Surgical Innovation

Pediatric surgical innovation symposium approaches

This year, there were a record number of entries (91) for the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) competition, which will be held  Oct. 8 at the fourth annual Pediatric Surgical Innovation Symposium, hosted by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. Twelve finalists have been selected to pitch their pediatric medical device innovation, and up to six innovations will be awarded up to $50,000 each, with awards based on presentations given before a panel of expert judges.

The finalists are:

  • PECA Labs, Pittsburgh, Pa. – synthetic vascular conduit for surgical repair of congenital heart defects that’s capable of minimally invasive, controlled expansion to grow with the patient
  • Maternal Life, Palo Alto, Calif. – low-cost closed system that captures and administers colostrum to newborns with zero percent loss
  • Magnamosis, Inc., San Francisco, Calif. – device to provide safer, less invasive repair of the esophagus in newborns with esophageal atresia/tracheoesophageal fistula, a condition requiring surgery that is currently performed by hand
  • JustRight Surgical, Louisville, Colo. – second generation surgical 5mm stapler sized for use with a wider range of pediatric surgical procedures and bringing the benefits of laparoscopy to patients
  • CareTaker Medical, Charlottesville, Va. – disposable, finger cuff for single patient use to continuously and non-invasively monitor neonatal  heart rate without adhesives, electrodes and wires
  • Nebula Industries, Melrose, Mass. – quick release medical tape to prevent neonatal and pediatric skin injuries
  • Lully, San Francisco, Calif. – moisture sensor and Smart Pod monitor, placed under the mattress, that are wirelessly connected to a smartphone app to prevent bedwetting episodes
  • Center for Advanced Sensor Technology, University of Maryland Baltimore County, Baltimore, Md. – low-cost, disposable multifunctional incubator for at-risk, low birth weight babies
  • Multisensor Diagnostics, Baltimore, Md. – non-invasive portable handheld device designed to perform rapid medical assessment of key vitals for pediatric patients
  • May & Meadow, Inc., Redwood City, Calif. – low-cost, mobile medical device for assessing feeding ability in infants at risk for feeding problems
  • PediaStent, Cleveland, Ohio – novel pediatric bioresorbable stent for use in repairing congenital heart lesions
  • Averia Health Solutions, Alexandria, Va. – low-cost concussion screening and management system that uses smartphone technology

“The impressive number of well qualified applications we received from all over the US as well as from other countries speaks to the enthusiasm of Medtech innovators to develop and test devices specifically for children,” said Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., Executive Director of the Sheikh Zayed Institute for Pediatric Surgical Innovation and NCC-PDI. “We are committed to building on this momentum and keeping the conversation going with all who applied and will provide consultation services if needed.”

Read more.

Spinal fusion surgical home helps kids go home sooner

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The first of its kind for pediatric patients, the Children’s National Spinal Fusion Surgical Home implements a newly developed model of care to streamline and optimize the spinal fusion process for adolescent idiopathic scoliosis patients.

Using frameworks of care used in adult models, along with best practices and literature reviews, a multidisciplinary team developed the first Spinal Fusion Surgical Home for pediatric patients. It standardizes the infection-control process, pain-management pathway, and physical-therapy program for patients undergoing spinal fusion.

“This model eliminates variability in the care process and increases the quality of care for pediatric patients,” said Matthew Oetgen, MD, MBA, Chief of Orthopaedic Surgery and Sports Medicine. “It’s just the start—by developing this model specifically for our young patients with adolescent idiopathic scoliosis, we are paving the way for a number of other kids that require different kinds of surgeries.”

Hallmarks of the spinal fusion surgical home
From pre-operative care through recovery, the Spinal Fusion Surgical Home streamlines care with an emphasis on increasing quality outcomes for patients. Children’s National provides an informational website and a single point of contact for scheduling procedures and pre-operative laboratory exams. Before surgery, patients and families attend an evening education class that features presentations from orthopaedic nurse practitioners, physical therapists, and anesthesiologists.

After surgery, a nurse follows up by phone to assess how the patient is handling pain and healing.

Increasing the quality of care
By implementing these standardized protocols, Children’s National has seen a decrease in the average length of stay for spinal fusion patients from about five days to three and a half days. The surgical home also has reduced the transfusion rate from 30 to 12 percent, and patient pain scores have decreased.  “Patients are getting better faster with less pain, and are getting to leave the hospital sooner,” says Karen Thomson, MD.

Children’s National also is creating surgical homes for sickle cell disease patients, who need a variety of different types of surgery, as well as for children who need Nissen fundoplication and heart surgery.

First 3D bioprinted placenta model for study of preeclampsia created

Drs. DeBiasi and du Plessis

Scientists at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National, in partnership with the University of Maryland, are the first to create a 3D bioprinted placenta model and use it to study preeclampsia, a life-threatening pregnancy complication. Bioprinting is the three-dimensional printing of biological tissue and organs through the layering of living cells, with cell function and viability preserved within the printed structure. Because the Institute’s bioprinted placenta model mimics the organ’s complex cellular structure, the model creates unprecedented opportunities to understand and develop new treatments for life-threatening maternal conditions involving the placenta.

Read the full press release. 

Treating injured adolescents at pediatric trauma centers associated with lower mortality

Swanson Russell photo shoot trauma emergency department Brand Photos FY13

As children mature into adolescence, they also transition from being cared for by pediatric healthcare providers to being cared for by health professionals who primarily treat adults. Controversy remains about whether a primarily pediatric or adult treatment location is optimal to meet the needs of injured adolescents. For this reason, the cutoff age for triaging children to pediatric versus adult trauma hospitals varies in different settings. A research team led by Randall S. Burd, MD, PhD, Chief of the Children’s National Health System Division of Trauma and Burn Surgery, found that injured adolescents treated at pediatric trauma centers (PTCs) had a lower mortality rate than injured adolescents treated at adult trauma centers (ATCs) or mixed trauma centers (MTCs), facilities that treat both adults and children, even when controlling for differences in patients.Trauma is a leading cause of death and acquired disability among adolescents. To determine any potential association between the type of trauma center and mortality rates, the research team examined 29,613  records for patients aged 15 to 19 years old drawn from the 2010 National Trauma Data Bank.“Trauma centers dedicated to the treatment of pediatric patients see a different adolescent population than do ATCs and MTCs,” Dr. Burd and colleagues write in an article published June 27 by JAMA Pediatrics. “After controlling for these differences, we observed that adolescent trauma patients have lower overall and in-hospital mortality when treated at PTCs.”

These findings, bolstered by additional research, have the potential to change the approach for triaging injured adolescents, says Dr. Burd, the paper’s senior author. The study findings suggest that commonly used age thresholds of 14 or 15 years might be safely adjusted higher.

Because the data were obtained from a large dataset, making that case will require closer examination – perhaps chart-by-chart analysis for each patient – to tease out nuances that differentiate care adolescents receive at different types of trauma hospitals, Dr. Burd says. “Are there differences in the process of care – or availability of specific resources – that account for the differences in outcome? Or, do the patients treated at each hospital type have differences in their injuries that we have not yet identified?”

Most adolescents (68.9 percent) included in the study were treated at an adult trauma center. In addition to being older, these youths were more likely to be severely injured and more frequently suffered severe injuries to the head, chest, and upper extremities. The most common traumatic injuries seen at adult centers resulted from children being passengers in motor vehicles (32.6 percent). Penetrating injuries from firearms (12 percent) and cutting or piercing (7.1 percent) were more common at adult centers.

Some 1,636 patients (5.5 percent) were treated at a pediatric trauma center, with many being transferred there from another hospital. Adolescents treated at pediatric trauma centers were more likely to be injured by a blunt rather than penetrating mechanism. The most common injuries seen at pediatric centers were injuries from a fall (25.9 percent) or injuries that resulted from being struck (26.1 percent).

“Because adolescents straddle the gap between pediatric and adult medicine, identifying differences in care among PTCs, ATCs, and MTCs will help determine the most appropriate triage strategies or identify practice strategies that can optimize the outcome for patients in this age group,” the authors conclude.

Related resources: Research at a Glance 

Smart Tissue Autonomous Robot

Supervised autonomous in vivo robotic surgery on soft tissues is feasible

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Surgeons and scientists from Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System are the first to demonstrate that supervised, autonomous robotic soft tissue surgery on a live subject (in vivo) in an open surgical setting is feasible and outperforms standard clinical techniques in a dynamic clinical environment.

The study, published May 4, 2016 in Science Translational Medicine, reports the results of soft tissue surgeries conducted on both inanimate porcine tissue and living pigs using proprietary robotic surgical technology, Smart Tissue Autonomous Robot (STAR). This technology removes the surgeon’s hands from the procedure and, instead, utilizes the surgeon as a supervisor, with soft tissue suturing autonomously planned and performed by the STAR robotic system.

Soft tissues are the tissues that connect, support, or surround other structures and organs of the body such as tendons, ligaments, fascia, skin, fibrous tissues, fat, synovial membranes, muscles, nerves, and blood vessels. Currently, more than 44.5 million soft tissue surgeries are performed in the United States each year.

“Our results demonstrate the potential for autonomous robots to improve the efficacy, consistency, functional outcome, and accessibility of surgical techniques,” says Peter C.W. Kim, MD, CM, PhD, Vice President and Associate Surgeon-in-Chief, Sheikh Zayed Institute for Pediatric Surgical Innovation. “The intent of this demonstration is not to replace surgeons, but to expand human capacity and capability through enhanced vision, dexterity, and complementary machine intelligence for improved surgical outcomes.”

While robot-assisted surgery (RAS) has increased in adoption in healthcare settings, the execution of soft tissue surgery has remained entirely manual, largely because unpredictable, elastic, and plastic changes in soft tissues occur during surgery, requiring the surgeon to make constant adjustments.

To overcome this challenge, STAR uses a tracking system that integrates near infrared florescent (NIRF) markers and 3D plenoptic vision, which captures light field information to provide images of a scene in three dimensions. This system enables accurate, uninhibited tracking of tissue motion and change throughout the surgical procedure. This tracking is combined with another STAR innovation, an intelligent algorithm that guides the surgical plan and autonomously makes adjustments to the plan in real time as tissue moves and other changes occur.  The STAR system also employs force sensing, submillimeter positioning, and actuated surgical tools. It has a bedside lightweight robot arm extended with an articulated laparoscopic suturing tool for a combined 8 degrees-of-freedom robot.

“Until now, autonomous robot surgery has been limited to applications with rigid anatomy, such as bone cutting, because they are more predictable,” says Axel Krieger, PhD, technical lead for Smart Tools at Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National. “By using novel tissue tracking and applied force measurement, coupled with suture automation software, our robotic system can detect arbitrary tissue motions in real time and automatically adjust.”

To compare the effectiveness of STAR to other available surgical procedures, the study included two different surgeries performed on inanimate porcine tissue (ex vivo), linear suturing, and an end-to-end intestinal anastomosis, which involves connecting the tubular loops of the intestine. The results of each surgery were compared with the same surgical procedure conducted manually by an experienced surgeon, by laparoscopy, and by RAS with the daVinci Surgical System.

Intestinal anastomosis was the surgical procedure conducted on the living subjects (in vivo) in the study.  The Children’s research team conducted four anastomosis surgeries on living pigs using STAR technology, and all subjects survived with no complications. The study compared these results with the same procedure conducted manually by an experienced surgeon using standard surgical tools.

“We chose the complex task of anastomosis as proof of concept because this soft tissue surgery is performed over one million times in the U.S. annually,” says Dr. Kim.

All surgeries were compared based on the metrics of anastomosis including the consistency of suturing based on average suture spacing, the pressure at which the anastomosis leaked, the number of mistakes that required removing the needle from the tissue, completion time, and lumen reduction, which measures any constriction in the size of the tubular opening.

The comparison showed that supervised autonomous robotic procedures using STAR proved superior to surgery performed by experienced surgeons and RAS techniques, whether on static porcine tissues or on living specimens, in areas such as consistent suture spacing, which helps to promote healing, and in withstanding higher leak pressures, as leakage can be a significant complication from anastomosis surgery. Mistakes requiring needle removal were minimal and lumen reduction for the STAR surgeries was within the acceptable range.

In the comparison using living subjects, the manual control surgery took less time, 8 minutes vs. 35 minutes for the fastest STAR procedure, however researchers noted that the duration of the STAR surgery was comparable to the average for clinical laparoscopic anastomosis, which ranges from 30 minutes to 90 minutes, depending on complexity of the procedure.

Dr. Kim says that since supervised, autonomous robotic surgery for soft tissue procedures has been proven effective, a next step in the development cycle would be further miniaturization of tools and improved sensors to allow for wider use of the STAR system.

He adds that, with the right partner, some or all of the technology can be brought into the clinical space and bedside within the next two years.