Sage’s Experience and Creativity Drive the Design and FDA 510(k) Clearance for a Revolutionary Endoluminal Surgical System

Lumendi develops medical devices to enable less invasive endoluminal procedures in the GI tract. Their products shift laparoscopic and open surgical procedures, which are typically performed in an operating room, to flexible endoscopy, which may be performed in an endoscopy suite on an outpatient basis.

Lumendi’s flagship product, the DiLumen Endoluminal Interventional Platform (EIP), is an endoscope accessory consisting of a soft, flexible sheath and two balloons: one proximal to the endoscope’s bending section and the other distal to the endoscope tip. When inflated, the balloons stabilize the area between them, establishing a therapeutic zone, which improves visualization, diagnosis, and endoscopic treatment during endoluminal procedures. Developed through collaboration with the Minimally Invasive Technologies program (MINT) at Weill Cornell Medical Center and NewYork-Presbyterian Hospital, the platform received FDA 510(k) clearance in December, 2016.

In 2015, Lumendi sought to enhance the DiLumen EIP’s capabilities by adding articulating instruments that could be steered and manipulated with flexibility and precise control by a physician using ergonomically designed hand tools. The DiLumen C² EIP would be a unique system designed to improve the endoscopist’s ability to visualize, retract, and dissect polyps in the colon during endoluminal procedures, including Endoscopic Submucosal Dissection (ESD) and Endoscopic Mucosal Resection (EMR).

Having worked with Sage during initial design work at MINT, the Lumendi team recognized Sage’s depth of experience and ability to solve complex engineering problems. As a result, Lumendi engaged Sage to design the DiLumen C² EIP’s articulating endoscopic instruments: a grasper, a monopolar electrosurgical knife, and monopolar electrosurgical scissors.

The DiLumen C² EIP’s articulating endoscopic instruments would be similar in design to hand-held laparoscopic instruments, but they required flexible shafts that could be navigated via 5mm working channels through the long, tortuous path in the colon to reach the cecum, about one meter in. Once there, the end-effectors needed to operate with precise motion control. Operation had to be reliable, consistent, and smooth, with no whipping during rotation. The grasper required ample force to manipulate tissue and maintain proper tension. Sage’s design had to overcome the complex challenges related to load variability and friction these requirements introduced.

At the proximal end, the physician would be operating controls using only their hands, so the ergonomics of the handle design was paramount. Additional challenges involved safely integrating monopolar power delivery into the knife and scissors. Sage’s design had to ensure that components in the internal mechanisms of the instruments were properly isolated from the user's hands, which was challenging given the already complex, space-constrained mechanical architecture and need for easy finger manipulation and hand ergonomics.

To overcome these complex challenges, Sage leveraged their extensive experience designing endoscopic instruments, deep understanding of how to apply loads and manipulate tissues over long distances, acuity in power integration, and ability to design solutions that meet critical safety requirements despite unique constraints.

Sage brainstormed solutions with a focus on meeting the mechanical, ergonomic, and regulatory requirements in the shortest period. They used creative engineering approaches to prototype as quickly as possible and then identified issues and redesigned iteratively. Sage completed Design Verification and Validation testing, enabling Lumendi to submit for and obtain FDA 510(k) clearance.

Sage also provided effective program management services to keep the projects on track, collaborated with Lumendi’s regulatory leadership to ensure compliance, and worked with Lumendi’s manufacturer, Primo Medical, to ensure the design was translated successfully into documentation that would enable successful product manufacturing.

To enable the launch of Lumendi’s DiLumen C² EIP, Sage completed designs for the three articulating instruments:

DiLumen Endolumenal Interventional Grasper (DiLumen I_g)
A sterile, single use, disposable endoscope accessory intended to be used for grasping and manipulating tissue within the digestive tract under direct endoscopic visualization.

DiLumen Endolumenal Interventional Scissors (DiLumen I_s) and
DiLumen Endolumenal Interventional Knife (DiLumen I_k)
Disposable monopolar electrosurgical devices intended to be used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures.

The instruments provide physicians with the reliability, flexibility, and precise control required, despite the challenging path through the colon. Sage was successful at defining a configuration that ensured safety while reconciling the mechanical and ergonomic demands of a hand operated instrument. Additionally, their forethought when developing the cabling subsystem enabled streamlined integration of monopolar energy to the shaft without compromising control, precision, and reliability. Lumendi obtained FDA 510(k) clearance for the DiLumen I_s in 2018 and the DiLumen I_k in 2019.

The collaboration with Lumendi and its manufacturing partners produced a truly innovative advance in flexible endoscopy with the support of Sage’s experienced and knowledgeable product development team. After working together for seven years, Sage and Lumendi continue to partner on future enhancements of the DiLumen C² EIP.