger 100 is made more flexible by using various gas sources for oxygen transport and carbon dioxide removal. For example, depending on the clinical application, both the inner fiber bundle 120 and the outer fiber bundle 116 can be used for oxygen transport and / or carbon dioxide removal, or only the outer fiber bundle 116 can be used for oxygen transport and the inner fiber bundle 120 can be used for carbon dioxide removal, and vice versa.

[0042] Furthermore, the dual-chamber gas exchanger 100 may be configured to increase the flow rate of one gas (e.g., oxygen or air). For example, the swept gas from one channel can be recirculated and combined with the gas in the other channel in clinical applications where the clinical need is greater for increased oxygen than for carbon dioxide removal. As a further example, if increased carbon dioxide removal is required, a clinician may increase the swept gas flow rate and / or surface area of ​​the oxygen supply membrane (described further below) exposed to air.

[0043] Referring to Figures 2, 3, 6, 7, 14, 15, 17, 18, 20, 21, and 23, the first chamber 110 of the dual-chamber gas exchanger 100 can be configured to transfer a sweep gas (e.g., oxygen) to the blood or to remove carbon dioxide from the blood. For example, the flow rate of the sweep gas for transferring oxygen may be between approximately 1 liter per minute and 6 liters per minute. An oxygen source then supplies the sweep gas to the first chamber 110. In one embodiment, the oxygen source is a small-volume, lightweight, battery-operated portable oxygen concentrator (e.g., a commercially available oxygen concentrator).

[0044] An oxygen concentrator converts air into a gas with a high oxygen concentration (e.g., an oxygen concentration exceeding approximately 90%). The oxygen concentrator can be integrated into a portable drive console configured to surround the oxygen concentrator and other components such as a power supply (e.g., a battery), a blood pump control unit, a flow sensor, and a blood gas sensor (Figures 11 and 13). For example, one embodiment may include a removable pump 126 that forms an integrated pump oxygenator (e.g., an integrated pump oxygenator; see Figure 12) which includes a pump drive unit controlled by a typical blood pump 126 and a blood pump control unit. The blood pump 126 can be easily connected to and disconnected from the dual-chamber gas exchanger 100 using quick connectors, typical fasteners, etc. However, in other embodiments, the oxygen source may be a fixed or portable oxygen tank, the atmosphere, etc.

[0045] Referring again to Figures 2, 3, 6, 7, 14, 15, 17, 18, 20, 21, and 23, the second chamber 113 of the dual-chamber gas exchanger 100 can be configured to remove carbon dioxide from the blood or to transfer oxygen to the blood. For example, the sweep gas flow rate for removing carbon dioxide may be approximately 6 liters per minute to 18 liters per minute. In one embodiment, a small air fan compresses air and mixes it with the sweep gas from the first chamber 110 (e.g., oxygen or oxygen-rich gas) to generate a high sweep gas flow for carbon dioxide removal. The sealed dual gas flow chamber 124 of this embodiment is located below the lower potting 119 or above the upper potting 117 of the inner fiber bundle 120 and the outer fiber bundle 116.

[0046] Continuing with reference to Figures 2, 3, 6, 7, 14, 15, 17, 18, 20, 21, and 23, the dual gas flow chamber 124 includes a first chamber 110 and a second chamber 113, each configured to receive one of the sweep gases from two gas inlets 121 (e.g., gas inlet 1 and gas inlet 2). For example, the sweep gases in each of the first chambers 110 and the outer chamber 113 may have different compositions and / or flow rates. The gas inlets 121 distribute the sweep gas to the open lumen fibers embedded in the upper potting 117 and lower potting 119 of the inner fiber bundle 120 and the outer fiber bundle 116, respectively. In this embodiment, oxygen or oxygen-rich gas flows through the open fiber lumen of the upper potting 119 and diffuses across the outer walls of the individual hollow fiber membranes in the first chamber 110 into the blood where blood oxygenation occurs. Furthermore, carbon dioxide from the blood diffuses into the lumen of the hollow fiber membrane and is removed from the blood. The swept gas flows through the hollow fiber membrane and exits the dual gas flow chamber 124 through the lower potting 119. In this embodiment, the swept gas exits the dual chamber gas exchanger 100 by exhausting it into the atmosphere. Thus, the dual chamber gas exchanger 100 receives the swept gas and diffuses it into separate fiber membrane bundles for blood oxygenation and carbon dioxide removal.

[0047] The outer housing 112 and the intermediate housing 118 are configured to form individual or mixed blood flow pathways for the inner fiber bundle 120 and the outer fiber bundle 116 (Figures 2, 3, 6, 7, 14, 15, 17, 18, 20, and 21). In this embodiment, various blood flow pathways are possible by opening or closing one or both of the blood flow gates 128 and 130 (see Figures 2-4, 6-8B, 14-16, and 20-22). The blood flow gates are mounted on a blood distributor 114 coupled to the outer housing 112, the intermediate housing 118, and the blood inlet 142. Figures 2-4 show the outer fiber bundle with surrounding blood flow pathways (see arrows in Figures 3 and 4). The blood distributor 114 receives blood from the blood inlet 142 and is fluidly connected to a first rectangular blood gate 128 (gate 1) formed as a vertical slit or gap on one side of the outer housing 112, while a second rectangular blood gate 130 (gate 2) is located on the opposite side of the intermediate housing 118. In one embodiment, the blood distributor 114 discharges the blood substantially uniformly to the outer fiber bundle 116 through gate 1 128 in a substantially circumferential direction, and exits through gate 2 130 into an intermediate annular space 132 (e.g., having a cylindrical or conical shape) located between the inner wall of the intermediate housing 118 and the outer surface of the inner fiber bundle 120. As a further alternative, the dual-chamber gas exchanger 100 is configured to filter out particulate matter in the blood. For example, the dual-chamber gas exchanger 100 may include filters such as depth filters, mesh foams, microporous filters, and filtration media.

[0048] As shown in Figures 6–8, in other embodiments of the dual-chamber gas exchanger 100, the outer fiber bundle 116 has an axial blood flow path. The blood distributor 114 is configured in a spiral vortex shape with a gradually decreasing cross-sectional area (see, for example, Figures 14–16, 17–19, and 20–22). Figures 5–8 show that the blood distributor 114 generally surrounds the upper end of the outer housing 112 and is attached to a first blood gate 128 (gate 1), generally in the form of a narrow slot. A second narrow slot blood gate 130 (gate 2) is located at the end of the intermediate housing 118 opposite gate 128. The spiral vortex blood distributor 114 gradually releases blood circumferentially (e.g., 360 degrees) through gate 128 to the upper end of the outer fiber bundle 116. The blood flows axially, exiting the outer fiber bundle 116 and passing through the gate 2 130 into the intermediate annular space 132 between the inner wall of the intermediate housing 118 and the outer surface of the inner fiber bundle 120. The flow path through the inner fiber bundle 120 is radial, which enhances biocompatibility and gas exchange efficiency and has low pressure loss.

[0049] Continuing to refer to Figures 6-8, the intermediate annular space 132 is generally formed between the inner wall of the intermediate housing 118 and the outer surface of the inner fiber bundle 120, and has a generally uniform pressure distribution (e.g., before blood enters the inner fiber bundle 120). The blood has a generally uniform pressure distribution that causes the blood to flow through the fiber membrane of the inner fiber bundle 120 in a substantially uniform radially inward direction (see Figures 3, 4, 7, 8, 18, and 19). Computational fluid dynamics analysis demonstrates substantially uniform flow and substantially uniform oxygen transport in the inner fiber bundle 120 and the outer fiber bundle 116 (Figures 9 and 10).

[0050] Therefore, the inner fiber bundle 120 and the outer fiber bundle 116 can be configured for various blood flow pathways (e.g., circumferential, axial, and / or radial) depending on the clinical application. For example, one embodiment of the dual-chamber gas exchanger 100 includes an inner fiber bundle 120 having a radial flow path and an outer fiber bundle 116 having a circumferential flow path (see Figures 2-4). As a further example, another embodiment of the dual-chamber gas exchanger 100 includes an inner fiber bundle 120 having a radial flow path and an outer fiber bundle 116 having an axial flow path (see Figures 6-8). As a further example, another embodiment of the dual-chamber gas exchanger 100 includes an inner fiber bundle 120 having a circumferential flow path and an outer fiber bundle 116 having a radial flow path (see Figures 14-16). As a further example, another embodiment of the dual-chamber gas exchanger 100 includes an inner fiber bundle 120 and an outer fiber bundle 116 having a radial flow path (see Figures 17-19). As a further example, another embodiment of the dual-chamber gas exchanger 100 includes an inner fiber bundle 120 having axial flow paths and an outer fiber bundle 116 having radial flow paths (see Figures 20-22). Other combinations and configurations of flow paths are feasible within the dual-chamber gas exchanger 100.

[0051] Referring to Figures 2, 3, 6, 7, 14, 15, 17, 18, 20, and 21, the inner fiber bundle 120 and outer fiber bundle 116 of this embodiment are cylindrical rings containing many hollow membrane fibers, or microporous hollow fibers having a pore size of generally less than 0.1 microns in diameter. The hollow membrane fibers of this embodiment are commercially available and have an outer diameter of about 250 to 400 microns and a wall thickness of about 30 to 50 microns, but hollow fiber membranes with other outer diameters and wall thicknesses can be realized in the dual-chamber gas exchanger 100. In other embodiments, the hollow membrane fibers are configured to be antithrombotic and have, for example, an antithrombotic coating (e.g., heparin or a functional equivalent). Alternatively, the hollow membrane fibers may be microporous membranes for filtering blood components for purposes such as hemodialysis.

[0052] The porosity (or void ratio) of each inner fiber bundle 120 and outer fiber bundle 116 is generally determined by the desired pressure loss across the inner and outer fiber bundles 120 and 116. In this embodiment, the porosity is in the range of approximately 0.4 to 0.7. Alternatively, coated or exposed hollow fibers may be used to allow the diffusion of oxygen and carbon dioxide through the non-porous epidermal layer of the outer wall of the membrane fibers. Hollow membrane fibers are typically commercially available in tape configurations, where individual hollow membrane fibers are arranged in predetermined configurations (i.e., parallel straight lines or biases, multi-directional, woven, spaced, etc.) that can form cylindrical or conical bundle configurations in tape windings. Alternatively, the hollow fiber membrane can be wrapped or wound (e.g., like a spool of twine). The hollow membrane fibers are attached to the lower potting 119 and upper potting 117, respectively (see Figures 2, 3, 6, 7, 14, 15, 17, 18, 20, and 21). For example, in this embodiment, the ends of the inner fiber bundle 120 and the outer fiber bundle 116 are trimmed to open the inner lumen of the membrane fibers and cast using a polymer (e.g., urethane, epoxy, etc.). A sweep gas is distributed through the lumen between the upper potting 117 and the lower potting 119.

[0053] In one embodiment, the dual-chamber gas exchanger 100 includes a heat exchanger configured to control blood temperature. The heat exchanger may include a cylindrical ring of heat exchange elements around at least one of the inner fiber bundle 120 or the outer fiber bundle 116. The cylindrical ring is formed of a plurality of capillaries potted on one of the inner fiber bundle 120 or the outer fiber bundle 116. The heat exchanger capillaries may be formed from a biocompatible metal, polymer, etc. The capillaries have lumens that are open to form separate flow paths. The heat exchanger further includes a sweep gas chamber and a heat transfer medium chamber configured to control the heat of the sweep gas and the heat transfer medium, respectively. In one embodiment, the sweep gas chamber and the heat transfer medium chamber are located on top of the outer housing 112 above the upper potting. However, in other embodiments, the sweep gas chamber and the heat transfer medium chamber are located below the outer housing 112 above the lower potting 119. Blood temperature is controlled by changing the flow rate and temperature of the heat transfer medium that flows through heat exchanger capillaries and hollow membrane fibers.

[0054] In other embodiments, instead of configuring a hollow fiber membrane as a heat exchanger, multiple hollow tubes are configured for heat transfer. In such configurations, a temperature-controlled fluid, such as water, is used to influence the temperature change of the blood.

[0055] The gas inlet 121 (Figures 1-3 and 5-7) is configured to operate at low pressure while providing uniform sweep gas to the outer fiber bundle 116 and / or inner fiber bundle 120. The gas inlet 121 includes inlet and outlet connectors sized to achieve the desired blood flow rate and pressure. For example, the dual-chamber gas exchanger 100 may include typical 1 / 4-inch or 3 / 8-inch barb fittings to accept standard device-assisted extracorporeal circulation tubing.

[0056] One embodiment of a dual-chamber gas exchanger includes an arterial sample port 136 and a venous sample port 138 (Figures 1 and 2) configured to allow an operator to collect blood samples from the dual-chamber gas exchanger 100 (e.g., using a syringe, conventional stopcock, emboss-type sample port, etc.). The arterial sample port 136 and the venous sample port 138 are further configured to collect blood before it flows into the inner fiber bundle 120 and / or the outer fiber bundle 116, and after the blood flow exits the inner fiber bundle 120 and / or the outer fiber bundle 116, in order to control various parameters (e.g., blood flow rate for oxygen concentration control, gas transfer rate, and pH).

[0057] In one embodiment, the dual-chamber gas exchanger 100 may be configured to remove air bubbles from the blood. One embodiment may include an outer vent port 140 (Figures 1, 3, 5-8, 12-15, and 17) located near a portion of the dual-chamber gas exchanger 100 where air bubbles typically accumulate. For example, the outer vent port 140 may be located on the outer wall of the outer housing 112 near the upper potting 117 (Figure 2). Furthermore, other embodiments of the dual-chamber gas exchanger 100 may include an inner vent port located near the top of the intermediate housing 118, such as the upper potting 117 of the inner fiber bundle 120, to remove air bubbles. Air bubbles are typically caused by trapped air that is not properly removed during priming, damaged hollow membrane fibers, or excessive negative pressure applied to the blood that pushes gas into the solution.

[0058] As shown in Figures 23A and 23B, an oxygen supply according to the principle of the present invention may consist of an oxygen-rich gas passing through a portion of the gas-exchange fiber bundle and air or other oxygen-deficient stripping gas passing through the other portion of the fiber bundle. If necessary, such an oxygen supply may have a gas channel through which the oxygen-rich sweep gas discharged from one of the inner or outer fiber bundles mixes with air for use as a sweep gas for the other of the inner or outer fiber bundle.

[0059] As shown in Figure 23A, the exchanger 200, which includes the fiber bundle 210, is configured to reuse the oxygen-rich swift sweep gas from the inner fiber bundle 220 within the outer fiber bundle 216. For example, oxygen from an external source such as a tank or an oxygen concentrator is diffused into the inner fiber bundle 220 through the bottom of the dual gas chamber or the plenum 224. The oxygen-rich gas passes through the inner fiber bundle 220, where the oxygen is partially depleted as it passes through the upper plenum 228, where it is mixed with the atmosphere entering from the inlet 230. The mixed gas flow then passes through the outer fiber bundle 216, removing or "striping" carbon dioxide from the blood entering the fiber bundle 210 horizontally in one of the aforementioned flow paths. Although not oxygen-rich, the mixed gas provides an initial stage of oxygenation in addition to removing carbon dioxide. Oxygenation is completed in the inner fiber bundle 220, where the oxygen is exposed to a gas with a higher oxygen concentration. The swept gas is ventilated into the atmosphere from the bottom of the dual gas chamber 232. Therefore, since atmospheric air is generally abundant and easy to use in the dual-chamber gas exchanger 200, it is possible to increase the gas flow rate and oxygen utilization efficiency of the mixed atmospheric air and oxygen sweep gas.

[0060] Referring to Figure 23B, an alternative embodiment of the dual-chamber gas exchanger 250 can be configured to allow oxygen-rich swept gas 252 to pass only through the inner fiber bundle 260 and air 254 to pass only through the outer fiber bundle 262. The plenum and isolation barrier are arranged accordingly.

[0061] In Figure 24, the oxygen supply unit 300 has a rectangular shape with separate gas inlets 323 and 324 at the top and a rectangular fiber bundle 302 positioned between the upper potting 317 and the lower potting 319. In contrast to the previous embodiment, the fiber bundle 302 has no barriers that create an isolated airflow region within it. The gas flow through the fiber bundle 302 is controlled by a movable partition 304 located in the gas inlet region 306 above the upper potting 317. The gas inlets 323 and 324 release gas on either side of the partition 304 and may be connected to different gas sources such as air and oxygen, respectively. Thus, moving the partition 304 adjusts the fiber region to which each gas is exposed. For example, blood flowing in the direction of the horizontal arrow in Figure 24 is first exposed to a gas entering from inlet 323, which may be air or other hypoxic stripping gas. After carbon dioxide has been at least partially removed, the blood may be exposed to an oxygen-rich gas supplied through inlet 324 for complete oxygenation. Of course, the blood flows perpendicular to the direction of the vertical arrow. In some embodiments, the partition 304 can be fixed. Although the adjustability of the fibrous region is lost, the efficiency of removing carbon dioxide from the blood using air or other low-oxygen gas and achieving final oxygenation with pure or other high-oxygen gas is retained.

[0062] In a further embodiment, as shown in Figure 25, the oxygen supplyer 400 has a cylindrical shape with separate gas inlets 423 and 424 at the top and an annular fiber bundle 402 positioned between the upper potting and the lower potting (not shown). A circular partition 404 with an adjustable diameter is positioned in the gas inlet region 406 above the upper potting. The gas inlets 423 and 424 are positioned outside and inside the partition 406 and may be connected to different gas sources such as air and oxygen, respectively. Adjusting the diameter of the partition 404 adjusts the fiber region to which each gas is exposed. For example, blood flowing in the direction of the horizontal arrow in Figure 24 is first exposed to a gas entering through the inlet 423, which may be air or other hypoxic stripping gas. After carbon dioxide has been at least partially removed, the blood may be exposed to an oxygen-rich gas delivered through the inlet 424 for complete oxygenation. Of course, the blood is flowing vertically in the direction of the vertical arrow. In some embodiments, the partition 404 may be fixed. While the adjustability of the fiber region is lost, the efficiency of removing carbon dioxide from the blood using air or other low-oxygen gases and achieving final oxygenation with pure or other high-oxygen gases is retained.

[0063] In yet another embodiment of the present invention, as shown in Figures 26A and 26B, a dual-chamber gas exchanger 500 (similar to the dual-chamber gas exchanger 100 described above) is further configured to change the sweep gas exchange rate independently of the sweep gas concentration (e.g., without changing the sweep gas flow rate and / or concentration). The dual-chamber gas exchanger 500 includes a partition mechanism 510, which in one embodiment is an adjustable opening such as an iris mechanism configured to change a portion of the surface area of ​​the dual-chamber gas exchanger membrane 512 that is in contact with the blood to transfer oxygen, and also, as described above, can change a portion of the surface area of ​​the dual-chamber gas exchanger membrane 512 that is in contact with the blood to remove carbon dioxide.

[0064] The partition mechanism 510 alters the portion of the swept gas for gas exchange by altering the access or fluid communication of the swept gas to separate pathways through different regions within the fiber bundle without a physical chamber wall (e.g., an intermediate housing). By altering access by controlling and regulating the region of the gas flow path that the swept gas is exposed to the patient's blood flow (e.g., the portion of the hollow fiber membrane exposed to the inlet gas flow), clinicians can more accurately and efficiently match the patient's requirements (e.g., metabolic needs).

[0065] In the illustrated embodiment, the partition mechanism 510 is a mechanical mechanism such as an iris-type or shutter-type mechanism (Figure 26B) configured to control the flowing gas by changing the opening area. In other embodiments, the opening area may have a circular or hexagonal shape so that the opening area is changed by changing the diameter or width. The partition mechanism 510 is fluidically coupled to at least one of the upper potting 514 and the lower potting 516. The helical vortex may distribute the gas to the fiber bundle (Figure 26B), or it may use a vortex inlet (provided in a previous embodiment) (Figure 26A). The partition mechanism 510 may be one or more valves, such as an array or series of valves that control the fluid access to the various flow paths described above. The opening area of ​​the partition mechanism 510 is controlled by a control device such as the blood pump control device described above. Therefore, the partition mechanism 510 allows the dual-chamber gas exchanger 500 to control the mixing and amount of swept gas to the portion of the dual-chamber gas exchanger membrane 512 that is exposed to and in fluid contact with the patient's blood, thereby moving oxygen and removing carbon dioxide.

[0066] This invention relates to a dual-chamber gas exchange device. The dual-chamber gas exchange device enhances the efficiency of gas exchange, such as oxygen and carbon dioxide, and features relatively low pressure loss, good biocompatibility, and unique flexibility, while requiring minimal volume and blood contact surface. The dual-chamber gas exchange device offers optimal blood flow pathway options and improves the efficiency of gas transfer in the inner and outer fiber bundles. Furthermore, the dual-chamber gas exchange device reduces the amount of oxygen simultaneously required for oxygen transfer into the blood and carbon dioxide removal from the blood. The reduced oxygen requirements and the reduction in size and weight of the dual-chamber gas exchange device further broaden its applications. For example, the dual-chamber gas exchange device can operate in a low-power, small, portable oxygen concentrator, providing the swept gas for oxygen transfer and carbon dioxide removal required in outpatient settings.

[0067] Furthermore, dual-chamber gas exchangers are further configured to enhance gas exchange using an active mixing mechanism. This active mixing mechanism utilizes inner and outer fiber bundles to reduce boundary layer effects in blood flow and improve gas exchange efficiency. The intermediate housing and inner fiber bundles form a cylindrical or conical space configured to enhance blood-membrane interaction by allowing high-momentum blood flow in the space between the outer surface of the membrane and the inner housing wall, so that blood encounters lower flow resistance, increased turbulence, and increased mixing before passing through the outer fiber and entering the inner fiber bundle. Thus, dual-chamber gas exchangers mix blood without introducing unnecessary high shear rates or stagnation zones, as is the case with typical blood oxygenators. Additionally, dual-chamber gas exchangers contain fewer components than typical blood oxygenators. Dual-chamber gas exchangers are configured to improve maintainability and operability compared to typical blood oxygenators by increasing access to joints and connecting areas.

[0068] The above is a complete description of preferred embodiments of the present invention, but various substitutions, modifications, and equivalents may be used. Therefore, the above description should not be construed as limiting the scope of the present invention as defined by the appended claims.

Claims

1. A blood oxygen supply device, A housing comprising a blood inlet, a blood outlet, a stripping gas inlet, an oxygenation gas inlet, and at least one gas outlet, The system comprises an oxygen supply fiber bundle disposed within the housing and configured such that blood flows through the blood flow region of the oxygen supply fiber bundle in a predetermined path from the blood inlet to the blood outlet, The stripping gas inlet is configured to direct the flow of stripping gas through the stripping region of the oxygen supply fiber bundle to the at least one gas outlet, and the oxygenation gas inlet is configured to direct the flow of oxygenation gas through the oxygenation region of the oxygen supply fiber bundle to the at least one gas outlet. The stripping gas region of the oxygen supply fiber bundle is located upstream of the oxygenation region of the oxygen supply fiber bundle, and is a blood oxygen supply device.

2. The blood oxygen supply device according to claim 1, wherein the fiber bundle is cylindrical, and at least a portion of the blood flow path is radially inward or radially outward.

3. The blood oxygen supply device according to claim 1, wherein the fiber bundle is cylindrical and at least a portion of the blood flow pathway follows an annular pathway.

4. The blood oxygen supply according to claim 1, wherein at least a portion of the blood flow path is unidirectional across the oxygen supply fiber bundle.

5. The blood oxygen supply device according to claim 1, wherein the fiber bundle is cylindrical, and the outer portion of the blood flow pathway follows an annular pathway, and the inner portion follows a radially inward pathway.

6. The blood oxygen supply device according to claim 5, wherein the blood inlet supplies blood to the outer portion, and the inner portion supplies blood to the blood outlet.

7. The blood oxygen supply device according to claim 6, wherein the stripping region is at least partially located in the outer portion of the blood flow path, and the oxygenation region is at least partially located in the inner portion of the blood flow path.

8. The blood oxygen supply device according to claim 5, wherein the blood inlet supplies blood to the inner portion and the outer portion supplies blood to the blood outlet.

9. The blood oxygen supply device according to claim 8, wherein the stripping region is at least partially located in the inner portion of the blood flow path, and the oxygenation region is at least partially located in the outer portion of the blood flow path.

10. The blood oxygen supply device according to claim 5, further comprising a cylindrical wall separating the outer and inner portions of a cylindrical fiber bundle, wherein blood flows from the blood inlet through the axial opening of the housing to the outer portion of the fiber bundle, flows through the outer portion of the fiber bundle in annular manner through the axial opening of the cylindrical wall, enters a distribution ring surrounding the inner bundle, and from there flows radially inward through the inner portion of the fiber bundle, and flows into an axial collection region along the central axis of the inner portion of the fiber bundle.

11. The blood oxygen supply device according to claim 1, wherein the oxygenated fiber bundle has a cross-sectional area, the stripping region that receives stripping gas from the stripping gas inlet has an inlet area that includes 20% to 80% of the cross-sectional area, and the oxygenation region that receives oxygenated gas from the oxygenated gas inlet has an inlet area that includes 80% to 20% of the cross-sectional area.

12. The blood oxygen supply device according to claim 11, further comprising a manifold splitter that directs stripping gas from the stripping gas inlet to the stripping region of the oxygen supply fiber bundle and oxygenation gas from the oxygenation gas inlet to the oxygenation region of the oxygen supply fiber bundle.

13. The blood oxygen supply device according to claim 12, wherein the manifold divider is positioned in a manifold that receives stripping gas from the stripping gas inlet and oxygenated gas from the oxygenated gas inlet, the manifold is open to the entire gas inlet side of the oxygenated fiber bundle, and the arrangement of the manifold divider controls the inlet region of the stripping area that receives stripping gas from the stripping gas inlet and the inlet region of the oxygenation area that receives oxygenated gas from the oxygenated gas inlet.

14. The blood oxygen supply device according to claim 13, wherein the manifold splitter is movable.

15. The blood oxygen supply device according to claim 14, wherein the manifold splitter is fixed.

16. The blood oxygen supply device according to claim 1, wherein the oxygenated fiber bundle further comprises an upper potting and a lower potting, and the manifold is disposed within the housing adjacent to one of the pottings.

17. The blood oxygen supply device according to claim 1, further comprising a blood pump connected to the blood inlet, an oxygenation gas source connected to the oxygenation gas inlet, and a stripping gas source connected to the stripping gas inlet.

18. A method of oxygenating the blood, (1) A housing having a blood inlet, a blood outlet, a stripping gas inlet, an oxygenation gas inlet, and at least one gas outlet; and (2) an oxygen supply fiber bundle disposed within the housing; The steps include: flowing blood through the blood inlet, through the oxygen supply fiber bundle, and to the blood outlet; The step of flowing a stripping gas through the stripping gas inlet and an oxygenation gas through the oxygenation gas inlet, wherein the stripping gas flows through the stripping region of the oxygen supply fiber bundle to the at least one gas outlet, and the oxygenation gas flows through the oxygenation region of the oxygen supply fiber bundle to the at least one gas outlet, A method wherein the stripping gas region of the oxygen supply fiber bundle is located upstream of the oxygenation region of the oxygen supply fiber bundle.

19. The method according to claim 18, wherein the blood moves through the stripping region of the oxygen supply fiber bundle in an annular channel.

20. The method according to claim 19, wherein the blood moves through the oxygenation region of the oxygen supply fiber bundle in a radially inward flow path.

21. The method according to claim 19, wherein the blood moves in a straight line through the stripping region and the oxygenation region of the oxygen supply fiber bundle.

22. The method according to claim 18, wherein the blood moves through the oxygen supply fiber bundle in a substantially uniform blood flow distribution.

23. The method according to claim 18, wherein the fiber bundle has a cross-sectional area, the stripping region that receives the stripping gas from the stripping gas inlet has an inlet area that includes 20% to 80% of the cross-sectional area, and the oxygenation region that receives the oxygenation gas from the oxygenation gas inlet has an inlet area that includes 80% to 20% of the cross-sectional area.

24. The method according to claim 23, further comprising the step of moving a manifold divider that directs a stripping gas from the stripping gas inlet to the stripping region of the oxygen supply fiber bundle and an oxygenation gas from the oxygenation gas inlet to the oxygenation region of the oxygen supply fiber bundle, thereby adjusting the relative area between the stripping region and the oxygenation region of the oxygenation fiber bundle.

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