Ultrasonic spinal disc therapeutics

Abstract

A system for ultrasonic degenerative disc therapy including an apparatus. The apparatus including a locator configured to locate a target area on a body of a patient. The apparatus including a gel applicator configured to apply a gel to the target area. The apparatus including an effector including a transducer configured to generate and transmit ultrasonic energy to the target area and at least one sensor configured to detect a temperature of the target area. The system including a controller communicatively connected to the apparatus configured to provide at least one control signal to the apparatus. The system including a power source electrically connected to the controller and the apparatus. The system including a recorder communicatively connected to the controller and the apparatus, the recorder configured to store at least one element of data measured by the sensor.

Description

DCW-00125ULTRASONIC SPINAL DISC THERAPEUTICSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 708,435, filed October 17, 2024, and U.S. Provisional Patent Application No. 63 / 896,909, filed October 10, 2025. The entire contents of each are hereby incorporated by reference herein in their entirety.BACKGROUND OF THE DISCLOSED SUBJECT MATTERField of the Disclosed Subject Matter

[0002] The disclosed subject matter relates to a system for treating spinal injuries and conditions. Particularly, the present disclosed subject matter is directed to utilizing ultrasound to heal spinal injuries and conditions, without requiring invasive surgery or subcutaneous sensors.Description of Related Art

[0003] There are methods for treating spinal disc degeneration. These methods and systems may be an outpatient therapy. These methods and systems may be an at-home therapy. These methods may require the invasive process of inserting one or more sensors or other components into the body of a patient using the therapeutics. These methods may require that a temperature of the affected area of the disc is monitored when ultrasonic energy is delivered to the area. An example of such system is disclosed in U.S. Patent No. 8,088,084, the entire contents of which are hereby incorporated by reference. A drawback to such systems is that they require inserting a temperature monitor (e.g. subcutaneous temperature senor) into the target area of the patient's body which presents risks of infection, pain, etc.FH13134721.1DCW-00125

[0004] There thus remains a need for an efficient and economic method and system for ultrasonic spinal disc therapeutics.SUMMARY OF THE DISCLOSED SUBJECT MATTER

[0005] The purpose and advantages of the disclosed subject matter will be set forth in and apparent from the description that follows, as well as will be learned by practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the appended drawings.

[0006] To achieve these and other advantages and in accordance with the purpose of the disclosed subject matter, as embodied and broadly described, the disclosed subject matter includes a system for ultrasonic degenerative disc therapy, the system including an apparatus including a locator, the locator configured to locate a target area on a body of a patient. The apparatus including a gel applicator, the gel applicator configured to apply a gel to the target area. The apparatus including an effector, the effector including a transducer, the transducer configured to generate and transmit ultrasonic energy to the target area and at least one sensor, the at least one sensor configured to detect a temperature of the target area. The system including a controller, the controller communicatively connected to the apparatus, the controller configured to provide at least one control signal to the apparatus. The system including a power source electrically connected to the controller and the apparatus, the power source configured to provide electrical energy to at least the controller and the apparatus. The system including a recorder, the recorder communicatively connected to the controller and the apparatus, the recorder configured to store at least one element of data measured by the sensor.

[0007] The disclosed subject matter also includes a method for intervertebral disc therapy, the method including locating a target area on a body of a patient, the target area -2-FH13134721.1DCW-00125 corresponding to a intervertebral disc of the patient, aligning a transducer configured to deliver ultrasonic energy with the target area, affixing the transducer in a manner suitable to deliver the ultrasonic energy to the target area, monitoring a temperature of the target area via at least one sensor configured to measure the temperature of the target area and delivering the ultrasonic energy to the target area.

[0008] It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the disclosed subject matter claimed.

[0009] The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the method and system of the disclosed subject matter. Together with the description, the drawings serve to explain the principles of the disclosed subject matter.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] A detailed description of various aspects, features, and embodiments of the subject matter described herein is provided with reference to the accompanying drawings, which are briefly described below. The drawings are illustrative and are not necessarily drawn to scale, with some components and features being exaggerated for clarity. The drawings illustrate various aspects and features of the present subject matter and may illustrate one or more embodiment(s) or example(s) of the present subject matter in whole or in part.

[0010] FIG. 1 is a schematic representation of the ultrasonic spinal disc therapeutic apparatus in accordance with the disclosed subject matter.

[0011] FIG. 2 is a schematic representation of the ultrasonic spinal disc therapeutic apparatus showing a maneuverable arm in accordance with the disclosed subject matter.-3-FH13134721.1DCW-00125

[0012] FIGS. 3 A and 3B are schematic representations of a bilateral ultrasonic transducers and annular phased ultrasonic transducers in accordance with the disclosed subject matter.

[0013] FIG. 4 is an orthogonal view of an ultrasound transducer in accordance with the disclosed subject matter.

[0014] FIG. 5 is a pressure plot of an exemplary ultrasound transducer over a distance from said transducer in accordance with the disclosed subject matter.

[0015] FIG. 6 is a schematic representation of the ultrasonic spinal disc therapeutic apparatus showing a group of discs with a target area and a locator in accordance with the disclosed subject matter.

[0016] FIG. 7 is a schematic representation of the ultrasonic spinal disc therapeutic apparatus showing a group of discs with a target area and a data recording system in accordance with the disclosed subject matter.

[0017] FIG. 8 is a flow diagram of a method for ultrasonic spinal disc therapeutics in accordance with the disclosed subject matter.

[0018] FIG. 9 is a schematic representation of a computing node in accordance with the disclosed subject matter.

[0019] FIGS. 10A and 10B are a view and cross-sectional view, respectively, of an assembled housing for a gel pad and transducer in accordance with the disclosed subject matter.

[0020] FIGS. 11A and 1 IB are drawing views of an assembled housing for a gel pad and transducer as shown in FIGS. 10A and 10B in accordance with the disclosed subject matter.-4-FH13134721.1DCW-00125

[0021] FIGS. 12A and 12B are a perspective view and cross-sectional view, respectively, of an assembled housing for a gel pad and transduce in accordance with the disclosed subject matter.

[0022] FIGS. 12C is a side view of an assembled housing for a gel pad and transducer as shown in FIGS. 12A and 12B in accordance with the disclosed subject matter.

[0023] FIGS. 13A - 13D are images of an assembled housing for a gel pad and transducer in accordance with the disclosed subject matter.

[0024] FIGS. 14A and 14B are images of a gel pad in accordance with the disclosed subject matter.

[0025] FIGS. 15A - 15D are views of a housing for a gel pad in accordance with the disclosed subject matter.

[0026] FIGS. 15E - 15F are drawing views of a housing for a gel pad as shown in FIGS. 15A-15D in accordance with the disclosed subject matter.

[0027] FIGS. 16A - 16C are a perspective view, side view, and bottom view, respectively, of a housing for a transducer in accordance with the disclosed subject matter.

[0028] FIG. 17 is an image of an arbitrary function generator, power amplifier, and transducer in accordance with the disclosed subject matter.

[0029] FIGS. 18A and 18B are images of a transducer in accordance with the disclosed subject matter.

[0030] FIGS. 19A and 19B are views of a transducer in accordance with the disclosed subject matter.

[0031] FIGS. 20 - 27 are views of an exemplary transducer in accordance with the disclosed subject matter.

[0032] FIGS. 28 A and 28B are images of exemplary back braces in accordance with the disclosed subject matter.-5-FH13134721.1DCW-00125

[0033] FIGS. 29A - 29E are plots of National Pain Scores (NPS) of leg pain obtained at multiple time points using an ultrasonic spinal stimulation therapeutic apparatus in accordance with the disclose subject matter.DETAILED DESCRIPTION OF AN EXEMPLARY EMBODIMENT

[0034] Reference will now be made in detail to exemplary embodiments of the disclosed subject matter, an example of which is illustrated in the accompanying drawings. The method and corresponding steps of the disclosed subject matter will be described in conjunction with the detailed description of the system.

[0035] The methods and systems presented herein may be used for non-invasively using ultrasonic energy to, non-invasively, repair degenerated intervertebral discs. The disclosed subject matter is particularly suited for outpatient systems and methods for non- invasively using ultrasonic energy on a target area of a patient’s body, the target area corresponding to degenerated intervertebral discs. For purpose of explanation and illustration, and not limitation, an exemplary embodiment of the system in accordance with the disclosed subject matter is shown in FIG. 1 and is designated generally by reference character 100. Similar reference numerals (differentiated by the leading numeral) may be provided among the various views and Figures presented herein to denote functionally corresponding, but not necessarily identical structures.

[0036] Without wishing to be bound to theory, the therapeutic effects of the methods and systems provided may occur through both cellular and neuromodulatory mechanisms. While long-term benefits such as tissue regeneration, extracellular matrix synthesis, and antiinflammatory responses are believed to result from stimulation of biological repair pathways, immediate reduction in pain and improvement in mobility (short-term benefits) may be explained by ultrasound-induced neuromodulation of peripheral nerves and mechanosensitive -6-FH13134721.1DCW-00125 cellular structures surrounding the target intervertebral disc. In particular, low-intensity pulsed ultrasound (LIPUS) energy may act through mechanical sound waves that inhibit or stimulate neurons and other excitable cells. The acoustic field generated by the transducer can transiently alter membrane polarization, ionic flux, or mechanosensitive ion-channel conductance, thereby modulating neural activity in tissues proximate to the target area. This non-thermal, mechanical interaction may lead to immediate attenuation of pain signaling or reflexive muscle tension even before cellular repair mechanisms are initiated.

[0037] Accordingly, the method and system described herein may achieve therapeutic benefit through multiple complementary biophysical pathways, including mechanical neuromodulation of nociceptive fibers, modulation of local inflammatory signaling, and stimulation of disc-cell biosynthesis, each contributing to overall spinal pain relief and functional restoration.Image Guided Outpatient Therapy

[0038] In accordance with an aspect of the present disclosure, a system and method for the treatment of intervertebral disc degeneration is provided which uses non-invasive, low-intensity pulsed ultrasound (LIPUS). The pulse duration and / or intensity can be uniform across multiple pulses; and in some embodiments the intensity / duration can vary across different pulses. Also, the power source (which can be an alternating current feed or direct current, e.g. battery powered) delivers the LIPUS energy based on the optimal, or target, ultrasound wave necessary to reach the intervertebral disc at the target area 116.

[0039] The optimal / target ultrasound wave can vary based on a variety of parameters, including body types and size, degree of disc damage, depth of target area 116, body mass index (BMI) of patient, bony anatomy of the patient, etc. The frequency range, pulse width, power source, or other input parameter may be adjusted to alter the ultrasonic wave for a given disc (target area 116). FIG. 5 depicts an exemplary pressure plot of a LIPUS treatment-7-FH13134721.1DCW-00125 in accordance with the present disclosure, wherein the maximum pressure coincides with a distance from the targeted location (or radius “r” as shown on the y-axis of the plot) of approximately zero. FIG. 4 depicts an exemplary ultrasound transducer probe that can be employed in accordance with the present disclosure.

[0040] Referring now to FIG. 1, a system 100 for ultrasonic intervertebral disc therapy is shown in schematic box diagram form, in accordance with the disclosed subject matter. System 100 may be configured to utilize ultrasonic energy to promote healing in degenerative intervertebral discs. System 100 includes an apparatus that may be configured for locating, imaging, administering ultrasonic energy to an internal portion of a human body, among other functions. System 100 includes a transducer 104. Transducer 104 is configured to generate and deliver ultrasonic energy to a target area 116. In various embodiments, transducer 104 may be a transmitter configured to convert electrical signals into ultrasound. In various embodiments, transducer 104 may be configured to receive ultrasounds and convert those ultrasounds into electrical signals. In various embodiments, transducer 104 may be a transceiver configured to convert electrical signals into ultrasounds and convert ultrasounds into electrical signals. Transducer 104 may be equally configured to deliver ultrasounds to a target area 116 and receive ultrasounds from one or more areas which may include target area 116. Transducer 104 may be configured to convert either or both of alternating current (AC) and direct current (DC) electrical signals into ultrasounds. In various embodiments, transducer 104 may be a piezoelectric transducer, wherein piezoelectric crystals change their size and shape according to an applied voltage. In various embodiments, transducer 104 may be a capacitive transducer, wherein electrostatic fields between a conductive diaphragm and a backing plate can be manipulated based on applied electrical energy. In various embodiments, transducer 104 may operate according to magnetostriction, wherein a material alters its shape or size according to a magnetic field-8-FH13134721.1DCW-00125 applied thereto. In various embodiments, transducer 104 may include one or silicon micromachining technology (MEMS) diaphragms, such as in micro-machine ultrasonic transducers (MUTs). In various embodiments, transducer 104 is configured to deliver unfocused ultrasonic energy. In various embodiments, transducer 104 is configured to deliver focused ultrasonic energy. In various embodiments, transducer 104 may be made of a single element, such a single piece of ceramic, like a piezoelectric component.

[0041] With continued reference to FIG. 1, transducer 104 may be disposed within an effector 128. The effector 128 may be any suitable housing configured to enclose, at least partially, the components discussed herein, and provide a handle or manipulation point for directing of the ultrasonic energy by the transducer. In various embodiments, a plurality of transducers are disposed within the effector 128, each of the transducers 104 operatively independent, or acting in concert, according to a user input or configuration. In various embodiments, effector 128 may include one or more switches, buttons, sliders, or the like in order to switch operating modes of the effector 128. For example, in a first operative mode, the effector 128 may operate as an ultrasonic probe configured to capture one or more images of an internal portion of a patient’s body, such as target area 116. The effector 128 may be used as an imaging probe in order to locate the target area 116 within the body of the patient. In various embodiments, effector 128 may be utilized alone to locate the target are 116. In various embodiments, one or more effectors 128 may be utilized to locate the target area 116. The effector 128 may be configured to be in imaging mode and ultrasonic energy delivery for therapy of degenerative discs simultaneously. For example, effector 128 may include two transducers 104, one configured (along with any other sensors required) to image the target area 116, while a second transducer is configured to deliver focused or unfocused ultrasonic energy to the target area 116 for therapy. Effector 128 may be in more than one operative mode at all times, such as imaging and therapy, or alternate between the two. This does not-9-FH13134721.1DCW-00125 limit the modes that effector 128 may be switched into based on the plurality of transducers found therein.

[0042] In various embodiments, transducer 104 includes an annular phased array of transducers. The annular phased array including at least two concentric rings. The adjustment of one or more parameters, as well as the physical arrangement and / or relative arrangement of the rings may be configured to “steer” the ultrasonic energy. For the purposes of this disclosure, “steering” ultrasonic energy is the phenomena of directing ultrasonic energy through physical or electrical manipulation of one or more transducers. In various embodiments utilizing a phased array of rings, axial steering capability of the ultrasonic energy may be realized. The electronics that control the one or more transducers 104 generating the ultrasonic energy may be more complex than that of the single transducer, those electronics encapsulated herein by controller 136 (which will be discussed in greater detail herein below). In various embodiments, the transducer 104, when a phased array may stagger the ultrasounds produced by one or more of the transducers, as well as time delay, or physically locate each transducer ring relative to the next such that the ultrasounds may be steered or focused. In various embodiments, the focal length of the annular phased transducer, the focal length may be about 5-6 centimeters (cm). In various embodiments the transducer 104 may be configured to generate ultrasonic energy over a length of 1-20 cm. In various embodiments the transducer 104 may be configured to generate ultrasonic energy over a length of over 20 cm. In various embodiments, the transducer 104 (or plurality thereof) may be configured to generate a high-intensity zone of energy at the target area 116 of about 17-22 cm.

[0043] With continued reference to FIG. 1, system 10 includes at least one sensor 124. The at least one sensor 124 configured to measure a temperature of a target area 116. The sensor 124 may be part of the transducer 104. In various embodiments, sensor 124 may-10-FH13134721.1DCW-00125 be a portion of one or more transducers 104. In various embodiments, sensor 124 may be a separate transducer 104, configured to deliver and receive ultrasonic energy. In various embodiments, sensor 124 may be disposed within effector 128 proximate to one or more transducers 104. In various embodiments, sensor 124 may be configured for ultrasound thermography. For the purposes of this disclosure, “ultrasound thermography” is a process wherein a thermal image of a subject is capture utilizing one or more types of radiation from the subject and surroundings, akin to thermal imaging from infrared radiation. In various embodiments, sensor 124 may be configured to capture relative thermal images of a target area 116 or another part of a patient’s body. In various embodiments, sensor 124 may be configured for ultrasound thermometry. For the purposes of this disclosure, “ultrasound thermometry” is the process of measuring one or more temperatures of a target area. For example, sensor 124 may be configured to measure the temperature of target area 116 before, during and after the delivery of ultrasound energy. In various embodiments, sensor 124 may be configured to measure a temperature of target area 116 from outside a patient’s body, requiring no subcutaneous insertion of any sensors.

[0044] The sensor disclosed herein does not require any subcutaneous placement of equipment within a patient, thereby avoiding the myriad of drawbacks (e.g. biocompatible sensor materials, increased patient pain, infection, etc.) of conventional disc repair techniques. Also, there is no need to insert a sensor within a patient to monitor temperature of the surrounding tissue of the targeted disc; instead, the entire apparatus remains exterior to the patient’s skin. In various embodiments, sensor 124 (and / or any number of transducers 104) may measure thermal energy and / or temperature of target area 116 automatically and continuously. In various embodiments, sensor 124 may be configured to respond to one or more commands from a medical provider, doctor, patient, or other users, computer programs or a combination thereof. In various embodiments, sensor 124 may provide temperature-11-FH13134721.1DCW-00125 information to one or more controllers (such as controller 136) and / or one or more transducers 104, the ultrasonic energy emitted therefrom focused, steered or otherwise adjusted based on said temperature. Sensor 124 may be configured to send data gathered from one or more measurements taken at a target area 116 or surrounding areas of a patient’s body to one or more data stores, such as data store 704, which will be discussed herein below. Further, effector 128 may include an acoustic absorber proximate to the one or more transducers 104 configured to attenuate standing wave formation and prevent unwanted temperature elevation. In various embodiments, system 100 may include a cooling system, which will be described in greater detail in reference to FIG. 6.

[0045] With continued reference to FIG. 1, system 100 may be configured to administer or assist in the administration of one or more drugs or cell therapies. For example and without limitation, system 100 may include one or more reservoirs for the holding of one or more drugs or therapies. The one or more drugs may be configured for treatment of degenerative discs such as degenerative disc disease. The one or more drugs may be configured as sensitizers which can be administered prior to ultrasound energy being delivered to target area 116. Sensitizers can enhance the responsiveness of surrounding tissue to the ultrasound energy. The one or more drugs may be administered (e.g., topically) prior to ultrasound energy being delivered to target area 116. For example and without limitation, the one or more drugs applied topically can include di-alpha tocopheryl (i.e., vitamin E), an antiinflammatory gel (e.g., topical ibuprofen, topical hydrocortisone), a preparation containing an anti-inflammatory ingredient (e.g., hydrocortisone), and / or a preparation containing an antihistamine active ingredient. In various embodiments, the drugs administered prior to the ultrasound energy may be activated by the ultrasound energy being delivered to target area 116. In various embodiments, the drugs administered prior to the ultrasound energy may be modulated (e.g., altered or adjusted drug behavior, drug release, or drug effect) by the-12-FH13134721.1DCW-00125 ultrasound energy being delivered to target area 116. By way of example, ultrasound energy being delivered to target area 116 may increase the permeability of surrounding tissues, which may enhance the penetration of administered drugs into the target area 116. In another example, the ultrasound energy may alter the distribution of administered drugs within the target area 116. In various embodiments, the drugs previously administered may be activated by the ultrasound energy via a phase transition, such as liquid to gas phase, such as liquid nanodroplets to gas bubbles. In various embodiments, the drugs may be time release drugs configured to coincide with delivery of ultrasound energy. The one or more drugs may be administered intravenously, intradiscally, epidurally, subcutaneously, orally, or topically, according to one or more embodiments of the disclosed subject matter. The one or more drugs administered may include an anti-inflammatory, an anti-histamine, a corticosteroid (e.g., hydrocortisol), and / or a local anesthetic.

[0046] In various embodiments, the one or more drugs may be configured to be administered post ultrasound energy delivery. In various embodiments, the drugs previously administered may be activated by the ultrasound energy via a phase transition, such as liquid to gas phase, such as liquid nanodroplets to gas bubbles. In various embodiments, the drugs may be time release drugs configured to coincide with delivery of ultrasound energy. The one or more drugs may be administered intravenously, intradiscally, epidurally, subcutaneously, orally, or topically, according to one or more embodiments of the disclosed subject matter.

[0047] With continued reference to FIG. 1, system 100 and further, the apparatus includes a locator 108. The locator 108 is configured to locate a target area on a body of a patient and align one or more components with said target area through delivery of the ultrasonic energy. In various embodiments, locator 108 is a portion of another component described herein, such as effector 128. In various embodiments, locator 108 is a wearable-13-FH13134721.1DCW-00125 component configured to attach to the body of the patient. In various embodiments, the locator 108 may be a back brace including a maneuverable orifice configured to attach to the effector 128. For example and without limitation, locator 108 may include a moveable orifice configured to attach and tilt effector 128 to deliver ultrasound energy to target area 116. The locator can be configured (e.g. contoured and / or adjustable surface) to register with the anatomy of a patient (e.g. particular spinal vertebrae) to ensure proper positioning of the effector. In various embodiments, locator 108 may be communicatively connected to the one or more imaging probes, such as transducer 104, the locator configured to maneuver automatedly to the location and orientation such that effector 128 may deliver ultrasonic energy to the target area 116.

[0048] In various embodiments, locator 108 may be communicatively connected to the one or more imaging probes, and be configured to prompt the user to locate the effector 128 to the correct location and orientation for ultrasonic energy delivery. For example and without limitation, locator 108 may provide audio and or visual prompts, such as a video of the back of the patient, ultrasound images of the internal portion of the patient’s body, or haptic feedback such as vibrating, buzzing or the like to indicate correct or incorrect placement of locator 108 and thereby placement of effector 128. In various embodiments, locator 108 may be a standalone component, such as a robotic or mechanical arm, the arm configured to be maneuvered by the medical provider or the patient and hold the effector 128 in an orientation. In various embodiments, locator 108 may be configured to automatedly place and hold effector 128 in an orientation appropriate for delivery of target area 116.

[0049] In various embodiments, locator 108 may be completely software -based, the locator 108 configured to utilize sensor 124 measurements and information about the patient’s body to indicate to a patient or medical provider regarding the placement of the effector 128.-14-FH13134721.1DCW-00125

[0050] With continued reference to FIG. 1, system 100 includes a gel applicator 112, the gel applicator 112 configured to apply a gel to the target area 116. In some embodiments, the gel can include a salt colloidal suspension. In some embodiments, the gel can contain ibuprofen. In some embodiments, the gel can contain di-alpha-tocopheryl (i.e., Vitamin E). In various embodiments the gel application 112 may be attached to the effector 128, the gel applicator 112 configured to expel or eject the gel onto the patient’s body proximate the target area 112 in response to a user interaction. For example, the gel applicator 112 may include a trigger, button, switch, or other mechanical interface configured to expel gel in response to an interaction, such as a user pull of the trigger on an area proximate the target area 112. For example, the gel applicator 112 may be configured to expel gel automatedly in response to one or more signals provided by the controller 136, sensor 124 or one or more users. For example, a user such a medical provider or the patient may outline an area on a computer screen corresponding to the application area of the gel, the gel applicator 112 may automatedly apply the gel when the effector 128 is in that area, detected by one or more onboard or off-board sensors such as accelerometers and / or cameras. In various embodiments, the gel applicator 112 may be external to the effector 128. Gel applicator 112 may be its own effector, configured to be held by a medical provider, patient, mechanical / robotic arm, or the like. The external gel applicator 112 may be automatedly or manually applied by the gel applicator 112.

[0051] With continued reference to FIG. 1, gel applicator 112 may include a gel pad configured to be affixed proximate target area 116 on a first side and the transducer 104 and / or effector 128 on a second side. In various embodiments gel applicator 112 may be a gel pad affixed to a patient’s body proximate the target area 116. The gel may be configured to acoustically couple the transducer 104 to the target area 116. The gel applicator 112 and / or gel pad may be configured to enhance the targeting and navigation of the ultrasonic-15-FH13134721.1DCW-00125 energy to the target are 116. One or more gel applicators 112 may be swapped based on the imaging or therapeutic mode of effector 128. For example, a different type of gel, different thickness of gel pad or applied gel, or diameter / shape / size of area the gel is applied to, may be altered based on the task and area of patient.

[0052] With continued reference to FIG. 1, system 100 includes a controller 136, the controller communicatively connected to the apparatus, the controller 136 configured to provide at least one control signal to the apparatus. The controller 136 may be electrically and communicatively connected to the transducer 104, sensor 124, and any data store or recorder 132. Controller 136 may be configured to provide electrical signals to and from a power source 120 and transducer 104, the signals indicated the frequency, range, intensity and other characteristics of the ultrasonic energy generated. Controller 136 may be a portion of the power source 120, or vice versa. Controller 136 may be communicatively connected to one or more user interfaces such as a remote, graphical user interface (GUI), computer program, or the like configured to allow user input to alter the ultrasonic energy and delivery thereof. The system 100 includes power source 120 electrically connected to the controller and the apparatus, the power source configured to provide electrical energy to at least the controller 136 and the apparatus, and additionally to any other electrical component connected thereto, such as recorder 132, data store 704, or the like.

[0053] With continued reference to FIG. 1, system 100 includes a recorder 132. Recorder 132 may communicatively connected to the controller 136 and the apparatus (transducer 104, sensor 124 and effector 128). The recorder 132 configured to store at least one element of data measured by the sensor 124. In various embodiments, recorder 132 is configured to store one or more images captured by ultrasound imaging. In various embodiments, recorder 132 is configured to store video of one or more ultrasound imaging-16-FH13134721.1DCW-00125 sessions. In various embodiment’s, recorder 132 is configured to store one or more thermal images captured via ultrasound thermography.

[0054] In various embodiments, recorder 132 is configured to store one or more temperature measurements of target area 116, surrounding tissue, or another portion of a patient’s body. In various embodiments, recorder 132 is configured to store a plurality of temperatures measured at target area 116 over a period of time. In various embodiments, recorder 132 is configured to store a plurality of temperatures over a period of ultrasonic energy delivery periods. In various embodiments, recorder 132 is configured to store a plurality of temperatures corresponding to time stamped characteristics of ultrasonic energy. In various embodiments, recorder 132 is configured to store changes in ultrasonic energy commands over a period of time, over a period of temperature measurements, or the like. In various embodiments, recorder is configured to store one or more time periods of ultrasonic energy delivery, such as the time elapsed during ultrasonic energy delivery, number of sessions, date of sessions, time of day of sessions, and the like.

[0055] In various embodiments, recorder 132 is configured to store information regarding sessions of ultrasonic energy delivery over a period of time and the temperatures measured during those sessions. For example, recorder 132 may store the temperature over a first 20 minute session on a first day and then also record the temperature over a second 20 minute session on a second day. Recorder 132 may be configured to transmit this data to one or more medical providers, data stores (704), databases, medical records, graphical user interfaces, or the like. Recorder 132 may be configured to store and retrieve data based on an interaction with a user’s smartphone, computer, or the like. Recorder 132 may be electrically connected to one or more components of system 100 such as effector 128, transducer 103, sensor 124, controller 136, power source 120, or any other component via a conductive wire, fiber optic cable, wireless via WIFI or another wireless protocol, or another method not-17-FH13134721.1DCW-00125 described herein. Recorder 132 may be powered by power source 120 or another power source connected thereto, as in a backup power source, battery, or the like. Recorder 132 may be configured to receive and record data remotely form system 100 over an internet or cellular connection.Home-based therapy system

[0056] Referring now to FIG. 2 and in accordance with another aspect of the present disclosure, a system 200 disclosed herein can be configured for remote, or “telehealth”, applications outside of a healthcare facility, e.g. where a patient can operate the device, in some scenarios independently, at home as described in part above.

[0057] System 200 includes a portable LIPUS ultrasound device configured much the same as system 100 with various embodiments and components configured for in home continued therapy of intervertebral disc degeneration by ultrasound therapeutics. The device can be operable by a single person, e.g. the patient, spouse, family member, caretaker, medical professional, doctor, nurse, or the like.

[0058] A portable power source similar to or the same as power source 120 may be available for home use by a patient. The at-home power source 220 may be capable of delivering the same LIPUS energy, at appropriate depths, as noted in the outpatient therapy described above in reference to power source 120 and transducer 104. In various embodiments, the portable power source (e.g. Lithium-ion battery) can be removable and rechargeable. The device that can be configured with the ultrasound transducer 204 in a known and / or manueverably fixed location with the remainder of the device sized / shaped such that when a user attaches / wears the device, the ultrasound transducer 204 is located at the appropriate position and angle to target the affected disc.

[0059] With continued reference to FIG. 2, transducer 204 may be similar to or the same as transducer 104, and take on similar or identical arrangements and embodiments-18-FH13134721.1DCW-00125 thereof. Transducer 204 is configured to generate and deliver ultrasonic energy to a target area 116. In various embodiments, transducer 204 may be a transmitter configured to convert electrical signals into ultrasound. In various embodiments, transducer 204 may be configured to receive ultrasounds and convert those ultrasounds into electrical signals. In various embodiments, transducer 204 may be a transceiver configured to convert electrical signals into ultrasounds and convert ultrasounds into electrical signals. Transducer 204 may be equally configured to deliver ultrasounds to a target area 116 and receive ultrasounds from one or more areas which may include target area 116. Transducer 204 may be configured to convert either or both of alternating current (AC) and direct current (DC) electrical signals into ultrasounds. In various embodiments, transducer 204 may be a piezoelectric transducer, wherein piezoelectric crystals change their size and shape according to an applied voltage. In various embodiments, transducer 204 may be a capacitive transducer, wherein electrostatic fields between a conductive diaphragm and a backing plate can be manipulated based on applied electrical energy. In various embodiments, transducer 204 may operate according to magnetostriction, wherein a material alters its shape or size according to a magnetic field applied thereto. In various embodiments, transducer 204 may include one or silicon micromachining technology (MEMS) diaphragms, such as in micro-machine ultrasonic transducers (MUTs). In various embodiments, transducer 204 is configured to deliver unfocused ultrasonic energy. In various embodiments, transducer 204 is configured to deliver focused ultrasonic energy. In various embodiments, transducer 104 may be made of a single element, such a single piece of ceramic, like a piezoelectric component.

[0060] In an exemplary embodiment, the home based therapy device may be configured as a girdle / brace / belt or otherwise wearable device with a receptacle for the ultrasound transducer that provides the proper position and angle for targeting the affected disc. In various embodiments, this locator may be similar to or the same as locator 108, and-19-FH13134721.1DCW-00125 comprise substantially shirt-like construction, the locator configured to attach to a user’s body (like a shirt worn on the torso) and hold the effector 228 in the appropriate location and orientation. Additionally, a unique ultrasound gel delivery system will be part of the system to enhance the ultrasound wave targeting.

[0061] The locator 208 is configured to locate a target area on a body of a patient and align one or more components with said target area through delivery of the ultrasonic energy. In various embodiments, locator 208 is a portion of another component described herein, such as effector 228. In various embodiments, locator 208 is a wearable component configured to attach to the body of the patient. In various embodiments, the locator 208 may be a back brace including a maneuverable orifice configured to attach to the effector 228. For example and without limitation, locator 208 may include a moveable orifice configured to attach and tilt effector 228 to deliver ultrasound energy to target area 116. The back brace can include a supportive body configured to conform to the back of a patient, at least one transducer integrated into the supportive body and positioned to deliver ultrasound energy to a target area 116 on a patient’s back, and at least one adjustment strap for securing the back brace in place. For example and without limitation, the locator 208 may be a back brace including a pair of transducers 104, with one transducer positioned on each side of the patient’s midline. FIGS. 28A-28B show images of exemplary back braces which can comprise the effector 208. In various embodiments, locator 208 may be communicatively connected to the one or more imaging probes, such as transducer 204, the locator configured to maneuver automatedly to the location and orientation such that effector 228 may deliver ultrasonic energy to the target area 116.

[0062] In various embodiments, locator 208 may be communicatively connected to the one or more imaging probes, and be configured to prompt the user to locate the effector 228 to the correct location and orientation for ultrasonic energy delivery. For example and-20-FH13134721.1DCW-00125 without limitation, locator 208 may provide audio and or visual prompts, such as a video of the back of the patient, ultrasound images of the internal portion of the patient’s body, or haptic feedback such as vibrating, buzzing or the like to indicate correct or incorrect placement of locator 108 and thereby placement of effector 228. In various embodiments, locator 208 may be a standalone component, such as a robotic or mechanical arm, the arm configured to be maneuvered by the medical provider or the patient and hold the effector 228 in an orientation. In various embodiments, locator 208 may be configured to automatedly place and hold effector 228 in an orientation appropriate for delivery of target area 116.

[0063] In various embodiments, locator 208 may be completely software -based, the locator 208 configured to utilize sensor 224 measurements and information about the patient’s body to indicate to a patient or medical provider regarding the placement of the effector 228. In various embodiments, effector 228 may be attached to an arm 240, the arm 240 including at least a first end and at least a second end, defining a maneuverable (e.g. repositionable) and adjustable length therebetween, the effector 228 attached to the second end of the arm 240. The arm 240 may be formed from a plurality of links, each link attached to the adjacent links by a joint, the plurality of links maneuverable relative to each other link. For example, each joint may be maneuverable about three axes, each joint selectably fixable. For example the arm may be configured with any number of links, each link increasing the maneuverability of arm 240. Arm 240 may be configured to hold effector 228 and attach to locator 208. Arm 240 may be configured to assist the patient in the at-home therapy by holding the effector 228 so the patient may operate other components or at angles and positions the patient is not able to reach. Each joint is configured to hold the position of the arm. For example and without limitation, each joint may have a locked mode and a moveable mode. Each joint may be a revolute joint, a prismatic joint, ball joint, knuckle joint or-21-FH13134721.1DCW-00125 another type of joint. Each joint may be a universal joint or a compound rotational joint, such that one link may rotate and tilt relative to an adjacent link.

[0064] For example and without limitation, system 200 may be communicatively coupled to one or more computing devices and one or more data stores. System 200 may be configured to receive a digital map of a patient’s spine, including a predetermined target area 116. The system 200 could then be manually or robotically manipulated to position effector 228 to deliver the ultrasonic energy to said target area, the effector including one or more accelerometers, and one or more gyroscopes to detect a relative orientation and position with the digital map. Effector 228 may then include an audio, visual or audiovisual cue, indicator, alert, alarm, or other type of signal intended to guide the patient or physician in placing the effector 228 relative to target area 116. The digital map of the patient’s spine may be measured and plotted by the system 200 itself, through the use of one or more ultrasound imaging probes (like effector 228 in probe mode) or a one or more other techniques, like a radiograph assessment, CAT scan, MRI, or the like.

[0065] With further reference to FIG. 2, system 200 includes sensor 224 and effector 228, similar to sensor 124 and effector 128, respectively. The at least one sensor 224 configured to measure a temperature of a target area 116. In various embodiments, sensor 224 may be a portion of one or more transducers 204. In various embodiments, sensor 224 may be a separate transducer 204, configured to deliver and receive ultrasonic energy. In various embodiments, sensor 224 may be disposed within effector 228 proximate to one or more transducers 204. In various embodiments, sensor 224 may be configured for ultrasound thermography and / or ultrasound thermometry. For example, sensor 224 may be configured to measure the temperature of target area 116 before, during and after the delivery of ultrasound energy. In various embodiments, sensor 224 may be configured to measure a-22-FH13134721.1DCW-00125 temperature of target area 116 from outside a patient’s body, requiring no subcutaneous insertion of any sensors.

[0066] The sensor disclosed herein does not require any subcutaneous placement of equipment within a patient, thereby avoiding the myriad of drawbacks (e.g. increased pain, infection, etc.) of conventional disc repair techniques. In various embodiments, sensor 224 may be configured to respond to one or more commands from a medical provider, doctor, patient, or other users, computer programs or a combination thereof. In various embodiments, sensor 224 may provide temperature information to one or more controllers (such as controller 236) and / or one or more transducers 204, the ultrasonic energy emitted therefrom focused, steered or otherwise adjusted based on said temperature. Sensor 224 may be configured to send data gathered from one or more measurements taken at a target area 116 or surrounding areas of a patient’s body may to one or more data stores, such as recorder 232, which will be discussed herein below.

[0067] With continued reference to FIG. 2, transducer 204 may be disposed within an effector 228. The effector 228 may be any suitable housing configured to enclose, at least partially, the components discussed herein, and provide a handle or manipulation point for directing of the ultrasonic energy by the transducer, especially by a patient or a medical provider in an at-home therapy. In various embodiments, a plurality of transducers are disposed within the effector 228, each of the transducers 204 operatively independent, or acting in concert, according to a user input or configuration

[0068] For example, in a first operative mode, the effector 228 may operate as an ultrasonic probe configured to capture one or more images of an internal portion of a patient’s body, such as target area 116. The effector 228 may be used as an imaging probe in order to locate the target area 116 within the body of the patient. In various embodiments, effector 228 may be utilized alone to locate the target are 116. In various embodiments, one-23-FH13134721.1DCW-00125 or more effectors 228 may be utilized to locate the target area 116. The effector 228 may be configured to be in imaging mode and ultrasonic energy delivery for therapy of degenerative discs simultaneously. For example, effector 228 may include two transducers 204, one configured (along with any other sensors required) to image the target area 116, while a second transducer is configured to deliver focused or unfocused ultrasonic energy to the target area 116 for therapy. Effector 128 may be in more than one operative mode at all times, such as imaging and therapy, or alternate between the two.

[0069] With continued reference to FIG. 2, system 200 includes gel pad 212 configured to be affixed proximate target area 116 on a first side and the transducer 204 and / or effector 228 on a second side. In various embodiments gel pad 212 may be affixed to a patient’s body proximate the target area 116. The gel pad 212 may be configured to acoustically couple the transducer 204 to the target area 116. The gel pad 212 may be affixed to the effector 228, such that when the effector 228 is pressed against the patient’s body proximate to the target area 116, the gel pad 212 is pressed against the skin of the patient.The gel pad 212 may be configured to enhance the targeting and navigation of the ultrasonic energy to the target are 116. One or more gel pads 212 may be swapped based on the imaging or therapeutic mode of effector 228. For example, a different type of gel, different thickness of gel pad or applied gel, or diameter / shape / size of area the gel is applied to, may be altered based on the task and area of patient.

[0070] With continued reference to FIG. 2, system 200 includes recorder 232.Recorder 232 is configured to allow for a feature of the device to be a therapy recording capability, which can be stored locally in a (e.g. flash) memory on the device. The usage history can also be transmitted to appropriate medical professionals with therapy usage data. The recorder 232 configured to store at least one element of data measured by the sensor 224. In various embodiments, recorder 232 is configured to store one or more images captured by-24-FH13134721.1DCW-00125 ultrasound imaging. In various embodiments, recorder 232 is configured to store video of one or more ultrasound imaging sessions. In various embodiment’s, recorder 232 is configured to store one or more thermal images captured via ultrasound thermography.

[0071] In various embodiments, recorder 232 is configured to store one or more temperature measurements of target area 116, surrounding tissue, or another portion of a patient’s body. In various embodiments, recorder 232 is configured to store a plurality of temperatures measured at target area 116 over a period of time. In various embodiments, recorder 232 is configured to store a plurality of temperatures over a period of ultrasonic energy delivery periods. In various embodiments, recorder 232 is configured to store a plurality of temperatures corresponding to time stamped characteristics of ultrasonic energy. In various embodiments, recorder 232 is configured to store changes in ultrasonic energy commands over a period of time, over a period of temperature measurements, or the like. In various embodiments, recorder is configured to store one or more time periods of ultrasonic energy delivery, such as the time elapsed during ultrasonic energy delivery, number of sessions, date of sessions, time of day of sessions, and the like.

[0072] In various embodiments, recorder 232 is configured to store information regarding sessions of ultrasonic energy delivery over a period of time and the temperatures measured during those sessions. For example, recorder 232 may store the temperature over a first 20 minute session on a first day and then also record the temperature over a second 20 minute session on a second day. Recorder 232 may be configured to transmit this data to one or more medical providers, data stores (704), databases, medical records, graphical user interfaces, or the like. Recorder 232 may be configured to store and retrieve data based on an interaction with a user’s smartphone, computer, or the like. Recorder 232 may be electrically connected to one or more components of system 200 such as effector 228, transducer 204, sensor 224, controller 236, power source 220, or any other component via a conductive wire,-25-FH13134721.1DCW-00125 fiber optic cable, wireless via WIFI or another wireless protocol, or another method not described herein. Recorder 232 may be powered by power source 220 or another power source connected thereto, as in a backup power source, battery, or the like. Recorder 232 may be configured to receive and record data remotely form system 200 over an internet or cellular connection.

[0073] The at home therapy utilized with system 200 includes the ability to send efficacy data to one or more medical professionals. For example and without limitation, data regarding ultrasonic energy delivery time, intensity, wavelength, temperature, and cell information to one or more medical professionals. In various embodiments, at least a portion of the data is time and date stamped such that the medical professional can analyze the sessions and progression of the disc over a period of time. In various embodiments, data related to a reduction in temperature, swelling or cell health in the target area 116 may be transmitted to the one or more medical professionals. One or more medical professionals may assess the therapy sessions and compliance with the prescribed at-home therapy. One or more medical professionals may be notified of the system’s use, sessions completed, and all the data related to the ultrasonic energy. One or more medical professionals may be able to intervene remotely through a computer program, such as shutting down the system, increasing or decreasing aspects of the ultrasound wave, increasing length of sessions, or locking out the user from interacting with any electronic component. In various embodiments, the home-based therapy system 200 can be reusable for a predefined period of time (e.g. a predetermined number of approved operation cycles), in accordance with regulatory requirements. In various embodiments, the home-based therapy system 200 can be reusable for a predefined period of time such as a total therapy limit as measured in total minutes of ultrasonic energy delivery, time of day, day of the week, or another temporal limit. In various embodiments, similar to the outpatient treatment described above, the home--26-FH13134721.1DCW-00125 based therapy device can deliver LIPUS therapy in discrete treatments, e.g., 20 minute LIPUS intervals, which can be adjusted as desired by the user. In various embodiments, certain inputs to the ultrasonic energy may not be adjustable by the user, such as intensity, wavelength, focus, steering, or the like in order to comply with one or more regulatory and safety concerns.Additional anatomic targets for both focused and homebased therapy

[0074] In accordance with another aspect of the present disclosure, the system disclosed herein can use LIPUS therapy, as described above for both in-facility and at-home treatments, based on treatment of pain in other affected areas of the body. For example, focused, image guided and / or targeted therapy, as opposed to non-focused bracing can be employed. Additionally, treatment can target orthopedic indications initially, and adapt (e.g. reposition the LIPUS probe and / or adjust LIPUS interval) to address any focal inflammatory condition as a potential indication. Furthermore, the system disclosed herein can be employed in wound care and / or cosmetic therapies, e.g. to increase collagen synthesis induced by LIPUS.

[0075] Referring now to FIG. 3 A, an effector 128 is shown in schematic diagram form. The effector 128 as shown in FIG. 3 A includes two transducers 104. The transducers 104 are configured to deliver ultrasonic energy posteriorly and bilaterally, the transducers place on either side of a disc’s target area 116. In various embodiments, each transducer 104 is focusable and maneuverable, the position and orientation of each may be configured to aim at the target area 116 to each deliver ultrasonic energy. In various embodiments, a single transducer or phased array transducer may be maneuvered between sessions or within the same session to deliver ultrasonic energy posteriorly and bilaterally. In various embodiments, a single transducer 104 may be moved and aimed to target area 116 from multiple angles in order to deliver the ultrasonic energy from a plurality of locations and-27-FH13134721.1DCW-00125 directions. In various embodiments, the dual array shown in FIG. 3A can ensure symmetry of the energy delivered to target area 116. In a posterior bilateral treatment the transducers could be placed simultaneously in a dual array, or consecutively, positioning each side to reach the affected disc based on pre-procedure radiograph assessment. Transducer 104 may produce ultrasonic energy 308 in a substantially linear path, among others.

[0076] The apparatus disclosed herein can target a specific (e.g. damaged) intervertebral disc and align the ultrasound transducer to deliver the ultrasound wave to the affected disc’s target area 116. Additionally, the device can be customized for other spinal targets, e.g., facet joint, SI joint, the vertebrobasilar nerve, etc. A transducer 104 and locator 108 device is also disclosed which accurately position the transducer to reach the targeted disc, and gel delivery system that enhances targeting and navigation of the ultrasound wave to the affected disc.

[0077] Referring now to FIG. 3B, a phased array transducer 104 is shown in axonometric view. The annular phased array includes at least two concentric rings. The adjustment of one or more parameters, as well as the physical arrangement and / or relative arrangement of the rings may be configured to steer the ultrasonic energy. The electronics that control the one or more transducers 104 generating the ultrasonic energy may be more complex than that of the single transducer, those electronics encapsulated herein by controller (136, 236). In various embodiments, the transducer 104 may include a phased array that may stagger the ultrasounds produced by one or more of the transducers, as well as a time delay, or physically locate each transducer ring relative to the next such that the ultrasounds may be steered or focused. In various embodiments, the focal length of the annular phased transducer may be about 5-6 centimeters (cm). In various embodiments the transducer 104 may be configured to generate ultrasonic energy over a length of 1-20 cm. In various embodiments the transducer 104 may be configured to generate ultrasonic energy over a-28-FH13134721.1DCW-00125 length of over 20 cm. In various embodiments, the transducer 104 (or plurality thereof) may be configured to generate a high-intensity zone of energy at the target area 116 of about 17- 22 cm.

[0078] Now referring to FIG. 4, an orthogonal section view of an ultrasound transducer in accordance with the disclosed subject matter is depicted. Transducer 104 may be focusable or unfocusable, consistent with this disclosure. Transducer 104 may be configured to generate ultrasonic energy 308 in a substantially conical path, according to embodiments. Transducer 104 may be configured to generate ultrasonic energy 308 in an alterable path, focusable cone, or linear path as described and shown, and at varying wavelengths across the entire ultrasound spectrum. Transducer 104 may be focusable to a focal point 404. The focal point 404 may be steerable, such that the pressure exerted on that point is moveable and / or adjustable. The transducer 104 may be configured to automatedly adjust the focus and or steer the ultrasonic energy to focal point 404 based on one or more ultrasonic images.

[0079] Now referring to FIG. 5, a pressure plot of ultrasonic energy in a transverse plane is depicted. The pressure plot shown in FIG. 5 has a focus shown by the intense coloration at 30 mm, 40 mm and 75 mm depths from the transducer 104. The pressure plot shown focus at exemplary depths, but this does not limit the depth, angle, focus size or other characteristics of the ultrasonic energy produced by the system herein.

[0080] Now referring to FIG. 6, a schematic representation of the ultrasonic spinal disc therapeutic apparatus showing a group of discs with a target area and a locator in accordance with the disclosed subject matter is depicted. The system shown herein is similar to or the same as any system as described herein. System 600 includes transducer 104, which may be the same or similar to any transducer or grouping described herein. System 600 includes locator 108, the locater may be similar to or the same as any locator described-29-FH13134721.1DCW-00125 herein, software or hardware based. Locator 108 may include one or more mechanical or robotic arms as described herein. System 600 includes sensor 124. Sensor 124 may be a single sensor or a sensor suite working in tandem. The sensor suite may include a plurality of sensors of the same or differing typologies and functions. Each of the transducer and sensor(s) may be affixed to the end of an effector 128, the effector 128 may be similar to or the same as any effector described herein. The effector 128 may be affixed to the end of one or more robotic arms, included in a wearable device.

[0081] The system 600 includes gel 112, the gel 112 may be a gel applicator and / or a gel pad consistent with the disclosure herein. System 600 may be configured to target a target area 116, the target area including a portion of an intervertebral disc. System 600 includes a power source 120, the power source 120 may be a portable power source for home use or a commercially available power source for a medical provider and / or home use.

[0082] System 600 may include a cooling system 604. The cooling system 604 may be configured to lower the temperature of any component described herein, for example the transducer 104 and / or power source 120. Cooling system 604 may be configured as a liquidbased cooling system. The liquid cooling system 604 may include one or more refrigeration systems configured to lower the temperature of a liquid, said liquid passed near a relatively hot component, the liquid heated by the component through induction, convection or another similar methodology. Cooling system 604 may be a configured as an air-based cooling system. The air-based cooling system 604 may include one or more components configured to cool air, akin to a window-based air conditioner. The cooling system 604 may be configured to pass cool air past hotter components, thereby heating the air and extracting said hot air through convection. In various embodiments, cooling system 604 may be formed as one or more fins, the fins affixed to a component that retains relative heat, the heat configured-30-FH13134721.1DCW-00125 to move down the fin and away from the component, such a transducer 104. Cooling system 604 may be a once-through cooling system or a close circuit recirculating system.

[0083] Now referring to FIG. 7, a schematic representation of the ultrasonic spinal disc therapeutic apparatus showing a group of discs with a target area and a data recording system in accordance with the disclosed subject matter is depicted. The system includes components as described herein. The system shown herein is similar to or the same as any system as described herein. System 700 includes transducer 104, which may be the same or similar to any transducer or grouping described herein. System 700 includes sensor 124.Sensor 124 may be a single sensor or a sensor suite working in tandem. The sensor suite may include a plurality of sensors of the same or differing typologies and functions. Each of the transducer and sensor(s) may be affixed to the end of an effector 128, the effector 128 may be similar to or the same as any effector described herein. The effector 128 may be affixed to the end of one or more robotic arms, included in a wearable device.

[0084] The system 700 includes gel 112, the gel 112 may be a gel applicator and / or a gel pad consistent with the disclosure herein. System 700 may be configured to target a target area 116, the target area including a portion of an intervertebral disc. System 700 includes a power source 120, the power source 120 may be a portable power source for home use or a commercially available power source for a medical provider and / or home use.

[0085] The system includes a recorder 132, the recorder 132 configured as described herein. Recorder 132 may communicatively connected to the controller 136 and the apparatus (transducer 104, sensor 124 and effector 128). The recorder 132 configured to store at least one element of data measured by the sensor 124. In various embodiments, recorder 132 is configured to store one or more images captured by ultrasound imaging. In various embodiments, recorder 132 is configured to store video of one or more ultrasound-31-FH13134721.1DCW-00125 imaging sessions. In various embodiment’s, recorder 132 is configured to store one or more thermal images captured via ultrasound thermography.

[0086] In various embodiments, recorder 132 is configured to store one or more temperature measurements of target area 116, surrounding tissue, or another portion of a patient’s body. In various embodiments, recorder 132 is configured to store a plurality of temperatures measured at target area 116 over a period of time. In various embodiments, recorder 132 is configured to store a plurality of temperatures over a period of ultrasonic energy delivery periods. In various embodiments, recorder 132 is configured to store a plurality of temperatures corresponding to time stamped characteristics of ultrasonic energy. In various embodiments, recorder 132 is configured to store changes in ultrasonic energy commands over a period of time, over a period of temperature measurements, or the like. In various embodiments, recorder is configured to store one or more time periods of ultrasonic energy delivery, such as the time elapsed during ultrasonic energy delivery, number of sessions, date of sessions, time of day of sessions, and the like.

[0087] In various embodiments, recorder 132 is configured to store information regarding sessions of ultrasonic energy delivery over a period of time and the temperatures measured during those sessions. For example, recorder 132 may store the temperature over a first 20 minute session on a first day and then also record the temperature over a second 20 minute session on a second day. Recorder 132 may be configured to transmit this data to one or more medical providers, data stores (704), databases, medical records, graphical user interfaces, or the like. Recorder 132 may be configured to store and retrieve data based on an interaction with a user’s smartphone, computer, or the like. Recorder 132 may be electrically connected to one or more components of system 700 such as effector 128, transducer 103, sensor 124, controller 136, power source 120, or any other component via a conductive wire, fiber optic cable, wireless via WIFI or another wireless protocol, or another method not-32-FH13134721.1DCW-00125 described herein. Recorder 132 may be powered by power source 120 or another power source connected thereto, as in a backup power source, battery, or the like. Recorder 132 may be configured to receive and record data in data store 704 remotely from system 700 over an internet or cellular connection.

[0088] Now referring to FIG. 8, a method 800 for ultrasonic degenerative intervertebral disc therapy is shown in flow diagram form. The method 800 includes, at step 805, locating a target area on a body of a patient, the target area corresponding to an intervertebral disc of the patient. The target area may be the same or similar to target area 116. The target area may be a portion of one or more intervertebral discs having undergone damage. The target area 116 may be afflicted with degenerative disc disease. The target area 116 may be damaged from a physical or congenital injury or condition. Locating a target area 116 may include locating via one or more ultrasound images. The ultrasound images may be captured by the same or different transducers as the component emitting the therapeutic ultrasonic energy. Locating the target area 116 may include one or more other imaging methods such as MRI, CAT scan, or the like.

[0089] With continued reference to FIG. 8, method 800 includes, at step 810, aligning a transducer configured to deliver ultrasonic energy with the target area. Aligning a transducer area may include aligning a transducer 104. The transducer 104 may be configured to deliver ultrasonic energy. Aligning the transducer may include aligning the transducer 104 with an arm such as arm 240. Aligning the transducer may include aligning the transducer 104 via one or more locators 108, such as wearable device, holographic map, or clothing item configured to align said transducer. Aligning the transducer 104 may include aligning the transducer 104 to the target area 116 on a patient’s body and toward the side (for unilateral delivery) or angle up or down on the spine. Aligning the transducer 104 may include aligning a bilateral transducer on the body oriented toward the target area 116.-33-FH13134721.1DCW-00125

[0090] With continued reference to FIG. 8, method 800 includes, at step 815, affixing the transducer in a manner suitable to deliver the ultrasonic energy to the target area.Affixing the transducer may include affixing the transducer 104 to a patient’s body via one or more locator 108, such as a wearable device, apparel item or robotic or mechanical arm 240. Affixing the transducer may include affixing the transducer 104 via one or more locators 108, such as wearable device, holographic map, or clothing item configured to affix said transducer to or relative to a patient’s body. Affixing the transducer 104 may include affixing the transducer 104 to the target area 116 on a patient’s body and toward the side (for unilateral delivery) or angle up or down on the spine. Affixing the transducer 104 may include affixing a bilateral transducer on the body oriented toward the target area 116.

[0091] With continued reference to FIG. 8, method 800 includes, at step 820, monitoring a temperature of the target area via at least one sensor configured to measure the temperature of the target area. Monitoring the temperature of the target area 116 may include monitoring the temperature of the target area via one or more ultrasonic imaging probes.Monitoring the temperature of the target area 116 may include monitoring the temperature of the target area via one or more other types of sensors such as an infrared thermometer. Monitoring the temperature of the target area 116 may include monitoring the temperature relative to a predetermined temperature threshold. Monitoring the temperature of the target area 116 may include monitoring the temperature relative to a predetermined temperature floor value.

[0092] With continued reference to FIG. 8, method 800 includes, at step 825, delivering the ultrasonic energy to the target area. Delivering the ultrasonic energy to the target area 116 may include utilizing one or more transducers as described herein. Delivering the ultrasonic energy to the target area 116 may include utilizing a focusable, steerable or unfocusable transducer or plurality of transducers as described herein. Delivering the-34-FH13134721.1DCW-00125 ultrasonic energy may include delivering ultrasonic energy to one or more affected discs affected by one or more conditions, injuries or degenerative disc disease. Delivering the ultrasonic energy may include delivering the ultrasonic energy to the target area 116 includes delivering the ultrasonic energy for at least 20 minutes in a session, in a day, in a week, or over another period of time. Delivering the ultrasonic energy may include delivering the ultrasonic energy to the target area 116 comprises delivering the ultrasonic energy for at least 20 minutes, once a day for about 3-5 days. Delivering the ultrasonic energy may include delivering the ultrasonic energy posteriorly and bilaterally. The ultrasonic energy may be delivered by one or more bilateral transducers or a grouping a transducers. Delivering the ultrasonic energy may include delivering the ultrasonic energy posteriorly and unilaterally. The ultrasonic energy may be delivered by one or more unilateral transducers or consecutively aligned and affixed transducers. Delivering the ultrasonic energy may include adjusting the ultrasonic energy based on the temperature detected by the at least one sensor and / or one or more ultrasonic imaging probes.

[0093] It should be understood that the methods and systems described herein may be applied for other treatments, including but not limited to, bacterial infection eradication, calcium deposit management, bone spur (e.g., myositis ossificans, joint mice) treatment, enhancement of circulation, desensitization, inflammation control (e.g., inflammation control for carpal tunnel), insect bite neutralization, and / or wound healing. In some embodiments, the target area may be a region of the patient’s body with a bacterial infection. In some embodiments, the target area may be a region of the patient’s body having calcium deposits. In some embodiments, the target area may be a region of the patient’s body with inadequate circulation. In some embodiments, the target area may be a nerve, nerve tissue, and / or hypersensitive tissues. In some embodiments, the target area may be a region of the patient’s body having inflammation and / or pain (e.g., a wrist of a patient with carpal tunnel). In some-35-FH13134721.1DCW-00125 embodiments, the target area may be a region of the patient’s body with an insect bite and / or displaying swelling as result of an insect bite. In some embodiments, the target area may be a region of the patient’s body having a wound.

[0094] As shown in FIG. 9, computer system / server 912 in computing node 910 is shown in the form of a general-purpose computing device. The components of computer system / server 912 may include, but are not limited to, one or more processors or processing units 916, a system memory 928, and a bus 918 that couples various system components including system memory 928 to processor 916.

[0095] Bus 918 represents one or more of any of several types of bus structures, including a memory bus or memory controller, a peripheral bus, an accelerated graphics port, and a processor or local bus using any of a variety of bus architectures. By way of example, and not limitation, such architectures include Industry Standard Architecture (ISA) bus, Micro Channel Architecture (MCA) bus, Enhanced ISA (EISA) bus, Video Electronics Standards Association (VESA) local bus, Peripheral Component Interconnect (PCI) bus, Peripheral Component Interconnect Express (Pie), and Advanced Microcontroller Bus Architecture (AMBA).

[0096] Computer system / server 912 typically includes a variety of computer system readable media. Such media may be any available media that is accessible by computer system / server 912, and it includes both volatile and non-volatile media, removable and nonremovable media.

[0097] System memory 928 can include computer system readable media in the form of volatile memory, such as random access memory (RAM) 930 and / or cache memory 932. Computer system / server 912 may further include other removable / non-removable, volatile / non-volatile computer system storage media. By way of example only, storage system 934 can be provided for reading from and writing to a non-removable, non-volatile-36-FH13134721.1DCW-00125 magnetic media (not shown and typically called a "hard drive"). Although not shown, a magnetic disk drive for reading from and writing to a removable, non-volatile magnetic disk (e.g., a "floppy disk"), and an optical disk drive for reading from or writing to a removable, non-volatile optical disk such as a CD-ROM, DVD-ROM or other optical media can be provided. In such instances, each can be connected to bus 918 by one or more data media interfaces. As will be further depicted and described below, memory 928 may include at least one program product having a set (e.g., at least one) of program modules that are configured to carry out the functions of embodiments of the disclosure.

[0098] Program / utility 940, having a set (at least one) of program modules 942, may be stored in memory 928 by way of example, and not limitation, as well as an operating system, one or more application programs, other program modules, and program data. Each of the operating system, one or more application programs, other program modules, and program data or some combination thereof, may include an implementation of a networking environment. Program modules 942 generally carry out the functions and / or methodologies of embodiments as described herein.

[0099] Computer system / server 912 may also communicate with one or more external devices 914 such as a keyboard, a pointing device, a display 924, etc.; one or more devices that enable a user to interact with computer system / server 912; and / or any devices (e.g., network card, modem, etc.) that enable computer system / server 912 to communicate with one or more other computing devices. Such communication can occur via Input / Output (RO) interfaces 922. Still yet, computer system / server 912 can communicate with one or more networks such as a local area network (LAN), a general wide area network (WAN), and / or a public network (e.g., the Internet) via network adapter 920. As depicted, network adapter 920 communicates with the other components of computer system / server 912 via bus 918. It should be understood that although not shown, other hardware and / or software components-37-FH13134721.1DCW-00125 could be used in conjunction with computer system / server 912. Examples, include, but are not limited to: microcode, device drivers, redundant processing units, external disk drive arrays, RAID systems, tape drives, and data archival storage systems, etc.

[0100] Exemplary housing assembly for transducer and gel pad

[0101] Now referring to FIGS. 10A-10B and 11 A-l IB, views of a housing assembly for holding a transducer and gel pad are shown (FIGS. 20-27 are additional views of an exemplary embodiment). The housing assembly 1100 includes a transducer housing 1102 and a gel pad housing 1103. The transducer housing 1102 and gel pad housing 1103 further comprising a transducer 1101 and gel pad 1104, respectively, disposed within. FIG. 17 shows an example of electronic equipment (including a single channel arbitrary function generator and power amplifier) used to drive transducers by providing the electrical signal necessary to generate and modify the ultrasound waves. FIGS. 18A-18B and 19A-19B show examples of transducers used. The transducer housing 1102 and the gel pad housing 1103 are generally cylindrically shaped with their perimeters substantially aligned (e.g. equivalent outer diameters) when assembled to build the housing assembly 1100. The transducer housing 1102 is a cylindrical shell (or “puck”) with a first end 1108 that comprises a solid surface and a second end 1110 that comprises an open end. The first end 1108 and second end 1110 are oriented perpendicular to the longitudinal axis of the transducer housing 1102. The transducer housing 1102 can also include a slot 1111 through which the cable of the transducer can extend through. In this way, the cable can move freely within the slot to bend and flex naturally during positioning and maneuvering of the housing assembly 1100. The gel pad housing 1103 is a cylindrical shell with a first end 1112 oriented perpendicular to the longitudinal axis of the gel pad housing 1103 and parallel with the second end 1110 of the transducer housing 1102. A second end 1109 of the gel pad housing 1103 comprises an open end through which a gel pad 1104 can extend through. The second end 1109 can be angled or-38-FH13134721.1DCW-00125 slanted with respect to the first end 1112. The angle of the second end 1109 can correspond to the angled surface of the gel pad 1104 extending through the second end 1109. For purposes of illustration and not limitation, the angle of the second end 1109 can be approximately 30 degrees ~ 60 degrees (e.g. 45 degrees) with respect to the horizontal plane (oriented parallel to the bottom surface 1112).

[0102] The first end 1112 of the gel pad housing 1103 is proximal to the second end 1110 of the transducer housing 1102. The transducer housing 1102 and the gel pad housing 1103 are coupled to each other at one or more connections 1107 positioned radially around the perimeters of the two housings. A coupling element disposed between the transducer housing 1102 and the gel pad housing 1103 form the connections 1107 thereof. In some embodiments, the first end 1112 of the gel pad housing 1103 and the second end 1110 of the transducer housing 1102 are spaced a distance apart. In other embodiments, the first end 1112 of the gel pad housing 1103 and the second end 1110 of the transducer housing 1102 are flush against each other. The distance between the first end 1112 and the second end 1110 can depend on the coupling element or the height of the transducer used.

[0103] The transducer housing 1102 and gel pad housing 1103 further include protrusions 1105 and 1106, respectively, that are aligned with the longitudinal axis of the each of the housings and arranged radially around the perimeters of each of the housings. As shown in cross-sectional view (FIG. 10B) and drawings views (FIG. 11A-1 IB), the transducer housing 1102 comprises at least one through-channel 1113a, defining a passage for a connection element, and disposed within a protrusion 1105. The through-channel 113a is colinear with the longitudinal axis of the transducer housing 1102.The gel pad housing 1103 comprises at least one channel 1113b, defining a passage for a connection element, and disposed within a protrusion 1106. The at least one channel 1113b extends colinear with the-39-FH13134721.1DCW-00125 longitudinal axis of the gel pad housing 1103 from the first end 1112 through at least a portion of a thickness of the gel pad housing 1103.

[0104] Connection elements can be fasteners (e.g., screws, nuts, bolts) which can be inserted through the through-channel 1113a and the channel 1113b to form a connection 1107 between the transducer housing 1102 and the gel pad housing 1103. In some embodiments, the transducer housing 1102 and gel pad housing 1103 are connected with magnets. Magnets can be embedded at one end of each of the housings so that when the housings are brought close together, the magnets attract each and form a connection 1107. In other embodiments, the transducer 1102 and gel pad housing 1103 include threaded features such that the helical ridges of one housing mesh with the grooves of the other housing and form a threaded connection. In further embodiments, the transducer 1102 and gel pad housing 1103 further comprise interlocking joints. In other words, the housings have complementary shapes or features such as dovetail joints, tongue-and-groove joints, and mortise-and-tenon joints. Various other coupling mechanisms can be used to connect the transducer housing 1102 and gel pad housing 1103 such as snap-fit connections, clip connections, adhesives, and click- and-release mechanisms.

[0105] To assemble the housing, the transducer 1101 is inserted into the transducer housing 1102. In following, the gel pad 1104 can be inserted into the gel pad housing 1103 and the housings can be coupled. Alternatively, the transducer housing 1102 holding the transducer 1101 can be coupled to the gel pad housing 1103 before inserting the gel pad 1104.

[0106] Now referring to FIGS. 12A-12C, views of a housing assembly for holding a transducer and gel pad are shown. The housing assembly 1200 includes a transducer housing 1102 and a gel pad housing 1103. The transducer housing 1102 and gel pad housing 1103 further comprising a transducer 1101 and gel pad 1104, respectively, disposed within. The-40-FH13134721.1DCW-00125 transducer housing 1102 and the gel pad housing 1103 are generally cylindrically shaped with their perimeters substantially aligned when assembled to build the housing assembly 1200. The transducer housing 1102 is a cylindrical shell with a first end 1108 that comprises a solid surface and a second end 1110 that comprises an open end. The first end 1108 and second end 1110 are oriented perpendicular to the longitudinal axis of the transducer housing 1102. The first end 1108 further comprises an opening 1202 positioned at the radial center of the base through which through which the cable of the transducer can pass through. In this way, the cable can move freely within the slot to bend and flex naturally during positioning and maneuvering of the housing assembly 1200 The gel pad housing 1103 is a cylindrical shell with a first end 1112 oriented perpendicular to the longitudinal axis of the gel pad housing 1103 and parallel with the second end 1110 of the transducer housing 1102. A second end 1109 of the gel pad housing 1103 comprises an open end through which a gel pad 1104 can extend through. The second end 1109 can be angled or slanted with respect to the first end 1112. The angle of the second end 1109 can correspond to the angled surface of the gel pad 1104 extending through the second end 1109.

[0107] The first end 1112 of the gel pad housing 1103 is proximal to the second end 1110 of the transducer housing 1102. The transducer housing 1102 and the gel pad housing 1103 are coupled to each other at one or more connections 1107 positioned radially around the perimeters of the two housings. A coupling element disposed between the transducer housing 1102 and the gel pad housing 1103 form the connections 1107 thereof. In some embodiments, the first end 1112 of the gel pad housing 1103 and the second end 1110 of the transducer housing 1102 are spaced a distance apart. In other embodiments, the first end 1112 of the gel pad housing 1103 and the second end 1110 of the transducer housing 1102 are flush against each other. The distance between the first end 1112 and the second end 1110 can depend on the coupling element or the height of the transducer used.-41-FH13134721.1DCW-00125

[0108] The transducer housing 1102 and gel pad housing 1103 further include protrusions 1105 and 1106, respectively, that are aligned with the longitudinal axis of the each of the housings and arranged radially around the perimeters of each of the housings. As shown in cross-sectional view (FIG. 12B) and drawings views (FIG. 12C), the transducer housing 1102 comprises at least one through-channel 1113a, defining a passage for a connection element, and disposed within a protrusion 1105. The through-channel 113a is colinear with the longitudinal axis of the transducer housing 1102. The gel pad housing 1103 comprises at least one channel 1113b, defining a passage for a connection element, and disposed within a protrusion 1106. The at least one channel 1113b extends colinear with the longitudinal axis of the gel pad housing 1103 from the first end 1112 through at least a portion of a thickness of the gel pad housing 1103. Connection elements can be fasteners (e.g., screws, nuts, bolts) which can be inserted through the through-channel 1113a and the channel 1113b to form a connection 1107 between the transducer housing 1102 and the gel pad housing 1103.

[0109] It should also be understood that the transducer housing 1102 and gel pad housing 1103 can be other shapes which can depend on the geometry of the transducer 1101 and the gel pad 1104 introduced into the housings.

[0110] It should be understood that the transducer housing 1102 can comprise any number of slots and / or openings positioned at the radial center or off radial center of the first end 1108 of the transducer housing 1102 or positioned on the lateral surface of the transducer housing 1102. The location of a slot or opening may depend on the location of the cable connection of the transducer so that the cable of the transducer extends through the slot or opening. The slots or openings can be sized and shaped to accommodate wires, cables of different diameters, or other members extending from the transducer.-42-FH13134721.1DCW-00125

[0111] In some embodiments of the housing assembly, an individual may receive one treatment. A treatment is considered to be the continuous operation of the housing assembly over the targeted area. In some operations of the housing assembly, an individual may receive a number of treatments. Depending on the duration of the treatment and / or the driving voltage of the transducer, there may be heat emitted by the transducer which is conducted through the gel pad and to the skin of the individual. The heat can serve a therapeutic purpose and provide various beneficial therapeutic outcomes such as cell growth or anti-inflammatory effects. The references in the Appendix provide descriptions of the methods of treatment and therapeutic outcomes associated with different treatment regimens.

[0112] In some embodiments of the housing assembly, prolonged use of the transducer and a high driving voltage can dissipate significant amounts of heat which can be uncomfortable or painful for the individual undergoing the treatment. Integrating a cooling system can help regulate temperature gradients within the housing assembly and across the transducer 1101 and gel pad 1104. In some embodiments, openings or vents on the housing assembly can facilitate heat dissipation from the transducer. In other embodiments, the housing assembly can further comprise a cooling system. The cooling system can be configured to lower the temperature of any component or region of the housing assembly (e.g., transducer 1101, gel pad 1104, transducer housing 1102, gel pad housing 1103, power source of the transducer). In some embodiments, the cooling system is a liquid cooling system. The liquid cooling system may include one or more refrigeration systems configured to lower the temperature of a liquid in which the liquid is passed near a relatively hot region of the housing assembly. In some embodiments, liquid can be stored in a reservoir external to the housing assembly and subsequently flowed through the housing assembly and recirculated through the refrigeration system to cool the liquid before recirculating the fluid (i.e., a closed circuit recirculating cooling system). In other embodiments, the cooling system-43-FH13134721.1DCW-00125 is a once-through cooling system in which the liquid that flows through the housing assembly is discarded (e.g., discarded in a waste reservoir) after exiting the housing assembly. The liquid is heated by induction, convection, or another method of heating. By way of example, the housing assembly can include one or more channels disposed within the housing assembly (disposed within at least one of the individual housings, the transducer housing 1102 and the gel pad housing 1103) and in liquid communication with each other, in which one or more channels are in liquid communication with at least two openings of the housing assembly. The at least two openings of the housing define an inlet and outlet for a liquid, such as water or a coolant, to enter the housing, flow through the channels, and exit the housing. The inlet and outlet can each further comprise a connector for attaching a liquid line such as a tube. In operation, a pump can be used to flow liquid through the inlet of the housing assembly and through the one or more channels, and exiting through the outlet. Prior to entering the inlet, the liquid can be cooled using a refrigeration system.

[0113] In still other embodiments, the cooling system is an air-cooling system. In those embodiments, the housing assembly can include fans to convect hot air away from the housing assembly and the skin of the individual. The housing assembly can include one or more openings that are vents where one or more fans can be affixed to. In some embodiments, vents and fans are on the first end 1108 of the housing assembly. The one or more fans are oriented to blow air away from the interior of the housing assembly.

[0114] In further embodiments, the cooling system includes one or more fins, in which the fins are affixed to components that retain heat. Other cooling systems are possible such as heat sinks or Peltier cooling systems. In some embodiments, a combination of multiple cooling systems can be integrated with the housing assembly. For example, a Peltier cooling system can be used with a fan to blow cool air over hot regions of the housing assembly, heating the air, and removing the hot air through convection. In some-44-FH13134721.1DCW-00125 embodiments, thermal management materials, such as phase change materials or thermal pads, can be incorporated in the transducer to absorb, and redistribute heat.

[0115] In some embodiments, the housing assembly can further include a temperature monitoring system. In some embodiments, the housing assembly can include one or more temperature sensors to monitor the temperature throughout operation. In some embodiments, the cooling system of the housing assembly is responsive to the temperature recorded by the temperature sensors. In those embodiments, the cooling system is triggered by the temperature sensor and the settings (e.g., flow rate, voltage) of the cooling system can be automatically adjusted. In other embodiments, the operator of the housing assembly can manually adjust the settings of the cooling system.

[0116] Now referring to FIGS. 13A-13D, images of a housing assembly for a transducer and gel pad are shown. As shown in FIG. 13 A, the transducer housing 1102 can comprise an opening 1301 and a slot 1302. The housing assembly can be sized and shaped to fit within a hand of an individual. In some operations of the housing assembly, the housing assembly can be manually positioned over the skin of the targeted area of an individual and held in place for contact with the skin. In some embodiments, an articulated arm holds the housing assembly and maneuvers it to the targeted area and applies an amount of pressure to keep the housing assembly in place during operation. The targeted area of an individual can be determined by ultrasound to determine the segment of the spine where the housing assembly should be positioned over.

[0117] Exemplary gel pad

[0118] Now referring to FIGS. 14A-14B, images of a gel pad are shown. The gel pad 1104 is a soft deformable material that is made of water-based gels, which can be formed of a mixture of water, glycerin, and polypropylene glycol. The water-based gel pad can additionally include thickeners, stabilizers, or preservatives. The gel pad is formulated to-45-FH13134721.1DCW-00125 have properties that are conducive to ultrasound waves, such as acoustic transparency, adhesiveness, and minimal air bubbles. As shown in FIGS. 14A-14B, the gel pad 1104 includes a first end 1401 and a second end 1402 in which the first end 1401 is perpendicular to the longitudinal axis of the gel pad 1104 and the second end 1402 is angled with respect to the first end 1401. In operation, the first end 1401 of the gel pad 1104 is disposed within the gel pad housing 1103 such that the first end 1401 is in direct contact with the transducer 1110 and the second end 1402 of the gel pad 1104 (i.e., the angled end of the gel pad 1104) at least partially extends from the second end 1109 of the gel pad housing 1103. In this way, the second end 1402 of the gel pad 1104 can be pressed against the patient’s skin and be in direct contact with the surface anatomy corresponding to the target area.

[0119] In some embodiments, the second end 1402 is also perpendicular to the longitudinal axis of the gel pad. In other embodiments, the second end 1402 is angled with respect to the first end 1401 and has an angle of approximately 30 degrees. In still other embodiments, the second end 1402 is angled with respect to the first end 1401 and has an angle between 20 and 45 degrees. An angled surface can offer several benefits such as improved acoustic coupling, focused or targeted delivery of the ultrasound waves, consistent energy transmission, minimize reflections, and optimize energy absorption of ultrasound waves by target tissues. An angled surface can help ensure optimal contact and acoustic coupling between the gel pad and skin thus reducing energy loss so that the ultrasound waves are delivered consistently to the intended target. In addition, an angled surface can minimize air pockets or gaps between the gel pad and skin which can interfere with the transmission of ultrasound waves.

[0120] Exemplary gel pad housing

[0121] Now referring to FIGS. 15A-15D, views of a gel pad housing are shown. The gel pad housing 1103 is generally a cylindrical shell with a first end 1502 and second end-46-FH13134721.1DCW-001251503, in which the second end 1503 is an open end with a diameter large enough for a gel pad 1104 to extend through. The gel pad housing 1103 further includes a surface 1501 disposed within the gel pad housing 1103 that has an adjustable pitch.

[0122] The surface 1501 is shaped and sized to fit within the housing 1103 such that there is a gap tolerance between the surface 1501 and the interior of the housing 1103 for the pitch of the surface 1501 to be adjusted. The pitch of the surface 1501 can be adjusted to enable the housing 1103 to accommodate different gel pads 1104, which can have a second end 1402 with various angles, including a horizontal surface. The gel pad 1104 is deformable such that the pitch of the surface 1501 can be adjusted to an angle which may be different than the angle surface of the gel pad. In some embodiments, the surface 1501 comprises a hinge, pivot, or other articulating component to tilt the surface.

[0123] Now referring to FIGS. 15E-15F, views of a gel pad housing are shown. The gel pad housing 1103 is a cylindrical shell with a first end 1502 oriented perpendicular to the longitudinal axis of the gel pad housing 1103 and a second end 1503 comprising an open end through which a gel pad 1104 can extend through and the second end 1503. The solid surface on the first end 1502 can be formed of a material that facilitates acoustic coupling between the transducer 1101 and the gel pad 1104. The solid surface on the first end 1502 can be formed of a material that has various properties including acoustic transparency, uniform density and composition. In addition, the solid surface on the first end 1502 can be a smooth flat surface to ensure uniform contact (i.e., minimal air pockets from irregular surfaces or roughness of the surface) between the transducer 1101 and the gel pad 1104.

[0124] Exemplary transducer housing

[0125] Now referring to FIGS. 16A-16C, views of a transducer housing are shown. The transducer housing 1102 is generally a cylindrical shell with a first end 1601 and a second end 1602, in which the first end 1601 is an open end with a diameter large enough for-47-FH13134721.1DCW-00125 a transducer 1101 to be inserted into and the second end 1602 comprises a solid surface. The first end 1601 and second end 1602 are oriented perpendicular to the longitudinal axis of the transducer housing 1102. The transducer housing 1102 can further include an opening 1603 on the second end 1602. In some embodiments, the opening 1603 can be on the lateral surface of the transducer housing 1102. The location of the opening 1603 may depend on the location of the cable connection of the transducer so that the cable of the transducer extends through the opening 1603.

[0126] With continued reference to FIGS. 16A-16C and additional reference to FIGS. 15E-15F, the first end 1601 of the transducer housing 1102 can be coupled with the first end 1502 of the gel pad housing 1103 to build the housing assembly. Various coupling mechanisms can be used to couple the transducer housing and the gel pad housing including fasteners (e.g., screws, nuts, bolts), magnets, clips, snap-fit connections, adhesives, or click- and-release mechanisms. In some embodiments, the transducer 1102 and gel pad housing 1103 include threaded features such that the helical ridges of one housing mesh with the grooves of the other housing and form a threaded connection. In other embodiments, the transducer 1102 and gel pad housing 1103 further comprise interlocking joints. In other words, the housings have complementary shapes or features such as dovetail joints, tongue- and-groove joints, and mortise-and-tenon joints.

[0127] Referring now to FIGS. 29A - 29E, plots of different subjects who underwent treatment using the ultrasonic spinal stimulation therapeutic apparatus are shown. The plots illustrate the change in reported leg pain over a series of clinical visits and subsequent followup evaluation. The horizontal axis corresponds to six discrete time points: a first visit, a second visit, a third visit, and three post-treatment follow-up assessments conducted at approximately seven, fourteen, and thirty days after the last treatment. For each visit, both-48-FH13134721.1DCW-00125 pre-treatment and post-treatment leg pain scores are recorded using a numerical pain scale (e.g., 0 indicating no pain and 10 indicating maximal pain).

[0128] As shown in FIGS. 29A - 29E, a reduction in leg pain is generally observed immediately following a treatment session, indicating a short-term therapeutic effect of the ultrasonic spinal stimulation. Furthermore, the pain scores reported at the follow-up evaluations remain reduced relative to the first visit pre-treatment assessment, demonstrating a durable long-term benefit. Repeated administration of the treatment can produce both immediate relief and sustained improvement in leg pain symptoms.

[0129] The present disclosure may be embodied as a system, a method, and / or a computer program product. The computer program product may include a computer readable storage medium (or media) having computer readable program instructions thereon for causing a processor to carry out aspects of the present disclosure.

[0130] The computer readable storage medium can be a tangible device that can retain and store instructions for use by an instruction execution device. The computer readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. A non- exhaustive list of more specific examples of the computer readable storage medium includes the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), a static random access memory (SRAM), a portable compact disc read-only memory (CD-ROM), a digital versatile disk (DVD), a memory stick, a floppy disk, a mechanically encoded device such as punch-cards or raised structures in a groove having instructions recorded thereon, and any suitable combination of the foregoing. A computer readable storage medium, as used herein, is not to be construed as being transitory signals per-49-FH13134721.1DCW-00125 se, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide or other transmission media (e.g., light pulses passing through a fiber-optic cable), or electrical signals transmitted through a wire.

[0131] Computer readable program instructions described herein can be downloaded to respective computing / processing devices from a computer readable storage medium or to an external computer or external storage device via a network, for example, the Internet, a local area network, a wide area network and / or a wireless network. The network may comprise copper transmission cables, optical transmission fibers, wireless transmission, routers, firewalls, switches, gateway computers and / or edge servers. A network adapter card or network interface in each computing / processing device receives computer readable program instructions from the network and forwards the computer readable program instructions for storage in a computer readable storage medium within the respective computing / processing device.

[0132] Computer readable program instructions for carrying out operations of the present disclosure may be assembler instructions, instruction-set-architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, state-setting data, or either source code or object code written in any combination of one or more programming languages, including an object oriented programming language such as Smalltalk, C++ or the like, and conventional procedural programming languages, such as the “C” programming language or similar programming languages. The computer readable program instructions may execute entirely on the user’s computer, partly on the user’s computer, as a stand-alone software package, partly on the user’s computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user’s computer through any type of network, including a local area network (LAN) or a wide area network-50-FH13134721.1DCW-00125(WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider). In some embodiments, electronic circuitry including, for example, programmable logic circuitry, field-programmable gate arrays (FPGA), or programmable logic arrays (PLA) may execute the computer readable program instructions by utilizing state information of the computer readable program instructions to personalize the electronic circuitry, in order to perform aspects of the present disclosure.

[0133] Aspects of the present disclosure are described herein with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the disclosure. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer readable program instructions.

[0134] These computer readable program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks. These computer readable program instructions may also be stored in a computer readable storage medium that can direct a computer, a programmable data processing apparatus, and / or other devices to function in a particular manner, such that the computer readable storage medium having instructions stored therein comprises an article of manufacture including instructions which implement aspects of the function / act specified in the flowchart and / or block diagram block or blocks.

[0135] The computer readable program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of-51-FH13134721.1DCW-00125 operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer implemented process, such that the instructions which execute on the computer, other programmable apparatus, or other device implement the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0136] The flowchart and block diagrams in the Figures illustrate the architecture, functionality, and operation of possible embodiments of systems, methods, and computer program products according to various embodiments of the present disclosure. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of instructions, which comprises one or more executable instructions for implementing the specified logical function(s). In some alternative embodiments, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and / or flowchart illustration, and combinations of blocks in the block diagrams and / or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts or carry out combinations of special purpose hardware and computer instructions.

[0137] While the disclosed subject matter is described herein in terms of certain preferred embodiments, those skilled in the art will recognize that various modifications and improvements may be made to the disclosed subject matter without departing from the scope thereof. Moreover, although individual features of one embodiment of the disclosed subject matter may be discussed herein or shown in the drawings of the one embodiment and not in other embodiments, it should be apparent that individual features of one embodiment may be combined with one or more features of another embodiment or features from a plurality of embodiments.-52-FH13134721.1DCW-00125

[0138] In addition to the specific embodiments claimed below, the disclosed subject matter is also directed to other embodiments having any other possible combination of the dependent features claimed below and those disclosed above. As such, the particular features presented in the dependent claims and disclosed above can be combined with each other in other manners within the scope of the disclosed subject matter such that the disclosed subject matter should be recognized as also specifically directed to other embodiments having any other possible combinations. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosed subject matter to those embodiments disclosed.It will be apparent to those skilled in the art that various modifications and variations can be made in the method and system of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter include modifications and variations that are within the scope of the appended claims and their equivalents.-53-FH13134721.1

Claims

DCW-00125CLAIMSWhat is claimed is:

1. A system for ultrasonic degenerative disc therapy, the system comprising: an apparatus comprising: a locator, the locator configured to locate a target area on a body of a patient; a gel applicator, the gel applicator configured to position a gel at the target area; an effector, the effector comprising: a transducer, the transducer configured to generate ultrasonic energy to the target area; and at least one sensor, the at least one sensor configured to detect a temperature of the target area; a controller, the controller communicatively connected to the apparatus, the controller configured to provide at least one control signal to the apparatus; a power source electrically connected to the controller and the apparatus, the power source configured to provide electrical energy to at least the controller and the apparatus; and a recorder, the recorder communicatively connected to the controller and the apparatus, the recorder configured to store at least one element of data measured by the sensor.

2. The apparatus of claim 1, wherein the locator comprises a wearable component, the wearable component configured to attach to the body of the patient.

3. The apparatus of claim 2, wherein the locator is configured to attach to the effector, the locator configured to direct the effector to deliver ultrasonic energy to the target area.-54-FH13134721.1DCW-001254. The apparatus of claim 1, wherein the effector is configured to capture at least one image of the target area via the ultrasonic energy.

5. The apparatus of claim 4, wherein the locator is configured to attach the effector to a target area of the body based on the image of the effector.

6. The apparatus of claim 1, wherein the effector is attached to an arm, the arm comprising a first end and a second end, defining a maneuverable length therebetween, the effector attached to the second end of the arm.

7. The apparatus of claim 6, wherein the arm is configured with at least one joint, the at least one joint configured to hold a relative position of the arm.

8. The apparatus of claim 1, wherein the effector is configured to deliver ultrasonic energy posteriorly and bilaterally.

9. The apparatus of claim 1, wherein the effector is configured to deliver ultrasonic energy posteriorly and unilaterally.

10. The apparatus of claim 1, wherein the transducer is configured to be focusable.

11. The apparatus of claim 1, wherein the transducer comprises an annular phased array, the annular phased array comprising at least two concentric rings, each ring configured to transmit ultrasonic energy.

12. The apparatus of claim 11, wherein the transducer is configured to deliver steerable ultrasonic energy, the transducer configured to alter at least a path of the ultrasonic energy.

13. The apparatus of claim 1, wherein the apparatus further comprises a cooling system, the cooling system configured to cool the transducer.

14. The apparatus of claim 1, wherein the gel applicator comprises a gel pad configured to be affixed to the target area on a first side and the transducer on second side, defining a gel thickness therebetween, the gel configured to enhance targeting and navigation of the ultrasonic energy to the intervertebral disc.-55-FH13134721.1DCW-0012515. A method for intervertebral disc therapy, the method comprising: locating a target area on a body of a patient, the target area corresponding to a intervertebral disc of the patient; aligning a transducer configured to deliver ultrasonic energy with the target area; affixing the transducer in a manner suitable to deliver the ultrasonic energy to the target area; monitoring a temperature of the target area via at least one sensor configured to measure the temperature of the target area; and delivering the ultrasonic energy to the target area.

16. The method of claim 15, wherein delivering the ultrasonic energy to the target area comprises delivering the ultrasonic energy for at least 20 minutes.

17. The method of claim 16, wherein delivering the ultrasonic energy to the target area comprises delivering the ultrasonic energy for at least 20 minutes, once a day for about 3-5 days.

18. The method of claim 15, wherein delivering the ultrasonic energy further comprises delivering the ultrasonic energy posteriorly and bilaterally.

19. The method of claim 15, wherein delivering the ultrasonic energy further comprises delivering the ultrasonic energy posteriorly and unilaterally.

20. The method of claim 15, further comprising adjusting the ultrasonic energy based on the temperature detected by the at least one sensor.

21. A system for ultrasonic degenerative disc therapy, the system comprising: a housing assembly, the housing assembly comprising: a transducer housing, the transducer housing generally a cylindrical shell and having a first end with a solid surface and an open end at a second end, the first end-56-FH13134721.1DCW-00125 and the second end oriented perpendicular to the longitudinal axis of the transducer housing; a gel pad housing, the gel pad housing generally a cylindrical shell and having a first end and a second end, the first end oriented perpendicular to the longitudinal axis of the gel pad housing and the second end oriented at an angle with respect to the first end; the first end of the gel pad housing proximal to the second end of the transducer housing, wherein a coupling element disposed between the transducer housing and the gel pad housing forms a connection thereof.

22. The system of claim 21, further comprising a transducer disposed within the transducer housing, the transducer configured to generate and transmit ultrasonic energy to the target area.

23. The system of claim 21, further comprising a gel pad disposed within the gel pad housing.

24. The system of claim 23, wherein the gel pad comprises a first end and a second end, the first end oriented perpendicular to a longitudinal axis of the gel pad and the second end angled with respect to the first end.

25. The system of claim 1, the transducer housing further comprising an opening for a cable of the transducer to extend through.

26. The system of claim 1, the gel pad housing further comprising a surface disposed within the gel pad housing, the surface having an adjustable pitch.

27. The system of claim 1, the housing assembly further comprising a cooling system.

28. The system of claim 27, the cooling system a liquid based cooling system.

29. The system of claim 28, the housing assembly comprising one or more channels in fluid communication with an inlet and an outlet of the housing assembly.-57-FH13134721.1DCW-0012530. The system of claim 1, the transducer housing comprising at least one through-channel, the through-channel defining a passage for a fastener, the through-channel colinear with the longitudinal axis of the transducer housing.

31. The system of claim 30, the gel pad housing further comprising at least one channel defining a passage for the fastener; the channel extending from the first end through at least a portion of a thickness of the gel pad housing.FH13134721.1

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