Wearable modular extracorporeal life support device for the treatment of single and multiple organ failure in mobile settings

Abstract

To provide a wearable extracorporeal life support device.SOLUTION: In one exemplary embodiment, a wearable extracorporeal life support device includes a catheter fluidly connected to a pump and first and second modular extracorporeal life support components. The device may also be configured to be attached to a garment. The pump and the first and second modular extracorporeal life support components may be fluidly connected in series. The pump and the first and second modular extracorporeal life support components may also be fluidly connected in parallel. The first modular extracorporeal life support component may be a lung membrane and the second modular extracorporeal life support component may be a dialysis membrane.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] (Claim of Priority) This application claims the benefit of priority of U.S. Provisional Application No. 62 / 690,403, filed on Jun. 27, 2018, which is incorporated herein by reference in its entirety.

[0002] (Technical Field) The disclosed embodiments relate to the field of medical devices and, in particular, may include wearable devices for various forms of extracorporeal life support and methods of employing such devices. In some embodiments, the wearable device combines extracorporeal membrane oxygenation and extracorporeal continuous renal replacement therapy and is equally applicable to mobile support for liver failure, heart failure, and selective brain perfusion, as well as combinations thereof, as part of multiple organ failure treatment / support. The device may also support use outside of the home and medical facilities using end-user self-operating features.

Background Art

[0003] (Background) Extracorporeal life support (ECLS) includes multiple forms of extracorporeal rescue therapy. Typically, it refers to the use of long-term extracorporeal cardiopulmonary bypass in patients suffering from acute reversible heart failure or respiratory failure. As technology has advanced, organ support functions other than gas exchange, such as liver, kidney, and heart support, are being provided by ECLS. In addition, ECLS is not only used to extend the survival rate of organs for transplantation in brain-dead donors but also to provide lung function for patients awaiting such transplantation.

[0004] Extracorporeal membrane oxygenation (ECMO) is one form of ECLS. ECMO is a technique that provides gas exchange outside the body for those patients who are unable to provide an adequate amount of gas exchange or perfusion on their own. ECMO removes blood from the patient, removes carbon dioxide, and oxygenates the blood.

[0005] Extracorporeal membrane oxygenation has been used for severe respiratory failure in adult trauma patients over the past several decades. Typically, it is performed through venovenous ECMO (VV ECMO) in which deoxygenated blood is drained from a large central vein and pumped through a gas exchange membrane before being returned to the central venous circulation (Cannon et al., 2018). In this configuration, the pulmonary circulation is not bypassed and the heart is not exposed to any significant changes in preload or afterload.

[0006] In a hospital setting, patients suffering from respiratory failure generally initiate acceptance of mechanical ventilation (MV). A mechanical ventilator is a large machine that requires the patient to be bedridden. The patient may also typically be anesthetized or sedated and may require medical paralysis to receive mechanical ventilation. ECMO as used in a hospital is used as a last resort capacity to attempt to rescue patients who can no longer be assisted by a mechanical ventilator or other treatments. The CESAR study (Cost-Effectiveness and Evaluation of Conventional Ventilation versus Extracorporeal Membrane Oxygenation for Severe Adult Respiratory Failure) showed an improvement in 6-month survival without severe disability in patients with acute respiratory distress syndrome who received ECMO versus those who received conventional ventilation (Peek et al., 2009). The CESAR study was a multi-center randomized controlled trial conducted in the United Kingdom that demonstrated a significant reduction in death and long-term disability in patients transported for management to a high-volume ECMO center (Neff et al., 2013; P eek et al.,2009).

[0007] Mechanical ventilation, particularly in the context of patients on ECMO, can lead to progressive muscle atrophy. Technological advancements have led to the development of protocols for "ambulatory ECMO". These combine existing blood pumps and bypass oxygenators into an integrated system that can be moved behind the patient. Ambulatory ECMO is typically used as a bridge to lung transplantation, accelerating recovery by minimizing sedation and bed rest and enabling patients to receive physical therapy while awaiting an available lung. In most cases, traditional ECMO access is through the femoral vein, which poses a risk of catheter dislodgement and thus endangers mobility.

[0008] Extracorporeal life support (ECLS) also includes renal support. Acute kidney injury (AKI) is estimated to affect one in five inpatients and 40% of critically ill patients worldwide (Clemens et al., 2016). Even a small increase in serum creatinine (0.3 - 0.4 mg / dL) has been associated with increased mortality, which then shows a stepwise progression with worsening renal function. Among survivors of AKI who require in-hospital dialysis, 10% - 30% still require dialysis at discharge (Heung et al., 2015). Chronic kidney disease or renal failure can be fatal without dialysis or kidney transplantation.

[0009] Available modalities of renal replacement therapy include peritoneal dialysis (PD), intermittent hemodialysis (IHD), and continuous renal replacement therapy (CRRT). Peritoneal dialysis uses the peritoneum as a natural semipermeable membrane for the diffusive removal of solutes. This is a very effective treatment modality in patients with chronic renal failure, and patient outcomes are comparable to at least those treated with hemodialysis (Pannu et al., 2005). In adult patients, acute peritoneal dialysis is not widely used. The use of peritoneal dialysis is limited by both logistics and practical considerations (Pannu et al., 2005). Hemodialysis is a process of solute clearance based on diffusion across a membrane, driven by the concentration gradient between the blood and the dialysate. Generally, intermittent hemodialysis is prescribed for 3 to 6 hours per treatment, and the treatment is performed multiple times per week (Pannu et al., 2005). Dialysis is typically performed in a hospital or dialysis center, and the patient sits connected to a large machine for several hours while their blood is filtered.

[0010] Continuous renal replacement therapy (CRRT) describes various blood purification techniques that are intended to be applied 24 hours a day. The patient's blood is removed and pumped through a hemofilter, similar to a dialysis machine. CRRT helps prevent hemodynamic fluctuations, which are more common with faster IHD. Solute removal using CRRT is achieved by either convection (hemofiltration), diffusion (hemodialysis), or a combination of both methods (hemodiafiltration). CRRT provides a slower solute clearance per unit time compared to intermittent replacement therapy but can exceed the clearance achieved with IHD over 24 hours (Pannu et al., 2005). A typical CRRT circuit involves a double-lumen catheter, tubing to transport blood from the patient's body through the catheter to the CRRT machine, the CRRT machine, and return tubing to return the blood to the patient's body. The most commonly applied modalities are continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and continuous venovenous hemodiafiltration (CVVHDF). CRRT for the management of AKI and resulting severe metabolic derangements has become common in many trauma centers (Neff et al., 2009).

[0011] In a hospital setting, CRRT is used in combination with other extracorporeal therapies, including ECMO. During ECMO, a decrease in urine output, which can be associated with acute kidney injury or acute renal failure, is commonly observed. Patients with acute cardiopulmonary failure are at high risk of developing acute kidney injury and fluid overload. In these patients, renal replacement therapy, typically IHD or CRRT, is added. Classical indications for initiation of renal replacement therapy in patients on ECMO include uremia, acidosis, electrolyte abnormalities, and fluid overload.

[0012] In some other inpatients, they originally require dialysis and are placed on renal replacement therapy, typically IHD or CRRT, and then develop secondary pulmonary complications. In these patients, mechanical ventilation or ECMO is added.

[0013] In patients receiving both CRRT and ECMO, the most common technique is to use separate vascular access for CRRT and ECMO. This is typically done so that the CRRT and ECMO systems do not interfere with each other's hemodynamics.

[0014] Additional plastic lines in the circuit configuration increase the risk of clotting because the main causes of clotting on artificial surfaces are protein adsorption and platelet activation / aggregation. The additional lines also increase damage to the blood due to contact activation of the inflammatory and coagulation cascades as they are exposed to plastic. This is particularly applicable when the blood flow rate through the ECLS system is low, between 250 and 500 ml / min, because at lower infusion rates, the blood is more likely to form clots on the plastic surface. Although less prominent, this problem also persists under high-flow (1 - 5 L / min) conditions.

[0015] During the exposure of blood to plastic, to minimize thrombotic complications and reduce platelet loss, the current approach is to inject heparin, which inactivates thrombi and subsequently reduces clot formation. However, this often leads to bleeding complications, which, like thrombotic complications, are undesirable, especially in trauma patients who may already be bleeding.

[0016] Advances in centrifugal pump-driven venovenous and venoarterial lung assist technologies have made it possible to bring ECMO technology to deployed soldiers in military hospitals (Neff et al., 2013). It has also been made possible for deployed soldiers to be transported to the United States while still under ECMO (Neff et al., 2013).

[0017] "Partial lung support" is a method of assisting ventilation and oxygenation of the lungs to an extent less than full mechanical ventilation, accomplished by modifying blood and gas flow through a polymeric gas exchange filter known as a lung membrane (Neff et al., 2013). At lower blood flow rates (<1,000 mL / min), significant CO2 removal is possible, but physiologically significant oxygenation is not achievable. Changes in gas flow through the lung membrane can adjust the amount of CO2 removed while maintaining a constant blood flow through the circuit. Using this approach, up to 50% of the metabolically produced CO2 can be removed (Batchinsky et al., 2011).

[0018] Early partial lung support after injury can lead to improved outcomes in patients without access to mechanical ventilation. The blood flow rates for these systems are relatively low (e.g., 500 - 1,000 mL / min compared to 5 L / min for full ECMO), and thus, vascular access catheters can be easily placed using standard ultrasound-guided Seldinger technique (Cannon et al., 2018).

[0019] Continuous blood filtration has also been demonstrated to improve outcomes in patients who are injured and develop AKI during combat operations (Neff et al., 2013).

[0020] Devices used for partial lung support or continuous blood filtration in hospital settings and for military use for deployed soldiers are large and bulky. This does not allow for the continuation of treatment outside of a hospital or a specialized dialysis center. It is important to develop a device that is mobile and wearable and requires little supervision by medical staff for the continuation of treatment outside of a hospital. Every day, approximately 10,000 people reach the age of 65, which justifies the need to find out-of-hospital / home treatment options for an aging population that will require some form of lung, kidney, or other organ support. The development of extracorporeal left ventricular assist devices (LVADs) for patients with heart failure and continuous positive airway pressure (CPAP) ventilators for patients suffering from sleep apnea have shown the success of these devices. Similar or greater impacts in the aging population are envisioned using the devices of the disclosed embodiments. Summary of the Invention Means for Solving the Problems

[0021] (Abstract) The disclosed embodiments may include devices that enable wearable and mobile in-home or out-of-hospital modular organ support, organ replacement, and continuous extracorporeal life support. The device may provide respiratory support to a patient, for example, in a conscious state, without the need for intubation and mechanical ventilation, anesthesia, paralysis, and bedridden. The device may also enable, through the use of lung membranes, for example, ambulatory extracorporeal CO2 removal, partial oxygenation, and partial lung support. The disclosed embodiments of the device may also enable, through the use of dialysis membranes, for example, the extracorporeal removal of metabolites, cytokines, inflammatory mediators, pathogens, and other blood-containing compounds by ambulatory or in-home use. The device may also enable the concomitant use of lung membranes and dialysis membranes or other organ support devices connected to the device in any order. The disclosed embodiments may provide organ support or organ replacement modules, devices, and / or components. The disclosed embodiments may provide organ replacement or organ support for the lungs, kidneys or renal portions, liver, heart, brain (via selective perfusion dedicated to the brain), intestine (e.g., stomach or other abdominal organs), or combinations thereof. Additionally, the disclosed embodiments may provide integrated partial or total organ support, organ system support, multi-system organ support, and selective organ-specific or combined organ system support for any number of organs in any combination or grouping of support. The disclosed embodiments may provide an extension of the survival rate of organs for organ harvesting and transplantation in brain-dead donors. For example, extending lung function or other body functions for patients awaiting transplantation.

[0022] The disclosed embodiments may include a wearable device for extracorporeal life support of a patient, comprising a pump and a catheter fluidly connected to first and second, third, etc. modular extracorporeal life support components, wherein the pump and the first and second, third, etc. modular extracorporeal life support components are configured to be attached to clothing or an external reinforcement body support structure (e.g., exoskeleton).

[0023] In at least some embodiments, the pump, the first modular extracorporeal life support component, and the second or third modular extracorporeal life support component, etc., may be fluidly connected in series. In at least some embodiments, at least one of the pump, the first modular extracorporeal life support component, and the second modular extracorporeal life support component may be fluidly connected in parallel. Combinations of series and parallel connections are envisioned in any particular order, depending on the requirements dictated by patient conditions or treatment goals for the selection of support for the organs.

[0024] In at least some embodiments, the first modular extracorporeal life support component may be a lung membrane. In at least some embodiments, the second modular extracorporeal life support component may be a dialysis membrane. Reverse orders or other combinations for the organs and organ systems are also envisioned.

[0025] In at least some embodiments, the device may further comprise a battery, a power source, or an energy generator of any design.

[0026] In at least some embodiments, a portion of the catheter may be inserted into the jugular vein or other major vein or artery within the body. In at least some embodiments, at least a portion of the catheter inserted into the jugular vein is advanced into the superior and inferior vena cava.

[0027] The disclosed embodiments may include a method of providing mobile, walkable, or out-of-home, hospital, or treatment facility extracorporeal life support that involves pumping a patient's blood through a pump into first and second modular extracorporeal life support components, where the pump and the first and second modular extracorporeal life support components are fluidly connected in a series, parallel, or other combination connection in the case of multiple organ support functions, and the pump and the first and second modular extracorporeal life support components are configured to be attached to clothing such that they include any type of exoskeleton or external support structure.

[0028] The disclosed embodiments may include a method of providing mobile, walkable extracorporeal life support that involves pumping a patient's deoxygenated blood through a first line into a pump, pumping the deoxygenated blood to a lung membrane where the blood is oxygenated and carbon dioxide is removed, pumping the oxygenated blood from the lung membrane to a dialysis membrane where the blood is filtered, and returning the blood to the patient through a second line or the same line. The disclosed embodiments provide mobile extracorporeal life support during transport of a patient between hospitals or from a hospital to home or from home to a hospital, as well as for use at home or outside of a treatment facility and / or hospital in general. In non-limiting examples, embodiments of the present disclosure provide home dialysis to a patient without relying on a hospital or the need to travel to or be admitted to a treatment facility.

[0029] The disclosed embodiments may include a method of providing anticoagulation in extracorporeal life support that involves pumping a patient's blood through an extracorporeal circuit, pumping the blood to a lung membrane and a dialysis membrane within the extracorporeal circuit, injecting citrate or another anticoagulant (e.g., unfractionated heparin "UFH", direct thrombin inhibitor "DTI", antiplatelet agent, etc.) into the blood within the extracorporeal circuit, returning the blood to the patient, or using another form of anticoagulation and thrombus mitigation either by coating the ECLS system with an anticoagulant or blood modifier or embedding such agents within the polymers that make up the circuit.

[0030] As used herein, the term "garment" refers to any item of clothing, including but not limited to, a vest-shaped exoskeleton of any design or other external support structure / building, etc.

[0031] As used herein, the term "catheter" refers to any tube, including but not limited to, an intravenous catheter, a venous catheter, a cannula, or any tube for peripheral access to the body, such as a double-lumen catheter.

[0032] An arterial catheter may be used because it is applicable to other methods for removing blood from the body (including but not limited to, a catheter, cannula, or any tube for peripheral access to the body through any artery in the body, such as a double-lumen catheter or other catheter design).

[0033] A combination of an arterial catheter and a venous catheter or peripheral vascular cannula insertion may be used because it is applicable to other methods for removing blood from the body (including but not limited to, a catheter, cannula, or any tube for peripheral access to the body through any artery in the body, such as a double-lumen catheter or other catheter design, inserted into the elbow or femoral vein).

[0034] As used herein, the term "lung membrane" refers to any device, such as an oxygenator, a membrane oxygenator, a lung replacement membrane, an artificial lung, etc., used to add oxygen to the blood and remove carbon dioxide therefrom.

[0035] As used herein, the term "dialysis membrane" refers to any device, such as a dialysis filter, a dialysis replacement membrane, a kidney replacement membrane, an artificial kidney, a dialysis device, etc., used to remove metabolites (such as lactic acid, myoglobin, creatinine, etc.), inflammatory mediators, cytokines, or pathogens.

[0036] As used herein, the term "hepatocyte membrane" refers to a dialysis filter for liver dialysis, hepatocyte replacement membrane, artificial liver, dialysis device, or any device used to remove, for example, toxins (such as albumin-bound substances such as ammonia, phenylalanine, tyrosine, or bilirubin, bile acids, metabolites of aromatic amino acids, medium-chain fatty acids, and cytokines).

[0037] As used herein, the term "selective intestinal or brain perfusion system" refers to either exclusively supporting the intestine or brain by their selective perfusion or any combination of perfusion of one or both of them with other organ system support.

[0038] The disclosed embodiments may include a wearable device for extracorporeal life support of a patient, including modular components for providing life support. The modular components are small enough to be continuously carried or worn by the patient and may be used at home, outside a treatment facility, or during the performance of daily tasks outside the home. In some embodiments, the device may be used to provide continuous treatment since the device can always be accompanied by the patient.

[0039] In at least some embodiments, the device may include a catheter that can provide a central venous access inserted via the right internal jugular vein. The catheter may be for the delivery and / or removal of fluids from the body. The catheter may have two lumens and may allow blood to be drained from the superior vena cava and inferior vena cava. One lumen may allow deoxygenated blood to be removed from the body while the other lumen may allow oxygenated blood to return to the body. Other catheter designs, including additional catheter lumens (such as 2, 3, 4, etc.) or groups of holes, are envisioned.

[0040] Although cannulation within the femoral vessels is conceivable, the neck is desirable to maintain mobility. Access through the jugular vein may allow for more efficient gas exchange than access through the femoral vein. This is because, in part, not only can the jugular vein accommodate larger catheters, but also because the jugular vein is a central vein rather than a peripheral vein, providing immediate access and blood delivery to the heart. In addition to combat trauma and motor vehicle accidents, jugular vein cannulation can be a preferred option due to limb loss resulting from traumatic amputation.

[0041] Access through the jugular vein may also allow for a reduction in the length of the line from the placement of the catheter within the jugular vein to the components of the device as compared to the placement of a catheter within the femoral vein. The reduction in line length may allow for less blood to be exposed to the plastic and potentially be activated and damaged as a result. The reduction in line length may also allow for a smaller pressure through the circuit and a smaller volume of fluid to be required to prime the system with flush water prior to use. The reduction in line length may also reduce the total volume of blood outside the body at any given time, which can help avoid impairments in blood pressure that are possible with an extracorporeal blood system.

[0042] In another embodiment of the device, the length of the connection between the catheter and the components of the device within the circuit can be adjustable to, for example, a potentially shortest length to include the integration of multiple capabilities and modules into a single device performing different organ support functions.

[0043] In another embodiment, the device may include a pump. The pump may be, but is not limited to, a roller pump, an impeller pump, a diagonal pump, or a centrifugal pump, or any blood propulsion / suction device. The pump may, for example, propel blood using suction through one of the lines from one of the ports of a double-lumen catheter. The pump may be fluidly connected to the components. In another embodiment, the pump may, for example, assist patients suffering from reduced cardiac function or heart failure.

[0044] In another embodiment, the device may include a lung membrane component. The blood flow to the lung membrane may be controlled by a pump. Gas exchange within the lung membrane can be determined by the permeability of the membrane to oxygen and carbon dioxide (its diffusion coefficient), the available membrane surface area, the pressure gradient for oxygen or carbon dioxide between the gas compartment and the blood, and the amount of time the gas and blood are in interfacial contact across the membrane. Countercurrent gas and blood flow within the lung membrane can provide optimal gas exchange by maintaining a pressure gradient for oxygen transport from the gas to the blood along the entire length of the membrane surface. Up to 50% of the CO2 produced by the body can be removed by the lung membrane and adjusted as needed, but higher efficiency is also envisioned using the latest catheter / line or a larger-sized catheter / line.

[0045] In another embodiment, the lung membrane may include an input for a sweep gas. In some embodiments, the sweep gas may be ambient air, either alone or enriched with other compounds / gases. In some other embodiments, the sweep gas may be oxygen, for example, from an oxygen tank or generated by a small compressor.

[0046] In another embodiment, the design of the lung membrane may also include a heat exchanger to heat or cool the blood by convection.

[0047] In another embodiment, the device may also include a dialysis membrane. The dialysis membrane removes cytokines and inflammatory mediators as well as pathogens and metabolites from the blood. The dialysis fluid is input through an inlet line, passes through the dialysis membrane, and the waste fluid is output from the dialysis membrane through an outlet line.

[0048] In another embodiment, the device may include a hepatic membrane component. The hepatic membrane removes toxins from the blood. The hepatic membrane may assist patients suffering from hepatic insufficiency.

[0049] In another embodiment, the blood may be returned to the patient through a second line to a second lumen of the cervical catheter and the blood may be injected into the right atrium.

[0050] In another embodiment, the device may also enable the concomitant use of a pulmonary membrane component and a dialysis membrane component. In some embodiments, the pump, the pulmonary membrane, and the dialysis membrane may be in series, parallel, or a combination thereof. For example, the pump may be in series with a pulmonary membrane and a dialysis membrane that are in parallel. As another example, the pump, the pulmonary membrane, and the dialysis membrane may be in series with a dialysis membrane that receives oxygenated blood from the pulmonary membrane. In yet another example, the three components may be in series with a dialysis membrane that receives deoxygenated blood from the patient and provides filtered blood to the pump and the pulmonary membrane.

[0051] In another embodiment of the device, since anticoagulation is performed within the dialysis circuit and systemic agents are not administered to a given patient, citrate anticoagulation of the dialysis membrane may be used to avoid the need to administer heparin for anticoagulation purposes. In another embodiment, citrate anticoagulation of the pulmonary membrane may be used to avoid the need to administer heparin for anticoagulation purposes. In another embodiment, citrate anticoagulation of both the pulmonary membrane and the dialysis membrane may be used to avoid the need to administer heparin for anticoagulation purposes. Thus, performing combination therapy with renal dialysis and lung support may lead to a new solution to the anticoagulation problem in ECLS.

[0052] In another embodiment, fluids, drugs, and diagnostic tests may be administered through the circuitry of the device, either passively or via a special collection or delivery device / module / tool.

[0053] In some embodiments, a clamp may block fluid flow through some or all of the tubing as an additional safety measure.

[0054] In some embodiments, the device may include a power source, such as a battery. The battery may power the pump and compressor. The battery may have a charge life for about 8 hours of use. The battery may be interchangeable with other batteries.

[0055] In another embodiment, the pump and any modular components may be attached to clothing. In some embodiments, the power source may be attached to clothing. The components of the device may be attached to clothing by snaps, friction fits, hooks, or any similar suitable manner. The components of the device may be attached to clothing at the front, back, left, right, or any position on the clothing that allows for comfortable movement by the patient.

[0056] In another embodiment, the clothing may be worn on the upper body of the patient. In another embodiment, the clothing may be wearable under other clothing. In another embodiment, the clothing may be, for example, a vest.

[0057] In another embodiment, the device may be used to treat patients suffering from acute or chronic lung failure. Acute or chronic lung failure may include acute respiratory distress syndrome, chronic obstructive pulmonary disease (COPD), emphysema, bronchitis, or acute lung injury resulting from other causes such as trauma and resuscitation, smoke inhalation and burns, lung contusion, chemical weapons, blast injury, or infection.

[0058] In another embodiment, the device may be used to control the level of CO2 in the circulating blood for the purpose of optimizing the cerebral / brain perfusion pressure. In this case, the CO2 value will be obtained via in-line sensing technology embedded within the device and used to regulate the blood flow and sweep gas flow within the device to achieve higher or lower CO2 levels in the blood.

[0059] In another embodiment, the device may be used to treat patients suffering from acute or chronic renal failure and may be used.

[0060] In another embodiment, the device may be used to treat patients suffering from acute or chronic liver failure.

[0061] In another embodiment, the device may be used to treat patients suffering from acute or chronic heart failure.

[0062] In another embodiment, the device may be used to selectively perfuse the head and brain to treat patients suffering from traumatic brain injury or to optimize the blood supply to the brain, with or without traumatic brain injury, via precise control of the circulating CO2 level in the blood.

[0063] In another embodiment, the device may enable early initiation of partial lung support. The device may enable initiation of partial lung support prior to the need for mechanical ventilation in patients. The device may enable hybrid breathing, where the patient can breathe naturally, at least partially, while receiving support from the device. The device may prevent the need to anesthetize and intubate the patient during treatment.

[0064] In another embodiment, by avoiding the need for intubation and mechanical ventilation, the device may also enable coughing, sneezing, or other natural clearances of the patient's airway.

[0065] In some embodiments, the use of the device may eliminate the need for handover between different services. In some embodiments, the use of the device may eliminate the need to exchange devices during medical transportation between the point of care and the hospital, or within the hospital department, or at home during autonomous use of the device by the patient outside the hospital or treatment center.

[0066] In some embodiments, the device may be used to provide early treatment to military personnel injured on the battlefield. The device may be used to provide treatment at or near the point of injury at the scene.

[0067] In some embodiments, the device may be used to provide early treatment to government officials injured on the battlefield during an individual trauma or car accident, or during a mass casualty situation. The device may be used to provide treatment at or near the point of injury at the scene, or during ambulatory support or use at home.

[0068] In another embodiment, the device may be used to treat chronic pulmonary insufficiency by CO2 removal and partial oxygenation outside the home or treatment center or hospital.

[0069] In some embodiments, the device may be used to perform long-term wearable multi-organ support using either selective organ perfusion or combined perfusion of several organs.

[0070] In another embodiment, the device may be used to treat pulmonary insufficiency by CO2 removal and partial oxygenation.

[0071] In another embodiment, the device may treat renal insufficiency in the patient's home. The device may make it possible for the patient to avoid traveling to a dialysis center or hospital. The device may enable treatment without direct continuous supervision by medical staff.

[0072] In another embodiment, the device may include at least one sensor for measuring the oxygenation level of the blood within the device. The device may include one or more sensors and may measure the flow rate within the device. The device may include one or more sensors and may measure the internal pressure of the device. The device may include one or more sensors and may identify air bubbles within the device.

[0073] In another embodiment, the pump may be controlled by a processor, such as a programmable logic controller or other suitable controller, that can be easily programmed by a patient or healthcare provider. Programming may be accomplished, for example, wirelessly, through a USB cable, using buttons, a touch screen, or other actuation and / or input mechanisms on the pump controller, or wirelessly. For example, a healthcare provider may be able to remotely control the device through a wireless connection. This may provide an easy way for a physician or healthcare provider to monitor a patient and make any necessary adjustments outside of a specialist treatment setting.

[0074] In another embodiment, the pump and / or control system may provide information and / or feedback and / or readings to the patient or healthcare provider through visual signals on a display or through the automatic collection and analysis of medical information for the purpose of assessing, diagnosing, or predicting which patients need support initiated, which patients need support stopped, and which patients will benefit from which particular form of support.

[0075] By providing a consistent, demand-responsive, mobile treatment, the device will eliminate the need for handoffs between services and the need to change equipment. Most importantly, providing a mobile, modular, and wearable device for ambulatory extracorporeal support will prevent the need to anesthetize and intubate a patient during treatment.

[0076] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate the disclosed embodiments and, together with the description, serve to explain the disclosed embodiments. The present invention provides, for example, the following. (Item 1) A wearable device for extracorporeal life support of a patient, comprising a catheter fluidly connected to a pump and first and second modular extracorporeal life support components, wherein the pump and the first and second modular extracorporeal life support components are configured to be attached to clothing. (Item 2) The wearable device according to Item 1, wherein the pump, the first modular extracorporeal life support component, and the second modular extracorporeal life support component are fluidly connected in series. (Item 3) The wearable device according to Item 1, wherein at least one of the pump, the first modular extracorporeal life support component, and the second modular extracorporeal life support component is fluidly connected in parallel. (Item 4) The wearable device according to Item 1, wherein the first modular extracorporeal life support component is a lung membrane. (Item 5) The wearable device according to Item 4, wherein the second modular extracorporeal life support component is a dialysis membrane. (Item 6) The wearable device according to Item 1, wherein the modular extracorporeal life support component is a liver membrane. (Item 7) The wearable device according to Item 1, wherein the modular extracorporeal life support component provides selective perfusion of the head of the patient. (Item 8) The wearable device according to Item 1, further comprising a battery. (Item 9) The wearable device according to Item 1, wherein at least a portion of the catheter is inserted into the jugular vein. (Item 10) The wearable device according to item 8, wherein at least a part of the catheter inserted into the jugular vein is inserted into the superior and inferior vena cavae. (Item 11) The wearable device according to item 1, wherein the device automatically collects, analyzes, and correlates medical information to assess, diagnose, and predict the needs of the associated patient and the corresponding support to be initiated, which associated patient needs and corresponding support should be discontinued, and which associated patient needs will benefit from which specific form of support. (Item 12) The wearable device according to item 1, further comprising at least one in-line sensor embedded in the device, the in-line sensor being used to regulate blood flow and sweep gas flow within the device to achieve higher or lower CO2 levels in the blood. (Item 13) The wearable device according to item 1, wherein the modular extracorporeal life support component treats chronic pulmonary insufficiency outside a treatment center by CO2 removal and partial oxygenation of the blood. (Item 14) The wearable device according to item 1, wherein the modular extracorporeal life support component extends the survival rate of organs for transplantation. (Item 15) A method for providing mobile walkable extracorporeal life support, comprising pumping a patient's blood through a pump into first and second modular extracorporeal life support components, wherein the pump and the first and second modular extracorporeal life support components are fluidly connected in series, and the pump and the first and second modular extracorporeal life support components are configured to be attached to clothing. (Item 16) A method for providing mobile walkable extracorporeal life support, comprising pumping a patient's deoxygenated blood through a first line into a pump, Pumping deoxygenated blood to a lung membrane, where the blood is oxygenated and carbon dioxide is removed, and pumping the oxygenated blood from the lung membrane to a dialysis membrane, where the blood is filtered, and returning the blood to the patient through a second line A method comprising. (Item 17) A method of providing anticoagulation in extracorporeal life support, pumping a patient's blood through an extracorporeal circuit, pumping the blood to a lung membrane and a dialysis membrane within the extracorporeal circuit, injecting an anticoagulant into the blood within the extracorporeal circuit, returning the blood to the patient A method comprising. (Item 18) A method of providing mobile walkable extracorporeal life support, pumping a patient's blood through an extracorporeal circuit, pumping the blood to first and second modular extracorporeal life support components within the extracorporeal circuit, returning the blood to the patient A method comprising. (Item 19) The method according to item 13, further comprising administering a fluid through the circuit. (Item 20) The method according to item 13, further comprising administering a drug through the circuit. (Item 21) The method according to item 13, further comprising administering a diagnostic test through the circuit.

Brief Description of the Drawings

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[0081]

Figure 5

[0082]

Figure 6

[0083]

Figure 7

DETAILED DESCRIPTION OF THE INVENTION

[0084] The annotations appearing in the figures are for illustration only and are not limitations of the claimed invention.

[0085] (DETAILED DESCRIPTION) Reference will now be made in detail to the present embodiments (exemplary embodiments) of the present disclosure, examples of which are illustrated in the accompanying drawings.

[0086] Figure 1 illustrates an exemplary wearable extracorporeal life support device 20 that combines extracorporeal membrane oxygenation and extracorporeal continuous renal replacement therapy, according to at least some embodiments of the present disclosure. The same or similar concepts would apply if other organ support membranes were added to the device. In some embodiments, the wearable extracorporeal life support device 20 may be a vest 20. The dual-lumen catheter 22 may be inserted into the patient, for example, via the right jugular vein (not shown). The catheter 22 may have two ports and may be capable of draining blood from the superior vena cava and the inferior vena cava. One lumen (e.g., lumen 24) may be capable of allowing deoxygenated blood to be removed from the body, while the other lumen (e.g., lumen 26) may be capable of allowing oxygenated blood to return to the body.

[0087] According to at least some embodiments of the present disclosure, the line from the dual-lumen catheter 22 may be attached to the vest 20, for example, in front of the patient. According to at least some embodiments, the line from the dual-lumen catheter 22 may be attached to the vest 20 behind the patient's neck, or on the left or right side of the vest 20. According to at least some embodiments, the line may be attached to the vest 20 at any other location. According to another embodiment, the line may not be attached to the vest 20.

[0088] The pump 30 may propel blood using suction through one of the lines from one of the ports of the double-lumen catheter 22. The pump 30 may be fluidly connected to the inlet of the lung membrane 32. The inlet of the lung membrane 32 may also be fluidly connected to the catheter 22. The lung membrane 32 may remove CO2 from the blood. The lung membrane 32 may also oxygenate the blood. The design of the lung membrane 32 may also include a heat exchanger if a fluid warmer is available, and may heat the blood by convection. In some embodiments, the lung membrane 32 uses a 1 / 4-inch tubing size and a 15 French (F) catheter to support a minimum flow of 500 ml / min, and may also accommodate higher flow rates up to, for example, 1 liter (L) / min using an 18F catheter, 2 L / min using a 23F catheter, and 4 liters / min maximum using a 32F catheter (all using 1 / 2-inch tubing).

[0089] In another embodiment, the outlet of the lung membrane 32 may return blood through a second line to a second lumen of the double-lumen catheter 22 (e.g., a cervical catheter) and may inject the blood into the right atrium.

[0090] In another embodiment, the lung membrane 32 may include an input for a sweep gas, remove CO2, and provide oxygenation. In some embodiments, the sweep gas line 34 may be connected to a small compressor mounted on the device 20, which will generate oxygen and circulate ambient air through the lung membrane 32 for gas exchange purposes. In some embodiments, the sweep gas line 34 may input ambient air into the lung membrane 32.

[0091] In another embodiment, the shunt line 36 is in parallel, series, or other combination They may be connected to the inlet line and the outlet line. The shunt line 36 may direct a side flow of blood from the lung membrane 32 into the inlet of the dialysis membrane 40. The dialysis membrane 40 may remove at least one of metabolites, inflammatory mediators, cytokines, and / or pathogens. This may be accomplished using various generally established configurations of kidney dialysis.

[0092] In another embodiment, the pump 30 may be fluidly connected to the dialysis membrane 40. The outlet of the dialysis membrane 40 may return the blood through a second line to the second lumen of the double-lumen catheter 22 and may inject the blood into the right atrium.

[0093] Figure 1 shows the pump 30 connected in series to the lung membrane 32 and the dialysis membrane 40, although various other configurations are contemplated, some of which are illustrated in Figures 2-7.

[0094] The lung membrane 32, the dialysis membrane 40, and the pump 30 may be attached to the vest 20 at the front, back, left, right side, or any location that is considered possible on the vest 20.

[0095] In some embodiments, the device 20 may include a power source 42, such as a battery.

[0096] Figures 2-7 are illustrations of various configurations of the pump 30, the lung membrane 32, and the dialysis membrane 40 according to at least some embodiments of the present disclosure. In Figures 2-7, deoxygenated blood is represented by a dashed line and oxygenated blood is represented by a solid line.

[0097] Figure 2 illustrates the pump 30, the lung membrane 32, and the dialysis membrane 40 in series. Deoxygenated blood enters the catheter 22 and enters the pump 30 from the first line. The deoxygenated blood is then pumped to the lung membrane 32, where the blood is oxygenated and carbon dioxide is removed. The oxygenated blood then enters the dialysis membrane 40, where at least one of metabolites, inflammatory mediators, cytokines, and / or pathogens is removed. The filtered and oxygenated blood is then finally returned to the patient through another line.

[0098] Figure 3 illustrates the pump 30 in series with the parallel lung membrane 32 and dialysis membrane 40. Deoxygenated blood from the patient can enter the pump 30 and can be pumped in parallel with both the lung membrane 32 and the dialysis membrane 40. The oxygenated blood from the lung membrane 32 can be combined with the filtered deoxygenated blood from the dialysis membrane 40 and returned to the patient in one line.

[0099] Figure 4 illustrates the dialysis membrane 40, the pump 30, and the lung membrane 32 in series. Deoxygenated blood from the patient can enter the dialysis membrane 40. The filtered deoxygenated blood then enters the pump 30 and is pumped to the lung membrane 32. The oxygenated blood is then returned to the patient. In some embodiments, the series of connections can provide direct control of the flow through the dialysis membrane. Additionally, the series of connections can simplify the tubing and connections of the system.

[0100] Figure 5 shows the pump 30 and the dialysis membrane 40 in parallel with the lung membrane 32 in series. The deoxygenated blood from the patient can enter both the parallel pump 30 and the dialysis membrane 40. The blood filtered from the dialysis membrane 40 can then be combined with the blood from the pump 30 and pumped to the lung membrane 32. The oxygenated blood is then returned to the patient. In some embodiments, the parallel arrangement can be advantageous because if one of the devices in the present device becomes clogged, the other device can operate independently or be replaced for a different device. In some embodiments, the blood can flow through one system at a time, for example, through the dialysis membrane 40 or through the lung membrane 32. Thus, the parallel connection provides a modular design. In addition, the parallel arrangement can provide a lower internal pressure of the fluid dialysis membrane 40, which can be beneficial for maintaining blood viability. For example, higher pressures may require turbulent flow and destruction of red blood cells. In some embodiments, lung support may require a blood flow higher than the maximum flow that the dialysis membrane 40 can support. The parallel connection can enable independent blood flow adjustment, and the flow through the lung membrane 32 can be increased or decreased as needed using independent adjustment of the flow through the dialysis membrane 40. For example, the blood flow may be in the range of 50 ml / min to 500 ml / min. It can be beneficial. For example, higher pressures may require turbulent flow and destruction of red blood cells. In some embodiments, lung support may require a blood flow higher than the maximum flow that the dialysis membrane 40 can support. The parallel connection can enable independent blood flow adjustment, and the flow through the lung membrane 32 can be increased or decreased as needed using independent adjustment of the flow through the dialysis membrane 40. For example, the blood flow may be in the range of 50 ml / min to 500 ml / min.

[0101] Figure 6 shows the dialysis membrane 40 in parallel with the pump 30 and the lung membrane 32 in series. The deoxygenated blood from the patient can enter both the parallel pump 30 and the dialysis membrane 40. The blood from the pump 30 is then pumped to the lung membrane 32. The oxygenated blood from the lung membrane 32 can be combined with the filtered and deoxygenated blood from the dialysis membrane 40 and returned to the patient in one line.

[0102] Figure 7 shows the dialysis membrane 40 in parallel with the pump 30 and the lung membrane 32 in series. The deoxygenated blood from the patient can enter the pump 30 and be pumped to the lung membrane 32. The oxygenated blood is then separately returned to the patient and can enter the dialysis membrane 40. The blood filtered from the dialysis membrane 40 can be combined with the deoxygenated blood from the patient before entering the pump 30.

[0103] FIG. 2-7 illustrates exemplary embodiments of various configurations of pump 30, lung membrane 32, and dialysis membrane 40, although other configurations not shown are also contemplated. In one embodiment, only pump 30 and lung membrane 32 are used for a patient who requires lung support and not kidney support. In another embodiment, only pump 30 and dialysis membrane 40 are used for a patient who requires patient kidney support and not lung support.

[0104] Furthermore, exemplary embodiments are described herein, but the scope thereof includes any embodiments having equivalent elements, modifications, omissions, combinations, adaptations, or alterations (e.g., aspects across various embodiments), based on the present disclosure. Elements in the claims should be construed broadly based on the terms employed in the claims and not limited to the examples described herein or the examples during the prosecution of the present application, which examples should be construed as non-exclusive. Furthermore, the steps of the disclosed methods can be modified in any manner including rearranging the steps or inserting or deleting steps. Accordingly, the specification and examples are intended to be regarded as merely exemplary, with the true scope and spirit being indicated by the full scope of the following claims and their equivalents.

Claims

**Claim 1** A system for providing mobile walkable extracorporeal life support, the system comprising: a first modular extracorporeal life support component and a second modular extracorporeal life support component; a pump for pumping a patient's blood into the first modular extracorporeal life support component and the second modular extracorporeal life support component; and wherein: the first modular extracorporeal life support component and the second modular extracorporeal life support component are different organ support membranes; the pump, the first modular extracorporeal life support component, and the second modular extracorporeal life support component are fluidly connected in series; the pump, the first modular extracorporeal life support component, and the second modular extracorporeal life support component are configured to be attached to clothing; the system further comprises a module, the module being a dialysis membrane for discharging metabolites. **Claim 2** The system of claim 1, wherein the pump supports blood flow to a patient's tissue and / or organ. **Claim 3** The system of claim 1, wherein the pump, the first modular extracorporeal life support component, and the second modular extracorporeal life support component are configured to simultaneously provide support to a patient's body and support to a patient's tissue and / or organ.

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