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.
Claims
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 opening is 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 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 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 a liquid, preferably 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 opening of the transfer bag.
7. The transfer assembly according to claim 1, wherein the transfer bag further comprises an integrated closure in the vicinity of the opening, such as an integrated wire, to close the opening of the transfer bag after the preterm baby is received in the transfer bag, wherein the closure of the opening of the transfer bag is facilitated by loosely securing the integrated closure 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 opening is 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 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 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-of-parts 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.
11-16. (canceled)
17. 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 the 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 a liquid, preferably artificial amniotic fluid (AAF), to the 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.
18. The method according to claim 17, wherein the transfer bag comprises an integrated closure in the vicinity of the opening the method further comprises the step of: closing the opening of the transfer bag by loosely securing the integrated closure of the transfer bag around the umbilical cord connected to the preterm baby.
19. The method according to claim 17, 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 opening of the transfer bag is facing upwards away from the horizontal plane.
20-27. (canceled)
Description
EXAMPLES
[0095] The present invention will be further described by way of example only with reference to the accompanying drawings, in which:
[0096] FIG. 1 shows the different parts of the transfer assembly of the first aspect of the invention.
[0097] FIG. 2 is a cross-sectional view of a part of the connection between the base device and the transfer device.
[0098] FIG. 3 depicts the method of transferring a preterm baby from the natural womb into the transfer bag according to the fifth aspect of the invention.
[0099] FIG. 4 shows a transfer device according to the sixth aspect of the invention.
[0100] FIG. 5 shows a detailed part of the transfer device according to the sixth aspect of the invention.
[0101] FIG. 6 shows the different parts of the transfer device according to the sixth aspect of the invention.
[0102] FIG. 7 is a brief guideline on the use of the transfer device according to the sixth aspect of the invention.
[0103] FIG. 8 depicts the method of transferring a preterm baby from the natural womb into a transfer bag according to the prior art.
[0104] FIG. 9 depicts the method of transferring a preterm baby from the natural womb into the transfer bag according to the seventh aspect of the invention.
[0105] FIG. 1 shows a transfer assembly 1 according to the present invention comprising an birth canal retractor 2 (also referred to as an inflatable retractor) comprising an inflatable insertion ring or retractor ring 3 (also referred to as the access ring) connected to the retractor sleeve 4. The insertion ring 3 as shown in FIG. 1 is inflatable in order to increase the diameter of the opening provided by the insertion ring 3 and to allow access of the preterm baby (not shown) in the natural womb (not shown) to the birth canal retractor 2.
[0106] The retractor sleeve 4 of the birth canal retractor 2 is further connected at its other end to the base device 5. The base device 5 as shown in FIG. 1 comprises a rigid ring 5A (also referred to as the base body) provided with clips 5B in order to releasably secure the base device 5 to the transfer device 6. The base body 5A is provided with a pass-through opening 5C with a sufficient diameter in order to allow the preterm baby (not shown) to pass-through the base device 5 into the transfer device 6 and in order to allow the medical practitioner (not shown) to monitor the progress of the delivery (cervical dilation) and to guide the preterm baby through the transfer assembly 1 into the transfer device 6.
[0107] The transfer device 6 is provided with a flexible transfer bag 7 provided with a glove 7A to receive the hand of the medical practitioner (not shown). The transfer bag 7 is further provided with a supply 8 for supplying artificial amniotic fluid to the interior of the transfer bag 7 and, subsequently, the complete transfer assembly 1. As shown in FIG. 1, the supply 8 might also be used as a drain for draining artificial amniotic fluid from the interior of the transfer assembly 1. Further, as shown in FIG. 1, the transfer bag 7 is provided with an air valve 9 to release air from the transfer bag 7 in case of supplying artificial amniotic fluid to the interior of the transfer bag 7.
[0108] The transfer device 6 is further provided with a coupling member 6A, which coupling member 6A has similar dimensions as the base device 5. The coupling member 6A is depicted in FIG. 1 as a rigid ring which allows connection to the base device 5. In particular the opening 6B provided in the coupling member 6A cooperates with the opening 5C provided in the base body 5A.
[0109] A detailed cross-sectional view of the coupling member 6A of the transfer device 6 and the base body 5A of the base device 5 is shown in FIG. 2. Here the base body 5A is the lower rigid ring provided with clips 5B. The base body 5A cooperates with the coupling member 6A by form-fittingly connecting to the coupling member 6A. In order to provide a reliable connection between the coupling member 6A and the base body 5A, the coupling member 6A is provided with a sealing circumferential flexible O-ring 10A and a labyrinth closure 10B provided in a recess of the coupling member 6A.
[0110] FIG. 3 provides schematical view of the method of transferring a preterm baby from the natural womb 21. First (FIG. 3A), the birth canal retractor 2 is placed in the birth canal 22 wherein the insertion ring 3 is positioned such that the birth canal retractor 2 abuts the cervix 23. FIG. 3A further shows the retractor sleeve 4 and the base device 5 provided with clips 5B. Secondly, during the cervical dilation phase (FIG. 3B) the diameter of the insertion ring 3 is inherently, manually or automatically increased. The progress of the dilation can still be checked by hand by, for example, the medical practitioner (not shown). Subsequently, when cervical dilation is sufficient for delivery of the preterm baby, the transfer device 6 is releasably secured to the base device 5 (FIG. 3C). FIG. 3C further shows the clips 5B, coupling member 6A, transfer bag 7 and glove 7A integrated in the transfer bag 7. In FIG. 3D the preterm baby 20 is transferred from the natural womb 21 via the birth canal retractor 2 into the transfer bag 7 of the transfer device 6 by assistance of the hand 24 of the medical practitioner received in the integrated glove 7A. Once the preterm baby 20 is fully transferred into the transfer bag 7, the transfer device 6 can be detached from the birth canal retractor 2, by unclipping the base body 5A of the base device 5 from the coupling member 6A of the transfer device 6 as shown in FIG. 3E. Once the transfer device 6 is detached from the base device 5 (FIG. 3F) the transfer bag 7 can be placed onto a transfer station (not shown) for cannulation of the umbilical cord 25 still connected to the preterm baby 20 and the natural placenta 26 located in the natural womb 21. After cannulation of the umbilical cord 25 and connecting the cannulated umbilical cord 25 to an artificial placenta (not shown), the birth canal retractor 2 is removed from the birth canal 22 (FIG. 3G). Although not shown in FIG. 3G, the insertion ring 3 is preferably first deflated before removal.
[0111] FIGS. 4, 5 and 6 show an assembled transfer device according to the alternative embodiment of the present invention comprising the transfer device and the expandable ring. The transfer bag (connected to the expandable ring) is not shown in FIGS. 4 and 5. The head of the transfer device has two slits for inserting artificial amniotic fluid into the expanded biobag. The two slits to the right of the amniotic fluid slits in FIG. 6 are for inserting heated air into the bumper part of the double walled biobag. At the right side of the transfer device, control buttons and the main supply tubes are located. The main supply tube holds low voltage electric control wires, air supply and amniotic fluid supply and removal tubes. The other end of the main supply tube is attached to power supply unit(s), plus a control—and a monitoring device (not shown). The expandable ring (FIG. 5), is equipped with wedges to, when expanded in the birth channel, maintain a fixed position in this birth channel.
[0112] FIG. 7 shows the buttons and their functions on the transfer device according to the alternative embodiment of the present invention. At the beginning of the process, i.e. after the transfer device is inserted in the birth canal, the artificial amniotic fluid (AAF) button starts blinking. After pressing once, the artificial amniotic fluid flows into the biobag. Subsequently the ring button starts blinking. By pressing (and holding) the ring button, the ring inflates. By the time the ring is inflated to the full extend the buttons starts blinking. In order to stop the inflation of the ring and supply of the artificial amniotic fluid, the ring button is released. Once the preterm baby completely entered the transfer bag (also referred to as biobag) the air button starts blinking. By pressing the air button the bumper is inflated. During 15 seconds air will flow into the bumper closing the transfer bag. By the time the bumper reaches the maximum amount of air, the air button light will turn off.
[0113] FIG. 8 shows a method of assistance delivery of a baby using a device known transfer device the so-called Odón device (see also: Schvartzman, Javier A., et al. “Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study.” Reproductive health 15.1 (2018): 1-10). In FIG. 8A an inserter is applied on the head of the baby. A soft plastic bell assures perfect adaptation to the foetal head and prevents damage. In FIG. 8B the inserter progressively positions the Odón device around the head of the baby. Positioning occurs as the inserter gently produces the sliding of the two surfaces of the folded sleeve along the birth canal and around the baby's head. In FIG. 8C, when the Odón device is properly positioned, a marker on the insertion handle become clearly visible in the reading window. A minimal and self-limited amount of air is pumped into an air chamber in the inner surface. This produces a secure grasp around the head of the baby that fixes the inner surface and allows for traction as shown in FIG. 8D. The inserter is subsequently removed. In FIG. 8E, the head is delivered taking advantage of the sliding effect of the two surfaces of the folded sleeve. Lubrication of the surfaces further facilitates the extraction process. If needed, traction can be applied up to 19 kg (which is equivalent to the force applied with the metal vacuum extractor).
[0114] FIG. 9 shows the method of the present invention using the alternative transfer device. In order to provide the transfer device shown in FIG. 9, a folded double layer biobag (the light blue part in FIG. 9, point 1) is attached at the top of the device, inserted under the expandable ring (the green part in FIG. 9), and at the other end the (folded) biobag is attached at the right part of the expandable ring. Before insertion of the transfer device, the birth channel may be disinfected. The sterile transfer device, consisting of a cylindrical control rod (base body) with as attachments a collapsed double layer biobag and an expandable ring, is inserted into the vagina when the mother has between 7-9 cm of dilatation. The device is positioned such in the vagina that the expandable ring, after full expansion, generates an access gate to the attached biobag. The biobag is on one side attached to the cylindrical rod an on the other side to the inflatable ring. Subsequently, the upper cylinder (the ring) is inflated. The expansion of the ring in the birth channel, together with the surface structures in the outside of the ring, fixates the ring relative to the birth channel. After the full expansion of the expandable ring, the insertion tube of the transfer device is (partially) retracted from the birth canal, thus increasing the filled volume of the biobag which generates a slightly lower environmental pressure in the biobag. Simultaneously, artificial amniotic fluid is inserted into the transfer device while pulling the insertion tube of the transfer device. The perinate (preterm baby) is then, due to the slightly lower environmental pressure in the biobag, the maternal contractions plus the maternal all-fours position, slowly transferred into the biobag. After the baby is completely inside the biobag, i.e. ‘born’ into the biobag, and for at least the larger part thereof outside the birth channel as can be understood from FIG. 9, the expandable ring is de-expanded (e.g. deflated). The diameter of the expandable ring after de-expansion is such that the flows in the umbilical cord, which then goes through the hole in the expandable ring, are not occluded. The whole device, including the inside the biobag captured perinate, is then removed from the birth channel. Next the outer wall of the double-walled (double-layer) biobag is, through the tubing in the cylindrical control rod, inflated with sterilized air, for additional thermal insulation and protection of the baby in the bag while keeping the weight of the bag low. If necessary extra sterilized artificial Amniotic fluid is inserted through the tubing in the control rod into the inner part of the biobag.
