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Jorge Odon

Childbirth Device







http://www.bbc.co.uk/news/magazine-25137800
3 December 2013

Odon childbirth device: Car mechanic uncorks a revolution

by

Vibeke Venema



A "potentially revolutionary" device to help women during difficult births has come from an unlikely source - a car mechanic from Argentina, who based the idea on a party trick.

Apart from having five children of his own, Jorge Odon had no connection with the world of obstetrics. He did however have a talent for invention.

"It comes naturally - for instance if I have a problem in my workplace I will go to bed and my head will think it through and I will wake up in the middle of the night with a solution," he says.

But until 2005, all his patents - eight in total - were in the field of mechanics, stabilisation bars, car suspensions and the like.

All this changed after Odon's staff at the garage showed him a YouTube video revealing how to extract a loose cork from inside an empty bottle. It's remarkably simple. You tilt the bottle, stuff a plastic bag down the neck and blow into the opening. The bag balloons inside the bottle, wrapping itself tightly around the cork. Then you just pull it out.

Odon immediately challenged a friend, Carlos Modena, to a bet over dinner. He placed a bottle containing a cork on the dinner table, and laid out several objects, including a bread bag. Thoroughly puzzled, Modena insisted the only way of getting the cork out would be to smash the bottle. So Odon showed him his trick, and won the bet.

But that night, as he slept next to his wife, Odon had a lightbulb moment - what if he used the same principle to help women give birth? At 04:00 he tried to wake her up. "Marcela, this cork trick could make labour easier!" he said. His wife mumbled, "That's nice," turned over and went back to sleep.

In the days that followed, Odon kept mulling it over, but found it difficult to get people to listen to him. Most thought the idea was crazy. Eventually he persuaded Modena to introduce him to his family's obstetrician.
Odon demonstrates his device on a state-of-the-art mannequin Jorge Odon demonstrates the device on a dummy at Des Moines University

"We went to a hospital and sat - in our suits - in a room full of expectant mothers," Odon says. "My friend was still sceptical, so when we went to see the doctor, at first he sat quite far away from me. But once he saw that the doctor was interested in this idea and quite impressed, he moved his chair closer and started saying 'we' have invented this!"

Encouraged, Odon registered a patent and set about building a prototype. He and Modena took his daughter's dolls and some jam jars, and began experimenting in his workshop. "Two men in the toilet, with my daughters' toys, taking them out of a jar, with Vaseline. Our colleagues could see us and obviously they thought we were a little bit mad," he says.

Once he had a working model, Odon approached Dr Javier Schvartzman at the Centre for Medical Education and Clinical Research in Buenos Aires. When Odon got out his bottle and cork, Schvartzman wondered if he was being secretly filmed for a hidden-camera show.

"When he showed me the trick I thought it was crazy - crazy but interesting," he says. But he agreed to work with Odon to develop the device.

The first prototype was a glass uterus, into which two large bags were introduced. When Schvartzman explained that thrusting a bag all the way into the uterus might perforate its lining, Odon adapted the model so that the bag was only applied over the head.

By 2008, the project had come to the attention of the World Health Organization. On a visit to Buenos Aires, its chief co-ordinator for improving maternal and perinatal health, Dr Mario Merialdi, asked for a demonstration. The meeting, planned to last 10 minutes, stretched to two hours.

"I was intrigued, but also sceptical because for many years, almost centuries, there has been no innovation in this area of work," Merialdi says.

Birthing instruments are used in about one in 10 births, usually forceps, or the ventouse - where a suction cap attached to the head helps to pull the baby out. Both have downsides. Forceps may damage vaginal tissues and can fracture the baby's skull, as there is no limit to how much force you can apply. A ventouse delivery is less traumatic for the mother, but may still damage the baby's scalp.

Forceps were first developed in the 16th Century by the Chamberlen family, Huguenot surgeons who fled to London from France, and kept their invention under wraps. Once their secret got out, other surgeons copied them. "The Victorian era saw some monstrous modifications such as attaching the handles of the forceps to a winch, while the mother was tied down, in order to improve the traction," says Damian Eustace from the Royal College of Obstetricians and Gynaecologists. However, the forceps in use today haven't changed much since the late 1800s - the more complicated they become, the harder they are to use and the more expensive to sterilise.

The earliest known vacuum extractor - the Air Tractor - was produced in 1838 by James Young Simpson in Edinburgh. But it only really became a practical alternative to the forceps in the 1950s with the development of the Malmstrom extractor, named after Swedish professor Tage Malmstrom. "Modifications of his original design are still in use on labour wards today," Eustace says, but new materials (plastics and siliconised rubber) have radically improved the apparatus and, at least in the UK, it is now used more commonly than forceps.

The Odon device imitates the bottle trick. A double layer of plastic is inserted via the birth canal to surround the baby's head. Some air is then pumped into the bag, inflating a plastic chamber that gently grips the head around the chin (there is no obstruction to the baby's breathing because it does not breathe through the nose until birth). Then the baby can be pulled out through the birth canal, without causing damage or bleeding.

In 2008, Odon took his creation to Des Moines University in Iowa for extensive testing in a state-of-the-art birth simulator, with WHO experts observing closely. This was a turning point for Odon.

"I couldn't believe that they would believe in me. It was a special moment," he says.

The experts could see the potential for this cheap and simple device in developing countries, where prolonged or obstructed births are often fatal.

Worldwide, about 5.6 million babies are stillborn or die soon after birth every year. Some 260,000 mothers die as well - 99% of all maternal deaths occur in developing countries. Mothers may bleed to death or die from infection, whereas newborns are in danger of suffocating. Where the mother survives, she may suffer serious complications such as fistula, where tearing links the vagina with the rectum or bladder.

Schvartzman says the most important thing is that the Odon device is easy to use - it could potentially be used by a midwife without a doctor present. It also reduces the risk of transmission from mother to baby of infections such as HIV. And, in developed countries, it could help bring down soaring rates of Caesarean births.

"These features combined make it a potentially revolutionary development in obstetrics," says Merialdi.

The next phase was to test the device in real-life situations.

"The first time I saw it used I promised that if it worked, I would shave off my moustache," Odon says. The moustache had to go.

"I am not sure I would be very comfortable letting my wife, the mother of my children, use some device that has never been tested," Odon says. "But all the women who have volunteered for these trials, they do it for the progress of science, which is something truly beautiful."

Mariana Macchiarola, a 35-year-old singing teacher, was one of 30 women who agreed to pioneer the device. Like the others, she had given birth before.

"To give birth to my first son was a good experience, but quite painful," she says. "I was very frightened and they ended up having to help me by giving me an episiotomy (a cut to the perineum). I suffered a little - it's labour, right?"

In the initial trials the bag was inserted using a spatula, but it wasn't easy. So Odon went home to work on the problem. By the fifth birth, he had invented an inserter, "a very ingenious instrument that permits us to introduce the bag in a very easy way," Schvartzman says.

Macchiarola was the first patient to benefit from the inserter, which was finished the night before she gave birth, in an unusually busy hospital ward.

"Jorge was there, as well as several midwives and obstetricians. There were people filming. It was something truly spectacular," she says. "I had no pain whatsoever. It was very quick and I got to enjoy watching the birth of my son. The first time, I hadn't managed to see it, given my desperation! This time around, I could enjoy it. And it wasn't necessary to get an episiotomy."
Mariana Macchiarola with her baby Leon and husband Pablo Salinas in the hospital Patient No 5 - the inserter was invented the night before baby Leon was born

The inserter evolved still further, with Odon submitting three more patents over the course of 30 trial deliveries. Trials are now continuing on 100 healthy women in Argentina. The next phase of the study will see it tested in problem births in Africa, Asia and Europe.

If the trials go well, Merialdi predicts the device could be in clinical use in two or three years' time. The US company that will manufacture the device, Becton Dickinson and Company, says it will sell it cheaply to developing countries. This is very important to Odon.

"The important thing is that it's affordable so that it can reach everywhere," he says. "More than the economic side of this I have always wanted to save lives, to help people."

Schvartzman puts the success of the project down to two factors: "The genius of Jorge Odon - and the fact that we paid attention.

"Maybe another doctor would have said goodbye, but we didn't, and that's what has led to this fantastic device," he says. "Doctors are very structured in their thinking and Jorge is a free mind, he can think of new things."

Merialdi agrees that it took an outsider to think of a new approach.

"Albert Einstein used to say that sometimes imagination is more important than knowledge and this is actually the case, because Jorge didn't have any knowledge of obstetrics," he says.

"It's also true that although delivery is a biological function, it's also a mechanical process and so it's not surprising that a mechanic found a way to solve the problem of protracted or obstructed labour. I doubt an obstetrician like me would have thought of a plastic bag with an air chamber in it."

Odon's life has changed completely since he developed his device, and he has handed over the running of the garage to his son.

"In the beginning I used to work in my mechanic workshop so every time there was a birth I had to change my clothes very quickly and go to the hospital, so it was quite crazy. Now I am just working 24/7 on this, otherwise my health would have deteriorated."

But he still can't quite believe that his dream is about to become reality.

"I woke up one night with this idea, it almost felt magical. What I cannot understand is how I came up with a solution to help babies be born. I'm moved by the potential of this invention and I'm especially grateful to the doctors who first believed in me."







Interviews

http://www.bbc.co.uk/programmes/p01lf8w9

http://www.bbc.co.uk/podcasts/series/outlook
 


Patents

DEVICE FOR EXTRACTING ELEMENTS FROM CAVITIES
WO2012164139

Device for extracting elements from a cavity
ZA201000541

METHOD OF EXTRACTION OF AT LEAST ONE ELEMENT CONTAINED IN A CAVITY AND DEVICE FOR PERFORMING SAME
WO2008068367

DEVICE FOR EXTRACTING ELEMENTS FROM A CAVITY
US2010241134

A device to extract elements contained in a cavity, additional to patent of invention P060105329, and of preferable application to assistance at childbirth and/or extraction of elements seated in cavities of the human body, facilitating the task of medical professionals. Said device is comprised of a bag having one of its ends open, through which it is possible to introduce the element to be extracted, in which, in a first embodiment and on the outer surface of the bag and along all its circumference line, there is at least one air chamber being able to get in contact with the element to be extracted when receiving inner pressure, being said chamber connected to a pressure generating means; and in a second embodiment, an outward fold is defined on said bag, forming an annular cavity at the time it gets in contact with the cavity containing the element to be extracted.

0001] The present invention relates to a device to extract elements contained in a cavity; said device allows to perform the method of extraction described and claimed in patent application No. P060105329 submitted in Argentina on Dec. 1, 2006 and not published up to the date this application is filed.

[0002] The proposed device is preferably used to assist at childbirth and/or to extract elements seated in cavities of the human body, facilitating the task of medical professionals.

[0003] Along with the uncountable uses of the present invention and that of the method of said patent application No. P060105329, we find this invention applicable in the field of gastroenterology, in cases such as: extraction of rectal foreign bodies, extraction of esophagogastric foreign bodies and extraction of biliary stones; in the field of urology: in cases such as extraction of urinary tract stones, extraction of elements accidentally displaced along with medical instrumental; in the field of vascular surgery: in cases such as clot displacement and/or vascular prosthesis or to revascularize critical organs, and, lastly in the field of otorrinolaringology: in cases such as extraction of foreign bodies impacted in ears or nostrils and for cerumen extraction.

PRIOR ART OF THE INVENTION AND ITS IMPROVEMENTS

[0004] In relation to the prior art of this invention and, in particular, in the field of neonatology, reference may be made to the tools and accessories presently used at childbirths, among which the most popular are those called "forceps", which use has caused irreparable harm in newborns.

[0005] The device disclosed by application P060105329 is known to us as able to perform the proposed method and it comprised one, two or more flexible bags or containers, each of them with a handle, that had to be inserted by the medical professional for the extraction, for instance, of a baby.

[0006] In examinations conducted with equivalent materials and elements, it was noted that the use of said devices at childbirth gave rise to problems in the insertion of the bags into the uterine cavity, in particular, while trying to surround the fetus. As well, there was a possibility that the health professional may make an incorrect movement during extraction causing injuries to the vagina of the woman in labor.

[0007] Those problems were deeply examined and have been solved with the present device, which comprises a bag or flexible container open on one of its ends, and on which outer surface a closed air-containing element or chamber is fixed or defined, the latter being connected to an air injection means, having a traction handle that closes the other end of the bag at the time of its assembly.

[0008] It is important to emphasize that for any of the devices used to perform the extraction method stated in patent application No. P060105329, the responsibility for the timely decision to use the device will lie on the health professional, who will assess the specific conditions of every birth or the techniques to be used.

[0009] It is expected that the utilization of this device will do away with or reduce the use of forceps or other vacuum generating devices, which pose great risk when used in assistance to delivery.

MAIN OBJECT OF THE PRESENT INVENTION

[0010] The device of the present invention is initially comprised of a bag with its two ends open, one of them is closed at the traction handle, on which outer surface an air chamber is positioned, and then an outward fold is made on the open bag. Said closed chamber is connected to a cannula or pipe that crosses the bag until reaching the screw-shaped piece that is part of the traction handle of the present extraction device. A disk-shaped piece will allow apart from the fastening of the bag on to the traction handle, that the bag keeps its round section with the same diameter throughout the device, which will facilitate the extraction of the baby's head while coming out of the vagina. A cannula or pipe to feed air to the chamber will run inside the handle previously crossing the conical body, coming out by the handle's end until reaching a presostatic measuring or indicating gauge and an air pump. Said pump will feed air to the chamber up to a desired pressure; it will be possible to release air in case pressure is exceeding or when endangers the outcome of the extraction method. The preferred fastening of the bag will be made between the disk and a conical body, the mentioned screw-shaped piece will tighten one against the other and will screw its threaded end into a pertinent hole made in the inner of the handle.

[0011] Said open bag and chamber shall be preferably made of extremely flexible material, film-type of some microns wide, with a highest traction resistance, said material being hypoallergenic and covered with fine lubricating jel.

[0012] Said open bag with its external air chamber around itself shall be inserted by the medical professional between the head of the fetus and the uterine cervix, after breaking waters has taken place. To accomplish this, he could use an outward fold to be made on the bag, pushing with a flat spatula-type instrument from inside the line of the fold until placing said bag on the fetus' shoulders. Sometimes, the professional could resort to the ecographic images, by means of which he will see that the mentioned bag reaches the desired position. Said fold shall approximately and preferably be made at the furthest level of the air chamber.

[0013] Once the bag is placed at the level of the fetus' shoulders, the chamber will be filled with air by means of a cannula or pipe, which enters the interior of the bag and the traction handle of the device of the present invention, crossing said bag until reaching the mentioned air chamber. Once the chamber is filled with air at the necessary pressure, the only thing to do is to pull on the traction handle of the device so as to extract the baby, and thus a simple delivery is achieved with no traumatism at all.

[0014] The end of the bag, opposed to that of the handle, shall be inserted through the cervix of the uterus.

[0015] In a preferable embodiment, the air chamber shall comprise of a regulating and compensating valve for the inlet of air or another fluid of very low pressure, which valve shall be calibrated to act as an air outlet valve pursuant to the adjustment selected by the tocogynelogist professional. As part of this system, it shall be possible to use, in an external manner, a presostatic measuring or indicating gauge that will be of help for the assisting professional.

[0016] It is important to maintain a controlled inner pressure in the air chamber since the value of said pressure may increase when extracting the flexible element from the interior of the cavity up to values that may complicate the extraction due to the increase of volume that causes this greater generated pressure. Said regulating valve shall be a relief valve for this generated pressure, avoiding that said pressure raises beyond a predetermined value.

BRIEF DESCRIPTION OF THE FIGURES

[0017] In order to better understand the object of this present invention, some schematic figures shall illustrate the invention, in its preferred embodiment, which are included by way of example, in which:

[0018] FIG. 1 illustrates a perspective view of the device for the extraction of elements of the present invention in a first preferred embodiment;

[0019] FIG. 2 allows to see the application of the device of the first embodiment of this invention in the extraction of a baby, preferably;

[0020] FIG. 3 shows a perspective view of the device for the extraction of elements of the present invention in a second preferred embodiment;

[0021] FIG. 4 allows to see the application of the device of the second embodiment of this invention in the extraction of a baby, preferably;

[0022] In said figures, equal references correspond to identical elements of the invention.

 

  

DETAILED DESCRIPTION OF THE INVENTION

[0023] In FIG. 1, it is seen that the device in the first preferred embodiment is comprised of a bag 1 with one of its ends (1a) open, on which outer surface an air chamber is positioned or defined, and then an outward fold 3 is made on the open bag 1. Said closed chamber 2 is connected to a cannula or pipe 4 that crosses the bag 1 until reaching a screw-shaped piece 11 that is part of the traction handle 5 of the present extraction device. In this figure, piece 11 is seen, as well as the disk 10, in an open position in order to facilitate the understanding of how the closed end 1b of the bag 1 is fixed to the traction handle.

[0024] Said disk 10 (of variable shape and diameter, according to the characteristics of the delivery) allows not only the fastening of the bag to the traction handle 5 but also that said bag maintains a determined round section, which will facilitate the extraction of the fetus' head at the time it exits the vagina. The mentioned disk may vary in diameter and also may be removed from the device.

[0025] The cannula or pipe 4 for feeding air into the chamber 2 shall enter the interior of the handle previously passing the conical body 9, coming out by the end of the handle until reaching a preostatic measuring and indicating gauge 7 and an air pump 6. From said pump 6, air will be supplied into the chamber until a desired pressure; it shall be possible to release air in case pressure is exceeding or when it endangers the successful outcome of the extraction method.

[0026] The preferred fastening of the bag 1 shall be made between the disk 10 and the conical body 9, the screw 11 shall tighten one against the other and shall screw its threaded end into a pertinent hole made in the interior of the handle 5.

[0027] FIG. 2 shows a schematic view of the fitting of the device of FIG. 1 in a preferred use of same at a stage of the delivery. Here it is possible to see a woman "a" in whose womb "b" there is her fetus "c"; the bag 1, that is part of the device of the present invention, is fitted taking advantage of the fold 3 of the bag 1, either with the hand or with a thin element that slides between the bag and the external fold, allowing to move the chamber 2 to a position close to the fetal cervix "e".

[0028] Once the device of the present invention is placed, the chamber 2 shall be filled with air, operating the air pump 6 and controlling the pressure by means of the presostatic measuring and indicating gauge 7. Once said chamber is filled, the only thing to be made is to gently pull, in a straight direction, by the handle 5, accompanying the woman's pushes and also accompanying the gentle exit of air that was insufflated into the device; hence the extraction of the fetal cephalic pole is obtained.

[0029] The greatest volume attained in the external air chamber when extracting the fetus is due to the fact that at the time of the extraction, the fluid contained therein is retained in the section that lies in the interior of the cavity, and therefore, said greater pressure shall better fix the fetus that shall be moved within the bag as if on a conveyor belt.

[0030] Said annular chamber having a shape of an inflated ring shall adopt, due to its manufacturing design, a conical shape that allows to properly position the fetus' head.

[0031] In summary and to clearly understand the way to use the device described in the preceding paragraphs, the steps to be performed are mentioned as follows:

Insertion of bag 1 into the uterus until the air chamber makes contact with the fetus' shoulders.

[0033] At this stage, the woman in labor shall be in a normal delivery position.

Entrance of air or another fluid at very low pressure into the air chamber 3 by means of the air pump 6.

[0035] At this stage, the assisting professional shall proceed to insufflate air through the valves until noting, aided by an ecographer, if necessary, the distribution of the air chamber among the spaces and intertices of the fetal head and the mother's uterus. The reading of the presostatic measuring gauges shall assure the control of internal pressures, which shall never be higher than those pressures generated in the uterine wall.

Traction exerted by the obstetrician accompanied by the pushes of labor.

[0037] The physician shall proceed to collaborate with the woman in labor, accompanying the contractions and pushes with the synchronized traction of the handle that holds the closed end of the bag. The fetus shall slip within the bag as moved by a conveyor belt. Valves which at first were used for the entrance of insufflated air, shall now work to compensate pressure; it will be possible to expel part of the air and maintain the necessary pressure to assist the "virtual push" caused by the traction made by the professional from the chambers or probes.

[0038] In the second preferred embodiment of the device, as shown in FIGS. 3 and 4, the round air chamber of the first embodiment is no longer incorporated. Said air chamber shall be formed in the round inner cavity "d" of fold 3 of bag 1, at the time the outer surface of the bag's end makes contact with the outer surface of the same bag 1. This nearness of surfaces shall be forced when passing through the uterus cervix and by the inner walls of the vagina. The air accumulated in said round cavity "d" shall act as part of a clamp that moves in all directions (a 360[deg.] revolving clamp).

[0039] FIG. 4 shows the "conveyor belt" phenomenon.

[0040] Bag 1, in any of the preferred embodiments of this invention, has, at the area where it will contact "e" the cavity walls (or vagina walls in case of childbirth), a sufficient and necessary rugosity so as to provide a fixed fastening surface. The inner face of bag 1 is designed without rugosity: it is smooth and treated with liquid or gel to support the slipping function of the virtual "conveyor belt".

[0041] When pulling from the handle 5, the rugose surface "d" shall get adhered or attached to the face contacting the tunnel or cavity that contains the element, the round cavity "d" shall act as an "air fastening clamp", able to move in all directions, and shall displace the object to be extracted as if on a "conveyor belt" between the inner faces of the bag 1 (movement of arrows "f")

[0042] This so-called "conveyor belt", which in its inner part holds the object to be extracted, protects against friction in the outlet channel and facilitates the extraction of the object since the rubbing of the conveyor belt takes place between the walls of the device.

[0043] The "air fastening clamp" is made with the natural air chamber (round inner cavity "d" formed adjacently to the fold) which is created during the placement of the device. As well, this "air fastening clamp" facilitates the dilation of the outlet channel.

[0044] Alternatively and pursuant to the professional's option, one of the two preferred embodiments may be used, that is: with external air chamber 2, chamber 2 that will be connected to an external pressure generating means; without external air chamber 2 and with an external pressure generating means; and finally, without any external air chamber 2 and without any external pressure generating means.

[0045] The device of the present invention in its two preferred embodiments shall allow to accompany the birth of the fetus, holding same with a round air chamber, with no risk at all for the child or the mother. In particular, it shall be of great help for the woman in labor so that, during a long expulsion stage, the obstetrician may provide assistance during the extraction of the fetus without using any rigid mechanical tools that may harm any of the parties.

[0046] On a separate note and with the corresponding technological sufficiency, this novel system can find other applications in many fields of the industry, to with pipes of big diameter such as gas pipes, oil ducts or poly ducts, or of medium or small diameter, such as water, gas, telephone and power supply nets.

[0047] It is undoubtly understood that when the present invention is put into practice, changes to certain manufacturing details and shape, may be made, without departing from the main principles which are clearly stated in the following claims.




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