Although laparoscopic surgery has provided major benefits such as less scarring and quicker recovery, not much has advanced in the field over the past 20 years.
Ernesto Molmenti, MD, PhD, MBA, Northwell Health’s vice chair of surgery, chief of the Division of Surgical Innovation, director of kidney transplantation and professor of surgery, medicine and pediatrics, in collaboration with the Feinstein Institutes for Medical Research, has developed a new device — a surgical/clinical “introducer” — that allows surgeons to safely insert instruments and other devices into the body during interventional procedures.
“We are developing something that will not only revolutionize minimally invasive surgery, it will make minimally invasive surgery even less invasive,” Dr. Molmenti said.
Dr. Molmenti’s introducer was evaluated by independent, external, clinical, technical, regulatory, intellectual property and commercial experts, and has been patented for robotic, laparoscopic and interventional radiology procedures. Northwell Health, which is supporting its development with a $2.5 million investment, is working with Irish-based i360medical to design, develop, project manage and commercialize the introducer to a global strategic acquirer. Northwell and i360medical have been working together for the past several years to develop an innovation ecosystem across both organizations. Internal ideas and unmet needs from the health system’s clinical cohort are evaluated and those with potential proceed to design, development and commercialization.
“We’re engaging the clinicians pretty much on a weekly basis,” said Derek Young, i360medical founder and CEO. “We’ve set up a portal through which Northwell physicians and health care staff can submit ideas in a supportive and confidential manner. We have a proven bespoke innovation process combined with our internal expertise to determine if there is clinical value — technical and commercial.
“We’re very commercially focused with a positive track record in bringing new inventive devices and technologies to the international markets, but at the same time, we’re a real large multidisciplinary clinician network on a global scale. There are large numbers of ideas coming in to our portal — on average, we get about 300 ideas a year coming into the system, which is fantastic to see.”
Richard Mulry, managing director and COO of Northwell Holdings and Ventures, Northwell Health’s commercialization arm, said “It is incredibly gratifying to see the creative work being performed throughout our health system. Its development and advancement toward the market will have a far reaching impact in the delivery of care.”
There are five million laparoscopic procedures performed each year in the US. Although it has left an indelible mark on the field, for years the technique has utilized trocars — pen-shaped instruments inserted with a sharp triangular point that are used to create a hollow tube that permits entry of instruments into the abdomen (or other cavities) during surgery. Using trocars can result in complications, such as intra-abdominal vascular and visceral injuries, bleeding, herniation, postoperative pain and prolonged hospitalizations. Some are life-threatening.
When developing the introducer, Dr. Molmenti questioned whether surgeons could use smaller instruments with no trocars (which would allow for less scars, diminished tissue trauma, quicker surgeries and better outcomes).
“If we could develop surgical instruments that are half the size of the current ones,” he said, “we could introduce them without trocars in the setting of minimal tissue damage. Furthermore, we could place as many instruments as we wish because the scars would be insignificant. Surgeries could become safer, less traumatic and technically more accessible to surgeons in training, who could perform cases that they otherwise may not be able to undertake early in their careers. From an interventional radiology perspective, the introducer could allow for image-guided and sensor-directed placement of devices in a safer, more precise and controlled way.
“Northwell continues to excel to be at the forefront of medical progress and transformation. Dr. Molmenti is taking the lead to foster innovation and represent us,” said Gene Coppa, MD, chair of surgery and senior vice president and executive director of surgical services.
The device could also provide the opportunity to develop a new discipline, where Emergency Department physicians perform minimally invasive procedures such as inserting a camera into a body cavity. Dr. Molmenti calls it “Interventional Emergency Medicine,” and believes it could shift a sizeable number of diagnostic (and possibly therapeutic) procedures from the operating room to the emergency room.
“Being able to diagnose various pathologies without opening the body can serve many purposes and provide invaluable information in emergency room, trauma and intensive care unit patients with uncertain diagnoses,” he said. “The introducer can also benefit emergency response teams and battlefield units as suggested by our consultants at Walter Reed National Medical Center.
“From a medical perspective, the benefits would be monumental. From a financial perspective, the cost savings would be immense.”
Lance Becker, MD, chair of emergency medicine at North Shore University Hospital, Long Island Jewish Medical Center and the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, works closely with Dr. Molmenti and sees the opportunity to develop Interventional Emergency Medicine into a Center of Excellence.
“With the new innovation that Dr. Molmenti has developed, we may treat patients with more accuracy, making life-saving diagnosis of critical illness more quickly, and with less invasiveness so patients can go home faster,” he said. “Imagine if with a simple small puncture, patients could avoid having to go to the operating room unnecessarily, or if serious intra-abdominal bleeding could be more rapidly detected and treated. This could be a real game-changer and colleagues from around the world would want to come to Northwell to learn how to perform these procedures.”
“It is our obligation to serve those in need by defying the current dogmas and developing a new, better and safer standard of care,” said Dr. Molmenti, who has multiple other patents, including one for a device to simplify knot tying in laparoscopic and robotic surgeries. “Let’s have the courage to dream, and the strength to make those dreams come true.”
In addition to his contributions to surgical device innovation, Dr. Molmenti has published more than 250 manuscripts (including in The New England Journal of Medicine and The Lancet); written five textbooks (translated into Chinese, Japanese and Spanish); received multiple clinical and basic science research awards; mentored students, residents and fellows; and founded Northwell’s Division of Transplantation in 2007.
“The Feinstein Institutes for Medical Research are home to medical innovation, as evidenced by Dr. Molmenti’s device,” said Kevin J. Tracey, MD, Feinstein Institutes president and CEO, professor of neurosurgery and molecular medicine at Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, and president of the Elmezzi Graduate School of Molecular Medicine.