Aim of Type 1 PICD (Cat. No 174773)

Type1 Pre-Induction Cervical Dilator (PICD) is a double balloon catheter that functions as a mechanical device in order to facilitate the IOL process when the cervical conditions are unfavorable. Type1 PICD does not offer the optional use of intra-cervical PG medications. It does not have an injection valve or an opening outlet to the cervical canal.

MECHANISM OF ACTION OF TYPE1 PICD

• Gradual dilatation of the cervix by the pressure applied by the inflated
   balloons, which are located on both openings of the cervix.
• Release of endogenous prostaglandin from the decidua adjacent to the
   inflated uterine balloon.

TYPE1 PICD COMPONENTS

Type1 PICD consists of a double balloon catheter with two corresponding valves the uterine marked U and the vaginal marked V. One balloon is inflated at the location of the internal cervical ostium which is the uterine balloon (1). The second balloon located at the external cervical ostium which is the vaginal balloon (2). For each balloon a corresponding inflating and deflating valve is located at the other extremity of the catheter.
The valves are marked U (3) for the uterine balloon and V (4) for the vaginal balloon. Type1 PICD includes one clamp (5) located at the uterine valve arm. This clamp is used to allow pre-inflation of 20ml of normal saline into the uterine arm. The pre-inflated solution trapped between the clamp (in closed position) and the uterine valve will facilitate the uterine balloon inflation holding the catheter in place with a long forceps while the other hand is free to release the pre-inflated fluid trapped in the catheter uterine arm.

INSERTION TECHNIQUE:

Preparing the device for insertion
Before inserting the device, the clamp located in the uterine arm is closed off. Twenty (20) ml of physiologic saline solution are administered into the region between the U-valve and the clamp
(Fig. A).

Inserting the device and inflating the uterine balloon
With the patient in lithotomic position, insert a large vaginal speculum into the vagina. . Expose the cervix and prepare it for insertion of the device.
The device is then inserted into the cervix and advanced until both balloons have entered the cervical canal up to the demarcation ring (7). The clamp is then released, and manual pressure on the pre-inflated uterine valve forces the fluid into the uterine balloon (1)
(Figure B and C).
Once the uterine balloon is inflated, the device is pulled out until the uterine balloon is held in place against the internal cervical os.

Inflating the vaginal balloon and removing the speculum
At this stage the vaginal balloon is inflated with twenty (20) ml of normal saline and the speculum removed. (Fig D).

Additional inflating of the balloons and fixing the position of the PICD
More fluid is now added to each balloon in turn, in increments of 20 ml, until each balloon contains 80ml of fluid. At that point, the end of the device is being taped to the patient's thigh.
(Figure E and F).

Removing the device
Deflate both balloons through the corresponding valves (marked U and V). It is recommended to begin the procedure of introducing the device late in the afternoon or evening, at the patient's and doctor's convenience. The device is then removed the following morning. After removing the device, a cervical dilatation of 3 cm or greater can be expected.
Warning: The device should not remain in place longer than 12 hours after insertion.

FURTHER LABOR MANAGEMENT

Labor can be induced by artificial rupture of the membranes and by administration of intravenous oxytocin. If the membranes rupture spontaneously before removing the device, deflate the balloons and remove the device since contractions signaling active labor usually develop.

Spontaneous expulsion of the device
Spontaneous expulsion might occur if uterine contractions are regular, active labor has begun, and with cervical dilatation greater than 5 cm. After spontaneous expulsion of the device it is recommended to assess the cervical dilatation and the stage of labor.

Advantages

Type1 PICD offers the following advantages:
• Ripens and dilates the cervix by a mechanical device for better, more
  comfortable results.
• Eliminates the side effects of repeat medications.
• Affords excellent results with minimal discomfort.
• Adapts to contour of the cervical canal for easy insertion.
• Suits patients where prolonged uterine contractions are preferably
  avoided (IUGR, postdates) as well as those who have delivered
  previously by Caesarean section.
• Gives patients the ability to move and walk around while the device in
  place and is ideal for planned overnight cervical dilation and next day
  delivery.
• Is a cost-effective method with high success rates that have been
  documented by clinical trials.
Type1 PICD meets U.S regulations (K040625).