WO2023227692A1 - Procédé et dispositif de repositionnement sans contact et non invasif d'un objet, tel qu'une lentille, par rapport à un œil - Google Patents

Procédé et dispositif de repositionnement sans contact et non invasif d'un objet, tel qu'une lentille, par rapport à un œil Download PDF

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Publication number
WO2023227692A1
WO2023227692A1 PCT/EP2023/063986 EP2023063986W WO2023227692A1 WO 2023227692 A1 WO2023227692 A1 WO 2023227692A1 EP 2023063986 W EP2023063986 W EP 2023063986W WO 2023227692 A1 WO2023227692 A1 WO 2023227692A1
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WO
WIPO (PCT)
Prior art keywords
ultrasound
transducer array
ultrasound transducer
eye
lens
Prior art date
Application number
PCT/EP2023/063986
Other languages
English (en)
Inventor
Marcel Alexander-Schuck
Simon MADGE
Original Assignee
No-Touch Robotics Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by No-Touch Robotics Gmbh filed Critical No-Touch Robotics Gmbh
Publication of WO2023227692A1 publication Critical patent/WO2023227692A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1662—Instruments for inserting intraocular lenses into the eye
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable

Definitions

  • the present invention relates to a method and a device for relocating in a contactless, non- invasive manner an object with regards to an eye of a human or animal body.
  • the invention relates to a method and a device for relocating in a contactless, non-invasive manner a lens such as an intraocular lens with regards to an eye of a patient.
  • the body part typically comprises a volume which is filled with a fluid and in which the object may swim or on which the object may float.
  • the object may be introduced or implanted within the fluid volume.
  • the object may then be specifically relocated such as to be positioned and/or oriented in a desired configuration.
  • the object to be relocated is a lens, particularly an artificial lens such as an intraocular lens, and in which the body part at which the lens is to be relocated is an eye of a patient.
  • the method and/or device described herein may relate to other types of objects, such as a medical implant or a prostheses, to be relocated within the eye.
  • an artificial lens may be implanted into a patient’s eye.
  • an intraocular lens may be implanted into the eye as part of a treatment for cataracts or near-sightedness.
  • the lens is typically implanted during cataract surgery after the eye’s natural lens has been removed.
  • IOL implantation may carry several risks, such as losing and/or unintended rotation of the implanted lens after surgery.
  • extended depth of focus IOLS and IOLS that include a correction for astigmatism collectively commonly referred to as “premium IOLs”
  • premium IOLs a correct placement and/or rotational orientation of the IOL inside the eye is generally important as incorrect placement of the lens may, inter-alia, significantly impair a patient’s vision.
  • a second surgical procedure is conventionally required within a short timeframe after the first surgical implantation procedure in order to adjust the lens placement and/or orientation.
  • second surgical procedure is generally undesirable as it, inter-alia, requires additional efforts and costs and, furthermore, bears a risk of infection and/or damage to other parts of the eye.
  • a method for relocating in a contactless, non- invasive manner an object with regards to an eye of a human body or an animal body comprises at least the following steps, preferably in the indicated order: (i) generating an acoustic pressure amplitude distribution in a fluid comprised in the eye in a manipulation body volume including the object by irradiating the manipulation body volume with ultrasonic sound emitted by an ultrasound transducer array, and
  • a device for relocating in a contactless, non- invasive manner an object with regards to an eye of a human or animal body comprises at least an ultrasound transducer array and a controller for controlling the ultrasound transducer array.
  • the controller and the ultrasound transducer array are configured for implementing and/or controlling the method according to an embodiment of the first aspect of the invention.
  • acoustic forces in order to thereby manipulate the position and/or orientation of an object relative to an eye from outside the body of a patient.
  • the acoustic forces are generated using ultrasonic sound emitted by an ultrasound transducer array in such specific manner such as to generate an acoustic pressure amplitude distribution (PAD) within a fluid comprised in the eye and to then specifically manipulate the generation of the acoustic PAD such that its spatial arrangement and/or its spatial amplitude distribution are modified in an intended way.
  • PAD acoustic pressure amplitude distribution
  • the generation of ultrasonic sound by the ultrasound transducer array is manipulated in such a manner that, as a result of the acoustic PAD being modified, a force acting onto the object is generated, the force being sufficiently strong and being suitably directed for displacing the object in an intended way.
  • FR 2211207 Bl describes an ultrasound instrument for eye surgery.
  • DE 19623213 Al describes an eye surgical instrument for disintegrating of eye lenses using ultrasound.
  • EP 617599 Bl discloses an ultrasonic therapy apparatus delivering ultrasonic waves with thermal and cavitation effects.
  • US 7178530 B2 discloses a method of ameliorating vision-inhibiting effects of cataracts and the like.
  • EP 2996649 Al discloses a touchless user interface for ophthalmic devices.
  • WO 2016/131055 Al discloses systems and methods for eye health monitoring.
  • CA 2213648 Al discloses a chan’s fluid depletion monitoring device.
  • US 3990452 A discloses a medical machine for performing surgery and treating using ultrasonic energy.
  • EP 2512599 Bl discloses an ultrasound treatment device.
  • WO 2017/161348 Al describes effective ocular lens positioning methods and an apparatus.
  • WO 2017/161348 Al describes methods and an apparatus that can be used to adjust an effective lens position of the eye in order to correct a refractive error of the eye.
  • the methods and apparatus can be configured to apply energy to the sclera and other regions of the eye in order to adjust the effective lens position of the eye for far vision.
  • the sclera can be treated in order to shrink or relax the sclera, and combinations thereof in order to adjust the position of the lens of the eye in order to correct vision related to a refractive error of the eye.
  • a target location of the lens can be determined to correct the refractive error of the eye, and the energy applied in order to move the lens toward the target location.
  • ultrasonic sound emitted by an ultrasound transducer array is specifically used for generating an acoustic pressure amplitude distribution (PAD) in a fluid comprised in the eye in which an object is to be specifically displaced and/or oriented within a volume referred to herein as “manipulation body volume”.
  • PAD acoustic pressure amplitude distribution
  • ultrasound may be specifically emitted with high intensity and with an intensity distribution which is macroscopically non-homogeneous such that, as a result of the irradiated ultrasonic sound, an acoustic PAD comprising areas of higher pressure amplitude and areas of lower pressure amplitude is generated within the fluid in the manipulation body volume.
  • the PAD may then be specifically positioned relative to the object to be relocated and the ultrasound transducer array may be specifically manipulated such that the PAD is modified with regards to its spatial arrangement and/or spatial amplitude distribution.
  • the modification may be induced such that forces are applied to the object, such forces being sufficiently strong for displacing the object and/or rotating the object in an intended direction.
  • ultrasound is generally used to induce modifications at tissue surrounding an object to be relocated, such modification taking effect typically within hours, days or even weeks after an ultrasound treatment.
  • ultrasound is applied such as to generate forces which affect the object immediately, i.e. typically in less than a second or even within milliseconds.
  • the ultrasound is applied in a manner such that no permanent modifications are induced within tissue surrounding the object to be relocated, but, instead, only temporary modifications are induced in such tissue.
  • a PAD is generated which changes characteristics within the manipulation body volume only temporarily and preferably fully reversibly immediately after finishing the ultrasonic treatment, but not permanently.
  • WO 2022/002825 Al describes contactless manipulation of objects using controlled electroacoustic transducers.
  • WO 2022/058281 Al discloses a method for handling an object in a pressure amplitude distribution. While these prior patent applications relate to non-medical appliances and do not teach specifically relocating an object with regards to an eye, characteristics and/or details of the approaches described in these prior patent applications may be transferred to and/or adapted for embodiments of the method and device described herein. Accordingly, the full content of these prior patent applications shall be included herein by reference.
  • the method and the device described herein may be embodied such that small objects such as lenses may be relocated in relation to a body part such as an eye in a human or animal body.
  • object may represent any type of lens to be implanted and/or relocated within an eye, such as an artificial lens, a replacement lens, an intraocular lens, etc. It may also relate to another implantable device such as an eye implant or an eye prosthesis.
  • relocating may be understood as translocating, displacing, moving, rotating, turning, etc., i.e. as a motion in which a location and/or an orientation of the object is changed.
  • the object may be displaced within the body of the patient or the object may be translocated from outside the patient’s body to inside the patient’s body.
  • the object may have a small size of for example less than 5 cm, preferably less than 2 cm, less than 1 cm or even less than 5 mm in a maximum extension direction.
  • the objects may have a macroscopic size of for example more than 0.5 mm, preferably more than 1 mm, more than 2 mm or even more than 4 mm.
  • the object may have a flat shape, i.e. a quasi- two-dimensional shape.
  • a thickness of the object may be smaller than 5 mm, preferably smaller than 2 mm or even smaller than 1 mm.
  • the object may have a small weight, for example a weight in a range of milligrams to a few grams, e.g. between 1 mg and 10g, preferably between 10 mg and 1g.
  • the body part is an eye in which the object is to be arranged.
  • the eye is generally comprised in a living organism.
  • the eye comprises fluid in or at which the object may be accommodated.
  • the fluid may be a liquid.
  • the fluid may have a low viscosity similar to the viscosity of water, the viscosity of oil, the viscosity of a water solution or the viscosity of a water emulsion.
  • the fluid may be comprised in a manipulation body volume within which the object is to be relocated.
  • the fluid may for example fill a cavity in the eye.
  • the cavity may form the manipulation body volume.
  • the cavity may be enclosed with living tissue such as a skin, a membrane, muscles, etc.
  • the fluid may be comprised in a manipulation body volume formed by a fluid fdm.
  • the fluid may be a liquid comprised in a capsular bag of a patient’s eye.
  • the fluid may be provided as a liquid film such as a fdm of tear fluid at the patient’s eye.
  • the manipulation body volume comprising the fluid may have a volume in a range from a few microliters to several millilitres, e.g. between 1 pl and 100 ml, preferably between 10 pl and 10 ml.
  • the objects may be arranged such as to swim in or float on the fluid comprised in the manipulation body volume. Due to the low viscosity of the fluid and the small size and mass of the object, the object may be displaced and/or reoriented upon application of relatively small forces.
  • such forces may be lower than 1 N, preferably lower than 0.1 N, lower than 10 mN or even lower than 1 mN.
  • the forces may be between 0.1 mN and 0.1 N, preferably between 1 mN and 30 mN.
  • the forces required to relocate the object are generated by submitting the object to an acoustic pressure amplitude distribution (PAD) generated by irradiating the manipulation body volume with ultrasonic sound.
  • PAD acoustic pressure amplitude distribution
  • the PAD may additionally also be generated in volumes adjacent to the manipulation body volume inside or outside of the patient’s body, i.e. for example within a coupling fluid provided adjacent to the patient’s eye.
  • the ultrasonic sound may have frequencies above 20 kHz, for example in a range of between 20 kHz and 2 MHz or even between 20 kHz and 5 MHz.
  • the ultrasonic sound may have frequencies of preferably between 20 kHz and 200 kHz, more preferably between 30 kHz and 150 kHz.
  • the ultrasonic sound may have frequencies of between 500 kHz and 5 MHz.
  • the ultrasonic sound may be emitted with high intensities.
  • an acoustic excess pressure in comparison to an environment may be in a kPa-range, for example in an air-filled volume in many cases below 50 kPa or even below 10 kPa.
  • the ultrasonic sound is emitted by an ultrasound transducer array.
  • the ultrasound transducer array may comprise one or more ultrasound generators (sometimes also referred to as electro-acoustic transducers) and, optionally, one or more acoustic lenses.
  • An operation of the ultrasound transducer array may be controlled by a controller.
  • an intended PAD may be generated within the manipulation body volume.
  • ultrasonic waves may be emitted by one or preferably several ultrasound generators.
  • the ultrasound generators may be arranged at different locations and/or may be directed in different directions.
  • the ultrasound emitted by the ultrasound generators may be focused or deflected by acoustic lenses.
  • standing ultrasound waves and/or beats of ultrasound waves may be generated and may result in a stationary or quasi- stationary PAD (i.e. a PAD in which the pressure amplitude distribution changes at a frequency which is many magnitudes smaller than the frequency of the ultrasonic sound).
  • a pressure distribution is generally non-homogeneous, i.e. local pressures may vary with partial volumes having higher pressures than neighbouring partial volumes. Due to the non- homogeneous pressure distribution, pressure gradients are established within the PAD.
  • forces may be applied onto an object comprised in the manipulation body volume upon being submitted to the PAD. Particularly, at least with regards to some of the embodiments described herein, such forces act along a direction corresponding to the pressure gradient being effective at a given location of the object to be relocated.
  • the acoustic PAD is specifically modified by suitably manipulating the ultrasound transducer array.
  • the object is relocated by generating at least two PADs in a sequential manner, of which an initial PAD may correspond to an original state of the object and a final PAD may correspond to a target state of the object.
  • the object or portions thereof may be “trapped” in for example one or more low pressure regions of the respective PAD. If the PAD is manipulated, the object generally follows this manipulation.
  • the PAD is modified with regards to its spatial arrangement and/or its spatial amplitude distribution.
  • the location at which the PAD is generated within the manipulation body volume may be intentionally displaced by suitably manipulating the ultrasound transducer array.
  • the entire ultrasound transducer array or components thereof may be suitably displaced.
  • single ultrasound generators and/or acoustic lenses or other components comprised in the ultrasound transducer array may be displaced with respect to other components in the ultrasound transducer array.
  • an operation of one or more ultrasound generators and/or acoustic lenses and/or other components comprised in the ultrasound transducer array may be specifically manipulated such as to modify an amplitude and/or a phase of the ultrasonic sound emitted thereby.
  • the spatial arrangement and/or the spatial amplitude distribution of the PAD may be modified in a manner such as to generate pressure gradients which result in substantial forces being applied to the object in an intended direction.
  • the object may be precisely relocated within the manipulation body volume such as to be arranged in relation to the eye at an intended position and/or an intended orientation.
  • the ultrasonic sound is irradiated with an energy density which is sufficiently low to avoid tissue damage, scarring, relaxation of muscles, tensioning of muscles and/or cavitation within the manipulation body volume.
  • an energy density of such ultrasonic sound shall be limited to an extend at which living tissue is not injured and no activation of muscles is influenced by the irradiated ultrasonic sound.
  • the energy density of the ultrasonic sound shall be low enough to prevent cavitation.
  • Cavitation refers to the formation of small vapor-filled cavities in the liquid. This is caused by the static pressure of a liquid being reduced to below the liquid's vapor pressure. The pressure gradients of the PAD are chosen such that cavitation is prevented.
  • the pressure amplitude of the low pressure regions within the PAD are chosen sufficiently high to prevent cavitation Accordingly, while the ultrasonic sound shall be emitted by the ultrasound transducer array with an intensity being sufficiently high for generating the PAD such as to induce sufficient forces acting directly onto the object for displacing the object, the ultrasonic sound intensity shall be limited to values low enough to prevent secondary effects resulting from tissue being irreversibly modified by absorption of ultrasonic energy, i.e. to prevent for example injury or scarring of living tissue.
  • the acoustic pressure amplitude distribution is generated with at least one first pressure region of lower acoustic pressure and at least one second pressure region of higher acoustic pressure, wherein a size and/or a geometry and/or an amplitude of the first and second pressure regions is set in dependence of positional and/or geometrical characteristics of the object.
  • the PAD may be generated such as to include first and second pressure regions which significantly differ with regards to the acoustic pressure being present in the respective regions.
  • the ultrasound transducer array may be configured and/or may be operated such that the size and/or the geometry of the first and second pressure regions is specifically adapted taking into account positional characteristics of the object, i.e. where the object is arranged with regards to the body part, and/or taking into account geometrical characteristics of the object, i.e. which dimensions and/or shape the object has.
  • the larger the object is the larger the size of the first and/or second pressure regions may be set.
  • the acoustic pressure amplitude distribution is generated in a manner such that the object is predominantly comprised within the first pressure region of lower acoustic pressure and is interposed between at least two second pressure regions of higher acoustic pressure.
  • the PAD may be generated with two second pressure regions of higher acoustic pressure enclosing a first pressure region of lower acoustic pressure in between.
  • the PAD may then be arranged and the sizes and/or geometries of the first and second pressure regions may be adapted such that the object is entirely included in the first pressure region or at least a predominant portion of the object is included in the first pressure region.
  • the second pressure regions of higher acoustic pressure are arranged at opposite sides of the object and thereby “clamp” or trap the object in between these higher pressure regions.
  • the PAD may thereby act similar to a contactless tweezer or pincer for grabbing the object and possibly relocating the object.
  • the PAD having two second pressure regions of higher acoustic pressure enclosing a first pressure region of lower acoustic pressure in between may also be referred to as a “twin trap”.
  • the ultrasound is emitted such as to have a wavelength in the manipulation body volume, the wavelength being between 100% and 400%, preferably being between 150% and 300%, of lateral dimensions of the object in an irradiation direction of the irradiated ultrasonic sound.
  • the ultrasound is emitted with a frequency being in the ultrasonic frequency band, i.e. beyond 20 kHz.
  • Dimensions of pressure variations within the PAD typically depend on the wavelength of the irradiated ultrasound.
  • dimensions of a low-pressure first pressure region should be similar or equivalent to a half of the wavelength of the irradiated ultrasound.
  • the wavelength of the irradiated ultrasonic sound should be such that a half of the wavelength X/2 is in a similar order of magnitude as the dimensions of the object, i.e.
  • the half of the wavelength X/2 should be approximately 1 to 2 times the lateral dimensions of the object. Accordingly, for an object having a width of for example 6 mm, a wavelength X of the ultrasonic sound generating the PAD should be in a range of 12 - 24 mm.
  • the wavelength X depends on characteristics, particularly on the speed of sound, of the fluid into which the ultrasound is irradiated.
  • the speed of sound c in water is about 1500 m/s.
  • the pressure amplitude distribution is generated such as to completely enclose the object.
  • the volume, in which the acoustic PAD is generated does not fully include the entire object to be relocated
  • every portion of the object is comprised in the fluid included in the volume including the PAD, such that the entire object may freely float or swim and may therefore be easily relocated.
  • the manipulation body volume is set such that its dimensions are at most triple, preferably at most double the dimensions of the object.
  • the manipulation body volume including the PAD shall preferably extend in a close proximity to the object to be relocated, but does not necessarily need to extend far beyond the contour of the object.
  • various beneficial effects may be achieved, such as limiting an energy consumption for the ultrasonic sound generation, limiting side effects onto body portions remote from the object, etc.
  • the object comprises a central object body and at least one elongate protrusion radially extending from a circumference of the central object body.
  • the acoustic pressure amplitude distribution is generated in a manner such that the protrusion is predominantly comprised within the first pressure region of lower acoustic pressure and is interposed between at least two second pressure regions of higher acoustic pressure.
  • the object may be e.g. lens.
  • Such lens may be composed of the central lens body and of at least one or preferably two or more protrusions.
  • the lens body forms a core of the lens providing for its optical effects, i.e. for example for its optically diverging or converging characteristics.
  • such lens body has a generally flat shape with a main extension in a plane orthogonal to an optical axis of the lens and with a significantly smaller extension in a direction parallel to the optical axis.
  • the lens body has a circular shape in a top view along its optical axis while being defined by upper and lower surfaces extending in a direction orthogonal to the optical axis, at least one of such upper and lower surfaces generally having a concave or convex shape.
  • the lens body has a diameter in a range of a few millimetres, for example between 2 mm and 30 mm, in most cases between 4 mm and 15 mm.
  • the one or more protrusions extend laterally from a circumference of the lens body.
  • the protrusions may extend within the main extension plane of the lens body or at a small angle thereto, i.e. typically with less than 30° or less than 15°.
  • the protrusions may form small elongate legs.
  • the protrusions may at least partially extend in a radial outward direction with regards to a circumference of the lens body. Particularly, the protrusions may extend at an angle of between 0° and 90°, preferably at a small angle of between 5° and 30° with respect to the circumference of the lens body.
  • the protrusions generally have a length being substantially longer than its width.
  • the protrusions may have a length of more than 1 mm, preferably more than 2 mm or more than 4 mm, but less than 15 mm, preferably less than 8 mm.
  • the width of the protrusions may be e.g. more than 0.5 mm, preferably more than 1 mm, but less than 4 mm, preferably less than 2 mm.
  • the irradiation of the ultrasonic sound emitted by the ultrasound transducer array may be specifically configured such as to generate a first low- pressure region enclosed by two second high pressure regions with dimensions of the respective pressure regions being adapted to enclose and “grab” or “clamp” at least one of the protrusions of the lens instead of grabbing or clamping the entire lens.
  • the PAD instead of generating the PAD with dimensions such as to form an acoustic tweezer with a size for grasping the entire lens, the PAD may be generated with substantially smaller dimensions in order to reduce the size of the acoustic tweezer for grasping only one or more of the small protrusions of the lens.
  • the entire lens may be relocated by suitably tweezing and relocating its radially protruding legs.
  • the frequency of the emitted ultrasound generally has to be set to a higher value in comparison to the above mentioned case where the entire lens is to be enclosed between two high pressure regions.
  • ultrasonic sound frequency may allow for generating two second pressure regions of higher acoustic pressure with relatively small lateral dimensions and being separated from each other by an intermediate first pressure region of lower acoustic pressure also having small dimensions.
  • pressure gradients between the first and second pressure regions may be steeper compared to a case of lower ultrasonic sound frequencies. Accordingly, using high ultrasonic sound frequencies may serve for generating a smaller acoustic tweezer with steeper pressure gradients and therefore more precisely defined grasping “flanks”. Thereby, grabbing and relocating the lens by tweezing only its lateral protrusions may allow for a more precise relocation procedure.
  • the characteristics and advantages described above with respect to embodiments in which the PAD is adapted for enclosing the entire lens may be adopted in an analogue manner to embodiments in which the PAD is adapted for enclosing only the small sized protrusions at the lens.
  • the ultrasound may be emitted such as to have a wavelength in the manipulation body volume, the wavelength being between 100% and 400% of lateral dimensions of the protrusion, specifically of the width of the protrusion.
  • the PAD may be generated such as to completely enclose the protrusion.
  • the manipulation body volume may be set such that a sub-volume thereof including a PAD forming the twin trap has dimensions which are at most triple, preferably at most double, the dimensions of the protrusion, particularly the width of the protrusion.
  • two or more PADs may be generated within the manipulation body volume such that each PAD forms a twin trap enclosing and capturing one of the protrusions.
  • the acoustic pressure amplitude distribution is generated by irradiating the manipulation body volume with the ultrasonic sound in a focused manner such as to induce acoustic streaming within a focus volume, wherein the ultrasonic sound is focused such that the focus volume is arranged in sufficiently close proximity to the object such that the force sufficient for displacing the object is locally applied to the object as a result of the induced acoustic streaming.
  • the PAD is preferably generated by irradiating ultrasonic sound with an energy density being sufficiently low to avoid acoustic streaming.
  • quasi-stationary acoustic fields may be generated by superimposing ultrasonic sound emitted by at least two ultrasound transducers, thereby providing a quasi- stationary PAD.
  • the ultrasonic sound is emitted with low power and preferably at low frequencies of for example between 20 kHz and 1.5 MHz, preferably between 20 kHz and 500 kHz.
  • the ultrasound is typically generated without being focused or at least without being focused to a very small focus volume. In such ultrasound regime, typically no or at most a non-essential amount of ultrasound acoustic streaming is induced.
  • the PAD is generated by irradiating ultrasonic sound with an energy density being sufficiently high to induce acoustic streaming.
  • acoustic streaming generally occurs in volumes where ultrasonic sound is present at high energy densities and therefore portions of such ultrasonic sound are locally absorbed in the fluid medium transferring the ultrasonic sound. Due to such ultrasonic sound absorption, forces are generated within the fluid medium. Due to such forces, portions of the fluid medium are displaced such that a stream or flow of fluid medium is generated. Typically, such stream produces flow vortices within the fluid medium.
  • ultrasonic sound emitted by ultrasound transducers typically has to be focused onto a small volume, such volume being referred to herein as “focus volume”. Such focus volume may also be referred to as “focal point”.
  • the focusing of the ultrasonic sound may be achieved by using an acoustic lens such as a Fresnel lens.
  • ultrasonic sound focusing may be achieved by implementing several ultrasound transducers in an array of transducers and controlling the transducers with different phases and possibly different amplitudes.
  • the ultrasonic sound is generally emitted with relatively high power and, furthermore, the ultrasonic sound is focused onto the focus volume such that acoustic streaming occurs within the focus volume.
  • the ultrasonic sound may be irradiated with a frequency of between 0.5 MHz and 5 MHz, preferably between 0.75 MHz and 3 MHz and more preferably between 1 MHz and 2 MHz.
  • the ultrasonic sound is focussed to a focus volume of less than 30 mm 3 , preferably to a focus volume of less than 20 mm 3 , less than 10 mm 3 or even less than 3 mm 3 .
  • a cross-section of the focus volume may be smaller than 10 mm 2 , preferably smaller than 6 mm 2 or even smaller than 3 mm 2 .
  • the ultrasonic sound shall be focused to a focus volume which is arranged in close proximity to the object.
  • the focus volume may be interpreted as the volume in which at least 90% of the ultrasound energy emitted by an ultrasound generator is focused, i.e. at most a minor portion of such ultrasound energy is comprised outside the focus volume.
  • the focus volume shall be close enough to at least portions of the object such that the forces generated by the flow vortices induced due to the acoustic streaming affect the object.
  • the flow vortices resulting from the acoustic streaming shall reach at least portions of the object and thereby push these portions of the object into an intended direction corresponding to or being at an angle to a flow direction within the flow vortices.
  • the ultrasonic sound may be focused such that the focus volume is laterally spaced apart from an outer edge or a circumference of the object by less than 10 mm, preferably less than 5 mm or even less than 2 mm.
  • the object comprises a central object body and at least one elongate protrusion radially extending from a circumference of the central object body.
  • the ultrasonic sound is focused such that the focus volume is arranged in sufficiently close proximity to the protrusion.
  • acoustic streaming may preferably be induced in a focus volume being arranged very close to such elongate protrusions.
  • the term “sufficiently close proximity to the protrusion” may be interpreted as defined in one of the preceding paragraphs. Accordingly, the flow vortices generated by the acoustic streaming may act onto the protrusions and push the protrusions into an intended direction. Thereby, the central object body may be displaced and/or rotated as it is mechanically connected to the protrusions affected by the acoustic streaming.
  • the object is a lens comprised in the eye and the ultrasonic sound is irradiated in an irradiation direction being arranged at an angle of less than 60° relative to an optical axis of the lens.
  • the one or more ultrasound transducers used for irradiating the ultrasonic sound generally emit the ultrasonic sound along an irradiation direction corresponding to a transducer axis.
  • Such transducer axis is generally perpendicular to a surface by which the acoustic oscillations are emitted.
  • the transducer axis is the axis along which the acoustic oscillations are emitted and/or propagate through the medium.
  • the ultrasound transducer may be configured and arranged such as to emit the ultrasonic sound with the transducer axis being at an angle of less than 60°, preferably less than 45° or preferably between 5° and 25° in relation to the optical axis of the lens.
  • the ultrasound transducer is configured and arranged such that the transducer axis points at the desired focus volume or focal point. Due to such arrangement and orientation of the transducer axis, the flow vortices in the medium resulting from the acoustic streaming are generated with a flow direction and flow orientation relative to the lens such as to beneficially induce sufficient forces for relocating the lens.
  • the ultrasound transducer array comprises a plurality of ultrasound transducers arranged circumferentially around an optical axis of the lens, upon the lens being comprised in the manipulation body volume, such as to generate multiple focus volumes which are arranged symmetrically and in sufficiently close proximity with regards to the lens, i.e. with regards to the central lens body and/or the protrusion(s).
  • the ultrasound transducer array comprises at least two and preferably more than two ultrasound transducers. These ultrasound transducers are then arranged at opposing sides relative to the optical axis of the lens, assuming that the lens is comprised in the manipulation body volume within the patient’s eye. Each of the ultrasound transducers is arranged at a same lateral distance with regards to the optical axis of the lens. Furthermore, each of the ultrasound transducers is arranged, oriented and configured such as to emit its ultrasonic sound in a focused manner towards a focus volume being in sufficiently close proximity to at least a portion of the lens. Therein, the focus volumes generated by the various ultrasound transducers are arranged symmetrically with regards to the lens. Accordingly, in such arrangement, multiple focal points or focus volumes are generated and are symmetrically arranged in a vicinity of the lens.
  • Rotation of the lens may then be achieved by rotating the arrangement of transducers around the optical axis of the lens as this results in a rotation of the pattern of generated focal points.
  • rotation of the lens may be achieved by electronically controlling a phase and amplitude of the ultrasound transducers in order to dislocate and/or disorient the generated focal points, thereby inducing forces onto the lens for relocating the lens.
  • a combination of mechanically displacing and/or rotating the transducer array and controlling the phase and amplitude of the transducers may allow manipulations over a wide range. For example, mechanical coarse positioning may first be implemented before then precisely positioning the lens for example at an intended angle using electronic fine positioning.
  • the ultrasound transducer array is manipulated such that the acoustic pressure amplitude distribution is laterally displaced and/or rotated within a plane crossing an emission direction of the ultrasonic sound.
  • the PAD and particularly its spatial arrangement and/or its spatial amplitude distribution may be manipulated such that they are displaced within the plane crossing the emission direction of the ultrasonic sound.
  • such plane may be orthogonal to the emission direction.
  • the emission direction may correspond to a direction of propagation of the ultrasonic sound, i.e. to an irradiation direction.
  • the plane may extend along a surface or an interface of the eye at which the object is to be relocated. Accordingly, using the method proposed herein, the object may be displaced along and/or rotated with respect to such eye surface/interface.
  • a fluid coupling medium is interposed between the manipulation body volume and the ultrasound transducer array, the fluid coupling medium having acoustic properties corresponding to acoustic properties of the fluid surrounding the object in the manipulation body volume within a tolerance of ⁇ 50%.
  • Such coupling medium may be a fluid such as a liquid, a gel or the like.
  • Such coupling medium should have acoustic properties such as a speed of sound which is same or similar to the acoustic properties of the fluid in the manipulation body volume.
  • the acoustic properties of the fluid coupling medium are in a range of between 50% and 150% of those in the fluid of the manipulation body volume.
  • the tolerance may be preferably smaller than 50%, i.e. for example 30%, 20% or 10%. Accordingly, ultrasonic sound generated at the ultrasound transducer array may easily be transmitted to the fluid in the manipulation body volume and, particularly, it may be prevented that substantial portions of such ultrasonic sound are reflected at interfaces which, without the provision of the fluid coupling medium, would occur at transitions between the fluid in the manipulation body volume and e.g. a gas-filled volume abutting thereto.
  • the ultrasound transducer array is mechanically fixed to the eye including the manipulation body volume.
  • the ultrasound transducer array may not move relative to the eye at which the object is to be relocated.
  • the eye, in which a lens is to be relocated may be stabilized during the relocation procedure due to its fixation relative to the ultrasound transducer array.
  • the object is a lens, particularly an intraocular lens
  • the manipulation body volume is arranged at an eye of a patient.
  • the method and device described herein may be particularly beneficial for displacing and/or rotating an artificial lens within a manipulation body volume comprised in the eye of a patient.
  • the method may be applied upon the lens having been implanted into a capsular bag in the eye in a first surgery procedure, but then having been dislocated and/or disoriented, i.e. moved and/or rotated from its desired position and/or orientation.
  • the lens may then be rearranged and/or reoriented in a contactless, non- invasive relocation procedure such that a second surgery procedure may be avoided.
  • the ultrasound transducer array comprises at least two ultrasound generators laterally arranged next to each other.
  • the controller is configured for individually controlling an operation of each of the ultrasound generators independently from the other ultrasound generator such that a pattern of the ultrasonic sound generated by the ultrasound transducer array is displaced in a lateral direction and/or a depth direction.
  • the ultrasound transducer array may preferably include plural ultrasound generators.
  • Each ultrasound generator may operate independently from the other ones. Accordingly, each ultrasound generator may emit ultrasonic sound with an individual frequency, amplitude and/or phase.
  • the ultrasound generators may be arranged next to each other. Neighbouring ultrasound generators may directly abut to each other or may be spaced from each other.
  • the ultrasound generators of the ultrasound transducer array may be arranged along a common surface.
  • Such common surface may be planar or curved. Particularly, such common surface may extend substantially in parallel to a plane or a curved surface in which the object is to be relocated with respect to the eye.
  • the controller may individually control the operation of each single ultrasound generator or of subgroups of ultrasound generators independently from other ones of the ultrasound generators.
  • a pattern with which the ultrasonic sound is generated by the ultrasound transducer array may be affected.
  • Such ultrasonic sound pattern generally affects characteristics of the acoustic PAD such as its spatial arrangement and/or its spatial amplitude distribution.
  • the ultrasonic sound pattern may be affected in a controlled manner such that it is displaced in a lateral direction along a plane crossing the emission direction of the ultrasonic sound and/or in a depth direction perpendicular to such lateral direction. Accordingly, by suitably controlling the multiple ultrasound generators, the ultrasonic sound pattern may be affected such that the resulting modifications in the PAD result in a generation of forces acting onto the object in order to relocate the object in an intended manner.
  • the ultrasound transducer array or its ultrasound generators or other components do not necessarily have to be moved themselves in order to displace the object via induced modifications in the PAD.
  • modifications in the PAD may be generated only by suitably controlling the individual ultrasound generators for example with respect to the amplitude and/or phase of ultrasonic sound generated thereby.
  • no moving parts are generally required in the ultrasound transducer array.
  • the controller is configured for individually controlling an operation of each of plural ultrasound generators in the ultrasound transducer array independently from another ultrasound generator in the ultrasound transducer array with regards to a phase of ultrasound emitted by the ultrasound generators as well as with regards to an amplitude of ultrasound emitted by the ultrasound generators.
  • controller and the plural ultrasound generators are adapted such that each of the ultrasound generators may be controlled independently from the other ultrasound generators with regards to both their phase as well as their amplitude.
  • the individual ultrasound generators are typically controlled independently from each other only with regards to their phases but not with regards to their amplitudes.
  • a position of a PAD may be controlled by suitably adopting the phases of the ultrasound emitted by the various ultrasound generators, but also an evolution of the pressure amplitudes comprised in the PAD may be suitably controlled.
  • the relocation procedure may be divided into initial and subsequent phases wherein, in the initial phase, some coarse positioning of the object is established using larger pressure amplitudes in the emitted ultrasound whereas, in the subsequent phase, pressure amplitudes are reduced for enabling fine positioning of the object.
  • the ultrasound transducer array comprises at least one acoustic lens
  • the controller is configured for controlling the at least one acoustic lens such that a pattern of the ultrasonic sound generated by the ultrasound transducer array is displaced in a lateral direction and/or a depth direction.
  • such ultrasound pattern may also be affected by suitably controlling one or more acoustic lenses comprised in the ultrasound transducer array.
  • acoustic lenses may be configured for focusing, diverging and/or redirecting ultrasound transmitted there through.
  • the one or more acoustic lenses may be controlled by the controller of the relocation device with regards to their acoustic properties, thereby affecting ultrasound transmission through the individual acoustic lens, and/or with respect to a spatial arrangement of each one or more acoustic lens, thereby affecting ultrasound transmission through the entire acoustic lens arrangement.
  • the one or more acoustic lenses may be specifically controlled for modifying the pattern of ultrasonic sound in a way such that the resulting PAD induces forces onto the object in the manipulation body volume such as to displace the object in an intended manner.
  • the ultrasound transducer array comprises at least two ultrasound generators laterally arranged next to each other in a symmetric configuration with regards to an axis of symmetry and the device is configured for an alignment and mechanical fixation with regards to the eye such that the axis of symmetry is aligned with an optical axis of the object.
  • the ultrasound transducer array may be arranged such that its axis of symmetry coincides with the optical axis of the object, i.e. for example of the lens, to be relocated upon the device being suitably mechanically fixed and aligned with regards to the eye accommodating the lens.
  • the ultrasound transducer array may for example be easily rotated around the axis of symmetry, thereby also displacing the PAD generated by its ultrasound generators in a rotation motion around the axis of symmetry. Accordingly, upon the axis of symmetry being aligned with the optical axis of the object, displacing the PAD in such manner may be established such that the object is exclusively rotated around its optical axis while avoiding any lateral displacement thereof.
  • the relocation device further comprises a displacement mechanism configured for mechanically displacing at least one component comprised in the ultrasound transducer array in a manner such that a pattern of the ultrasonic sound generated by the ultrasound transducer array is displaced in a lateral direction and/or a depth direction.
  • the relocation device may comprise a specific displacement mechanism with which the positioning of components comprised in the ultrasound transducer array may be affected.
  • Such one or more component may be each component which influences ultrasound generation and/or ultrasound propagation within the ultrasound transducer array.
  • such component may be one of the ultrasound generators, one of the acoustic lenses, an acoustic reflector, an acoustic deflector, an acoustic absorber or the like.
  • the displacement mechanism may comprise one or more actuators.
  • the actuators may operate electromechanically, pneumatically, hydraulically, etc.
  • the displacement mechanism may be configured for displacing the at least one component comprised in the ultrasound transducer array along a linear or curved path.
  • the pattern of ultrasonic sound generated by the ultrasound transducer array may be affected in an intended manner such that the resulting modification in the PAD results in suitable forces being applied to the object to be relocated in the intended manner.
  • the relocation device may comprise a fixation mechanism for fixing the ultrasound transducer array relative to the eye in which the object is to be relocated.
  • the relocation device may comprise a suction unit via which an underpressure may be generated between the eye and the ultrasound transducer array, thereby sucking the ultrasound transducer array to e.g. a surface of an eye in which a lens is to be relocated.
  • the displacement mechanism comprises a rotation mechanism including an actuator for rotating the ultrasound transducer array around a rotation axis coinciding with the optical axis of the object.
  • the displacement mechanism may comprise an actuator such as a motor.
  • Such actuator may be part of a rotation mechanism which is specifically configured for rotating the ultrasound transducer array around an axis coinciding with the optical axis of e.g. the lens to be relocated.
  • the displacement mechanism is mainly or purely configured for rotating the transducer array in a motorised manner.
  • the PAD may be precisely displaced such as to precisely rotate the object to be relocated within the eye.
  • any linear or non-linear lateral displacement of the transducer array and therefore of the object to be relocated may be avoided accordingly.
  • the ultrasound transducer array is configured for emitting ultrasonic sound in an irradiation direction being arranged at an angle of less than 60° relative to an optical axis of the object.
  • irradiating the ultrasonic sound at an non-rectangular angle with respect to the optical axis of for example a lens may be beneficial particularly in cases where the lens is to be displaced using acoustic streaming effects.
  • the device may further comprise a rail supporting ultrasound generators of the ultrasound transducer array such as to be displaceable along the rail, wherein the rail is configured such that, for each of multiple positions along the rail, the ultrasound generators are positioned at a defined distance in relation to a centre point of the object.
  • the ultrasound generators may be arranged along a rail having for example a semi-circular or C-type shape.
  • the rail may define a displacement path along which the ultrasound generators may be displaced.
  • Such displacement path may be semi-circular such that its centre coincides with the centre point of the object to be relocated or with a distal location arranged on the optical axis of the object but distally spaced apart from the object.
  • Such centre point or distal location may be any position at or close to the object at which the PAD is to be generated such as to induce the forces required for relocating the object.
  • each of plural ultrasound generators of the ultrasound transducer array is configured, arranged and oriented such that its transducer axis intersects an optical axis of the object at a location distal to an extension plane in which the object is arranged.
  • the ultrasound generators may be arranged and oriented such that their transducer axes intersect the optical axis of a lens at a side of a vertical/ depth plane, in which the lens body is located, opposite to a side at which the ultrasound generators are located.
  • the ultrasound generators shall be arranged and oriented such that their transducer axes intersect the optical axis of the lens above such extension plane.
  • each transducer axis of each individual ultrasound generator may intersect the vertical/depth plane in which the lens is located at separate locations.
  • the transducer axis of a first ultrasound generator may intersect the vertical/depth plane at a left side of the lens
  • the transducer axis of a second ultrasound generator may intersect the same plane at a right side of the lens and both transducer axes may intersect the optical axis of the lens at a position distal to the lens.
  • the device may further comprise a sealing lip configured for sealingly enclosing a fluid coupling medium between the ultrasound transducer array and the eye.
  • Such sealing lip may be arranged around a volume in between the ultrasound transducer array, on the one side, and the surface of the eye or a surface of tissue adjacent to the eye, on the other side. Such volume may be filled with fluid coupling medium before starting the relocation procedure.
  • the sealing lip may hinder the coupling medium from escaping from the volume.
  • the sealing lip may be specifically shaped and/or adapted for providing a reliable seal between the relocation device and the anatomy of the patient’s eye.
  • the sealing lip may be shaped to enclose the eye circumferentially, e.g. it may mainly extend in a circumferential direction around the optical axis.
  • the device may further comprise a suction unit configured for generating an underpressure between at least portions of the device and the eye for fixing the device relative to the eye.
  • the suction unit may be connected in fluid communication to the volume in between the relocation device and the patient’s eye such as to generate a locally reduced pressure in such volume. Due to such underpressure, the relocation device may temporarily be sucked towards the eye and may thereby be fixed at the eye. Using an underpressure may allow a reliable fixation of the relocation device while, at the same time, enabling softly fixing and possibly releasing the relocation device before and after the relocation procedure.
  • the suction unit may comprise a pump for generating the underpressure.
  • the device may further comprise a tempering unit and a temperature controller for controlling a temperature of fluid coupling medium interposed between the ultrasound transducer array and the eye.
  • the tempering unit and the temperature controller may be configured for setting the temperature of the fluid coupling medium to an increased temperature or a reduced temperature in relation to an ambient temperature and/or in relation to an initial temperature.
  • the tempering unit may be configured for thermalising the fluid coupling medium and the temperature controller may be configured for controlling a thermalisation degree.
  • the tempering unit may cool the fluid coupling medium in order to absorb heat generated during the relocation procedure as a result of absorbing ultrasound energy within the eye and/or within the fluid coupling medium. Accordingly, the tempering unit may be used for avoiding excessive heat at the patient’s eye during the relocation procedure.
  • the device may further comprise a temperature sensor to monitor a temperature of the fluid coupling medium.
  • the device may further comprise a pumping unit for at least one of exchanging and circulating a fluid coupling medium interposed between the ultrasound transducer array and the eye.
  • a pumping unit may be included in the device for exchanging and/or circulating fluid coupling medium in the volume adjacent to the patient’s eye during the relocation procedure.
  • exchanging and/or circulating may help in thermalising the fluid coupling medium and/or homogenising a temperature within such fluid coupling medium.
  • the pumping unit may pump the fluid coupling medium for example through an external reconditioning unit.
  • Such reconditioning unit may for example cool and/or clean the fluid coupling medium before reuse, i.e. for example before re-injecting it into the volume adjacent to the eye.
  • Fig. 1 shows a device for relocating an intraocular lens within an eye of a patient in accordance with an embodiment of the present invention.
  • Fig. 2(a), (b) show a top view and a side view of an intraocular lens.
  • Fig. 3(a), (b) show top views onto an intraocular lens arranged in a pressure amplitude distribution in a fluid comprised in the patient’s eye in a first configuration and in a second configuration.
  • Fig. 4 shows a top view onto an intraocular lens having elongate protrusions and being arranged in two pressure amplitude distributions.
  • Fig. 5 shows a perspective view onto a relocation device for relocating a lens by means of focused ultrasonic sound for inducing acoustic streaming.
  • Fig. 6 shows an enlarged section of Fig. 5.
  • Fig. 7 shows a lens with flow vortices induced by acoustic streaming.
  • Fig. 8 shows a device for relocating an intraocular lens within an eye of a patient in accordance with a further detailed embodiment of the present invention.
  • Fig. 1 shows a device 1 for relocating in a contactless, non-invasive manner an object 3 with regards to an eye 9 of a human or animal body part 5.
  • the object 3 is an intraocular lens 7.
  • the IOL 7 shall be relocated and/or reoriented within a capsular bag 11 in the eye 9.
  • the IOL 7 comprises a circular central lens body 71 as well as two elongate protrusions 73 or legs radially extending from a circumference of the central lens body 71.
  • the protrusions 73 may serve for fixing the IOL 7 in an intended location and/or orientation within the capsular bag 11 in the eye 9.
  • the relocation device 1 comprises an ultrasound transducer array 13 and a controller 15 for controlling the ultrasound transducer array 13.
  • the ultrasound transducer array 13 comprises multiple ultrasound generators 17. Furthermore, the ultrasound transducer array 13 comprises multiple acoustic lenses 19.
  • the ultrasound generators 17 and the acoustic lenses 19 are arranged in a two-dimensional pattern along a curved surface which is substantially parallel to an outer surface of the eye 9. Accordingly, the ultrasound generators 17 and the acoustic lenses 19 are arranged such that each of the ultrasound generators 17 may emit ultrasonic sound 21 in a irradiation direction towards the IOL 7 in the capsular bag 11, while the ultrasonic sound 21 may be transmitted through an associated one of the acoustic lenses 19 and may be e.g. focused and/or deflected thereby.
  • the ultrasound transducer array 13 is adapted for specifically generating an acoustic pressure amplitude distribution (PAD) 23 in a fluid 25 comprised in the eye 9 in a manipulation body volume 27.
  • the fluid 25 is comprised in the capsular bag 11, i.e. the PAD 23 is generated such as to at least partly extend throughout the inner volume of the capsular bag 11.
  • the IOL 7 may swim or float in a manner such as to be easily displaced in a lateral direction and/or in a depth direction and/or rotated using relatively small forces.
  • such forces may be generated by, in a first processing step, generating the acoustic PAD 23 in a manner such as to “clamp” the IOL 7.
  • the ultrasound transducer array 13 may emit ultrasonic sound 21 with such a pattern such that the generated PAD 23 comprises at least one first pressure region 29 of lower acoustic pressure and for example two second pressure regions 31 of higher acoustic pressure.
  • a frequency of the ultrasonic sound 21 used for generating the PAD 23 may be adapted such that a half X/2 of the wavelength X of the ultrasonic sound 21 is same or similar as lateral dimensions of the IOL 7 such as its width. Accordingly, the generated PAD 23 may be located such that the IOL 7 is included within the first pressure region 29 of lower acoustic pressure and is enclosed by the second pressure regions 31 of higher acoustic pressure at both of its opposite sides. Particularly, the protrusions 73 of the IOL 7 may be arranged approximately along a linear line (oriented in Fig. 3(a) in the y-direction) representing the low-pressured first pressure region 29.
  • the ultrasound transducer array 13 is manipulated in a manner such that the PAD 23 is modified with regards to its spatial arrangement and/or its spatial amplitude distribution.
  • the PAD 23 is modified such that the ultrasound pattern generates the low-pressured first pressure region 29 and the adjacent high- pressured second pressure regions 31 in a configuration which is rotated by 90° in comparison to the configuration in the first processing step.
  • the PAD 23 may be modified such as to induce forces which are sufficient for displacing the IOL 7 to an intended position and/or orientation.
  • the controller 15 may individually control an operation of each of the ultrasound generators 17 independently from other ultrasound generators 17 such that the pattern of ultrasonic sound 21 generated by the ultrasound transducer array 13 is displaced in a lateral direction, i.e. moved in a linear and/or rotational motion within an x-y-plane orthogonal to a z-direction corresponding to the ultrasound irradiation direction.
  • the ultrasound generators 17 may be operated such that the pattern of ultrasonic sound 21 generated by the ultrasound transducer array 13 is displaced in a depth direction, i.e. moved in the z-direction.
  • the controller 15 may control the acoustic lenses 19 such that the pattern of ultrasonic sound 21 generated by the ultrasound transducer array 13 is displaced in the lateral direction and/or a depth direction.
  • the relocation device 1 comprises a displacement mechanism 33. This displacement mechanism 33 may displace at least one of the components, i.e. one of the ultrasound generators 17, one of the acoustic lenses 19 and/or one of an optional multitude of other components, in a manner such that the pattern of ultrasonic sound 21 generated by the ultrasound transducer array 13 is displaced laterally or in the depth direction.
  • the ultrasound transducer array 13 may be operated such that the PAD 23 is modified in a manner such as to generate forces via which the IOL 7 may be precisely relocated in six degrees of freedom, i.e. along three orthogonal directions x, y, z and/or around three orthogonal rotation axis.
  • the method proposed herein may also be used for assisting in an initial implantation of an IOL (or prosthesis or body part) by translocating the respective object from outside of a body to inside of the body. This may help in implementing an increased automation of a surgical procedure.
  • a liquid or gel serving as a fluid coupling medium 35 is interposed between the ultrasound transducer array 13 and an outer surface of the eye 9.
  • the fluid coupling medium 35 has similar acoustic properties as the fluid 25 within the capsular bag 11.
  • the relocation device 1 may comprise a fixation mechanism 37 via which the ultrasound transducer array 13 may be temporarily mechanically fixed to the eye 9 including the manipulation body volume 27.
  • the fixation mechanism 37 may be implemented with sealing lips 41 and a suction unit 39 (only indicated very schematically) which may generate an underpressure between the ultrasound transducer array 13 and an outer surface of the eye 9. Thereby, the eye 9 may be stabilized, if e.g. the relocation device 1 is used to assist in cataract / IOL surgery.
  • Fig. 4 shows an alternative embodiment in which, instead of enclosing the IOL 7 in its entirety between a single pair of opposing high-pressured second pressure regions 31 as in the embodiment represented in Fig. 3, two pairs of smaller high-pressured second pressure regions 31 are generated adjacent to each one of protrusions 73 radially extending from the circumference of the central lens body 71 of the IOL 7.
  • a single larger sized twin trap instead of using a single larger sized twin trap in which the entire IOL 7 is trapped in a low-pressured first pressure region 29 having similar lateral dimensions as the IOL 7 itself and being interposed between two relatively large sized high-pressured second pressure regions 31 , as is the case in the embodiment of Fig. 3, the embodiment of Fig.
  • Figs. 5 to 7 visualise an alternative embodiment for trapping and relocating the IOL 7.
  • ultrasonic sound 21 is emitted by two or more ultrasound generators 17 at high intensity and in a focused manner to form PADs 23 such as to induce acoustic streaming in focus volumes 81 close to the lens 7 for intentionally effecting forces onto the lens 7 for relocating same.
  • each ultrasound generator 17 may comprise or may be coupled with an acoustic lens such as a Fresnel lens. Additionally or alternatively, focusing may be achieved by implementing the transducers as an array of transducers that are controlled with different phases and, possibly, different amplitudes.
  • the two or more ultrasound generators 17 may be arranged in an array and/or may be arranged such as to be displaceable with respect to each other.
  • the ultrasound generators 17 may be arranged at different angles with respect to each other and/or with respect to the optical axis 79 of the lens 7.
  • two ultrasound generators 17 are coupled to a C-shaped rail 85 and may be displaced relative to each other along this rail 85.
  • a position and/or orientation of the ultrasound 21 emitted by each of the ultrasound generators 17 may be adapted or modified in an intended manner.
  • the ultrasound generators 17 may be arranged such that their emitted ultrasound 21 is directed with its propagation direction 89 being at an angle a of less than 60°, preferably less than 45° and most preferably between 5° and 25° with respect to the optical axis 79 of the lens 7.
  • the rail 85 may be rotated around a centre axis 87.
  • the ultrasound 21 is focused, i.e.
  • the ultrasound generators 17 may be arranged in a symmetric configuration with regards to an axis 91 of symmetry.
  • Such axis 91 may be set such as to coincide with the optical axis 79 of the lens 7.
  • the axis 91 may be set such as to coincide with the centre axis 87.
  • the ultrasound transducer array 13 may symmetrically extend and rotate around the optical axis 79 of the lens 7 in order to thereby rotate the lens 7 by suitably displacing the PAD 23 in a rotation motion.
  • the focusing is set such that the focus volume 81 is arranged in sufficiently close proximity to the lens 7 or, preferably, to one of its elongate protrusions 73, such that, as a result of the high-intensity ultrasonic sound 21 within the focus volume 81, forces are effected onto the lens 7 for displacing it.
  • the high-intensity ultrasonic sound 21 within the focus volume 81 is absorbed in the fluid 25 within the manipulation body volume 27, thereby inducing some acoustic streaming within or close to the focus volume 81.
  • the ultrasound generators 17 are configured, arranged and oriented such that there transducer axes 89 intersect the optical axis 79 of the lens 7 at a location 93 distal to an extension plane of the lens 7.
  • each of the transducer axes 89 intersects the extension plane of the lens 7 at an intersection location 95 which is laterally spaced apart from the optical axis 79.
  • the focus volume 81 arranged at such intersection location 95 may be positioned at or close to one of the elongate protrusions 73 at the outer circumference of the lens 7. Accordingly, two focus volumes 81 are generated, one per protrusion 73, i.e. one at a first side of the central lens body and one at an opposite second side thereof.
  • such acoustic streaming generally induces flow vortices 83 within the fluid 25.
  • a fluid flow in such flow vortices 83 generates forces onto the lens 7 and/or its elongate protrusions 73.
  • these forces are used for translocating and/or rotating the lens 7.
  • Fig. 8 shows a further detailed representation of an embodiment of the relocation device 1.
  • the device 1 comprises a tempering unit 97 and a temperature controller 99 for controlling the temperature in the fluid coupling medium 35 between the ultrasound transducer array 13 and the eye 9.
  • the temperature controller 99 is connected to a temperature sensor 101 arranged within the fluid coupling medium 35 for measuring its temperature.
  • the device 1 comprises a pumping unit 103 which may exchange and/or circulate the fluid coupling medium 35.
  • the tempering unit 97, the temperature controller 99, the temperature sensor 101, the pumping unit 103, the displacement mechanism 33, the fluid coupling medium 35, the fixation mechanism 37 and/or the suction unit 39 may communicate and/or exchange signals with each other and/or with the controller 15.
  • the embodiments of the invention use acoustic pressure amplitude distributions to manipulate an object inside the body in a direct, non-invasive manner.
  • a pressure amplitude distribution is generated inside the body by means of at least one, preferably multiple electroacoustic transducers that are located outside the body.
  • the arrangement of transducers might also comprise at least one acoustic lens to focus or manipulate the acoustic PAD in a desired manner. This arrangement is referred to as the transducer array.
  • the transducer array is preferably coupled to the body via a coupling medium, preferably a fluid or gel.
  • the coupling medium preferably exhibits similar acoustic properties to those of the body, in order to facilitate good transmission of the acoustic energy /PAD into the body with little losses and heating.
  • the coupling medium may further be used to control the temperature (esp. cooling) of the body during the procedure.
  • the PAD comprises regions of high and low acoustic pressures. Particularly, the PAD comprises at least one, preferably at least two regions of high acoustic pressure.
  • the PAD is generated dependent on certain attributes of the object to be moved, particularly dependent on its size, location inside its body (and resulting distance from the transducer array), orientation, acoustic properties of its material, etc.
  • the PAD is generated directly at/in the vicinity of the object to be manipulated, in order to achieve direct manipulation.
  • Direct manipulation refers to the circumstance that the (acoustic) forces resulting from the PAD (more precisely its local gradients), act in the immediate vicinity of or directly on the body to be manipulated.
  • the manipulation does not (at least not primarily) rely on “secondary effects”, such as tissue damage/scarring, relaxation and/or tensioning of muscles, cavitation, etc.
  • the acoustic energy is kept to a level that is sufficiently low to limit losses/heating to below critical values (i.e., values at which significant cell or tissue damage would occur) and to prevent cavitation.
  • Manipulation refers to the translocation and/or rotation of the object in any plane and/or around any axis. Manipulation is achieved by generating at least two PADs in a sequential manner, of which an initial PAD corresponds to the original state of the object and a final PAD corresponds to the target state of the object. The object is “trapped” in the low pressure regions of the respective PAD. If the PAD is manipulated, the object follows this manipulation.
  • FIG. 2 shows schematic top and side views of an IOL and the introduced coordinate system.
  • Figure 1 shows a side view of the embodiment with the IOL already implanted into the capsular bag of the eye.
  • the transducer array consisting of multiple individual electroacoustic transducers is placed above the eye and oriented such that the acoustic energy (sound waves) are emitted in the direction of the eye.
  • the transducer array is coupled to the eye via a coupling medium.
  • a schematic representation of the generated PAD in a vertical plane is shown. It consists of two adjacent high pressure regions in the immediate vicinity of the IOL.
  • Figure 3 shows a top view of the IOL to be rotated and the surrounding PAD in a horizontal plane.
  • the forces resulting from the PAD are symbolized by the small arrows. The magnitude of these forces depends on the local gradients of the PAD and can be adjusted by adjusting the acoustic power supplied to the transducer array.
  • the IOL is in its initial angular position around its optical axis (an axis passing through the rotational centre of the IOL, parallel to the z axis) and surrounded by the first PAD.
  • the PAD is rotated clockwise to transfer a torque to the IOL.
  • Figure 3(b) shows the IOL in its final angular position rotated in the clockwise direction by 90° and surrounded by the final PAD.
  • the PAD is rotated in several intermediate steps, e.g., in 10° intervals, before reaching the final PAD.
  • the PAD can be moved horizontally to achieve a horizontal movement of the lens.
  • a PAD exhibiting regions of high acoustic pressure above and below the IOL is generated.
  • a manipulation of the lens in the vertical direction is then achieved by moving the location of these high pressure regions vertically.
  • the acoustic wavelength X should be chosen according to the geometry of the object to be manipulated.
  • the main body of the IOL (the central circular lens part) has a diameter in the range of 6 mm.
  • the spacing between the high pressure regions of the PAD should be such that this body is accommodated in between them.
  • the high pressure regions of the considered PAD occur at a distance of X/2, as shown in Fig. 3(a). Choosing, for example, X/2 to be 1.5 times the characteristic dimension of the manipulated object (6 mm), results in an acoustic wavelength of 18 mm, which in turn results in a desirable acoustic frequency of
  • acoustic streaming refers to a flow in a fluid driven by the absorption acoustic oscillations. Acoustic oscillations are caused by at least one electroacoustic transducer.
  • the fluid refers to the fluid inside the capsular back in the immediate surrounding and in contact with the intraocular lens.
  • the acoustic field (pressure amplitude distribution) is focused on the legs of the intraocular lens, as schematically shown e.g. in Fig. 6.
  • Streaming is caused around the focal points in close proximity to the legs of the lens.
  • the focal points are located away from the optical axis of the lens. This streaming/flow of fluid results in a force acting on the lens.
  • the device (Fig. 5) consists of at least one transducer.
  • the transducer axis refers to the axis perpendicular to the surface by which the acoustic oscillations are emitted, i.e. the transducer axis is the axis along which the acoustic oscillations propagate through the medium.
  • the transducer is arranged, such that the optical axis of the lens and the transducer axis have an angle ⁇ 60°, preferably ⁇ 45°, particularly >5° and ⁇ 25° to each other.
  • the transducer is arranged, such that the transducer axis points at the desired focal point. Focusing is achieved by using an acoustic lens, such as a Fresnel lens. Alternatively or additionally, focusing is achieved by implementing the transducer as an array of transducers that are controlled with different phases (and amplitudes).
  • a plurality of transducers is used, that are arranged circumferentially around the optical axis of the lens to generate multiple focal points that are symmetrically arranged in the vicinity of the lens.
  • Rotation of the lens is achieved by rotating the arrangement of transducers around the optical axis of the lens. This results in a rotation of the generated focal points.
  • rotation of the lens is achieved by electronically controlling the phase and amplitude of the transducers to dislocate and/or disorient the generated focal point.
  • the transducers (for streaming) are operated between 500 kHz and 5 MHz, preferably between 750 kHz and 3 MHz, particularly between 1 MHz and 2 MHz.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un procédé et un dispositif (1) de repositionnement sans contact et non invasif d'un objet (3), tel qu'une lentille intraoculaire (7), par rapport à un œil (9) humain ou animal. Le procédé consiste : • à générer une distribution d'amplitude de pression acoustique (23) dans un fluide (25) compris dans l'œil, dans un volume de corps de manipulation (27) contenant l'objet, par irradiation dudit volume par ultrasons (21) émis par un réseau de transducteurs à ultrasons (13) ; et • à manipuler le réseau de transducteurs à ultrasons de sorte que la distribution d'amplitude de pression acoustique soit modifiée par rapport à sa disposition spatiale et/ou sa distribution d'amplitude spatiale, de sorte qu'une force suffisante pour déplacer l'objet soit appliquée localement à l'objet par la distribution d'amplitude de pression acoustique modifiée.
PCT/EP2023/063986 2022-05-25 2023-05-24 Procédé et dispositif de repositionnement sans contact et non invasif d'un objet, tel qu'une lentille, par rapport à un œil WO2023227692A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102022113321.4A DE102022113321A1 (de) 2022-05-25 2022-05-25 Verfahren und Vorrichtung zum berührungslosen, nicht-invasiven Verlagern eines Objekts, wie z.B. einer Linse, in Bezug auf einen Körperteil, wie z.B. ein Auge
DE102022113321.4 2022-05-25

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Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2211207B1 (fr) 1972-12-21 1976-10-08 Krasnov Mikhail
US3990452A (en) 1975-06-13 1976-11-09 Fibra-Sonics, Inc. Medical machine for performing surgery and treating using ultrasonic energy
EP0617599B1 (fr) 1991-12-20 1996-10-16 Technomed Medical Systems Appareil de therapie par ultrasons emettant des ondes ultrasoniques produisant des effets thermiques et des effets de cavitation
DE19623213A1 (de) 1996-06-11 1998-01-02 Geuder Hans Gmbh Augenchirurgisches Instrument zum Zertrümmern von Augenlinsen mittels Ultraschall und zum Absaugen von Linsentrümmern
CA2213648A1 (fr) 1997-10-14 1999-04-14 Timothy Y. C. Chan Appareil de surveillance de la depletion de liquide du chan
US7178530B2 (en) 2002-10-25 2007-02-20 Rines Robert H Method of ameliorating vision-inhibiting effects of cataracts and the like
EP2996649A1 (fr) 2013-05-16 2016-03-23 WaveLight GmbH Interface utilisateur sans contact pour dispositifs ophtalmiques
WO2016131055A1 (fr) 2015-02-13 2016-08-18 Wright Kenneth A Systèmes et procédés de surveillance de la santé oculaire
WO2017053673A1 (fr) * 2015-09-24 2017-03-30 Visionage Therapies, Llc Procédés et appareil soniques et ultrasoniques pour le traitement du glaucome
WO2017161348A1 (fr) 2016-03-18 2017-09-21 Aleyegn Technologies, Llc Procédés et appareils de positionnement de lentille oculaire effectif
EP2512599B1 (fr) 2009-12-10 2020-02-12 Theraclion SA Dispositif de traitement ultrasonore
WO2022003682A1 (fr) * 2020-06-29 2022-01-06 Shaare Zedek Scientific Ltd. Dispositif de manipulation intra-oculaire
WO2022002825A1 (fr) 2020-06-30 2022-01-06 ETH Zürich Manipulation sans contact d'objets à l'aide de transducteurs électroacoustiques commandés
WO2022058281A1 (fr) 2020-09-15 2022-03-24 ETH Zürich Procédé de manutention d'un objet dans une distribution d'amplitude de pression

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2211207B1 (fr) 1972-12-21 1976-10-08 Krasnov Mikhail
US3990452A (en) 1975-06-13 1976-11-09 Fibra-Sonics, Inc. Medical machine for performing surgery and treating using ultrasonic energy
EP0617599B1 (fr) 1991-12-20 1996-10-16 Technomed Medical Systems Appareil de therapie par ultrasons emettant des ondes ultrasoniques produisant des effets thermiques et des effets de cavitation
DE19623213A1 (de) 1996-06-11 1998-01-02 Geuder Hans Gmbh Augenchirurgisches Instrument zum Zertrümmern von Augenlinsen mittels Ultraschall und zum Absaugen von Linsentrümmern
CA2213648A1 (fr) 1997-10-14 1999-04-14 Timothy Y. C. Chan Appareil de surveillance de la depletion de liquide du chan
US7178530B2 (en) 2002-10-25 2007-02-20 Rines Robert H Method of ameliorating vision-inhibiting effects of cataracts and the like
EP2512599B1 (fr) 2009-12-10 2020-02-12 Theraclion SA Dispositif de traitement ultrasonore
EP2996649A1 (fr) 2013-05-16 2016-03-23 WaveLight GmbH Interface utilisateur sans contact pour dispositifs ophtalmiques
WO2016131055A1 (fr) 2015-02-13 2016-08-18 Wright Kenneth A Systèmes et procédés de surveillance de la santé oculaire
WO2017053673A1 (fr) * 2015-09-24 2017-03-30 Visionage Therapies, Llc Procédés et appareil soniques et ultrasoniques pour le traitement du glaucome
WO2017161348A1 (fr) 2016-03-18 2017-09-21 Aleyegn Technologies, Llc Procédés et appareils de positionnement de lentille oculaire effectif
WO2022003682A1 (fr) * 2020-06-29 2022-01-06 Shaare Zedek Scientific Ltd. Dispositif de manipulation intra-oculaire
WO2022002825A1 (fr) 2020-06-30 2022-01-06 ETH Zürich Manipulation sans contact d'objets à l'aide de transducteurs électroacoustiques commandés
WO2022058281A1 (fr) 2020-09-15 2022-03-24 ETH Zürich Procédé de manutention d'un objet dans une distribution d'amplitude de pression

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