Breethe Device

Source: Abiomed

UMMC First Hospital in the World to Use the Abiomed Breethe OXY-1 SystemTM for a Patient

A portable, external oxygenation device developed by a physician-scientist and a biomedical engineer from the University of Maryland offers the benefits of extracorporeal mechanical oxygenation (ECMO) and frees up patients to ambulate. Moreover, in December 2020, doctors at the University of Maryland Medical Center were the first in the world to use the device, the Abiomed Breethe OXY-1 SystemTM, in a human. After the patient's care regimen of several weeks of V-V ECMO, the Breethe system facilitated ambulation, and the fulcrum towards recovery tipped shortly thereafter.

The device was borne out of a need observed by Bartley P. Griffith, MD, Thomas E. and Alice Marie Hales Distinguished Professor in Transplant Surgery at the University of Maryland School of Medicine.

"I've witnessed many people firsthand as they've struggled to breathe," says Dr. Griffith. "Shortness of breath is more excruciating than cancer pain or heart failure, and I wanted to do what I could about it."

Partnering with biomedical engineer Zhongjun Jon Wu, PhD, Peter Angelos Distinguished Professor in Entrepreneurial Surgical Sciences at the University of Maryland School of Medicine, and others, Dr. Griffith designed and patented an artificial lung system.1 Comprising of an oxygen concentrator and a carbon dioxide scrubber, the system reduces the bulkiness associated with ECMO machines. The portability of the device allows patients with acute and chronic lung conditions to ambulate while on mechanical oxygenation, advantageous for recovery.

UM Inventors Push Through Setbacks to Make Artificial Lung Capability a Reality

From idea to in-human, the process took nearly two decades and more than $50 million in NIH and private funding. Dr. Griffth and Dr. Wu's original patented design was purchased by industry,2 only to be shelved when a larger business soon acquired the company they had sold the patent to. Wanting their invention to have a chance to benefit patients, the University of Maryland team founded Breethe, Inc., and went back to the drawing board to develop a device with an even better design, one that did not require external oxygen tanks.

The result is a device that uses a novel process separating the gas phases of extracorporeal oxygenation and carbon dioxide removal. Through the use of a dual-lumen catheter, the device removes venous blood from the body through one lumen and returns oxygenated blood through the other, much like an umbilical cord. Once the extracted blood is in the pump oxygenator, it is passed through an oxygen concentrator before moving onto a second stage where carbon dioxide is scrubbed from the blood. Moreover, because the blood is accelerated through the system during a centrifugal force-based process, blood stasis is reduced and clots are prevented. Accordingly, the device does not require patients to take the high levels of anticoagulants that ECMO does.

The pump oxygenator, although durable for more than 30 days, is designed to be disposable and removable from the rest of the system as a single-user device.

Current Use of Breethe at University of Maryland Medical Center

Dr. Griffith says the hospital, which has offered Breethe to at least eight patients in the first two months alone, is currently using the device for patients with acute respiratory distress syndrome (ARDS), including patients with COVID-19 and trauma-related conditions who would ordinarily require mechanical ventilation or ECMO.

While the FDA issued a 510(k) clearance of the device in October 2020 for usage of up to six hours, previous guidance issued in April 2020 permits use of the device for longer periods during the COVID-19 public health emergency.

Potential Other Applications of Breethe

The Abiomed Breethe OXY-1 System also has a strong potential to be advantageous for patients with end-stage chronic lung disease. It is posited that after safety trials, the device could receive clearance for long-term use and become something akin to dialysis, where patients return to the hospital every three or four weeks to have their pump oxygenators replaced.

Breethe also has applications for interventional cardiology, and Dr. Griffith thinks that the device could revolutionize how some procedures are performed in the cath lab. Abiomed, maker of the implantable Impella heart pump that decompresses the left ventricle, sees value in combining Impella with Breethe as an evolved form of ECpella.

Another benefit of the device is its under two-minute startup time, which gives it an advantage over ECMO in coming to the assistance of patients with cardiogenic shock. As such, Dr. Griffith says it could become an "emergent resuscitation machine."

Artificial Lung Capability: The Possible Beginning of a Paradigm Shift

"This device has the potential to be paradigm shifting," says Dr. Griffith. While he and others have previously sought ways to reconfigure ECMO to permit patient ambulation and exercise3,4,5he cites Breethe's place as an "external appliance that patients will accommodate to" as they go about their normal daily lives.

Dr. Griffith anticipates the day, after appropriate safety studies, that patients may be discharged and go home with a Breethe device and, later, when the device becomes small enough to fit into a backpack with the oxygenator worn on a belt loop. He mentions that just as the initial heart pumps were outside the body, the Breethe device contains the seed of the technology that could, perhaps in a generation's time, make it a replacement for transplant with human lungs.

"A lot of people didn't believe we can do this," he adds, "but we've had really strong feedback so far from the patients who have received it at UMMC."

Disclosures: Dr. Griffith helped develop the Breethe technology and currently serves as a paid Abiomed advisory board member.

Related Content

1Wu Z, Griffith B, Wells DN, inventors; University of Maryland, Baltimore, Breethe, Inc., assignees. Artificial lung system and its methods of use. US patent 10,413,655. September 7, 2017.

2Gellman BN, Koert A, Wu Z, Zhang J, Griffith BP, inventors; Thoratec LLC, University of Maryland, Baltimore, assignees. Integrated centrifugal blood pump-oxygenator, an extracorporeal life support system and a method of de-bubbling and priming an extracorporeal life support system. US patent 10,258,729. January 26, 2017.

3JP, Kon ZN, Evans C, Wu Z, Iacono AT, McCormick B, Griffith BP. Ambulatory veno-venous extracorporeal mechanical oxygenation: innovation and pitfalls. J Thorac Cardiovasc Surg. 2011 Oct;142(4)755-61. doi: 10.1016/j.jtcvs.2011.07.029.

4Pasrija C, Mackowick KM, Raithel M, Tran D, et al. Ambulation with femoral arterial cannulation can be safely performed on venoarterial extracorporeal mechanical oxygenation. Ann Thorac Surg. 2019 May;107(5):1389-1394. doi: 10.1016/j.athoracsur.2018.10.048.

5Garcia JP, Iacono A, Kon ZN, Griffith BP. Ambulatory extracorporeal mechanical oxygenation: a new approach for bridge-to-lung transplantation. J Thorac Cardiovasc Surg. 2010 Jun;139(6):e137-9. Doi: 10.1016/j.jtcvs.2009.12.021.