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Title:
SYSTEMS, DEVICES AND METHODS FOR ADJUSTING FETAL POSITION
Document Type and Number:
WIPO Patent Application WO/2021/148929
Kind Code:
A1
Abstract:
Aspects of embodiments pertain to a fetus positioning device, comprising: a plurality of expandable members that are coupleable with each other; wherein the plurality of selectively expandable members are configured such that when coupled with each other and operably engaged with a pregnant female subject, the plurality of expandable members are arranged relative to female subject allowing to selectively apply, through expansion, forces onto the abdomen of the female subject.

Inventors:
HADAR ERAN (IL)
TRAISTMAN IDAN (IL)
Application Number:
PCT/IB2021/050353
Publication Date:
July 29, 2021
Filing Date:
January 18, 2021
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
MOR RESEARCH APPLIC LTD (IL)
International Classes:
A61B5/00; A61F5/00; A61G7/07
Foreign References:
CN108836596A2018-11-20
CN206526150U2017-09-29
CN208974248U2019-06-14
CN108095963A2018-06-01
CN212853868U2021-04-02
CN211797327U2020-10-30
US7333850B22008-02-19
Attorney, Agent or Firm:
RICHTER, Allen et al. (IL)
Download PDF:
Claims:
CLAIMS:

What is claimed is:

1. A fetus positioning device, comprising: a plurality of expandable members that are coupleable with each other; wherein the plurality of selectively expandable members are configured such that when coupled with each other and operably engaged with a pregnant female subject, the plurality of expandable members are arranged relative to the pregnant female subject allowing to selectively apply, through expansion, forces onto the abdomen of the pregnant female subject.

2. The fetus positioning device of claim 1, wherein the plurality of expandable members are coupled with each other by connecting elements and/or a support structure.

3. The fetus positioning device of claim 1 or 2, wherein the plurality of expandable members are controllably expandable and collapsible.

4. The fetus positioning device of any one or more of the preceding claims, wherein the plurality of expandable members, when in operable position, are arranged to allow selectively applying forces onto the female subject's abdomen in directions which are about parallel to a coronal plane of the pregnant female subject and/or in dorsal and/or ventral directions.

5. The fetus positioning device of any one or more of the preceding claims, wherein the plurality of selectively expandable members are inflatable with a fluid and collapsible or debatable by withdrawing the fluid from the expandable members.

6. The fetus positioning device of any one or more of the preceding claims, wherein the plurality of selectively expandable members are coverable or covered with a removable sterile sheath.

7. The fetus positioning device of any one or more of the preceding claims, further comprising pressure sensors for measuring a pressure applied on a pregnant female's abdomen by at least one of the expandable members.

8. The fetus positioning device of any one or more of the preceding claims, wherein the expandable members, when operably coupled with each other, delineate an annular geometry.

9. The fetus positioning device of any one or more of the preceding claims, wherein when in operable position, the female abdomen remains largely exposed or unobstructed, thereby allowing a medical professional conducting medical procedures and/or examination.

10. The fetus positioning device of any one or more of the preceding claims, further comprising a support onto which the female subject can lie down and for securing the expandable members.

11. The fetus positioning device of claim 10, wherein when operably engaged, the female subject is sandwiched between the support and the expandable members which are securely coupled with the support.

12. The fetus positioning device of claim 11, wherein the expandable members are securely coupled with directly or indirectly with the support.

13. The fetus positioning device of any one or more of the preceding claims, further comprising at least one user control interface for controlling expansion and contraction of each one of the plurality of members. 14. The fetus positioning device of any one or more of the preceding claims, wherein each one of the plurality members is equipped with a user control interface for controlling expansion and contraction thereof.

15. The fetus positioning device of any one or more of the preceding claims, further comprising: a fluid delivery apparatus including: at least one conduit that is in fluid communication with the plurality of expandable members to allow selectively and individually cause expansion or collapsing of the members; a pump operable to deliver fluid to the expandable members the conduit and to withdraw fluid from the expandable members; and a controller for controlling operation of the pump.

16. A fetus positioning system comprising: a fetus positioning device according to any one or more of the preceding claims; a fetus imaging apparatus for acquiring image data descriptive of a fetus carried by the pregnant female subject; a memory operable to receive the image data; a processor operable to generate, based on the acquired image data, a control signal for controlling expansion and contraction of the plurality of expandable members.

17. The fetus positioning system of claim 16, further comprising: a display device, wherein the memory and processor are further operable to display, based on the acquired image data, images via the display device.

18. The fetus positioning system of claim 16 or 17, wherein the imaging apparatus comprises an ultrasonography imaging apparatus.

19. The fetus positioning system of any one or more of the claims 16 to 18, wherein the processor and the memory are operable to perform the following steps: determining, based on the acquired image data, a fetal position in the female subject; and if the fetus not in the desired position, providing, based on the acquired image data, a control signal for controlling the pump to controllably and adaptively apply, via the plurality of members, pressure onto the female subject's abdomen to cause positioning a fetus in the female from the undesired into a desired position.

20. The fetus positioning system of any one or more of the claims 16 to 19, wherein the processor and the memory are operable to perform the following steps: adaptively pressurizing or depressurizing the plurality of expandable members to cause positioning a fetus from the undesired into a desired position.

21. The fetus positioning system of claim 19 or claim 20, wherein the undesired fetal position includes breech presentation, and the desired fetal position includes cephalic presentation.

22. The fetus positioning system of any one or more of the claims 16 to 21, wherein an output provided by the pressure sensors is used for determining the amount of pressure that is applied onto the female subject.

23. The fetus positioning system of any one or more of the claims 16 to 22, wherein an output provided by the pressure sensors is used for determining the amount that is to be applied for positioning the fetus in the desired position. 24. A fetus positioning system comprising: a fetus positioning device according to any one or more of the preceding claims; a fetus monitoring apparatus for acquiring data descriptive of a position or presentation of a fetus carried by a pregnant female subject; a memory operable to receive the data; a processor operable to generate, based on the acquired data, a control signal for controlling expansion and contraction of the plurality of expandable members to reposition the fetus.

25. The fetus positioning system of claim 24, further comprising: a display device configured to display information relating to the data.

26. The fetus positioning system of claim 24 or 25, wherein the monitoring apparatus comprises an ultrasonography imaging apparatus.

27. The fetus positioning system of any one or more of the claims 24 to 26, wherein the processor and the memory are operable to perform the following steps: determining, based on the acquired data, a fetal position in the female subject; and providing, based on the acquired image data, a control signal for controlling the pump to controllably and adaptively apply, via the plurality of members, pressure onto the female subject's abdomen to cause positioning a fetus in the female from the undesired into a desired position.

28. The fetus positioning system of any one or more of the claims 24 to 27, wherein the processor and the memory are operable to perform the following steps: adaptively pressurizing or depressurizing the plurality of expandable members to cause positioning a fetus from the undesired into a desired position.

29. The fetus positioning system of claim 27 or claim 28, wherein the undesired fetal position includes breech presentation, and the desired fetal position includes cephalic presentation.

30. The fetus positioning system of any one or more of the claims 24 to 29, wherein an output provided by the pressure sensors is used for determining the amount of pressure that is applied onto the female subject.

31. The fetus positioning system of any one or more of the claims 24 to 30, wherein an output provided by the pressure sensors is used for determining an amount and/or direction/or duration of the pressure that is to be applied for positioning the fetus in the desired position.

32. A method for positioning a fetus in a subject, comprising: acquiring an image of a fetus in a subject by a fetus imaging apparatus; determining a position of a fetus in the subject by a fetus position analyzer and control engine; if it is determined that the fetus is in an undesired position: controllably expanding at least one of a plurality of expandable members for applying, by the at least one expandable member, pressure onto the abdomen of the human subject for positioning the fetus in a desired position.

33. A method for positioning a fetus in a subject, comprising: acquiring an image of a fetus in a subject; detecting that the fetus in the subject is in an undesired position: expanding at least one of a plurality of expandable members for applying pressure onto the abdomen of the human subject for positioning the fetus in a desired position.

Description:
SYSTEMS, DEVICES AND METHODS FOR ADJUSTING FETAL POSITION

[0001] The present disclosure relates in general to pregnancy and childbirth.

BACKGROUND

[0002] One of the many problems that may arise during childbirth include breech presentation in which the baby's head is positioned distally and the lower limbs proximally to the mother's vaginal cavity.

[0003] Breech presentation and delivery usually requires a Caesarean section ("C- section") to successfully remove the baby from the birth canal. C-section deliveries have various disadvantages over vaginal delivery. C-section deliveries may for example greatly increase the risk of infection, are usually associated with prolonged periods of recovery for the mother and possibly elevated child mortality. In addition, C-section deliveries may increase the risk of future C-sections and other maternal or neonatal complications in subsequent deliveries.

BRIEF DESCRIPTION OF THE FIGURES

[0004] The figures illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0005] For simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity of presentation. Furthermore, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. References to previously presented elements are implied without necessarily further citing the drawing or description in which they appear. The figures are listed below.

[0006] FIG. 1A is a schematic illustration of a fetus positioning device, according to some embodiments.

[0007] FIG. IB is a schematic illustration of the fetus positioning device operably engaged with a pregnant human subject, according to some embodiments. [0008] FIG. 1C is a schematic illustration of a user control interface of the fetus positioning device, according to some embodiments.

[0009] FIG. ID is a schematic top view illustration of the fetus positioning device, according to some embodiments.

[0010] FIG. IE is a schematic illustration of varying pitch orientation of an expandable member of the fetus positioning device.

[0011] FIG. 2 is a schematic illustration of a fetus positioning system, according to some embodiments.

[0012] FIG. 3A is a flowchart of a method for positioning a fetus, according to some embodiments.

[0013] FIG. 3B is a flowchart of a method for positioning a fetus, according to some other embodiments.

DETAILED DESCRIPTION

[0014] Aspects of disclosed embodiments pertain to systems, devices and methods for adjusting fetal position, for example, from breech into cephalic presentation to prevent breech vaginal birth or C-section delivery and to allow vaginal delivery, in a cephalic presentation, instead.

[0015] Referring to FIGs. 1A-C, a fetus positioning device 1100, when operably engaged with an (e.g., human) female subject 500, is operable to selectively and, optionally, adaptively, apply pressure onto the abdomen of pregnant female subject 500 to reposition a fetus carried thereby, from an undesired position (e.g., breech presentation or transverse) into a desired position (e.g., cephalic presentation). The pressure may be applied at a plurality of locations of the abdomen, sequentially and/or simultaneously, by a plurality of expandable members.

[0016] Static thresholds are predetermined thresholds that remain constant. Dynamic thresholds are forcefully changed, for example, at a certain time of day, or a certain day of the year. Adaptive thresholds are changed in response to changes in characteristics the fetus positioning device and/or system and may vary depending on a variety of parameters (e.g., based on a present and/or position of the fetus). A position of the fetus in the subject's womb may be determined and/or continuously monitored for example, through image acquisition of the fetus by employing for instance, ultrasound imaging. Other methods may include haptic (e.g., tactile) sensors and/or through touching or/pressing and/or otherwise engaging the subject's abdomen by a medical professional (e.g., physician or nurse).

[0017] In some embodiments, operating parameters of fetus positioning device 1100 may be manually, automatically, or semi-automatically controlled. Operating parameters of fetus positioning device 1100 can pertain, for example, to the amount of pressure female subject 500 may be subjected to; the location(s) where to apply pressure; the timing when to apply pressure at the one or more locations; duration to apply pressure at a certain magnitude onto the subject's abdomen; a direction in which members apply stress and/or pressure onto the abdomen, and/or a propagation velocity at which pressure shall be applied at the various locations of the subject's abdomen. For example, pressure may be (e.g., automatically) applied onto the abdomen in timed coordination, for example, based on image and/or other information relating to fetus position information.

[0018] In some embodiments, fetus positioning device 1100 may comprise a plurality of expandable members 1102 which are configured to form an annular structure. The annular structure may be resilient or sturdy enough to allow applying pressure and/or stress onto a women's abdomen for the purpose of repositioning a fetus, without causing damage to the annular structure, i.e., the annular structure remains intact. The annular structure may lie in a plane that is about parallel to a coronal plane of female subject 500. In some embodiments, the plurality of expandable members may be included in and arranged along a flexible tube.

[0019] In some examples, the plurality of expandable members 1102 may be coupled (e.g., frictionally and/or form-fittingly) with each other. The plurality of expandable members 1102 may for example comprise connecting elements for coupling expandable members 1102 with each other, directly or indirectly. Optionally, expandable members 1102 may be separate from each other and operably engageable with the connecting elements for allowing connecting expandable members 1102 with each other to form an annular structure as exemplified and shown in FIGs. 1A-D. In a further example, expandable members 1102 may be coupled with an (e.g., collapsible) support structure 1104, which may be implemented as a support frame. Optionally, the plurality of expandable members 1102 are coverable or covered with a removable sterile sheath (not shown). Optionally, at least a front surface of the expandable members may be treated and/or made of smooth material such to avoid injury of the underlying abdomen tissue. The expression "sterile sheath" may pertain to a sheath that was considered sterile at least until it was removed from its packaging.

[0020] The plurality of selectively expandable members 1102, when coupled with each other, are configured such that when operably engaged with pregnant female subject 500, the plurality of members are arranged relative to female subject 500 allowing to selectively apply, through their expansion, forces onto the female subject's abdomen. For example, pressure may be applied onto the abdomen in timed coordination by the plurality of expandable members 1102, for example, based on acquired image and/or other information comprising and/or relating to fetus position information. For example, a user of fetus positioning device 1100 may view an image of a fetus position in the female subject's abdomen and, based on the observed position, control operating parameters of one or more of expandable members 1102, for example, by engaging a user control interface 1105. In the example shown in FIG. 1C, pressure applied by each expandable member 1102 onto a surface (e.g., abdomen) and/or the amount of expansion of each expandable member 1102 may be controllable with a user control interface 1105 located adjacent the corresponding expandable member 1102.

[0021] Flowever, this example should by no means be construed in a limiting manner. Correspondingly, in some other examples, operating parameters of fetus positioning device 1100 (e.g., amount of pressurization of each expandable member 1102) may be individually and remotely controllable (e.g., by a user) from or by a computing device, as outlined in more detail below. In an additional example, operating parameters of expandable members 1102 may be controlled automatically based on the acquired image information, as will be outlined in more detail below. In some embodiments, operating parameter of fetus positioning device 1100 may be automatically controlled without user-intervention.

[0022] Optionally, each one of the plurality of expandable members is individually selectable to be controllably expandable and reducible (e.g., collapsible and/or contractible). Optionally, the amount of pressure that may be applied, e.g., by each one of the expandable members, onto the female subject's abdomen, may be controllably adaptable.

[0023] In some embodiments, fetus positioning device 1100 may be configured to have a plurality of sets of expandable members 1102. Optionally, a set of expandable members 1102 is jointly controllable. For example, each set of expandable members is individually selectable to controllably expand or reduce, jointly, the selected set of expandable members. In a further example, the amount of pressure that may be applied onto the female subject's abdomen jointly by expandable members 1102 of a set may be controllably adaptable.

[0024] As shown schematically in FIG. ID, the plurality of expandable members 1102, when in operable position, may form an annular structure which may lie in a plane that is about parallel to a coronal plane of female subject 500. This way, female abdomen remains largely exposed or unobstructed, thereby allowing a medical professional conducting medical procedures and/or examination such as C-section, without requiring disengaging or removing fetus positioning device 1100.

[0025] The forces Fr that may be applied by expandable members 1102 may point inwardly, radially, in an about medial direction with respect to expandable members 1102. Optionally, the forces Fr may not only have a medial component but also a dorsal component, i.e., the forces Fr may not only point in an about medial direction, but also towards the back of subject 500. In some examples, forces Fr may have additional or other directional components. Optionally, the force direction applied onto subject 500 by the expandable members may be controlled individually. In some embodiments, the forces applied by expandable members 1102 onto subject 500 may be normal and/or shear and/or friction forces. In some embodiment, a direction of expansion of an expandable member 1102 may be controlled. For instance, with respect to the subject's coronal plane, a pitch orientation of an expansion direction may be controlled (e.g., by drivers and/or actuators and/or other orientation adjustment mechanisms), for example, as schematically shown in FIG. IE. Although not illustrated, a yaw orientation (relative to a radial direction with respect to the annular geometry) of expandable member 1102 may also be controlled. In some embodiments, expandable members 1102 may also be controllable with respect to their roll orientation relative to the coronal plane.

[0026] In some embodiments, the selectively expandable members 1102 may comprise balloons that are inflatable with a fluid (e.g., air, gas, or water) and collapsible or debatable by withdrawing fluid from expandable members 1102. For that purpose, fetus positioning device 1100 may comprise, for example, a fluid delivery apparatus 1110 that includes a plurality of conduits 1112 that are in fluid communication, respectively with the plurality of expandable members 1102, and a pump 1114 and, optionally, actuatable valves configured to impart pressure on fluid such to deliver fluid to the expandable members via conduits 1112 and to withdraw fluid from expandable members 1102 via conduits 1112 to cause or allow collapsing of expandable members 1102. Optionally, pump 1114 may comprise a plurality of individually controllable compressors.

[0027] It is noted that conduits 1112 may be comprise a plurality of individual conduit sections to allow selectively and individually cause expansion or collapsing of expandable members 1102 by a pump controller 1116.

[0028] In some embodiments, fetus positioning device 1100 may comprise pressure and/or other haptic (e.g., tactile) sensors (not shown) for sensing, for example, a pressure-related parameter imparted by expandable members 1102 onto female subject 500. For instance, one or more pressure sensors may be arranged on the front side (pointing inwardly as shown in FIG. 2D with respect to arrows Fr ) of each expandable member 1102 for sensing the amount of and, optionally, a direction and/or location of the pressure imparted on the corresponding expandable member engaging with the abdomen of female subject 500. In some further embodiments, pressure sensors may be employed which are configured to sense a fluid pressure in expandable members 1102 and/or respective conduits 1112. In addition, sensor may be arranged onto the expandable members to measure shear stress. In some embodiments, sensors (e.g,. for measuring pressure and/or shear stress) may be arranged onto the women's abdomen, in addition to sensors arranged on device 1100, to provide additional or alternative feedback regarding the impact on the abdomen when employing device 1100.

[0029] In some embodiments, pressure may be applied adaptively, for example, based on a control signal. In some embodiments, pressure may be applied according to a preset magnitude. For example, the operation of an expandable member may be set to "ON" or "OFF". If set to "ON", the expandable member may be pressurized until a sensed threshold pressure is reached (e.g., exceeded).

[0030] Operation of pump controller 1116 may be controlled based on a user input provided via user control interface 1105 and/or based on, for example, a sensor output including, for examples, images acquired by a fetus imaging apparatus and/or a pressure- related parameter value sensed by the one or more pressure sensors. Optionally, user control interface 1105 may comprise a visual indicator for indicating the amount of pressure applied onto the female subject by the corresponding expandable member 1102 and/or to indicate the amount of pressurization of the same expandable member 1102. In some embodiments, fetus positioning device 1100 may incorporate or include imaging devices (not shown), such as ultrasound transducers. In some embodiments, one or more expandable members may 1102 may include or may be equipped with imaging devices.

[0031] In some embodiments, fetus positioning device 1100 may comprise a support 1106 onto which female subject 500 can lie down and for securing expandable members 1102. In some examples, the support may herein also be referred to as "dorsum support". When operably engaged, female subject 500 is sandwiched between expandable members 1102 and support 1106. Expandable members 1102 may be securely coupled with support 1106 via fastener elements 1108 (e.g., length-adjustable straps) for tightly engaging fetus positioning device 1100 with female subject 500. Optionally, expandable members 1102 may be coupled with support structure 1104, which may be coupled with support 1106. Optionally, expandable members 1102 may comprise connecting elements which may be coupled with support 1106. [0032] In some embodiments, the medical professional may also perform manual maneuvers alongside the operation of fetus positioning device 1100 to assist in the repositioning of the fetus.

[0033] Additional reference is made to FIG. 2. According to some embodiments, a fetus positioning system 2000 may comprise fetus positioning device 1100 and a control and imaging subsystem 1200 that may comprise a fetus imaging apparatus 1202 for conducting fetus imaging for monitoring purposes and, optionally, for controlling operation of fetus positioning device 1100. Control and imaging subsystem 1200 may be communicably coupled with components of fetus positioning device 1100 via (wired and/or wireless) communication links of a network 1300 for receiving data from fetus positioning device 1100 (e.g., from pressure sensors) and/or for controlling fetus positioning device 1100.

[0034] Certain aspects of control and imaging subsystem may be implemented by a computing device, which may include a multifunction mobile communication device also known as "smartphone", a personal computer, a laptop computer, a tablet computer, a server (which may relate to one or more servers or storage systems and/or services associated with a business or corporate entity, including for example, a file hosting service, cloud storage service, online file storage provider, peer-to-peer file storage or hosting service and/or a cyberlocker), personal digital assistant, a workstation, a wearable device, a handheld computer, a notebook computer, a vehicular device, a stationary device and/or a home appliances control system.

[0035] In some examples, fetus imaging apparatus 1202 may be configured to acquire, in conjunction with a memory device 1204 and processor 1206, image data of a fetus carried by pregnant female subject 500. Based on the acquired image data, images of the fetus (and, optionally, womb) may then be displayed to a user via a display device 1208 for monitoring and/or diagnostic purposes such as, for example, for determining the position of a fetus in human subject 500. Optionally, fetus imaging apparatus 1202 may comprise an ultrasonography imaging apparatus. Optionally, haptic sensors (e.g., pressure sensors) may be applied for monitoring and/or diagnostic purposes such as, for example, determining a position of fetus in human subject 500. For example, based on output provided by the pressure sensors, a control signal may be provided by processor 1206 for controlling the operation of fetus positioning device 1100.

[0036] Optionally, support 1106 may comprise sensors 1118 for sensing, e.g., physiological parameters of subject 500 and/or of the fetus, e.g., for monitoring purposes, for example, to ensure wellbeing of the subject and the fetus during the procedure. Optionally, (e.g., wearable) physiological sensors 1120 may be removably coupled with subject 500 for sensing, e.g., physiological parameters of subject 500 and/or of the fetus, e.g., for monitoring purposes, for example, to ensure wellbeing of the subject and the fetus during the procedure.

[0037] In some embodiments, memory device 1204 and processor 1206 may be operable to implement a fetus position analyzer and control engine 1210 generating based on the acquired image data, a control signal for controlling expansion and contraction of the plurality of expandable members 1102. For example, pump 1114 may be controlled by a pump controller 1116 by the control signal received from processor 1206.

[0038] In some embodiments, memory device 1204 and processor 1206 are operable to determine, based on the acquired image data, a fetus position in female subject 500. If the fetus not in a desired position, processor 1206 may provide, based on the acquired image data, a control signal for controlling the pump to controllably and adaptively apply, via the plurality of expandable members 1102, pressure onto the female subject's abdomen to cause positioning a fetus in female subject from the undesired position (e.g., breech presentation) into a desired position (e.g., cephalic presentation). For example, based on the control signal, expandable members 1102 may be operated in timed coordination for applying a required pressure at selected locations onto the abdomen of female subject 500.

[0039] In some embodiments, output signals provided by the pressure sensors may be used as a feedback for determining the amount of pressure that is to be applied onto the female subject by expandable members 1102 for positioning the fetus in the desired position. Clearly, in some scenarios, at least for the abdomen location pertaining to one or more selected expandable members 1102, no pressure may have to be applied. [0040] In some embodiments, the location of each expandable member 1102 may be registered with the position of female subject 500. The registration may be performed manually, semi-automatically or automatically.

[0041] For example, markers may be provided on fetus positioning device 1100 for positioning the device with respect to female human subject 500 in a desired position such that fetus images acquired by fetus imaging apparatus 1202 are registered with respect to the location information of expandable members 1102.

[0042] In some examples, fetus position analyzer and control engine 1210 may receive one or more fetus images acquired by fetus imaging apparatus 1202; and may further receive camera images acquired by camera 1212. Based on, for example, location information of acquired fetus images relative to subject 500 and further based on, for example, the position of at least one expandable member 1102 relative to female subject 500, and additionally based on, for example, the location and orientation of female subject 500 relative to a World Coordinate system describing location information of objects in the delivery room where female subject 500 is located, the location of the same at least one expandable member 1102 relative to subject 500 may be automatically or semi-automatically registered with acquired fetus image data. Optionally, the expression "semi-automatically" may, for instance, require registration approval by a user of fetus positioning system 2000.

[0043] In some embodiments, based on the images acquired by camera 1212 a state of expandable members 1102 may be determined. For example, the extent of expansion of each expandable member 1102.

[0044] Control and imaging subsystem 1200 may further comprise a communication unit 1214 for allowing the transmission of control signals to hardware components of, e.g., fetus positioning device 1100, such as pump controller 1116 and/or the like. Communication unit 1214 may include, for example, include I/O device drivers (not shown) and network interface drivers (not shown) for enabling the transmission and/or reception of data over network 1400. A device driver may for example, interface with a keypad or to a USB port. A network interface driver may for example execute protocols for the Internet, or an Intranet, Wide Area Network (WAN), Local Area Network (LAN) employing, e.g., Wireless Local Area Network (WLAN)), Metropolitan Area Network (MAN), Personal Area Network (PAN), extranet, 2G, 3G, 3.5G, 4G including for example Mobile WIMAX or Long Term Evolution (LTE) advanced, Bluetooth ® (e.g., Bluetooth smart) , ZigBee™, near-field communication (NFC) and/or any other current or future communication network, standard, and/or system. In some embodiments, system 2000 may comprise a safety button (not shown) which, when pressed, causes the expandable members to deflate.

[0045] Referring to FIG. 3, a method for positioning a fetus a subject may comprise, in some embodiments, acquiring an image of a fetus in a subject (block 3100A), e.g., by a fetus imaging apparatus.

[0046] In some embodiments, the method may further comprise determining, based on the acquired image, a position of the fetus in the subject (block 3200A), e.g., by a fetus position analyzer and control engine.

[0047] In some embodiments, method may comprise, if it is determined that the fetus is in an undesired position, controllably expanding at least one of a plurality of expandable members for applying, by the at least one expandable member, pressure onto the abdomen of the human subject for positioning the fetus in a desired position (block 3300A).

[0048] In some embodiments, a method may include acquiring data descriptive of a position of a fetus in a subject (block 3100B).

[0049] In some embodiments, the method may comprise, expanding, based on the acquired data, at least one of a plurality of expandable members for positioning the fetus in a desired position (block 3200B).

[0050] It is noted that the term "subject", used herein, may relate to any individual being medically or clinically inspected, such as a "patient", a "human", etc.

[0051] Additional Examples:

[0052] Example 1 pertains to a fetus positioning device, comprising: a plurality of expandable members that are coupleable with each other; wherein the plurality of selectively expandable members are configured such that when coupled with each other and operably engaged with a pregnant female subject, the plurality of expandable members are arranged relative to female subject allowing to selectively apply, through expansion, forces onto the abdomen of the female subject. [0053] Example 2 includes the subject matter of Example 1 and, optionally, wherein the plurality of expandable members are coupled with each other by connecting elements and/or a support structure.

[0054] Example 3 includes the subject matter of Example 1 or 2 and, optionally, wherein the plurality of expandable members are controllably expandable and collapsible.

[0055] Example 4 includes the subject matter of any one or more of the Examples 1 to 3 and, optionally, wherein the plurality of expandable members, when in operable position, are arranged to allow selectively applying forces onto the female subject's abdomen in directions that have directional components which are about parallel to a coronal plane of the female subject and, optionally, dorsal or ventral components. Accordingly, a force may be applied onto the subject's body pointing inwardly with respect to the annular structure and, optionally, also downwardly (dorsal direction) or upwardly (in ventral direction).

[0056] Example 5 includes the subject matter of any one or more of the Examples 1 to 4 and, optionally, wherein the plurality of selectively expandable members are inflatable with a fluid and collapsible or debatable by withdrawing the fluid from the expandable members.

[0057] Example 6 includes the subject matter of any one or more of the Examples 1 to 5 and, optionally, wherein the plurality of selectively expandable members are coverable or covered with a removable sterile sheath.

[0058] Example 7 includes the subject matter of any one or more of the Examples 1 to 6 and, optionally, further comprises pressure sensors for measuring a pressure applied on a pregnant female's abdomen by at least one of the expandable members.

[0059] Example 8 includes the subject matter of any one or more of the Examples 1 to 7 and, optionally, wherein the expandable members, when operably coupled with each other, delineate an annular geometry.

[0060] Example 9 includes the subject matter of any one or more of the Examples 1 to 8 and, optionally, wherein when in operable position, the female abdomen remains largely exposed or unobstructed, thereby allowing a medical professional conducting medical procedures and/or examination.

[0061] Example 10 includes the subject matter of any one or more of the Examples 1 to 9 and, optionally, further comprises an (e.g., dorsum) support onto which the female subject can lie down and for securing the expandable members.

[0062] Example 11 includes the subject matter of any one or more of the Examples 1 to 11 and, optionally, wherein when operably engaged, the female subject is sandwiched between the support and the expandable members which are securely coupled with the support.

[0063] Example 12 includes the subject matter of any one or more of the examples 1 to 11 and, optionally, wherein the expandable members are securely coupled with directly or indirectly with the support.

[0064] Example 13 includes the subject matter of any one or more of the Examples 1 to 12 and, optionally, further comprises at least one user control interface for controlling expansion and contraction of each one of the plurality of members.

[0065] Example 14 includes the subject matter of any one or more of the Examples 1 to 13 and, optionally, wherein each one of the plurality members is equipped with a user control interface for controlling expansion and contraction thereof.

[0066] Example 15 includes the subject matter of any one or more of the Examples 1 to 14 and, optionally, further comprises a fluid delivery apparatus including at least one conduit that is in fluid communication with the plurality of expandable members to allow selectively and individually cause expansion or collapsing of the members; a pump operable to deliver fluid to the expandable members the conduit and to withdraw fluid from the expandable members; and a controller for controlling operation of the pump.

[0067] Example 16 pertains to a fetus positioning system comprising: a fetus positioning device according to any one or more of the preceding claims; a fetus imaging apparatus for acquiring image data descriptive of a fetus carried by the pregnant female subject; a memory operable to receive the image data; a processor operable to generate, based on the acquired image data, a control signal for controlling expansion and contraction of the plurality of expandable members. [0068] Example 17 includes the subject matter of Example 16 and, optionally, a display device, wherein the memory and processor are further operable to display, based on the acquired image data, images via the display device.

[0069] Example 18 includes the subject matter of Examples 16 or 17 and, optionally, wherein the imaging apparatus comprises an ultrasonography imaging apparatus.

[0070] Example 19 includes the subject matter of any one or more of the Examples 16 to 18 and, optionally, wherein the processor and the memory are operable to perform the following steps: determining, based on the acquired image data, a fetal position in the female subject; and, if the fetus not in the desired position, providing, based on the acquired image data, a control signal for controlling the pump to controllably and adaptively apply, via the plurality of members, pressure onto the female subject's abdomen to cause positioning a fetus in the female from the undesired into a desired position.

[0071] Example 20 includes the subject matter of any one or more of the Examples 16 to 19 and, optionally, wherein the processor and the memory are operable to perform the following steps: adaptively pressurizing or depressurizing the plurality of expandable members to cause positioning a fetus from the undesired into a desired position.

[0072] Example 21 includes the subject matter of Examples 19 or 20 and, optionally, wherein the undesired fetal position includes breech presentation, and the desired fetal position includes cephalic presentation.

[0073] Example 22 includes the subject matter of any one or more of the Examples 16 to 21 and, optionally, wherein an output provided by the pressure sensors is used for determining the amount of pressure that is applied onto the female subject.

[0074] Example 23 includes the subject matter of any one or more of the Examples 16 to 22 and, optionally, wherein an output provided by the pressure sensors is used for determining the amount of pressure that is to be applied for positioning the fetus in the desired position.

[0075] Example 24 pertains to a method for positioning a fetus in a subject, comprising: acquiring an image of a fetus in a subject by a fetus imaging apparatus; determining a position of a fetus in the subject by a fetus position analyzer and control engine; if it is determined that the fetus is in an undesired position: controllably expanding at least one of a plurality of expandable members for applying, by the at least one expandable member, pressure onto the abdomen of the human subject for positioning the fetus in a desired position.

[0076] Example 25 includes another method for positioning a fetus in a subject, the method comprising:

[0077] acquiring an image of a fetus in a subject;

[0078] detecting that the fetus in the subject is in an undesired position; and

[0079] (e.g., controllably) expanding at least one of a plurality of expandable members for positioning the fetus in a desired position. The method may also include controllably reducing (e.g., through deflation), at least one of a plurality of expandable members for positioning the fetus in a desired position.

[0080] Example 26 includes a fetus positioning system comprising:

[0081] a fetus positioning device according to any one or more of the preceding examples 1 to 15;

[0082] a fetus monitoring apparatus for acquiring data descriptive of a position or presentation of a fetus carried by a pregnant female subject;

[0083] a memory operable to receive the data;

[0084] a processor operable to generate, based on the acquired data, a control signal for controlling expansion and contraction of the plurality of expandable members to reposition the fetus.

[0085] Example 27 includes the subject matter of example 26 and, optionally, a display device configured to display information relating to the data.

[0086] Example 28 includes the subject matter of example 26 and/or example 27 and, optionally, wherein the monitoring apparatus comprises an ultrasonography imaging apparatus. [0087] Example 29 includes the subject matter of any one or more of the examples 26 to 28 and, optionally, wherein the processor and the memory are operable to perform the following steps:

[0088] determining, based on the acquired data, a fetal position in the female subject; and

[0089] providing, based on the acquired image data, a control signal for controlling the pump to controllably and adaptively apply, via the plurality of members, pressure onto the female subject's abdomen to cause positioning a fetus in the female from the undesired into a desired position.

[0090] Example 30 includes the subject matter of any one or more of the examples 26 to 29 and, optionally, wherein the processor and the memory are operable to perform the following steps:

[0091] adaptively pressurizing or depressurizing the plurality of expandable members to cause positioning a fetus from the undesired into a desired position.

[0092] Example 31 includes the subject matter of example 29 and/or example 30, wherein the undesired fetal position includes breech presentation, and the desired fetal position includes cephalic presentation.

[0093] Example 32 includes the subject matter of any one or more of the Examples 26 to 31, wherein an output provided by the pressure sensors is used for determining the amount of pressure that is applied onto the female subject.

[0094] Example 33 includes the subject matter of any one or more of the examples 26 to 32, wherein an output provided by the pressure sensors is used for determining an amount and/or direction/or duration of the pressure that is to be applied for positioning the fetus in the desired position.

[0095] The modules, subsystems and/or systems described above may include various processing, storing, communication, display and/or input devices, software and/or hardware elements and/or a combination thereof. [0096] The methods and processes described above may be carried out via processing, storage, communication, display and/or input devices using respective software and/or hardware elements.

[0097] While the invention has been described with respect to a limited number of embodiments, these should not be construed as limitations on the scope of the invention, but rather as exemplifications of some of the embodiments.

[0098] Any digital computer system, unit, device, module and/or engine exemplified herein can be configured or otherwise programmed to implement a method disclosed herein, and to the extent that the system, module and/or engine is configured to implement such a method, it is within the scope and spirit of the disclosure. Once the system, module and/or engine are programmed to perform particular functions pursuant to computer readable and executable instructions from program software that implements a method disclosed herein, it in effect becomes a special purpose computer particular to embodiments of the method disclosed herein. The methods and/or processes disclosed herein may be implemented as a computer program product that may be tangibly embodied in an information carrier including, for example, in a non- transitory tangible computer-readable and/or non-transitory tangible machine-readable storage device. The computer program product may directly loadable into an internal memory of a digital computer, comprising software code portions for performing the methods and/or processes as disclosed herein.

[0099] Additionally or alternatively, the methods and/or processes disclosed herein may be implemented as a computer program that may be intangibly embodied by a computer readable signal medium. A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a non-transitory computer or machine-readable storage device and that can communicate, propagate, or transport a program for use by or in connection with apparatuses, systems, platforms, methods, operations and/or processes discussed herein. [0100] The terms "non-transitory computer-readable storage device" and "non- transitory machine-readable storage device" encompasses distribution media, intermediate storage media, execution memory of a computer, and any other medium or device capable of storing for later reading by a computer program implementing embodiments of a method disclosed herein. A computer program product can be deployed to be executed on one computer or on multiple computers at one site or distributed across multiple sites and interconnected by one or more communication networks.

[0101] These computer readable and executable instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks. These computer readable and executable program instructions may also be stored in a computer readable storage medium that can direct a computer, a programmable data processing apparatus, and/or other devices to function in a particular manner, such that the computer readable storage medium having instructions stored therein comprises an article of manufacture including instructions which implement aspects of the function/act specified in the flowchart and/or block diagram block or blocks.

[0102] The computer readable and executable instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer implemented process, such that the instructions which execute on the computer, other programmable apparatus, or other device implement the functions/acts specified in the flowchart and/or block diagram block or blocks

[0103] The term "engine" and "module" may comprise one or more computer modules, wherein a module may be a self-contained hardware and/or software component that interfaces with a larger system. [0104] A module or engine may comprise a machine or machines executable instructions. A module or engine may be embodied by a circuit or a controller programmed to cause the system to implement the method, process and/or operation as disclosed herein. For example, a module or engine may be implemented as a hardware circuit comprising, e.g., custom very large-scale integration (VLSI) circuits or gate arrays, an Application-specific integrated circuit (ASIC), off-the-shelf semiconductors such as logic chips, transistors, and/or other discrete components. A module or engine may also be implemented in programmable hardware devices such as field programmable gate arrays, programmable array logic, programmable logic devices and/or the like.

[0105] In the discussion, unless otherwise stated, adjectives such as "substantially" and "about" that modify a condition or relationship characteristic of a feature or features of an embodiment of the invention, are to be understood to mean that the condition or characteristic is defined to within tolerances that are acceptable for operation of the embodiment for an application for which it is intended.

[0106] Unless otherwise specified, the terms "substantially", "'about" and/or "close" with respect to a magnitude or a numerical value may imply to be within an inclusive range of -10% to +10% of the respective magnitude or value.

[0107] It is important to note that the method may include is not limited to those diagrams or to the corresponding descriptions. For example, the method may include additional or even fewer processes or operations in comparison to what is described in the figures. In addition, embodiments of the method are not necessarily limited to the chronological order as illustrated and described herein.

[0108] Discussions herein utilizing terms such as, for example, "processing", "computing", "calculating", "determining", "establishing", "analyzing", "checking", "estimating", "deriving", "selecting", "inferring" or the like, may refer to operation(s) and/or process(es) of a computer, a computing platform, a computing system, or other electronic computing device, that manipulate and/or transform data represented as physical (e.g., electronic) quantities within the computer's registers and/or memories into other data similarly represented as physical quantities within the computer's registers and/or memories or other information storage medium that may store instructions to perform operations and/or processes. The term determining may, where applicable, also refer to "heuristically determining".

[0109] It should be noted that where an embodiment refers to a condition of "above a threshold", this should not be construed as excluding an embodiment referring to a condition of "equal or above a threshold". Analogously, where an embodiment refers to a condition "below a threshold", this should not to be construed as excluding an embodiment referring to a condition "equal or below a threshold". It is clear that should a condition be interpreted as being fulfilled if the value of a given parameter is above a threshold, then the same condition is considered as not being fulfilled if the value of the given parameter is equal or below the given threshold. Conversely, should a condition be interpreted as being fulfilled if the value of a given parameter is equal or above a threshold, then the same condition is considered as not being fulfilled if the value of the given parameter is below (and only below) the given threshold.

[0110] It should be understood that where the claims or specification refer to "a" or "an" element and/or feature, such reference is not to be construed as there being only one of those elements. Hence, reference to "an element" or "at least one element" for instance may also encompass "one or more elements".

[0111] Terms used in the singular shall also include the plural, except where expressly otherwise stated or where the context otherwise requires.

[0112] In the description and claims of the present application, each of the verbs, "comprise" "include" and "have", and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of components, elements or parts of the subject or subjects of the verb.

[0113] Unless otherwise stated, the use of the expression "and/or" between the last two members of a list of options for selection indicates that a selection of one or more of the listed options is appropriate and may be made. Further, the use of the expression "and/or" may be used interchangeably with the expressions "at least one of the following", "any one of the following" or "one or more of the following", followed by a listing of the various options. [0114] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments or example, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, example and/or option, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment, example or option of the invention. Certain features described in the context of various embodiments, examples and/or optional implementation are not to be considered essential features of those embodiments, unless the embodiment, example and/or optional implementation is inoperative without those elements.

[0115] It is noted that the terms "in some embodiments", "according to some embodiments", "according to some embodiments of the invention", "for example", "e.g.", "for instance" and "optionally" may herein be used interchangeably.

[0116] The number of elements shown in the Figures should by no means be construed as limiting and is for illustrative purposes only.

[0117] It is noted that the terms "operable to" can encompass the meaning of the term "modified or configured to". In other words, a machine "operable to" perform a task can in some embodiments, embrace a mere capability (e.g., "modified") to perform the function and, in some other embodiments, a machine that is actually made (e.g., "configured") to perform the function.

[0118] Throughout this application, various embodiments may be presented in and/or relate to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the embodiments. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. [0119] The phrases "ranging/ranges between" a first indicate number and a second indicate number and "ranging/ranges from" a first indicate number "to" a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals there between.