Nashville Surgical Instruments


The Kumar PRE-VIEW* Cholangiography

Kumar PRE-VIEW* Cholangiography Clamp & Catheter (Latex Free)

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Instructions for Use: (This is not a primer of surgical techniques or cholecystectomy)

1. Apply the Kumar PRE-VIEW* Cholangiography Clamp through the right mid-subcostal port at the beginning of the laparoscopic cholecystectomy procedure. Use it as a regular grasper for traction of the gallbladder during cystic duct dissection.

2. When cystic duct dissection is complete, milk cystic duct towards the gallbladder to eliminate sludge, mucous or gravel from the cystic duct. This enhances cystic duct patency.

3. Re-position and apply the Kumar Clamp completely across the lower part of the body of the gallbladder (Fig. 1), just above the Hartmann's pouch. During this step, it is helpful to grasp the Hartmann's pouch with a grasper through the epigastric port and feed it into the jaws of the Clamp. (Usually, the tips of the Clamp jaws, at this time, point at the cystic artery, Fig.1). Caution: Avoid injury to the lower surface of liver from the tips of the Clamp jaws.

4. By sterile technique, remove Catheter from package. Remove needle guard & flush Catheter.

5. Open the Clamp channel valve. Insert and advance Catheter into the Clamp channel.

6. Laparoscopically visualize the Catheter needle as it exits the lower end of the channel. Flush Catheter again to eliminate any air bubbles.

7. Advance the Catheter and puncture Hartmann's Pouch in a Bull's eye manner, adjusting the Clamp by tilting or rotating as needed (Figure 1). Rarely it is necessary to guide the Catheter / needle with a grasper through the epigastric port.

Figure 1

8. Aspirate to confirm biliary access. Inject dye for cholangiography. Fluoroscopy is preferred.

9. After completion of cholangiography, open Clamp jaws and use Catheter to aspirate and empty the gallbladder. The emptied gallbladder is much easier to separate from the liver bed and extract from the portsite.

10. Remove Catheter under direct vision. Close channel valve (or leave it open as a smoke vent!) and use the Kumar Clamp as a grasper to finish the operation.


Cystic Duct Obstruction due to small stones, gravel, sludge or mucous (without Hydrops or acute cholecystitis) can be resolved by milking the cystic duct towards the gallbladder. Dye can flow around a tiny stone in the cystic duct without flushing the stone into the common bile duct. The chances of flushing such a stone are no different than during cystic duct cannulation. The clinical experience is that such tiny stones do pass uneventfully.

(Aspiration of Hydrops)

Acute Cholecystitis (Hydrops) due to a stone that is impacted at the neck of the gallbladder:

1. The gallbladder is usually so distended that it cannot be grasped. Introduce a 5 mm. grasper through the right lateral port and, with the jaws open, push the body/fundus of the gallbladder towards the diaphragm as far as possible (Figure 2 above).

2. Introduce the Kumar Clamp through the right mid-subcostal port. Advance the Clamp jaws to the lowest part of the body of the gallbladder, keeping the jaws open (Figure 2 above).

If visualization of the cystic duct area is limited, it is helpful to add an additional port through which a fan-shaped retractor can be introduced to retract the viscera and improve visualization.

3. Advance Catheter and aspirate gallbladder at the lowest, dependant location.

4. Aspiration relieves the pressure that is pushing the stone into the neck of the gallbladder. This allows the impacted stone to dislodge and fall back into the gallbladder. Compression of the impacted stone with a grasper through the epigastric port may also be helpful.

5. The decompressed gallbladder can now be grasped and cholangiography dye can be injected, preferably through the same access or the needle can be moved to a lower location.

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WARNINGS AND PRECAUTIONS

1. The device is for use by qualified surgeons, who are familiar with this device prior to surgery.

2. Always operate the instruments under direct laparoscopic monitoring.

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HOW SUPPLIED

The Kumar PRE-VIEW* Cholangiography Clamp is a reusable 5 mm grasper, supplied non-sterile.

The Kumar PRE-VIEW* Cholangiography Catheter is 76 cm. long, 16 ga. with a 19 ga., 1.25 cm. long needle. It is supplied sterile and is for single patient use only. Discard after use. DO NOT RESTERILIZE OR REUSE.

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STERILIZATION

The Kumar PRE-VIEW* Cholangiography Clamp: Clean & steam autoclave in accordance with the guidelines of Association for Advancement of Medical Instruments (AAMI): Standards and Recommended Practices: Sterilization in Healthcare Facilities. CLEAN & STERILIZE AFTER EACH USE. Additional Instructions are provided in each Clamp package and below.

The Kumar PRE-VIEW* Cholangiography Catheter is supplied sterile and is for single patient use only. .Sterility is guaranteed unless package is opened or damaged. DO NOT RESTERILIZE.

CAUTION: Federal (USA) law restricts this device to use by or on the order of a physician.

Manufactured for: Nashville Surgical Instruments, 2005 Kumar Lane, Springfield, TN, 37172 USA
*U.S. Patent No. 5,224,931 and *Trademark.

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INSTRUCTIONS FOR CLEANING AND STERILIZATION
For Kumar PRE-VIEW* Cholangiography Clamp Only

Preparation

Inspect instrument after each use for damaged or loose parts** and proper function. Remove any gross contamination. To assure cleaning of all surfaces, the clamp jaws, channel valve and the flush-port cap must be open. 

Pre-Rinse

1. An initial cold water and blood/protein-dissolving enzyme solution rinse (or soak for heavy contamination) helps remove blood, tissue and debris from device lumens, joints & serrations.

2. Flush and clean interior of instrument through Flush Port (after undoing the black plastic cap), and the catheter channel (with the metal one-way valve at the top) with cold water and blood/protein-dissolving enzyme and antiseptic solution. Allow solution contact for 5minutes.

3. Pre-clean clamp jaws and tips with a brush.

Washing / Decontamination

1. Place instrument in a separate wire basket on top shelf of the automated washer / decontaminator and allow a full cycle run.

2. Allow instrument to air dry in basket. Then remove & inspect for any residual contamination.

3. Allow residue of rinse water to remain in instrument channels. This allows steam to form during the sterilization process. If needed, inject distilled or de-ionized water in to channels.        

Packaging

Follow institutional Policy and Procedures. Wrap properly for steam sterilization with sterilization indicator strip in lowest and most inaccessible portion of the packaging. Use two layers of non woven disposable sterilization wrap on outside of packaging. Seal with sterilization indicator tape. Label and initial.

Sterilization

l. Follow sterilizer manufacturer instructions for use of the steam sterilizer.

2. Recommended Minimum Exposure Times (Minutes after conditioning) for Steam      Sterilization: Gravity 250^°F (121^{° C}): 30 minutes, Gravity 270^°-274^°F (132^°-134^°C): 15 minutes, Pre-vac  270^°-274^°F (132^°- 134^°C): 4 minutes.

3. Remove from sterilizer and allow to cool on sterilizer rack. Assure package integrity and store on designated shelves for sterile instruments.

4. Inspect instrument closely before each use for damaged, loose parts and proper function.

Loose Parts Advisory

There are three (3) loose or removable parts on the Clamp: the black plastic cap over the flush port, the channel valve assembly and the screw at the bottom that holds the valve in place. None of these enter the body during normal use. Caution is necessary when the operation is converted to open surgery.
* Patent and Trademark    

Bibliography

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