Heilbronn, Germany
Heilbronn, Germany

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Cremers B.,Universitatsklinikum des Saarlandes | Link A.,Universitatsklinikum des Saarlandes | Werner C.,Universitatsklinikum des Saarlandes | Gorhan H.,Novalung GmbH | And 5 more authors.
Artificial Organs | Year: 2015

Patients with cardiogenic shock have a very high mortality. Here we report the first use of a percutaneous pulsatile cardiac assist device, based on a diagonal pump synchronized with the heart cycle by means of an electrocardiographic signal in adult pigs. Eight domestic pigs underwent mandatory ventilation. During sinus rhythm, there were no differences between pulsatile and nonpulsatile perfusion with regard to pulmonary artery pressure, pulmonary wedge pressure, central venous pressure, mean arterial pressure (MAP), mean pulse pressure, and mean coronary artery flow (CAF). After 2min of complete cardiac arrest (ventricular fibrillation), circulatory support with the i-cor in venoarterial nonpulsatile extracorporeal membrane oxygenation (ECMO) mode (3L/min) restored systemic circulation, with an increase of MAP to 78.3mmHg and CAF to 5.27mL/min. After changing from ECMO settings to pulsatile mode (3L/min, 75bpm, pulse amplitude range 3500rpm), MAP did not change significantly (75.6mmHg); however, CAF increased to 8.45mL/min. After changing back to nonpulsatile mode, MAP remained stable (83.6mmHg), but CAF decreased to 4.85mL/min. Thereafter, pulsatile cardiac assist was established with a reduced blood flow of 2.5L/min, and the pulse amplitude range was extended to 4500 rpm. Under these conditions, MAP remained stable (71.0mmHg), but CAF significantly increased to 15.2mL/min (P<0.05). Percutaneous cardiac support using a venoarterial cardiac assist device equipped with a novel diagonal pump is able to restore and increase systemic and coronary circulation during ventricular fibrillation. Electrocardiographically triggered synchronized cardiac assist provides an additional increase of coronary artery flow. These promising results are to be confirmed in humans. © 2014 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.1.4-2 | Award Amount: 7.42M | Year: 2012

Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death worldwide. Long-term respiratory support increases the life expectancy and the quality of life of COPD patients and decreases the cost of care. Currently available artificial lungs, such as Novalungs iLA system, fail after ~ one month, mainly due to thrombus formation at the blood/machine interface. The size of current systems restrict patient mobility. We aim to create a wearable bioartificial lung (AmbuLung) for long-term application in an outpatient setting. The goals are to (1) miniaturise the existing iLA system, including the supporting technology and patient monitoring system; (2) cellularise the diffusion membrane with endothelial cells to decrease thrombogenicity and to increase the gas-exchange rate; and (3) evaluate the developed system in pre-clinical and clinical studies. The innovation includes (i) development of a novel alveolo-capillary gas-exchange membrane, functionalised with bioactive molecules and seeded with endothelial cells, ii) miniaturisation of mechanical and electronic device components, and (iii) novel vascular access system. For cellularisation, endothelial cells derived from FDA approved clinical grade human pluripotent stem cells will be used. Cell differentiation, scale-up, seeding, and maintenance will be performed using established automatable and scalable dynamic bioreactor technology. A mathematical model will be developed to predict and refine the function of this complex system in vitro and in vivo. AmbuLung will be evaluated in a pig model, assessing functionality, and non-thrombogenicity. The data will provide information required for potential clinical transfer. If successful, a clinical trial will be carried out on 5 COPD patients after acquisition of necessary regulatory approvals. Evaluation of efficacy of the intervention will be based on multidimensional health status grading.

Novalung Gmbh | Date: 2014-07-28

An arrangement for extracorporeal life support is further developed in such a way that a pump actuating signal produces a wave-like surging and subsiding pump output for a pulsatile flow. The pump is preferably a non-occlusive blood pump, such as a diagonal pump, for example. In a preferred variant of embodiment the control signal is provided by an ECG. This allows the diastolic pressure to be increased in order to improve the oxygen balance of the heart muscle.

Novalung GmbH | Date: 2014-05-08

An oxygenator module for gas exchange between blood and a gas in an extracorporeal lung support system, with several layers of semipermeable, gas-perfusable hollow fibers, wherein the hollow fibers of one of the layers are oriented at an angle of rotation about a central longitudinal axis of the oxygenator module with respect to the hollow fibers of another one of the layers, and with a potting which extends along the central longitudinal axis and in which the hollow fibers are fixed, wherein the potting defines a cavity that extends along the central longitudinal axis and in which the hollow fibers are arranged and which is blood-perfusable in the direction of the central longitudinal axis, wherein the potting has an essentially circular inner sheath surface that limits the cavity radially outward: as well as a method for producing the oxygenator module.

Novalung Gmbh | Date: 2010-02-11

The invention relates to a device (1) for the treatment of a biological fluid, comprising at least three chambers, wherein a first chamber (3), which is provided for receiving the biological fluid, and a second chamber (7), which is provided for receiving a gas, are separated from each other by at least one gas-permeable and liquid-impermeable membrane (9), said membrane (9) being used to transfer gas molecules between the first and second chambers (3, 7), and wherein the first chamber (3) and a third chamber (13) are separated from each other by at least one liquid-permeable membrane (15) which is used to transfer one or more components between the first and third chambers (3, 13). The second chamber (7) is delimited or enclosed by the at least one gas-permeable and liquid-impermeable membrane (9) and is located inside the first chamber (3) or is substantially enclosed by the first chamber (3) such that the biological fluid surrounds the second chamber (7). Similarly, the third chamber (13) is delimited or enclosed by the at least one liquid-permeable membrane (15) and is located inside the first chamber (3) or is substantially enclosed by the first chamber (3) such that the biological fluid surrounds the third chamber (13).

Novalung GmbH | Date: 2014-07-22

The present invention relates to a perfusion cannula for placement of an access, having a cannula wall and a perfusion lumen which is surrounded by the cannula wall and in which a fluid flow can flow through the perfusion cannula, wherein the perfusion cannula furthermore comprises at least one sensor lumen and at least one sensor device, in particular an ECG sensor, which is arranged at least partially in the sensor lumen. As a result, it is possible to provide a particularly reliable perfusion cannula with improved functionality and for reliable handling, in particular in conjunction with an extracorporeal lung support system.

A device with a blood pump, at least two points of access to the abdominal wall and tubes connecting the blood pump and points of access to the abdominal wall, which is known as a peritoneal dialysis system, is equipped with a CO_(2 )removal arrangement, in order to use it tor blood oxygenation and/or CO_(2 )removal.

The invention relates to a medical technology measuring system (1) comprising a measuring device (10) for measuring a characteristic of a fluidin particular, for pressure measurementwherein the measuring device comprises a lead (20) which extends along a central longitudinal axis (M) and is equipped to guide a fluidin particular, bloodinside a longitudinal cavity (24) enclosed by a wall, and a sensor device (30) comprising a sensor (32) which is equipped to measure a characteristic of the fluid guided in the longitudinal cavity, wherein the measuring system (1) has an overmolding (9) which at least partially surrounds the measuring device (10)preferably, both at least the sensor device (30) and also a section of the lead (20). As a result, the measuring device can be fastened and positioned on the lead in a simple and/or reliable, robust manner. The invention further relates to a method for producing such a medical technology measuring system.

Novalung GmbH | Date: 2015-05-15

The invention relates to a medico-technical measuring device (1) for measuring a property of a fluidin particular, for pressure measurementcomprising a line (20) extending along a central longitudinal axis (M) and configured to guide a fluidin particular, bloodwithin a longitudinal cavity (24) delimited by a wall (22), and a sensor unit (30) having a sensor (32), which sensor unit is configured to measure a property of the fluid guided in the longitudinal cavity (24). The line (20) is provided with a radial cavity (26) inserted in the wall (22) in a radial direction, in which the sensor unit (30) is at least partially arranged, and which is integrated in the wall (22) such that the sensor (32) is in communication with the fluid. In this way, a measuring device can be provided that allows simple handlingin particular, in combination with a comparatively precise measurementespecially, pressure measurement. The invention further relates to a method for producing the measuring device, or to a measuring method using the measuring device.

News Article | January 28, 2017
Site: www.techtimes.com

Zika Virus - What You Should Know Doctors in Canada have taken desperate measures in the face of a desperate situation: They removed a young mother’s lungs for six days while she waited for a transplant. The procedure was thought to be a world first - a drastic solution amid the urgent need for a lung transplant. In April last year, 32-year-old Melissa Benoit was rushed to a hospital in Toronto for a severe lung infection, with doctors realizing soon enough that she only had hours to live. She was suffering respiratory failure from a recent case of influenza, getting into a spiral from which “her lungs were not going to recover,” recounted Dr. Niall Ferguson in a media conference. While on temporary life support, Benoit came within an inch of her life. The bacteria in her lungs were largely antibiotic-resistant, sending her into septic shock and lowering her blood pressure dramatically. Her organs also started to shut down. The team of doctors came up with a daring plan to save her, which was to remove both lungs to eliminate the source of infection. Many unintended consequences were anticipated, including her plunging oxygen and blood pressure levels. Ferguson, part of the University Health Network managing the Toronto hospital, shared they proceeded with the difficult discussion despite not having seen any recourse of that kind done before. Dr. Shaf Keshavjee, director of the lung transplant program, was one of the three surgeons who handled Benoit and part of the 13-member team that performed the nine-hour procedure to remove the badly infected lungs. “[W]e could barely pry it out of her chest,” Keshavjee said of each heavy, rock-like lung they extricated. The patient was supported by two machines, namely a Novalung that filled her blood with oxygen while taking carbon dioxide out, and extracorporeal membrane oxygenation for helping the heart pump the blood throughout the body. In about 20 minutes post-lung removal, Benoit’s blood pressure stabilized and she could be left on the pumps that offer the circulation, the surgeon added. In five to six days, donor lungs matched her blood type and size, so they proceeded with the transplant, which turned out to be successful. From there, Benoit began to recover her strength after months spent in the hospital and muscles so spent that she could not even lift her hand, sit up, or stand. She was also left with damaged kidneys but is hoping to recover enough to receive a kidney transplant from her own mother. Benoit said it took her a while to realize everything that happened. “You really come from the brink of death to back living at home,” she shared, saying she is happy and grateful to be finally home. The team’s report was discussed in the Journal of Thoracic and Cardiovascular Surgery. In what appeared as a Christmas miracle, 5-month-old Daniel McCabe from Wisconsin found an organ match in 40 minutes and successfully underwent liver transplant last December. The short wait that Daniel, who suffered biliary atresia, had to go through was quite unusual as the typical waiting period for a liver lasts 86 days for kids and 149 days for adults. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.

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