Ultrasonic probe with pressure measurement capability

Abstract

Ultrasound probes with pressure measurement capabilities are disclosed herein for detecting and determining whether body tissue is being over-compressed during an ultrasound imaging procedure. For example, an ultrasound probe can include a probe body, an articulating probe head attached to the probe body, and a pressure sensing device housed in an articulating region between the articulating probe head and the probe body. In another example, a method of an ultrasound probe includes placing an articulating probe head of the ultrasound probe on a skin surface of a patient and moving the articulating probe head of the ultrasound probe over the patient while transmitting ultrasound signals from the articulating probe head into the patient for ultrasound imaging. The method also includes monitoring for any measured pressure values caused by the articulating probe head of the ultrasound probe on the patient that exceed a threshold pressure value.

Description

[0001] Priority

[0002] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 076,589, filed September 10, 2020, which is incorporated by reference in its entirety into the present application. TECHNICAL FIELD

[0003] The present application relates to the field of medical devices, and more particularly to an ultrasound probe with pressure measurement capability. BACKGROUND

[0004] There are currently a variety of existing ultrasound systems that include a wired or wireless ultrasound probe connected to a display connected to the probe. These systems can be used by a clinician to assess a site, such as a blood vessel, for placement of a vascular access device (“VAD”), including a catheter. These systems can also be used by a clinician to assess placement of a VAD or catheter at a selected site. However, the patient’s body tissue can be significantly compressed while assessing such a site by simply using an intended ultrasound probe. Compression of the body tissue can compromise the vascular purchase by the VAD or catheter, which in turn can result in an extravasation of the catheter that is dangerous to the patient’s health. Existing ultrasound systems do not provide for measuring the body tissue compression pressure caused by the ultrasound probe during ultrasound imaging.

[0005] Disclosed herein are ultrasound probes, ultrasound systems, and ultrasound methods with pressure measurement capability for detecting and determining whether body tissue is being over-compressed during ultrasound imaging. SUMMARY

[0006] Disclosed herein is an ultrasound probe, in some embodiments, the ultrasound probe includes a probe body; an articulating probe head attached to the probe body; and a pressure sensing device housed in an articulation region between the articulating probe head and the probe body.

[0007] In some embodiments, the ultrasound probe further includes a boot connecting the articulating probe head to the probe body in the articulation region. The boot is configured to cover or incorporate the pressure sensing device therein.

[0008] In some embodiments, the pressure sensing device is configured to detect a deformation in or around an elastic material of the boot. The deformation is caused by pressing the articulating probe head into a patient.

[0009] In some embodiments, the pressure sensing device is communicatively coupled to a controller of the ultrasound probe. The controller is configured to convert an electrical signal corresponding to the deformation to a measured pressure value.

[0010] In some embodiments, the ultrasound probe is configured to provide the measured pressure value to a display for display to a clinician.

[0011] In some embodiments, the ultrasound probe includes logic configured to compare the measured pressure value to a threshold pressure value.

[0012] In some embodiments, the ultrasound probe includes a speaker configured to emit an audio signal to alert a clinician when the measured pressure value exceeds the threshold pressure value.

[0013] In some embodiments, the ultrasound probe includes a light emitting diode configured to emit a visual signal to alert a clinician when the measured pressure value exceeds the threshold pressure value.

[0014] In some embodiments, the pressure sensing device is a pressure transducer.

[0015] In some embodiments, the pressure transducer is a piezoresistive strain gauge pressure transducer. The piezoresistive strain gauge pressure transducer includes a strain gauge bonded to a flexible diaphragm in a hinged region between the hinged probe and the probe body. Deformation of the diaphragm provides a corresponding measurable change in the strain gauge resistance, the change indicative of pressure resulting from the deformation caused by pressing the hinged probe into a patient.

[0016] In some embodiments, the pressure transducer is a variable capacitance pressure transducer. The pressure transducer includes a diaphragm electrode and an opposing electrode in a hinged region between the hinged probe and the probe body. Deformation of the flexible diaphragm affects the distance between the diaphragm electrode and the opposing electrode, thereby providing a corresponding measurable change in capacitance, the change indicative of pressure resulting from the deformation caused by pressing the hinged probe into a patient.

[0017] Also disclosed herein are ultrasound systems including, in some embodiments, a console and an ultrasound probe. The console includes a display configured to present an ultrasound image on a display screen of the display. The ultrasound probe includes a probe body; a hinged probe attached to the probe body; and a pressure sensing device housed in a hinged region between the hinged probe and the probe body.

[0018] In some embodiments, the ultrasound probe further includes a protective cover connecting the hinged probe to the probe body in the hinged region. The protective cover is configured to cover or incorporate the pressure sensing device therein.

[0019] In some embodiments, the pressure sensing device is configured to detect deformation in or around an elastic material of the protective cover. The deformation is caused by pressing the hinged probe into a patient.

[0020] In some embodiments, the pressure sensing device is communicatively coupled to a controller of the console. The controller is configured to convert the electrical signal corresponding to the deformation to a measured pressure value.

[0021] In some embodiments, the ultrasound probe is configured to provide the measured pressure value to a display for display to a clinician.

[0022] In some embodiments, the console includes logic configured to compare the measured pressure value to a threshold pressure value.

[0023] In some embodiments, the console includes a speaker configured to emit an audio signal to alert the clinician when the measured pressure value exceeds the threshold pressure value.

[0024] In some embodiments, the display is configured to emit a visual signal to alert the clinician when the measured pressure value exceeds the threshold pressure value.

[0025] In some embodiments, the display is configured to display visual feedback including a visualization of the target vein and a catheter placed in the target vein.

[0026] In some embodiments, the pressure sensing device is a piezoresistive strain gauge pressure transducer. The piezoresistive strain gauge pressure transducer includes a strain gauge bonded to a flexible diaphragm in a hinged region between the hinged probe and the probe body. Deformation of the diaphragm provides a corresponding measurable change in the strain gauge resistance, the change indicative of pressure resulting from the deformation caused by pressing the hinged probe into the patient.

[0027] In some embodiments, the pressure sensing device is a variable capacitance pressure transducer. The pressure transducer includes a diaphragm electrode and an opposing electrode in a hinged region between the hinged probe and the probe body. Deformation of the flexible diaphragm affects the distance between the diaphragm electrode and the opposing electrode, thereby providing a corresponding measurable change in capacitance, the change indicative of pressure resulting from the deformation caused by pressing the hinged probe into the patient.

[0028] Also disclosed herein is a method of an ultrasound system, the method including, in some embodiments, an ultrasound probe acquisition step, an ultrasound probe placement step, an ultrasound probe movement step, and a pressure monitoring step. The ultrasound probe acquisition step includes acquiring an ultrasound probe. The ultrasound probe includes a probe body; an articulating probe head attached to the probe body; and a pressure sensing device housed in an articulating region between the articulating probe head and the probe body. The ultrasound probe placement step includes placing the articulating probe head of the ultrasound probe on a skin surface of a patient. The ultrasound probe movement step includes moving the articulating probe head of the ultrasound probe over the patient while transmitting ultrasound signals from the articulating probe head into the patient for ultrasound imaging. The pressure monitoring step includes monitoring any measured pressure values caused by the articulating probe head of the ultrasound probe on the patient that exceed a threshold pressure value.

[0029] In some embodiments, the pressure monitoring step includes viewing the measured pressure values on a display screen of a display.

[0030] In some embodiments, the pressure monitoring step includes monitoring a visual signal on a display screen of a display that alerts a clinician when any measured pressure value exceeds a threshold pressure value.

[0031] In some embodiments, the pressure monitoring step includes monitoring an audio signal that alerts a clinician when any measured pressure value exceeds a threshold pressure value.

[0032] In some embodiments, the method further includes a catheter placement adjustment step. The catheter placement adjustment step includes adjusting catheter placement in response to any measured pressure value that exceeds a threshold pressure value to ensure sufficient vessel engagement that minimizes catheter extravasation.

[0033] These and other features of the concepts provided herein will become more apparent from the following detailed description in conjunction with the accompanying drawings, which provide specific embodiments of the concepts provided herein. BRIEF DESCRIPTION OF DRAWINGS

[0034] Figure 1 A wired ultrasound system including a console and an ultrasound probe is shown in accordance with some embodiments.

[0035] Figure 2 A wireless ultrasound system including a console and an ultrasound probe is shown in accordance with some embodiments.

[0036] Figure 3 A block diagram of an ultrasound system in accordance with some embodiments of Figure 1 is shown.

[0037] Figure 4 A wired ultrasound system including a companion device and an ultrasound probe is shown in accordance with some embodiments.

[0038] Figure 5 A wireless ultrasound system including an accompanying device and an ultrasound detector is shown according to some embodiments.

[0039] Figure 6 The following are illustrated according to some implementation schemes. Figure 2 , Figure 4 A block diagram of an ultrasound system of size 5.

[0040] Figure 7 A front view of an ultrasonic detector including a pressure sensing device according to some embodiments is shown.

[0041] Figure 8 A perspective view of an ultrasonic detector according to some embodiments is shown.

[0042] Figure 9 A cross-section of an ultrasonic detector according to some embodiments is shown.

[0043] Figure 10 Another cross-section of an ultrasonic detector according to some embodiments is shown.

[0044] Figure 11 A detailed view of the hinge region of an ultrasonic detector including a pressure sensing device according to some embodiments is shown. Detailed Implementation

[0045] 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 readily separated from that specific embodiment and optionally combined with any of the many other embodiments disclosed herein, or features that substitute for features of any of the many other embodiments disclosed herein.

[0046] With respect to the terms used herein, it is also to be understood that these terms are used for the purpose of describing certain embodiments and that the 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 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 necessarily appear in that order and embodiments including these features or steps need not necessarily be limited to the three features or steps. Additionally, any of the aforementioned features or steps can include one or more features or steps, unless otherwise indicated. Labels such as "left," "right," "front," "back," "top," "bottom," "over," "under," and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation or direction. Instead, such labels are used for convenience and are not intended to imply any particular fixed location, orientation or direction.

[0047] "proximal," "proximal portion," or "proximal end portion" of, for example, a catheter includes the portion of the catheter intended to be proximate to a clinician when the catheter is used on a patient. Likewise, "proximal length" of, for example, a catheter includes the length of the catheter intended to be proximate to a clinician when the catheter is used on a patient. "Proximal end" of, for example, a catheter includes the end of the catheter intended to be proximate to a clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0048] "distal," "distal portion," or "distal end portion" of, for example, a catheter includes the portion of the catheter intended to be proximate to or in a patient when the catheter is used on a patient. Likewise, "distal length" of, for example, a catheter includes the length of the catheter intended to be proximate to or in a patient when the catheter is used on a patient. "Distal end" of, for example, a catheter includes the end of the catheter intended to be proximate to or in a patient when the catheter is used on a patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter; however, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context indicates otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0049] Finally, in the following description, the terms "or" and "and / or," as used herein, are to be interpreted as inclusive or meaning any one or any combination. As an 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." Only terms clearly indicated to the contrary are excluded from this definition.

[0050] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.

[0051] As described above, existing ultrasound systems do not provide for measuring the compression pressure of body tissue caused by an ultrasound probe during ultrasound imaging. Disclosed herein are ultrasound probes, ultrasound systems, and ultrasound methods having pressure measurement capabilities for detecting and determining whether body tissue is being over-compressed during ultrasound imaging.

[0052] Ultrasound system

[0053] Figure 1 A wired ultrasound system 100 is shown in accordance with some embodiments. Figure 3 A block diagram of the wired ultrasound system 100 is shown in accordance with some embodiments.

[0054] As shown, the wired ultrasound system 100 includes a console 102, a display 104, and a wired ultrasound probe 106. During operation of the wired ultrasound system 100, the articulated probe 132 of the wired ultrasound probe 106 is placed against the skin of a patient. Ultrasound beams are produced to ultrasound image a portion of a target, such as a blood vessel under the surface of the patient's skin. The ultrasound image of the blood vessel can be depicted on the display screen of the display 104 along with a measured pressure value as described below. The wired ultrasound system 100 is useful for evaluating an access site, for example, a blood vessel in a patient prior to performing a percutaneous puncture with a needle to place a VAD (e.g., a catheter) into the blood vessel. The wired ultrasound system 100 can also be used to evaluate an access site after the VAD is placed. However, it should be appreciated that the wired ultrasound system 100 can be used for various ultrasound-based medical procedures other than catheterization. For example, a percutaneous puncture using a needle can be performed to biopsy tissue of an organ of a patient.

[0055] The console 102 houses the various components of the wired ultrasound system 100, and it will be appreciated that the console 102 can take any of a variety of forms. Included in the console 102 are a processor 108 and a memory 110, 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 wired ultrasound system 100, as well as performing various logical operations or algorithms during operation of the wired ultrasound system 100 in accordance with executable instructions 114 stored in the memory 110 for execution by the processor 108 via logic 112. For example, the console 102 is configured to instantiate one or more processes by way of the instructions 114 for controlling functions of the wired ultrasound system 100, processing electrical signals from the ultrasound transducers 140 of the wired ultrasound probe 106 into ultrasound images, processing electrical signals from the pressure sensing device of the wired ultrasound probe 106 into measured pressure values, etc. A digital controller / analog interface 116 is also included in the console 102 and is in communication with both the processor 108 and other system components to manage the interface between the wired ultrasound probe 106 and other system components set forth herein.

[0056] A controller of the console 102, optionally implemented between the processor 108 and the memory 110 of the console 102, is communicably coupled to the pressure sensing device 134 of the wired ultrasound probe 106 set forth below. The controller is configured to convert electrical signals corresponding to deformations of the protective cover 138 of the wired ultrasound probe 106, those deformations being caused by the articulating probe 132 being pressed into a patient, into measured pressure values. In particular, the logic 112 of the console 102 is configured to compare each measured pressure value to a threshold pressure value to alert a clinician when the measured pressure value exceeds the threshold pressure value. For example, the console 102 can include a speaker configured to emit an audio signal to alert the clinician when the measured pressure value exceeds the threshold pressure value. In another example, the display 104 is configured to emit a visual signal on a display screen to alert the clinician when the measured pressure value exceeds the threshold pressure value.

[0057] The wired ultrasound system 100 also includes a port 118 for connection with additional components, such as optional components including a printer, a storage medium, a keyboard, etc. The port 118 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.

[0058] The console 102 includes a power connection 120 to enable operable connection with an external power source 122. An internal power source 124, such as a battery, can also be used with or without the external power source 122. A power management circuit 126 is included in the digital controller / analog interface 116 of the console 102 to regulate power usage and distribution.

[0059] The display 104 includes a display screen integrated into the console 102 to provide a graphical user interface (“GUI”) presenting one or more ultrasound images of a target, such as a blood vessel, obtained by the wired ultrasound probe 106, as well as any relevant information 104, such as a measured pressure value for the articulating probe 132 when the one or more ultrasound images are obtained. In addition, the display 104 can be configured to display visual feedback including a visualization of the target, such as a blood vessel, such as a vein, and a VAD, such as a catheter placed in the target. Nonetheless, the display 104 can alternatively be separate from the console 102 and communicatively coupled thereto. Control buttons (see Figure 1 ) accessed through a console button interface 128 of the console 102 can be used to immediately invoke a desired mode of the wired ultrasound system 100 to the display screen to aid in an ultrasound-based medical procedure, such as assessing the aforementioned target or placing a VAD therein.

[0060] The wired ultrasound probe 106 is used in conjunction with ultrasound-based visualization of a target, such as a blood vessel, to prepare for placement of a VAD, such as a catheter, into the target. Such visualization provides real-time ultrasound guidance and helps reduce complications typically associated with VAD placement, such as catheter extravasation. The wired ultrasound probe 106 is configured to provide electrical signals from an ultrasound transducer 140 of the wired ultrasound probe 106, electrical signals from a pressure sensing device of the wired ultrasound probe 106, or a combination thereof, to the console 102 for real-time ultrasound guidance in VAD placement or other medical procedures.

[0061] Figure 1 and 7 FIG. 11 illustrates various views of the wired ultrasound probe 106, in accordance with some embodiments.

[0062] As shown, the wired ultrasound probe 106 includes a probe body 130, an articulating probe head 132 attached to the probe body 130, and a pressure sensing device 134 housed in an articulation region 136 between the articulating probe head 132 and the probe body 130. The wired ultrasound probe 106 also includes a protective cover 138 connecting the articulating probe head 132 to the probe body 130 in the articulation region 136. The protective cover 138 is configured to cover or incorporate the pressure sensing device 134 therein.

[0063] The articulating probe 132 houses an array of ultrasound transducers 140, which are piezoelectric ultrasound transducers or capacitive micro-machined ultrasound transducers ("CMUTs"). The articulating probe 132 is configured for placement against the skin of a patient near an intended VAD placement site in which the ultrasound transducers 140 in the articulating probe 132 can generate ultrasound signals and transmit the generated ultrasound signals in a plurality of pulses into the patient, receive reflected ultrasound signals or ultrasound echoes from the patient by reflection of the generated ultrasound pulses by the patient's body, and convert the reflected ultrasound signals into corresponding electrical signals for processing into ultrasound images by the console 102. In this way, a clinician can use the wired ultrasound system 100 to determine and establish vascular access with a suitable VAD placement site.

[0064] The pressure sensing device 134 is configured to detect a deformation in or around the resilient material of the protective boot 138 caused by pressing the articulating probe 132 into the patient. The pressure sensing device 134 can be a pressure transducer or a plurality of pressure transducers. For example, the pressure transducer can be a piezoresistive strain gauge pressure transducer. Such a pressure transducer includes a strain gauge bonded to a flexible diaphragm in the articulating region 136 between the articulating probe 132 and the probe body 130. Deformation of the diaphragm provides a corresponding measurable change in the strain gauge resistance that is indicative of the pressure caused by the deformation from pressing the articulating probe 132 into the patient. In another example, the pressure transducer is a variable capacitance pressure transducer. For example, the pressure transducer includes a diaphragm electrode and an opposing electrode in the articulating region 136 between the articulating probe 132 and the probe body 130. Deformation of the flexible diaphragm affects the distance between the diaphragm electrode and the opposing electrode, thereby providing a corresponding measurable change in capacitance that is indicative of the pressure caused by the deformation from pressing the articulating probe 132 into the patient.

[0065] The wired ultrasound probe 106 also includes control buttons 142 for controlling certain aspects of the wired ultrasound system 100 during an ultrasound-based medical procedure, thereby eliminating the need for the clinician to reach outside of the sterile field around the patient to control the wired ultrasound system 100. For example, the control buttons 142 included on the wired ultrasound probe 106 (see FIG. 1) can be used to invoke a desired mode by the clinician immediately to the display screen to assist in VAD placement or some other ultrasound-based medical procedure. Figure 7 ) can be used to invoke a desired mode by the clinician immediately to the display screen to assist in VAD placement or some other ultrasound-based medical procedure.

[0066] Figure 3The wired ultrasound probe 106 is shown to also include a button and memory controller 144 for managing buttons and ultrasound probe operations. The button and memory controller 144 can include non-volatile memory (e.g., EEPROM). The button and memory controller 144 is in operable communication with a probe interface 146 of the console 102, which includes input / output ("I / O") components 148 for interfacing with the ultrasound transducer 140 and button and memory I / O components 150 for interfacing with the button and memory controller 144.

[0067] Figure 2 and 5 A wireless ultrasound system 152 is shown in accordance with some embodiments. Figure 4 A wired ultrasound system 100 is shown in accordance with some other embodiments in addition to the above-described embodiments; indeed, Figure 4 The wired ultrasound probe 106 shown is similar to the wireless ultrasound probe 154 in that processing of electrical signals from the ultrasound transducer 140 and pressure sensing device 134 of the wired ultrasound probe 106 is performed by the wired ultrasound probe 106 itself so as to be displayed on the companion device 156 via a wired connection rather than a wireless connection. Figure 3 A block diagram of the wireless ultrasound system 152 is shown in accordance with some embodiments.

[0068] While a description of the wireless ultrasound system 152 is set forth below, it should be understood that the wireless ultrasound system 152 includes similar components as the wired ultrasound system 100 set forth above, albeit distributed differently in the wireless ultrasound system 152. For example, the wireless ultrasound probe 154 itself can include the processor 108, memory 110, instructions 114, and logic 112 of the console 102 for controlling various functions of the wireless ultrasound probe 154, converting electrical signals corresponding to deformation within or around the protective cover 138 of the wireless ultrasound probe 154 into measured pressure values, processing electrical signals from the ultrasound transducer 140 into ultrasound image data or files, etc. Nonetheless, the companion device 156 (e.g., a Figure 2 the console 102 of Figure 4 and Figure 5 a smartphone, phablet, or tablet) still includes a processor, memory, instructions, logic, etc. However, such components need not be configured to process electrical signals from the ultrasound transducer 140 into, for example, ultrasound image data or files. Indeed, such components can instead be configured to display ultrasound images corresponding to ultrasound image data or files provided by the wireless ultrasound probe 154.

[0069] As shown, the wireless ultrasound system 152 includes a wireless ultrasound probe 154 and a companion device 156, e.g., Figure 4and Figure 5 a smartphone, phablet, or tablet computer, or in some embodiments, Figure 2 console 102. The companion device 156 includes a display 158 and a wireless module 160 configured for wireless communication with the wireless ultrasound probe 154 and optionally a remote electronic health record ("EHR") system. During operation of the wireless ultrasound system 152, the articulating probe 132 of the wireless ultrasound probe 154 is placed against the skin of a patient. An ultrasound beam is produced to image a portion of a target, such as a blood vessel beneath the surface of the patient's skin, with ultrasound waves. By wirelessly providing data corresponding to measured pressure values from the wireless ultrasound probe 154 to the companion device 156, an ultrasound image of the blood vessel and the measured pressure values can be depicted on a display screen of the display 158 of the companion device 156. The wireless ultrasound system 152 is used to evaluate a target, such as a blood vessel within a patient, prior to performing a percutaneous puncture with a needle to place a VAD, such as a catheter, into the blood vessel. However, it should be understood that the wireless ultrasound system 152 can be used for various ultrasound-based medical procedures other than catheter insertion. For example, a percutaneous puncture using a needle can be performed to biopsy tissue of an organ of a patient.

[0070] Figures 7-11 Various views of the wired ultrasound probe 106 are shown in accordance with some embodiments; however, the wired ultrasound probe 106 and the wireless ultrasound probe 154 share at least the features described below.

[0071] As shown, the wireless ultrasound probe 154 includes a probe body 130, an articulating probe head 132 attached to the probe body 130, and a pressure sensing device 134 housed in an articulating region 136 between the articulating probe head 132 and the probe body 130. The wired ultrasound probe 106 also includes a protective boot 138 connecting the articulating probe head 132 to the probe body 130 in the articulating region 136. This protective boot 138 is configured to cover or incorporate this pressure sensing device 134. The wireless ultrasound probe 154 with the articulating probe head 132 is capable of vein and catheter visualization. Similar to the wired ultrasound probe 106 described above, Figures 7-11 The wireless ultrasound probe 154 depicted in FIG. 1 can be used to evaluate an access site before and after placement of a VAD.

[0072] The probe body 130 houses a printed circuit board assembly ("PCBA") 162. The PCBA 162 includes a plurality of electronic components of the wireless ultrasound probe 154 shown in its block diagram. (See Figure 6The PCBA 162 is communicatively coupled to control buttons 142, which include a power button configured to switch power from a power source 163 (e.g., an internal battery) to the wireless ultrasound probe 154 and various other buttons for operating the wireless ultrasound probe 154.

[0073] Similar to the articulating probe 132 of the wired ultrasound probe 106, the articulating probe 132 of the wireless ultrasound probe 154 houses the ultrasound transducer array 140, where the ultrasound transducers 140 are piezoelectric ultrasound transducers or CMUTs. Again, the articulating probe 132 is configured to be placed against the skin of a patient near an intended VAD placement site at which the ultrasound transducers 140 in the articulating probe 132 can generate ultrasound signals and emit the generated ultrasound signals in a plurality of pulses into the patient, receive reflected ultrasound signals or ultrasound echoes from the patient by reflecting the generated ultrasound pulses off the patient’s body, and convert the reflected ultrasound signals into corresponding electrical signals for processing into an ultrasound image by the wireless ultrasound probe 154.

[0074] Like the wired ultrasound probe 106, the pressure sensing device 134 of the wireless ultrasound probe 154 is configured to detect a deformation in or around the resilient material of the protective cover 138 caused by the probe being pressed into the patient by the articulating probe 132. The pressure sensing device 134 can be a pressure transducer or a plurality of pressure transducers disposed in the articulating region 136 between the probe body 130 and the articulating probe 132. As described above, the pressure transducer can be a piezoresistive strain gauge pressure transducer that includes a strain gauge bonded to a flexible diaphragm in the articulating region 136 between the articulating probe 132 and the probe body 130. As further set forth above, the pressure transducer can be a variable capacitance pressure transducer that includes a diaphragm electrode and an opposing electrode in the articulating region 136 between the articulating probe 132 and the probe body 130.

[0075] The pressure sensing device 134 is communicatively coupled to a controller of the wireless ultrasound probe 154, which is optionally implemented between the processor 166 and the memory 168 of the wireless ultrasound probe 154. (See Figure 6 The controller is configured to convert the electrical signals corresponding to the deformation in or around the resilient material of the protective cover 138 into a measured pressure value. The wireless ultrasound probe 154 is configured to provide the measured pressure value to the companion device 156 for display to the clinician on a display screen of the companion device 156.

[0076] In particular, the wireless ultrasound probe 154 includes logic 164 configured to compare the measured pressure value to a threshold pressure value. If the measured pressure value exceeds the threshold pressure value, the wireless ultrasound probe 154 can transmit an electrical signal to the companion device 156 to visually or audibly alert the clinician that the measured pressure value exceeds the threshold. The wireless ultrasound probe 154 can additionally or alternatively include a speaker configured to emit an audio signal to alert the clinician when the measured pressure value exceeds the threshold pressure value. Additionally or alternatively, the wireless ultrasound probe 154 can include a light emitting diode configured to emit a visual signal to alert the clinician when the measured pressure value exceeds the threshold pressure value. In this way, the wireless ultrasound probe 154 can be used to detect and determine whether the body tissue is being over-compressed during ultrasound imaging. In particular, if a patient has excessive fatty tissue, the fatty tissue can compress significantly under the pressure induced by the articulated probe 132. This can allow, for example, a greater portion of a catheter to be advanced into a blood vessel. However, when the pressure induced by the articulated probe 132 is removed, the fatty tissue can rebound, causing some of the catheter to be withdrawn, thereby reducing the catheter engagement length. This can result in catheter extravasation. Once the clinician is alerted that the pressure exceeds the threshold, the clinician can check the proper placement of the catheter within the blood vessel to avoid catheter extravasation.

[0077] Figure 6 A block diagram of the wireless ultrasound system 152 is shown in accordance with some embodiments.

[0078] As shown, the wireless ultrasound probe 154 includes a processor 166 for managing system functions by using a general operating system 167, a memory 168 including a file system 169, and applications 170 that can be stored in the memory 168 and executed by the processor 166. Some of the applications 170 can provide a user interface to allow a clinician to monitor the pressure induced by the articulated probe 132 on a patient. A beamforming tool 172 including appropriate circuitry is also controlled by the processor 166 to enable the generation, reception, and further processing of signals. For example, the beamforming tool 172 generates electrical signals received by the ultrasound transducers 140 in the articulated probe 132. The articulated probe 132 transmits ultrasound signals corresponding to these electrical signals into a region of a patient and receives reflected ultrasound signals from the patient. The reflected ultrasound signals are in turn converted by the ultrasound transducers 140 in the articulated probe 132 into corresponding electrical signals that are provided to the beamforming tool 172 for further processing into ultrasound image data or files for display on the companion device 156. Note that the wireless ultrasound probe 154 can include different components, e.g., more or fewer components than those set forth herein, including those that enable the wireless ultrasound probe 154 to operate wirelessly with the companion device 156, e.g., a wireless module 174.

[0079] The wired or wireless ultrasound system 100 or 152 having the integrated pressure sensing device 134 provides multi-functionality for VAD placement as described above in addition to vein visualization. Having a wired or wireless ultrasound system 100 or 152 that not only provides ultrasound imaging but also ensures that application of the wired or wireless ultrasound probe 106 or 154 to the patient's skin does not result in excessive pressure caused by the articulating probe 132 advantageously reduces the risk of catheter extravasation.

[0080] Method

[0081] The method includes a method of using the wired or wireless ultrasound system 100 or 152. For example, the method includes one or more of an ultrasound probe acquisition step, an ultrasound probe placement step, an ultrasound probe movement step, a pressure monitoring step, and a catheter placement adjustment step.

[0082] The ultrasound probe acquisition step includes acquiring the wired or wireless ultrasound probe 106 or 154. As described above, the wired and wireless ultrasound probes 106 and 154 include a probe body 130, an articulating probe head 132 connected to the probe body 130, and a pressure sensing device 134 housed in an articulation region 136 between the articulating probe head 132 and the probe body 130.

[0083] The ultrasound probe placement step includes placing the articulating probe head 132 of the wired or wireless ultrasound probe 106 or 154 on the skin surface of a patient.

[0084] The ultrasound probe movement step includes moving the articulating probe head 132 of the wired or wireless ultrasound probe 106 or 154 over the patient while transmitting ultrasound signals from the articulating probe head 132 into the patient for ultrasound imaging.

[0085] The pressure monitoring step includes monitoring any measured pressure values caused by the articulating probe head 132 of the ultrasound probe on the patient that exceed a threshold pressure value. The monitoring can include viewing the measured pressure values on a display screen of the display 104 of the console 102 or on the display 158 of the companion device 156. Such monitoring can also include monitoring audio signals or video signals on the display screen of the display 104 or 158. When any measured pressure value exceeds the threshold pressure value, such signals alert the clinician.

[0086] The method also includes a catheter placement adjustment step. The catheter placement adjustment step includes adjusting catheter placement in response to any measured pressure values that exceed the threshold pressure value to ensure adequate vessel engagement that minimizes catheter extravasation.

[0087] While some embodiments have been disclosed herein, and while specific implementations have been disclosed with specificity, this is not intended to be a limitation on the scope of the concepts provided herein. Additional adaptations and modifications can occur to persons of ordinary skill in the art, and are intended to fall within the scope of the concepts provided herein. Accordingly, the disclosure provided herein is to be construed as illustrative only and not as limiting of the scope of the concepts provided herein.

Claims

1. An ultrasonic probe, characterized by, including: a probe body configured for external use on a patient by a clinician; an articulating probe including one or more ultrasound transducers and attached to the probe body, the articulating probe configured to be placed on a skin surface of the patient and configured to articulate relative to the probe body; and a pressure sensing device housed in an articulation region between the articulating probe and the probe body.

2. The ultrasonic probe of claim 1, wherein, further including a protective cover connecting the articulating probe to the probe body in the articulation region, the protective cover configured to cover or incorporate the pressure sensing device therein.

3. The ultrasonic probe of claim 2, wherein, the pressure sensing device configured to detect a deformation in or around an elastic material of the protective cover caused by pressing the articulating probe into the patient.

4. The ultrasonic probe of claim 3, wherein, the pressure sensing device communicatively coupled to a controller of the ultrasound probe, the controller configured to convert an electrical signal corresponding to the deformation into a measured pressure value.

5. The ultrasonic probe of claim 4, wherein, the ultrasound probe configured to provide the measured pressure value to a display for display to the clinician.

6. The ultrasonic probe of claim 1, wherein, the ultrasound probe including logic configured to compare the measured pressure value from the pressure sensing device to a threshold pressure value.

7. The ultrasonic probe of claim 6, wherein, the ultrasound probe including a speaker configured to emit an audio signal to alert the clinician when the measured pressure value exceeds the threshold pressure value.

8. The ultrasonic probe of claim 6, wherein, the ultrasound probe including a light emitting diode configured to emit a visual signal to alert the clinician when the measured pressure value exceeds the threshold pressure value.

9. The ultrasonic probe of claim 1, wherein, the pressure sensing device is a pressure transducer.

10. The ultrasonic probe of claim 9, wherein, the pressure transducer is a piezoresistive strain gauge pressure transducer including a strain gauge bonded to a flexible diaphragm in the articulation region between the articulating probe and the probe body, deformation of the flexible diaphragm providing a corresponding measurable change in strain gauge resistance, the change indicative of pressure caused by pressing the articulating probe into the patient to cause the deformation.

11. The ultrasonic probe of claim 9, wherein, the pressure transducer is a variable capacitance pressure transducer including a diaphragm electrode and an opposing electrode in the articulation region between the articulating probe and the probe body, deformation of a flexible diaphragm affecting a distance between the diaphragm electrode and the opposing electrode, thereby providing a corresponding measurable change in capacitance, the change indicative of pressure caused by pressing the articulating probe into the patient to cause the deformation.

12. An ultrasound system characterized by, including: a console including a display, the console configured to present ultrasound images on a display screen of the display; and an ultrasound probe, the ultrasound probe including: a probe body configured for external use on a patient by a clinician; an articulating probe including one or more ultrasound transducers and attached to the probe body, the articulating probe configured to be placed on a skin surface of the patient and configured to articulate relative to the probe body; and a pressure sensing device housed in an articulation region between the articulating probe and the probe body.

13. The ultrasound system of claim 12, wherein, The ultrasound probe further includes a protective cover connecting the articulated probe to the probe body in the articulated region, the protective cover configured to cover or incorporate the pressure sensing device therein.

14. The ultrasound system of claim 13, wherein, The pressure sensing device is configured to detect a deformation in or around the resilient material of the protective cover caused by pressing the articulated probe into the patient.

15. The ultrasound system of claim 14, wherein, The pressure sensing device is communicatively coupled to a controller of the console, the controller configured to convert an electrical signal corresponding to the deformation into a measured pressure value.

16. The ultrasound system of claim 15, wherein, The ultrasound probe is configured to provide the measured pressure value to the display for display to the clinician.

17. The ultrasound system of claim 12, wherein, The console includes logic configured to compare the measured pressure value from the pressure sensing device to a threshold pressure value.

18. The ultrasound system of claim 17, wherein, The console includes a speaker configured to emit an audio signal to alert the clinician when the measured pressure value exceeds the threshold pressure value.

19. The ultrasound system of claim 17, wherein, The display is configured to emit a visual signal to alert the clinician when the measured pressure value exceeds the threshold pressure value.

20. The ultrasound system of claim 12, wherein, The display is configured to display visual feedback including a visualization of a target vein and a catheter placed in the target vein.

21. The ultrasound system of claim 12, wherein, The pressure sensing device is a piezoresistive strain gauge pressure transducer including a strain gauge bonded to a flexible diaphragm in the articulated region between the articulated probe and the probe body, deformation of the flexible diaphragm providing a corresponding measurable change in strain gauge resistance, the change indicative of pressure caused by pressing the articulated probe into the patient to cause the deformation.

22. The ultrasound system of claim 12, wherein, The pressure sensing device is a variable capacitance pressure transducer including a diaphragm electrode and an opposing electrode in the articulated region between the articulated probe and the probe body, deformation of a flexible diaphragm affecting a distance between the diaphragm electrode and the opposing electrode, thereby providing a corresponding measurable change in capacitance, the change indicative of pressure caused by pressing the articulated probe into the patient to cause the deformation.

23. A method of an ultrasound system, characterized by, comprising: acquiring an ultrasound probe, the ultrasound probe comprising: a probe body configured to be supported by a clinician and for external use on a patient; an articulated probe including one or more ultrasound transducers and attached to the probe body, the articulated probe configured to articulate relative to the probe body; and a pressure sensing device housed in an articulated region between the articulated probe and the probe body; placing the articulated probe of the ultrasound probe on a skin surface of the patient; moving the articulated probe of the ultrasound probe over the patient while transmitting ultrasound signals from the articulated probe into the patient for ultrasound imaging; and monitoring, from the pressure sensing device, any measured pressure values from the articulated probe of the ultrasound probe on the patient that exceed a threshold pressure value.

24. The method of claim 23, wherein, monitoring any measured pressure values that exceed the threshold pressure value includes viewing the measured pressure values on a display screen of a display.

25. The method of claim 24, wherein, Monitoring any measured pressure values that exceed the threshold pressure value includes monitoring a visual signal on the display screen of the display that alerts the clinician when any measured pressure value exceeds the threshold pressure value.

26. The method of claim 24, wherein, Monitoring any measured pressure values that exceed the threshold pressure value includes monitoring an audio signal that alerts the clinician when any measured pressure value exceeds the threshold pressure value.

27. The method of claim 23, wherein, Also included is adjusting catheter placement in response to any measured pressure values that exceed the threshold pressure value to ensure adequate vessel engagement that minimizes catheter extravasation.

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