MXPA99008930A - Delivery preparation and facilitation device and preparatory gymnastics - Google Patents

Abstract

The present invention pertains to a device for preparing a pregnant woman to delivery and facilitating the delivery itself. Said device comprises an entirely expandable stretch body, which is positioned in the expulsion area of the urogenital canal in such a way that it is partly inside the vagina and partly outside. The invention also relates to a preparatory gymnastics method involving the inventive device.

Description

DEVICE FOR PREPARING CHILDBIRTH AND FACILITATING CHILDBIRTH, AS WELL AS METHOD FOR PREPARATORY GYMNASTICS LIGHTING Description of the invention The invention relates to a device for preparing and facilitating the delivery of the pregnant woman which comprises an expandable oblong body that can be placed in such a way in the region of the exit of the pelvic row that is partially found inside the vagina and partially outside of it; It is also related to a method of preparatory gymnastics of childbirth through the use of a device of this nature. In the Federal Republic of Germany there are around 850,000 births per year. According to the most recent data available from the 1995 perinatal statistics, the frequency of perineotomies that are practiced in the case of primiparous and multiparous women is 58.9% in total (without taking into account the frequency of 17.4% of the section (cesarean section)). This means that approximately 500,650 perineotomies are carried out annually in Germany (Kommission für Perinatologie und Neonatology BPE-Jahresbericht 1995). In the case of approximately 20% of all deliveries, a perineal tear must be added to this, due to which morbidity is increased further (risk of consequential damage).

Despite numerous traditional and modern methods for the preparation of childbirth and the facilitation of childbirth (eg READ, LEB0YER, 0DENT), the figures mentioned above have remained almost unchanged in their mutual relationship for decades. Even the modern preparatory exercise of childbirth during pregnancy and the advice of pregnant women by the midwives have only been able to improve these figures insignificantly. The perineotomy (Episiotomy) described for the first time in 1742 by OULD has not lost anything of its fearsomeness even after 250 years. Even when it was considered and carried out as a "relief" for the woman, and to accelerate the delivery, it is still feared by many women for the painfulness that results, and hated for its serious consequences. For this reason, avoiding perineotomy is a need long cherished by the specialized sector, with the purpose of facilitating labor for the parturients and making them less distressing. An additional problem for modern childbirth aid lies in the fact that the disproportion between the infantile head and the female pelvis is increasing. The cranial circumference of newborns is constantly increasing, so the measurement program developed by HAUSMMN for the normal sizes of the biparietal diameter (BIP) in the ultrasound should be continuously modified upwards. The reason for this could be due, on the one hand, to the ever-increasing flood of lights, noises and irritations to which pregnant women are exposed; on the other hand, the type of modern androgynous woman who is currently natural (tall, narrow female pelvis, and slender waist), which naturally hinders childbirth. For the treatment of the discomfort of (esplacno) ptosis and incontinence in women, it is known to introduce an inflatable balloon deep inside the vagina in order to cause a mechanical closure of the urinary bladder with the latter in the inflated state. lifting of the matrix. For example, EP 0663197 A1 discloses a stable support body of elastic rubber material, with regions of different wall thicknesses, than from a base area with which a piece of hose is attached in an obturating manner. it widens conically in the direction toward a cover surface at the other end of the support body. The cover surface is reinforced annularly and has a soft inner region of concave configuration. The support body is inserted into the vagina with the base facing down, and left for hours is your place to support the wall of the vagina.

In US Pat. No. 3,626,949 Al, a cervical dilator is disclosed, which, however, has not transpired in practice. It is a PVC wrap with hose connection to be filled with a fluid medium under pressure. The sheath is inserted bent into the cervical canal and then periodically widened under pressure, whereby the envelope expands radially against the wall of the uterus simulating uterine contractions (labor pains). Between opposite ends of the sheath is a non-expandable waist in the radial direction that is placed within the edge of the cervix (uterine or tench snout), thereby preventing the expanded waist from deviating in the axial direction under pressure. Another cervical dilator is described in US 3480017 Al. This uses a casing that can be inflated to form a substantially discoid body that during use is placed inside the uterine orifice and inflated by a filling tube that is provided with openings for inside the envelope. The envelope has a surrounding groove, so that a groove is formed in the cylindrical outer wall of the inflated envelope to the disc shape. The opening of the uterine orifice supported in the groove must be able to expand in this way in order to start labor. The use of the known device is only possible by a physician with practice in, by means of the handle formed by the filling tube, carefully moving the sheath towards the cervix without injuring the amniotic sac or the infant head. Due to its discoid flat shape the cervical dilator is only suitable particularly for this application. A dilator insertable into the perineum described in document FR-592104-A is constituted by an oblong balloon of elastic material which, even when inflated, can be laterally widened, is limited in its longitudinal expansion. By means of a methodical use and a progressive expansion it is possible to achieve with it that the tissue exercised in this way gives way during the birth without tearing. For this it is also possible to activate the balloon intermittently through a three-way valve. During use, care must be taken that the balloon is only inserted so much into the vagina that its central section fits into the region of the perineum. When inflated, the balloon must form within the perineum a constriction by means of which it is fixed in the axial direction. In the design of the ball with a central filling tube there is a danger that its inner end is pushed too close to the tench snout (portio uteri) when it is inserted, where serious injuries are possible (bleeding, spontaneous rupture of the bag amniotic). In the case of the design of the balloon with internal straps resistant to traction that prevent its longitudinal expansion, there is a danger that from a certain degree of inflation, the balloon will be catapulted suddenly towards the inside in the direction of the uterine orifice, in where the serious injuries already referred to can occur. Accordingly, the known device should only be used under medical supervision, since by virtue of the corresponding abdominal circumference it is also practically impossible for the pregnant woman to find the correct axial position of the balloon. Faced with this situation, the task of the present invention consists in structuring the device of the type under consideration so that its use is pleasant and free of risks for the pregnant woman, and that it can be easily carried out by herself.; Finally, it should substantially contribute to avoid perineal tears or episotomies that are accompanied by labor. Parallel to this should be counteracted unwanted ptosis of the floor of the pelvis, urinary incontinence that ensues later, and sexual disorders due to organic and psychosomatic complications that occur postpartum. This task is solved by a device with the features of claim 1, as well as by a method with the features of claim 13. The device according to the invention is formed by an expandable notched oblong body that can be placed in the region of the exit of the pelvic row, so that it is partially inside the vagina and partially outside of it. By expanding the oblong body it is possible to transiently expand the vaginal canal and preexpand the pelvic row as well as the hymenal limbus to facilitate labor. With this effect of exercise and expansion, episiotomies and perineal tears can be avoided to a large extent, as well as the unwanted ptosis of the pelvic floor and the sequelae that go along with it. In this the expandable body is kept at a distance from the cervix, which in no way should touch to avoid irritation. Due to the fact that the expandable oblong body is notched, since its waist serves to accommodate it in the region of the hymenal limbus, the device is self-centered and self-reliant in the region of the hymenal limbus. This can be achieved, for example, by means of a body configuration in the form of an 8"on its longitudinal axis.For this it is important that the expandable body can be expanded in its entirety, that is, even by its waist, since it is Precisely because of this it is possible to specifically exercise the expansion in the region of the pelvic row In accordance with an advantageous development, it is provided that the body can be expanded by a variable fluid filling. example, liquid or watery liquids that are eventually tempered, or gases such as air.In special cases you can also use the breath air that is insufflated with the mouth.It is also convenient that the body is configured as a ball whose end oriented outside during use is connected a filling hose.As a harmless material pleasant to the skin is applicable, for example, latex or a silicone product. According to a preferred embodiment, the balloon is composed of two half shells which are joined to one another along a circumferential edge.

Conveniently the circumferential edge is disposed in the region of the waist. In this, the half that is located outside the vagina can have a wall thickness greater than the half that is inside. This ensures that the balloon self-stabilizes when the pressure increases, and that a slight increase in pressure leads to vaginal dilation. Another advantageous embodiment provides that the device comprises an air pump with a pressure gauge connected to the balloon filling hose. By means of the boma, which for example can be made as a manual operation pump, the expandable body can be inflated step by step up to a maximum pressure that fluctuates around approximately 160 mm Hg and whose reading is provided by the manometer. An air bleed screw which serves to release the pressure after the therapy is completed or as a discharge during use is conveniently provided on the manometer. Finally, it should be noted that the maximum expansion of the balloon transversely to the longitudinal axis is from 9 to 10 cm, preferably from 9.4 to 9.6 cm. This corresponds approximately to the average diameter of a baby head with a circumference of approximately 35 cm at birth.

Another improvement provides that a safety valve is provided in the pressure gauge in order to limit the maximum pressure. The pressure is limited for this, for example, to 200 mm Hg. If the limit pressure is exceeded, the safety valve opens. According to another convenient embodiment, the balloon composed of two half sheaths is structured so that the half sheaths form two chambers separated one from the other in a gas-tight manner. By means of this it is possible to fill and empty the cameras in each case independently of each other, by means of which the balloon can be individually adapted to the needs of the patient. For this purpose, the hose provided to fill and empty the half sheath placed inside the vagina is passed through the other half sheath. Both hoses then exit the end of the ball facing outwards. This device is suitable especially for patients who have already given birth and in whom the perineal tear occurred in previous deliveries has caused large and painful scarring. It is convenient to fill this device alternately by pumping this device in pressure graduations of 10 mm, in order to exert a reciprocal effect on the outlet of the vagina. An advantageous development of this embodiment is that the half-sheath that is inside the vagina can be inflated by an independent hose. For this, the independent hose can either extend outside the device, or extend through the inside of the half sheath that is outside the vagina, so that both hoses come out on the outside of the pelvic row . In addition, a variant is advantageous in which both hoses extend concentrically one inside the other. Finally, it is convenient that the device has a three-step valve to select the filling mode of both sheath halves. In this way, it is possible to fill both sleeve halves independently of each other independently or simultaneously. The reading of the inflation pressure for the corresponding filling mode can be carried out in each case on the manometer. The deflation sequence can also be selected using the three-way valve. In the case of concentrically extending hoses, a three-way valve whose construction has a corresponding structure can be provided. In addition to the device described above, the invention still relates to a method of preparatory calving gymnastics, the device according to the invention finds its application so that the expandable body is placed partially on the outside and partially inside the limbus hymenal, it then expands to a desired expansion and finally remains for a certain time in its position in the expanded state. Conveniently the expansion of the device increases each time the use of the device is repeated in order to achieve a progressive increase in the preexpansion of the pelvic row. The process that can be carried out as an expansion exercise should be done several times a day from the 36th week of pregnancy. Additionally, it is advantageous if the expanded body pulls gently in the direction of exit from the vagina after a certain interval of permanence. The residence time of the device in the vagina is in each case 10-20, preferably 15 minutes, depending on the subjective perception of the patient: A too strong expansion voltage is a sign that the balloon pressure is too high . The step-by-step operation of the air bleed screw remedies this. The numerous advantages of the mentioned method are easier delivery due to the already achieved preexpansion of the pelvic row and the external vaginal ring (limbus hymenal), a rapid delivery process, especially in the case of primiparous, a better supply of oxygen for the baby due to a load of reduced pressure on the infantile head in the phase of expulsion, saving means (oxytocic) to (promote) uterine contractions, particularly in the case of primiparae a decrease in labor pain and less convulsions due to a more expandable musculature, a clear reduction of local anesthetics and anesthetics, lower risk of allergic shock by local narcotics, reduction of peridural anesthesia and epidural anesthesia (spinal anesthesia), the fact that the perineotomy is largely dispensed with, that for the parturient is always painful and therefore feared, with the inevitable perineorrhaphy that follows, as well as a more rapid regeneration of the vaginal musculature due to the preservation of the cavernous bulbous muscle, the spongy bulbous muscle and the sphincter muscle of the anus, by virtue of which the incidence of muscular macro- and micro-ridges is reduced. The additional advantages as sequelae of a childbirth without problems are a better attention to the infant by the mother, which is more active and agile by virtue of not having suffered the perineotomy, and therefore can attend to the child herself and not feel Sick and injured. Due to the absence of pain achieved, a greater production of prolactin occurs, which favors breastfeeding. It is also important that the physiology, function and aesthetics of the vagina and vulva are preserved to a large extent, so that the subsequent sexual life is not impaired. The social security institutions are discharged for shorter periods of stay in the clinics and for the possibility of ambulatory deliveries. The invention will now be described on the basis of exemplary embodiments together with the accompanying drawings. They show: Figure 1 an embodiment of the device according to the invention when being used, in the relaxed state; Figure 2 shows the embodiment of the device according to the invention according to Figure 1 when employed, in the expanded state; 3 shows a section through the embodiments of the device according to the invention according to FIGS. 1 and 2; 4 shows a section through another embodiment of a device according to the present invention. Figures 1 - 3 show the balloon 1 for pneumatic dilation of the pelvic row, which continues in vagina 2 from the uterine orifice 7 of uterus 10. The expandable balloon 1 configured in oval form and 8 with central waist 15 it has in its half 14 that it is outside the vagina 2 a greater wall thickness than the half 13 that is inside. The waist of the ball itself is reinforced. In the uninflated state, the balloon is folded, slip gel is applied, and it is inserted into the vagina so that it is still possible to see approximately 3 - 4 cm of the balloon 1 in front of the vulva 3. This is important by virtue of that the external region of the vagina 2 should be enlarged, but especially the hymenal limbus 4. This is the most sensitive part of the female pelvic floor, and at the same time the most exposed due to the danger of the perineal tear. Now the balloon 1 is inflated by carefully pumping step by step with the manual pump 5 in graduations of 20 mm Hg up to a pressure of maximum 160 mm Hg, the reading of which is given by the manometer 6. The sensation of expansion that the pregnant woman experiences subjectively marks the limit . After approximately 15 - 20 minutes the device is gently and gently pulled towards the outside of the vagina, so that the patient experiences a "birthing sensation" and delves into the subsequent exercises, which leads to considerable anxiety. . This exercise is carried out several times a day, being that the patient continuously expands and with absolute absence of pain the exit of the vagina. It is important to measure the desired diameter of the balloon by a corresponding inflation (number of pumping movements) outside the vagina. The pressure indicated by the pressure gauge should never exceed 200 mm Hg. The corresponding marks are indicated on the scale. The maximum diameter of the waist should be of maximum 9.5 cm, because the biparietal diameter of the infantile head at the time of delivery has an average of this size, corresponding to a circumference of 35 mm of the head. If during the ultrasound examination the doctor finds that it will be an extraordinarily large baby, then the diameter of the expansion can be adjusted without major problems. However, in this case too, the patient should adapt the size of the balloon to its subjective sensation. The results of the following investigations are the basis of the calculation for the necessary pressures in the dilation of the pelvic row: According to the scientific work of R. CALDEIRO-BARCIA, the intra-muscular pressure can rise up to 100 mm Hg during the normal activity of uterine contractions. The systolic blood pressure of the parturient (usually 120 mm Hg) can rise in the short term to 180 and above 200 mm Hg during uterine contractions (expulsion) in the expulsion stage. The pressure of the uterine musculature reaches towards the end of the opening stage a pressure of up to 200 mm Hg against the surrounding vaginal tissue. According to C. LINDGREN, the maximum pressure on the infantile head in the region of the perineum 8 reaches, shortly before delivery, peak values of up to 300 mm Hg during uterine (expulsion) contractions. In order to maintain the artificial dilation described here within the physiological range, a limitation of 200 mm Hg is recommended. In principle, dilation should not be carried out before the 36th week of pregnancy. The demonstration and explanation of the process for the dilation of the pelvic row should, in principle, be carried out in the patient by the attending physician or by the midwife. It is recommended to allow the first dilation to be carried out by the attending physician or the midwife under continuous control of CTG (Cardiotocography = continuous recording of cardiac tones and infantile contractions). The cleaning after use is carried out with soap and water and air drying. Disinfection is recommended with the disinfectants commonly used in commerce. In Figure 3 are also illustrated the hose connection 16 as well as the expandable balloon 1 in its expanded state 17. The two sheath halves 13, 14 are glued or welded together so that they overlap along the edge circumferential that coincides with waist 15. The overlapped region is indicated by stripes. Figure 4 shows a section through another embodiment of the device according to the present invention. It shows two half sheaths 21, 22 of the balloon 20 that are inflated independently of one another. In the region of the waist 23, a membrane 24 having an opening 25 communicating with a first branch hose 26 is disposed inside the balloon. The outer half sheath 22 communicates with another branch hose 28 through an opening 27 in the wall. The two branch hoses 26, 28 are connected to a three-way valve 29, which in turn is connected to a pressure gauge 31 and a manual pump 32 through a hose 30. Finally, a purge screw 33 is still shown. of air between the manometer 31 and the hand pump 32, as well as an elastic welding seam 34 in the passage of the first branch hose 26 through the wall of the outer half sheath 22. In the case of the embodiment according to FIG. 4, three positions can be adjusted by the three-way valve 29. In a first position communication occurs between the hose 30 and the two branch hoses 26, 28. In this way both chambers are inflated or deflated simultaneously, ie the two half sheaths 21, 22. In another position a communication is established between the hose 30 and the branch hose 26 towards the inner half sheath 21, being that the communication to the second branch hose 28 is interrupted. In a third position a communication is established between the hose 30 and the branch hose 28 towards the outer half sheath 22, where the communication to the other branch hose 26 is interrupted. In this way it is possible to inflate the outer half sheath 22 by means of the hand pump 22 or to deflate it by means of the air purge screw 33. In this case the branch hose 26 to the inner half sheath 21 extends through the outer half sheath 22 directly to the membrane 24, at whose opening 25 it opens. By means of a structure of two cameras of this kind, the volume of the balloon 20 can be adapted individually to the needs of the user. The reading of the pressure of the chambers of the balloon in each case connected can be carried out independently in the manometer 31.

Claims (15)

1. CLAIMS Device for preparing and facilitating the delivery of the pregnant woman which comprises an expandable oblong body that can be placed in such a way in the region of the exit of the pelvic row that is partially inside the vagina and partially outside of it, characterized due to the fact that the body is configured in such a way that it can be expanded in its entirety, being that it has a coexpandible waist that during use is driven in the region of the hymenal limbus in a self-centering manner.
2. Device in accordance with the claim 1, characterized by the fact that the body can be expanded by a variable inflation of air or fluid.
3. Device in accordance with the claim 2, characterized in that the body is configured as a ball at the end of which, when it is facing outwards, at least one filling hose is connected.
4. Device in accordance with the claim 3, characterized in that the balloon is composed of two half shells that are joined to one another along a circumferential edge.
5. Device according to claim 4, characterized in that the circumferential edge is arranged in the region of the waist.
6. Device according to claim 4, characterized in that the thickness of the wall of the outer half sheath during use is greater than that of the inner half sheath.
7. Device according to claim 3, characterized in that it comprises an air pump with a pressure gauge connected to the balloon filling hose.
8. Device according to claim 7, characterized in that an air purge screw is positioned between the air pump and the pressure gauge by means of which the internal pressure of the balloon can be adjusted.
9. Device according to claim 7, characterized in that a safety valve is provided in order to limit the maximum pressure.
10. Device according to claim 4, characterized in that the half-shells form two chambers separated one from the other in a gas-tight manner.
11. 11. Device according to claim 10, characterized in that the half sheath that is inside the vagina can be inflated by means of a separate filling hose.
12. Device according to claim 10, characterized in that the device comprises a three-way valve for selecting the filling mode of both half sheaths.
13. 13. Method for gymnastic preparation prior to delivery by using a device according to claim 1, characterized in that the expandable body is partially placed on the outside and partially inside the limbus hymenal, then expanded to a desired expansion, and finally it remains in the expanded state for a certain time in its position.
14. Method according to claim 13, characterized in that the expansion of the expandable body increases each time the use is repeated, in order to achieve a progressive increase in the preexpansion of the pelvic row.
15. 15. Method according to claim 14, characterized in that the expandable body is stretched in the direction of the vagina after an interval of permanence. Method according to claim 15, characterized in that the time of tenure is 10-20 minutes, preferably 15 minutes. Method according to claim 14, characterized in that the expansion of the notched region is selected up to a diameter of 10 cm.