WO2005013834A1

WO2005013834A1 - Tamponade balloon assembly

Info

Publication number: WO2005013834A1
Application number: PCT/GB2004/003372
Authority: WO
Inventors: Sabaratnam Arulkumaran
Original assignee: St George's Enterprises Limited
Priority date: 2003-08-06
Filing date: 2004-08-05
Publication date: 2005-02-17
Also published as: GB0318425D0

Abstract

The invention provides and improved tamponade balloon assembly for stanching bleeding from body cavities; it is especially useful for the control of postpartum uterine bleeding. The assemble comprises an expandable balloon, a drain tube and pressure sensing means.

Description

TAMPONADE BALLOON ASSEMBLY

Field of the Invention

The invention relates to a tamponade balloon assembly suitable for preventing or staunching bleeding in body cavities. It is particularly suitable with a control of bleeding from the uterus resulting from post partum haemorrhage.

Background and Review of the Art known to the Applicant

Globally there are 600,000 maternal deaths each year following childbirth. It is estimated that 25% of the deaths are due to post partum haemorrhage. 99% of these deaths take place in developing countries and 1% in developed countries. The deaths in the developing world are generally due to three delays: delay in seeking treatment, in reaching the Hospital and in obtaining the treatment in the Hospital. In the developed world maternal mortality is rare (8-10 maternal deaths in each triennium in the UK), but a number of laparotomies are needed to control the bleeding and many end in hysterectomy. The removal of the uterus prevents these young mothers having more children. During surgery they lose many litres of blood, which needs to be replaced. Some women might need up to 30 units of blood. As a result, the avoidance of haemorrhage remains the principal basis for the active management of the third stage of labour. Initially, ecbolic drugs are used as a prophylactic measure to ensure the maintenance of a well-contracted uterus. Modern management techniques also include the use of prostaglandins. Where these conservative therapies fail to halt blood loss, uterine packing with various configurations of gauze has been used. However, uterine packing has been the subject of much debate with a suggestion that there is significant risk of continued haemorrhage and subsequent infection. As a result, there have been a number of attempts at balloon tamponade, i.e. the use of an inflatable balloon to exert pressure on the uterine wall.

As early as 1983, an inflatable intrauterine device was described in US patent 4,552,557. The device had a shaped, inflatable portion that could be inflated within the uterus to provide tamponade. At its lower end was a drainage channel, attached to the outer surface of the wall of the device to permit drainage of blood from below the inflated unit.

In 1997, the use of a device (known as a Sengstaken-Blakemore balloon) having two inflatable portions was described for the control of post-partum haemorrhage (International Journal of Gynaecology and Obstetrics 58 (1997) 251 - 252, Chan, C. et al).

In the same year, a complex device for staunching uterine bleeding was described in US patent number 6024753. This device had an expandable balloon and handle and was provided with a peristaltic pump for introduction of fluid into the balloon. The device was provided with an external pressure sensing element, which provided control signals to the pump to vary the volume of the balloon in response to subsequent contraction of uterus. The drainage systems of earlier devices was abandoned.

In 2001 a tamponade balloon was described (International Journal of Gynaecology and Obstetrics 72 (2001) 139 - 142, Bakri, Y. N. et al) that had an inflatable, elastic balloon with a drainage channel that passed from one side of the balloon to the other and extending approximately half a balloon diameter beyond the balloon. The earlier teaching of the provision of pressure measurement was abandoned. The following year (BJOG: an International Journal of Obstetrics and Gynaecology, August 2002, volume 109, page 963, Danso, D. and Reginald, E.) the use of a bracing suture together with a prostatic balloon catheter was described for treatment of post partum haemorrhage.

Despite almost 20 years of experimentation with balloon tamponade, no one design of device could be said to provide the optimal system for treatment of post partum haemorrhage. It is an object of the present invention to provide a solution to the problems of control of bleeding and indication of success and a rational basis for determination of the appropriate degree of inflation.

Summary of the Invention

In its broadest first aspect, the invention provides a tamponade balloon assembly comprising: an expandable balloon, so sized and shaped so as to apply pressure to the walls of a body cavity, in use, when in its expanded configuration; a filling tube, in fluid communication with the interior of the expandable balloon, to allow a fluid to be introduced and removed from the balloon, so adjusting the expansion of the balloon, the point of attachment of the filling tube to the balloon defining a proximal end of the balloon; a drainage tube, attached to said balloon, and having an open end located towards the distal end of the balloon; and pressure sensing means operably connected to the interior of the balloon.

Preferably, the open end of the drainage tube is substantially flush with the surface of the balloon when in its expanded configuration. More preferably, the open end of the drainage tube is recessed below the surface of the balloon when in its expanded configuration.

hi a second aspect of the invention, there is provided a tamponade balloon assembly comprising: an expandable balloon, so sized and shaped so as to apply pressure to the walls of a body cavity, in use, when in its expanded configuration; a filling tube, in fluid communication with the interior of the expandable balloon, to allow a fluid to be introduced and removed from the balloon, so adjusting the expansion of the balloon; a drainage tube, attached to said balloon; and pressure sensing means located within the interior of the balloon.

Preferably, the pressure sensing means is located wholly within the interior of the balloon.

Included within the scope if the invention is a tamponade balloon assembly substantially as described herein, with reference to and as illustrated by any appropriate combination of the accompanying drawings.

Brief Description of the Drawings

The invention will now be described with reference to the accompanying drawings in which:

Figure 1 is a schematic diagram illustrating a tamponade balloon according to the present invention.

Figure 2 is a cross-section through a tamponade balloon of the present invention showing the relationship between the filling tube, drain tube and pressure sensing element.

Figure 3 is a partial cross-section through part of a tamponade balloon assembly according to the present invention and illustrating a preferred means of arranging the filling tube, drain tube and pressure signal. Figure 4 is a cross-section through part of the tamponade balloon assembly.

Figures 5 and 6 are cross-sections through part of the tamponade balloon, illustrating the location of the drain tube.

Description of the Prefened Embodiments

Figure 1 is a schematic diagram illustrating the overall structure of a tamponade balloon assembly, generally indicated as 1, according to the present invention. The assembly comprises an expandable balloon 2, sized and shaped so as to apply pressure to the walls of the body cavity, in use, when it is in its expanded configuration. Typically, for use as an intrauterine tamponade device, the balloon will be approximately pear shaped with an overall length of around 15cm, and a width of around 10cm. The tamponade balloon assembly would also find application in staunching bleeding in other body cavities, such as from the pelvic area following hysterectomy. Knowledge of the anatomy of the target body cavity will allow a person skilled in the art to choose a suitable size of balloon.

Also provided is a filling tube 3 in fluid communication with the interior 4 of the expandable balloon 2. This allows a fluid to be introduced and removed from the balloon 2 to adjust its expansion. For reference purposes, the point of attachment of the filling tube 3 to the balloon 2 defines a proximal end 5 of the balloon 2.

The filling tube 3 will, for convenience of use, be fitted with a valve arrangement to seal the fluid inside the balloon after filling.

Also provided is a drainage tube 7. This tube allows for drainage of blood and other body materials from the body cavity. In one particularly preferred invention, to be described in more detail below, the drainage tube 7 has an open end 8 located towards the distal end 6 of the balloon 2. The drainage tube 7 could be located on the outside of the balloon 2 but it is particularly advantageous that it enters the proximal end 5 of the balloon, passes through the interior 4 of the balloon and exits at the distal end 6. In this way, the surface of the balloon may be kept relatively smooth so providing an even tamponade effect and preventing the drainage tube 7 from being squeezed shut.

Also provided is pressure sensing means 9 operably connected to the interior of the balloon to measure the pressure therein. A number of pressure sensing devices will be known to those skilled in the art and a particularly preferred embodiment will be described below. The pressure sensing means 9 will have the means to transmit its reading to the outside of the body. In this embodiment, this is achieved by the use of a wire 10 connected to a pressure display unit 11. It could be envisaged that the pressure sensing means 9 could be wholly contained within the interior 4 of the balloon 2 and transmit its signal in a wireless mode by use of suitable transponding devices.

Figure 2 is a partial cross-section of a particularly preferred embodiment of a tamponade balloon 2 forming part of an overall tamponade balloon assembly. In this embodiment, the filling tube 3 passes through the outer surface of the balloon 2, so defining a distal end 5 of the balloon 2 and affixed to the proximal end of the balloon 6. The filling tube 3 is in fluid communication with the interior of the balloon 4 via one or more holes 12 in the wall of the filling tube 3. The drainage tube 7 is located within the filling tube 3 and is arranged to have an open end 8 toward the distal end 6 of the balloon 2. In this embodiment, the filling tube may advantageously be made from a flexible plastics material, capable of being bent into shape by a supervising clinician (to assist in fitting the device) and retaining that shape for at least long enough to fit the device. Given this teaching, the skilled addressee will be able to choose a suitable material.

Also located within the filling tube 3 is the pressure sensing means 9. In this particularly preferred embodiment, the pressure sensing means 9 is itself a flexible, air-filled balloon, the outer surface of which is in fluid communication with the interior 4 of the tamponade balloon 2 via the lumen of the filling tube 3 and the hole 12. Pressure sensing devices of this form are known in themselves and are commonly used as intrauterine pressure monitors. The skilled addressee is referred to US patent 5,951,497 for details of construction and operation, hi this embodiment, the pressure sensing means 9 transmits its signal via a column of air within another tube 10 towards the other end of the assembly, illustrated in figure 3. To more clearly illustrate the arrangement of tubes in this assembly, a cross-section marked A-A will be illustrated and described below.

The portion of the tamponade balloon assembly illustrated in figure 2 is that which fits within the body cavity in use. It is connected via its tube arrangement to the external portion illustrated in figure 3. Figure 3 illustrates how the drainage tube 7 may conveniently be routed through the side wall of the filling tube 3 to an exit port 13. Any blood or other material that drains through the drainage tube 7 may thereby be either collected or observed as it leaves the drainage port 13. The pressure signal tube 10 is in operable communication with a pressure sensing port 14 for connection to a suitable measurement and display device. Such devices are commonly used with the intrauterine pressure measurement device described in US patent 5,951,497. The drainage tube 3 is in fluid connection with filling ports 15 and 16, via a three-way valve 17. Operation of the valve allows fluid to be introduced into and removed from the interior of the balloon.

Figure 4 is the section A-A of figure 2 illustrating how, in this most preferred embodiment, the drainage tube 7 and the pressure sensing tube 10 are located within the lumen 18 of the filling tube 3.

It is particularly preferable in any embodiment of the tamponade balloon assembly that the open end 8 of the drainage tube 7 is substantially flush with the surface of the balloon when in its expanded configuration. This feature is to stop the end of the drainage tube 7 from kinking and so blocking the tube 7. Figure 5 illustrates one such arrangement where the drainage tube 7 passes through the surface of the balloon 2 so that its open end 8 is substantially flush with the surface of the balloon, indicated by the dotted line, hi this configuration, the tube 7 protrudes by a small distance P. By 'substantially flush' it is meant that this distance P is small enough that the tube 7 cannot kink. For a particularly flexible tube, this distance P should be less than the tube diameter, D. For a less flexible tube, the distance P could be slightly larger than D. Given this teaching, it will be apparent to those skilled in the art how long they may allow the tube 7 to protrude through this surface of the balloon 2. Figure 6 shows a further, and most particularly preferred embodiment of the invention, where the open end 8 of the drainage tube 7 is recessed below the surface of the balloon 2 when in its expanded configuration. By 'recessed below the surface', we mean that the open end of the tub 8 should be below the convex surface enclosing the actual balloon, indicated by the dotted line 19.

The tamponade balloon assembly described herein preferably uses a non-elastic material for manufacture of the balloon itself. This allows the balloon to expand to a maximum size before the internal pressure increases markedly. This therefore prevents over- inflation of the balloon and possible damage to the patient.

Use of the Device

In use as an intrauterine device to staunch uterine bleeding, the balloon is inserted into the uterus and warm saline introduced into the interior of the balloon to inflate it. Using the pressure sensing means, fluid is introduced until the internal pressure equals or exceeds the systemic arterial pressure of the patient, this way, the presence of an internal pressure sensing device allows the tamponade balloon assembly to be operated in a rational way for the prevention of uterine bleeding.

The use of the intrauterine pressure sensing system (described in US patent 5,951,497), which is used routinely to measure intra-amniotic pressure and uterine contractions in labour, is particularly advantageous, as a common pressure measuring and display unit can be used for both devices. The tamponade balloon 2 is built around the pressure sensing area of this device. The tamponade balloon is introduced into the uterine cavity and filled with fluid. The pressure-sensing catheter, which is now covered within the balloon with the fluid inside can be connected to the pressure measuring device. This device can be kept by the bedside to read out the pressure in eg. a digital format. Alternatively, the intrauterine catheter can be connected to a foetal monitor to read the pressure. The pressure measurement allows the supervising clinician to fill the tamponade balloon until the desired pressure is reached, typically a little above the systolic blood pressure of the patient.

By maintaining the pressure within the balloon, the tamponade can be maintained over 6 to 12 hours. This will allow the blood vessels to be sealed off by clotting mechanisms. The balloon can then be deflated and taken out. Should there be blood accumulation within the uterine cavity, the pressure within the balloon is likely to increase and this may be monitored via the pressure sensing system and could advantageously be incorporated into the unit with an alarm to signal any pressure increase and thus be indicative of continuing bleeding.

By monitoring any blood that may emerge from the drainage tube, the supervising clinician can readily determine whether the tamponade has been successful in staunching the bleeding, and so, in the case of a uterine tamponade balloon, can make a rational decision as to whether the woman needs a laparotomy to control the bleeding. The tamponade balloon assembly will, however, act as a therapeutic intervention by stopping the bleeding in the vast majority of cases. Carried out in time, this test and approach will avoid a large number of women needing blood transfusion, laporotomies and hysterectomies. It may also help to reduce the number of maternal deaths. It will be especially helpful in developing countries as most of the deaths take place while waiting to go to the Hospital from a primary healthcare centre. The care giver in the primary healthcare centre can be trained to introduce and inflate the balloon. The three delay model, which causes maternal death, is well known and by using the tamponade balloon assembly, it is possible to avoid delay in obtaining effective treatment. This will not only save lives but will also avoid transfer to other centres, perhaps several hundred miles distance and avoid unnecessary blood transfusion, laparotomy and hysterectomy.

Claims

1. A tamponade balloon assembly comprising: an expandable balloon, so sized and shaped so as to apply pressure to the walls of a body cavity, in use, when in its expanded configuration; a filling tube, in fluid communication with the interior of the expandable balloon, to allow a fluid to be introduced and removed from the balloon, so adjusting the expansion of the balloon, the point of attachment of the filling tube to the balloon defining a proximal end of the balloon; a drainage tube, attached to said balloon, and having an open end located towards the distal end of the balloon; and pressure sensing means operably connected to the interior of the balloon.

2. A tamponade balloon assembly according to claim 1 wherein the open end of the drainage tube is substantially flush with the surface of the balloon when in its expanded configuration.

3. A tamponade balloon assembly according to claim 1 wherein the open end of the drainage tube is recessed below the surface of the balloon when in its expanded configuration.

4. A tamponade balloon assembly comprising: an expandable balloon, so sized and shaped so as to apply pressure to the walls of a body cavity, in use, when in its expanded configuration; a filling tube, in fluid communication with the interior of the expandable balloon, to allow a fluid to be introduced and removed from the balloon, so adjusting the expansion of the balloon; a drainage tube, attached to said balloon; and pressure sensing means located within the interior of the balloon.

5. A tamponade balloon assembly according to claim 4, wherein the pressure sensing means is located wholly within the interior of the balloon.

6. A tamponade balloon assembly according to either of claims 4 and 5 wherein the open end of the drainage tube is substantially flush with the surface of the balloon when in its expanded configuration.

7. A tamponade balloon assembly according to either of claims 4 and 5 wherein the open end of the drainage tube is recessed below the surface of the balloon when in its expanded configuration.

8. A tamponade balloon assembly substantially as described herein, with reference to and as illustrated by any appropriate combination of the accompanying drawings.