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Description
The Kimberly-Clark* MIC* Gastrostomy (Fig 1) / Bolus
Feeding Tube (Fig 2) allow for delivery of enteral nutrition
and medication directly into the stomach and/or gastric
decompression.
Indications For Use
The Kimberly-Clark* MIC* Gastrostomy / Bolus Feeding
Tube are indicated for use in patients who require long term
feeding, are unable to tolerate oral feeding, who are at low
risk for aspiration, require gastric decompression and / or
medication delivery directly into the stomach.
Contraindications
Contraindications for placement of a gastrostomy feeding
tube include, but are not limited to ascites, colonic
interposition, portal hypertension, peritonitis and morbid
obesity.
Warning
Do not reuse, reprocess, or resterilize this medical device.
Reuse, reprocessing, or resterilization may 1) adversely
affect the known biocompatibility characteristics of the
device, 2) compromise the structural integrity of the
device, 3) lead to the device not performing as intended,
or 4) create a risk of contamination and cause the
transmission of infectious diseases resulting in patient
injury, illness, or death.
Complications
The following complications may be associated with any
low-profile gastrostomy 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 Kimberly-Clark* MIC* Gastrostomy / Bolus feeding tubes
may be placed surgically, 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.
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.
Warning: The insertion site for infants and children should
be high on the greater curvature to prevent occlusion of the
pylorus when the balloon is inflated.
Tube Preparation
1. Select the appropriate gastrostomy feeding tube, remove
from the package and inspect for damage.
2. Using a Luer slip syringe, inflate the balloon with sterile or
distilled water through the balloon port (Fig 1C & 2C).
• Inflate the balloon with 2-3 ml of sterile or distilled water
for low volume tubes identified by LV following the REF
code number.
• Inflate the balloon with 7-10 ml sterile or distilled water
for Standard tubes.
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. Lubricate the tip of the tube with a water soluble lubricant.
Do not use mineral oil. Do not use 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 appose 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 CoNFIGURATIoN To
ENSURE ATTACHMENT 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.
NoTE: For gastrostomy tube placement, the best angle
of insertion is a true right angle to the surface of the
skin. The needle should be directed toward the pylorus if
conversion to PEGJ tube is anticipated.
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 J tip guidewire, up to .038", through the needle
and into stomach. Confirm position.
6. Remove the introducer needle, keeping the J tip guidewire
in place and dispose of according to facility protocol.
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.
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. Select the appropriate gastrostomy feeding tube
and prepare according to the directions in the Tube
Preparation section above.
2. Advance the distal end of the tube over the guidewire,
through the stoma tract and into the stomach.
3. Verify that the tube is in the stomach, remove the
guidewire or peel-away sheath if utilized and inflate the
balloon.
4. Using the Luer slip syringe, inflate the balloon.
• Inflate the LV balloon with 2-3 ml of sterile or distilled
water.
• Inflate the standard balloon with 7-10 ml of sterile or
distilled water.
CAUTIoN: Do NoT ExCEED 5 ML ToTAL BALLooN
voLUME INSIDE THE Lv BALLooN. Do NoT USE AIR. Do
NoT INjECT CoNTRAST INTo THE BALLooN.
CAUTIoN: Do NoT ExCEED 20 ML ToTAL BALLooN
voLUME IN THE STANDARD BALLooN. Do NoT USE AIR.
Do NoT INjECT CoNTRAST INTo THE BALLooN.
5. Gently pull the tube up and away from the abdomen until
the balloon contacts the inner stomach wall.
6. Clean the residual fluid or lubricant from the tube and
stoma.
7. Gently slide the SECUR-LOK* ring to approximately 1-2 mm
(approximately 1/8 inch) above the skin.
verify Tube Position and Patency
1. Attach a catheter tip syringe with 10 ml water to the
feeding port. Aspirate gastric contents. When air or
gastric contents are observed, flush the tube.
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