Devices, systems and methods for controlling pain through application of focused ultrasound targeted to 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] The present application relates to devices, systems and methods for delivering focused ultrasound into a subject's body, and more particularly, to devices, systems and methods for relieving acute or chronic pain using focused ultrasound to target one or more nerves in a painful subject, for example, with or without causing neuromodulation or nerve ablation.

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

[0003] A subject may experience peripheral nerve pain due to a variety of conditions: for example, a patient may experience acute pain due to, for example, surgery or injury, or the pain may be chronic pain due to diseases such as, for example, 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.

[0004] The most common method for managing pain is narcotics, which can have a variety of side effects.

[0005] Thus, devices and methods for improving pain management, such as, for example, non-narcotic based pain control, would be useful. Summary of the Invention

[0006] This application relates to devices, systems and methods for delivering focused ultrasound into a subject's body. More particularly, devices, systems and methods are provided for alleviating pain using focused ultrasound targeted to one or more nerves in a subject suffering from pain. In one example, focused ultrasound can be delivered to alleviate pain without damaging the target nerve or other tissue. Alternatively, focused ultrasound can be delivered to cause neuromodulation or ablation of one or more target nerves. The pain treated is acute pain, including but not limited to acute surgical pain where pain is relieved by specific peripheral nerve blockade. Pain may also be chronic pain, including but not limited to complex regional pain syndrome (CRPS) type 1 and type 2, phantom limb pain, trigeminal neuralgia, Bell's palsy, intercostal pain, postherpetic neuralgia, endometriosis, neuroma, etc.

[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 prior work with low-intensity focused ultrasound has been used for transcranial stimulation or inhibition of neural structures, such as direct activation of brain regions using transcranial focused ultrasound pulses or eliciting motor activity in response to transcranial focused ultrasound. High-intensity ultrasound has previously been used for ablation of tissues, such as solid tumors. There has been limited work to date using low-intensity ultrasound for neuromodulation of the peripheral nervous system, such as partial inhibition of the vagus nerve.

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

[0009] According to one example, a device is provided for relieving pain in a subject, the device including a housing including a surface configured for placement against the skin of the subject, an imaging element 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 waves from the surface into the body, and a controller coupled to the imaging element, processing the reflected signals to identify a target area within the body, e.g., a peripheral nerve, and coupled to the one or more transducer elements to control the delivery of focused ultrasound waves to the target area for pain relief.

[0010] According to another example, a method for relieving pain in a subject is provided, the method including the steps of placing a contact surface of an ultrasound device against the skin of the subject to acoustically couple one or more transducers of the device to the skin, activating an imaging element of the device to transmit signals from the surface into the subject's body and receive reflected signals from the body to identify a target area within the body, such as a peripheral nerve, and delivering focused ultrasound from the one or more transducer elements from the surface to the target area within the body to relieve pain.

[0011] In one example, a device herein can include one or more acoustic transducers coupled to a controller, the device being capable of, for example, producing an intensity of up to 500 watts per square centimeter (i.e., 0-500 W / cm 2 In another example, the device is configured to transmit low intensity ultrasound having a power of, for example, about 500-2000 watts per square centimeter (500-2000 W / cm). 2 ) at a frequency of, for example, about 1 kilohertz to 10 megahertz (1 KHz to 10 MHz).

[0012] In some instances, ultrasonic energy is emitted substantially continuously by one or more ultrasonic transducers, in other instances, ultrasonic energy is emitted intermittently, and in still other instances, ultrasonic energy is emitted in the form of pulses.

[0013] Optionally, the devices and methods herein may be configured to deliver high intensity ultrasound to cause thermal ablation or neurolysis of the target nerve to relieve pain. Alternatively, the methods may utilize focused ultrasound to peripheral nerve tissue to relieve acute and chronic pain through both thermal and non-thermal mechanisms (i.e., high intensity vs. low intensity ultrasound). Optionally, neuromodulation may be achieved through one or both of stimulation and inhibition of nerve conduction or ultrasound energy transmission to tissue.

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

[0015] In one example, the position of the transducer can be determined before or during application of the transducer, and optionally the focal length of the ultrasound transducer can be calibrated based on image guidance. For example, the controller can identify various tissue structures between the skin and the target nerve based at least in part on the signal from the imaging element, for example, the thickness of the skin, and / or the location and / or thickness of the fat and muscle layers, and can further modify the signal to the FUS transducer to account for different ultrasound attenuation of tissue along the path to the target nerve to enhance focusing of the acoustic energy. Once the correct position and / or focal length is determined, the transducer can be applied directly to the epidermis, with or without a coupling material, such as a gel, between the transducer and the epidermis. The focused ultrasound energy can then be transmitted through the skin and intervening soft tissue to the target peripheral nerve.

[0016] In another example, an implantable micro-ultrasound device can be provided, for example, the entire device can be implanted in a subject's body in close proximity to a target peripheral nerve or nerve plexus and used to deliver focused ultrasound energy locally to the nerve. Such a device can be applied by surgically exposing the peripheral nerve and implanting the device surrounding 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] Yet another example includes a focused ultrasound device having an ultrasound transducer coupled to an exposed peripheral nerve, which would be applied by surgically exposing the peripheral nerve and coupling the ultrasound transducer to the peripheral nerve, for example, using a fluid-filled coupling cone or cylinder or other coupling material.

[0018] Yet another example includes devices and methods in which a transcutaneous focused ultrasound transducer is placed on and / or attached to the subject's epidermis along with an image management device, such as an imaging ultrasound device. The imaging device can then be used to identify the location of the targeted nerve or other structure. For example, a software program can be used to transmit focused ultrasound energy transcutaneously to the target structure continuously, intermittently or in a pulsed manner for a period of time (hours to days).

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

[0020] The invention will be better understood from the following description of specific examples taken in conjunction with the accompanying drawings, in which like reference numbers identify the same elements, and in which: [Figure 1] FIG. 1 illustrates an example of a device for delivering focused ultrasound to target nerves within a subject's body to suppress pain. [Diagram 2] FIG. 2 is a schematic diagram illustrating example components that may be included in the device of FIG. [Diagram 3] FIG. 3 shows an alternative embodiment of a device that includes an adjustable ultrasound imaging element.

[0021] The drawings are not intended to be limiting in any way, and it is contemplated that various examples of the invention may be embodied in other various ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and, together with the detailed description, serve to explain the principles of the invention, although it should be understood that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[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 an example of one of the best modes conceivable for carrying out the present invention. As will be understood, the present invention is also capable of various other obvious modes without departing from the present invention. For this reason, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0023] Before describing the embodiments, it is to be understood that the invention is not limited to particular embodiments described, as such may, of course, vary, and the scope of the present invention will be limited only by the appended claims. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0024] Where a range of values ​​is given, it is understood that each intervening value between the upper and lower limits of that range, to the tenth of the unit of the lower limit, is also specifically disclosed unless the context clearly dictates otherwise. Each smaller range between any stated value or intervening value in a stated range and any other stated value or intervening value in a stated range is encompassed within the invention. The upper and lower limits of such smaller ranges may each be independently included or excluded within the range, and each range is encompassed within the invention, whether or not both or either are included in the smaller range, subject to the specifically excluded limit in the stated range. Where a stated range includes one or both of the limits, ranges excluding either or both of those included limits are also intended to be included within the invention.

[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some possible exemplary methods and materials are described herein.

[0026] It should be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to a "compound" includes a plurality of such compounds, and a reference to a "polymer" includes a reference to one or more polymers and equivalents thereof known to those skilled in the art.

[0027] In this specification, certain ranges are indicated by the term "about" before the numerical values. The term "about" is used in this specification to provide literal support for the exact numerical value following the term and for a numerical value close to or close to the numerical value following the term. In determining whether a numerical value is close to or close to a specifically stated numerical value, the close or close unstated numerical value may be a numerical value that provides a substantial equivalent to the specifically stated numerical value in the context in which it is presented.

[0028] 1 illustrates an example of a device 10 for relieving peripheral nerve pain in a subject's body 90, including a housing 20 that houses one or more components for operating the device 10, such as a FUS transducer 30, an imaging or localization element 40, a controller 50, and a power source 60, as shown in FIG 2. The housing 20 can include a contact surface 22 configured to be placed against the subject's skin 92 to cause focused ultrasound to be delivered from the transducer 30 through the surface 22 and into the subject's body 90, as described further elsewhere herein.

[0029] Optionally, housing 20 can have a shape to provide a handheld device, e.g., a shape to facilitate a subject holding device 10. For example, housing 20 itself can have a shape, e.g., an elongated cylindrical or other shape, that allows a user to hold device 10, and / or one or more handles, grips or other features (not shown) can extend from housing 20 to facilitate manipulation of device 10 during use.

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

[0031] 1, the FUS transducer 30 can include a plurality of piezoelectric elements 31 providing an array, such that the transducer 30 can deliver focused ultrasound along a first axis 34 to generate a beam that focuses ultrasound energy at a desired location along the first axis 34, such as a target nerve 94, as further described elsewhere herein. For example, as shown in FIG. 1, the transducer elements 31 can be mounted adjacent the contact surface 22 and acoustically coupled to the skin 92 where the elements 31 are contacted with the surface 22, such that 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 on or adjacent the substantially planar surface 32 in a substantially planar array, although it will be understood that the elements 31 can be provided in other arrangements, such as having a concave, convex surface, or other arrangements centered on the axis 38 (not shown), as desired. In one example, the elements 31 may be arranged adjacent to one another on the plane 32, e.g., with one or more annular sets of elements 31 arranged in a circular array on the surface 32, each comprising a plurality of elements 31 spaced radially from one another, or may be provided in a linear array, e.g., including one or more rows, each row comprising a plurality of square, rectangular, hexagonal or other shaped piezoelectric elements (not shown).

[0032] The acoustic pad 38 is attached to or otherwise coupled to the planar surface 32 that defines the contact surface 22 of the device 10, so that, for example, the transducer 30 can be acoustically coupled to the subject's skin 92 and / or can facilitate pressing the device 10 against the skin 92. For example, the pad 38 can be a bag or other flexible membrane that contains an acoustic gel, water or other fluid, foam or other material that fills the space between the planar surface 32 and the contact surface 22 and enhances the coupling of the transducer 30 to the skin 92. Optionally, the pad 46 is adjustable, for example along the 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 can be sufficiently flexible so that the distance between the surfaces 32, 22 can be adjusted by displacing gel or other pad material outward within the membrane, and the membrane can expand outward to allow for the displacement without bursting.

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

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

[0035] The imaging element 40 may be fixed relative to the housing 20 such that the intersection angle of the axes 34, 44 is fixed, for example, as shown in FIG. 1 (even though the angle may be otherwise electronically changed, as described elsewhere herein). Alternatively, the imaging element 40 may be movable relative to the housing 20 to change the direction of the second axis 44. For example, as shown in FIG. 3, an imaging element 40' may be provided that is coupled to the housing 20 by a mechanism that provides one or more degrees of freedom of movement of the imaging element 40' relative to the housing 20. In the illustrated example, the imaging element 40' is attached to the housing 20 using a hinge 48' that allows the imaging element 40' to pivot about a single axis relative to the housing 20, and by, for example, pivoting the imaging transducer 42, the second axis 44 may be substantially parallel to the first axis 34 and intersect with the first axis 34 at an acute angle, for example, between about zero and ninety degrees (0-90°), that increases as the imaging element 40' is pivoted. Additionally or alternatively, the entire imaging element 40 may be movable spatially relative to the housing 20 , for example in one or more directions in a plane parallel to the plane 32 .

[0036] With further reference to FIG. 2, a controller 50 (including one or more processors, memory and / or other electronic components (not shown)) is coupled to the imager 40 and receives the incident signal D i Control the delivery of reflected signals D r The reflected signals may be processed, for example, to identify one or more tissue structures within the body 90. For example, the controller 50 may analyze the reflected signals to identify the 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, provide energy to the transducer elements 31 to control the delivery of focused ultrasound to the target nerve 94, thereby relieving pain. The controller 50 is coupled to a power source 60, which can, for example, include one or more batteries, a transformer, and / or other components necessary to deliver signals to the transducer elements 31 to cause the elements 31 to generate acoustic energy directed along the first axis 34. Additionally or alternatively, the device 10 can include a connector 62 that allows the device 10 to be connected to an external power source, for example, by simply plugging it into an electrical outlet, or can include a connector that allows the device 10 to be connected to an external power source that can generate the power and / or signals necessary to operate the transducer 30 and / or imaging elements 40. When activated, the device 10 can provide FUS energy substantially continuously, intermittently, and / or in a pulsed format as desired. Optionally, device 10 may include a user interface, e.g., a touch screen, a set of buttons, etc. (not shown), allowing a user to select desired parameters of the energy to be delivered, e.g., to vary one or more of the intensity, duration, waveform, etc. as desired.

[0038] Optionally, the controller 50 can control one or more of the phase, intensity, pulse width and frequency of the signal to the piezoelectric elements 31 to generate an ultrasound beam focused in a focal zone directed to the target nerve 94. For example, based at least in part on the location of the target nerve 94 identified by the imaging element 40, the controller 50 can modify the signal to move the depth of the focal zone of the ultrasound beam B and / or move the focal zone laterally relative to the first axis 34 to focus the acoustic energy on the target nerve 94. Additionally, based at least in part on the signal from the imaging element 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 fat and muscle layers. The controller 50 can modify the signal to the elements 31 of the transducer 30 to account for different ultrasound attenuation of tissue along the path to the target nerve 92 to enhance focusing of the acoustic energy. Additionally or alternatively, if the imaging element 40 is movable, the orientation of the imaging element 40 can be manually adjusted and the controller 50 can modify the signal to adjust the focal zone based at least in part on the position of the target nerve.

[0039] Additionally or alternatively, the location of the focal zone can be adjusted manually, for example, using acoustic pads 38. For example, the distance from plane 32 (and thus transducer elements 31) to contact surface 22 can be adjusted by adjusting the pressure applied to pads 38, for example, to displace gel or other material within pads 38, thereby providing a desired distance for positioning tissue of interest within the focal zone prior to delivery of FUS energy.

[0040] Alternatively, the FUS transducer 30 may be mounted within the housing 20 such that the FUS transducer 30 can be moved during use, for example, using one or more servo motors or other actuators. For example, the housing 20 may be secured to the subject's body 90, for example, using one or more straps or other features (not shown), and the controller 50 may process signals from the imager 40 to identify one or more regions within the body 90 for treatment. The transducer 30 may be continuously or intermittently actuated and then 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 tissue within the body 90. For example, if the target treatment region is larger than the focal zone, the transducer 30 may be moved during treatment to deliver acoustic energy to the entire region. Similarly, if the target region includes a long nerve, the transducer 30 may 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, with each region receiving acoustic energy for a preset or customized duration.

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

[0042] The device 10 may, for example, have a maximum power output of 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 to 10 MHz). Alternatively, device 10 may be configured to transmit low intensity ultrasound waves, for example, at a frequency of, for example, about 500 to 2000 watts per square centimeter (500 to 2000 W / cm 2The device 10 may be configured to transmit high intensity ultrasound waves having intensities of about 100 Hz to 100 Hz, for example at frequencies between about one kilohertz and ten megahertz (1 KHz to 10 MHz). As such, the device 10 may be used to provide temporary pain relief by applying FUS energy without damaging the target nerve, or may be used to provide permanent pain relief by causing neuromodulation, ablation, or other at least partial destruction of the nerve.

[0043] 1 , in use, the device 10 may be used by a subject or a caregiver to relieve pain in a peripheral nerve of the subject. Generally, the contact surface 22 may be placed against the skin 92 of the subject, thereby acoustically coupling the FUS transducer 20 to the skin 92. Optionally, an acoustic gel or other material may be applied to the skin 92 and / or contact surface 22 prior to placement to enhance acoustic coupling, if desired.

[0044] Upon actuation of the imaging device 40, the controller 50 causes the imaging transducer 42 to transmit a signal D from the surface 22 into the subject's body 90. i and a reflected signal D from the body 20. r 4. The FUS transducer 30 may receive a signal to identify a target nerve or other tissue of interest 94 within the body 90. Optionally, the device 10 may be moved along the skin 92 and / or the pads 38 may be pressed or released as needed, for example under guidance from the imaging element 40. Additionally or alternatively, if the imaging element 40 is movable, the device 10 may be applied to the skin 92 generally above the target nerve 94, the imaging element 40 may be moved to identify a position relative to the FUS transducer 30, and the controller 50 may calibrate the signal required to direct a focal zone to the target nerve 94.

[0045] Once the target nerve 94 is within the focal zone of the FUS transducer 30, the FUS transducer 30 may be activated to deliver focused ultrasound to the target nerve 94, for example, to relieve pain. Optionally, the FUS transducer 30 may be manually activated by a user, for example, after confirming the location of the target nerve 94 (e.g., using an output device on the housing 20). Alternatively, the controller 50 may automatically activate the FUS transducer 30 upon confirming that the target nerve 94 is within the focal zone. The FUS energy may be delivered for a preset amount of time, or the user may activate the FUS transducer 30 for a desired amount of time.

[0046] The devices, systems, and methods herein can be used to deliver focused ultrasound to various peripheral nerves, such as, for example, 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, auriculotemporal nerve, mental nerve, buccal nerve, infraorbital nerve, supraorbital nerve, superior auricular nerve, greater occipital nerve, greater auricular nerve, and lesser occipital nerve, to relieve acute and / or chronic pain. Conditions that may be treated include phantom limb pain, CRPS (types I and II), acute surgical pain: certain peripheral nerve blockade, neuroma, headache, trigeminal neuralgia, Bell's palsy, glossopharyngeal nerve, intercostal neuralgia, trigeminal neuralgia, neurolysis (e.g., celiac plexus, superior and inferior hypogastric plexus, etc.), endometriosis pain, shingles (e.g., postherpetic neuralgia), nerve root section, lower back pain, rheumatoid arthritis pain, and cancer-related pain.

[0047] While the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail, It is to be understood, however, that the invention is not limited to the specific forms or methods disclosed, but rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Claims

1. A device for relieving peripheral neuralgia of a subject, comprising a housing including a surface configured to be placed against the skin of the subject, an imaging element on the housing configured to transmit a signal from the surface into the subject's body and receive a reflected signal from the body, one or more transducer elements configured to deliver focused ultrasound from the surface into the body, a controller coupled to the imaging element to process the reflected signal to identify a target nerve in the body and coupled to the one or more transducer elements to control delivery of focused ultrasound to the target nerve to relieve pain.

2. The device according to claim 1, wherein the one or more transducer elements are configured to deliver focused ultrasound along a first axis, and the imaging element is offset from the one or more transducers such that an imaging signal is delivered along a second axis intersecting the first axis.

3. The device according to claim 1, wherein the imaging element includes an ultrasonic imaging element configured to transmit an ultrasonic signal into the body and receive an ultrasonic signal reflected from a tissue structure in the body.

4. The device according to claim 3, wherein the ultrasonic imaging element includes an array of piezoelectric transducers.

5. A device for relieving peripheral neuralgia of a subject, comprising a housing including a surface configured to be placed against the skin of the subject, one or more transducer elements configured to deliver focused ultrasound into the body along a first axis from the surface, An ultrasonic imaging device on a housing configured to transmit an ultrasonic signal into a subject's body along a second axis from the surface and receive a reflected signal from the body, the ultrasonic imaging device being offset from the one or more transducer elements such that the second axis intersects the first axis, A device comprising a controller coupled to the imaging device for processing the reflected signal to identify a target nerve in the body and coupled to the one or more transducer elements for controlling the delivery of focused ultrasound to the target nerve to relieve pain.

6. The device according to claim 2 or 5, Characterized in that the imaging device is movable relative to the housing to adjust the angle of the second axis relative to the first axis.

7. The device according to claim 6, Characterized in that the imaging device is attached to the housing by a hinge configured to adjust the angle of the second axis.

8. The device according to claim 6, Further comprising a handle attached to the imaging device for adjusting the angle of the second axis.

9. The device according to any one of claims 1 to 5, Characterized in that the one or more transducer elements include an array of piezoelectric elements attached adjacent to the surface so as to be acoustically coupled to the skin.

10. The device according to claim 9, Characterized in that the surface includes a pad configured to couple the array to the skin.

11. The device according to claim 10, A device, characterized in that the pad has an adjustable height along the first axis.

12. In the device according to claim 9, 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 the target nerve. A device characterized by that.

13. In the device according to any one of claims 1 to 5, further comprising a power source coupled to the one or more transducer elements and the controller to supply electrical energy to the one or more transducer elements for delivering focused ultrasound. A device characterized by that.

14. In the device according to any one of claims 1 to 5, the controller is configured to calibrate the delivery of focused ultrasound based at least in part on the distance from the one or more transducers to the target nerve. A device characterized by that.

15. In the device according to any one of claims 1 to 5, the housing includes a patch configured to be placed against the skin of a subject. A device characterized by that.

16. In the device according to claim 15, the patch includes an adhesive on the surface for fixing the patch to the skin of the subject. A device characterized by that.

17. In the device according to any one of claims 1 to 5, the surface further includes a material for acoustically coupling the one or more transducers to the skin of the subject. A device characterized by that.

18. A device for relieving peripheral neuralgia of a subject, A housing sized to be implantable within a subject's body adjacent to a target nerve, one or more acoustic transducers configured to deliver focused ultrasound from the housing to the target nerve through intervening tissue, and a controller coupled to the one or more transducers and configured to control delivery of the focused ultrasound. A device characterized by comprising the above.

19. In the device according to any one of claims 1 to 5 and 18, a device characterized in that the housing is configured to be directly coupled to the target nerve.

20. In the device according to claim 19, a device further comprising a material configured to acoustically couple the one or more transducers to the target nerve.

21. In the device according to claim 19, a device characterized in that the material includes a member filled with a fluid.

22. In the device according to any one of claims 1 to 5 and 18, a device characterized in that the controller is configured to operate the one or more transducers to transmit low-intensity ultrasound at a frequency of about 1 kilohertz to 10 megahertz (1 kHz to 10 MHz).

23. In the device according to claim 22, a device characterized in that the intensity is about 0 to 500 watts per square centimeter (i.e., 0 to 500 W / cm ２ ).

24. In the device according to any one of claims 1 to 5 and 18, The device is characterized in that the controller is configured to operate the one or more transducers to transmit high-intensity ultrasonic waves at a frequency of about 1 kilohertz to 10 megahertz (1 kHz to 10 MHz).

25. In the device according to claim 24, wherein the intensity is about 500 to 2000 watts per square centimeter (i.e., 500 to 2000 W / cm ２ ).

26. In the device according to any one of claims 1 to 5 and 18, the device is characterized in that the controller is configured to operate the one or more transducers in any one of substantially continuously, intermittently, and in a pulsed format.

27. A system for relieving peripheral neuralgia of a subject, comprising the device according to claim 18, and an imaging device configured to identify a target nerve in the body of the subject and determine a position on the skin of the subject where the device is to be placed.

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