The Next Era in GI Surgery BioDynamixTM

AnastomosisThe Colon Ring

Clinical Training Team

HISTORY OFCompression Anastomosis

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

• “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.

Results in—

4

The Velocity of Change

• “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

When change occurs—

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

• 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)

The Perfect Solution for GI Anastomosis

Murphy Button

1891

• 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)

1984

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

1989

• 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

ColonRingTM

Detachable Anvil Head Assembly

Trocar

Operating Knob

ColonRing™ Housing

Cutting Trigger

Cutting Handle

ColonRingTM

Applier

Locking Spring

Purse String Notch

Grasping Notch

Plastic Anvil Ring

Anvil Shaft

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

Nitinol Leaf Spring at 6% Deformation

Nitinol Leaf Spring at 1% Deformation

Steel Leaf Spring at 0.4% Deformation

Work Zone 6%-1%

Nitinol Leaf Spring at 0% Deformation

• When released on tissue, Nitinol leaf springs will follow the unloading plateau curve to compress the tissue.

Implementing Nitinol’s Unique Features

• When cooled & loaded, Nitinol leaf springs are deformed (Flattened).

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

• Leafs within the same ring can tolerate different deformation levels while still exerting almost the same force around the entire ring.

Nitinol Spring Leaf at 6% Deformation (Thick Tissue)

Nitinol Spring Leaf at 3% Deformation (Thin Tissue)

Tissue Thickness

Tissue Thickness

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 Anastomosis Concept

Compression Force

Spikes

Mechanical Force

Biological 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

27 mm ExternalDiameter

18 mm InternalDiameter

Stapled anastomosis reduces lumen

diameter ~10mm

Lumen Size – ColonRingTM vs. Staplers

Ring Discharged

4.5-5.0 mm lip

Lumen Size -- Staplers

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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

Postop 3 Months PO

Compression Anastomosis vs. Staplers

Compression Anastomosis Staplers

1. No puncture of viable bowel wall layers Staplers puncture the viable colonic wall – bleeding and exposure to bowel microbial flora

2. Ring is expelled from the body within 30 days Staples stay in the body for years

3. Anastomotic circumference healing is free of foreign body reaction Healing may be by foreign body reaction

4. Preservation of continuity of bowel wall layers

Staplers hinder the natural structure of the reconnected bowel wall – sustained trauma to the tissue

5. Recovery of the lumen in one month Lumen will lose 10-15% of its size

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.

404%

435

42%15615%

40239%

>25 cm<10 cm 11-15 cm 16-25 cm

Height of AnastomosisIn 1,033 Cases