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Qty
Component
®
1
MiniONE
Balloon Button (Fig 1)
2
4 x 4 inch Gauze
1
Water Soluble Lubricant
1
12" Bolus Feeding set with Straight Adapter*
1
12" Y-Port Feeding set with Right Angle Adapter*
1
Large Syringe (Catheter or ENFit
1
Luer-Slip Syringe (5/6ml 12-14F), (10/12ml 16-24F) For balloon inflation or channeling feed/medication
1
Optional Introducer / Stiffener (12-18F only)
*The feeding sets and large syringe are not included with the SM1-5 kit configurations of the MiniONE
TYPE OF USAGE – INITIAL PLACEMENT VS REPLACEMENT
®
The MiniONE
Balloon Button may be placed either during an initial placement procedure or as a replacement device.
PERFORMING AN INITIAL PLACEMENT
If the patient does not currently have a stoma tract for placement of the MiniONE
to be created. This process can only be completed by a healthcare professional. Follow the instructions below starting with the
SUGGESTED INITIAL PLACEMENT PROCEDURES section in order to properly locate a proper stoma location, secure the stomach
to the abdominal wall, create a stoma tract, dilate and measure the stoma, and place the device.
REPLACING A FEEDING DEVICE IN AN ESTABLISHED STOMA SITE
If it is determined that a device placed in an existing stoma needs to be replaced (due to non-optimal functionality or as a pro-active
replacement), the current device can be removed from the stoma and the new device can be inserted in the same stoma site. If
performing a device replacement, skip straight to the DEVICE PLACEMENT PROCEDURE section for the proper method of placing
the new device.
NOTE: Device replacement can be performed by the healthcare professional or at home by the patient/caregiver. Do not attempt to
replace the device until first discussing the procedure with your healthcare professional.
CAUTION: Selection of the correct size feeding device is critical for safety and comfort of the patient. An inappropriate-
ly sized selection of the correct sized device can cause necrosis, buried bumper syndrome, and/or hypergranulation
tissue. If patient size/weight has changed size the device was placed, fit is too tight or too loose, or it has been over six
months since the device was last measured, it is recommended that you speak to your healthcare professional to
ensure that device size does not need changed.
WARNING: THE MINIONE
NEL TRAINED IN PERCUTANEOUS GASTROSTOMY TUBE PLACEMENT. A THOROUGH UNDERSTANDING OF THE TECH-
NICAL PRINCIPLES, CLINICAL APPLICATIONS, AND RISKS ASSOCIATED WITH PERCUTANEOUS GASTROSTOMY TUBE
PLACEMENT IS RECOMMENDED PRIOR TO USING THIS DEVICE.
Initial placement of the MiniONE
guidance. Follow the instructions below for the operator's preferred method of placement.
NOTE: 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.
OPTION A: RADIOLOGIC PLACEMENT
1. Place the patient in the supine position.
2. Prep and sedate the patient according to clinical protocol.
3. Ensure 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 rate of iv injection and recommendations for use with insulin dependent pa-
tients.
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 dilati on, 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 abdominal
muscle (N.B. the superior epigastric artery courses along the medial aspect of the rectus) and directly over the body of the stom-
ach 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 pacify the transverse colon.
8. Prep and drape according to facility protocol.
9. Follow instructions in the GASTROPEXY PLACEMENT section.
OPTION B: ENDOSCOPIC PLACEMENT
1. Perform routine Esophagogastroduodenoscopy (EGD). Once the procedure is complete and no abnormalities are identified that
could pose a contraindication to placement of the tube, place the patient in the supine position and insufflate the stomach with air.
2. Transilluminate through the anterior abdominal wall to select a gastrostomy site that is free of major vessels, viscera and scar
tissue. The site is usually one third the distance from the umbilicus to the left costal margin at the midclavicular line.
3. Depress the intended insertion site with a finger. The endoscopist should clearly see the resulting depression on the anterior
surface of the gastric wall.
4. Prep and drape the skin at the selected insertion site.
5. Follow instructions in the GASTROPEXY PLACEMENT section.
®
)*
SUGGESTED INITIAL PLACEMENT PROCEDURES
®
BALLOON BUTTON SHOULD ONLY BE USED BY OR UNDER THE SUPERVISION OF PERSON-
®
Balloon Button may be performed percutaneously under laparoscopic, fluoroscopic, or endoscopic
KIT CONTENTS
Provide access into stomach for feeding, medication, decompression
Clean/dry stoma area during or after placement
Place on balloon / stoma area for easier insertion
For channeling feed / medication into button or decompression
For channeling feed / medication into button or decompression
For channeling feed / medication / decompression with feeding set
Provides stiffness during placement of device
®
Component Usage Details
®
Balloon Button device.
Balloon Button device, a new stoma tract will need
5
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