KIMBERLY-CLARK* MIC-KEY * J/TJ Laparoscopic Introducer Kit For Use with: MIC-KEY* Low-Profile Jejunal/ Transgastric-Jejunal Feeding Tube Fig 1 Fig 2 Fig 3 Fig 4 Fig 5 Fig 6 Fig 7 Fig 8 Fig 9 Fig 10 Fig 11 Fig 12 Fig 13 Fig 14 Fig 15 Fig 16 Fig 17 Fig 18 Fig 19 Fig 20 0086 Fig 21 Fig 22 * Registered Trademark or Trademark of <strong>Kimberly</strong>-<strong>Clark</strong> Worldwide, Inc. © 2007 KCWW. All Rights Reserved. Distributed in the U.S. by KIMBERLY-CLARK Global Sales, LLC, Roswell, GA 30076 USA • In USA, please call 1-800-KCHELPS • www.kchealthcare.com KIMBERLY-CLARK, Roswell, GA 30076 USA KIMBERLY-CLARK N.V., Belgicastraat 13, 1930 Zaventem, Belgium Sponsored in Australia by KIMBERLY-CLARK Australia Pty Limited; 52 Alfred Street, Milsons Point, NSW 2061 • 1-800-101-021 2
e KIMBERLY-CLARK* MIC-KEY * J/ TJ Laparoscopic Introducer Kit For Use with: MIC-KEY* Low-Profile Jejunal/ Transgastric-Jejunal Feeding Tube Kit Contents: Gastrointestinal Anchor Set with SAF-T-PEXY* T-Fasteners Scalpel Hemostat Dilator Safety Introducer Needle Stoma Measuring Device Seeking Cathether Syringe Directions for Use Intended Use: The KIMBERLY-CLARK* MIC-KEY* J/TJ Laparoscopic Introducer Kit is intended to facilitate primary placement of the KIMBERLY-CLARK* MIC-KEY* Low-Profile Jejunal Feeding Tube and the KIMBERLY-CLARK* MIC-KEY* Low-Profile Transgastric-Jejunal Feeding Tube. It is recommended that this kit be used only with the KIMBERLY-CLARK* MIC-KEY* brand of Jejunal and Transgastric-Jejunal Feeding Tubes. Warning: The SAF-T-PEXY* device contains 3/0 Biosyn® synthetic absorbable suture that in non-clinical studies retained tensile strength to approximately 75% of U.S.P. and E.P. minimum knot strength at 14 days and approximately 40% at 21 days post implantation. Absorption of the suture is essentially complete within 90 to 110 days. The kinetics of gastric wall adhesion to the anterior abdominal wall relative to suture absorption must be considered prior to using the SAF-T-PEXY* device when a compromised healing response is anticipated, especially when fixation of the gastric wall to the anterior abdominal wall is not expected within 14 days. Contraindications: Contraindications include, but are not limited to ascites, colonic interposition, portal hypertension, gastric varices, peritonitis, aspiration pneumonia and morbid obesity (stoma lengths longer than 10 cm). Note: Verify package integrity prior to opening. Do not use if package is damaged or sterile barrier compromised. Warning: Do not reuse, reprocess, or resterilize this medical device. Reuse, reprocessing, or resterilization may 1) adversely affect the known biocompatibility characteristics of the device, 2) compromise the structural integrity of the device, 3) lead to the device not performing as intended, or 4) create a risk of contamination and cause the transmission of infectious diseases resulting in patient injury, illness, or death. Suggested Laparoscopic Placement Procedure 1. Prior to placement procedure precautionary CT scan or ultrasound may be helpful to identify if the left lobe of the liver is over the fundus or body of the stomach. However, anatomy location may change after insufflation of the peritoneum. 2. Place the patient in the supine position. 3. Prep and sedate according to clinical protocol and place a nasogastric or orogastric tube into the stomach. 4. Glucagon may be administered to diminish gastric peristalsis. 5. Make a skin nick inferior to or into the umbilicus and grasp and elevate the fascia. 6. Insert a needle at the incision site into the peritoneal cavity to insufflate the peritoneum. 7. Prior to insufflation place a skin mark over the desired tube placement site and define the gastropexy pattern by placing three skin marks equidistant (2 cm apart) from the tube insertion site and in a triangle configuration. Allow adequate distance between the insertion site and SAF-T-PEXY* placement so as to prevent interference of the anchor set and balloon once inflated. (Fig 1) 8. Once proper peritoneal position is confirmed insufflate the peritoneum through the needle. (Fig 2) 9. Replace the needle with a trocar, insert a laparoscope and perform a diagnostic laparoscopy according to clinical practice. 10. Insufflate the stomach sufficiently to improve gastric access and allow SAF-T-PEXY* needle insertion and T-fastener deployment. 11. Determine the gastrostomy site using finger depression on the abdominal wall and visualization with the laparoscope, taking into account marks placed prior to insufflation. (Fig 3) 12. If the stomach is obscured by other organs insert additional trocars where graspers may enable the stomach to be in view so a feeding tube may be placed. Caution: Maintaining proper stomach insufflation is critical to preventing T-Fastener placement through the posterior gastric wall. Placing the SAF-T-PEXY*: Caution: The suture locks may pose a choking hazard. Use appropriate measures to prevent swallowing by young children or mentally-disabled patients. Caution: Verify package integrity prior to opening. Do not use if package is damaged or sterile barrier is compromised. Caution: The SAF-T-PEXY* needle point is sharp. Note: It is recommended to perform a three-point gastropexy that approximates an equilateral triangle to help ensure secure and uniform attachment of the gastric wall to the anterior abdominal wall. An alternate pattern will need to be identified if placing a low volume balloon gastrostomy tube. 13. Reconfirm the skin marks at the tube insertion site and the gastropexy triangle configuration. 14. Inject the puncture sites with lidocaine and administer local anesthesia to the skin and peritoneum. 15. <strong>Care</strong>fully remove the preloaded SAF-T-PEXY* device from the protective sheath and maintain slight tension on the trailing suture, noting that the suture is held to the needle by a retaining snap on the side of the needle hub. 16. Attach a Luer slip syringe containing 1-2 ml of sterile water or saline to the needle hub. (Fig 4) 17. Under laparoscopic visualization insert the preloaded SAF-T-PEXY* slotted needle with a single sharp thrust through one of the marked corners of the triangle until it is within the gastric lumen. (Fig 5) The simultaneous return of air into the syringe confirms correct Intragastric position. After confirmation of correct position, remove the syringe from the device. 18. Release the suture strand and bend the locking tab on the needle hub. (Fig 6) Firmly push the inner hub into the outer hub until the locking mechanism clicks into place. (Fig 7) This will dislodge the T-Bar from the end of the needle and lock the inner stylet into position. (Fig 8) 19. Withdraw the needle while continuing to gently pull the T-Bar until it is flush against the gastric mucosa. Discard the needle according to facility protocol. 20. Gently slide the suture lock down to the abdominal wall. A small hemostat may be clamped above the suture lock to temporarily hold it in place. 21. Repeat the procedure until all three anchors have been inserted in the corners of the triangle. After the three SAF-T-PEXY* devices are properly positioned, pull on the sutures to approximate the stomach to the anterior abdominal wall. Close the suture lock with the supplied hemostat until an audible “click” is heard securing the suture. Any excess suture may be cut and removed. (Fig 9) Note: For additional suture security, a knot may be tied in the suture strand at the surface of the suture lock. Creating the Stoma Tract: Warning: Take care not to advance the puncture needle too deeply in order to avoid puncturing the posterior gastric wall, pancreas, left kidney, aorta or spleen. Caution: Avoid the epigastric artery that usually courses at the junction of the medial two thirds and lateral one-third of the rectus muscle. Note: The best angle of insertion is a 45-degree angle to the surface of the skin. 22. With the stomach still insufflated and in apposition to the abdominal wall, identify the puncture site at the center of the Gastropexy triangle pattern. With laparoscopic guidance confirm that the site overlies the distal body of the stomach below the costal margin and above the transverse colon. 23. Anesthetize the puncture site (location marked earlier) with local injection of lidocaine down to the peritoneal surface (distance from skin to the anterior gastric wall is usually 1-5 cm). 24. Insert the safety introducer needle into the gastric lumen. (Fig 10) Note: Use laparoscopic visualization to verify correct needle placement. Additionally, to aid in verification, a water-filled syringe may be attached to the needle hub and air aspirated from the gastric lumen. Guidewire Placement: Note: Do not pull up on J-guidewire in the subsequent steps requiring its use as the guidewire could become dislodged. 25. Advance a guidewire through the introducer needle, into the gastric lumen and confirm position. 26. Remove the safety introducer needle (keeping the guidewire in place) and activate the safety collar. (Fig 11) Slide the introducer needle safety collar down the needle shaft while removing the needle to prevent an inadvertent needle stick. (Fig 12-14) Dispose of the needle according to facility protocol. 27. Advance the seeking catheter over the guidewire, into the antrum of the stomach and beyond the ligament of Treitz. 28. Confirm that the seeking catheter and guidewire rests approximately 10 - 15 cm beyond the ligament of Treitz. 29. After confirmation of proper placement, remove the seeking catheter leaving the guidewire in place. Dilation: Caution: Excess lubricant may cause difficulty in gripping the dilator segments. Note: Maintain a 45-degree angle to the skin while dilating so as not to kink the guidewire. 30. Use the #11 safety scalpel blade to create a small skin incision that extends alongside the guidewire, downward through the subcutaneous tissue and the fascia of the abdominal musculature. (Fig 15) After the incision is made, lock the scalpel cover in place and discard according to facility protocol. 31. Apply water-soluble lubricant at incision site. 32. Advance the serial dilator over the guidewire. (Fig 16) Use a firm clockwise / counter clockwise twisting motion while advancing to create a tract into the gastric lumen. 33. While holding the serial dilator stationary, grasp the next dilator sleeve and with gentle pressure and slight clockwise / counter clockwise twisting motion insert the next dilator into the stoma tract. Slide the segment forward until a physical stop is felt. 34. Advance the red color-coded sleeve through the stoma tract and into the stomach. Measuring the Stoma Length: 35. Moisten the tip of the Stoma Measuring Device with water-soluble lubricant. 36. Remove the dilator, leaving the guidewire in place and place on a clean surface. 37. Advance the Stoma Measuring Device over the guidewire, through the stoma tract and into the stomach. DO NOT USE FORCE. (Fig 17) 38. Fill the Luer slip syringe with 5 ml of sterile or distilled water and attach to the balloon port. Depress the syringe plunger and inflate the balloon. Pull the device toward the abdomen until the balloon rests against the inside of the stomach wall. 39. Slide the plastic disc down to the abdomen and record the measurement proximal to the disc. Add an additional 4-5 mm to the measured shaft length to ensure a proper fit post tube placement. Record final measurement. (Fig 18) 40. Remove the water in the balloon and the Stoma Measuring Device leaving the guidewire in place. Resume Dilation: 41. Resume dilation by advancing the dilator over the guidewire, through the stoma tract and into the stomach using firm pressure and a clockwise / counter clockwise twisting motion. (Fig 19) 42. Continue dilation until all dilator sleeves have been advanced. 43. Twist the dilator hub to release the peel-away sheath from the dilator. (Fig 20) 44. Lubricate the exterior of the peel-away sheath with a water-soluble lubricant and advance the sheath through the tract and into the stomach. 45. Remove the dilator, leaving the guidewire and the peel-away sheath in the stomach with the remainder securely maintaining position through the tract and exiting the stoma site. Tube Placement: 46. Select the appropriate KIMBERLY-CLARK* MIC-KEY* Low-Profile Jejunal / Transgastric-Jejunal Feeding Tube while maintaining stomach and stoma tract access via the prepositioned peel-away sheath. Peel the sheath down to skin level. 47. Inspect and prepare the Jejunal / Transgastric-Jejunal tube according to the KIMBERLY-CLARK* MIC-KEY* Low-Profile Jejunal / Transgastric- Jejunal Tube Directions For Use. 48. Insert the introducer cannula provided in the feeding tube packaging into the jejunal port of the feeding tube in order to open the one-way valve. Advance the tube over the guidewire and ensure that the wire passes through the cannula and out of the tube. Continue placing the tube down the peel-away sheath and past the Ligament of Treitz. (Fig 21) 49. After the Jejunal / Transgastric-Jejunal Feeding Tube has been advanced through the peel-away sheath and is in position, peel the sheath away from the tube, remove and dispose of according to facility protocol. 50. Inflate the balloon of the feeding tube to the specified volume in the KIMBERLY-CLARK* MIC-KEY* Low-Profile Jejunal / Transgastric-Jejunal Feeding Tube Directions For Use. (Fig 22) 51. Remove the guidewire from the tube while maintaining distal tube position past the ligament of Treitz. Remove the introducer cannula. 52. Clean the residual fluid or lubricant from the tube and stoma. 53. Complete the placement procedure according to the KIMBERLY-CLARK* MIC-KEY* Low-Profile Jejunal / Transgastric-Jejunal Feeding Tube Directions For Use. 54. Evacuate the air maintained in the stomach and laparoscopically confirm appropriate tube and SAF-T-PEXY* Fastener placement. Laparoscopically confirm that there is no leakage around the internal site. To further confirm that tube placement is secure, radiologic examination may be performed. 55. Deflate the pneumoperitoneum, remove the laparoscope, and close the trocar sites. 56. Upon completion of the procedure, refer to the KIMBERLY-CLARK* MIC-KEY* Low-Profile Jejunal / Transgastric-Jejunal Feeding Tube Directions for Use for specific instructions regarding use of the device. Post Procedure: 57. Inspect the stoma and gastropexy sites daily and assess for signs of infection, including: redness, irritation, edema, swelling, tenderness, warmth, rashes, purulent or gastrointestinal drainage. Assess for any signs of pain, pressure or discomfort. 58. After the assessment, routine care should include cleansing the skin around the stoma site and gastropexy sites with warm water and mild soap, using a circular motion, moving from the tube and external bolsters outward, followed by a thorough rinsing and drying well. The sutures may be absorbed or they may be cut and removed if indicated by the placing physician. After the sutures dissolve (or are cut) the suture locks may be removed and discarded. The internal T-bars will release and pass through GI tract. Note: It is recommended not to cut the sutures prior to ten days post procedure. Biosyn® is a registered trademark of US Surgical Corporation. For more information, please call 1-800-KCHELPS in the United States, or visit our web site at www.kchealthcare.com. For more information about these products, please call 1-800-528-5591 in the United States. Internationally, please call +801-572-6800 Educational Materials: “A Guide to Proper <strong>Care</strong>” and a Stoma Site and Enteral Feeding Tube Troubleshooting Guide is available upon request. Please contact your local representative or Customer <strong>Care</strong>. Single Use Only Sterilized Using Ethylene Oxide Do Not Use If Package Is Damaged Do Not Resterilize Latex-Free Rx Only Attention: Read Instructions 3
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