Netanya, Israel

Niti Surgical Solutions

www.nitisurgical.com
Netanya, Israel
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Zbar A.P.,Chaim Sheba Medical Center | Nir Y.,Niti Surgical Solutions | Weizman A.,Niti Surgical Solutions | Rabau M.,Proctology Unit | Senagore A.,University of Southern California
Techniques in Coloproctology | Year: 2012

The main serious risks of anastomotic construction in the colon and rectum include dehiscence and stricture formation. There is a resurgence of interest in sutureless anastomoses formed by compression elements since the introduction of shape memory alloy (SMA) systems, which evoke minimal early inflammatory response whilst maintaining anastomotic integrity. Currently, the most commonly used SMA is the nickel-titanium (NiTi) alloy that is highly biocompatible, returning to its predeformed stable (austenite) shape under different mechanical and thermal loads for use in humans. Pre-clinical data for shape memory alloy systems in colorectal anastomoses are limited, but it appears to be safe in porcine and canine models with limited leakage and reduced stricture formation. There does not appear to be any difference in tissue biochemistry of inflammatory markers when compared with conventional stapled techniques, although the few studies available show a markedly reduced early inflammatory response at the anastomotic site with the NiTi device. The majority of the clinical data concerning compression anastomoses are derived from the biofragmentable anastomotic ring device. This device has fallen out of use because of reported leaks, instrumental failure and problems with device expulsion. A novel SMA device, the NiTi anastomotic ring, permits construction of a low rectal anastomosis construction during open or laparoscopic procedures. The preliminary data demonstrate a safety comparable to conventional staple technology. This device also provides the potential of benefit of reduced anastomotic inflammation, because the compression ring results in direct serosato- serosa (or alternatively serosa-to-muscularis propria) apposition without the persistence of residual foreign material. This type of construction could lead to a reduced incidence of early anastomotic leakage and/or the development of anastomotic stenosis. Randomized clinical trials employing a NiTi arm for elective, emergency and high-risk colorectal anastomoses are required to determine its indications and clinical profile as well as to assess whether such technology may selectively obviate the need for proximal diversion in low colorectal anastomoses. © Springer-Verlag 2012.


Kopelman D.,Technion - Israel Institute of Technology | Kopelman Y.,Gastroenterology and Hepatology Institute | Peled D.,Niti Surgical Solutions | Willenz U.,Lahav Research Institute | And 2 more authors.
Surgical Innovation | Year: 2013

Background: There are limited large animal models for the research of novel anastomotic technologies. Subtotal colectomy requires the anastomosis of relatively remote segments of the alimentary tract that are different anatomically, histologically, and pose significant physiological challenge. The quest for a foreign material-free anastomotic line reintroduced nitinol compression anastomosis into clinical use in the last decade. Objective: To evaluate the safety, histological, and physiological parameters of side-to-side ileocolic nitinol compression anastomosis in a newly developed large animal model, mimicking the human subtotal colectomy. Intervention: Resection of the entire spiral colon with an ileocolic side-to-side compression anastomosis in 12 animals, compared to resection of a short ileal segment in 6 animals. All anastomoses were constructed by using a novel nitinol-based compression device. The animals were followed up to 30 days postoperatively and were reoperated and sacrificed. Results: All 12 animals underwent successful subtotal colectomy with side-to-side nitinol compression anastomosis. No signs of abdominal infection were found. The increase in the colectomized animals' bodyweight over the postoperative course was significantly lower and the animals presented with longer periods of diarrhea. The histopathology revealed minimal inflammation and foreign body reaction with good alignment of the bowel wall layers in both groups. The anastomotic line width was shown to be reduced during the healing course of the compression anastomoses. Conclusions: Side-to-side nitinol compression anastomosis is safe and demonstrates favorable functional and histopathological features. The porcine model of subtotal colectomy can be used for further research of novel anastomotic technologies. © The Author(s) 2013.


Weizman A.,Niti Surgical Solutions | Monassevitch L.,Niti Surgical Solutions | Greenberg K.,Niti Surgical Solutions | Millis S.,Niti Surgical Solutions | And 2 more authors.
Journal of Materials Engineering and Performance | Year: 2011

Reconstruction of the digestive system lumen patency (anastomosis creation) after its partial surgical removal is a common and crucial procedure. The conventional anastomosis methods use devices for mechanical suturing which are associated with high failure risk and can lead to major complications. The compression anastomosis as a sutureless method seems to be a promising alternative. However, attempts during the last two centuries have not been completely successful due to the complex character of the tissuehealing process. The specific mechanical behavior of Nitinol alloys was applied to the force element of the compression devices. These devices are becoming more widely adopted in surgery practice. The compression anastomosis device enables the anastomosis of colonic and intestinal tissue based on compression forces exerted by Nitinol leaf springs. By means of changing the strain distribution in the stressed leaves with varying moments of inertia, one can gain full control of the different stages in the force-deflection profile (i.e., linear elastic stage and the force plateau stage). The target of this study is the comparison of different Nitinol leaf geometries and evaluation of the finite elements analysis as a tool for preliminary design of such geometries. The results of this analysis allow us to establish regulation of the spring's mechanical behavior, thus controlling the anastomosis creation in the compression anastomosis device. © ASM International.


Patent
Niti Surgical Solutions | Date: 2011-01-10

A surgical clip assembly which includes a pair of generally linear compression elements for securing tissue between them and for applying to the secured tissue a compression force. The clip assembly has an initial, open position in which the linear compression elements may be positioned about tissue to be secured between them. The assembly also has a final, closed position where the compression elements are substantially parallel to each other, applying a compressive force to the secured tissue. The clip assembly also includes a force means disposed between the pair of compression elements and operative to transmit operational forces between them.


Trademark
Niti Surgical Solutions | Date: 2012-03-22

Pharmaceutical preparations for the treatment of disorders of the gastrointestinal tract; colonic preparations; plasters for medical purposes; sanitary preparations for medical purposes; disinfectants. Suture materials; medical and surgical devices for the evaluation, diagnosis and treatment of disorders of the gastrointestinal tract; rigid and flexible medical endoscopes; trocars; anastomosis devices; endoscopic retrograde cholangiopancreatograpy; suture materials; surgical meshes; ROTH nets and other endoscopic ancillary devices. Medical services; hygienic care for human beings.


Trademark
Niti Surgical Solutions | Date: 2012-03-22

Pharmaceutical preparations for the treatment of disorders of the gastrointestinal tract; colonic preparations; plasters for medical purposes; sanitary preparations for medical purposes; disinfectants. Suture materials; medical and surgical devices for the evaluation, diagnosis and treatment of disorders of the gastrointestinal tract; rigid and flexible medical endoscopes; trocars; anastomosis devices; endoscopic retrograde cholangiopancreatograpy; suture materials; surgical meshes; ROTH nets and other endoscopic ancillary devices. Medical services; hygienic care for human beings.


Trademark
Niti Surgical Solutions | Date: 2012-03-22

Pharmaceutical preparations for the treatment of disorders of the gastrointestinal tract, for diabetes, liver dysfunction, digestive tract dysfunction and obesity; colonic preparations; dietetic substances adapted for medical use, plasters, materials for dressings in the gastrointestinal tract, and bariatric procedures; sanitary preparations for medical purposes; disinfectants. Surgical, medical apparatus and instruments; orthopedic articles; suture materials; medical and surgical devices for the evaluation, diagnosis and treatment of disorders of the gastrointestinal tract, for diabetes, liver dysfunction, digestive tract dysfunction and obesity; endoscopes; trocars; anastomosis; ercps, suture materials, nets, meshes and other ancillary devices. Medical services; hygienic care for human beings, IT services for reimbursement and office management of dysfunctions of the gastrointestinal tract, diabetes, liver, digestive tract and obesity.


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Trademark
Niti Surgical Solutions | Date: 2012-03-22

Pharmaceutical preparations for the treatment of disorders of the gastrointestinal tract; colonic preparations; plasters for medical purposes; sanitary preparations for medical purposes; disinfectants. Suture materials; medical and surgical devices for the evaluation, diagnosis and treatment of disorders of the gastrointestinal tract; rigid and flexible medical endoscopes; trocars; anastomosis devices; endoscopic retrograde cholangiopancreatograpy; suture materials; surgical meshes; ROTH nets and other endoscopic ancillary devices. Medical services; hygienic care for human beings.


Trademark
Niti Surgical Solutions | Date: 2010-04-06

Common metals and their alloys for use in medical and industrial applications; common metals being shape-memory metals and their alloys for use in medical and industrial applications. Surgical apparatus and instruments for use in general surgery, colorectal surgery, bariatric surgery, gastro-intestinal surgery, orthopedic surgery, maxillofacial surgery, pediatric surgery, cardiovascular surgery, gastroenterology and urology; surgical and medical apparatus and instruments for use in dental surgery; surgical and medical apparatus and instruments for use in veterinary surgery; surgical and medical apparatus and instruments comprised primarily of common metals and their alloys for use in surgical procedures, compression anastomosis procedures, intestinal resections and tissue closure; sutures. Manufacturing and processing in the nature of casting, tempering and treating of shape-memory metals and metal alloys for use in medical and industrial applications.


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