WO2018037298A1

WO2018037298A1 - Uterine balloon tamponade device

Info

Publication number: WO2018037298A1
Application number: PCT/IB2017/054458
Authority: WO
Inventors: Nicolaas Hendrik SMIT; Dirk Christiaan DE VILLIERS
Original assignee: Smit Nicolaas Hendrik; De Villiers Dirk Christiaan
Priority date: 2016-08-26
Filing date: 2017-07-24
Publication date: 2018-03-01
Also published as: ZA201901850B

Abstract

A uterine balloon tamponade device comprises an inflatable balloon (1), an inflation lumen (2) communicating with the interior of the balloon, a control stopcock (7) within the length of the inflation lumen (2), and an attachment fitting (11) at the proximal end of the lumen for connecting the lumen to a reservoir of inflation liquid (8). The shape and size of the inflatable balloon provides a balloon wall having an inflated un-stretched cylindrical shape with domed ends or an ellipsoidal shape with a volumetric capacity of at least 400 ml and preferably from 650 to 850 ml. The balloon may be a blow moulded balloon. A distal end (5) of a lumen that may be the inflation lumen (2) or a drainage lumen may have a multitude of transverse perforations (6) through its wall to render the end of the lumen more flexible than it would be otherwise. The balloon in the uninflated condition may be folded for packaging.

Description

UTERINE BALLOON TAMPONADE DEVICE

CROSS-REFERENCE(S) TO RELATED APPLICATIONS This application claims priority from South African provisional patent application number 2016/05936 filed on 26 August 2016, which is incorporated by reference herein.

FIELD OF THE INVENTION This invention relates to a uterine balloon tamponade device for controlling post-partum hemorrhage. More particularly, the invention relates to a balloon tamponade device for controlling uterine and vaginal postpartum hemorrhage.

BACKGROUND TO THE INVENTION

Postpartum hemorrhage is most commonly caused by uterine atony whereby the uterus fails to contract normally after the delivery of a baby. This condition apparently occurs in about 5 percent of deliveries. Hemorrhage continues to be one of the major causes of maternal deaths generally, with obstetrical hemorrhage being the third leading cause of maternal death by hemorrhage in the United States. Worldwide, maternal hemorrhage qualifies as the leading cause of maternal death.

Techniques for managing obstetrical hemorrhage may be medical, mechanical, or surgical. Hysterectomy is an effective surgical procedure for treating this condition but bears a severe consequence of barrenness for young women who have not yet completed childbearing.

One of the mechanical procedures often used for managing obstetrical hemorrhage involves packing the uterus with heavy gauze. This procedure remains controversial because of a high failure rate, and is considered a waste of time by some medical practitioners. The high failure rate is attributable to the inherent difficulty in packing the uterus properly so that there is an even distribution of pressure along the entire inner surface of the organ.

In terms of mechanism of action, the intrauterine balloon is believed to act by exerting inward to outward pressure against the uterine wall, resulting in a reduction in persistent capillary and venous bleeding from the endometrium and the myometrium. A variety of balloon tamponades and catheters is available commercially and each has its own distinct features. These include the Bakri™ balloon, the BT-Cath® balloon, Foley catheters, the Rusch balloon, and the Sengstaken-Blakemore tube. The Bakri™ postpartum balloon and the BT-cath balloon tamponade catheter are specifically designed for postpartum intrauterine tamponade use, and they are, as far as applicant is aware, the only such devices approved by the US Food and Drug Administration of the USA for this application. However, in situations in which these devices are unavailable, other balloons such as others of those mentioned above can be used to achieve a similar effect. In addition, the more simple "surgical glove" and "condom" tamponades may also be used.

The Bakri™ balloon tamponade has a dual lumen with an inner lumen that passes through the balloon to project from a distal surface of the balloon. The inner lumen serves the purpose of collecting blood from the outside of the distal end of the balloon and enabling it to drain away through the inner lumen. The blood that drains in this way may be collected and can be measured or simply visually assessed. The Bakri™ balloon is typically inflated to a volume of between 300 and 350 ml and has a maximum operating volume stated by the manufacturer to be 500 ml, although it has an actual maximum capacity closer to about 800 ml.

The BT-Cath® balloon tamponade marketed by UTAH MEDICAL PRODUCTS INC has a drainage port that is flush with the distal surface of the balloon so as to make placement close to the fundus possible.

Such prefabricated balloon tamponades are costly and, not only that, but need to be available "on site" so that they can be rapidly deployed if and when needed. This represents a disadvantage to more informal and cost sensitive maternity facilities and is therefore impractical to implement in many circumstances.

At the more simple end of the scale there are the so-called "surgical glove" and "condom" tamponades that are inexpensive but typically only assembled as and when required using available surgical quality tubing and other components. The latter type of devices may operate effectively to some extent and are indeed of relatively low cost.

Inflation of a balloon is either effected using bags of saline solution that may either be held at a particular height on a stand if one is available to provide gravity induced pressure within the balloon or using one or more syringes for transferring quantities of saline to the balloon. If a stand or the like is not available, the bag can be lifted to the right height and a stopcock opened to allow the pressure to adjust in the bag. Such an activity should be carried out periodically such as every 20 or 30 minutes. It is commonly accepted that the pressure of operation within a balloon should be sufficient to counteract systolic blood pressure in a patient and such a pressure typically translates to be in the region of about 1 .4 to about 2.1 meters of water. The systolic pressure in mm Hg may be multiplied by 13 for use in determining the height of the bag of saline above a supine patient. On this basis, if the systolic blood pressure is 120 mm Hg, the height of the bag should be 1 .56 meters above the patient. The pressure of the column of water is aimed at being sufficient to stop bleeding from the placental bed.

Once the uterus starts contracting the water should be able to push back into the saline bag. The balloon should not prevent uterine contraction and retraction and therefore if the inflation liquid cannot push back freely into the bag a controlling stopcock is opened periodically so that the inflation liquid may be released in a stepwise manner. If the patient is not being transported and a hanger to keep the saline bag at the correct height is available, then such a stopcock may be left open.

A rather general problem with existing balloon tamponades is the fact that the volumetric capacity of the balloon is at least somewhat variable and as the volume is increased above a predetermined volume, the balloon becomes stretched. Stretching of the balloon wall itself means that some of the pressure applied to the interior of the balloon is absorbed by the stretching action which in turn means that the pressure exerted by the balloon itself is unknown. The devices of which applicant is aware vary as regards the control and monitoring of the pressure at which they operate and the manner in which the pressure is applied and controlled.

Also, it is envisaged that in instances in which a distal end of a drainage or inflation lumen is capable of engaging the inner wall of the uterus, it is considered that in many instances the contact could be deleterious or at least injure the patient and possibly delay healing to some extent.

Accordingly, a more effective device and procedure would be advantageous to address post- partum haemorrhage and bleeding. Ideally, the procedure should present minimal long-term health consequences to the patient; be quick and easy to implement; be easily learned; and require no specialized instrumentation.

As regards publications in the relevant field, United States patent publication US4619261 to Guerriero, discloses a hydrostatic pressure application device for controlling bleeding from an internal wound. The device of Guerriero comprises a balloon captured within a net. The net is secured to an area surrounding a wound with surgical sutures, so that hydraulic pressure applied to the balloon expands the balloon and causes pressure to be applied at the wound. Pressure so applied at the wound causes a cessation in bleeding. Disadvantageously, however, because the device is sutured to an area surrounding the wound, applying and removing the device of Guerriero requires an operative (surgical) procedure. United States patent publication US4207891 to Bolduc, discloses a fluid dispensing instrument having a dispenser that operates to place a drug material into a uterine cavity, and an expandable balloon that operates to move the drug material from the uterine cavity into both canals of the Fallopian tubes. However, the dispensing instrument of Bolduc is not configured and operated in a manner directed to the control of post-partum hemorrhage and bleeding.

United States patent US6520977 to Piraka discloses a uterine balloon for controlling hemorrhaging in a patient after childbirth. The balloon of Piraka is filled with a physiologic solution by means of a catheter inserted through a valve in the balloon. A fill system, a control system, and a pressure relief valve are each employed for maintaining a constant solution pressure in the balloon. However, no means are disclosed for determining whether bleeding has been effectively stopped, in order to adapt balloon pressure accordingly.

United States patent US6676680 to Packer discloses a uterine balloon that is similar but has a drainage lumen that terminates at the distal end of the balloon.

The preceding discussion of the background to the invention is intended only to facilitate an understanding of the present invention. It should be appreciated that the discussion is not an acknowledgment or admission that any of the material referred to was part of the common general knowledge in the art as at the priority date of this application.

SUMMARY OF THE INVENTION

In accordance with this invention there is provided a uterine balloon tamponade device comprising an inflatable balloon, an inflation lumen communicating with the interior of the balloon between a proximal end and a distal end that communicates with the interior of the balloon, a control stopcock within the length of the inflation lumen, and an attachment fitting at the proximal end of the lumen for connecting the lumen to a reservoir of inflation liquid, the device being characterized in that the shape and size of the inflatable balloon provides a balloon wall in an un-stretched condition with a volumetric capacity of at least 400 ml.

Further features of the invention provide for the volumetric capacity of the inflatable balloon in an un-stretched condition to be from 500 to 1000 ml, preferably from 650 to 850 ml, and most preferably about 750 ml; for the inflatable balloon to be a blow moulded balloon typically of a translucent medical extrusion grade thermoplastic elastomer having a Shore A hardness of from 30 to 60; for the inflatable balloon to have a generally cylindrical shape with domed ends or an ellipsoidal shape in the inflated but un-stretched condition; for the inflation lumen to extend into the balloon and along a substantial part of a length thereof from a proximal end of the balloon toward a distal end thereof; for the inflation lumen to have an internal drainage lumen passing therethrough from the distal end of the balloon and out of the proximal end thereof with the two lumens separating at a junction unit that may optionally include a stopcock in one of the inflation lumen, the drainage lumen, or both; for the proximal end of the inflation lumen to be either permanently attached to a reservoir in the form of a reservoir bag for receiving inflation liquid that is conveniently water or a saline solution or, alternatively, for the proximal end of the inflation lumen to have a connection fitting that is adapted for connection to a separate reservoir bag in which instance the connection fitting may optionally include a spike for penetrating a sealed reservoir bag of saline solution; and for the reservoir bag to have a capacity in an un- stretched condition of from 500 ml to 1000 ml and preferably about 750 ml.

The invention also provides a uterine balloon tamponade device in which a distal end region of a lumen that is either the inflation lumen or the drainage lumen if one is present in either case being a lumen that is capable of directly or indirectly impinging the uterine surface of a patient in use is provided with a multitude of transverse perforations through the wall thereof positioned relative to each other to render the end region of the lumen more flexible than it is without the presence of the multitude of holes through the wall of the lumen.

It is that a uterine balloon tamponade as defined above can be packaged by folding the an inflated balloon to a required shape and packaging it in a suitably sterile package.

For the purposes of this specification the term "ellipsoidal" is intended to have an extended meaning and to embrace such shapes as an egg shape and also somewhat lopsided three- dimensional generally ellipsoidal shapes. In use, the typically soft balloon may be inserted into the uterus of a patient in the case of postpartum hemorrhage after birth, normally at the site of the detached placenta, and inflated with water from a reservoir bag that is either permanently or temporarily attached to the inflation lumen. The pressure in the balloon is conveniently determined by the water head that is set by determining the height in meters that the water in the reservoir bag should be located above the patient. The balloon is preferably large enough to accept all the water from the reservoir bag before the balloon material starts to stretch; that is typically about 750 ml in a preferred embodiment of the invention. The reservoir bag may be hung up at a predetermined height above the patient to counter the systolic blood pressure of the patient. The water head will continue to exert just enough force on the wound that is sufficient to arrest bleeding. As the uterus contracts naturally, the pressure will remain substantially constant as fluid is allowed to flow back into the reservoir bag in instances in which it is suspended on a suitable stand.

The device of this invention may therefore serve as a constant pressure device, at least in instances in which a suitable stand is available because the uterine balloon material is not in a stretched condition when in use and thus the water column height is a true reflection of the actual pressure in the balloon. Also, the pressure in the balloon remains substantially the same as the uterus contracts, thus allowing the uterus to contract freely.

Of course, if a suitable stand is not available, the reservoir bag can be held at the predetermined height temporally while a stopcock is opened to allow the pressure in the bag to adjust to the correct pressure and the stopcock can then be closed and the reservoir bag laid down at the level of a patient. In such an instance the bag should be raised to the correct height periodically, for example every 20 or 30 minutes, and the stopcock opened to allow the pressure in the balloon to adjust to the correct pressure, as may be necessary. In order that the invention may be more fully understood a more detailed description thereof and of various embodiments thereof follows with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings:

Figure 1 is a schematic illustration of one embodiment of the invention in its operative position;

Figure 2 is an enlarged elevation of the inflatable balloon of the embodiment of the invention illustrated in Figure 1 in the inflated condition;

Figure 3 is a three-dimensional view of the balloon illustrated in Figure 2;

Figure 4 is a three-dimensional view of the balloon illustrated in Figure 3 in the collapsed condition;

Figure 5 is a sectional elevation of the perforated end of the inflation lumen utilised in the embodiment illustrated in Figures 1 to 4;

Figure 6 is the same as the lower part of Figure 1 but illustrating one variation of the inflatable balloon assembly;

Figure 7 is an enlarged elevation of the inflatable balloon of the embodiment of the invention illustrated in Figure 6 in the inflated condition; Figure 8 is an elevation similar to Figure 7 of a third and simplified embodiment of inflatable balloon according to the invention in the inflated condition; and,

Figure 9 Is a view of one alternative shape of inflated balloon.

DETAILED DESCRIPTION WITH REFERENCE TO THE DRAWINGS

In the embodiment of the invention illustrated in Figures 1 to 4 of the drawings, a uterine balloon tamponade device comprises an inflatable balloon (1 ), an inflation lumen (2) communicating with the interior of the balloon between a proximal end (3) and a distal end (4) with the distal end of the inflation lumen being located within the balloon. The volumetric capacity of the balloon in an un-stretched condition may be as low as 400 ml; could be between 500 and 1000 ml; is preferably between 650 to 850 ml, and in this particular instance is about 750 ml. The final preferred volumetric capacity of the balloon without the walls becoming stretched is yet to be determined.

The balloon is a blow moulded balloon of a translucent medical extrusion grade thermoplastic elastomer having a Shore A hardness of from 30 to 60. Two thermoplastic elastomers that have been identified as appearing to be suitable are those sold under the trade references "Phoenix™ 04501 " having a Shore A hardness of about 50 and "Phoenix™ 04351 " having a Shore A hardness of about 35. Both of these plastic materials are products marketed by Phon Tech Industrial Company of Taiwan. No colorants or additives are used which has the effect of minimizing costs and keeping the manufacturing process as simple as possible. The Shore A 35 hardness material yields a satisfactory soft balloon having a wall thickness in the thinner regions thereof of 0.2 to 0.3mm. It is readily manufactured using a blow moulding method.

The blow moulded balloon in this variation of the invention has a generally right circular cylindrical shape with domed ends in the inflated and un-stretched condition. Figure 2 illustrates one shape in which the distal end (4) of the balloon is basically of hemispherical shape whilst the proximal end (3) is somewhat more squat in the axial dimension.

The inflation lumen (2) enters the proximal end of the balloon centrally and extends along a substantial part of a length thereof toward the distal end of the balloon. This arrangement enables the flexible balloon in the collapsed condition to be folded around the lumen that is within the balloon and to facilitate inflation thereof wherein the balloon is required for use. The inflation lumen may be a clear, translucent or colored thermoplastic elastomer material such as "Phoenix™ 04501 " from Phon Tech Industrial Company. The latter material is a medical grade material and has a Shore A hardness of about 80. The inflation lumen thus has a distal end region (5) (see Figures 2. 4 and 5) that is capable of directly or indirectly impacting the uterine surface of a patient, especially during installation and inflation. As a result, it is preferred that the relevant part of the length of the lumen towards its free end be provided with a multitude of transverse perforations (6) through the wall thereof positioned relative to each other so as to render the end region of the lumen more flexible than it is without the presence of the multitude of holes through the wall of the lumen. In this way the end region of the lumen is rendered more flexible and less likely to cause injury or damage of any sort to the patient.

Simply by way of example, the inflation lumen may have an outer diameter of about 9 mm, and an inner diameter of about 6 mm in which instance the holes can have a diameter of about 4 mm and be spaced apart in rows of two to four, for example three, angularly offset by 90 ^e and staggered by a half of their spacing that may for example be about 10 mm. The holes may be formed using a hole punch plier for low volumes or an automated jig for higher volume production.

The inflation lumen has the balloon neck of the blow moulded balloon directly heat welded to it where it enters the balloon. A heated die may be used for this purpose and for higher speed production a temperature controlled impulse sealer with cooled dies may be used.

The inflation lumen communicates by way of a control stopcock (7) with a flexible reservoir bag (8) at its proximal end. For this purpose the proximal end of the inflation lumen may be permanently secured to the flexible reservoir bag or, alternatively, it may be provided with a connection fitting (1 1 ) at the proximal end for connecting the inflation lumen to an already filled flexible reservoir bag of inflation liquid.

In the instance in which the proximal end of the inflation lumen is permanently attached to the flexible reservoir bag, the bag can be left empty so that it can be filled as and when required for use with water or preferably saline solution. The capacity of the flexible reservoir bag can in that instance be chosen to be convenient when considering the capacity of the inflatable balloon in its un-stretched condition and in the instance that the balloon has a capacity of about 750 ml, then the capacity of the flexible reservoir bag would preferably also be about 750 ml. In the other instance in which a connection fitting (1 1 ) is provided at the proximal end of the inflation lumen, the connection fitting may be provided with a spiked formation suitable for penetrating a standard production bag of, for example, saline solution, so that the solution can enter the inflation lumen. During the manufacture of the inflatable balloon tamponade device the formed balloon is folded at a suitable stage, such as threefold parallel to its axis, as illustrated in Figure 4, making sure that most of the air inside it is removed and the stopcock is then closed.

At installation the stopcock should be closed and a permanently attached flexible reservoir bag may then be filled with 750 ml clean water or saline solution to a maximum indicator line. On the other hand, if the proximal end of the inflation lumen is provided with a connection fitting, this may then be connected to a standard 1 litre saline bag.

The flexible reservoir bag or standard saline bag is hung or held (if there is no hanger) at a height of about 1 .6 m or other appropriate height above the patient if the situation so indicates. The target height may be determined from the systolic blood pressure as indicated above. As a general guide, height markings for systolic blood pressures of 120, 140 and 160 mm Hg may be indicated on the drip set as 120 mm Hg systolic blood pressure for a height of 1 .6 m; 140 mm Hg systolic blood pressure for a height of 1 .8 m; and 160 mm Hg systolic blood pressure for a height of 2.1 m.

In use, the usual practices apply to the installation and removal of the balloon tamponade such as the fact that the balloon should be kept in the uterus for a maximum of 24 hours. If bleeding has not considerably decreased after 24 hours, surgical intervention should be considered.

The construction of the inflatable balloon can be varied widely. In particular, as illustrated in Figures 6 and 7, the device may include a drainage lumen (21 ) located within the inflation lumen where it passes through the inflatable balloon with a distal end region of the drainage lumen extending out of the distal end of the balloon, as indicated by numeral (22). In this instance the inflation and the drainage lumens are separated at a junction unit (23) that may optionally include a stopcock if required in either the inflation lumen or the drainage lumen. Other arrangements of the flexible balloon are also possible and, as illustrated in Figure 8, the inflation lumen (25) may terminate in the region of the proximal end of the balloon (26).

Also, as illustrated in Figure 9, the shape of the inflated balloon may be varied widely and may, for example, be a symmetrical or asymmetrical ellipsoidal shape.

Throughout the specification unless the contents requires otherwise the word 'comprise' or variations such as 'comprises' or 'comprising' will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

Claims

CLAIMS:

1 . A uterine balloon tamponade device comprising an inflatable balloon, an inflation lumen communicating with the interior of the balloon between a proximal end and a distal end that communicates with the interior of the balloon, a control stopcock within the length of the inflation lumen, and an attachment fitting at the proximal end of the lumen for connecting the lumen to a reservoir of inflation liquid, the device being characterized in that the shape and size of the inflatable balloon provides a balloon wall in an un- stretched condition with a volumetric capacity of at least 400 ml.

2. A uterine balloon tamponade device as claimed in claim 1 in which the volumetric capacity of the inflatable balloon in an un-stretched condition is from 500 to 1000 ml.

3. A uterine balloon tamponade device as claimed in claim 2 in which the volumetric capacity of the inflatable balloon in an un-stretched condition is from 650 to 850 ml.

4. A uterine balloon tamponade device as claimed in any one of the preceding claims in which the inflatable balloon is a blow moulded balloon of a medical extrusion grade thermoplastic elastomer having a Shore A hardness of from 30 to 60.

5. A uterine balloon tamponade device as claimed in any one of the preceding claims in which the inflatable balloon has a generally cylindrical shape with domed ends or an ellipsoidal shape in the inflated but un-stretched condition.

6. A uterine balloon tamponade device as claimed in any one of the preceding claims in which the inflation lumen extends into the balloon and along a substantial part of a length thereof from a proximal end of the balloon toward a distal end of the balloon.

7. A uterine balloon tamponade device as claimed in any one of the preceding claims in which the inflation lumen has an internal drainage lumen passing therethrough from the distal end of the balloon and out of the proximal end thereof with the two lumens separating at a junction unit.

8. A uterine balloon tamponade device as claimed in claim 7 in which a stopcock is included in either one of the inflation lumen, the drainage lumen, or both. A uterine balloon tamponade device as claimed in any one of the preceding claims in which the proximal end of the inflation lumen is permanently attached to a reservoir in the form of a reservoir bag for receiving inflation liquid.

0. A uterine balloon tamponade device as claimed in claim 9 in which the reservoir bag has a capacity of from 500 ml to 1000 ml.

1 . A uterine balloon tamponade device as claimed in any one of claims 1 to 8 in which the proximal end of the inflation lumen has a connection fitting that is adapted for connection to a separate reservoir bag.

2. A uterine balloon tamponade device as claimed in any one of the preceding claims in which a distal end region of a lumen that is capable of directly or indirectly impinging the uterine surface of a patient in use is provided with a multitude of transverse perforations through the wall thereof positioned relative to each other to render the end region of the lumen more flexible than it is without the presence of the multitude of holes through the wall of the lumen.