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Nashville Surgical Instruments
Phone: 615-382-4996                                                                         Fax: 615-382-4199      

Instructions For Use

Kumar Clamp® - Kumar Catheter® - Kumar SILS Clamp

For

For Kumar Cholangiography® -  PRE-VIEW Cholangiography®

 Rev Sept 2011            Only          

INDICATIONS FOR USE:
The Kumar Clamp® & the Kumar Catheter® are intended to provide a method of laparoscopic cholangiography, and are to be used strictly in combination with each other.

The Kumar SILS Clamp is a longer version of the Kumar Clamp
® for use in SILS (Single Incision Laparoscopic Surgery) and Bariatrics.
®Registered Trademark

CONTRAINDICATIONS:
The device is not intended for use when the associated surgical techniques are contraindicated.

DEVICE DESCRIPTION:

The Kumar Clamp® & the Kumar SILS Clamp are both stainless-steel, reusable 5mm laparoscopic graspers with long (3.8 cm) atraumatic jaws and shaft lengths of 37 cm. and 45 cm respectively. The Clamps also have a channel for introduction of the single-use Kumar Catheter®.

A valve at the top of this channel can be opened to insert the Catheter or closed to maintain pneumo-peritoneum during laparoscopy. The Catheter is made of translucent tubing (16 ga.) and carries a 19 ga., 1.25 cm long needle at the end.

The Kumar Clamp
® is used as a grasper at the infundibulum during cystic duct dissection in conventional laparoscopic cholecystectomy. For cholangiography, the Clamp applies completely across the lower part of the body of the gallbladder and the Catheter needle punctures the Hartmann's pouch of the gallbladder for biliary access or aspiration.


For management of CYSTIC DUCT OBSTRUCTION OR HYDROPS: See below and under Acute Cholecystitis.


Instructions for Use:
Conventional Procedure

(The use and applications for SILS vary according to the surgeon's preferences)

Please note that this is not a primer of surgical techniques or cholecystectomy.

1. Apply the Kumar Clamp® thru the right mid-sub-costal port at the beginning of the conventional laparoscopic cholecystectomy procedure. Use it as a regular grasper for traction at the infundibulum during dissection of the cystic duct.

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 Kumar Clamp®.

4. The Hartmann's pouch becomes bulging and prominent due to compression caused by the Kumar Clamp®. Caution: Avoid injury to the lower surface of liver from the tips of the Kumar Clamp® jaws.

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

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

7. Advance the Kumar Catheter® and puncture the Hartmann's Pouch in a Bull's eye manner, adjusting the Kumar Clamp® by tilting or rotating as needed (Fig. 1).

8.
Aspirate to confirm biliary access. Inject dye for cholangiography under fluoroscopy.

9. After Cholangiography, open Clamp jaws and use the Kumar Catheter® to aspirate and empty the gallbladder. This will make it much easier to separate the gallbladder from the liver bed and to extract from the portsite.

10. Remove Kumar Catheter
® under direct vision. The channel valve can now be closed (or left open as a smoke vent!) and the Kumar Clamp® can be used as a gallbladder grasper to finish the operation. CAUTION: IT IS NOT AN INSULATED INSTRUMENT.

Figure 1



Cystic Duct Obstruction


This can occur due to small stones, gravel, sludge or mucous with or without acute cholecystitis or Hydrops:

A. When there is no Acute Cholecystitis or Hydrops, cystic duct obstruction can be resolved by milking of the cystic duct towards the gallbladder as a routine maneuver after dissection of the cystic duct. 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 into the common bile duct are no different than during cystic duct cannulation, when a tiny stone in the distal cystic duct can be pushed into the common bile duct. The clinical experience is that such tiny stones pass uneventfully.

B. When there is Acute Cholecystitis (Hydrops) due to a stone that is impacted at the neck of the gallbladde. Experience in use of SILS in setting is limited.

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

2. Introduce the Kumar Clamp
® through the right mid-subcostal port and apply it on the body of the gallbladder, with the Clamp jaws open. Advance the CIamp jaws to the lowest part of the body of the gallbladder, keeping the jaws open (Figure 2).

3. Advance the Kumar Catheter
® through the Clamp channel. Puncture and aspirate the gallbladder at the lowest, dependent location.

4. Aspiration relieves the pressure that is pushing the impacted stone into the neck of the gallbladder. Physiologically, in fact, a negative pressure is created behind the stone. This allows the stone to dislodge. Manipulation of the impacted stone with a grasper may also be helpful.

5. The decompressed gallbladder can now be grasped and cholangiography dye can be injected, preferably through the same access. Sometimes, it may be necessary to move the Clamp and the needle to a lower level on the body of the gallbladder.

Figure #2
(Aspiration of Hydrops with Open Clamp Jaws)


WARNINGS AND PRECAUTIONS

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

2. Avoid injury to the lower surface of the liver from the tips of the Clamp jaws.

2. Always operate the instruments under direct laparoscopic monitoring.

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 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.

HOW SUPPLIED

The Kumar Clamp® is a reusable 5 mm grasper of 37 cm length. It is supplied non-sterile. The Kumar SILS Clamp is similar and of 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.

STERILIZATION

The Kumar Clamp® and The Kumar SILS Clamp: 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. Additional Instructions are on page 4.

The Kumar Catheter® is supplied sterile and is for single patient use only.

                           

Sterility is guaranteed unless package is opened or damaged.
DO NOT RESTERILIZE.


CAUTION: Do NOT close or tighten the Channel
Calve when Catheter is in the channel.
This can damage the catheter.

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
Phone: 615-382-4996                                              Fax: 615-382-4199  
www.NashvilleSurg.com


INSTRUCTIONS FOR CLEANING & STERILIZATION
Kumar Clamp® - Kumar SILS Clamp

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 the Flush Port and the Catheter Channel (Fig. 1) with cold water and blood/protein-dissolving enzyme and antiseptic solution. Allow solution contact for 5 minutes.

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 and date.

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 (121c): 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

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.


Nashville Surgical Instruments
www.NashvilleSurg.com

2005 Kumar Lane
Springfield, TN. 37172
Phone: 615-382-4996
Fax: 615-382-4199



® Registered Trademark of Nashville Surgical Instruments