Systems and methods for positioning ultrasonic patches

Abstract

The present invention provides a method and apparatus (300) for positioning an ultrasound patch on the surface of a subject. The apparatus includes a first fixing unit (210) and a second fixing unit (310) adapted to be fixed to the surface of the subject at a first position and a second position, respectively, with a space between them for the exposed surface of the subject. The apparatus also includes a retaining unit (260) for positioning the patch on the exposed surface of the subject within the space between the fixing units, the retaining unit being adapted to receive the ultrasound patch. The retaining unit is adapted to be coupled to the first and second fixing units at the surface of the subject, and when coupled to the first and second fixing units, the position of the retaining unit is adjustable relative to the first and second fixing units.

Description

Technical Field

[0001] This invention relates to the field of ultrasound imaging, and more particularly to the field of ultrasound imaging patches. Background Technology

[0002] Typically, ultrasound devices are probes operated by ultrasound specialists to capture the desired images. These probes are extremely useful for diagnosis, but less so for monitoring and visualization during procedures such as vascular access, CTO perforation, AV fistula, and below-knee (BTK) surgery. The main reason is that imaging must be performed in a hands-free manner to allow clinicians to perform the procedure.

[0003] Many different ultrasound patches have been designed for this purpose; however, while they have solved the problem of handheld imaging, various issues remain. For example, current ultrasound patches cannot provide the following: correction for minor patch misalignments during subject placement and movement during treatment / monitoring; creation of stable images over long monitoring periods; and handling of depth-of-focus variations for imaging vessels at different depths.

[0004] Small movements may occur during the placement of the ultrasound probe onto the subject's surface. Furthermore, during treatment, the skin will shift relative to blood vessels due to manipulation of the skin during device insertion and movement of the subject. Both can lead to less accurate final images and may even necessitate patch replacement.

[0005] Furthermore, the vessels that need to be imaged often vary in depth beneath the skin. Some vessels lie close to the skin, while in other areas, they are 50 mm or more below the skin surface. This requires varying depths of focus, which is currently not possible using a single standard probe. For this purpose, clinicians sometimes use gloves filled with US gel; however, this method is quite cumbersome.

[0006] Therefore, a more reliable positioning method and ultrasound probe are needed, especially an ultrasound patch that is located on the surface of the subject.

[0007] Document US 2010 / 0168577 discloses an apparatus for acquiring ultrasound-generated data from a patient, which includes a fixation system and a probe configured for connection to the fixation system. Summary of the Invention

[0008] This invention is defined by the claims.

[0009] According to an example of one aspect of the invention, an apparatus for positioning an ultrasound patch on the surface of a subject is provided, the apparatus comprising:

[0010] A first fixation unit, wherein the first fixation unit is adapted to be fixed to the surface of the subject at a first position;

[0011] The second fixation unit is adapted to be fixed to the surface of the subject at a second position different from the first position, and there is space between the first position and the second position for the subject's exposed surface;

[0012] A holding unit for positioning on the exposed surface of the subject within the space, wherein the holding unit is adapted to receive an ultrasound patch; and

[0013] The retaining unit is adapted to be connected to the first fixing unit and the second fixing unit at the surface of the subject, thereby fixing the retaining unit to the vicinity of the exposed surface of the subject, and when the retaining unit is connected to the first fixing unit and the second fixing unit, the position of the retaining unit relative to the first fixing unit and the second fixing unit is adjustable.

[0014] The device provides a hands-free ultrasound imaging method in which the position of the ultrasound transducer can be adjusted manually by the user or automatically by using a mechanical adjustment mechanism to fine-tune the captured image after the ultrasound image has been initially fixed to the subject.

[0015] In this way, the position of the ultrasound probe can be adjusted to compensate for errors during placement or subject movement without requiring a complete repositioning of the probe and holding unit.

[0016] By providing two separate fixation units suitable for being secured to a subject at two different locations, and having an exposed portion of the subject's surface between the two fixation units to receive a retention unit, the fixation units can be positioned to receive a retention unit of any suitable size. Furthermore, because the fixation units are positioned on either side of the retention unit, no clamping pressure is applied directly to the retention unit or the ultrasound patch (which could cause distortion of the patch and imaging area), thereby improving the imaging accuracy of the patch when used with the device.

[0017] In one embodiment, the position of the holding unit can be adjusted by one or more of the following:

[0018] Translation adjustment; and

[0019] Rotate to adjust.

[0020] In this way, the probe position can be adjusted in any way needed. The probe position can be adjusted within a plane tangent to the subject's surface, or within a plane tangent to the subject's surface.

[0021] In one embodiment, the device further includes a permanent fixation unit adapted to fix the retention unit to the surface of the subject such that the position of the retention unit cannot be changed.

[0022] In this way, once the correct location is found, the holding unit (and the ultrasound probe) can be fixed in place for long-term imaging.

[0023] In one embodiment, the device includes a temporary handle adapted to be removably connected to the holding unit.

[0024] In this way, a handle can be provided to improve the accuracy of placement and adjustment, and no handle is needed to retain part of the device when it is worn by the subject.

[0025] In another embodiment, the temporary handle is connected to the holding unit via a magnet.

[0026] In one embodiment, the holding unit includes a support portion adapted to adjust the distance between the ultrasonic transducer and the surface of the subject.

[0027] In this way, different depths of focus can be imaged using the transducer.

[0028] In another embodiment, the device further includes an ultrasonic patch having a transducer array, and a support portion having a window adjacent to the surface of the subject, the window including a first portion having a first width and a second portion having a second width located on either side of the first portion, wherein the first width is smaller than the second width, and the window is configured such that the transducer array is aligned with the window in use.

[0029] In another embodiment, the support portion includes a support material adapted for acoustic coupling between the ultrasonic transducer and the subject's surface. In this way, acoustic coupling can be improved.

[0030] In another embodiment, the support material includes a hydrogel material.

[0031] In this way, acoustic coupling can be maintained and sustained for long imaging periods.

[0032] In one embodiment, the first fixing unit and the second fixing unit each include:

[0033] Adhesive patches suitable for conforming to and adhering to the surface of a subject; and

[0034] The receiving unit includes a recessed portion adapted to receive the holding unit; and

[0035] The holding unit includes a protruding portion suitable for reception by the receiving unit.

[0036] According to an example of one aspect of the invention, an apparatus for positioning an ultrasound patch on the surface of a subject is provided, the apparatus comprising:

[0037] A first fixation unit, wherein the first fixation unit is adapted to be fixed to the surface of the subject at a first position;

[0038] The second fixing unit is adapted to be fixed to the surface of the subject at a second position different from the first position, and there is space between them for the exposed surface of the subject;

[0039] A holding unit for positioning within the space on the exposed surface of the subject, wherein the ultrasound patch is integrally formed with the holding unit; and

[0040] The retaining unit is adapted to be connected to the first fixing unit and the second fixing unit at the surface of the subject, and when the retaining unit is connected to the first fixing unit and the second fixing unit, the position of the retaining unit relative to the first fixing unit and the second fixing unit is adjustable.

[0041] According to an example of one aspect of the present invention, a method for positioning an ultrasound patch on the surface of a subject is provided, the method comprising:

[0042] The first fixation unit is fixed to the surface of the subject at the first position;

[0043] The second fixation unit is fixed to the surface of the subject at a second position different from the first position, and there is space between the first position and the second position for the subject's exposed surface;

[0044] Within the space, a holding unit suitable for holding the ultrasound patch is positioned on the exposed surface of the subject;

[0045] A retaining unit suitable for holding the ultrasonic transducer is connected to a first fixing unit and a second fixing unit at the surface of the subject, thereby fixing the retaining unit near the exposed surface of the subject; and

[0046] Adjust the position of the holding unit relative to the first fixed unit and / or the second fixed unit.

[0047] In one embodiment, adjusting the position of the holding unit includes one or more of the following:

[0048] Perform translation adjustments; and

[0049] Perform rotation adjustment.

[0050] In one embodiment, the holding unit includes a support portion adapted to adjust the distance between the ultrasound patch and the subject's surface, and adjusting the position of the holding unit further includes providing a support material to the support portion, the support material being adapted to provide acoustic coupling between the ultrasound patch and the subject's surface.

[0051] In one embodiment, the method further includes securing the holding unit to the surface of the subject after adjusting the position of the holding unit.

[0052] According to an example of one aspect of the present invention, an ultrasonic patch is provided, comprising:

[0053] The first array group includes a primary transducer array having a first orientation; and

[0054] The second array group includes at least two secondary transducer arrays, wherein each secondary transducer array has an orientation different from the first orientation.

[0055] The second array group is arranged such that at least two secondary transducer arrays are positioned on either side of the primary transducer array.

[0056] Ultrasonic patches offer a way to capture multiple image streams, each suitable for a different purpose. In other words, ultrasonic patches provide a multi-functional image capture method within a single unit, meaning that ultrasonic patches do not need to be swapped on a function-by-function basis. Therefore, ultrasonic patches offer a more efficient workflow.

[0057] In one embodiment, at least two secondary transducer arrays have the same orientation.

[0058] In another embodiment, at least two secondary transducer arrays are perpendicular to the primary transducer array.

[0059] In this way, ultrasound data can be captured in two planes set on either side of the primary vertical plane, thus providing a cross-sectional view on either side of the primary imaging plane.

[0060] In one embodiment, at least two secondary transducer arrays have different orientations.

[0061] In one embodiment, the first array group includes a plurality of primary transducer arrays.

[0062] In this way, multiple views can be captured in the first orientation without repositioning the ultrasound patch.

[0063] In one embodiment, the first array group is adapted to capture preliminary ultrasound data for locating an ultrasound patch.

[0064] In one embodiment, the second array group is adapted to capture preliminary ultrasound data for locating ultrasound patches.

[0065] In this way, the position of the holding unit can be adjusted based on the incoming ultrasound data, without having to activate all array groups at once.

[0066] In one embodiment, the primary transducer array and at least two secondary transducer arrays include a CMUT.

[0067] In one embodiment, the ultrasound probe includes a flip-chip connection.

[0068] In this way, the components of the ultrasonic transducer array can be directly bonded to the PCB or flexible circuit of the ultrasonic probe, thereby reducing the amount of space between transducer components and improving the coverage of the transducer array.

[0069] According to an example of one aspect of the invention, a system for positioning an ultrasound probe on the surface of a subject is provided, the system comprising:

[0070] The ultrasonic patch as described above; and

[0071] A device for positioning an ultrasound patch on the surface of a subject, the device comprising:

[0072] A first fixation unit, wherein the first fixation unit is adapted to be fixed to the surface of the subject at a first position;

[0073] A second fixation unit, wherein the second fixation unit is adapted to be fixed to the surface of the subject at a second position different from the first position;

[0074] Holding unit, wherein the holding unit is adapted to receive ultrasonic patch; and

[0075] The retaining unit is adapted to be connected to the first fixing unit and the second fixing unit at the surface of the subject, and when the retaining unit is connected to the first fixing unit and the second fixing unit, the position of the retaining unit relative to the first fixing unit and the second fixing unit is adjustable.

[0076] This device provides a hands-free method of ultrasound imaging, in which the position of the ultrasound patch can be adjusted to fine-tune the captured image after the ultrasound image has been initially fixed to the subject.

[0077] In this way, the position of the ultrasound patch can be adjusted to compensate for errors during placement or subject movement, without requiring a complete repositioning of the probe and holding unit.

[0078] In one embodiment, the device further includes a support portion for adjusting the distance between the ultrasound patch and the subject's surface.

[0079] In this way, the depth of focus of the device can be changed without altering the ultrasound patch. It should be noted that the actual depth of focus of the probe remains unchanged; rather, the position of the focal point within the subject's body is altered using the support portion.

[0080] In one embodiment, the support portion has an aperture adjacent to the surface of the subject, and if the support portion has a thickness below a given value, the aperture includes a first portion aligned with the primary transducer array and a second portion aligned with at least two secondary transducer arrays.

[0081] In this way, the aperture can be aligned with the transducer array to allow ultrasound waves to reach the subject without reducing the stability of the support portion.

[0082] According to an example of one aspect of the present invention, a method for positioning an ultrasound patch on the surface of a subject is provided, the method comprising:

[0083] An ultrasonic patch is provided to the holding unit, wherein the ultrasonic patch includes:

[0084] The first array group includes a primary transducer array having a first orientation; and

[0085] The second array group includes at least two secondary transducer arrays, wherein each secondary transducer array has an orientation different from the first orientation.

[0086] The second array group is arranged such that at least two secondary transducer arrays are positioned on either side of the primary transducer array.

[0087] The first fixation unit is fixed to the surface of the subject at the first position;

[0088] The second fixation unit is fixed to the surface of the subject at a second position different from the first position;

[0089] The retaining unit is connected to the first and second fixing units at the surface of the subject; and

[0090] Adjust the position of the holding unit relative to the first fixed unit and the second fixed unit.

[0091] In one embodiment, the method further includes:

[0092] Preliminary ultrasound data were obtained from the first array group; and

[0093] Based on preliminary ultrasound data, the position of the holding unit relative to the first and second fixing units is adjusted.

[0094] In one embodiment, the method further includes:

[0095] Preliminary ultrasound data were obtained from the second array group; and

[0096] Based on preliminary ultrasound data, the position of the holding unit relative to the first and second fixing units is adjusted.

[0097] In this way, the position of the holding unit can be adjusted based on the incoming ultrasound data, without having to activate all array groups at once.

[0098] According to an example of one aspect of the invention, an apparatus for positioning an ultrasound probe on the surface of a subject is provided, the apparatus comprising:

[0099] A first fixation unit, wherein the first fixation unit is adapted to be fixed to the surface of the subject at a first position;

[0100] A second fixation unit, wherein the second fixation unit is adapted to be fixed to the surface of the subject at a second position different from the first position;

[0101] Holding unit, wherein the holding unit is adapted to receive an ultrasonic probe; and

[0102] The retaining unit is adapted to be connected to the first fixing unit and the second fixing unit at the surface of the subject, and when the retaining unit is connected to the first fixing unit and the second fixing unit, the position of the retaining unit relative to the first fixing unit and the second fixing unit is adjustable.

[0103] According to an example of one aspect of the present invention, a method for positioning an ultrasound probe on a surface of a subject is provided, the method comprising:

[0104] The first fixation unit is fixed to the surface of the subject at the first position;

[0105] The second fixation unit is fixed to the surface of the subject at a second position different from the first position;

[0106] A holding unit suitable for holding the ultrasonic transducer is connected to the first fixation unit and the second fixation unit at the surface of the subject; and

[0107] Adjust the position of the retaining unit relative to the first fixed unit and / or the second fixed unit.

[0108] These and other aspects of the invention will become apparent and will be illustrated from the embodiments described below. Attached Figure Description

[0109] To better understand the invention and to more clearly illustrate how it can be implemented, reference will now be made to the accompanying drawings by way of example only, wherein:

[0110] Figure 1An ultrasound diagnostic imaging system for explaining general operation is shown;

[0111] Figure 2A A device for positioning an ultrasound probe on the surface of a subject is shown;

[0112] Figure 2B It shows Figure 2A The device wherein the holding unit is connected to the first fixing unit and the second fixing unit;

[0113] Figure 3 It shows Figure 2A and 2B Exemplary implementation 200 of the device;

[0114] Figure 4 The image shows the effect when applied to the subject's arm. Figure 3 Examples of devices;

[0115] Figure 5A A cross-sectional view of the device is shown when it is applied to the surface of the subject;

[0116] Figure 5B It shows a support portion. Figure 5A The device;

[0117] Figure 6 An example of a device including a temporary handle is shown;

[0118] Figure 7 The method of the present invention is shown;

[0119] Figure 8 An example of an ultrasonic patch is shown;

[0120] Figure 9 It shows when contained in Figure 5B When inside the device Figure 8 Ultrasonic patches;

[0121] Figure 10 Another example of an ultrasonic patch is shown; and

[0122] Figure 11 Several additional examples of ultrasonic patches are shown. Detailed Implementation

[0123] The invention will be described with reference to the accompanying drawings.

[0124] It should be understood that while the detailed description and specific examples indicate exemplary embodiments of the apparatus, system, and method, they are for illustrative purposes only and are not intended to limit the scope of the invention. These and other features, aspects, and advantages of the apparatus, system, and method of the present invention will be better understood from the following description, the appended claims, and the accompanying drawings. It should be understood that these drawings are schematic only and are not drawn to scale. It should also be understood that the same reference numerals are used in all the drawings to denote the same or similar parts.

[0125] The present invention provides an apparatus for positioning an ultrasound patch on the surface of a subject. The system includes a first fixing unit and a second fixing unit adapted to be fixed to the surface of the subject at a first position and a second position, respectively, with a space between them for the exposed surface of the subject. The system also includes a retaining unit for positioning the patch on the exposed surface of the subject within the space between the fixing units, the retaining unit being adapted to receive the ultrasound patch.

[0126] The retaining unit is adapted to be connected to the first fixation unit and the second fixation unit at the surface of the subject, and when the retaining unit is connected to the first fixation unit and the second fixation unit, the position of the retaining unit relative to the first fixation unit and the second fixation unit is adjustable.

[0127] Another aspect of the present invention provides an ultrasonic patch comprising a first array group and a second array group. The first array group includes a primary transducer array having a first orientation, and the second array group includes at least two secondary transducer arrays, wherein each secondary transducer array has an orientation different from the first orientation. The second array group is arranged such that at least two secondary transducer arrays are disposed on either side of the primary transducer array.

[0128] First, refer to Figure 1 To describe the general operation of the exemplary ultrasound system 2.

[0129] The system includes an array transducer probe 4 having a transducer array 6 for transmitting ultrasonic waves and receiving echo information. The transducer array 6 may include: a CMUT transducer; a piezoelectric transducer made of a material such as PZT or PVDF; or any other suitable transducer technology. In this example, the transducer array 6 is a two-dimensional array formed by transducers 8 capable of scanning a 2D plane or a three-dimensional volume of the region of interest. In another example, the transducer array may be a one-dimensional array.

[0130] The transducer array 6 is coupled to a microwave beamformer 12 that controls the transducer elements to receive signals. As described in U.S. Patents 5,997,479 (Savord et al.), 6,013,032 (Savord), and 6,623,432 (Powers et al.), the microwave beamformer is capable of performing at least partial beamforming on signals received by a subarray (often referred to as a “patch”) of transducers.

[0131] It should be noted that the microwave beamformer is entirely optional. Furthermore, the system includes a transmit / receive (T / R) switch 16 to which the microwave beamformer 12 can be coupled, and this switch toggles the array between transmit and receive modes, protecting the main beamformer 20 from high-energy transmitted signals when the microwave beamformer is not used and the transducer array is directly operated by the main system beamformer. Transmission of the ultrasonic beam from the transducer array 6 is guided by a transducer controller 18, which is coupled to the microwave beamformer via the T / R switch 16 and the main transmit beamformer (not shown), which can receive input from the user interface or control panel 38. The controller 18 may include transmission circuitry arranged to drive the transducer elements of the array 6 (directly or via the microwave beamformer) during transmit mode.

[0132] In a typical line-by-line imaging sequence, the beamforming system within the probe operates as follows. During transmission, a beamformer (which, depending on the implementation, may be a microwave beamformer or a main system beamformer) activates a transducer array or sub-apertures of the transducer array. A sub-aperture can be a one-dimensional line formed by transducers or a two-dimensional sheet formed by transducers within a larger array. In transmission mode, the focusing and steering of the ultrasonic beam generated by the array or its sub-apertures are controlled as described below.

[0133] After receiving the backscattered echo signal from the subject, the received signal undergoes receive beamforming (as described below) to align the received signal, and, in the case of a sub-aperture, the sub-aperture is then translated, for example, by a transducer element. The translated sub-aperture is then activated and the process is repeated until all transducer elements of the transducer array have been activated.

[0134] For each row (or sub-aperture), the total signal received for the associated row used to form the final ultrasound image will be the sum of the voltage signals measured by the transducer elements of a given sub-aperture during reception. Following the beamforming process below, the resulting row signals are typically referred to as radio frequency (RF) data. Each row signal (RF dataset) generated from each sub-aperture then undergoes additional processing to generate the row of the final ultrasound image. Variations in the amplitude of the row signal over time contribute to the variation in brightness of the ultrasound image with depth, where high-amplitude peaks will correspond to bright pixels (or sets of pixels) in the final image. Peaks appearing near the beginning of a row signal will represent echoes from shallow structures, while peaks that gradually appear later in the row signal will represent echoes from structures at increasing depth within the subject's body.

[0135] One of the functions controlled by the transducer controller 18 is the direction in which the beam is turned and focused. The beam can be turned directly forward from the transducer array (orthogonal to the transducer array) or turned at different angles to obtain a wider field of view. The turning and focusing of the transmitted beam can be controlled according to the actuation time of the transducer elements.

[0136] In general ultrasound data acquisition, two methods can be distinguished: plane wave imaging and "beamsteer" imaging. These two methods are distinguished by the presence of beamforming in the transmission ("beamsteer" imaging) and / or reception modes (plane wave imaging and "beamsteer" imaging).

[0137] First, let's look at the focusing function. By simultaneously activating all transducer elements, the transducer array generates a plane wave, which diverges as it travels through the subject. In this case, the ultrasound beam remains unfocused. By introducing a position-dependent time delay into the transducer activation, the wavefront of the beam can be converged to a desired point, called the focal region. The focal region is defined as the point where the lateral beamwidth is less than half the width of the transmitted beam. In this way, the lateral resolution of the final ultrasound image is improved.

[0138] For example, if a time delay causes the transducer elements to activate in series, starting with the outermost element and ending at the center element of the transducer array, a focal region will be formed at a given distance from the probe, aligned with the center element. The distance between the focal region and the probe will vary depending on the time delay between each subsequent activation of the transducer elements. After the beam passes through the focal region, it will begin to diverge, forming a far-field imaging region. It should be noted that for the focal region set close to the transducer array, the ultrasonic beam will diverge rapidly in the far field, resulting in beamwidth artifacts in the final image. Typically, the near field, positioned between the transducer array and the focal region, displays less detail due to significant overlap in the ultrasonic beam. Therefore, changing the position of the focal region can lead to a significant change in the final image quality.

[0139] It should be noted that in transmission mode, only one focal point can be defined unless the ultrasound image is divided into multiple focal regions (each focal region can have a different transmission focal point).

[0140] Alternatively, upon receiving an echo signal from within the subject's body, the reverse process can be performed to achieve receiver focusing. In other words, the incoming signal can be received by the transducer elements and undergoes an electronic time delay before being transmitted to the system for signal processing. The simplest example of this is called delayed-and-sum beamforming. The receiver focusing of the transducer array can be dynamically adjusted according to time.

[0141] Now consider the function of beam steering. By correctly applying time delays to the transducer elements, a desired angle can be imparted to the ultrasonic beam as it leaves the transducer array. For example, by activating the transducers on the first side of the array, followed by the remaining transducers in sequence, and finally ending at the opposite side of the array, the wavefront of the beam will be angled towards the second side. The magnitude of the steering angle relative to the normal of the transducer array depends on the magnitude of the time delay between the activation of subsequent transducer elements.

[0142] Furthermore, a focused and steerable beam can be achieved, where the total time delay applied to each transducer element is the sum of the focusing time delay and the steerable time delay. In this case, the transducer array is called a phased array.

[0143] In the case of CMUT transducers, a DC bias voltage is required for their activation, and transducer controller 18 can be coupled to control DC bias controller 45 for the transducer array. DC bias controller 45 sets the DC bias voltage applied to the CMUT transducer elements.

[0144] For each transducer element in the transducer array, an analog ultrasonic signal, typically referred to as channel data, enters the system through a receiving channel. In the receiving channel, a partially beamformed signal is generated from the channel data by a microwave beamformer 12 and then passed to the main receiving beamformer 20, where the partially beamformed signals from individual transducers are combined into a fully beamformed signal, referred to as radio frequency (RF) data. The beamforming performed at each stage can be performed as described above, or additional functionality can be included. For example, the main beamformer 20 can have 128 channels, each receiving partially beamformed signals from sheets formed by dozens or hundreds of transducer elements. In this way, signals received by thousands of transducers in the transducer array can effectively contribute to a single beamformed signal.

[0145] The beamformed received signal is coupled to signal processor 22. Signal processor 22 can process the received echo signal in various ways, such as: bandpass filtering; decimation; I and Q component separation; harmonic signal separation, which is used to separate linear and nonlinear signals to enable the identification of nonlinear (higher harmonics of the fundamental frequency) echo signals returning from tissue and microbubbles. The signal processor can also perform additional signal enhancement, such as speckle reduction, signal recombination, and noise cancellation. The bandpass filter in the signal processor can be a tracking filter whose passband slides from higher to lower frequency bands as the echo signal is received from increasing depths, thereby rejecting higher-frequency noise from greater depths, which typically lacks anatomical information.

[0146] The beamformer for transmission and the beamformer for reception are implemented in different hardware and can have different functions. Of course, the receive beamformer is designed to take into account the characteristics of the transmit beamformer. Figure 1 For simplicity, only the receiving beamformers 12 and 20 are shown in the diagram. In a complete system, there would also be a transmission chain with a transmitting microwave beamformer and a main transmitting beamformer.

[0147] The function of microwave beamformer 12 is to provide an initial combination of signals to reduce the number of analog signal paths. This is typically performed in the analog domain.

[0148] The final beamforming is performed in the main beamformer 20, and typically after digitization.

[0149] The transmit and receive channels use the same transducer array 6 with a fixed frequency band. However, the bandwidth occupied by the transmit pulse can vary depending on the transmit beamforming used. The receive channel can capture the entire transducer bandwidth (which is the classical approach), or it can extract only the bandwidth containing the expected information (e.g., harmonics of the main harmonic) by using bandpass processing.

[0150] The RF signal can then be coupled to a B-mode (i.e., brightness mode or 2D imaging mode) processor 26 and a Doppler processor 28. The B-mode processor 26 performs amplitude detection on the received ultrasound signal to image structures within the body, such as organs, tissues, and blood vessels. In the case of line-by-line imaging, each line (beam) is represented by an associated RF signal whose amplitude is used to generate the brightness value assigned to a pixel in the B-mode image. The exact location of a pixel within the image is determined by the position of the associated amplitude measurement along the RF signal and the line (beam) number of the RF signal. B-mode images of this structure can be formed in harmonic or fundamental image modes or a combination of both, as described in U.S. Patents 6,283,919 (Roundhill et al.) and 6,458,083 (Jago et al.). The Doppler processor 28 processes temporally different signals caused by tissue movement and blood flow for the detection of moving matter, such as the flow of blood cells in the image field. Doppler processor 28 typically includes a wall filter whose parameters are set to allow or reject echoes returning from a selected type of substance within the body.

[0151] The structural and motion signals generated by the B-mode processor and the Doppler processor are coupled to a scan converter 32 and a multi-plane reformer 44. The scan converter 32 arranges the echo signals into a spatial relationship, according to which they are received in the desired image format. In other words, the scan converter converts RF data from a cylindrical coordinate system to a Cartesian coordinate system suitable for displaying ultrasound images on an image display 40. In the case of B-mode imaging, the brightness of a pixel at a given coordinate is proportional to the amplitude of the RF signal received from that location. For example, the scan converter can arrange the echo signals into a two-dimensional (2D) fan-shaped format or a pyramidal three-dimensional (3D) image. The scan converter can overlay the B-mode structural image with colors corresponding to motion at various points in the image field, where a given color is generated using Doppler-estimated velocity. The combined B-mode structural image and color Doppler image depict the motion of tissue and blood flow within the structural image field. A multiplane redefinition converter converts echoes received from points in a common plane within a volumetric region of the body into an ultrasound image of that plane, as described in U.S. Patent 6,443,896 (Detmer). A volumetric renderer 42 converts echo signals from a 3D dataset into a projected 3D image viewed from a given reference point, as described in U.S. Patent 6,530,885 (Entrekin et al.).

[0152] 2D or 3D images are coupled from the scan converter 32, multiplane reformer 44, and volume rendering unit 42 to the image processor 30 for further enhancement, buffering, and temporary storage for display on the image display 40. The image processor may be adapted to remove certain imaging artifacts from the final ultrasound image, such as: acoustic shadowing, e.g., caused by strong attenuators or refraction; posterior enhancement, e.g., caused by weak attenuators; reverberation artifacts, e.g., highly reflective tissue interfaces are set close together; and so on. Furthermore, the image processor may be adapted to perform certain speckle reduction functions to improve the contrast of the final ultrasound image.

[0153] In addition to their use in imaging, blood flow values ​​generated by the Doppler processor 28 and tissue structure information generated by the B-mode processor 26 are coupled to the quantization processor 34. Besides structural measurements such as organ size and gestational age, the quantization processor generates measurements of different flow states, such as the volume fraction of blood flow. The quantization processor can receive input from the user control panel 38, such as the points to be measured in the anatomical structures of the image.

[0154] Output data from the quantization processor is coupled to the graphics processor 36 for reproducing measurement graphs and values ​​along with images on the display 40, and for outputting audio from the display device 40. The graphics processor 36 can also generate graphic overlays for display alongside ultrasound images. These overlays may contain standard identification information such as patient name, date and time of the image, imaging parameters, etc. For these purposes, the graphics processor receives input from the user interface 38, such as the patient name. The user interface is also coupled to the transmission controller 18 to control the generation of ultrasound signals from the transducer array 6, and thus the images generated by the transducer array and the ultrasound system. The transmission control function of the controller 18 is only one of the functions performed. The controller 18 also considers the operating mode (given by the user) in the receiver analog-to-digital converter and the corresponding required transmitter and bandpass configurations. The controller 18 may be a state machine with fixed states.

[0155] The user interface is also coupled to a multiplane reformer 44 for selecting and controlling multiple planes of multiplane reformed (MPR) images that can be used to perform quantization measurements in the image field of the MPR images.

[0156] Figure 2A A device 100 for positioning an ultrasound probe 110 (e.g., an ultrasound patch) on the surface of a subject is shown. The ultrasound probe 110 can be arranged to operate with the ultrasound system 2 in a similar manner to that described above with respect to the array transducer probe 4.

[0157] The device includes a first fixation unit 120 and a second fixation unit 130, adapted to be fixed to the surface of a subject at a first position and a second position, respectively. The first and second fixation units are fixed to the surface of the subject, with a space between them for the exposed surface of the subject. The first and second fixation units can be fixed to the surface of the subject by any suitable means. (See below for reference.) Figure 3 Let's discuss some examples of such suitable approaches.

[0158] The device also includes a holding unit 140 adapted to receive an ultrasound probe. The holding unit is adapted to be positioned on the exposed surface of the subject within the space between a first fixing unit and a second fixing unit. In other words, the holding unit holds the ultrasound probe in place during ultrasound scanning. It should be noted that the ultrasound probe 110 may be integrally formed with the holding unit.

[0159] The retaining unit is adapted to be connected 150 to the first fixation unit and the second fixation unit at the surface of the subject.

[0160] Figure 2B It shows Figure 2A The device wherein the holding unit 140 is connected to the first fixing unit 120 and the second fixing unit 130.

[0161] When the holding unit is connected to the first fixing unit and the second fixing unit, the position of the holding unit relative to the first fixing unit and the second fixing unit is adjustable, as shown by the arrow.

[0162] Depending on the implementation of the holding unit, the first fixing unit, and the second fixing unit, the position of the holding unit can be adjusted by translation or rotation.

[0163] This device provides a method for fine-tuning the position of the ultrasound probe after initial placement to generate the most feasible images with minimal intervention from the clinician. In other words, the position of the ultrasound probe can be slightly adjusted after the holding unit has been attached to the first and second fixation units (which secure the holding unit near the subject's surface). Therefore, the user does not need to perform both the actions of holding the ultrasound transducer on the subject's surface and fine-tuning the transducer's position.

[0164] Therefore, this device provides improved image quality and accuracy captured by the ultrasonic transducer.

[0165] The connection between the holding unit and the first and second fixation units allows for, for example, a 3-5 mm fine-tuning of the holding unit's position after it has been placed on the subject's surface. Depending on the ultrasound probe used, the fine-tuning of the holding unit's position can be greater than 5 mm. For example, the holding unit can receive the ultrasound transducer on the subject's arm and hold it on the skin's surface, while still allowing for some movement of 3-5 mm after connection.

[0166] Rotational adjustments can be performed by manipulating only one side of the holding unit, such as the left or right side. Combined with translational adjustments, the device provides adjustments to correct for any given misalignment or movement of the skin relative to the imaged blood vessel / multiple blood vessels.

[0167] Furthermore, the device can be easily adjusted during ongoing measurements or monitoring to quickly and simply re-optimize the images. After adjustment, the user can continue using the ultrasound system hands-free.

[0168] This device combines a reusable ultrasonic module, an ultrasonic transducer, and a disposable holding unit with a fine-tuning mechanism. The components of the device can be modular, with each unit tailored to a given application. Using this modular approach, the device can be adapted to meet the needs of a specific application, while the ultrasonic module can be manufactured to be universally compatible with the holding unit. In other words, the holding unit can be provided in various forms suitable for different situations while still being able to receive the same ultrasonic module.

[0169] Figure 3 It shows Figure 2A and Figure 2B Exemplary implementation 200 of the device.

[0170] Figure 3 The example shown includes an exploded view of a first fixing unit 210, which includes an adhesive patch 220 adapted to conform to and adhere to a surface of a subject and a receiving unit 230 including a recessed portion 240 adapted to receive a protrusion 250 of a receiving unit 260. The receiving unit may be rigid or flexible. Those skilled in the art will understand that all the retaining units illustrated herein (e.g., 140, 260) may be adapted to have protrusions arranged to be placed within the receiving unit.

[0171] Figure 3 The example shown provides only one possible way to fix the fixation unit to the surface of the subject and one possible combination of ways to connect the holding unit to the first fixation unit and the second fixation unit.

[0172] For example, the first and second fixation units can be fixed to the subject's surface by one or more of the following: (see above reference) Figure 3 The described adhesive patch; a strip surrounding the subject, wherein the strip holds the device connected to the retaining unit at a first or second position on the surface of the subject; a suction cup adapted to hold itself against the surface of the subject by suction; an elastic band surrounding the subject, etc.

[0173] Furthermore, the connection between the retaining unit and the first and second fixing units can be achieved through one or more of the following: (see above) Figure 3 The described protruding portion and receiving portion; protruding portion formed on the fixing unit and receiving portion formed on the holding unit; multiple protruding portions formed on the fixing unit or holding unit and multiple receiving portions formed on the holding unit or fixing unit; magnetic connection; button and hole arrangement structure; press fit arrangement structure, etc.

[0174] Any of the above-described fixing methods can be used in conjunction with any of the above-described connection methods.

[0175] Figure 4 It shows Figure 3 Example 300 of the device shows a second fixation unit 310 when applied to the arm of a subject 320.

[0176] The device may also include a permanent fixation unit adapted to fix the retention unit to the surface of the subject, such that the position of the retention unit cannot be changed.

[0177] A permanent fixation unit can be any device that attaches a retention unit to the subject's surface so that the retention unit does not move relative to the subject's surface. The fixation unit can be attached to the subject's surface on a semi-permanent basis, such as by microporous tape or plaster, or on a permanent basis, such as by an adhesive that requires solvent removal.

[0178] For example, subjects undergoing long-term monitoring may require better fixation subsequently achieved with an adhesive plaster cast. After initial placement and fine-tuning of the retention unit, a second adhesive plaster cast can be applied to firmly secure the ultrasound patch to the skin. In this case, the device may remain on the skin for several days. Only a portion of the ultrasound patch may be covered with adhesive plaster, or the entire ultrasound patch may be covered with adhesive plaster to completely seal the area.

[0179] Figure 5A A cross-sectional view 400 of the device 410 is shown when it is applied to the surface 420 of the subject. Figure 5A In the example shown, the device is used to image blood vessels 430 located at a depth of 10-80 mm or greater below the surface of the skin.

[0180] Figure 5B A cross-sectional view 440 of the device 410 is shown when it is applied to the surface 420 of the subject. Figure 5B In the example shown, the device was used to image blood vessels 435 located at a depth of less than 10 mm below the surface of the skin.

[0181] Figure 5B The device also includes a support portion 450 adapted to adjust the distance between the ultrasonic transducer and the surface of the subject.

[0182] Ultrasonic probes may include ultrasonic lenses for focusing a beam of ultrasonic signals at a single point, for example, in applications where deflection or focusing of the electron ultrasonic beam is not feasible, such as 1D transducer arrays for 2D imaging.

[0183] The support portion provides a method for altering the depth of focus of an ultrasound probe. When the probe is held over the surface of the subject to image an area of ​​interest near the surface, this depth of focus is typically located 10 to 45 mm from the ultrasound probe, depending on the lens of the probe itself; otherwise, the area of ​​interest will not be in focus. In other words, the support portion and support material can be used to compensate for the fixed focus of the ultrasound probe and lens combination and provide a way to change the perceived focus within the subject's body.

[0184] In other words, this device can be combined with various support sections to generate different depths of focus depending on the position of the holding unit, without changing the ultrasound image generation device. Using dedicated support sections with heights varying between 0 mm and 15 mm, the current depth of focus of the ultrasound equipment can be varied according to the current imaging application. It should be noted that support sections of any height can be used, for example, support sections with a height greater than 15 mm can be used.

[0185] For example, when dealing with things like Figure 5A When imaging superficial vessels of the blood vessel 430 shown, the holding unit can be applied directly to the subject's surface 420 to focus the ultrasound waves at the vessel depth 430. A support material such as acoustic gel can be placed between the holding unit and the subject's surface.

[0186] As a further example, when imaging blood vessels at the skin level, for example... Figure 5B The device, as shown in the diagram (vascular 435), may include a support portion 450 with a thickness of up to 15 mm to focus ultrasound waves at the skin level. The support portion may include a support material 460, such as an acoustic coupling material. The support material can be any material capable of providing acoustic coupling between the ultrasound probe within the holding unit and the subject's surface.

[0187] In addition to altering the depth of the ultrasound probe's focal point, the support portion and support material can be used to perform translational adjustments to fine-tune the height of the ultrasound probe, i.e., the distance between the ultrasound probe and the subject's surface. Furthermore, the support portion and support material can be used to perform rotational adjustments of the ultrasound probe relative to the subject's surface.

[0188] In some cases, long-term monitoring is required. During extended monitoring periods, some liquid-based support materials may dry out, resulting in areas of image distortion. Therefore, hydrogel materials can be provided as support materials within the support portion to mitigate the drying effect over time, thereby providing accurate images over longer periods, such as several days.

[0189] In other words, the support portion and support material can provide a height offset for the ultrasound probe without interfering with the ultrasound signal. Various commercially available materials are available as support materials. In one example, the support material could be a standard ultrasound gel held in a suitable container. The support material can also allow the device to move after initial application. In other words, the support material can help maintain the movement of the unit during the aforementioned fine-tuning adjustments.

[0190] The support section provides an additional aspect to the modularity of the device. It can be a single reusable module containing all electronic components (such as the ultrasonic transducer) and several disposable holding units, as well as a support section that utilizes the built-in fine-tuning mechanism described above to change the depth of focus (0-15mm).

[0191] The following is for reference. Figure 9 Further details on the support component.

[0192] Figure 6 An example of a device 500 is shown, including a temporary handle 510 adapted to be removably coupled to a holding unit 520. The temporary coupling between the temporary handle and the holding unit can be achieved by a magnet disposed on the temporary handle and a corresponding magnet disposed on the holding unit.

[0193] A temporary handle can be used to facilitate placement of the retention unit on the subject's skin. In this way, the initial placement of the retention unit may be more accurate, and the accuracy of fine-tuning adjustments may be improved.

[0194] Figure 7 A method 600 for positioning an ultrasound probe on a surface of a subject is shown. Figure 6 In the example shown, the ultrasound probe is positioned on a surface close to the region of interest (e.g., a blood vessel) 605 to be imaged.

[0195] In step 610, the first fixing unit 615 is fixed to the surface of the subject at the first position.

[0196] In step 620, the second fixing unit 625 is fixed to the surface of the subject at a second position different from the first position.

[0197] In step 630, a holding unit 635 adapted to hold the ultrasonic transducer is coupled to a first fixing unit and a second fixing unit at the surface of the subject.

[0198] In step 640, the position of the holding unit undergoes an adjustment 645 with respect to the first and / or second fixing unit to align the holding unit with a region of interest, such as the blood vessel to be imaged. The arrangement of the fixing units of this invention provides the user with the flexibility common to diagnostic ultrasound probes, allowing the transducer to be moved around to optimize image acquisition quality.

[0199] In step 650, after the holding unit's position is adjusted, the holding unit is secured to the subject's surface via a permanent fixing unit 655. Once the optimal position has been identified, this step allows the user to fix the transducer's position relative to the area of ​​interest.

[0200] Alternatively, the first and second fixation units can be attached to the retaining unit and the ultrasound probe before being placed on the subject's surface. Then, before securing the first and second fixation units to the subject's surface, the ultrasound probe can be used to check that the retaining unit is largely in the correct position. The position of the retaining unit can then be fine-tuned as described above.

[0201] Figure 8 An example 700 of an ultrasonic patch 710 is shown, which includes a first array group 720 and a second array group 740. The first array group 720 includes a primary transducer array 730 having a first orientation, and the second array group 740 includes at least two secondary transducer arrays 750, wherein each secondary transducer array has an orientation different from the first orientation.

[0202] like Figure 8 As shown, the second array group 740 is arranged such that at least two secondary transducer arrays 750 are disposed on either side of the primary transducer array 730. In this example, the first array group 720 includes two primary transducer arrays.

[0203] The ultrasonic patch 710 can be used as the ultrasonic probe 110 in the above-described device.

[0204] Ultrasonic patches (e.g.) Figure 8The configuration of the ultrasound patch 710 shown depends on the clinical application of the patch and user needs. For example, clinical needs may include: how to navigate the ultrasound patch to the area of ​​interest; guiding the positioning of the device within the area of ​​interest; monitoring parameters of the subject such as vessel diameter and blood flow; guiding surgery, such as positioning catheters; and monitoring surgical outcomes.

[0205] exist Figure 8 In the example shown, at least two secondary transducer arrays 750 can be used to help position the ultrasound patch 710 on the area of ​​interest. By providing secondary transducer arrays on either side of the primary transducer array, positioning accuracy can be improved in addition to providing a proper clinical view. Furthermore, combining this feature with the fine-tuning capability of the device described above can further improve the placement accuracy of the ultrasound transducer patch.

[0206] It has been recognized that during interventional procedures, when a catheter is placed inside a blood vessel, even if the primary ultrasound transducer 730 is not fully aligned with the axis of the blood vessel, the two secondary arrays 750 enable the user to track whether the catheter enters and leaves the area of ​​interest, thus providing only partial images of the anatomy.

[0207] For example, when using an ultrasound patch to monitor surgery on a blood vessel, two secondary transducer arrays can be used to generate cross-sectional views of the blood vessel of interest and help guide the placement of the first array group in the plane using the blood vessel to obtain an accurate longitudinal image of the blood vessel of interest. Furthermore, after placement is complete, the secondary transducer arrays can be used to determine blood flow and the diameter of the blood vessel, thereby increasing the functionality of the ultrasound patch.

[0208] The primary and secondary transducer arrays can utilize CMUT units. CMUT units enable optimal configuration to support both monitoring and image-guided applications. In this way, multiple transducer arrays can be used for "real-time" imaging while still using a single readout electronics.

[0209] Since the CMUT is only effective when a DC bias voltage is applied, individual transducer arrays can be activated independently while still sharing the beamforming channel for all transducer arrays. Therefore, only a single readout system is needed for all transducer arrays. Switching of the DC bias voltage can be automated and performed at a sufficiently high speed to acquire real-time images of the region of interest.

[0210] In clinical applications, the primary ultrasound transducer 730 provides a large field of view. For example, when a secondary transducer array has been used to guide the placement of the primary ultrasound transducer array on top of the vessel of interest, a full view of the tissue (e.g., stenosis) can be visualized.

[0211] Primary and secondary transducer arrays can be used to perform 2D and 3D ultrasound imaging, depending on the application.

[0212] Figure 9 This shows what happens when it is held inside the device as described above. Figure 8 The ultrasonic patch 710 includes a support portion 760 having a window 770 adapted to be positioned adjacent to the surface of the subject.

[0213] If the support portion has a thickness less than a given value, such as less than 5 mm, or less than 3 mm, then the aperture includes a first portion 780 aligned with the primary transducer array and a second portion 790 aligned with at least two secondary transducer arrays.

[0214] The width w1 of the first part is smaller than the width w2 of the second part, thereby increasing the stiffness of the support part.

[0215] By shaping the aperture in this way, the stiffness of the support portion and the support material can be increased, thereby ensuring good acoustic contact between the ultrasound patch and the subject's surface. For example, reinforcements can be placed in the support material at non-imaging locations so that the reinforcements do not interfere with the imaging process. For larger thicknesses, H-shapes are not permitted because, in this case, the material properties would hinder good contact with the device and the skin.

[0216] Figure 10 An example 800 of an ultrasonic patch is shown, in which a secondary transducer array 810 is oriented at different angles from each other and is not perpendicular to the primary transducer array 820.

[0217] Figure 10 The specific arrangement shown is optimized for performing accurate blood flow measurements using a secondary array. For accurate blood flow measurements to be performed, motion must exist in the direction of the ultrasound beam. If the blood flow is perpendicular to the beam, there is no relative motion between pulses. Therefore, by aligning the primary transducer array along the length of the blood vessel, the secondary transducers are prevented from being perpendicular to the blood flow, thus ensuring accurate flow measurement. Therefore, the secondary transducers not only allow for the acquisition of the blood vessel cross-section in a preferred manner but also enable monitoring of blood flow through the region of interest.

[0218] Figure 11 Various examples 900 of ultrasonic transducer patches utilizing different configurations of primary transducer array 910 and secondary transducer array 920 are shown. As can be seen from the examples, any number and arrangement of primary and secondary arrays can be used depending on the needs of a given application. Furthermore, the ultrasonic patch may include one or more tertiary transducer arrays 930 adapted to complement the primary and secondary transducer arrays, but which are not part of a first or second array group.

[0219] By studying the accompanying drawings, disclosure, and appended claims, those skilled in the art can understand and implement variations of the disclosed embodiments in practicing the claimed invention. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite articles "a" or "an" do not exclude multiple. A single processor or other unit can perform the functions of several items recited in the claims. The fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used for benefit. If a computer program has been discussed above, it can be stored / distributed on a suitable medium, such as an optical storage medium or solid-state medium provided with or as part of other hardware, but it can also be distributed in other forms, such as via the Internet or other wired or wireless telecommunications systems. If the term "suitable" is used in the claims or description, note that the term "suitable" is intended to be equivalent to the term "configured as." Any reference numerals in the claims should not be construed as limiting the scope.

Claims

1. A device (100) for positioning an ultrasound patch (110) on the surface of a subject, the device comprising: A first fixing unit (120), wherein the first fixing unit is adapted to be fixed to the surface of the subject at a first position; A second fixing unit (130) is adapted to be fixed to the surface of the subject at a second position different from the first position, and has space between the first position and the second position for the exposed surface of the subject; A retaining unit (140) for positioning on the exposed surface of the subject within the space, wherein the retaining unit is adapted to receive the ultrasound patch; The retaining unit is adapted to be coupled to the first fixing unit and the second fixing unit at the surface of the subject, thereby securing the retaining unit to the vicinity of the exposed surface of the subject, and the position of the retaining unit relative to the first fixing unit and the second fixing unit is adjustable when the retaining unit is coupled to the first fixing unit and the second fixing unit; and The first fixing unit and the second fixing unit are configured as two separate fixing units.

2. The apparatus (100) according to claim 1, wherein, The position of the holding unit (140) can be adjusted by one or more of the following: Translation adjustment; and Rotate to adjust.

3. The apparatus (100) according to any one of claims 1 to 2, wherein, The device further includes a permanent fixation unit (655) adapted to fix the retaining unit to the surface of the subject such that the position of the retaining unit cannot be changed.

4. The apparatus (100) according to any one of claims 1 to 2, wherein, The device includes a temporary handle (510) adapted to be removably coupled to the holding unit.

5. The apparatus (100) according to claim 4, wherein, The temporary handle (510) is connected to the holding unit via a magnet.

6. The apparatus (100) according to any one of claims 1 to 2, wherein, The holding unit (140) includes a support portion (450) adapted to adjust the distance between the ultrasonic transducer and the surface of the subject.

7. The apparatus (100) according to claim 6, wherein, The device further includes an ultrasonic patch having a transducer array, and the support portion (450) has a window (770) adjacent to the surface of the subject, and the window includes a first portion having a first width (w1) and a second portion having a second width (w2) located on either side of the first portion, wherein the first width is smaller than the second width, and the window is configured such that the transducer array is aligned with the window in use.

8. The apparatus (100) according to claim 6, wherein, The support portion (450) includes a support material (460) adapted to provide acoustic coupling between the ultrasonic transducer and the surface of the subject.

9. The apparatus (100) according to claim 8, wherein, The support material (460) includes a hydrogel material.

10. The apparatus (100) according to any one of claims 1 to 2, wherein, The first fixing unit and the second fixing unit each include: An adhesive patch (220) adapted to conform to and adhere to the surface of the subject; and The receiving unit (230) includes a recessed portion adapted to receive the holding unit; and The holding unit includes a protruding portion (250) adapted to be received by the receiving unit.

11. A device (100) for positioning an ultrasound patch (110) on the surface of a subject, the device comprising: A first fixing unit (120), wherein the first fixing unit is adapted to be fixed to the surface of the subject at a first position; A second fixing unit (130) is adapted to be fixed to the surface of the subject at a second position different from the first position, and there is space between them for the exposed surface of the subject; A retaining unit (140) for positioning on the exposed surface of the subject within the space, wherein the ultrasound patch is integrally formed with the retaining unit; The retaining unit is adapted to be coupled to the first fixing unit and the second fixing unit at the surface of the subject, and when the retaining unit is coupled to the first fixing unit and the second fixing unit, the position of the retaining unit relative to the first fixing unit and the second fixing unit is adjustable; and The first fixing unit and the second fixing unit are configured as two separate fixing units.

12. A method (600) for positioning an ultrasound patch on the surface of a subject, the method comprising: The first fixing unit (610) is fixed to the surface of the subject at the first position; The second fixing unit is fixed (620) to the surface of the subject at a second position different from the first position, and there is space between the first position and the second position for the exposed surface of the subject; Within the space, a holding unit suitable for holding the ultrasound patch is positioned on the exposed surface of the subject; The retaining unit is coupled (630) to the first fixing unit and the second fixing unit at the surface of the subject, thereby fixing the retaining unit to the vicinity of the exposed surface of the subject; and Adjust (640) the position of the holding unit relative to the first fixing unit and the second fixing unit; as well as The first fixing unit and the second fixing unit are configured as two separate fixing units.

13. The method (600) according to claim 12, wherein, Adjusting the position of the holding unit (640) includes one or more of the following: Perform translation adjustments; and Perform rotation adjustment.

14. The method (600) according to claim 13, wherein, The holding unit includes a support portion adapted to adjust the distance between the ultrasound patch and the surface of the subject, and adjusting the position of the holding unit further includes providing a support material to the support portion, the support material being adapted to provide acoustic coupling between the ultrasound patch and the surface of the subject.

15. The method (600) according to any one of claims 12 to 14, wherein, The method further includes securing (650) the retaining unit to the surface of the subject after adjusting the position of the retaining unit.

Images