AMT MINI ONE BALLOON BUTTON Instructions For Use Manual page 6

WARNING: INITIAL PLACEMENT OF THE MINIONE
TO AFFIX THE STOMACH WALL TO THE ANTERIOR ABDOMINAL WALL. DO NOT USE THE RETAINING BALLOON OF THE
DEVICE AS A GASTROPEXY DEVICE. AN EARLY BALLOON FAILURE MAY PREVENT THE STOMACH FROM ATTACHING
TO THE ANTERIOR ABDOMINAL WALL.
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 PRE-
VENT 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.
5. Follow instructions in the CREATE THE STOMA TRACT section.
CAUTION: After the MiniONE
heals and the stomach is fully affixed to the anterior abdominal wall.
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 coursed 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 PUNCTUR-
ING 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.
OPTION A. RADIOLOGIC PLACEMENT ONLY (4A & 5A):
4A. 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.
5A. Advance a guidewire, up to .038", through the needle and into the stomach. Confirm position.
OPTION B. ENDOSCOPIC PLACEMENT ONLY (4B & 5B):
4B. Use endoscopic visualization to verify correct needle placement.
5B. Advance a guidewire, up to .038", through the needle into the stomach. Using endoscopic visualization, grasp the guidewire
with atraumatic forceps.
6. Remove the introducer needle, leaving the guidewire in place and dispose of according to facility protocol.
7. Follow instructions in the DILATION section.
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.
4. Measure the Stoma Length with the AMT Stoma Measuring Device by following the MEASURE THE STOMA LENGTH section.
CAUTION: Avoid excessive dilation of stoma tract as this can increase the possibility of the balloon pulling through the stoma.
CAUTION: Selection of the correct size feeding device is critical for the safety and comfort of the patient. Measure
the length of the patient's stoma with the AMT balloon stoma measuring device (fig 2). The shaft length of the select-
ed feeding device should be the same as the length of the stoma. An inappropriately sized feeding device can cause
necrosis, buried bumper syndrome, and/or hypergranulation tissue.
1. Please refer to Manufacturer's Directions for Use for Stoma Measuring Device being used. It is recommended that AMT's Balloon
Stoma Measurement Device be used for measurement of the stoma.
2. Be sure to select the appropriate size MiniONE
appears to be between two sizes, always select the next larger size MiniONE
should rotate easily.
WARNING: UNDER-SIZING THE DEVICE MAY CAUSE EMBEDDING WITH EROSION INTO THE GASTRIC WALL, TISSUE
NECROSIS, INFECTION, SEPSIS, ASSOCIATED SEQUELAE, AND/OR DEVICE FAILURE.
GASTROPEXY PLACEMENT
®
BALLOON BUTTON REQUIRES THAT A GASTROPEXY IS PERFORMED
®
Balloon Button is placed, do not remove the gastropexy sutures until the stoma site fully
CREATE THE STOMA TRACT
MEASURE THE STOMA LENGTH
®
Balloon Button for the abdominal wall thickness measured. If the measurement
DILATION
®
Balloon Button. Once placed, the external flange
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