Chait Trapdoor™ Cecostomy Catheter
Suggested Instructions for Use

Device Description

The Chait Trapdoor™ Cecostomy Catheter is a percutaneously placed device which facilitates antegrade colonic cleansing. Its design features a unique low profile, "trap door" fitting enhancing patient compliance. Multi-curl tip configuration provides atraumatic retention within the cecum.

Contraindications

• Previous surgical procedures
• Coagulopathies
• Patients too large to accept the Trapdoor™ device due to excessive soft tissue between the skin surface and the cecum. The Trapdoor™ device accommodates cecostomy tracts of 6 centimeters and shorter.
• Persons with known medical problems that put them at risk during the procedure

Indications for Use

The Chait Trapdoor™ Cecostomy Catheter is used to instill fluids through a cecostomy into the colon to promote evacuation of the contents of the lower bowel through the anal opening and is intended to be an aid in the management of fecal incontinence. The catheter is placed and maintained in a percutaneously prepared opening such as a cecostomy.

Placement of the Chait Trapdoor™ Cecostomy Catheter is a two-step procedure. Initially, a temporary loop retention drainage catheter is percutaneously placed into the cecum and maintained while the tract matures.

NOTE: Use of suture anchors is recommended to assist introduction of the temporary drainage catheter. Instruct the patient to flush the temporary drainage catheter twice daily using a 10 cc syringe and 10 ml of water. This catheter flushing procedure and a normal rectal enema regimen should be continued for one week before initiating antegrade cecostomy enemas.

NOTE: The temporary drainage catheter should be removed after appropriate tract maturation and replaced with the Chait Trapdoor™ Cecostomy Catheter. (This will be approximately 6 weeks after the procedure.)

Suggested Instructions for Use of the Chait Trapdoor™ Cecostomy Catheter

1. Confirm the position of the temporary drainage catheter within the cecum with contrast. Release the locking loop mechanism on the temporary drainage catheter by releasing the locking mechanism securing the loop. Pass the stiffener provided with the cecostomy catheter or a stiff wire guide into the loop to help straighten the catheter. (Figure 1)

Figure 1                    

2. Carefully pull the catheter out over a pre-positioned wire guide such as a .038 inch Amplatz Ultra Stiff Wire Guide. Confirm cecostomy tract length to be 6 centimeters or shorter.

NOTE: Measure the cecostomy tract length with a wire guide and hemostat to confirm the tract is 6 centimeters or shorter in order to accommodate the Chait Trapdoor™ Cecostomy Catheter.

3. Insert the metal stiffener into the Chait Trapdoor™ Cecostomy Catheter to straighten the coils and push the catheter through the tract over the pre-positioned wire guide. Once the catheter is inserted, remove the metal stiffener until Trapdoor™ is flush with access site. (When the stiffener and wire guide are removed, the extra catheter coils will reform in the cecum.) Confirm catheter position within the cecum and patency using contrast injection. (Figure 2)

Figure 2                    

Maintenance of the Chait Trapdoor™ Cecostomy Catheter

Instruct the patient to read and understand the Patient Guide titled "Caring for Your Temporary & Trapdoor ™ Cecostomy Catheter" prior to initial catheter introduction.

• Once the Chait Trapdoor™ Cecostomy Catheter has been placed, the patient can resume the cecostomy enema regimen that the patient had been using with the temporary cecostomy catheter.
               
• Instruct the patient to begin antegrade cecostomy enemas the day following discharge and to perform these enemas while seated on a toilet.
                 
• Access the Chait Trapdoor ™ Cecostomy Catheter by inserting the metal cannula tip on the clear connection tube into the opening of the Trapdoor™ . The opposite end of the connection tube has a large tapered fitting that will fit most taper tip syringes. Additional security for the connection between the Trapdoor™ and connecting tube can be achieved by inserting the pin in the top half of the Trapdoor™ into the small hole in the soft plastic block on the connecting tube, in addition to inserting the metal tube into the opening in the Trapdoor™ . (Figure 3)

Figure 3                    

• Instruct the patient to administer a phosphate enema through the connecting tube attached to the Chait Trapdoor™ Cecostomy Catheter. After waiting fifteen minutes from initiating infusion of the phos-phate enema, attach the saline enema via a gravity bag to complete the enema.
                   
• The saline antegrade enema should be continued until the bowel drainage becomes clear. (The usual saline volume is 200-500 ml.)
              
• After use, remove the connecting tube and the pin from the Trapdoor ™ fitting. Close the Trapdoor ™ fitting to prevent leakage. (Figure 4)
              
• Post-procedural orders for the patient should include a high-fiber diet and a decrease in consumption of constipating foods.

Figure 4                    

Catheter Exchange

1. Using fluoroscopic guidance, introduce an Amplatz Ultra Stiff Wire Guide through the Chait Trapdoor ™ Cecostomy Catheter and into the cecum.

NOTE: If the catheter does not readily permit passage of the wire guide, use of a rigid stiffening cannula is recommended. Prior to insertion of the stiffening cannula into the catheter, advance the Amplatz Ultra Stiff Wire Guide through the cannula allowing 2-3 cm of extension beyond the tip. While maintaining distal positioning of the wire guide within the cannula, advance the stiffening cannula and wire guide, as a unit, through the Chait Trapdoor ™ Cecostomy Catheter and into the cecum.

2. Remove the catheter leaving the wire guide in place.

NOTE: If stiffening cannula was used for wire guide placement, remove the stiffening cannula prior to catheter removal.

3. Introduce a new Chait Trapdoor ™ Cecostomy Catheter over the wire guide and advance into position.

Packaging

Supplied sterile in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged.

Storage

Store this product in a dark, dry, cool place. Avoid extended exposure to light.

References

P. G. Chait, B. Shandling, H. F. Richards, B. L. Connolly: "Fecal Incontinence in Children: Treatment with Percutaneous Cecostomy Tube Placement – A Prospective Study," Radiology, 203 (1997), 621-624.