1. The Next Era in GI Surgery BioDynamixTM Anastomosis The Colon Ring USE OF THE ColonRingTM Clinical Training Team

2. 2 ColonRingTM Purse String Notch Plastic Anvil Ring Locking Spring 10 9 11 Detachable Anvil Head Assembly 12 Anvil Shaft 8 Piercing Trocar 7 Operating Knob 5 13 Cutting Trigger Grasping Notch 6 1 Colon RingTM 2 ColonRing™ Housing 3 Applier 4 Cutting Handle

3. Use of the Colon RingTM in Colon Surgery

4. OR Protocol Procedural Limitations: No anastomosis should be placed proximal to the ileocecal valve. At present, there is no piercing ancillary trocar to push through a stapled proximal stump. The ColonRingtm should not be used in anyone with a known allergy to nickel.

5. Surgical Technique

6. Surgical Technique

7. Surgical Technique

8. Surgical Technique

9. Surgical Technique

10. Surgical Technique

11. OR Staff Instructions

12. OR Staff Instructions

13. Colon RingTM Approved Procedures Right Hemicolectomy w/Ileocolic Anastomosis Only if already being done, or if already using circular stapler for anastomosis Leave distal colonic segment open Introduce ring applier through open end Piercing trocar to pass thru colon ~5 cm distal to open bowel end Alternately, pass applier proximally through distal colotomy Anvil in distal ileum (side) Form anastomosis and check visually Close proximal colon with linear stapler or sutures Consider buttressing anastomosis with absorbable sutures Transverse or Segmental Resections w/Colocolonic Anastomosis Rarely done As above, or end-to-end through colotomy

14. Colon RingTM Approved Procedures Left Colectomy/Hemicolectomy w/Colocolonic Anastomosis Will usually require proximal enterotomy for insertion of applier with anvil placed distally, especially for anastomoses above 20-23 cm Sigmoidectomy w/Colorectal Anastomosis Anterior and Low Anterior Resections w/Colorectal Anastomosis Total Colectomy w/Ileorectal Anastomosis Proctocolectomy w/Ileoanal Anastomosis J-Pouch Ileal Colonic Closure of Colostomy w/Colocolonic or Colorectal Anastomosis If anastomosis above 20-23 cm, may require proximal enterotomy Closure of Hartmann Procedure w/Colorectal Anastomosis

15. Bubble Test Precautions Precautions in Bubble Testing When preparing to use a bubble test for verification of intact colorectal anastomosis, it is advisable to assure that there be no trapped extraluminal air under the rectal segment (while instilling warm saline solution) which, if present, could be forced from under the rectum and would appear to be a positive indication of an anastomotic or peri-anastomotic leak when the rectal segment is distended with air. Gently moving the rectum side-to-side or up-and-down may allow for any trapped extraluminal air to escape. Care should be taken not to place tension on the anastomotic area during the post-anastomotic period which might cause serosal tearing due to the rigidity of the compression ring anastomosis.

16. Bubble Test Precautions Precautions in Bubble Testing Sufficient air should be introduced within the rectal vault, while closing off the proximal sigmoid segmentto prevent proximal bowel distention, so that there is a significant pressure gradient sufficient to demonstrate the presence of any anastomotic or peri-anastomotic leak. Methylene blue may be instilled rectally in a further attempt to demonstrate a potential leak if so desired. Although lack of visualizing intra-abdominal methylene blue is not conclusive evidence of the absence of an anastomotic or peri-anastomotic leak, it would certainly suggest integrity of the bowel.

17. Bubble Test Interpretation Interpretation of Bubble Testing Bubbles which are of small to moderate size and flow only for 1-2 seconds and which cannot be demonstrated repeatedly with additional air insufflation are more likely to represent trapped extraluminal air from under the rectum. Bubbles which are extremely small and are contained in a steady stream, especially if they are repeatedly demonstrable, are more likely to represent a tiny leak. Bubbles of small to moderate size which are free-flowing, fairly persistent, and demonstrable on repeated testing may likely indicate a significant leak. By carefully turning the anastomosed bowel while insufflating additional air rectally, it is frequently possible to localize the site of any tiny or significant leak.

18. Treatment of Leaks Treatment of Apparent Anastomotic or Peri-Anastomotic Leaks If, after careful testing and cautious evaluation of any perceived bubbles, it is deemed likely that the bubbles were a result of trapped extraluminal air behind the rectum, nothing further need be done if the surgeon is comfortable with the anastomosis and peri-anastomotic area. If it is deemed likely that a tiny leak might be present (more likely from a "dog-ear" than from the anastomosis), but further testing cannot demonstrate either a localized site of the leak or any prolonged persistenceof that leak, it may be appropriate to do nothing further if the surgeon has confidence in his anastomosis and peri-anastomotic area. A soft silicone drain might be advantageous in this situation.

19. Treatment of Leaks Treatment of Apparent Anastomotic or Peri-Anastomotic Leaks If there appears to be a tiny leak and the involved site appears to involve one or both "dog-ears," it may be sufficient to cautiously suture that site with a 3-0 or 4-0 suture of choice, with or without interposition of fatty tissue, and retest for a persistent leak. If none persists, nothing further need be done other than drainage, if desired. If a persistent leak is present, diversion might be considered. If a significant leak is determined to be present, suture repair, including interposition of fatty tissue, may be consideredif it is felt likely that the leak can be locally controlled. Alternately, reconstruction of the anastomosis or diversion should be considered as deemed appropriate by the surgeon.