WO2009103298A2

WO2009103298A2 - Soliman-mourad intra-abdominal balloon device

Info

Publication number: WO2009103298A2
Application number: PCT/EG2008/000009
Authority: WO
Inventors: Mohammed Mourad Youssif; Hossam Hassan Soliman Saad
Original assignee: Mohammed Mourad Youssif; Hossam Hassan Soliman Saad
Priority date: 2008-02-18
Filing date: 2008-02-18
Publication date: 2009-08-27
Also published as: WO2009103298A3; WO2009103298A4

Abstract

The balloon device is composed of two balloons located intra-abdominally, an anterior balloon that should fit to the anterior uterine wall, and a posterior one that should fit to the posterior uterine wall. The aim of the device, is compression of the Anterior uterine wall against the posterior one, thus minimizing uterine bleeding by closing the blood sinuses and opposing the bleeding surfaces tightly against each other. A closed none laparotomy technique could be adopted in which slight further modification could be done, through insertion of a posterior pelvic intra-peritoneal balloon through a Douglas pouch incision done from the vaginal side and inflated to compress the uterus anteriorly against a balloon or band, or garment around the lower anterior abdominal wall. The balloon device can be inflated by gas or fluid and can be left from few hours up to few days.

Description

Soliman-Mourad intra-abdominal balloon device

Technical field

In the field of obstetrics ladies are exposed to the risk of extensive morbidity and even mortality because of postpartum hemorrhage.

Postpartum hemorrhage is considered one of the biggest challenges for an obstetrician, being the leading cause of maternal mortality all over the world, it is also considered as the first cause of maternal mortality in the developing world.

Some times all measures to control intractable postpartum hemorrhage fail leading to maternal death, sometimes hysterectomy would be the only possible solution, yet some ladies would unfortunately have one living baby, or even no babies at all, consequently they could loose their capability to get pregnant and to deliver a baby, which could lead to severe personal and family problems, in addition hysterectomy by itself is a major operation which could be followed by many recognized complications that in itself could lead to maternal mortality and morbidity.

To regain a uterus capable of contracting once again, the lady has to partially restore her general condition and to have once again a rising hemoglobin level, even if hysterectomy is a must as in cases of damaged uterus, the general condition, hemoglobin and the blood pressure must be improved before proceeding to hysterectomy. That could only be attained by aggressive blood and fluid transfusion, and in the same time minimizing any uterine blood loss. Background Art

Many physical methods and procedures have been tried in the overwhelming attempts of the Obstetricians to combat the lethal postpartum hemorrhage, after exhausting away all medical uterotonic and ecobolic drugs.

The physical methods include the B-lynch operation and it's modification in which the anterior and posterior lower uterine walls are held together tightly by surgical strings passing around above the fundus, yet this invasive procedure was reported to be a cause of uterine gangrene and uterine wall injury due to the sharp flesh cutting effect of the strings, in addition it requires much experience and training. Another balloon method that was tried for some time, yet didn't gain much publicity is the Bakri intrauterine balloon, in which a balloon is placed inside the uterine cavity and inflated aiming to compress the bleeding atonic intrauterine walls, yet ignoring the distensible nature of the atonic uterus with no existing counter pressure from outside the wall to limit that distensibility and exert any compressing effect to the inside, which is considered as a completely different mechanism of action, using only one balloon placed inside the uterine cavity. Disclosure of Invention

The Soliman - Mourad balloon device is composed of two latex or rubber balloons, an anterior and a posterior one, both balloons are interconnected together at the upper poles by a tough yet malleable and flexible rubber or latex. The lower poles of both balloons are free with a nosel connected to a rubber inflation/deflation catheter. The balloon device is designed so that when both balloons are inflated, compression of the anterior uterine wall against the posterior one occurs, thus compressing and closing the blood sinuses and opposing the bleeding endouterine surfaces tightly against each other. Once the balloon located in place, the inflation/deflation catheters pass into the vagina, in a fashion that the catheter of the posterior balloon pass through an incision in the Douglas pouch, whereas the catheter of the Anterior balloon pass either through an incision in the Anterior fornix of the vagina into the vagina after dissecting away the urinary bladder, or through a very small incision in the lower uterine segment or the incision line in case of Caesarean section.

Both catheters are fixed by a clamp holding them together at the vulval level. In absence of laparotomy , a modified closed technique could be followed, a balloon is inserted intra-peritoneally within the pelvic cavity into the Douglas pouch through the vaginal route, with it's nosel and inflation/deflation catheter passing out through the vulva. A forth balloon can be tightly squeezed upon the lower anterior abdominal wall at the pelvic level to assist in further squeezing the Anterior uterine wall the balloon is inflated and a strong band or garment is wrapped tightly around the circumference of the lower abdomen and pelvis in order to squeeze both the anterior and posterior uterine walls between the balloon posteriorly and the band or garment anteriorly.

Such inflated balloons are effective in markedly decreasing postpartum hemorrhage, it can be left from few hours up to few days and can simply be removed by deflation and withdrawal through the incision at the Douglas pouch by exerting traction on the posterior balloon catheter thus pulling the device out of the vulva. Brief Description of Drawings

Figure 1 , is a photo of a simplified model of the invention. The view is a lateral sagital view of the uterus and the device, in which the Anterior balloon can be seen in orange color within a transparent thin plastic bag and carrying the number(l), where as the orange posterior balloon can be seen within a thin plastic bag (half white, half transparent) and carrying the number(2), the upper poles of both balloons are connected together by a transparent thin elastic plastic sheet that covers the uterine fundus(4), where as the uterus is seen in orange compressed between both balloons and carrying number(3). The inflation/deflation catheters are seen in yellow and should be coming out of both the anterior and posterior vaginal fornices. Figure 2, represents a model of the two balloons used in the none laparotomy closed technique, where ballon(5) should be located in the pelvic cavity within the peritonium of the Douglas pouch inserted from the vaginal side through a very small incision with it's inflation/deflation nossel and catheter passing out of the vulval ring. Balloon(6) is the one that should be located on the lower anterior abdominal wall from outside to compress the uterus against balloon(5) in the Douglas pouch. Instead or in association with balloon number(6) the Anti-shock garment can be used.

Claims

1 - An intra peritoneal balloon system, located within both the pelvic and abdominal cavity.

2- Both Anterior and posterior uterine walls are surrounded by balloons expressing strong squeezing pneumatic or hydrostatic pressure on the uterine walls and the fundus from outside.

3- A closed technique can be done in which a balloon can be inserted intra - peritoneally within the Douglas pouch through an incision in the posterior vaginal fornix without the need for laparotomy. The uterus may be squeezed against an outside band or balloon tightly located on the lower anterior abdominal wall .

4. The balloons can be pulled out through the vulva after deflation without the need to open the abdomen even in the cases in which the open laparotomy technique was adopted for insertion.

5- A second balloon should be located on the abdomen from outside to compress the anterior uterine wall against the one located in the Douglas pouch.

6- The balloon device can be inflated by Gas or fluid.

7- Further extra balloon can be located and inflated inside the uterine cavity in the same time with the external balloons to increase the uterine wall squeezing effect.

8- A manometer should be connected to the Balloon catheters to control the pressure limits according to the requirement and situation.