Puerpera monitoring system and method

Abstract

An ultrasound system includes: a flexible substrate configured to be held on an abdomen of a puerpera patient; a transducer array disposed on the flexible substrate and configured to acquire scan data; and a control system. The transducer array includes a plurality of transducer elements distributed across a transducer region sized to image the entire uterus of the puerpera patient. The control system is configured to operate the transducer array to acquire the scan data of the entire uterus of the puerpera patient at predetermined intervals and to generate a uterus image of the entire uterus based on the scan data.

Description

Background Technology

[0001] This disclosure relates generally to medical monitoring and imaging, and more specifically to systems and methods for monitoring postpartum hemorrhage (PPH) in parturient patients.

[0002] Postpartum hemorrhage (PPH), resulting in severe vaginal bleeding after delivery, is a leading cause of maternal mortality. PPH can occur in the early postpartum period (i.e., within the first 24 hours) or the late postpartum period (i.e., 24 hours or more after delivery). The primary cause of PPH is uterine atony (i.e., the inability of the uterus to contract after delivery). Trauma such as lacerations of the uterus, cervix, or vagina can also cause PPH. Retained placenta or clots can also cause PPH. Furthermore, various placental-related causes, such as abnormal placental formation, including placenta accreta (PAS); congenital or acquired coagulopathy; and uterine inversion, can also lead to PPH. Currently, attempts are being made to prevent PPH through measures such as routine medication administration and avoiding delivery trauma (e.g., via episiotomy). Signs of PPH may include dizziness, fainting, and blurred vision. However, PPH is difficult to predict and can occur in postpartum patients without any risk factors. Summary of the Invention

[0003] This summary is provided to introduce a series of concepts that will be further described in the detailed embodiments below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to help limit the scope of the claimed subject matter.

[0004] In one aspect of this disclosure, an ultrasound system includes: a flexible substrate configured to be held on the abdomen of a postpartum patient; a transducer array disposed on the flexible substrate and configured to acquire scan data; and a control system. The transducer array includes a plurality of transducer elements distributed across a transducer region, the size of which is set to image the entire uterus of the postpartum patient. The control system is configured to operate the transducer array to acquire the scan data of the entire uterus of the postpartum patient at predetermined intervals, and to generate a uterine image of the entire uterus based on the scan data.

[0005] In one implementation, the control system is further configured to generate multiple uterine images of the entire uterus and to identify postpartum hemorrhage (PPH) indicators based on the multiple uterine images.

[0006] In another embodiment, the control system is further configured to compare the plurality of uterine images with a baseline image to identify the PPH index.

[0007] In another implementation, the PPH index is identified based on changes across the multiple uterine images.

[0008] In another embodiment, the PPH indicator includes the identification of at least one of uterine atony, retained placental tissue, or endometritis based on the plurality of uterine images.

[0009] In another embodiment, the control system is configured to control the transducer array so that different subsets of the transducer elements are fired sequentially to capture sub-aperture full matrix capture (FMC) data.

[0010] In another embodiment, FMC data from multiple subsets of transducer elements are used to generate the uterine image of the entire uterus.

[0011] In another embodiment, the flexible substrate is connected to a stretchable mesh configured to conform to the torso of the postpartum patient and hold the transducer array on the abdomen.

[0012] In another embodiment, the flexible substrate includes a patch configured to adhere to the abdomen.

[0013] In another embodiment, the transducer array is configured to image the entire uterus of the parturient patient from a location on the abdomen of the parturient without being moved, wherein the transducer array includes a width number of elements distributed across the width of the transducer region and a height number of transducer elements distributed across the height of the transducer region, wherein the width of the transducer region is greater than the height of the transducer region.

[0014] In another embodiment, the transducer region is configured to image an area within the patient's body large enough to span the entire uterus. Optionally, the transducer region may have, for example, a width of about 20 cm, a height of about 30 cm, and a depth of about 20 cm.

[0015] In another aspect of this disclosure, a method for monitoring postpartum hemorrhage (PPH) in a postpartum patient includes controlling a transducer array of an ultrasound system to acquire scan data of the entire uterus of the postpartum patient. The transducer array includes a plurality of transducer elements located on a flexible substrate configured to be held on the abdomen of the postpartum patient. The plurality of transducer elements are distributed across a transducer region sized to image the entire uterus of the postpartum patient without moving the transducer array from its position on the outer surface of the postpartum patient's abdomen. The method also includes generating at least one uterine image of the entire uterus based on the scan data, and identifying postpartum hemorrhage (PPH) indicators based on the at least one uterine image of the entire uterus.

[0016] In one implementation, the method further includes generating multiple uterine images of the entire uterus and identifying the postpartum hemorrhage (PPH) indicator based on the multiple uterine images.

[0017] In another embodiment, the method further includes comparing the plurality of uterine images with a baseline image to identify the PPH index.

[0018] In another embodiment, the method further includes determining changes across the plurality of uterine images, wherein the PPH index is identified based on these changes.

[0019] In another embodiment, the PPH indicator includes the identification of at least one of uterine atony, retained placental tissue, or endometritis based on at least one uterine image of the entire uterus.

[0020] In another embodiment, the method further includes automatically controlling the transducer array to acquire scan data of the entire uterus of the parturient patient at a first predetermined interval, and generating at least one uterine image of the entire uterus at the predetermined interval to generate multiple uterine images, wherein the PPH index is identified based on the multiple uterine images.

[0021] In another embodiment, the method further includes adjusting the predetermined interval of image acquisition to a second predetermined interval in response to identifying the PPH index for subsequent acquisition of the scan data of the entire uterus, wherein the second predetermined interval is shorter than the first predetermined interval.

[0022] In another embodiment, controlling the transducer array further includes activating a subset of the transducer elements among the plurality of transducer elements to capture sub-aperture full matrix capture (FMC) data, and the method further includes generating the image of the entire uterus based on the FMC data captured by the plurality of different subsets of transducer elements.

[0023] In another embodiment, the transducer array includes a plurality of subsets of transducer elements between a first side and a second side of the transducer region, wherein the subset of activated transducer elements includes each subset of the plurality of subsets of transducer elements that are sequentially activated between the first side and the second side.

[0024] Various other features, objects, and advantages of the invention will become apparent from the following description taken in conjunction with the accompanying drawings. Attached Figure Description

[0025] This disclosure is described with reference to the following figures.

[0026] Figure 1 It is an implementation scheme of the block diagram of the ultrasound system according to various aspects of this disclosure.

[0027] Figures 2 to 4 This is a schematic diagram of one embodiment of a transducer array according to various aspects of this disclosure.

[0028] Figure 5A The present disclosure illustrates a device worn on a postpartum patient and includes a device positioned around the abdomen of the postpartum patient. Figure 2 An exemplary ultrasound system with a band of transducer arrays.

[0029] Figure 5B It is a device worn on the body of a postpartum patient according to various aspects of this disclosure, including one positioned on the abdomen of the postpartum patient. Figure 2 Another illustration of another exemplary ultrasound system with a patch of transducer arrays.

[0030] Figure 6 This is a schematic diagram of a diagnostic system including an ultrasound system as part of one embodiment of the present disclosure.

[0031] Figure 7 This is a schematic diagram of a neural network classifier trained to detect one or more PPH metrics according to one embodiment of the present disclosure.

[0032] Figure 8 This is a schematic diagram illustrating the construction of an exemplary trained neural network according to the present disclosure.

[0033] Figure 9 This is a flowchart of a method for monitoring postpartum hemorrhage (PPH) in postpartum patients.

[0034] Figure 10 This is another flowchart of a method for monitoring postpartum hemorrhage (PPH) in postpartum patients. Detailed Implementation

[0035] In this description, certain terms are used for the purpose of brevity, clarity, and ease of understanding. No unnecessary limitations should be inferred from these terms beyond the requirements of the prior art, as they are used for descriptive purposes only and are intended to be understood in a broad sense.

[0036] As used herein, unless otherwise limited or restricted, discussions of specific orientations are provided by way of example only for particular embodiments or related illustrations. For instance, discussions of “top,” “bottom,” “front,” “back,” “left,” “right,” “horizontal,” “vertical,” and “longitudinal” features and / or relative movements (e.g., “upward” and “downward” movement) are generally intended only to describe the orientation of such features relative to a reference frame of a particular example or illustration. Accordingly, for example, in some arrangements or embodiments, a “top” feature may sometimes be positioned below a “bottom” feature (etc.). Alternatively or additionally, embodiments may be arranged with different orientations such that the “top” and “bottom” features are arranged horizontally relative to each other, for example, in a “left-to-right” orientation.

[0037] The terms “comprising,” “including,” or “having,” as used herein, and variations thereof, are intended to cover the elements listed thereafter and their equivalents, as well as any additional elements. An embodiment described as “comprising,” “including,” or “having” certain elements is also considered to be “substantially composed of those certain elements” and “composed of those certain elements.”

[0038] As used herein, the term controller or module may refer to, be part of, or include: application-specific integrated circuits (ASICs); electronic circuits; combinational logic circuits; field-programmable gate arrays (FPGAs); processors (shared processors, dedicated processors, or group processors) that execute code; or other suitable components that provide the aforementioned functionality; or combinations of some or all of the foregoing, such as in a system-on-a-chip. The term controller or module may include memory (shared memory, dedicated memory, or group memory) storing code executed by a processor. As used herein, the term code may include software, firmware, and / or microcode, and may refer to programs, routines, functions, classes, and / or objects. The term shared, as used above, means that some or all of the code from multiple modules can be executed using a single (shared) processor. Additionally, some or all of the code executed by multiple different processors may be stored in a single (shared) memory. The term group, as used above, means that a group of processors can be used to execute some or all of the code comprising a portion of a single controller or module. Similarly, a group of memories can be used to store some or all of the code comprising a single controller or module.

[0039] This document describes aspects of the disclosure in terms of functional and / or logical block components and various processing steps. It should be understood that such block components can be implemented by any number of hardware, software, and / or firmware components configured to perform specified functions. For example, one embodiment may employ various integrated circuit components (e.g., memory elements, digital signal processing elements, logic elements, lookup tables, etc.) that can perform various functions under the control of one or more processors or other control devices. Furthermore, those skilled in the art will understand that one or more of the disclosed inventions can be implemented in conjunction with any number of medical devices, including any number of different physiological data acquisition devices, and the system described herein is merely an exemplary application. The connecting lines shown in the various figures included herein are intended to represent exemplary functional relationships and / or physical couplings between various components. It should be noted that in actual embodiments, many alternative or additional functional relationships or physical connections may exist.

[0040] Postpartum hemorrhage (PPH) is a leading cause of maternal death worldwide. The inventors have recognized that while risk factors for PPH are known, a comprehensive system for assessing multiple risk factors and identifying high-risk patients does not exist. Although risk factors for uterine atony, endometritis, placenta accreta (PAS), and retained placental tissue are known, the diagnosis of PPH usually occurs after the patient has gone to the hospital due to massive hemorrhage, i.e., after PPH has already occurred.

[0041] In view of the above, the inventors have strived to develop a system for actively monitoring parturient patients and identifying patients at high risk of PPH. In one aspect of this disclosure, an ultrasound system is worn that periodically scans the parturient patient to generate images of the patient's uterus. The uterine images are then compared to baseline images to identify the presence of uterine atony, retained placental tissue, and / or endometritis. Identification of risk factors for PPH can alert caregivers and patients to the need for enhanced monitoring and awareness of PPH risk, enabling caregivers to take early intervention measures to prevent PPH or mitigate its effects.

[0042] Figure 1A high-level view depicts the components of an ultrasound system 10 that can be employed according to the method of the invention. The ultrasound system 10 shown includes a transducer array 14 (e.g., an array of transducer elements arranged together as a single transducer) having transducer elements (e.g., piezoelectric crystals) adapted to contact a subject or postpartum patient 18 during the imaging process. The transducer array 14, including the transducer elements, can be fabricated by assembling individual transducer crystals, or it can be a thin-film array fabricated by a thin-film deposition process. Each transducer element in the transducer array 14 can be individually triggerable for transmitting and / or receiving. The transducer array 14 can be configured as a bidirectional transducer capable of transmitting and receiving ultrasound waves into and from the subject or postpartum patient 18. In such a specific implementation, in transmit mode, the transducer array elements convert electrical energy into ultrasound waves and transmit these ultrasound waves into the postpartum patient 18. In receive mode, the transducer array elements convert the ultrasound energy (backscattered waves) received from the patient 18 into electrical signals (or scan data).

[0043] Each transducer element in transducer array 14 is associated with a corresponding transducer circuit, which may be provided as one or more application-specific integrated circuits (ASICs) 20, which (although depicted external to transducer array 14) may house transducer array 14 (e.g., in the same housing as the transducer array). That is, each transducer element in transducer array 14 is electrically connected to a corresponding pulse generator 22, transmit / receive switch 24, preamplifier 26, scan gain 34, and / or as part of or disposed on the ASIC 20. In other embodiments, this arrangement may be simplified or otherwise modified. For example, components shown in the integrated circuit 20 may be positioned upstream or downstream of the depicted arrangement; however, the basic functions depicted will generally still be provided for each transducer element. In the depicted example, the referenced circuitry is conceptualized as being implemented on a single ASIC 20 (indicated by dashed lines); however, in other embodiments, some or all of these functions may be provided on the same or different integrated circuits. The transducer circuit can be used to control the switching of the transducer elements. The transducer circuit can also be used to group the transducer elements into one or more sub-apertures (e.g., in response to a control signal from the control system 36).

[0044] Similarly, Figure 1The depicted ultrasound system 10 provides a variety of other imaging components to enable image formation. Specifically, examples of the depicted ultrasound system 10 also include a beamformer 32, a control system 36, a receiver 38, and a scan converter 40, which cooperate with the transducer circuitry to generate an image or a series of images 42, which may be stored and / or displayed to an operator or otherwise processed as discussed herein. The transducer array 14 can be connected via a wired or wireless connection (e.g., via a wireless communication unit as part of the transducer array communicating over a Wi-Fi network). The ultrasound data is transmitted to the beamformer using technology or some other means. The control system 36 for the ultrasound system 10 includes at least one hardware controller having a processing unit 44 (e.g., a microprocessor) and a memory unit 46, configured to execute stored routines to process the acquired ultrasound signals to generate meaningful images and / or motion frames of the entire uterus, which can be displayed on the display 47 of the ultrasound system 10. The control system 36 (e.g., in response to movement of the parturient patient) can utilize one or more algorithms (e.g., stored in the memory unit 46) to change the focus position of the transducer elements and / or to trigger the firing sequence (timing) of the transducer elements. As described below, the control system 36 can utilize a trained machine learning model stored in the memory unit 46 to compare the generated ultrasound images with baseline ultrasound images (e.g., images of a healthy uterus). The processing unit can use this comparison to identify the presence of PPH indicators, such as uterine atony, retained placental tissue, or endometritis. Once multiple ultrasound images have been acquired, the control system 36 can then identify the presence of the PPH index by comparing the multiple uterine images and checking whether there are changes in the uterine images that indicate the presence of the PPH index.

[0045] Ultrasound information can be processed by other or different mode-related modules (e.g., B-mode, color Doppler, power Doppler, M-mode, spectral Doppler anatomical M-mode, strain, strain rate, etc.) to form 2D or 3D datasets such as image frames. For example, one or more modules can generate B-mode, color Doppler, power Doppler, M-mode, anatomical M-mode, strain, strain rate, spectral Doppler image frames, and combinations thereof. Image frames are stored, and timing information indicating the time of acquisition of the image frame in memory can be recorded for each image frame. These modules may include, for example, a scan conversion module for performing scan conversion operations, thereby converting the image frame from polar coordinates to Cartesian coordinates. A video processor module may be provided that reads image frames from memory and displays image frames in real time during surgery on a patient. The video processor module can store image frames in an image memory, read from and display images from that image memory. The ultrasound system 10 shown may include a console system or a portable system, such as a handheld or knee-mounted system.

[0046] The ultrasound system 10 is operable to acquire ultrasound scan data continuously or at predetermined intervals at a frame rate suitable for the imaging situation. Typical frame rates range from 20 fps to 120 fps, but can be lower or higher. The acquired ultrasound scan data can be displayed on the monitor 47 at the same, slower, or faster display rate as the frame rate. An image buffer may be included to store processed frames of acquired ultrasound scan data that are not scheduled for immediate display. Preferably, the image buffer has sufficient capacity to store frames of ultrasound scan data for at least several minutes. Frames of ultrasound scan data are stored in a manner that facilitates retrieval based on their acquisition order or time. The image buffer can be embodied in any known data storage medium. It is noteworthy that, since the uterus does not move rapidly, the frame rate used for imaging the uterus may be relatively low. For example, the frame rate could be one image every few seconds, or even once every few minutes.

[0047] Display 47 can be any device capable of transmitting visual information to a user. For example, display 47 may include a liquid crystal display, a light-emitting diode (LED) display, and / or any suitable one or more displays. Display 47 is operable to present ultrasound images and / or any suitable information.

[0048] The components of the ultrasonic system 10 can be implemented in software, hardware, firmware, etc. The various components of the ultrasonic system 10 can be communicatively connected. The components of the ultrasonic system 10 can be implemented individually and / or integrated in various forms.

[0049] Figure 2This is a schematic diagram of one embodiment of a transducer array 14 (e.g., working together to form a single ultrasonic transducer system). Here, the transducer array 14 includes a flexible substrate 48 and a flexible array 50 formed of transducer elements 52 (e.g., piezoelectric crystals) connected together on or through the flexible substrate 48. The transducers can be fabricated by assembling individual transducer crystals onto the flexible substrate 48, or they can be a thin-film array fabricated by a thin-film deposition process. In some embodiments, the transducer elements 52 may be made of lead zirconate titanate (PZT). In various embodiments, the flexible substrate 48 may be formed of any of a variety of flexible biocompatible materials, such as silicone resins or polymers such as polypropylene, polyamide, polycarbonate, etc. The substrate may also be made of biocompatible fabrics (e.g., polyester) and / or organic fibers (e.g., cotton). The flexible substrate 48 may be stretchable, such as elastically deflecting over the mother's abdomen throughout labor and changing shape with the mother's abdomen. A variety of different materials are suitable for this substrate, including ferroelectric polymers from the PVDF material family.

[0050] The number of transducer elements 52 forming the flexible array 50 can range from 10 to 100 or more. During operation, the transducer elements 52 are used to acquire data for imaging the entire uterus of the parturient patient and / or to identify one or more indicators of postpartum hemorrhage (PPH), such as uterine atony, retained placental tissue, or the presence of endometritis. Different subsets of the transducer elements 52 (e.g., two or more transducer elements 52, but fewer than the total number of transducer elements 52 forming the flexible array 50) are sequentially triggered or fired (i.e., to emit ultrasound). Thus, a subset of the transducer elements 52 may be fired or triggered, then different subsets of the transducer elements 52 may be fired or triggered, and the firing sequence continues until every transducer element in the transducer elements 52 has been fired or triggered. In some embodiments, the data is acquired using sub-aperture full matrix capture (FMC). In some implementations, transducer elements 52 can be fired or triggered individually and sequentially (as opposed to subsets). Different subsets may have the same number of transducer elements 52, or the number of transducer elements 52 comprising subsets may differ. All transducer elements 52 of the flexible array 50 receive ultrasound energy returned from the patient. For example, suppose six transducer elements 52 form a subset 53 of transducer elements 52, and transducer element 55 in subset 53 emits ultrasound waves; then transducer element 55, the remainder of the subset 53, and all transducer elements 52 outside subset 53 receive ultrasound energy returned from the patient. The depicted layout of transducer elements 52 is scaled in two dimensions (2D). This use of transducer elements 52 ensures sufficient depth of field for Doppler measurements to enable the measurement of postpartum hemorrhage (PPH) indicators. As described in more detail below, acquiring scan data according to the sequential firing of transducer elements enables the localization of PPH indicators within the uterus.

[0051] like Figure 3 As depicted, the flexible substrate 48 may be part of a single flexible band 54 configured to be positioned around the patient's abdomen (e.g., such as...). Figure 5A A flexible band 54 is disposed around the abdomen 56 of the postpartum patient 18. A flexible substrate 48 may be part of or coupled to the flexible band 54. A transducer array 14 is disposed on the inner surface of the band 54 and oriented such that the transducer elements 52 face the abdomen. The band 54 may be designed to make the patient comfortable. For example, the flexible band 54 may be a flexible band made of a stretchable mesh material, such as an elastic band, etc. Figure 4As shown (e.g., similar to materials used in postpartum underwear), the material is thin, soft, breathable, and cool. The flexible band 54 can also be elastic to accommodate patients of different body types. In some embodiments, the flexible band 54 may have full openings 58, 60 at corresponding ends 62, 64 (e.g., upper and lower ends) to allow the flexible band 54 to slide along the patient's body until it is positioned around the abdomen. In some embodiments, the flexible band 54 may be adjustable to fit and wrap around the patient's abdomen (e.g., similar to an abdominal binder) and secured via fasteners (e.g., hook and loop fasteners).

[0052] In other embodiments, the transducer array 14 can be attached to and held on the mother's abdomen by other means. For example, such as... Figure 5B As shown, the flexible substrate 48 may be part of a patch 59 adhered to the abdomen 56 of the mother patient 18. The patch 59 is configured to remain adhered to the abdomen 56 as it changes shape throughout labor. The patch 59 may be made of a flexible material on which the flexible substrate 48 is mounted or otherwise embedded. For example, the patch 59 may comprise a flexible foam material configured to expand and contract to allow movement of the flexible substrate 48 to adapt to the changing shape of the mother's abdomen throughout labor. Alternatively, the patch may be made of a flexible substrate material and thus integral with the flexible substrate 48, such that the transducer element 52 is mounted on the substrate material of the patch. The patch 59 is configured to hold the transducer region 56 in sufficient contact with the skin of the mother's abdomen to enable ultrasound imaging of the entire uterus described herein by the transducer array 14.

[0053] Patch 59 can be adhered to the skin of the postpartum woman's abdomen via a biocompatible adhesive such as a pressure-sensitive adhesive (PSA), made of materials such as acrylic, silicone, and rubber. Patch 59 may have adhesive on its outer edge or on the portion surrounding the transducer region. Patch 59 may have adhesive strategically placed around the transducer region 56 and is configured to facilitate the flexible substrate 48 as the postpartum patient's abdomen flexes. For example, patch 59 may have adhesive on its sides, outside the transducer region 56, and adjacent to sides 68 and 70 (see [link to relevant documentation]). Figure 4 Alternatively or otherwise, patch 59 may include adhesive at strategic and intermittent locations, such as centered above and below transducer region 56 and / or centered above and below sides 68 and 70 of transducer region 56, along the top and bottom edges above and below transducer region 56, to keep the transducer array against the mother's abdomen so that imaging can continue throughout and after delivery.

[0054] like Figure 4 As shown, transducer elements 52 are distributed on transducer region 66. Transducer region 66 is the area on a flexible substrate occupied by the transducer elements and is configured to image the entire uterus of the patient from a location on the skin surface of the mother's abdomen without being moved. Since transducer region 66 remains constant, while the size of the mother's uterus varies from patient to patient, transducer region 66 is configured such that uteri of different sizes can be fully imaged when transducer array 14 is placed on the patient. Therefore, transducer region 66 is configured to image areas large enough to span the entire uterus of the patient, such as via beam control, without moving or repositioning transducer array 14 on the skin surface of the mother's abdomen. Adjusting the focus position of transducer elements 52 and / or changing the firing sequence (e.g., timing) of transducer elements 52 allows transducer region 66 to remain constant while the uterine region of the size to be determined varies from patient to patient.

[0055] Transducer region 66 is a region on a flexible substrate occupied by a plurality of transducer elements 52 and having a first side 68 and an opposing second side 70. For example, the plurality of transducer elements may be assembled as individual transducer crystals, or may be a thin-film array fabricated by a thin-film deposition process. Transducer region 66 exemplarily has a width of approximately 15 cm and a height of approximately 10 cm between the first side 68 and the second side 70, but other combinations of width and height will be apparent to those skilled in the art. In various embodiments, the transducer region may be at least 10 cm wide, such as between 10 cm and 20 cm, and at least 5 cm high, such as between 5 cm and 10 cm (or higher, such as 15 cm). In one such embodiment, transducer region 66 may comprise an array of transverse 512 elements (distributed across width) and longitudinal 64 elements (distributed across height). In some embodiments, the transducer elements 52 are fired sequentially from the first side to the second side to image the entire uterus. The transducer region 66 may be smaller than the area to be imaged within the patient's body. The area to be imaged within the patient's body may have, for example, a width of about 20 cm, a height of about 30 cm, and a penetration depth of about 20 cm, and the transducer array 14 is configured to emit ultrasound waves to penetrate the abdomen to reach the appropriate area and depth to image an area within the patient's body spanning the entire uterus.

[0056] The ultrasound system 10 can be configured such that ultrasound images are evaluated and converted into data that can be used to assess PPH, including the identification of one or more PPH indicators. In some embodiments, PPH indicators can be identified by a physician or other clinician who evaluates the ultrasound images and manually enters information indicating whether various PPH factors (such as those listed herein) are positive or negative. Alternatively, the ultrasound system 10 can be configured to automatically process ultrasound images to identify one or more PPH indicators. Figure 6 One embodiment is shown in which ultrasound image 42 is sent to computer 310, which is configured to process the image using software configured to detect PPH indications. Diagnostic system 300 may include a software-based neural network 302, which may be in the form of program code residing in the memory of computer 310. Diagnostic system 300 is operable to identify PPH indications, such as uterine atony, endometritis, or retained placental tissue. First module 304 may output a 3-D model of a portion of the patient's anatomy (specifically, the uterus of a parturient patient) to computer 310 for data processing via neural network 302. Second module 306 may include a database of anatomical datasets or models, and may output one or more of these models to computer 310 for processing by neural network 302. That is, the 3-D model can be compared with the model database via neural network 302. Neural network 302 can then return a diagnosis based on this comparison. Data processing may provide one or more of visual output, auditory output, and diagnosis 308 via a suitable visual display (e.g., display 47).

[0057] Figure 7An embodiment of a neural network classifier 322 with multiple outputs 323a, 323b, 323c, 323d (e.g., binary outputs, where each output is "1" or "0", where "1" corresponds to "yes" and "0" corresponds to "no") is shown. In this neural network classifier, each output 323a, 323b, 323c, 323d represents the response of the neural network 302 to a specific input set containing one or more PPH indicators. For example, one output 323a may represent the normal state of the absence of a PPH indicator, while another output 323b may represent the response to the presence or absence of uterine atony. In either case, if the indicator is detected, the output state of the corresponding indicator will be "1", otherwise "0". Similarly, the neural network 302 may output the appropriate state of other PPH indicators such as retained placental tissue 323c or endometritis 323d. The input to this neural network classifier is an image 330 of a patient's uterus and a database 328 of uterine image databases of healthy and diseased uteruses. The neural network 302 and classifier 322 can be significantly more complex or simpler, depending on the underlying model of the anatomical feature in question (i.e., the uterus). Alternatively or in addition, other outputs may be included for use with other PPH indicators, such as abnormal placental formation, for example, placenta accreta (PAS).

[0058] Figure 8 An embodiment of a construction 325 for a trained neural network 334 to detect one or more PPH indicators based on ultrasound images acquired from pregnant women is shown. A set of uterine images stored in a database 328 is formulated (e.g., by the methods described above or by any method used to generate ultrasound images of the uterus) to be used as training and testing data, which includes uterine images from subjects 326, including normal subjects and subjects exhibiting one or more PPH indicators. Construction 325 includes developing a supervised classifier using a labeled training set 324 of uterine images, which includes images of normal uteruses and images of abnormal uteruses containing one or more PPH indicators. The neural network 302 is trained with the training set 324, where each training image consists of data (e.g., 3-D ultrasound models) collected from one or more patients or test subjects, and where each image in the training set 324 is labeled, including a label indicating whether the PPH indicator is positive or negative and whether the patient from whom the image was obtained ultimately has PPH. The training set may also include prenatal images. Test set 327 is used to test neural network 302, such as to generate feedback for further training of neural network 302, so as to generate trained neural network 334.

[0059] The flexible band 54 is designed to be worn throughout and after labor, including during any or all of the pre-labor, intrapartum, and postpartum phases of labor. The flexible band 54 can be worn by the mother during the early stages of labor or before the onset of labor. The transducer array 14 then proceeds to image the entire uterus throughout labor. Postpartum, the flexible band 54 continues to be worn. The transducer array 14 continues to image the entire uterus, and repositioning of the flexible band 54 is not required. The flexible substrate 48 is configured to flex and adjust its shape as the mother's abdomen changes shape throughout the labor process (including postpartum). The flexible substrate 48 is configured to be attached to the mother's abdomen via the flexible band 54 or patch 59. The flexible substrate 48 is further configured to facilitate the movement and flexion of the transducer array 14, such that the transducer array 14 remains adequately positioned and substantially stationary on the mother's abdomen, so that the transducer array can continue to image the entire uterus throughout the labor and postpartum period, even as the shape of the mother's abdomen flexes and changes.

[0060] Figure 9 This is a flowchart of a method 600 for monitoring PPH in a parturient patient. In step 601, the transducer array of an ultrasound system is controlled to acquire scan data of the entire uterus of the parturient patient. The transducer array includes multiple transducer elements, such as transducer elements on a flexible substrate configured to be held in a static position on the abdomen of the parturient patient to acquire uterine images. Multiple transducer elements are distributed across a transducer region whose size is set to image the entire uterus of the patient without moving the transducer array. In step 603, at least one uterine image of the entire uterus is generated based on the scan data acquired in step 601. Finally, in step 605, PPH indicators, such as uterine atony, retained placental tissue, or the presence of endometritis, are identified based on at least one uterine image of the entire uterus.

[0061] Figure 10 This is a flowchart of method 700 for monitoring PPH in a parturient patient. At step 701, the transducer array of an ultrasound system is controlled to acquire scan data of the entire uterus of the parturient patient at first predetermined intervals. In some embodiments, controlling the transducer array further includes activating a subset of transducer elements among a plurality of transducer elements to capture sub-aperture full matrix capture (FMC) data, and generating an image of the entire uterus based on the FMC data generated from the plurality of different subsets of transducer elements. In some embodiments, the transducer array includes a plurality of subsets of transducer elements between a first and a second side of a transducer region, and controlling the transducer array further includes sequentially activating subsets of transducer elements between the first and second sides.

[0062] At step 703, multiple uterine images of the entire uterus are generated, such as ultrasound image 42 generated by ultrasound system 10 as described above. At step 705, the multiple uterine images are compared with a baseline image, which may be a generalized baseline depicting a healthy uterus or a patient-specific baseline, such as an image of the patient's uterus acquired at an earlier time. At step 707, changes are detected across multiple uterine images, such as between a first image of the entire uterus and one or more images captured later. At step 709, a PPH index is identified based on the comparison with the baseline image and the changes across the multiple uterine images. At step 711, a predetermined interval is adjusted to a second predetermined interval, wherein the second predetermined interval is shorter than the first predetermined interval, so that ultrasound imaging of the uterus occurs more frequently.

[0063] Figure 9 and Figure 10 The steps of the method described above are not limited to the order and sequence shown and described in the figures, and in various embodiments, these steps may be performed in a different order. Figure 9 or Figure 10 Some of the steps in the above method can be performed or carried out substantially simultaneously or in parallel where appropriate, in order to reduce delays and processing time.

[0064] This written description uses examples to disclose the invention, including the best mode, and also enables any person skilled in the art to perform and use the invention. Certain terms are used for the purposes of brevity, clarity, and ease of understanding. Unnecessary limitations should not be inferred from this description beyond the requirements of the prior art, as such terms are used for descriptive purposes only and are intended to be understood broadly. The patent scope of this invention is defined by the claims and may include other examples that may occur to a person skilled in the art based on the full scope of this disclosure. Such other examples are intended to be within the scope of the claims if they have features or structural elements that are not different from the literal language of the claims, or if they include equivalent features or structural elements that are not substantially different from the literal language of the claims.

Claims

1. An ultrasound system, the ultrasound system comprising: A flexible substrate configured to be held on the abdomen of a postpartum patient; A transducer array disposed on the flexible substrate and configured to acquire scan data, wherein the transducer array includes a plurality of transducer elements distributed across a transducer region, the size of which is set to image the entire uterus of the parturient patient. The control system includes at least one hardware controller and is configured to: Operate the transducer array to acquire scan data of the entire uterus of the parturient patient at predetermined intervals; and Based on the scan data, images of the entire uterus are generated at the predetermined intervals.

2. The system of claim 1, wherein the control system is further configured to generate multiple uterine images of the entire uterus and to identify postpartum hemorrhage (PPH) indicators based on the multiple uterine images.

3. The system of claim 2, wherein the control system is further configured to compare the plurality of uterine images with a baseline image to identify the PPH index.

4. The system of claim 2, wherein the PPH index is identified based on changes across the plurality of uterine images.

5. The system of claim 2, wherein the PPH index includes the identification of at least one of the following based on the plurality of uterine images: uterine atony, retained placental tissue, placenta accreta, or endometritis.

6. The system of claim 1, wherein the control system is configured to control the transducer array such that different subsets of the transducer elements are fired sequentially to capture sub-aperture full matrix capture (FMC) data.

7. The system of claim 6, wherein FMC data from a plurality of subsets of transducer elements are used to generate the uterine image of the entire uterus.

8. The system of claim 1, wherein the flexible substrate is connected to a stretchable mesh configured to conform to the torso of the postpartum patient and hold the transducer array on the abdomen.

9. The system of claim 1, wherein the flexible substrate includes a patch configured to adhere to the abdomen.

10. The system of claim 1, wherein the transducer array comprises a width number of elements distributed across the width of the transducer region and a height number of transducer elements distributed across the height of the transducer region, wherein the width of the transducer region is greater than the height of the transducer region.

11. The system of claim 10, wherein the width of the transducer region is at least 15 cm and the height of the transducer region is at least 5 cm.

12. A method for monitoring postpartum hemorrhage (PPH) in parturient patients, the method comprising: A transducer array of an ultrasound system is controlled to acquire scan data of the entire uterus of a parturient patient, wherein the transducer array includes a plurality of transducer elements located on a flexible substrate configured to be held on the abdomen of the parturient patient, and wherein the plurality of transducer elements are distributed across a transducer region whose size is set to image the entire uterus of the parturient patient. At least one uterine image of the entire uterus is generated based on the scan data; as well as Postpartum hemorrhage (PPH) indicators are identified based on at least one uterine image of the entire uterus.

13. The method of claim 12, further comprising generating a plurality of uterine images of the entire uterus, and identifying the postpartum hemorrhage (PPH) index based on the plurality of uterine images.

14. The method of claim 13, further comprising comparing the plurality of uterine images with a baseline image to identify the PPH index.

15. The method of claim 13, further comprising determining changes across the plurality of uterine images, wherein the PPH index is identified based on the changes.

16. The method of claim 12, wherein the PPH index includes the identification of at least one of uterine atony, retained placental tissue, placenta accreta, or endometritis based on the at least one uterine image of the entire uterus.

17. The method of claim 12, further comprising automatically controlling the transducer array to acquire scan data of the entire uterus of the parturient patient at a first predetermined interval, and generating at least one uterine image of the entire uterus at the first predetermined interval to generate a plurality of uterine images, wherein the PPH index is identified based on the plurality of uterine images.

18. The method of claim 17, further comprising, in response to identifying the PPH index, automatically controlling the transducer array to acquire the scan data of the entire uterus of the parturient patient at a second predetermined interval for subsequent acquisition of the scan data of the entire uterus, wherein the second predetermined interval is shorter than the first predetermined interval.

19. The method of claim 12, wherein controlling the transducer array further comprises activating a subset of the transducer elements among the plurality of transducer elements to capture sub-aperture full matrix capture (FMC) data, and wherein the image of the entire uterus is generated based on the FMC data captured by a plurality of different subsets of the transducer elements.

20. The method of claim 12, wherein the transducer array comprises a plurality of subsets of transducer elements between a first side and a second side of the transducer region, wherein activating a subset of transducer elements comprises each subset of the plurality of subsets of transducer elements that are sequentially activated between the first side and the second side.

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