GB2547924A

GB2547924A - Birthing device for assisting childbirth

Info

Publication number: GB2547924A
Application number: GB1603691.5A
Authority: GB
Inventors: Van Der Berg Dukaydah
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-03-03
Filing date: 2016-03-03
Publication date: 2017-09-06
Anticipated expiration: 2036-03-03
Also published as: GB201603691D0; GB2547924B

Abstract

A birthing device for preventing obstructed labour during childbirth comprises sleeve material 108 between a first opening 112 and a second opening 110 with a first loop 106 attached to the first opening 112 and optionally a second loop 104 attached to the sleeve 108 between the first and second openings 112,110. The first opening 112 has a diameter smaller than a babys head and the second opening 110 has a diameter larger than a babys head. The device is placed, in use, between a babys head 200 and a birth canal 202 by use of an insertion tool 203 or an operators hand to create a double layer of sleeve material to lower the friction coefficient between sliding interfaces during childbirth. There may be an aperture in the sleeve between the first and second loops 106,104 to allow trapped air to escape. Alternatively, the sheet of material may have at least two flaps extending away from a first opening to which a suction cup may be attached.

Description

BIRTHING DEVICE FOR ASSISTING CHILDBIRTH

The present invention relates to a birthing device for assisting childbirth. More particularly, the present invention relates to a birthing device for preventing obstructed labour during childbirth.

Every year, approximately 28 million women (20% of all women who give birth) experience obstructed labour during childbirth. Obstructed labour occurs when despite strong uterine contractions, the presenting part of the foetus cannot progress through the birth canal. The most frequent cause of obstructed labour is cephalo-pelvic disproportion (a mismatch between the foetal head and the mother’s pelvic brim). Other causes of obstructed labour include malpresentation or malposition of the foetus.

Once obstructed labour has occurred, it can only be alleviated by means of an operative delivery, either by a caesarean section or by other instrumental delivery (forceps, vacuum extraction or symphysiotomy). Maternal complications of obstructed labour include intrauterine infections following prolonged rupture of membranes, trauma to the bladder and/or rectum due to pressure from the foetal head or damage during delivery, and a ruptured uterus with consequent haemorrhage, shock or even death. In the infant, neglected obstructed labour may result in asphyxia leading to stillbirth, brain damage or neonatal death.

Accordingly, it is an object of the present invention to provide a birthing device for preventing obstructed labour during childbirth in order to circumvent the above-mentioned maternal and infant complications commonly associated with obstructed labour.

According to a first aspect of the invention, there is provided a birthing device for preventing obstructed labour during childbirth comprising: - a sleeve having a first opening at one end, and a second opening at the other end; - the first opening having a diameter smaller than a baby’s head; - the second opening having a diameter larger than a baby’s head; - a first loop member attached to the sleeve proximate to the first opening, or preferably attached to the end of the first opening; and optionally - a second loop member attached to the sleeve between the first loop member and the second opening.

The first opening may have a diameter of less than 12 cm, or less than 11 cm, or less than 10 cm, or less than 9 cm, or less than 8 cm.

The second opening may have a diameter of more than 7 cm, or more than 8 cm, or more than 9 cm.

The sleeve may be configured to receive in use at least part of a hand as an insertion means. Alternatively, the sleeve may be configured to receive an elongate insertion means that is more slender than a hand.

The insertion means may comprise plastic and/or metal material. The insertion means may be configured to be held in the hand. The insertion means may be more slender than a hand, to enable insertion and/or positioning of the birthing device within a constricted body cavity such as the birth canal.

The insertion means aids in guiding the sleeve material between the first and second loop member and the second loop member itself onto the baby’s head for correct positioning when in use for preventing obstructed labour during childbirth.

The sleeve may be made of flexible material such as polyethylene. The polyethylene may be very low-density polyethylene (VLDPE), linear low-density polyethylene (LLDPE), low-density polyethylene (LDPE) or medium-density polyethylene (MDPE). The flexible material is also preferably hypoallergenic.

The sleeve material has a thickness of about 30 to about 60 microns. Preferably the sleeve material has a thickness of about 30, about 40, about 45 or about 50 microns. More preferably, the sleeve material has a thickness of about 40 or about 50 microns. A lubricating gel may be distributed over the surface of the sleeve material.

The first and second loop members may be or may form any closed loop shape such as square, oval or circular. Preferably, the first and second loop members are oval or circular in shape. Preferably, the first loop member forms an oval or circular shape around or proximate to the first opening. Preferably, the second loop member forms an oval or circular shape along the circumference of the sleeve material. Preferably, the second loop member may be positioned along the circumference of the sleeve material midway along the sleeve.

The first and second loop members may be made of elastomeric material having viscoelasticity. The elastomeric material may be natural or synthetic rubber.

The first and second loop members may be made of flexible material such as polyethylene. The polyethylene may be very low-density polyethylene (VLDPE), linear low-density polyethylene (LLDPE), low-density polyethylene (LDPE) or medium-density polyethylene (MDPE). The flexible material is also preferably hypoallergenic.

The first and second loop members have a thickness of about 3 to about 10 mm. Preferably, the first and second loop members have a thickness of about 3 to about 9 mm, more preferably about 3 to about 8 mm, more preferably about 3 to about 7 mm, more preferably about 3 to about 6 mm, more preferably about 3 to about 5 mm or even more preferably about 3 to about 4 mm.

The first and/or second loop member maj' be visible under ultrasound. Preferably, the second loop member is visible under ultrasound.

There may be one or more apertures in the sleeve material. Such apertures can prevent air being trapped by the sleeve material, which may not be desirable.

There may be one or more apertures in the sleeve material between the first and second loop member.

The aperture may have a diameter of about 1 mm to about 5 mm. Preferably, the diameter of the aperture is about 1 mm to about 4 mm, more preferably about 1 mm to 3 mm, more preferably about 1 mm to about 2 mm.

The distance between the first and second loop members is between about 8 cm to about 20 cm, preferably about 10cm to about 15 cm, more preferably about 12 cm to about 15 cm.

The distance between the second loop member and the second opening is between about 20 cm to about 40 cm, preferably about 25 cm to about 35 cm, more preferably about 30 cm to 35 cm.

The distance between the first and second openings of the sleeve is between about 28 cm to about 60 cm, preferably about 30 cm to about 50 cm, more preferably about 30cm to about 45 cm.

The sleeve may taper towards the first opening.

According to a second aspect of the invention, there is provided a method of preventing obstructed labour during childbirth using a birthing device having a sleeve with at least one opening, comprising the steps of: - inserting and/or positioning the birthing device within a birth canal, wherein inserting comprises placing the birthing device on the baby’s head, optionally using an insertion means; and - creating a double layer of sleeve material between the baby’s head and the birth canal surface to enable easier passage of the baby through the birth canal.

The friction coefficient of a material is the measure of the sliding resistance of a material over another material. The double layer of sleeve material between the baby’s head and the birth canal surface results in a significantly reduced friction coefficient to enable easier passage of the baby through the birth canal; thereby preventing the occurrence of obstructed labour.

The sleeve material has a thiekness of about 30 to about 60 microns. Preferably the sleeve material has a thickness of about 30, about 40, about 45 or about 50 microns. More preferably, the sleeve material has a thickness of about 40 or about 50 microns. A lubricating gel may be distributed over the surface of the sleeve material.

The opening may have a diameter of about 8 cm to about 10 cm. Preferably the opening has a diameter of about 8 cm, about 9 cm or about 10 cm.

According to a third aspect of the invention, there is provided a method of preventing obstructed labour during childbirth using a birthing device according to the first aspect of the invention.

The method may comprise the steps of: - inserting and/or positioning a birthing device of the first aspect of the invention within a birth canal, wherein inserting comprises placing the birthing device on the baby’s head optionally using an insertion means; and - creating a double layer of sleeve material between the baby’s head and the birth canal surface to enable easier passage of the baby through the birth canal.

The double layer of sleeve material between the baby’s head and the birth canal surface results in a significantly reduced friction coefficient to enable easier passage of the baby through the birth canal; thereby preventing the occurrence of obstructed labour.

According to a fourth aspect of the invention, there is provided a birthing device for preventing obstructed labour during childbirth comprising: - a sheet of material having an opening, wherein the opening has a diameter smaller than a baby’s head; - a loop member attaehed to the sheet of material proximate to the opening, or preferably attached to the end of the opening; and - at least two flaps extending away from the opening, wherein in use the two or more flaps are placed over the baby’s head to create a double layer of sheet material to reduce the friction coefficient between the baby’s head and birth canal passage.

The sheet of material and each flap may be made of flexible material such as polyethylene. The polyethylene may be very low-density polyethylene (VLDPE), linear low-density polyethylene (LLDPE), low-density polyethylene (LDPE) or medium-density polyethylene (MDPE). The flexible material is also preferably hypoallergenic.

The sheet of material and each flap has a thickness of about 30 to about 60 microns. Preferably the sheet of material has a thickness of about 30, about 40, about 45 or about 50 microns. More preferably, the sheet of material has a thickness of about 40 or about 50 microns.

The opening may have a diameter of less than 10cm, less than 9cm or less than 8cm.

The opening may have a suction cap attached to the opening to allow for placement onto the baby’s head to aid in holding the birthing device onto the baby’s head when in use.

The loop member may be or may form any closed loop shape such as square, oval or circular. Preferably, the first and second loop members are oval or circular in shape. Preferably, the first loop member forms an oval or circular shape around or proximate to the opening.

The loop member may be made of elastomeric material having viscoelasticity. The elastomeric material may be natural or synthetic rubber.

The loop member may be made of flexible material such as polyethylene. The polyethylene may be very low-density polyethylene (VLDPE), linear low-density polyethylene (LLDPE), low-density polyethylene (LDPE) or medium-density polyethylene (MDPE). The flexible material is also preferably hypoallergenic.

The loop member has a thickness of about 3 to about 10 mm. Preferably, the loop member has a thickness of about 3 to about 9 mm, more preferably about 3 to about 8 mm, more preferably about 3 to about 7 mm, more preferably about 3 to about 6 mm, more preferably about 3 to about 5 mm or even more preferably about 3 to about 4 mm.

One or more flaps may have a second loop member 118 along the width of the flap.

The skilled person will appreciate that all preferred features or embodiments of any aspect of the invention can be applied to all aspects of the invention.

Embodiments of the present invention will now be described, purely by way of example, with reference to the accompanying drawings, in which:

Figures 1.1 to 1.3 are a sequence of drawings showing how a birthing device according to an embodiment may be used.

Figure 2 is a picture of the birthing device according to a first embodiment of the invention.

Figure 3 is a drawing of the birthing device according to a second embodiment of the invention.

Figure 4 is a drawing of the birthing device according to a first embodiment of the invention having one or more apertures in the sleeve material between the first and second loop members.

Figure 5 is a drawing of the birthing device according to a fourth embodiment of the invention.

Figures 1.1 to 1.3 illustrate an example use of a birthing device according to an embodiment. It will be appreciated that this example use is merely illustrative, and is not intended to limit the scope of the invention.

Figure 1.1 shows step 1, in which the operator puts the birthing device onto their dominant hand 100, with the hand 100 within the second opening 110 of the sleeve. The hand 100 with the birthing device thereon is inserted into the birth canal 202. The hand 100 is held with the fingertips a few centimetres away from the baby’s head 200 or with the fingertips being placed onto the baby’s head 200.

Figure 1.2 shows step 2, in which the first opening 112 is placed onto the baby’s head 200. The sleeve material 108 between the first loop member 106 and the second loop member 104 is placed between the baby’s head 200 and the birth canal surface 202 by the use of an insertion means 203 or by the operator’s hand 100. The insertion means 203 allows the sleeve material 108 to be tucked inside the area between the baby’s head 200 and the surface of the birth canal 202.

Figure 1.3 shows step 3, in which the placement of the sleeve material 108 so as to allow it to be tucked inside the area between the baby’s head 200 and the surface of the birth canal 202 facilitates the creation of a double layer of sleeve material 108 between the baby’s head 200 and birth canal surface 202 which significantly lowers the friction coefficient between the sliding interfaces 120 allowing the baby an easier passage through the birth canal as the baby’s head 200 progresses through the birth canal 202 during childbirth.

Referring to Figure 2, a birthing device for preventing obstructed labour during childbirth is shown comprising a sleeve having a first opening 112 at one end, and a second opening 110 at the other end, a first loop member 106 attached to the end of the first opening 112; and a second loop member 104 attached to the sleeve between the first loop member 106 and the second opening 110.

Referring to Figure 3, a birthing device for preventing obstructed labour during childbirth is shown comprising a sleeve having a first opening 112 at one end, and a second opening 110 at the other end and a first loop member 106 attached to the end of the first opening 112.

Referring to Figure 4, a birthing device for preventing obstructed labour during childbirth is shown comprising a sleeve having a first opening 112 at one end, and a second opening 110 at the other end, a first loop member 106 attached to the end of the first opening 112; and a second loop member 104 attached to the sleeve between the first loop member 106 and the second opening 110. At least one aperture is present in the sleeve material between the first loop member 106 and the second loop member 104. The at least one aperture is arranged to provide a pathway by which any trapped air can escape, thereby reducing the potential for pockets of air being trapped between a double layer of sheet material 108.

Referring to Figure 5, a birthing device for preventing obstructed labour during childbirth is shown comprising: - a sheet of material having an opening 113, wherein the opening 113 has a diameter smaller than a baby’s head; - a loop member 114 attached to the sheet of material proximate to the opening, or preferably attached to the end of the opening 113; - a suction cap attached to the opening 113; and - at least two flaps extending away from the opening 113.

The skilled person will appreciate that a number of modifications and variations may be made, without departing from the scope of the invention, as defined by the appended claims.

Claims

1. A birthing device for preventing obstructed labour during childbirth comprising: - a sleeve having a first opening at one end, and a second opening at the other end; - the first opening having a diameter smaller than a baby’s head; - the second opening having a diameter larger than a baby’s head; - a first loop member attached to the sleeve proximate to the first opening, or preferably attached to the end of the first opening; and optionally - a second loop member attached to the sleeve between the first loop member and the second opening.

2. A birthing device according to claim 1 wherein the sleeve is made of polyethylene.

3. A birthing device according to claim 2, wherein the polyethylene is selected from very low-density polyethylene, linear low-density polyethylene, low-density polyethylene or medium-density polyethylene.

4. A birthing device according to any one of the preceding claims, wherein the sleeve has a sleeve material thickness of about 30 to about 60 microns.

5. A birthing device according to any one of the preceding claims, wherein the first and/or the second loop member is or may form a closed loop shape.

6. A birthing device according to claim 5, wherein the first and/or second loop member forms an oval or circular shape.

7. A birthing device according to any one of the preceding claims, wherein the first and/or second loop member is made of elastomeric material.

8. A birthing device according to claim 7, wherein the elastomeric material is natural or synthetic rubber.

9. A birthing device according to any one of claims 1 to 6, wherein the first and/or second loop member is made from polyethylene.

10. A birthing device according to any one of the preceding claims, wherein the first and/or second loop members have a thickness of about 3 to about 10 mm.

11. A birthing device according to any one of the preceding claims, wherein the distance between the first and second loop members is about 8 cm to about 20 cm.

12. A birthing device according to any one of the preceding claims, wherein the distance between the second loop member and the second opening is between about 20 cm to about 40 cm.

13. A birthing device according to any one of the preceding claims, wherein there is one or more aperture in the sleeve material between the first loop member and the second loop member.

14. A birthing device according to claim 13, wherein the aperture has a diameter of about 1 mm to about 3 mm.

15. A method of preventing obstructed labour during childbirth using a birthing device according to any one of the preceding claims, comprising the steps of: - inserting and/or positioning the birthing device within a birth canal, wherein inserting comprises placing the birthing device on the baby’s head, optionally using an insertion means; and - creating a double layer of sleeve material between the baby’s head and the birth canal surface to enable easier passage of the baby through the birth canal.

16. A method of preventing obstructed labour during childbirth using a birthing device having a sleeve with at least one opening, comprising the steps of: - inserting and/or positioning the birthing device within a birth canal, wherein inserting comprises placing the birthing device on the baby’s head, optionally using an insertion means; and - creating a double layer of sleeve material between the baby’s head and the birth canal surface to enable easier passage of the baby through the birth canal.

17. A birthing device for preventing obstructed labour during childbirth comprising: - a sheet of material having an opening, wherein the opening has a diameter smaller than a baby’s head; - a loop member attached to the sheet of material proximate to the opening, or preferably attached to the end of the opening; and - at least two flaps extending away from the opening, wherein in use the two or more flaps are placed over the baby’s head to create a double layer of sheet material to reduce the friction coefficient between the baby’s head and birth canal passage.

18. A birthing device according to claim 17 wherein the sheet of material and each flap is made of polyethylene.

19. A birthing device according to claim 18, wherein the polyethylene is selected from very low-density polyethylene, linear low-density polyethylene, low-density polyethylene or medium-density polyethylene.

20. A birthing device according to any one of claims 17 to 19, wherein the sheet of material and each flap has thickness of about 30 to about 60 microns.

21. A birthing device according to any one of claims 19 to 20, wherein the opening has a diameter of less than 10cm, or less than 9cm, or less than 8cm.

22. A birthing device according to any one of claims 17 to 21, wherein the opening has a suction cup attached thereto.