Surgery: kinesitherapy – Kinesitherapy – Exercising appliance
Reexamination Certificate
1999-10-15
2003-11-18
Casler, Brian L. (Department: 3703)
Surgery: kinesitherapy
Kinesitherapy
Exercising appliance
C604S099020, C604S101010, C606S119000, C606S193000
Reexamination Certificate
active
06648842
ABSTRACT:
The present invention relates to a device for helping a pregnant women to prepare for giving birth and to make giving birth easier which has an expandable elongated body which is positionable in the region of the vaginal orifice such that it is located partly inside the vagina and partly outside of the vagina. The invention further relates to an exercise method involving the use of such a device for preparing to give birth.
In Germany, there are approximately 850,000 births per year. According to the most recent available perinatal statistics of 1995, the rate of episiotomy, among both first time and subsequent births, was a total of 58.9% (less the rate of cesarean section of 17.4%). This means that approximately 500,650 epiosotomies are carried out yearly in Germany (Commission for Perinatalogy and Neonatalogy, BPE Annual Report 1995). In about 20% of all births a tear in the perineum occurs as a result of which the risk of death due to complications is further increased. In spite of numerous traditional and modem methods for preparing and for facilitating giving birth (e.g. Leboyer, Read, Odent), the mentioned statistics remain unchanged in relation to one another after decades. Even the new age pregnancy exercises to prepare for giving birth and the pregnancy consultation of midwives have only improved these figures unsubstantially.
The episiotomy, first described by Ould in 1742, still conjures up a horrible image even after 250 years. Although, it was proposed and carried out as a relief for women and to accelerate delivery, it is still feared by many women to this day due to its painfulness, and it is hated for its negative consequences. Avoidance of the episiotomy has therefore been a long felt need in the field along with the goal to make the delivery easier for mothers with less fear involved.
An additional problem of modem birthing assistance is the increasing disproportion between the fetal/infant head and the female pelvis. The cranial circumference of newborns is steadily increasing such that the measurement program established by Hausmann for the standard size of the biparietal diameter using ultrasound must be continuously upwardly corrected. The cause for this might be seen, on the one hand, to be the result of increasing exposure of pregnant women to light, noise, and other stimulation (for example neon lights, electro smog, car noise, etc . . . ), and on the other hand, due to the natural, modem androgenous type of woman (tall, narrow female pelvis and narrow hips) which naturally makes giving birth more difficult.
It is known for treating sedimentation of the blood and incontinence problems in women to insert an inflatable balloon deep into the vagina in order to provide, in the inflated state, a mechanical blockage of the bladder while raising the uterus. For example, European Patent publication EP 0,663,197 A1 describes a support body which keeps its shape and is made of elastic rubber material with areas of different wall thickness which expands conically from a base region in the direction of a top surface at the opposite end of the support body in a conical manner, a piece of hose being sealingly connected to the base region. The top surface is reinforced in a ring-shape and has a soft concavely formed inner region. The support body is inserted into the vagina with the base downward and is left in place for hours to support the vaginal wall.
U.S. Pat. No. 3,626.949 describes a cervical dilator which has not however achieved any significant success in practice. It discloses a PVC envelope or case having a hose connection for filling up the case with a fluid under pressure. The case can be inserted into the cervical canal while folded up and is then periodically expanded under pressure such that the case expands radially against the cervical wall to thereby simulate contractions. Between opposed ends of the case there is a waist portion which is not expandable in a radial direction, which waist portion is positioned inside the edge of the cervix in order to prevent that the expanded waist portion moves in an axial direction under pressure.
A further cervical dilator is described in U.S. Pat. No. 3,480,017. This dilator uses an inflatable case which is inflatable to a substantially disk-shaped body, which is positioned in use inside the uterus and inflatable using an inflation tube whose opening is inside the case. The case comprises a circumferential constriction such that a groove is formed in the cylindrical exterior wall of the case when inflated into a disk. The cervix supported by the groove can be expanded in this way in order to induce birth. The application of the known device is only possible by a doctor who has acquired the skills to manipulate the shell against the cervix using the inflating tube as a handle, without damaging the amniotic sack or the fetus' head. As a result of its flat disk shape, the known cervical dilator is particularly suited only for this application.
In French Patent publication FR-592,104, there is described a dilator to be inserted in the perineum which is made of an elongated elastic material balloon which can be laterally expanded by inflation while having its lengthwise expansion limited. By methodical use and progressive expansion, tissue having undergone such exercise will yield while giving birth without tearing.
This prior art balloon can also be actuated intermittently using a three-way valve. During use, it is important to pay attention that the balloon is only inserted into the vagina to the extend that the middle section of the balloon rests in the area of the perineum. During inflation, the balloon should form inside the perineum a ring-shaped constriction by means of which the balloon is secured in the axial direction.
In the embodiment of this prior art in which the balloon has a central inflation tube, there is the danger that the inner end of the tube is pushed during insertion too close to the cervix where serious injury is possible (causing bleeding or breakage of the amniotic sack).
In the case of the embodiment in which the balloon is provided with non-stretchable inner strips for preventing a lengthwise extension of the balloon, there is the danger that the balloon will be suddenly catapulted inwardly towards the cervix during inflation once a predetermined level of inflation is reached, which can lead to the above-mentioned serious injuries.
The known device should therefore only be used under the supervision of a physician, in particular because it is practically impossible for a pregnant woman, due to the corresponding size of her abdomen, to locate the correct axial position of the balloon.
Accordingly, it is the object of the present invention to construct the above-mentioned device such that its application for a pregnant women is pleasant and safe, and can be carried out easily by herself; and, finally such that its use should substantially contribute to the significant reduction of perineum tearing or episiotomies occuring during birth. Associated therewith, an undesired drop in the pelvic floor, and later occurrences of bladder incontinence and sexual disturbance as a result of physiological and psychosomatic complications occurring postpartum can be prevented.
This object is provided by a device having the characteristics of claim
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as well as a method having the characteristics of claim
1
.
The device according to the invention comprises an expandable elongated shaped body which is positionable in the region of the vaginal orifice such that it is located partway inside the vagina and partway outside the vagina. By the expansion of the elongated body, the vagina can be substantially expanded and the birth canal as well as the vaginal orifice can be expanded in advance to facilitate giving birth. With this training and stretching effect, eposiotomies as well as an undesirable drop in the pelvic floor can be avoided to a large extent along with complications associated therewith. The expandable body maintains its distance from the cervix which it should never contact in order avoi
Casler Brian L.
Thanh LoAn H.
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