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Page 2 of 5 Tzabari et al. Mini-invasive Surg 2018;2:9 I http://dx.doi.org/10.20517/2574-1225.2018.11

the uterus, their tissue architecture is different: smooth muscle in the lower third of the cervix is 6.4%, 18%
[2]
in the middle third and 28.8% in the upper third, in the body of the uterus it is 68.8% . The muscle tissue
of the uterus is different from other striated muscles in the body. It is retractile, which means that it is able
[3]
to rest while being contracted . The cervix does not function as other sphincters in the body and expands
[4]
passively and gradually as it is a fibrous organ which contains hyaluronic acid, collagen and proteoglycan .
Most intrauterine procedures need dilatation of the cervix in order to be able to introduce optical or surgical
devices. As most of the cervix is composed of fibrous tissue and just small part of it is muscle, dilatation of
the cervix without being originally primed by hormones as is the case during delivery, is certainly a non-
physiological process. Therefore it is common that cervical dilatation by itself is associated with crucial pain
[5]
if anesthesia is not used and involves the risk of the cervical incompetence in the future .

The cervical incompetence as the result of dilatation with Hegar rods and curettage is likely to be due to the
damage occurring from the stretching of fibrous tissues of the cervix in two directions (longitudinal and
[6]
transverse) .

Using laminaria causes only tranverse streching of the tissues and the dilatation occurs gradually over
several hours. Gradual dilatation and softening of the dilating cervix reduce the risk of injuries and
[7]
perforation ; anesthesia is not needed, however two sessions are mandatory for insertion and removal and
dilation procedure takes several hours.

Both Hegar rods and laminaria have been in use for many years for dilatation. Recently, a new method was
introduced. It is a 3-mm diameter triple balloon which is easily inserted into the uterus, anchored; and the
two dilating balloons are inflated with saline creating lateral pressure of up to 6 bars which results in gradual
dilatation of the cervix up to 8-9 mm within 5-7 min. The method is less painful and anesthesia usually is
not needed unless surgical procedures are planned.

METHODS
Subject selection
The study included 15 women undergoing termination of pregnancy for different indications.

Inclusion criteria
1. Females with 18 years of age or older;
2. Subjects undergoing termination of pregnancy;
3. Subjects willing to sign informed consent form.

Exclusion criteria
1. Subjects younger than 18 years of age;
2. Subjects unwilling or unable to sign the informed consent form.

Description
The device is compound of three balloons and a catheter. The distal balloon anchors the device in its place
beyond the internal Os. Two elongated dilating balloons are designed in order to enable efficient dilation
of any cervices ranging in length from 3 to 7 cm. The outer diameter of the deflated semi-rigid catheter is
7 French (2.3 mm), enabling easy insertion of the catheter in the cervical canal. Prior to the dilation, the
dimeter of the cervix is measured with calibrated Hegar rods.

The catheter with deflated balloons [Figure 1] is inserted through the cervix into the uterus. An anchoring
balloon is inflated through the “anchor channel” [Figure 1] with 2.5 mL syringe with 1.5 mL of saline