WO2021091501A1

WO2021091501A1 - A method for the treatment of uterine atony by electrostimulation and a corresponding device

Info

Publication number: WO2021091501A1
Application number: PCT/TR2020/050023
Authority: WO
Inventors: Ali Sahap ODACILAR; Eylem ODACILAR
Original assignee: Odacilar Ali Sahap; Odacilar Eylem
Priority date: 2019-11-04
Filing date: 2020-01-13
Publication date: 2021-05-14

Abstract

The invention is a method and a corresponding treatment device for treating uterine atony, which is one of the most important causes of postpartum bleeding, by electrostimulation and it is characterized by a treatment device that allows placing the electrode or electrodes on its uterus to be adjacent to the proximal portion of tubas, transmitting the electric current from the main unit to the electrode, inducing the myometrial contraction by the electric currents spreading from the electrode ends to the uterus, retraction of myometrium with contraction and shortening of it, rapidly cross contracting, flexing and obstructing of uterine veins with the contraction of myometrium fibers and stopping the bleeding.

Description

A METHOD FOR THE TREATMENT OF UTERINE ATONY BY ELECTROSTIMULATION AND A CORRESPONDING DEVICE

Technological Field:

The invention relates to treating uterine atony, which is one of the postpartum bleeding reasons named postpartum hemorrhage.

This invention relates to a method for the treatment of uterine atony, which is one of the most important causes of postpartum bleeding, by electrostimulation and a corresponding treatment device. The State of the Art:

It is stated that today the rate of global maternal mortality occurring during childbirth is about 250,000-300,00 annually 90-95% of these maternal deaths occur in low and middle-income countries and the maternal mortality rates in these regions are unacceptably high. For example, this rate is 1/31 in the Sub- Saharan Africa regions and 25% of these deaths are due to postpartum hemorrhage. Except that postpartum hemorrhage causes maternal mortality, it can also cause complications such as renal failure, liver failure, consumption coagulopathy, hypovolemic shock and ARDS (Acute Respiratory Distress Syndrome). ACOG (The American College of Obstetricians and Gynecologists) has defined postpartum hemorrhage (PPH) as an expected blood loss of 500 ml and more in vaginal delivery and of 1000 ml and more in cesarean delivery. PPH is divided into itself as primer (within 24 hours after birth) and seconder (between 24 hours after birth and first 12 weeks). 5%15 of all deliveries are complicated with PPH. The causes of PPH can be sorted as uterine atony (80% for this reason), placenta retention, genital tract traumas, uterine rupture, uterine inversion, consumption coagulopathy, inherited or acquired bleeding disorders. As stated above, the most important cause of PPH is uterine atony. Uterine atony is an important, unforeseen and life-threatening postpartum bleeding cause whose risk factors are known, but its pathophysiological mechanisms have not been completely resolved. The subject matter of the invention presents a method and a device for treating uterine atony.

It is known that nowadays the medicines used as primary care for the medical treatment of uterine atony are oxytocin, ergot alkaloids (methergine) and misoprostol. If the patient is stable, the other treatment options are, if required, blood and blood product transfusion, haemostatic agents, pelvic arterial embolization, uterine tamponade (bakri tamponade balloon catheter or foley catheter), massive transfusion protocol, laparotomy (uterine artery ligation, B- Lynch with the aim of compression or square suture, internal iliac artery ligation), bimanual uterine compression, aortic compression or pelvic packaging, hysterectomy and NASG (nonpneumatic antishock garment). The success of the treatment options listed above is relative and they are thought- provoking in terms of the side effects resulting from their use. The treatment methods, which are highly dependent on human ability, always create risk factors.

In the known art, oxytocin is the most frequently used medical agent in the treatment of dose-dependent labor induction, cervical maturation and postpartum hemorrhage. The amino acid structure of oxytocin resembles arginine vasopressin. Therefore, it has a clear antidiuretic effect. In the control of PPH, there is a high dose need and accordingly, it can create a water intoxication picture. This situation can lead to convulsions and deaths. In the acute developing PPH cases, as a result of its IV push usage without being diluted with the aim of rapid effect, it can cause hypotension, myocardial ischemia and chest pain. In hypotensive cases, its usage is contraindicated and in PPH cases, its usage is limited due to hypotension occurring as a result of high blood loss. Also, when this agent is used for labor induction, it raises the atony risk and a high dose of this agent is again needed in the treatment of resultant atony. This situation is the best example of being remained incapable of uterine atony treatment under today’s conditions.

Misoprostol (prostaglandin E1), this agent used in peptic ulcer treatment is among the leading medical treatment options in the uterine atony treatment. Previous uterine surgery and cesarean create contraindication for its use. Among its side effects, there are life-threatening complications such as uterine tachysystole and uterine rupture. Ergot alkaloids (methergine), this agent cannot be used, because it increases the blood pressure in hypertensive patients. Among its side effects, there are pulmonary edema, convulsion, intracranial hemorrhage, retinal detachment and coronary spasm. In the general view of the most frequently used medical agents, there is no option that can be accepted as a gold standard for the patient.

When the surgical methods that can be used in the uterine atony treatment are investigated, because it requires high surgical experience the need for experienced surgeon and the rise of maternal morbidity that can arise due to the procedure-related complications (such as ureter ligation, vein injury) make this treatment solution a challenging and relatively risky situation. Uterine curettage, which is one of the surgical methods, is the removal of the uterus and this means that no further labor can be performed. This method, which is used in the cases of necessity, can be very upsetting for the patients. Although the removal of uterus from the patient resolves the problem in some cases, it cannot be mentioned as a treatment method. This situation is the same as the elimination of the problem by cutting the arm of a patient having a broken arm. This is not an acceptable situation taking into account today’s technology and possibilities. As a consequence, there is a need for a treatment method in which the state of art for the uterine atony treatment is overcome and its disadvantages are eliminated. The Brief Description of the Invention:

The invention is a treatment method for uterine atony treatment, in which the state of art is overcome, its disadvantages are eliminated, additionally involves extra advantages and a corresponding treatment device.

The object of the invention is to present a new device that provides a treatment method by electrostimulation for the treatment of uterine atony leading to postpartum PPH. Another object of the invention is to present a new device that provides retraction and shortening together with contraction by applying electrostimulation to myometrium in the uterus with the aim of rapid cross contracting, flexion and obstruction of uterine veins. Another object of the invention is to present a new method that provides treating of uterine atony in patients independently of surgeon’s ability.

Another object of the invention is to present a new treatment device that provides a treatment method for treating uterine atony efficiently without causing any side effects in patients.

To perform all objects that are mentioned above and will appear from the following detailed description, the present invention is a method and a corresponding treatment device for treating uterine atony, which is one of the most important causes of postpartum bleeding, by electrostimulation and it is characterized in that it comprises at least one electrode that provides contraction in uterus myometrial fibers by electric currents it receives from the main unit and placed on its uterus to be adjacent to the proximal portion of tubas, comprises battery that provides energy supply to the electrode and is situated in the main unit, comprises a control panel in which the frequency and voltage intensity of current from electrodes to uterus can be adjusted and are situated in the main unit, comprises a control card in the main unit, which provides to be able to transmit electric currents from battery to the electrodes by processing the commands coming from the control panel and/or the software loaded on it and comprises the connection section in which the electric current can be transmitted from battery to electrodes with the help of wired or wireless networks.

The Description of Drawings:

The invention will be described by referring to the appended drawings, thereby the features of the invention will be clearly understood. However, it is not intended to limit the invention to these certain embodiments. On the contrary, it is intended to cover all alternatives, modifications and equivalents which may be included within the scope of the invention defined by the appended claims. It should be understood that the illustrated details are shown with the aim of describing only preferred embodiments of the present invention and these are presented with the aim of providing the most practical and easy to understand the definition of both method designing and the rules and conceptual features of the invention. In these drawings; Figure - 1 is the representative view of the treatment device according to the invention.

Figure -2 is the view illustrating the situation in which the treatment device according to the invention is applied to the uterus. The figures, which will help to understand this invention, are numbered as shown in attached drawing are given below with their names. The Description of References:

I. Treatment device lO.Main unit

II. Battery

12.Control card

13.Control panel

14.Connection section

15.Connection cable

16. Electrode

A. Uterus

B. Tuba

C. Myometrium fibers

The Description of the Invention:

In this detailed description, the treatment device (1) of the present invention is described with examples such that they will not create any limiting effect only for a better understanding of the subject. In this description, a method for the treatment of uterine atony, which is one of the most important causes of postpartum hemorrhage, by electrostimulation and a corresponding treatment device (1) is described.

In Figure 1 , the view of the treatment device (1) according to the invention is given. According to this, the treatment device (1) involves the electrodes (16) connected by the connection cables (15) to the main unit (10) over the connection section (14.) The number of the electrodes (16), particularly at least one electrode, can be used in the desired and needed numbers. The main unit (10) transmit low voltage electric current (such that it will not create an electric shock effect in the human body) to the electrodes (16) over the connection cables (15) The energy supply of the electric current is provided from the battery (11) situated in the main unit (10). The frequency and voltage intensity of the electric current can be adjusted over the control panel (13). The control card (12) allows the transmission of the electric current to the connection cables (15) from the battery (11) by processing the commands coming from the control panel (13).

In Figure 2, the view showing the situation, in which the treatment device (1) according to the invention is applied to the uterus (A) is given. Accordingly, the electrodes (16) connected to the main unit (10) of the treatment device (1) according to the invention with the connection cables (15) is situated in the adjacent proximal portion of the uterus (A) tubas (B). The low voltage electric current is transmitted from the main unit (10) to the electrodes (16). The uterine veins are surrounded by the fibers (C) in the myometrium in the shape of a transverse lattice. The electric currents spreading from the electrode (16) ends to the uterus (A) induce the myometrial contraction. Myometrium is subjected to the retraction along with the contraction and it becomes shorter. The uterine veins are cross contracted rapidly, flexed and obstructed with the contraction of myometrium fibers (C). By this means, the uterine atony is treated and the bleeding is stopped. With the aim of stopping the bleeding more efficiently, the stimulation degree to the uterus (A) can be adjusted by changing the frequency and intensity of the electric current coming from the electrodes (16) over the control panel (13).

In the figures, it is seen that there are two electrodes (16). The numbers of the electrodes (16) can be increased and decreased. As well as the voltage value and frequency of the electric current given to the electrodes (16) can be adjusted by the surgeon over the control panel (13), they can be adjusted by software loaded on the control card (12) in accordance with the automation. It is found appropriate that the electric current given the uterus (A) with the electrodes is in the range of 0-20 milliampere. Alternatively, the electric current can be transmitted to the electrodes (16) from the main unit (10) by the wireless network methods, thereby the problem of cable resistance is avoided. However, the invention is preferably used with connection cable (15), because it is a safer method.

Claims

1- The invention is a method and a corresponding treatment device (1) for the treatment of uterine atony, which is one of the most important causes of postpartum bleeding, by electrostimulation, wherein it is characterized in that;

- it contains at least one electrode (16) situated in its uterus (A) to be adjacent to the proximal portion of tubas (B), which provides contraction in uterus (A) myometrial fibers by electric currents it receives from the main unit (10), - it contains the battery (11) situated in the main unit (10), that provides energy supply to the electrode (16),

- it comprises a control panel (13) situated on the main unit (10), in which the frequency and voltage intensity of current that the electrodes (16) will give to the uterus (A) can be adjusted, - it comprises a control card (12) in the main unit (10), which provides to be able to transmit electric currents from the battery (11) to the electrodes (16) by processing the commands coming from the control panel (13) and/or the software loaded on it,

- it comprises the connection section (14) in which the electric current can be transmitted from the battery (11 ) to the electrodes (16) with the help of wired or wireless networks.

2- A treatment device (1) as in Claim 1 , wherein the electric current between the battery (11) and the electrode (16) is provided with the connection cable (15).

3- A treatment device (1) as in Claim 1 , wherein the electric current transmission between the battery (11) and the electrode (16) is provided with any one of the wireless network methods. 4- A treatment device (1) as in Claim 1 , wherein the electric current given to the uterus (A) with the electrodes (16) is in the range of 0-20 milliampere. 5- The invention is a method for the treatment of uterine atony, which is one of the most important causes of postpartum bleeding, by electrostimulation, and a corresponding treatment device (1), wherein it comprises the following procedure steps;

- placing the electrode (16) or electrodes (16) on its uterus (A) to be adjacent to the proximal portion of tubas (B),

- transmitting the electric current from the main unit (10) to the electrode (16),

- inducing the myometrial contraction by the electric currents spreading from the electrode (16) ends to the uterus (A), - retraction of the myometrium with contraction and shortening of it,

- rapidly cross contracting, flexing and obstructing of uterine veins with the contraction of myometrium fibers (C) and stopping the bleeding.