Cook Medical G38437 - NEEDLE, ASPIRATION, SINGLE LUMEN, OVUM, EACH

Cook Medical G38437 - NEEDLE, ASPIRATION, SINGLE LUMEN, OVUM, EACH

Ova-Stiff, EchoTip Single Lumen Ovum Aspiration Needle - OSN

Used for laparoscopic or ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles.

• The ergonomic handle provides comfort and control during use.
• The extra-stiff, smooth needle cannula enables precise placement of the needle tip in the follicle.
• EchoTip enhances the visualization of the needle tip under ultrasound.

Contains

A stainless steel single lumen needle supplied with or without vacuum line and/or needle guide (depending on code ordered).

Contraindications

This device should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted disease, a recent uterine perforation, a recent caesarean section, or who is currently pregnant.

Additional Notes

Intended for one time use only. This is a sterile device and should be stored at room temperature away from direct sunlight. If the product package is open or damaged when received, do not use this device. The shelf life of the product is 3 years from the date of manufacture.

Precautions

Where possible, the needle tip should be kept within the stroma or follicles to prevent the aspiration of air into the needle. This minimises the potential for oocyte damage and frothing in the test tube.

Hematuria may occur due to the aspiration needle penetrating a filled bladder during transvaginal ultrasound aspiration. This complication typically resolves spontaneously within a day. Extravasation of urine may occur within the abdominal cavity if a needle puncture traverses the bladder. Patients should be monitored for evidence of this known complication; however, there is typically no associated discomfort or adverse sequelae. Infection may be introduced via needle puncture and result in urinary tract infection (UTI), pelvic inflammatory disease (PID), uterine infection or cystitis. Vaginal bleeding has been reported to be associated with the transvaginal route for oocyte retrieval via needle aspiration. Bleeding is typically easily controlled with direct pressure.

Instructions for Use - Ultrasound Guided Procedure

1. Position the patient in the lithotomy position on operating table. Local or general anaesthetic may be administered as necessary.
2. Carefully remove the needle from the packaging maintaining the sterility of the product.
3. The sterile needle should be inspected for tip sharpness and kinking of any supplied tubing.
4. Connect the needles vacuum tubing to a vacuum pump. The vacuum used with a specific gauge and/or type of ovum pick-up needle is at the discretion of the clinician performing the procedure.
5. For needle sets, fit the silicone stopper onto the collection tube (designed to fit 15 mL Falcon tubes).
6. The aspiration system should be tested for patency by placing the tip in a spare test tube containing approximately 5 mL of culture medium and applying vacuum. Before proceeding, change the collection test tube.
7. Introduce an ultrasound transducer into the vaginal fornix to visualise the ovary and follicles. Identify the follicles to be aspirated. Check for the presence of blood vessels in and around the ovary and determine a direct path into the ovarian follicles to be aspirated.
8. Insert the aspiration needle or guide needle into the transducer needle guide. Ensure the tubing does not become kinked during use. Puncture vaginal wall with needle or guide needle. If guide needle used, advance aspiration needle in preparation for follicle puncture.
9. Following visualisation of the follicle to be aspirated, line up the follicle using the needle guide on the ultrasound monitor and advance the needle tip into the centre of an ovarian follicle via a rapid, stabbing motion. The combination of the needle bevel and Echotip enhances visualisation of the position of the needle tip. The handle indent indicates bevel orientation as well as facilitating grip.
10. Apply vacuum to aspirate the follicular contents into the test tube. As the follicle collapses, rotate the needle tip within the follicle to curette the follicular walls. If required the follicle can be flushed, as described below. Repeat steps 9 and 10 on the remaining follicles. Follicle Flushing:
• Use a non-toxic syringe filled with a follicle-flushing buffer. Flush through the aspiration line.
• With the needle tip in the collapsed follicle, slowly inject (1-2 mL per second) the flushing medium to refill the follicle.
• Replace the stopper (if removed) and aspirate the follicular contents.
11. Withdraw the needle from the patient and reposition the transducer to visualise the remaining ovary. Repeat steps 8 to 10
12. At the completion of the aspiration procedure, remove the needle from the ultrasound guide, rinse with flushing buffer and then discard in an appropriate sharps container.

Laparoscopic Procedure

• Position the patient in the lithotomy position.
• Follow steps 2 through 6 as previously described.
• Under laparoscopic guidance, make a small skin nick to assist placement of the trocar/cannula.
• Place trocar/needle assembly through the abdominal wall in the desired location. Remove trocar if used while leaving the cannula in place.
• Under laparoscopic vision, place the needle through the abdominal cannula and advance needle tip into the ovarian follicle.
• Using a vacuum unit, aspirate and/or flush the follicle to obtain the oocyte. Repeat steps 5 and 6 on the remaining follicles and ovary.
• When the desired number of oocytes has been aspirated, remove the needle rinse and discard.