US20220280799A1 - Apparatus and method for treatment of dry eyes - Google Patents
Apparatus and method for treatment of dry eyes Download PDFInfo
- Publication number
- US20220280799A1 US20220280799A1 US17/679,450 US202217679450A US2022280799A1 US 20220280799 A1 US20220280799 A1 US 20220280799A1 US 202217679450 A US202217679450 A US 202217679450A US 2022280799 A1 US2022280799 A1 US 2022280799A1
- Authority
- US
- United States
- Prior art keywords
- energy
- eyelid
- distal end
- optical fiber
- tip
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
Links
- 238000011282 treatment Methods 0.000 title claims abstract description 34
- 238000000034 method Methods 0.000 title description 13
- 208000003556 Dry Eye Syndromes Diseases 0.000 title description 11
- 206010013774 Dry eye Diseases 0.000 title description 10
- 210000000744 eyelid Anatomy 0.000 claims abstract description 96
- 239000000835 fiber Substances 0.000 claims abstract description 51
- 210000004175 meibomian gland Anatomy 0.000 claims abstract description 12
- 230000003287 optical effect Effects 0.000 claims abstract description 9
- 210000001519 tissue Anatomy 0.000 claims description 15
- 239000013307 optical fiber Substances 0.000 claims description 13
- 238000002604 ultrasonography Methods 0.000 claims description 3
- 239000000560 biocompatible material Substances 0.000 abstract description 3
- 230000008878 coupling Effects 0.000 abstract description 3
- 238000010168 coupling process Methods 0.000 abstract description 3
- 238000005859 coupling reaction Methods 0.000 abstract description 3
- 210000001508 eye Anatomy 0.000 description 21
- 238000010438 heat treatment Methods 0.000 description 13
- 239000000463 material Substances 0.000 description 11
- 210000000720 eyelash Anatomy 0.000 description 8
- 210000004087 cornea Anatomy 0.000 description 5
- 230000006378 damage Effects 0.000 description 4
- 210000004907 gland Anatomy 0.000 description 4
- 230000001681 protective effect Effects 0.000 description 4
- 208000010217 blepharitis Diseases 0.000 description 3
- 230000007246 mechanism Effects 0.000 description 3
- 229920001296 polysiloxane Polymers 0.000 description 3
- 210000003786 sclera Anatomy 0.000 description 3
- 238000010008 shearing Methods 0.000 description 3
- 210000003491 skin Anatomy 0.000 description 3
- 241000238876 Acari Species 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 2
- 206010065062 Meibomian gland dysfunction Diseases 0.000 description 2
- 241001303601 Rosacea Species 0.000 description 2
- 241000746998 Tragus Species 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 210000000795 conjunctiva Anatomy 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 238000001126 phototherapy Methods 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 201000004700 rosacea Diseases 0.000 description 2
- 230000028327 secretion Effects 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 239000012780 transparent material Substances 0.000 description 2
- 201000004384 Alopecia Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 210000000080 chela (arthropods) Anatomy 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 208000037976 chronic inflammation Diseases 0.000 description 1
- 230000006020 chronic inflammation Effects 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 238000002716 delivery method Methods 0.000 description 1
- 210000003780 hair follicle Anatomy 0.000 description 1
- 208000024963 hair loss Diseases 0.000 description 1
- 230000003676 hair loss Effects 0.000 description 1
- 210000003128 head Anatomy 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 230000005923 long-lasting effect Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 238000004904 shortening Methods 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000000015 thermotherapy Methods 0.000 description 1
- 238000011277 treatment modality Methods 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N5/0613—Apparatus adapted for a specific treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
-
- 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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N5/0613—Apparatus adapted for a specific treatment
- A61N5/0625—Warming the body, e.g. hyperthermia treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N5/067—Radiation therapy using light using laser light
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N2005/063—Radiation therapy using light comprising light transmitting means, e.g. optical fibres
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
- A61N2005/0643—Applicators, probes irradiating specific body areas in close proximity
- A61N2005/0644—Handheld applicators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N2005/065—Light sources therefor
- A61N2005/0651—Diodes
Definitions
- the present invention relates to an apparatus and method of treating dry eyes using a disposable/removable tip and an energy source that treats as well as heats a Meibomian Gland, the energy source being selected from among light sources, radio frequency (RF) sources and/or ultrasound (US) or other sources.
- RF radio frequency
- US ultrasound
- blepharitis a chronic inflammation of the eyelid margin. This is because if eyelid glands are chronically inflamed, they produce too little or even no secretions, which leads to an unstable tear film
- the treatment of chronic blepharitis is not trivial, as it is often caused by pathogens such as bacteria and skin mites.
- IPL Intelligent Pulsed Light
- IPL is a light pulse therapy that may be used to treat the inflammatory causes of dry eye, stimulate the eyelid glands and accelerate healing.
- Other light sources such as LED or laser light, may be used.
- the use of a light source is for the purpose of generating heat, and causing photomodulation, so as to heat up the area of a Meibomian Gland, so other sources of generating heat may be used.
- Meibomian gland expression is also a therapeutic approach, in which the glands are squeezed, generally after being heated through the use of IPL energy, LED energy or other energy, to force the meibum secretion out. Typically, this is achieved by pressing the eyelid from the outside with a finger, against a q-tip placed between the eyelid and the sclera. Sometimes, dedicated pincers or paddles are used for MGX.
- a method of treating ocular tissue by application of energy for treating dry eye includes: providing an energy generating device, the device further comprising a tip, and the tip has an extension that can be inserted posterior to an eyelid; the energy-generating device provides energy to the posterior of the eyelid; the method includes the steps of: inserting the tip posteriorly of the eyelid prior to applying energy to the posterior surface of the eyelid; and, applying energy from the energy device to the posterior surface of the eyelid.
- a shielding extension is provided on the extension and includes a thermally insulative material such that energy not absorbed by a target tissue is prevented from reaching ocular tissue located posterior to the eyelid.
- the shielding extension is configured to be inserted posterior to an eyelid between the ocular conjunctiva and palpebral conjunctiva.
- the tip may be a removable tip.
- the energy generating device is a light energy generating device.
- the light energy device may be one or more of: LED energy or IPL.
- the energy device may be one or more of: RF energy or ultrasonic energy.
- a method of treating ocular tissue during application of energy for treating dry eye may include: providing an energy generating device, the device further comprising a tip which may be generally U-shaped and configured to be inserted both anterior and posterior to an eyelid; the energy-generating device provides energy to one or both of the anterior and the posterior of the eyelid; the method comprising the steps of: inserting the tip anteriorly and posteriorly of the eyelid prior to applying energy to one or more of the anterior and posterior surfaces of the eyelid; and, applying energy from the energy device to one or more of the anterior and posterior surfaces of the eyelid.
- a shielding extension is provided on the posterior portion of the tip and is comprised of a thermally insulative material such that energy not absorbed by a target tissue is prevented from reaching ocular tissue located posterior to the eyelid.
- the energy generating device further comprises a shaft having a distal end portion; the shaft may be movable toward and away from the anterior of the eyelid; and, the energy generating device may be mounted on the distal end portion of the shaft; the method includes the steps of: moving the shaft distally to contact the anterior of the eyelid; activating the energy-generating device to provide energy to the posterior of the eyelid; and, moving the shaft further distally to apply pressure to the eyelid positioned between the distal portion of the shaft and the tip extension posterior of the eyelid.
- An objective of embodiments herein is to eliminate or at least alleviate the problems discussed above.
- An embodiment relates to a disposable/removable tip (DT) attachable on the (distal) end of a fiber bundle, allowing transmitting light energy from the fiber bundle to an eyelid and comprising a contact surface made of bio-compatible material, which allows to contact the eyelid.
- the disposable/removable tip allows transmitting light energy from the fiber bundle to the posterior surface of the eyelid.
- the DT preferably comprises a bent or inflected structure of a transparent or translucent material.
- the DT has a spatula distal tip bent down with respect to the optical fiber bundle.
- the DT comprises means (e.g. opaque or reflecting portions of the DT) for protecting the eyelashes, hair follicle or an eye against damage caused by light or high temperature.
- the DT comprises a distal tip and a proximal tip which form a clamp preferably bent downwards with respect to the fiber bundle and adapted to encompass or grasp an eyelid therebetween.
- a disposable/removable tip has a lot of advantages compared to a tip fixed to a medical device or light guide. But however it should be clear that the treatment can also be administered with a fixed tip having the same features as described above.
- Another embodiment relates to an add-on device, comprising a fiber bundle, having a distal end and a proximal end, wherein a disposable/removable tip is attachable to the distal end, while the proximal end is connected to an optical coupler, designed for optical and/or energy coupling with light source, like a Lumenis M22 handpiece or other IPL devices.
- Another embodiment relates to a system of the disposable/removable tip and the add-on device.
- Another aspect of the invention is a method for treating blepharitis or Meibomian gland dysfunction comprising the steps of treating a patient's eyelids with IPL/Light using a disposable tip as described above and preferably also executing Meibomian gland expression (MGX).
- MGX Meibomian gland expression
- Yet another aspect of the invention is the use of a protective contact lens that is inserted prior to treatment that protects a cornea and other ocular surfaces from the light and/or heat sources used in the course of treatment for dry eyes by providing thermal isolation through use of the protective contact lens as described herein.
- Yet another aspect of the invention is to connect the tip to a vacuum source causing the tip to “stick” to the eyelid.
- the tips described above and below in the drawings may comprise (a) through hole(s) in the soft material of the tips that is/are connected to a vacuum source on a proximal end having (a) distal suction ending(s) in the vicinity of a patient' s posterior or anterior eyelid.
- the vacuum source can be included in the add-on device or the IPL/light source.
- FIG. 1 shows a disposable tip with a round, soft shape
- FIG. 2 a shows a disposable tip with a concave shape
- FIG. 2 b shows an alternative disposable tip with a concave shape
- FIG. 3 a shows a disposable tip with an eyelid clamp
- FIG. 3 b shows a disposable tip with light guidance
- FIG. 3 c shows a disposable tip with an eyelid clamp moved with a telescope
- FIG. 3 d shows a disposable tip with an eyelid clamp moved with a sledge
- FIG. 4 shows a system for forwarding light energy.
- FIG. 5 shows an insert for the protection of the patient's eye.
- Anatomical terms of location like distal and proximal refer to the devices described not to a patient (except where mentioned otherwise). In consequence, a distal end of a device may be closer to a patient, than a proximal end of the device.
- a disposable or removable tip (DT) 1 may be constructed of a transparent or translucent material, such as silicone, which allows delivery of light energy (preferably IPL or laser) to an eyelid 5 .
- the DT 1 may be provided in clean/sterile state i.e. packaging, for example one for each eye, to allow hygienic treatment for every patient.
- the DT packaging is opened and the DT 1 is mounted over the distal end 4 of the fiber bundle 2 .
- Mounting may be accomplished by adhesive, force-fitted (friction between sides of the fiber bundle 2 and an annular part of the DT surrounding the fiber bundle 2 ) or form-fitted (e.g. by a thread).
- the fiber bundle 2 in particular an optical fiber cable, also known as a fiber optic cable, is an assembly similar to an electrical cable, but containing one or more optical fibers that are used to carry light, which light source may be Intense Pulse Light (IPL)or another light source, such as LEDs.
- the fiber bundle 2 may be surrounded by a protective tube 12 , which may have a reflective inner surface.
- a semi-transparent material can be used to manufacture the DT 1 , for example, by doping or tinting the material.
- One such material is silicone.
- the DT 1 By using such a technique, a part of the light energy will be absorbed by the DT 1 , thus heating it and resulting in delivery of this heat to a surrounding patient's tissue, for example an eyelid.
- heat has been shown to be a useful treatment modality for MGD, alleviating some Dry Eye symptoms.
- the DT may include a temperature sensor for sensing the temperature of the tip itself and/or a patient's eyelid while in use.
- a transparent material may be used to forward as much of the light energy as possible.
- the treatment process might comprise a first step, wherein an eyelid 5 is heated up with a heating element or a light source as described above.
- a second step after the eyelid has been heated a predetermined time or the temperature of the eyelid has exceeded a predetermined threshold—the outside of the eyelid is touched and pressure is put on the eyelid 5 , which is now clamped between the tip and a piece or stop, like a Q-Tip, that is positioned in back of the eyelid 5 .
- the heating can be maintained during the second step.
- the steps of heating and exerting pressure on an eyelid can be conducted simultaneously or intermittently.
- the materials used may be bio-compatible, for example silicone, to allow light forwarding from the fiber bundle 2 and delivery to a patient's skin/tissue, for example, safe contact with an eyelid 5 or even an eye. This applies at least for light transmitting parts of the DT 1 or parts coming into contact with a patient, like the surface of a contact zone facing the patient. Other parts of the DT 1 might comprise different types of materials.
- FIG. 1 depicts a design which provides a more comfortable treatment experience for a patient.
- the light beam 3 may be transmitted via the fiber bundle 2 and to the distal end 4 of the fiber bundle 2 and then into the disposable tip (DT) 1 .
- This DT 1 transmits heat from the light beam 3 via a contact surface to the patient's eyelid.
- a round, soft tip 11 allows a comfortable interface for the physical contact between the tip 11 and the eyelid 5 .
- the soft tip 11 may also be hemispherically shaped (shown in FIG. 2 a , 3 a ) so that, when contacting the eyelid, the softness of the material distributes the force and in consequence the pressure on the eyelid 5 .
- FIG. 2 a depicts a concave-shaped DT 1 which enables better conformation to the natural curvature of the eyelid 5 , as a mere surface contact would do. This allows stable delivery of light and heat from a light source, as well as the capability to generate a vacuum between the DT 1 and the eyelid 5 , effectively attaching the DT 1 to the eyelid 5 (similar to the principle of a vacuum cup).
- FIG. 2 b depicts an enhanced version of the DT 1 of FIG. 2 a to allow usage of the DT 1 for MGX.
- the fiber bundle 2 is positioned within a lumen 22 of a tube 21 or shaft.
- the tube 21 surrounds the fiber bundle 2 .
- the tube has one end aligned with the distal end 4 of the fiber bundle 2 while the other end of the tube 21 has an open end with the fiber bundle 2 proceeding further proximal.
- a handle (not depicted) for manually moving the tube 21 axially/translational may be attached proximal to the distal tip.
- the DT 1 is attached to the external tube 21 , thus covering also the centered fiber bundle 2 . Therefore, the DT 1 may overlap the tube 21 in a proximal direction, like a cap.
- the attachment e.g. force-fitted
- the attachment is of such a strength, which allows movement within the DT 1 , in particular shearing forces, induced by moving the fiber bundle 2 inside the lumen 22 in a distal direction relatively to the tube 21 .
- the tube 21 or DT 1 is gently pulled away from the eyelid 5 or/and at the same time pushing the fiber bundle 2 towards the eyelid 5 .
- This causes a change of the radius of the concave shaped contact surface, as the fiber bundle 2 presses towards the center of the concave contact surface, while the outer part of the concave contact surface is pulled away by the tube 21 , which is connected at the outer part of the DT 1 .
- the effect is that a first region (center region 25 ) of the eyelid 5 is moved in one direction while a second region (outer region 23 ), which is very close to the first region, is moved to the opposite direction. This causes a shearing force on the eyelid 5 which leads to a squeezing effect, effectuating MGX.
- a DT 1 is provided which is easy to assemble and in addition to IPL treatment allows MGX treatment.
- FIG. 3 a depicts another embodiment of a DT 1 in a cross section of the eyelid 5 with the DT 1 shown placed on both sides of the eyelid 5 .
- the DT 1 includes both an inner (proximal) 32 and an outer (distal) tip 31 of a clamp.
- a gap 34 separates tips 31 and 32 and may have a variable distance so that the distance between the tips may be changed.
- the outer tip 31 (distal) of the DT 1 is located between the eyelid 5 and the sclera 33 .
- the eyelid 5 is placed between both tips 31 , 32 and the distance between the tips 31 , 32 is reduced to create a squeezing force suitable for effecting MGX.
- the reduction in distance between the tips may be accomplished with a sliding or other mechanism (to be discussed below in connection with FIGS. 3C and 3D ).
- the sliding or other action that varies the distance between tips 31 and 32 may be manual or may be automated using a motor or other mechanism under manual control or under control of a suitable controller.
- a pressure-sensing device may be incorporated so that the degree of force exerted on the eyelid clamped between tips 31 and 32 is controllable.
- this embodiment allows a more typical delivery method of MGX, in particular, using a squeezing force (two opposite forces aligned) instead of a shearing force (two opposite forces parallel misaligned). Both embodiments allow, in addition, light/heat treatment.
- a squeezing force two opposite forces aligned
- a shearing force two opposite forces parallel misaligned
- FIG. 3 b depicts a similar embodiment or even an enhancement of the previous embodiment of FIG. 3 a with the goal of a more efficient energy delivery to the target organs (the Meibomian glands 35 ) as well as to protect eyelashes 36 .
- the proximal tip 32 may be opaque or comprise an opaque plastic 37 preferably at least covering part of the surface which—in the case of use—touches the eyelid in the region of the eyelashes. This prevents the eyelashes from being damaged.
- the outer surface (not facing the patient's eyelid) of the DT 1 and especially of the distal end of the DT 1 may be coated with a highly reflective layer 38 .
- the reflective layer 38 prevents light from traveling beyond the distal end of the tip, by reflecting the light/heat back into the tip which may amplify the amount of light/heat reaching the posterior surface of the eyelid.
- the light/heat energy can be delivered to the posterior surface of the eyelid 5 in the vicinity of the Meibomian glands 35 .
- An additional advantage of this design, due to the reflective layer 38 is the avoidance of light flashes to the patient's eye, thus increasing patient's comfort and safety.
- a further device for the protection of the patient's eye, such as the cornea, will be described below in connection with FIG. 5 .
- the treatment process might comprise a previous/first step, where the eyelid 5 is heated up with a heating element (not displayed) or by the light device itself, as explained previously.
- the heated portion is, according to the construction of this embodiment, at the proximal part of the distal tip 31 , which faces the Meibomian gland 35 . Heating exactly this spot is a result of the reflection of energy by the reflective layer 38 .
- the typical human eyelid thickness is 3-4 mm, with the eyelashes 36 located on the outside (related to the human head) and the Meibomian glands 35 located on the inside, occupying 400-600 ⁇ m of the eyelid 5 sagittal cross-section. According to this, the distance between the two tips 31 , 32 has to be adapted.
- FIG. 3 c depicts another enhancement of the previous embodiments, more clearly displaying the movement possibilities to perform MGX.
- a telescoping element 40 connects the distal tip 31 and the proximal tip 32 of the DT 1 , which can telescope in directions 41 so that the proximal tip 32 is movable towards or away from the eye.
- a cylindrical tube 39 is mounted on the distal side of the proximal tip 32 or fiber bundle 2 . During treatment, the cylindrical tube 39 is brought into contact with the eyelid 5 either by sliding the telescoping element 40 in a direction to decrease the distance between the two tips 31 , 32 and, thus, clamping the eyelid 5 and performing MGX.
- the telescoping element 40 may be fixed and the cylindrical tube 39 moved in directions 43 as shown in FIG. 3 c to move the tube 39 into contact with the eyelid 5 , such that the eyelid is clamped between the distal tip 31 and the tube 39 .
- FIG. 3 d depicts a similar arrangement, wherein, instead of a telescoping element 40 , a proximal tip 32 mounted on the distal end of a fiber bundle 2 may be moved in directions 42 towards and away from the eyelid 5 .
- This can be accomplished by a sliding element or elements as described in connection with FIG. 3 c , wherein a part connected with the distal tip 31 slides onto a part connected with the proximal tip 32 in a direction towards or away from the eyelid 5 .
- An end element 29 which may be similar to tip 1 of FIGS. 1, 2 a and 2 b , may be mounted on the distal end of the proximal tip 32 . It is to be understood that, while in FIG. 3 d a fiber bundle 2 is shown, that the source of light/heat may be mounted on the proximal end 32 itself so that no fiber bundle may be required.
- FIG. 3 d shows a heating/light element 27 which may be mounted on or within distal tip 31 .
- the heating/light element 27 may be used to heat the eyelid 5 and the contained Meibomian gland 35 either in conjunction with the heat/light from the source of light/heat from the fiber 2 or otherwise so that the gland is heated from both sides of the eyelid 5 .
- the arrangement of capturing the eyelid between the tips 31 and 32 may lead to less force being put by the distal tip 31 on a patient's eye as in the embodiment, for example, of FIG. 1 , and this in turn may lead to less discomfort to the patient.
- FIG. 4 depicts a system in which the treatment end of an available MGD treatment device 51 , like the Lumenis M22 IPL, may be more easily handled and manipulated close to the treatment area.
- This embodiment comprises an add-on device that is attachable to the handpiece 52 via optical lightguide or lightguide interface 53 . It allows light energy delivery through the fiber and out from the distal end 4 of the fiber 2 around an eye's orbit (upper and lower eyelids 5 ).
- the proximal end of the fiber bundle 2 is attached to an optical coupler or interface 54 , which allows each individual fiber to spread out, for better coverage of the lightguide 53 surface area, to allow better optical and energy coupling.
- This part may be multi-use due to the need for accuracy and the high quality/expensive materials required.
- the distal end 4 of the fiber bundle 2 may include an interface (such as handle adapter 55 ), for example made of plastic.
- An ergonomic handle 56 may be attached thereto, allowing comfortable positioning of the distal end 4 of the fiber bundle 2 to small areas around the eyes, without the burden of having to manually hold and manipulate the handpiece 52 of the MGD treatment device 51 .
- a stiffening element which may be a harness or a relatively stiff tube, in which the distal end 4 is threaded, may be used so that the distal end 4 can be directly applied over an eyelid 5 to be treated, without fear of the distal end 4 bending and emitting light energy to undesired areas around an eye.
- the fiber bundle 2 employed may also incorporate a filter to allow for wavelength selection as well as act as an energy damper to reduce the original fluence emitted by the MDG treatment device 51 to acceptable levels for eyelid 5 treatment.
- the add-on device allows an adjustability or variability in fluences different to the one(s) provided by the MDG treatment device 51 , thus providing the possibility for more effective treatments.
- the add-on device or fiber bundle 2 may be disposable or reusable.
- the fiber bundle 2 may be distributed in a sterile package.
- Parts of the add-on device like the bundle interfaces 54 , 55 or the DT switch may degrade after sterilization or cleaning so that this add-on device would become unusable. This feature would prevent accidental double use of this single use item.
- the fiber bundle 2 may contain 20 - 50 fibers with a plastic casing, to achieve a treatment area (bundle end 4 ) of —5 mm diameter.
- the distal end 4 of the fiber bundle 2 itself may optionally be covered by a DT 1 , e.g. by a soft, biocompatible material, like silicon, as described in various previous embodiments.
- a DT 1 e.g. by a soft, biocompatible material, like silicon, as described in various previous embodiments.
- the handle 56 may include an operating button 58 to trigger an IPL pulse and or a switch for controlling the clamp mechanism.
- the handle needs to include an interface, e.g. an electrical connection to the MDG treatment device.
- the IPL pulse generation may be controlled from the handpiece 52 or from a footswitch operatively connected to the add-on device.
- an L-shaped distal tip 31 may be removable mounted on the distal end 4 of the fiber bundle 2 or on the distal end of the ergonomic handle 56 .
- the distal tip 31 may function as a shield that is inserted behind the eyelids to protect the eye while the upper and/or lower eyelids 5 are treated.
- a modular solution which allows for the use of the current handpiece 52 for treatment of Rosacea and supports the current MGD protocol delivered from tragus to tragus. Most MGD patients also suffer from Rosacea, making it necessary to treat them for this indication to alleviate the MGD symptoms.
- FIG. 5 that figure shows an additional element 59 that may be interposed between the tip 31 and the eye 60 .
- the purpose of the element 59 is to protect the eye against any stray light/heat from causing damage to the eye 60 , either due to excess light or the heat generated by the light (or other) source.
- the element or shield 59 may be in the form of a contact lens, such as a soft-type contact lens, with no optical changing capabilities, that the doctor may place on the eye to be treated for dry eye.
- the shield 59 may be a tinted with a biocompatible dye or ink and may be chosen to be completely opaque to the wavelengths of light generated by a light source selected to heat the eyelid.
- the lenses may vary in size and on extent of coverage of the eye, and thus may be corneal, semi-scleral or scleral, depending on the treatment to be provided.
- the element may even be completely opaque and maybe made of a material that reflects light and/or provides heat insulating properties so that the eye is not subjected to excess heating which might cause damage to the eye being treated.
- the shield may also be a disposable that maybe discards after each treatment or of a design that can be sterilized and reused.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Pathology (AREA)
- Ophthalmology & Optometry (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Physics & Mathematics (AREA)
- Optics & Photonics (AREA)
- Radiation-Therapy Devices (AREA)
Abstract
Description
- This application is a continuation application of U.S. application Ser. No. 16/367,774, filed Mar. 28, 2019, which is related to and claims priority to U.S. provisional application Ser. No. 62/649,786, filed Mar. 29, 2018, as well as U.S. provisional application Ser. No. 62/666,162, filed May 3, 2018, and 62/718,134, filed Aug. 13, 2018, the entire contents of all of which are herein incorporated by reference.
- The present invention relates to an apparatus and method of treating dry eyes using a disposable/removable tip and an energy source that treats as well as heats a Meibomian Gland, the energy source being selected from among light sources, radio frequency (RF) sources and/or ultrasound (US) or other sources.
- One main reason for dry eyes is blepharitis, a chronic inflammation of the eyelid margin. This is because if eyelid glands are chronically inflamed, they produce too little or even no secretions, which leads to an unstable tear film The treatment of chronic blepharitis is not trivial, as it is often caused by pathogens such as bacteria and skin mites.
- It has been shown that, for example, treatment with IPL (Intense Pulsed Light) light therapy or other has a long-lasting effect and bacteria and skin mites are successfully eliminated. IPL is a light pulse therapy that may be used to treat the inflammatory causes of dry eye, stimulate the eyelid glands and accelerate healing. Other light sources, such as LED or laser light, may be used. The use of a light source is for the purpose of generating heat, and causing photomodulation, so as to heat up the area of a Meibomian Gland, so other sources of generating heat may be used.
- U.S. Pat. Nos. 9,333,370 and 10,085,814, assigned to the assignee of the present invention, are directed to dry eye treatments and are herein incorporated by reference in their entireties.
- In the course of treatment, several pulses of light may be delivered to a patient's eyelids. Care should be taken to avoid direct light entry into a cornea, as well as exposure of eyelashes to the energy (to avoid hair loss). In addition, direct heating of a cornea and other ocular surfaces should be avoided.
- In the treatment of MGD (Meibomian Gland Dysfunction, or evaporative Dry Eye), Meibomian gland expression (MGX) is also a therapeutic approach, in which the glands are squeezed, generally after being heated through the use of IPL energy, LED energy or other energy, to force the meibum secretion out. Typically, this is achieved by pressing the eyelid from the outside with a finger, against a q-tip placed between the eyelid and the sclera. Sometimes, dedicated pincers or paddles are used for MGX.
- In an aspect, a method of treating ocular tissue by application of energy for treating dry eye includes: providing an energy generating device, the device further comprising a tip, and the tip has an extension that can be inserted posterior to an eyelid; the energy-generating device provides energy to the posterior of the eyelid; the method includes the steps of: inserting the tip posteriorly of the eyelid prior to applying energy to the posterior surface of the eyelid; and, applying energy from the energy device to the posterior surface of the eyelid.
- In another aspect, a shielding extension is provided on the extension and includes a thermally insulative material such that energy not absorbed by a target tissue is prevented from reaching ocular tissue located posterior to the eyelid.
- In a further aspect, the shielding extension is configured to be inserted posterior to an eyelid between the ocular conjunctiva and palpebral conjunctiva. The tip may be a removable tip. Further, the energy generating device is a light energy generating device. The light energy device may be one or more of: LED energy or IPL.
- In yet a further aspect, the energy device may be one or more of: RF energy or ultrasonic energy.
- In an aspect, a method of treating ocular tissue during application of energy for treating dry eye may include: providing an energy generating device, the device further comprising a tip which may be generally U-shaped and configured to be inserted both anterior and posterior to an eyelid; the energy-generating device provides energy to one or both of the anterior and the posterior of the eyelid; the method comprising the steps of: inserting the tip anteriorly and posteriorly of the eyelid prior to applying energy to one or more of the anterior and posterior surfaces of the eyelid; and, applying energy from the energy device to one or more of the anterior and posterior surfaces of the eyelid.
- In another aspect, a shielding extension is provided on the posterior portion of the tip and is comprised of a thermally insulative material such that energy not absorbed by a target tissue is prevented from reaching ocular tissue located posterior to the eyelid.
- In a further aspect, the energy generating device further comprises a shaft having a distal end portion; the shaft may be movable toward and away from the anterior of the eyelid; and, the energy generating device may be mounted on the distal end portion of the shaft; the method includes the steps of: moving the shaft distally to contact the anterior of the eyelid; activating the energy-generating device to provide energy to the posterior of the eyelid; and, moving the shaft further distally to apply pressure to the eyelid positioned between the distal portion of the shaft and the tip extension posterior of the eyelid.
- An objective of embodiments herein is to eliminate or at least alleviate the problems discussed above.
- An embodiment relates to a disposable/removable tip (DT) attachable on the (distal) end of a fiber bundle, allowing transmitting light energy from the fiber bundle to an eyelid and comprising a contact surface made of bio-compatible material, which allows to contact the eyelid. Preferably the disposable/removable tip allows transmitting light energy from the fiber bundle to the posterior surface of the eyelid.
- For this purpose, the DT preferably comprises a bent or inflected structure of a transparent or translucent material. Preferably the DT has a spatula distal tip bent down with respect to the optical fiber bundle.
- Even more preferably the DT comprises means (e.g. opaque or reflecting portions of the DT) for protecting the eyelashes, hair follicle or an eye against damage caused by light or high temperature.
- According to another preferred embodiment of the invention, the DT comprises a distal tip and a proximal tip which form a clamp preferably bent downwards with respect to the fiber bundle and adapted to encompass or grasp an eyelid therebetween.
- A disposable/removable tip has a lot of advantages compared to a tip fixed to a medical device or light guide. But however it should be clear that the treatment can also be administered with a fixed tip having the same features as described above.
- Another embodiment relates to an add-on device, comprising a fiber bundle, having a distal end and a proximal end, wherein a disposable/removable tip is attachable to the distal end, while the proximal end is connected to an optical coupler, designed for optical and/or energy coupling with light source, like a Lumenis M22 handpiece or other IPL devices.
- Another embodiment relates to a system of the disposable/removable tip and the add-on device.
- Another aspect of the invention is a method for treating blepharitis or Meibomian gland dysfunction comprising the steps of treating a patient's eyelids with IPL/Light using a disposable tip as described above and preferably also executing Meibomian gland expression (MGX).
- Yet another aspect of the invention is the use of a protective contact lens that is inserted prior to treatment that protects a cornea and other ocular surfaces from the light and/or heat sources used in the course of treatment for dry eyes by providing thermal isolation through use of the protective contact lens as described herein.
- Yet another aspect of the invention is to connect the tip to a vacuum source causing the tip to “stick” to the eyelid. For this purpose the tips described above and below in the drawings may comprise (a) through hole(s) in the soft material of the tips that is/are connected to a vacuum source on a proximal end having (a) distal suction ending(s) in the vicinity of a patient' s posterior or anterior eyelid. The vacuum source can be included in the add-on device or the IPL/light source.
- Some embodiments of apparatuses and/or methods will be described in the following by way of example only, and with reference to the accompanying figures, in which
-
FIG. 1 shows a disposable tip with a round, soft shape; -
FIG. 2a shows a disposable tip with a concave shape; -
FIG. 2b shows an alternative disposable tip with a concave shape; -
FIG. 3a shows a disposable tip with an eyelid clamp; -
FIG. 3b shows a disposable tip with light guidance; -
FIG. 3c shows a disposable tip with an eyelid clamp moved with a telescope; -
FIG. 3d shows a disposable tip with an eyelid clamp moved with a sledge; -
FIG. 4 shows a system for forwarding light energy. -
FIG. 5 shows an insert for the protection of the patient's eye. - Various exemplary embodiments will now be described more fully with reference to the accompanying drawings in which some example embodiments are illustrated.
- Anatomical terms of location, like distal and proximal refer to the devices described not to a patient (except where mentioned otherwise). In consequence, a distal end of a device may be closer to a patient, than a proximal end of the device.
- In general, referring now to
FIG. 1 , a disposable or removable tip (DT) 1 may be constructed of a transparent or translucent material, such as silicone, which allows delivery of light energy (preferably IPL or laser) to aneyelid 5. - The
DT 1 may be provided in clean/sterile state i.e. packaging, for example one for each eye, to allow hygienic treatment for every patient. - During the procedure, the DT packaging is opened and the
DT 1 is mounted over thedistal end 4 of thefiber bundle 2. Mounting may be accomplished by adhesive, force-fitted (friction between sides of thefiber bundle 2 and an annular part of the DT surrounding the fiber bundle 2) or form-fitted (e.g. by a thread). - The
fiber bundle 2, in particular an optical fiber cable, also known as a fiber optic cable, is an assembly similar to an electrical cable, but containing one or more optical fibers that are used to carry light, which light source may be Intense Pulse Light (IPL)or another light source, such as LEDs. Thefiber bundle 2 may be surrounded by aprotective tube 12, which may have a reflective inner surface. - In several of the following embodiments, a semi-transparent material can be used to manufacture the
DT 1, for example, by doping or tinting the material. One such material is silicone. By using such a technique, a part of the light energy will be absorbed by theDT 1, thus heating it and resulting in delivery of this heat to a surrounding patient's tissue, for example an eyelid. For some applications, heat has been shown to be a useful treatment modality for MGD, alleviating some Dry Eye symptoms. According to another aspect of the invention the DT (not shown), the DT may include a temperature sensor for sensing the temperature of the tip itself and/or a patient's eyelid while in use. - If heating is not desired or is achieved by other means, a transparent material may be used to forward as much of the light energy as possible.
- The treatment process might comprise a first step, wherein an
eyelid 5 is heated up with a heating element or a light source as described above. In a second step—after the eyelid has been heated a predetermined time or the temperature of the eyelid has exceeded a predetermined threshold—the outside of the eyelid is touched and pressure is put on theeyelid 5, which is now clamped between the tip and a piece or stop, like a Q-Tip, that is positioned in back of theeyelid 5. According to one alternative, the heating can be maintained during the second step. According to further alternatives, the steps of heating and exerting pressure on an eyelid can be conducted simultaneously or intermittently. - The materials used may be bio-compatible, for example silicone, to allow light forwarding from the
fiber bundle 2 and delivery to a patient's skin/tissue, for example, safe contact with aneyelid 5 or even an eye. This applies at least for light transmitting parts of theDT 1 or parts coming into contact with a patient, like the surface of a contact zone facing the patient. Other parts of the DT1 might comprise different types of materials. -
FIG. 1 depicts a design which provides a more comfortable treatment experience for a patient. Thelight beam 3 may be transmitted via thefiber bundle 2 and to thedistal end 4 of thefiber bundle 2 and then into the disposable tip (DT) 1. ThisDT 1 transmits heat from thelight beam 3 via a contact surface to the patient's eyelid. A round,soft tip 11 allows a comfortable interface for the physical contact between thetip 11 and theeyelid 5. Thesoft tip 11 may also be hemispherically shaped (shown inFIG. 2a, 3a ) so that, when contacting the eyelid, the softness of the material distributes the force and in consequence the pressure on theeyelid 5. -
FIG. 2a depicts a concave-shapedDT 1 which enables better conformation to the natural curvature of theeyelid 5, as a mere surface contact would do. This allows stable delivery of light and heat from a light source, as well as the capability to generate a vacuum between theDT 1 and theeyelid 5, effectively attaching theDT 1 to the eyelid 5 (similar to the principle of a vacuum cup). -
FIG. 2b depicts an enhanced version of theDT 1 ofFIG. 2a to allow usage of theDT 1 for MGX. Thefiber bundle 2 is positioned within alumen 22 of atube 21 or shaft. Thetube 21 surrounds thefiber bundle 2. The tube has one end aligned with thedistal end 4 of thefiber bundle 2 while the other end of thetube 21 has an open end with thefiber bundle 2 proceeding further proximal. A handle (not depicted) for manually moving thetube 21 axially/translational may be attached proximal to the distal tip. - The
DT 1 is attached to theexternal tube 21, thus covering also the centeredfiber bundle 2. Therefore, theDT 1 may overlap thetube 21 in a proximal direction, like a cap. The attachment (e.g. force-fitted) between theDT 1 andtube 21 is of such a strength, which allows movement within theDT 1, in particular shearing forces, induced by moving thefiber bundle 2 inside thelumen 22 in a distal direction relatively to thetube 21. - To treat MGX, the
tube 21 orDT 1 is gently pulled away from theeyelid 5 or/and at the same time pushing thefiber bundle 2 towards theeyelid 5. This causes a change of the radius of the concave shaped contact surface, as thefiber bundle 2 presses towards the center of the concave contact surface, while the outer part of the concave contact surface is pulled away by thetube 21, which is connected at the outer part of theDT 1. - This causes pulling the eyelid's 5 external surface (where the
outer region 23 of theDT 1 is located), by anoutward force 24, due to the vacuum between theDT 1 andeyelid 5, while pushing acenter region 25 of the eyelids, aligned with thefiber bundle 2, by aninward force 26. - The effect is that a first region (center region 25) of the
eyelid 5 is moved in one direction while a second region (outer region 23), which is very close to the first region, is moved to the opposite direction. This causes a shearing force on theeyelid 5 which leads to a squeezing effect, effectuating MGX. - Advantageously, a
DT 1 is provided which is easy to assemble and in addition to IPL treatment allows MGX treatment. -
FIG. 3a depicts another embodiment of aDT 1 in a cross section of theeyelid 5 with theDT 1 shown placed on both sides of theeyelid 5. In this embodiment, theDT 1 includes both an inner (proximal) 32 and an outer (distal)tip 31 of a clamp. Agap 34 separatestips DT 1 is located between theeyelid 5 and thesclera 33. Theeyelid 5 is placed between bothtips tips FIGS. 3C and 3D ). The sliding or other action that varies the distance betweentips tips - Advantageously, this embodiment allows a more typical delivery method of MGX, in particular, using a squeezing force (two opposite forces aligned) instead of a shearing force (two opposite forces parallel misaligned). Both embodiments allow, in addition, light/heat treatment. The combination of providing MGX and light/heat therapy has proven to be very efficient.
-
FIG. 3b depicts a similar embodiment or even an enhancement of the previous embodiment ofFIG. 3a with the goal of a more efficient energy delivery to the target organs (the Meibomian glands 35) as well as to protecteyelashes 36. In theDT 1 with thedistal tip 31 and theproximal tip 32 forming a clamp as described before, theproximal tip 32 may be opaque or comprise anopaque plastic 37 preferably at least covering part of the surface which—in the case of use—touches the eyelid in the region of the eyelashes. This prevents the eyelashes from being damaged. - The outer surface (not facing the patient's eyelid) of the
DT 1 and especially of the distal end of theDT 1 may be coated with a highlyreflective layer 38. Thereflective layer 38 prevents light from traveling beyond the distal end of the tip, by reflecting the light/heat back into the tip which may amplify the amount of light/heat reaching the posterior surface of the eyelid. - Advantageously, the light/heat energy can be delivered to the posterior surface of the
eyelid 5 in the vicinity of theMeibomian glands 35. An additional advantage of this design, due to thereflective layer 38 is the avoidance of light flashes to the patient's eye, thus increasing patient's comfort and safety. A further device for the protection of the patient's eye, such as the cornea, will be described below in connection withFIG. 5 . - The treatment process might comprise a previous/first step, where the
eyelid 5 is heated up with a heating element (not displayed) or by the light device itself, as explained previously. The heated portion is, according to the construction of this embodiment, at the proximal part of thedistal tip 31, which faces theMeibomian gland 35. Heating exactly this spot is a result of the reflection of energy by thereflective layer 38. By clamping the eyelid in the embodiments shown inFIGS. 3a and 3 bt, no additional tool, like a q-tip, is necessary. - The typical human eyelid thickness is 3-4 mm, with the
eyelashes 36 located on the outside (related to the human head) and theMeibomian glands 35 located on the inside, occupying 400-600 μm of theeyelid 5 sagittal cross-section. According to this, the distance between the twotips -
FIG. 3c depicts another enhancement of the previous embodiments, more clearly displaying the movement possibilities to perform MGX. Atelescoping element 40 connects thedistal tip 31 and theproximal tip 32 of theDT 1, which can telescope indirections 41 so that theproximal tip 32 is movable towards or away from the eye. Acylindrical tube 39 is mounted on the distal side of theproximal tip 32 orfiber bundle 2. During treatment, thecylindrical tube 39 is brought into contact with theeyelid 5 either by sliding thetelescoping element 40 in a direction to decrease the distance between the twotips eyelid 5 and performing MGX. Alternatively, thetelescoping element 40 may be fixed and thecylindrical tube 39 moved indirections 43 as shown inFIG. 3c to move thetube 39 into contact with theeyelid 5, such that the eyelid is clamped between thedistal tip 31 and thetube 39. -
FIG. 3d depicts a similar arrangement, wherein, instead of atelescoping element 40, aproximal tip 32 mounted on the distal end of afiber bundle 2 may be moved indirections 42 towards and away from theeyelid 5. This can be accomplished by a sliding element or elements as described in connection withFIG. 3c , wherein a part connected with thedistal tip 31 slides onto a part connected with theproximal tip 32 in a direction towards or away from theeyelid 5. Anend element 29, which may be similar totip 1 ofFIGS. 1, 2 a and 2 b, may be mounted on the distal end of theproximal tip 32. It is to be understood that, while inFIG. 3d afiber bundle 2 is shown, that the source of light/heat may be mounted on theproximal end 32 itself so that no fiber bundle may be required. - Additionally,
FIG. 3d shows a heating/light element 27 which may be mounted on or withindistal tip 31. The heating/light element 27 may be used to heat theeyelid 5 and the containedMeibomian gland 35 either in conjunction with the heat/light from the source of light/heat from thefiber 2 or otherwise so that the gland is heated from both sides of theeyelid 5. - The arrangement of capturing the eyelid between the
tips distal tip 31 on a patient's eye as in the embodiment, for example, ofFIG. 1 , and this in turn may lead to less discomfort to the patient. -
FIG. 4 depicts a system in which the treatment end of an availableMGD treatment device 51, like the Lumenis M22 IPL, may be more easily handled and manipulated close to the treatment area. This embodiment comprises an add-on device that is attachable to thehandpiece 52 via optical lightguide orlightguide interface 53. It allows light energy delivery through the fiber and out from thedistal end 4 of thefiber 2 around an eye's orbit (upper and lower eyelids 5). - The proximal end of the
fiber bundle 2 is attached to an optical coupler orinterface 54, which allows each individual fiber to spread out, for better coverage of thelightguide 53 surface area, to allow better optical and energy coupling. This part may be multi-use due to the need for accuracy and the high quality/expensive materials required. - The
distal end 4 of thefiber bundle 2 may include an interface (such as handle adapter 55), for example made of plastic. Anergonomic handle 56 may be attached thereto, allowing comfortable positioning of thedistal end 4 of thefiber bundle 2 to small areas around the eyes, without the burden of having to manually hold and manipulate thehandpiece 52 of theMGD treatment device 51. - Otherwise, without the
handle 56, the operator may hold thedistal end 4 of thebundle 2 like a pen while treating the patient. In order that thedistal end 4 maintains its shape, a stiffening element, which may be a harness or a relatively stiff tube, in which thedistal end 4 is threaded, may be used so that thedistal end 4 can be directly applied over aneyelid 5 to be treated, without fear of thedistal end 4 bending and emitting light energy to undesired areas around an eye. - The
fiber bundle 2 employed may also incorporate a filter to allow for wavelength selection as well as act as an energy damper to reduce the original fluence emitted by theMDG treatment device 51 to acceptable levels foreyelid 5 treatment. The add-on device allows an adjustability or variability in fluences different to the one(s) provided by theMDG treatment device 51, thus providing the possibility for more effective treatments. - Depending on the use case, the add-on device or
fiber bundle 2 may be disposable or reusable. Thefiber bundle 2 may be distributed in a sterile package. - Parts of the add-on device like the bundle interfaces 54, 55 or the DT switch may degrade after sterilization or cleaning so that this add-on device would become unusable. This feature would prevent accidental double use of this single use item.
- The
fiber bundle 2 may contain 20-50 fibers with a plastic casing, to achieve a treatment area (bundle end 4) of —5 mm diameter. - The
distal end 4 of thefiber bundle 2 itself may optionally be covered by aDT 1, e.g. by a soft, biocompatible material, like silicon, as described in various previous embodiments. By covering the relatively harddistal end 4 with the DT 1 (soft cap), theDT 1 may even contact a patient'seyelid 5, without causing discomfort to the patient or harm the tissue. - The
handle 56 may include anoperating button 58 to trigger an IPL pulse and or a switch for controlling the clamp mechanism. In such a case, the handle needs to include an interface, e.g. an electrical connection to the MDG treatment device. Alternatively, the IPL pulse generation may be controlled from thehandpiece 52 or from a footswitch operatively connected to the add-on device. - In addition, as may be seen on 3 a-d, an L-shaped
distal tip 31, as previously described, may be removable mounted on thedistal end 4 of thefiber bundle 2 or on the distal end of theergonomic handle 56. Thedistal tip 31 may function as a shield that is inserted behind the eyelids to protect the eye while the upper and/orlower eyelids 5 are treated. - The proposed invention/embodiments would allow for:
- 1. Better access to structures around the eye, including the upper or
lower eyelid 5, while avoiding unintended exposure of theeyelashes 36 or the cornea, which may result from use of alarge lightguide 53 such as the currentM22 IPL handpiece 52. - 2. Ease of use, through the dedicated, lightweight
ergonomic handle 56. This is enabled by the fact that thecurrent IPL handpiece 52 fulfills the energy and cooling functions, while the proposed handle's 56 sole function would be to hold the fibers'distal end 4 and bring it into direct contact above or below the eyelids 5 (i.e. it only fulfills the ergonomic/usability functions). - 3. A sterile, disposable design.
- 4. A modular solution, which allows for the use of the
current handpiece 52 for treatment of Rosacea and supports the current MGD protocol delivered from tragus to tragus. Most MGD patients also suffer from Rosacea, making it necessary to treat them for this indication to alleviate the MGD symptoms. - 5. Fluence reduction for improved safety around the
eyelid 5 area through the design of thefiber bundle 2 as an energy damper (current M22 IPL has a lower limit on delivered fluence, which may be considered by some as too high for MGD in certain cases). - 6. More specific selection of light spectrum, for improved treatment efficacy, by the use of a doped fiber as a low-pass filter, in addition to the built-in high-pass filter in the IPL's
handpiece 52. - Turning now to
FIG. 5 , that figure shows anadditional element 59 that may be interposed between thetip 31 and theeye 60. The purpose of theelement 59 is to protect the eye against any stray light/heat from causing damage to theeye 60, either due to excess light or the heat generated by the light (or other) source. The element or shield 59 may be in the form of a contact lens, such as a soft-type contact lens, with no optical changing capabilities, that the doctor may place on the eye to be treated for dry eye. Theshield 59 may be a tinted with a biocompatible dye or ink and may be chosen to be completely opaque to the wavelengths of light generated by a light source selected to heat the eyelid. The lenses may vary in size and on extent of coverage of the eye, and thus may be corneal, semi-scleral or scleral, depending on the treatment to be provided. The element may even be completely opaque and maybe made of a material that reflects light and/or provides heat insulating properties so that the eye is not subjected to excess heating which might cause damage to the eye being treated. The shield may also be a disposable that maybe discards after each treatment or of a design that can be sterilized and reused. - 1 disposable/removable tip (DT)
- 2 fiber bundle
- 3 IPL (Intense Pulse Light)/light beam
- 4 distal end of fiber bundle
- 5 eyelid
- 11 round/soft tip
- 12 protective tube
- 21 tube
- 22 lumen
- 23 outer region
- 24 outward force
- 25 center region
- 26 inward force
- 27 heating element
- 29 end element
- 31 outer (distal) tip
- 32 inner (proximal) tip
- 33 sclera
- 34 intersecting gap
- 35 Meibomian glands
- 36 eyelashes
- 37 opaque plastic
- 38 reflective layer
- 39 cylindrical tube
- 40 telescope
- 41 expanding/shortening direction
- 42 moving direction
- 43 moving direction
- 51 MGD treatment device
- 52 handpiece
- 53 lightguide
- 54 optic coupler
- 55 handle adapter
- 56 handle
- 57 proximal end
- 58 operating button
- 59 shield
- 60 eye
Claims (19)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US17/679,450 US20220280799A1 (en) | 2018-03-29 | 2022-02-24 | Apparatus and method for treatment of dry eyes |
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201862649786P | 2018-03-29 | 2018-03-29 | |
US201862666162P | 2018-05-03 | 2018-05-03 | |
US201862718134P | 2018-08-13 | 2018-08-13 | |
US16/367,774 US11285334B2 (en) | 2018-03-29 | 2019-03-28 | Apparatus and method for treatment of dry eyes |
US17/679,450 US20220280799A1 (en) | 2018-03-29 | 2022-02-24 | Apparatus and method for treatment of dry eyes |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/367,774 Continuation US11285334B2 (en) | 2018-03-29 | 2019-03-28 | Apparatus and method for treatment of dry eyes |
Publications (1)
Publication Number | Publication Date |
---|---|
US20220280799A1 true US20220280799A1 (en) | 2022-09-08 |
Family
ID=68054600
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/367,774 Active US11285334B2 (en) | 2018-03-29 | 2019-03-28 | Apparatus and method for treatment of dry eyes |
US17/679,450 Pending US20220280799A1 (en) | 2018-03-29 | 2022-02-24 | Apparatus and method for treatment of dry eyes |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/367,774 Active US11285334B2 (en) | 2018-03-29 | 2019-03-28 | Apparatus and method for treatment of dry eyes |
Country Status (6)
Country | Link |
---|---|
US (2) | US11285334B2 (en) |
EP (1) | EP3773371A4 (en) |
KR (1) | KR102671817B1 (en) |
CN (2) | CN111971004B (en) |
IL (1) | IL277201A (en) |
WO (1) | WO2019186571A1 (en) |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US12029905B2 (en) | 2020-05-04 | 2024-07-09 | Btl Healthcare Technologies A.S. | Device and method for unattended treatment of a patient |
US12064163B2 (en) | 2021-10-13 | 2024-08-20 | Btl Medical Solutions A.S. | Methods and devices for aesthetic treatment of biological structures by radiofrequency and magnetic energy |
US12076576B2 (en) | 2019-04-11 | 2024-09-03 | Btl Medical Solutions A.S. | Methods and devices for aesthetic treatment of biological structures by radiofrequency and magnetic energy |
US12109426B2 (en) | 2016-05-10 | 2024-10-08 | Btl Medical Solutions A.S. | Aesthetic method of biological structure treatment by magnetic field |
US12109427B2 (en) | 2016-07-01 | 2024-10-08 | Btl Medical Solutions A.S. | Aesthetic method of biological structure treatment by magnetic field |
US12115365B2 (en) | 2021-11-03 | 2024-10-15 | Btl Healthcare Technologies A.S. | Device and method for unattended treatment of a patient |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111714793A (en) * | 2020-05-21 | 2020-09-29 | 温州医科大学附属眼视光医院 | High-precision meibomian gland diagnosis and treatment instrument |
WO2022013435A2 (en) * | 2020-07-16 | 2022-01-20 | Photon Therapeutics Ltd. | Uv radiation devices and methods of use thereof |
WO2022053980A1 (en) * | 2020-09-10 | 2022-03-17 | Lumenis Be Ltd. | Dry eye treatment system with disposable tip and corneal shield |
CA3192274A1 (en) * | 2020-09-10 | 2022-03-17 | May KLEINMAN BEN TSVI | Dry eye treatment system with disposable tip and corneal shield |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6454763B1 (en) * | 1999-08-05 | 2002-09-24 | Paradigm Medical Industries Inc. | Laser surgical handpiece with photon trap |
US20070191821A1 (en) * | 2006-02-15 | 2007-08-16 | Advanced Vision Education, Llc | Apparatus and method for using intense pulsed light to non-invasively treat conjunctival blood vessels, pigmented lesions, and other problems |
US20130172959A1 (en) * | 2011-12-07 | 2013-07-04 | Lumenis Ltd. | Apparatus and method for applying light in ocular and periocular areas |
US20150005750A1 (en) * | 2013-04-30 | 2015-01-01 | Tear Film Innovations Llc | Systems and Methods For the Treatment of Eye Conditions |
US9606304B2 (en) * | 2014-12-02 | 2017-03-28 | Innovations In Optics, Inc. | High radiance light emitting diode light engine |
Family Cites Families (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7513893B2 (en) * | 2004-03-12 | 2009-04-07 | Abraham Ebbie Soroudi | Device and method for treatment of eyelid diseases |
US7514692B2 (en) * | 2005-06-22 | 2009-04-07 | Ge Medical Systems Israel, Ltd. | Method and apparatus for reducing polarization within an imaging device |
WO2013003594A2 (en) | 2011-06-28 | 2013-01-03 | Tearscience, Inc. | Methods and systems for treating meibomian gland dysfunction using radio-frequency energy |
US9314369B2 (en) * | 2006-05-15 | 2016-04-19 | Tearscience, Inc. | System for inner eyelid treatment of meibomian gland dysfunction |
EP3078358B1 (en) * | 2006-08-21 | 2021-01-06 | Tearscience, Inc. | Apparatus for treating gland dysfunction |
JP5242356B2 (en) * | 2008-12-08 | 2013-07-24 | 株式会社ニデック | Ophthalmic equipment |
CN101744605B (en) * | 2008-12-08 | 2014-07-30 | 株式会社尼德克 | Ophthalmological device |
AU2012271562A1 (en) | 2011-06-17 | 2014-01-30 | Allergan, Inc. | D -serine for the treatment of visual system disorders |
US9724230B2 (en) * | 2012-01-04 | 2017-08-08 | Sight Sciences, Inc. | Dry eye treatment apparatus and methods |
US9510972B2 (en) * | 2012-01-04 | 2016-12-06 | Sight Sciences, Inc. | Dry eye treatment systems |
US9039718B2 (en) * | 2012-07-24 | 2015-05-26 | Blephex, Llc | Method and device for treating an ocular disorder |
US10039932B2 (en) * | 2012-11-20 | 2018-08-07 | Biolase, Inc. | Eyelid treatment device |
US9763827B2 (en) * | 2013-04-30 | 2017-09-19 | Tear Film Innovations, Inc. | Systems and methods for the treatment of eye conditions |
US20140331383A1 (en) * | 2013-05-10 | 2014-11-13 | Ann Bially | Eye mask for sleeping |
WO2014210152A2 (en) * | 2013-06-25 | 2014-12-31 | TECLens, LLC | Apparatus for phototherapy of the eye |
US9700461B2 (en) * | 2014-06-27 | 2017-07-11 | Iridex Corporation | Convex contact probe for the delivery of laser energy |
CN204218239U (en) * | 2014-10-13 | 2015-03-25 | 中山尚荣美容仪器有限公司 | A kind of false eyelashes air-dry apparatus |
US10695219B2 (en) * | 2016-04-08 | 2020-06-30 | ThermiGen, LLC | Apparatus and method for treatment of dry eye using radio frequency heating |
-
2019
- 2019-03-28 CN CN201980022186.1A patent/CN111971004B/en active Active
- 2019-03-28 WO PCT/IL2019/050370 patent/WO2019186571A1/en active Application Filing
- 2019-03-28 KR KR1020207031273A patent/KR102671817B1/en active IP Right Grant
- 2019-03-28 CN CN202310331647.1A patent/CN116212243A/en active Pending
- 2019-03-28 US US16/367,774 patent/US11285334B2/en active Active
- 2019-03-28 EP EP19774244.8A patent/EP3773371A4/en active Pending
-
2020
- 2020-09-07 IL IL277201A patent/IL277201A/en unknown
-
2022
- 2022-02-24 US US17/679,450 patent/US20220280799A1/en active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6454763B1 (en) * | 1999-08-05 | 2002-09-24 | Paradigm Medical Industries Inc. | Laser surgical handpiece with photon trap |
US20070191821A1 (en) * | 2006-02-15 | 2007-08-16 | Advanced Vision Education, Llc | Apparatus and method for using intense pulsed light to non-invasively treat conjunctival blood vessels, pigmented lesions, and other problems |
US20130172959A1 (en) * | 2011-12-07 | 2013-07-04 | Lumenis Ltd. | Apparatus and method for applying light in ocular and periocular areas |
US20150005750A1 (en) * | 2013-04-30 | 2015-01-01 | Tear Film Innovations Llc | Systems and Methods For the Treatment of Eye Conditions |
US9606304B2 (en) * | 2014-12-02 | 2017-03-28 | Innovations In Optics, Inc. | High radiance light emitting diode light engine |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US12109426B2 (en) | 2016-05-10 | 2024-10-08 | Btl Medical Solutions A.S. | Aesthetic method of biological structure treatment by magnetic field |
US12109427B2 (en) | 2016-07-01 | 2024-10-08 | Btl Medical Solutions A.S. | Aesthetic method of biological structure treatment by magnetic field |
US12076576B2 (en) | 2019-04-11 | 2024-09-03 | Btl Medical Solutions A.S. | Methods and devices for aesthetic treatment of biological structures by radiofrequency and magnetic energy |
US12029905B2 (en) | 2020-05-04 | 2024-07-09 | Btl Healthcare Technologies A.S. | Device and method for unattended treatment of a patient |
US12064163B2 (en) | 2021-10-13 | 2024-08-20 | Btl Medical Solutions A.S. | Methods and devices for aesthetic treatment of biological structures by radiofrequency and magnetic energy |
US12115365B2 (en) | 2021-11-03 | 2024-10-15 | Btl Healthcare Technologies A.S. | Device and method for unattended treatment of a patient |
Also Published As
Publication number | Publication date |
---|---|
IL277201A (en) | 2020-10-29 |
CN111971004A (en) | 2020-11-20 |
WO2019186571A1 (en) | 2019-10-03 |
KR20200139739A (en) | 2020-12-14 |
US11285334B2 (en) | 2022-03-29 |
EP3773371A4 (en) | 2022-01-05 |
CN116212243A (en) | 2023-06-06 |
EP3773371A1 (en) | 2021-02-17 |
US20190299016A1 (en) | 2019-10-03 |
KR102671817B1 (en) | 2024-05-31 |
CN111971004B (en) | 2023-04-18 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20220280799A1 (en) | Apparatus and method for treatment of dry eyes | |
US20210369381A1 (en) | Apparatus and method for applying light in ocular and periocular areas | |
US11540949B2 (en) | Dry eye treatment system with disposable tip and corneal shield | |
US20170181890A1 (en) | Illuminated treatment probe for delivering laser energy | |
JP2019519323A (en) | Handheld ophthalmic laser system with replaceable contact tip and treatment guide | |
US20110046614A1 (en) | Apparatus and method for using intense pulsed light to non-invasively treat conjunctival blood vessels, pigmented lesions, and other problems of the eye and eyelid | |
JP2013519492A (en) | Multiple fiber surgical probe with flexibility | |
WO2022053980A1 (en) | Dry eye treatment system with disposable tip and corneal shield | |
US20220118281A1 (en) | Device and method for treating dry eyes | |
CA3202333A1 (en) | Device and method for treating dry eyes |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: LUMENIS BE LTD., ISRAEL Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:LUMENIS LTD.;REEL/FRAME:059089/0732 Effective date: 20210901 Owner name: LUMENIS LTD., ISRAEL Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ALTMAN, HERNAN;REEL/FRAME:059089/0707 Effective date: 20190513 |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: FINAL REJECTION MAILED |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: RESPONSE AFTER FINAL ACTION FORWARDED TO EXAMINER |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: FINAL REJECTION MAILED |
|
STCV | Information on status: appeal procedure |
Free format text: NOTICE OF APPEAL FILED |