|Title of Invention||
AN INFLATABLE UTERINE DEVICE TO CONTROL UTERINE BLEEDING
|Abstract||An inflatable uterine device to control uterine bleeding, comprising an inflatable balloon (10) and a hose (11) connecting the balloon to a fluid source. The fluid source comprises an open container (12). A first end of the hose can be integrally connected to the inflatable balloon and a second end of the hose can be integrally connected to the container. A suspension means (14; 15) is provided at the second end of the hose. The device is produced by feeding an upper film (18) from a first roll (17), feeding a lower film (20) from a second roll (19) and joining the films along contour lines forming an inflatable balloon (10), a container (12) and a hose (11) connecting the balloon to the container in an open fluid path. The films are cut outside said contour lines.|
|Full Text||AN INFLATABLE UTERINE DEVICE TO CONTROL UTERINE BLEEDING
The present invention relates to an Inflatable uterine device to control
uterine bleeding. Uterine bleeding can be caused by post-partum hemorrhages
following childbirth. Severe uterine bleedings can be a serious problem
due to the large loss of blood. Hemorrhage is one of the major causes of
maternal mortality. The invention relates also to a method for producing the
A device used for stanching uterine bleeding comprising an expandable
balloon and a tubular handle connected therewith for the insertion of the balloon
into the uterine cavity is disclosed in US6024753. The device further includes
a hose for connecting the balloon to a fluid source. The hose is connected
to a pump, which is controlled by a control unit. Both the pump and the
control unit will require well-trained personnel and will involve high costs for
producing and for operating the device, which is a drawback in several instances.
A similar device is disclosed in US4552557. The pressure of an inflatable
portion is measured by a pressure gauge. The device in one embodiment
will allow accumulated blood or mucosal debris present in the uterus to
In the devices disclosed in US6024753 and US4552557 an inflatable
balloon is used. The balloon is formed by a material that will allow the balloon
to expand and to fill the uterine cavity completely when inflated. The requirements
on the material result in a high cost for producing the device. The
pump and pressure measuring means will involve further costs and possible
problems handling the equipment.
A further drawback is that the devices may include air. Such embedded
air has to be removed, so as not to risk that air embolism will occur if the balloon
ruptures. The removal of air involves further costs.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a device for controlling
or stanching uterine bleedings that is without the drawbacks mentioned
above. The device according to the invention can be produced at a very low
cost and can be used under very primitive conditions. No pump or similar device
is necessary to provide the required pressure for inflating the balloon and
for exerting sufficient pressure on uterine blood vessels to curtail bleeding.
According to the invention the fluid source comprises a container with
an opening that will allow filling of a fluid, preferably water, into the container
and through the hose into the balloon. Preferably, the opening is formed as a
funnel, so as to facilitate the filling of fluid.
The hose close to the container or the container itself is provided with
suspension means. The suspension means can be used to suspend the device
at such a height in relation to the balloon that the pressure in the balloon
will reach a sufficient level. Normally, the surface of fluid in the container will
be kept at least 1 m above the balloon. A1m long hose corresponds to a
pressure in the balloon of about 70 mm Hg, which in most circumstances will
The length of the hose will normally be no more than 3 meters, thus restricting
the maximum pressure that can be obtained from the water pressure
to about 220 mm Hg (29,3 kPa). At this pressure neither the tissue in the uterine
cavity nor the uterus itself can be damaged. A working pressure of approximately
70 mm Hg would be a normal pressure. The hose may be provided
with markings over a section or the complete length. The markings indicate
the pressure in the balloon when the container is lifted. The hose may
also be provided with a more detailed scale that can be used if a pressure
clamp is used to raise the pressure in the system.
The device, comprising the container, the hose and the balloon, according
to the present invention can all be in an integral form and no connectors
or similar devices are required to be present. When inflated the balloon
will fill the uterine cavity and exert a sufficient pressure on the surrounding
tissue to curtail bleeding.
Different methods can be used for producing the device according to
the invention. In one embodiment two sheets that are welded together in the
appropriate shape form the device. The sheets are fed from two rolls to a
welding and cutting device. Preferably, side edges of the device are welded
and cut in one step. The cut out device is then either folded to an appropriate
shape and size or rolled into a roll. The device is sterilised and wrapped in a
package. If folded the device preferably is disposed on a sheet or plate that
will function as a base plate when the device is unpacked. As a result of this
producing method no air will be present within the device. As no cavities with
air will be present in the device it is ensured that no air embolism occurs during
use of the device.
The package may include a clamp or similar device that can be used to
close the container and/or to raise the pressure in the balloon. In the latter
case the clamp can be moved over the hose from the container towards the
balloon and may include rolls or other rotating means.
The balloon has a size when inflated that is sufficient to fill the uterus of
most women. Preferably a non-resilient material is used. A major advantage
of using a non-resiiient material is that the pressure in the area of filling the
device, a filling pressure, will equal to a working pressure of the device. Thus,
there will be no need for measuring the pressure of the balloon when it is located
in the uterus.
The term non-resilient should be understood to include materials that
are completely without resilience and materials that will have a low degree of
resilience and a substantially linear relation between expansion and pressure
increase. When a non-resilient material is used the volume of the inflated balloon
is at least 0,3 litre. In prior art devices the resilient material will cause a
resistance when the pressure is increased. Therefore, the pressure normally
has to be measured within the uterus.
It is possible to produce the device at very low costs. Biocompatible but
low-cost materials can be used, because it is not required that the material is
resilient. Large amounts of the device can be distributed in developing countries
to save many lives.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a schematic plan view of the device according to the invention.
Fig. 2 is a schematic side elevation view of a production line for producing
the device according to the invention.
Fig. 3 is a schematic plan view of the production line in Fig. 2.
Fig. 4 is a cross sectional view from line IV-IV in Fig. 1.
Fig. 5 is a schematic plan view of the device in Fig. 1 on a base plate
with folding lines indicated with dashed lines.
Fig. 6 is a schematic plan view of the device in Fig. 5 in a folded condition.
Fig. 7 is a schematic side elevation view of the folded device.
Fig. 8 is a schematic side elevation view of the device rolled into a
Fig. 9 is a schematic side elevation view of the device in Fig. 1 extended
and filled with liquid and an enlarged section showing a clamping element.
Fig. 10 shows schematically a first embodiment of an introducing member.
Fig. 11 shows schematically a second embodiment of an introducing
Referring to Fig. 1, it can be seen that a device according to the invention
comprises three main sections. It should also be noted that the device is
shown in a configuration when delivered and ready for use. A balloon 10 constitutes
the part of the device that is designed to fit in the human uterus. The
balloon 10 is circular or approximately circular and completely fiat in a non-
inflated condition. In an inflated condition (not shown) it will assume a some-
what flattened but spherical shape. The volume of the balloon 10 in the inflated
condition is between 0,3 litre and 2,5 litres, corresponding to a diameter
of about 0,13 m to about 0,20 m. An appropriate size is achieved with a diameter
of 0,155 m resulting in a maximum volume of about 1,5 litre. A balloon
of that size will for most women exert a sufficient pressure, even if the balloon
is not fully inflated. As an alternative two sizes of the balloon are provided. A
smaller sized balloon will hold from about 0,31 to about 1,51, and a larger
sized balloon will hold from about 11 to about 2,51.
A balloon that is not fully inflated will adapt to the form of the uterus
more closely and the shape of the balloon is of less importance. By using thin
films the balloon can fill small and irregularly shaped cavities. Other sizes of
the balloon may be provided for specific conditions such as when a differently
sized uterus is to be treated. The design of the device and the thin material
used will allow the use of more than one balloon if necessary.
An annular flap 35 can be provided on the edge of the balloon opposite
to the connection between the hose and the balloon. The flap 35 can receive
a tip of an introducing member, for instance as the one shown in Fig. 10.
The balloon is integral with a hose 11 extending from the balloon to a
container 12. The length of the hose 11 from a first end connected to the balloon
to a second end connected to the container 12 will be sufficient to give
the required pressure when the container 12 is filled with water and raised.
The container is designed to be filled with a liquid, such as water, and has
one open end where water can be filled and an opposite end, which is integrally
connected to the hose. In the embodiment shown in Fig. 1 the open end
is shaped as a funnel 13, so as to facilitate the filling of water. The funnel
shaped opening 13 will allow water to be poured into the container.
The container 12 is provided with a suspension means to facilitate the
suspension thereof in a raised position. In the embodiment shown in Fig. 1 a
longitudinal pocket 14 extending from a lower part of the container 12 to the
funnel shaped opening 13 is used. The pocket is formed to receive a vertical
rod or pin and is open in one end and closed in the other end. The open end
is located at the lower part of the container 12. Fig. 9 shows an example of
the use of the suspension means. Also a recess 15 formed between the
pocket 14 and the funnel shaped opening 13 can be used as a suspension
At an appropriate distance from the balloon 10 the hose 11 is provided
with a scale 16 that can be used when an increased pressure is required. The
use of the scale is further described with reference to Fig. 9 and the enlarged
In a preferred embodiment two sheets that are welded together form
the device. A space between the sheets formed by welding seams can be
filled with a liquid such as water as disclosed above. The complete device is
mounted on a plate or sheet 23 that will hold the device and facilitate the handling
thereof when the device is to be used. The plate 23 can be made from
paper only or from a plastic film coated paper sheet.
An example of a production line for the manufacturing thereof is shown
in Fig. 2. A plastic film is rolled on a first roll 17 and forms an upper film 18. A
corresponding plastic film is rolled on a second roll 19 and forms a lower film
20. The plastic film can be made from different plastic materials with appropriate
properties. The material should allow a combined cutting and welding
process and should also be biocompatible. Suitable materials are polypropylene,
polymers such as ethylene methacrylic acid copolymer (EMA) and Eth-
ylene Vinyl Acetate (EVA). At least the balloon is formed by thin films of a
rigid or non-flexible material that are welded together.
The upper film 18 and the lower film 20 are conveyed over a working
table 21 to a welding and cutting device 22. The films are welded together
along the contour lines forming the device as shown in Fig. 1. There are no
welded seams in the funnel shaped opening 13 and in the opening of the
pocket 14. In a preferred embodiment the seams are welded and the device
is cut out at the same time.
The welding and cutting device 22 can include a press form or a similar
device that moves up and down as shown at arrow A, or a laser that welds
and cuts in one step. Also other welding techniques, such as RF-heat-welding
can be used.
As can be seen in Fig. 3 the films 18, 20 are so wide that two devices
fit beside each other. The films can be even wider, so as to allow three or
more devices to be welded and cut at the same time.
In connection with or after the welding and cutting steps the device is
mounted on the plate or sheet 23, which can be formed by paper or a plastic
material. The sheet 23 is fed from a third roll 31 below the working table 21. In
a preferred embodiment the device is attached to the plate 23 in the welding
seams along the contour of the device. It is then a simple measure to release
the device section by section from the plate 23 when the device is used.
In an alternative embodiment the sheet 23 engages the two films before
the welding and cutting device 22. Thereby the films will adhere to the
sheet 23 during the cutting and welding step. The complete device including
the plate 23 is then wrapped into a package. A cutting device 30 moving up
and down as shown at arrow B in Fig. 2 cuts the plates into suitable sizes.
The cutting device can also be a rotating device or a laser device or any other
The device is sterilised with an appropriate method. Among the sterilization
technologies currently available, ethylene oxide (EtO) gas can be mentioned.
It is also possible to use other methods, such as gamma radiation and
electron-beam radiation. Normally, the device is sterilised in the package.
Fig. 4 is a cross sectional view of the complete device including the
plate 23 wrapped in a package. It should be noted that the extension of the
device in the vertical direction is exaggerated to facilitate the understanding of
the invention. A plastic covering film 24 is wrapped over the device and attached
to the plate 23 to form a sealed and sterile package. Three sections of
the hose 11 and the balloon 10 are discernible as separate hollow spaces.
These hollow spaces will be inflated when a liquid is poured into the container
12. Welded seams 24 are formed where the device is attached to the plate
Dashed lines in Fig. 5 indicate folding lines where the device can be
folded to assume the shape shown in Fig. 6 and Fig. 7. The device is folded
twice towards the centre of the device and the plate 23 will form a protective
cover. By folding the device as shown an extremely compact package will be
achieved. The size can be as small as a few millimetres thick, 350 mm long
and 185 mm wide. A package of that size can be stored and distributed at
very low costs, which in most cases, such as for use in developing countries,
It is also possible to roll the device to form a product roll. Fig. 8 shows a
product roll 34 where the sheet 23 forms a protective exterior of the roll.
Fig. 9 illustrates schematically the device in use. It should be assumed
that the balloon is located within the uterus. The container 12 is suspended
on a vertical rod 26 extending from a base plate 27. The longitudinal pocket
14 is used for suspending the device. A liquid such as water has been poured
into the container through the funnel shaped opening. An assumed water
level is indicated at 28 and is located at a height of h above the balloon. As
discussed above h should be in the interval of 1-3 m. The length of the hose
is from about 1,0 m to about 3,0 m and preferably from about 1,5 m to 2,5 m.
A suitable lower distance h=1,0 m corresponds to a pressure of about 70 mm
Hg. If air may enter the space between the films during or after the manufacturing
of the device a priming step is taken before the device is used.
If it is desirable to increase the pressure in the balloon further a clamping
element 29 can be mounted on the hose 11, preferably in the area of the
scale 16. The clamping element 29 comprises in the shown embodiment two
cylinders or wheels 32 bearing against each other. The cylinders 32 can be
moved apart, so as to allow the hose to be inserted there between. The cylinders
32 are then pressed against each other as shown in the enlarged detail
view in Fig. 9. In another embodiment (not shown) one cylinder rotates
against an abutment.
By moving the clamping element 29 in the direction of arrow C liquid
within the hose will be forced toward the balloon where the pressure will rise.
The increased pressure within the balloon will contribute to provide a sufficient
pressure on uterine blood vessels to curtail bleeding. The position of the
clamp 29 in relation to the scale will indicate the pressure in lower part of the
hose and in the balloon.
The clamping element 29 can also be used to close the container. It is
then possible to increase the working pressure by enclosing the container 12
in a cuff or similar device. The pressure of the cuff is increased in a conventional
manner and will lead to a corresponding increase of the working pressure.
An advantage of using a non-resilient material is that the pressure that
can be observed in the cuff will be equal to the working pressure of the balloon
and the complete device.
Fig. 10 shows an introducing member 36 that can be used to introduce
the balloon into the uterus. In the embodiment shown the introducing member
comprises an elongated handle 37. The handle is in one end provided with a
head having two extending rounded sections 38 and between said sections a
rounded tip 39. The rounded tip has a size that will allow it to be inserted in
the annular flap 35, when the balloon is to be introduced into the uterus. The
two side sections 38 extend beyond the rounded tip and will ensure that no
damage is caused to the uterus.
The introducing member can be rigid and be made from a plastic material.
It is also possible to form it in paper from the sheet 23. In that case the
introducing member is punched. In another embodiment the introducing
member is formed by a gel that will dissolve in contact with blood and other
In the alternative embodiment shown in Fig. 11 the introducing member
36 comprises a handle 37 with two sticks 40 extending in parallel from the
handle. One of the sticks is arranged on one side of the flat balloon and then
inserted through the annular flap 35 while the other stick extends on the opposite
side of the balloon. With this arrangement it is possible to wind the
empty flattened balloon around the introducing member and then to introduce
it in the uterus.
Normally, the balloon is introduced into the uterus empty and then a
smaller amount of liquid is filled into the balloon. When the balloon is inflated
by the liquid the introducing member can be withdrawn leaving the balloon in
the uterus. Then a suitable amount of liquid is filled into the container 12 and
the container is raised to an appropriate height over the balloon.
In one embodiment the material and the thickness of the hose are chosen
so as to withstand a pressure lower than a pressure where any tissue is
damaged. When the clamping element is used and the pressure is increased
over what can be obtained by positioning the container at a maximum distance
from the balloon the limited strength of the material will ensure that the
pressure is not increased to an injurious level. At higher pressures the hose,
or any other part of the device exposed to the pressure, will rupture. It may be
appropriate to provide the hose with a specific rupture section 33 that will be
an indication of fracture. The section can be formed with a weakened material
or as a thinner part.
In an embodiment where all elements of the device are integrally connected
to each other the device can be produced, stored and transported very
efficiently. The storage and transport will be simplified also as a result of the
thin and compact design. No separate parts or connectors have to be used,
unless a clamping device is included. This design will facilitate in maintaining
the device under sterile condition also during troublesome circumstances.
1. An inflatable uterine device to control uterine bleeding, comprising an inflatable
balloon (10) and a hose (11) connecting the balloon to a fluid source,
that the fluid source comprises a fillable container (12),
that the inflatable balloon (10) is made from a substantially non-resilient
that a first end of the hose is integrally connected to the inflatable balloon
that a second end of the hose is integrally connected to the container.
2. An inflatable device as claimed in claim 1, wherein a suspension means
(14; 15) is provided at the second end of the hose.
3. An inflatable device as claimed in claim 1, wherein an opening (13) of the
container (12) is provided to allow filling of liquid into the container.
4. An inflatable device as claimed in claim 3, wherein said opening (13) is
5. An inflatable device as claimed in claim 1, wherein the length of the hose
(11) is sufficient to allow the container (12) to be elevated a distance from the
balloon (10) corresponding to a water column that exceeds 1 m.
6. An inflatable device as claimed in claim 1, wherein the balloon (10) has a
volume ranging from 0,31 to 1,51.
7. An inflatable device as claimed in claim 1, wherein the balloon (10) has a
volume ranging from 11 to 2,51.
8. An inflatable device as claimed in claim 1, wherein the balloon (10), the
hose (11) and the container (12) all are formed by the same material.
9. An inflatable device as claimed in claim 1, wherein a rupture section (33) is
formed in the hose (11).
10. An inflatable device as claimed in claim 1, also comprising a clamping
element (29), said clamping element (29) comprising at least one rotating
means pressing a section of the hose and closing the hose.
11. A method for producing an inflatable uterine device to control uterine
bleeding, characterised by
feeding an upper film (18) of a substantially non-resilient material plastic material
from a first roll (17),
feeding a lower film (20) of a substantially non-resilient material plastic material
plastic material from a second roll (19),
joining said upper film (18) and said lower film (20) along contour lines forming
the device and
cutting the films outside said contour lines.
12. A method as claimed in claim 11, wherein the contour lines forms an inflatable
balloon (10), a container (12) and a hose (11) connecting the balloon
to the container in an open fluid path, said container (12) having an open end
formed by the absence of a joint between said upper film (18) and said lower
13. A method as claimed in claim 11, also comprising the step of joining said
upper film (18) and said lower film (20) simultaneously with said cutting.
14. A method as claimed in claim 11, also comprising the steps of feeding a
sheet (23) from a third roll (31) below said lower film (20), adhering the joined
upper film (18) and lower film (20) to said sheet (23) and cutting the sheet
(23) to form a plate including said inflatable balloon (10), said container (12)
and said hose (11).
15. A method as claimed in claim 14, also comprising the steps of folding
twice opposite side edges of said plate towards each other and enclosing
said upper film (18) and said lower film (20) between sides of said sheet (23).
16. A method as claimed in claim 14, also comprising the step of rolling the
plate into a product roll (34), the sheet (23) forming the outside of the product
17. A method as claimed in claim 11, also comprising the step of feeding a
sheet (23) from a third roll (31) below said lower film (20), joining said upper
film (18) and said lower film (20) and adhering the films to the sheet (23) simultaneously.
An inflatable uterine device to control uterine bleeding, comprising an
inflatable balloon (10) and a hose (11) connecting the balloon to a fluid
source. The fluid source comprises an open container (12). A first end of the
hose can be integrally connected to the inflatable balloon and a second end
of the hose can be integrally connected to the container. A suspension
means (14; 15) is provided at the second end of the hose.
The device is produced by feeding an upper film (18) from a first roll
(17), feeding a lower film (20) from a second roll (19) and joining the films
along contour lines forming an inflatable balloon (10), a container (12) and a
hose (11) connecting the balloon to the container in an open fluid path. The
films are cut outside said contour lines.
|Indian Patent Application Number||543/KOLNP/2004|
|PG Journal Number||39/2008|
|Date of Filing||23-Apr-2004|
|Name of Patentee||ATOS MEDICAL AB|
|Applicant Address||BOX 183, S-242 22 HORBY|
|PCT International Classification Number||A61B 17/42|
|PCT International Application Number||PCT/SE02/01866|
|PCT International Filing date||2002-10-15|