Ultrasound needle guidance systems and methods including pain reduction vibration

Abstract

Ultrasound probes that include vibration transducers configured to vibrate skin or other tissue during a vascular access procedure. A first subset of the vibration transducers can cause ultrasonic vibrations of a first patient interface surface of the probe to obtain an ultrasound image. A second subset of the vibration transducers can cause vibrations of a second patient interface surface of the probe at a frequency different from the ultrasonic frequency to reduce a pain associated with the vascular access procedure. The second patient interface surface may extend laterally away from the ultrasound probe toward an insertion site. The second patient interface surface may include a vascular access device.

Description

ULTRASOUND NEEDLE GUIDANCE SYSTEMS AND METHODS INCLUDINGPAIN REDUCTION VIBRATIONPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 539,014, filed September 18, 2023, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] Needle insertion procedures can cause pain and / or discomfort to the patient during the insertion process. Vibrations of the skin or tissue adjacent the needle insertion site have been shown to reduce the pain experienced by the patient. Vascular access procedures can in some instances be particularly painful. Ultrasound probes are commonly used to assist the clinician during vascular access procedures, such as providing ultrasound images to help the clinician guide a vascular access device into a blood vessel.

[0003] Disclosed herein are ultrasound probes and methods for vibrating the skin during a vascular access procedure to reduce the pain experienced by the patient during the vascular access procedure.SUMMARY

[0004] Disclosed herein is an ultrasound probe that, according to some embodiments, includes a probe body and a plurality of vibration transducers coupled with the probe body. A probe head disposed at a distal end of the probe body includes a first subset of the vibration transducers operatively coupled with a patient interface surface of the probe head, where the patient interface surface is configured to operative couple with a skin surface of a patient, and where the first subset of the vibration transducers are configured to define a vibration of the patient interface surface such that the vibration of the patient interface surface propagates into a target area of the patient. A second patient interface surface includes a second subset of the vibration transducers operatively coupled therewith, where the second patient interface surface is configured to operative couple with the skin surface, and the second subset of the vibration transducers are configured to define a vibration of at least a portion of the target area. The probe further includes a console coupled with the vibration transducers, where the console includesone or more processors and a memory having logic stored thereon that, when executed by the one or more processors, causes the performance of operations of the probe.

[0005] The operations include (i) delivering a first excitation electrical signal having an ultrasonic frequency to the first subset of the vibration transducers to cause an ultrasonic vibration to propagate into the target area, (ii) receiving an imaging electrical signal from the first subset of the vibration transducers based on reflections of the ultrasonic vibration emanating one or more anatomic elements within the target area, and (iii) depicting on a display coupled with the ultrasound probe an image of the target area based on the imaging electrical signal. The operations further include delivering a second excitation electrical signal having a pain reduction frequency, different from the ultrasonic frequency, to the second subset of the vibration transducers to cause a second vibration of at least a portion of the target area, where the second vibration is configured to reduce a pain experienced by the patient resulting from a medical procedure within the target area.

[0006] In some embodiments, the target area includes a blood vessel configured to receive a vascular access device therein and, in some embodiments, the medical procedure includes inserting the vascular access device within the blood vessel.

[0007] In some embodiments, the pain reduction frequency is less than the ultrasonic frequency, and in some embodiments, the pain reduction frequency is adjustable.

[0008] In some embodiments, the first subset of the vibration transducers are oriented such that a direction of the ultrasonic vibration is disposed substantially perpendicular with respect to the skin surface.

[0009] In some embodiments, the patient interface surface of the probe head includes the second patient interface surface, and in some embodiments, the first subset of the vibration transducers includes the second subset of the vibration transducers.

[0010] In some embodiments, the second subset of the vibration transducers are oriented such that a direction of the second vibration is different than the direction of the ultrasonic vibration, and in some embodiments, the direction of the second vibration is substantially parallel with an insertion pathway for the vascular access device.

[0011] In some embodiments, the second patient interface surface is positioned laterally away from the patient interface surface, and in some embodiments, the second patient interface surface extends laterally away from a front side of the probe body toward an insertion site for the vascular access device.

[0012] In some embodiments, the second patient interface surface is located adjacent the insertion site during use, and in some embodiments, the second patient interface surface is shaped so as to extend at least partially around the insertion site.

[0013] In some embodiments, the probe body includes an arm extending between the second patient interface surface and the probe body. In some embodiments, a length of the arm is adjustable, and in some embodiments, an angle of the arm with respect to the probe body is adjustable. In some embodiments, the angle of the arm is biased so as to maintain contact of the second interface surface with the skin surface when an orientation of the probe body is adjusted with respect to the skin surface.

[0014] In some embodiments, the ultrasound probe further includes a vascular access device handle coupled with the probe via a cable, where the vascular access device handle includes the second subset of vibration transducers operatively coupled therewith causing at least a portion of the vascular access device handle to vibrate according to the second vibration, and where the vascular access device handle is configured to couple with the vascular access device such that the vascular access device defines the second patient interface surface.

[0015] In some embodiments, the vascular access device handle is configured to detachably couple with the vascular access device, and in some embodiments, the second subset of vibration transducers are attached to the vascular access device handle such that the direction of the second vibration is disposed substantially parallel with a longitudinal axis of the vascular access device.

[0016] Also disclosed herein is a system method of an ultrasound probe that, according to some embodiments, includes: (i) delivering a first excitation electrical signal having an ultrasonic frequency to a first subset of a plurality of vibration transducers of the ultrasound probe to cause a first interface surface of the ultrasound probe to vibrate at the ultrasonic frequency, where the first interface surface is in operational contact with a skin surface of the patient so that the ultrasonic vibration propagates into a target area of the patient; (ii) receiving an imaging electrical signal from the first subset of the vibration transducers based onreflections of the ultrasonic vibration emanating from one or more anatomic elements within the target area; (iii) performing a logic operation on the imaging electrical signal to generate an ultrasound image of the target area, where the logic operation is executed by one or more processors of the ultrasound probe; (iv) depicting the ultrasound image on a display coupled with the ultrasound probe; and (v) delivering a second excitation electrical signal having a pain reduction frequency, different from the ultrasonic frequency, to a second subset of the plurality of vibration transducers to cause a second interface surface of the ultrasound probe to vibrate at the pain reduction frequency, where the second interface surface is in operational contact with the skin surface so that the second interface surface causes at least a portion of the target area to vibrate at the pain reduction frequency.

[0017] In some embodiments of the system method, the pain reduction frequency is less than the ultrasonic frequency, and in some embodiments of the system method, the pain reduction frequency is adjustable.

[0018] In some embodiments of the system method, the first patient interface surface includes the second patient interface surface, and in some embodiments of the system method, the first subset of the vibration transducers includes the second subset of the vibration transducers.

[0019] In some embodiments of the system method, the second subset of the vibration transducers are oriented such that a direction of the second vibration is disposed at an angle with respect to the ultrasound probe.

[0020] In some embodiments of the system method, the second patient interface surface is positioned laterally away from the patient interface surface, and in some embodiments of the system method, the ultrasound probe includes an arm extending between the second patient interface surface and a probe body of the ultrasound probe.

[0021] In some embodiments of the system method, the ultrasound probe includes a vascular access device handle coupled with the ultrasound probe via a cable. In such embodiments, the vascular access device handle includes the second subset of vibration transducers operatively coupled therewith causing at least a portion of the vascular access device handle to vibrate according to the second vibration, and the vascular access device handle is configured to couple with a vascular access device such that the vascular access device defines the second patient interface surface. In some embodiments of the systemmethod, the second subset of vibration transducers are attached to the vascular access device handle such that the direction of the second vibration is disposed substantially parallel with a longitudinal axis of the vascular access device.

[0022] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.BRIEF DESCRIPTION OF DRAWINGS

[0023] FIG. 1 illustrates an ultrasound probe coupled with a display, where the probe is shown in use with a patient, according to some embodiments.

[0024] FIG. 2A illustrates a detailed front view of a distal portion of the probe of FIG.1 in use with the patient, according to some embodiments.

[0025] FIG. 2B illustrates a detailed side view of the distal portion of the probe of FIG.1 in use with the patient, according to some embodiments.

[0026] FIGS. 3A and 3B illustrate different embodiments of a vibration mechanism of the probe of FIG. 1, according to some embodiments

[0027] FIG. 4 illustrates a block diagram of a console of the probe of FIG. 1, according to some embodiments.

[0028] FIG. 5A is a side view illustration of another embodiment of an ultrasound probe, according to some embodiments.

[0029] FIG. 5B is a detailed top view illustration of a portion of an arm extending away from a front side of the probe of FIG. 5 A, according to some embodiments.

[0030] FIG. 6 is a front view illustration of an exemplary arrangement of two sets of pain reduction vibration transducers angled toward, according to some embodiments.

[0031] FIGS. 7A-7D illustrate various exemplary waveforms of electrical signals provided to vibration transducers, according to some embodiments.

[0032] FIG. 8 is a front view illustration of another embodiment of an ultrasound probe, according to some embodiments.

[0033] FIG. 9 illustrates a block diagram of a system method of the probes of FIGS. 1, 5A, and / or 8, according to some embodiments.DESCRIPTION

[0034] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0035] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and 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 the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. In addition, any of the foregoing features or steps can, in turn, further include one or more features or steps unless indicated otherwise. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” 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 to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0036] References to approximations may be made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially parallel” is recited with respect to a component, it is understood that in further embodiments, the component can have a precisely parallel orientation.

[0037] With respect to “proximal,” a “proximal portion” or “proximal section” of, for example, a needle includes a portion or section of the needle intended to be near a clinician when the needle is used on a patient. Likewise, a “proximal length” of, for example, the needle includes a length of the needle intended to be near the clinician when the needle is used on the patient. A “proximal end” of, for example, the needle includes an end of the needle intended to be near the clinician when the needle is used on the patient. The proximal portion, the proximal section, or the proximal length of the needle can include the proximal end of the needle; however, the proximal portion, the proximal section, or the proximal length of the needle need not include the proximal end of the needle. That is, unless context suggests otherwise, the proximal portion, the proximal section, or the proximal length of the needle is not a terminal portion or terminal length of the needle.

[0038] With respect to “distal,” a “distal portion” or a “distal section” of, for example, a needle includes a portion or section of the needle intended to be near or in a patient when the needle is used on the patient. Likewise, a “distal length” of, for example, the needle includes a length of the needle intended to be near or in the patient when the needle is used on the patient. A “distal end” of, for example, the needle includes an end of the needle intended to be near or in the patient when the needle is used on the patient. The distal portion, the distal section, or the distal length of the needle can include the distal end of the needle; however, the distal portion, the distal section, or the distal length of the needle need not include the distal end of the needle. That is, unless context suggests otherwise, the distal portion, the distal section, or the distal length of the needle is not a terminal portion or terminal length of the needle.

[0039] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0040] The phrases “connected to,” “coupled with,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to physical, mechanical, electrical, magnetic, electromagnetic, fluid, wireless, and thermal interaction. Two components may be coupled with each other even though they are not in direct contact or communication with each other. For example, two components may be coupled with each other through an intermediate component.

[0041] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and / or actions may be interchanged withone another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and / or use of specific steps and / or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and / or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.

[0042] Disclosed herein are ultrasound probes and methods configured to assist a user in accessing a vasculature of a patient. The probe are configured to (i) obtain and display an ultrasound image of a target area of a patient and (ii) reduce a pain sensation (e.g., provide a numbing action) associated with medical procedure performed in the target area, such as a vasculature access procedure, for example. These and other features and functionalities will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments in greater detail.

[0043] FIG. 1 illustrates a hand-held ultrasound probe (probe) 100 coupled with a display 110 via a cable 112. The probe 100 is shown in use with a patient 50 (e.g., an arm of the patient), where a patient interface surface 102 of the probe 100 is in operable contact with a skin surface 51 of the patient 50. The probe 100 is configured to obtain an ultrasound image 111 of a target area 55 of the patient 50. The probe 100 is further configured to depict the ultrasound image 111 on the display 110. A vascular access device (VAD) 60 is shown in relation to a blood vessel 56 of the target area 55, such as when the VAD 60 is being inserted into the blood vessel 56, for example. The ultrasound image 111 includes a VAD image 60A and a blood vessel image 56A. As such, the probe 100 and the display 110 enable a user to ultrasonically visualize the position of the VAD 60 with respect to the blood vessel 56 and thereby, help the user guide the VAD 60 into the blood vessel 56. The probe 100 include a number of controls 104 disposed on an exterior of a body 106 of the probe 100 to enable the user to define or adjust the operation of the probe 100. The controls 104 may be disposed on a front side 107 of the body 106 or any other side of the body 106 to be accessible by the user. The VAD 60 may include any medical device configured for insertion into a blood vessel, such as a needle, a stylet, a catheter, an introducer, a guidewire, or a dilator, for example.

[0044] FIG. 2A is a detailed front view illustration of a distal portion of the probe 100 including a probe head 200. The probe 100 includes a plurality of vibration transducers 220 which may include a first subset defining ultrasound transducers 222 and a second subset defining pain reduction transducers 224. In some embodiments, the ultrasound transducers 222 and pain reduction transducers 224 may be completely separate from each other, such that the operation of the ultrasound transducers 222 is separate from the operation of the pain reduction transducers 224. In other embodiments, the ultrasound transducers 222 and pain reduction transducers 224 may operationally overlap, i.e. a portion of the ultrasound transducers 222 may perform the operation of the ultrasound transducers 222 and the pain reduction transducers 224. Similarly, a portion of the pain reduction transducers 224 may perform the operation of the pain reduction transducers 224 and the ultrasound transducers 222. Further still, all the ultrasound transducers 222 and the pain reduction transducers 224 may perform both operations of the ultrasound and pain reduction transducers 222, 224. Unless otherwise specified the ultrasound and pain reduction transducers 222, 224 may be physically arranged in any fashion, e.g., arranged in separate groups or interspersed among each other. The relative numbers of vibration transducers 220 within the ultrasound and pain reduction transducers 222, 224 may be same or different, i.e., either of the ultrasound and pain reduction transducers 222, 224 may include more vibration transducers 220 than the other.

[0045] The ultrasound transducers 222 may be configured to obtain the ultrasound image 111. More specifically, the ultrasound transducers 222 may be configured to project ultrasound imaging vibrations 222 A into the target area 55 and receive reflected ultrasound imaging vibrations 222B emanating from anatomic elements such as the blood vessel 56. In some embodiments, the ultrasound transducers 222 may be oriented such that the ultrasound imaging vibrations 222A are projected in a substantial perpendicular direction with respect to the patient interface surface 102 and / or the skin surface 51 so that the ultrasound imaging vibrations 222A may be propagated beneath the skin surface 51 to the blood vessel 56 or other anatomic elements beneath the skin surface 51. In some embodiments, the ultrasound transducers 222 may be operatively coupled with a distal end wall 205 so that the ultrasound transducers 222 cause the distal end wall 205 including the patient interface surface 102 to ultrasonically vibrate. The ultrasound transducers 222 are configured to produce the ultrasound imaging vibrations 222B at an ultrasound frequency based on an ultrasound electrical signal having a frequency component at the ultrasound frequency.

[0046] The pain reduction transducers 224 may be configured to reduce a pain sensation (e.g., provide a numbing action) as experienced by the patient by producing pain reduction vibrations 224A. As discussed above, the vibration of the skin and / or related tissue may reduce the pain experienced by the patient or otherwise enhance a comfort of the patient during a vascular access procedure. The pain reduction transducers 224 are configured to vibrate the skin and / or tissue of the target area 55 at a pain reduction frequency that is different from the ultrasonic frequency of the ultrasound transducers 222 as further described below. In some embodiments, the pain reduction frequency is less than the ultrasound frequency. The pain reduction transducers 224 are configured to produce the pain reduction vibrations 224B at a pain reduction frequency based on a pain reduction electrical signal having a frequency component at the pain reduction frequency.

[0047] In some embodiments, the pain reduction transducers 224 may be operatively coupled with the distal end wall 205 similar to the ultrasound transducers 222. In other embodiments, as described below, the pain reduction transducers 224 may be operatively coupled with another wall or element of the probe 100. In some embodiments, the pain reduction transducers 224 may be oriented similar to the ultrasound transducers 222 such that the pain reduction vibrations 224A are projected in a substantial perpendicular direction with respect to the patient interface surface 102 and / or the skin surface 51. In other embodiments, as described below, the pain reduction transducers 224 may be oriented such that a direction of the pain reduction vibrations 224A is disposed at an angle with respect to the interface surface 102 and / or the skin surface 51.

[0048] FIG. 2B is a detailed right side view illustration of the distal portion of the probe 100 including a probe head 200 with the front side 107 facing to the left on the page. Additionally, a side cross-sectional view of the patient 50 in shown including the skin surface 51 and the blood vessel 56. The pain reduction transducers 224 are shown coupled with the distal end wall 205. The ultrasound transducers 222 are not shown in FIG. 2B for clarification purposes.

[0049] The VAD 60 is shown inserted through the skin surface 51 at an insertion site 61, where the VAD 61 forms an angle 231 with respect to the skin surface 51. In the illustrated embodiment, the vibration transducers 220 of the pain reduction transducers 224 are oriented at an angle 232 with respect to the patient interface surface 102 so that the direction of the pain reduction vibrations 224A is disposed at the angle 232. In some embodiments, the angle 232 issubstantially equal to the angle 231. As such, the direction of the pain reduction vibrations 224A is parallel with the VAD 231. Such an alignment may be advantageous, because the skin vibrates longitudinally with respect to VAD 60 which can reduce a friction between the skin and the VAD 60. Therefore, insertion of the VAD 60 may require a reduced force. The orientation of the pain reduction transducers 224 at the same angle as the VAD 60 is just one exemplary orientation of many potential orientations a may be recognized by one of ordinary skill. For example, in another embodiment, the pain reduction transducers 224 may be oriented perpendicular to the VAD 60 or at some other oblique angle.

[0050] FIGS. 3A and 3B illustrate different embodiments of a vibration mechanism of the probe 100. FIG. 3A illustrates a vibration mechanism 300 that is generally configured to cause the probe body 106 including the probe head 200 and the bottom wall 205 to vibrate as a single unit. The vibration mechanism 300 includes a plurality of piezo electric elements 315 (shown as a single element 315 for clarity) that are configured to change in length 316 according to an electrical signal applied to the piezo electric element 315 via the wires 311. The piezo electric elements 315 are coupled between the bottom wall 205 and a mass component 317. When an electrical signal, having a frequency component (i.e., alternating current component), is applied to the piezo electric elements 315, the length 316 changes based on the electrical signal such that the probe body 106 vibrates at the frequency of the electrical signal.

[0051] FIG. 3B illustrates a vibration mechanism 320 that is generally configured to cause the bottom wall 205 to vibrate with respect to the body 106. The vibration mechanism 320 includes a plurality of piezo electric elements 335 (again shown as a single element 335) that are configured to change in length 336 according to electrical signal applied to the piezo electric element 315 via the wires 331. The piezo electric elements 335 are coupled between the bottom wall 305 and another portion of the body 106, such as an internal wall 325, for example, where the bottom wall 205 is movably coupled with the body 106, such as via compliant bellows or a deflectable portion of the body 106, for example. When the electrical signal, having a frequency component (i.e., alternating current component), is applied to the piezo electric element 335, the length 336 changes based on the electrical signal such that the bottom wall 305 vibrates with respect to the body 106 at the frequency of the electrical signal.

[0052] The probe 100 may employ either of the vibration mechanisms 300, 320 to cause the skin of the patient vibrate. For example, the probe 100 may utilize the vibrationmechanism 300 to generate the ultrasound imaging vibrations 222A and utilize the vibration mechanism 320 to generate the pain reduction vibrations 224A or vice versa. Similarly, the probe 100 may utilize either of the vibration mechanisms 300, 320 to generate both the ultrasound imaging vibrations 222A and the pain reduction vibrations 224A.

[0053] FIG. 4 illustrates a block diagram of the console 400 that is included with the probe 100, such as within the body 106, according to some embodiments. The console 400 is generally configured to govern the operation of the probe 100. The console 400 includes a number (1, 2, or more) of processors 410 and memory 420 (e.g., a non-transitory computer- readable medium) having logic stored thereon. In the illustrated embodiment, the logic includes inter alia imaging logic 421 and vibration control logic 422. The console 400 is powered via a power source 440 (e.g., a battery or a facility power source). A power converter 440 receives power from the power source 430 and is coupled with other components of the console 400 to provide power to other components of the console 400 in a converted state appropriate for the operation of the other components.

[0054] A signal generator 460 is coupled between the power converter 430 and the vibration transducers 220. The signal generator 460 is configured to provide electrical signals to the vibration transducers 220. More specifically, the signal generator 460 provides the ultrasonic electrical signal to the ultrasound imaging subset 222 of the vibration transducers 220, where the ultrasonic electrical signal includes the ultrasonic frequency. The signal generator 460 also provides the pain reduction electrical signal to the pain reduction subset 222 of the vibration transducers 220, where the pain reduction electrical signal includes the pain reduction frequency. A signal conditioner receives electrical imaging signals from the ultrasound imaging subset 222 and converts the electrical imaging signals into data for processing by the processors 410 according to the imaging logic 421.

[0055] The console 400 is coupled with the display 110 so that imaging logic 421 when executed by the processors 410 may cause the ultrasound image 111 to the depicted on the display 110. In some embodiments, the display 110 may include a user interface, such as a graphical user interface (GUI). In such embodiments, the probe 100 may receive input from the display 110. For example, the user may adjust any number of operating parameters of the probe 100, such as the pain reduction frequency or an intensity of the pain reduction vibrations, for example.

[0056] The console is also coupled with the controls 104, so that the user may control the operation of the probe 100 while grasping the body 106. For example, the probe 100 may be configured such that the user may activate and / or deactivate either or both of the ultrasound imaging transducers 222 or the pain reduction transducers 224.

[0057] The imaging logic 421 is configured to receive the imaging electrical signal from the ultrasound imaging transducer 222 and generate an ultrasound image 111 of the target area 55 including the blood vessel image 56A and / or the VAD image 60A. The imaging logic 421 is further configured to depict the ultrasound image 111 on the display 110.

[0058] The vibration control logic 422 is configured to activate the signal generator 460 according to defined vibration frequencies and / or waveforms so that the signal generator 460 can in turn provide the electrical signals to the ultrasound imaging transducers 222 or the pain reduction transducers 224. In some embodiments, the define the vibration frequency or waveform to the pain reduction transducers 224 based on input from the user via the display 110 (GUI) of the controls 104. In some embodiments, the vibration control logic 422 may enable to the vibration frequency or waveform of the pain reduction transducers 224 to be adjusted by the user via the display 110 (GUI) of the controls 104. As such, the vibration frequency or waveform of the pain reduction transducers 224 may be adjustable.

[0059] In use, the user may activate the ultrasound imaging transducers 222 and place the probe 110 on the patient 50 such that the probe head 200 is disposed over the target area 55. The user may observe the ultrasound image 111 on the display to identify the presence and / or location of the blood vessel 56. In preparation for inserting the VAD 60 through the skin surface 51 and into the blood vessel 56, the user may activate the pain reduction transducers 224 to generate an area of reduced pain sensation (e.g., provide numbing effect) at the insertion site 61. While the pain reduction transducers 224 are activated, the user may insert the VAD 60 into the blood vessel 56. Thereafter, the user may deactivate the pain reduction transducers 224.

[0060] FIGS. 5 A and 5B illustrate another embodiment of an ultrasound probe that can, in certain respects, resemble components of the probe 100 described in connection with FIGS. 1-4. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals. Relevant disclosure set forth above regarding similarly identified features may not be repeated hereafter. Moreover,specific features of the probe 100 and related components shown in FIGS. 1-4 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and / or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the probe 500 of FIGS 5 A and 5B. Any suitable combination of the features, and variations of the same, described with respect to the probe 100 and components illustrated in FIGS. 1-4 can be employed with the probe 500 and components of FIGS. 5 A and 5B, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter.

[0061] Referring to FIG. 5A, the probe 500 includes the ultrasound transducers 222 and the pain reduction transducers 224 of the vibration transducers 220 as shown and described in relation to the proper 100. The probe 500 differs from the probe 100 in that the pain reduction transducers 224 are located separate from the ultrasound transducers 222. More specifically, the pain reduction transducers 224 are located spaced away from the front side 107of the probe 500 so that the pain reduction transducers 224 may be located near the insertion site 61, thereby defining reduced pain sensitivity adjacent the insertion site 61.

[0062] The probe 500 includes an arm 550 extending away from the front side 107. The arm 550 extends between the body 106 and a pad 505, where the pad 505 includes a second patient interface surface 502. The pad 505 is configured to impart the pain reduction vibrations to the patient 50. The pain reduction transducers 224 are incorporated into or operatively coupled with the arm 550 so that either vibration mechanism 300, 320 may be employed to enable the second patient interface surface 502 to impart the pain reduction vibrations to the skin surface 51. For example, the vibration mechanism 300 may be employed at any location along the arm 550 to cause the arm 550 and the body 106 to vibrate. By way of another example, the vibration mechanism 320 may be employed between the arm 550 and the body 105 to cause the arm 550 to vibrate with respect to the body 106. Other implementations of either vibration mechanism 300 or 320, as contemplated by one or ordinary skill, are also considered.

[0063] In the illustrated embodiment, the pain reduction transducers 224 are coupled with the pad 505 thereby causing the second patient interface surface 502 to vibrate. As shown, the pain reduction transducers 224 are disposed an angle with respect to the patient interface surface 502 to align with the VAD 60 as similarly shown in FIG. 2B and described therewith.The pain reduction transducers 224 may be disposed any other orientation with respect to the patient interface surface 502 as may be contemplated by one of ordinary skill. A cable 563 provides for an electrical connection between the pain reduction transducers 224 and the console 400 within the body 106.

[0064] Although not required, the arm 550 may include a pivoting mechanism 560 so that the arm is rotatably coupled with the body 106. By allowing the arm 550 to rotate with respect to the body 106, the second patient interface surface 502 may remain in contact with the skin surface 51 when the user adjusts the orientation of the body 106, e.g., pivots the body 106 about the patient interface surface 102 during imaging of the target area 55 as indicated by the arrow 503. In some embodiments, the pivoting mechanism 560 may include a biasing member 561, such as a torsional spring, for example. The biasing member 561 may help ensure that the second patient interface surface 502 remains in contact with the skin surface 51 when the user adjusts the orientation of the body 106. In some embodiments, the arm 550 may be rotated by the user about the pivoting mechanism 560 so that the arm 550 is disposed away from the skin surface, i.e. out of the way, in an instance where providing the pain reduction vibrations is not desired or needed.

[0065] In a similar fashion, although not required, the arm 550 may include a second pivoting mechanism 565 to enable the pad 505 to rotate with respect to the arm 550. The second pivoting mechanism 565 may enable the second patient interface surface 502 to remain flat against the skin surface 51 when the angle of the arm 550 with respect to the skin surface 51 is adjusted.

[0066] Although not required, the arm 550 may include an extension mechanism 570 to allow positioning of the pad 505 closer to or further away from the body 106. Such extensibility may enable to user to locate the pad 505 adjacent different locations of the insertion site 61. The extension mechanism 570 may include any suitable mechanism to provide extending and retracting the arm 550, such as the telescopic mechanism illustrated in FIG. 5A. The extension mechanism 570 may be configured such that the user may manually extend and / or retracted the arm 550. The extension mechanism 570 may be configured such that in the absence of a deliberate action by the user, the extension of the arm 550 may remain fixed, such as via a friction, a detent, a latch, or the like.

[0067] FIG. 5B is a detailed top view of a distal portion of the arm 550 including the pad 505. As the pain associated insertion of the VAD 60 may located adjacent the insertion site, it may advantage to focus the pain reduction vibrations on the insertion site 61. In some embodiments, the shape of the pad 505 may be configured to focus the pain reduction vibrations on the insertion site 61. In the illustrated embodiment, the pad 505 includes a C-shape that partially encircles the insertion site 61. The pain reduction transducers 224 of the vibration transducers 220 are arranged along the C-shape so that the vibration transducers 220 extend around the insertion site 61. Such an arrangement may provide for a maximum reduction in pain associated with the insertion of the VAD 60 through the skin surface 51 and into the blood vessel 56. Other shapes of the pad 505 are also contemplated. For example, in other embodiments, the pad 505 may include a U-shape. In the illustrated embodiment, the pad 505 is spaced away from the body 106. However, in other embodiments, the pad 505 may extend away from a point adjacent the body 106.

[0068] FIG. 6 illustrates an exemplary arrangement of the pain reduction transducers 224 that may in some embodiments be employed by the probe head 200 or the pad 505 as viewed from the front of the probe 100. FIG. 6 shows the pain reduction transducers 224 in relation to the insertion path 605 for the VAD 60 extending between the insertion site 61 and the blood vessel 56. In the illustrated exemplary arrangement, the pain reduction transducers 224 include a first subset 624A and a second subset 624B of the pain reduction transducers 224. The first subset 624A and a second subset 624B are disposed on opposite sides of the insertion path 605. The first subset 624A are oriented so that the pain reduction vibrations 624C defined by the first subset 624A are directed toward the insertion path 605. Similarly, the second subset 624B are oriented so that the pain reduction vibrations 624D defined by the second subset 624A are also directed toward the insertion path 605 from a side of the insertion path 605 opposite the pain reduction vibrations 624C. As such, the pain reduction vibrations 624C and the pain reduction vibrations 624D may converge on the insertion path 605, e.g., any location along the insertion path 605 between the insertion site 61 and the blood vessel 56. The convergence of the pain reduction vibrations 624C. 624D may enhance the pain reduction effect of the vibrations at or adjacent the insertion path 605.

[0069] In some embodiments, the pain reduction vibrations 624C. 624D may be in phase such that first subset 624A and a second subset 624B compress and expand the body tissue at the same time. Such an in-phase condition may cause an enhanced compression andexpansion of the tissue at the conversion point which may enhance the pain reduction effect at the conversion point. In other embodiments, the pain reduction vibrations 624C. 624D may be out of phase such that first subset 624A and a second subset 624B compress and expand the body tissue at different times (i.e., opposite times). Such an out-of-phase condition may cause a greater motion of the tissue at the conversion point which may enhance the pain reduction effect at the conversion point.

[0070] FIGS. 7A-7D illustrate plots of various waveforms of excitation electrical signals that the signal generator 460 may provide the vibration transducers 220, the excitation electrical signals define the vibration characteristics of the vibration transducers 220. The plots show time along the X-axis and amplitude along the Y-axis. The various waveforms of FIGS. 7A-7D may be employed by any of the embodiments of the ultrasound probe shown and described herein unless other was specified. Similarly, the various waveforms of FIGS. 7A- 7D may be employed with either vibration mechanism 300, 320 unless other was specified.

[0071] FIG. 7A illustrates an embodiment where the ultrasound transducers 222 are separate from the pain reduction transducers 224. In this illustrated embodiment, the ultrasound transducers 222 receive an ultrasound signal 722 having an ultrasound frequency 732 and an ultrasound amplitude 742. Similarly, the pain reduction transducers 224 receive a pain reduction signal 724 having a pain reduction frequency 734 and a pain reduction amplitude 744. In the illustrated embodiment, the pain reduction frequency 734 may be less than the ultrasound frequency 732. Similarly, the pain reduction amplitude 744 may be greater than the ultrasound amplitude 742. In some embodiments, the pain reduction frequency 734 may be sub-sonic. As shown, the pain reduction signal 724 may be substantially sinusoidal in shape.

[0072] FIG. 7B illustrates an embodiment where the ultrasound transducers 222 and the pain reduction transducers 224 are excited by a single composite signal. In this illustrated embodiment, the ultrasound signal 722 is superimposed onto the pain reduction signal 724. As such, the ultrasound transducers 222 and the pain reduction transducers 224 may vibrate at both the ultrasound frequency 732 and the pain reduction frequency 734. Similarly, the ultrasound transducers 222 and the pain reduction transducers 224 may vibrate at both the ultrasound amplitude 742 and the pain reduction amplitude 744.

[0073] FIG. 7C illustrates a pain reduction signal 725 having a substantially square or rectangular waveform. The square waveform may cause a more aggressive compression ormotion the skin or tissue at a given frequency than a sinusoidal waveform which may enhance the pain reduction effect.

[0074] FIG. 7D illustrates a pain reduction signal 726 having a sawtooth waveform. The sawtooth waveform includes a rising edge 726A and falling edge 726B. In different embodiments, the rising edge 726A or the falling edge 726B may be steeper than the other which may be advantageous. For example, in an embodiment, where the direction of the pain reduction vibrations is at least partially aligned with the insertion path 605, a non-symmetrical sawtooth waveform may enable insertion of the VAD 60. More specifically, in a case where a steeper rising edge 726B causes the tissue to move opposite the direction of VAD insertion at a greater speed than the shallower falling edge 726B causes the tissue to move in the direction of VAD insertion, the force required for insertion of the VAD 60 may be reduced. The reduction of force may result in an enhanced pain reduction effect.

[0075] FIG. 8 illustrates another embodiment of an ultrasound probe 800 that can, in certain respects, resemble components of the probes 100, 500 described above. The probe 800 includes a VAD handle 850 electrically coupled with console 400 via a cable 853. The probe head 200 of the probe 800 includes the ultrasound transducers 222 and the VAD handle 850 includes the pain reduction transducers 224. As such, the probe head 200 is configured to obtain the ultrasound image 111 and the VAD handle 850 is configured to vibrate the skin and tissue to provide the pain reduction effect.

[0076] The VAD handle 850 is coupled with the VAD 60 via an attachment mechanism 840 so that the pain reduction vibrations as generated by the pain reduction transducers 224 are transferred to the VAD 60. In turn, the VAD 60 transfers the pain reduction vibrations to the skin and / or tissue of the patient 50. In the illustrated embodiment, the pain reduction vibrations may include lateral pain reduction vibrations 824 A directed substantially perpendicular to the VAD 60 and / or the longitudinal pain reduction vibrations 824B directed substantially parallel with the VAD 60. In some embodiments, either of the lateral pain reduction vibrations 824A or the longitudinal pain reduction vibrations 824B may be omitted.

[0077] The VAD 60 may be disposed substantially parallel with longitudinal axis 855 of the VAD handle 850, although other orientations of the VAD 60 with the VAD handle 850 are considered. The attachment mechanism 840 may include any suitable attachment featuresor components, such as a clamp or a clip, for example. The attachment mechanism 840 may provide for selective attachment to and detachment from of the VAD 60.

[0078] The pain reduction transducers 224 may include lateral pain reduction transducers 825A configured to define the lateral pain reduction vibrations 824A. The VAD handle 850 may employ either of the vibration mechanisms 300, 320 to enable lateral pain reduction transducers 825A to cause the distal portion 62 of the VAD to vibrate in a lateral direction. Accordingly, the lateral pain reduction transducers 825A may be oriented perpendicular to the VAD 60.

[0079] The pain reduction transducers 224 may include longitudinal pain reduction transducers 825B configured to define the longitudinal pain reduction vibrations 824B. The VAD handle 850 may employ either of the vibration mechanisms 300, 320 to enable longitudinal pain reduction transducers 825B to cause the distal portion 62 of the VAD to vibrate in a longitudinal direction. Accordingly, the longitudinal pain reduction transducers 825B may be oriented perpendicular to the VAD 60.

[0080] The lateral pain reduction transducers 825A and longitudinal pain reduction transducers 825B may be coupled with the console 400 independent of each other so that the signal generator may provide an excitation electrical signal to either of the lateral pain reduction transducers 825 A or the longitudinal pain reduction transducers 825B independent of the other. As such, the frequencies, amplitudes, and / or waveforms of the excitation electrical signals provided to the lateral pain reduction transducers 825A or the longitudinal pain reduction transducers 825B may be different. Similarly, the lateral pain reduction transducers 825A or the longitudinal pain reduction transducers 825B may be activated and / or deactivated independent of each other. In an embodiment where the longitudinal pain reduction transducers 825B include a sawtooth waveform, the steeper rising edge 726A may distally directed along the VAD 60 and the shallower falling edge 726B may proximally directed along the VAD 60.

[0081] In use, the user may attach the VAD handle 850 to the VAD 60 and insert the VAD into the blood vessel 56 via manipulation of the VAD handle 850. Thereafter, the user may detach the VAD handle 850 from the VAD 60.

[0082] FIG. 9 illustrates a block diagram of the system method 900 of an ultrasound probe that may, according to some embodiments, include all or any subset of the following steps, actions, or processes as may be defined by logic and executed by processors of the probe.The method 900 may include delivering a first excitation electrical signal having an ultrasonic frequency to a first subset of a plurality of vibration transducers (the ultrasound imaging transducers) of the ultrasound probe to cause a first interface surface of the ultrasound probe to vibrate at the ultrasonic frequency (block 910). The first interface surface is in operational contact with a skin surface of the patient so that the ultrasonic vibration propagates into a target area of the patient. The method 900 may further include receiving an imaging electrical signal from the first subset of the vibration transducers (block 920). The imaging electrical signal is based on reflections of the ultrasonic vibration emanating from one or more anatomic elements within the target area. The method 900 may further include performing a logic operation on the imaging electrical signal to generate an ultrasound image of the target area (block 930). The method 900 may further include depicting the ultrasound image on a display coupled with the ultrasound probe (block 940). The method 900 may further include delivering a second excitation electrical signal to a second subset of the plurality of vibration transducers (the pain reduction transducers) to cause a second interface surface of the ultrasound probe to vibrate at the pain reduction frequency (block 950). The pain reduction frequency is different from the ultrasonic frequency and the second interface surface is in operational contact with the skin surface so that the second interface surface causes at least a portion of the target area to vibrate at the pain reduction frequency.

[0083] In some embodiments of the method 900, the pain reduction frequency is less than the ultrasonic frequency, and in some embodiments of the method 900, the pain reduction frequency is adjustable. In some embodiments of the method 900, the first patient interface surface includes the second patient interface surface, and in some embodiments of the method 900, the first subset of the vibration transducers includes the second subset of the vibration transducers.

[0084] In some embodiments of the method 900, the second subset of the vibration transducers are oriented such that a direction of the second vibration is disposed at an angle with respect to the ultrasound probe. In some embodiments of the method 900, the second patient interface surface is positioned laterally away from the patient interface surface, and in some embodiments of the method 900, a probe body of the ultrasound probe includes an arm extending between the second patient interface surface and the probe body.

[0085] In some embodiments of the method 900, the ultrasound probe includes a vascular access device handle coupled with the ultrasound probe via a cable. In suchembodiments, the vascular access device handle includes the second subset of vibration transducers operatively coupled therewith causing the vascular access device handle to vibrate according to the second vibration, and the vascular access device handle is configured to couple with a vascular access device such that the vascular access device defines the second patient interface surface. In some embodiments of the method 900, the second subset of vibration transducers are attached to the vascular access device handle such that the direction of the second vibration is disposed substantially parallel with a longitudinal axis of the vascular access device.

[0086] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMSWhat is claimed is:

1. An ultrasound probe, comprising: a probe body; a plurality of vibration transducers coupled with the probe body; a probe head disposed at a distal end of the probe body, the probe head including a first subset of the plurality of vibration transducers operatively coupled with a patient interface surface of the probe head, wherein: the patient interface surface is configured to operatively couple with a skin surface of a patient at a target area of the patient, and the first subset of the vibration transducers are configured to define an ultrasonic vibration of the patient interface surface; a second patient interface surface having a second subset of the plurality of vibration transducers operatively coupled therewith, wherein: the second patient interface surface is configured to operatively couple with the skin surface, and the second subset of the vibration transducers are configured to define a pain reduction vibration of the second patient interface surface; and a console coupled with the vibration transducers, the console including one or more processors and a memory having logic stored thereon that, when executed by the one or more processors, causes the performance of operations including: delivering a first excitation electrical signal having at an ultrasonic frequency to the first subset of the plurality of vibration transducers; receiving an imaging electrical signal from the first subset of the plurality of vibration transducers; depicting on a display coupled with the ultrasound probe an image of the target area based on the imaging electrical signal; and delivering a second excitation electrical signal at a pain reduction frequency to the second subset of the vibration transducers, wherein: the pain reduction frequency is different from the ultrasonic frequency, andthe pain reduction vibration is configured to reduce a pain experienced by the patient resulting from a medical procedure within the target area.

2. The ultrasound probe according to claim 1, wherein the target area includes a blood vessel configured to receive a vascular access device therein.

3. The ultrasound probe according to claim 2, wherein the medical procedure includes inserting the vascular access device within the blood vessel.

4. The ultrasound probe according to any of the preceding claims, wherein the pain reduction frequency is less than the ultrasonic frequency.

5. The ultrasound probe according to any of the preceding claims, wherein the pain reduction frequency is adjustable.

6. The ultrasound probe according to any of the preceding claims, wherein the first subset of the vibration transducers are oriented such that a direction of the ultrasonic vibration is disposed substantially perpendicular with respect to the skin surface.

7. The ultrasound probe according to any of the preceding claims, wherein the patient interface surface of the probe head includes the second patient interface surface.

8. The ultrasound probe according to any of the preceding claims, wherein the first subset of the vibration transducers includes the second subset of the vibration transducers.

9. The ultrasound probe according to any of claims 1-6, wherein the second subset of the vibration transducers are oriented such that a direction of the second vibration is different than the direction of the ultrasonic vibration.

10. The ultrasound probe according to any of claims 1-6 or claim 9, wherein the direction of the second vibration is oriented to be substantially parallel with an insertion pathway for the vascular access device during use.

11. The ultrasound probe according to any of claims 1-6, claim 9, or claim 10 wherein the second patient interface surface is positioned laterally away from the patient interface surface.

12. The ultrasound probe according to claim 11, wherein the second patient interface surface extends laterally away from a front side of the probe body toward an insertion site of the vascular access device.

13. The ultrasound probe according to any of claims 1-6 or 9-12, wherein during use the second patient interface surface is located adjacent the insertion site.

14. The ultrasound probe according to claim 13, wherein the second patient interface surface is shaped so as to extend at least partially around the insertion site.

15. The ultrasound probe according to any of claims 1-6 or 9-14, wherein the probe body includes an arm extending between the second patient interface surface and the probe body.

16. The ultrasound probe according to claim 15, wherein a length of the arm is adjustable.

17. The ultrasound probe according to claim 15 or claim 16, wherein an angle of the arm with respect to the probe body is adjustable.

18. The ultrasound probe according to claim 17, wherein an angle of the arm is biased to maintain contact of the second interface surface with the skin surface when an orientation of the probe body is adjusted with respect to the skin surface.

19. The ultrasound probe according to any of claims 1-6, further including a vascular access device handle coupled with the probe via a cable, wherein: the vascular access device handle includes the second subset of vibration transducers operatively coupled therewith causing at least a portion of the vascular access device handle to vibrate according to the second vibration, and the vascular access device handle is configured to couple with the vascular access device such that the vascular access device defines the second patient interface surface.

20. The ultrasound probe according to claim 19, wherein the vascular access device handle is configured to detachably couple with the vascular access device.

21. The ultrasound probe according to claim 19 or claim 20, wherein the second subset of vibration transducers are attached to the vascular access device handle such that the direction of the second vibration is disposed substantially parallel with a longitudinal axis of the vascular access device.

22. A system method of an ultrasound probe, comprising: delivering a first excitation electrical signal having an ultrasonic frequency to a first subset of a plurality of vibration transducers of the ultrasound probe to cause a first interface surface of the ultrasound probe to vibrate at the ultrasonic frequency, the first interface surface in operational contact with a skin surface at a target area of the patient ; receiving an imaging electrical signal from the first subset of the vibration transducers; performing a logic operation on the imaging electrical signal to generate an ultrasound image of the target area, the logic operation executed by one or more processors of the ultrasound probe; depicting the ultrasound image on a display coupled with the ultrasound probe; and delivering a second excitation electrical signal having a pain reduction frequency, different from the ultrasonic frequency, to a second subset of the plurality of vibration transducers to cause a second interface surface of the ultrasound probe to vibrate at the pain reduction frequency.

23. The system method according to claim 22, wherein the pain reduction frequency is less than the ultrasonic frequency.

24. The system method according to claim 22 or claim 23, wherein the pain reduction frequency is adjustable.

25. The system method according to any of claims 22-24, wherein the first patient interface surface includes the second patient interface surface.

26. The system method according to any of claims 22-25, wherein the first subset of the vibration transducers includes the second subset of the vibration transducers.

27. The system method according to any of claims 22-24, wherein the second subset of the vibration transducers are oriented such that a direction of the second vibration is disposed at an angle with respect to the ultrasound probe.

28. The system method according to any of claims 22-24 or claim 27, wherein the second patient interface surface is positioned laterally away from the patient interface surface.

29. The system method according to any of claims 22-24, 27, or 28, wherein a probe body of the ultrasound probe includes an arm extending between the second patient interface surface and the probe body.

30. The system method according to any of claims 22-24, wherein the ultrasound probe includes a vascular access device handle coupled with the ultrasound probe via a cable, and wherein: the vascular access device handle includes the second subset of vibration transducers operatively coupled therewith causing at least a portion of the vascular access device handle to vibrate according to the second vibration, and the vascular access device handle is configured to couple with a vascular access device such that the vascular access device defines the second patient interface surface.

31. The system method according to claim 30, wherein the second subset of vibration transducers are attached to the vascular access device handle such that the direction of the second vibration is disposed substantially parallel with a longitudinal axis of the vascular access device.

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