Patent Description:
The administration of uterotonic drugs during the third stage of labor drastically reduces the risk of postpartum haemorrhage. Where drugs are not shown to be sufficient to stop bleeding, the uterine tamponade technique is used. This technique involves compression of the uterine viscus with gauze in order to stretch and tampon the walls of the uterus and thus stop blood loss. However, the technique is undermined by the possibility of the so-called "masking", that is, the loss stops only apparently, the blood continues to flow passing by capillarity through the gauze itself, becoming visible only after some time. Furthermore, it is possible when removing the gauze to forget some of them on the spot.

An alternative to tamponade with gauze involves the use of catheters. These include the insertion of a deflated balloon, through the vagina and cervix, into the uterus and subsequent filling with a saline solution. The balloon, thanks to the pressure exerted on the damaged walls of the uterus, stops the bleeding. One of the most used is the Bakri balloon, a temporary means for achieving haemostasis in cases where conservative management of postpartum uterine bleeding is indicated (<NPL>). It is a device of a certain complexity which is accompanied by costs that cannot be faced in many disadvantaged geographical areas, which therefore still lack adequate tools to deal with this dangerous emergency.

Rudimentary approaches to remedy the unavailability of adequate equipment have been described and typically use condoms that are inserted into the uterus with the aid of forceps, inflated and then held in place by closing the end with what is available, for example a tie. These approaches remain lacking both from the point of view of sterility and effectiveness, where the closures do not guarantee the necessary tightness to ensure the correct pressure of the balloon on the uterine walls.

As an example, <NPL> describe the use of a condom to stop uterine bleeding, connected to a catheter via an O-ring.

<CIT>, <CIT>, <CIT> describe a balloon for uterine insertion, where a balloon is connected to a catheter.

There is therefore a strong need for an effective and low-cost device in the treatment of postpartum haemorrhage.

The present invention is defined by appended claim <NUM> and relates to a device for intrauterine insertion capable of providing a haemostatic effect in the uterine cavity.

The subject of the present disclosure is a device <NUM> (<FIG>) for intrauterine insertion which includes:.

characterized in that said catheter <NUM> is connected with a seal connector <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to said balloon <NUM>.

In an embodiment, <FIG>, said device <NUM> for intrauterine insertion also comprises a uterine introducer <NUM>.

In one embodiment, said uterine introducer <NUM> is a rigid polygonal section bar with at least <NUM> sides (<FIG>).

Said uterine introducer <NUM> has no sharp edges or angles and has a section such as to guarantee the necessary rigidity. In a preferred form, the section of said introducer is cross, star, toothed wheel. Even more preferably, said uterine introducer has a cross section, where the edges are rounded.

The geometry of said uterine introducer <NUM> is advantageously selected so as to allow the passage of fluid through said catheter <NUM> into said balloon even during the insertion and positioning of said introducer. In fact, said polygonal section with at least <NUM> sides ensures that even when said introducer <NUM> inserted in said catheter <NUM> is held in the hands, a lumen always remains in said catheter <NUM> for the passage of fluid.

In an alternative form, <FIG>, said uterine introducer is a straw <NUM>, where said straw is closed at one end, where said closure leaves no sharp edges. On said closed end, holes are made which allow the passage of fluid. Also this embodiment allows the passage of fluid inside said straw during insertion and positioning. Said closure which leaves no sharp edges avoids the sharp edges that would be present using a rigid straw having both ends open.

In one embodiment, said balloon is a condom.

In one embodiment, not forming part of the claimed invention, <FIG>, said seal connector <NUM> is a cable gland <NUM>. Said cable gland <NUM> comprises a perforated head <NUM>, a perforated body <NUM>, said head and said body being axially arranged with respect to each other, or along the length of said cable gland, when the cable gland is assembled, with an end portion <NUM> of said body <NUM> received in a receiving portion <NUM> of said head <NUM>; a gasket <NUM> arranged axially with respect to said head and said body and interposed between them when said cable gland is assembled, where said gasket has an upper portion <NUM> and a lower portion <NUM>, said lower portion <NUM> being received in said body and said gasket being tapered downwards, i.e. from said upper portion <NUM> to said lower portion <NUM>.

Said perforated head and said perforated body engage each other preferably by screwing. Preferably, said perforated head <NUM> has an internal thread and said perforated body <NUM> has an external thread, where said internal and external thread are complementary to each other.

In one embodiment, said cable gland is made of polymeric material.

In a further embodiment, not forming part of the claimed invention, said seal connector <NUM> is of the type shown schematically in <FIG>, B.

In this embodiment, said seal connector is a seal connector with rubber bands and two rigid gear wheels, seal connector <NUM>, and comprises a first perforated body <NUM> and a second perforated body <NUM>, mounted axially, i.e. one above the other, in such a way that the hole of said first perforated body <NUM> is aligned with the hole of said second perforated body <NUM>. Said sealing connector has a length which extends from said first perforated body to said second perforated body. Inside said first and second perforated bodies <NUM> and <NUM> are housed axially, or along the length of said seal connector, two rubber bands mounted on special supports. <FIG> shows a vertical section of said sealing connector <NUM> which shows the supports <NUM> and <NUM> on which the elastic <NUM> is mounted. In the section that mirrors that of <FIG>, there are two further supports, mirroring those shown in <FIG>, on which the second elastic is housed.

Said first and said second perforated body <NUM> and <NUM> receive, respectively, a first toothed wheel <NUM> and a second toothed wheel <NUM>. Said first and second toothed wheel <NUM> and <NUM> engage each other so as to form a ratchet, that is a mechanical device that allows a rotary movement around the axis in a sense only, where the play linked to the distance between the teeth that allows rotation in the opposite direction is negligible.

The catheter <NUM> is inserted, crossing it axially, or along its length, into said hermetic connector <NUM>.

Once the balloon has been inserted at the distal end <NUM> of the catheter <NUM> and after having inserted the set of catheter plus balloon inside the aforementioned perforated bodies <NUM> and <NUM>, the same are made to rotate between them, and the rubber bands inside them seal the balloon to the catheter ensuring its seal.

In a further embodiment, not forming part of the claimed invention, said sealing connector <NUM> is of the type shown schematically in <FIG>.

Said sealing connector <NUM> comprises a perforated head <NUM> and a hollow tapered body <NUM>.

Said hollow tapered body <NUM> has a proximal end <NUM> and a distal end <NUM>. A uterine introducer <NUM> is grafted onto the distal end <NUM> of said perforated body <NUM>. Said uterine introducer is a straw, which has a proximal end <NUM> and a distal end <NUM>. Said uterine introducer <NUM> is closed to said distal end <NUM> by means of a closure plug <NUM>, without said closure leaving sharp edges. In said distal end <NUM> of said uterine introducer <NUM>, there are holes which allow the passage of fluid.

During use, a balloon is inserted on the distal end <NUM> of said uterine introducer <NUM> and the set is passed through the perforated head <NUM> which closes on the introducer <NUM> through pins <NUM>, so as to ensure the seal.

The device according to this embodiment can always be used but is particularly advantageous in cases of haemorrhage following a caesarean section, where it is necessary to introduce the balloon bound to the sealing connector <NUM> into the uterus, which is passed through the cervix and then the vagina before being connected via the proximal end <NUM> to the catheter <NUM>.

According to the claimed invention, said sealing connector is of the type schematized in <FIG> and <FIG>.

Said seal connector in this embodiment is a seal connector with rubber bands and two toothed wheels, one of which is radially deformable, seal connector <NUM>, and comprises a first perforated body <NUM> and a second perforated body <NUM>, mounted axially. Two elastic bands, <NUM>' and <NUM>", are axially housed inside said first and second perforated bodies <NUM> and <NUM>. In <FIG>, the bottom perspective view of said sealing connector <NUM> shows the lower base <NUM> of said second perforated body <NUM> and the supports <NUM> and <NUM> on which said first and said second elastic <NUM>' and <NUM>" are conveniently mounted, respectively. The view of figure 1B shows the upper base <NUM> of said first perforated body <NUM> and the supports <NUM> and <NUM>, mirroring those present on said first body and shown in <FIG>, on which said first and said second elastic <NUM>' and <NUM>" are conveniently mounted. Said first elastic <NUM>' is housed on said supports <NUM> and <NUM>, said second elastic <NUM>"' is housed on said supports <NUM> and <NUM>.

The distinctive feature of said connector is to be found in the fact that said first and second perforated bodies <NUM> and <NUM> accommodate, respectively, a first toothed wheel <NUM> capable of deforming radially and a second rigid toothed wheel <NUM>. Said first and second toothed wheel <NUM> and <NUM> engage with each other so as to form a ratchet, that is a mechanical device that allows a rotary movement around the axis in one direction only, where the play linked to the distance between the teeth that allows rotation in the opposite direction is negligible.

<FIG> shows the same perspective views 9A, 9B, 9C, in the absence of the rubber bands.

The catheter is inserted, crossing it axially, into said seal connector <NUM>, as described for the embodiment schematized in <FIG>.

Once the balloon has been inserted at the distal end of the catheter and after having inserted the set of catheter plus balloon inside the aforementioned perforated bodies <NUM> and <NUM>, assembled with said first and said second elastic as described, they are made to rotate between them, and said rubber bands seal the balloon to the catheter ensuring its tightness.

In a further embodiment, not forming part of he claimed invention, said sealing connector is of the type schematized in <FIG> and comprises a membrane, or cylinder, elastic or auxetic.

Said seal connector with membrane or cylinder elastic or auxetic, seal connector <NUM>, comprise four perforated bodies <NUM>, <NUM>, <NUM>, <NUM> each having an upper end and a lower end. Once axially assembled, said four perforated bodies are arranged in such a way that said perforated bodies <NUM> and <NUM> are located in the center, said perforated bodies <NUM> and <NUM> are located, respectively, at the distal end and at the proximal end of said seal connector <NUM>. Said perforated body <NUM> comprises a first rigid toothed wheel <NUM>. Said perforated body <NUM> comprises a second toothed wheel <NUM>, capable of deforming radially. An elastic cylinder <NUM> is inserted inside said perforated bodies, which has an upper portion <NUM> and a lower portion <NUM>. Said upper portion <NUM> is folded over the upper end of the perforated body <NUM>. In said upper end of the perforated body <NUM> there is a mechanism <NUM> which allows its locking when the perforated body <NUM> is axially mounted on said perforated body <NUM>.

Similarly, said lower portion <NUM> is folded onto the lower end of said perforated body <NUM>, an end in which there is a mechanism <NUM> that allows locking it when the perforated body <NUM> is axially mounted on said perforated body <NUM>.

Constrained said elastic cylinder <NUM> to said upper end of the perforated body <NUM> and to the lower end of said perforated body <NUM>, said perforated body <NUM> is assembled to said perforated body <NUM> and locked.

Once assembled, the toothed wheels <NUM> and <NUM> engage with each other so as to form a ratchet, that is a mechanical device that allows a rotary movement around the axis in one direction only, where the play linked to the distance between the teeth that allows rotation in the opposite sense it is negligible.

Said perforated bodies <NUM> and <NUM> also comprise teeth <NUM> and <NUM>, respectively. Said teeth <NUM> and <NUM> have the purpose of not allowing the rotation of said perforated bodies <NUM> and <NUM> when they are put into rotation in implementing the ratchet mechanism.

The catheter is inserted, crossing it axially, into said seal connector <NUM>, as described in relation to the embodiment of <FIG>.

Once the balloon has been inserted at the distal end of the catheter and after having inserted the set of catheter plus balloon inside the aforementioned perforated bodies <NUM>, <NUM>, <NUM> and <NUM>, the perforated bodies <NUM> and <NUM>, to which the perforated bodies <NUM> and <NUM> are rigidly connected, respectively, are made to rotate with each other, and the membrane inside them seals the balloon to the catheter, thus guaranteeing its tightness.

In an alternative embodiment, not forming part of the claimed invention, the elastic membrane <NUM> is replaced by an auxetic geometry of deformable material <NUM>, as schematized in <FIG>.

In a further embodiment, not forming part of the claimed invention, said seal connector is characterized by a hook mechanism and comprises an auxetic membrane, seal connector <NUM>. Said seal connector <NUM>, shown schematically in <FIG>, comprises a first perforated body <NUM> and a second perforated body <NUM>, axially mounted. The two axial ends of an auxetic cylinder <NUM> are constrained inside said first and second perforated bodies. The perforated body <NUM> has a hook mechanism <NUM> which fits into the seat <NUM> of the perforated body <NUM>, blocking any axial movement.

Once the balloon has been inserted at the distal end of the catheter and after having inserted the set of catheter plus balloon inside the aforementioned perforated bodies <NUM> and <NUM>, the perforated bodies are axially approached to facilitate their interlocking by means of components <NUM> and <NUM> , and this axial compression causes a reduction in the diameter of the auxetic membrane inside them, sealing the balloon to the catheter ensuring its tightness.

In a further embodiment, not forming part of the claimed invention, said sealing connector is shown in <FIG>, seal connector <NUM>, and it is composed of two bodies <NUM> and <NUM>, hinged together by means of cylindrical pin <NUM> which, together with bearing <NUM>, allows said connector a rotational motion around the axis of the cylinder itself.

Once the balloon has been inserted at the distal end of the catheter and after having inserted the catheter and balloon assembly, the two bodies <NUM> and <NUM>, after being hinged, close by means of a clip <NUM> on the body <NUM> which fits into a cavity <NUM> on body <NUM>, sealing the balloon to the catheter ensuring its tightness.

Advantageously, the device according to the present invention is characterized by a great simplicity of assembly, where the elements that compose it are either easy to manufacture or even already available, not to the detriment of its effectiveness, whereas the seal connector <NUM>, <NUM> , <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> allows to connect the end of the catheter <NUM> to the balloon <NUM> in a sealed way, so as to avoid any possible leakage in the passage of fluid through the tube to inflate the balloon, ensuring the due efficiency of tamponade.

Advantageously, said uterine introducer <NUM>, inserted in said catheter <NUM>, makes it less flexible and more rigid in the final part, thus assisting the operator in inserting the same and positioning the balloon.

Claim 1:
A device (<NUM>) for intrauterine insertion which comprises:
- an expandable balloon (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>), sized to fill the uterine cavity during expansion and to exert pressure against its boundary wall on substantially the total surface of said wall;
- a catheter (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>), where said distal end (<NUM>) of said catheter is connected with the proximal end (<NUM>) of said balloon (<NUM>), and said proximal end (<NUM>) of said catheter is connected to a source of fluid and means (<NUM>) for supplying pressurized fluid to the balloon (<NUM>) through said catheter to effect and maintain its expanded condition,
wherein said catheter (<NUM>) is connected with a seal connector (<NUM>) to said balloon (<NUM>), characterized in that said seal connector (<NUM>) comprises:
- a first perforated body (<NUM>) and a second perforated body (<NUM>), mounted axially, i.e. along the axis;
- two elastic bands, (<NUM>') and (<NUM>") axially housed inside said first and second perforated bodies (<NUM>) and (<NUM>), where a first elastic (<NUM>') is mounted on supports (<NUM>) and (<NUM>) comprised, respectively, on said second and on said first perforated body and a second elastic (<NUM>") is mounted on supports (<NUM>) and (<NUM>) present, respectively, on said second and on said first perforated body;
where said first and said second perforated body receive, respectively, a first toothed wheel (<NUM>) capable of radially deforming and a second rigid toothed wheel (<NUM>), where said first and second toothed wheel (<NUM>) and (<NUM>) engage between them so as to form a ratchet, that is a mechanical device that allows a rotary movement around the axis in one direction only.