Patent Description:
Nowadays there are many devices used to extract elements that are inside a cavity, that change their shape when they are introduced in the cavity.

Forceps are one of these instruments. Forceps is an obstetrical instrument similar to tongs, which help to remove a baby from the outside. Once each part is introduced in the cavity it tighten on the head of the fetus.

Patent <CIT>; states to be an "obstetrical extractor". This extractor is placed covering the fetus' head. It has strings, which are pulled closing the opening in which the fetus' head is introduced.

Patent <CIT> states to be "an inflatable catheter and its methods of usage". This catheter includes an external and an internal canal, the internal canal moves regarding to the external, and an inflatable balloon with a first portion fixed to the distal tip of the external canal, and a second portion fixed to the portion of the internal canal that stretches beyond the tip of the external canal. The distal tip of the balloon can introduce, like a telescope with movements in proximal way, the internal canal inside the external.

Patent <CIT>, states to be "a flexible grasping device". This device consists of a net-like structure that is arranged covering the fetus' head and has, in its distal tip, a cylindrical portion around the fetus' head which closes once pulling from a drawstring.

Patents <CIT>; <CIT>; <CIT> and <CIT>, all from Gary Alexander, state to be "a device for assisting during childbirth". This device consists of a hollow, stretched and flexible member that fits around the fetus' head. A drawstring is arranged at the end of the fetus' head, to restrict the opening of this once pulling from the end. To pull the drawstring, the auxiliary element to introduce the device inside the cavity has to be placed.

<CIT>, published as <CIT>, states to be a "device to extract elements which are inside a cavity". This device comprises a folded sleeve with an air chamber in said fold, which is disposed around the fetus' head. Once the air chamber is inflated, it is disposed around the fetus' head shackling it.

Patent application <CIT> states to be a "tube of air bag design on glove, forceps and vacuum use to open the birth canal during labor delivery". This device comprises a double wrapping glove that leaves at least the first pharynx of the fingers uncovered. The hand with the glove is introduced into the vagina and it inflates. With the uncovered fingers, the baby is grabbed.

All precedent applications showed relatively small device-head contact areas, whether because they are like lineal circuits or defined like the one from Nguyen. In <CIT> there is a bigger contact area, however it is still not the originally desired size.

None of the precedent disclose or suggest a reduction or shrinkage of the wide external portion of the device diameter to extract an element that is inside a cavity; and that the tension while reducing the said wide external portion of the diameter is performed on one of the handles and not on the device distal that is in contact with the element to be extracted.

The invention consists of a flexible sleeve folded in its central area defining the inner and the external sleeve. The free ends of the sleeve are partially connected, and have their corresponding traction handles. The external sleeve has the means to hold the adjustment strip. The external sleeve has, in the inner part, diverse pockets to put the tentacles of an applicator. In one realization, there is also an air chamber, with toroid shape, at least partially fixed to the inner part of the external sleeve, and near the central part of the sleeves with the means to inflate / deflate said air chamber.

The diameter regulator of the device to extract elements which are inside a cavity comprises an adjustment strip, with an average diameter, and at least one mean to modify said diameter, in which the adjustment strip is arrange loosely in the inner part of the external sleeve. Triggering the at least one mean to modify said average diameter, a soft arrangement of the diameter is produced on the element to be extracted in the cavity avoiding an increase in external diameter of the device. The adjustment strip, which presents at least one longitudinal opening, has a circular shape, like a truncated cone or a truncated cone with a circular portion in the side of greater diameter. The mean to modify said average diameter comprises at least: one string and a hollow case with a distal end near the fold, and a proximal end that is fixed to the base of the traction handle of the flexible sleeve.

It is an object of the present invention to provide a diameter regulator of a device used to extract an element that is inside a cavity in which the diameter of the device is changed to the opposite side of the greater part of the element to be extracted.

Another object of present invention is to provide diameter regulator of a device used to extract an element that is inside a cavity surrounding an external air chamber that prevents to increase its diameter once it is inflated.

Another object of present invention is to provide a diameter regulator of a device used to extract an element that is inside a cavity that presents less friction during the extraction respect to the cavity while reducing the diameter of the device.

Another object of present invention is to provide a diameter regulator of a device used to extract an element that is inside a cavity generating more contact with said element having fewer chances of loosen it. There is better effectiveness in the traction with less air pressure in the fastening of the element to be extracted. By reducing the diameter with an adjustment strip, the device has a more extensive area of support with the element to be extracted.

Another object of present invention is to provide a diameter regulator of a device used to extract an element that is inside a cavity that simplifies the introduction of the device in the cavity, closing the ends of the applicator tentacles while it is being introduced.

Another object of present invention is to provide a diameter regulator of a device used to extract an element that is inside a cavity that reduces the traction force required to extract the element while having a smallest diameter due to the adjustment of the adjustment strip, resulting in a smallest contact between the device and the cavity.

Another object of present invention is to provide a diameter regulator of a device used to extract an element that is inside a cavity that indicates the measurement of the diameter of the element to be extracted.

Another object of present invention is to provide a diameter regulator of a device used to extract an element that is inside a cavity in which it is no necessary to deflate the air chamber to facilitate the displacement of the device in the cavity.

Another object of present invention is to provide a diameter regulator of a device used to extract an element that is inside a cavity in which it can be measured the traction force to which the adjustment strip is submitted.

The diameter regulator of a device used to extract an element that is inside a cavity of the present invention is used together with two known instruments in the states of art:
A flexible folded sleeve (<NUM>), with a distal end (<NUM>) ready to fit around the element to be extracted, and another proximal end (<NUM>) with traction handles, both ends open, presenting in the distal end the fold (<NUM>) which has, an inner sleeve (<NUM>) and an external sleeve (<NUM>), whose proximal ends are partially connected with each other. The external sleeve has pockets all along (<NUM>) and in its inner part to lodge spatulas of the applicator. Also, in the inner part it has the media (<NUM>) to hold the adjustment strip (<NUM>). These media are on the external side respect to the longitudinal pockets to close the opening of the applicators' tentacles during the introduction process of the device inside the cavity. The proximal end of the flexible folded sleeve has at least two traction handles (<NUM>,<NUM>) one on each side of the open end, where the base of one of the handles is fixed to the proximal end of the hollow case through which a string passes to regulate the diameter of the device; and in one realization of the flexible sleeve it has an air chamber (<NUM>), with teroid shape, fixed to the external sleeve, near the proximity of the fold, so that said air chamber remains between the internal sleeve and the external sleeve. In this case, the fixation of the adjustment strip is performed over the inner part of the external sleeve, so that it can regulate itself on the external diameter of the air chamber. The air chamber has it corresponding means to inflate/deflate (<NUM>). An applicator (<NUM>) to introduce a flexible folded sleeve inside the cavity that lodges the element to be extracted. The applicator presents a cup (<NUM>), spatulas (<NUM>) that fit in the longitudinal pockets of the external sleeve and a guide indicator (<NUM>) of the movement of the spatulas respect to the cup.

The diameter regulator (<NUM>) of a device to extract an element that is inside a cavity, which acts changing the diameter of a flexible sleeve around the element to be extracted or the external diameter of an air chamber, comprises an adjustment strip (<NUM>) which has an average diameter (<NUM>) when is arranged inside the device, and at least one mean to modify the said medium diameter (<NUM>).

The adjustment strip, has a width that ranges preferably distal medium of the element to be extracted up to a mayor transversal dimension zone, and with at least one longitudinal opening (<NUM>), it has circumference shape (<NUM>), of truncated cone (<NUM>) or of truncated cone with a circular portion (<NUM>) in the widest diameter of the cone. It is placed inside the media to hold said adjustment strip. This means are closed in their transversal sides and open on its longitudinal sides thought which the adjustment strip passes.

When the device is used to assist childbirth, the adjustment strip, preferably has a width that ranges from the shoulders of the fetus up to the high of nose and ears.

In another method, one of the close sides can be opened with a fix mechanism that locks it when the device is being used.

In another method the adjustment strip is formed of diverse separate ribbons, having each of them in their ends the corresponding media to modify the diameter.

In another method, one of the diverse separate ribbons is linked within itself, not with the need a media to modify the diameter, but with a system of fastening / unfastening. The fastening system can be with Velcro closure or with a clasp. This will be useful to put the adjustment strip around the sleeve and inside the media to hold the adjustment strip.

The adjustment strip and the media to modify the diameter are made of a flexible material.

On each end (<NUM>) of the adjustment strip (<NUM>) a distal end is fixed (<NUM>) of at least one string. The link between the adjustment strip and the at least one string is such that, by pulling the opposite end of said string, the regulation strip modifies its diameter and that of the device according to the necessity, having an extraction device of elements content in a cavity with diverse external diameters.

The way to regulate the diameter of the adjustment strip is triggered through a pulling system of a string or something similar.

The configuration between the inner sleeve and the element to be extracted is fundamental for its correct extraction. A combination of the contact area and the diameter of the inner sleeve will generate that the element to be extracted shall remain perfectly inside the device in a way that, by pulling the handles in the open end of the sleeves, it is dragged along the cavity until it appears through it. A width area of contact will make less pressure directly on the element to be extracted.

When it is used to assist childbirths, the configuration of the contact between the sleeve and the cephalic pole of this invention is substantially of higher quality than in other devices of previous art. With forceps the contact area is of two rectangles that face each other slightly curved under the lower jaw. In those devices that used a circular net, the contact area, which is closed with a rope under the chin of the fetus, includes the mouth, the nose, the ears and the eyes and reach almost the fontanel. The head of the fetus is submitted to pressure while pulling from the device. This pressure in the cephalic pole is produced by the deformation of the net of square spaces to rhomboidal spaces. Being the longitudinal axis stretched the transversal axis is reduced, causing the net to reduce over the cephalic pole. This extensive contact area is not what is pretended to be achieved, but the one that is the result of the design of the own circular net. In the case of the inflatable glove, the contact area correspond to the tip of the fingers.

In this realization, being a strip of considerable width and able to regulate anatomically around the cephalic pole, the result is a contact area that only includes the high of the nose or ears. It is never around the neck only, because due to the width of the adjustment strip, even though the device of extraction is supported on the shoulders of the fetus, there will always be a portion of said adjustment strip that will concur with the jaw, chin and the nape of the fetus. The design of the adjustment strip will determine the size and the location of the contact area while pulling the device. The same shall happen in case the adjustment strip acts only over the external diameter of the air chamber. The combination of the pressure from the air chamber and the adjustment strip shall make the internal diameter of the air chamber to make pressure over the cephalic pole assuming its morphology. With the regulation of the adjustment strip a widest contact area shall be possible and with lesser pressure while inflate it.

In another embodiment, one of the ends of the adjustment strips is directly fixed to the hollow case, regulating the diameter of the adjustment strip only with one side of said strip.

A sleeve, of flexible material, that presents a folding in its central area, and in the proximity of said fold means to support the adjustment strip in a loose way. Said means area preferably open supports of transversal orientation in respect to the sleeves in which said adjustment strip is arranged. These means are on the inner side of the external sleeve.

The pulling system comprises a hollow case (<NUM>) located between two sleeves, with the distal end (<NUM>) near to the folding area and the proximal end (<NUM>) on the handles side, being this end fixed to one of the handles. The string or similar element (<NUM>) is introduced inside a hollow case though the distal end or through a lateral hole (<NUM>) near to said end and goes over inside the hollow case, so that one of its ends fix to the adjustment strip in the attachment points (<NUM>) located in the open end of the adjustment strip. In case there is more than one string, the separation between the attachment points of the adjustment strip can have, or not, the same separation among the entrances of the string to the hollow case. To make the pulling operation easier, the distal end of the hollow case can be put in a way that allows the strings to enter in parallel way to the hollow case. <FIG> depicts the disposition of a hub and of a buttonhole.

In a preferred realization, the proximal end of the hollow case is linked to a case support (<NUM>) fixed to one of the traction handles through a hollow tension screw (<NUM>). This hollow tension screw will be used to adjust the tension of the hollow case. The support of the case has a hole collinear with the access to the case and a guide over which the pulling trigger (<NUM>) slides. The at least one of the strings that passes through the hollow case, the tension screw and the collinear hole of support of the case, fix to an axis (<NUM>) that is fixed to the pulled trigger. This axis slides inside the collinear hole of support of the case between two extreme positions. In the position when the adjustment strip is release, the axis is introduced into the support of the case and in the position of when the adjustment strip has reduced the diameter of the device, the axis is moved and the trigger blocked. The axis can present a graduated scale (<NUM>) that shows the measurement of the diameter that is being hold.

In another method, the adjustment strip can be parted in more than one place, being for this reason, formed by at least two sections of the adjustment strip. Each pair of ends of the strip hall have its corresponding pulling media.

In another method, the pulling system has a dynamometer (<NUM>) connected to the at least one string that shows the tension to which it is submitted said string and, at the same time, shows the tension to which the adjustment strip is submitted. By putting traction on the device to extract the element, the adjustment strip, already regulated, shall pressure over the element to be extracted to drag it, together with the device, outside the cavity. In case of any action from the element to be extracted of remaining in its position respect to the cavity, the regulation strip shall undergo a traction that will be seen in the tension of the at least one string. Once the traction of the device increases, and being the element to be extracted opposing to this traction, the higher will be the tension that the at least one string, the adjustment strip and the element to be extracted suffer. This tension can be important because it can generate undesirable effects on the element to be extracted. By placing coaxially a dynamometer with the at least one string the values of the tension can be controlled. The dynamometer can be a spring (<NUM>) or a scaled spring (<NUM>).

When used for assisting during childbirth, the tension of the force shall be limited not to damage the cephalic pole.

The device already to be used presents a flexible folded sleeve, with the adjustment strip in the position inside the medias to hold the device, and the end of the hollow case fixed to one of the traction handles. The adjustment strip is arranged loose. The extraction device is assembled introducing the applicator tentacles inside the pockets of the sleeve, forming a combination of the device with the regulator and the applicator. This is introduced inside the cavity until the tip of the applicator makes a first contact with the element to be extracted. The pushing of the combination continues and this generates the opening of the distal ends of the applicator. Once the greater area of the element to be extracted is passed, a first regulation of the adjustment strip is done. Pulling the trigger and blocking it in its new position. In this first regulation, the angles of the ends of the tentacles will be modify falling back on the element to be extracted. The cavity axis cause them to be parallel, and what is more, it will shorten the external diameter of the device, reducing the pressure over the walls of the cavity. The distal ends of the tentacles shall make no pressure against the wall of the cavity due to keep on pushing; this way, the pressure against the walls of the cavity shall be reduced. The pushing continues until the insertion is over. In the final position of the combination, the adjustment strip is regulated one more time up to its final measure, letting the measure of the diameter of the element to be extracted to be measured, which is seen in the pulling system. If the sleeve has an air chamber, it can be inflated, and the external diameter shall not be increase due to the restriction that the regulated adjustment strip imposes. The applicator is removed. It is pulled from the traction handle to remove the element that is inside the cavity, having the possibility to increase the inflation pressure if it were necessary.

In case of use for assisting during childbirth, when the device has an air chamber, little before the crowning, the chamber has to be deflate, because there is no enough room for the cephalic pole, the bag and the inflated air chamber. The deflate has to be done in a precise moment, because if it is performed beforehand the cephalic pole can be loosen extracting the device without the fetus, and it is performed with delay it can produce tears in the birth canal. With the present invention, it is not necessary to have an air chamber because the adjustment strip with trunk shape of cone drags easily the cephalic pole.

Claim 1:
A diameter regulator device to extract a fetus from a cavity, comprising:,
flexible sleeve (<NUM>) folded in its central area thus defining an inner sleeve (<NUM>) and an external sleeve (<NUM>), and thus having a distal end (<NUM>) and a proximal end (<NUM>), wherein the proximal end (<NUM>) has at least two traction handles (<NUM>,<NUM>), the proximal ends of the inner sleeve (<NUM>) and the external sleeve (<NUM>) linked among each other, wherein the distal end (<NUM>) and the proximal end (<NUM>) are both open, and presenting in the distal end (<NUM>) the fold (<NUM>) which defines the inner sleeve (<NUM>) and the external sleeve (<NUM>), and wherein the external sleeve (<NUM>) has longitudinal pockets (<NUM>) all along and its inner part to lodge the spatulas (<NUM>) of the applicator (<NUM>), an applicator (<NUM>) comprising a cup (<NUM>), spatulas (<NUM>) that fit in the longitudinal pockets (<NUM>) of the external sleeve (<NUM>) and a guide indicator (<NUM>) of the movement of the spatulas with respect to the cup (<NUM>),
CHARACTERIZED in that:
the diameter regulator device further comprises an adjustment strip (<NUM>) having ends (<NUM>) being made of a flexible material, and being formed into an open circumferential shape (<NUM>) with a longitudinal opening (<NUM>) between the ends (<NUM>), wherein the adjustment strip (<NUM>) is placed between the inner sleeve (<NUM>) and the external sleeve (<NUM>) thereby encircling the inner sleeve (<NUM>), and wherein on each end (<NUM>) a distal end of at least one string (<NUM>) is fixed; and in that
the diameter regulator device further comprises at least one means (<NUM>) to modify the diameter of the adjustment strip (<NUM>), by pulling the opposite ends of said strings (<NUM>) through a pulling system.