Hands-free ultrasound probe, assembly, system and method

Abstract

Hand-free ultrasound probes, assemblies, systems, and methods are disclosed herein. For example, an ultrasound probe assembly can include an ultrasound probe and a disposable pad coupled to a patient-facing side of the ultrasound probe. The ultrasound probe can include a probe body, a stabilizer extending from the probe body, a probe head including ultrasound transducers in an array located in a patient-facing portion of the probe body, and a needle guide holder extending from the probe body. The stabilizer is configured to stabilize the ultrasound probe hand-free by the pad in contact with a skin surface of a patient when the ultrasound probe is placed on the patient. An ultrasound system can include a console and the above-described ultrasound probe assembly. A method can include using the above-described ultrasound system for hand-free ultrasound imaging while inserting a needle into an anatomical target to establish an insertion site for placement of a vascular access device.

Description

[0001] Priority

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 085,072, filed September 29, 2020, the entirety of which is incorporated by reference into this application. TECHNICAL FIELD

[0003] The present application relates to the field of medical devices, and more particularly to hand- free ultrasound probes, assemblies, systems, and methods. BACKGROUND

[0004] Various ultrasound systems exist that include a wired or wireless ultrasound probe. Whether wired or wireless, ultrasound systems such as the above require a clinician to hold and operate the ultrasound probe with one hand while ultrasound imaging, and simultaneously use the other hand to establish an insertion site in which to place a vascular access device (“VAD”), such as a catheter or the like. The need to operate with two hands while ultrasound imaging and establishing an insertion site or placing a VAD therein can be difficult, particularly for less experienced clinicians. For example, a clinician can miss a target blood vessel while attempting to establish an insertion site, causing discomfort or pain to the patient. There is therefore a need for ultrasound systems with hand-free ultrasound probes. Indeed, with hand-free ultrasound imaging, a clinician would be able to use both hands to establish an insertion site and place a VAD therein.

[0005] Disclosed herein are hand-free ultrasound probes, assemblies, systems, and methods. SUMMARY

[0006] An ultrasound probe assembly is disclosed, which in some embodiments includes an ultrasound probe and a disposable pad coupled to a patient-facing side of the ultrasound probe. The ultrasound probe includes a probe body, a stabilizer extending from the probe body, a probe head in a patient-facing portion of the probe body, and a needle guide holder extending from the probe body. The stabilizer is configured for hand-free stabilization of the ultrasound probe when placed on a patient. The probe head includes an ultrasound transducer in an array form. The pad is configured to contact a skin surface of a patient.

[0007] In some embodiments, the needle guide holder extends from the probe body along the stabilizer and toward a center of the stabilizer.

[0008] In some embodiments, the needle guide holder is configured to rotate toward and away from the patient-facing side of the ultrasound probe for different needle insertion angles, with a needle disposed in a needle through-hole of a needle guide coupled to the needle guide holder.

[0009] In some embodiments, the probe body and the needle guide holder include complementary locking features at where the needle guide holder extends from the probe body. The locking features are configured to lock the needle guide holder in different positions for different needle insertion angles.

[0010] In some embodiments, the ultrasound probe assembly further includes one or more needle guides. The one or more needle guides are configured to attach to the needle guide holder. Each of the one or more needle guides includes a needle through-hole configured to guide a needle into a patient beneath the probe.

[0011] In some embodiments, each of the one or more needle guides is configured for insertion of a needle into a patient at a different needle insertion angle.

[0012] In some embodiments, the stabilizer includes two arcuate stabilizer arms extending from opposite sides of the probe body.

[0013] In some embodiments, each of the two stabilizer arms includes a hook in a patient-facing side of the stabilizer that secures the stabilizer to the pad.

[0014] In some embodiments, the pad includes two arcuate pad arms having a common boundary with the two stabilizer arms. Each of the two pad arms includes an aperture in a clinician-facing side of the pad. The hooks are correspondingly disposed in the apertures beneath latches that partially cover the apertures.

[0015] In some embodiments, each of the two pad arms is connected beneath the probe. The pad includes an ultrasound window configured to allow ultrasound signals generated from the ultrasound transducer to be transmitted and reflected ultrasound signals to be received by the ultrasound transducer.

[0016] In some embodiments, the patient-facing portion of the pad is formed of a conformable material to make the patient comfortable.

[0017] In some embodiments, the pad includes an adhesive configured to adhere the pad to a skin surface of the patient.

[0018] In some embodiments, the patient-facing portion of the pad is contoured such that an outer portion of the pad is thicker than an inner portion of the pad, thereby making the pad conform to a skin surface of the patient.

[0019] In some embodiments, the patient-facing portion of the pad includes two contoured pad arm extensions extending away from the stabilizer. The two pad arm extensions are configured to conform across a limb of the patient.

[0020] In some embodiments, the ultrasound probe further includes one or more magnetic sensors. The one or more magnetic sensors are configured to detect magnetic field changes of the magnetized needle for visual needle guidance to the anatomical target on the display screen while ultrasound imaging the anatomical target.

[0021] Also disclosed herein is an ultrasound system including a console and an ultrasound probe assembly. The console includes a display configured to present an ultrasound image on a display screen of the display. The ultrasound probe assembly includes an ultrasound probe and a disposable pad coupled to a patient-facing side of the ultrasound probe. The ultrasound probe includes a probe body, a stabilizer extending from the probe body, a probe head in a patient-facing portion of the probe body, and a needle guide holder extending from the probe body. The stabilizer is configured for hands-free stabilization of the ultrasound probe when placed on a patient. The probe head includes an ultrasound transducer in an array form. The pad is configured to contact a skin surface of the patient.

[0022] In some embodiments, the console and the display are further configured to provide visual guidance of the magnetized needle of the ultrasound probe assembly toward the anatomical target on the display screen of the display. The ultrasound probe further includes one or more magnetic sensors configured to detect magnetic field changes of the needle for the visual guidance.

[0023] Also disclosed herein is a method of an ultrasound system, in some embodiments, including an obtaining step, an assembling step, a moving step, a monitoring step, and a needle insertion step. The obtaining step includes obtaining an ultrasound probe. The ultrasound probe includes a probe body, a stabilizer extending from the probe body, and a probe head in a patient-facing portion of the probe body. The assembling step includes fastening a disposable pad to a patient-facing side of the ultrasound probe to form an ultrasound probe assembly. The moving step includes moving the ultrasound probe assembly over a patient while the ultrasound probe transmits generated ultrasound signals from an ultrasound transducer in an array form in the probe head into the patient and receives reflected ultrasound signals from the patient by the ultrasound transducer. The monitoring step includes monitoring an ultrasound image on a display screen of the ultrasound system to identify an anatomical target of the patient. The needle insertion step includes inserting a needle into the anatomical target while the ultrasound probe assembly is hands-free stabilized on the anatomical target by the stabilizer.

[0024] In some embodiments, the assembling step includes inserting hooks of the patient-facing side of the stabilizer into orifices of the clinician-facing side of the pad and sliding the hooks under latches that partially cover the orifices.

[0025] In some embodiments, the method further includes an adhering step. The adhering step includes adhering the pad to the patient over the anatomical target after identifying the anatomical target during the monitoring step. The pad includes an adhesive for adhering the pad to the patient in the adhering step.

[0026] In some embodiments, the method further comprises an attaching step. The attaching step comprises attaching a needle guide to a needle guide holder extending from the probe body. The needle guide comprises a needle through hole configured to guide a needle into a patient beneath the probe.

[0027] In some embodiments, the needle guide is selected from one needle guide or a plurality of other needle guides for use in the needle insertion step at a particular needle insertion angle.

[0028] In some embodiments, the method further comprises a rotating step. The rotating step comprises rotating the needle guide holder toward or away from a patient-facing side of the ultrasound probe for use in the needle insertion step at a particular needle insertion angle.

[0029] In some embodiments, the rotating step comprises locking the needle guide holder into place at a particular needle insertion angle. The probe body and the needle guide holder comprise complementary locking features at where the needle guide holder extends from the probe body.

[0030] In some embodiments, the method further comprises another monitoring step. The other monitoring step comprises monitoring visual guidance of the needle on a display screen. The ultrasound probe further comprises one or more magnetic sensors configured to detect a change in a magnetic field when the needle is magnetized for the visual guidance.

[0031] These and other features of the concepts provided herein will become more apparent from the following description in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 A perspective view of a first ultrasound probe assembly including a first ultrasound probe and a first disposable pad coupled thereto is shown in accordance with some embodiments.

[0033] Figure 2 A front view of the ultrasound probe assembly of Figure 1 is shown.

[0034] Figure 3 An exploded view of the ultrasound probe assembly of Figure 1 is shown.

[0035] Figure 4 A perspective view of a second ultrasound probe assembly including a first ultrasound probe and a second disposable pad coupled thereto is shown in accordance with some embodiments.

[0036] Figure 5 A perspective view of a second ultrasound probe assembly including a first ultrasound probe and a second disposable pad coupled thereto is shown in accordance with some embodiments.Figure 4 a front view of the ultrasound probe assembly of

[0037] Figure 6 a perspective view of a third ultrasound probe assembly including the second ultrasound probe and a third disposable pad coupled thereto is shown in accordance with some embodiments.

[0038] Figure 7 an exploded view of the ultrasound probe assembly of Figure 6

[0039] Figure 8 a cross-sectional view of the ultrasound probe assembly of Figure 6

[0040] a cross-sectional view of the ultrasound probe of Figure 9 Figure 6 a perspective view of the pad of

[0041] Figure 10 Figure 6 a perspective view of the pad of

[0042] Figure 11 a block diagram of an ultrasound system in accordance with some embodiments. DETAILED DESCRIPTION

[0043] Before certain specific embodiments are disclosed in more detail, it is to be understood that the terminology used herein is for the purpose of describing certain specific embodiments and is not intended to be limiting. It is also to be understood that certain specific embodiments disclosed herein can have features that are capable of being readily separated from the specific embodiments and optionally combined with or substituted for features of any of a variety of other specific embodiments disclosed herein.

[0044] With respect to the terms used herein, it is also to be understood that these terms are used for the purpose of describing certain specific embodiments and are not intended to 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 group of features or steps and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not be in that order and the specific embodiments including such features or steps need not be limited to the three features or steps. Moreover, any of the foregoing features or steps can comprise one or more features or steps, unless otherwise indicated. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to mean any particular fixed position, orientation, or direction. On the contrary, such terms are used in relation to an example orientation or position of an object to be reflected in the description of the object. Terms of approximation, such as “approximately,” “substantially,” “almost,” “notably,” and the like, are used as labels that refer to conditions where a quantitative comparison is made between nominally or commonly understood values. Such terms are used to refer to conditions where a value or behavior is within some percentage range of a nominally stated value. Such terms of approximation are not used to refer to an approximate, estimated, or near value or behavior.​​​

[0045] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter includes a portion of the catheter intended to be proximate to a clinician when the catheter is used on a patient. Similarly, for example, a "proximal length" of a catheter includes a length of the catheter intended to be proximate to a clinician when the catheter is used on a patient. For example, a "proximal end" of a catheter includes an end of the catheter intended to be proximate to a clinician when the catheter is used on a patient. A proximal portion, proximal end portion, or proximal length of a catheter can include a proximal end of the catheter; however, a proximal portion, proximal end portion, or proximal length of a catheter need not include a proximal end of the catheter. That is, unless context dictates otherwise, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of the catheter.

[0046] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter includes a portion of the catheter intended to be proximate to or within a patient when the catheter is used on the patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter intended to be proximate to or within a patient when the catheter is used on the patient. For example, a "distal end" of a catheter includes an end of the catheter intended to be proximate to or within a patient when the catheter is used on the patient. A distal portion, distal end portion, or distal length of a catheter can include a distal end of the catheter; however, a distal portion, distal end portion, or distal length of a catheter need not include a distal end of the catheter. That is, unless context dictates otherwise, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of the catheter.

[0047] Finally, in the description herein, the terms "or" and "and / or" are used in their inclusive senses, meaning any one or any combination. For example, "A, B, or C" or "A, B, and / or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B, and C." This definition also applies to the use of "or" and "and / or" in the claims.

[0048] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0049] As noted above, various ultrasound systems exist that include a wired or wireless ultrasound probe. Whether wired or wireless, ultrasound systems such as those described above require a clinician to hold and operate the ultrasound probe with one hand while ultrasound imaging, and simultaneously use the other hand to establish an insertion site with a needle in which to place a VAD, such as a catheter or the like. The need to operate with two hands while ultrasound imaging and establishing an insertion site or placing a VAD therein can be difficult, particularly for less experienced clinicians. For example, a clinician can miss a target blood vessel while attempting to establish an insertion site, causing discomfort or pain to the patient. There is therefore a need for ultrasound systems with a hands-free ultrasound probe. Indeed, with hands-free ultrasound imaging, a clinician would be able to use both hands to establish an insertion site and place a VAD therein.

[0050] Disclosed herein are hands-free ultrasound probes, assemblies, systems, and methods. In one example, an ultrasound probe assembly can include an ultrasound probe and a disposable pad coupled to a patient-facing side of the ultrasound probe. The ultrasound probe can include a probe body, a stabilizer extending from the probe body, a probe head, including ultrasound transducers in an array located in a patient-facing portion of the probe body, and a needle guide holder extending from the probe body. The stabilizer is configured for the ultrasound probe to be stabilized hands-free by the pad in contact with a skin surface of a patient when the ultrasound probe is placed on the patient. In another example, an ultrasound system can include a console and the ultrasound probe assembly described above. In yet another example, a method can include using the ultrasound system described above to perform hands-free ultrasound imaging while inserting a needle into an anatomical target to establish an insertion site for placement of a VAD. These and other features of the hands-free ultrasound probes, assemblies, systems, and methods provided herein will become more apparent from the following description in conjunction with the accompanying drawings, in which:

[0051] Ultrasound probe assembly

[0052] Figures 1-3 Various views of a first ultrasound probe assembly 100 are shown in accordance with some embodiments; Figure 4 and Figure 5 Various views of a second ultrasound probe assembly 200 are shown in accordance with some embodiments; Figures 6-8 Various views of a third ultrasound probe assembly 300 are shown in accordance with some embodiments. Notably, Figure 9 and Figure 10 An ultrasound probe 302 and a disposable pad 304 of the ultrasound probe assembly 300 are shown, respectively.

[0053] As shown, ultrasound probe assemblies 100 and 200 include the same ultrasound probe 102, but include different disposable pads 104 and 204 coupled to the patient-facing side of ultrasound probe 102. Ultrasound probe assembly 300 includes ultrasound probe 302 and a disposable pad 304 coupled to the patient-facing side of ultrasound probe 302 similar to pad 104.

[0054] Ultrasound probe 102 or 302 includes a probe body 106 or 306, a probe head 108 located in a patient-facing portion of probe body 106 or 306, a needle guide holder 110 or 310 extending from probe body 106 or 306, and a stabilizer 112 extending from probe body 106 or 306.

[0055] As described above, probe body 106 or 306 constitutes a central portion of a housing of ultrasound probe 102 or 302, probe head 108 is located in a patient-facing portion of probe body 106 or 306, needle guide holder 110 or 310 extends from probe body 106 or 306, and stabilizer 112 extends from probe body 106 or 306. As a central portion of a housing of ultrasound probe 102 or 302, probe body 106 or 306 houses a plurality of electronic components of ultrasound probe 102 or 302. In one example, probe body 106 or 306 can house a printed circuit board assembly (“PCBA”) including a plurality of integrated circuits configured for wired or wireless operation of ultrasound probe 102 or 302. In another example, probe body 106 or 306 can house or otherwise include therein one or more magnetic sensors 122 described below, which are communicatively coupled to the PCBA and oriented to sense magnetic signals in the same direction as needle guide holder 110 or 310 extends from probe body 106 or 306.

[0056] When a rotatable needle guide holder 310 is present (e.g., a rotatable needle guide holder of the ultrasound probe 302), the probe body 306 can include a locking feature that is complementary to a locking feature of the needle guide holder 310 from which the needle guide holder 310 extends from the probe body 306 at a location of the locking feature of the needle guide holder. For example, the probe body 306 can include a shaft 313 disposed in a pair of opposing through holes in a pair of inwardly facing faces of the probe body 306, respectively, on which the needle guide holder 310 is rotatably mounted. Further, at least one of the inwardly facing faces can include teeth molded therein and extending radially from the through hole thereof that are complementary to teeth of the needle guide holder 310 so as to form a Hirth joint therebetween. Such a locking feature is configured to lock the needle guide holder 310 in any one of a plurality of different positions corresponding to different needle insertion angles. Additionally, a fixed needle guide holder 110 (e.g., a fixed needle guide holder of the ultrasound probe 102) is molded with the probe body 106.

[0057] The probe 108 is configured to be placed against the skin of a patient, e.g., proximate to an intended VAD placement site. The probe 108 includes an ultrasound transducer 114 in an array form and a patient-facing acoustic lens 116 configured to focus generated ultrasound signals emitted by the ultrasound transducer 114 on an anatomical target, e.g., a blood vessel. Indeed, the ultrasound transducer 114, which can be a piezoelectric ultrasound transducer, a capacitive micromachined ultrasound transducer (“CMUT”), or the like, is configured to generate ultrasound signals in a plurality of pulses and emit the generated ultrasound signals into the patient, receive reflected ultrasound signals or ultrasound echoes from the patient by way of the generated ultrasound pulses being reflected by the patient’s body, and convert the reflected ultrasound signals into corresponding electrical signals for processing into ultrasound images.

[0058] The needle guide holder 110 or 310 extends from the probe body 106 or 306 along a stabilizer 112 side (e.g., stabilizer arm 118) and toward the center of the stabilizer 112. Such a needle guide holder can be fixed in position, similar to the needle guide holder 110 of the ultrasound probe 102, which is molded with the probe body 106 for a single but different needle insertion angle for each different needle guide of the one or more needle guides 134. Alternatively, such a needle guide holder can be configured to rotate toward and away from the patient-facing side of the ultrasound probe 302, similar to the needle guide holder 310. So configured, the needle guide holder 310 can rotate with each different needle guide of the one or more needle guides 134 toward and away from the patient-facing side of the ultrasound probe 302 for a plurality of different needle insertion angles. Notably, the needle guide holder 110 of the ultrasound probe 102 has the advantage that the needle insertion angle depends only on the angle provided by the selected needle guide, which reduces procedure complexity. That is, the needle guide holder 310 of the ultrasound probe 302 has the advantage that the needle insertion angle can be adjusted more finely between the position of the needle guide holder 310 and the selected needle guide.

[0059] The needle guide holder 310 can include a locking feature that is complementary to a locking feature of the probe body 306. Indeed, at least one of the pair of outward facing faces of the needle guide holder 310 can include teeth molded therein that extend radially from a through hole of the needle guide holder 310 through which the needle guide holder 310 is mounted on the shaft 313 of the probe body 306. The foregoing teeth are complementary to teeth of the probe body 306, thereby forming a Hirth joint therebetween as described above. Again, such a locking feature is configured to lock the needle guide holder 310 in any one of a plurality of different positions corresponding to different needle insertion angles.

[0060] The stabilizer 112 is configured for hands-free stabilization of the ultrasound probe 102 or 302 when placed on a patient. As shown, the stabilizer 112 can include two arcuate stabilizer arms 118 of a housing extending from opposite sides of the probe body 106 or 306; however, the stabilizer 112 is not so limited. Indeed, the stabilizer arms 118 need not be of a housing. For example, the stabilizer arms 118 can instead be separate rods or tubes coupled to the probe body 106 or 306. Moreover, the stabilizer arms 118 can instead be linear rather than arcuate. In one example, the stabilizer arms 118 can form a "V" shape with the probe body 106 or 306 at the apex of the "V." In another example, the stabilizer arms 118 can form a "U" shape with the probe body 106 or 306 at the bottom of the "U." Not only that, but the ends of the stabilizer arms 118 can also instead be connected. When the stabilizer arms 118 are arcuate, the connection of the ends of the stabilizer arms 118 results in a circular stabilizer, when the stabilizer arms 118 form a "V" shape with the probe body 106 or 306, such a connection results in a triangular stabilizer, and when the stabilizer arms 118 form a "U" shape with the probe body 106 or 306, such a connection results in a rectangular stabilizer.

[0061] As Figure 3 As best shown, the stabilizer 112 can include hooks 120 on the patient-facing side of the stabilizer 112 configured for fastening the pad 104, 204, or 304 to the stabilizer 112. Indeed, each of the stabilizer arms 118 can include hooks 120 molded into the patient-facing side of the stabilizer 112 for fastening the pad 104, 204, or 304 to the stabilizer 112. As described below, each of the pad arms 124 can correspondingly include apertures 128 in the clinician-facing side of the pad 104, 204, or 304. The hooks 120 are configured to be disposed in the apertures 128 under latches 130 that partially cover the apertures 128 for fastening the pad 104, 204, or 304 to the stabilizer 112. Notably, the stabilizer 112 is not limited to hooks 120 for fasteners nor is the pad 104, 204, or 304 limited to corresponding apertures 128 for fasteners. Indeed, fasteners need not be present on the stabilizer 112 or the pad 104, 204, or 304 as the stabilizer 112 can include a relatively flat surface on its patient-facing side configured to adhere the pad 104, 204, or 304 to the stabilizer 112. (See, e.g., FIG. 6, which shows a pad 304 according to this embodiment.) Figure 7

[0062] ​The ultrasound probe 102 or 302 can further include one or more magnetic sensors 122 configured to detect changes in a magnetic field due to a magnetized medical device. The changes detected in the magnetic field are processed in sequence while the anatomical target is being ultrasonically imaged to guide the medical device to the selected anatomical target. For example, the magnetized medical device can be a needle 138 and the anatomical target (a blood vessel), where the one or more magnetic sensors 122 are configured to detect changes in the magnetic field due to the needle 138 for guiding the needle 138 to the blood vessel while the blood vessel is being ultrasonically imaged. The one or more magnetic sensors 122 can be disposed in the probe body 106 or 306 proximate to a patient-facing side of the ultrasound probe 102 or 302 and oriented in the same direction as the needle guide holder 110 or 310 extends from the probe body 106 or 306. (See, e.g., FIGS. 1 and 2.) Figure 2 The one or more magnetic sensors 122 can additionally or alternatively be disposed in the stabilizer 112 and oriented toward the needle guide holder 110 or 310. Indeed, multiple magnetic sensors 122 can be distributed between the probe body 106 or 306 and the stabilizer 112, e.g., along the stabilizer arm 118. In this manner, the magnetic sensors 122 can encircle the needle guide holder 110 or 310 and detect changes in the magnetic field due to the magnetized medical device from various different angles for guiding the medical device to the anatomical target while the anatomical target is being ultrasonically imaged.

[0063] The pad 104, 204, or 304 is configured to be in contact with a skin surface of a patient. Indeed, the pad 104, 204, or 304 includes an adhesive (e.g., silicone adhesive, hydrogel, etc.) structured to adhere the pad 104, 204, or 304 to the skin surface of the patient. In view of the foregoing, the pad 104, 204, or 304 is intended for use with a single patient, after which it is disposed of. In this manner, the ultrasound probe 102 or 302 as a fixed device can be safely used with multiple patients with the ultrasound probe 102 or 302 being properly cleaned between successive patients.

[0064] Similar to the stabilizer 112 to which the pad 104, 204, or 304 is configured to couple, the pad 104, 204, or 304 can include two arcuate pad arms 124 that extend congruently with the two stabilizer arms 118; however, similar to the stabilizer 112, the pad 104, 204, or 304 is not limited thereto. Indeed, the pad arms 124 generally extend congruently with the stabilizer arms 118. Thus, the pad arms 124 can instead be linear rather than arcuate. In one example, the pad arms 124 can form a "V" shape, with each of the two pad arms 124 connected at the apex of the "V." In another example, the pad arms 124 can likewise form a "U" shape, with each of the two pad arms 124 connected at the bottom of the "U." Notably, these embodiments of the pad 104, 204, or 304 include an ultrasound window 126 configured to align with the acoustic lens 116 of the probe 108 to allow the generated ultrasound signals to be emitted from the ultrasound transducer 114 and received by the ultrasound transducer 114. Finally, the ends of the pad arms 124 opposite the ends connected in the "V" shape, "U" shape, etc. can also be connected as with the ends of the stabilizer arms 118. The connection of the above-mentioned ends of the pad arms 124 results in a circular pad when the pad arms 124 are arcuate, a triangular pad when the pad arms 124 form a "V" shape, and a rectangular pad when the pad arms 124 form a "U" shape.

[0065] As Figure 3 and Figure 10 As best shown, the pad 104, 204, or 304 can include an aperture 128 in the clinician-facing side of the pad 104, 204, or 304 that is configured for fastening the pad 104, 204, or 304 to the stabilizer 112. Indeed, each of the pad arms 124 can include an aperture 128 molded in the clinician-facing side of the pad 104, 204, or 304 for fastening the pad 104, 204, or 304 to the stabilizer 112. As noted above, each of the stabilizer arms 118 can accordingly include a hook 120 in the patient-facing side of the stabilizer 112. The hook 120 is configured to be disposed in the aperture 128 beneath a latch 130 that partially covers the aperture 128 for fastening the pad 104, 204, or 304 to the stabilizer 112. Notably, the pad 104, 204, or 304 is not limited to the aperture 128 for a fastener, nor is the stabilizer 112 limited to the corresponding hook 120 for a fastener. Indeed, a fastener need not be present on the pad 104, 204, or 304 or the stabilizer 112, as the pad 104, 204, or 304 can include an adhesive configured for adhering the pad 104, 204, or 304 to the stabilizer 112 when the stabilizer 112 includes a relatively flat surface on the patient-facing side as described above. (See, e.g., FIG. 3, which shows a pad 304 according to this embodiment.) Figure 7 , which shows a pad 304 according to this embodiment.)

[0066] Pads made of 104, 204, or 304 stainless steel can be contoured to suit different contact patterns intended for contact with patients. For example... Figures 1-3 As shown, for example, the contour of the patient-facing portion of pad 104 can be formed such that the outer surface of pad 104 is thicker than the inner surface of pad 104, so that when pad 104 is placed on the patient's skin, the pad conforms to the patient's curved skin surface (e.g., the skin surface of a limb such as an arm or leg). In practice, as... Figure 2 As shown in the optimal configuration, the patient-facing portion of the pad 104 is radially oriented, ensuring that when the pad 104 is placed on the patient's skin, it conforms to the patient's curved skin surface. Figure 4 and Figure 5 As shown, for example, the patient-facing portion of pad 204 may alternatively include two contoured pad arm extensions 132 that extend away from the clinician-facing side of pad 204 and are configured to conformally span the patient's limb (e.g., arm or leg). Figures 1-3 The pad shown is similar to 104. Figure 4 and Figure 5 The pad 204 shown is radial, as... Figure 5 Ideally, this design ensures that pad 204 conforms to the patient's limb when placed on the limb. Regardless of the contact mode, the patient-facing portion of pads 104, 204, or 304 is formed of a conformal material (e.g., gel) with rounded edges for patient comfort.

[0067] The ultrasound detector assembly 100, 200, or 300, or its ultrasound detector 102 or 302, may also include one or more needle guides 134 configured to attach to a needle guide holder 110 or 310. Each of the one or more needle guides 134 includes a needle through-hole 136 configured to guide a needle 138 inserted or otherwise arranged in the needle through-hole 136 to a selected anatomical target (e.g., a blood vessel) located below the probe 108 in the patient. In practice, each of the one or more needle guides 134 is configured to guide the needle 138, etc., into the patient at different needle insertion angles for optimal access to the selected anatomical target below the probe 108. However, as described above, the needle insertion angle may be related to the needle guide holder 110 or 310 and the selected needle guide. In fact, the needle guide retainer 110 is fixed, while the needle guide retainer 310 is rotatable, such that the needle insertion angle relative to the needle guide retainer 110 depends only on the needle insertion angle provided by the selected needle guide, and the needle insertion angle relative to the needle guide retainer 310 depends on the combination of the rotation of the needle guide retainer 310 and the needle insertion angle provided by the selected needle guide.

[0068] Some examples of needle guides are disclosed in U.S. 2015 / 0112200, which is incorporated by reference in its entirety.

[0069] The ultrasound probe assembly 100, 200, or 300, or the ultrasound probe 102 or 302 thereof, can further include one or more needles 138 configured to access a selected anatomical target of a patient as described above.

[0070] Ultrasound system

[0071] Figure 11 A block diagram of an ultrasound system 140 is shown in accordance with some embodiments.

[0072] As shown, the ultrasound system 140 includes the ultrasound probe assembly 100, 200, or 300 and a console 142.

[0073] The console 142 houses various components, including a processor 144 and a memory 146, such as a random access memory (“RAM”) or a non-volatile memory (e.g., an electrically erasable programmable read-only memory (“EEPROM”)) for controlling various functions of the ultrasound system 140 and controlling various logic operations or algorithms performed via logic 148 during operation of the ultrasound system 140. For example, the console 142 is configured to instantiate one or more processes for controlling various functions of the ultrasound system 140, including processing electrical signals from the ultrasound transducers 114 of the ultrasound probe 102 or 302 into ultrasound images, and processing electrical signals from one or more magnetic sensors 122 of the ultrasound probe 102 or 302 into on-screen visual guidance for magnetizing a medical device (e.g., a needle), etc., by executable instructions 150 stored in the memory 146 and executed by the processor 144. In practice, the one or more processes can include beamforming by a beamformer configured to drive the ultrasound transducers 114 and receive, amplify, and digitize reflected ultrasound signals; signal processing by a signal processor configured to detect an amplitude of each of the above-mentioned reflected ultrasound signals or digitized signals corresponding thereto; and image processing by an image processor configured to manage storage of the detected amplitudes and transmit an ultrasound image corresponding to a set of the detected amplitudes to a display screen of a display 164 upon completion of the ultrasound image. A digital controller / analogue interface 152 is also included in the console 142 and is in communication with the processor 144 and other system components to manage the interface between the ultrasound probe 102 or 302 and other system components.

[0074] The controller of the console 142, optionally implemented between the processor 144 and the memory 146 of the console 142, is communicatively coupled to the one or more magnetic sensors 122 of the ultrasound probe 102 or 302. The controller is configured to convert electrical signals from the one or more magnetic sensors 122, which correspond to detected changes in magnetic fields due to the magnetized medical device in the presence of the one or more magnetic sensors 122, into on-screen visual guidance for magnetizing the medical device (e.g., the needle 138). Notably, the logic 148 of the console 142 is configured to analyze the detected changes in real-time for the ultrasound image for the on-screen visual guidance. The display 164 is configured to emit a visual signal on the display screen to alert the clinician when the trajectory of the magnetized medical device is not aligned with the selected anatomical target (e.g., a blood vessel). The console 142 can also include a speaker (not shown) configured to emit an audio signal to alert the clinician when the trajectory of the magnetized medical device is not aligned with the selected anatomical target.

[0075] Some examples of magnetic-based needle guides are disclosed in U.S. 8,388,541; U.S. 8,781,555; U.S. 8,849,382; U.S. 9,456,766; U.S. 9,492,097; U.S. 9,521,961; U.S. 9,554,716; U.S. 9,636,031; U.S. 9,649,048; U.S. 10,449,330; U.S. 10,524,691; and U.S. 10,751,509, each of which is incorporated by reference in its entirety into this application.

[0076] The ultrasound system 140 also includes a port 154 for connection with additional components, such as optional components including a printer, storage media, keyboard, etc. The port 154 can be a universal serial bus (“USB”) port, although other types of ports can be used for this connection or any other connection shown or described herein.

[0077] The console 142 includes a power connection 156 to enable operable connection to an external power source 158. An internal power source 160 (e.g., a battery) can also be used with or without the external power source 158. A power management circuit 162 is included in the digital controller / analog interface 152 of the console 142 to regulate the use and distribution of power.

[0078] A display 164, including a display screen integrated into the console 142, is configured to provide a graphical user interface (“GUI”) on the display screen, present one or more ultrasound images of an anatomical target (e.g., a blood vessel) obtained by the ultrasound probe 102 or 302 on the display screen, and display any relevant information on the display screen while the one or more ultrasound images are being obtained, such as graphical elements in a screen visual guidance of a magnetized medical device (e.g., the needle 138) towards the selected anatomical target (e.g., the blood vessel). In addition, the display 164 can be configured to display visual feedback, including a visualization of the selected anatomical target and a VAD (e.g., a catheter placed in the selected anatomical target). Nonetheless, alternatively, the display 164 can be separate from the console 142 and communicatively coupled to the console. Control buttons (see Figure 1 ) accessed through a console button interface 166 of the console 142 can be used to bring up the desired mode of the ultrasound system 140 to the display screen to assist in an ultrasound-based medical procedure, such as assessing the aforementioned selected anatomical target or placing a VAD therein.

[0079] Simply returning to the ultrasound probe 102 or 302, the ultrasound probe 102 or 302 includes a button and memory controller 168 structured for operable communication with a probe interface 170 of the console 142, which includes an input / output (“I / O”) component 172 for connection with the ultrasound transducer 114 and a button and memory I / O component 174 for connection with the button and memory controller 168.

[0080] Method

[0081] The method includes a method of establishing an insertion site with the ultrasound system 140. The method includes one or more steps selected from an obtaining step, an assembling step, a moving step, a monitoring step, an attaching step, an adhering step, a rotating step, a needle insertion step, and another monitoring step.

[0082] The obtaining step includes obtaining the ultrasound probe 102 or 302. As described above, the ultrasound probe 102 or 302 includes the probe body 106 or 306, the stabilizer 112 extending from the probe body 106 or 306, and the probe head 108 in the patient-facing portion of the probe body 106 or 306.

[0083] The assembling step includes fastening the disposable pad 104, 204, or 304 to a patient-facing side of the ultrasound probe 102 or 302 to form the ultrasound probe assembly 100, 200, or 300. Fastening the pad 104, 204, or 304 to the ultrasound probe 102 or 302 includes inserting the patient-facing side hooks 120 of the stabilizer 112 into the clinician-facing side apertures 128 of the pad 104, 204, or 304 and sliding the hooks 120 under the latches 130 that partially cover the apertures 128.

[0084] The moving step includes moving the ultrasound probe assembly 100, 200, or 300 over the patient while the ultrasound probe 102 or 302 transmits generated ultrasound signals from the ultrasound transducers 114 in the probe 108 into the patient and receives reflected ultrasound signals from the patient by the ultrasound transducers 114.

[0085] The monitoring step includes monitoring the ultrasound image on the display screen of the ultrasound system 140 to identify an anatomical target of the patient.

[0086] The attaching step includes attaching a selected needle guide to the needle guide holder 110 or 310 extending from the probe body 106 or 306. Like any of the one or more needle guides 134, the selected needle guide includes a needle through-hole 136 configured to guide a needle 138 into the patient beneath the probe 108. The selected needle guide is selected from among the other guides of the one or more needle guides 134 for use in the needle insertion step at a particular needle insertion angle.

[0087] The adhering step includes adhering the pad 104, 204, or 304 to the patient over the selected anatomical target after the selected anatomical target is identified during the monitoring step. Adhering the pad 104, 204, or 304 to the patient advantageously allows hands-free ultrasound imaging so the clinician can use both hands for other steps including the needle insertion step. As described above, the pad 104, 204, or 304 includes an adhesive for adhering the pad 104, 204, or 304 to the patient in the adhering step.

[0088] The rotating step includes rotating the needle guide holder toward or away from the patient-facing side of the ultrasound probe 302 for use in the needle insertion step at a particular needle insertion angle. As described above, the needle guide holder 310 can be locked into place by the complementary locking features of the Hirth joint between the needle guide holder 310 and the probe body 306. Thus, the rotating step can include locking the needle guide holder 310 into place at the particular needle insertion angle.

[0089] The needle insertion step includes inserting the needle 138 into the selected anatomical target while the ultrasound probe assembly 100, 200, or 300 is stabilized on the anatomical target by the stabilizer 112 without being hand-held.

[0090] Another monitoring step includes monitoring on-screen visual guidance of the needle on the display screen, if magnetized. The ultrasound probe 102 or 302 also includes one or more magnetic sensors 122 configured to detect changes in the magnetic field due to the needle 138 for on-screen visual guidance. If the on-screen visual guidance indicates that the trajectory of the needle 138 is not aligned with the selected anatomical target, the console 142 can be configured to emit a visual or audible signal to alert the clinician so that the clinician can adjust the needle guide holder 310 or exchange the selected needle guide for another needle guide to achieve a different needle insertion angle during the needle insertion step.

[0091] After one or more of the above steps, including at least the needle insertion step, a VAD such as a catheter (e.g., a peripheral intravenous catheter ["PIVC"] or midline catheter) can be placed in the selected anatomical target through the insertion site or its needle trajectory established by the needle 138 during the needle insertion step. If the VAD is magnetized or includes a magnetized element therein, the placement of the VAD can be further monitored by on-screen visual guidance.

[0092] While some particular embodiments have been disclosed herein, and while specific implementations have been disclosed in detail, the particular embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations or modifications can occur to those of ordinary skill in the art, and such adaptations or modifications are intended to be within the scope of the concepts provided herein. Accordingly, while the particular embodiments have been disclosed, additional adaptations or modifications can occur to others, and such adaptations or modifications are intended to be within the scope of the concepts provided herein.

Claims

1. An ultrasonic detector assembly, characterized in that, include: An ultrasonic detector, the ultrasonic detector comprising: Detector body; A stabilizer extending from the detector body, the stabilizer being configured to allow the ultrasound detector to be stabilized hands-free when the ultrasound detector is placed on a patient; A probe, located in the patient-facing portion of the detector body, comprises an array of ultrasonic transducers; and A needle guide retainer extending from the detector body; and A disposable pad, attached to the patient-facing side of the stabilizer, is configured to contact the patient's skin surface. in: The stabilizer includes a first elongated, bow-shaped stabilizer arm and a second elongated, bow-shaped stabilizer arm extending along the patient-facing side of the ultrasound detector. The first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm: Extending away from the opposite right and left sides of the detector body, respectively, and Extending away from the front side of the detector body, and The constant distance between the middle sections of the first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm is greater than the constant distance between the free end sections of the first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm.

2. The ultrasonic detector assembly according to claim 1, characterized in that, The needle guide retainer extends in front of the first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm.

3. The ultrasonic detector assembly according to claim 1, characterized in that, The needle guide retainer is configured to rotate toward and away from the patient-facing side of the stabilizer for different needle insertion angles, wherein the needle is arranged in a needle through-hole of a needle guide connected to the needle guide retainer.

4. The ultrasonic detector assembly according to claim 3, characterized in that, The detector body and the needle guide retainer include complementary locking features at the extension of the needle guide retainer from the detector body, the complementary locking features being configured to lock the needle guide retainer in different positions for the different needle insertion angles.

5. The ultrasonic detector assembly according to claim 1, characterized in that, It also includes one or more needle guides configured to attach to the needle guide retainer, each of the one or more needle guides including a needle through-hole configured to guide a needle into the patient below the probe.

6. The ultrasonic detector assembly according to claim 5, characterized in that, Each of the one or more needle guides is configured to insert the needle into the patient at a different needle insertion angle.

7. The ultrasonic detector assembly according to claim 1, characterized in that, Each of the first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm includes a hook in the patient-facing side of the stabilizer that secures the stabilizer to the disposable pad.

8. The ultrasonic detector assembly according to claim 7, characterized in that, The disposable pad includes two arched pad arms having a common boundary with the first elongated arched stabilizer arm and the second elongated arched stabilizer arm. Each of the two arched pad arms includes an opening in the disposable pad on the clinician-facing side, in which the hook is correspondingly arranged below a latch that at least partially covers the opening.

9. The ultrasonic detector assembly according to claim 8, characterized in that, Each of the two bow-shaped disposable pad arms is connected below the probe. The disposable pad includes an ultrasonic window configured to allow the emission of generated ultrasonic signals from the ultrasonic transducer and the reception of reflected ultrasonic signals by the ultrasonic transducer.

10. The ultrasonic detector assembly according to claim 1, characterized in that, The patient-facing portion of the disposable pad is formed of a conformal material.

11. The ultrasonic detector assembly according to claim 10, characterized in that, The disposable pad includes an adhesive configured to adhere the disposable pad to the patient's skin surface.

12. The ultrasonic detector assembly according to claim 10, characterized in that, The contour of the patient-facing portion of the disposable pad is formed such that the outer part of the disposable pad is thicker than the inner part of the disposable pad, thereby allowing the disposable pad to conform to the patient's skin surface.

13. The ultrasonic detector assembly according to claim 10, characterized in that, The patient-facing portion of the disposable pad includes two undulating pad arm extensions extending away from the stabilizer, the two undulating pad arm extensions being configured to conformally span the patient's limb.

14. The ultrasonic detector assembly according to claim 1, characterized in that, The ultrasound detector also includes one or more magnetic sensors configured to detect changes in the magnetic field of the magnetized needle, for visually guiding the magnetized needle to the anatomical target on a display screen while performing ultrasound imaging of the anatomical target.

15. The ultrasonic detector assembly according to claim 1, characterized in that, The first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm define an opening between the first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm, and the first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm extend more than 180 degrees around the opening.

16. The ultrasonic detector assembly according to claim 1, characterized in that, The first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm define an opening between the first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm, and the needle guide retainer extends above the opening.

17. The ultrasonic detector assembly according to claim 1, characterized in that, The stabilizer and the detector body combine to define a smooth, continuous dorsal peripheral edge of the ultrasonic detector assembly.

18. The ultrasonic detector assembly according to claim 1, characterized in that, The detector body is located on the outer periphery of the stabilizer.

19. An ultrasonic system, characterized in that, include: A control console, including a display configured to present ultrasound images on the display screen; and An ultrasonic detector assembly, the ultrasonic detector assembly comprising: An ultrasonic detector, the ultrasonic detector comprising: Detector body; A stabilizer extending from the detector body, the stabilizer being configured to allow the ultrasound detector to be stabilized hands-free when placed on a patient; A probe, located in the patient-facing portion of the detector body, comprises an array of ultrasonic transducers; and A needle guide retainer extending from the detector body; and A disposable pad, attached to the patient-facing side of the stabilizer, is configured to contact the patient's skin surface. in: The stabilizer includes a first elongated, bow-shaped stabilizer arm and a second elongated, bow-shaped stabilizer arm extending along the patient-facing side of the ultrasound detector. The first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm: Extending away from the opposite right and left sides of the detector body, respectively, and Extending away from the front side of the detector body, and The constant distance between the middle sections of the first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm is greater than the constant distance between the free end sections of the first elongated bow-shaped stabilizer arm and the second elongated bow-shaped stabilizer arm.

20. The ultrasonic system according to claim 19, characterized in that, The console and the display are further configured to provide visual guidance of the magnetized needle of the ultrasound detector assembly to an anatomical target on the display screen, the ultrasound detector further including one or more magnetic sensors configured to detect changes in the magnetic field of the magnetized needle for the visual guidance.

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