Instructions for Use
Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Description
The HALYARD* MIC* Gastric-Jejunal Feeding Tube
(Fig 1)
provides for simultaneous gastric decompression / drainage and
delivery of enteral nutrition into the distal duodenum or proximal jejunum.
Indications For Use
The HALYARD* MIC* Gastric-Jejunal feeding tube is indicated for use in patients who cannot absorb adequate nutrition through
the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of
aspiration, or in those who have had previous esophagectomy or gastrectomy.
Contraindications
Contraindications for placement of a Gastric-Jejunal feeding tube include, but are not limited to ascites, colonic interposition,
portal hypertension, peritonitis and morbid obesity.
Complications
The following complications may be associated with any Gastric-Jejunal feeding tube:
• Skin Breakdown
• Infection
• Hypergranulation Tissue
• Stomach or Duodenal Ulcers
• Intraperitoneal Leakage
• Pressure Necrosis
Note:
Verify package integrity. Do not use if package is damaged or sterile barrier compromised.
Placement
The HALYARD* MIC* Gastric-Jejunal feeding tube may be placed percutaneously under fluoroscopic or endoscopic guidance or as
a replacement to an existing device using an established stoma tract.
Caution:
A gastropexy must be performed to affix the stomach to the anterior abdominal wall, the feeding tube insertion
site identified and stoma tract dilated prior to initial tube insertion to ensure patient safety and comfort. The length of the tube
should be sufficient to be placed 10–15 cm beyond the Ligament of Treitz.
Caution:
Do not use the retention balloon of the feeding tube as a gastropexy device. The balloon may burst and fail to
attach the stomach to the anterior abdominal wall.
Tube Preparation
1. Select the appropriate size MIC* Gastric-Jejunal feeding tube, remove from the package and inspect for damage.
2. Using the 6 ml Luer slip syringe contained in the kit, inflate the balloon with 5 ml sterile or distilled water through the
balloon port
(Fig 1-E)
.
3. Remove the syringe and verify balloon integrity by gently squeezing the balloon to check for leaks. Visually inspect the
balloon to verify symmetry. Symmetry may be achieved by gently rolling the balloon between the fingers. Reinsert the
syringe and remove all the water from the balloon.
4. Using a 6 ml Luer slip syringe, flush water through both the gastric
(Fig 1-A)
and jejunal ports
(Fig 1-B)
to verify patency.
5. Lubricate the distal end of the tube with water-soluble lubricant. Do Not Use Mineral Oil Or Petroleum Jelly.
6. Generously lubricate the jejunal lumen with water-soluble lubricant. Do Not Use Mineral Oil Or Petroleum Jelly.
Suggested Radiologic Placement Procedure
1. Place the patient in the supine position.
2. Prep and sedate the patient according to clinical protocol.
3. Insure that the left lobe of the liver is not over the fundus or the body of the stomach.
4. Identify the medial edge of the liver by CT scan or ultrasound.
5. Glucagon 0.5 to 1.0 mg IV may be administered to diminish gastric peristalsis.
Caution:
Consult Glucagon instructions for use for rate of IV injection and recommendations for use with insulin
dependent patients.
6. Insufflate the stomach with air using a nasogastric catheter, usually 500 to 1,000 ml or until adequate distention is
achieved. It is often necessary to continue air insufflation during the procedure, especially at the time of needle puncture
and tract dilation, to keep the stomach distended so as to oppose the gastric wall against the anterior abdominal wall.
7. Choose a catheter insertion site in the left sub-costal region, preferably over the lateral aspect or lateral to the rectus
abdominis muscle (N.B. the superior epigastric artery courses along the medial aspect of the rectus) and directly over the
body of the stomach toward the greater curvature. Using fluoroscopy, choose a location that allows as direct a vertical
needle path as possible. Obtain a cross table lateral view prior to placement of gastrostomy when interposed colon or small
bowel anterior to the stomach is suspected.
Note:
PO/NG contrast may be administered the night prior or an enema administered prior to placement to opacify the
transverse colon.
8. Prep and drape according to facility protocol.
Gastropexy Placement
Caution:
It is recommended to perform a three point gastropexy in a triangle configurati on to ensure attac hment of the
gastric wall to the anterior abdominal wall.
1. Place a skin mark at the tube insertion site. Define the gastropexy pattern by placing three skin marks equidistant from the
tube insertion site and in a triangle configuration.
Warning: Allow adequate distance between the insertion site and gastropexy placement to prevent
interference of the T-Fastener and inflated balloon.
2. Localize the puncture sites with 1% lidocaine and administer local anesthesia to the skin and peritoneum.
3. Place the first T-Fastener and confirm Intragastric position. Repeat the procedure until all three T-Fasteners are inserted at
the corners of the triangle.
4. Secure the stomach to the anterior abdominal wall and complete the procedure.
Create the Stoma Tract
1. Create the stoma tract with the stomach still insufflated and in apposition to the abdominal wall. Identify the puncture
site at the center of the gastropexy pattern. With fluoroscopic guidance confirm that the site overlies the distal body of the
stomach below the costal margin and above the transverse colon.
Caution:
Avoid the epigastric artery that courses at the junction of the medial two-thirds and lateral one-third of the
rectus muscle.
Warning: Take care not to advance the puncture needle too deeply in order to avoid puncturing the
posterior gastric wall, pancreas, left kidney, aorta or spleen.
2. Anesthetize the puncture site with local injection of 1% lidocaine down to the peritoneal surface.
3. Insert a .038” compatible introducer needle at the center of the gastropexy pattern into the gastric lumen directed toward
the pylorus.
Note:
The best angle of insertion is a 45 degree angle to the surface of the skin.
4. Use fluoroscopic visualization to verify correct needle placement. Additionally, to aid in verification, a water filled syringe
may be attached to the needle hub and air aspirated from the gastric lumen.
Note:
Contrast may be injected upon return of air to visualize gastric folds and confirm position.
5. Advance a guidewire, up to .038”, through the needle and coil in the fundus of the stomach. Confirm position.
6. Remove the introducer needle, leaving the guidewire in place and dispose of according to facility protocol.
7. Advance a .038” compatible flexible catheter over the guidewire and using fluoroscopic guidance, manipulate the guidewire
into the antrum of the stomach.
8. Advance the guidewire and flexible catheter until the catheter tip is at the pylorus.
9. Negotiate through the pylorus and advance the guidewire and catheter into the duodenum and 10–15 cm beyond the
Ligament of Treitz.
10. Remove the catheter and leave the guidewire in place.
Dilation
1. Use a #11 scalpel blade to create a small skin incision that extends alongside the guidewire, downward through the
subcutaneous tissue and fascia of the abdominal musculature. After the incision is made, dispose of according to facility
protocol.
2. Advance a dilator over the guidewire and dilate the stoma tract to the desired size.
3. Remove the dilator over the guidewire, leaving the guidewire in place.
Tube Placement
Note:
A peel-away sheath may be used to facilitate advancement of the
tube through the stoma tract.
1. Advance the distal end of the tube over the guidewire, through the stoma tract and into the stomach.
2. Rotate the HALYARD* MIC* Gastric-Jejunal tube while advancing to facilitate passage of the tube through the pylorus and
into the jejunum.
3. Advance the tube until the tip of the tube is 10–15 cm beyond the Ligament of Treitz and the balloon is in the stomach.
4. Using a Luer slip syringe, inflate the balloon with 7–10 ml of sterile or distilled water.
Caution:
Do not exceed 20 ml total balloon volume. Do not use air. Do not inject contrast into the balloon.
5. Gently pull the tube up and away from the abdomen until slight tension is felt and the balloon contacts the inner stomach
wall.
6. Gently slide the SECUR-LOK* external retention ring down the tube toward the abdomen until it rests 2–3 mm above the
skin. Do not suture the ring to the skin.
7. Remove the guidewire.
Verify Tube Position
1. Verify proper tube placement radiographically to avoid potential complication (e.g. bowel irritation or perforation) and
ensure the tube is not looped within the stomach or small bowel.
Note:
The jejunal portion of the tube contains tungsten which is radiopaque and can be used to radiographically confirm
position. Do not inject contrast into the balloon.
2. Flush the lumen to verify patency.
3. Check for moisture around the stoma. If there are signs of gastric leakage, check the tube position and external bolster
placement. Add fluid as need in 1–2 ml increments.
Caution:
Do not exceed 20 ml total balloon volume.
4. Check to assure that the external bolster is not placed too tightly against the skin and rests 2–3 mm above the abdomen.
5. Document the date, the type, the size and lot number of the tube, the fill volume of the balloon, skin condition and patient
tolerance to the procedure. Start feeding and medication administration per physician orders and after confirmation of
proper tube placement and patency.
HALYARD
*
MIC
*
Gastric-Jejunal Feeding Tube (GJ-Tube)
A
B
E
C
D
F
Fig 1
