Pleural Effusion Shunt with External Pump Chamber Catalog No. 42-9005 Instructions for Use Denver Biomedical, Inc.
Table of Contents Description 2 Indications 2 Contraindications 2 Warnings 4 Cautions 4 Sterility 5 Operative Procedure 5 Patient Preparation 5 Priming the Shunt and Confirming Shunt Patency 6 Pleural Catheter Placement 6 Peritoneal Catheter Placement 8 Closing Procedure 10 Post-Operative Management 10 Removal of the Shunt 11 Testing Shunt Function 12 Ordering Information 12 Instructions for Use 1
DESCRIPTION The Denver Pleural Effusion Shunt with External Pump Chamber consists of a fenestrated pleural catheter, a flexible pump chamber containing two miter valves and a fenestrated peritoneal catheter (Figure 1). Each catheter has a polyester cuff located approximately 15 cm from the pump chamber and approximately 7 cm from the closest fenestration. The cuffs are designed to permit tissue ingrowth into the cuff material. This permits the pump chamber to be located outside the patient. The valved pump chamber is designed to be manually pumped by the patient or a caregiver to transfer the fluid in the pleural space into the peritoneal cavity. The second valve serves as a check that helps prevent reflux of liquid into the peritoneal catheter when the shunt is pumped. The shunt is constructed of medical grade silicone rubber, with the exception of the cuffs, which are polyester. No connections at surgery are required; however, both of the catheters may be shortened for optimal positioning in the patient. An integral barium sulfate stripe in the catheter walls permits visualization by x-ray or fluoroscopy to confirm proper positioning. INDICATIONS The Denver Pleural Effusion Shunt with External Pump Chamber is indicated for adult, pediatric, and neonatal patients with: * Chylothorax * Intractable Pleural Effusion CAUTION: Benefits of instituting pleuro-peritoneal shunting in patients with malignant pleural effusion should be weighed against the potential hazards of dissemination of pleural fluid containing malignant cells. CONTRAINDICATIONS The Denver Pleural Effusion Shunt with External Pump Chamber is not designed for pleuro-venous shunting. Pleuro-peritoneal shunting is contraindicated in patients with an infected pleural space, septic pleural fluid, and patients with, or suspected of having intra-abdominal infections such as diverticulitis. 2 Denver P.E.S. with External Pump Chamber
Peritoneal Catheter 15.5 Fr. 5.08 mm O.D. 2.67 mm I.D. Length: 60 cm 7 cm Polyester Cuff 0.75 1.0 cm 15 cm 2nd One Way Valve 1st One Way Valve Flow Pump Chamber 15 cm Polyester Cuff 0.75 1.0 cm Pleural Catheter 15.5 Fr. 5.08 mm O.D. 2.67 mm I.D. Length: 60 cm 7 cm Figure 1: Dimensions for the Denver Pleural Effusion Shunt Instructions for Use 3
WARNINGS Never inject directly into the tubing portion of the shunt, as leakage or tearing of the catheter may occur. Particulate matter may cause shunt occlusion, necessitating replacement of the shunt. (See Testing Shunt Function on page 12). CAUTIONS Federal (U.S.A.) law restricts this device to use by or on the order of a physician. Use sterile technique in all phases of the use of this product. Benefits of instituting pleuro-peritoneal shunting in patients with neoplastic fluid should be weighed against the potential hazards of dissemination of pleural fluid containing malignant cells. Exercise extreme care to prevent the shunt from coming in contact with bare fingers, towels, drapes, talc, or any linty or granular surfaces. (Silicone rubber is highly electrostatic and, as a result, attracts airborne particles and surface contaminants that could produce tissue reaction). Confirm shunt patency prior to insertion. Prime the shunt prior to insertion to eliminate large air bubbles from the chamber and catheters. Use rubber shod instruments when handling the shunt. Possible cuts or tears can occur if rubber shod instruments are not used Exercise care when placing ligatures to avoid cutting or occluding the catheters. Do not use stainless steel ligatures.. Potential complications of pleural effusion shunt implantation and use include, but may not be limited to, the following: pneumothorax, laceration of lung or liver, wound infection, infection in the pleural space or peritoneal cavity, empyema, or subcutaneous tumor growth around the track of the shunt. The patient or caregiver must be willing to pump the shunt on a regular basis (typically several minutes, three or four times a day). Without pumping, the shunt will not relieve symptoms of the pleural effusion. The shunt can become occluded by proteins or cellular debris. If occlusion occurs, the shunt must be partially or totally replaced to restore function. 4 Denver P.E.S. with External Pump Chamber
STERILITY This product has been sterilized by ethylene oxide. It is for single use only; do not resterilize. Denver Biomedical, Inc., will not be responsible for any product that is resterilized, nor accept for credit or exchange any product that has been opened but not used. As long as the individual package is not opened or damaged, the product is sterile. If the package is damaged, do not use the product. To help prevent damage to sterile packaging, it is recommended that products be stored in the product box. OPERATIVE PROCEDURE Proper medical and surgical procedures are the responsibility of the physician. The appropriateness of any procedure must be based upon the needs of the patient. PATIENT PREPARATION 1. It may be helpful in young patients with chylothorax secondary to congenital heart surgery to clamp any chest tube which is being used to drain the pleural fluid. Clamping the chest tube for 12 to 24 hours prior to shunt placement will allow pleural fluid to accumulate. 2. Raise the affected hemithorax slightly, approximately 25-30 degrees. 3. Prep and drape the patient s chest and abdomen. 4. Carefully assess the location for the chest and abdominal incisions, keeping in mind that both the pleural and peritoneal catheters must be tunneled a short distance to allow the polyester cuffs to lie in the subcutaneous tissue. CAUTION: Exercise extreme care to prevent the shunt from coming in contact with bare fingers, towels, drapes, talc, or any linty or granular surfaces. (Silicone rubber is highly electrostatic and, as a result, attracts airborne particles and surface contaminants that could produce tissue reaction). Instructions for Use 5
PRIMING THE SHUNT AND CONFIRMING SHUNT PATENCY CAUTION: Confirm shunt patency prior to insertion. Prime the shunt prior to insertion to eliminate large air bubbles from the chamber and catheters. CAUTION: Use sterile technique in all phases of the use of this product. 1. Immerse the entire shunt in sterile saline. Compress the pump chamber repeatedly until the shunt is filled with fluid. 2. Expel air bubbles by elevating the peritoneal end of the shunt and alternately tapping and compressing the pump chamber while the pleural catheter remains immersed in the saline. Continue to pump the shunt until all large air bubbles have been eliminated. PLEURAL CATHETER PLACEMENT 1. Make a short transverse incision over the lower chest (7th or 8th intercostal space), in the mid-axillary line. Make a second short transverse incision in the mid to posterior axillary line, approximately 4-6 cm superiorly to the first incision. (Figure 2). 2nd Incision 1st Incision Figure 2: Making the 1st and 2nd Incisions 6 Denver P.E.S. with External Pump Chamber
2. After assessing the positioning of the pleural catheter, the catheter may be cut at this time to a length that is appropriate for the patient. 3. Draw the pleural catheter into the lower incision, using forceps to tunnel the catheter approximately 4-6 cm to the upper incision. (Figure 3) NOTE: The valves in the pump chamber allow flow in only one direction. Be certain that the shunt is properly oriented by referring to the arrows on the pump chamber. Figure 3: Placing the Pleural Catheter CAUTION: Use rubber shod instruments when handling the shunt. Possible cuts or tears can occur if rubber shod instruments are not used. 4. Pass the catheter over the surface of the rib and through the intercostal muscles in the mid to posterior axillary line (Figure 3). 5. Advance the catheter into the pleural space until the polyester cuff lies within the subcutaneous tunnel approximately 1/2 to 1 cm from the incision. 6. Pump the shunt to confirm free flow of fluid from the chest. Instructions for Use 7
PERITONEAL CATHETER PLACEMENT 1. Make a short transverse incision below the costal margin on the same side as the pleural catheter placement. Make a second short transverse incision over the mid-rectus sheath in the upper abdomen, approximately 4-6 cm from the first incision. (Figure 4). 2. Within the second incision, divide the anterior rectus sheath transversely. Split the fibers of the rectus abdominis muscle to expose the posterior rectus fascia. Place 2 non-absorbable concentric purse string sutures in the posterior fascia. 3rd Incision 4th Incision Figure 4: Making the 3rd and 4th Incisions 3. The peritoneal catheter may be cut at this time to a length that is appropriate for the patient. 4. Draw the catheter into the first incision, using forceps to tunnel the catheter approximately 4-6 cm to the second incision (Figure 5). 8 Denver P.E.S. with External Pump Chamber
Figure 5: Placing the Peritoneal Catheter 5. Make a small stab incision within the purse string sutures and insert the peritoneal catheter into the peritoneal cavity. 6. Tie the purse string sutures snugly around the catheter. Care should be taken to insure a watertight seal without reducing the inner diameter of the catheter. Suture the cuff on the catheter just outside the peritoneum with the pursestring sutures. CAUTION: Exercise care when placing ligatures to avoid cutting or occluding the catheters. Do not use stainless steel ligatures. Instructions for Use 9
CLOSING PROCEDURE 1. Irrigate all incisions with antibiotic solution. 2. Suture both of the catheters to the skin with non-absorbable suture. These sutures are intended to stay in place even after tissue ingrowth around the cuffs has occurred. CAUTION: Exercise care when placing ligatures to avoid cutting or occluding the catheters. Do not use stainless steel ligatures. 3. Close the incisions in layers. POST-OPERATIVE MANAGEMENT It will be necessary to pump the shunt to transfer the pleural fluid into the peritoneal cavity. Each full compression with subsequent release of the pump chamber will transfer approximately 2 ml of fluid through the shunt. 1. Place the patient in a supine position. 2. Grasp the shunt between the thumb and forefingers of one hand, with the flat side of the chamber resting on the forefingers. Firmly compress the center of the pump chamber with the thumb. Lift the thumb from the pump chamber to release compression. 3. The shunt should be pumped repeatedly, immediately after placement, until the hemithorax is cleared of fluid. It will be helpful to determine the volume of fluid within the pleural space prior to pumping the shunt. 4. Obtain an x-ray of the affected side to evaluate clearing of the effusion. 5. Once the effusion is determined to be cleared, a regular daily schedule of pumping should be planned. The frequency of pumping should be based upon the expected volume of fluid produced on a daily basis. Regardless, it is recommended that the shunt be pumped every day and that the pumping is enough to clear the pleural space of fluid. 6. A caregiver or the patient should be carefully instructed on how and when to pump the shunt. The frequency and duration of pumping should be determined by the surgeon. 7. It is vital that the caregiver or patient be carefully instructed on pumping the shunt and that they be able to demonstrate this capability before the patient is discharged from the hospital. 10 Denver P.E.S. with External Pump Chamber
Figure 6: Dissect Around the Cuff on the Pleural Catheter REMOVAL OF THE SHUNT Once it is determined that no additional fluid is accumulating in the pleural space, the shunt can be removed. 1. Position, prep and drape the patient as in the shunt placement procedure. Instructions for Use 11
2. Pass forceps through the skin entrance wound on the patient's chest and dissect around the cuff located on the pleural catheter (Figure 6). 3. Apply a constant pulling traction on the pleural catheter to remove it. 4. Open the abdominal incision and divide the purse string suture placed around the catheter. Dissect around the cuff and remove the catheter from the peritoneal cavity. 5. Close the posterior rectus fascia with absorbable suture and close the incision in layers. TESTING SHUNT FUNCTION Place the patient in the supine position. Grasp the shunt between the thumb and forefingers of one hand, with the flat side of the chamber resting on the forefingers. Firmly compress the pump chamber with the thumb. There should be little resistance to this compression. If there is resistance, then there may be an occlusion within the pump chamber or in the peritoneal catheter. If the pump chamber fails to refill readily after compression, the pleural catheter may be occluded. WARNING: Particulate matter may cause shunt occlusion, necessitating replacement of the shunt. ORDERING INFORMATION Catalog No. Description 42-9005 Pleural Effusion Shunt with External Pump Chamber WARRANTY Denver Biomedical, Inc. warrants that this medical device is free from defects in both materials and workmanship. THE ABOVE WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PUR- POSE. Suitability for use of the medical device for any surgical procedure shall be determined by the user. Denver Biomedical, Inc. shall not be liable for incidental or consequential damages of any kind. 12 Denver P.E.S. with External Pump Chamber
Sales, Customer Service, and Technical Product Information Contact Denver Biomedical, Inc. 14998 W. 6th Ave., Bldg. E 700 Golden, CO 80401-5025 USA Telephone: (303) 279-7500 (800) 824-8454 Fax: (303) 279-7575 E-mail: dbi-info@denverbio.com Website: www.denverbiomedical.com European Authorized Representative The Surgical Company Terminalweg 19a 3821 AJ Amersfoort The Netherlands DENVER is a registered trademark of Denver Biomedical, Inc. Printed in USA P/N 1125-0502E