Vent for Emphysema:A Minimally Invasive Approach to Breathing Easy

Vent for Emphysema: A Minimally Invasive Approach to Breathing Easy

The Emphasys Endobronchial Valve (EBV™) is designed to redirect airflow to healthier lung segments by blocking inhaled air to the diseased portion. Upon exhalation, trapped air is intended to be vented out (as shown in illustration), creating the potential for non-surgical bronchial lung volume reduction. CREDIT: Courtesy of Emphasys Medical, Inc.™

For patients with emphysema, a lung disease typically caused by cigarette smoking, the fundamental act of breathing becomes a battle. Approximately two million Americans are affected by emphysema, and the vast majority are over age 50. Emphysema occurs when damage to the air sacs affects the elasticity of the lungs, trapping air in the lungs and enlarging the chest wall. In lung volume reduction surgery (LVRS), those parts of the lung most affected by emphysema are surgically removed in order to improve the function of the rest of the lung. After LVRS, patients typically experience less shortness of breath and improved quality of life. In a new clinical trial, the Endobronchial Valve for Emphysema Palliation Trial (VENT), physician-scientists at Columbia are investigating the potential benefits of a less invasive approach to lung reduction.

The VENT trial builds upon the findings of the five-year, multi-center National Emphysema Treatment Trial (NETT), published in The New England Journal of Medicine in May 2003. This landmark study was administered by the National Institutes of Health (NIH) in cooperation with the Centers for Medicare and Medicaid Services (CMS) and was spearheaded at Columbia by Mark E. Ginsburg, MD, Assistant Clinical Professor of Surgery at Columbia University College of Physicians & Surgeons and Surgical Director of The LeBuhn Center for Chest Disease and Respiratory Failure at NewYork-Presbyterian Hospital/ Columbia University Medical Center, along with Byron M. Thomashow, MD, Associate Professor of Clinical Medicine at Columbia and Medical Director of The Courtesy of Emphasys Medical, Inc.™ LeBuhn Center for Chest Disease and Respiratory Failure.

The objective of the NETT was to compare the best medical treatments available with LVRS in patients with severe emphysema. The study demonstrated that in select patients, LVRS significantly reduced both shortness of breath and mortality as compared to medical management alone. As a result of the NETT, the CMS approved coverage for bilateral LVRS in designated centers of excellence, such as Columbia.

Dr. Ginsburg and his co-investigator of the VENT trial, Roger A. Maxfield, MD, Associate Clinical Professor of Medicine at Columbia University College of Physicians & Surgeons, are now hoping to dig a bit deeper into LVRS and reveal the benefits of the new minimally invasive approach. "With the VENT study, we're testing if the Emphasys Endobronchial Valve (EBV™) procedure can be performed effectively through an airway. The EBV™ is an implantable device—it's essentially a one-way valve designed to allow trapped air to vent from the isolated lung segment during exhalation while preventing air inflow during inhalation," explains Dr. Ginsburg.

The Emphasys Endobronchial Valve (EBV™) is designed to redirect airflow to healthier lung segments by blocking inhaled air to the diseased portion. Upon exhalation, trapped air is intended to be vented out (as shown in illustration), creating the potential for non-surgical bronchial lung volume reduction.
"Right now lung reduction surgery is done as an open-chest operation, and it has fairly significant morbidity associated with it," he continues. "If we could take away the trauma of the procedure, we would gain a lot in terms of patient outcomes. The minimally invasive procedure could provide a much faster recovery time; the hope is that patients will stay in the hospital for less than 48 hours—versus an average stay of 9-10 days after open lung reduction. It would also be a less costly procedure."

VENT is a multi-center, randomized, prospective clinical trial designed to primarily study the safety and effectiveness of the EBV™ procedure. Of the 20 centers participating in the trial, Columbia is the only center based in the tri-state area. To be eligible for the trial, patients must have severe emphysema, with the worst damage prevalent in the upper lungs. All patients will be required to undergo pulmonary rehabilitation before and after surgery, and patients will be followed for 18 months after randomization.
"If our outcomes prove as promising as I suspect, then this would be another step forward beyond the NETT—and a major advancement for treating patients with severe emphysema," adds Dr. Ginsburg.

For more information about the VENT trial (IRB# AAAA0812), please contact Dr. Ginsburg at 212.305.1158.

An engineered lung worked when implanted into a rat

An engineered lung worked when implanted into a rat.

Ker Than for National Geographic News Published June 2010

For the first time scientists have reconstructed working lungs in the lab and transplanted them into a living animal.

The achievement is a breakthrough in biomedical engineering that could lead to replacement lungs for humans in the near future, experts say.

Currently, the only way to replace diseased lungs in adults is a lung transplant, a high-risk procedure that's vulnerable to tissue rejection.

In a new study, researchers took lungs from a living rat and used detergents to remove lung cells and blood vessels, revealing the organ's underlying matrix.

This lung "skeleton"—made of flexible proteins, sugars, and other chemicals—consists of a branching network that divides more than 20 times into smaller and smaller structures. (See an interactive graphic of lung structure.)

The researchers placed these "decellularized" lungs into a bioreactor, a machine filled with a slurry containing different types of lung cells extracted from rat fetuses.

(Related: "Scientists Grow Lung Cells From Stem Cells.")

Within several days, the fetal cells naturally attached to the lung matrix and formed a functional lung.

"By and large, the correct subsets of cells went to their correct anatomical locations," explained study leader Laura Niklason, a biomedical engineer at Yale University. "It appears that the lung matrix has cues, or 'zip codes,' that tell the cells where to land."

When the team implanted the engineered lungs into an adult rat for short periods of time—between 45 minutes and two hours—the lungs exchanged oxygen and carbon dioxide in the same way as natural lungs.

"Leap Forward"
By using a natural lung matrix, Niklason's team has avoided one of the biggest hurdles of lung-regeneration attempts—finding a suitable "scaffold" for lung cells to attach to.

Because manufacturing techniques cannot yet replicate nature's complex design, attempts to create synthetic scaffolds have been unsuccessful.

Niklason spent several years trying to create a synthetic lung scaffold, but in the end concluded it was too difficult.

"I decided I couldn't do it, and probably nobody else could either," she said.

The new research represents a "real leap forward" in lung regeneration, said Peter Lelkes, a biomedical engineer at Drexel University in Philadelphia.

"People have engineered organs such as bone and cartilage before, but by comparison to the lung, these are all kids' games," added Lelkes, who was not involved with the study.

Stem Cell Hurdle
Niklason estimates it will be about 20 to 25 years before her team's technique can be used in humans.
That's because a few technical and scientific challenges remain.

Chief among these is finding ways of creating stem cells—which can transform into any other type of cell—from patients with lung disease. No techniques currently exist for creating such cells, which would carry no risk of immune rejection.

(Related: "Liposuction Fat Turned Into Stem Cells, Study Says.")

"The stem cell issue," Niklason said, "is really the big fundamental scientific hurdle."

The research is detailed in this week's issue of the journal Science.

Image courtesy Science/AAAS

Artificial Lung Closer to Clinical Trial ?

Artificial Lung Closer to Clinical Trial


Clinical Trials
After nearly a decade at the drawing board, "We are looking at what we consider final design changes," Merz says. Clinical trials may get under way in one to two years. The National Institutes of Health recently granted Bartlett $4.8 million to continue the research.

Early animal studies have been promising. In the latest study, University of Texas researcher Joseph Zwischenberger, MD, tried out the BioLung on sheep whose lungs had been badly burned by inhaling smoke. Six of the eight sheep on the BioLung survived five days, whereas only one of six sheep on an external breathing machine survived that long.

Meanwhile, Bartlett has been testing the waters for future human trials. "What we wanted to do was see what the transplantation centers were thinking," he says. So he sent them a survey.

Thirty-one transplant centers completed the survey -- and those were responsible for 72% of all lung transplants in the United States in 1999. Most said they would like to see the BioLung studied in fewer than 25 animals for 30 days before beginning to test the device on humans. Almost all of them said they would support and participate in a clinical trial.

"The FDA would have the final word," Bartlett says. "This is just a start."

A one-month study on two dozen animals may seem hasty, but the situation is dire. Last year, 1,054 people received lung transplants, but 477 died on the waiting list. As of August this year, 3,797 people were still waiting to be matched to a donor.

Most of the transplant centers that responded to Bartlett's survey said the device should be tested first on people with idiopathic (meaning "of unknown cause") pulmonary fibrosis. Among the sickest of these patients, few survive longer than three months.

see more info at
http://www.webmd.com/lung/features/artificial-lung-closer-to-clinical-trial?page=2

Doctors are currently experimenting with artificial lungs

So just how close are we to being able to create a bionic person?



LUNGS
Doctors are currently experimenting with artificial lungs as a way to give patients waiting for a donated lung an increased chance of survival.

One such device is the BioLung, a machine which is roughly the size of a drinks can that is implanted in the chest. The device is packed with hollow plastic fibres perforated with holes so tiny that only gas molecules can pass through them.

As blood filters through the fibres, carbon dioxide escapes through the holes and is replaced by oxygen from the surrounding air.

Researchers claim it can reproduce 100 per cent of normal lung function. Clinical trials are expected to be under way in the next few years.

BIONIC HAND
Not dissimilar to Will Smith's arm in the film I, Robot, in 2007 there was a bionic revolution close to home when Livingston-based company Touch Bionics introduced the first commercially available bionic hand.

LEG
Earlier this year a biotech company in New Zealand revealed that it had created a pair of robotic legs which had helped a man walk again.

The device is not an implant, but rather a robotic exoskeleton, or Rex - a pair of robotic legs that support and assist a person who usually uses a wheelchair. Users strap themselves in and control their movements using a joystick and control pad.

see more om medical progress and lung

Lung taste receptors may help treat asthma

Lung taste receptors may help treat asthma


London: Human lungs can detect bitter tastes the same way as the tongue can, potentially paving the way to new treatments for asthma.

The team from the University of Maryland School of Medicine, US, found that contrary to what they thought, the airways in the lungs opened in response to a bitter taste.

Senior study author Stephen Liggett said: "I initially thought the bitter-taste receptors in the lungs would prompt a 'fight or flight' response to a noxious inhaleant causing chest tightness and coughing so you would leave the toxic environment, but that's not what we found," reports a newspaper.


"It turns out that the bitter compounds worked the opposite way from what we thought," according to the journal Nature Medicine.

"They all opened the airway more profoundly than any known drug that we have for treatment of asthma or chronic obstructive pulmonary disease."

"This could replace or enhance what is now in use and represents a completely new approach," said Liggett.

The team tested bitter substances on human and mouse airways. Quinine and chloroquinine, normally used to combat malaria, were used as they taste bitter along with the artificial sweetner saccharin, which has a bitter aftertaste.


Liggett said: "Based on our research we think that the best drugs would be chemical modifications of bitter compounds which would be aerosolised and then inhaled into the lungs in an inhaler."

The discovery was made by accident when the team were studying muscle receptors that cause contraction and relaxation in the lungs.

It is thought that the bitter substances affect how calcium controls muscles.

U.S. medical team uses new method to save soldier's life

A breath of life: U.S. medical team uses new method to save soldier's life

Seth Robbins/Stars and Stripes

Dr. Matthias Amann, left, and Dr. Alois Philipp make final preparations for transporting a 22-year-old soldier to the university hospital in Regensburg. Philipp, a perfusionist, helped to develop the ECMO machine, which had been used the previous day to evacuate the soldier after he had been shot in the chest. It was the first time that the innovative and portable heart-lung machine had been used in a combat evacuation.

LANDSTUHL, Germany -- A U.S. team for the first time in a combat evacuation has used an innovative and portable heart-lung machine, saving a 22-year-old soldier wounded in Afghanistan.
The soldier had been shot in the chest, and a bullet had shredded his lungs.
That’s when Dr. (Lt. Col.) Sandra Wanek got the call. The trauma surgeon led this week’s medevac mission out of Afghanistan as part of Landstuhl Regional Medical Center’s Lung Rescue Team, which flies to combat zones to treat servicemembers with the most serious lung injuries and evacuate them to Germany.

Within hours, Wanek and her team were bound for Kandahar.
When they got there Wednesday, they operated on him for five hours and tried several different ventilators, but all of them failed.
“I just could not improve his oxygenation to the point where it was safe to fly,” Wanek said.
After missing an evacuation flight and doing one more hour of surgery, Wanek chose to use the device — known as an extracorporeal membrane oxygenation (ECMO) machine — for the first time.
The machine, developed in Germany, forces the patient’s blood through an artificial membrane that lets oxygen in and takes carbon dioxide out.

 

 “It takes the place of your lungs,” Wanek said Thursday in the intensive care unit at Landstuhl, where the soldier was being treated. “We are removing all the CO2 from his body and giving him all the oxygen he needs. I don’t have to count on his lungs to do anything.”

Without it, she said, the soldier would likely have died.
The flight out of Afghanistan on Wednesday was the first time the machine, not much bigger than a suitcase, was used while transporting a patient out of a combat zone.
“This is the most exciting thing I’ve ever done in the Army,” Wanek said, looking at her unconscious patient. “It’s the most desperate feeling in the world to have someone who is young and whose wounds are survivable and know that I have nothing I can do for him. But now I do. And it’s small enough; it’s transportable; and it’s safe.”

The soldier, whose name was not released, was flown Thursday from Landstuhl to the university hospital in Regensburg, Germany, where the heart-lung machine was first developed and where doctors have particular expertise with it. It’s also where German doctors trained Wanek and her team on how to use the ECMO, before it was brought to Afghanistan. “We trained in July, and this is the first person who needed it,” she said.

Extracorporeal membrane oxygenation was developed in the 1980s as a way to save the lives of premature infants with underdeveloped lungs. Later, doctors began to use the machines on adults with lung failure, most recently with H1N1 influenza patients.

The early machines, however, were too big and heavy — more than 200 pounds — to be used in transit, such as from an accident scene, so a lighter and more compact device was developed.
In 2006, Regensburg doctors started taking the compact machines on rescue flights and ambulances to treat patients with severe lung injuries, such as from gunshot wounds or stabbings, or acute respiratory illness. They have transported about 70 patients hooked up to the machines.
Unlike a ventilator, which pushes air into the lungs, the ECMO machine bypasses the lungs entirely. The machine, which costs about $300,000, has the approval of the U.S. Food and Drug Administration, though it’s not used stateside to treat patients in transit, Wanek said.

The machine connects to blood vessels in two places: the groin and the jugular vein. Wanek recalled how nervous she was in Afghanistan when she had to unclamp the veins and let the soldier’s blood flow through the tubes.

“I had not felt my heart beat that hard in a long time,” she said.
The machine worked even better than she expected, and by the time the team landed at Landstuhl several hours later, the soldier’s condition had started to improve, said Air Force Maj. Clayne Benson, another anesthesiologist on the lung rescue team.

Dr. Alois Philipp — one of the developers of the machine — accompanied the soldier back to the Regensberg hospital. Philipp will care for the soldier until his lung injuries heal and he is healthy enough to return to Landstuhl. When the soldier does return, Wanek hopes to hand the young man a scrapbook of photos so that he can see all that was done to keep him alive.
“He’s a history-making soldier,” she said, “and he doesn’t know it yet.”

By Seth Robbins

Stars and Stripes

Published: October  2010

RePneu Lung Volume Reduction Coil (LVRC) System

PneumRx, Inc. Announces CE Mark Approval For Its RePneu® Lung Volume Reduction Coil (LVRC™) System

(www.pneumrx.com ), a medical device company dedicated to bringing innovation and improvements to the treatment of lung disease, today announced that it has received CE Mark approval for its RePneu Lung Volume Reduction Coil (LVRC) System to treat the later stages of emphysema.

The RePneu LVRC System is a minimally invasive device intended to improve lung function in emphysema patients by brochoscopically implanting Nitinol coils into the lungs to compress damaged tissue (lung volume reduction) and restore elastic recoil to the healthier lung tissue. This treatment offers a minimally invasive alternative to lung volume reduction surgery, and works independently of collateral ventilation.

The CE mark approval enables PneumRx to move forward with commercialization in Europe and other select markets. PneumRx intends to launch its RePneu LVRC System in Europe in the last quarter of 2010. PneumRx plans to continue its ongoing partnership with physicians through training and by offering novel products for the diagnosis and treatment of lung disease.

"We are thrilled to have achieved this important milestone, and look forward to introducing our RePneu LVRC to the European market to help improve the lives of so many people who are suffering from emphysema and have few other viable treatment options," said Erin McGurk, President and CEO of PneumRx, Inc. "We are extremely pleased with the significant improvements in pulmonary function tests, exercise tolerance, and quality of life experienced by our clinical trial patients, and expect to bring these same benefits to a broader population of emphysema patients with the commercialization of the RePneu LVRC System in Europe."

About PneumRx, Inc.
PneumRx, Inc. is a rapidly growing medical device company focused on the development and commercialization of innovative products to treat emphysema using minimally-invasive techniques. It is a privately held company located in Mountain View, California.

SOURCE PneumRx, Inc.