Ultrasound needle guidance systems and methods

Abstract

Disclosed herein is an ultrasound probe including a vibration transducer configured to vibrate skin or other tissue during a vascular access procedure. The vibration transducers of the first subset may cause ultrasonic vibration of a first patient interface surface of the probe to obtain an ultrasound image. The second subset of vibration transducers may cause a second patient interface surface of the probe to vibrate at a frequency different than the ultrasound frequency to mitigate pain associated with the vascular access procedure. The second patient interface surface may extend laterally away from the ultrasound probe toward the insertion site. The second patient interface surface may include a vascular access device.

Description

[0001] Priority

[0002] This application claims priority benefit of U.S. Provisional Application No. 63 / 539,014, filed September 18, 2023, which is incorporated by reference in its entirety into the present application. BACKGROUND

[0003] Needle insertion procedures can cause pain and / or discomfort to a patient during the insertion process. It has been shown that vibration of the skin or tissue proximate to a needle insertion site alleviates the pain experienced by the patient. In some cases, vascular access procedures can be particularly painful. Ultrasound probes are often used to assist a clinician during a vascular access procedure, such as providing ultrasound images to help the clinician guide a vascular access device into a blood vessel.

[0004] Disclosed herein are ultrasound probes and methods for vibrating skin during a vascular access procedure to alleviate pain experienced by a patient during the vascular access procedure. SUMMARY

[0005] According to some embodiments, an ultrasound probe is disclosed herein that 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, wherein the patient interface surface is configured to operatively couple with a skin surface of a patient, and wherein the first subset of the vibration transducers is configured to define vibration of the patient interface surface such that the vibration of the patient interface surface propagates into a target region of the patient. A second patient interface surface includes a second subset of the 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 is configured to define vibration of at least a portion of the target region. The probe further includes a console coupled with the vibration transducers, wherein the console includes one or more processors and a memory having logic stored thereon that, when executed by the one or more processors, causes performance of operations of the probe.

[0006] These operations include (i) delivering a first excitation electrical signal having an ultrasound frequency to a first subset of the vibratory transducers to cause ultrasound vibrations to propagate into the target region, (ii) receiving an imaging electrical signal from the first subset of the vibratory transducers based on reflections of the ultrasound vibrations off of one or more anatomical elements within the target region, and (iii) rendering an image of the target region on a display coupled to the ultrasound probe based on the imaging electrical signal. These operations further include delivering a second excitation electrical signal having a pain-reducing frequency different from the ultrasound frequency to a second subset of the vibratory transducers to cause second vibrations of at least a portion of the target region, wherein the second vibrations are configured to reduce pain experienced by the patient resulting from the medical procedure within the target region.

[0007] In some embodiments, the target region 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 into the blood vessel.

[0008] In some embodiments, the pain-reducing frequency is less than the ultrasound frequency, and in some embodiments, the pain-reducing frequency is adjustable.

[0009] In some embodiments, the first subset of the vibratory transducers is oriented such that a direction of the ultrasound vibrations is arranged substantially perpendicular relative to a skin surface.

[0010] In some embodiments, the patient interface surface of the probe head includes a second patient interface surface, and in some embodiments, the first subset of the vibratory transducers includes a second subset of the vibratory transducers.

[0011] In some embodiments, the second subset of the vibratory transducers is oriented such that a direction of the second vibrations is different from a direction of the ultrasound vibrations, and in some embodiments, the direction of the second vibrations is substantially parallel to an insertion path of the vascular access device.

[0012] 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 of the vascular access device.

[0013] In some embodiments, during use, the second patient interface surface is positioned proximate to the insertion site, and in some embodiments, the second patient interface surface is shaped to extend at least partially around the insertion site.

[0014] In some embodiments, the probe body includes an arm extending between the second patient interface surface and the probe body. In some embodiments, the length of the arm is adjustable, and in some embodiments, the angle of the arm relative 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 adjusting the orientation of the probe body relative to the skin surface.

[0015] In some embodiments, the ultrasound probe further includes a vascular access device handle coupled with the probe via a cable, wherein the vascular access device handle includes a second subset of the vibration transducers operatively coupled therewith, such that at least a portion of the vascular access device handle vibrates according to the second vibration, and wherein 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.

[0016] 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 the vibration transducers are attached to the vascular access device handle such that the direction of the second vibration is arranged substantially parallel to a longitudinal axis of the vascular access device.

[0017] According to some embodiments, also disclosed herein is a system method of an ultrasound probe, comprising: (i) delivering a first excitation electrical signal having an ultrasound 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 ultrasound frequency, wherein the first interface surface is in operative contact with a skin surface of a patient such that the ultrasound vibrations propagate into a target region of the patient; (ii) receiving imaging electrical signals from the first subset of vibration transducers based on reflections of the ultrasound vibrations off one or more anatomical elements within the target region; (iii) performing logical operations on the imaging electrical signals to generate an ultrasound image of the target region, wherein the logical operations are performed by one or more processors of the ultrasound probe; (iv) rendering the ultrasound image on a display coupled with the ultrasound probe; and (v) delivering a second excitation electrical signal having a pain-relief frequency different from the ultrasound 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-relief frequency, wherein the second interface surface is in operative contact with the skin surface such that the second interface surface vibrates at least a portion of the target region at the pain-relief frequency.

[0018] In some embodiments of the system method, the pain-relief frequency is less than the ultrasound frequency, and in some embodiments of the system method, the pain-relief frequency is adjustable.

[0019] In some embodiments of the system method, the first patient interface surface comprises the second patient interface surface, and in some embodiments of the system method, the first subset of vibrational transducers comprises the second subset of vibrational transducers.

[0020] In some embodiments of the system method, the second subset of vibrational transducers is oriented such that the direction of the second vibration is arranged at an angle relative to the ultrasound probe.

[0021] 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 comprises an arm extending between the second patient interface surface and a probe body of the ultrasound probe.

[0022] In some embodiments of the system method, the ultrasound probe comprises a vascular access device handle coupled to the ultrasound probe via a cable. In such embodiments, the vascular access device handle comprises the second subset of vibrational transducers operatively coupled thereto, such that at least a portion of the vascular access device handle vibrates 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 system method, the second subset of vibrational transducers is attached to the vascular access device handle such that the direction of the second vibration is arranged substantially parallel to a longitudinal axis of the vascular access device.

[0023] These and other features of the concepts provided herein will become more apparent from the following description in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 An ultrasound probe coupled with a display is shown in accordance with some embodiments, with the probe shown in use with a patient.

[0025] Figure 2A A detailed front view of a distal portion of the probe of Figure 1 is shown in use with a patient in accordance with some embodiments.

[0026] Figure 2B A detailed side view of a distal portion of the probe of Figure 1 is shown in use with a patient in accordance with some embodiments.

[0027] Figure 3A and Figure 3B Different embodiments of the vibrational mechanism of the probe of Figure 1 are shown in accordance with some embodiments.

[0028] Figure 4 A block diagram of a console of a probe according to some embodiments is shown. Figure 1

[0029] Figure 5A A side view illustration of another embodiment of an ultrasound probe according to some embodiments is shown.

[0030] Figure 5B A detailed top view illustration of a portion of an arm of a front side of a probe according to some embodiments is shown. Figure 5A

[0031] Figure 6 A front view illustration of an exemplary arrangement of two sets of pain- reducing vibration transducers angled toward each other according to some embodiments is shown.

[0032] Figures 7A to 7D Various exemplary waveforms of electrical signals provided to vibration transducers according to some embodiments are shown.

[0033] Figure 8 A front view illustration of another embodiment of an ultrasound probe according to some embodiments is shown.

[0034] Figure 9 A block diagram of a system method of a probe according to some embodiments is shown. Figure 1 Figure 5A and / or Figure 8 A block diagram of a system method of a probe according to some embodiments is shown. DETAILED DESCRIPTION

[0035] Before certain specific embodiments are disclosed in more detail, it is to be understood that the particular embodiments disclosed herein are not limiting in scope to the concepts provided herein. It is also to be understood that the particular embodiments disclosed herein can have features that can be readily separated from the particular embodiments and that the features can optionally be combined with or substituted for features of any of the many other embodiments disclosed herein.

[0036] ​​​With respect to the terms used herein, it should also 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 used merely to identify different features or steps in a group of features or steps and are not intended to designate a sequence or numerical quantity. For example, a “first,” “second,” and “third” feature or step need not necessarily appear in that order and a particular embodiment including such features or steps need not necessarily be limited to the three features or steps. Additionally, any of the features or steps of the preceding description can further include one or more features or steps unless otherwise indicated. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation or direction. Rather, such terms are used to reflect, for example, relative location, orientation or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0037] Throughout this specification, approximations can be made reference to, such as by use of the term “substantially.” For each such reference, it should be understood that, in some embodiments, a value, feature or characteristic can be specified without approximation. For example, where a qualifier such as “about” and “substantially” is used, these terms include within their scope the specified word without the qualifier. For example, where the term “substantially parallel” is recited with respect to a component, it should be understood that, in other embodiments, the component can have an orientation that is exactly parallel.

[0038] “Proximal” with respect to, for example, a “proximal portion” or a “proximal segment” of a needle includes the portion or segment of the needle that is intended to be placed near a clinician when the needle is used on a patient. Likewise, “proximal length” of, for example, a needle includes the length of the needle that is intended to be placed near a clinician when the needle is used on a patient. “Proximal end” of, for example, a needle includes the end of the needle that is intended to be placed near a clinician when the needle is used on a patient. The proximal portion, proximal segment, or proximal length of a needle can include the proximal end of the needle; however, the proximal portion, proximal segment, or proximal length of a needle need not include the proximal end of the needle. That is, unless the context otherwise indicates, the proximal portion, proximal segment, or proximal length of a needle is not the distal portion or distal length of the needle.

[0039] “Distal” with respect to, for example, a “distal portion” or a “distal segment” of a needle includes the portion or segment of the needle that is intended to be placed near or in a patient when the needle is used on the patient. Likewise, “distal length” of, for example, a needle includes the length of the needle that is intended to be placed near or in a patient when the needle is used on the patient. “Distal end” of, for example, a needle includes the end of the needle that is intended to be placed near or in a patient when the needle is used on the patient. The distal portion, distal segment, or distal length of a needle can include the distal end of the needle; however, the distal portion, distal segment, or distal length of a needle need not include the distal end of the needle. That is, unless the context indicates otherwise, the distal portion, distal segment, or distal length of a needle is not the terminal portion or terminal length of the needle.

[0040] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0041] The phrases “connected to,” “coupled to,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to physical, mechanical, electrical, magnetic, electromagnetic, fluid, wireless, and thermal interaction. Two components can be coupled to each other even though they are not in direct contact or communication with each other. For example, two components can be coupled to each other by way of an intermediate component.

[0042] Any method disclosed herein comprises one or more steps or actions for performing the method described. The method steps and / or actions can be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of an embodiment, the order and / or use of specific steps and / or actions can be modified. Further, sub routines or only a portion of a method described herein can be a separate method that is part of the overall method. In other words, some methods can include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and / or interchangeable, unless otherwise stated, or such combinations or interchanges would be contrary to the operability of any embodiment.

[0043] Disclosed herein are ultrasound probes and methods configured to assist a user in accessing a patient’s vasculature. The probes are configured to: (i) obtain and display an ultrasound image of a target region of a patient; and (ii) mitigate pain sensation (e.g., provide a numbing effect) associated with a medical procedure performed in the target region, such as a vasculature access procedure. These and other features and functionalities will become more apparent to those of ordinary skill in the art in view of the drawings and the following description, which describe certain embodiments in greater detail.

[0044] Figure 1A handheld ultrasound probe (probe) 100 is shown 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 a patient), with a patient interface surface 102 of the probe 100 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 region 55 of the patient 50. The probe 100 is further configured to render 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 region 55, such as when the VAD 60 is inserted into the blood vessel 56. The ultrasound image 111 includes a VAD image 60A and a blood vessel image 56A. Thus, the probe 100 and the display 110 enable a user to ultrasonically visualize a position of the VAD 60 relative to the blood vessel 56, thereby assisting the user in guiding the VAD 60 into the blood vessel 56. The probe 100 includes a plurality of controls 104 arranged externally to a main body 106 of the probe 100 to enable the user to define or adjust an operation of the probe 100. The controls 104 can be arranged on a front side 107 of the main body 106 or any other side of the main body 106 so as to be accessible by the user. The VAD 60 can include any medical device configured for insertion into a blood vessel, such as a needle, a stylet, a catheter, a guide, a wire, or a dilator.

[0045] Figure 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 can include a first subset defining ultrasound transducers 222 and a second subset defining pain relief transducers 224. In some embodiments, the ultrasound transducers 222 and the pain relief transducers 224 can be completely separate from one another, such that operation of the ultrasound transducers 222 is separate from operation of the pain relief transducers 224. In other embodiments, the ultrasound transducers 222 and the pain relief transducers 224 can be operationally overlapping, i.e., a portion of the ultrasound transducers 222 can perform operation of both the ultrasound transducers 222 and the pain relief transducers 224. Similarly, a portion of the pain relief transducers 224 can perform operation of both the pain relief transducers 224 and the ultrasound transducers 222. Further, all of the ultrasound transducers 222 and the pain relief transducers 224 can perform operation of both the ultrasound transducers 222 and the pain relief transducers 224. Unless otherwise indicated, the ultrasound transducers 222 and the pain relief transducers 224 can be physically arranged in any manner, e.g., arranged in separate groups or interspersed with one another. The relative number of vibration transducers 220 within the ultrasound transducers 222 and the pain relief transducers 224 can be the same or different, i.e., either of the ultrasound transducers 222 and the pain relief transducers 224 can include more vibration transducers 220 than the other.

[0046] The ultrasound transducer 222 can be configured to obtain the ultrasound image 111. More specifically, the ultrasound transducer 222 can be configured to project ultrasound imaging vibrations 222A into the target region 55 and receive reflected ultrasound imaging vibrations 222B emanating from anatomical elements, such as the blood vessel 56. In some embodiments, the ultrasound transducer 222 can be oriented such that the ultrasound imaging vibrations 222A are projected in a substantially perpendicular direction relative to the patient interface surface 102 and / or the skin surface 51, such that the ultrasound imaging vibrations 222A can propagate to the blood vessel 56 or other anatomical elements beneath the skin surface 51. In some embodiments, the ultrasound transducer 222 can be operatively coupled with the distal wall 205, such that the ultrasound transducer 222 ultrasonically vibrates the distal wall 205, including the patient interface surface 102. The ultrasound transducer 222 is configured to generate the ultrasound imaging vibrations 222B at an ultrasound frequency based on an ultrasound electrical signal having a frequency component at the ultrasound frequency.

[0047] The pain reduction transducer 224 can be configured to reduce the sensation of pain experienced by the patient (e.g., provide a numbing effect) by generating pain reduction vibrations 224A. As described above, vibrations of the skin and / or associated tissue can reduce the sensation of pain experienced by the patient or otherwise enhance the comfort of the patient during a vascular access procedure. The pain reduction transducer 224 is configured to vibrate the skin and / or tissue of the target region 55 at a pain reduction frequency that is different from the ultrasound frequency of the ultrasound transducer 222, as described further below. In some embodiments, the pain reduction frequency is less than the ultrasound frequency. The pain reduction transducer 224 is configured to generate the pain reduction vibrations 224B at the pain reduction frequency based on a pain reduction electrical signal having a frequency component at the pain reduction frequency.

[0048] In some embodiments, similar to the ultrasound transducer 222, the pain reduction transducer 224 can be operatively coupled with the distal wall 205. In other embodiments, as described below, the pain reduction transducer 224 can be operatively coupled with another wall or element of the probe 100. In some embodiments, the pain reduction transducer 224 can be oriented similar to the ultrasound transducer 222, such that the pain reduction vibrations 224A are projected in a substantially perpendicular direction relative to the patient interface surface 102 and / or the skin surface 51. In other embodiments, as described below, the pain reduction transducer 224 can be oriented such that the direction of the pain reduction vibrations 224A is disposed at an angle relative to the interface surface 102 and / or the skin surface 51.

[0049] Figure 2Bis a detailed right side view illustration of the probe 100 including the distal portion of the probe head 200 with the front side 107 facing the left side of the page. Additionally, a side cutaway view of the patient 50 is shown including the skin surface 51 and the blood vessel 56. The pain relief transducer 224 is shown coupled with the distal end wall 205. For clarity, the ultrasound transducer 222 is not shown in Figure 2B

[0050] The VAD 60 is shown inserted through the skin surface 51 at the insertion site 61 with the VAD 61 forming an angle 231 relative to the skin surface 51. In the illustrated embodiment, the vibrating transducer 220 of the pain relief transducer 224 is oriented at an angle 232 relative to the patient interface surface 102 such that the direction of the pain relief vibrations 224A are disposed at the angle 232. In some embodiments, the angle 232 is substantially equal to the angle 231. Thus, the direction of the pain relief vibrations 224A are parallel to the VAD 231. Such an alignment can be advantageous because the skin longitudinally vibrates relative to the VAD 60 which can reduce friction between the skin and the VAD 60. Thus, the insertion of the VAD 60 can require reduced force. The pain relief transducer 224 being oriented at the same angle as the VAD 60 is merely one exemplary orientation out of many potential orientations that one of ordinary skill in the art can recognize. For example, in another embodiment, the pain relief transducer 224 can be oriented perpendicular to the VAD 60 or at some other oblique angle.

[0051] Figure 3A and Figure 3B Different embodiments of the vibration mechanism of the probe 100 are shown. Figure 3A A vibration mechanism 300 is shown that is generally configured to vibrate the probe body 106 including the probe head 200 and the bottom wall 205 as a single unit. The vibration mechanism 300 includes a plurality of piezoelectric elements 315 (shown as a single element 315 for clarity) that are configured to change in length 316 in accordance with an electrical signal applied to the piezoelectric elements 315 via wires 311. The piezoelectric elements 315 are coupled between the bottom wall 205 and a mass component 317. When an electrical signal having a frequency component (i.e., an alternating component) is applied to the piezoelectric 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.

[0052] Figure 3B ​A vibration mechanism 320 is shown that is generally configured to vibrate the bottom wall 205 relative to the body 106. The vibration mechanism 320 includes a plurality of piezoelectric elements 335 (again, shown as a single element 335) that are configured to change a length 336 in accordance with an electrical signal applied to the piezoelectric elements 315 via the wire 331. The piezoelectric elements 335 are coupled between the bottom wall 305 and another portion of the body 106, such as the inner wall 325, with the bottom wall 205 movably coupled to the body 106, such as via a compliant bellows or deflectable portion of the body 106. When an electrical signal having a frequency component (i.e., an alternating component) is applied to the piezoelectric elements 335, the length 336 changes based on the electrical signal such that the bottom wall 305 vibrates relative to the body 106 at the frequency of the electrical signal.

[0053] The probe 100 can employ either of the vibration mechanisms 300, 320 to vibrate the patient’s skin. For example, the probe 100 can utilize the vibration mechanism 300 to generate the ultrasound imaging vibrations 222A and the vibration mechanism 320 to generate the pain relief vibrations 224A, or vice versa. Similarly, the probe 100 can utilize either of the vibration mechanisms 300, 320 to generate both the ultrasound imaging vibrations 222A and the pain relief vibrations 224A.

[0054] Figure 4 A block diagram of a console 400 included with the probe 100, such as included within the body 106, is shown in accordance with some embodiments. The console 400 is generally configured to manage the operation of the probe 100. The console 400 includes a plurality (1, 2, or more) of processors 410 and a memory 420 (e.g., a non-transitory computer readable medium) having logic stored thereon. In the illustrated embodiment, the logic specifically includes imaging logic 421 and vibration control logic 422. The console 400 is powered via a power source 440 (e.g., a battery or facility power). A power converter 440 receives power from the power source 430 and is coupled with the other components of the console 400 in order to provide power to the other components of the console 400 in a converted state suitable for operation of the other components.

[0055] A signal generator 460 is coupled between the power converter 430 and the vibration transducer 220. The signal generator 460 is configured to provide electrical signals to the vibration transducer 220. More specifically, the signal generator 460 provides an ultrasound electrical signal to the ultrasound imaging subset 222 of the vibration transducer 220, where the ultrasound electrical signal includes an ultrasound frequency. The signal generator 460 also provides a pain relief electrical signal to the pain relief subset 222 of the vibration transducer 220, where the pain relief electrical signal includes a pain relief frequency. The signal conditioner receives the electrical imaging signal from the ultrasound imaging subset 222 and converts the electrical imaging signal to data for processing by the processor 410 in accordance with the imaging logic 421.

[0056] The console 400 is coupled with the display 110 such that the imaging logic 421, when executed by the processor 410, can cause the ultrasound image 111 to be depicted on the display 110. In some embodiments, the display 110 can include a user interface, such as a graphical user interface (GUI). In such embodiments, the probe 100 can receive input from the display 110. For example, a user can adjust any number of operational parameters of the probe 100, such as the pain relief frequency or the intensity of the pain relief vibrations.

[0057] The console is also coupled with the controls 104 such that a user can control the operation of the probe 100 while grasping the body 106. For example, the probe 100 can be configured such that a user can activate and / or deactivate either or both of the ultrasound imaging transducer 222 or the pain relief transducer 224.

[0058] The imaging logic 421 is configured to receive imaging electrical signals from the ultrasound imaging transducer 222, and to generate the ultrasound image 111 of the target region 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.

[0059] The vibration control logic 422 is configured to activate the signal generator 460 according to a defined vibration frequency and / or waveform, such that the signal generator 460, in turn, can provide electrical signals to the ultrasound imaging transducer 222 or the pain relief transducer 224. In some embodiments, the vibration frequency or waveform of the pain relief transducer 224 is defined based on input by a user via the display 110 (GUI) of the controls 104. In some embodiments, the vibration control logic 422 can enable the vibration frequency or waveform of the pain relief transducer 224 to be adjusted by a user via the display 110 (GUI) of the controls 104. Thus, the vibration frequency or waveform of the pain relief transducer 224 can be adjustable.

[0060] In use, a user can activate the ultrasound imaging transducer 222 and place the probe 110 on the patient 50 such that the probe head 200 is disposed on the target region 55. The user can 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 into the blood vessel 56, the user can activate the pain relief transducer 224 to generate a region of pain relief (e.g., to provide a numbing effect) at the insertion site 61. While the pain relief transducer 224 is activated, the user can insert the VAD 60 into the blood vessel 56. Thereafter, the user can deactivate the pain relief transducer 224.

[0061] Figure 5A andFigure 5B Another embodiment of an ultrasound probe is shown, which can be similar in certain respects to the probe 100 described in connection with Figures 1 to 4 The components of the probe 100 described are understood to apply to all of the embodiments shown. Accordingly, like features are denoted with like reference numerals. The relevant disclosure set forth above in connection with like-identified features can not be repeated hereafter. Moreover, particular features of the probe 100 and related components shown in Figures 1 to 4 may not be shown in the drawings or identified by reference numerals, or not specifically discussed in the subsequent written description. However, such features are obviously the same or substantially the same as the features depicted in and / or described with respect to the other embodiments. Accordingly, the relevant description of such features applies equally to the features of the probe 500 of Figure 5A and Figure 5B Any suitable combination of features described with respect to the probe 100 and components shown in Figures 1 to 4 may be used with the probe 500 and components of Figure 5A and Figure 5B The same pattern of disclosure applies to the other embodiments depicted in the subsequent drawings and described hereafter.

[0062] With reference to Figure 5A , the probe 500 includes an ultrasound transducer 222 of a vibration transducer 220 and a pain-reducing transducer 224, as shown and described with respect to the probe 100. The probe 500 differs from the probe 100 in that the pain-reducing transducer 224 is positioned separately from the ultrasound transducer 222. More specifically, the pain-reducing transducer 224 is positioned spaced apart from the front side 107 of the probe 500 such that the pain-reducing transducer 224 can be located proximate the insertion site 61, thereby defining a reduced pain sensitivity proximate the insertion site 61.

[0063] The probe 500 includes an arm 550 extending away from the front side 107. The arm 550 extends between the main body 106 and a pad 505, where the pad 505 includes a second patient interface surface 502. The pad 505 is configured to apply pain-reducing vibrations to the patient 50. The pain-reducing transducer 224 is incorporated into or operatively coupled with the arm 550 such that either of the vibration mechanisms 300, 320 can be employed to enable the second patient interface surface 502 to apply pain-reducing vibrations to the skin surface 51. For example, the vibration mechanism 300 can be employed at any location along the arm 550 to vibrate the arm 550 and the main body 106. As another example, the vibration mechanism 320 can be employed between the arm 550 and the main body 105 to vibrate the arm 550 relative to the main body 106. Other implementations of the vibration mechanism 300 or 320 are contemplated as well, as would be appreciated by one of ordinary skill in the art.

[0064] In the illustrated embodiment, the pain relief transducer 224 is coupled with the pad 505 to vibrate the second patient interface surface 502. As shown, the pain relief transducer 224 is arranged at an angle relative to the patient interface surface 502 to align with the VAD 60, as Figure 2B illustrated and described in the'1 1 1 Patent. The pain relief transducer 224 can be arranged in any other orientation relative to the patient interface surface 502, as can be contemplated by one of ordinary skill in the art. The cable 563 provides an electrical connection between the pain relief transducer 224 and the console 400 within the main body 106.

[0065] Although not required, the arm 550 can include a pivot mechanism 560 such that the arm is rotatably coupled with the main body 106. By allowing the arm 550 to rotate relative to the main body 106, the second patient interface surface 502 can remain in contact with the skin surface 51 when a user adjusts the orientation of the main body 106, for example, by pivoting the main body 106 about the patient interface surface 102 as indicated by arrow 503 during imaging of the target region 55. In some embodiments, the pivot mechanism 560 can include a biasing member 561, such as a torsion spring. The biasing member 561 can help ensure that the second patient interface surface 502 remains in contact with the skin surface 51 when a user adjusts the orientation of the main body 106. In some embodiments, the arm 550 can be rotated by a user about the pivot mechanism 560 such that the arm 550 is arranged away from the skin surface, i.e., arranged out of the way, in situations where it is not desirable or needed to provide pain relief vibrations.

[0066] In a similar manner, although not required, the arm 550 can include a second pivot mechanism 565 to enable the pad 505 to rotate relative to the arm 550. The second pivot mechanism 565 can enable the second patient interface surface 502 to remain flat against the skin surface 51 when adjusting the angle of the arm 550 relative to the skin surface 51.

[0067] Although not required, the arm 550 can include an extension mechanism 570 to allow the pad 505 to be positioned closer or further from the main body 106. Such extension can enable a user to position the pad 505 near different locations of the insertion site 61. The extension mechanism 570 can include any suitable mechanism to provide extension and retraction of the arm 550, such as Figure 5A the telescoping mechanism illustrated in the'1 1 1 Patent. The extension mechanism 570 can be configured such that a user can manually extend and / or retract the arm 550. The extension mechanism 570 can be configured such that extension of the arm 550 can remain fixed without intentional action by the user, such as via friction, detents, latches, etc.

[0068] Figure 5BThis is a detailed top view of the distal portion of arm 550, including pad 505. Since the pain-associated insertion of VAD 60 may be located near the insertion site, it can be advantageous to concentrate the pain-relieving vibration on the insertion site 61. In some embodiments, the shape of pad 505 can be configured to concentrate the pain-relieving vibration on the insertion site 61. In the illustrated embodiment, pad 505 comprises a C-shape partially surrounding the insertion site 61. The pain-relieving transducer 224 of the vibration transducer 220 is arranged along the C-shape such that the vibration transducer 220 extends around the insertion site 61. Such an arrangement can provide maximum relief of pain associated with the insertion of VAD 60 through the skin surface 51 into the blood vessel 56. Other shapes of pad 505 are also contemplated. For example, in other embodiments, pad 505 may comprise a U-shape. In the illustrated embodiment, pad 505 is spaced apart from body 106. However, in other embodiments, pad 505 may extend away from points adjacent to body 106.

[0069] Figure 6 An exemplary arrangement of the pain-relieving transducer 224 is shown when viewed from the front of the detector 100. In some embodiments, the exemplary arrangement may be adopted by the detector head 200 or the pad 505. Figure 6 In the illustration, a pain-relieving transducer 224 is shown in relation to an insertion path 605 extending between the insertion site 61 and the blood vessel 56 for the VAD 60. In the illustrated exemplary arrangement, the pain-relieving transducer 224 includes a first subset 624A and a second subset 624B. The first subset 624A and the second subset 624B are arranged on opposite sides of the insertion path 605. The first subset 624A is oriented such that a pain-relieving vibration 624C defined by the first subset 624A is guided toward the insertion path 605. Similarly, the second subset 624B is oriented such that a pain-relieving vibration 624D defined by the second subset 624A is also guided toward the insertion path 605 from the side of the insertion path 605 opposite to the pain-relieving vibration 624C. Therefore, the pain-reducing vibrations 624C and 624D can converge on the insertion path 605, for example, at any location along the insertion path 605 between the insertion site 61 and the blood vessel 56. The convergence of the pain-reducing vibrations 624C and 624D can enhance the pain-reducing effect of the vibrations at or near the insertion path 605.

[0070] In some embodiments, the pain relief vibrations 624C, 624D can be in phase, such that the first subset 624A and the second subset 624B compress and expand the body tissue at the same time. Such in-phase conditions can result in enhanced compression and expansion of the tissue at the transition point, which can enhance the pain relief effect at the transition point. In other embodiments, the pain relief vibrations 624C, 624D can be out of phase, such that the first subset 624A and the second subset 624B do not compress and expand the body tissue at the same time (i.e., at opposite times). Such out-of-phase conditions can result in greater movement of the tissue at the transition point, which can enhance the pain relief effect at the transition point.

[0071] Figures 7A to 7D Plots showing various waveforms of excitation electrical signals that the signal generator 460 can provide to the vibration transducer 220 (the excitation electrical signals defining the vibration characteristics of the vibration transducer 220) are shown. The plots show time along the X-axis and amplitude along the Y-axis. Unless otherwise indicated, the various waveforms can be employed by any embodiment of the ultrasound probe shown and described herein. Similarly, unless otherwise indicated, the various waveforms can be employed with any of the vibration mechanisms 300, 320. Figures 7A to 7D Figures 7A to 7D

[0072] Figure 7A An embodiment in which the ultrasound transducer 222 is separate from the pain relief transducer 224 is shown. In the illustrated embodiment, the ultrasound transducer 222 receives an ultrasound signal 722 having an ultrasound frequency 732 and an ultrasound amplitude 742. Similarly, the pain relief transducer 224 receives a pain relief signal 724 having a pain relief frequency 734 and a pain relief amplitude 744. In the illustrated embodiment, the pain relief frequency 734 can be less than the ultrasound frequency 732. Similarly, the pain relief amplitude 744 can be greater than the ultrasound amplitude 742. In some embodiments, the pain relief frequency 734 can be subsonic. As shown, the shape of the pain relief signal 724 can be substantially sinusoidal.

[0073] Figure 7B An embodiment in which the ultrasound transducer 222 and the pain relief transducer 224 are excited by a single composite signal is shown. In the illustrated embodiment, the ultrasound signal 722 is superimposed on the pain relief signal 724. Thus, the ultrasound transducer 222 and the pain relief transducer 224 can vibrate at both the ultrasound frequency 732 and the pain relief frequency 734. Similarly, the ultrasound transducer 222 and the pain relief transducer 224 can vibrate at both the ultrasound amplitude 742 and the pain relief amplitude 744.

[0074] Figure 7C ​​A pain relief signal 725 having a substantially square or rectangular waveform is shown. The square waveform can cause more intense compression or movement of the skin or tissue at a given frequency than a sinusoidal waveform, which can enhance the pain relief effect.

[0075] Figure 7D A pain relief signal 726 having a sawtooth waveform is shown. The sawtooth waveform includes a rising edge 726A and a falling edge 726B. In different embodiments, the rising edge 726A or the falling edge 726B can be steeper than the other, which can be advantageous. For example, in an embodiment where the direction of the pain relief vibration is at least partially aligned with the insertion path 605, an asymmetric sawtooth waveform can enable insertion of the VAD 60. More specifically, where the steeper rising edge 726B causes tissue to move in a direction opposite the VAD insertion direction at a greater speed than the slower falling edge 726B causes tissue to move in the VAD insertion direction, the force required to insert the VAD 60 can be reduced. The reduction in force can result in an enhanced pain relief effect.

[0076] Figure 8 Another embodiment of an ultrasound probe 800 is shown, which can be similar in certain respects to the components of the above-described probes 100, 500. The probe 800 includes a VAD handle 850 that is electrically coupled to the console 400 via a cable 853. The probe head 200 of the probe 800 includes an ultrasound transducer 222, and the VAD handle 850 includes a pain relief transducer 224. Thus, the probe head 200 is configured to obtain ultrasound images 111, and the VAD handle 850 is configured to vibrate the skin and tissue to provide a pain relief effect.

[0077] The VAD handle 850 is coupled to the VAD 60 via an attachment mechanism 840, such that pain relief vibrations generated by the pain relief transducer 224 are transmitted to the VAD 60. The VAD 60 in turn transmits the pain relief vibrations to the skin and / or tissue of the patient 50. In the illustrated embodiment, the pain relief vibrations can include transverse pain relief vibrations 824A directed substantially perpendicular to the VAD 60 and / or longitudinal pain relief vibrations 824B directed substantially parallel to the VAD 60. In some embodiments, either of the transverse pain relief vibrations 824A or the longitudinal pain relief vibrations 824B can be omitted.

[0078] The VAD 60 can be arranged substantially parallel to a longitudinal axis 855 of the VAD handle 850, although other orientations of the VAD 60 to the VAD handle 850 are contemplated. The attachment mechanism 840 can include any suitable attachment features or components, such as a clamp or a clip. The attachment mechanism 840 can provide selective attachment and detachment from the VAD 60.

[0079] The pain-reducing transducer 224 can include a lateral pain-reducing transducer 825A configured to define a lateral pain-reducing vibration 824A. The VAD handle 850 can employ any of the vibration mechanisms 300, 320 to enable the lateral pain-reducing transducer 825A to vibrate the distal portion 62 of the VAD in a lateral direction. Thus, the lateral pain-reducing transducer 825A can be oriented perpendicular to the VAD 60.

[0080] The pain-reducing transducer 224 can include a longitudinal pain-reducing transducer 825B configured to define a longitudinal pain-reducing vibration 824B. The VAD handle 850 can employ any of the vibration mechanisms 300, 320 to enable the longitudinal pain-reducing transducer 825B to vibrate the distal portion 62 of the VAD in a longitudinal direction. Thus, the longitudinal pain-reducing transducer 825B can be oriented perpendicular to the VAD 60.

[0081] The lateral pain-reducing transducer 825A and the longitudinal pain-reducing transducer 825B can be coupled to the console 400 independently of one another such that the signal generator can provide an excitation electrical signal to either the lateral pain-reducing transducer 825A or the longitudinal pain-reducing transducer 825B independently of the other. Thus, the frequency, amplitude, and / or waveform of the excitation electrical signal provided to the lateral pain-reducing transducer 825A or the longitudinal pain-reducing transducer 825B can be different. Similarly, the lateral pain-reducing transducer 825A or the longitudinal pain-reducing transducer 825B can be activated and / or deactivated independently of the other. In embodiments in which the longitudinal pain-reducing transducer 825B includes a sawtooth waveform, the steeper rising edge 726A can direct distally along the VAD 60 while the shallower falling edge 726B can direct proximally along the VAD 60.

[0082] In use, a user can 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 can detach the VAD handle 850 from the VAD 60.

[0083] Figure 9 A block diagram of a system method 900 of an ultrasound probe is shown, which, according to some embodiments, can include all or any subset of the following steps, actions or processes as can be defined by logic and executed by a processor of the probe.

[0084] The method 900 can include delivering a first excitation electrical signal having an ultrasound frequency to a plurality of vibrational transducers (ultrasound imaging transducers) of a first subset of the ultrasound probe to cause a first interface surface of the ultrasound probe to vibrate at the ultrasound frequency (block 910). The first interface surface is in operative contact with a skin surface of the patient such that the ultrasound vibrations propagate into a target region of the patient. The method 900 can also include receiving an imaging electrical signal from the vibrational transducers of the first subset (block 920). The imaging electrical signal is based on reflections of the ultrasound vibrations off one or more anatomical elements within the target region. The method 900 can also include performing logical operations on the imaging electrical signal to generate an ultrasound image of the target region (block 930). The method 900 can also include rendering the ultrasound image on a display coupled with the ultrasound probe (block 940). The method 900 can also include delivering a second excitation electrical signal to a plurality of vibrational transducers (pain relief transducers) of a second subset to cause a second interface surface of the ultrasound probe to vibrate at a pain relief frequency (block 950). The pain relief frequency is different than the ultrasound frequency, and the second interface surface is in operative contact with the skin surface such that the second interface surface causes at least a portion of the target region to vibrate at the pain relief frequency.

[0085] In some embodiments of the method 900, the pain relief frequency is less than the ultrasound frequency, and in some embodiments of the method 900, the pain relief frequency is adjustable. In some embodiments of the method 900, the first patient interface surface comprises the second patient interface surface, and in some embodiments of the method 900, the vibrational transducers of the first subset comprise the vibrational transducers of the second subset.

[0086] In some embodiments of the method 900, the vibrational transducers of the second subset are oriented such that the direction of the second vibration is disposed at an angle relative 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, the probe body of the ultrasound probe comprises an arm extending between the second patient interface surface and the probe body.

[0087] In some embodiments of the method 900, the ultrasound probe comprises a vascular access device handle coupled with the ultrasound probe via a cable. In such embodiments, the vascular access device handle comprises the vibrational transducers of the second subset operatively coupled therewith, such that the vascular access device handle vibrates 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 vibrational transducers of the second subset are attached to the vascular access device handle such that the direction of the second vibration is disposed substantially parallel to a longitudinal axis of the vascular access device.

[0088] While certain specific embodiments have been disclosed herein, and while the detailed description herein has set forth various specific embodiments, it should be understood that these specific embodiments have been disclosed by way of example only. Various adaptations and modifications of the concepts herein disclosed can be readily effected without departing from the scope of the concepts provided herein. The concepts in their broader aspects are therefore not limited to the specific embodiments disclosed. Accordingly, the disclosure of specific embodiments is not intended to limit the concepts provided herein, which can be adapted and modified as desired.

Claims

1. An ultrasonic detector, comprising: Detector body; Multiple vibration transducers are connected to the detector body; A detector head, disposed at the distal end of the detector body, the detector head including a first subset of the plurality of vibration transducers operatively coupled to a patient interface surface of the detector head, wherein: The patient interface surface is configured to operatively attach to the patient's skin surface at a target area of ​​the patient, and The vibration transducers of the first subset are configured to define ultrasonic vibrations on the surface of the patient interface; The second patient interface surface has a second subset of the plurality of vibration transducers operatively coupled thereto, wherein: The second patient interface surface is configured to be operatively coupled to the skin surface, and The vibration transducers of the second subset are configured to define pain-reducing vibrations on the surface of the second patient interface; and A control console, connected to the vibration transducer, includes one or more processors and a memory storing logic thereon, the logic causing operations to be performed when executed by the one or more processors, the operations including: A first excitation electrical signal with an ultrasonic frequency is delivered to the plurality of vibration transducers in the first subset; Imaging electrical signals are received from the plurality of vibration transducers in the first subset; An image of the target region is drawn on a display connected to the ultrasonic detector based on the imaging electrical signal; and A second excitation electrical signal is delivered to the vibration transducers of the second subset at a pain-relief frequency, wherein: The pain relief frequency is different from the ultrasound frequency, and The pain-relieving vibration is configured to alleviate pain experienced by the patient as a result of medical procedures performed in the target area.

2. The ultrasound detector of claim 1, wherein the target region includes a blood vessel configured to receive vascular entry into the device therein.

3. The ultrasound detector of claim 2, wherein the medical procedure includes inserting the vascular access device into the blood vessel.

4. The ultrasound detector according to any one of the preceding claims, wherein the pain relief frequency is less than the ultrasound frequency.

5. The ultrasound detector according to any one of the preceding claims, wherein the pain relief frequency is adjustable.

6. The ultrasound detector according to any one of the preceding claims, wherein the vibration transducers of the first subset are oriented such that the direction of the ultrasound vibration is arranged substantially perpendicular to the skin surface.

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

8. The ultrasonic detector according to any one of the preceding claims, wherein the vibration transducers of the first subset include the vibration transducers of the second subset.

9. The ultrasonic detector according to any one of claims 1 to 6, wherein the vibration transducers of the second subset are oriented such that the direction of the second vibration is different from the direction of the ultrasonic vibration.

10. The ultrasonic detector according to any one of claims 1 to 6 or 9, wherein the direction of the second vibration is oriented substantially parallel to the insertion path of the vascular entry device during use.

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

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

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

14. The ultrasound detector of claim 13, wherein the second patient interface surface is shaped to extend at least partially around the insertion site.

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

16. The ultrasonic detector of claim 15, wherein the length of the arm is adjustable.

17. The ultrasonic detector according to claim 15 or 16, wherein the angle of the arm relative to the detector body is adjustable.

18. The ultrasound detector of claim 17, wherein the angle of the arm is biased to maintain contact between the second interface surface and the skin surface when the orientation of the detector body is adjusted relative to the skin surface.

19. The ultrasound detector according to any one of claims 1 to 6, further comprising a vasculature entry device handle connected to the detector via a cable, wherein: The vascular access device handle includes a second subset of vibratory transducers operatively coupled thereto, such that at least a portion of the vascular access device handle vibrates according to the second vibration, and The handle of the vascular access device is configured to connect with the vascular access device such that the vascular access device defines the second patient interface surface.

20. The ultrasound detector of claim 19, wherein the vascular access device handle is configured to be detachably connected to the vascular access device.

21. The ultrasonic detector of claim 19 or 20, wherein the vibration transducer of the second subset is attached to the vascular entry device handle such that the direction of the second vibration is arranged substantially parallel to the longitudinal axis of the vascular entry device.

22. A system method for an ultrasonic detector, comprising: A first excitation electrical signal having an ultrasonic frequency is delivered to a plurality of vibrating transducers of a first subset of the ultrasound detector, such that a first interface surface of the ultrasound detector vibrates at the ultrasonic frequency, the first interface surface being in operative contact with the skin surface at the target area of ​​the patient. Receive imaging electrical signals from the vibration transducers of the first subset; Logical operations are performed on the imaging electrical signal to generate an ultrasound image of the target region, the logical operations being performed by one or more processors of the ultrasound detector; The ultrasound image is displayed on a monitor connected to the ultrasound detector; as well as A second excitation electrical signal having a pain-relief frequency different from the ultrasound frequency is delivered to the plurality of vibration transducers in the second subset, so that the second interface surface of the ultrasound detector vibrates at the pain-relief frequency.

23. The system method of claim 22, wherein the pain relief frequency is less than the ultrasound frequency.

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

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

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

27. The system method according to any one of claims 22 to 24, wherein the vibration transducers of the second subset are oriented such that the direction of the second vibration is arranged at an angle relative to the ultrasonic detector.

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

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

30. The system method according to any one of claims 22 to 24, wherein the ultrasound detector includes a vasculature access device handle connected to the ultrasound detector via a cable, and wherein: The vascular access device handle includes a second subset of vibratory transducers operatively coupled thereto, such that at least a portion of the vascular access device handle vibrates according to the second vibration, and The handle of the vascular access device is configured to connect with the vascular access device such that the vascular access device defines the second patient interface surface.

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

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