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    • INSTRUCTIONS LAPAROSCOPIC & PERITONEOSCOPIC PLACEMENT OF PERITONEAL DIALYSIS CATHETERS (Division of Janin Group, Inc.) 14 A Stonehill Road Oswego, IL 60543-9400 Copyright© 2007 by Janin Group, Inc. Tel: 630.554-5533 All rights reserved. No part of this publication (including illustrations) may be used or reproduced in any form or by any 800.323.5389 means, or stored in any database or retrieval system, without prior written permission of Janin Group, Inc. Fax: 630.554-5535 U.S. Patent No. DES 370,531 and 6,589,212. Canadian patent #2,390.543, European patents pending. Page 1
    • Introduction While there are a lot of similarities between laparoscopic and peritoneoscopic placement of PD catheters, there are differences. The laparoscopic and the peritoneoscopic instructions are clearly indicated by: The Y-TEC® System of peritoneal dialysis (PD) catheter placement is a well established procedure. Since 1983, over 28 articles and/or studies have repeatedly L = Laparoscopic and consistently shown the superior outcomes and longevity. The System consists primarily of a series of disposable trays or pacs for use by surgeons. There is also an P = Peritoneoscopic optional set of instruments and a disposable pac designed specifically for use by interventional nephrologists. Laparoscopic placement generally means the use of general anesthesia (local anesthesia optional) with one umbilical puncture site for the Catheter Implantation Site Options scope and a second puncture site for the Quill® Catheter Guide through which the catheter is subsequently inserted. Peritoneoscopic placement generally means local anesthesia with a single puncture site for the Quill® Catheter Guide through which the Preferred sites: scope is inserted and later becomes the pathway for the catheter insertion. 1. Left, lateral border of rectus sheath, 2-3 cm below umbilicus. 2. Right, lateral border of rectus sheath, 2-3 cm below umbilicus. Performed either by a surgeon or an interventional nephrologist, the procedure 3. Medial border of rectus sheath, 2-3 cm below umbilicus. is easy, reproduceable, accurate, and cost-effective. The disposable pacs and the optional instruments are illustrated in the back of this booklet. Anatomical landmarks: A. Umbilicus Indications for Use B. Iliac crest If the patient is a suitable candidate for peritoneal dialysis therapy, the Y-TEC® C. Inferior and superior epigastric arteries system can be used to implant a peritoneal dialysis catheter. Note: 1. Sites should be above superior iliac crest. Contraindications for Use 2. Do NOT implant the catheter or place the exit-site at the patient’s Do NOT use any peritoneal catheter if the patient is not a suitable candidate for beltline. peritoneal dialysis therapy. 3. Do NOT implant the catheter or place the exit-site in the patient’s skin folds. Potential Complications Laparoscopic procedures and general anesthesia all have inherent risks associ- ated with their use. All such risks apply to the use of the Y-TEC® instruments and disposables. Refer to qualified, recognized standard medical/surgical texts and/or literature for specific details. Peritoneal dialysis potentially has a number of complications that may occur which generally are not caused by the catheter per se, but which may affect the quality of the therapy. These complications include: • Infections (exit-site and tunnel) • Leakage (initial or latent) • Peritonitis • Fluid flow obstruction (inflow or outflow) • Bowel perforation • Bleeding (subcutaneous or peritoneal) • Sepsis • Ileus • Proximal (exit) cuff erosion • Distal (rectus / deep) cuff erosion Refer to qualified, recognized standard medical texts and/or literature for specific details and therapy. Patient Preparation Qualifications • Implanting a catheter is the first and possibly the most critical part of a life- L P • Patient sedation. support system. Therefore, it needs to be implanted by a qualified, licensed physician or other health care practitioner supervised by and under the direction of such a physician. L • General anesthesia. Sterility P • Attach blood pressure cuff and pulse rate monitors. • Use an aseptic procedure to open the package and to remove the con- tents. L P • Abdominal preparation. • Package contents are designed for one time (single) use only. Do NOT re- • Drape patient and abdomen in standard manner. clean and re-sterilize. • Do NOT use components if package is previously opened, or is crushed, • Insert appropriately-sized introducer for laparoscope in normal manner, cracked, cut, or otherwise damaged. L preferably at the umbilicus. Caution • Insufflate appropriate volume of gas. The medical techniques, procedures, potential complications stated herein do NOT • Insert scope. give full and/or complete coverage or descriptions. Nor are they a substitute for • Optional: Place patient in typical Trendelenburg position. adequate training and sound medical judgment by the physician. Refer to quali- fied, recognized standard medical texts and/or literature for specific details, results, • Examine peritoneal cavity to identify and avoid adhesions and/or omen- complications, and prescription details. tum. P • Anesthetize primary catheter insertion site. Page 2
    • Patient Preparation (continued) Position Checking (continued) L P • Make 3-5 cm long horizontal skin incision. • Perform blunt dissection with hemostats to the anterior surface of the rectus sheath. P • Ask patient to tighten abdominal muscles prior to inserting the Quill ® Catheter Guide Assembly. Figure 3 L P • Examine peritoneum to find best location for catheter (see Figure 4). Figure 1 • Insert Quill® Catheter Guide Assembly at 20o—30o angle toward L P coccyx into the peritoneum (see Figure 1). Position Checking Figure 4 L P • Remove Trocar from Assembly. L • Advance the Quill® Guide Assembly fully into the peritoneum so that the (optional) L • Place cap (from catheter package) on Quill® Guide cannula. P • Advance the scope and Quill® Guide Assembly fully into the peritoneum so that the distal end is pointed to the desired location. • Remove the scope from the cannula. P • Insert Y-TEC® scope into cannula & lock together. • Confirm location of cannula (and scope) within the peritoneum (see Figure 2). • Return patient to normal supine position. L P • Remove tape from Quill® Guide and cannula via a hemostat using a winding motion as if one is winding a clock. Removing the Cannula L • Remove cap from cannula. P • Remove the cannula from the Quill Guide with a slight twisting motion and ® L retraction of the cannula (see Figure 5). Figure 2 P • Remove scope. • Attach air insufflation kit to cannula. • Place patient in typical Trendelenburg position. • Insufflate filtered room air (approximately 700—1200 cc, depending on patient size). (see Figure 3) • Detach air insufflation kit (place thumb or finger on cannula to retain air). • Re-insert scope. Figure 5 Page 3
    • Removing the Cannula (continued) Inserting the Catheter (continued) P • Clamp tab with the Quill perpendicular to the axis of the Quill , near the P • Advance catheter and Cuff Implantor simultaneously 1 cm to both dilate the ® ® ® L L shoulder of the tab. Quill® Guide (and rectus) and advance the cuff into the rectus muscle (see • Insert and dilate the Quill® Guide with the small dilator (goal is to dilate Figure 8). rectus muscle—see Figure 6). • Dilate the rectus muscle with the large dilator. 2 1 Figure 8 Figure 6 Removing Tools L P • Check cuff locations visually or digitally. Inserting the Catheter • Retract the Quill® Guide parallel with the catheter (see Figure 9). L P • Prepare the catheter by soaking it in sterile saline (or water) and squeeze the air out of the cuffs by rotating the submerged cuffs between fingers. • Lubricate the catheter stylette with sterile gel or saline. • Insert the stylette into the catheter. • Lubricate the catheter. • Insert catheter (with stylette) carefully into the Quill® Guide. Be sure to follow the Quill® Guide through the rectus muscle and into the desired location in the peritoneum (see Figure 7). Figure 9 P • Retract Cuff Implantor parallel with the catheter (see Figure 10). ® L • Retract the catheter stylette. • Allow any remaining air to exit. Figure 7 P • Advance catheter through the Quill Guide and off the stylette. Note: Keep ® L the tip of the stylette within the abdomen to help the catheter through the rectus. Make sure the catheter is not doubled on itself, kinked, or twisted. Catheters that are doubled on themselves rarely function. Kinked catheters inhibit fluid flow. Twisted catheters migrate within 48 hours. L • Confirm visually the proper placement of the catheter. L P • Advance catheter until distal cuff reaches rectus sheath (there will be an increase in resistance). Figure 10 • Position Y-TEC® Cuff Implantor® parallel with and over the catheter, be- tween the two cuffs. Page 4
    • Checking Catheter Patency Supplemental Notes L P • Test catheter patency via infusion of 100-500 cc sterile saline or dialysate. If catheter • Supportive dialysis can begin immediately with reduced volumes and the patient in a is functioning well, fluid will flow out in a steady drip if catheter tip is lowered below the supine position. The abdomen should be continuously dry for 8-12 hours per day for primary site. The catheter tip can also be raised approximately 12-15 cm above the the first 7 days. patient’s abdomen and fluid will rise and fall within the catheter tube in conjunction with respiration. • Catheter immobilization is important to allow the fibroblasts to grow into the cuffs L properly and adequately. • Remove scope and introducer. Tunneling the Catheter L P • Lay the catheter on the patient’s abdomen to determine the best exit-site Y-TEC® System Instruments location. That location should be distal, lateral, and below the primary site. The goal is to have a gentle, curved downward-facing exit-site. • Mark a spot as the exit-site about 3-4 cm distal to the distal cuff. P • Anesthetize exit-site location. • Make a stab incision with #11 scalpel blade to full width of blade L P (see Figure 11). 3 Figure 11 4 2 1 • Insert Tunnelor® Tool at the exit-site. 1. FS series Y-TEC® scope 2.2 mm x 150 mm L P • Advance Tunnelor® Tool to primary site. 2. Fiberoptic light guide • Slide end of catheter over tip of Tunnelor® Tool approximately 3-4 cm (see Figure 12). 3. Fiberoptic light source • Retract Tunnelor® Tool and catheter into tunnel and out of exit-site. 4. Sterilization tray • Optional: Create a space within the tunnel for the distal cuff. • Check catheter at primary site and exit-site to ensure it is not twisted or kinked. • Push catheter off Tunnelor® Tool. • Attach catheter connector and cap. Catheter Stylette • Close primary incision site. Titanium Connector 1 2 Figure 12 1. Catheter Stylette (not to scale) L • Close scope incision site. 2. Titanium catheter connector, 2 piece (not to scale) L P • Do not suture the exit-site. • Apply appropriate dressings to the primary site, catheter exit site, and cathe- ter itself. Page 5
    • Y-TEC® disposable procedure pacs for peritoneal dialysis catheters References implantation are sterilized with ethylene oxide. Do not use if package is opened or damaged. Do not re-use or re-sterilize components of pac. Adamson, A. S., et. al. “Endoscopic placement of CAPD catheters: a review of one hundred proce- dures.” Nephrology Dialysis Transplantation. Vol. 7: 1992, 855-857. Y-TEC® Disposable Pac—Interventional Nephrologists (primarily) Ash, Stephen R. “Chronic Peritoneal Dialysis Catheters: Effects of Catheter Design, Materials, and Location.” Seminars in Dialysis. Vol. 3, No. 1: Jan - March 1990, 39-46. • VP-112 suitable for all catheters. Ash, Stephen R. “Peritoneal Access Devices and Placement Techniques.” Dialysis Therapy. Second • U.S.A. (only). Edition. Philadelphia: Hanley & Belfus, Inc., 1993, 23-28. Ash, Stephen R. “Who Should Place Peritoneal Catheters? A Nephrologist’s View.” Nephrology News & Issues. June 1993. Ash, Stephen R., David J. Carr, and Jose A. Diaz-Buxo. “Peritoneal Access Devices Hydraulic Function and Biocompatibility.” Clinical Dialysis, Third Edition. Norwalk, CT: Appelton & Lange, 1995, 295-321. Ash, Stephen R. and John T. Daugirdas. “Peritoneal Access Devices.” Handbook of Dialysis. Second Edition, New York: Little Brown & Co., 1994, 274-300. Ash, Stephen R., Alan E. Handt and Richard Bloch. “Peritoneoscopic Placement of the Tenckhoff Catheter: Further Clinical Experience.” Peritoneal Dialysis Bulletin. Vol. 3, No. 1: 1983, 8-12. Ash, Stephen R. and W. Kirt Nichols. “Placement, repair, and removal of chronic peritoneal catheters.” The Textbook of Peritoneal Dialysis. Dordrecht, the Netherlands: Kluwer Academic Publishers, 1994, 315-334. Ash, S.R., et. al. “Placement of the Tenckhoff Peritoneal Dialysis Catheter Under Peritoneoscopic Visualization.” Dialysis and Transplantation. Vol. 10, No. 5: May 1981, 383-386. Asif, Arif, et. al. “Peritoneal Dialysis Underutilization: The Impact of an Interventional Nephrology Perito- neal Dialysis Access Program.” Seminars in Dialysis. Vol. 16, No. 3: May-June 2003, 266-271. Asif, Arif, et. al. “Peritoneoscopic Placement of Peritoneal Dialysis Catheter & Bowel Perforation: Experi- ence of an Interventional Nephrology Program.” American Journal of Kidney Diseases. Vol. 42, No. 6: December, 2003, 1270-1274. The VP-112 DLX pac contains: (1) Quill® Catheter Guide Assembly, 2.6 mm dia. (1) 3.0 Nylon Suture with Cutting Needle Chadha, I., Mulgaonkar, S., et. al. “Outcome of Laparoscopic Tenckhoff Catheter Insertion (LTCI) (1) Small Dilator, 4.8 mm dia. (2) 4.0 Nylon Suture with Cutting Needle Versus Surgical Tenckhoff Catheter Insertion (STCI): A Prospective Randomized Comparison.” Perito- (1) Large Dilator, 6.4 mm dia. (1) 60 cc Disposable Syringe neal Dialysis International. Vol. 14, Supplement 1: 1994, S88. (1) Tunnelor® Tool (1) 10 cc Disposable Syringe (1) Y-TEC® Cuff Implantor® (2) 18g x 1-1/2” Needles Copley, Brian J., et. al. “Peritoneoscopic Placement of Swan Neck Peritoneal Dialysis Catheters.” (1) Mayo Stand Cover (2) 22g x 1-1/2” Needles Peritoneal Dialysis International. Vol. 16, Supplement 1: 1996. (1) Full Body Fenestrated Drape (2) 25g x 5/8” Needles (2) Incision Utility Drapes (1) 22g x 3-1/2” Needle Crohn, K.R., et. al. “Tenckhoff Insertion in the Acute Dialysis Unit: Safe and Cost Effective.” Peritoneal (1) Scope Drape (1) Scalpel with #11 Blade Dialysis International. Vol. 14, Supplement 1: 1994, S16. (10) 4x4 Radiopaque Sponges (1) Suture Scissors (1) 30 ml Lidocaine, 1%, w/o epinephrine (1) Tissue Forceps Cruz, Cosme and Mark D. Faber. “Peritoneoscopic Implantation of Tenckhoff Catheters for CAPD: (1) 3.0 Vicryl® Suture with Cutting Needle (2) Hemostats (1) 4.0 Vicryl® Suture with Cutting Needle (1) Air Insufflation Set (IA-102) Effect on Catheter Function, Survival and Tunnel Infection.” Contributions to Nephrology. Vol. 89: (1) Instruction Sheet 1991, 35-39. Cruz, C., et. al. “Can the Incidence of Peritoneal Catheter Tunnel Infections be Reduced?” Abstract Program of the American Society of Nephrology. 1987, 98A. Y-TEC® Disposable Pacs—Surgeons (primarily) Doñate, T., et. al. “Peritoneal Catheter (PC) Implantation through Y-TEC System.” Peritoneal Dialysis International. Vol. 13, Supplement 1: 1993, S39. • VP-210 and VP-310 suitable for all catheters. Gadallah, Merit F., et. al. “Peritoneoscopic versus Surgical Placement of Tenckhoff Catheters: A Prospective Study on Outcome.” American Journal of Kidney Diseases, Vol. 33, No. 1: January, 1999, 118-122. Gokal, Ram, Stephen R. Ash, et. al. “Peritoneal Catheters and Exit-Site Practices: Toward Optimum Peritoneal Access.” Peritoneal Dialysis International. Vol. 13, No. 1: 1993, 29-39. Handt, Alan E. and Stephen R. Ash. “Longevity of Tenckhoff Catheters Placed by the Y-TEC Peri- toneoscopic Technique.” Perspectives in Peritoneal Dialysis. Vol. 2, No. 3: September, 1984, 30-33. Hilton, D.D. and R.S. Smith. “Three Years Experience of Laparoscopic Insertion of Catheters for C.A.P.D. Using Y-TEC Needlescope.” Second International Congress on Access Surgery. Maastricht, the Netherlands: Abstract II, November 1990, 20. Hilton, D.D., et. al. “Eight-Year Audit of Surgically and Laparoscopically Placed Peritoneal Dialysis Catheters.” 12th Annual Meeting of the International Society of Blood Purification. Maastricht, the Netherlands: September 1994, 173-174. Kriger, Frank L., et. al. “Use of a Single Delivery System for Peritoneal Dialysis: Results of a Multicen- ter Trial.” Journal of the American Society of Nephrology. Vol. 2, No. 3. September 1991, 364. The VP-210 STD pac (shown) contains: (1) Quill® Catheter Guide Assembly, 2.6 mm dia. Maher, E.R., et. al. “Comparison of two Techniques for Insertion of Tenckhoff Peritoneal Dialysis (1) Small Dilator, 4.8 mm dia. (1) Large Dilator, 6.4 mm dia. Catheters.” Xth International Congress of Nephrology, London, 1987. (1) Tunnelor® Tool (1) Y-TEC® Cuff Implantor® Nahman, N. Stanley, et. al. “Modification of the Percutaneous Approach to Peritoneal Dialysis Catheter (1) Procedure Sheet Placement Under Peritoneoscopic Visualization: Clinical Results in 78 Patients.” Journal of the Ameri- can Society of Nephrology. Vol. 3, No. 1: 1992, 103-107. The VP-310 LTD pac contains: Everything from the VP-210 except Y-TEC® Cuff Implantor®. Pastan, S., et. al. “Prospective Comparison of Peritoneoscopic and Surgical Implantation of CAPD Catheters.” American Society for Artificial Internal Organs. Vol. 20, 1991 Abstracts, 107. Pastan, Stephen, et. al. “Prospective Comparison of Peritoneoscopic and Surgical Implantation of CAPD Catheters.” Trans American Society for Artificial Internal Organs. Vol. XXXVII, 1991, M154- Trademarks M156. Paul R., Vos G.A., et. al. “Needlescope Technique for CAPD Catheter Placement.” Second Interna- “Y®”, “Y-TEC®”, Quill® Catheter Guide Assembly, Tunnelor®, Cuff Implantor®, tional Congress on Access Surgery. Maastricht, the Netherlands: Abstract II, November 1990, 47. Janin Group, Inc., Oswego, IL 60543. Page 6 510-107-03 6/07