US-12622728-B2 - Transfer of a preterm baby from a natural womb

US12622728B2US 12622728 B2US12622728 B2US 12622728B2US-12622728-B2

Abstract

The present invention relates to a transfer assembly for transferring a preterm baby from a natural womb of a pregnant mammal to a transfer bag, comprising abase device having a pass-through opening configured to allow the preterm baby to pass through the base device, and wherein the base device is connected to a birth canal retractor, said birth canal retractor comprises a flexible sleeve disposed between the base device and an adjustable access ring, which retractor is to be inserted into the birth canal of the pregnant mammal at least with the access ring thereof, and wherein the access ring is configured to be expanded or inflated while in the birth canal, wherein the assembly further comprising a transfer device comprising the transfer bag, said transfer bag being a flexible bag provided with an opening configured to allow the preterm baby to be received in the transfer bag, and wherein the opening is further provided with a coupling member, which coupling member is releasably secured to the base device, and wherein the transfer bag is provided with at least one integrated glove for receiving the hand of a medical practitioner in order to allow the transfer the preterm baby from the natural womb into the transfer bag.

Inventors

Franciscus Leonardus Marie DELBRESSINE
Tamara HOVELING
Marlou MONINCX
Juliette Stephanie VAN HAREN
Guid OEI
Marieke Beatrijs VAN DER HOUT-VAN DER JAGT

Assignees

TECHNISCHE UNIVERSITEIT EINDHOVEN

Dates

Publication Date: 20260512
Application Date: 20210924
Priority Date: 20200924

Claims (13)

1 . A transfer assembly for transferring a preterm baby from a natural womb of a pregnant mammal to a transfer bag, the assembly comprising: a base device comprising an annular shaped pass-through opening having a central axis, wherein the pass-through opening is configured to allow the preterm baby to pass through the base device, and wherein the base device further comprises a womb facing side and a transfer bag facing side; and a transfer device comprising the transfer bag, said transfer bag being a flexible bag provided with an annular shaped opening having a central axis, wherein the annular shaped opening is configured to allow the preterm baby to be received in the transfer bag, and wherein the annular shaped opening is further provided with a coupling member, which coupling member is releasably secured to the transfer bag facing side of the base device in such configuration that the central axis of said pass-through opening coincides with the central axis of said annular shaped opening, wherein the womb facing side of the base device is connected to a birth canal retractor, said birth canal retractor comprises a flexible sleeve disposed in a cylindrical configuration between the womb facing side of the base device and an adjustable access ring, wherein the birth canal retractor is arranged to be inserted into the birth canal of the pregnant mammal at least with the access ring thereof, wherein the access ring is configured to be expanded or inflated while in the birth canal, thereby providing an access for the preterm baby to the transfer assembly through the access ring in an expanded or inflated state of the access ring, and wherein the transfer bag is provided with at least one integrated glove for receiving the hand of a medical practitioner in order to allow the medical practitioner to transfer the preterm baby from the natural womb into the transfer bag.
2 . The transfer assembly according to claim 1 , wherein the womb facing side of the base device and the birth canal retractor forms one integral birth canal retractor device.
3 . The transfer assembly according to claim 1 , wherein the birth canal retractor is arranged to be inserted into the birth canal of the pregnant mammal at least with the access ring and a substantial part of the flexible sleeve.
4 . The transfer assembly according to claim 1 , wherein the base device and/or the transfer device further comprises an inlet for supplying artificial amniotic fluid (AAF) to the interior of the transfer assembly.
5 . The transfer assembly according to claim 1 , wherein the transfer bag is further provided with a valve to release air from the transfer bag to the exterior.
6 . The transfer assembly according to claim 1 , wherein the integrated glove is positioned opposite to the annular shaped opening of the transfer bag.
7 . The transfer assembly according to claim 1 , wherein the transfer bag further comprises an integrated wire to close the annular shaped opening of the transfer bag after the preterm baby is received in the transfer bag, wherein the closure of the annular shaped opening of the transfer bag is facilitated by loosely securing the integrated wire around the umbilical cord connected to the preterm baby.
8 . A kit for assembling a transfer assembly for transferring a preterm baby from a natural womb of a pregnant mammal to a transfer bag, the kit-of-parts comprising: a base device comprising an annular shaped pass-through opening having a central axis, wherein the pass-through opening is configured to allow the preterm baby to pass through the base device, and wherein the base device further comprises a womb facing side and a transfer bag facing side; and a transfer device comprising the transfer bag, said transfer bag being a flexible bag provided with an annular shaped opening having a central axis, wherein the annular shaped opening is configured to allow the preterm baby to be received in the transfer bag, and wherein the annular shaped opening is further provided with a coupling member, which coupling member is configured to be releasably secured to the transfer bag facing side of the base device in such configuration that the central axis of said pass-through opening coincides with the central axis of said annular shaped opening, wherein the transfer bag is provided with at least one integrated glove for receiving the hand of a medical practitioner in order to allow the medical practitioner to transfer the preterm baby from the natural womb into the transfer bag.
9 . The kit according to claim 8 , the kit further comprising: a birth canal retractor configured to be connected to the womb facing side of the base device, said birth canal retractor comprises a flexible sleeve disposed in a cylindrical configuration between a first open end connectable to the womb facing side of the base device and a second open end provided with an adjustable access ring, wherein the birth canal retractor is arranged to be inserted into the birth canal of the pregnant mammal at least with the access ring thereof, wherein the access ring is configured to be expanded or inflated while in the birth canal, thereby providing an access for the preterm baby to the transfer assembly through the access ring in an expanded or inflated state of the access ring.
10 . The kit according to claim 8 , wherein the base device further comprises a birth canal retractor connected to the womb facing side of the base device, said birth canal retractor comprises a flexible sleeve disposed in a cylindrical configuration between the womb facing side of the base device and an adjustable access ring, wherein the birth canal retractor is arranged to be inserted into the birth canal of the pregnant mammal at least with the access ring thereof, and wherein the access ring is configured to be expanded or inflated while in the birth canal, thereby providing an access for the preterm baby to the transfer assembly through the access ring in an expanded or inflated state of the access ring.
11 . A method for transferring a preterm baby from a natural womb of a pregnant mammal to a transfer bag, the method comprising the steps of: i) providing a kit according to claim 9 ; ii) providing an pregnant mammal; iii) performing lavage of the birth canal of the pregnant mammal; iii) inserting the birth canal retractor connected to the base device into the birth canal of the pregnant mammal at least with the access ring thereof; iv) monitoring a cervical dilation of the pregnant mammal and simultaneously increasing the diameter of the access ring while in the birth canal such that it eventually provides an access for the preterm baby to the transfer assembly; v) in case sufficient cervical dilation is observed, releasably securing the transfer device to the base device to form a transfer assembly; vi) supplying artificial amniotic fluid (AAF) to an interior of the transfer assembly; vii) allowing a medical practitioner to access the natural womb by hand using the integrated glove provided in the transfer bag; and viii) transferring the preterm baby from the natural womb into the transfer bag.
12 . The method according to claim 11 , wherein the transfer bag comprises an integrated wire in the vicinity of the annular shaped opening, the method further comprises the step of: closing the annular shaped opening of the transfer bag by loosely securing the integrated wire of the transfer bag around the umbilical cord connected to the preterm baby.
13 . The method according to claim 11 , wherein the method further comprises the step of: releasing the transfer device from the base device and placing the transfer bag on a horizontal plane such that the annular shaped opening of the transfer bag is facing upwards away from the horizontal plane.

Description

TECHNICAL FIELD The present invention relates to a transfer assembly for transferring a preterm baby from a natural womb of a pregnant mammal to a transfer bag. The present invention further relates to a kit-of-parts for assembling a transfer assembly. Also the present invention relates to a transfer device and/or a birth canal retractor for use in a transfer assembly of the present invention. An alternative transfer device is provided as well. Further, the present invention relates to a method for transferring a preterm baby from a natural womb of a pregnant mammal to a transfer bag. BACKGROUND Preterm birth, also known as premature birth, is the birth of a baby at fewer than 37 weeks gestational age, as opposed to full-term delivery at approximately 40 weeks. Very early preterm birth is before 32 weeks, early preterm birth occurs between 32-36 weeks, late preterm birth is between 34-36 weeks' gestation. The World Health Organization defines the following sub-categories of preterm birth, based on gestational age: extremely preterm (less than 28 weeks);very preterm (28 to 32 weeks); andmoderate to late preterm (32 to 37 weeks). In line with the various regulations and directives throughout the world, there is a common understanding that induction or caesarean birth should not be planned before 39 completed weeks unless medically indicated as premature infants are at greater risk for cerebral palsy, delays in development, hearing problems and problems with their vision. The earlier a baby is born, the greater these risks will be. However, despite this common understanding, spontaneous preterm birth may occur as well as the induction of labour or caesarean required for other medical reasons. There may be certain medical reasons for early delivery such as preeclampsia. Also, in view of the recent COVID-19 pandemic medical necessity for caesarean birth is more likely to occur in order to allow a pregnant woman to be intubated without having a direct negative effect on the foetus. Preterm birth is the most common cause of death among infants worldwide. About 15 million babies are preterm each year (5% to 18% of all deliveries). Late preterm birth accounts for 75% of all preterm births. This rate is inconsistent across countries. In the United Kingdom 7.9% of babies are born pre-term and in the United States 12.3% of all births are before 37 weeks gestation. Approximately 0.5% of births are extremely early periviable births (20-25 weeks of gestation), and these account for most of the deaths. In many countries, rates of premature births have increased between the 1990s and 2010s. Complications from preterm births resulted in 0.81 million deaths in 2015, down from 1.57 million in 1990. The chance of survival at 22 weeks is about 6%, while at 23 weeks it is 26%, 24 weeks 55% and 25 weeks about 72%. The chances of survival without any long-term difficulties are lower. Given the significant low survival rates of preterm birth, there is a need to develop procedures increasing the survival rates of preterm birth. DESCRIPTION OF THE INVENTION In order to increase the survival rate of a preterm birth, in particular extremely preterm birth, the present invention provides hereto a transfer assembly for transferring a preterm baby from a natural womb of a pregnant mammal to a transfer bag. By providing such a transfer assembly, the preterm baby can be transferred, or transported by using the transfer bag, to an artificial womb to let the prematurely born child extend its stay. To let the child develop further in the artificial womb, a safe transfer from the natural womb to an artificial womb is now provided by the present invention. It is stressed that the artificial womb and the transfer assembly according to the present invention for transferring the preterm baby to the artificial womb is intended to be used only in case of spontaneous preterm birth or induction of labour or caesarean required for other medical reasons in order to increase the survival rate of the preterm baby. By transferring a preterm baby from the natural womb to an artificial womb using the transfer assembly of the present invention, direct contact between the ambient environment (i.e. containing oxygen) and the preterm baby is herewith prevented. Thus optimizing and extending the ideal situation for the preterm baby, in particular for the lungs of the preterm baby, to further develop in a womb-like surrounding. Although one could argue that by providing the transfer assembly (including a transfer bag) according to the present invention and the eventual transfer of the preterm baby to an artificial womb, the transfer of the perinate from the natural womb to an artificial womb cannot qualify as giving birth. However, although the perinate is not in direct contact with the ambient environment (i.e. containing oxygen) and thus may (legally) considered not wholly brought into the world as such (as a self-breathing human being), in view of the present inve