WO2008080622A1

WO2008080622A1 - Applicator for the use of birth gel for human birth

Info

Publication number: WO2008080622A1
Application number: PCT/EP2007/011460
Authority: WO
Inventors: Andreas F. Schaub
Original assignee: Hcb Happy Child Birth Holding Ag
Priority date: 2007-01-03
Filing date: 2007-12-28
Publication date: 2008-07-10
Also published as: EP2125095A1

Abstract

The present invention relates to an applicator for the insertion of substances that make birth easier into the birth canal of women during human vaginal birth.

Description

Applicator for the application of birth gel in human birth

description

The present invention relates to an applicator for introducing birth-promoting substances into the birth canal of women in human vaginal delivery.

The vaginal delivery of a child is a complex process and is determined by three key factors: the birth object (fetus, amnion, placenta), the birth canal (consisting of a bony portion and a soft tissue tube) and the birthing force. From the scientific literature, various birth forces are known, which promote or inhibit the vaginal birth (vaginal bearing) of a human fetus. Birth-promoting forces here are labor and gravity, birth-inhibiting forces are the elasticity of the cervix and the birth canal. The birth of a human child is divided into 3 phases: the opening period, the expulsion period and the placental period. The average duration of birth is 12 hours for first-time mothers, 8 hours for multipen mothers. The shorter average duration of labor in multipregnants compared to first-time mothers is due to the diminished elastic force of the birth canal, since in multi-pregnancies the soft tissue tube (inner uterine segment - cervical canal - soft tissue insertion tube (vagina and vulva)) are rolled out by the previous vaginal births on human birth mechanics, therefore, is that the force of extension of the birth canal (the force necessary to open, stretch and roll out the birth canal) is considered to be an essential force impeding the birth (Dudenhausen, Schneider, gynecology and obstetrics, De Gruyter (1994), pages 113 to 121). In veterinary medicine, the birth-mechanical significance of the frictional force between the birth object and the birth canal has been known for decades. The application of lubricants to the birth canal to reduce this frictional force is in veterinary medicine

5 Obstetrics A standard method (Richter, Götze, Animal Obstetrics, 4th Edition, Paul Parey Publishing, Legal Issues in Obstetrics, page 614), and lubricants for this purpose are commercially available. In animal birth, relatively high volumes of lubricants can be used. This gives rise to the possibility of using liquid, aqueous formulations which serve as a substitute for the lubricious amniotic fluid or the allantoic fluid in the livestock. Such high volumes can not be applied for lack of practicability in human vaginal delivery. 5 A significant difference between birth in humans and human birth is that the role of the amniotic fluid in human birth at the appointment has no significant relevance to the lubrication of the birth canal, but may increase the resulting frictional forces. Fruit water, as an aqueous substance in humans, does not have a pronounced lubricating effect per se. Today, in humans, only births from cranial layers are usually carried out vaginally, in which the departure of amniotic fluid during birth due to the sealing by the head is only to be considered insignificant. The Vernix Caseosa, as the sole lubricating substance of the birth object, is usually no longer around the date of birth and is only slightly effective on the head anyway. The use of amniotic fluid or amniotic fluid replacement for lubrication of the birth canal prior to or during a vaginal delivery in humans is therefore an insufficiently suitable measure for reducing the frictional forces and for facilitating the vaginal birth in humans.

EP 1 467 707 B1 discloses the use of a physiologically acceptable organic substance for the production of a Composition containing no alkali metal salts of metaphosphates for use as a lubricant in vaginal births of women. Numerous examples of suitable, physiologically harmless organic substances are mentioned. The object of this invention is the reduction of the newly recognized essential obstacle-preventing force, namely the frictional force between the birth object and the birth canal, by the use of a lubricant in humans.

WO 2006/050951 discloses a lubricating composition which comprises (a) a polyacrylic acid, (b) a water-soluble thickener and (c) a humectant, and (d) optionally water. It is stated in the document that such compositions are distinguished by good physiological compatibility, excellent lubricity and good adhesion properties.

In practice, the application of the above-mentioned compositions may be associated with difficulties in the context of human birth. In fact, in the case of manually applied application of such compositions in clinical investigations, a very wide range of application quality results in fact. In addition to the risk of introducing the composition into the birth canal in an inadequate amount or improperly, the manual introduction of the lubricant to the woman giving birth may also be unpleasant or even painful.

Therefore, the object underlying the present invention was to provide a device which can be applied vaginally and which ensures a uniform distribution of lubricants in the birth canal to improve and standardize the application of lubricating compositions into the birth canal of women during labor. - A -

This object has been achieved according to the invention by means of an applicator for introducing birth-promoting substances into the birth canal of women in human birth

(a) a hollow body with distal and proximal ends for receiving and transporting the birth-facilitating substances in its interior,

(B) at least one distributor head formed at the distal end of the hollow body with at least one outlet opening for application of the birth-facilitating substances into the birth canal, and

(c) means for introducing and / or transporting the birth-facilitating substances into the hollow body at the proximal end of the hollow body.

The applicator according to the invention, which allows a uniform and gentle introduction of birth-facilitating substances into the birth canal, comprises as a first component a hollow body with distal and proximal end. The hollow body may be a hollow body of any shape and / or any outer or inner cross-section, which has no sharp corners, points or edges, at its two ends in each case has an opening and in this way for receiving and transport is capable of birth-facilitating substances in its interior. The outer or inner cross-section can be constant over the entire length of the hollow body or vary, wherein the hollow body can taper in the case of a non-constant outer or inner cross-section to both the distal end and the proximal end. The term "transport" as used herein refers to the passage of the birth-promoting substances through the interior of the hollow body, which may be effected with or without application of external pressure, depending on the formulation or viscosity of the birth-relief substances.

According to the invention, the outer cross section of the hollow body is preferably round or elliptical. In a particularly preferred embodiment of the present invention, the outer cross section of the hollow body is round. in the In contrast, the inner cross section of the hollow body may take any shape, such as round, elliptical, square or rectangular.

The inner diameter of the hollow body may be, for example, in a range of about 0.1 to about 5.0 cm. In a preferred embodiment, the hollow body has an inner diameter in the range of about 0.5 to about 2.0 cm.

As a second component, the applicator according to the invention comprises at least one distributor head, which is formed at the distal end of the above-described hollow body. The invention thus provides the possibility that the applicator has only a single distributor head, which is to be regarded as preferred in the context of this application. Furthermore, however, it may also be expedient for the applicator to have two or more distributor heads, provided that this allows a good adaptation to the conditions of the birth canal.

The shape of the dispensing head may vary widely and includes any configuration that is capable of causing any injury to the birthing duct when the applicator is used professionally. As inappropriate shapes are in particular considered in this context, which have sharp corners, points or edges.

With these requirements in mind, in a preferred embodiment of the present invention, the dispensing head is designed to transition from the distal end of the hollow body into a tapered shape and terminate into a rounded tip, with a substantially conically tapered shape being particularly suitable.

Alternatively, there is the possibility that the distributor head from the distal Starting from the end of the hollow body initially radially expanded and expires from a point maximum outside diameter to a rounded tip. Particularly suitable in the context of this invention is a distributor head which has a substantially spherical, elliptical, club-shaped or mushroom-shaped form, a club-shaped or mushroom-shaped configuration being particularly preferred. The transition from the hollow body to the distributor head can be configured both continuously and discontinuously, wherein a continuous transition is to be preferred.

A distributor head according to the present invention has at least one outlet opening, which can be arranged in any desired form, in particular radially, and serve to apply the birth-relief substances into the birth canal. In a preferred embodiment, the header has 2-50 exit ports, more preferably 5-25 exit ports, and most preferably 10-15 exit ports, each of which may be equal in diameter or may vary in diameter. The diameter of the exit orifices is, for example, in a range of about 0.01 to about 10 mm, preferably in a range of about 0.1 to about 5 mm, and most preferably in a range of about 0.5 to about 2 mm. According to the invention, the outlet openings can be distributed as desired on the surface of the distributor head, wherein a uniform distribution is considered to be particularly useful.

Furthermore, the erfiπduπgsgemäße applicator comprises as a third component means for introducing the birth-facilitating substances in the hollow body described above, wherein these means are formed at the proximal end of the hollow body. Such means may include an attachment for attaching a container in which the birth-relief substances are stored separately. In a preferred embodiment, the container is a pressurized container, such as a can, where the term "pressurized container" refers to a closed container whose internal pressure is above the pressure of the external environment lies. Further, it may be preferred that the container is a container from which the birth-relief substances can emerge using external pressure. Examples of such containers include in particular syringes or tubes.

Alternatively, the means for introducing the birth-facilitating substances into the hollow body can also be a pressing device with a distal and proximal end, which is arranged coaxially to the hollow body and has at its distal end a piston with at least one piston disc sealingly fitting in the hollow body, wherein the piston is guided longitudinally displaceable in the hollow body. Preferably, behind the above-described first piston disc, a second piston disc is present, which is fitted into the hollow body and the leadership of the pressing device, which may consist of two crossed flat strips, for example, is used in the hollow body.

In a preferred embodiment, the pressing device may further comprise at its proximal end a handle unit, such as a thrust washer or a syringe barrel, which allows easy and safe handling of the applicator when introducing the birth-facilitating substances into the birth canal.

In a particularly preferred embodiment, the present invention provides that between the proximal end of the hollow body and the distributor head in addition a Eindringbegrenzungselement may be included on the outside of the hollow body, by means of which the penetration depth of the applicator is limited in the birth canal. By definition, the term "penetration-limiting element" in the context of the present application means any structure on the outside of the hollow body whose diameter is greater than the outer diameter of the hollow body. For the purposes of this invention, the penetration limiting element is preferably designed to be Diameter exceeds the diameter of the vaginal region of the childbearing, so that penetration of the applicator beyond the position of the Eindringbegrenzungselements addition is not possible with proper handling of the applicator. The Eindringbegrenzungselement may for example have the form of a patch on the hollow body ring structure, with other forms are also conceivable.

Furthermore, the applicator according to the invention may additionally comprise markings on its outer side, which permit a determination or control of the penetration depth of the applicator into the birth canal. For this purpose, in particular on the outside of the hollow body between the distributor head and Eindringbegrenzungselement a marker be applied, by means of which, for example, the distance of the child's head from the output of the birth canal can be measured.

The applicator according to the invention is characterized in that it has a length in the range of about 10 to about 100 cm, preferably from about 20 to about 60 cm, and a penetration depth in the birth canal in the range of about 1 to about 90 cm, preferably from about 5 to about 40 cm allows.

According to the invention, the applicator or the individual components of the applicator can consist of a multiplicity of materials which are physiologically compatible. Examples of physiologically compatible materials include plastic, rubber, stainless steel or the like, with plastic and / or rubber being particularly suitable as the material. Furthermore, it is preferred that the materials selected for the components of the applicator are substantially free of latex, at least in the region of the parts in contact with the patient.

In a preferred embodiment, the applicator according to the invention is designed for single use. However, it is also possible to use the applicator several times, for which, after first use, a sterilization of the applicator before reuse is to perform.

The birth-relief substances used in the context of the present invention are preferably formulated as a fluid, gel or foam. However, one skilled in the art of drug technology will appreciate that the birth-promoting substances may also be applied in other suitable formulations.

The amount of birth-promoting substances introduced into the birth canal by means of the applicator according to the invention can vary within a wide range. Depending on the condition of the woman in labor, duration of labor and / or other factors, the total amount of birth-relief substances introduced into the birth canal may range from about 1 to about 3000 ml, preferably from about 5 to about 500 ml and more preferably from about 10 to about 100 ml. In this context, the invention provides that the birth-relief substances can be applied both continuously during insertion of the applicator into the birth canal and in a step after insertion of the applicator into the birth canal. Furthermore, it is still possible to apply the total amount of birth-relief substances distributed over several times.

Birth-alleviating substances in the sense of the present invention include any means or compositions which can be introduced into the birth canal of the woman giving birth by means of the applicator according to the invention and influence the birth process in a positive way. Suitable birth-relief substances include, for example, lubricants and pharmaceutically active substances, which may optionally be combined with each other. Pharmaceutically active substances that can be used in the present invention include, for example, birth initiators, birth control agents, analgesics, and agents for the prevention of bacterial or viral infections. Specific examples of such pharmaceutically active substances are described in EP 1 467 707 B1 and WO 2006/050951, the disclosure of which is hereby incorporated by reference.

In a preferred embodiment, birth-relief substances include, in particular, lubricating compositions. Lubricating compositions useful in the present invention include, for example, those disclosed in EP 1 467 707 B1 and WO 2006/050951. Especially preferred in this context are compositions comprising a polyacrylic acid, a salt of a polyacrylic acid or a mixture of several polyacrylic acids. The polyacrylic acid may be crosslinked and / or chemically modified and have an average molecular weight in the range of 2000 D to 500,000 D. Polyacrylic acids which are particularly suitable for the purposes of the present invention are explicitly mentioned in EP 1 467 707 B1 and WO 2006/050951.

In the context of the present invention, it is preferred that the applicator is already filled with the birth-promoting substances before use, wherein the term "filled" is to be understood as meaning that the birth-relief substances are located inside the hollow body of the applicator according to the invention.

Alternatively, according to a second aspect, the present invention provides a kit in which the applicator according to the invention and the birth-relief substances are present separately from each other before use. For this purpose, the kit may comprise, in addition to the applicator, a container for birth-relief substances in which a suitable dosage unit of birth-alleviating substances is contained. Suitable containers for this purpose are, in particular, pressurized containers, syringes or tubes. By using the applicator according to the invention for introducing birth-promoting substances into the birth canal of women giving birth, human birth can be considerably facilitated and even shortened in time. For this purpose, the birth-facilitating substances before insertion of regular labor, in the opening phase, the expulsion phase and / or the placenta of human birth one or more times be introduced into the birth canal, the application preferably in the intrauterine region of the birth canal, in the area of Cervix and / or into the vaginal area of the birth canal. In this way, in particular the friction between birth canal and birth object can be greatly reduced. At the same time this reduces the risk of injury or long-term damage. Furthermore, due to the low friction, the labor of labor can be reduced, which can lead to a prevention or reduction of vaginal surgery or caesarean sections. After the birth of the child and / or after the birth of the placenta, the birth canal is rinsed with an aqueous aseptic solution, preferably with a mild aqueous aseptic saline solution, to dissolve the lubricant.

Description of the figures

Fig. 1 shows the schematic longitudinal section of an embodiment of the applicator according to the present invention.

Fig. 2 shows the schematic longitudinal section of a further embodiment of the applicator according to the present invention.

Fig. 3 shows the schematic longitudinal section of yet another embodiment of the applicator according to the present invention.

In Fig. 1-3 are various embodiments of the applicator according to the invention for introducing birth-promoting substances in the Birth canal of women presented in the human birth. The applicator comprises in each case a hollow body (1) with distal and proximal end, a distributor head (2) with at least one outlet opening (3) formed at the distal end of the hollow body (1), and means for introducing and / or transporting the birth-facilitating substances into the hollow body (1) at the proximal end of the hollow body (1).

In the embodiment illustrated in FIG. 1, the applicator comprises a distributor head (2) which, starting from the distal end of the hollow body, merges into a substantially conically tapered shape and ends at a rounded tip with an outlet opening (3). As means for introducing and / or transporting the birth-facilitating substances into the hollow body (1), a pressing device (4) is used, which consists of two crossed flat strips (5, 6) and whose proximal end is a pressure plate as handle unit (10 ) is trained. At its distal end, the pressing device (4) has a piston (7) which is inserted into the hollow body (1) and which in each case comprises a first piston disc (8) and a second piston disc (9). On the outside of the hollow body (1), the applicator additionally has a penetration limiting element (11) by means of which the penetration depth of the applicator into the birth canal is limited.

Fig. 2 shows an applicator according to the invention with a distributor head (2), which initially extends radially from the distal end of the hollow body and expires from a point maximum outside diameter to a rounded tip. The distributor head (2) has a mushroom-shaped shape and a plurality of outlet openings (3). As a means for introducing and / or transporting the birth-facilitating substances into the hollow body (1), a pressing device (4) is again shown, as described in the explanation of FIG. 1, in which case a syringe knob as a handle unit (10 ) serves.

Fig. 3 shows an alternative embodiment of an applicator with Distributor head (2), which initially extends radially from the distal end of the hollow body and expires from a point maximum outside diameter to a rounded tip. The distributor head (2) has here a club-shaped form as well as a plurality of outlet openings (3). As a means for introducing and / or transporting the gebriererleichtemden substances in the hollow body (1) a projection (12) for applying or attaching a container is shown in this embodiment, from which the birth-friendly substances can be transferred if necessary in the applicator.

Claims

claims

An applicator for introducing birth-promoting substances into the birth canal of women in human birth, comprising

2. Applicator according to claim 1, characterized in that the hollow body has a round cross-section.

3. Applicator according to claim 1 or 2, characterized in that the hollow body has an inner diameter in the range of 0.1 to 5.0 cm, preferably from 0.5 to 2.0 cm.

4. An applicator according to any one of claims 1-3, characterized in that the distributor head, starting from the distal end of the hollow body transitions into a substantially conically tapering shape and terminates in a rounded tip.

5. An applicator according to any one of claims 1-3, characterized in that the distributor head starting from the distal end of the hollow body initially radially expanded and maximum from one point

Outside diameter to a rounded tip expires.

6. Applicator according to one of claims 1-5, characterized in that the transition from the hollow body to the distributor head runs steadily.

7. Applicator according to one of claims 1-6, characterized in that the distributor head has a plurality of radially arranged outlet openings.

8. Applicator according to one of claims 1-7, characterized in that the distributor head 2-50, preferably 5-25, more preferably 10-15 outlet openings.

9. Applicator according to one of claims 1-8, characterized in that the outlet openings have an inner diameter in the range of 0.01 to 10 mm, preferably from 0.1 to 5 mm and more preferably from 0.5 to 2 mm.

10. Applicator according to claim 1-9, characterized in that the outlet openings are distributed uniformly over the surface of the distributor head.

11. An applicator according to any one of claims 1-10, characterized in that it is in the means for introducing the birth-facilitating substances in the hollow body to a neck for applying or securing a container, in particular a pressurized container or a container from which the birth-relief

Substances may leak under application of external pressure acts.

12. An applicator according to any one of claims 1-10, characterized in that it is in the means for introducing the birth-facilitating

Substances in the hollow body is a pressing device with distal and proximal end, wherein the pressing device is arranged coaxially to the hollow body and at its distal end with a piston Has at least one sealingly fitting in the hollow body piston disc, which is guided longitudinally displaceable in the hollow body.

13. An applicator according to claim 12, characterized in that the pressing device at the proximal end additionally comprises a handle unit.

14. An applicator according to any one of claims 1-13, characterized in that between the proximal end of the hollow body and Verteilerkopfo additionally a penetration depth of the applicator in the birth canal restricting Eindringbegrenzungselement is included on the outside of the hollow body.

15. Applicator according to one of claims 1-14, characterized in that it additionally comprises markings for determining the penetration depth.

16. An applicator according to any one of claims 1-15, characterized in that the penetration depth of the applicator in the birth canal in a0 range from 1 to 90 cm, preferably from 5 to 40 cm.

17. Applicator according to one of claims 1-16, characterized in that it consists of plastic and / or rubber. 5

18. An applicator according to any one of claims 1-17, characterized in that it is intended for single use.

19. An applicator according to any one of claims 1-18, characterized in that the birth-alleviating substance is formulated as a fluid, gel or foamo.

20. An applicator according to any one of claims 1-19, characterized in that introduced into the birth canal total amount birth-alleviating substances in a range from 1 to 3000 ml, preferably from 5 to 500 ml and more preferably from 10 to 100 ml.

21. An applicator according to any one of claims 1-20, characterized in that the birth-alleviating substance comprises a composition having a lubricating action.

22. An applicator according to claim 21, characterized in that the composition having a sliding action comprises a polyacrylic acid.

23. An applicator according to any one of claims 1-22, characterized in that it is filled with the birth-alleviating substances.

A kit comprising an applicator according to any of claims 1-22 and a container for birth-alleviating substances.

Use of an applicator according to any one of claims 1-23 or a kit according to claim 24 for introducing birth-gentle substances into the birth canal of women prior to the onset of regular labor, during the opening phase, expulsion phase and / or placenta phase of human birth. ,

26. Use according to claim 25, characterized in that the birth-relief substances in the intrauterine region of the

Birth canal, in the area of the cervix and / or in the vaginal area of the birth canal are introduced.