NiTi Surgical Solutions, a startup with headquarters in Israel and the U.S, is developing an innovative new way to bring an ease and reliability to intestinal anastomoses. The company has just introduced a new device (see side image), dubbed BowelRing™, at the ongoing American College of Surgeons (ACS) 95th Annual Clinical Congress in Chicago. The company is apparently named for its reliance on nitinol shape memory alloys. NiTi’s first product was the ColonRing™ endoluminal device, pictured below, designed for the creation of end-to-end and end-to-side anastomoses in both open and laparoscopic surgeries, and it has already been approved by the FDA as well as by European regulators. Interestingly, ColonRing’s endoluminal nitinol ring is “naturally” expelled (read: you poop it out) from the body after the circular anastomosis has been achieved.
Here’s how the company describes its technology:
NiTi’s unique line of products utilizes Nitinol-based elements to press together the ends of resected tissue, enabling natural reconnection and healing after removing a section as part of a surgery. The company’s first marketed product launched earlier this year, ColonRing™, provides physicians with a revolutionary reconnection technology for surgeries such as colon cancer surgery, and represents the first of several Nitinol devices NiTi expects to bring to market as part of its innovative platform. The BowelRing with BioDynamix Anastomosis Technology is currently being evaluated for side-to-side anastomosis, most often utilized in small bowel and right colon procedures.
NiTi’s products are based on patented Nitinol (Nickel Titanium), a shape memory metal alloy that can be stretched far beyond the limits of other materials such as steel, yet completely returns to the original shape and mechanical properties. In practice as a BioDynamix™ Anastomosis device, the exclusive Nitinol springs stretch to bring the ring or the clip to an open state. After the ring or the clip is set during colorectal surgery, the process of returning to their original closed position, controlled by the Nitinol springs, begins. The tissue trapped within the ring or the clip is cut off from its blood supply and becomes necrotic. The two pieces of tissue along the outside of the ring or the clip are held in close proximity to allow a naturally prescribed healing process.
The first phase of wound healing – the lag or inflammatory phase – includes the critical task of phagocytosis or “cleaning” the damaged tissue of bacteria and other foreign cell matter. The lag phase is shorter with the NiTi BioDynamix™ Anastomosis technology than with stapling because the extent of tissue trauma is minimal. With NiTi BioDynamix™ Anastomosis, NiTi’s unique and successful implementation of compression anastomosis based on the unique properties of the shape memory alloy Nitinol, healing takes place by fibrous adhesion, without suppuration and formation of granulation tissue. This process is called “healing by first intention.” For patients going through colorectal surgery, it results in re-epithelialization and the full adaptation of the wall layers of anastomosed tissue or, in other words, the full recovery of the natural multi-layer tissue structure.
The ring or the clip releases only after the tissue has moved through the phases of healing and gained its full strength.
Here’s a video that demonstrates the use of the ColonRing™ (CAR™ 27) BioDynamix7trade; Anastomosis device in colorectal surgery:
To learn more, dive into the BioDynamix technology page…
White papers: Advancing BioDynamix Anastomosis Technology ; Institutional Guide to BioDynamix Anastomosis
Company website: NiTi Surgical Solutions…