EXTRABODIMENTARY SURVIVAL SYSTEM WITH BLOOD RECIRCULATION ROUTE

Abstract

The invention relates to an extracorporeal blood processing system comprising a blood oxygenator (114, 214, 314, 414) having an inlet for receiving deoxygenated blood and an outlet for expelling oxygenated blood. The system also includes a recirculation flow path for recirculating some of the oxygenated blood exiting the oxygenator outlet back into the oxygenator inlet. The system may further include a double-lumen cannula (122, 322, 422) coupled to the oxygenator. The cannula includes a manifold (154, 364, 460) having a first blood channel communicating with the oxygenator outlet, a second blood channel communicating with the oxygenator inlet, and a third blood channel connecting the first blood channel to the second blood channel. Figure for abstract: Figure 1A

Description

Title of the invention: EXTRABORAL SURVIVAL SYSTEM WITH BLOOD RECIRCULATION ROUTE technical field

[0001] This disclosure relates to an extracorporeal life support system and methods for manufacturing and / or using an extracorporeal life support system. More specifically, this disclosure relates to extracorporeal life support systems that include a blood return line. TECHNOLOGICAL BACKGROUND

[0002] Certain medical procedures (for example, medical procedures that treat a heart or respiratory condition) may require the use of a life support system that assists cardiac and pulmonary functions by artificially supporting the heart and lung function. In some cases, this can be achieved by an extracorporeal membrane oxygenation (ECMO) system, also known as an extracorporeal life support system (ECLS). An ECMO is an extracorporeal system that provides both cardiac and respiratory support to a patient whose heart and lungs are unable to provide an adequate amount of gas exchange to maintain life. An ECMO works by removing blood from a patient's body to purify and oxygenate the red blood cells while also removing carbon dioxide.The purified and oxygenated blood is then returned to the patient.

[0003] ECMO systems may comprise multiple devices that together form a blood recirculation loop between the patient and a blood oxygenator. For example, some ECMO systems may include a blood reservoir, a blood pump to supply blood flow, an oxygenator to oxygenate the blood, a blood filtering device (which may be integrated into the oxygenator in some systems), a heat exchanger (to heat and / or cool blood), one or more oxygen sensors positioned at various locations along blood lines, and a control console. It may be noted that a blood line (e.g., a tube) may extend from the patient to the blood reservoir, then to a blood pump, then through the oxygenator, and close the loop by returning to the patient.Consequently, the blood pump can assist the heart by pumping blood through the circulatory loop, while the oxygenator can assist the lungs by oxygenating blood that is ultimately returned to the patient.

[0004] It may also be noted that the amount of oxygen that can be delivered to the patient may depend on the blood circulation rate through the circulatory loop. However, there may be cases in which the flow rate of blood drawn from and returned to the patient may be capped and / or limited, so that additional oxygenation cannot be achieved by increasing the flow rate. Therefore, it may be desirable to design an ECMO system that can maximize the oxygen content in the blood returning to the patient without increasing the flow rate through the system. One method for maximizing the oxygen content in the blood returning to the patient without increasing the flow rate may include adding a blood return line (e.g., a recirculation line) that carries some of the oxygenated blood leaving the oxygenator back into the oxygenator for further oxygenation.ECMO systems including a blood return line that carries some of the oxygenated blood back into the oxygenator for further oxygenation are described here. SUMMARY.

[0005] An example of an extracorporeal blood processing system may include a blood oxygenator having an inlet and an outlet. The blood oxygenator is configured to pass deoxygenated blood, in particular blood received from a patient, through the oxygenator inlet. The blood oxygenator is configured to expel oxygenated blood from the oxygenator through the outlet, and in particular, is configured to deliver this oxygenated blood to the patient. Deoxygenated blood received from a patient can pass into the oxygenator inlet and oxygenated blood from the oxygenator can exit through the outlet and pass to the patient. The system also includes a recirculation flow path configured to recirculate some of the oxygenated blood exiting the oxygenator outlet back into the oxygenator inlet.

[0006] In addition to, or as an alternative to, any example described herein, the extracorporeal blood processing system is configured to combine the recirculated oxygenated blood with the deoxygenated blood before passing through the oxygenator. The recirculated oxygenated blood can combine with the deoxygenated blood before passing through the oxygenator.

[0007] In addition to or as an alternative to any example described herein, the extracorporeal blood processing system is configured to combine the recirculated oxygenated blood with the oxygenated blood inside the oxygenator. Oxygenated blood returned to circulation can combine with deoxygenated blood inside the oxygenator.

[0008] In addition to, or as an alternative to, any example described herein, the extracorporeal blood processing system is configured to combine recirculated oxygenated blood with deoxygenated blood within the recirculation flow path. Oxygenated blood returned to circulation can combine with deoxygenated blood within the recirculation flow path.

[0009] Oxygenated blood returned to circulation can have an oxygen saturation level. Deoxygenated blood can have an oxygen saturation level.

[0010] In addition or alternatively to any example described herein, the extracorporeal blood processing system is configured to form partially oxygenated blood by combining the recirculated blood with the deoxygenated blood, so that said partially deoxygenated blood has an oxygen saturation level that lies between the oxygen saturation level of the oxygenated blood and the oxygen saturation level of the deoxygenated blood before passing through the oxygenator.

[0011] In addition to, or as an alternative to, any example described herein, the extracorporeal blood processing system is configured to increase the oxygen saturation of the partially oxygenated blood when the partially oxygenated blood passes through the oxygenator.

[0012] In addition or alternatively to any example described herein, the extracorporeal blood processing system is configured to circulate the partially oxygenated blood passing through the oxygenator with a flow rate greater than the oxygenated blood leaving the oxygenator, and in particular returning to the patient.

[0013] In addition or alternatively to any example described herein, the extracorporeal blood processing system is configured to circulate the partially oxygenated blood passing through the oxygenator with a flow rate equal to the sum of the flow rate of the blood leaving the oxygenator, and in particular returning to the patient, and the flow rate of the oxygenated blood passing through the recirculation flow path.

[0014] In addition or alternatively to any example described herein, the system further comprises a recirculation pump coupled to the oxygenator, the recirculation pump being configured to pump oxygenated blood back into circulation in the oxygenator.

[0015] In addition or alternatively to any example described herein, the system further comprises a blood pump coupled to the oxygenator, the blood pump being configured to pump deoxygenated blood from the patient into the oxygenator.

[0016] In addition to, or as an alternative to, any example described herein, the extracorporeal blood processing system includes a first blood channel configured to circulate blood from the oxygenator, in particular blood passing from the oxygenator to the patient, and the first blood channel includes a first oxygen sensor positioned within it.

[0017] In addition to or alternatively to any example described herein, the extracorporeal blood processing system includes a second blood channel configured to circulate blood to the oxygenator, in particular blood passing from the patient to the oxygenator, and the second blood channel includes a second oxygen sensor positioned therein.

[0018] In addition or alternatively to any example described herein, the first oxygen sensor is configured to detect a blood oxygen saturation level in the first bloodway, the second oxygen sensor is configured to detect a blood oxygen saturation level in the second bloodway, and the first oxygen sensor, the second oxygen sensor or both the first oxygen sensor and the second oxygen sensor are configured to send a signal to the oxygenator indicating the blood oxygen saturation level in the first bloodway and the second bloodway, respectively.

[0019] In addition or alternatively to any example described herein, the oxygenator is configured to adjust the blood oxygen saturation level in the first bloodway in response to a signal received from the first oxygen sensor, the second oxygen sensor, or both the first and second oxygen sensors.

[0020] In addition or alternatively to any example described herein, the system further comprises a double-lumen cannula coupled to the oxygenator, the double-lumen cannula comprising a collector having a first blood channel, a second blood channel and a third blood channel, the third blood channel connecting the first blood channel to the second blood channel.

[0021] In addition to or alternatively to any example described herein, the extracorporeal blood processing system is configured: to circulate oxygenated blood from the oxygenator, in particular blood passing from the oxygenator to the patient, through the first blood channel of the collector; to circulate deoxygenated blood to the oxygenator, in particular blood passing from the patient to the oxygenator, through the second blood channel of the collector; and to circulate a portion of the oxygenated blood passing from the first blood channel, through the third blood channel and to combine said portion of the oxygenated blood with deoxygenated blood in the second blood channel.

[0022] Another illustrative example is an extracorporeal blood processing system, comprising a blood circulation pathway coupled to a blood oxygenator and a blood recirculation pathway. The blood circulation pathway is configured to pass deoxygenated blood, in particular deoxygenated blood extracted from a The blood recirculation pathway is configured to return oxygenated blood from the oxygenator to the patient, specifically before returning it to the patient.

[0023] In addition or alternatively to any example described herein, the extracorporeal blood processing system is configured to circulate blood passing through the oxygenator with a flow rate greater than the oxygenated blood leaving the oxygenator, and in particular, passing to the patient.

[0024] In addition or alternatively to any example described herein, the extracorporeal blood processing system is configured to circulate blood passing through the oxygenator with a flow rate equal to the sum of the flow rate of oxygenated blood leaving the oxygenator, and in particular passing to the patient, and the flow rate of oxygenated blood leaving the oxygenator and passing into the blood recirculation pathway.

[0025] Another illustrative example is an extracorporeal blood processing system, comprising a blood oxygenator having an inlet and an outlet, and a double-lumen cannula coupled to the oxygenator. The cannula has a distal end configured to be positioned in a patient and a proximal end comprising a manifold. The manifold comprises a first blood channel in fluidic communication with the oxygenator outlet, a second blood channel in fluidic communication with the oxygenator inlet, and a third blood channel connecting the first blood channel to the second blood channel. The manifold is configured to pass oxygenated blood received from the oxygenator through the first blood channel. The manifold is configured to pass deoxygenated blood, in particular deoxygenated blood received from the patient, through the second blood channel.The collector is configured to pass some of the oxygenated blood from the first blood channel through the third blood channel so that it combines with deoxygenated blood in the second blood channel.

[0026] The above summary of certain embodiments, aspects, and / or examples is not intended to describe every embodiment or implementation of this disclosure. The figures and detailed description that follow illustrate these embodiments in more detail. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The disclosure can be more fully understood by considering the following detailed description in relation to the accompanying drawings, on which:

[0028] Fig. 1A illustrates an example of an extracorporeal blood processing system;

[0029] Figure 1B illustrates another example of a blood processing system extracorporeal;

[0030] Fig. 2A illustrates another example of an extracorporeal blood processing system;

[0031] Fig. 2B illustrates another example of an extracorporeal blood processing system;

[0032] Figure 3 illustrates an example of an extracorporeal blood processing system including a double-lumen cannula;

[0033] Figure 4 illustrates an example of a double-lumen cannula collector. [Fig.3].

[0034] Although aspects of the invention may be subject to various modifications and variations, details of these have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and variations within the spirit and scope of the disclosure. DETAILED DESCRIPTION

[0035] For the terms defined below, these definitions shall apply unless a different definition is given elsewhere in this description.

[0036] All numerical values ​​herein are assumed to be modified by the term "approximately," whether or not this is explicitly stated. The term "approximately" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the value quoted (for example, having the same function or the same result). In many cases, the term "approximately" may include numbers that are rounded to the nearest significant figure.

[0037] An enumeration of numeric ranges by endpoints includes all numbers in that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this description, the singular forms "a," "an," and "the" include multiple referents unless the content clearly indicates otherwise. As used in this description, the term "or" is generally used in its sense including "and / or" unless the content clearly indicates otherwise.

[0038] It should be noted that references in the description to "an embodiment," "certain embodiments," "other embodiments," etc., indicate that the described embodiment may include one or more particular properties, structures, and / or features. However, such enumerations do not necessarily mean that all embodiments include the particular properties, structures, and / or features. Furthermore, when particular properties, structures, and / or features are described with reference to an embodiment, it should be understood that such properties, structures, and / or features may also be used in relation to other embodiments. of implementation, whether or not they are explicitly described, unless the contrary is clearly established.

[0039] The detailed description that follows should be read with reference to the drawings, in which similar elements in different drawings are numbered in the same way. The drawings, which are not necessarily to scale, represent illustrative embodiments and are not intended to limit the scope of disclosure.

[0040] In a normal heart, blood circulates via a closed pathway such that deoxygenated (venous) blood enters the right atrium via both the superior and inferior vena cava. The venous blood then passes through the right ventricle and is pumped via the pulmonary artery to the lungs, where it absorbs oxygen. After absorbing oxygen in the lungs, the blood becomes oxygenated arterial blood. The oxygenated arterial blood is then returned via the pulmonary veins to the left atrium and passes into the left ventricle. The oxygenated arterial blood is then pumped through the aorta and optionally throughout the entire body.

[0041] It may be noted that if the lungs are unable to sufficiently oxygenate the blood, an oxygenator located outside the body can be used to oxygenate the blood. As discussed above, extracorporeal membrane oxygenation (ECMO) is a life-support system using breathing and cardiac pumping that can be used to assist patients while medical treatments are administered to address their underlying condition. When assisted by an ECMO system, the oxygenation of the patient's blood and the removal of carbon dioxide can occur outside the body.

[0042] ECMO is generally performed using a heart-lung bypass system, which may be called a "circuit." The circuit may include one or more tubing lines designed to transfer blood from a patient's body to the oxygenator and back to the patient. As described above, the oxygenator can add oxygen to the blood while also removing carbon dioxide (for example, the oxygenator performs the function of a healthy lung).

[0043] In some examples, an ECMO circuit may include a blood pump, an oxygenator, tubing lines (for transfer to and from the body), flow and / or pressure sensors, a heat exchanger (for cooling and / or heating the blood), a computer console, and arterial and / or venous access points for collecting blood into the circuit. It may be noted that the function of the blood pump is to generate blood flow in the ECMO circuit (e.g., circulating blood from the patient to the oxygenator and back to the patient). The blood pump may be positioned in the tubing line between the patient and the oxygenator. In some ECMO systems, a roller pump may be used to generate blood flow in the ECMO circuit. However, in other ECMO systems, other blood pumps, including centrifugal pumps, may be used to generate blood flow in the ECMO circuit.

[0044] In certain ECMO systems, the oxygenator may comprise a casing having multiple chambers or channels separated by a semi-permeable membrane, whereby the patient's blood can flow through one chamber or channel, while a gaseous oxygen mixture (i.e., a sweep gas) flows through another chamber or channel. The semi-permeable membrane may comprise multiple microporous hollow fibers, each fiber having a lumen extending through it through which the gaseous oxygen mixture flows. Gas exchange may occur via diffusion of gases through multiple microporous fibers, such that oxygen moves from inside the hollow fibers into the blood while carbon dioxide diffuses from the blood into the hollow fibers, where it is swept away by the sweep gas flowing through the fiber. This gas exchange allows for the oxygenation of venous blood and the elimination of carbon dioxide.In some ECMO systems, the oxygenator may include integrated heat exchangers that allow circulating blood to be cooled and / or warmed before returning to the patient.

[0045] It can be noted that the oxygen saturation level in the blood after passing through the oxygenating membrane (e.g., post-oxygenated blood) can be a function of the volume or flow rate of gaseous oxygen flowing through the semi-permeable membrane (e.g., hollow fibers) and also of the blood flow rate passing through the semi-permeable membrane (e.g., hollow fibers). Consequently, an increase in the volume or flow rate of blood through the semi-permeable membrane can increase the volume of oxygen delivered in the post-oxygenated blood. As discussed above, there may be cases in which the blood flow rate in the ECMO circuit may be capped and / or limited, so that additional oxygenation cannot be achieved by increasing the blood flow rate through the oxygenator.A method for maximizing the oxygen content in the blood returning to the patient without increasing the flow of the system to and from the patient may include adding a blood return line that routes some of the oxygenated blood back into the oxygenator for further oxygenation, thereby increasing the blood flow through the oxygenator without increasing the blood flow to / from the patient.

[0046] Figure 1A illustrates an ECMO system 10 comprising a blood return line that returns some of the oxygenated blood to the oxygenator for further oxygenation. The ECMO system 10 may include a blood pump 12 designed to extract deoxygenated blood from a patient 50 and propel the blood to an oxygenator 14. Furthermore, after the blood has passed through the semi-permeable membrane of the oxygenator 14, the post-oxygenated blood can be returned to the patient 50.

[0047] Figure 1A illustrates a type of ECMO life support system designed to assist pulmonary function. This type of ECMO system may be referred to as a veno-venous (VV) ECMO life support system. The veno-venous ECMO system shown in Figure 1A may include two separate cannulation sites (e.g., sites where tubular elements are inserted into the patient's body). For example, Figure 1A shows a first cannulation site where a cannula is inserted into the femoral vein 30. Although not shown in Figure 1A, the cannula inserted into the femoral vein 30 may be guided into the inferior vena cava, for example, so that it can be used to drain deoxygenated blood from the patient. As illustrated in [Fig.1A], a cannula inserted into the femoral vein 30 can be connected to a tubular line 24 (e.g., a length of tubing) which can be coupled to the pump 12.Therefore, it can be noted that pump 12 can be used to remove (e.g., pull, drain, extract, etc.) deoxygenated blood from patient 50.

[0048] Figure 1A further illustrates that the ECMO life support system may also include a tubular line 20 (e.g., a length of tubing) extending between the pump 12 and the oxygenator 14. The tubular line 20 may be an extension of the tubular line 24. For example, the tubular line 20 and the tubular line 24 may be a continuous tubular element that passes through the pump 12 and connects to it. Alternatively, the tubular line 20 and the tubular line 24 may be separate tubular elements, each comprising an end region that connects to the pump 12. In other cases, the pump 12 may be directly attached to or integrated with the oxygenator 14, thus eliminating the need for the tubular line 20 between them. The tubular lines 20 / 24 may be designated as a drainage line removing deoxygenated blood from the patient.

[0049] Furthermore, the veno-venous ECMO system shown in [Fig. 1A] represents a second cannulation site in which a cannula is inserted into the right jugular vein 32. Although not shown in [Fig. 1A], the cannula inserted into the right jugular vein 32 can be guided into the right atrium, for example, so that it can be used to return oxygenated blood to the patient. As shown in [Fig. 1A], a cannula inserted into the right jugular vein 32 can be connected to a tubular line 22 (for example, a length of tubing) which can be coupled to the oxygenator 14. It may be noted that the pump 12 can be used to propel oxygenated blood from the oxygenator 14 to the patient 50. The tubular line 22 can be designated as a return line returning oxygenated blood back to the patient.

[0050] Figure 1A further illustrates that the ECMO life support system 10 may also include an oxygen source 18 coupled to the oxygenator 14. The oxygen source 18 may, in some cases, include an oxygen reservoir which is coupled to the oxygenator 14 via the tubular pathway 26. The oxygenator 14 can extract oxygen from the oxygen source 18 to oxygenate blood passing through the semi-permeable membrane of the oxygenator 14.

[0051] As discussed here, the ECMO system 10 may include a blood pump 12 designed to extract deoxygenated blood from the inferior vena cava of a patient 50 (the direction of deoxygenated blood out of the patient is represented by arrow 38) and propel the blood to an oxygenator 14 (the direction of deoxygenated blood from the pump to the oxygenator is represented by arrow 34). After the deoxygenated blood enters the oxygenator 14, it can pass through the semi-permeable membrane of the oxygenator 14, so that red blood cells absorb oxygen (extracted from the oxygen source 18) and carbon dioxide is released. After the blood has passed through the semi-permeable membrane of the oxygenator 14, the post-oxygenated blood can return to the patient (the direction of the post-oxygenated blood going to the patient is represented by arrow 36) through the tubular pathway 22.After passing through a cannula inserted into the right jugular vein 32, the post-oxygenated blood can be released into the patient's right atrium 50.

[0052] As discussed here, deoxygenated blood can enter oxygenator 14 so that it can pass through or across the semi-permeable membrane of oxygenator 14 to absorb oxygen. In general, the term "deoxygenated blood" can be defined as blood that has a low oxygen saturation compared to blood leaving the lungs. For example, in a normal patient, the oxygen saturation level of oxygenated blood leaving the lungs can be 95% or higher. Therefore, it can be noted that the oxygen saturation level of the deoxygenated blood leaving patient 50 and flowing into the ECMO system 10 of [Fig. 1A] can be approximately 65%. Furthermore, if the deoxygenated blood leaving the patient passes through oxygenator 14 at a constant flow rate and constant volume, the oxygen saturation level in the post-oxygenated blood can increase to 95% or more.

[0053] It may further be noted that if the ECMO system 10 shown in [Fig. 1 A] operates at a constant flow rate, the oxygen saturation level in the post-oxygenated blood may remain at a substantially constant level. However, in some cases, it may be desirable to increase the blood saturation level of the post-oxygenated blood. As discussed here, one method for increasing the blood saturation level of the post-oxygenated blood may be to increase the blood flow rate through the oxygenator 14. However, if a patient does not have sufficient blood volume for Increasing blood flow sufficiently can cause the vessel walls to collapse over the drainage and / or return cannulas, thus preventing complete blood flow. Therefore, it may be desirable to increase the saturation level of post-oxygenated blood without increasing blood flow in the system to / from the patient.

[0054] The system illustrated in [Fig.1A] can increase the blood saturation level of post-oxygenated blood without increasing the blood flow in the system to / from the patient. More specifically, [Fig. 1A] illustrates that the ECMO system 10 may include a blood return line that transfers post-oxygenated blood from the outlet of oxygenator 14 and returns it to the inlet of oxygenator 14. The blood in the return line may combine with deoxygenated blood that is drawn from patient 50 to pass through oxygenator 14. For example, [Fig. 1A] illustrates a recirculation pump 40 that may be designed to direct (e.g., pull, drain, extract, etc.) an outlet of post-oxygenated blood from oxygenator 14 through a tubular pathway 42 (the direction of the post-oxygenated blood flowing out of oxygenator 14 through the recirculation pathway is represented by arrow 46). Furthermore, [Fig.[A] illustrates the post-oxygenated blood "recirculated" passing through the recirculation pump 40 and returning to the oxygenator 14 via the tubular pathway 44 (the direction of the post-oxygenated blood flowing out of the recirculation pump 40 and returning to the oxygenator 14 is represented by arrow 48).

[0055] It can be noted that when post-oxygenated blood enters the oxygenator 14 from the recirculation line 42 / 44, it can combine with deoxygenated blood from the patient's drainage line before passing through or via the semi-permeable membrane of the oxygenator 14. Consequently, the recirculated post-oxygenated blood, which is mixed with the deoxygenated blood, can increase the oxygen level in the deoxygenated blood from the drainage line from the patient before it passes through the semi-permeable membrane of the oxygenator 14. The oxygen level in the deoxygenated blood that has combined with the recirculated post-oxygenated blood can have an oxygen saturation level that lies between the oxygen saturation level of the deoxygenated blood and the oxygen saturation level of the post-oxygenated blood passing through the recirculation line.Thus, the blood mixture entering oxygenator 14 can have an oxygen saturation level that is between the oxygen saturation level of the deoxygenated blood and the oxygen saturation level of the post-oxygenated blood passing through the recirculation pathway. After the deoxygenated blood is combined with the recirculated post-oxygenated blood, the blood mixture can then pass through oxygenator 14, so its oxygen level is further increased. It can also be noted that when this "recirculation cycle" continues (e.g., . When some of the post-oxygenated blood is returned to circulation in oxygenator 14 to mix with deoxygenated blood from the patient, the oxygen saturation level in the post-oxygenated blood leaving oxygenator 14 can increase over time to 100% saturation. Furthermore, once the hemoglobin is saturated to 100%, additional oxygen will be added in the form of dissolved oxygen in the plasma, which can increase the blood oxygen content by approximately 10%.

[0056] Furthermore, it can be noted that the flow rate of blood passing through the patient's drainage pathway to the oxygenator 14 (via tubular pathways 24 / 20), the flow rate of post-oxygenated blood passing through the recirculation flow pathway (via tubular pathways 42 / 44), and the flow rate of post-oxygenated blood returning to the patient (via tubular flow pathway 22) can have different values. Specifically, the flow rate of blood passing through the oxygenator 14 can be equal to the sum of the flow rate of blood passing through the recirculation flow pathway and the flow rate of blood from / returning to the patient. Consequently, the flow rate of blood from the patient and the flow rate of blood returning to the patient can be less than the flow rate of blood passing through the oxygenator 14. Moreover, the flow rate of blood passing through the recirculation flow pathway is also less than the flow rate of blood passing through the oxygenator 14.

[0057] Furthermore, [Fig. 1A] illustrates that in certain examples, the ECMO system 10 may include a control device or console 16 coupled to various components of the ECMO system 10. For example, [Fig. 1A] illustrates that the console 16 may be coupled to the pump 12. However, it is also envisaged that the console 16 may be coupled to the oxygenator 14, the recirculation pump 40, and / or the oxygen source 18. In addition, the console 16 may include a computing device. The console 16 may further include, among other suitable components, a processor, a display, memory, and an input / output (I / O) unit.

[0058] The console processor 16 may comprise a single processor or more than one processor working individually or with each other. The processor may be configured to execute instructions, including instructions that may be loaded into memory and / or other suitable memory. Examples of processor components may include, but are not limited to, microprocessors, microcontrollers, multicore processors, graphics processing units, digital signal processors, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), discrete circuits, and / or other suitable types of data processing devices.

[0059] The memory of the console 16 may comprise a single memory component or more than one memory component, each operating individually or with each other. Example types of memory may include random access memory (RAM), EEPROM, FLASH, suitable volatile storage devices, suitable non-volatile storage devices, persistent memory (e.g., read-only memory (ROM), hard disk drive, flash memory, optical disk memory, and / or other suitable persistent memory), and / or other suitable types of memory. The memory may be, or may include, computer-readable non-transient media.

[0060] The I / O units of the console 16 may comprise a single I / O component or more than one I / O component, each working individually or with each other. Example I / O units may be any type of communication port configured to communicate with other components of the building management system. Example types of I / O units may include wired ports, wireless ports, radio frequency (RF) ports, low-energy Bluetooth ports, Bluetooth ports, near-field communication (NFC) ports, HDMI ports, Wi-Fi ports, Ethernet ports, VGA ports, serial ports, parallel ports, component video ports, S-video ports, composite audio / video ports, DVI ports, USB ports, optical ports, and / or other suitable ports.

[0061] Furthermore, [Fig. 1A] illustrates that the ECMO system 10 may include one or more sensors 52 / 54 / 56 positioned in one or more tubular channels connecting different components of the ECMO system 10. For example, [Fig. 1A] illustrates a sensor 52 positioned in tubular channel 24, a sensor 54 positioned in tubular channel 22, and a sensor 56 positioned in tubular channel 44. In some examples, the sensors 52 / 54 / 56 may be oxygen sensors, carbon dioxide sensors, pressure sensors, flow sensors, or the like. Moreover, it may be noted that the console 16 may be designed to communicate with one or more of the sensors 52 / 54 / 56. For example, sensors 52 / 54 / 56 may be oxygen sensors designed to detect oxygen saturation levels in blood flowing through tubular pathways 24 / 22 / 44, respectively.For example, sensor 52 can detect the oxygen saturation level and / or the flow rate of deoxygenated blood being removed from the patient, sensor 54 can detect the oxygen saturation level and / or the flow rate of oxygenated blood being returned to the patient, and sensor 44 can detect the oxygen saturation level and / or the flow rate of oxygenated blood in the recirculation flow path. In some examples, the values ​​detected by sensors 52 / 54 / 56 can be transmitted (e.g., communicated) back to console 16. These values ​​(e.g., data) are then transmitted. The data transmitted back to the console can be used to calculate and control flow rates for additional oxygenation. Transmission of the detected values ​​can be carried out via a wireless connection, a wired connection, or other means of communication capable of transmitting signals between the console 16 and the sensors 52 / 54 / 56.

[0062] Furthermore, it can be noted that the console 16 can communicate with various components of the ECMO system 10, and adjust them, in response to detected signals sent by sensors 52 / 54 / 56 to the console 16. For example, sensor 52 can detect and transmit one or more blood oxygen saturation levels in tubular line 24, sensor 54 can detect and transmit one or more blood oxygen saturation levels in tubular line 22, and sensor 56 can detect and transmit one or more blood oxygen saturation levels in tubular line 44. Based on the received signals, the console 16 can communicate with various components to adjust the oxygen saturation levels in the ECMO circuit in the oxygenated blood returned to the patient.For example, the control unit 16 can communicate with the recirculation pump 40, so that the control unit 16 increases the pumping action of the recirculation pump 40 (for example, increases the rotational speed of the recirculation pump 40) to increase the blood flow in the recirculation circuit. The increased flow from the recirculation pump 40 can increase the amount of blood passing through the oxygenator 14, thus increasing the oxygen saturation level in the post-oxygenated blood. Furthermore, the control unit 16 can communicate with the recirculation pump 40, so that the control unit 16 decreases the pumping action of the recirculation pump 40 (for example, decreases the rotational speed of the recirculation pump 40) to decrease the blood flow in the recirculation circuit.The reduced flow rate of the recirculation pump 40 can decrease the amount of blood passing through the oxygenator 14, thereby reducing the oxygen saturation level in the post-oxygenated blood. In other cases, the console 16 can communicate with an adjustable flow restrictor (not shown) placed in the recirculation circuit (for example, along the flow path 42 / 44) to regulate the blood flow in the recirculation circuit.

[0063] It can be noted that other parameters can be detected and communicated to the console 16, so that the console 16 adjusts one or more components of the ECMO circuit based on the detected parameters. For example, sensors 52 / 54 / 56 can detect the blood flow in one or more tubular channels (e.g., tubular channels 20 / 22 / 24 / 42 / 44) of the ECMO circuit and communicate the flow rate(s) to the console 16. Based on the detected flow rates, the console 16 can communicate with various components of the ECMO system 10 to adjust the various components of the ECMO circuit. For example, the console 16 can communicate with the pump 12, so that The console 16 adjusts (e.g., increases or decreases) the pumping action of pump 12 (e.g., increases or decreases the rotational speed of pump 12) to increase blood flow in tubular pathways 22 / 24 / 44. The increased flow from pump 12 can increase the amount of blood passing through oxygenator 14, thereby increasing the oxygen saturation level in post-oxygenated blood. A decrease in the flow from pump 12 can decrease the amount of blood passing through oxygenator 14, thereby decreasing the oxygen saturation level in post-oxygenated blood. It may be noted that a form and function of the console 116 and sensors 52 / 54 / 56 described herein can be applied to any of the ECMO life support systems described with reference to Figures IB to 5.

[0064] While the above discussion describes a veno-venous ECMO life support system used with a recirculation circuit, it is envisaged that a recirculation circuit (such as the one described in relation to [Fig. 1A]) can be used with different ECMO life support systems. For example, a recirculation circuit (such as the one described in relation to [Fig. 1A]) can be used with a veno-atrial ECMO life support system. It may be noted that veno-venous and veno-atrial ECMO life support systems can have various cannulation configurations.

[0065] For example, [Fig. 1B] illustrates another veno-venous ECMO life support system 100. The ECMO system 100 is similar in form and function to the ECMO system 10 illustrated in [Fig. 1A]. For example, the ECMO system 10 may include a blood pump 112 designed to remove deoxygenated blood from a patient 50 through a tubular blood channel 124 (the direction of deoxygenated blood out of the patient is represented by arrow 138) and propel the blood to an oxygenator 114 through a tubular blood channel 120 (the direction of deoxygenated blood from the pump to the oxygenator is represented by arrow 134). Once deoxygenated blood enters oxygenator 114, it can pass through the semi-permeable membrane of oxygenator 114, allowing red blood cells to absorb oxygen (extracted from an oxygen source 118) and carbon dioxide is released.

[0066] Furthermore, after the blood passes through the semi-permeable membrane of the oxygenator 114, some of the post-oxygenated blood can return to the oxygenator 114 via a recirculation pathway, so that a recirculation pump 140 can direct (e.g., draw, drain, extract, etc.) post-oxygenated blood out of the oxygenator 114 through a tubular pathway 142 (the direction of the post-oxygenated blood flowing out of the oxygenator 114 is shown by arrow 146). In addition, the recirculated post-oxygenated blood can pass through the recirculation pump 140 and return to the oxygenator 114 via the tubular pathway 144 (the direction of the post-oxygenated blood flowing out of the oxygenator 114 is shown by arrow 148).

[0067] Similar to the return pathway described above in relation to [Fig. 1A], post-oxygenated blood entering oxygenator 114 can combine with deoxygenated blood before passing through the semi-permeable membrane of oxygenator 114. Consequently, the recirculated post-oxygenated blood can increase the oxygen level in the deoxygenated blood before it passes through the semi-permeable membrane of oxygenator 114. It can further be noted that when this recirculation cycle continues (for example, when post-oxygenated blood is recirculated into oxygenator 114 to mix with deoxygenated blood), the oxygen saturation level in the post-oxygenated blood leaving oxygenator 114 will increase over time.

[0068] However, as an alternative to the dual-cannulation-site ECMO 10 system described in relation to [Fig. 1A], the ECMO 110 system shown in [Fig. 1B] uses a dual-lumen cannula 122 introduced into the patient 50 via the internal jugular vein 32, so that it is further guided into the right atrium of the heart. The dual-lumen cannula 122 may include a first perfusion lumen (e.g., an inner lumen) extending coaxially inside a second drainage lumen (e.g., an outer lumen). Consequently, a fluid (e.g., blood) can flow through both the perfusion and drainage lumens. Although not shown in [Fig. 1B], the drainage lumen may include one or more openings arranged along its distal end region in fluidic communication with the drainage lumen.Furthermore, the perfusion lumen can extend distally beyond the end of the drainage lumen. When positioned in the heart, the drainage lumen is positioned in the right atrium and the perfusion lumen is positioned in the main pulmonary artery, for example.

[0069] The double-lumen cannula 122 functions by returning oxygenated blood to the patient from the ECMO circuit via its perfusion lumen, which can be positioned in the pulmonary artery, and by drawing deoxygenated blood from the patient to the ECMO circuit via its drainage lumen, which can be positioned in the right atrium. Figure 1B illustrates that the double-lumen cannula 122 may include a hub or collector 154 having an inlet port 162 and an outlet port 164. It may be noted that the inlet port 162 can be coupled to an outlet of the oxygenator 114. Consequently, post-oxygenated blood exiting the oxygenator 114 can enter the inlet port of the collector 162, so that the post-oxygenated blood passes through the perfusion lumen and into the main pulmonary artery. Furthermore, it can be noted that the outlet port 164 of the collector 154 can be coupled to the tubular blood channel 124.As a result, deoxygenated blood can drain through the drainage lumen positioned in the right atrium, moving through the drainage lumen. and pass into the tubular bloodway 124, so that the pump 112 can propel it towards the oxygenator 114. After passing through the oxygenator 114 and through the perfusion lumen of the double-lumen cannula 122 inserted into the right jugular vein 32, the post-oxygenated blood can be released into the patient's right atrium 50.

[0070] Similar to the ECMO 10 system discussed above, the ECMO 100 system may include one or more sensors (such as sensors 52 / 54 / 56) positioned in one or more tubular channels connecting various components of the ECMO 100 system. For example, one sensor may be positioned in tubular channel 124 and another sensor may be positioned in tubular channel 122. In some examples, the sensors may be oxygen sensors, flow sensors, or the like. Furthermore, it may be noted that the console 16 may be designed to communicate with one or more of the sensors. For example, the sensors may be oxygen sensors designed to detect oxygen saturation levels in the blood flowing through tubular channels 124 / 122, respectively.For example, the sensor in channel 124 can detect the oxygen saturation level and / or the flow rate of deoxygenated blood being removed from the patient, while the sensor in channel 122 can detect the oxygen saturation level and / or the flow rate of oxygenated blood being returned to the patient. In some examples, the values ​​detected by the sensors can be transmitted (e.g., communicated) back to the console 116. The transmission of detected values ​​can be accomplished via a wireless connection, a wired connection, or other means of communication capable of transmitting signals between the console 116 and the sensors. As noted above, it can be observed that the console 116 can communicate with various components of the ECMO 100 system and adjust them in response to detected signals sent by the sensors to the console 116.

[0071] Figure 2A illustrates another veno-venous ECMO 200 life support system. The ECMO 200 system is similar in form and function to the EMCO 10 system shown in Figure 1A. For example, Figure 2A shows a first cannulation site into which a cannula is inserted into the femoral vein. Although not shown in Figure 2A, the cannula inserted into the femoral vein can be guided into the inferior vena cava, allowing it to be used to remove deoxygenated blood from the patient. As illustrated in [Fig.2A], a cannula inserted into the femoral vein 30 can be connected to a tubular line 224 (e.g., a length of tubing) which can be coupled to the pump 212. Therefore, it can be noted that the pump 212 can be used to remove (e.g., pull, drain, extract, etc.) deoxygenated blood from the patient 50 (the direction of the deoxygenated blood out of the patient is represented by arrow 238).

[0072] It may further be noted that the pump 212 can also be used to propel blood to an oxygenator 214 through a tubular pathway 244 (the direction of deoxygenated blood flowing through the pump 212 to the oxygenator 214 is represented by arrow 248). After the blood passes through the semi-permeable membrane of the oxygenator 214, the post-oxygenated blood can return to the patient (the direction of post-oxygenated blood to the patient is represented by arrow 236). After passing through a cannula inserted into the right jugular vein 32, the post-oxygenated blood can be released into the patient's right atrium 50.

[0073] In addition, the ECMO 200 system may include a recirculation circuit to recirculate blood through the oxygenator 214. As described above in relation to [Fig. 1A], after the blood passes through the semi-permeable membrane of the oxygenator 214, some of the post-oxygenated blood may return to the inlet side of the oxygenator 214 via a blood return line. However, as an alternative to the design disclosed in relation to [Fig. 1A], the ECMO 200 system shown in [Fig. 2A] may not include a separate recirculation pump dedicated to driving the post-oxygenated blood return pathway (e.g., blood flow through the tubular pathway 242). Rather, [Fig. 2A] illustrates that the ECMO 200 system may use the pump 212 for siphoning (e.g., drawing, draining, extracting, etc.).) of post-oxygenated blood out of oxygenator 214 through a tubular recirculation pathway 242 (the direction of post-oxygenated blood flowing out of oxygenator 214 is represented by arrow 246).

[0074] As illustrated in [Fig.2A], the recirculated post-oxygenated blood can pass through the pump 212 and return to the inlet side of the oxygenator 214 via the tubular path 244 (the direction of the post-oxygenated blood flowing out of the oxygenator 214 is represented by arrow 248). It can be noted that post-oxygenated blood entering pump 212 can combine with deoxygenated blood drawn from the patient through tubular pathway 224 before passing through the semi-permeable membrane of oxygenator 214. It is further envisaged that post-oxygenated blood within the return pathway can combine with deoxygenated blood before entering pump 212, either within pump 212 or within tubular pathway 244. Therefore, the recirculated post-oxygenated blood can increase the oxygen level in the deoxygenated blood before it passes through the semi-permeable membrane of oxygenator 214.It can also be noted that when the oxygen recirculation cycle continues (e.g., when post-oxygenated blood is recirculated and mixed with deoxygenated blood before entering oxygenator 214), the oxygen saturation level in the post-oxygenated blood returning to the patient will increase over time.

[0075] In the ECMO 200 system, a flow regulator 280 can be positioned in the blood recirculation channel 242 to regulate the flow of recirculated blood through the pump 212 to the oxygenator 214. The flow regulator 280 can be controlled by the console 216, for example, to automatically adjust the orifice through the flow regulator 280 in response to a desired adjustment of the oxygen saturation level of the oxygenated blood leaving the oxygenator 214 and / or returning to the patient 50. For example, based on the oxygen saturation level of the post-oxygenated blood returning to the patient, which can be detected with an oxygen sensor as described above, the console 216 can automatically adjust (increase or decrease) the blood flow through the flow regulator 280.In other cases, a user can manually adjust (increase or decrease) the blood flow through the 280 flow regulator with the console or other control device.

[0076] Figure 2B illustrates another veno-venous ECMO life support system 300. The ECMO system 300 may be similar in form and function to the ECMO system 100 shown in Figure 1B. For example, the ECMO system 100 may include a blood pump 312 designed to remove deoxygenated blood from a patient 50 through a tubular blood channel 324 (the direction of the deoxygenated blood out of the patient is shown by arrow 338). It may further be noted that the pump 312 may also be used to propel blood to an oxygenator 314 through a tubular channel 344 (the direction of the deoxygenated blood flowing through the pump 312 to the oxygenator 314 is shown by arrow 348). When deoxygenated blood enters oxygenator 114, it can pass through or over the semi-permeable membrane of oxygenator 114, which allows red blood cells to absorb oxygen (extracted from an oxygen source 118) and carbon dioxide is released.Furthermore, after the blood has passed through the semi-permeable membrane of the oxygenator 314, the post-oxygenated blood can return to the patient (the direction of the post-oxygenated blood exiting an outlet port of the oxygenator is represented by arrow 336).

[0077] Like the dual-cannulation-site ECMO 100 system described in relation to [Fig. 1B], the ECMO 300 system shown in [Fig. 2B] uses a dual-lumen cannula 322 introduced into the patient 50 via the internal jugular vein 32, so that it is further guided into the right atrium of the heart. As described here, the dual-lumen cannula 322 may comprise a first perfusion lumen (e.g., an inner lumen) extending coaxially inside a second drainage lumen (e.g., an outer lumen). Consequently, a fluid (e.g., blood) may flow through both the perfusion lumen and the drainage lumen. Although not shown in [Fig. 2B], the drainage lumen may It comprises one or more openings arranged along its distal end in fluidic communication with the drainage lumen. Furthermore, the perfusion lumen may extend distally beyond the end of the drainage lumen. When positioned in the heart, the drainage lumen is positioned in the right atrium and the perfusion lumen is positioned in the main pulmonary artery, for example.

[0078] As discussed here, the double-lumen cannula 322 functions by returning oxygenated blood to the patient from the ECMO circuit via its perfusion lumen, which can be positioned in the pulmonary artery, and by drawing deoxygenated blood from the patient to the ECMO circuit via its drainage lumen, which can be positioned in the right atrium. Figure 2B illustrates that the double-lumen cannula 322 may include a hub or manifold 354 having an inlet port 362 and an outlet port 364. It may be noted that the inlet port 362 can be coupled to an outlet of the oxygenator 314. Consequently, post-oxygenated blood exiting the oxygenator 314 can enter the inlet port of the manifold 362, so that the post-oxygenated blood passes through the perfusion lumen and into the main pulmonary artery. Furthermore, it can be noted that the outlet port 364 of the collector 354 can be coupled to the tubular blood channel 324.As a result, deoxygenated blood can drain through the drainage lumen positioned in the right atrium, move through the drainage lumen and pass into the tubular bloodway 324, so that the pump 312 can propel it towards the oxygenator 314. After passing through the oxygenator 314 and through the perfusion lumen of the double-lumen cannula 322 inserted into the right jugular vein 32, post-oxygenated blood can be released into the patient's right atrium 50.

[0079] In addition, the ECMO 300 system may include a recirculation or return circuit to recirculate blood through the oxygenator 314. As described above in relation to [Fig. 1B], after the blood has passed through the semi-permeable membrane of the oxygenator 314, some of the post-oxygenated blood may return to the inlet side of the oxygenator 314 via a recirculation circuit. [Fig. 2B] illustrates that the ECMO 300 system may use the pump 312 to siphon (e.g., draw, drain, extract, etc.) post-oxygenated blood out of the oxygenator 314 through a tubular passage 342 (the direction of the post-oxygenated blood flowing out of the oxygenator 314 is represented by arrow 346).

[0080] As illustrated in [Fig. 2B], the recirculated post-oxygenated blood can pass through the pump 312 and return to the inlet side of the oxygenator 314 via the tubular passage 344 (the direction of the post-oxygenated blood flowing out of the oxygenator 314 is represented by arrow 348). It may be noted that the post-oxygenated blood entering the pump 312 can combine with the deoxygenated blood extracted from the The patient passes through tubular line 324 before passing through or via the semi-permeable membrane of oxygenator 314. It is further envisaged that the post-oxygenated blood within the return line may combine with deoxygenated blood before entering pump 312, either within pump 312 or within tubular line 344. Therefore, the recirculated post-oxygenated blood may increase the oxygen level in the deoxygenated blood before it passes through the semi-permeable membrane of oxygenator 314. It may also be noted that as the oxygen recirculation cycle continues (e.g., as post-oxygenated blood is recirculated and mixed with deoxygenated blood before entering oxygenator 314), the oxygen saturation level in the post-oxygenated blood returning to the patient will increase over time.

[0081] In the ECMO 300 system, a flow regulator 380 can be positioned in the blood recirculation channel 342 to regulate the flow of recirculated blood through the pump 312 to the oxygenator 314. The flow regulator 380 can be controlled by the console 316, for example, to automatically adjust the orifice through the flow regulator 380 in response to a desired adjustment of the oxygen saturation level of the oxygenated blood leaving the oxygenator 314 and / or returning to the patient 50. For example, based on the oxygen saturation level of the post-oxygenated blood returning to the patient, which can be detected with an oxygen sensor as described above, the console 316 can automatically adjust (increase or decrease) the blood flow through the flow regulator 380.In other cases, a user can manually adjust (increase or decrease) the blood flow through the 380 flow regulator with the console or another control device.

[0082] Figure 3 illustrates another veno-venous ECMO life support system 400. The ECMO system 400 may be similar in form and function to other ECMO systems described herein. For example, the ECMO system 400 may include a blood pump 412 designed to remove deoxygenated blood from a patient 50 through a tubular blood channel 424 (the direction of deoxygenated blood out of the patient is shown by arrow 438). It may further be noted that the pump 412 may also be used to propel blood to an oxygenator 414 through a tubular channel 444 (the direction of deoxygenated blood flowing through the pump 412 to the oxygenator 414 is shown by arrow 448). When deoxygenated blood enters oxygenator 414, it can pass through or over the semi-permeable membrane of oxygenator 414, allowing red blood cells to absorb oxygen (extracted from an oxygen source 418) and carbon dioxide is released.Furthermore, after the blood passes through the semi-permeable membrane of the oxygenator. 414, post-oxygenated blood can return to the patient (the direction of post-oxygenated blood exiting an outlet port of the oxygenator is represented by arrow 436).

[0083] Like other dual-cannulation-site ECMO systems described herein, the ECMO 400 system shown in [Fig. 3] uses a dual-lumen cannula 422 introduced into the patient 50 via the internal jugular vein 32 so that it is further guided into the right atrium of the heart. As described herein, the dual-lumen cannula 422 may include a first perfusion lumen (e.g., an inner lumen) extending coaxially inside a second drainage lumen (e.g., an outer lumen). Consequently, a fluid (e.g., blood) may flow through both the perfusion and drainage lumens. Although not shown in [Fig. 3], the drainage lumen may include one or more openings arranged along its distal end region in fluidic communication with the drainage lumen. In addition, the perfusion lumen may extend distally beyond the end of the drainage lumen.When positioned in the heart, the drainage lumen is positioned in the right atrium and the perfusion lumen is positioned in the main pulmonary artery, for example.

[0084] As discussed here, the double-lumen cannula 422 functions by returning oxygenated blood to the patient from the ECMO circuit via its perfusion lumen, which can be positioned in the pulmonary artery, and by drawing deoxygenated blood from the patient to the ECMO circuit via its drainage lumen, which can be positioned in the right atrium. Figure 3 illustrates that the double-lumen cannula 422 may include a hub or collector 460 having an inlet port 462 and an outlet port 464. It may be noted that the inlet port 462 can be coupled to an outlet of the oxygenator 414. Consequently, post-oxygenated blood exiting the oxygenator 414 can enter the inlet port of the collector 462, so that the post-oxygenated blood passes through the perfusion lumen and into the main pulmonary artery. Furthermore, it can be noted that the outlet port 464 of the collector 460 can be coupled to the tubular blood channel 424.As a result, deoxygenated blood can drain through the drainage lumen positioned in the right atrium, move through the drainage lumen and pass into the tubular bloodway 424, so that the pump 412 can propel it towards the oxygenator 414. After passing through the oxygenator 414 and through the perfusion lumen of the double-lumen cannula 422 inserted into the right jugular vein 32, post-oxygenated blood can be released into the patient's right atrium 50.

[0085] In addition, the ECMO 400 system may include a recirculation or return circuit to recirculate blood through the oxygenator 414. As described above, after passing blood through the semi-permeable membrane From the oxygenator 414, some of the post-oxygenated blood can combine with deoxygenated blood that is extracted from the patient before returning to the oxygenator 414. However, as an alternative to the ECMO 10 / 100 / 200 / 300 systems described above, the ECMO 400 system uses a return line 472 (shown in [Fig.4]) inside the manifold 460 to combine the post-oxygenated blood leaving the oxygenator but not returning to the patient with deoxygenated blood that is extracted from the patient before returning to the oxygenator 414.

[0086] Fig. 4 illustrates a detailed view of the manifold 460 shown in Fig. 3. The manifold 460 may include an inlet port 462 (for example, an inlet connection, a luer fitting, etc.) and an outlet port 464 (for example, an outlet connection, a luer fitting, etc.). As described here, the inlet port 462 can be connected to an outlet of the oxygenator 414 via the tubular route 456. In addition, the outlet port 464 can be connected to the tubular route 424, whereby deoxygenated blood passes from patient 50 to the pump 412 (and to the oxygenator 414) via the tubular route 424. It can be noted from [Fig. 4] that the manifold 460 may include a first lumen 464 designed to pass post-oxygenated blood from the inlet port 462 through the manifold 460 and into the perfusion lumen of the double-lumen cannula 422 (shown in [Fig. 3]).For example, arrows 468 illustrate the flow path of post-oxygenated blood passing from oxygenator 414, through collector 460 and into the perfusion lumen of double-lumen cannula 422.

[0087] Furthermore, [Fig. 4] illustrates that the collector 460 may include a second lumen 466 designed to pass the deoxygenated blood draining through the drainage lumen (for example, positioned in the right atrium) of the double-lumen cannula 422 through the collector 460 and into the tubular pathway 424 (shown in [Fig. 3]), so that the pump 412 can propel it towards the oxygenator 414. For example, the arrows 470 illustrate the flow path of the deoxygenated blood passing from the drainage lumen of the double-lumen cannula 422, through the collector 460 and into the tubular pathway 424 (shown in [Fig. 3]).

[0088] Furthermore, [Fig. 4] illustrates that the collector 460 may include a return or recirculation path 472 which may include a third lumen 474 mutually connecting the first lumen 464 and the second lumen 466 within the hub or collector 460. It may be noted that the return path 472 is designed to allow some of the post-oxygenated blood passing through the first lumen 464 to separate and move through the third lumen 474, so that the post-oxygenated blood can combine with the deoxygenated blood passing through the second lumen 466. For example, the arrows 476 illustrate the blood flow path post-oxygenated blood passes from the first lumen 464 of the collector 460, through the third lumen 474 of the return line 472 and into the second lumen 466 of the collector 460, so that the post-oxygenated blood can combine with the deoxygenated blood before passing through the tubular line 424 and then through the semi-permeable membrane of the oxygenator 414. Although not shown, in some cases a one-way valve may be placed along the return line 472 to allow blood to flow in only one direction through the return line 472 (e.g., allowing blood to flow through the return line 472 only from the first lumen 464 (e.g., a perfusion lumen having oxygenated blood returning to the patient) to the second lumen 466 (e.g., a drainage lumen having deoxygenated blood withdrawn from the patient)).

[0089] Similar to other oxygen return pathways described herein, post-oxygenated blood passing through the return channel 472 can increase the oxygen level in the deoxygenated blood before it passes through the semi-permeable membrane of the oxygenator 414. It may further be noted that as the oxygen recirculation cycle continues (e.g., as post-oxygenated blood is recirculated and mixed with deoxygenated blood before entering the oxygenator 414), the oxygen saturation level in the post-oxygenated blood returning to the patient will increase over time.

[0090] Dual lumen cannulas are described in U.S. Patent No. 9,168,352, entitled Dual Lumen Cannula.

[0091] In some embodiments, the ECMO systems described herein and / or components thereof may be made from a metal, a metal alloy, a polymer (some examples of which are described below), a metal-polymer composite, ceramics, combinations thereof, and the like, or another suitable material.

[0092] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block ester, polyurethane (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL® available from DSM Engineering Plastics), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as HYTREL® available from DuPont), polyamide (e.g., DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, polyamide / ether block, and polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene copolymers and vinyl acetate (EVA), silicones, polyethylene (PE), high-density polyethylene MARLEX®, low-density polyethylene MARLEX®, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propylvinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, polyisobutylene (PIB), polyisobutylene polyurethane (PIBU),polyurethane-silicone copolymers (e.g., Elast-Eon® from AorTech Biomaterials or ChronoSil® from AdvanSource Biomaterials), ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer / metal composites, and the like. In some embodiments, the sheath may be mixed with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0093] Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and / or super-elastic nitinol;other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® B2® ALLOY), other alloys of nickel-chromium, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, similar; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys R30003 (such as ELGILOY®, PHYNOX® and similar); platinum-enriched stainless steel; titanium;Platinum; palladium; gold; combinations thereof; or any other suitable material.

[0094] It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made to the details, in particular with regard to the form, size, and arrangement of the steps, without exceeding the scope of disclosure. This may include, where appropriate, the use of any of the features of an example embodiment used in other embodiments.

Claims

Demands

1. Extracorporeal blood processing system, comprising: a blood oxygenator (14) having an inlet and an outlet, the blood oxygenator (14) is configured to pass deoxygenated blood, in particular received from a patient, into the oxygenator inlet, and the blood oxygenator (14) is configured to exit oxygenated blood from the oxygenator through the outlet, and in particular is configured to pass this oxygenated blood to the patient; and a recirculation flow path configured to recirculate a portion of the oxygenated blood exiting the oxygenator outlet back into the oxygenator inlet;and the extracorporeal blood processing system further comprises a double-lumen cannula (122) coupled to the oxygenator (14), the double-lumen cannula (122) comprising a collector (154) having a first blood channel, a second blood channel and a third blood channel, and wherein the third blood channel connects the first blood channel to the second blood channel.

2. The blood processing system according to claim 1, configured to combine recirculated oxygenated blood with deoxygenated blood before passing through the oxygenator (14).

3. The blood processing system according to claim 2, configured to combine recirculated oxygenated blood with deoxygenated blood inside the oxygenator (14) or inside the recirculation flow path.

4. The blood processing system according to claim 2, configured to form partially oxygenated blood by combining recirculated blood with deoxygenated blood, such that said partially oxygenated blood has an oxygen saturation level that lies between the oxygen saturation level of oxygenated blood and the oxygen saturation level of deoxygenated blood before passing through the oxygenator (14).

5. The blood treatment system according to claim 4, configured to increase blood oxygen saturation partially oxygenated when partially oxygenated blood passes through the oxygenator (14).

6. The blood processing system according to claim 4, configured to circulate the partially oxygenated blood passing through the oxygenator (14) with a flow rate greater than that of the oxygenated blood leaving the oxygenator (14), and in particular returning to the patient.

7. The blood processing system according to claim 4, configured to circulate partially oxygenated blood passing through the oxygenator (14) with a flow rate equal to the sum of the flow rate of blood exiting the oxygenator (14), and in particular returning to the patient, and the flow rate of oxygenated blood passing through the recirculation flow path.

8. The blood processing system according to claim 1, further comprising a recirculation pump (40) coupled to the oxygenator (14), the recirculation pump (40) being configured to pump oxygenated blood recirculated back into the oxygenator (14).

9. The blood processing system according to claim 8, further comprising a blood pump (12) coupled to the oxygenator (14), the blood pump (12) being configured to pump deoxygenated blood from the patient into the oxygenator (14).

10. The blood processing system according to claim 1, comprising a first blood line (22) configured to circulate blood from the oxygenator (14), in particular blood passing from the oxygenator (14) to the patient, and the first blood line (22) comprises a first oxygen sensor (54) positioned therein.

11. The blood processing system according to claim 10, comprising a second blood channel (24) configured to circulate blood to the oxygenator, in particular blood passing from the patient to the oxygenator (14), and the second blood channel (24) comprises a second oxygen sensor (52) positioned therein.

12. The blood processing system according to claim 10, wherein the first oxygen sensor (54) is configured to detect a blood oxygen saturation level in the first blood channel (22), the second oxygen sensor (52) is configured to detect a blood oxygen saturation level in the second bloodway (24), and wherein the first oxygen sensor (54), the second oxygen sensor (52) or both the first oxygen sensor and the second oxygen sensor are configured to send a signal to the oxygenator (14) indicating the blood oxygen saturation level in the first bloodway (22) and the second bloodway (24), respectively.

13. The blood processing system according to claim 12, wherein the oxygenator (14) is configured to adjust the blood oxygen saturation level in the first blood channel (22) in response to a signal received from the first oxygen sensor (54), the second oxygen sensor (52), or both the first and second oxygen sensors.

14. The blood processing system according to claim 1, configured: to circulate blood from the oxygenator (14), in particular blood passing from the oxygenator (14) to the patient, through the first blood channel of the collector (154); to circulate deoxygenated blood to the oxygenator, in particular blood passing from the patient to the oxygenator (14), through the second blood channel of the collector (154); and to circulate a portion of the oxygenated blood passing from the first blood channel, through the third blood channel and to combine said portion of the oxygenated blood with deoxygenated blood in the second blood channel.

15. Extracorporeal blood processing system, comprising: a blood circulation pathway coupled to a blood oxygenator, wherein the blood circulation pathway is configured to pass deoxygenated blood, in particular deoxygenated blood withdrawn from a patient, through a blood oxygenator and, in particular, to return it to the patient; and a blood recirculation pathway, the blood recirculation pathway being configured to recirculate oxygenated blood leaving the oxygenator back into the oxygenator, in particular before returning it to the patient; and the extracorporeal blood processing system further comprises a double-lumen cannula (122) coupled to the oxygenator, the double-lumen cannula (122) comprising a collector (154) having a first blood channel, a second blood channel and a third blood channel, and wherein the third blood channel connects the first blood channel to the second blood channel.

16. The blood processing system according to claim 15, configured to circulate blood passing through the oxygenator (14) with a flow rate greater than the oxygenated blood exiting the oxygenator (14), and in particular passing towards the patient.

17. The blood processing system according to claim 15, configured to circulate blood passing through the oxygenator (14) with a flow rate equal to the sum of the flow rate of oxygenated blood leaving the oxygenator, and in particular passing to the patient, and the flow rate of oxygenated blood leaving the oxygenator and passing into the blood recirculation pathway.

18. An extracorporeal blood processing system, comprising: a blood oxygenator (414) having an inlet and an outlet; and a double-lumen cannula (422) coupled to the oxygenator, the cannula having a distal end configured to be positioned in a patient and a proximal end comprising a manifold (460), in which the manifold (460) comprises a first blood channel in fluidic communication with the oxygenator outlet, a second blood channel in fluidic communication with the oxygenator inlet, and a third blood channel connecting the first blood channel to the second blood channel; in which the manifold is configured to pass oxygenated blood received from the oxygenator through the first blood channel; in which the manifold is configured to pass deoxygenated blood, in particular deoxygenated blood received from the patient, through the second blood channel;in which the collector is configured to pass a portion of oxygenated blood from the first bloodway through the third bloodway in such a way that it combines with deoxygenated blood in the second bloodway.

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