A Medical Device Daily
NiTi Surgical Solutions (Hollywood, Florida and Chesterfield, Missouri), a surgical device company, reported that the U.S. Patent and Trade Office (USPTO) has issued U.S. Patent No. 7,527,185 covering compression anastomosis ring assembly for use in joining severed organ wall portions of a hollow organ. The patent, which was assigned to NiTi by the inventors of the technology, is the key patent covering the company's novel ColonRing medical device – a revolutionary closure technology for colorectal surgery such as colon cancer surgery. The ColonRing, launched earlier this month in the U.S. is designed to help a patient's body heal naturally, after which it is expelled from the body.
More than 500,000 surgeries involving gastrointestinal tract resection are performed in the U.S. annually, according to the company. ColonRing represents the first major advance in this area in more than 30 years, NiTi noted.
The safety and efficacy of ColonRing (also known as CAR 27) has been established in multiple clinical trials and commercial use in the U.S., Europe and other parts of the world, according to NiTi. The company's line of products utilizes Nitinol-based elements to press together the ends of resected tissue, enabling natural reconnection and healing of the intestine after removing a section as part of a surgery. The company is commercializing a family of FDA-cleared and CE-marked disposable tissue closure devices.
NiTi Surgical Solutions has leveraged the features of Nitinol in the ColonRing technology. In the ColonRing, the Nitinol leaf springs stretch to open the ring for placement in the bowel, and then gradually return to their original closed position, adapting to variations in tissue thickness and accommodating compressed tissue. The Nitinol leaf springs continuously apply constant force range of pressure around the full circumference of the anastomosis. As the compression progresses over several days, the tissue trapped within the ring becomes necrotic, while healthy tissue is generated along the ring's outer perimeter.
In other patent activity:
• Atherotech (Birmingham, Alabama) said it has received a patent on its method to derive and report apolipoprotein B100 (apoB) using the Vertical Auto Profile (VAP) technology. According to the company, the patent recognizes the unique ability of the VAP cholesterol test to accurately report apoB, the next milestone in heart disease risk assessment.
The patent states that Atherotech provides a "system and method that measures the concentration of apoB without requiring a separate apoB specific test." Atherotech added apoB measurement to its VAP test in 2007 and has since reported more than 1 million apoB results. The VAP test is the only single cholesterol test that routinely reports apoB, the company said.
ApoB is a protein found on all atherogenic (bad) lipoproteins present in blood circulation, and elevated apoB values represent increased risk for heart disease. In prospective studies, apoB has been shown to be superior to LDL cholesterol in predicting cardiovascular events and in following the progression of heart disease, according to Atherotech. ApoB is particularly valuable in hypertriglyceridemic and insulin-resistant states where LDL levels would be falsely reassuring and not representative of true atherosclerotic particle burden, the company noted.
People with a family history or an existing condition of diabetes, high blood pressure or heart disease – or who are already taking cholesterol-lowering medication – are candidates for the comprehensive VAP test, according to Atherotech President Mike Mullen.
• Novocell (San Diego), a stem cell engineering company, said it has received U.S. Patent No. 7,534,608 with method claims covering the company's stem cell therapy for the production of functional pancreatic, insulin-producing cells from human embryonic stem cells (hES). Novocell's therapy is being developed as a method for the use of hES cells to replace insulin-producing pancreatic cells that are destroyed in people with diabetes.
The patent claims are supported by landmark research by Novocell demonstrating for the first time that hES cells can be turned into pancreatic cells capable of releasing insulin in response to glucose challenge in mice.