Patent Description:
Handheld probes generally take the form of an elongated handle for holding and positioning the probe. The probes have an emission portion that is physically larger than the elongated handle in a dimension that is roughly normal to the direction of ultrasound transmission.

Existing ultrasound probes lack sufficient maneuverability to allow treatment to complex regions of the body that have three-dimensional contours and tight spaces, such as the area between fingers. Additionally, existing treatment devices are limited by fixed treatment patterns, such as lines, patches, or other large planar contours.

Accordingly, a need exists for systems for ultrasound treatment where the patient contact footprint is reduced and a user has increased control over the exact placement of energy. Prior art can be found in <CIT>, <CIT> and <CIT>.

The present disclosure overcomes the aforementioned drawbacks by presenting systems for ultrasound treatment with a reduced patient contact footprint and improved ultrasound probe maneuverability.

In one aspect, this disclosure provides an ultrasound treatment system. The ultrasound treatment system can include an ultrasound probe, a controller, and a power supply. The ultrasound probe can include a contact surface. The ultrasound probe can be movable by a user along a treatment surface in an arbitrary surface pattern while maintaining contact between the contact surface and the treatment surface. The controller can be operably coupled to the ultrasound probe. The controller can, in use, control the emission of therapeutic ultrasound energy from the ultrasound probe. The power supply can, in use, provide power to the ultrasound probe sufficient for the emission of the therapeutic ultrasound energy. The ultrasound probe can transmit the therapeutic ultrasound energy into a treatment pattern beneath the treatment surface that mimics the arbitrary surface pattern.

In another aspect, this disclosure provides an ultrasound treatment system. The ultrasound treatment system can include an ultrasound probe, a power supply, and a controller. The ultrasound probe can have a transducer and a user interface. The transducer can, in use, emit a therapeutic ultrasound energy. The user interface can generate a first signal in response to a first user command and a second signal in response to a second user command. The power supply can, in use, provide power to the transducer sufficient for the emission of the therapeutic ultrasound energy. The controller can be operably coupled to the transducer and the user interface. The controller can, in use, control the emission of the therapeutic ultrasound energy from the transducer. The controller can, in use, receive signals from the user interface. The controller can, in response to the first signal, direct the transducer to emit a first therapeutic ultrasound energy. The controller can, in response to the second signal, direct the transducer to emit a second therapeutic ultrasound energy. The first therapeutic ultrasound energy and the second therapeutic ultrasound energy can have at least one different spatial or temporal property.

According to the invention, the ultrasound system includes an ultrasound probe, a controller, a position sensor, and a power supply. The ultrasound probe can have a contact surface. The ultrasound probe can be movable by a user along a treatment surface in an arbitrary surface pattern while maintaining contact between the contact surface and the treatment surface. The controller can be operably coupled to the ultrasound probe. The controller can, in use, control the emission of a therapeutic ultrasound energy from the ultrasound probe. The position sensor can, in use, measure a position of the ultrasound probe along the treatment surface and transmit a position signal to the controller corresponding to the position of the ultrasound probe along the treatment surface. The power supply can, in use, provide power to the ultrasound probe sufficient for the emission of the therapeutic ultrasound energy. The controller can, in response to the position signal indicating that the ultrasound probe is moving along the treatment surface, and in response to the measured position, vary a pulse width of the therapeutic ultrasound energy, a power amplitude of the therapeutic ultrasound energy, and a timing between pulse of the therapeutic ultrasound energy to produce a series of ultrasound pulse that have equal energy and are equally spaced along the surface pattern.

In a further aspect, this disclosure provide a non-claimed method of depositing therapeutic ultrasound energy from an ultrasound probe into a target medium. The method can include one or more of the following steps: a) coupling the ultrasound probe to the target medium; b) subsequent to step a), activating emission of therapeutic ultrasound energy from the ultrasound probe; c) subsequent to step b), moving the ultrasound probe along a treatment surface above the target medium in an arbitrary surface pattern, thereby directing therapeutic ultrasound energy from the ultrasound probe into the target medium in a treatment pattern that mimics the surface pattern; and d) subsequent to step c), deactivating emission of the therapeutic ultrasound energy from the ultrasound probe.

In yet another aspect, this disclosure provide a non-claimed method of depositing therapeutic ultrasound energy from an ultrasound probe into a target medium. The method can include one or more of the following steps: a) coupling the ultrasound probe to the target medium; b) subsequent to step a), moving the ultrasound probe along a treatment surface above the target medium in an arbitrary surface pattern; c) activating a user interface of the ultrasound probe for either less than a pre-determined length of time or greater than or equal to the pre-determined length of time when the ultrasound probe is at a first location; d) if the user interface is activated for less than the pre-determined length of time, directing a single therapeutic ultrasound pulse into the target medium beneath the surface pattern at the first location; e) if the user interface is activated for greater than or equal to the pre-determined length of time, directing two or more therapeutic ultrasound pulses into the target medium beneath the surface pattern, the first of the two or more therapeutic ultrasound pulses directed into the target medium at the first location and the second of the two or more therapeutic ultrasound pulses directed into the target medium at a distance from the location along the surface pattern.

In another aspect, this disclosure provide a non-claimed method of depositing therapeutic ultrasound energy from an ultrasound probe into a target medium. The method can include one or more of the following steps: a) coupling the ultrasound probe to the target medium; b) subsequent to step a), activating emission of therapeutic ultrasound energy from the ultrasound probe; c) subsequent to step b), moving the ultrasound probe along a treatment surface above the target medium in an arbitrary surface pattern, thereby directing therapeutic ultrasound energy from the ultrasound probe into the target medium in a treatment pattern that mimics the surface pattern; and d) subsequent to step c), deactivating emission of the therapeutic ultrasound energy from the ultrasound probe.

The foregoing and other aspects and advantages of the invention will appear from the following description. In the description, reference is made to the accompanying drawings which form a part hereof, and in which there is shown by way of illustration a preferred aspect of the disclosure. Such aspect does not necessarily represent the full scope of the disclosure, however, and reference is made therefore to the claims and herein for interpreting the scope of the disclosure.

Before the present invention is described in further detail, it is to be understood that the invention is not limited to the particular embodiments described. 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. The scope of the present invention will be limited only by the claims. As used herein, the singular forms "a", "an", and "the" include plural embodiments unless the context clearly dictates otherwise. Where a range of values is recited, this disclosure contemplates all combinations of the upper and lower bounds of those ranges that are not explicitly disclosed. For example, if ranges of <NUM> to <NUM> and <NUM> to <NUM> are disclosed, this disclosure contemplates ranges of <NUM> to <NUM> and <NUM> to <NUM>. Aspects of the present disclosure that are referenced with respect to systems are applicable to the disclosed methods, and vice versa, unless the context clearly dictates otherwise. Similarly, aspects of the present disclosure that are referenced with respect to one exemplary system are applicable to other disclosed systems or with respect to one method are applicable to the other disclosed methods, unless the context clearly dictates otherwise.

Specific structures, devices, and methods relating to improved ultrasound treatment efficiency and operation are disclosed. Methods do not form part of the claimed invention, which is defined by the independent claim. It should be apparent to those skilled in the art that many additional modifications beside those already described are possible without departing from the inventive concepts. In interpreting this disclosure, all terms should be interpreted in the broadest possible manner consistent with the context. Variations of the term "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, so the referenced elements, components, or steps may be combined with other elements, components, or steps that are not expressly referenced. Embodiments referenced as "comprising" certain elements are also contemplated as "consisting essentially of" and "consisting of" those elements.

As used herein, "maximum physical dimension" shall refer to the largest measurable size of an object or geometric shape. For example, the maximum physical dimension of a circle is the circle's diameter, the maximum physical dimension of a square or rectangle is the square or rectangle's diagonal, etc..

This disclosure provides systems for ultrasound treatment with a reduced patient contact footprint and improved ultrasound probe maneuverability. The reduced footprint and increased maneuverability can allow motion that can conform to regions of interest of the body which have complex three-dimensional contours and tight spaces, such as the areas between the fingers.

Referring to <FIG>, this disclosure provides an ultrasound probe <NUM>. The ultrasound probe <NUM> can include an ultrasound transducer <NUM> for emitting ultrasound energy. The ultrasound probe <NUM> can have a cable bundle <NUM> (as illustrated), or can have a wireless interface for communication with other aspects of the system or can be configured as a stand-alone system with all aspects that are necessary for function of the ultrasound probe <NUM> located within the probe itself. The ultrasound probe <NUM> can include a probe housing <NUM>. The probe housing <NUM> can include a handle portion <NUM> and a tip portion <NUM>.

The ultrasound transducer <NUM> can be a single transduction element or a multi-element array. The ultrasound transducer <NUM> can emit therapeutic ultrasound energy.

The handle portion <NUM> can have a length along an axial direction <NUM> that is greater than a maximum diameter normal to the axial direction <NUM>. In certain aspects, the handle portion <NUM> has a length along the axial direction <NUM> that is at least twice the maximum diameter normal to the axial direction <NUM>, including but not limited to, a length that is at least three times the maximum diameter, at least four times the maximum diameter, at least five times the maximum diameter, or at least ten times the maximum diameter. The handle portion <NUM> can be configured to fit comfortably in the hand of an adult human. The handle portion <NUM> can have a smooth surface or can have indentations intended to accommodate the fingers of a user. The handle portion <NUM> can have a maximum physical dimension orthogonal to the axial direction <NUM> ranging from <NUM> to <NUM>, including but not limited to, a maximum physical dimension orthogonal to the axial direction <NUM> ranging from <NUM> to <NUM>. The handle portion <NUM> can have a diameter ranging from <NUM> to <NUM>, including but not limited to, a diameter ranging from <NUM> to <NUM>. The handle portion <NUM> can have a length along the axial direction <NUM> ranging from <NUM> to <NUM>, including but not limited to, a length along the axial direction ranging from <NUM> to <NUM>.

The tip portion <NUM> can include a contact surface <NUM> for coupling the ultrasound energy to a target surface. The contact surface <NUM> can have a flat shape, or a convex shape, or a rectangular concave or convex shape. In certain aspects, the tip portion <NUM> and contact surface <NUM> can be the same material. In certain aspects, the tip portion <NUM> and contact surface <NUM> can be composed of different materials. In certain aspects, the tip portion <NUM> has a thickness of approximately an integer multiple of one-half wavelength of the ultrasound energy. In certain aspects the tip portion <NUM> is acoustically transparent, such as an acoustically transparent thin film. The contact surface <NUM> can have a convex curved shape.

In certain aspects, the handle portion <NUM>, the tip portion <NUM>, or both can have one or more bends such that the handle portion <NUM>, the tip portion <NUM>, or both form a non-zero angle with respect to the axial direction <NUM>. The tip portion <NUM> can have a tapered shoulder, such that its maximum physical dimension orthogonal to the axial direction <NUM> reduces as the tip portion <NUM> extends away from the handle portion <NUM> along the axial direction <NUM>. The tip portion <NUM> can have a circular cross section such that its cross section normal to the axial direction <NUM> reduces as the tip portion <NUM> extends away from the handle portion <NUM> along the axial direction <NUM>. The tip portion <NUM> can have a rectangular cross section such that its cross section normal to the axial direction <NUM> reduces as the tip portion <NUM> extends away from the handle portion <NUM> along the axial direction <NUM>.

The tip portion <NUM> can have a maximum physical dimension orthogonal to the axial direction <NUM> ranging from <NUM> to <NUM>, including but not limited to, a maximum physical dimension orthogonal to the axial direction ranging from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, or from <NUM> to <NUM>. The tip portion <NUM> can have diameters or widths ranging from <NUM> to <NUM>, including but not limited to, diameters or widths ranging from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, or from <NUM> to <NUM>. The tip portion <NUM> can have a length along the axial direction <NUM> ranging from <NUM> to <NUM>, including but not limited to, a length along the axial direction <NUM> ranging from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, or from <NUM> to <NUM>.

In certain aspects, the ultrasound probe <NUM> can emit ultrasound in a direction that is substantially parallel to the axial direction <NUM>. In certain aspects, the ultrasound probe <NUM> can emit ultrasound in direction that is not parallel to the axial direction <NUM>. In certain aspects, the ultrasound probe <NUM> can emit ultrasound in more than one direction.

In certain aspects, the contact surface <NUM> can have a maximum physical dimension of less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, or less than <NUM>. In certain aspects, the contact surface <NUM> can have a diameter or width of less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, or less than <NUM>.

A strong acoustic focus can be characterized by an f-number, which equals the transducer focal depth divided by the transducer aperture. In certain aspects, the f-number can range from <NUM> to <NUM>. In certain aspects, a deep treatment (i.e., a large focal depth) can entail a large ultrasound transducer <NUM> aperture and a correspondingly large tip portion <NUM>. In certain aspects, a superficial treatment (i.e., a small focal depth) can entail a much smaller tip portion <NUM>. In certain aspects the length of the tip portion <NUM> along the axial direction <NUM> is on the order of the focal depth of a transducer <NUM> that is focused. For example, if transducer <NUM> is focused <NUM> deep into tissue and transducer <NUM> has an acoustic focus of <NUM>, then tip portion <NUM> can have an axial length about <NUM> to place the focus at the desired position. In certain aspects the length of tip portion <NUM> along the axial direction <NUM> is less than <NUM> or less than <NUM> or less than <NUM>.

The transducer <NUM> can be positioned within the probe housing at a distance from the contact surface <NUM> that allows the nose portion <NUM> to be lengthened to allow visual feedback of the point of contact between the contact surface <NUM> and a treatment surface. In certain aspects, the transducer <NUM> can be positioned at a distance from the contact surface <NUM> that is at least equal to a focal depth of the ultrasound from the contact surface <NUM>, including but not equal to, a distance from the contact surface <NUM> that is at least <NUM>%, at least <NUM>%, at least <NUM>%, at least <NUM>%, at least <NUM>%, or at least <NUM>% of a focal depth of the ultrasound from the contact surface <NUM>.

In certain aspects, the tip portion <NUM> can be detachable from the handle portion <NUM>. In certain aspects, the tip portion <NUM> can function as an acoustic waveguide. In certain aspects, the tip portion <NUM> can be swappable and/or disposable. The tip portion <NUM> can include the ultrasound transducer <NUM>, so the tip portion <NUM> including the ultrasound transducer <NUM> can be detachable, swappable, and/or disposable. The tip portion, with or without the ultrasound transducer <NUM>, can be single-use or limited-use. The usage of the tip portion <NUM>, with or without the ultrasound transducer <NUM>, can be monitored to ensure that the tip portion <NUM> is not used past a usable lifetime. One example of a system for monitoring the use lifetime of the tip portion <NUM> is a crypto chip.

An acoustic coupling medium <NUM> can occupy the volume between the ultrasound transducer <NUM> and the contact surface <NUM>. In certain applications, the acoustic coupling medium <NUM> is incorporated into the tip portion <NUM> itself, as a liquid, gel, or a solid.

The ultrasound probe <NUM> can include a user interface <NUM>, which can take the form of a button, a touch-pad, a switch, or other forms that can be manipulated by a user to control the emission of ultrasound energy. The user interface <NUM> can be used to activate or deactivate the emission of ultrasound energy. The user interface <NUM> can be located on the handle portion <NUM>. The user interface <NUM> can be located in a position where a user's finger or thumb naturally falls when holding the ultrasound probe <NUM>. A remote user interface <NUM> can be positioned remote from the ultrasound probe <NUM> as described elsewhere herein.

The ultrasound probe <NUM> can deliver pulsed ultrasound energy having pulse widths ranging from <NUM> ns to <NUM> seconds per pulse, including but not limited to, pulse widths ranging from <NUM> to <NUM>, or from <NUM> to <NUM>. The ultrasound probe <NUM> can also emit continuous ultrasound energy.

The ultrasound probe <NUM> can deliver pulsed ultrasound energy having power amplitudes ranging from <NUM> mW to <NUM> kW per pulse, including but not limited to, power amplitudes ranging from <NUM> W to <NUM> kW per pulse, or <NUM> W to <NUM> W. The ultrasound probe <NUM> can deliver continuous ultrasound energy having power amplitudes in the same ranges as the pulsed ultrasound energy, including zero amplitude.

The ultrasound probe <NUM> can deliver pulsed ultrasound energy having periods ranging from <NUM> to <NUM>, including but not limited to, periods ranging from <NUM> to <NUM>, or from <NUM> to <NUM>. The ultrasound probe <NUM> can deliver continuous ultrasound energy for a single defined length of time or can deliver continuous ultrasound energy that is emitted when a user activates the user interface <NUM>.

The ultrasound transducer <NUM> can emit ultrasound energy at frequencies ranging from <NUM> to <NUM>, including but not limited to, frequencies ranging from <NUM> to <NUM>. In certain aspects, the ultrasound transducer <NUM> can be configured as a broadband emitter capable of delivering wideband pulses. In certain aspects, the ultrasound transducer <NUM> can be configured to operate at multiple distinct frequencies simultaneously.

The ultrasound transducer <NUM> can be controlled to deliver ultrasound energy with varying spatial and temporal characteristics. In some aspects, the spatial and temporal characteristics are varied by user programming. In some aspects, the spatial and temporal characteristics are varied as the result of feedback from one or more of the sensors described herein.

The ultrasound probe <NUM> can be configured to deliver focused ultrasound energy that focuses at distances ranging from <NUM> to <NUM> from the contact surface <NUM>, including but not limited to, distances ranging from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, or from <NUM> to <NUM> from the contact surface <NUM>.

In certain aspects, the ultrasound probe <NUM> can emit focused ultrasound energy. In certain aspects, the ultrasound probe <NUM> can emit unfocused ultrasound energy. In certain aspects, the ultrasound probe <NUM> can emit defocused ultrasound energy. Focusing, defocusing, or no focusing can be achieved via concave, convex, or flat eletroacoustic transduction elements. In certain aspects, beamshaping control can be achieved with lenses, electronic phasing, and arrays. Beamshaping elements can be disposed within the handle portion <NUM>, the tip portion <NUM>, the contact surface <NUM>, or a combination thereof. The ultrasound transducer <NUM> with beamshaping element can be movable, exchangeable, or programmatically movable or exchangeable in response to feedback or labeling. The tip portion <NUM> or contact surface <NUM> including beamshaping elements can be movable, exchangeable, or programmatically movable or exchangeable in response to feedback or labeling.

In certain aspects, the ultrasound transducer <NUM> can be affixed to remain stationary within the probe housing <NUM>. The ultrasound transducer <NUM> can be stationary relative to the contact surface <NUM>. Certain existing technologies produce multiple pulses of ultrasound in distinct locations by moving a transducer within a housing by a motion mechanism, such as a motor. The present disclosure does not require this type of motion mechanism to achieve the disclosed effects. The ultrasound treatment pattern is thus controlled by a user by moving the ultrasound probe <NUM> along a treatment surface in a surface pattern that mimics the desired treatment pattern.

Referring to <FIG>, this disclosure provides an ultrasound system <NUM>. The ultrasound system <NUM> can include the ultrasound probe <NUM> as described herein, and one or more of the following features: a power source <NUM>; a controller <NUM>; a display <NUM>; a remote user interface <NUM>; a user terminal <NUM>; a memory <NUM>; one or more secondary energy delivery modules <NUM>; an electrical sensor <NUM>; a motion sensor <NUM>; an orientation sensor <NUM>; a coupling sensor <NUM>; an audio indicator <NUM>; a haptic indicator <NUM>; and an optical indicator <NUM>. These features can be located in or on the ultrasound probe <NUM> or remote from the ultrasound probe <NUM>.

The power source <NUM> can be an electric power providing means known to those having ordinary skill in the art to be capable of powering an ultrasound system <NUM> as described herein. Examples of power sources <NUM> can include, but are not limited to, alternating current (AC) to direct current (DC) power supplies capable of providing electrical energy to the ultrasound probe <NUM> and other parts of the ultrasound system <NUM> that require power, a battery capable of generating at least <NUM> watt, and the like. The power source <NUM> can also include charging circuits for charging a rechargeable power supply, such as a battery. In some aspects, the power source <NUM> can generate power ranging from <NUM> watt to <NUM> watts. In addition, a radiofrequency driver can provide kHz or MHz drive frequencies to the ultrasound transducer <NUM>.

The controller <NUM> can be a computing system or purely electronic system capable of providing instructions or control to the various electronic components of the ultrasound system <NUM> in order to operate the ultrasound system <NUM> as described herein. In certain aspects, a user interface <NUM> switch can activate energy directly. The controller <NUM> can direct the ultrasound transducer <NUM> to emit ultrasound energy having pre-determined spatial and temporal parameters.

The display <NUM> can be a visual means capable of communicating relevant information to a user. Examples of displays <NUM> can include, but are not limited to, computer monitors, a display screen on a personal device, such as a smart phone, a tablet, a smart watch, or the like, a projection system, and the like.

The remote user interface <NUM> can be an interface capable of manipulation by a user to control the emission of ultrasound energy, including treatment settings, such as power and timing. The remote user interface <NUM> can be used to activate or deactivate the emission of ultrasound energy. Examples of remote user interfaces <NUM> include, but are not limited to, a foot switch, a microphone equipped with voice recognition software, a camera equipped with gesture recognition software, and the like.

The memory <NUM> can be any storage medium capable of electronically storing parameters or other information relevant to the operation of the ultrasound system <NUM>. Examples of memory <NUM> include, but are not limited to, EEPROM, hard drives, flash memory, and other similar means of electronic storage of information.

The user terminal <NUM> can be a remote system suitable for receiving user instruction relating to aspects of operation of the ultrasound system <NUM> that are not the activation or deactivation of the emission of the ultrasound energy. Examples of a user terminal <NUM> can include, but are not limited to, an input to computer, such as a keyboard or a mouse, an input on personal device, such as a touch screen on a smart phone, a tablet, a smart watch, or the like, a microphone equipped with voice recognition software, a camera equipped with gesture recognition software, a foot switch, and the like.

The one or more secondary energy delivery modules <NUM> can include a photon-based energy source, a radiofrequency energy source, a thermal energy source, or a mechanical energy source. The secondary energy delivery modules <NUM> can be located within the ultrasound probe <NUM> or as a separate module.

Electrical sensors <NUM> can be deployed to monitor the distribution and usage of electrical signals within the systems. Examples of electrical sensors <NUM> can include, but are not limited to, current sensors, voltage sensors, power sensors, and the like, and combinations thereof. The electrical sensors <NUM> can be located within the ultrasound probe <NUM> or in other portions of the ultrasound system <NUM> which require electrical signal monitoring.

Many sensors can function as both motion sensors <NUM> and orientation sensors <NUM>, with the distinction lying in the type of information that is extracted from the sensor. A motion sensor <NUM> functions to determine motion or lack of motion of the ultrasound probe <NUM> relative to a pre-existing position. An orientation sensor <NUM> functions to determine a relative positioning of the ultrasound probe <NUM> relative to an external frame, such as a gravitational frame or a surface of a patient's skin. Examples of motion sensors <NUM> and orientation sensors <NUM> can include, but are not limited to, accelerometers, gyroscopes, magnetometers, geomagnetic sensors, global positioning systems, optical sensors, gesture sensors, a camera and associated motion or orientation detecting software, and other sensors capable of measuring the motion or orientation of the ultrasound probe <NUM>.

A coupling sensor <NUM> determines if the ultrasound source is acoustically coupled to the target medium. Examples of coupling sensors <NUM> can include, but are not limited to, a capacitive sensor, a system that utilizes a frequency sweep function to determine coupling, such as the system disclosed in <CIT>, and other sensors capable of measuring whether the ultrasound probe <NUM> is coupled to its target. In certain aspects, the controller <NUM> can receive a signal from the coupling sensor <NUM>, and can terminate emission of ultrasound energy in response to a signal indicating that the ultrasound probe <NUM> is not coupled to the target medium.

An audio indicator <NUM> provides an audio signal to a user. Examples of an audio indicator <NUM> include, but are not limited to, a speaker, and other similar audio generation devices. The audio indicator <NUM> can be located within the ultrasound probe <NUM> or external to the ultrasound probe <NUM>.

A haptic indicator <NUM> provides a haptic signal to a user. Examples of a haptic indicator <NUM> include, but are not limited to, a vibratory motor, an electroactive polymer, a piezoelectric material, and other similar haptic generation devices. The haptic indicator <NUM> can be located within the ultrasound probe <NUM> or external to the ultrasound probe <NUM>. If the haptic indicator <NUM> is external to the ultrasound probe <NUM>, the haptic indicator <NUM> can be located in a wearable technology, such as a wrist band, in a form that a user can contact, such as a foot mat or a seat, or in a holdable form, such as a portable device.

An optical indicator <NUM> provides a visual signal to a user. The optical indicator <NUM> should be located in a position where the user can see the optical indicator <NUM> itself or the light that is emitted from the optical indicator <NUM>. In one aspect, the optical indicator <NUM> can project light to the target surface so the user can monitor the target surface and receive the visual signal simultaneously. Examples of an optical indicator <NUM> include, but are not limited to, a light emitting diode (LED), a fiber optic coupled to a light source, and other similar light generating devices. The optical indicator <NUM> can be located within the ultrasound probe <NUM> or external to the ultrasound probe <NUM>.

In certain aspects, transducer element temporal and/or spatial apodization is utilized to mitigate and control acoustic edge effects.

Referring to <FIG>, an ultrasound probe <NUM> is illustrated moving along a target surface, the ultrasound probe <NUM> emitting controlled ultrasound energy to generate a treatment pattern <NUM> beneath the target surface. The treatment pattern <NUM> consists of lesions that are roughly equal in size and relative spacing. The treatment pattern <NUM> that is illustrated is an arbitrary treatment pattern (shown as a zig-zag or curvilinear pattern for the sake of illustration).

Referring to <FIG>, an ultrasound probe <NUM> is illustrated moving along a target surface, the ultrasound probe <NUM> emitting controlled ultrasound energy to generate a treatment pattern <NUM> beneath the target surface. The treatment pattern consists of lesions that are roughly equal in relative spacing. The treatment pattern <NUM> that is illustrated is a circular pattern.

Referring to <FIG>, an ultrasound probe <NUM> is coupled to a skin surface beneath a patients eye and moved along the skin surface, the ultrasound probe <NUM> emitting controlled ultrasound energy to generate a treatment pattern beneath the skin surface. The treatment pattern <NUM> consists of lesions that are roughly equal in size. The treatment pattern <NUM> that is illustrated is a curved pattern. In certain aspects, the treatment pattern <NUM> can be located along periorbital locations. In certain aspects, the treatment pattern <NUM> can be located along perioral locations. In certain aspects, the treatment pattern <NUM> can be located along perinasal locations. In certain aspects, the treatment pattern <NUM> can be located along tendons, ligaments, muscles, and other musculoskeletal tissue.

Referring to <FIG>, four different treatment patterns <NUM> were generated in a plastic petri dish acoustically coupled to tip portion <NUM> with water. A high-intensity linear treatment pattern <NUM>, a high-intensity zig-zag treatment pattern <NUM>, a high-intensity circular treatment pattern <NUM>, and a low-intensity linear treatment pattern <NUM> were generated with an ultrasound system <NUM> as described herein.

In one aspect, this disclosure provides an ultrasound system <NUM> that is capable of depositing ultrasound energy in a treatment pattern <NUM>, the ultrasound energy being deposited in pre-determined amounts with pre-determined spacing along the treatment pattern <NUM>. If the pre-determined amount of ultrasound energy is sufficient to generate a lesion, then a resulting pattern of lesions take the shape of the treatment pattern <NUM>. A user can thereby generate treatment patterns <NUM> by moving the contact surface <NUM> along the treatment surface in a desired pattern. The pre-determined amounts of ultrasound energy and the pre-determined spacing can be programmed into the ultrasound system <NUM>, such as by storage in the memory <NUM>. As a user moves the ultrasound probe <NUM> along the surface, the controller <NUM> can perform real-time monitoring of the motion or the speed of the ultrasound probe <NUM> and can direct the ultrasound probe <NUM> to vary the emission in order to maintain the pre-determined amounts and pre-determined spacing. For example, if the controller <NUM> senses that the ultrasound probe <NUM> is moving fast, the controller <NUM> can instruct the ultrasound probe <NUM> to emit shorter pulses of ultrasound and to provide less time between pulses. Similarly, if the controller <NUM> senses that the ultrasound probe <NUM> is moving slow, the controller <NUM> can instruct the ultrasound probe <NUM> to emit longer pulses of ultrasound and to provide more time between pulses. The speed can be measured by the motion sensor <NUM> or the orientation sensor <NUM>.

In certain aspects, the spacing between pulses is temporal spacing, such that the user interface <NUM> switch activates one pulse if pressed a single time, or activates a train of equally spaced or non-equally spaced pulses if held.

In one aspect, this disclosure provides an ultrasound system <NUM> that is capable of guiding a user to move the ultrasound probe <NUM> at a speed to achieve a pre-determined ultrasound treatment. The pre-determined ultrasound treatment can be programmed into the ultrasound system <NUM>, such as by storage in the memory <NUM>. The ultrasound system <NUM> can then calculate the required speed of the ultrasound probe <NUM> along the surface to achieve the pre-determined ultrasound treatment, measure the speed that the ultrasound probe <NUM> is moving along the treatment surface, and prompt the user to move the ultrasound probe <NUM> faster if the measured speed is less than the required speed or prompt the user to move the ultrasound probe <NUM> slower if the measured speed is greater than the required speed. In some aspects, the required speed will be a range of speeds. For example, the optical indicator <NUM> can provide a visual signal of a first color (for example, red) to prompt the user to move the ultrasound probe <NUM> slower, a visual signal of a second color (for example, green) to prompt the user to move the ultrasound probe <NUM> faster, and/or a visual signal of a third color (for example, blue) to indicate to the user that the speed of the ultrasound probe <NUM> is within a pre-determined acceptable range of speeds. As another example, the audio indicator <NUM> can provide an audio signal of a first kind (for example, a buzzer sound) to prompt the user to move the ultrasound probe slower, an audio signal of a second kind (for example, a beeping sound) to prompt the user to move the ultrasound probe faster, and/or an audio signal of a third kind (for example, silence or a sound of a bell dinging) to indicate to the user that the speed of the ultrasound probe <NUM> is within the pre-determined acceptable range of speed. Similarly, as another example, the haptic indicator <NUM> can provide a haptic signal of a first kind (for example, an intense constant buzzing feeling), a second kind (for example, an intense pulsed buzzing feeling), and/or third kind (for example, no buzzing feeling or a gentle constant or pulsed buzzing feeling) to prompt the user in the same ways described above.

In one aspect, this disclosure provides a system that is capable of delivering constant energy to a target by utilizing real-time sensing of the acoustic coupling to the target. This feature is particularly relevant for embodiments where the ultrasound probe <NUM> is maneuvered by a user along a surface. In some aspects, the system can stop emission of ultrasound energy if the coupling is interrupted. In some aspects, the system can produce an alarm if the coupling is interrupted. In certain aspects, the ultrasound system <NUM> can record the position at which the coupling is interrupted, can prompt the user to return to the position, and can resume emission of ultrasound energy once the ultrasound probe <NUM> has returned to the position and coupling has been re-established.

Referring to <FIG>, this disclosure provides a non-claimed method <NUM> of depositing therapeutic ultrasound energy. The method <NUM> can include one or more of the following steps: at process block <NUM>, coupling the ultrasound probe <NUM> to a target surface; at process block <NUM>, subsequent to the coupling, initiating emission of therapeutic ultrasound energy from the ultrasound probe <NUM>; at process block <NUM>, subsequent to the initiating, moving the ultrasound probe <NUM> along the target surface such that the contact surface <NUM> traces a surface pattern on the target surface, thereby directing the therapeutic ultrasound energy beneath the target surface in a treatment pattern <NUM> that mimics the surface pattern; and at process block <NUM>, subsequent to the moving, deactivating the ultrasound probe <NUM>. In certain aspects, the method can also include directing a secondary energy beneath the target surface, the secondary energy selected from the group consisting of photo-based energy, RF energy, thermal energy, or mechanical energy.

Referring to <FIG>, this disclosure provide a non-claimed method <NUM> of depositing therapeutic ultrasound energy from an ultrasound probe into a target medium. The method <NUM> can include one or more of the following steps: at process block <NUM>, coupling the ultrasound probe to the target medium; at process block <NUM>, suebsequent to the coupling, moving the ultrasound probe along a treatment surface above the target medium in an arbitrary surface pattern; at process block <NUM>, activating a user interface of the ultrasound probe for either less than a pre-determined length of time or greater than or equal to the pre-determined length of time when the ultrasound probe is at a first location; at decision block <NUM>, determining if the user interface is activated for less than a pre-determined length of time or greater than or equal to a pre-determined length of time; at process block <NUM>, if the user interface is activated for less than the pre-determined length of time, directing a single therapeutic ultrasound pulse into the target medium beneath the surface pattern at the first location; and at process block <NUM>, if the user interface is activated for greater than or equal to the pre-determined length of time, directing two or more therapeutic ultrasound pulses into the target medium beneath the surface pattern, the first of the two or more therapeutic ultrasound pulses directed into the target medium at the first location and the second of the two or more therapeutic ultrasound pulses directed into the target medium at a distance from the location along the surface pattern.

Referring to <FIG>, this disclosure provides a non-claimed method <NUM> of depositing therapeutic ultrasound energy from an ultrasound probe into a target medium. The method <NUM> can include one or more of the following steps: at process block <NUM>, coupling the ultrasound probe to the target medium; at process block <NUM>, subsequent to the coupling, moving the ultrasound probe along a treatment surface above the target medium in an arbitrary surface pattern; at process block <NUM>, monitoring the motion of the ultrasound probe along the treatment surface; at process block <NUM>, directing therapeutic ultrasound energy into the target medium in a treatment pattern beneath the treatment surface that mimics the surface pattern; and at process block <NUM>, varying a spatial or temporal parameter of the therapeutic ultrasound energy in response to the motion of the ultrasound probe.

In certain aspects, the methods <NUM>, <NUM>, <NUM> can include emitting ultrasound pulses that are spaced apart by a length of time ranging from <NUM> to <NUM>, including but not limited to, a length of time ranging from <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, or <NUM> to <NUM>. In certain aspects, the methods <NUM>, <NUM>, <NUM> can include emitting ultrasound energy at a pulse repetition rate of between <NUM> (continuous wave) and <NUM>, including but not limited to, between <NUM> and <NUM>, between <NUM> and <NUM>, or between <NUM> and <NUM>.

In certain aspects, the methods <NUM>, <NUM>, <NUM> can include emitting ultrasound pulses that are spaced apart by distances ranging from <NUM> to <NUM>, including but not limited to, distances ranging from <NUM> to <NUM>, from <NUM> to <NUM>. or from <NUM> to <NUM>. In certain aspects, the method can include emitting continuous ultrasound energy.

In certain aspects, the methods, <NUM>, <NUM>, <NUM> can include creating lesions spaced apart by distances ranging from <NUM> to <NUM>, including but not limited to, distances ranging from <NUM> to <NUM>, from <NUM> to <NUM>. or from <NUM> to <NUM>. In certain aspects, the method can include lesions that have zero space between them, or a continuous line of lesions.

In certain aspects, the methods <NUM>, <NUM>, <NUM> can include moving the ultrasound probe <NUM> a greater distance than the distance between lesions, for example, by taking a non-linear path.

In certain aspects, the methods <NUM>, <NUM>, <NUM> can determine when and where to emit ultrasound energy and create lesions by measuring the distance that the ultrasound probe <NUM> travels along whatever path it travels. For example, the ultrasound probe <NUM> can emit a first ultrasound energy and create a first lesion at a first point, then the ultrasound probe <NUM> can be moved half of the pre-determined distance in one direction and half of the pre-determined distance in a second direction at a right angle to the first direction, thus resulting in the ultrasound probe <NUM> having moved to a second point at an absolute distance of <MAT> of the pre-determined distance from the first point, then the ultrasound probe <NUM> can emit a second ultrasound energy and create a second lesion at the second point. This example is non-limiting and serves only to illustrate the aspect of the disclosure where the ultrasound probe <NUM> can move a pre-determined distance and result in emissions and lesions that are a distance apart that is shorter than the pre-determined distance. In this aspect, the movement of the ultrasound probe <NUM> determines the distance between emissions and lesions.

In certain aspects, the methods <NUM>, <NUM>, <NUM> can determine when and where to emit ultrasound energy and create lesions by measuring the absolute distance the ultrasound probe <NUM> travels in whatever direction it travels. In other words, the methods <NUM>, <NUM>, <NUM> can map out a circle centered around a first point where the ultrasound probe <NUM> emits a first ultrasound energy and/or creates a first lesion, then the ultrasound probe <NUM> can be moved any distance within the circle without emitting further energy and/or creating further lesions, then when the ultrasound probe <NUM> is moved to any point on the circle the ultrasound probe emits a second ultrasound energy and/or creates a second lesion.

In certain aspects, the methods <NUM>, <NUM>, <NUM> can determine when and where to emit ultrasound energy and create lesions by measuring the absolute distance the ultrasound probe <NUM> travels in a pre-determined direction. In other words, the methods <NUM>, <NUM>, <NUM> can map out a specific point where the next emission and lesion will occur, and if/when the ultrasound probe <NUM> passes over that specific point, the ultrasound probe can be triggered to emit ultrasound energy and create a lesion.

In certain aspects, the methods <NUM>, <NUM>, <NUM> can include at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, or at least <NUM> emissions of pulses of ultrasound energy and/or creations of lesions within a short overall treatment time. The short overall treatment time can be less than <NUM> hour, one-half hour, <NUM> minutes, <NUM> minutes, <NUM> minute, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> second, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> seconds, less than <NUM> milliseconds, less than <NUM> milliseconds, less than <NUM> milliseconds or less than <NUM> millisecond. Traditional therapeutic treatment systems require overall treatment times that are significantly longer than those afforded by the present disclosure. One advantage of the shortened overall treatment time can be less patient discomfort, among others.

In addition to the fast treatment times and the short overall treatment times, the systems and methods described herein can also afford coverage of large areas in less time that conventional treatment systems.

In certain aspects, the methods <NUM>, <NUM>, <NUM> can treat at least <NUM>,<NUM> lesions per square centimeter per second, at least <NUM> million lesions per cubic centimeter per second, at least <NUM> lesions per square centimeter per second, at least <NUM> thousand lesions per cubic centimeter per second, at least <NUM> lesions per square centimeter per second, at least <NUM> lesions per cubic centimeter per second, at least <NUM> lesions per cubic centimeter per second, at least <NUM> lesions per square centimeter per second, at least <NUM> lesions per square centimeter per second, and at least <NUM> lesions per cubic centimeter per second.

In certain aspects, the systems and methods described herein can limit a number of ultrasound pulses that are emitted in response to a user action or can limit a number of overall ultrasound pulses for a given treatment. This feature can be utilized for safety by limiting the total energy transmitted to a subject. For example, the systems and methods can limit the emission to <NUM> ultrasound pulses of a given energy level, and then once the 1000th pulse is emitted, the controller can terminate emission of the ultrasound energy. This feature can be utilized to define a fixed emission pattern or a fixed energy output.

The systems and methods described herein can provide fast ultrasound lesioning in patients that drastically reduces treatment time and discomfort levels. In certain aspects, the method can include creating lesions at a rate ranging from <NUM> lesions per second to <NUM> lesions per second, including but not limited to, a rate ranging from <NUM> lesion per second to <NUM> lesions per second, <NUM> lesions per second to <NUM> lesions per second, <NUM> lesions per second to <NUM> lesions per second, <NUM> lesions per second to <NUM> lesions per second, <NUM> lesions per second to <NUM> lesions per second, or <NUM> lesions per second to <NUM> lesions per second.

The creation of lesions described herein is achieved by way of delivery of a conformal distribution of ultrasound energy to a target where the lesion is desired. Although the systems and methods of this disclosure are described with respect to the creation of lesions, it should be appreciated that the systems and methods can also be utilized for the creation of other ultrasound effects that can be achieved by delivery of a conformal distribution of ultrasound energy. For example, the systems and methods described herein can create an ablative thermal effect, a non-ablative thermal effect, a non-linear effect, a biological effect, a stable cavitation effect, an inertial cavitation effect, an acoustic streaming effect, a drug delivery effect, including but not limited to, an effect enhancing the transdermal delivery of a drug, an effect enhancing the efficacy of a drug, and the like, an acousto-mechanical effect, an acousto-elastic effect, a hyperthermia effect, an acoustic resonance effect, a visco-acoustic effect, or any combination thereof. These effects can be provided in an arbitrary pattern as described herein.

The conformal distribution of ultrasound energy can be varied by directing the transducer <NUM> to emit ultrasound energy having varied spatial and temporal parameters.

The systems and methods described herein can deliver a first conformal distribution of ultrasound energy having a first set of spatial and temporal parameters, a second conformal distribution of ultrasound energy having a second set of spatial and temporal parameters, a third conformal distribution of ultrasound energy having a third set of spatial and temporal parameters, and so on, up to an nth conformal distribution of ultrasound energy having an nth set of spatial and temporal parameters. These conformal distributions can be delivered in an arbitrary pattern as described herein.

The combinations of these conformal distributions of ultrasound energy are too numerous to explicitly recite, so the following list of exemplary combinations are not intended to be limiting.

As one example, a treatment pulse train can provide alternating pulses that have different intensity, have different pulse length, generate different lesion size, and/or have different treatment depths. In a similar fashion, the treatment pulse train can provide periodic rotations of various different pulse properties, such that a first, sixth, eleventh, etc. pulse can have a first set of properties, a second, seventh, twelfth, etc. pulse can have a second set of properties, a third, eighth, thirteenth, etc. pulse can have a third set of properties, a fourth, ninth, fourteenth, etc. pulse can have a fourth set of properties, and a fifth, tenth, fifteenth, etc. pulse can have a fifth set of properties. These periodic rotations of various different pulse properties can repeat.

As another example, a treatment pulse train can include a randomized component to determining one or more of the properties described herein. For example, if a pattern of lesions having depths randomized between a minimum depth and a maximum depth is desired, a random depth can be selected for each pulse in real time or prior to treatment and the particular ultrasound pulse can be transmitted to that depth. The same is true for other properties, such as spacing between pulses, either time or distance, pulse intensity, lesion size, and the like.

Treatment pulse trains can be programmed to provide regularly repeating pulses or can be programmed to provide any pattern of treatment pulses. For example, the treatment pulse train can regularly emit a pulse and/or generate a lesion at pre-determined times and/or pre-determined distances. The treatment pulse train can be programmed to provide a given number of pulses that are regularly spaced, either in time or distance, and then "skip" one or more pulses, then resume providing a second given number of pulses, and then "skip" one or more pulses, and so on. The treatment pulse train can be programmed to vary spacing between pulses, in time and/or distance, according to a defined function, such as linear, quadratic, sinusoidal, or any function thought to be useful for treatment. In one specific example, the treatment pulse train can be programmed to deliver pulses that are close to one another immediately following user initiation of the pulse train, but which exponentially space out as time progresses following user initiation of the pulse train.

The various different spatial and/or temporal parameters that can be varied as described above can be prompted by an input to the user interface. Again, the number of ways this aspect can be implemented are too numerous to explicitly recite here, so the following examples are not intended to be limiting. For example, a first press of a switch can initiate a slow pulsed emission with high intensity, then a second press of the switch can initiate a faster pulsed emission with lower intensity, then a third press of the switch can terminate emission. As another example, a first press of a switch can initiate emission at a first depth, a second press of the switch can initiate emission at a second depth, a third press of the switch can initiate emission at a third depth, and so on, until an nth press of the switch terminates emission.

Referring to <FIG>, a Schlieren image shows the ultrasound emission from an ultrasound probe <NUM> having a contact surface <NUM> of a few millimeters and the ultrasound energy focused to a depth of about <NUM> beyond the contact surface <NUM>. Referring to <FIG>, a Schlieren image shows the ultrasound emission from an ultrasound probe <NUM> having a contact surface <NUM> of a few millimeters and the ultrasound energy focused to a depth of about <NUM> beyond the contact surface <NUM>.

Referring to <FIG>, an image shows a treatment device <NUM> according to one aspect of the present disclosure. The image is a perspective view taken from the tip portion <NUM> end of the treatment device at an angle between <NUM>° and <NUM>° relative to the axial direction <NUM>. The treatment device <NUM> shown in <FIG> also contains the other components which are identified in <FIG>.

In certain aspects, the ultrasound probe <NUM> can be configured to interface directly with an unmodified computer or personal device. For example, the ultrasound probe <NUM> can include all of the electronics necessary for the functions described herein and can be interfaced with the unmodified computer or personal device via a standard interface, such as a USB interface.

In certain aspects, the ultrasound system <NUM> can include an ultrasound imaging system. The ultrasound imaging system can include an ultrasound imaging transducer or the ultrasound transducer <NUM> can be a joint therapy/imaging transducer. The ultrasound imaging transducer can be located in the ultrasound probe <NUM> or can be located in a separate housing. The ultrasound imaging system can include the necessary electronic components to be operable, as would be understood by a person having ordinary skill in the art.

Referring to <FIG> a plurality of lesions were created in a line segment pattern by a <NUM> transducer focused into a porcine muscle tissue, ex vivo. <FIG> is a photograph of a sagittal plane cross section cut perpendicular to the treatment surface and shows the gross pathology of the ultrasound lesions generated by the treatment. Delivery of a first conformal distribution of ultrasound energy having a first set of spatial and temporal parameters generated one larger lesion <NUM> at a first depth. Delivery of a second, third, and fourth conformal distribution of ultrasound energy having a second set of spatial and temporal parameters generated three smaller lesions <NUM> at a second depth. This example exhibits the control of the depth and size of conformal distributions of ultrasound energy and resulting lesions that can be achieved with the methods and systems described herein. Lesions were centered at <NUM> depth. Acoustic energy for the large lesion was <NUM> J and for the smaller lesions was <NUM> J. The pulse rate was <NUM>.

Referring to <FIG>, a plurality of lesions were created in an arc surface pattern by a <NUM> transducer focus into a porcine muscle tissue, ex vivo. <FIG> is a photograph of a coronal plan cross section cut parallel to the treatment surface. Delivery of a first, second, third, fourth, fifth, and sixth conformal distribution of ultrasound energy having the same spatial and temporal parameters generated six lesions <NUM> at the same depth along an arc treatment pattern beneath the arc surface pattern. This example exhibits the deposition of conformal distributions of ultrasound energy in an arbitrary pattern, in this case, an arc treatment pattern. Lesions were centered at <NUM> depth. The cross section was cut at the same depth of <NUM>. Acoustic energy was <NUM> J, the pulse rate was <NUM>, and the arc was approximately <NUM> in diameter.

Claim 1:
An ultrasound treatment system comprising:
an ultrasound probe (<NUM>) having a contact surface (<NUM>), the ultrasound probe movable by a user along a treatment surface in an arbitrary surface pattern (<NUM>) while maintaining contact between the contact surface and the treatment surface;
a control module (<NUM>) operably coupled to the ultrasound probe, the control module, in use, controlling the emission of a therapeutic ultrasound energy from the ultrasound probe;
a position sensor (<NUM>, <NUM>) that, in use, measures a position of the ultrasound probe along the treatment surface and transmits a position signal to the control module corresponding to the position of the ultrasound probe along the treatment surface; and
a power supply (<NUM>) that, in use, provides power to the ultrasound probe sufficient for the emission of the therapeutic ultrasound energy,
wherein the control module, in response to the position signal indicating that the ultrasound probe is moving along the treatment surface, and in response to the measured position, varies a pulse width of the therapeutic ultrasound energy, a power amplitude of the therapeutic ultrasound energy, and a timing between pulses of the therapeutic ultrasound energy to produce a series of ultrasound pulses that have equal energy and are equally spaced along the arbitrary surface pattern.