A system and method for applying acoustic wave therapy through epithelia
The system addresses the invasiveness of existing eye treatments by using acoustic waves to soften and enhance tissue elasticity, offering a noninvasive solution for conditions like presbyopia, cataracts, and glaucoma.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- SHOCKWAVE MEDICAL INC
- Filing Date
- 2025-10-14
- Publication Date
- 2026-04-30
AI Technical Summary
Existing treatments for eye conditions such as presbyopia, cataracts, age-related macular degeneration, dry eye, glaucoma, and keratoconus are invasive, risky, or require constant application, necessitating a need for noninvasive alternatives.
A treatment apparatus and medical system that delivers acoustic waves through an epithelium using an interface and acoustic wave emitter to target ocular tissue, reducing hardness and improving elasticity.
The system provides a less invasive treatment by softening ocular tissue, improving flexibility, and enhancing fluid drainage, thus addressing various eye conditions effectively.
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Figure US2025050977_30042026_PF_FP_ABST
Abstract
Description
A SYSTEM AND METHOD FOR APPLYING ACOUSTIC WAVE THERAPY THROUGH EPITHELIACROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application claims priority and benefit under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 712,092, filed October 25, 2024, and entitled “A SYSTEM AND METHOD FOR APPLYING ACOUSTIC WAVE THERAPY TO OCULAR TISSUE.” The disclosure of the prior Application is considered part of and is incorporated by reference in this Patent Application.FIELD OF THE DISCLOSURE
[0002] The present disclosure relates generally to the field of medical devices and methods, and more specifically to systems and methods for applying acoustic wave therapy through epithelia.BACKGROUND
[0003] Hardening of biological tissue can cause, or at least contribute to, various health conditions. For example, the hardening of ocular tissue can contribute to presbyopia, cataracts, age-related macular degeneration, dry eye, glaucoma, and various other eye conditions. Specifically, lens tissue tends to harden over time, which often leads to presbyopia as the lens loses elasticity and flexibility to focus on nearby objects. A cataract is a clouding of the lens often accompanied by hardening of the lens tissue. Glaucoma is a group of eye conditions, often associated with ocular hypertension, which result in irreversible damage to the optic nerve. Hardening or blockage of the sclera, zonules, and trabecular meshwork can contribute to poor drainage of ocular fluid and ocular hypertension. Keratoconus is an eye condition where the cornea bulges into a cone shape leading to vision problems.
[0004] Existing treatments for various eye conditions include surgery (such as refractive surgery, lens replacement surgery, laser trabeculoplasty, or corneal crosslinking), medication (such as prescription eye drops or oral medications), and refractive correction devices (such as eyeglasses, contact lenses, or implants). Refractive correctiondevices can be cumbersome to wear and, like medications, require constant and / or perpetual use or application. On the other hand, surgery carries a high degree of risk and is often used only when medications are not effective. Thus, there is a need for noninvasive (or less invasive) treatments for eye conditions that do not require constant or perpetual application.SUMMARY
[0005] This Summary is provided to introduce in a simplified form a selection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter.
[0006] One innovative aspect of the subject matter of this disclosure can be implemented in a treatment apparatus. The treatment apparatus includes an interface configured to provide fluid to an epithelium (such as a surface of an eye), where the interface has a body configured to hold the fluid in contact with the epithelium so that the fluid reaches the epithelium via an opening in the body. The treatment apparatus also includes an acoustic wave emitter configured to generate acoustic waves in the fluid held by the body of the interface so that the acoustic waves radiate toward tissue for treatment under the epithelium, where the acoustic waves are emitted via one or more spark gaps formed by one or more conductors wound around a shaft.
[0007] Another innovative aspect of the subject matter of this disclosure can be implemented in a medical system. The medical system includes pulse generator configured to generate one or more voltage pulses. The medical system also includes an acoustic wave treatment apparatus configured to convert the one or more voltage pulses into acoustic waves in a fluid medium contacting an epithelium (such as a surface of an eye) so that the acoustic waves radiate toward tissue for treatment under the epithelium, where the acoustic waves are emitted via one or more spark gaps formed by one or more conductors wound around a shaft.DESCRIPTION OF THE FIGURES
[0008] Illustrative aspects of the present disclosure are described in detail below with reference to the following figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative and exemplary rather than restrictive.
[0009] FIG. 1 shows a block diagram of an example medical system, according to some implementations.
[0010] FIGS. 2A and 2B show an example system for treating ocular tissue, according to some implementations.
[0011] FIGS. 3 A and 3B show an example ocular interface for an acoustic wave treatment apparatus, according to some implementations.
[0012] FIG. 4 shows another example system for treating ocular tissue, according to some implementations.
[0013] FIG. 5 shows an example acoustic wave emitter for an acoustic wave treatment apparatus, according to some implementations.
[0014] FIG. 6 shows an internal structure of an example acoustic wave emitter, according to some implementations.
[0015] FIG. 7 shows an internal structure of another example acoustic wave emitter, according to some implementations.
[0016] FIG. 8 shows an internal structure of another example acoustic wave emitter, according to some implementations.
[0017] FIG. 9 shows a block diagram of an example computing system, according to some implementations.DETAILED DESCRIPTION
[0018] In the following description, numerous specific details are set forth such as examples of specific components, circuits, and processes to provide a thorough understanding of the present disclosure. The term “coupled” as used herein means connected directly to or connected through one or more intervening components orcircuits. The terms “electronic system” and “electronic device” may be used interchangeably to refer to any system capable of electronically processing information. Also, in the following description and for purposes of explanation, specific nomenclature is set forth to provide a thorough understanding of the aspects of the disclosure.However, it will be apparent to one skilled in the art that these specific details may not be required to practice the example implementations. In other instances, well-known circuits and devices are shown in block diagram form to avoid obscuring the present disclosure. Some portions of the detailed descriptions which follow are presented in terms of procedures, logic blocks, processing and other symbolic representations of operations on data bits within a computer memory.
[0019] These descriptions and representations are the means used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. In the present disclosure, a procedure, logic block, process, or the like, is conceived to be a self-consistent sequence of steps or instructions leading to a desired result. The steps are those requiring physical manipulations of physical quantities.Usually, although not necessarily, these quantities take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated in a computer system. It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities.
[0020] Unless specifically stated otherwise as apparent from the following discussions, it is appreciated that throughout the present application, discussions utilizing the terms such as “accessing,” “receiving,” “sending,” “using,” “selecting,” “determining,” “normalizing,” “multiplying,” “averaging,” “monitoring,” “comparing,” “applying,” “updating,” “measuring,” “deriving” or the like, refer to the actions and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system’s registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.
[0021] Certain standard anatomical terms of location may be used herein to refer to the anatomy of animals, and namely humans, with respect to the exampleimplementations. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms, are used herein to describe a spatial relationship of one element, device, or anatomical structure to another device, element, or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between elements and structures, as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the elements or structures, in use or operation, in addition to the orientations depicted in the drawings. For example, an element or structure described as “above” another element or structure may represent a position that is below or beside such other element or structure with respect to alternate orientations of the subject patient, element, or structure, and vice-versa. As used herein, the term “patient” may generally refer to humans, anatomical models, simulators, cadavers, and other living or non-living objects.
[0022] In the figures, a single block may be described as performing a function or functions; however, in actual practice, the function or functions performed by that block may be performed in a single component or across multiple components, or may be performed using hardware, using software, or using a combination of hardware and software. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and steps have been described below generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present disclosure. Also, the example systems or devices may include components other than those shown, including well-known components such as a processor, memory and the like.
[0023] The techniques described herein may be implemented in hardware, software, firmware, or any combination thereof, unless specifically described as being implemented in a specific manner. Any features described as modules or components may also be implemented together in an integrated logic device or separately as discrete but interoperable logic devices. If implemented in software, the techniques may berealized at least in part by a non-transitory processor-readable storage medium including instructions that, when executed, performs one or more of the methods described herein. The non-transitory processor-readable data storage medium may form part of a computer program product, which may include packaging materials.
[0024] The non-transitory processor-readable storage medium may comprise random access memory (RAM) such as synchronous dynamic random-access memory (SDRAM), read only memory (ROM), non-volatile random access memory (NVRAM), electrically erasable programmable read-only memory (EEPROM), FLASH memory, other known storage media, and the like. The techniques additionally, or alternatively, may be realized at least in part by a processor-readable communication medium that carries or communicates code in the form of instructions or data structures and that can be accessed, read, or executed by a computer or other processor.
[0025] The various illustrative logical blocks, modules, circuits and instructions described in connection with the implementations disclosed herein may be executed by one or more processors (or a processing system). The term “processor,” as used herein may refer to any general-purpose processor, special-purpose processor, conventional processor, controller, microcontroller, or state machine capable of executing scripts or instructions of one or more software programs stored in memory.
[0026] As described above, hardening of ocular tissue can cause, or at least contribute to, various eye conditions, such as presbyopia, cataracts, age-related macular degeneration, dry eye, glaucoma, and keratoconus. Existing treatments for such eye conditions include surgery (such as refractive surgery, lens replacement surgery, laser trabeculoplasty, or corneal cross-linking), medication (such as prescription eye drops or oral medications), and refractive correction devices (such as eyeglasses, contact lenses, or implants). Aspects of the present disclosure recognize that acoustic waves (such as shock waves or cavitation waves produced by intravascular lithotripsy) can also be used to reduce the hardness and / or improve elasticity of ocular tissue.
[0027] Intravascular lithotripsy (IVL) is an interventional procedure to modify calcified plaque in diseased arteries. In existing IVL procedures, a catheter carrying an enclosure (such as a balloon) is advanced into the vasculature along a guide wire until the enclosure is aligned with the calcified plaque. The catheter then uses acoustic pressure tobreak up the calcium deposits. For example, the enclosure can be filled with a volume of fluid (such as saline) that surrounds one or more acoustic wave emitters. The calcified plaque modification can be achieved by creating acoustic waves, specifically, ultrasonic short pulse waves (also referred to as “shock waves”) via a transfer of energy into the fluid. More specifically, the energy enters the surrounding fluid faster than the speed of sound, which creates the acoustic shock waves.
[0028] As used herein, the term “emitter” can refer to any device or component of a medical system that can transfer energy (such as electrical or optical energy) into a fluid medium resulting in the generation of acoustic shock waves and / or cavitation bubbles. Additional acoustic waves (also referred to as “cavitation waves”) and / or waterjets can be generated upon the collapse of the cavitation bubbles. Example suitable emitter technologies include electrohydraulic generation of shock waves (where energy is delivered via voltage or current to pairs of electrodes separated by a spark gap submerged in the fluid) and laser generation of shock waves (where a laser pulse is transmitted into and absorbed by the fluid).
[0029] In some aspects, a treatment apparatus (also referred to herein as an “acoustic wave treatment apparatus”) may be configured to adapt acoustic wave therapy to treat biological tissue through an epithelium (such as a surface of an eye). In some implementations, the biological tissue may include ocular tissue (such as the lens, sclera, trabecular meshwork, and / or zonules). In some implementations, the treatment apparatus may include an interface (also referred to herein as an “epithelial interface” or an “ocular interface”) and an acoustic wave emitter. The interface is configured to provide fluid to the epithelium. In some implementations, the fluid may include a riboflavin solution. The acoustic wave emitter is configured to generate acoustic waves (such as shock waves and / or cavitation waves) in the fluid that radiate toward tissue for treatment under the epithelium. In some implementations, the acoustic waves may be emitted via one or more spark gaps formed by one or more conductors wound around a shaft.
[0030] Particular implementations of the subject matter described in this disclosure can be implemented to realize one or more of the following potential advantages. By delivering acoustic waves to ocular tissue, aspects of the present disclosure can treat various eye conditions (such as presbyopia, cataracts, age-related macular degeneration, dry eye, glaucoma, and / or keratoconus) in a less invasive manner without the need forconstant or perpetual application of the treatment. More specifically, acoustic wave therapy may reduce the density and / or hardness of the target tissue or otherwise improve its flexibility and / or elasticity, which can help slow or reverse some eye conditions (such as by reducing intraocular pressure through improved fluid drainage). Various characteristics or properties of the acoustic waves can be tuned or adapted to the acoustic properties of the target tissue to improve the efficacy of the treatment.
[0031] Although certain aspects of the present disclosure are described in detail herein in the context of treating ocular tissue (such as the lens, sclera, trabecular meshwork, and zonules) and various eye conditions (such as presbyopia, cataracts, age-related macular degeneration, dry eye, glaucoma, and keratoconus), such context is provided for convenience and clarity, and the concepts disclosed herein are applicable to any suitable medical procedure. Description of the eye anatomy and associated medical issues and procedures is presented herein to aid in the description of the concepts disclosed herein. However, it should be understood that these techniques and systems can be implemented in the context of any medical procedure involving the use of acoustic wave therapy to treat biological tissue through various types of epithelia. For example, in some implementations, the medical systems of the present disclosure can be adapted to treat calcium deposits and / or lesions beneath the surface of the skin.
[0032] FIG. 1 shows a block diagram of an example medical system 100, according to some implementations. The medical system 100 is configured to treat biological tissue with acoustic wave therapy by applying the acoustic waves through an epithelium. In the example of FIG. 1, the epithelium is associated with a surface of an eye 101. Thus, in some implementations, the medical system 100 may be used to treat ocular tissue.Example suitable ocular tissue can include the lens, sclera, zonules, or trabecular mesh network, among other examples.
[0033] The medical system 100 includes an energy source 110 and an acoustic wave treatment apparatus 120. The energy source 110 is configured to generate one or more pulses of energy 112. In some implementations, the energy source 110 may be an electrical power supply (such as a voltage source or a current source). In such implementations, each energy pulse 112 may include a pulse of voltage or current applied to a conductive medium. In some other implementations, the energy source 110 may bea laser power supply. In such implementations, each energy pulse 112 may include a pulse of light transmitted over an optical waveguide (such as optical fiber).
[0034] The acoustic wave treatment apparatus 120 is configured to convert the energy pulses 112 into acoustic waves 104 that impinge on the epithelium. In some implementations, the acoustic wave treatment apparatus 120 may include an epithelial interface 122 and an acoustic wave emitter 124. The epithelial interface 122 is configured to provide fluid 102 to the epithelium (such as the surface of the eye 101). The fluid 102 serves as a medium for the generation of acoustic waves 104. More specifically, a body of the epithelial interface 122 is configured to form a fluid cavity or chamber that holds the fluid 102 in contact with the epithelium. For example, the epithelial interface 122 may have an opening at the bottom that allows the fluid 102 to reach the surface of the eye 101. As shown in FIG. 1, the sidewalls of the epithelial interface 122 form a “cup” with the surface of the eye 101 that holds the fluid 102 therein (where the surface of the eye 101 forms the bottom of the cup).
[0035] The acoustic wave emitter 124 is configured to generate the acoustic waves 104 in the fluid 102 based on the energy pulses 112. As shown in FIG. 1, the emitter 124 may be at least partially submerged in the fluid 102. More specifically, the emitter 124 can be positioned and / or configured to emit the acoustic waves 104 in a direction of the tissue for treatment under the epithelium (such that the acoustic waves 104 radiate toward the surface of the eye 101). In some implementations, the emitter 124 may generate the acoustic waves 104 using electrohydraulic generation techniques. In such implementations, the emitter 124 may include one or more pairs of electrodes that are separated by respective spark gaps, where the electrodes are electrically coupled to the energy source 110. In some other implementations, the emitter 124 may generate the acoustic waves 104 using laser generation techniques. In such implementations, the emitter 124 may include the distal ends of one or more optical fibers that are optically coupled to the energy source 110.
[0036] For electrohydraulic generation of acoustic waves 104, the emitter 124 transmits a current (or voltage) pulse 112 into the fluid 102, which may be a conductive solution. The acoustic waves 104 are created by electrical discharges across pairs of electrodes in the emitter 124. More specifically, the current pulse 112 delivered to the electrodes produces one or more ionization bubbles on the electrode surfaces.Subsequently, current arcs across the ionization bubble from one electrode to another, across the spark gap therebetween, resulting in the energy release. The energy from this electrical discharge enters the surrounding fluid 102 faster than the speed of sound, producing an acoustic shock wave 104 that propagates outward to modify the target tissue beneath the epithelium.
[0037] For laser generation of acoustic waves 104, the emitter 124 transmits a laser pulse 112 into the fluid 102. The acoustic waves 104 are created by the fluid 102 absorbing the light emitted by the emitter 124. More specifically, the laser pulse 112 delivers a large amount of energy in a small volume of fluid 102, in a very short time, which creates a rapidly expanding vapor bubble that pushes the fluid 102 outward (such as through heating and / or vaporization of the surrounding fluid). This rapid expansion produces an acoustic shock wave 104 that propagates outward to modify the target tissue. The acoustic energy intensity can be higher if a fluid is chosen that exhibits strong absorption at the laser wavelength that is employed.
[0038] In some aspects, the energy used to generate an initial shock wave may create one or more rapidly expanding and collapsing vapor bubbles that produce secondary shock waves through cavitation (also referred to as a “cavitation waves”). For example, when a vapor bubble collapses near a boundary or surface (such as the epithelium), the side of the bubble furthest from the boundary collapses faster than the side of the bubble near the boundary. Such asymmetrical collapse of the bubble can create a high-speed jet of liquid that pierces through the bubble in a direction toward the boundary.
[0039] The acoustic waves 104 (including shock waves and / or cavitation waves) can modify the tissue beneath the epithelium, for example, by reducing the density and / or hardness of the target tissue or otherwise improving its flexibility and / or elasticity. In some implementations, various characteristics or properties of the acoustic waves 104 can be tuned or otherwise adapted to the acoustic properties of the target tissue to improve the efficacy of the acoustic wave therapy.
[0040] FIGS. 2A and 2B show an example system 200 for treating ocular tissue, according to some implementations. In some implementations, the system 200 may be one example of the system 100 of FIG. 1. More specifically, the system 200 includes an energy source 210 and an acoustic wave treatment apparatus 220. FIG. 2A shows apartially exploded view of the acoustic wave treatment apparatus 220 and FIG. 2B shows the acoustic wave treatment apparatus 220 positioned on a patient's eye.
[0041] The energy source 210 is configured to generate one or more pulses of energy (such as the energy pulses 112 of FIG. 1). In some implementations, the energy source 210 may be an electrical power supply (such as a voltage source or a current source). In some other implementations, the energy source 210 may be a laser power supply. The energy source 210 is coupled to the acoustic wave treatment apparatus 220 via a transmission line 230 or other medium. In some implementations, the transmission line 230 may include a conductive medium (such as a cable or wire) that carries electrical pulses (such as current or voltage) from the energy source 210 to the acoustic wave treatment apparatus 220. In some other implementations, the transmission line 230 may include an optical medium (such as an optical fiber or waveguide) that carries laser pulses from the energy source 210 to the acoustic wave treatment apparatus 220.
[0042] The acoustic wave treatment apparatus 220 is configured to convert the energy pulses from the energy source 210 into acoustic waves that impinge on ocular tissue. The acoustic wave treatment apparatus 220 includes an ocular interface 222 and an acoustic wave emitter 224. In some implementations, the ocular interface 222 and the acoustic wave emitter 224 may be examples of the epithelial interface 122 and the acoustic wave emitter 124, respectively, of FIG. 1. As described with reference to FIG.1, the ocular interface 222 is configured to provide fluid to the surface of the eye and the acoustic wave emitter 224 is configured to generate acoustic waves (such as shock waves and / or cavitation waves) in the fluid. The ocular interface 222 is coupled to a negative pressure source 240 (such as a syringe) which can provide vacuum pressure or suction to secure the ocular interface 222 to the surface of the eye. Although depicted as a syringe in FIGS. 2A and 2B, the negative pressure source 240 can be any suitable source of vacuum pressure.
[0043] In some implementations, the acoustic wave treatment apparatus 220 may include an adapter (not shown for simplicity) that couples the acoustic wave emitter 224 to the ocular interface 222 and maintains a fixed separation distance between the emitter 224 and the surface of the eye. Because acoustic waves tend to decay very rapidly, the adapter can help to ensure a consistent and effective treatment by maintaining a constant distance between the emitter 224 and the surface of the eye. In some implementations,the separation distance between the emitter 224 and the surface of the eye may be between 1mm and 20mm.
[0044] In some implementations, the system 200 also may include a computing system 250. As shown in FIG. 2A, the computing system 250 can be coupled to the energy source 210. More specifically, the computing system 250 can store software or instructions for controlling and / or tuning various characteristics of the energy pulses output by the energy source 210. Example suitable pulse characteristics include pulse duration (or width), pulse amplitude, and pulse repetition rate, among other examples. In some implementations, the energy pulses may be tuned to produce cavitation bubbles that are between 1mm and 5mm in width.
[0045] FIGS. 3A and 3B show an example ocular interface 300 for an acoustic wave treatment apparatus, according to some implementations. In some implementations, the ocular interface 300 may be one example of the ocular interface 222 of FIGS. 2A and 2B. As described with reference to FIGS. 2A and 2B, the ocular interface 300 is configured to provide a fluid pathway for acoustic waves to flow from the emitter 224 to a treatment location on or below a surface of an eye while maintaining a fixed and / or stable relationship between the emitter 224 and the treatment location which reduces or minimizes attenuation of the acoustic waves. FIG. 3A shows a perspective view of the ocular interface 300 and FIG. 3B shows a sectional view of the ocular interface 300 positioned on the surface of the eye.
[0046] In the example of FIGS. 3A and 3B, the ocular interface 300 has a body 310 in the shape of an open-ended cylinder or frustrum. However, the body 310 can have any shape, size, volume, and / or dimensions suitable for holding the fluid medium. In some implementations, the body 310 of the ocular interface 300 may be formed of stainless steel or other material having high corrosion resistance and / or a high acoustic reflection coefficient (such as to reduce or minimize attenuation of the acoustic waves). The opening at the top of the cylinder is configured to receive and / or couple to an acoustic wave emitter (such as the acoustic wave emitter 224 of FIGS. 2A and 2B). The opening at the bottom of the cylinder is configured to contact or otherwise interface with the surface of the eye. For example, the bottom of the cylinder can be curved, deformable, or otherwise configured to conform to the shape or curvature of the surface of the eye. As shown in FIG. 3B, the body 310 of the ocular interface 300 forms a fluid chamber 312with the surface of the eye that can hold or otherwise contain fluid therein. In some implementations, the fluid chamber 312 may have a volume between ImL and 50mL.
[0047] In some implementations, the ocular interface 300 may receive the fluid via a fluid inlet port 334. For example, the fluid inlet port 334 can be coupled to a fluid source via fluid tubing 344. The fluid source can be configured to inject or otherwise deposit the fluid into the fluid chamber 312 via the fluid tubing 344 and the fluid inlet port 334. In some implementations, the fluid source may be configured to deposit between 3mL and lOmL of fluid into the fluid chamber 312. Example suitable fluids include water, an aqueous solution, or a saline solution having a sodium chloride concentration greater than or equal to 5mg / ML.
[0048] In some implementations, the ocular interface 300 may further include a skirt 320 and a vacuum port 332. The skirt 320 is configured to form a seal between the surface of the eye and the opening of the body 310 that contacts the surface of the eye. For example, the skirt 320 can be formed of an elastomeric material (such as a thermoplastic elastomer) that can deform or otherwise allow the skirt 320 to conform to the shape or curvature of the surface of the eye. The seal prevents the fluid from flowing out of the fluid chamber 312 (and onto the eye). In the example of FIGS. 3 A and 3B, the skirt 320 is shown to have an annular bottom surface. In some implementations, the bottom surface of the skirt 320 may have an inner diameter equal to ~10mm.
[0049] In some implementations, the skirt 320 may form a vacuum seal 324 with the surface of the eye between various contact surfaces 322. The vacuum seal creates suction between the skirt 320 and the surface of the eye which helps to secure or immobilize the ocular interface 300 on the surface of the eye. The vacuum seal can be created by vacuum pressure (or negative pressure) received via the vacuum port 332. For example, the vacuum port 332 can be coupled to a negative pressure source (such as the negative pressure source 240 of FIGS. 2A and 2B) via vacuum tubing 342.
[0050] FIG. 4 shows another example system 400 for treating ocular tissue, according to some implementations. In some implementations, the system 400 may be one example of the medical system 100 of FIG. 1 or the system 200 of FIGS. 2 A and 2B. More specifically, the system 400 includes a pulse generator 410 and an acoustic wave treatment apparatus 420. With reference to FIG. 2A, the pulse generator 410 may be oneexample of the pulse generator 210 and the acoustic wave treatment apparatus 420 may be one example of the acoustic wave treatment apparatus 220.
[0051] The pulse generator 410 is configured to generate one or more pulses of energy (such as the energy pulses 112 of FIG. 1). In the example of FIG. 4, the pulse generator 410 is an electrical power supply (such as a voltage source or a current source) configured to generate one or more electrical pulses (such as current or voltage pulses). In some implementations, the pulse generator 410 may generate voltage pulses that are between 0.5kV and 15kV. In some implementations, the repetition rate (or frequency) of the pulses may be between 4Hz and 2kHz. In some implementations, higher frequency pulses may be associated with lower voltage amplitudes. The pulse generator 410 is coupled to the acoustic wave treatment apparatus 420 via a transmission line or other conductive medium (such as a cable or wire) that carries the electrical pulses from the pulse generator 410 to the acoustic wave treatment apparatus 420.
[0052] The acoustic wave treatment apparatus 420 is configured to convert the electrical pulses from the pulse generator 410 into acoustic waves that impinge on ocular tissue. The acoustic wave treatment apparatus 420 includes the ocular interface 222 and an acoustic wave emitter 421. As described with reference to FIGS. 1-3B, the ocular interface 222 is configured to provide or otherwise hold fluid in contact with the surface of the eye and the acoustic wave emitter 421. The ocular interface 222 is coupled to a negative pressure source 440 which can provide vacuum pressure or suction to secure the ocular interface 222 to the surface of the eye (such as described with reference to FIGS.3A and 3B). Although depicted as a syringes in FIG. 4, the negative pressure source 440 can be any suitable source of vacuum pressure.
[0053] The acoustic wave emitter 421 is configured to generate acoustic waves (such as shock waves and / or cavitation waves) in the fluid held by the ocular interface 222. In some implementations, the emitter 421 may be one example of the acoustic wave emitter 124 of FIG. 1. In the example of FIG. 4, the emitter 421 is configured to generate the acoustic waves using electrohydraulic generation techniques (such as described with reference to FIG. 1). For example, the emitter 421 can include one or more pairs of electrodes that are separated by respective spark gaps, where the electrodes are electrically coupled to the pulse generator 410. In some implementations, the acoustic wave treatment apparatus 420 may include an adapter (not shown for simplicity) thatcouples the emitter 421 to the ocular interface 222 and maintains a fixed separation distance between the emitter 421 and the surface of the eye.
[0054] The system 400 further includes a fluid source 460 that can provide fluid to and / or from the acoustic wave treatment apparatus 420. In some implementations, the fluid source 460 may be coupled to the acoustic wave emitter 421 (as shown in FIG. 4). For example, the fluid can be deposited in a cavity or chamber surrounding the electrodes in the emitter 421 to ensure that the spark gaps are submerged or otherwise surrounded by fluid for the generation of acoustic shock waves. The system 400 may further include a fluid pump 462 (such as a peristaltic pump) that can provide vacuum pressure or suction to the acoustic wave treatment apparatus 420. In some implementations, the fluid pump 462 may be coupled between the fluid source 460 and the emitter 421. For example, the fluid pump 462 may be used to evacuate excess bubbles produced as a result of the acoustic waves.
[0055] In some implementations, the system 400 also may include a computing system 450. As shown in FIG. 4, the computing system 450 can be coupled to the pulse generator 410. More specifically, the computing system 450 can store software or instructions for controlling and / or tuning various characteristics of the electrical pulses output by the pulse generator 410. Example suitable pulse characteristics include pulse duration (or width), pulse amplitude, and pulse repetition rate, among other examples. In some implementations, the energy pulses may be tuned to produce cavitation bubbles that are between 1mm and 5mm in width.
[0056] In some aspects, the ocular interface 222 may be filled with a saline solution and the system 400 may be used to treat ocular tissue. In some implementations, the system 400 may be configured for treating presbyopia. For example, the acoustic wave emitter 421 may be configured to emit acoustic waves that impinge on hardened ocular tissue. Example hardened tissue may include one or more of the eye lens, sclera, and zonular inserts, among other examples. The acoustic waves may be tailored (via the pulse generator 410) to be effective for softening such hardened tissue and to transmit passively through softer media and tissue. In some other implementations, the system 400 may be configured for lowering intraocular pressure and / or treating glaucoma. For example, acoustic waves generated by the acoustic wave emitter 421 may be tuned to target the trabecular meshwork and improve outflow of aqueous humor from the eye.
[0057] In some other aspects, the ocular interface 222 may be filled with a riboflavin solution and the system 400 may be used to treat keratoconus. In contrast with existing corneal cross-linking methods, which require removal of an epithelial layer of the cornea, the riboflavin in the ocular interface 222 can penetrate through the epithelial layer when it is disrupted by acoustic waves emitted by the acoustic wave emitter 421. Accordingly, the keratoconus treatment of the present disclosure is less invasive than existing corneal cross-linking methods. In some implementations, the system 400 may further include an ultraviolet light source (not shown for simplicity) for cross-linking riboflavin and corneal proteins. In some implementations, the ultraviolet light source may emit light having a wavelength between 315 nm and 400 nm.
[0058] In some aspects, the riboflavin solution may have a concentration of riboflavin between 0.01% and 1%. In some implementations, the riboflavin solution may have a riboflavin concentration less than 0.1%. In some aspects, the riboflavin solution may have a concentration of dextran between 10% and 40%. In some implementations, the riboflavin solution may have a dextran concentration equal to 20%.
[0059] FIG. 5 shows an example acoustic wave emitter 500 for an acoustic wave treatment apparatus, according to some implementations. In some implementations, the acoustic wave emitter 500 may be one example of the acoustic wave emitter 421 of FIG.4. The acoustic wave emitter 500 includes an outer shell (or housing) 510. The outer shell 510 houses or encloses various electrodes disposed in a fluid chamber (not shown for simplicity). In some implementations, the outer shell 510 may be formed, at least in part, from a plastic or polymer material. The acoustic wave emitter 500 also includes a fluid inlet 504, a fluid outlet 506, and tubing 508 which extend beyond the outer shell 510. The fluid inlet 504 and fluid outlet 506 can be fluidically coupled to a fluid source (such as the fluid source 460 of FIG. 4). The tubing 508 houses energy guides (such as electrical wires and / or other conductors) that connect or otherwise couple the electrodes to a voltage pulse generator (such as the pulse generator 410 of FIG. 4).
[0060] The acoustic wave emitter 500 further includes a polymer membrane 502 that acts as a physical barrier between the fluid chamber (housed within the outer shell 510) and the epithelium (such as the eye). In this way, the polymer membrane 502 can prevent debris generated by the degradation of electrode materials (such as due to shock waves) from contacting the eye. In some implementations, the polymer membrane 502may be formed from a polyether block amide material, a thermoplastic polyurethane material, a nylon material, or any combination thereof. In some implementations polymer membrane 502 may have a thickness between 0.1 mm and 0.5 mm. In some implementations, the polymer membrane 502 may be formed of a material having a sufficiently low acoustic impedance so that acoustic waves can propagate through the membrane. In some other implementations, the polymer membrane 502 may be a fine mesh or other kind of barrier.
[0061] FIG. 6 shows an internal structure of an example acoustic wave emitter 600, according to some implementations. In some implementations, the acoustic wave emitter 600 may be one example of the acoustic wave emitter 500 of FIG. 5. The acoustic wave emitter 600 includes a fluid inlet 604 and a fluid outlet 606 fluidically coupled to a fluid chamber 608. With reference to FIG. 5, the fluid inlet 604 may be one example of the fluid inlet 504, the fluid outlet 606 may be one example of the fluid outlet 506, and the fluid chamber 608 may be housed within the outer shell 510. As described with reference to FIG. 4, the fluid inlet 604 may carry fluid from a fluid source (such as the fluid source 460) into the fluid chamber 608 and the fluid outlet 606 may carry fluid and / or air bubbles out of the fluid chamber 608. The bottom of the fluid chamber 608 is sealed with a polymer membrane 602 (such as the polymer membrane 502 of FIG. 5).
[0062] In the example of FIG. 6, the acoustic wave emitter 600 also includes a pair of electrical wires 614 and 616 having distal portions disposed within the fluid chamber 608. More specifically, the distal portions of the electrical wires 614 and 616 are wound or otherwise wrapped around a shaft 612 (such as in the shape of a coil) and submerged in the fluid within the fluid chamber 608. In some implementations, the shaft 612 may have a non-conductive outer surface. For example, the shaft 612 can be formed from a ceramic or other non-conductive material. The proximal portions of the electrical wires 614 and 616 can be coupled to a voltage pulse generator (such as the pulse generator 410 of FIG. 4). With reference for example to FIG. 5, the proximal portions of the electrical wires 614 and 616 may be housed within the tubing 508.
[0063] The electrical wires 614 and 616 may be insulated along their lengths and include uninsulated portions at their distal ends. The uninsulated portion of the first electrical wire 614 includes an exposed conductive surface that forms a first electrode. The uninsulated portion of the second electrical wire 616 includes an exposed conductivesurface that forms a second electrode. The term “electrode pair” refers to two electrodes positioned in close proximity such that application of a sufficiently high voltage can cause an electrical current to transmit across a gap (also referred to as a “spark gap”) between the electrodes, such as by passing through a conductive fluid or gas. In the context of the present disclosure, a spark gap broadly refers to any region of an emitter where current transmits across an electrode pair.
[0064] In the example of FIG. 6, the distal (uninsulated) ends of the electrical wires 614 and 616 represent an electrode pair separated by a distance forming a spark gap 620. The size of the spark gap 620 (corresponding to the distance between the distal ends of the wires 614 and 616) can vary depending on the desired sonic output of the acoustic wave emitter 600 (or strength of the therapy). In some implementations, the spark gap 620 may be at least 0.05 mm wide. In some other implementations, the spark gap 620 may be at least 0.1 mm wide. Still further, in some implementations, the spark gap 620 may be at most 3 mm wide. As shown in FIG. 6, the electrical wires 614 and 616 are wound parallel (or side by side) to one other, with a consistent spacing between them.
[0065] In some implementations, at least one of the wires 614 or 616 may be formed of Inconel, tungsten, molybdenum, tantalum, vanadium, niobium, chromium, rhenium, or titanium. In some implementations, at least one of the wires 614 or 616 may be formed of a refractory metal. In some implementations, at least one of the wires 614 or 616 may be formed of a metal having a melting temperature greater than 2500° Celsius. Aspects of the present disclosure recognize that during repeated electrohydraulic generation of acoustic waves, one electrode may wear out faster than the other electrode. Thus, in some implementations, the electrical wires 614 and 616 may be formed of different metals having different melting temperatures and / or different characteristic impedances. For example, having electrodes formed from different materials may help to promote even wearing of the two electrical wires. In some implementations, the electrical polarity of the electrical wires 614 and 616 may be switched or alternated during voltage pulsing to promote even wearing of the electrodes.
[0066] Although a single spark gap 620 is shown in the example of FIG. 6, the acoustic wave emitter 600 may include one or more additional sparks gaps formed from one or more additional electrode pairs (not shown for simplicity). For example, in some implementations, a third electrical wire and a fourth electrical wire may be wound aroundthe shaft 612 to form a second electrode pair separated by a second spark gap. In some implementations, the spark gap(s) may be coupled in series to the spark gap 620 formed by the electrical wires 614 and 616. In some other implementations, the additional spark gap(s) may be electrically isolated from the spark gap 620 and / or coupled in parallel to a separate terminal of the voltage pulse generator.
[0067] FIG. 7 shows an internal configuration of another example acoustic wave emitter 700, according to some implementations. In some implementations, the acoustic wave emitter 700 may be one example of the acoustic wave emitter 500 of FIG. 5. The acoustic wave emitter 700 includes a fluid inlet 704 and a fluid outlet 706 fluidically coupled to a fluid chamber 708. With reference to FIG. 5, the fluid inlet 704 may be one example of the fluid inlet 504, the fluid outlet 706 may be one example of the fluid outlet 506, and the fluid chamber 708 may be housed within the outer shell 510. As described with reference to FIG. 4, the fluid inlet 704 may carry fluid from a fluid source (such the fluid source 460) into the fluid chamber 708 and the fluid outlet 706 may carry fluid and / or air bubbles out of the fluid chamber 608. The bottom of the fluid chamber 708 is sealed with a polymer membrane 702 (such as the polymer membrane 502 of FIG. 5).
[0068] In the example of FIG. 7, the acoustic wave emitter 700 also includes an electrical wire 714 having a distal portion disposed within the fluid chamber 708. More specifically, the distal portion of the electrical wire 714 is wound or otherwise wrapped around a shaft 712 (such as in the shape of a coil) and submerged in the fluid within the fluid chamber 708. In some implementations, the shaft 712 may have a conductive outer surface. For example, the shaft 712 can be formed from stainless steel or any other conductive material. The proximal portion of the electrical wire 714 can be coupled to a voltage pulse generator (such as the pulse generator 410 of FIG. 4). With reference for example to FIG. 5, the proximal portion of the electrical wire 714 may be housed within the tubing 508. The shaft 712 can also be coupled to the voltage pulse generator via one or more conductors housed within the tubing 508.
[0069] The electrical wire 714 may be insulated along its length and include an uninsulated portion at its distal end. The uninsulated portion of the electrical wire 714 includes an exposed conductive surface that forms a first electrode. The conductive outer surface of the shaft 712 forms a second electrode. In the example of FIG. 7, the distal (uninsulated) end of the electrical wire 714 and the conductive outer surface of the shaft712 represent an electrode pair separated by a distance forming a spark gap 720. The size of the spark gap 720 can vary depending on the desired sonic output of the acoustic wave emitter 700 (or strength of the therapy). In some implementations, the spark gap 720 may be at least 0.05 mm wide. In some other implementations, the spark gap 720 may be at least 0.1 mm wide. Still further, in some implementations, the spark gap 720 may be at most 3 mm wide. As shown in FIG. 7, the electrical wire 714 is wound around the shaft 712, maintaining a consistent spacing with the outer surface of the shaft 712.
[0070] In some implementations, the electrical wire 714 may be formed of copper, Inconel, tungsten, molybdenum, tantalum, vanadium, niobium, chromium, rhenium, and titanium. In some implementations, the electrical wire 714 may be formed of a refractory metal. In some implementations, the electrical wire 714 may be formed of a metal having a melting temperature greater than 2500° Celsius. In some implementations, the electrical wire 714 and the conductive shaft 712 may be formed of the same material(s). In some other implementations, the electrical wire 714 and the conductive shaft 712 may be formed of different materials.
[0071] FIG. 8 shows another internal structure of an example acoustic wave emitter 800, according to some implementations. In some implementations, the acoustic wave emitter 800 may be one example of the acoustic wave emitter 500 of FIG. 5. The acoustic wave emitter 800 includes a fluid inlet 804 and a fluid outlet 806 fluidically coupled to a fluid chamber 808. With reference to FIG. 5, the fluid inlet 804 may be one example of the fluid inlet 504, the fluid outlet 806 may be one example of the fluid outlet 806, and the fluid chamber 808 may be housed within the outer shell 510. As described with reference to FIG. 4, the fluid inlet 804 may carry fluid from a fluid source (such the fluid source 460) into the fluid chamber 808 and the fluid outlet 806 may carry fluid and / or air bubbles out of the fluid chamber 808. The bottom of the fluid chamber 808 is sealed with a polymer membrane 802 (such as the polymer membrane 502 of FIG. 5).
[0072] In the example of FIG. 8, the acoustic wave emitter 800 also includes electrical wires 814 and 816 having distal portions disposed within the fluid chamber 808. More specifically, the distal portions of the electrical wires 814 and 816 are wound or otherwise wrapped around a shaft 812 and submerged in the fluid within the fluid chamber 808. In some implementations, the shaft 812 may have a conductive outer surface. For example, the shaft 812 can be formed from stainless steel or any otherconductive material. The proximal portions of the electrical wires 814 and 816 can be coupled to a voltage pulse generator (such as the pulse generator 410 of FIG. 4). With reference for example to FIG. 5, the proximal portions of the electrical wires 814 and 816 may be housed within the tubing 508. The shaft 812 can also be coupled to the voltage pulse generator via one or more conductors housed within the tubing 508.
[0073] The electrical wires 814 and 816 may be insulated along their lengths and include uninsulated portion at their distal ends. The uninsulated portion of the first electrical wire 814 includes an exposed conductive surface that forms a first electrode. The uninsulated portion of the second electrical wire 816 includes an exposed conductive surface that forms a second electrode. The conductive outer surface of the shaft 812 forms a third electrode. In the example of FIG. 8, the distal (uninsulated) end of the first wire 814 and the conductive outer surface of the shaft 812 represent a first electrode pair separated by a distance forming a first spark gap 822, whereas the distal end of the second wire 816 and the conductive outer surface of the shaft 812 represent a second electrode pair separated by a distance forming a second spark gap 824. In some implementations, the spark gaps 822 and 824 may be formed on opposite sides of the shaft 812 (or offset by 180° about the circumference of the shaft 812).
[0074] The sizes of the spark gaps 822 and 824 can vary depending on the desired sonic output of the acoustic wave emitter 800 (or strength of the therapy). In some implementations, the spark gap 822 and / or the spark gap 824 may be at least 0.05 mm wide. In some other implementations, the spark gap 822 and / or the spark gap 824 may be at least 0.1 mm wide. Still further, in some implementations, the spark gap 822 and / or the spark gap 824 may be at most 3 mm wide. As shown in FIG. 8, each of the electrical wires 814 and 816 is wound around the shaft 812, maintaining a consistent spacing with the outer surface of the shaft 812.
[0075] In some implementations, at least one of the wires 814 or 816 may be formed of copper, Inconel, tungsten, molybdenum, tantalum, vanadium, niobium, chromium, rhenium, and titanium. In some implementations, at least one of the wires 814 or 816 may be formed of a refractory metal. In some implementations, at least one of the wires 814 or 816 may be formed of a metal having a melting temperature greater than 2500° Celsius. In some implementations, the electrical wires 814 and / or 816 may be formed of the same material(s) as the conductive shaft 812. In some other implementations, theelectrical wires 814 and / or 816 may be formed of different materials than the conductive shaft 812. In some implementations, voltage pulses may be delivered to the electrical wires 814 and 816 via separate channels, such that acoustic waves can be generated at the first spark gap 822 independently of the second spark gap 824 (and vice versa).
[0076] In some implementations, the various spark gaps associated with the acoustic wave emitters 600, 700, and 800 may be located at least 10 mm from a bottom-most region of the ocular interface (or at least 10 mm from the surface of the eye). In some other implementations, the spark gaps may be positioned at least 20 mm away from the bottom-most region of the ocular interface. Such spacing between the spark gaps and the target tissue may promote a more uniform sonic output along the treatment area. In some implementations, the spacing between the spark gaps and the target tissue may allow for smooth fluid flow and movement in and out of the chamber.
[0077] FIG. 9 shows a block diagram of an example computing system 900, according to some implementations. In some implementations, the computing system 900 may be one example of any of the computing systems 250 or 550 of FIGS. 2 A and 4, respectively, and may be used for controlling a delivery of voltage pulses to an acoustic wave emitter (such as any of the acoustic wave emitters 421, 500, 600, 700, or 800 of FIGS. 4-8).
[0078] The system 900 can be a host computer connected to a network. The system 900 can be a client computer or a server. The system 900 can be any suitable type of microprocessor-based device, such as a personal computer, workstation, server, or handheld computing device (or a portable electronic device) such as a phone or tablet. The system 900 can include, for example, one or more of processors 902, input device 906, sensor device 907, output device 908, storage 910, and communication device 904. The input device 906 and output device 908 can generally correspond to those described above and can either be connectable or integrated with the computer.
[0079] The input device 906 can be any suitable device that provides directed input, such as a touch screen, keyboard or keypad, mouse, or voice-recognition device, in other words, input or directions provided or initiated by a user. The sensor device 907 can be one or more of any suitable sensor devices, such as a pressure sensor, a thermal sensor, an electrical sensor (such as current, voltage, resistance, and / or impedance sensors), or avisualization element. The output device 908 can be any suitable device that provides output, such as a touch screen, haptics device, or speaker. The storage 910 can be any suitable device that provides storage, such as an electrical, magnetic, or optical memory, including a RAM, cache, hard drive, or removable storage disk. The communication device 904 can include any suitable device capable of transmitting and receiving signals over a network, such as a network interface chip or device. The components of the computer can be connected in any suitable manner, such as via a physical bus or wirelessly.
[0080] The sensor devices 907 can provide feedback to an operator using system 900 by measuring parameters in the surrounding environment and thereby indicating a status of the system 900, and further providing for guidance on what further steps the operator may decide to implement with system 900. For example, in implementations where the sensor devices include a visualization element, an operator of the system 900 may be able to more clearly understand where an emitter is located relative to a target ocular tissue, prior to, during, and after delivering therapy. Other sensor devices 907 can include sensors for pressure, temperature, capacitance, focused light, ambient light, stiffness, and other environmental or anatomical parameters.
[0081] The software 912, which can be stored in storage 910 and executed by processor 902, can include, for example, the programming that embodies the functionality of the present disclosure (such as embodied in the devices as described above). The software 912 can also be stored and / or transported within any non-transitory computer-readable storage medium for use by, or in connection with, an instruction execution system, apparatus, or device, such as those described above, that can fetch instructions associated with the software from the instruction execution system, apparatus, or device and execute the instructions. In the context of this disclosure, a computer-readable storage medium can be any medium, such as storage 910, that can contain or store programming for use by, or in connection with, an instruction execution system, apparatus, or device.
[0082] The software 912 can also be propagated within any transport medium for use by, or in connection with, an instruction execution system, apparatus, or device, such as those described above, that can fetch instructions associated with the software from the instruction execution system, apparatus, or device and execute the instructions. In thecontext of this disclosure, a transport medium can be any medium that can communicate, propagate, or transport programming for use by, or in connection with, an instruction execution system, apparatus, or device. The transport-readable medium can include, but is not limited to, an electronic, magnetic, optical, electromagnetic, or infrared wired or wireless propagation medium.
[0083] The system 900 can be connected to a network, which can be any suitable type of interconnected communication system. The network can implement any suitable communication protocols and can be secured by any suitable security protocols. The network can comprise network links of any suitable arrangement that can implement the transmission and reception of network signals, such as wireless network connections, T1 or T3 lines, cable networks, DSL, or telephone lines. The system 900 can implement any operating system suitable for operating on the network. The software 912 can be written in any suitable programming language, such as C, C++, Java, or Python. In various embodiments, application software embodying the functionality of the present disclosure can be deployed in different configurations, such as in a client / server arrangement or through a Web browser as a Web-based application or Web service, for example.
[0084] Although the systems and methods described herein have been discussed primarily in the context of treating ocular tissue, the systems and methods herein can be used for a variety of tissues. For further examples, implementations of the embodiments disclosed herein may be used for treating soft tissues, such as cancer and tumors (i.e., non-thermal ablation methods), blood clots, fibroids, cysts, organs, scar and fibrotic tissue removal, multi-morphology tissue, or other tissue destruction and removal. The systems and methods could also be used for neurostimulation treatments, targeted drug delivery, treatments of tumors in body lumens (e.g., tumors in blood vessels, the esophagus, intestines, stomach, or vagina), wound treatment, non-surgical removal and destruction of tissue, or used in place of thermal treatments or cauterization for venous insufficiency and fallopian ligation (i.e., for permanent female contraception).
[0085] In one or more examples, the systems and methods described herein could also be used for tissue engineering methods, for instance, for mechanical tissue decellularization to create a bioactive scaffold in which new cells (e.g., exogenous or endogenous cells) can replace the old cells; introducing porosity to a site to improve cellular retention, cellular infiltration / migration, and diffusion of nutrients and signalingmolecules to promote angiogenesis, cellular proliferation, and tissue regeneration similar to cell replacement therapy. Such tissue engineering methods may be useful for treating ischemic heart disease, fibrotic liver, fibrotic bowel, and traumatic spinal cord injury (SCI). For instance, for the treatment of spinal cord injury, the devices and assemblies described herein could facilitate the removal of scarred spinal cord tissue, which acts like a barrier for neuronal reconnection, before the injection of an anti-inflammatory hydrogel loaded with lentivirus to genetically engineer the spinal cord neurons to regenerate.
[0086] As provided herein, it should be appreciated that any disclosure of a numerical range describing dimensions or measurements such as thicknesses, length, weight, time, frequency, temperature, voltage, current, angle, etc. is inclusive of any numerical increment or gradient within the ranges set forth relative to the given dimension or measurement.
[0087] Those of skill in the art will appreciate that information and signals may be represented using any of a variety of different technologies and techniques. For example, data, instructions, commands, information, signals, bits, symbols, and chips that may be referenced throughout the above description may be represented by voltages, currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof.
[0088] The various illustrative logics, logical blocks, modules, circuits and algorithm processes described in connection with the implementations disclosed herein may be implemented as electronic hardware, computer software, or combinations of both. The interchangeability of hardware and software has been described generally, in terms of functionality, and illustrated in the various illustrative components, blocks, modules, circuits and processes described herein. Whether such functionality is implemented in hardware or software depends upon the particular application and design constraints imposed on the overall system.
[0089] In the foregoing specification, implementations have been described with reference to specific examples thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader scope of the disclosure as set forth in the appended claims. The specification anddrawings are, accordingly, to be regarded in an illustrative sense rather than a restrictive sense.
[0090] As used herein, a phrase referring to “at least one of’ a list of items refers to any combination of those items, including single members. As an example, “at least one of: a, b, or c” is intended to cover: a, b, c, a-b, a-c, b-c, and a-b-c.
[0091] Various modifications to the implementations described in this disclosure may be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the spirit or scope of this disclosure. Thus, the claims are not intended to be limited to the implementations shown herein, but are to be accorded the widest scope consistent with this disclosure, the principles and the novel features disclosed herein.
Claims
CLAIMS1. A treatment apparatus comprising:an interface configured to provide fluid to an epithelium, the interface having a body configured to hold the fluid in contact with the epithelium so that the fluid reaches the epithelium via an opening in the body; andan acoustic wave emitter configured to generate acoustic waves in the fluid held by the body of the interface so that the acoustic waves radiate toward tissue for treatment under the epithelium, the acoustic waves emitted via one or more spark gaps formed by one or more conductors wound around a shaft.
2. The treatment apparatus of claim 1, wherein the epithelium comprises a surface of an eye and the tissue for treatment includes ocular tissue.
3. The treatment apparatus of claim 1, wherein the acoustic waves comprise shock waves or cavitation waves.
4. The treatment apparatus of claim 1, wherein the one or more conductors includes a first electrical wire having an uninsulated portion.
5. The treatment apparatus of claim 4, wherein the one or more conductors further includes a second electrical wire having an uninsulated portion separated from the uninsulated portion of the first electrical wire by a distance forming a first spark gap of the one or more spark gaps.
6. The treatment apparatus of claim 5, wherein the uninsulated portions of the first and second electrical wires are located at distal ends of the first and second electrical wires.
7. The treatment apparatus of claim 5, wherein the shaft has a non-conductive outer surface.
8. The treatment apparatus of claim 5, wherein the one or more conductors further include a third electrical wire having an uninsulated portion and a fourth electrical wire having an uninsulated portion separated from the uninsulated portion of the third electrical wire by a distance forming a second spark gap of the one or more spark gaps.
9. The treatment apparatus of claim 5, wherein the first electrical wire comprises a first material and the second electrical wire comprises a second material having a different melting point than the first material.
10. The treatment apparatus of claim 4, wherein the shaft has a conductive outer surface.
11. The treatment apparatus of claim 10, wherein the uninsulated portion of the first electrical wire is separated from the conductive outer surface of the shaft by a distance forming a first spark gap of the one or more spark gaps.
12. The treatment apparatus of claim 11, wherein the one or more conductors further includes a second electrical wire having an uninsulated portion separated from the conductive outer surface of the shaft by a distance forming a second spark gap of the one or more spark gaps.
13. The treatment apparatus of claim 1, wherein the acoustic wave emitter further comprises a polymeric membrane forming a barrier between the one or more spark gaps and the epithelium.
14. The treatment apparatus of claim 1, wherein the fluid comprises a riboflavin solution.
15. A medical system comprising:a pulse generator configured to generate one or more voltage pulses; and an acoustic wave treatment apparatus configured to convert the one or more voltage pulses into acoustic waves in a fluid medium contacting an epithelium so that the acoustic waves radiate toward tissue for treatment under the epithelium, the acousticwaves emitted via one or more spark gaps formed by one or more conductors wound around a shaft.
16. The medical system of claim 15, wherein the one or more conductors includes a first electrical wire having an uninsulated portion.
17. The medical system of claim 16, wherein the one or more conductors further includes a second electrical wire having an uninsulated portion separated from the uninsulated portion of the first electrical wire by a distance forming a first spark gap of the one or more spark gaps.
18. The medical system of claim 16, wherein the shaft has a conductive outer surface.
19. The medical system of claim 18, wherein the uninsulated portion of the first electrical wire is separated from the conductive outer surface of the shaft by a distance forming a first spark gap of the one or more spark gaps.
20. The medical system of claim 15, wherein the fluid medium comprises a riboflavin solution.
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