A wearable modular extracorporeal life support device for mobile treatment of organ failure

Abstract

In an 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 can also be configured to be attached to clothing. The pump and the first and second modular extracorporeal life support components can be fluidly connected in series. The pump and the first and second modular extracorporeal life support components can also be fluidly connected in parallel. The first modular extracorporeal life support component can be a lung membrane and the second modular extracorporeal life support component can be a dialysis membrane.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 690,403, filed on June 27, 2018, the entire contents of which are incorporated herein by reference. Technical Field

[0003] 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 employing such devices. In some embodiments, the wearable device combines extracorporeal membrane oxygenation and extracorporeal continuous renal replacement therapy, but will be equally applicable to mobile support of liver, heart failure, and selective cerebral perfusion and combinations thereof as part of multi-organ failure treatment / support. The device may also support home and outdoor medical facility use with self-operated end-user features. Background Art

[0004] Extracorporeal life support (ECLS) includes many forms of extracorporeal rescue therapy. It generally refers to the use of prolonged extracorporeal cardiopulmonary bypass in patients with acute reversible heart or respiratory failure. As technology has advanced, ECLS has provided organ support functions other than gas exchange, such as liver, kidney, and heart support. In addition, ECLS has been used for organ harvesting and prolonging the viability of organs for transplantation in brain-dead donors, as well as for providing lung function to patients awaiting such a transplant.

[0005] Extracorporeal membrane oxygenation (ECMO) is a form of ECLS. ECMO is a technology that provides extracorporeal gas exchange to patients who are unable to provide adequate amounts of gas exchange or perfusion on their own. ECMO removes blood from the patient, removes carbon dioxide and oxygenates the blood.

[0006] Extracorporeal membrane oxygenation has been used for decades in adult trauma patients with severe respiratory failure. It is usually performed via venovenous ECMO (VV ECMO), in which deoxygenated blood is drained from a large central vein and pumped through a gas exchange membrane before returning to the central venous circulation (Cannon et al., 2018). In this configuration, the pulmonary circulation is not bypassed, and the heart does not experience any significant changes in preload or afterload.

[0007] In a hospital setting, patients with respiratory failure are often started on mechanical ventilation (MV). Mechanical ventilators are large machines that require the patient to be bedridden. Patients are also often anesthetized or sedated and may require medical paralysis to receive mechanical ventilation. ECMO used in hospitals is used as a last resort to save patients who are no longer being helped by a mechanical ventilator or other therapies. The CESAR study (Clinical Efficacy and Economic Evaluation of Conventional Ventilatory Support Versus Extracorporeal Membrane Oxygenation in Severe Adult Respiratory Failure) showed that patients who received ECMO had an improved 6-month survival rate without severe disability compared to conventional ventilation in patients with acute respiratory distress syndrome (Peek et al., 2009). The CESAR study was a multicenter randomized controlled trial conducted in the United Kingdom that showed that patients referred to experienced ECMO centers experienced a significant reduction in death and long-term disability (Neff et al., 2013; Peek et al., 2009).

[0008] The confinement of patients receiving mechanical ventilation, especially ECMO, can lead to gradual muscle degeneration. Advances in technology have led to the development of “ambulatory ECMO” protocols. These combine existing blood pumps and bypass oxygenators into an integrated system that can be wheeled behind the patient. Ambulatory ECMO is often used as a bridge to lung transplant to speed recovery by minimizing sedation and bed rest, and allows patients to undergo physical therapy while waiting for an available lung. In most cases, conventional ECMO access is through the femoral vein, which is dangerous to move due to the risk of dislodging the catheter.

[0009] Extracorporeal life support (ECLS) also includes renal support. It is estimated that acute kidney injury (AKI) affects one in five hospitalized patients worldwide and 40% of critically ill patients (Clemens et al., 2016). Even small increases in serum creatinine (0.3-0.4 mg / dL) are associated with increased mortality, indicating a progressive deterioration in renal function. Among AKI survivors who require dialysis in the hospital, 10% to 30% still require dialysis at the time of discharge (Heung et al., 2015). Without dialysis or kidney transplantation, chronic kidney disease or renal failure can be fatal.

[0010] Available modalities for 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 diffusion removal of solutes. It is a very effective treatment for patients with chronic renal failure, and patient outcomes are at least the same as those of patients treated with hemodialysis (Pannu et al., 2005). In adult patients, acute peritoneal dialysis is not widely used. Logistical and practical considerations limit the use of peritoneal dialysis (Pannu et al., 2005). Hemodialysis is a solute removal process based on transmembrane diffusion driven by the concentration gradient between blood and dialysate. Typically, intermittent dialysis is performed for three to six hours per treatment, with multiple treatments per week (Pannu et al., 2005). Dialysis is usually performed in a hospital or dialysis center, where the patient sits for several hours and is buckled into a large machine while the blood is filtered.

[0011] Continuous renal replacement therapy (CRRT) describes a variety of blood purification techniques designed to be applied 24 hours a day. The patient's blood is removed and pumped through a blood filter similar to a dialyzer. CRRT helps prevent the hemodynamic fluctuations common when IHD is faster. Solute removal in CRRT is achieved by convection (hemofiltration), diffusion (hemodialysis), or a combination of these two methods (hemodiafiltration). Compared with intermittent therapy, CRRT has a lower solute clearance rate per unit time, but it can even exceed the clearance rate of IHD over 24 hours (Pannu et al., 2005). The usual CRRT circuit includes a double-lumen catheter that transports blood from the patient's body through the catheter to the CRRT machine, the CRRT machine, and a return tube that transports blood back to the patient. The most commonly used methods are continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and continuous venovenous hemodiafiltration (CVVHDF). In many trauma centers, CRRT has become commonplace for the management of AKI and the severe metabolic disorders caused by it (Neff et al., 2009).

[0012] In the hospital setting, CRRT has also been used in combination with other extracorporeal therapies, including ECMO. Decreased urine output is commonly seen during ECMO, which may be associated with acute kidney injury or acute renal failure. Patients with acute cardiopulmonary insufficiency may be at high risk for acute kidney injury and fluid overload. In these patients, renal replacement therapy is added, typically IHD or CRRT. Classic indications for starting renal replacement therapy in ECMO patients include uremia, acidosis, electrolyte abnormalities, and fluid overload.

[0013] In some other hospitalized patients, they initially required dialysis and were placed on renal replacement therapy (usually IHD or CRRT) and then developed secondary pulmonary complications. In these patients, mechanical ventilation or ECMO was added.

[0014] For patients receiving both CRRT and ECMO, the most common technique is to use separate vascular access for CRRT and ECMO. This is usually done so that the CRRT and ECMO systems do not interfere with each other's hemodynamics.

[0015] The additional plastic tubing of the circuit increases the risk of blood clotting, as the main causes of clotting on artificial surfaces are protein adsorption and platelet activation / aggregation. The additional tubing also increases the damage to the blood when it is exposed to plastic due to inflammation and contact activation of the coagulation cascade. This is especially true when pumping blood through the ECLS system at low blood flow rates of 250-500 ml / min, as blood is more likely to form clots on plastic surfaces at lower infusion rates. Although less pronounced, this problem still exists under high flow conditions (1-5 L min).

[0016] To minimize thrombotic complications and reduce platelet loss during exposure of blood to plastic, the current approach is to infuse heparin, which inactivates thrombin 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.

[0017] Advances in centrifugal pump-driven venous and pulmonary venous assistance have made it possible to bring ECMO technology to deployed soldiers in military hospitals (Neff et al., 2013). It has also allowed deployed soldiers to be transported to the United States while still on ECMO (Neff et al., 2013).

[0018] "Partial lung support" is a method of assisting lung ventilation and oxygenation to a lesser degree than full mechanical ventilation and is achieved by varying the blood and gas flow through a polymer gas exchange filter, called a pneumoperitoneum (Neff et al., 2013). At lower blood flow rates (<1000 mL / min), although physiologically significant oxygenation cannot be achieved, significant CO2 removal can still be achieved. Variations in gas flow through the pneumoperitoneum can regulate the amount of CO2 removal while maintaining a constant blood flow through the circuit. Using this approach, up to 50% of metabolically produced CO2 can be removed (Batchinsky et al., 2011).

[0019] Partial lung support early after injury improves outcomes in patients who are not mechanically ventilated. The relatively low blood flow rates of these systems (e.g., 500-1000 mL / min compared to 5 L / min for full ECMO) allow for easy placement of vascular access catheters using the standard ultrasound-guided Seldinger technique (Cannon et al., 2018).

[0020] Continuous hemofiltration has also been shown to improve outcomes in patients who sustained injuries in combat and developed AKI (Neff et al., 2013).

[0021] The equipment used for partial lung support or continuous hemofiltration in the hospital setting and for military use with deployed soldiers is large and cumbersome. It does not allow for continued care outside of the hospital or outside of a dedicated dialysis center. It is important to develop a device for continued care outside of the hospital that is mobile, wearable, and requires less supervision by medical staff. Approximately 10,000 people turn 65 every day, demonstrating the need to find out-of-hospital / home care treatment options for the aging population that will require lung, kidney, or other organ support. Developments such as the extracorporeal left ventricular assist device (LVAD) for heart failure patients and the continuous positive airway pressure (CPAP) ventilator for sleep apnea patients have demonstrated the success of these devices. Using the devices of the disclosed embodiments, a similar or greater impact on the aging population can be envisioned. Summary of the invention

[0022] The disclosed embodiments may include a device that allows wearable mobile home or hospital out-of-hospital modularization, organ support, organ replacement, and continuous extracorporeal life support. For example, the device can provide respiratory support to the patient when he is conscious, without intubation and mechanical ventilation, anesthesia, loss of ability, and bedriddenness. The device can also achieve, for example, ambulatory extracorporeal CO2 removal, partial oxygenation, and partial lung support by using a lung membrane. The disclosed embodiments of the device can also allow, for example, ambulatory or home use, by using a dialysis membrane to remove metabolites, cytokines, inflammatory mediators, pathogens, and other compounds contained in the blood. The device can also allow the concomitant use of lung membranes and dialysis membranes or other organ support devices connected to the device in any order. The disclosed embodiments can provide organ support or organ replacement modules, devices, and / or components. The disclosed embodiments can provide organ replacement or organ support for lungs, kidneys or kidneys, liver, heart, brain (through dedicated selective perfusion of the brain), intestines (such as stomach or other abdominal organs), or a combination thereof. Additionally, the disclosed embodiments can provide integrated partial or full 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 can be used for organ collection in brain dead donors and for extending the viability of organs for transplantation. For example, extending lung function or other body function in patients awaiting transplantation.

[0023] The disclosed embodiments may include a wearable device for extracorporeal life support of a patient, comprising: a catheter fluidly connected to a pump and a first, second, third, etc. modular extracorporeal life support component; wherein the pump and the first, second, third, etc. modular extracorporeal life support components are configured to be attached to clothing or an external enhanced body support structure (such as an exoskeleton).

[0024] In at least some embodiments, the pump, the first modular extracorporeal life support component, and the second or third modular extracorporeal life support component can 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 can be fluidly connected in parallel. It is contemplated that series and parallel connections can be combined with the support selector of the organ in any particular order, as required by the patient's condition or treatment goals.

[0025] In at least some embodiments, the first modular extracorporeal life support component can be a lung membrane. In at least some embodiments, the second modular extracorporeal life support component can be a dialysis membrane. The reverse order or other combinations of organs and organ systems are contemplated.

[0026] In at least some embodiments, the device may also include a battery, power source, or energy generator of any design.

[0027] In at least some embodiments, a portion of the catheter can be inserted into the jugular vein or other major veins or arteries in the body. In at least some embodiments, at least a portion of the catheter inserted into the jugular vein is advanced into the superior vena cava and the inferior vena cava.

[0028] The disclosed embodiments may include a method of providing mobile ambulatory or at-home, outside of a hospital or treatment facility, extracorporeal life support, comprising pumping a patient's blood via a pump into first and second modular extracorporeal life support components; wherein, in the case of multiple organ support functions, the pump and the first and second modular extracorporeal life support components are fluidly connected in series, parallel, or other combination connections; and wherein the pump and the first and second modular extracorporeal life support components are configured to attach to a garment to include an exoskeleton or any kind of external support structure.

[0029] The disclosed embodiments may include a method of providing mobile ambulatory extracorporeal life support, comprising: pumping deoxygenated blood of a patient to a pump via a first line; 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 via a second line or the same line. The disclosed embodiments provide mobile extracorporeal life support, such as during transportation of a patient between hospitals or from a hospital to home or from home to a hospital; and for use typically at home or outside of a treatment facility and / or hospital. In a non-limiting example, embodiments of the present disclosure provide home dialysis to a patient and are independent of a hospital or the need to travel or be admitted to a treatment facility.

[0030] The disclosed embodiments may include a method of providing anticoagulation in extracorporeal life support, comprising: pumping a patient's blood through an extracorporeal circuit; pumping the blood to a lung membrane and a dialysis membrane in the extracorporeal circuit; injecting citrate or other anticoagulants into the blood in the extracorporeal circuit (e.g., unfractionated heparin "UFH", direct thrombin inhibitors "DTI", antiplatelet agents, etc.); and returning the blood to the patient, or using other forms of anticoagulation and thrombus relief by coating an expelling agent or blood conditioning agent on the ECLS system; or embedding such agents into the polymers that make up the circuit.

[0031] As used herein, the term "garment" refers to any article of clothing, such as but not limited to a vest exoskeleton or other external support construction / structure of any design.

[0032] As used herein, the term "catheter" refers to an intravenous catheter, an IV catheter, a cannula, or any tube used for peripheral access to the body, such as, but not limited to, a double lumen catheter.

[0033] As with other means of removing blood from the body, an arterial catheter (a catheter, cannula, or any tube for peripheral access to the body through any artery in the body, such as but not limited to a double lumen catheter or other catheter design) may be used.

[0034] As with other means of removing blood from the body, a combination of an arterial catheter and a venous catheter or a peripheral vascular cannula (a catheter, cannula, or any tube used for peripheral access to the human body through any artery in the body, such as, but not limited to, a double lumen catheter or other catheter design inserted in the cubital or femoral vein) may be used.

[0035] As used herein, the term "lung membrane" refers to, for example, an oxygenator, membrane oxygenator, lung replacement membrane, artificial lung, or any device used to add oxygen to the blood and remove carbon dioxide from the blood.

[0036] As used herein, the term "dialysis membrane" refers to a dialysis filter, a dialysis substitute membrane, a kidney substitute membrane, an artificial kidney, a dialyzer, or any device used, for example, to remove metabolites (e.g., lactate, myoglobin, creatinine, etc.), inflammatory mediators, cytokines, or pathogens.

[0037] As used herein, the term "liver membrane" refers to a dialysis filter, a liver replacement membrane, an artificial liver, a dialyzer, or any device used for liver dialysis, for example, for removing toxins such as ammonia, phenylalanine, tyrosine, or albumin-bound substances such as bilirubin, bile acids, metabolites of aromatic amino acids, medium-chain fatty acids, and cytokines.

[0038] As used herein, the term selective gut or brain perfusion system refers to supporting the gut or brain specifically by selectively perfusing them or a combination of either or both with support of other organ systems.

[0039] The disclosed embodiments may include a wearable device for extracorporeal life support of a patient, comprising modular components for providing life support. The modular components may be small enough to be carried or worn continuously by the patient and may be used outside of a treatment facility at home, during the performance of daily tasks outside of the home. In some embodiments, the device may be used to provide continuous treatment because the device may be with the patient at all times.

[0040] In at least some embodiments, the device can include a catheter that can provide venous access via the right jugular vein. The catheter can be used to deliver and / or remove fluids from the body. The catheter can have two holes to allow blood to be drained from the superior vena cava and the inferior vena cava. One lumen can allow deoxygenated blood to be removed from the body, while the other lumen can allow oxygenated blood to be returned to the body. Other catheter designs can be envisioned, including additional catheter lumens (2, 3, 4, etc.) or groups of holes.

[0041] Although the jugular vein is needed to maintain mobility, it is possible to cannulate the femoral vessels. Access through the jugular vein may allow for more efficient gas exchange than access through the femoral vein. This is partly because the jugular vein can accommodate larger catheters, but also because the jugular vein is a central vein that can be accessed immediately and delivers blood to the heart rather than to peripheral veins. In addition, in cases of combat trauma and motor vehicle accidents where limb loss has occurred due to traumatic amputation, jugular cannulation may be preferred.

[0042] Access through the jugular vein can also allow for a reduction in the length of tubing from the placement of the catheter in the jugular vein to the device components compared to placement of the catheter in the femoral vein. The reduction in tubing length can allow less blood to be activated and potentially damaged due to exposure to plastic. The reduction in tubing length can also allow for less pressure through the circuit, as well as a smaller volume of fluid required to prime the system before use. Reducing the length of the tubing also reduces the total amount of blood outside the body at any time, which can help avoid blood pressure disturbances that may be caused by an extracorporeal blood system.

[0043] In another embodiment of the device, the length of the catheter and the connection between the components of the device in the circuit may be adjustable, for example, to the shortest possible length to include incorporating multiple capabilities and modules into a single device that performs different organ support functions.

[0044] 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. For example, the pump may push blood through one of the lines by suctioning from one of the ports of a double lumen catheter. The pump may be fluidly connected to the component. In another embodiment, for example, the pump may support a patient with reduced heart function or heart failure.

[0045] In another embodiment, the device may include a pulmonary membrane component. Blood flow to the pulmonary membrane may be controlled by a pump. Gas exchange in the pulmonary membrane may be determined by the membrane's permeability to oxygen and carbon dioxide (its diffusion coefficient), the available membrane surface area, the pressure gradient of oxygen or carbon dioxide between the gas chamber and the blood, and the amount of time that the gas and blood are in contact across the membrane. Countercurrent gas and blood in the pulmonary membrane may provide optimal gas exchange by maintaining a pressure gradient to transfer oxygen from the gas to the blood along the entire length of the membrane surface. Up to 50% of the CO2 produced in the body may be removed by the pulmonary membrane and adjusted as needed, but newer catheters / lines or catheters / lines of larger sizes may also achieve higher efficiency.

[0046] In another embodiment, the lung membrane may include an input of a purge gas. In some embodiments, the purge gas may be ambient air alone or enriched with other compounds / gases. In some other embodiments, for example, the purge gas may be oxygen from an oxygen tank or oxygen generated by a small compressor.

[0047] In another embodiment, the design of the lung membrane may also include a heat exchanger to heat or cool the blood by convection.

[0048] In another embodiment, the device may further include a dialysis membrane. The dialysis membrane removes cytokines and inflammatory mediators as well as pathogens and metabolites from the blood. Dialysate is input through an inlet line and passes through the dialysis membrane; effluent is output from the dialysis membrane through an outlet line.

[0049] In another embodiment, the device may include a liver membrane component. The liver membrane may remove toxins from the blood. The liver membrane may support patients with reduced liver function.

[0050] In another embodiment, blood can be returned to the patient through a second line to a second lumen of the jugular catheter and the blood can be injected into the right atrium.

[0051] In another embodiment, the device may also allow the use of a lung membrane component and a dialysis membrane component at the same time. In some embodiments, the pump, lung membrane, and dialysis membrane may be connected in series, in parallel, or a combination thereof. For example, a pump may be connected in series with a lung membrane and a dialysis membrane connected in parallel. As another example, a pump, lung membrane, and dialysis membrane may be connected in series with a dialysis membrane that receives oxygenated blood from the lung membrane. In other examples, these three components may be connected in series with a dialysis membrane that receives deoxygenated blood from a patient and provides filtered blood to the pump and lung membrane.

[0052] In another embodiment of the device, citrate anticoagulation of the dialysis membrane can be used to avoid the need to administer heparin for anticoagulation purposes, because the anticoagulation is performed in the dialysis circuit and no systemic medication is given to the patient. In another embodiment, citrate anticoagulation of the lung membrane can be used to avoid the need to administer heparin for anticoagulation purposes. In another embodiment, citrate anticoagulation of both the lung membrane and the dialysis membrane can be used to avoid the need to administer heparin for anticoagulation purposes. Thus, performing combined therapy of renal dialysis and pulmonary support will bring new solutions to the anticoagulation problem in ECLS.

[0053] In another embodiment, fluids, medications, and diagnostic tests may be administered passively through the device's circuit or through special retrieval or delivery devices / modules / tools.

[0054] In some embodiments, the clamp may block flow through some or all of the tubes as an added safety measure.

[0055] In some embodiments, the device may include a power source, such as a battery. The battery may power the pump and the compressor. The battery has a useful life of about 8 hours. The battery may be interchangeable with other batteries.

[0056] In another embodiment, the pump and any modular components can be attached to the garment. In some embodiments, the power source can be attached to the garment. The components of the device can be attached to the garment by snaps, friction fit, hooks, or any similar suitable means. The components of the device can be attached to the garment in the front, back, left, right, or any position that allows the patient to move comfortably.

[0057] In another embodiment, the garment can be worn on the patient's upper body. In another embodiment, the garment can be worn under other garments. In another embodiment, the garment can be, for example, a vest.

[0058] In another embodiment, the device can be used to treat patients with acute or chronic lung failure. Acute or chronic lung failure can include acute respiratory distress syndrome, chronic obstructive pulmonary disease (COPD), emphysema, bronchitis, or acute lung injury due to trauma and resuscitation, smoke inhalation and burns, lung contusions, chemical weapons, blast injuries, or other causes such as infection.

[0059] In another embodiment, the device can be used to control CO2 levels in the circulating blood to optimize brain / cerebral perfusion pressure. In this case, the CO2 value will be obtained through online sensing technology embedded in the device and used to adjust the blood flow and air flow in the sweep device to achieve higher or lower CO2 levels in the blood.

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

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

[0062] In another embodiment, the device may be used to treat patients suffering from acute or chronic heart failure.

[0063] In another embodiment, the device can be used to selectively perfuse the head and brain by precisely controlling the level of circulating CO2 in the blood to treat patients with traumatic brain injury or to optimize blood supply to the brain in the presence and absence of traumatic brain injury.

[0064] In another embodiment, the device may allow for early initiation of partial lung support. The device may allow for partial lung support to be initiated before the patient requires a mechanical ventilator. The device may allow for mixed breathing, where the patient is able to partially breathe naturally while also receiving support from the device. The device may prevent the need for anesthesia and intubation of the patient while providing treatment.

[0065] In another embodiment, the device may also allow for coughing, sneezing, or other natural clearance of the patient's airway by avoiding the need for intubation and mechanical ventilation.

[0066] In some embodiments, the use of the device can eliminate the need for switching between different services. In some embodiments, the use of the device can eliminate the need to change devices during medical transport at home during autonomous use of the device by the patient, between hospitals, or within a department of a hospital or outside a hospital or treatment center, at a point where support is enabled.

[0067] In some embodiments, the device can be used to provide early treatment to military personnel injured in the field. The device can be used to provide treatment at or near the point of injury in the field.

[0068] In some embodiments, the device can be used to provide early treatment to civilian personnel injured in the field during individual trauma or motor vehicle accidents or in mass casualty situations. The device can be used to provide treatment at or near the point of injury in the field or for ambulatory support or use at home.

[0069] In another embodiment, the device can be used to treat chronic lung failure at home or outside a treatment center or hospital by removing CO2 and partial oxygenation.

[0070] In some embodiments, the device can be used to perform long-term wearable multi-organ support through selective organ perfusion or combined perfusion of multiple organs.

[0071] In another embodiment, the device can be used to treat lung failure through CO2 removal and partial oxygenation.

[0072] In another embodiment, the device can treat renal failure while the patient is at home. The device can allow the patient to avoid going to a dialysis center or hospital. The device can perform treatment without the need for direct, continuous supervision by medical staff.

[0073] In another embodiment, the device may include at least one sensor for measuring the oxygenation level of blood in the device. The device may include one or more sensors to measure the flow rate in the device. The device may include one or more sensors to measure the pressure in the device. The device may include one or more sensors to identify bubbles in the device.

[0074] In another embodiment, the pump can be controlled by a processor, such as a programmable logic controller or other suitable controller, which can be easily programmed by the patient or healthcare provider. For example, programming can be done via 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 access the device via a wireless connection. This can provide an easy way for a physician or healthcare provider to monitor the patient and make any necessary adjustments outside of a professional care setting.

[0075] In another embodiment, the pump and / or control system can provide information and / or feedback and / or readings to the patient or healthcare provider via visual signals on a display or by automatically collecting and analyzing medical information to assess, diagnose or predict which patients need to initiate support; which patients need to discontinue support and which patients will benefit from which specific form of support.

[0076] By providing this consistent, on-demand mobile care, the device will eliminate the need to switch between services and change gear. Most importantly, providing a mobile, modular, wearable device for ambulatory extracorporeal support will avoid the need to anesthetize and intubate patients while providing treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0077] 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.

[0078] Figure 1 are photographs of exemplary combined devices consistent with at least one disclosed embodiment.

[0079] Figure 2 is a diagram of components, connections, and fluid flow paths of an exemplary combination device in accordance with at least one disclosed embodiment.

[0080] Figure 3 is a diagram of components, connections, and fluid flow paths of an exemplary combination device in accordance with at least one disclosed embodiment.

[0081] Figure 4 is a diagram of components, connections, and fluid flow paths of an exemplary combination device in accordance with at least one disclosed embodiment.

[0082] Figure 5 is a diagram of components, connections, and fluid flow paths of an exemplary combination device in accordance with at least one disclosed embodiment.

[0083] Figure 6 is a diagram of components, connections, and fluid flow paths of an exemplary combination device in accordance with at least one disclosed embodiment.

[0084] Figure 7 is a diagram of components, connections, and fluid flow paths of an exemplary combination device in accordance with at least one disclosed embodiment.

[0085] The annotations appearing in the drawings are exemplary only and do not limit the claimed invention. DETAILED DESCRIPTION

[0086] Reference will now be made in detail to present embodiments of the present disclosure (exemplary embodiments), examples of which are illustrated in the accompanying drawings.

[0087] Figure 1 An exemplary wearable extracorporeal life support device 20 is shown 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 will apply where other organ support membranes are added to the device. In some embodiments, the wearable extracorporeal life support device 20 can be a vest 20. For example, a double-lumen catheter 22 can be inserted into the patient's body via the right jugular vein (not shown). The catheter 22 can have two holes to allow blood to be discharged from the superior vena cava and the inferior vena cava. One lumen (e.g., lumen 24) can allow deoxygenated blood to be removed from the body, while another lumen (e.g., lumen 26) can allow oxygenated blood to be returned to the body.

[0088] 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.

[0089] The pump 30 can push the blood through one of the lines by means of suction from one of the ports of the double lumen catheter 22. The pump 30 can be fluidly connected to the inlet of the membrane 32. The inlet of the membrane 32 can also be fluidly connected to the catheter 22. The membrane 32 can remove CO2 from the blood. The membrane 32 can also oxygenate the blood. If there is a liquid heater, the design of the membrane 32 can also include a heat exchanger to heat the blood by convection. In some embodiments, the membrane 32 can support a minimum flow rate of 500 ml / min using a 1 / 4 inch tube size and a 15 French (F) catheter, and can also accommodate higher flow rates, such as 1 liter (L) per minute using an 18F catheter; 2L per minute using a 23F catheter to 4 liters per minute using a 32F catheter and all using a 1 / 2 inch tube.

[0090] In another embodiment, the outlet of the lung membrane 32 can return blood to the second lumen of the double lumen catheter 22 (eg, a jugular vein catheter) through a second line and can inject blood into the right atrium.

[0091] In another embodiment, the lung membrane 32 may include an input for a purge gas to remove CO2 and provide oxygenation. In some embodiments, a purge 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. In some embodiments, a purge gas line 34 may input ambient air to the lung membrane 32.

[0092] In another embodiment, the shunt line 36 can be connected to the inlet line, the outlet line in parallel, in series, or in other combinations. The shunt line 36 can direct the side flow of blood from the lung membrane 32 to the inlet of the dialysis membrane 40. The dialysis membrane 40 can remove at least one of metabolites, inflammatory mediators, cytokines, and / or pathogens. This can be accomplished using various commonly established kidney dialysis configurations.

[0093] In another embodiment, the pump 30 can be fluidly connected to the dialyzer 40. The outlet of the dialyzer 40 can return blood to the second lumen of the double lumen catheter 22 through a second line and can infuse the blood into the right atrium.

[0094] Although Figure 1 A pump 30 is shown connected in series to a lung membrane 32 and a dialysis membrane 40, but various other configurations are contemplated, some of which are described in detail in the accompanying drawings. Figures 2 to 7 Shown in.

[0095] 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 or any possible position thereon.

[0096] In some embodiments, device 20 may include a power source 42, such as a battery.

[0097] Figures 2 to 7 is an illustration of various configurations of pump 30, lung membrane 32, and dialysis membrane 40, in accordance with at least some embodiments of the present disclosure. Figures 2 to 7 In the figure, the dotted line represents deoxygenated blood and the solid line represents oxygenated blood.

[0098] Figure 2 A pump 30, a lung membrane 32, and a dialysis membrane 40 are shown in series. Deoxygenated blood enters the catheter 22 and enters a first line leading to the pump 30. 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 ultimately returned to the patient through another line.

[0099] Figure 3 A pump 30 is shown in series with a parallel lung membrane 32 and a dialyzer membrane 40. Deoxygenated blood from the patient may enter the pump 30 and may be pumped in parallel to the lung membrane 32 and the dialyzer membrane 40. Oxygenated blood from the lung membrane 32 may be combined with filtered deoxygenated blood from the dialyzer membrane 40 and returned to the patient in the same line.

[0100] Figure 4A dialysis membrane 40, pump 30, and lung membrane 32 are shown connected in series. Deoxygenated blood from a 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 connection can provide direct control of the flow through the dialysis membrane. In addition, the series connection can simplify the tubing and connections of the system.

[0101] Figure 5 A parallel pump 30 and a dialysis membrane 40 are shown in series with a lung membrane 32. Deoxygenated blood from a patient may enter the parallel pump 30 and the dialysis membrane 40. Then, the filtered blood from the dialysis membrane 40 may 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, if one of the devices is coagulated, the other device may be operated independently or replaced with a different device, and the parallel arrangement may be advantageous. In some embodiments, blood may flow through one system at a time, such as through the dialysis membrane 40 or through the lung membrane 32. Therefore, the parallel connection provides a modular design. In addition, the parallel arrangement may provide a lower fluid pressure in the dialysis membrane 40, which may be beneficial for maintaining blood viability. For example, higher pressures may require turbulence and damage to red blood cells. In some embodiments, lung support may require a higher blood flow rate than the maximum flow rate that the dialysis membrane 40 can support. The parallel connection may allow independent blood flow regulation, and the flow rate through the lung membrane 32 may be high or low as needed, while the flow rate to the dialysis membrane 40 may be independently regulated. For example, blood flow may range from 50 ml / min to 500 ml / min.

[0102] Figure 6 A dialysis membrane 40 is shown in parallel with a pump 30 and a lung membrane 32 in series. Deoxygenated blood from the patient may enter the parallel pump 30 and 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 may be combined with the filtered deoxygenated blood from the dialysis membrane 40 and returned to the patient in the same line.

[0103] Figure 7 A dialysis membrane 40 is shown in parallel with the pump 30 and the lung membrane 32 in series. Deoxygenated blood from the patient can enter the pump 30 and can be pumped to the lung membrane 32. Oxygenated blood can then be returned to the patient and enter the dialysis membrane 40 separately. Filtered blood from the dialysis membrane 40 can be combined with the deoxygenated blood from the patient and then enter the pump 30.

[0104] although Figures 2 to 7Exemplary embodiments of various configurations of pump 30, lung membrane 32, and dialysis membrane 40 are shown, but other configurations not shown are contemplated. In one embodiment, only pump 30 and lung membrane 32 are used for patients who require lung support but not kidney support. In another embodiment, only pump 30 and dialysis membrane 40 are used for patients who require kidney support but not lung support.

[0105] In addition, although illustrative embodiments have been described herein, the scope includes any and all embodiments with equivalent elements, modifications, omissions, combinations (e.g., various aspects of various embodiments), adaptations, or changes based on the present disclosure. The elements in the claims should be interpreted broadly based on the language used in the claims, and are not limited to the examples described in this specification or during the prosecution of this application, which examples should be interpreted as non-exclusive. In addition, the steps of the disclosed method can be modified in any way, including by reordering steps or inserting or deleting steps. Therefore, this specification and embodiments are to be considered as examples only, and the true scope and spirit are indicated by the full scope of the attached claims and their equivalents.

Claims

1. A wearable device for extracorporeal life support of a patient, comprising: catheters, pumps and modular extracorporeal life support components including dialysis membranes or liver or lung membranes; wherein said pump and said modular extracorporeal life support components are configured to be attached to a garment; The pump is fluidly connected in series with the lung membrane of the modular extracorporeal life support component and the catheter; and The dialysis membrane of the modular extracorporeal life support component is fluidly connected in parallel with the lung membrane of the modular extracorporeal life support component.

2. The wearable device according to claim 1, wherein: The modular extracorporeal life support component provides selective perfusion to the patient's head. The wearable device according to claim 1 , further comprising a battery.

4. The wearable device of claim 1, wherein at least a portion of the catheter is inserted into a jugular vein.

5. The wearable device according to claim 4, wherein: At least a portion of the catheter inserted into the jugular vein is advanced into the superior vena cava and the inferior vena cava.

6. The wearable device according to claim 1, wherein: The device automatically collects and analyzes medical information to assess, diagnose and predict which relevant patients require and initiate corresponding support, which relevant patients require and discontinue corresponding support, and which relevant patients require and will benefit from which specific form of support.

7. The wearable device of claim 1 , further comprising at least one online sensor embedded in the device, the online sensor being used to adjust blood flow and purge gas flow in the device to achieve higher or lower CO2 levels in the blood.

8. The wearable device according to claim 1, wherein: The modular extracorporeal life support unit treats chronic lung failure outside of a treatment center by removing CO2 and partially oxygenating the blood.

9. The wearable device according to claim 1, wherein: The modular extracorporeal life support component prolongs the viability of an organ for transplantation.

10. The wearable device according to claim 1, wherein: The wearable device's lung membrane supports blood flow ranging from 500 ml / min to 4 L / min.

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