Ultrasonic probe and ultrasonic system

Abstract

The utility model relates to an ultrasonic probe and an ultrasonic system. The ultrasound probe includes: a probe including an ultrasound transducer array configured to transmit a generated ultrasound signal into a target area of a patient, receive a reflected ultrasound signal from the patient, and convert the reflected ultrasound signal into a corresponding electrical signal; a light source configured to project, upon activation, a visual indication onto a skin surface of the patient, where the visual indication includes one or more visual characteristics based on one or more characteristics of the anatomical target; and a signal converter configured to convert the electrical signal into ultrasound image data comprising an ultrasound image of the target region to determine when the anatomical target is present within the ultrasound image.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 529,217, filed on July 27, 2023, which is incorporated by reference in its entirety into this application. Technical Field

[0003] The present invention relates to the field of medical devices, and more particularly to an ultrasound probe and an ultrasound system. Background Art

[0004] Ultrasound imaging is a widely accepted tool for guiding interventional instruments (such as needles) to targets (such as blood vessels or organs) in the human body. In order to successfully guide, for example, a needle to a blood vessel using ultrasound imaging, the needle is monitored in real time immediately before and after percutaneous puncture so that the clinician can determine the distance and orientation of the needle relative to the blood vessel and ensure successful entry into the blood vessel. Current needle guidance systems include various limitations. A mechanical needle guide used with and attached to an ultrasound probe constrains the movement of the needle. The ultrasound image displayed on the screen requires viewing the screen while the needle is inserted, thus requiring the user to move their line of sight away from the insertion site during insertion. Magnetic needle tracking systems require the added expense of magnetized needles and magnetometers.

[0005] Disclosed herein are systems, devices, and methods that address these and other limitations associated with utilizing ultrasound imaging to provide guidance during vascular access procedures. Utility Model Content

[0006] According to some embodiments, an ultrasound probe is disclosed herein, comprising: a probe head, which includes an ultrasound transducer array, configured to transmit generated ultrasound signals into a target area of ​​a patient, receive reflected ultrasound signals from the patient, and convert the reflected ultrasound signals into corresponding electrical signals; a light source, which is configured to project a visual indication onto the skin surface of the patient after activation, wherein the visual indication includes one or more visual characteristics based on one or more characteristics of an anatomical target; and a signal converter, which is configured to convert the electrical signal into ultrasound image data including an ultrasound image of the target area so as to determine when the anatomical target is present within the ultrasound image.

[0007] In some embodiments, the light source includes a separate light source module attached to and operably connected to the ultrasound probe. In some embodiments, the separate light source module is configured to be attached to and operably connected to the ultrasound probe, and the ultrasound probe has a sterile barrier covering the probe, and the sterile barrier is arranged between the separate light source module and the ultrasound probe. In some embodiments, the separate light source module is wirelessly connected to the ultrasound probe. In some embodiments, the separate light source module is configured for single use.

[0008] In some embodiments, the one or more visual features include at least one of a point or a line. In some embodiments, the one or more visual features include a line, and wherein the line is configured to extend away from the ultrasound probe in a direction perpendicular to the front face of the ultrasound probe.

[0009] In some embodiments, the ultrasound probe is operably coupled to a needle tracking system configured to determine a position and orientation of a trackable needle relative to the ultrasound probe in order to determine a position of the trackable needle relative to an anatomical target.

[0010] According to some embodiments, an ultrasound system is also disclosed herein, comprising: a headset, comprising an augmented or virtual reality headset; and an ultrasound probe, operably coupled to the headset. The ultrasound probe comprises: a probe, comprising an ultrasound transducer array, configured to transmit a generated ultrasound signal into a target area of ​​a patient, receive a reflected ultrasound signal from the patient, and convert the reflected ultrasound signal into a corresponding electrical signal; and a signal converter, configured to convert the electrical signal into ultrasound image data including an ultrasound image of the target area, so as to determine when an anatomical target is present within the ultrasound image, wherein a display of the headset is configured to display a visual indication depicting a visual appearance on a skin surface of the patient associated with the ultrasound probe, the visual indication comprising one or more visual characteristics based on one or more characteristics of the anatomical target.

[0011] In some embodiments, the one or more visual features include at least one of a point or a line. In some embodiments, the one or more visual features include a line, and wherein the line is configured to extend away from the ultrasound probe in a direction perpendicular to the front face of the ultrasound probe.

[0012] In some embodiments, the ultrasound probe is operably coupled to a needle tracking system configured to determine a position and orientation of a trackable needle relative to the ultrasound probe in order to determine a position of the trackable needle relative to an anatomical target.

[0013] According to some embodiments, an ultrasound probe is also disclosed herein, comprising: a probe having an ultrasound transducer array, the ultrasound transducer array being configured to: (i) transmit a generated ultrasound signal into a target area of ​​a patient; (ii) receive a reflected ultrasound signal from the patient; and (iii) convert the reflected ultrasound signal into a corresponding electrical signal. The ultrasound probe also includes a light source configured to project a visual indication onto a skin surface of the patient and a console coupled to the probe and the light source. The console includes: a signal converter configured to convert the electrical signal into ultrasound image data including an ultrasound image of the target area; one or more processors; and a non-transitory computer-readable medium having logic stored thereon. The logic, when executed by the one or more processors, causes the operation of the probe, which operations include: (i) performing a determination process on the ultrasound image data to determine when an anatomical target is present within the ultrasound image; and (ii) activating the light source to project a visual indication onto the skin surface, wherein the visual indication includes one or more visual characteristics based on one or more characteristics of the anatomical target.

[0014] In some embodiments, the ultrasound probe includes a button configured to enable a user to selectively activate and deactivate the light source, and in some embodiments, operation further includes deactivating the light source when the anatomical target is not present within the ultrasound image.

[0015] In some embodiments, the light source includes a separate light source module attached to the ultrasound probe and operably connected to the ultrasound probe. The separate light source module can be configured to be attached to the ultrasound probe and operably connected to the ultrasound probe when the sterile barrier covers the probe, wherein the sterile barrier is arranged between the separate light source module and the ultrasound probe. The separate light source module can be wirelessly connected to the ultrasound probe, and the separate light source module can be configured for single use.

[0016] In some embodiments, the one or more visual characteristics include at least one of a dot, a line, and / or a plurality of colors. In some embodiments, the one or more visual characteristics include a line, and the line may extend away from the ultrasound probe in a direction perpendicular to the front face of the ultrasound probe. In some embodiments, the one or more characteristics of the anatomical target include an identity of the anatomical target and / or a position of the anatomical target relative to the ultrasound probe.

[0017] In some embodiments, the operations further include performing a localization process on the ultrasound image data to determine a position of the anatomical target relative to the ultrasound probe, and in some embodiments, activating the light source includes projecting a visual indication onto the skin surface at a location above the anatomical target. In some embodiments, the location of the visual indication defines an optimal or preferred insertion site for the needle to enter the anatomical target.

[0018] In some embodiments, the operations further include performing an identification process on the ultrasound image data to identify the anatomical target as a vein or an anatomical element other than a vein. In some embodiments, the one or more visual characteristics include a first color when the identification process identifies the anatomical target as a vein, and the one or more visual characteristics include a second color different from the first color when the identification process identifies the anatomical target as an anatomical element other than a vein.

[0019] In some embodiments, one or more visual characteristics include a third color when the positioning process determines that the anatomical target is centered relative to the ultrasound probe, and one or more visual characteristics include a fourth color different from the third color when the positioning process determines that the anatomical target is positioned away from the center of the ultrasound probe.

[0020] In some embodiments, performing the localization process includes applying a first trained machine learning model to the ultrasound image data, resulting in determining the position of the anatomical target relative to the ultrasound probe. In some embodiments, performing the identification process includes applying a second trained machine learning model to the ultrasound image data, resulting in identifying the anatomical target as a vein or an anatomical element other than a vein.

[0021] In some embodiments, the ultrasound probe is operably coupled to a needle tracking system, the needle tracking system being configured to determine the position and orientation of the trackable needle relative to the ultrasound probe, wherein the operation further comprises: receiving needle tracking data from the needle tracking system, and performing a tracking process on ultrasound image data in conjunction with the needle tracking data to determine the position of the trackable needle relative to the anatomical target. In such embodiments, one or more visual characteristics include visual characteristics based on the position of the trackable needle relative to the anatomical target. The visual characteristics based on the position of the trackable needle can be configured to indicate when the trackable needle is aligned with the anatomical target. In some embodiments, the visual characteristics based on the position of the trackable needle include: (i) a fifth color when the tracking process determines that the trackable needle is not aligned with the anatomical target; and (ii) a sixth color different from the fifth color when the tracking process determines that the trackable needle is aligned with the anatomical target.

[0022] Also disclosed herein is an ultrasound system comprising an ultrasound probe according to any of the above embodiments, except that the ultrasound probe is coupled to a headset (eg, an augmented or virtual reality headset) instead of a light source.

[0023] According to some embodiments, a computerized method is also disclosed herein, comprising receiving ultrasound image data converted from an electrical signal generated by an ultrasound probe of an ultrasound probe, wherein the ultrasound probe is placed on a skin surface of a patient above a target area, and wherein the ultrasound probe includes an ultrasound transducer array, the ultrasound transducer array being configured to: (i) transmit the generated ultrasound signal into the target area of ​​the patient; (ii) receive a reflected ultrasound signal from the patient; and (iii) convert the reflected ultrasound signal into a corresponding electrical signal. The method also includes performing a determination process on the ultrasound image data to determine when an anatomical target is present within the ultrasound image, and activating a light source of the ultrasound probe to project a visual indication onto the skin surface, wherein the visual indication includes one or more visual characteristics based on one or more characteristics of the anatomical target.

[0024] In some embodiments, the method also includes performing a localization process on the ultrasound image data to determine the position of an anatomical target within the target area relative to the ultrasound probe, wherein activating the light source also includes projecting a visual indication onto the skin surface at a location above the anatomical target, and in some embodiments, performing the localization process includes applying a first trained machine learning model to the ultrasound image data, resulting in determining the position of the anatomical target relative to the ultrasound probe.

[0025] In some embodiments, the method also includes performing an identification process on the ultrasound image data to identify the anatomical target as a vein or an anatomical element other than a vein, wherein activating the light source further includes at least one of: (i) projecting a visual indication having a first color when the identification process identifies the anatomical target as a vein; or (ii) projecting a visual indication having a second color different from the first color when the identification process identifies the anatomical target as an anatomical element other than a vein, and in some embodiments, performing the identification process includes applying a second trained machine learning model to the ultrasound image data, resulting in identification of the anatomical target as a vein or an anatomical element other than a vein.

[0026] According to some embodiments, an ultrasound imaging system is also disclosed herein, comprising a plurality of ultrasound probes, wherein each ultrasound probe comprises: a probe having an ultrasound transducer array, the ultrasound transducer array being configured to: (i) transmit a generated ultrasound signal into a target area of ​​a patient; (ii) receive a reflected ultrasound signal from the patient; and (iii) convert the reflected ultrasound signal into a corresponding electrical signal. Each ultrasound probe also comprises a light source configured to project a visual indication onto a skin surface of the patient and a console coupled to the probe and the light source. The console comprises a signal converter configured to convert the electrical signal into ultrasound image data comprising an ultrasound image of the target area. The console also comprises one or more processors and a non-transitory computer-readable medium having logic stored thereon. The logic, when executed by the one or more processors, causes the operation of the probe, the operations comprising: (i) performing a positioning process on the ultrasound image data to determine the position of the anatomical target relative to the ultrasound probe, wherein performing the positioning process comprises applying a first trained machine learning (ML) model to the ultrasound image data; and (ii) activating the light source to project a visual indication onto the skin surface at a position above the anatomical target. The system also includes a computing system coupled to each of the plurality of ultrasound probes, wherein the computing system includes a non-transitory computer-readable medium having ML logic stored thereon. The ML logic, when executed by the processor, performs ML operations including executing a first ML algorithm on a historical ultrasound image dataset to define a first trained ML model. The historical ultrasound image dataset includes an anatomical target location dataset received from the ultrasound probe, and an actual anatomical target location dataset, and each actual anatomical target location dataset corresponds to the anatomical target location dataset in a one-to-one relationship.

[0027] In some embodiments of the system, the operation also includes performing an identification process on the ultrasound image data to determine the identification of the anatomical target as a vein or an anatomical element other than a vein, and performing the identification process includes applying a second trained ML model to the ultrasound image data. The operation also includes: (i) when the identification of the anatomical target includes a vein, activating the light source to project a visual indication having a first color; and / or (ii) when the identification of the anatomical target includes an anatomical element other than a vein, activating the light source to project a visual indication having a second color, wherein the second color is different from the first color. The ML operation also includes performing a second ML algorithm on a historical ultrasound image dataset to define a second trained ML model, wherein the historical ultrasound image dataset also includes an anatomical target identification dataset received from an ultrasound probe, and an actual anatomical target identification dataset, and wherein each actual anatomical target identification dataset corresponds to the anatomical target identification dataset in a one-to-one relationship.

[0028] These and other features of the concepts provided herein will become more readily apparent to one of ordinary skill in the art in view of the accompanying drawings and the following description, which describe in more detail specific embodiments of such concepts. Additional details and features of the concepts provided herein may be disclosed in one or more of the following patents: U.S. Patent No. 10,322,230 and U.S. Published Application No. 2021-0085282, each of which is incorporated herein by reference in its entirety. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Embodiments of the disclosure are illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals indicate similar elements and in which:

[0030] Figure 1 shows an ultrasound probe in contact with a patient's skin surface according to some embodiments;

[0031] Figure 2A According to some embodiments Figure 1 An illustration of an ultrasound probe projecting a first visual indication onto a skin surface via a light source;

[0032] Figure 2B According to some embodiments Figure 1 An ultrasound probe projects a second visual indication onto the skin surface via light;

[0033] Figure 3 According to some embodiments, Figure 1 A block diagram of a control console of an ultrasound detector;

[0034] Figure 4 According to some embodiments, Figure 1 A block diagram of a computerized method for an ultrasound detector;

[0035] Figure 5 According to some embodiments, a method for defining Figure 1 an ultrasound system having an ultrasound detector having a trained machine learning module;

[0036] Figure 6 Another embodiment of an ultrasound probe according to some embodiments is shown, wherein the light source is a separate component;

[0037] Figure 7 Another embodiment of an ultrasound probe further comprising an earphone is shown according to some embodiments;

[0038] Figure 8 Another embodiment of an ultrasound probe that also includes a needle tracking system is shown in accordance with some embodiments. DETAILED DESCRIPTION

[0039] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may be optionally combined with or replace the features of any of the many other embodiments disclosed herein.

[0040] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concepts provided herein.Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide sequence or numerical restrictions.For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiments including such features or steps are not necessarily limited to these three features or steps.For convenience, using labels such as "left", "right", "top", "bottom", "front", "back", etc., these labels are not intended to imply, for example, any specific fixed position, orientation or direction.On the contrary, such labels are used to reflect, for example, relative position, orientation or direction.Singular forms of "a kind of", "one" and "the" include plural references, unless the context clearly stipulates otherwise.

[0041] The term "logic" may refer to hardware, firmware, or software configured to perform one or more functions. As hardware, the term "logic" may refer to or include circuits having data processing and / or storage functions. Examples of such circuits may include, but are not limited to or constrained to, hardware processors (e.g., microprocessors, one or more processor cores, digital signal processors, programmable gate arrays, microcontrollers, application specific integrated circuits "ASICs", etc.), semiconductor memories, or combinational components.

[0042] Additionally or alternatively, the term "logic" may refer to or include software, such as one or more processes, one or more instances, an application programming interface (API), a subroutine, a function, an applet, a servlet, a routine, a source code, an object code, a shared library / dynamic link library (dll), or even one or more instructions. The software may be stored in any type of suitable non-transitory storage medium or transient storage medium (e.g., an electrical, optical, acoustic, or other form of propagating signal, such as a carrier wave, an infrared signal, or a digital signal). Examples of non-transitory storage media may include, but are not limited to or limited to: programmable circuits; non-persistent storage devices, such as volatile memory (e.g., any type of random access memory "RAM"); or persistent memory, such as non-volatile memory (e.g., read-only memory "ROM", power-powered RAM, flash memory, phase change memory, etc.), a solid-state drive, a hard drive, an optical drive, or a portable memory device. As firmware, the logic may be stored in a persistent storage device.

[0043] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0044] The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components may be coupled to each other even if they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component.

[0045] Any method disclosed herein includes one or more steps or actions for performing the described method. These method steps and / or actions can be interchangeable with each other. In other words, unless the proper operation of the embodiment requires a specific order of steps or actions, the order and / or use of specific steps and / or actions can be modified. In addition, a subroutine or only a portion of the method described herein can be a separate method within the scope of the disclosed text. In other words, some methods can include only a portion of the steps described in the more detailed method. In addition, all embodiments disclosed herein are combinable and / or interchangeable, unless otherwise stated, or such combination or interchange will be contrary to the operability of any embodiment.

[0046] Figure 1An ultrasound probe in contact with a patient's skin surface according to some embodiments is shown. The ultrasound probe (probe) 100 includes a probe 110 having an array of ultrasound transducers 112 arranged along its patient contact surface. The ultrasound transducer 112 is configured to: (i) project an ultrasound signal 113 into a patient 40; (ii) receive a reflected ultrasound signal 114 from the patient 40; and (iii) convert the reflected ultrasound signal 114 into an electrical signal. The array of ultrasound transducers 112 can be configured to detect movement of an anatomical target 50, such as pulsation of a blood vessel wall or movement of blood within a blood vessel. The probe 100 includes a console 115, which is generally configured to generate ultrasound image data from the electrical signal, as further described below. The probe 100 is placed on the patient 40 so that the probe 110 is positioned over a target area 45 of the patient 40. The logic of the console 115 is configured to, for example, detect the presence of one or more anatomical targets (such as the anatomical target 50) within the target area 45. As shown, in some cases, the detector 100 can be positioned on the patient 40 so that the anatomical target 50 is centered relative to the detector 100, that is, so that the anatomical target 50 is positioned at a position 51 aligned with the central axis 105 of the detector 100. In other cases, the detector 100 can be located at a position spaced apart from the central axis 105 on either side, such as a right position 52 or a left position 53.

[0047] Although not required, the probe 100 can be coupled to the display 140 via a wired or wireless connection so that an ultrasound image 141 as defined by the ultrasound image data can be depicted on the display 140. In the illustrated embodiment, the ultrasound image 141 depicts an anatomical target image 150 of the anatomical target 50. As shown, the anatomical target image 150 is centrally located within the ultrasound image 141 (i.e., the position 151 of the anatomical target image 150 is aligned with the central axis 145 of the ultrasound image 141), consistent with the central position of the anatomical target 50 relative to the probe 100. Also as shown, the anatomical target image 150 can be depicted at a position 152 or 153 relative to the central axis 145, consistent with the corresponding position 52 or 53 of the anatomical target 50 relative to the probe 100.

[0048] The probe 100 also includes a light source 120 configured to project a visual indication onto the skin surface, such as FIG. 2A to FIG. 2BFurther described. Detector 100 can also include one or more buttons 125, and one or more buttons are configured to enable the user to operate detector 100, including activation and / or deactivation of light source 120. Light source 120 can, for example, include any suitable light emitting device, such as laser, light emitting diode or optical fiber. In addition, light source 120 can include any number of (for example, 1, 2, 3 or more) light emitting devices. In the illustrated embodiment, light source 120 can be located on the front side 102 of detector 100. However, in other embodiments, light source 120 can be located at other positions (including multiple positions) on detector 100, such as on the right side, left side or rear side of detector 100.

[0049] Figure 2A 1 shows the detector 100 according to one embodiment projecting a visual indication 210 onto the skin surface 41 of the patient 40 via the light source 120. The visual indication 210 can be configured to convey information to the user 30 based on a plurality of characteristics of the anatomical target 50. According to one embodiment, the visual indication 210 can indicate that the detector 100 has detected the presence of the anatomical target 50 within the target area 45 (see Figure 1 ). In such embodiments, the visual indication 210 may be projected (i.e., the light source 120 may be activated) only when the anatomical target 50 is detected within the target area 45. In other words, activation of the light source 120 may be prevented unless the anatomical target 50 is detected within the target area 45. In some embodiments, the visual indication 210 may include illumination of an area 201 in front of the probe 100 to indicate that the anatomical target 50 is detected within the target area 45. According to one use case, the user 30 may adjust the position of the probe 100 on the skin surface until the light source 120 is activated to illuminate the area 201 as a result of detecting the anatomical target 50 within the target area 45.

[0050] Visual indication 210 may include a shape configured to indicate a location on skin surface 41, such as line 224 or point 222. In some embodiments, line 224 or point 222 may be projected in alignment with second central axis 205 of probe 100, where second central axis 205: (i) is aligned with Figure 1 and (ii) extending vertically away from the front face 102. In such an embodiment, the detector 100 can determine that the anatomical target 50 is located at the position 51 (see Figure 1 ). Thus, line 224 or point 222 can be projected directly onto anatomical target 50. According to another use case, user 30 can adjust the position of probe 100 on skin surface 45 until central axis 105 (see Figure 1) is arranged on the anatomical target 50, in which case the visual indication 210 may include a line 224 and / or a dot 222.

[0051] When the visual indication 210 includes a line 224, the line 224 can indicate that there is an anatomical target 50 directly below the line 224. Therefore, the user 30 can be confident that the needle 60 inserted into the patient along the line 224 will intersect the anatomical target 50. Similarly, when the visual indication 210 includes a point 225, the point 225 can indicate that there is an anatomical target 50 directly below the point 225. Therefore, the user 30 can be confident that the needle 50 inserted into the patient at the point 225 will intersect the anatomical target 50. In some embodiments, the point 225 can be projected at a defined distance from the front side 102 to indicate the best or preferred insertion site of the needle 50. In some embodiments, the visual indication 210 can, for example, include a set of scale lines 226 (or other markings) indicating a defined distance from the front side 102, such as 0.5 cm, 1 cm, 1.5 cm, and 2 cm. Of course, other distances can be indicated by the scale lines 226 as can be imagined by a person of ordinary skill.

[0052] The visual indication 210 may also include multiple colors to indicate the characteristics of the anatomical target 50. In some embodiments, the characteristics of the anatomical target 50 may include an identification. In the illustrated embodiment, the logic may determine that the identification of the anatomical target 50 is a vessel, and may further identify the vessel as a vein or some other anatomical element (including an artery). Therefore, based on the identification of the anatomical target 50, the visual indication 210 may also include a color or some other visual characteristic. According to one embodiment, the logic may determine that the anatomical target 50 is a vein, and project a visual indication 210 having a first color (e.g., green). Similarly, the logic may determine that the anatomical target 50 is an anatomical element other than a vein (e.g., an artery), and project a visual indication 210 having a second color (e.g., red) different from the first color.

[0053] According to another embodiment, the logic may determine that the anatomical target 50 is below the line 224 (i.e., centered relative to the ultrasound probe) and project a visual indication 210 having a third color. Similarly, the logic may determine that the anatomical target 50 is located at a position spaced apart from the line 224 and project a visual indication 210 having a fourth color different from the third color.

[0054] In some use cases, the user may deploy the probe 100 to find a vein to be entered by the needle 60. In such cases, the user may adjust the position of the probe 100 on the skin surface until the probe 100 projects a visual indication having a third color, in which case the user may be confident that the needle 60 will intersect the vein when inserted into the patient 40 along line 224 or at point 222.

[0055] As would be apparent to one of ordinary skill in the art, other visual characteristics of the visual indication 210 are also contemplated, such as flashing or strobing, color changes, text messages, markings, shapes, light intensities, or multiple projections, for example to indicate the above characteristics of the anatomical target 50, or for example other characteristics, such as ease of access, depth from the skin surface 41, or the presence of an obstruction.

[0056] Figure 2B The probe 100 according to another embodiment is shown projecting a visual indication 210 onto the skin surface 41 of the patient 40, wherein the anatomical target 50 is located at a position offset from the second central axis 205 (such as Figure 1 At position 52 or position 53 as shown. Figure 2B In the illustrated case, the anatomical target 50 is located at position 52. However, the following description may also apply to the case where the anatomical target 50 is located at position 53. According to this embodiment, the characteristics of the anatomical target 50 include the position of the anatomical target 50 relative to the detector 100. As shown, the visual indication 210 is projected onto the skin surface 41 at a position 252 offset from the second central axis 205 to indicate that the anatomical target 50 is located at position 52 offset from the central axis 105 (see Figure 1 ) place.

[0057] Figure 3 A block diagram of a console 115 according to some embodiments is shown. The console 115 is generally configured to manage the operation of the detector 100. The console 115 includes one or more processors 310 and a memory 320 (e.g., a non-transitory computer readable medium) having logic stored thereon. The logic includes determination logic 322, positioning logic 324, identification logic 326, and light source activation logic 328. The console 115 is powered via a power source 315 (e.g., a battery). The console 115 may optionally include a wireless module 305 to facilitate wireless communication with an external computing device 330 (sometimes referred to as a computing system), as further described below.

[0058] The console 115 includes an interface module 332 (e.g., a connector group) configured to achieve operational connection between the console 115 and the probe 110 and / or the light source 120. The signal conditioner 331 converts the electrical signal from the probe 110 into ultrasound image data for processing according to logic by one or more processors 310. Similarly, the signal conditioner 331 converts digital data from the processor 310 into electrical signals for the probe 110 and / or the light source 120.

[0059] The determination logic 322 receives ultrasound image data from the probe 110 and performs a determination process on the ultrasound image data to detect / determine the presence of the anatomical target 50 within the target region 45. Upon detecting the anatomical target 50, the positioning logic 324 performs a positioning process on the ultrasound image data, for example, to determine the position of the anatomical target 50 relative to the probe 100, such as at position 51, 52, or 53.

[0060] In addition, upon detecting the anatomical target 50, the identification logic 326 may perform an identification process on the ultrasound image data, for example, to identify the anatomical target 50, i.e., determine that the anatomical target 50 is a vein or some other anatomical element, such as a bone, a nerve cluster, an artery, or a bifurcation of a blood vessel. According to one embodiment, the ultrasound image data may include Doppler ultrasound data, and the identification logic 326 may be configured to identify the anatomical target 50 based at least in part on the Doppler ultrasound data, wherein the Doppler ultrasound data is configured to detect / determine movement of the anatomical target 50 or a portion thereof. Such movement may include pulsation of at least a portion of the anatomical target 50 or flow of blood within the anatomical target 50.

[0061] According to one embodiment, the memory 320 may optionally include a machine learning (ML) model 325 trained for localization, and performing a localization process on the ultrasound image data may include applying the ML model 325 trained for localization to the ultrasound image data. The result of applying the ML model 325 trained for localization to the ultrasound image data may include determining the position of the anatomical target 50 relative to the detector 100.

[0062] According to one embodiment, the memory 320 may optionally include a machine learning (ML) model 327 trained for identification, and performing an identification process on the ultrasound image data may include applying the ML model 327 trained for identification to the ultrasound image data. The result of applying the ML model 327 trained for identification to the ultrasound image data may, for example, include determining an identification of the anatomical target 50 as a vein or some other anatomical element, such as an artery.

[0063] Figure 4 is a block diagram of a computerized method 400 according to some embodiments, the computerized method including all or any subset of the following actions, operations, or processes. Figure 4Each box shown in represents an operation of method 400 performed by an ultrasound probe disclosed herein. Method 400 includes receiving ultrasound image data converted from an electrical signal generated by an ultrasound probe of the ultrasound probe, wherein the ultrasound probe is placed on a skin surface of a patient above a target area (box 410). The ultrasound probe includes an ultrasound transducer array, which is configured to: (i) transmit the generated ultrasound signal into the target area of ​​the patient; (ii) receive reflected ultrasound signals from the patient; and (iii) convert the reflected ultrasound signals into corresponding electrical signals. Method 400 may also include performing a determination process on the ultrasound image data to determine when an anatomical target is present within the ultrasound image (box 420). Method 400 may also include activating a light source of the ultrasound probe to project a visual indication onto the skin surface, wherein the visual indication includes one or more visual characteristics based on one or more characteristics of the anatomical target (box 430).

[0064] The method 400 may also include performing a localization process on the ultrasound image data to determine a position of an anatomical target within the target region relative to the ultrasound probe, and projecting a visual indication onto the skin surface at a location above the anatomical target (block 440). The method 400 may also include applying a first trained machine learning model to the ultrasound image data, resulting in determining a position of the anatomical target relative to the ultrasound probe (block 450).

[0065] The method 400 may also include performing an identification process on the ultrasound image to identify the anatomical target as a vein or some other anatomical element, and projecting a visual indication having a first color when the identification process identifies the anatomical target as a vein (box 460). The method 400 may also include projecting a visual indication having a second color different from the first color when the identification process identifies the anatomical target as an anatomical element other than a vein (including an artery). The method 400 may also include applying a second trained machine learning model to the ultrasound image data, resulting in the identification of the anatomical target as a vein or some other anatomical element (box 470).

[0066] Figure 5An ultrasound imaging system (system) 500 is shown according to some embodiments. The system 500 is generally configured to define a ML model 325 trained for positioning and / or a ML model 327 trained for identification. The system 500 generally includes a plurality of detectors 510 (i.e., a plurality of detectors 100) coupled to an external computing device 330. According to one embodiment, the external computing device 330 may include a network server. In some embodiments, the external computing device 330 may be coupled to or incorporated into an EMR system 550. In other embodiments, the external computing device 330 may be incorporated into one or more of the detectors in the detector 100. The plurality of detectors 510 may be wirelessly coupled to the EMR system 550, and in such embodiments, the plurality of detectors 510 may transmit data (such as historical ultrasound image data sets) to the EMR system 550.

[0067] The external computing device 330 includes a database 530 and a machine learning (ML) logic 532 stored in a memory 510 (e.g., a non-transitory computer-readable medium). The ML logic 532 is configured to acquire historical ultrasound image data sets from multiple detectors 510 and / or EMR systems 550 to form a training data set 531 stored in the database 530. The ML logic 532 is further configured to apply an ML algorithm 534 to the training data set 531 to define a localization-trained ML model 325 and / or an identification-trained ML model 327, wherein the ML logic 532 may include or be configured to execute multiple ML algorithms 534 (e.g., prediction algorithms such as linear regression, logistic regression, classification and regression trees, naive Bayes, K-nearest neighbors, etc.). The historical ultrasound image data sets include location data sets and / or identification data sets received from multiple detectors 510 and actual anatomical target data sets that correspond to the ultrasound image data sets individually (i.e., according to a one-to-one relationship). More specifically, for a single ultrasound imaging event, each ultrasound image data set corresponds to an actual anatomical target data set.

[0068] The position data set of the ultrasound imaging event includes the determined position of the anatomical object, that is, the position of the anatomical object 50 relative to the probe 100, such as the positions 51 to 53 determined by the probe 100 (see Figure 1) in a location in the display 140. The actual anatomical target dataset includes an independent determination of the location, such as a visual determination of the location of an anatomical target image 150 depicted on the display 140, or includes a direct determination by the user 30, such as the position of the needle 60 relative to the probe 100 when inserted. In some cases, the independent determination of the location can be recorded in the EMR of the patient 40. Similarly, the actual anatomical target dataset can include an independent identification of the anatomical target 50 as a vein or some other anatomical element (including an artery). The independent identification can include utilizing a separate ultrasound imaging system, a needle tracking system, a catheter tracking system, etc. In some cases, the independent identification of the anatomical target 50 can be recorded in the EMR of the patient 40.

[0069] The external computing device 330 may be coupled to the EMR system 550, and the ML logic 532 may acquire the actual anatomical target data set from the EMR system 550. The localization-trained ML model 325 and / or the identification-trained ML model 327 may be stored in the memory 520 of the external computing device 330. The ML logic 532 may transmit or transfer the localization-trained ML model 325 and / or the identification-trained ML model 327 to the detector 100 for storage in the memory 320.

[0070] Figure 6 Another embodiment of an ultrasound probe 600 is shown, which may be similar in some respects to a combination of Figures 1 to 4 The components, features, and functionality of the ultrasound probe 100 described herein. It should be understood that all illustrated embodiments may have similar features. Therefore, the relevant disclosures described above regarding similarly identified features may not be repeated in the following. Figures 1 to 4 Certain features of the ultrasound probe 100 and related components shown in the drawings may not be shown in the drawings or identified by reference numerals, or may not be specifically discussed in the subsequent written description. However, such features may obviously be the same or substantially the same as features depicted in other embodiments and / or described with respect to such embodiments. Therefore, the relevant description of such features is equally applicable to the features of the ultrasound probe 600. Figures 1 to 4 Any suitable combination of features and variations thereof of the ultrasound probe 100 and component descriptions shown in Figure 6 The ultrasonic probe 600 system and components are used together, and vice versa. This mode of the disclosed text is also applicable to other embodiments depicted in subsequent figures and described below.

[0071] Ultrasound probe (probe) 600 includes a light source module 610, which is a separate component from the probe 600. The light source module 610 can be attached to the probe 600. In the illustrated embodiment, the light source module 610 is configured to be attached to the front 602 of the probe 600. However, in other embodiments, the light source module 610 can be attached to the probe 600 at other positions (such as the right side, the left side or the back side). The light source module 610 can also be detachable from the probe 600. In some embodiments, the light source module 610 can be configured for single use, that is, the light source module 610 can be a disposable component. The light source module 610 includes a light source 620. The light source module 610 can be attached to the probe 600, such as via a strip, a clamp, a clamp, an adhesive or one or more magnets.

[0072] The light source module 610 is configured to be operably coupled to the detector 600 when the light source module 610 is attached to the detector. However, in some embodiments, the light source module 610 can be operably coupled to the detector 600 even when the light source module 610 is not physically attached to the detector 600. In some embodiments, the light source module 610 can include a plurality of electrical connection members (e.g., pins) configured to make electrical contact with corresponding electrical connection members (e.g., sockets) of the detector 600.

[0073] According to one embodiment, the light source module 610 can be configured to wirelessly couple with the detector 600. Thus, the light source module 610 can include console components such as a battery, a processor, a memory, and a wireless module, for example, to enable the light source module 610 to be operably coupled with the detector 600.

[0074] In some embodiments, the probe 600 can include a sterile barrier 630, such as a plastic or elastomeric covering (e.g., a bag) covering the probe 600 (including the front face 602). In such embodiments, the light source module 610 can be attached to the probe 600 with the sterile barrier 630 disposed between the light source module 610 and the probe 600. In other words, the light source module 610 is configured to be attached to the probe 600 without disabling the sterile barrier 630.

[0075] Figure 7 An embodiment of an ultrasound probe (probe) 700 coupled to a headset 760 is shown. The headset 760 may be a virtual or augmented reality headset configured to depict an image 770 of the probe 700 used with a patient 40 on a display 765. In some embodiments, the probe 700 may omit a light source. Thus, the image 770 may include visual indications 710 appearing on the skin surface 41 of the patient 40. The visual indications 710 may include information about FIG. 2A to FIG. 2B All or any subset of the features of the described visual indication 210. The headset 760 may be coupled to the detector 700 via a wired or wireless connection.

[0076] Figure 8 An embodiment of an ultrasound probe (probe) 800 having a needle tracking system 880 is shown, which is integrated into the probe 800 or otherwise operably coupled thereto. The needle tracking system 880 is generally configured to track a trackable needle 881 relative to an anatomical target 50. More specifically, the probe 800 determines the position of the anatomical target 50 relative to the probe 800, and the needle tracking system 880 determines the position of the trackable needle 881 relative to the probe 800.

[0077] The needle tracking system 880 is configured to magnetically track a trackable needle 881. The trackable needle 881 includes a plurality (e.g., 1, 2, 3, or more) of magnetic elements 882 configured to generate one or more magnetic fields 883. The needle tracking system 880 also includes a plurality (e.g., 1, 2, 3, or more) of magnetometers 885 configured to detect the one or more magnetic fields 883. In the illustrated embodiment, the console 815 may be similar in some respects to Figure 3 The components and features of the console 115 of the present invention. The signal conditioner 831 includes the features and functionality of the signal conditioner 331 and is further configured to receive the electrical tracking signal from the magnetometer 885 and convert the electrical tracking signal into needle tracking data. The console 815 includes tracking logic 886 configured to receive the needle tracking data. The tracking logic 886 performs a tracking process on the ultrasound image data in conjunction with the needle tracking data to determine the position of the trackable needle 881 relative to the anatomical target 50.

[0078] The visual indication 810 may include all or any subset of the features of the visual indication 210, and may also include one or more visual characteristics based on the position of the trackable needle 881 relative to the anatomical target 50. In the illustrated embodiment, the visual characteristics are configured to indicate when the trackable needle 881 is aligned with the anatomical target 50. More specifically, the visual characteristics based on the position of the trackable needle 881 relative to the anatomical target 50 are configured to indicate when the position and orientation of the trackable needle 881 relative to the anatomical target 50 is such that insertion of the trackable needle 881 into the patient 40 will enter or intersect the anatomical target 50. In some embodiments, the visual characteristics based on the position of the trackable needle 881 include: (i) a fifth color (e.g., red) when the tracking process determines that the trackable needle is not aligned with the anatomical target; and (ii) a sixth color (e.g., green) different from the fifth color when the tracking process determines that the trackable needle is aligned with the anatomical target.

[0079] Additional details regarding the needle tracking system 880 may be found in the following U.S. patents and patent application publications: 2014 / 0257080; 2014 / 0257104; 9,155,517; 9,257,220; 9,459,087; and 9,597,008, each of which is incorporated herein by reference in its entirety.

[0080] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations and / or modifications are also encompassed. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. An ultrasonic detector, characterized in that: include: a probe including an ultrasound transducer array configured to transmit generated ultrasound signals into a target area of ​​a patient, receive reflected ultrasound signals from the patient, and convert the reflected ultrasound signals into corresponding electrical signals; a light source configured to project a visual indication onto a skin surface of the patient upon activation, wherein the visual indication comprises one or more visual characteristics based on one or more characteristics of an anatomical target; and A signal converter is configured to convert the electrical signal into ultrasound image data including an ultrasound image of the target region in order to determine when the anatomical target is present within the ultrasound image.

2. The ultrasonic detector according to claim 1, characterized in that: The light source includes a separate light source module attached to and operably coupled with the ultrasound probe.

3. The ultrasonic probe according to claim 2, characterized in that: The separate light source module is configured to be attached to and operably coupled with the ultrasound probe, the ultrasound probe having a sterile barrier covering the probe, the sterile barrier being disposed between the separate light source module and the ultrasound probe.

4. The ultrasonic detector according to claim 2, characterized in that: The separate light source module is wirelessly connected to the ultrasound probe.

5. The ultrasonic probe according to claim 2, characterized in that: The individual light source modules are configured for single use.

6. The detector according to claim 1, characterized in that: The one or more visual features include at least one of a point or a line.

7. The ultrasonic probe according to claim 6, characterized in that: The one or more visual characteristics include the line, and wherein the line is configured to extend away from the ultrasound probe in a direction perpendicular to a front face of the ultrasound probe.

8. The ultrasonic detector according to claim 1, characterized in that: The ultrasound probe is operably coupled to a needle tracking system configured to determine a position and orientation of a trackable needle relative to the ultrasound probe in order to determine a position of the trackable needle relative to the anatomical target.

9. An ultrasound system, characterized in that: include: Headsets, including augmented or virtual reality headsets; and An ultrasound probe operably connected to the earphone, the ultrasound probe comprising: a probe including an ultrasound transducer array configured to transmit generated ultrasound signals into a target area of ​​a patient, receive reflected ultrasound signals from the patient, and convert the reflected ultrasound signals into corresponding electrical signals; and a signal converter configured to convert the electrical signal into ultrasound image data including an ultrasound image of the target region so as to determine when an anatomical target is present within the ultrasound image, The display of the headset is configured to display a visual indication depicting what appears on a skin surface of the patient in relation to the ultrasound probe, the visual indication comprising one or more visual characteristics based on one or more characteristics of the anatomical target.

10. The ultrasound system according to claim 9, characterized in that The one or more visual features include at least one of a point or a line.

11. The ultrasound system according to claim 10, characterized in that The one or more visual characteristics include the line, and wherein the line is configured to extend away from the ultrasound probe in a direction perpendicular to a front face of the ultrasound probe.

12. The ultrasound system according to claim 9, characterized in that: The ultrasound probe is operably coupled to a needle tracking system configured to determine a position and orientation of a trackable needle relative to the ultrasound probe in order to determine a position of the trackable needle relative to the anatomical target.

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