Is there leakage of bile around the needle during injection of dye?
Since no incision (such as a ductotomy) has been made and biliary access has been obtained by only a needle puncture, there is no leakage of dye around the needle unless there is Cystic Duct Obstruction. See number 5 below.
Is there leakage of bile from the needle hole after the needle is removed?
Since the gallbladder has been emptied by aspiration after cholangiography, bile leakage is only a small droplet, just as upon cystic ductotomy.
Can the needle go through the back wall of the Hartmann’s pouch?
No. The needle length is only 1.25 cm and the angle of entry of the needle does not point towards the back wall of the Hartmann’s pouch.
If a stone is located in the Hartmann’s pouch, can it be pushed by the needle or washed by the dye in to the common bile duct? The Washable Stone?
This problem has not occurred in clinical practice in over hundreds of thousands of cholangiograms that have been performed with this method.
Three factors prevent the passage of a stone into the common bile duct during injection of dye into the Hartmann’s Pouch:
The valves of Heister in the cystic duct.
In addition, we know that a tiny stone in the cystic duct can be pushed in to the common bile duct during conventional cystic duct cannulation also. Experience has shown that these are not of clinical significance and pass uneventfully.
How can this method work if there is cystic duct obstruction?
Cystic duct obstruction can occur with or without Hydrops. It is managed by the Methods described above. Please See Details above.
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.
Washing / Decontamination
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 and date.
CAUTION: Federal (USA) law restricts this device to use by or on the order of a physician.
Nashville Surgical Instruments
2005 Kumar Lane
Springfield, TN, 37172 USA
Cystic duct obstruction can occur with or without Hydrops (Acute Cholecystitis):
This is also called a Hot Gallbladder. The following method is recommended:
This relieves the pressure that was pushing the stone in to the neck of the gallbladder.
In fact, a negative pressure has been created behind the stone, physiologically. The stone should fall back in to the gallbladder.
Applied through the right mid-subcostal port, the Kumar Clamp® is used as a
• Regular Grasper during dissection of cystic duct and during removal of the gallbladder from the liver bed as well as a
• Cholangiography Clamp.
No need to introduce and remove different instruments for different parts of the same operation.
Injury of the Common Bile Duct due to mistaken ductotomy of the common bile duct
(Type I injury) is eliminated!
After cholangiography, please note that a 19 ga. needle is located in the dependent portion of the gallbladder. Clamp jaws can be opened and the gallbladder is aspirated. This greatly facilitates the separation of the gallbladder from the liver bed and extraction from the portsite.
There are three (3) loose or removable parts on the Kumar Clamp® and the Kumar SILS Clamp® each: the black plastic cap over the flush port, the channel valve assembly and the screw 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.
The Kumar Clamp® (KC-002)is a reusable 5 mm grasper of 37 cm length. It is supplied non-sterile. The Kumar Clamp(KC-2XL) is a reusable 5mm grasper for Single Port, Bariatrics and Robotics and is 45 cm length. See Instructions for Sterilization below.
The Kumar 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 properly after use. DO NOT RESTERILIZE OR REUSE.
The Kumar Clamp®(KC-002) and The Kumar(KC-2XL) Clamp(used for Single Port, Bariatrics and Robotics): Clean and steam autoclave in accordance with the guidelines of Association for Advancement of Medical Instruments (AAMI): Standards and Recommended Practices: Sterilization in Healthcare Facilities. CLEAN AND STERILIZE AFTER EACH USE. See Detailed Instructions below.
The Kumar Catheter® is supplied sterile and is for single patient use only.
The Kumar Clamp® is a 5 mm laparoscopic grasper with
Caution: The Catheter fits snug into the Channel to prevent CO2 leak. Do NOT try to close the Channel Valve while Catheter is in the Channel. This can cut or damage the Catheter.
Sterility is guaranteed unless package is opened or damaged.
DO NOT RESTERILIZE.
CAUTION: Do NOT close or tighten the Channel
Valve when Catheter is in the channel.
This can damage the catheter.
Nashville Surgical Instruments
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Phone: 615-382-4996 Fax: 615-382-4199
Aspiration of Hydrops with Open Clamp Jaws
NASHVILLE SURGICAL INSTRUMENTS
2005 Kumar Lane, Springfield TN 37172
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