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US-12622809-B2 - Systems, methods, and apparatus for pressure-wave ocular therapy

US12622809B2US 12622809 B2US12622809 B2US 12622809B2US-12622809-B2

Abstract

Apparatus, systems, and methods for treating an eye utilizing ab externo pressure wave generation. The shockwave generator comprises a housing comprising a fluid-filled chamber and an eye-contacting surface or chamber configured to contact a surface of the eye. First and second coaxially-aligned electrodes disposed within the housing are configured to generate an electric arc across a gap between the electrode tips when energized and thus produce a shockwave in a fluid of the fluid-filled chamber. The shockwave generator is coupled to the surface of the eye before focusing a shockwave to a pre-determined location on or below the surface of the eye. A plurality of shockwave generators may be disposed within a fluid-filled chamber of a contact lens, which may comprise a contact balloon.

Inventors

  • Rajeev HEREKAR
  • Anjali Herekar
  • Satish Herekar

Assignees

  • SenoGen GmbH

Dates

Publication Date
20260512
Application Date
20200810

Claims (13)

  1. 1 . An apparatus for treating an eye, the apparatus comprising: a housing comprising a fluid-filled chamber and an eye-contacting surface configured to contact a surface of an eye; a first electrode disposed within the housing; and a second electrode disposed within the housing and coaxially aligned with the first electrode, wherein a distal tip of the first electrode and a distal tip of the second electrode are separated by a gap, wherein the first electrode and the second electrode are configured to generate an electric arc across the gap when energized and produce a shockwave in a fluid of the fluid-filled chamber, further comprising a fluid inlet and a fluid outlet in fluid communication with the fluid-filled chamber, wherein the apparatus further comprises a conductivity sensor at least partially disposed within the fluid-filled chamber and configured to measure a conductivity periodically or continuously of the fluid within the fluid-filled chamber wherein the conductivity sensor is configured to monitor changes in conductivity caused by release of metallic ions from the first and second electrodes during erosion of the electrodes.
  2. 2 . The apparatus of claim 1 , wherein an inner surface of the housing is configured to focus the shockwave to a predetermined location on or below the surface of the eye.
  3. 3 . The apparatus of claim 1 , further comprising a reflector disposed within the housing and configured to focus the shockwave to a predetermined location on or below the surface of the eye.
  4. 4 . The apparatus of claim 1 , further comprising one or more wires coupled to the first electrode or the second electrode and configured to provide energy thereto.
  5. 5 . The apparatus of claim 1 , wherein the first electrode and the second electrode comprise a first tip of a first wire and a second tip of a second wire.
  6. 6 . The apparatus of claim 1 , wherein the fluid comprises saline or water.
  7. 7 . The apparatus of claim 1 , wherein the first and second electrodes are coated with graphene to reduce erosion during shockwave production.
  8. 8 . The apparatus of claim 1 , wherein the housing is ellipsoidal.
  9. 9 . The apparatus of claim 1 , wherein the housing further comprises a fluid-filled wave guide disposed between the fluid-filled chamber and the eye-contacting surface and configured to fluidly couple the fluid-filled chamber and the eye-contacting surface.
  10. 10 . The apparatus of claim 1 , further comprising an acoustic lens disposed within the housing and configured to focus the shockwave to one or more predetermined locations on or below the surface of the eye.
  11. 11 . The apparatus of claim 1 , wherein the conductivity sensor comprises a pair of platinum electrodes.
  12. 12 . The apparatus of claim 1 , further comprising a light source at least partially disposed within the fluid-filled chamber and configured to emit light towards the surface of the eye.
  13. 13 . A system for treating an eye, the system comprising: the apparatus of claim 1 ; and an energy source operably coupled to the first electrode and the second electrode by one or more wires.

Description

CROSS-REFERENCE The subject matter of the present application is related to U.S. Provisional Patent Application No. 62/884,333, filed Aug. 8, 2019, entitled “Systems, Methods, and Apparatus for Pressure-Wave Ocular Therapy”; U.S. Provisional Patent Application No. 62/979,097, filed Feb. 20, 2020, entitled “Systems, Methods, and Apparatus for Pressure-Wave Ocular Therapy”; and U.S. Provisional Patent Application No. 63/043,988, filed Jun. 25, 20200, entitled “Systems, Methods, and Apparatus for Pressure-Wave Ocular Therapy”; the entire content of which is incorporated herein by reference. BACKGROUND Existing methods and apparatus for treating glaucoma, presbyopia, age-related macular degeneration (AMD), dry eye disease, and other ophthalmic conditions can produce less than ideal results. For example, many prior approaches to treating glaucoma focus on reducing intraocular pressure (TOP) of the eye and can be more complex and/or invasive than would be ideal. Current glaucoma interventions include, for example, paralimbal delivery of drugs (such as prostaglandins), stents (such as minimally-invasive glaucoma surgery (MIGS) or canaloplasty), laser-based treatments (such as selective laser trabeculoplasty (SLT) or micropulse laser trabeculoplasty (MLT)), transscleral cyclophotocoagulation (TS-CPC), ultrasound CPC, trabeculoplasty, or trabeculectomies. Complications from such therapies can include hypotony, hyphema, hemorrhage, high TOP spike rate, decreased visual acuity, and cataract formation. For example, therapies such as trabeculectomy surgery or implantation of glaucoma drainage devices can require invasive surgical intervention and potentially have adverse safety risks in some instances. Other non-penetrating therapies often lose efficacy over time. Treatment to reduce TOP with medicated eye drops can be less than ideal due to lack of patient compliance, side effects in some instances, and variations between patients which can lead to variations in dosing and bioavailability of such medications. In light of the above, improved methods and apparatus of treating glaucoma are needed. Ideally, such methods and apparatus would be less invasive than some of the prior treatments and provide successful reduction in TOP. Prior approaches for treating presbyopia focus on improving accommodative amplitude and/or replacing or repairing near acuity function in patients and can be more complex and/or invasive than would be ideal. Current presbyopia interventions include near acuity wearables (such as spectacles or contact lenses), lens or strut implants, drugs for miosis and lens-disaggregation, and incisional methods. Complications from such therapies can include complications of invasiveness, drug side effects, and the like in some instances. Additionally, such therapies often target only one possible source of reduced accommodation out of many, which may limit the overall efficacy of such therapies as singular treatment modalities. In light of the above, improved methods and apparatus of treating presbyopia are needed. Ideally, such methods and apparatus would be less invasive than some of the prior treatments and provide successful augmentation of accommodative amplitude. Prior approaches for treating AMD focus on delaying the onset of dry AMD and/or sealing leaking vasculature to limit degeneration in wet AMD and can be less effective than desired and/or incapable of reversing degeneration that has already occurred. Current interventions include nutritional interventions such as high antioxidant diets for dry AMD, laser photocoagulation for wet AMD, and intraocular anti-vascular endothelial growth factor (VEGF) therapies for wet AMD. Complications from such therapies can include continued degeneration of vision, a high rate of recurrence of leakage in wet AMD cases, scarring of the macula, eye infections, increased TOP, retinal detachment, and systemic vascular effects (e.g. hemorrhage, stroke, etc.) in some instances. Additionally, such therapies are rarely able to restore vision once it has been lost. In light of the above, improved methods and apparatus of treating AMD are needed. Ideally, such methods and apparatus would be less risky than some of the prior treatments and provide successful delay of degeneration and/or restoration of previously degenerated tissues. Prior approaches for treating dry eye disease focus on improving, supplementing, and/or replacing natural tear formation and can be less effective than would be ideal. Current interventions include over-the-counter eyedrops (artificial tears), antibiotics, immune-suppressing eyedrops, corticosteroid eyedrops, eye inserts, scleral lenses, light therapy and eyelid massage, tear-stimulating eye drops, tear duct plugs, and tear duct thermal cautery. Complications from such therapies include continued dryness, increased irritation, sweating, corneal abrasion, and other drug side effects. Additionally, such therapies often require prolonged usage which ca