LacriCATH. Instructions for use.

Directions to use the LaciCATH lacrimal duct catheter.

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Description: …Markings are placed 10 mm and 15 mm proximal to the beginning of the working portion of the balloon, which indicate when the balloon is placed correctly in the lacrimal system. The overall length of the catheter is approximately 24 cm long with a working length of 40 mm. The catheter is available in a 2 mm and 3 mm inflated diameter. The 3 mm balloon has a length of 15 mm and a folded profile of approximately 1.1 mm. The 2 mm balloon has a length of 13 mm and a folded profile of approximately 1.0 mm.

[My note: We measured the location of the black markings on the 3 mm balloon. The working portion of the balloon is marked on either end, and runs from 5 mm to 15 mm from the tip of the Lacricath. The other two black markings are 30 mm and 35 mm from the tip of the Lacricath.–CTL.]

Intended Use: The lacrimal duct catheter is intended for use during dilation of the obstructed nasolacrimal duct to correct epiphora. For patients 30 months and older, the recommended catheter is the 3 mm. For patients under 30 months of age, the recommended catheter is the 2 mm.

1. In patients older than 12 months of age, use of the lacrimal duct catheter is indicated as a primary procedure. In patients under 12 months of age, use is indicated as a secondary procedure following probing or failed intubation.

2. Nasolacrimal duct obstruction.

3. Dacryocystocele.

Contraindications:

1. Lacrimal sac tumor.

2. Dacryoliths

Warnings:

1. Intended for single patient use only. DO NOT REUSE.

2. After use, this product may be a potential biohazard…

3. Infection must be resolved with systemic antibiotics before surgery.

4. Deflate the balloon fully before withdrawing from the nasolacrimal duct.

5. The balloon must not be moved while inflated.

Cautions:

1. Do not exceed the recommended balloon inflation pressure.

2. Do not touch the balloon with instruments as it may puncture.

3. It is highly recommended that before using the lacrimal duct catheter in surgery for the first time, each surgeon reference a procedure overview sheet which can be downloaded from http://www.lacricath.com

Possible Patient Complications:

The potential exists for serious complications including:

1. Excessive bleeding

2. Canaliculi trauma

Procedure:

1. Select size of catheter appropriate for patient (see above).

2. Under general anesthesia, pass a Bowman probe down the nasolacrimal duct into the nose. Confirm the presence of the distal probe in the nose. Remove the probe.

3. CAUTION: Immediately before insertion of the catheter, remove the protective sleeve from the distal end. Lubricate with ophthalmic ointment if needed.

4. The balloon catheter is passed through the canaliculus and lacrimal sac into the nasolacrimal duct and pushed down the nasolacrimal duct to the nasal floor. Confirm the presence of the distal balloon catheter in the nose.

5. The balloon catheter is gradually inflated to 8 atm (bars) for 90 seconds using a primed inflation device filled with 10 cc of sterile saline.

6. Deflate the balloon. If necessary, an additional inflation can be done by gradually inflating the balloon to 8 atm (bars) for 60 seconds and then deflate.

7. Pull the balloon proximally so that it lies within the lacrimal sac extending into the nasolacrimal duct. There are two markings on the proximal catheter shaft which are 10 mm and 15 mm from the beginning of the working portion of the balloon. The punctum is aligned halfway between the 10 mm mark and the balloon. The balloon can also be palpated delicately in the lacrimal location. The balloon is gradually inflated to 8 atm (bars) for 60 seconds.

8. Deflate the balloon. If necessary, an additional inflation can be done by gradually inflating the balloon to 8 atm (bars) for 60 seconds and then deflate.

9. Aspirate all residual fluid to fully deflate the balloon until a vacuum is drawn within the balloon as indicated on the indicator gauge.

10. Rotate the catheter clockwise to reduce the profile of the deflated balloon and withdraw the catheter.

11. Irrigate the lacrimal system with fluorescein and recover in the nose with a #5 or #8 flexible clear feeding tube used as a suction catheter to confirm patency.

12. If irrigation is not possible, another dilatation procedure can be performed using a new catheter.

The above directions are from the package insert for the LacriCATH from:

Quest Medical, Inc.

An Atrion Company

One Allentown Parkway

Allen, TX 75002 USA

(800)627-0226

http://www.lacricath.com

http://www.questmedical.com