AU2019100697A4 - A Device and Method for Inducing Cervical Dilation - Google Patents

Abstract

A device for inducing cervical dilation, the device including: a shaft having a first end and a second end; a shaft tip formed at the first end; a primary aperture formed at the second end; and, a single balloon region formed at or near the first end, proximal to the shaft tip; wherein the first end is configured to be inserted into a cervical area such that fluid introduced through the primary aperture inflates the single balloon region to form a single balloon for inducing cervical dilation. 4m 32 30 35 55 FIGURE 1 FIGURE 2

Description

The present invention relates to a device and method for inducing cervical dilation or ripening. In particular, the present invention relates to a device 5 which is configured to mechanically induce cervical ripening during labour.

Background of the Invention

The following references to and descriptions of prior proposals or products are not intended to be and are not to be construed as, statements or admissions of common general knowledge in the art. In particular, the following prior art io discussion does not relate to what is commonly or well known by the person skilled in the art, but assists in the understanding of the inventive step of the present invention of which the identification of pertinent prior art proposals is but one part.

For medical reasons, related to both maternal and foetal indications, it is often is common practice in obstetrics to induce labour and to commence the childbirth process. Pre-labour artificial cervical ripening, to thereby induce labour is commonly undertaken to increase the likelihood of a vaginal birth outcome. Labour can be induced either medically, through the use of pharmacological compounds, or mechanically through the use of physical 20 means such as acupuncture or cervical sweeping. However, the efficacy and the result of these methods often vary.

Generally, mechanical cervical ripening methods may be considered less invasive, and safer than pharmacological compounds as the pharmacological compounds can cause adverse reactions for both the mother and baby, 25 whereas the mechanical methods do not introduce any new chemicals.

However, depending on the situation, an obstetrician may still recommend a pharmacological induction, or if required, a caesarean section, instead of a vaginal birth.

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The present invention seeks to provide a device and method for inducing cervical dilation which may ameliorate the foregoing shortcomings and disadvantages or which will at least provide a useful alternative.

Summary of the Invention

According to one aspect of the invention, there is provided herein a device for inducing cervical dilation, the device including: a shaft having a first end and a second end; a shaft tip formed at the first end; a primary aperture formed at the second end; and, a single balloon region formed at or near the first end, proximal to the shaft tip; wherein the first end is configured to be inserted into io a cervical area such that liquid or fluid introduced through the primary aperture inflates the single balloon region to form a single balloon for inducing cervical dilation.

Thus, according to one specific example, it will be appreciated that the device includes a single balloon only, when the balloon is inflated. Accordingly, for is example, the device can be inserted into and through a cervical canal, and when the shaft tip is through an internal orifice of the canal, the single balloon can be inflated, and can rest against and/or slightly through the internal orifice, thereby providing pressure against the cervix/cervical area.

According to one example, the shaft tip is formed from a single integral 20 material, such that the shaft tip is closed or formed closed.

In yet a further example, the shaft is attached to a patient such that attachment of the shaft causes traction or a force on the cervix.

According to another example, the device includes a secondary aperture formed at the second end, the secondary aperture being configured to receive 25 an introducer for guiding the first end through the cervical area.

In yet a further example, the primary aperture includes a valve. According to another form, the primary aperture can include a one-directional or non-return valve. Further, the secondary aperture can include a valve.

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It will be appreciated by persons skilled in the art that any combination of features described herein is possible.

Brief Description of the Drawings

The invention may be better understood from the following non-limiting description of a preferred embodiment, in which:

Figure 1 is a side cross-sectional view of an example of a device for inducing cervical ripening;

Figure 2 is another side cross-sectional view of the device for inducing cervical 10 ripening, showing an inflated balloon;

Figures 3A to 3D are perspective views of the device for inducing cervical ripening, showing an inflated balloon;

Figures 4 to 6 are internal plan views of an example insertion of the device of Figure 1 into a cervical area; and, is Figure 7 is a cross-sectional view of an example shaft wall.

Detailed Description of the Drawings

An example of a device 10 for cervical ripening or dilation is shown in Figures 1 to 7.

According to a particular example, as shown in Figure 1, a device 10 for inducing cervical ripening includes a shaft 15, where the shaft 15 has a first end 20 and a second end 25. The device 10 further includes a shaft tip 30 formed at the first end 20, and a primary aperture, which can include a valve 35 formed at the second end 25.

In the examples shown, a single balloon region 40 is formed at or near the first 25 end 20, proximal to the shaft tip 30. Accordingly, when the first end 20 is inserted into the cervix or a cervical area 70 (as shown in Figures 4 to 6 and

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2019100697 26 Jun 2019 further described below), liquid or fluid introduced through the primary aperture 35 inflates the single balloon region 40 to form a single balloon 45 (as shown in Figures 2 to 3D) for inducing cervical ripening. In these examples, Figure 1 shows the single balloon region 40 with a single deflated 5 balloon 50, prior to insertion of the device 10 in the cervical canal, and thus prior to inflation of the balloon, whereas Figures 2 to 3D show the balloon in an inflated state 45.

It will be appreciated by persons skilled in the art that by having a single balloon region 40, including a single inflatable balloon 45 minimises the pain io caused to a patient when the device 10 is inserted through the cervical area

70.

According to one particular example, the shaft tip 30 is formed from a single integral material. That is, in this example, the shaft tip 30 is closed or fluid-tight at the tip end 32. Thus, the shaft tip 30 does not include any holes or is apertures. It will be appreciated by persons skilled in the art that by forming the shaft tip 30 from a single integral material, and by having the tip end 32 closed, there is a decreased chance of infection or introducing any bacteria to a patient. Further, the fact that tip 32 is closed means that the device does not require the use of any closing mechanisms in secondary aperture 55 such as 20 a plug, spigot or the like. Accordingly, it will be appreciated that as no further closing mechanisms are required, the device is a simpler device to use.

In use, and as shown in Figures 4 to 6, the device 10 is inserted into the cervical area 70. It will be appreciated that the cervical area 70 is formed by an external orifice 72, a cervical cavity or canal 74, and an internal orifice 76.

The external orifice 72 and the internal orifice 76 are at opposing ends of the cervical canal 74, where the external orifice 72 typically opens into the vagina and the internal orifice 76 typically opens into the uterus (which holds the baby 80, as shown in Figure 6).

The device 10 is thus typically inserted into the cervical area 70 with the shaft 30 tip 30 entering through an external orifice 72. Once the balloon region 40 has entered the cervical canal 74, and past the internal orifice 76, the deflated

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2019100697 26 Jun 2019 balloon 50 is inflated by pumping or pushing liquid/fluid through the primary valve 35, via the use of a syringe or the like. Inflation of the balloon 45 applies further pressure on the cervix to move into a ripened state and thereby induce labour.

Additionally, the process can further include attaching the shaft 15 to a patient, such as the leg of the patient in order to cause a light traction or force on the cervix. That is, additional pressure can be applied to the cervix (and thereby assist with dilation), by placing pressure back through the internal orifice 76, against the cervical canal 72. It is further postulated that attachment io of the catheter 15 to the patient’s leg once the device 10 has been inserted and the balloon 45 has been inflated can cause further pressure and subsequent dilation of the cervix. That is, taping the catheter 15 to a patient’s leg can create a “pulling effect” on the balloon 45, which can assist with dilation.

is Although different variations may be possible, it will be appreciated by persons skilled in the art that the shaft 15 is typically a catheter, which is made of flexible or pliable material as too rigid a shaft can cause unnecessary damage to the patient. However, in order to assist in the insertion of the device 10, an introducer (not shown) can be used to stiffen or harden the catheter in order to allow the catheter to be more easily introduced into the cervical canal. In this example, the introducer can be introduced into the shaft 15 via a secondary aperture 55, formed at the second end 25, which can in one example, also include a valve. Thus, the secondary aperture 55 can be configured to receive an introducer into the shaft 15 for guiding and/or holding the shaft 15 (and more specifically, the first end 20) within the cervix/cervical area. The introducer can then be removed once the device 10 is within the cervical canal.

According to one specific example, the primary aperture 35 is a check valve (or a non-return valve), with a colour-coded component 65, which can be used 30 as an identifier to ensure that the syringe used to inflate the balloon 45 is inserted into the correct valve (that is, through the primary aperture). It will be

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2019100697 26 Jun 2019 appreciated that a non-return valve is used such that the aperture 35 is in a closed position until the non-return valve is activated by the tip of the syringe which engages the internal mechanism of the valve 35 to open it. This can then allow for fluid such as sterile water to be injected I pushed through to the 5 balloon lumen 46 into the balloon 45 for inflation.

In this example, the secondary aperture 55 is a hollow core valve, with its own colour coded area 65, to identify the type of valve. Thus, the secondary aperture 55 is formed such that medical professionals are not able to connect a syringe or the like to the secondary aperture or valve 55, although the io aperture 55 can be formed to receive an introducer as discussed above.

Notably, Figures 1 to 3D also show that the second end 25 of the shaft 15 can be split into a primary leg 36 and a secondary leg 56, such that the primary leg 36 and the secondary leg 56 extend from the shaft 15. The primary leg 36 can thus be formed to include the primary valve 35 and the secondary leg 56 can is include the secondary valve 55. It will be appreciated that this particular formation can keep the functions of the primary valve 35 and the secondary valve 55 separate, and also allow for both valves/apertures to be used at the same time by medical staff, if need be.

According to one particular example, as shown in Figures 2 and 7, for inflation 20 of the balloon 45, fluid enters the shaft wall 24 via the aperture 35, and exits at a balloon lumen 46, which is formed as part of the shaft wall 24. That is, the fluid exits the balloon lumen 46, where the balloon 45 is placed, through an opening 22 that goes through the tubing wall 24 of the shaft 15. Thus, the primary leg 36 is in fluid communication with the shaft wall 24 in order to then reach the balloon lumen 46 and inflate the balloon. Accordingly, in this particular example, the fluid for inflating the balloon does not pass through the centre of the shaft 15. Thus, if an introducer is used, the introducer can travel through the secondary leg 56 and through the shaft 15 without interfering with the fluid through the wall 24.

It will be appreciated by persons skilled in the art that the liquid used to inflate the balloon 45 is typically sterile water, although other liquids or fluids may be

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2019100697 26 Jun 2019 suitable. It will also be appreciated by persons skilled in the art that in these examples, the length of the catheter tip to balloon is approximately 3.3cm. Further, the balloon width (circumference) when inflated to 80ml is around 6cm, and the balloon height when inflated to 80 ml is around 5cm.

Figure 1 also shows that the shaft 15 can include an x-ray line 60, which is configured such that the device 10 would be visible through x-ray imaging if accidently left behind in a patient’s body.

Example Methods

According to one particular example, the device 10, can be used with the io following method to induce cervical ripening/dilation:

Patient Preparation (using sterile gloves and equipment):

1. Ensure there are no contraindications to the procedure and obtain informed consent

2. Perform an abdominal ultrasound to confirm placental location and fetal is presentation

3. Place the patient in the lithotomy position

4. Insert an appropriately sized vaginal spectrum and visualise the cervix

Device Placement:

1. Insert the shaft tip 30 of the device 10 into the vagina and advance through the cervix 70 until the balloon has entered the cervical canal 74 and past the internal orifice 76.

2. Using a sterile syringe (not shown) inflate the balloon 45 with sterile water via the coloured non-return valve to a volume of 80ml_. The balloon 45 should not be overinflated.

3. Perform a digital vaginal examination or ultrasound to ensure the balloon 45 is above the internal orifice 76 of the cervical canal 74. Ensure the catheter 15 is pulled back snug against the cervix 70

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4. If desired, move the patient out of the lithotomy position to a comfortable recline and strap the catheter to the patient’s leg under light traction

Device Removal:

Notably, the device 10 will typically fall out once the cervix is dilated. Otherwise, the device will typically be changed after 12 hours, in which case, the process below needs to be undertaken:

1. Deflate balloon completely with a syringe via the coloured non-return valve io 2. Carefully pull the device out of the vagina and inspect to ensure the device is intact and complete

3. If the device is intended to be single use, dispose of as per facility protocol, ensuring that the device is not reused or resterilised.

It will be appreciated by persons skilled in the art that many advantages may is be achieved by having a device with a single balloon region, and thus a single inflatable balloon. For example, the pain felt by the patient in respect of insertion is minimal. It is further postulated that the device 10 as described herein can be generally safer than pharmacological dilation, with a possible result of reducing hyperstimulation, foetal heart rate abnormalities and 20 decreasing the patient having a postpartum haemorrhage greater than 1 litre, which can present a risk to the mother.

The term “comprise” and variants of that term such as “comprises” or “comprising” are used herein to denote the inclusion of a stated integer or integers but not to exclude any other integer or integers, unless in the context 25 or usage an exclusive interpretation of the term is required. Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. All such variations and modifications are to be considered within the scope and spirit of the present invention the nature of which is to be determined from the 30 foregoing description.

Claims (4)

1. A device for inducing cervical dilation, the device including:

a. a shaft having a first end and a second end;

b. a shaft tip formed at the first end;

c. a primary aperture formed at the second end; and,

d. a single balloon region formed at or near the first end, proximal to the shaft tip;

wherein the first end is configured to be inserted into a cervical area such that fluid introduced through the primary aperture inflates the single balloon region io to form a single balloon for inducing cervical dilation.

2. The device of claim 1, wherein the shaft tip is formed from a single integral material, such that the shaft tip is closed.

3. The device of any one of claims 1 or 2, wherein the shaft is attached to a patient such that attachment of the shaft causes traction or a force on is the cervix.

4. The device of any one of claims 1 to 3, wherein the device includes a secondary aperture formed at the second end, the secondary aperture being configured to receive an introducer for guiding the first end through the cervical area.

20 5. The device of any one of claims 1 to 4, wherein the primary aperture includes a valve.