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Suggested Directions for Use
(Ancillary to gastrostomy and other procedures)
"T" Fastener (2 units/kit,
4 total points of attachment)
Each anchor unit is constructed of one-piece nylon. It
consists of a monofilament with bulkier "T" crosspieces molded
at each end, providing two separate points of attachment within the patient.
A single loop of monofilament suture will exit from the skin for each pair
of internally implanted "T" crosspieces. The filament and crosspieces
are impervious to the actions of all body fluids.
Needle Introducer Device with Pistol Grip & Trigger (1 unit/kit)
A specially designed 14 ga. non-coring introducer has a
pistol grip for optimum stability. Its steel cannula resembles a Seldinger
Needle with a 7 mm longitudinal side slot at the tip. This permits the nylon
"T" crosspiece to load within the distal bore, while the monofilament
"suture" exits via the slot and trails alongside the needle. The
trigger-controlled, spring-loaded device's obturator has a machined recess
resembling a biopsy needle's specimen notch to hold the "T." The
leading tip is sharply tapered for a non-cutting puncture.
WARNING: DO
NOT PUNCTURE SKIN WITH THIS DEVICE!
Loading and Testing the "T" Fastener/Introducer
Device
Press the introducer's lock release button, allowing the
trigger to spring forward. The cannula retracts over the obturator, exposing
the "biopsy specimen notch." The nylon "T" crosspiece
is loaded into that recess, with the filament oriented to exit from the
slot. Slowly pull the trigger until it locks into place, securing the obturator
(and the "T") within the bore, with the monofilament suture trailing
outside.
Test the device by pressing the lock release button. The
trigger springs forward. The cannula retracts, exposing (and releasing)
the "T" anchor. The point does not advance further into the
stomach.
Technique of Anchor Placement (X4) for a Percutaneous Gastrostomy.
The patient should have his bowel opacified by oral barium
the previous evening and remain NPO thereafter. Fluoroscopy and/or ultrasonography
are performed to identify and avoid vulnerable organs.
CAUTION: This product
should be used only by a licensed professional after learning the technical
principles, indications, and risks.
The stomach is insufflated with air by nasogastric tube
or gastroscope. Skin markers are placed in a 1-2 cm square surrounding the
planned gastrostomy site after scrubbing with the appropriate antiseptic
solution. Long acting local anesthesia is infiltrated. The skin is nicked,
and a mosquito hemostat is used at each corner for spreading a tissue tract.
The loaded introducer is advanced through the skin defect.
The operator maintains finger tension on the trigger to insure that the
"T" will not prematurely release within tissue. The device is
placed >2 cm into the gastric lumen under gastroscopic or fluoroscopic
control. Press the lock release button, so that the trigger can spring forward.
The trigger finger controls the trigger's movement, either slowing or assisting
the spring's action. The cannula retracts, exposing and releasing the "T"
anchor into the stomach. Rotate the introducer 90°. Reclose the
device fully by slowly pulling the trigger until it locks, and withdraw
the introducer.
Reload the next "T" crosspiece into the introducer.
Maintain gentle traction on the previously placed anchor(s) while introducing
subsequent anchors until all four (and the G-tube) are placed. The two nylon
loops are attached to adjacent skin with minimal tension with sterile and
adhesive strips. The tension should be readjusted daily. The nylon loops
may be used to secure the gastrostomy tube, obviating additional sutures.
Feeding is begun at the physician's discretion. Conventional
devices require 12-24 hours' delay. After three weeks, the sutures may be
cut at skin level. The "T" anchors will intrude into the gastric
lumen for harmless elimination from the body.
Reference
Wu, T.K.; Pietrocolla, D, and Welch, H.F. "A
New Method of Percutaneous Gastrostomy Using Anchoring Devices, American
Journal of Surgery 153:230-232, 1987. |