Devices, systems, and methods for suppressing pain by applying focused ultrasound targeting peripheral nerves.

Abstract

Devices, systems and methods are provided for relieving pain in a peripheral nerve of a subject. In one example, the device includes a surface configured to be placed against the skin of a subject, an imaging element on a housing configured to transmit signals from the surface into the subject's body and receive reflected signals from the body, and one or more transducer elements configured to deliver focused ultrasound waves from the surface into the body. A controller is coupled to the imaging element and processes the reflected signals to identify a target nerve within the body, and is coupled to the one or more transducer elements and controls the delivery of focused ultrasound waves to the target nerve to relieve pain.

Description

[Technical Field]

[0001] This application relates to a device, system, and method for delivering focused ultrasound into the body of a subject, and more particularly to a device, system, and method for alleviating acute or chronic pain using focused ultrasound targeting one or more nerves of a subject experiencing pain, without causing or inducing nerve modulation or nerve ablation.

[0002] Related application data This application claims the benefits of concurrently pending U.S. Provisional Application No. 63 / 210,864, filed on 15 June 2021, and U.S. Provisional Application No. 63 / 314,143, filed on 25 February 2022, the entire disclosures of which are expressly incorporated herein by reference. [Background technology]

[0003] Individuals may experience peripheral nerve pain due to a variety of circumstances. For example, patients may experience acute pain due to surgery or injury, or the pain may be chronic pain due to conditions such as complex regional pain syndrome (CRPS) types 1 and 2, phantom limb pain, trigeminal neuralgia, Bell's palsy, intercostal pain, postherpetic neuralgia, endometriosis, or neuroma.

[0004] The most common method of managing pain is narcotics, but these can come with various side effects.

[0005] Therefore, devices and methods for improving pain management, such as non-narcotic-based pain suppression, would be useful. [Overview of the project]

[0006] This application relates to a device, system, and method for delivering focused ultrasound into the body of a subject. More specifically, the application provides a device, system, and method for relieving pain using focused ultrasound targeting one or more nerves of a subject experiencing pain. In one example, focused ultrasound can be delivered to relieve pain without damaging the target nerve or other tissue. Alternatively, focused ultrasound can be delivered to induce neuromodulation or ablation of one or more target nerves. The pain to be treated is acute pain, including, but not limited to, acute surgical pain that is relieved by specific peripheral nerve blockade. The pain may also be chronic pain, including, but not limited to, complex regional pain syndrome (CRPS) types 1 and 2, phantom limb pain, trigeminal neuralgia, Bell's palsy, intercostal pain, postherpetic neuralgia, endometriosis, neuroma, and the like.

[0007] The use of focused ultrasound for neuromodulation has demonstrated success in a wide range of applications, from the removal of amyloid plaques in Alzheimer's disease to the inhibition of electrophysiological seizure activity. Most previous studies using low-intensity focused ultrasound have focused on transcranial stimulation or inhibition of neural structures, such as direct activation of brain regions using transcranial focused ultrasound pulses or induction of motor activity in response to transcranial focused ultrasound. High-intensity ultrasound has been used for tissue ablation, such as solid tumors. Previous studies using low-intensity ultrasound for neuromodulation of the peripheral nervous system, such as partial inhibition of the vagus nerve, have been limited.

[0008] However, currently, there are no devices or procedures that use focused ultrasound for peripheral nervous system neuromodulation, including either or both inhibition and excitation of peripheral nerves, for the purpose of acute and chronic pain suppression. Currently, the majority of pain management is achieved with narcotics, but narcotics have various side effects. Focused ultrasound can be used as a non-invasive, non-drug-based alternative method for pain suppression.

[0009] For example, a device is provided for relieving pain in a subject, the device comprising a housing including a surface configured to be placed against the subject's skin; an image sensor on the housing configured to transmit signals from the surface into the subject's body and receive reflected signals from the body; one or more transducer elements configured to deliver focused ultrasound from the surface into the body; and a controller coupled to the image sensor, which processes the reflected signals to identify a target area in the body, such as a peripheral nerve, and which is coupled to one or more transducer elements, which controls the delivery of focused ultrasound to the target area to relieve pain.

[0010] Another example provides a method for relieving pain in a subject, the method comprising: placing the contact surface of an ultrasound device against the subject's skin to acoustically couple one or more transducers of the device to the skin; activating the image sensor of the device to transmit a signal from the surface into the subject's body and receive reflected signals from the body to identify a target area in the body, such as a peripheral nerve; and delivering focused ultrasound from one or more transducer elements from the surface to the target area in the body to relieve pain.

[0011] For example, the device of this specification may include one or more acoustic transducers coupled to a controller, the device having an intensity of, for example, up to 500 watts per square centimeter (i.e., 0-500 W / cm²). 2 The device is configured to transmit low-intensity ultrasound with a frequency of approximately 1 kHz to 10 MHz. In another example, the device may have a frequency of approximately 500 to 2000 watts per square centimeter (500 to 2000 W / cm²). 2 The device can be configured to transmit high-intensity ultrasound having an intensity of ) at a frequency of, for example, about 1 kilohertz to 10 megahertz (1 kHz to 10 MHz).

[0012] In some examples, ultrasonic energy is emitted substantially continuously by one or more ultrasonic transducers. In other examples, ultrasonic energy is emitted intermittently. In yet another example, ultrasonic energy is emitted in the form of pulses.

[0013] Optionally, the devices and methods of this specification may be configured to deliver high-intensity ultrasound to induce thermal ablation or neuroslysis of target nerves to relieve pain. Alternatively, the methods may utilize focused ultrasound on peripheral nerve tissue to relieve acute and chronic pain through both thermal and non-thermal mechanisms (i.e., high-intensity versus low-intensity ultrasound). Optionally, neuromodulation may be achieved through either or both stimulation and inhibition of nerve conduction or ultrasound energy transmission to tissue.

[0014] In various examples, invasive or non-invasive devices can be provided. For example, a non-invasive ultrasound device can be provided that includes one or more focused ultrasound transducers that can be applied directly to the epidermis of a subject to target specific peripheral nerves. The application site of the device on the epidermis relative to the target peripheral nerve can be determined by imaging guidance, such as ultrasound or MRI imaging.

[0015] For example, the transducer position can be determined before or during the application of the transducer, and optionally, the focal length of the ultrasound transducer can be calibrated based on image guidance. For instance, the controller can identify various tissue structures between the skin and the target nerve, at least partially based on the signal from the image sensor, for example, the thickness of the skin and / or the location and / or thickness of the fat and muscle layers, and furthermore, the signal to the FUS transducer can be modified to enhance the focusing of acoustic energy by considering the different ultrasound attenuation of tissues along the path to the target nerve. Once the correct position and / or focal length is determined, the transducer can be applied directly to the epidermis with or without using a binding material such as a gel between the transducer and the epidermis. The focused ultrasound energy can then be transmitted to the target peripheral nerve through the skin and intervening soft tissues.

[0016] In another example, an implantable micro-ultrasound device can be provided, for example, by implanting the entire device in the subject's body in close proximity to a target peripheral nerve or nerve plexus, and using it to locally deliver focused ultrasound energy to the nerve. Such a device can be applied by surgically exposing the peripheral nerve and implanting the device around or in close proximity to the peripheral nerve. The focal length can be calibrated according to the distance to the nerve and the diameter of the nerve.

[0017] Another example involves a focused ultrasound device having an ultrasound transducer coupled to an exposed peripheral nerve. Such an example would be applied by surgically exposing the peripheral nerve and coupling the ultrasound transducer to the peripheral nerve using, for example, a fluid-filled coupling cone or cylinder or other coupling material.

[0018] In yet another example, a transcutaneous focused ultrasound transducer, a device and method for placement and / or attachment on a subject's epidermis together with an image management device such as an imaging ultrasound device are included. Thereafter, the imaging device can be used to identify the location of the targeted nerve or other structure. For example, a software program can be used to transcutaneously transmit focused ultrasound energy to the target structure continuously, intermittently or pulsatile for a period of time (from several hours to several days).

[0019] Other aspects and features of the present invention will become apparent upon consideration of the following description in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0020] The present invention is believed to be better understood from the following description of certain specific examples in conjunction with the accompanying drawings. In the drawings, like reference numerals identify like elements. [Figure 1] FIG. 1 shows an example of a device for delivering focused ultrasound to a target nerve in a subject's body to suppress pain. [Figure 2] FIG. 2 is a schematic diagram showing exemplary components that may be included in the device of FIG. 1. [Figure 3] FIG. 3 shows an alternative example of a device including an adjustable ultrasound imaging element.

[0021] The drawings are not intended to be limiting in any way, and it is contemplated that the various examples of the present invention may be implemented in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated herein and form a part hereof, illustrate some aspects of the present invention and serve to explain the principles of the present invention in conjunction with the detailed description, but it should be understood that the present invention is not limited to the exact arrangements shown.

Modes for Carrying Out the Invention

[0022] The following description of specific examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which is presented as an illustration of one of the best modes contemplated for carrying out the present invention. As will be understood, the present invention can take various other obvious forms without departing from the present invention. For this reason, the drawings and the description should be regarded as illustrative in nature and not restrictive.

[0023] Before describing the embodiments, it should be understood that the present invention is not limited to the specific embodiments described, and of course, can be modified. Also, since the scope of the present invention is limited only by the appended claims, it should be understood that the terms used in this specification are for the purpose of describing only specific embodiments and are not intended to be limiting.

[0024] When a range of values is given, it should be understood that each intervening value between the upper and lower limits of that range, to one-tenth of the unit of the lower limit value, is also specifically disclosed, unless the context clearly indicates otherwise. Each smaller range between any of the recited values or intervening values within the recited range and any other recited value or intervening value within the recited range is encompassed by the present invention. The upper and lower limits of those smaller ranges may independently be included in or excluded from the range, and the range is encompassed by the present invention whether both or either of them are included in the smaller range or neither is included in the smaller range, subject to any specifically excluded limit values within the recited range. When the recited range includes one or both of the limit values, ranges excluding one or both of those included limit values are also to be considered as included in the present invention.

[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art in which the present invention pertains. Any methods and materials similar to or equivalent to those described herein may be used in carrying out or testing the present invention, but several possible exemplary methods and materials are described herein.

[0026] In this specification and the appended claims, the singular forms "a," "an," and "the" refer to multiple subjects unless the context clearly indicates otherwise. For example, a reference to "compound" includes multiple such compounds, and a reference to "polymer" includes one or more polymers and their equivalents known to those skilled in the art.

[0027] In this specification, certain ranges are indicated by the term “approximately” preceding a number. The term “approximately” is used herein to provide literal backing for the exact number following the term and for numbers that are close to or approximate the number following the term. When determining whether a number is close to or approximates a specifically mentioned number, the close or approximate unmentioned number may be a number that, in the context in which it is presented, provides a substantially equivalent to the specifically mentioned number.

[0028] Referring to the drawings, Figure 1 shows an example of a device 10 for alleviating peripheral neuropathy in a subject's body 90, and as shown in Figure 2, the device 10 includes one or more components for operating the device 10, such as a FUS transducer 30, an imaging or positioning element 40, a controller 50, and a housing 20 that houses a power supply 60. The housing 20 may include a contact surface 22 configured to be placed against the subject's skin 92 so that focused ultrasound is delivered from the transducer 30 through the surface 22 into the subject's body 90, for example, as further described elsewhere in this specification.

[0029] Optionally, the housing 20 may have a shape that provides a handheld device, for example, a shape that facilitates the user holding the device 10. For example, the housing 20 itself may have a shape that allows the user to hold the device 10, for example, an elongated cylindrical shape or other shape, and / or one or more handles, grips or other features (not shown) may extend from the housing 20 to facilitate the operation of the device 10 during use.

[0030] Additionally or alternatively, the housing 20 may include one or more features to facilitate the attachment of the device 10 to the subject's body 90. For example, the contact surface 22 may include an adhesive or other sticky material that can secure the surface 22 to the skin 92 during use, but allows the device 10 to be removed without damaging the skin 92. Additionally or alternatively, the housing 20 may be provided with one or more straps (not shown) that can be wrapped at least partially around the subject's body, for example, a pair of straps on either side of the contact surface 22, having sufficient length to allow the straps to be wrapped around an appendage of the subject's body, e.g., an arm or leg, or a torso, during use. Optionally, the straps may include ends having cooperating fasteners, e.g., hook fasteners, snaps, clips, buttons, strings, etc. (not shown) for detachably fastening the ends together to hold the contact surface 22 against the skin 92. Alternatively, the subject or another person may simply hold the housing 20 during use to press the surface 22 against the skin 92.

[0031] Continuing to refer to Figure 1, the FUS transducer 30 may include a plurality of piezoelectric elements 31 providing an array, and as will be further described elsewhere in this specification, the transducer 30 may deliver focused ultrasound along a first axis 34 to generate a beam that focuses the ultrasound energy to a desired location along the first axis 34, for example, a target nerve 94. For example, as shown in Figure 1, the transducer elements 31 may be mounted adjacent to a contact surface 22 so that the elements 31 are acoustically coupled to the skin 92 in contact with the surface 22, and the ultrasound energy generated by the elements 31 is transmitted from the surface 22 into the subject's body 90 along the first axis 34. In the illustrated example, the transducer elements 31 are mounted or adjacent to a substantially flat surface 32 in a substantially flat array, but it will be understood that the elements 31 may be provided in other arrangement configurations, for example, having concave or convex surfaces, or other arrangement configurations (not shown) centered on an axis 38, as needed. In one example, the elements 31 may be arranged adjacent to each other on a plane 32, for example, in a circular arrangement on the surface 32 by one or more annular sets of elements 31, each including multiple elements 31 spaced radially apart from each other, or they may be provided in a linear array, for example, including one or more rows, each row including multiple square, rectangular, hexagonal or other shaped piezoelectric elements (not shown).

[0032] The acoustic pad 38 is attached to or otherwise bonded to a plane 32 defining the contact surface 22 of the device 10, so that, for example, the transducer 30 can be acoustically bonded to the subject's skin 92 and / or the device 10 can be pressed against the skin 92. For example, the pad 38 may be a bag or other flexible membrane containing an acoustic gel, water or other fluid, foam or other material that fills the space between the plane 32 and the contact surface 22 and enhances the bond between the transducer 30 and the skin 92. Optionally, the pad 46 may be adjustable, for example, along a first axis 34, so that the focal zone of the ultrasonic energy can be manually adjusted relative to the subject's body 90 when pressed against the skin 92. For example, the membrane may be sufficiently flexible so that the distance between the surfaces 32, 22 can be adjusted by displacing the gel or other pad material outward within the membrane, and the membrane may expand outward without rupturing to allow for displacement.

[0033] Alternatively, the depth of focus of the FUS energy can also be adjusted by adjusting the height between surfaces 44, 2 using other mechanisms. For example, in one alternative, a set of acoustic pads (not shown) with different dimensions, e.g., different heights and / or different acoustic properties, is provided, and the user can select from among them to attach to the device 10. In this alternative, the housing 20 may include one or more connectors adjacent to the plane 32, thereby allowing the selected pad to be attached to the housing 20 to provide a contact surface 22. The selected pad can be removed and replaced as needed, for example, when multiple locations are treated or when a single device is used to treat multiple subjects. This allows the user to customize a single device, i.e., a device comprising the FUS transducer 30 and the image sensor 40, during or between uses. The pads can be sealed so that they can be sterilized or otherwise cleaned during or as needed.

[0034] Continuing to refer to Figure 1, the image sensor 40 receives the incident ultrasonic signal Di For example, the signal is transmitted from the contact surface 22 into the subject's body 90, centered on a second axis 44, and the reflected signal D from the body 90 is transmitted. r The imaging sensor 40 includes an imaging or diagnostic ultrasound transducer 42 configured to receive the imaging signal D. The imaging sensor 40 can be mounted in the housing 20 such that the imaging transducer 42 is offset from the FUS transducer 30, for example, laterally with respect to a plane 32, and at an angle such that a second axis 44 intersects the first axis 34. The imaging transducer 42 receives, for example, the imaging signal D. i , D r This may also include one or more piezoelectric elements (only one shown for simplicity) located at the distal end of an imaging housing 46 mounted adjacent to the FUS transducer 30 so as to pass through the pad 38. Alternatively, other imaging devices may be provided that can generate signals that can be used to identify a target nerve 92 or other tissue of interest.

[0035] The image sensor 40 can be fixed to the housing 20 such that the intersection angle of the axes 34, 44 is fixed, as shown in Figure 1, for example (even if the angle can be electronically changed in other ways, as described elsewhere herein). Alternatively, the image sensor 40 may be movable relative to the housing 20 to change the direction of the second axis 44. For example, as shown in Figure 3, an image sensor 40' can be provided that is coupled to the housing 20 by a mechanism that provides one or more degrees of freedom of movement of the image sensor 40' relative to the housing 20. In the illustrated example, the image sensor 40' is attached to the housing 20 using a hinge 48' that allows the image sensor 40' to swing relative to the housing 20 about a single axis, and by swinging, for example, the imaging transducer 42, the second axis 44 can become substantially parallel to the first axis 34 and intersect the first axis 34 at an increasingly acute angle, e.g., about 0 to 90 degrees (0 to 90°), as the image sensor 40' swings. Additionally or alternatively, the entire image sensor 40 may be spatially movable relative to the housing 20, for example, in one or more directions in a plane parallel to the plane 32.

[0036] Referring further to Figure 2, the controller 50 (including one or more processors, memory and / or other electronic components (not shown)) is coupled to the image sensor 40 and the incident signal D i Controls the delivery of the reflected signal D r The data can be processed to identify, for example, one or more tissue structures within the body 90. For example, the controller 50 can analyze the reflex signals to identify a target nerve 94 (or other tissue of interest) and obtain depth and / or other spatial information of the nerve 94 relative to the FUS transducer 30.

[0037] The controller 50 is also coupled to the FUS transducer 30 and can, for example, supply energy to the transducer element 31 to control the delivery of focused ultrasound to the target nerve 94, thereby alleviating pain. The controller 50 is coupled to a power supply 60, which may include, for example, one or more batteries, a transformer, and / or other components necessary to deliver signals to the transducer element 31 to cause the element 31 to generate acoustic energy guided along the first axis 34. Additionally or alternatively, the device 10 may include a connector 62 that allows the device 10 to be connected to an external power source, for example, simply by plugging it into an electrical outlet, or a connector that allows connection to an external power source that can generate the power and / or signals necessary to operate the transducer 30 and / or the image sensor 40. When operating, the device 10 can supply FUS energy substantially continuously, intermittently and / or in a desired pulsed form, as needed. Optionally, device 10 may include a user interface, such as a touchscreen or a set of buttons (not shown), which may allow the user to select desired parameters of the energy supplied, such as intensity, duration, waveform, etc., and to change one or more of these as needed.

[0038] Optionally, the controller 50 can control one or more of the phase, intensity, pulse width, and frequency of the signal to the piezoelectric element 31, thereby generating an ultrasonic beam focused into a focal zone leading to the target nerve 94. For example, based at least partially on the location of the target nerve 94 identified by the image sensor 40, the controller 50 can modify the signal to shift the depth of the focal zone of the ultrasonic beam B and / or shift the focal zone laterally relative to the first axis 34 in order to concentrate acoustic energy on the target nerve 94. Furthermore, based at least partially on the signal from the image sensor 40, the controller 50 can identify various tissue structures between the skin 92 and the target nerve 94, for example, the thickness of the skin, and / or the location and / or thickness of the fat and muscle layers. To enhance the focusing of acoustic energy, the controller 50 can modify the signal to the element 31 of the transducer 30 to account for the different ultrasonic attenuations of tissue along the path to the target nerve 92. Additionally or alternatively, if the image sensor 40 is movable, the orientation of the image sensor 40 can be manually adjusted, and the controller 50 can modify the signal to adjust the focal zone based at least partially on the location of the target nerve.

[0039] Additionally or alternatively, the position of the focal zone can be manually adjusted, for example, using an acoustic pad 38. For instance, the distance from the plane 32 (and thus the transducer element 31) to the contact surface 22 can be adjusted by adjusting the pressure applied to the pad 38, for example, by displacing the gel or other material within the pad 38, thereby providing a desired distance to position the tissue of interest within the focal zone before supplying FUS energy.

[0040] Alternatively, the FUS transducer 30 may be mounted within the housing 20 so that it can be moved during use, for example, using one or more servo motors or other actuators. For example, the housing 20 can be secured to the subject's body 90 using, for example, one or more straps or other features (not shown), and the controller 50 can process signals from the image sensor 40 to identify one or more areas within the body 90 for treatment. After being actuated continuously or intermittently, the transducer 30 is moved within the housing 20 relative to the body 90, thereby moving the focal zone. In one example, the transducer 30 may be movable in a plane parallel to the plane 32, thereby moving the focal zone laterally relative to the tissue in the body 90. For example, if the target treatment area is larger than the focal zone, the transducer 30 can be moved during treatment to deliver acoustic energy to the entire area. Similarly, if the target area includes a long nerve, the transducer 30 can be moved to deliver FUS along the desired length of the nerve. Alternatively, the transducer 30 can be moved to deliver FUS to multiple regions while supplying acoustic energy to each region for a pre-set or customized duration.

[0041] Optionally, device 10 can include an output device (not shown) coupled to controller 50 to assist a user in positioning a focus zone relative to a target nerve. For example, one or more light indicators, speakers, etc. (not shown) that can provide an output when the target nerve is within the focus zone can be provided in housing 20. Additionally or alternatively, a display (also not shown) can be provided in housing 20 to provide an image based at least in part on signals from image capture device 40, such as to identify the location of target nerve 94 (and / or other tissue structures) and overlay a display of the focus zone to enable the user to manually position target nerve 94 within the focus zone. For example, controller 50 can process signals from image capture device 40 and present an image on the display indicating the location of target nerve 94 relative to the focus zone. As the user moves device 10, such as by pressing on pad 38 and / or moving contact surface 22 along skin 92, the position of target nerve 94 can be monitored as it moves relative to device 10 until the focus zone overlaps target nerve 94 in the image, after which the user can activate FUS transducer 30 to deliver FUS energy and relieve pain in the subject.

[0042] Device 10 can be configured to transmit low-intensity ultrasonic waves having an intensity of up to 500 watts per square centimeter (i.e., 0 - 500 W / cm 2 ) at a frequency of, for example, about 1 kilohertz to 10 megahertz (1 kHz - 10 MHz). Alternatively, device 10 can transmit ultrasonic waves having an intensity of about 500 - 2000 watts per square centimeter (500 - 2000 W / cm 2The device can be configured to transmit high-intensity ultrasound with a strength of 100 kHz at a frequency of approximately 1 kHz to 10 MHz. Thus, the device 10 can be used to temporarily relieve pain by applying FUS energy without damaging the target nerve, or it can be used to permanently relieve pain by causing nerve modulation, ablation, or other at least partial destruction of the nerve.

[0043] Referring further to Figure 1, during use, the device 10 may be used by the subject or caregiver to alleviate peripheral nerve pain in the subject. Generally, the FUS transducer 20 can be acoustically coupled to the skin 92 by placing the contact surface 22 against the subject's skin 92. Optionally, to enhance acoustic coupling, an acoustic gel or other material may be applied to the skin 92 and / or the contact surface 22 before placement, if necessary.

[0044] When the image sensor 40 is activated, the controller 50 sends a signal D to the imaging transducer 42 from the surface 22 into the subject's body 90. i It transmits the reflected signal D from body 20. r The device can receive signals to identify a target nerve or other tissue of interest 94 within the body 90. Optionally, the device 10 can be moved along the skin 92 and / or, under guidance from, for example, the image sensor 40, the pad 38 can be pressed or released as needed. Additionally or alternatively, if the image sensor 40 is movable, the device 10 can be applied to the skin 92 approximately over the target nerve 94, and the image sensor 40 can be moved to determine its position relative to the FUS transducer 30, allowing the controller 50 to calibrate the signals necessary to direct the focal zone to the target nerve 94.

[0045] When the target nerve 94 enters the focal zone of the FUS transducer 30, the FUS transducer 30 can be activated to deliver focused ultrasound to the target nerve 94, for example, to alleviate pain. Optionally, the user can manually activate the FUS transducer 30 after confirming the location of the target nerve 94 (for example, after confirmation using an output device on the housing 20). Alternatively, the controller 50 can automatically activate the FUS transducer 30 once it confirms that the target nerve 94 is within the focal zone. FUS energy may be supplied for a preset time, or the user may activate the FUS transducer 30 for a desired time.

[0046] The devices, systems, and methods described herein can be used to deliver focused ultrasound to various peripheral nerves, such as the lumbar plexus, femoral nerve, saphenous nerve, obturator nerve, lateral femoral cutaneous nerve, sciatic nerve, posterior tibial nerve, sural nerve, common peroneal nerve, deep peroneal nerve, superficial peroneal nerve, brachial plexus, intercostobrachial nerve, musculocutaneous nerve, median nerve, radial nerve, ulnar nerve, iliotibial nerve, iliolumbar nerve, intercostal nerve, superficial cervical plexus, auricular-temporal nerve, mental nerve, buccal nerve, infraorbital nerve, supraorbital nerve, superior auricular nerve, greater occipital nerve, greater auricular nerve, and lesser occipital nerve, in order to alleviate acute and / or chronic pain. Diseases that may be treated include phantom limb pain, CRPS (types I and II), acute surgical pain: specific peripheral nerve blockade, neuroma, headache, trigeminal neuralgia, Bell's palsy, glossopharyngeal nerve, intercostal neuralgia, trigeminal neuralgia, neuropathy (e.g., celiac plexus, superior and inferior hypogastric plexus), endometriosis pain, herpes zoster (e.g., postherpetic neuralgia), nerve root transection, lower back pain, rheumatoid arthritis pain, and cancer-related pain.

[0047] While the present invention is capable of various modifications and alternative forms, specific examples are shown in the drawings and described in detail herein. However, it should be understood that the present invention is not limited to any specific form or method disclosed, and that it encompasses all modifications, equivalents, and alternatives included in the appended claims.

Claims

1. A device for alleviating peripheral neuralgia in the subject, A housing including a surface configured to be placed against the skin of a subject, An image sensor on a housing configured to transmit signals from the surface into the body of a subject and to receive reflected signals from the body, One or more transducer elements configured to deliver focused ultrasound into the body from the surface, The system comprises a controller coupled to the image sensor, which processes the reflected signal to identify a target nerve in the body, and a controller coupled to one or more transducer elements, which controls the delivery of focused ultrasound to the target nerve to alleviate pain. The one or more transducer elements are configured to deliver focused ultrasound along a first axis, and the imaging sensor is offset from the one or more transducer elements such that the imaging signal is delivered along a second axis intersecting the first axis. The device is characterized in that the surface includes a pad attached to the housing, the pad is configured to connect the one or more transducer elements to the skin, and the image sensor is configured such that the imaging signal passes through the pad.

2. In the device according to claim 1, The device is characterized in that the image sensor includes an ultrasonic image sensor configured to transmit ultrasonic signals into the body and receive ultrasonic signals reflected from tissue structures within the body.

3. In the device according to claim 2, The device is characterized in that the ultrasonic imaging element includes an array of piezoelectric transducers.

4. A device for alleviating peripheral neuralgia in the subject, A housing including a surface configured to be positioned in contact with the skin of a subject, One or more transducer elements configured to deliver focused ultrasound into the body along a first axis from the surface, An image sensor on a housing configured to transmit an ultrasonic signal into the body of a subject along a second axis from the surface and to receive reflected signals from the body, wherein the image sensor is offset from one or more transducer elements such that the second axis intersects the first axis, The system comprises a controller coupled to the image sensor, which processes the reflected signal to identify a target nerve in the body, and a controller coupled to one or more transducer elements, which controls the delivery of focused ultrasound to the target nerve to alleviate pain. The device is characterized in that the surface includes a pad attached to the housing, the pad is configured to connect the one or more transducer elements to the skin, and the image sensor is configured so that the ultrasonic signal passes through the pad.

5. In the device according to any one of claims 1 to 4, The device is characterized in that the image sensor is movable relative to the housing to adjust the angle of the second axis with respect to the first axis.

6. In the device according to claim 5, The device is characterized in that the image sensor is attached to the housing by a hinge configured to adjust the angle of the second axis.

7. In the device according to claim 5, The device further comprises a handle attached to the image sensor for adjusting the angle of the second axis.

8. In the device according to any one of claims 1 to 4, The device is characterized in that the one or more transducer elements include an array of piezoelectric elements mounted adjacent to the surface so as to be acoustically coupled to the skin.

9. In the device according to any one of claims 1 to 4, The device is characterized in that the pad has an adjustable height along the first axis.

10. In the device according to claim 8, The device is characterized in that the controller is coupled to the array to control one or more of the phase, intensity, pulse width, and frequency of the signal to the piezoelectric element so as to generate an ultrasonic beam focused on a target nerve.

11. In the device according to any one of claims 1 to 4, A device further comprising a power supply coupled to the one or more transducer elements and the controller, which supplies electrical energy to the one or more transducer elements in order to deliver focused ultrasonic waves.

12. In the device according to any one of claims 1 to 4, The device is characterized in that the controller is configured to calibrate the delivery of focused ultrasound at least partially based on the distance from the one or more transducers to the target nerve.

13. In the device according to any one of claims 1 to 4, A device characterized in that the surface further includes a material for acoustically bonding one or more transducers to the skin of a subject.

14. In the device according to any one of claims 1 to 4, The device is characterized in that the pad includes a member filled with fluid.

15. In the device according to any one of claims 1 to 4, The device is characterized in that the pad has a flexible membrane containing foam.

16. In the device according to any one of claims 1 to 4, The device is characterized in that the pad has a flexible film containing an acoustic gel.

17. In the device according to any one of claims 1 to 4, The device is characterized in that the pad has a flexible film containing water.

18. In the device according to any one of claims 1 to 4, The device is characterized in that the controller is configured to operate one or more transducers to transmit low-intensity ultrasound at a frequency of 1 kilohertz to 10 megahertz (1 kHz to 10 MHz).

19. In the device according to claim 18, The intensity of the ultrasound is 0 to 500 watts per square centimeter (i.e., 0 to 500 W / cm²). ２ A device characterized by being ).

20. In the device according to any one of claims 1 to 4, The device is characterized in that the controller is configured to operate one or more transducers to transmit high-intensity ultrasound at a frequency of 1 kilohertz to 10 megahertz (1 kHz to 10 MHz).

21. In the device according to claim 20, The intensity of the ultrasound is 500 to 2000 watts per square centimeter (i.e., 500 to 2000 W / cm²). ２ A device characterized by being ).

22. In the device according to any one of claims 1 to 4, The device is characterized in that the controller is configured to operate the one or more transducers substantially continuously, intermittently, and in pulse form.

23. In the device according to any one of claims 1 to 4, A device characterized in that the housing has a shape that provides a handheld device.

24. In the device according to claim 23, The device is characterized in that the housing has an elongated cylindrical shape, and one or more handles, grips, or other features extend from the housing to facilitate operation of the device during use.

25. The device according to any one of claims 1 to 4 is further, A device comprising an output device connected to the controller, characterized in that it assists the user in positioning the focal zone of the one or more transducer elements relative to the target nerve.

26. In the device according to claim 25, The output device is characterized in that it includes one or more optical indicators or speakers provided in the housing, and provides an output when the target nerve is within the focal zone.

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