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Combined 14 clinical training--compression anastomosis

Combined 14 clinical training--compression anastomosis






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    Combined 14 clinical training--compression anastomosis Combined 14 clinical training--compression anastomosis Presentation Transcript

    • The Next Era in GI Surgery BioDynamixTM
      The Colon Ring
      Compression Anastomosis
      Clinical Training Team
    • Routine Anastomotic Techniques—Handsewn vs. Staples
      Until recently, there were only two routinely used techniques
      No difference whether sewn in one or two layers
      Stapling is faster
      Surgeon preference prevailed
      Literature supports whichever the surgeon uses
    • 3
      “Eminence-”…(Instead of Evidence-)…Based Medicine
      Results in—
      “Repeating the same mistakes with increasing confidence over an impressive number of years.”
      O'Donnell M.
      A sceptic's medical dictionary. London: BMJ Books, 1997.
    • 4
      The Velocity of Change
      When change occurs—
      “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.”
      Institute of Medicine
      Crossing the Quality Chasm 2001
    • Change Is Hard
    • About Compression Anastomosis
      • 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.
    • Compression Anastomosis Concept
      The Perfect Solution for GI Anastomosis
      CA has long been an attractive goal…older than staplers!!!
      • 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.
      Historical Evolution of Compression Anastomosis (CA)
      • First developed by Denans in 1826
      • Earliest practical device, the “Murphy Button” dates to 1891
      • More recent products –
      Valtrac (BAR) - introduced in 1984
      AKA-2 ring (Russia)
    • Murphy Button
      Two circular metallic rings
      Scalloped in the shape of a bowl
      Double purse strings
      Steel alloy coiled spring
      Necrosis of compressed tissue
      Very narrow lumen
      Frequent extrusion
      Limited clinical success
      Stenosis/Stricture - early or late
    • Valtrac Biofragmentable Ring (BAR)
      Biofragmentable Anastomotic Ring
      • Two rings (absorbable)
      • 87.5% polyglycolic acid
      • 12.5% barium sulfate
      • No springs
      • Double purse string
      • Snapped shut (clamp)
      • Four sizes—25, 28, 31, 34
      • 1.5-2.5 mm gap
      • ID size 11-20 mm
      • Passed transanal in 2-3 wks
      • Often incomplete absorption
      • Decent results
      • Difficult to use
    • AKA-2
      • Three sizes
      • Plastic anvil ring w/metal screw
      • Transanal applier w/
      • Double plastic rings
      • Multiple spikes
      • 6 blunt pins
      • 18 fish-hook pins
      • Coiled steel alloy springs
      • Double purse string
      • No consistent compression
      • Necrosis of incorporated tissue
      • Passed out with stool
      • Used primarily in Germany
    • Detachable Anvil Head Assembly
      Operating Knob
      Cutting Trigger
      Cutting Handle
      Purse String Notch
      Plastic Anvil Ring
      Locking Spring
      Anvil Shaft
      Grasping Notch
    • Nitinol’s Basic Properties
      The Colon Ring™ is manufactured with Nitinol, a biocompatible alloy of nickel and titanium with several unique properties –
      Shape Memory – Unlike steel, Nitinol fully recovers its shape when heated past a transition temperature.
      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.
      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.
      (Relaxes in cold and contracts in heat.)
    • Leaf Work Zone
      Work Zone 6%-1%
      Nitinol Leaf Spring at 6% Deformation
      Nitinol Leaf Spring at 1% Deformation
      Steel Leaf Spring at 0.4% Deformation
      Nitinol Leaf Spring at 0% Deformation
    • Implementing Nitinol’s Unique Features
      • When cooled & loaded, Nitinol leaf springs are deformed (Flattened).
      When released on tissue, Nitinol leaf springs will follow the unloading plateau curve to compress the tissue.
    • Nitinol’s Constancy of Stress (Force)
    • How the ColonRingTM Works
      Nitinol Spring Leaf at 6% Deformation
      (Thick Tissue)
      Nitinol Spring Leaf at 1% Deformation
      (Necrosed Tissue)
      Nitinol Spring Leaf at 3% Deformation
      (Thin Tissue)
    • Variation of Tissue Thickness within the Colon RingTM
      Tissue Thickness
      Tissue Thickness
      Nitinol Spring Leaf at 3% Deformation (Thin Tissue)
      Nitinol Spring Leaf at 6% Deformation (Thick Tissue)
      Leafs within the same ring can tolerate different deformation levels while still exerting almost the same force around the entire ring.
    • Application of the Colon RingTM
      The gap between the two ring elements adjusts according to tissue thickness.
      With greater tissue thickness, a larger gap is obtained (up to maximum).
      The Nitinol springs adjust the initial gap by compressing the tissue with a predefined force.
      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.
      The fact that a nearly constant force can be obtained gives the Colon RingTM the ability to control the compression process.
      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.
      At "zero" gap the ring detaches and is expelled naturally by intestinal peristalsis.
    • Compression Force
      Biological Force
      Compression Anastomosis Concept
      Mechanical Force
      • 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
    • 18 mm Internal
      27 mm External
      Lumen Size – ColonRingTMvs. Staplers
      Stapled anastomosis reduces lumen diameter ~10mm
      4.5-5.0 mm lip
      Ring Discharged
    • Lumen Size -- Staplers
    • Colon Ring™ Ease of Use
      • Colon Ring™ placement device is similar to common circular staplers, minimizing the surgeon’s learning time.
      • Compact anvil design allows for easy removal after ring is placed.
      • No anvil head is dragged through a fresh anastomosis.
      • The majority of surgeons rate it very easy to use.
    • Why Change?
    • Lawn Care Preference?
    • Landscape Preference?
    • Surgeon (and/or Patient) Preference? (at 3 Months)
      EEA Stapler w/Strictured Anastomosis
      ColonRingtm w/Almost Seamless Anastomosis
    • Surgeon Preference?
      Tissue Structure at 3 Weeks
    • ColonRing™ Anastomosis Appearance
      3 Months PO
    • Compression Anastomosis vs. Staplers
    • NiTi ColonRingTM Company Data
      Averages represent averages of all data received for a given data point
      Data collected from over 600 surgeons at 375 sites in North America, Europe and Asia
      Sites range from major university medical centers to community-based hospitals
      Patients were 56% female, 44% male
      Procedures were 7% right hemicolectomy, 48% left hemicolectomy, 45% anterior resection
      Cases were 50% open and 50% lap
      Average age – 62.4 (14 to 91)
      Average BMI – 28.1 (16 to 55)
      Over 8,000 cases performed worldwide
      Of the 3,500 AR procedures, more than 450 involved chemo-radiated patients
      In all 7,641 commercial cases covered in this document, a clinical leak rate of 3.0% (228 cases) was reported.
      >25 cm
      <10 cm
      11-15 cm
      16-25 cm
      Height of Anastomosis
      In 1,033 Cases