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A Novel Laparoscopic Device Used For Ureter Identification

Albert Y Huang, MD. Allotrope Medical Inc.

Iatrogenic ureteral injury during minimally invasive surgery is a concern for every physician that operates in the lower abdomen and pelvis. Approximately one million minimally invasive procedures are performed in these parts of the body across the specialties of Ob/Gyn, Colorectal Surgery, General Surgery and Urology, and there is a cumulative incidence of ureteral injury upwards of 10%. With each event resulting in prolonged hospitalization, additional procedures, and even return trips to the operating room, this is a devastating event. Along with these events, there is an average cost of $54,000 per injury resulting in a 5.4 billion dollar annual burden on the health care industry in the US alone.

The two methods currently used to assist in ureter identification and injury prevention are both time consuming and ineffective. Preoperative ureteral stent placement requires coordination with Urology specialists, a separate surgical equipment set-up, and subsequent re-draping of the patient after the stents are placed. Along with extended OR time and added costs to the procedure, stents have not been shown to decrease the incidence of iatrogenic ureteral injuries. The other method of ureter identification involves often time consuming dissection, ureterolysis and implementation of the Kelly reflex in an attempt to generate a contraction of the ureter to assist in identification. This method requires the ureter to be dissected out and pinched with instruments, and both steps inherently risk injury to the very structure that needs to be protected.

Allotrope Medical provides a paradigm shift in how to identify and protect the ureter during minimally invasive cases. With a hand held, single-use, battery powered device, our system uses safe electrical stimulation to reliably generate an easily visible full-length contraction in the ureter to quickly and easily identify the entire length of the ureter. This minimizes the need for extensive dissection, preoperative stent placement, and pinching tissues with instruments that have no haptic feedback in hopes of generating a peristaltic contraction. Our system is extremely tissue specific as well in minimally invasive procedures as skeletal muscles are typically paralyzed in these cases, and leaving only smooth muscle tissue such as the ureter as the only structures able to respond to the electrical stimulation.

We have performed multiple rounds of large animal testing to demonstrate device efficacy. We have refined our device into a stand-alone, handheld device with a single push button used to trigger the brief electrical impulse that serves as the genesis for the visible ureteral peristalsis. As the device fits through standard 5mm ports, and is simple to use, it has been demonstrated to fit seamlessly into the surgeon’s workflow and increase the physician and OR’s efficiency all while having the ability to potentially increase patient safety and improve outcomes. Our device and technology can also be applied and integrated into existing electrosurgical devices and even used in robotic platforms with ease.


Presented at the SAGES 2017 Annual Meeting in Houston, TX.

Abstract ID: 84195

Program Number: ET004

Presentation Session: Emerging Technology Session

Presentation Type: Podium

154

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