MIC-KEY*G Introducer Kit

MIC-KEY G Introducer Kit
*
For Use with: MIC-KEY* Low-Profile Gastrostomy Feeding Tube
Directions for Use
Kimberly-Clark* MIC-KEY* G Introducer Kit
For Use with: MIC-KEY* Low Profile Gastrostomy Feeding Tube
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Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076 USA
In USA, please call 1-800-KCHELPS • www.kchealthcare.com
Ballard Medical Products, Draper, UT 84020 USA Kimberly-Clark N.V., Belgicastraat 13, 1930 Zaventem, Belgium
Sponsored in Australia by Kimberly-Clark Australia Pty Limited; 52 Alfred Street,
Milsons Point, NSW 2061 • 1-800-101-021
製造販売元　キンバリークラーク・ヘルスケア・インク　横浜市西区みなとみらい二丁目2番1号
Kimberly-Clark* MIC-KEY* G Introducer Kit
For Use with: MIC-KEY* Low-Profile Gastrostomy Feeding Tube
Kit Contents:
Gastrointestinal Anchor Set with Saf-T-Pexy* T-Fasteners
Scalpel
Hemostat
Dilator
Introducer
Stoma Measuring Device
Guidewire
Syringe
Intended Use:
The Kimberly-Clark* MIC-KEY* G Introducer Kit is intended to facilitate the primary placement of the
Kimberly-Clark* and Kimberly-Clark* MIC-KEY* brand of Gastrostomy Feeding Tubes.
Contraindications:
Note: Verify package integrity prior to opening. Do not use if package is damaged or sterile barrier compromised.
Contraindications include, but are not limited to ascites, colonic interposition, portal hypertension, gastric
varices, peritonitis, aspiration pneumonia and morbid obesity
Suggested Radiologic Placement Procedure:
Caution: Consult Glucagon Directions For Use for rate of IV injection and recommendations for use with insulin
dependent patients.
Note: PO/NG contrast may be administered the night prior or an enema administered just prior to placement to
opacify the transverse colon.
1. Place the patient in the supine position.
2. Prep and sedate 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.
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. (Fig 1)
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.
8. Prep and drape according to facility protocol.
Placing the Saf-T-Pexy*:
WARNING: THE SAF-T-PEXY* DEVICE CONTAINS 3/0 BIOSYN® SYNTHETIC ABSORBABLE SUTURE THAT IN
NON-CLINICAL STUDIES RETAINED TENSILE STRENGTH TO APPROXIMATELY 75%OF U.S.P. AND E.P. MINIMUM
KNOT STRENGTH AT 14 DAYS AND APPROXIMATELY 40% AT 21 DAYS POST IMPLANTATION. ABSORPTION
OF THE SUTURE IS ESSENTIALLY COMPLETE WITHIN 90 TO 110 DAYS. THE KINETICS OF GASTRIC WALL
ADHESION TO THE ANTERIOR ABDOMINAL WALL RELATIVE TO SUTURE ABSORPTION MUST BE CONSIDERED
PRIOR TO USING THE SAF-T-PEXY* DEVICE WHEN A COMPROMISED HEALING RESPONSE IS ANTICIPATED,
ESPECIALLY WHEN FIXATION OF THE GASTRIC WALL TO THE ANTERIOR ABDOMINAL WALL IS NOT EXPECTED
WITHIN 14 DAYS.
Caution: The suture locks may pose a choking hazard. Use appropriate measures to prevent swallowing by
immature or mentally-disabled patients.
Caution: Verify package integrity of each pouch prior to opening. Do not use if package is damaged or sterile
barrier is compromised.
Caution: The SAF-T-PEXY* needle point is sharp.
Note: It is recommended to perform a three-point gastropexy that approximates an equilateral triangle to help
ensure secure and uniform attachment of the gastric wall to the anterior abdominal wall. An alternate pattern
will need to be identified if placing a low volume balloon gastrostomy tube. For additional suture security, a knot
may be tied in the suture strand at the surface of the suture lock.
1. Place a skin mark at the tube insertion site and define the gastropexy pattern by placing three skin marks
equidistant from the tube insertion site and in a triangle configuration. Allow adequate distance between
the insertion site and Saf-T-Pexy* placement so as to prevent interference of the anchor set and balloon once
inflated. (Fig 3)
2. Localize the puncture sites with 1% lidocaine and administer local anesthesia to the skin and peritoneum.
3. Carefully remove the pre-loaded Saf-T-Pexy* device from the protective sheath and maintain slight tension
on the trailing suture, noting that the suture is held to the needle by a retaining snap on the side of the needle
hub.
4. Attach a luer slip syringe containing 1-2 ml of sterile water or saline to the needle hub. (Fig 4)
5. Under fluoroscopic guidance, insert the preloaded
Saf-T-Pexy* slotted needle with a single sharp
thrust through one of the marked corners of the triangle until it is within the gastric lumen. (Fig 5) The
simultaneous return of air into the syringe and fluoroscopic visualization (contrast may be injected upon air
return to visualize gastric folds and confirm intraluminal position) confirms correct Intragastric position. After
confirmation of correct position, remove the syringe from the device.
6. Release the suture strand and bend the locking tab on the needle hub. (Fig 6) Firmly push the inner hub into
the outer hub until the locking mechanism clicks into place. (Fig 7) This will dislodge the T-Bar from the end
of the needle and lock the inner stylet into position. (Fig 8)
7. Withdraw the needle while continuing to gently pull the T-Bar until it is flush against the gastric mucosa.
Discard the needle according to facility protocol.
8. Gently slide the suture lock down to the abdominal wall. A small hemostat may be clamped above the suture
lock to temporarily hold it in place.
9. Repeat the procedure until all three anchor sets have been inserted in the corners of the triangle. After the
three Saf-T-Pexy* devices are properly positioned, pull on the sutures to appose the stomach to the anterior
abdominal wall. Close the suture lock with the supplied
hemostat until an audible “click” is heard
securing the suture. Any excess suture may be cut and removed. (Fig 9)
Creating the Stoma Tract:
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.
Caution: Avoid the epigastric artery that courses at the junction of the medial two thirds and lateral one-third of
the rectus muscle.
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 a PEGJ tube is anticipated.
1. 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.
2. Anesthetize the puncture site (location marked earlier) with local injection of 1% lidocaine down to the
peritoneal surface (distance from skin to the anterior gastric wall is usually 4-5 cm).
3. Insert the Safety
Introducer needle into the gastric lumen. (Fig 10)
Radiologic Verification:
Note: Contrast may be injected upon return of air to visualize gastric folds and confirm position.
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.
Guidewire Placement:
Note: DO NOT PULL UP on the J-guidewire in the subsequent steps requiring its use as the guidewire could
become dislodged. (Fig 15)
1. Advance the
J-guidewire, J end first, through the needle into the gastric lumen and confirm position.
2. Remove the safety introducer needle (keeping the J-guidewire in place) and activate the safety collar (Fig 12).
Slide the introducer needle safety collar down the needle shaft while removing the safety introducer needle
to prevent inadvertent needle stick (Fig 13-14). Dispose of according to facility protocol.
Dilation:
Caution: Excess lubricant may cause difficulty in gripping the dilator segments.
Note: Stay perpendicular to the skin while dilating so as not to kink the J-guidewire. During dilation, the JGuidewire may be left in place to insure maintenance of gastric lumen access.
1. Use the #11 safety
scalpel blade to create a small skin incision that extends alongside the guidewire,
downward through the subcutaneous tissue and the fascia of the abdominal musculature. (Fig 16) After the
incision is made, lock the scalpel cover in place and discard according to facility protocol.
2. Apply water soluble lubricant at incision site.
3. Advance the serial
dilator over the guidewire. Use a firm clockwise / counter clockwise twisting motion
while advancing to create a tract into the gastric lumen. (Fig 17)
4. Fluoroscopically verify placement of the dilator tip into the stomach.
5. While holding the serial dilator stationary, grasp the next dilator sleeve and with firm pressure and a
clockwise / counter clockwise twisting motion advance the subsequent dilator into the stoma tract. Slide the
segment forward until a physical stop is felt.
6. Advance the red color coded sleeve through the stoma tract and into the stomach.
Measuring the Stoma Length:
1. Moisten the tip of the
Stoma Measuring Device with water soluble lubricant.
2. Remove the dilator, leaving the guidewire in place and place on a clean surface.
3. Advance the Stoma Measuring Device over the guidewire , through the stoma tract and into the stomach. DO
NOT USE FORCE. (Fig 18)
4. Fill the Luer slip
syringe with 5 ml of sterile or distilled water and attach to the balloon port. Depress the
syringe plunger and inflate the balloon. Pull the device toward the abdomen until the balloon rests against the
inside of the stomach wall.
5. Slide the plastic disc down to the abdomen and record the measurement proximal to the disc. Add an
additional 4-5 mm to the measured shaft length to ensure a proper fit post tube placement. Record final
measurement. (Fig 19)
6. Remove the water in the balloon and the stoma measuring device leaving the guidewire in place.
Resume Dilation:
1. Resume dilation by advancing the dilator over the guidewire, through the stoma tract and into the stomach
using firm pressure and a clockwise / counter clockwise twisting motion.
2. Continue dilation until all dilator sleeves have been advanced.
3. Twist the dilator hub to release the peel-away sheath from the dilator. (Fig 20)
4. Lubricate the exterior of the peel-away sheath with a water soluble lubricant and advance the sheath through
the tract and into the stomach.
5. Remove the dilator and J-Guidewire, leaving the peel-away sheath in the stomach with the remainder
securely maintaining position through the tract and exiting the stoma site.
Tube Placement:
1. Select the appropriate Kimberly-Clark* MIC-KEY* Low-Profile Gastrostomy Tube while maintaining stomach
and stoma tract access via the pre-positioned peel-away sheath. Peel the sheath down to skin level.
2. Inspect and prepare the gastrostomy tube according to the Kimberly-Clark* MIC-KEY* Gastrostomy Tube
Directions For Use. Advance the tube down the peel-away sheath and into the stomach. (Fig 21)
3. After the gastrostomy tube has been advanced through the peel-away sheath and is in position in the
stomach, peel the sheath away from the tube, remove and dispose of according to facility protocol. (Fig 22)
4. Complete the placement procedure according to the Kimberly-Clark* MIC-KEY* Gastrostomy Tube Directions
For Use.
5. Upon completion of the procedure, refer to the Kimberly-Clark* MIC-KEY* Gastrostomy Tube Directions for
Use for specific instructions regarding use of the device.
Post Procedure:
1. Inspect the stoma and gastropexy sites daily and assess for signs of infection, including: redness, irritation,
edema, swelling, tenderness, warmth, rashes, purulent or gastrointestinal drainage. Assess for any signs of
pain, pressure or discomfort.
2. After the assessment, routine care should include cleansing the skin around the stoma site and gastropexy
sites with warm water and mild soap, using a circular motion, moving from the tube and external bolsters
outward, followed by a thorough rinsing and drying well.
The sutures may be absorbed or they may be cut and removed if indicated by the placing physician. After the
sutures dissolve (or are cut) the suture locks may be removed and discarded. The internal T-bars will release
and pass through GI tract.
Kimberly-Clark* MIC-KEY* G Introducer Kit
For Use with: MIC-KEY* Low-Profile Gastrostomy Feeding Tube
(continued)
Suggested Endoscopic Placement Procedure:
Dilation:
1. Prep and sedate the patient according to clinical protocol.
2. Perform routine Esophagogastroduodenoscopy (EGD). Once the procedure is complete and no abnormalities
are identified that could pose a contraindication to placement of the gastrostomy, place the patient in the
supine position and insufflate the stomach with air. (Fig 1)
3. Transilluminate through the anterior abdominal wall to select a gastrostomy site that is free of major vessels,
viscera and scar tissue. This site is usually one third the distance from the umbilicus to the left costal margin
at the midclavicular line.
4. Depress the intended insertion site with a finger. The endoscopist should clearly see the resulting depression
on the anterior surface of the gastric wall. (Fig 2)
5. Prep and drape the skin at the selected insertion site.
Caution: Excess lubricant may cause difficulty in gripping the dilator segments.
Note: Stay perpendicular to the skin while dilating so as not to kink the J-guidewire. Snaring and holding the Jguidewire taut will facilitate passage of the dilators over the J-guidewire during endoscopic placement. During
dilation, the J-Guidewire may be left in place to insure maintenance of gastric lumen access.
1. Use the
#11 safety scalpel blade to create a small skin incision that extends alongside the guidewire,
downward through the subcutaneous tissue and the fascia of the abdominal musculature. (Fig 16) After the
incision is made, lock the scalpel cover in place and discard according to facility protocol.
2. Apply water soluble lubricant at incision site.
3. Advance the serial
dilator over the guidewire. Use a firm clockwise / counter clockwise twisting motion
while advancing to create a tract into the gastric lumen. (Fig 17)
4. Endoscopically verify placement of the dilator tip into the stomach.
5. While holding the serial dilator stationary, grasp the next dilator sleeve and with firm downward pressure and
a clockwise / counter clockwise twisting motion advance the subsequent dilator into the stoma tract. Slide the
segment forward until a physical stop is felt.
6. Advance the red color coded sleeve through the stoma tract and into the stomach.
Placing the Saf-T-Pexy*:
WARNING: THE SAF-T-PEXY* DEVICE CONTAINS 3/0 BIOSYN® SYNTHETIC ABSORBABLE SUTURE THAT IN
NON-CLINICAL STUDIES RETAINED TENSILE STRENGTH TO APPROXIMATELY 75%OF U.S.P. AND E.P. MINIMUM
KNOT STRENGTH AT 14 DAYS AND APPROXIMATELY 40% AT 21 DAYS POST IMPLANTATION. ABSORPTION OF
THE SUTURE IS ESSENTIALLY COMPLETE WITHIN 90 TO 110 DAYS. THE KINETICS OF GASTRIC WALL ADHESION
TO THE ANTERIOR ABDOMINAL WALL RELATIVE TO SUTURE ABSORPTION MUST BE CONSIDERED PRIOR TO
USING THE SAF-T-PEXY* DEVICE WHEN A COMPROMISED HEALING RESPONSE IS ANTICIPATED, ESPECIALLY
WHEN FIXATION OF THE GASTRIC WALL TO THE ANTERIOR ABDOMINAL WALL IS NOT EXPECTED WITHIN 14
DAYS.
Caution: The suture locks may pose a choking hazard. Use appropriate measures to prevent swallowing by
immature or mentally-disabled patients.
Caution: Verify package integrity of each pouch prior to opening. Do not use if package is damaged or sterile
barrier is compromised.
Caution: The SAF-T-PEXY* needle point is sharp.
Note: It is recommended to perform a three-point gastropexy that approximates an equilateral triangle to help
ensure secure and uniform attachment of the gastric wall to the anterior abdominal wall. An alternate pattern will
need to be identified if placing a low volume balloon gastrostomy tube. For additional suture security, a knot may
be tied in the suture strand at the surface of the suture lock.
1. Place a skin mark at the tube insertion site and define the gastropexy pattern by placing three skin marks
equidistant from the tube insertion site and in a triangle configuration. Allow adequate distance between
the insertion site and Saf-T-Pexy* placement so as to prevent interference of the anchor set and balloon once
inflated. (Fig 3)
2. Localize the puncture sites with 1% lidocaine and administer local anesthesia to the skin and peritoneum.
3. Carefully remove the pre-loaded
Saf-T-Pexy* device from the protective sheath and maintain slight tension on
the trailing suture, noting that the suture is held to the needle by a retaining snap on the side of the needle hub.
4. Attach a Luer slip syringe containing 1-2 ml of sterile water or saline to the needle hub. (Fig 4)
5. Under endoscopic guidance, insert the preloaded Saf-T-Pexy* slotted needle with a single sharp thrust through
one of the marked corners of the triangle until it is within the gastric lumen. The simultaneous return of air into
the syringe and endoscopic visualization confirms correct Intragastric position. After confirmation of correct
position, remove the syringe from the device. (Fig 5)
6. Release the suture strand and bend the locking tab on the needle hub. (Fig 6) Firmly push the inner hub into
the outer hub until the locking mechanism clicks into place. (Fig 7) This will dislodge the T-Bar from the end
of the needle and lock the inner stylet into position. (Fig 8)
7. Withdraw the needle while continuing to gently pull the T-Bar until it is flush against the gastric mucosa.
Discard the needle according to facility protocol.
8. Gently slide the suture lock down to the abdominal wall. A small hemostat may be clamped above the suture
lock to temporarily hold it in place.
9. Repeat the procedure until all three anchor sets have been inserted in the corners of the triangle. After the
three Saf-T-Pexy* devices are properly positioned, pull on the sutures to appose the stomach to the anterior
abdominal wall. Close the suture lock with the supplied
hemostat until an audible “click” is heard
securing the suture. Any excess suture may be cut and removed. (Fig 9)
Note: For additional suture security, a knot may be tied in the suture strand at the surface of the suture lock.
Creating the Stoma Tract
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.
Caution: Avoid the epigastric artery that courses at the junction of the medial two thirds and lateral one-third of
the rectus muscle.
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 a PEGJ tube is anticipated.
1. With the stomach still insufflated and in apposition to the abdominal wall, identify the puncture site at the
center of the Gastropexy pattern. With endoscopic guidance confirm that the site overlies the distal body of
the stomach below the costal margin and above the transverse colon.
2. Anesthetize the puncture site (location marked earlier) with local injection of 1% lidocaine down to the
peritoneal surface (distance from skin to the anterior gastric wall is usually 4-5 cm).
3. Insert the
Safety Introducer needle into the gastric lumen. (Fig 10)
Endoscopic Verification:
Use endoscopic visualization to verify correct needle placement. (Fig 11)
Measuring the Stoma Length:
1. Moisten the tip of the
Stoma Measuring Device with water soluble lubricant.
2. Remove the dilator , leaving the guidewire in place and place on a clean surface.
3. Advance the Stoma Measuring Device over the guidewire , through the stoma tract and into the stomach. DO
NOT USE FORCE. (Fig 18)
4. Fill the
Luer slip syringe with 5 ml of sterile or distilled water and attach to the balloon port. Depress the
syringe plunger and inflate the balloon. Pull the device toward the abdomen until the balloon rests against the
inside of the stomach wall.
5. Slide the plastic disc down to the abdomen and record the measurement proximal to the disc. Add an
additional 4-5 mm to the measured shaft length to ensure a proper fit post tube placement. Record final
measurement. (Fig 19)
6. Remove all the water in the balloon and the stoma measuring device leaving the guidewire in place.
Resume Dilation:
1. Resume dilation by advancing the dilator over the guidewire, through the stoma tract and into the stomach
using firm pressure and a clockwise / counter clockwise twisting motion.
2. Continue dilation until all dilator sleeves have been advanced.
3. Twist the dilator hub to release the peel-away sheath from the dilator. (Fig 20)
4. Lubricate the exterior of the peel-away sheath with a water soluble lubricant and advance the sheath through
the tract and into the stomach.
5. Remove the dilator and J-Guidewire, leaving the peel-away sheath in the stomach with the remainder securely
maintaining position through the tract and exiting the stoma site.
Tube Placement:
1. Select the appropriate Kimberly-Clark* MIC-KEY* Low-Profile Gastrostomy Tube while maintaining stomach
and stoma tract access via the pre-positioned peel-away sheath. Peel the sheath down to skin level.
2. Inspect and prepare the gastrostomy tube according to the Kimberly-Clark* MIC-KEY* Gastrostomy Tube
Directions For Use. Advance the tube down the peel-away sheath and into the stomach. (Fig 21)
3. After the gastrostomy tube has been advanced through the peel-away sheath and is in position in the stomach,
peel the sheath away from the tube, remove and dispose of according to facility protocol. (Fig 22)
4. Complete the placement procedure according to the Kimberly-Clark* MIC-KEY* Gastrostomy Tube Directions
For Use.
5. Upon completion of the procedure, refer to the Kimberly-Clark* MIC-KEY* Gastrostomy Tube Directions for Use
for specific instructions regarding use of the device.
Post Procedure:
1. Inspect the stoma and gastropexy sites daily and assess for signs of infection, including: redness, irritation,
edema, swelling, tenderness, warmth, rashes, purulent or gastrointestinal drainage. Assess for any signs of
pain, pressure or discomfort.
2. After the assessment, routine care should include cleansing the skin around the stoma site and gastropexy
sites with warm water and mild soap, using a circular motion, moving from the tube and external bolsters
outward, followed by a thorough rinsing and drying well.
The sutures may be absorbed or they may be cut and removed if indicated by the placing physician. After the
sutures dissolve (or are cut) the suture locks may be removed and discarded. The internal T-bars will release
and pass through GI tract.
Biosyn® is a registered trademark of US Surgical Corporation.
For more information, please call 1-800-KCHELPS in the United States, or visit our web site at www.kchealthcare.com.
For more information about these products, please call 1-800-528-5591 in the United States.
Internationally, please call +801-572-6800
Educational Materials: “A Guide to Proper Care” and a Stoma Site and Enteral Feeding Tube Troubleshooting Guide is available upon
request. Please contact your local representative or Customer Care.
Guidewire Placement:
Note: DO NOT PULL UP on the J-guidewire in the subsequent steps requiring its use as the guidewire could
become dislodged. (Fig 15)
1. Advance the
J-guidewire, J end first, through the needle into the gastric lumen and confirm position.
2. Remove the safety introducer needle (keeping the J-guidewire in place) and activate the safety collar. (Fig 12)
Slide the introducer needle safety collar down the needle shaft while removing the safety introducer needle to
prevent inadvertent needle stick. (Fig 13-14) Dispose of according to facility protocol.
Single
Use Only
Sterilized Using
Ethylene Oxide
Sterile Unless
Damaged or Opened
* Registered Trademark or Trademark of Kimberly-Clark Worldwide, Inc.
© 2007 KCWW. All Rights Reserved.
14-63-769-0-01 / 70083918
Latex-Free
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Instructions