The Next Era in GI Surgery BioDynamixTM<br />Anastomosis<br />The Colon Ring<br />HISTORY OF<br />Compression Anastomosis<br />Clinical Training Team<br />
Routine Anastomotic Techniques—Handsewn vs. Staples<br />Until recently, there were only two routinely used techniques<br />No difference whether sewn in one or two layers<br />Stapling is faster<br />Surgeon preference prevailed<br />Literature supports whichever the surgeon uses<br />
3<br />“Eminence-”…(Instead of Evidence-)…Based Medicine<br />Results in—<br />“Repeating the same mistakes with increasing confidence over an impressive number of years.”<br />O'Donnell M. <br />A sceptic's medical dictionary. London: BMJ Books, 1997.<br />
4<br />The Velocity of Change<br />When change occurs—<br />“The lag between the discovery of more efficacious forms of treatment and their incorporation into routine patient care is unnecessarily long, in the range of about 15 to 20 years.”<br />Institute of Medicine<br />Crossing the Quality Chasm 2001<br />
About Compression Anastomosis<br /><ul><li>Compression anastomosis (CA) device is sutureless and staple-less – there are no punctures through viable colonic tissue.
CA consistently compresses the blood vessels, creating an immediate and virtually complete hemostasis.
CA device requires no foreign bodies (sutures, staples) to remain in the healing zone after 10-14 postoperative days.
The result is full recovery of the natural multi-layer tissue structure and normal lumen size. </li></li></ul><li>Compression Anastomosis Concept<br />The Perfect Solution for GI Anastomosis<br />CA has long been an attractive goal…older than staplers!!!<br /><ul><li>Results in an exceptionally clean seal.
Controlled local ischemia leads to necrosis, triggering a natural healing process.
Device is expelled from the body, resulting in a larger lumen than with a stapled anastomosis.</li></ul>Historical Evolution of Compression Anastomosis (CA)<br /><ul><li>First developed by Denans in 1826
Earliest practical device, the “Murphy Button” dates to 1891
More recent products –</li></ul>Valtrac (BAR) - introduced in 1984<br />AKA-2 ring (Russia)<br />
Murphy Button<br />Two circular metallic rings<br />Scalloped in the shape of a bowl<br />Double purse strings<br />Steel alloy coiled spring<br />Necrosis of compressed tissue<br />Very narrow lumen<br />Frequent extrusion<br />Limited clinical success<br />Stenosis/Stricture - early or late<br />1891<br />
Nitinol’s Basic Properties<br />The Colon Ring™ is manufactured with Nitinol, a biocompatible alloy of nickel and titanium with several unique properties –<br />Shape Memory – Unlike steel, Nitinol fully recovers its shape when heated past a transition temperature.<br />Superelasticity – Nitinol can be stretched far beyond the limits of other metal alloys (~20 times more than steel), while still remaining capable of returning to its original shape.<br />Constancy of Force – When deformed 1% to 6% from its predefined shape, Nitinol applies a consistent force range as it returns to its original shape.<br />(Relaxes in cold and contracts in heat.)<br />
Leaf Work Zone<br />Work Zone 6%-1%<br />Nitinol Leaf Spring at 6% Deformation<br />Nitinol Leaf Spring at 1% Deformation<br />Steel Leaf Spring at 0.4% Deformation<br />Nitinol Leaf Spring at 0% Deformation<br />
Implementing Nitinol’s Unique Features<br /><ul><li>When cooled & loaded, Nitinol leaf springs are deformed (Flattened).</li></ul>When released on tissue, Nitinol leaf springs will follow the unloading plateau curve to compress the tissue.<br />
How the ColonRingTM Works<br />Nitinol Spring Leaf at 6% Deformation<br /> (Thick Tissue)<br />Nitinol Spring Leaf at 1% Deformation<br />(Necrosed Tissue)<br />Nitinol Spring Leaf at 3% Deformation<br /> (Thin Tissue)<br />
Variation of Tissue Thickness within the Colon RingTM<br />Tissue Thickness<br />Tissue Thickness<br />Nitinol Spring Leaf at 3% Deformation (Thin Tissue)<br />Nitinol Spring Leaf at 6% Deformation (Thick Tissue)<br />Leafs within the same ring can tolerate different deformation levels while still exerting almost the same force around the entire ring. <br />
Application of the Colon RingTM<br />The gap between the two ring elements adjusts according to tissue thickness. <br />With greater tissue thickness, a larger gap is obtained (up to maximum).<br />The Nitinol springs adjust the initial gap by compressing the tissue with a predefined force.<br />The Nitinol springs within the ring act along the unloading plateau path (6%-1% of Strain) where a nearly constant force acts on the tissue.<br />The fact that a nearly constant force can be obtained gives the Colon RingTM the ability to control the compression process. <br />As the compression process progresses, the tissue trapped between the rings necroses, while the new anastomosis forms externally, and the gap decreases until "zero" gap occurs. <br />At "zero" gap the ring detaches and is expelled naturally by intestinal peristalsis.<br />
Compression Force<br />Spikes<br />Biological Force<br />Compression Anastomosis Concept<br />Mechanical Force<br /><ul><li>CA has long been an attractive goal…Results in exceptionally clean seal
Controlled local ischemia leads to necrosis, triggering natural healing process
Device is expelled from the body resulting in larger lumen</li></li></ul><li>18 mm Internal<br />Diameter<br />27 mm External<br />Diameter<br />Lumen Size – ColonRingTMvs. Staplers<br />Stapled anastomosis reduces lumen diameter ~10mm<br />4.5-5.0 mm lip<br />Ring Discharged<br />
NiTi ColonRingTM Company Data<br />435<br />Averages represent averages of all data received for a given data point<br />Data collected from over 600 surgeons at 375 sites in North America, Europe and Asia<br />Sites range from major university medical centers to community-based hospitals<br />Patients were 56% female, 44% male<br />Procedures were 7% right hemicolectomy, 48% left hemicolectomy, 45% anterior resection<br />Cases were 50% open and 50% lap<br />Average age – 62.4 (14 to 91)<br />Average BMI – 28.1 (16 to 55)<br />Over 8,000 cases performed worldwide<br />Of the 3,500 AR procedures, more than 450 involved chemo-radiated patients<br />In all 7,641 commercial cases covered in this document, a clinical leak rate of 3.0% (228 cases) was reported.<br />156<br />15%<br />42%<br />40<br />4%<br />402<br />39%<br />>25 cm<br /><10 cm <br />11-15 cm <br />16-25 cm <br />Height of Anastomosis<br />In 1,033 Cases<br />