WO2022172089A1 - Compound, method and system for ophthalmic surgery - Google Patents

Compound, method and system for ophthalmic surgery Download PDF

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Publication number
WO2022172089A1
WO2022172089A1 PCT/IB2022/000075 IB2022000075W WO2022172089A1 WO 2022172089 A1 WO2022172089 A1 WO 2022172089A1 IB 2022000075 W IB2022000075 W IB 2022000075W WO 2022172089 A1 WO2022172089 A1 WO 2022172089A1
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Prior art keywords
viscofluidic
range
ophthalmic composition
ovd
sodium hyaluronate
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PCT/IB2022/000075
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French (fr)
Inventor
Ehud Assia
Eran KALAN
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I Optima Ltd.
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Publication of WO2022172089A1 publication Critical patent/WO2022172089A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • A61P27/04Artificial tears; Irrigation solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728Hyaluronic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0048Eye, e.g. artificial tears

Definitions

  • the field of the invention relates to methods and systems for performing ophthalmic surgery. More particularly, the field of invention relates to compounds, methods, and systems for performing irrigation during ophthalmic surgery, such as ophthalmic surgery to treat cataracts.
  • Phacoemulsification is a surgical technique for treating cataracts in which the eye’ s internal lens fibers, which form the nucleus and cortex of a cataract, are emulsified and aspirated from within the eye. The aspirated fluids are replaced with a replacement fluid to maintain space in the anterior chamber of the eye. An artificial intraocular lens (“IOL”) implant is placed into the eye to replace the natural lens.
  • IOL intraocular lens
  • Figure 1 shows a first exemplary system for applying an exemplary viscofluidic ophthalmic surgical device to an eye.
  • Figure 2 shows a second exemplary system for applying an exemplary viscofluidic ophthalmic surgical device to an eye.
  • Figure 3 shows an exemplary method for performing phacoemulsification surgery that includes use of an exemplary viscofluidic ophthalmic surgical device.
  • a method includes providing a viscofluidic solution, wherein the viscofluidic solution includes a quantity of sodium hyaluronate dissolved in a quantity of saline, wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 80 centipoise to 250 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 70 to 500 dynes per centimeter; creating an incision in a cornea of an eye of a patient; and irrigating the eye of the patient with the viscofluidic solution.
  • the method also includes performing phacoemulsification to emulsify at least a portion of a lens of the eye of the patient; aspirating the portion of the eye of the patient; and injecting the viscofluidic solution into an anterior chamber of the eye of the patient, thereby to stabilize the anterior chamber and maintain an intraocular pressure within the eye of the patient.
  • the viscofluidic solution has a surface tension that is in a range of from 70 to 85 dynes per centimeter.
  • the viscofluidic solution has a viscosity that is in a range of from 114 centipoise to 216 centipoise at a shear rate of 0.1/second.
  • the viscofluidic solution has an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg.
  • the ophthalmic composition is isotonic.
  • a concentration of the sodium hyaluronate in the viscofluidic solution is in a range of from 0.1% to 0.2%. In some embodiments, a concentration of the sodium hyaluronate in the viscofluidic solution is in a range of from 0.05% to 0.2%.
  • an ophthalmic composition for irrigating ocular tissues during an intraocular surgical procedure includes a quantity of a sodium hyaluronate; and a quantity of a saline solution, wherein the sodium hyaluronate is dissolved in the saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 80 centipoise to 250 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 70 to 500 dynes per centimeter.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a surface tension that is in a range of from 70 to 85 dynes per centimeter. In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 114 centipoise to 216 centipoise at a shear rate of 0.1/second.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg.
  • the ophthalmic composition is isotonic.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient such that a concentration of the sodium hyaluronate in the ophthalmic composition is in a range of from 0.1% to 0.2%.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient such that a concentration of the sodium hyaluronate in the ophthalmic composition is in a range of from 0.05% to 0.2%.
  • a system includes a reservoir containing an ophthalmic composition, wherein the ophthalmic composition includes a quantity of sodium hyaluronate dissolved in a quantity of saline, wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 80 centipoise to 250 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 70 to 500 dynes per centimeter; a delivery tip in fluid communication with the reservoir, wherein the delivery tip is configured to deliver the ophthalmic composition to an eye of a patient; and a pressure mechanism configured to pressurize the ophthalmic composition; and a control system configured to control a flow rate and a pressure of the ophthalmic composition delivered to the eye.
  • control system is configured to control the flow rate and the pressure to thereby stabilize an intraocular pressure within the eye.
  • the pressure mechanism includes a mechanism configured to apply pressure to the reservoir.
  • the mechanism configured to apply pressure to the reservoir includes a pressurized gas or a mechanical compressing mechanism.
  • the pressure mechanism includes a pump configured to apply pressure to a flow line conveying the ophthalmic composition.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a surface tension that is in a range of from 70 to 85 dynes per centimeter. In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 114 centipoise to 216 centipoise at a shear rate of 0.1/second.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg.
  • a method includes providing a viscofluidic solution, wherein the viscofluidic solution includes a quantity of sodium hyaluronate dissolved in a quantity of a saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the viscofluidic solution with a viscosity that is in a range of from 400 centipoise to 1200 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 60 to 500 dynes per centimeter; creating an incision in a cornea of an eye of a patient; and irrigating the eye of the patient with the viscofluidic solution.
  • a method includes performing phacoemulsification to emulsify at least a portion of a lens of the eye of the patient; aspirating the portion of the eye of the patient; and injecting the viscofluidic solution into an anterior chamber of the eye of the patient, thereby to stabilize the anterior chamber and maintain an intraocular pressure within the eye of the patient.
  • the viscofluidic solution has a surface tension that is in a range of from 60 to 90 dynes per centimeter. In some embodiments, the viscofluidic solution has a viscosity that is in a range of from 700 centipoise to 900 centipoise at a shear rate of 0.1/second. In some embodiments, the viscofluidic solution has an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg. In some embodiments, the viscofluidic solution is isotonic.
  • an ophthalmic composition for irrigating ocular tissues during an intraocular surgical procedure includes a quantity of a sodium hyaluronate; and a quantity of a saline solution, wherein the sodium hyaluronate is dissolved in the saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 400 centipoise to 1200 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 60 to 500 dynes per centimeter.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a surface tension that is in a range of from 60 to 90 dynes per centimeter. In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 700 centipoise to 900 centipoise at a shear rate of 0.1/second.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg.
  • the ophthalmic composition is isotonic.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient such that a concentration of the sodium hyaluronate in the ophthalmic composition is in a range of from 0.05% to 0.2%.
  • a system includes a reservoir containing an ophthalmic composition, wherein the ophthalmic composition includes a quantity of sodium hyaluronate dissolved in a quantity of a saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 400 centipoise to 1200 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 60 to 500 dynes per centimeter; a delivery tip in fluid communication with the reservoir, wherein the delivery tip is configured to deliver the ophthalmic composition to an eye of a patient; a pressure mechanism configured to pressurize the ophthalmic composition; and a control system configured to control a flow rate and a pressure of the ophthalmic composition delivered to the eye.
  • control system is configured to control the flow rate and the pressure to thereby stabilize an intraocular pressure within the eye.
  • the pressure mechanism includes a mechanism configured to apply pressure to the reservoir.
  • the mechanism configured to apply pressure to the reservoir includes a pressurized gas or a mechanical compressing mechanism.
  • the pressure mechanism includes a pump configured to apply pressure to a flow line conveying the ophthalmic composition.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a surface tension that is in a range of from 60 to 90 dynes per centimeter.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 700 centipoise to 900 centipoise at a shear rate of 0.1/second.
  • the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg.
  • an exemplary viscofluidic ophthalmic surgical device (“OVD”).
  • OLED viscofluidic ophthalmic surgical device
  • an exemplary viscofluidic OVD is suitable for use for use for irrigation and other tasks as will be described in further detail hereinafter during the performance of ophthalmic surgery, such as phacoemulsification procedures to treat cataracts.
  • an exemplary viscofluidic OVD has fluid properties (e.g., viscosity, surface tension, etc.)
  • the viscofluidic OVD includes sodium hyaluronate (“NaHA”) dissolved in a saline solution (e.g., a solution of sodium chloride dissolved in water for injection (“WFI”).
  • a saline solution e.g., a solution of sodium chloride dissolved in water for injection (“WFI”).
  • M.W. average molecular weight
  • the average M.W. of the NaHA is in a range of from 2.5 x 10 6 Daltons to 3.5 x 10 6 Daltons.
  • the average M.W. of the NaHA is in a range of from 2.6 x 10 6 Daltons to 3.4 x 10 6 Daltons.
  • the average M.W. of the NaHA is in a range of from 2.7 x 10 6 Daltons to 3.3 x 10 6 Daltons. In some embodiments, the average M.W. of the NaHA is in a range of from 2.8 x 10 6 Daltons to 3.2 x 10 6 Daltons. In some embodiments, the average M.W. of the NaHA is in a range of from 2.9 x 10 6 Daltons to 3.1 x 10 6 Daltons. In some embodiments, the average M.W. of the NaHA is about 3 x 10 6 Daltons. In some embodiments, the average M.W. of the NaHA is 3 x 10 6 Daltons. In some embodiments, the average M.W. of the NaHA is in a range of from 2 x 10 6 Daltons to 3 x 10 6 Daltons.
  • a viscofluidic OVD that includes sodium hyaluronate (“NaHA”).
  • NaHA sodium hyaluronate
  • another suitable material includes hydroxypropyl methylcellulose (“HPMC”).
  • HPMC hydroxypropyl methylcellulose
  • another suitable material includes a high molecular weight polysaccharide.
  • NaHA is a linear molecule, and as such, in some embodiments, has a suitable average M.W. of about 3 x 10 6 Daltons, as discussed above.
  • a crosslinked or globular molecule such as a cross-linked or branched polysaccharide
  • a higher M.W. e.g., a M.W. in a range of from 3 x 10 6 Daltons to 30 x 10 6 Daltons
  • a higher concentration of the material may be used to provide similar rheological properties.
  • the viscofluidic OVD includes a quantity of the NaHA and a quantity of the saline that are sufficient so as to constitute the viscofluidic OVD having a certain concentration of the NaHA.
  • the viscofluidic OVD includes the NaHA at a concentration in a range of 0.1% to 0.2%.
  • the viscofluidic OVD includes the NaHA at a concentration in a range of 0.12% to 0.2%.
  • the viscofluidic OVD includes the NaHA at a concentration in a range of 0.14% to 0.2%.
  • the viscofluidic OVD includes the NaHA at a concentration in a range of 0.16% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.18% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.1% to 0.18%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.12% to 0.18%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.14% to 0.18%.
  • the viscofluidic OVD includes the NaHA at a concentration in a range of 0.16% to 0.18%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.1% to 0.16%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.12% to 0.16%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.14% to 0.16%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.1% to 0.14%.
  • the viscofluidic OVD includes the NaHA at a concentration in a range of 0.12% to 0.14%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.1% to 0.12%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.08% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.06% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.06% to 0.1%.
  • the viscofluidic OVD includes the NaHA at a concentration in a range of 0.05% to 0.09%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.05% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.06% to 0.08%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.065% to 0.075%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration of about 0.07%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration of 0.07%.
  • the viscofluidic OVD includes an isotonic solution of the NaHA in the saline, e.g., a solution that has the same or similar osmolality as plasma within human blood.
  • the viscofluidic OVD has an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg.
  • the viscofluidic OVD has an osmolality that is in a range of from 299 mOsm/kg to 381 mOsm/kg.
  • the viscofluidic OVD has an osmolality that is in a range of from 340 mOsm/kg to 381 mOsm/kg. In some embodiments, the viscofluidic OVD has an osmolality that is in a range of from 258 mOsm/kg to 340 mOsm/kg. In some embodiments, the viscofluidic OVD has an osmolality that is in a range of from 299 mOsm/kg to 340 mOsm/kg. In some embodiments, the viscofluidic OVD has an osmolality that is in a range of from 258 mOsm/kg to 299 mOsm/kg.
  • the viscofluidic OVD has a viscosity (e.g., as measured using a capillary viscometer, a Zahn cup, a falling sphere viscometer, a vibrational viscometer, or a rotational viscometer) that is in a range of from 80 centipoise (“cPs”) to 250 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 250 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 250 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 182 cPs to 250 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 216 cPs to 250 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 216 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 216 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 216 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 182 cPs to 216 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 182 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 182 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 182 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 148 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 148 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 114 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 1200 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 182 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 216 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 1000 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 182 cPs to 1000 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 216 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 800 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 800 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 800 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 182 cPs to 800 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 216 cPs to 800 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 360 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 640 cPs to 1200 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 920 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 920 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 360 cPs to 920 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 640 cPs to 920 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 640 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 360 cPs to 640 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 360 cPs at a shear rate of 0.1/second. [42] In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 400 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 500 cPs to 900 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 600 cPs to 800 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 650 cPs to 750 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 675 cPs to 725 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 700 cPs to 710 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is about 700 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is 700 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 700 cPs to 1100 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 800 cPs to 1100 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 700 cPs to 1000 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 800 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 850 cPs to 950 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 800 cPs to 1000 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is in a range of from 850 cPs to 950 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 800 cPs to 850 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 800 cPs to 825 cPs at a shear rate of 0.1/second.
  • the viscofluidic OVD has a viscosity that is about 815 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is 815 cPs at a shear rate of 0.1/second. In some embodiments, the suitable viscosity of the viscofluidic OVD varies depending on the molecular weight of a viscous component (e.g., NaHA, HPMC, a high molecular weight polysaccharide, etc.) included in the viscofluidic OVD.
  • a viscous component e.g., NaHA, HPMC, a high molecular weight polysaccharide, etc.
  • the viscofluidic OVD has a surface tension (e.g., as measured using a force tensiometer, a Du noisyiy ring, a Wilhemy plate, or a pendant drop test) that is greater than 70 dynes per centimeter (“dynes/cm”). In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 70 dynes/cm to 500 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 70 dynes/cm to 90 dynes/cm.
  • the viscofluidic OVD has a surface tension that is in a range of from 70 dynes/cm to 85 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 70 dynes/cm to 80 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 70 dynes/cm to 75 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 75 dynes/cm to 90 dynes/cm.
  • the viscofluidic OVD has a surface tension that is in a range of from 75 dynes/cm to 85 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 75 dynes/cm to 80 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 80 dynes/cm to 90 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 80 dynes/cm to 85 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 85 dynes/cm to 90 dynes/cm.
  • the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 500 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 90 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 85 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 80 dynes/cm.
  • the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 75 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 70 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 65 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 65 dynes/cm to 90 dynes/cm.
  • the viscofluidic OVD has a surface tension that is in a range of from 65 dynes/cm to 85 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 65 dynes/cm to 80 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 65 dynes/cm to 75 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 65 dynes/cm to 70 dynes/cm.
  • the viscofluidic OVD has a protein content that is less than 2 micrograms per milliliter. In some embodiments, the viscofluidic OVD has an absorbance of less than 0.20 absorbance units at 257 nm. In some embodiments, the viscofluidic OVD has a heavy metal content that is less than 10 parts per million. In some embodiments, the viscofluidic OVD has an endotoxin level of less than 0.25 endotoxin units per milliliter. In some embodiments, the viscofluidic OVD is non-inflammatory.
  • Figure 1 shows an exemplary embodiment of a system 100.
  • the system 100 includes a reservoir 5 containing a viscofluidic OVD 50.
  • the viscofluidic OVD 50 has a composition and fluid properties such as those described above.
  • the reservoir 5 is configured to be a single-use item (e.g., to be disposable after being used to perform a procedure on a single patient).
  • the reservoir 5 is positioned within a pressurized chamber 3.
  • the pressurized chamber 3 is configured to be reusable (e.g., to be used in the performance of procedures on multiple patients).
  • pressure is imparted to the chamber 3 by a pressurized fluid source 1 (e.g., an air compressor, a tank of a pressurized fluid such as a pressurized gas, etc.) pressing an air through air tube 2 and into the pressurized chamber 3.
  • a pressurized fluid source 1 e.g., an air compressor, a tank of a pressurized fluid such as a pressurized gas, etc.
  • pressure applied to the chamber 3 is regulated by an air regulator 18, which is set to a predefined over-pressure value.
  • pressure is imparted to the reservoir 5 within the chamber 3 by a mechanical compressing mechanism 4 that applies pressure to the reservoir 5.
  • Figure 1 illustrates a system 100 including both the pressurized fluid source 1 and the mechanical compressing mechanism 4, but it will be apparent to those of skill in the art that only the pressurized fluid source 1 or the mechanical compressing mechanism 4, and not both, may be sufficient to apply pressure to the reservoir 5.
  • the reservoir 5 is coupled to a control system 7 via a connector 6.
  • the control system 7 is reusable.
  • the control system 7 is configured to monitor and control pressure and flow of the viscofluidic OVD.
  • the fluid pathway from the connector 6 travels through a proportional valve 8 that is operable to regulate flow of the viscofluidic OVD, a pressure gauge 9 that is operable to measure pressure of the viscofluidic OVD, and a flow meter 10 that is operable to measure flow rate of the viscofluidic OVD.
  • a proportional valve 8 that is operable to regulate flow of the viscofluidic OVD
  • a pressure gauge 9 that is operable to measure pressure of the viscofluidic OVD
  • a flow meter 10 that is operable to measure flow rate of the viscofluidic OVD.
  • one or more of the proportional valve 8, the pressure gauge 9, and/or the flow meter 10 are implemented internally to the flow line.
  • one or more of the proportional valve 8, the pressure gauge 9, and/or the flow meter 10 are implemented externally to the flow line.
  • control system 7 includes a controller 14 (e.g., a computing device including a processor, a memory, etc.).
  • the proportional valve 8 is communicatively coupled to the controller 14 via a data line 15.
  • the pressure gauge 9 is communicatively coupled to the controller 14 via a data line 16.
  • the flow meter 10 is communicatively coupled to the controller 14 via a data line 17.
  • the viscofluidic OVD exits the control system 7 via an irrigation line 12 that is coupled to the control system 7 via a connector 11.
  • the irrigation line is configured to be single-use.
  • the irrigation line 12 includes a delivery tip 13 that is configured to be placed into the anterior chamber of the eye of a patient via an incision, as will be described in greater detail hereinafter with reference to method 300.
  • the control system 7 is configured to control intraocular pressure (“IOP”) w ithin the eye during performance of a procedure, such as a phacoemulsification procedure.
  • IOP intraocular pressure
  • the control system is configured to control IOP so as to maintain a target IOP as follows.
  • pressure and flow rate are measured by the pressure gauge 9 and the flow meter 10, respectively, and are communicated to the controller 14 via the data lines 16 and 17, respectively.
  • the controller 14 computes a theoretical current IOP based on the measured pressure and flow rate and a known resistance of the irrigation line 12.
  • the controller 14 communicates with the proportional valve 8 via the data line 15 and thereby controls the proportional valve 8 so as to open by a certain amount, which is determined based on the difference between calculated IOP and the target IOP, as well as based on known calibration parameters. Conversely, in some embodiments, if the calculated current IOP is too high as compared to the target IOP, then the controller 14 communicates with the proportional valve 8 via the data line 15 and thereby controls the proportional valve 8 so as to close by a certain amount, which is determined based on the difference between calculated IOP and the target IOP, as well as based on the known calibration parameters.
  • Figure 2 shows a second exemplary embodiment of a system 200.
  • the system 200 includes certain elements that are similar to or equivalent to elements of the system 100, as well as certain elements that are different than those of the system 100.
  • the elements of the system 200 that are similar to or equivalent to those of the system 100 are shown in Figure 2 and described hereinafter using the same reference numerals as are used in the above discussion of the system 100.
  • the system 200 includes a reservoir 5 containing a viscofluidic OVD 50.
  • the viscofluidic OVD 50 has a composition and fluid properties such as those described above.
  • the reservoir 5 is configured to be a single-use item (e.g., to be disposable after being used to perform a procedure on a single patient).
  • the reservoir 5 is coupled to a control system 7 via a connector 6.
  • the control system 7 is reusable.
  • the control system 7 is configured to monitor and control pressure and flow of the viscofluidic OVD 50.
  • the fluid pathway from the connector 6 travels through pump 19 that is operable to pressurize the viscofluidic OVD 50 within the control system 7 and to regulate flow of the viscofluidic OVD 50.
  • the pump 19 is a peristaltic pump. In some embodiments, the pump is controlled by rotational speed adjustment.
  • the viscofluidic OVD 50 travels through a pressure gauge 9 that is operable to measure pressure of the viscofluidic OVD 50, and a flow meter 10 that is operable to measure flow rate of the viscofluidic OVD 50.
  • a pressure gauge 9 that is operable to measure pressure of the viscofluidic OVD 50
  • a flow meter 10 that is operable to measure flow rate of the viscofluidic OVD 50.
  • one or more of the pump 19, the pressure gauge 9, and/or the flow meter 10 are implemented internally to the flow line.
  • one or more of the pump 19, the pressure gauge 9, and/or the flow meter 10 are implemented externally to the flow line.
  • the control system 7 includes a controller 14 (e.g., a computing device including a processor, a memory, etc.).
  • the pump 19 is communicatively coupled to the controller 14 via a data line 15.
  • the pressure gauge 9 is communicatively coupled to the controller 14 via a data line 16.
  • the flow meter 10 is communicatively coupled to the controller 14 via a data line 17.
  • the viscofluidic OVD exits the control system 7 via an irrigation line 12 that is coupled to the control system 7 via a connector 11.
  • the irrigation line is configured to be single-use.
  • the irrigation line 12 includes a delivery tip 13 that is configured to be placed into the anterior chamber of the eye of a patient via an incision, as will be described in greater detail hereinafter with reference to method 300.
  • the control system 7 is configured to control intraocular pressure (“IOP”) w ithin the eye during performance of a procedure, such as a phacoemulsification procedure.
  • IOP intraocular pressure
  • the control system is configured to control IOP so as to maintain a target IOP as follows.
  • pressure and flow rate are measured by the pressure gauge 9 and the flow meter 10, respectively, and are communicated to the controller 14 via the data lines 16 and 17, respectively.
  • the controller 14 computes a theoretical current IOP based on the measured pressure and flow rate and a known resistance of the irrigation line 12.
  • the controller 14 communicates with the pump 19 via the data line 15 and thereby controls the pump 19 to increase the applied pressure (e.g., for a pump that is controlled by rotational speed adjustment, to increase the rotational speed) by a certain amount, which is determined based on the difference between calculated IOP and the target IOP, as well as based on known calibration parameters.
  • the controller 14 communicates with the pump 19 via the data line 15 and thereby controls the pump 19 to decrease the applied pressure (e.g., for a pump that is controlled by rotational speed adjustment, to decrease the rotational speed) by a certain amount, which is determined based on the difference between calculated IOP and the target IOP, as well as based on the known calibration parameters.
  • FIG. 3 shows an exemplary method 300.
  • the exemplary method 300 describes the use of the exemplary system 100, which includes the exemplary viscofluidic OVD 50, in the performance of a phacoemulsification procedure for the treatment of cataracts.
  • step 305 one or more incisions are formed in the cornea by a practitioner. In some embodiments, at least one incision has a length that is from 1.9 mm to 2.75 mm.
  • a continuous curvilinear capsulorhexis (“CCC”) is created by the practitioner.
  • the CCC is created by use of a CCC-specific forceps.
  • the anterior capsule of the lens is opened, thereby enabling access to the lens's nucleus, while keeping the rest of the lens cover intact.
  • a capsulorhexis is created using another mechanism (e.g. a femtosecond laser, a precision nano-pulse capsulotomy device such as that commercialized by Centricity Vision, Inc. of Carlsbad, California under the trade name ZEPTO, etc.)
  • hydrodissection and hydrodelineation are performed by the practitioner.
  • hydrodissection refers to cortical cleaving, and includes injection of the exemplary viscofluidic OVD 50 under the anterior capsule such that a fluid wave traverses the posterior aspect of the lens and decompresses the capsule by depression of the central portion of the lens.
  • hydrodelineation refers separation of the epinucleus from the endonucleus in order to allow the epinucleus to serve as a protective cushion during manipulation and extraction of the endonucleus.
  • the exemplary viscofluidic OVD 50 injected into the eye during step 315 provides a working environment for phacoemulsification, as will be discussed hereinafter.
  • IOP within the eye is maintained through use of the exemplary viscofluidic OVD 50 in accordance with the operational techniques described above with respect to the exemplary systems 100 and 200.
  • step 320 nuclear rotation is performed by the practitioner. In some embodiments, nuclear rotation is performed with a second instrument. In some embodiments, nuclear rotation ensures that the nucleus is completely mobile and reduces the possibility of transferring stress to the posterior capsule and zonules during nuclear disassembly. In some embodiments, step 320 is omitted.
  • phacoemulsification is performed by the practitioner. It will be known to those of skill in the art that phacoemulsification refers to a emulsification of the lens of the eye through use of a handpiece with a delivery tip that is positioned in the eye. During a phacoemulsification process, the handpiece tip vibrates at an ultrasonic frequency (e.g., greater than 20,000 Hz), thereby causing at least a portion of the lens to emulsify, and allowing the lens, tissue of which forms a cataract, to be removed from the eye.
  • an ultrasonic frequency e.g., greater than 20,000 Hz
  • the working environment for the phacoemulsification of step 325 includes the viscofluidic OVD 50 that was injected into the eye in step 315.
  • phacoemulsification can be performed at various locations within the eye, including posterior chamber phacoemulsification.
  • fluid properties e.g., viscosity
  • certain advantages are realized during phacoemulsification.
  • turbulent flow within the viscofluidic OVD 50 is attenuated.
  • turbulent flow within the viscofluidic OVD 50 does not occur.
  • damage to surrounding tissue e.g., corneal endothelial cells
  • damage to surrounding tissue e.g., corneal endothelial cells
  • the viscosity of the viscofluidic OVD 50 due to the viscosity of the viscofluidic OVD 50, fragments of the lens are prevented from circulating and contacting the corneal endothelial cells. In some embodiments, due to the viscosity of the viscofluidic OVD 50, cavitation is prevented, thereby preventing tissue damage that could occur as a result of such cavitation.
  • step 330 the practitioner disassembles the nucleus of the eye into smaller pieces to facilitate removal.
  • the nucleus is disassembled by the application of mechanical force using a handheld instrument.
  • the nucleus is disassembled using the ultrasonic energy emitted by the phacoemulsification probe as discussed above.
  • the nucleus is disassembled by a femtosecond laser-assisted fragmentation technique.
  • step 330 is omitted.
  • the emulsified nucleus is aspirated from the eye by the practitioner (e.g., removed from the eye through the use of suction) and replaced by irrigation fluid, e.g., the viscofluidic OVD 50.
  • irrigation fluid e.g., the viscofluidic OVD 50.
  • cortical material remains attached to the capsular bag after nuclear disassembly and phacoemulsification.
  • an aspiration handpiece is used to remove the nucleus while a separate irrigation handpiece (e.g., the delivery tip 13 of the system 100 described above) is used to irrigate ocular tissue with the viscofluidic OVD 50.
  • the capsule is polished. In some embodiments, proper removal of lens epithelial cells prevents posterior capsular opacification and capsular phimosis.
  • step 340 the practitioner reforms the anterior chamber of the eye and the capsular bag using the viscofluidic OVD 50.
  • the viscofluidic OVD 50 possesses sufficient viscosity to maintain the shape of the anterior chamber and to maintain intraocular pressure within the anterior chamber, e.g., to stabilize the anterior chamber.
  • the viscofluidic OVD 50 possesses sufficient viscosity to maintain the shape of the anterior chamber and the intraocular pressure within the anterior chamber in the presence of an open incision.
  • step 345 the practitioner injects an artificial intraocular lens (“IOL”) into the capsular bag as a replacement for the natural lens.
  • IOL artificial intraocular lens
  • the IOL is a foldable IOL that is loaded onto a cartridge prior to injection.
  • the viscofluidic OVD 50 maintains the shape of the of the anterior chamber and the intraocular pressure within the anterior chamber during injection of the artificial IOL, and, as such, no further maintainer or other material needs to be injected during this step.
  • the procedure is completed by the practitioner, including rinsing the viscofluidic OVD 50 from the eye, closing incisions and any other related steps.
  • a device such as a visco-fluid that is positioned within the eye in order to control IOP during phacoemulsification is referred to as an “anterior chamber maintainer” (“ACM”).
  • ACM anterior chamber maintainer
  • the viscofluidic OVD 50 acts as an ACM when utilized to control IOP during phacoemulsification as discussed above with reference to the exemplary method 300.
  • the exemplary method 300 describes the use of the exemplary system 100, which includes the exemplary viscofluidic OVD 50, in the performance of a phacoemulsification procedure for the treatment of cataracts.
  • the exemplary viscofluidic OVD 50 may be employed as part of a different system during the performance of a phacoemulsification procedure for the treatment of cataracts.
  • the exemplary viscofluidic OVD 50 may be employed in systems and/or methods for performing other types of intraocular surgeries.
  • the viscofluidic OVD 50 is employed in a system and/or a method for performing intraocular glaucoma surgery, such as trabeculectomy, implantation of a shunt implant, and/or minimally invasive glaucoma surgery (“MIGS”).
  • the viscofluidic OVD 50 is employed in a system and/or a method for performing vitrectomy, such as anterior vitrectomy or pars plana vitrectomy.
  • the viscofluidic OVD 50 is employed in a system for performing vitrectomy as part of an irrigation/aspiration module of such a system.
  • the viscofluidic OVD 50 is employed in a system and/or a method for performing corneal transplant surgery, such as penetrating keratoplasty or lamellar keratoplasty.

Abstract

A method including providing a viscofluidic solution, wherein the viscofluidic solution includes a quantity of sodium hyaluronate dissolved in a quantity of a saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the viscofluidic solution with a viscosity that is in a range of from 400 centipoise to 1200 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 60 to 500 dynes per centimeter; creating an incision in a cornea of an eye of a patient; and irrigating the eye of the patient with the viscofluidic solution.

Description

COMPOUND, METHOD AND SYSTEM FOR OPHTHALMIC SURGERY
Cross-Reference to Related Application
[1] This application is an international (PCT) patent application relating to and claiming the benefit of commonly-owned, co-pending U.S. Provisional Patent Application No. 63/149,031, filed on February 12, 2021 and entitled “COMPOUND, METHOD AND SYSTEM FOR OPHTHALMIC SURGERY,” the contents of which are incorporated herein by reference in their entirety.
Field of the Invention
[2] The field of the invention relates to methods and systems for performing ophthalmic surgery. More particularly, the field of invention relates to compounds, methods, and systems for performing irrigation during ophthalmic surgery, such as ophthalmic surgery to treat cataracts.
Background of the Invention
[3] Phacoemulsification is a surgical technique for treating cataracts in which the eye’ s internal lens fibers, which form the nucleus and cortex of a cataract, are emulsified and aspirated from within the eye. The aspirated fluids are replaced with a replacement fluid to maintain space in the anterior chamber of the eye. An artificial intraocular lens (“IOL”) implant is placed into the eye to replace the natural lens.
Brief Description of the Figures
[4] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
[5] Figure 1 shows a first exemplary system for applying an exemplary viscofluidic ophthalmic surgical device to an eye.
[6] Figure 2 shows a second exemplary system for applying an exemplary viscofluidic ophthalmic surgical device to an eye.
[7] Figure 3 shows an exemplary method for performing phacoemulsification surgery that includes use of an exemplary viscofluidic ophthalmic surgical device.
Summary of the Invention
[8] In some embodiments, a method includes providing a viscofluidic solution, wherein the viscofluidic solution includes a quantity of sodium hyaluronate dissolved in a quantity of saline, wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 80 centipoise to 250 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 70 to 500 dynes per centimeter; creating an incision in a cornea of an eye of a patient; and irrigating the eye of the patient with the viscofluidic solution.
[9] In some embodiments, the method also includes performing phacoemulsification to emulsify at least a portion of a lens of the eye of the patient; aspirating the portion of the eye of the patient; and injecting the viscofluidic solution into an anterior chamber of the eye of the patient, thereby to stabilize the anterior chamber and maintain an intraocular pressure within the eye of the patient. [10] In some embodiments, the viscofluidic solution has a surface tension that is in a range of from 70 to 85 dynes per centimeter. In some embodiments, the viscofluidic solution has a viscosity that is in a range of from 114 centipoise to 216 centipoise at a shear rate of 0.1/second. In some embodiments, the viscofluidic solution has an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg. In some embodiments, the ophthalmic composition is isotonic.
[11] In some embodiments, a concentration of the sodium hyaluronate in the viscofluidic solution is in a range of from 0.1% to 0.2%. In some embodiments, a concentration of the sodium hyaluronate in the viscofluidic solution is in a range of from 0.05% to 0.2%.
[12] In some embodiments, an ophthalmic composition for irrigating ocular tissues during an intraocular surgical procedure includes a quantity of a sodium hyaluronate; and a quantity of a saline solution, wherein the sodium hyaluronate is dissolved in the saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 80 centipoise to 250 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 70 to 500 dynes per centimeter.
[13] In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a surface tension that is in a range of from 70 to 85 dynes per centimeter. In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 114 centipoise to 216 centipoise at a shear rate of 0.1/second. In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg. In some embodiments, the ophthalmic composition is isotonic. [14] In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient such that a concentration of the sodium hyaluronate in the ophthalmic composition is in a range of from 0.1% to 0.2%. In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient such that a concentration of the sodium hyaluronate in the ophthalmic composition is in a range of from 0.05% to 0.2%.
[15] In some embodiments, a system includes a reservoir containing an ophthalmic composition, wherein the ophthalmic composition includes a quantity of sodium hyaluronate dissolved in a quantity of saline, wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 80 centipoise to 250 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 70 to 500 dynes per centimeter; a delivery tip in fluid communication with the reservoir, wherein the delivery tip is configured to deliver the ophthalmic composition to an eye of a patient; and a pressure mechanism configured to pressurize the ophthalmic composition; and a control system configured to control a flow rate and a pressure of the ophthalmic composition delivered to the eye.
[16] In some embodiments, the control system is configured to control the flow rate and the pressure to thereby stabilize an intraocular pressure within the eye.
[17] In some embodiments, the pressure mechanism includes a mechanism configured to apply pressure to the reservoir. In some embodiments, the mechanism configured to apply pressure to the reservoir includes a pressurized gas or a mechanical compressing mechanism.
[18] In some embodiments, the pressure mechanism includes a pump configured to apply pressure to a flow line conveying the ophthalmic composition.
[19] In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a surface tension that is in a range of from 70 to 85 dynes per centimeter. In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 114 centipoise to 216 centipoise at a shear rate of 0.1/second. In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg.
[20] In some embodiments, a method includes providing a viscofluidic solution, wherein the viscofluidic solution includes a quantity of sodium hyaluronate dissolved in a quantity of a saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the viscofluidic solution with a viscosity that is in a range of from 400 centipoise to 1200 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 60 to 500 dynes per centimeter; creating an incision in a cornea of an eye of a patient; and irrigating the eye of the patient with the viscofluidic solution.
[21] In some embodiments, a method includes performing phacoemulsification to emulsify at least a portion of a lens of the eye of the patient; aspirating the portion of the eye of the patient; and injecting the viscofluidic solution into an anterior chamber of the eye of the patient, thereby to stabilize the anterior chamber and maintain an intraocular pressure within the eye of the patient.
[22] In some embodiments, the viscofluidic solution has a surface tension that is in a range of from 60 to 90 dynes per centimeter. In some embodiments, the viscofluidic solution has a viscosity that is in a range of from 700 centipoise to 900 centipoise at a shear rate of 0.1/second. In some embodiments, the viscofluidic solution has an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg. In some embodiments, the viscofluidic solution is isotonic.
[23] In some embodiments, a concentration of the sodium hyaluronate in the viscofluidic solution is in a range of from 0.05% to 0.2%. [24] In some embodiments, an ophthalmic composition for irrigating ocular tissues during an intraocular surgical procedure includes a quantity of a sodium hyaluronate; and a quantity of a saline solution, wherein the sodium hyaluronate is dissolved in the saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 400 centipoise to 1200 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 60 to 500 dynes per centimeter.
[25] In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a surface tension that is in a range of from 60 to 90 dynes per centimeter. In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 700 centipoise to 900 centipoise at a shear rate of 0.1/second. In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg. In some embodiments, the ophthalmic composition is isotonic.
[26] In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient such that a concentration of the sodium hyaluronate in the ophthalmic composition is in a range of from 0.05% to 0.2%.
[27] In some embodiments, a system includes a reservoir containing an ophthalmic composition, wherein the ophthalmic composition includes a quantity of sodium hyaluronate dissolved in a quantity of a saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 400 centipoise to 1200 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 60 to 500 dynes per centimeter; a delivery tip in fluid communication with the reservoir, wherein the delivery tip is configured to deliver the ophthalmic composition to an eye of a patient; a pressure mechanism configured to pressurize the ophthalmic composition; and a control system configured to control a flow rate and a pressure of the ophthalmic composition delivered to the eye.
[28] In some embodiments, the control system is configured to control the flow rate and the pressure to thereby stabilize an intraocular pressure within the eye.
[29] In some embodiments, the pressure mechanism includes a mechanism configured to apply pressure to the reservoir. In some embodiments, the mechanism configured to apply pressure to the reservoir includes a pressurized gas or a mechanical compressing mechanism.
[30] In some embodiments, the pressure mechanism includes a pump configured to apply pressure to a flow line conveying the ophthalmic composition.
[31] In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a surface tension that is in a range of from 60 to 90 dynes per centimeter.
[32] In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 700 centipoise to 900 centipoise at a shear rate of 0.1/second.
[33] In some embodiments, the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg. Detailed Description of the Invention
[34] The exemplary embodiments described herein relate to a viscofluidic ophthalmic surgical device (“OVD”). In some embodiments, an exemplary viscofluidic OVD is suitable for use for use for irrigation and other tasks as will be described in further detail hereinafter during the performance of ophthalmic surgery, such as phacoemulsification procedures to treat cataracts. In some embodiments, an exemplary viscofluidic OVD has fluid properties (e.g., viscosity, surface tension, etc.)
[35] In some embodiments, the viscofluidic OVD includes sodium hyaluronate (“NaHA”) dissolved in a saline solution (e.g., a solution of sodium chloride dissolved in water for injection (“WFI”). In some embodiments, the average molecular weight (“M.W.”) of the NaHA is in a range of from 2.4 x 106 Daltons to 3.6 x 106 Daltons. In some embodiments, the average M.W. of the NaHA is in a range of from 2.5 x 106 Daltons to 3.5 x 106 Daltons. In some embodiments, the average M.W. of the NaHA is in a range of from 2.6 x 106 Daltons to 3.4 x 106 Daltons. In some embodiments, the average M.W. of the NaHA is in a range of from 2.7 x 106 Daltons to 3.3 x 106 Daltons. In some embodiments, the average M.W. of the NaHA is in a range of from 2.8 x 106 Daltons to 3.2 x 106 Daltons. In some embodiments, the average M.W. of the NaHA is in a range of from 2.9 x 106 Daltons to 3.1 x 106 Daltons. In some embodiments, the average M.W. of the NaHA is about 3 x 106 Daltons. In some embodiments, the average M.W. of the NaHA is 3 x 106 Daltons. In some embodiments, the average M.W. of the NaHA is in a range of from 2 x 106 Daltons to 3 x 106 Daltons.
[36] The exemplary embodiments described herein make specific reference to a viscofluidic OVD that includes sodium hyaluronate (“NaHA”). However, it will be apparent to those of skill in the art that other biocompatible viscofluidic materials having similar physical properties (e.g., pseudoplastic properties, molecular weight, concentration, osmolality, viscosity, surface tension, absorbance, etc.) to the various embodiments of NaHA described herein may be equally applicable and suitable for use in the exemplary systems that will be described hereinafter. In some embodiments, another suitable material includes hydroxypropyl methylcellulose (“HPMC”). In some embodiments, another suitable material includes a high molecular weight polysaccharide. In some embodiments, a suitable M.W. for a given material depends on the molecular structure for that material, as materials having different molecular structures will have different rheological properties at the same M.W. For example, NaHA is a linear molecule, and as such, in some embodiments, has a suitable average M.W. of about 3 x 106 Daltons, as discussed above. In contrast, for a crosslinked or globular molecule, such as a cross-linked or branched polysaccharide, a higher M.W. (e.g., a M.W. in a range of from 3 x 106 Daltons to 30 x 106 Daltons) may provide similar rheological properties. Alternately, in some such embodiments in which a lower M.W. is used, a higher concentration of the material may be used to provide similar rheological properties.
[37] In some embodiments, the viscofluidic OVD includes a quantity of the NaHA and a quantity of the saline that are sufficient so as to constitute the viscofluidic OVD having a certain concentration of the NaHA. For example, in some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.1% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.12% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.14% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.16% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.18% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.1% to 0.18%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.12% to 0.18%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.14% to 0.18%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.16% to 0.18%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.1% to 0.16%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.12% to 0.16%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.14% to 0.16%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.1% to 0.14%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.12% to 0.14%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.1% to 0.12%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.08% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.06% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.06% to 0.1%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.05% to 0.09%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.05% to 0.2%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.06% to 0.08%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration in a range of 0.065% to 0.075%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration of about 0.07%. In some embodiments, the viscofluidic OVD includes the NaHA at a concentration of 0.07%.
[38] In some embodiments, the viscofluidic OVD includes an isotonic solution of the NaHA in the saline, e.g., a solution that has the same or similar osmolality as plasma within human blood. In some embodiments, the viscofluidic OVD has an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg. In some embodiments, the viscofluidic OVD has an osmolality that is in a range of from 299 mOsm/kg to 381 mOsm/kg. In some embodiments, the viscofluidic OVD has an osmolality that is in a range of from 340 mOsm/kg to 381 mOsm/kg. In some embodiments, the viscofluidic OVD has an osmolality that is in a range of from 258 mOsm/kg to 340 mOsm/kg. In some embodiments, the viscofluidic OVD has an osmolality that is in a range of from 299 mOsm/kg to 340 mOsm/kg. In some embodiments, the viscofluidic OVD has an osmolality that is in a range of from 258 mOsm/kg to 299 mOsm/kg.
[39] In some embodiments, the viscofluidic OVD has a viscosity (e.g., as measured using a capillary viscometer, a Zahn cup, a falling sphere viscometer, a vibrational viscometer, or a rotational viscometer) that is in a range of from 80 centipoise (“cPs”) to 250 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 250 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 250 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 182 cPs to 250 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 216 cPs to 250 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 216 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 216 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 216 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 182 cPs to 216 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 182 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 182 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 182 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 148 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 148 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 114 cPs at a shear rate of 0.1/second.
[40] In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 182 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 216 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 182 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 216 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 800 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 114 cPs to 800 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 148 cPs to 800 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 182 cPs to 800 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 216 cPs to 800 cPs at a shear rate of 0.1/second.
[41] In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 360 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 640 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 920 cPs to 1200 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 920 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 360 cPs to 920 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 640 cPs to 920 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 640 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 360 cPs to 640 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 80 cPs to 360 cPs at a shear rate of 0.1/second. [42] In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 400 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 500 cPs to 900 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 600 cPs to 800 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 650 cPs to 750 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 675 cPs to 725 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 700 cPs to 710 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is about 700 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is 700 cPs at a shear rate of 0.1/second.
[43] In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 700 cPs to 1100 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 800 cPs to 1100 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 700 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 800 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 850 cPs to 950 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 800 cPs to 1000 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 850 cPs to 950 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 800 cPs to 850 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is in a range of from 800 cPs to 825 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is about 815 cPs at a shear rate of 0.1/second. In some embodiments, the viscofluidic OVD has a viscosity that is 815 cPs at a shear rate of 0.1/second. In some embodiments, the suitable viscosity of the viscofluidic OVD varies depending on the molecular weight of a viscous component (e.g., NaHA, HPMC, a high molecular weight polysaccharide, etc.) included in the viscofluidic OVD. [44] In some embodiments, the viscofluidic OVD has a surface tension (e.g., as measured using a force tensiometer, a Du Noiiy ring, a Wilhemy plate, or a pendant drop test) that is greater than 70 dynes per centimeter (“dynes/cm”). In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 70 dynes/cm to 500 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 70 dynes/cm to 90 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 70 dynes/cm to 85 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 70 dynes/cm to 80 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 70 dynes/cm to 75 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 75 dynes/cm to 90 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 75 dynes/cm to 85 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 75 dynes/cm to 80 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 80 dynes/cm to 90 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 80 dynes/cm to 85 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 85 dynes/cm to 90 dynes/cm.
[45] In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 500 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 90 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 85 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 80 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 75 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 70 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 60 dynes/cm to 65 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 65 dynes/cm to 90 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 65 dynes/cm to 85 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 65 dynes/cm to 80 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 65 dynes/cm to 75 dynes/cm. In some embodiments, the viscofluidic OVD has a surface tension that is in a range of from 65 dynes/cm to 70 dynes/cm.
[46] In some embodiments, the viscofluidic OVD has a protein content that is less than 2 micrograms per milliliter. In some embodiments, the viscofluidic OVD has an absorbance of less than 0.20 absorbance units at 257 nm. In some embodiments, the viscofluidic OVD has a heavy metal content that is less than 10 parts per million. In some embodiments, the viscofluidic OVD has an endotoxin level of less than 0.25 endotoxin units per milliliter. In some embodiments, the viscofluidic OVD is non-inflammatory.
[47] Figure 1 shows an exemplary embodiment of a system 100. In some embodiments, the system 100 includes a reservoir 5 containing a viscofluidic OVD 50. In some embodiments, the viscofluidic OVD 50 has a composition and fluid properties such as those described above. In some embodiments, the reservoir 5 is configured to be a single-use item (e.g., to be disposable after being used to perform a procedure on a single patient). In some embodiments, the reservoir 5 is positioned within a pressurized chamber 3. In some embodiments, the pressurized chamber 3 is configured to be reusable (e.g., to be used in the performance of procedures on multiple patients). In some embodiments, pressure is imparted to the chamber 3 by a pressurized fluid source 1 (e.g., an air compressor, a tank of a pressurized fluid such as a pressurized gas, etc.) pressing an air through air tube 2 and into the pressurized chamber 3. In some embodiments, pressure applied to the chamber 3 is regulated by an air regulator 18, which is set to a predefined over-pressure value. In some embodiments, pressure is imparted to the reservoir 5 within the chamber 3 by a mechanical compressing mechanism 4 that applies pressure to the reservoir 5. Figure 1 illustrates a system 100 including both the pressurized fluid source 1 and the mechanical compressing mechanism 4, but it will be apparent to those of skill in the art that only the pressurized fluid source 1 or the mechanical compressing mechanism 4, and not both, may be sufficient to apply pressure to the reservoir 5. [48] In some embodiments, the reservoir 5 is coupled to a control system 7 via a connector 6. In some embodiments, the control system 7 is reusable. In some embodiments, the control system 7 is configured to monitor and control pressure and flow of the viscofluidic OVD. In some embodiments, the fluid pathway from the connector 6 travels through a proportional valve 8 that is operable to regulate flow of the viscofluidic OVD, a pressure gauge 9 that is operable to measure pressure of the viscofluidic OVD, and a flow meter 10 that is operable to measure flow rate of the viscofluidic OVD. In some embodiments, one or more of the proportional valve 8, the pressure gauge 9, and/or the flow meter 10 are implemented internally to the flow line. In some embodiments, one or more of the proportional valve 8, the pressure gauge 9, and/or the flow meter 10 are implemented externally to the flow line. In some embodiments, the control system 7 includes a controller 14 (e.g., a computing device including a processor, a memory, etc.). In some embodiments, the proportional valve 8 is communicatively coupled to the controller 14 via a data line 15. In some embodiments, the pressure gauge 9 is communicatively coupled to the controller 14 via a data line 16. In some embodiments, the flow meter 10 is communicatively coupled to the controller 14 via a data line 17.
[49] In some embodiments, the viscofluidic OVD exits the control system 7 via an irrigation line 12 that is coupled to the control system 7 via a connector 11. In some embodiments, the irrigation line is configured to be single-use. In some embodiments, the irrigation line 12 includes a delivery tip 13 that is configured to be placed into the anterior chamber of the eye of a patient via an incision, as will be described in greater detail hereinafter with reference to method 300.
[50] In some embodiments, the control system 7 is configured to control intraocular pressure (“IOP”) within the eye during performance of a procedure, such as a phacoemulsification procedure. In some embodiments, the control system is configured to control IOP so as to maintain a target IOP as follows. In some embodiments, at any given point in time during a procedure, pressure and flow rate are measured by the pressure gauge 9 and the flow meter 10, respectively, and are communicated to the controller 14 via the data lines 16 and 17, respectively. As a result, at any given time during the procedure, the controller 14 computes a theoretical current IOP based on the measured pressure and flow rate and a known resistance of the irrigation line 12. In some embodiments, if the calculated current IOP is too low as compared to the target IOP, then the controller 14 communicates with the proportional valve 8 via the data line 15 and thereby controls the proportional valve 8 so as to open by a certain amount, which is determined based on the difference between calculated IOP and the target IOP, as well as based on known calibration parameters. Conversely, in some embodiments, if the calculated current IOP is too high as compared to the target IOP, then the controller 14 communicates with the proportional valve 8 via the data line 15 and thereby controls the proportional valve 8 so as to close by a certain amount, which is determined based on the difference between calculated IOP and the target IOP, as well as based on the known calibration parameters.
[51] Figure 2 shows a second exemplary embodiment of a system 200. The system 200 includes certain elements that are similar to or equivalent to elements of the system 100, as well as certain elements that are different than those of the system 100. The elements of the system 200 that are similar to or equivalent to those of the system 100 are shown in Figure 2 and described hereinafter using the same reference numerals as are used in the above discussion of the system 100.
[52] In some embodiments, the system 200 includes a reservoir 5 containing a viscofluidic OVD 50. In some embodiments, the viscofluidic OVD 50 has a composition and fluid properties such as those described above. In some embodiments, the reservoir 5 is configured to be a single-use item (e.g., to be disposable after being used to perform a procedure on a single patient).
[53] In some embodiments, the reservoir 5 is coupled to a control system 7 via a connector 6. In some embodiments, the control system 7 is reusable. In some embodiments, the control system 7 is configured to monitor and control pressure and flow of the viscofluidic OVD 50. In some embodiments, the fluid pathway from the connector 6 travels through pump 19 that is operable to pressurize the viscofluidic OVD 50 within the control system 7 and to regulate flow of the viscofluidic OVD 50. In some embodiments the pump 19 is a peristaltic pump. In some embodiments, the pump is controlled by rotational speed adjustment. In some embodiments, after the pump 19, the viscofluidic OVD 50 travels through a pressure gauge 9 that is operable to measure pressure of the viscofluidic OVD 50, and a flow meter 10 that is operable to measure flow rate of the viscofluidic OVD 50. In some embodiments, one or more of the pump 19, the pressure gauge 9, and/or the flow meter 10 are implemented internally to the flow line. In some embodiments, one or more of the pump 19, the pressure gauge 9, and/or the flow meter 10 are implemented externally to the flow line. In some embodiments, the control system 7 includes a controller 14 (e.g., a computing device including a processor, a memory, etc.). In some embodiments, the pump 19 is communicatively coupled to the controller 14 via a data line 15. In some embodiments, the pressure gauge 9 is communicatively coupled to the controller 14 via a data line 16. In some embodiments, the flow meter 10 is communicatively coupled to the controller 14 via a data line 17.
[54] In some embodiments, the viscofluidic OVD exits the control system 7 via an irrigation line 12 that is coupled to the control system 7 via a connector 11. In some embodiments, the irrigation line is configured to be single-use. In some embodiments, the irrigation line 12 includes a delivery tip 13 that is configured to be placed into the anterior chamber of the eye of a patient via an incision, as will be described in greater detail hereinafter with reference to method 300.
[55] In some embodiments, the control system 7 is configured to control intraocular pressure (“IOP”) within the eye during performance of a procedure, such as a phacoemulsification procedure. In some embodiments, the control system is configured to control IOP so as to maintain a target IOP as follows. In some embodiments, at any given point in time during a procedure, pressure and flow rate are measured by the pressure gauge 9 and the flow meter 10, respectively, and are communicated to the controller 14 via the data lines 16 and 17, respectively. As a result, at any given time during the procedure, the controller 14 computes a theoretical current IOP based on the measured pressure and flow rate and a known resistance of the irrigation line 12. In some embodiments, if the calculated current IOP is too low as compared to the target IOP, then the controller 14 communicates with the pump 19 via the data line 15 and thereby controls the pump 19 to increase the applied pressure (e.g., for a pump that is controlled by rotational speed adjustment, to increase the rotational speed) by a certain amount, which is determined based on the difference between calculated IOP and the target IOP, as well as based on known calibration parameters. Conversely, in some embodiments, if the calculated current IOP is too high as compared to the target IOP, then the controller 14 communicates with the pump 19 via the data line 15 and thereby controls the pump 19 to decrease the applied pressure (e.g., for a pump that is controlled by rotational speed adjustment, to decrease the rotational speed) by a certain amount, which is determined based on the difference between calculated IOP and the target IOP, as well as based on the known calibration parameters.
[56] Figure 3 shows an exemplary method 300. The exemplary method 300 describes the use of the exemplary system 100, which includes the exemplary viscofluidic OVD 50, in the performance of a phacoemulsification procedure for the treatment of cataracts. In step 305, one or more incisions are formed in the cornea by a practitioner. In some embodiments, at least one incision has a length that is from 1.9 mm to 2.75 mm.
[57] In step 310, a continuous curvilinear capsulorhexis is (“CCC”) is created by the practitioner. In some embodiments, the CCC is created by use of a CCC-specific forceps. In some embodiments, as a result of CCC, the anterior capsule of the lens is opened, thereby enabling access to the lens's nucleus, while keeping the rest of the lens cover intact. As an alternative, in other embodiments, rather than forming a CCC, a capsulorhexis is created using another mechanism (e.g. a femtosecond laser, a precision nano-pulse capsulotomy device such as that commercialized by Centricity Vision, Inc. of Carlsbad, California under the trade name ZEPTO, etc.)
[58] In step 315, hydrodissection and hydrodelineation are performed by the practitioner. In some embodiments, hydrodissection refers to cortical cleaving, and includes injection of the exemplary viscofluidic OVD 50 under the anterior capsule such that a fluid wave traverses the posterior aspect of the lens and decompresses the capsule by depression of the central portion of the lens. In some embodiments, hydrodelineation refers separation of the epinucleus from the endonucleus in order to allow the epinucleus to serve as a protective cushion during manipulation and extraction of the endonucleus. In some embodiments, the exemplary viscofluidic OVD 50 injected into the eye during step 315 provides a working environment for phacoemulsification, as will be discussed hereinafter. In some embodiments, IOP within the eye is maintained through use of the exemplary viscofluidic OVD 50 in accordance with the operational techniques described above with respect to the exemplary systems 100 and 200.
[59] In step 320, nuclear rotation is performed by the practitioner. In some embodiments, nuclear rotation is performed with a second instrument. In some embodiments, nuclear rotation ensures that the nucleus is completely mobile and reduces the possibility of transferring stress to the posterior capsule and zonules during nuclear disassembly. In some embodiments, step 320 is omitted.
[60] In step 325, phacoemulsification is performed by the practitioner. It will be known to those of skill in the art that phacoemulsification refers to a emulsification of the lens of the eye through use of a handpiece with a delivery tip that is positioned in the eye. During a phacoemulsification process, the handpiece tip vibrates at an ultrasonic frequency (e.g., greater than 20,000 Hz), thereby causing at least a portion of the lens to emulsify, and allowing the lens, tissue of which forms a cataract, to be removed from the eye. In some embodiments, the working environment for the phacoemulsification of step 325 includes the viscofluidic OVD 50 that was injected into the eye in step 315. In various embodiments, phacoemulsification can be performed at various locations within the eye, including posterior chamber phacoemulsification.
[61] In some embodiments, due to the fluid properties (e.g., viscosity) of the viscofluidic OVD 50, certain advantages are realized during phacoemulsification. In some embodiments, due to the viscosity of the viscofluidic OVD 50, turbulent flow within the viscofluidic OVD 50 is attenuated. In some embodiments, due to the viscosity of the viscofluidic OVD 50, turbulent flow within the viscofluidic OVD 50 does not occur. As a result, in some embodiments, damage to surrounding tissue (e.g., corneal endothelial cells) that could potentially occur due to turbulence is prevented through use of the viscofluidic OVD 50. In some embodiments, due to the viscosity of the viscofluidic OVD 50, fragments of the lens are prevented from circulating and contacting the corneal endothelial cells. In some embodiments, due to the viscosity of the viscofluidic OVD 50, cavitation is prevented, thereby preventing tissue damage that could occur as a result of such cavitation.
[62] In step 330, the practitioner disassembles the nucleus of the eye into smaller pieces to facilitate removal. In some embodiments, the nucleus is disassembled by the application of mechanical force using a handheld instrument. In some embodiments, the nucleus is disassembled using the ultrasonic energy emitted by the phacoemulsification probe as discussed above. In some embodiments, the nucleus is disassembled by a femtosecond laser-assisted fragmentation technique. In some embodiments, step 330 is omitted.
[63] In step 335, the emulsified nucleus is aspirated from the eye by the practitioner (e.g., removed from the eye through the use of suction) and replaced by irrigation fluid, e.g., the viscofluidic OVD 50. In some embodiments, cortical material remains attached to the capsular bag after nuclear disassembly and phacoemulsification. In some embodiments, an aspiration handpiece is used to remove the nucleus while a separate irrigation handpiece (e.g., the delivery tip 13 of the system 100 described above) is used to irrigate ocular tissue with the viscofluidic OVD 50. In some embodiments, the capsule is polished. In some embodiments, proper removal of lens epithelial cells prevents posterior capsular opacification and capsular phimosis.
[64] In step 340, the practitioner reforms the anterior chamber of the eye and the capsular bag using the viscofluidic OVD 50. In some embodiments, the viscofluidic OVD 50 possesses sufficient viscosity to maintain the shape of the anterior chamber and to maintain intraocular pressure within the anterior chamber, e.g., to stabilize the anterior chamber. In some embodiments, the viscofluidic OVD 50 possesses sufficient viscosity to maintain the shape of the anterior chamber and the intraocular pressure within the anterior chamber in the presence of an open incision. [65] In step 345, the practitioner injects an artificial intraocular lens (“IOL”) into the capsular bag as a replacement for the natural lens. In some embodiments, the IOL is a foldable IOL that is loaded onto a cartridge prior to injection. As discussed above with reference to step 340, in some embodiments, the viscofluidic OVD 50 maintains the shape of the of the anterior chamber and the intraocular pressure within the anterior chamber during injection of the artificial IOL, and, as such, no further maintainer or other material needs to be injected during this step. In step 350, the procedure is completed by the practitioner, including rinsing the viscofluidic OVD 50 from the eye, closing incisions and any other related steps.
[66] In some cases, a device such as a visco-fluid that is positioned within the eye in order to control IOP during phacoemulsification is referred to as an “anterior chamber maintainer” (“ACM”). In some embodiments, the viscofluidic OVD 50 acts as an ACM when utilized to control IOP during phacoemulsification as discussed above with reference to the exemplary method 300.
[67] As noted above, the exemplary method 300 describes the use of the exemplary system 100, which includes the exemplary viscofluidic OVD 50, in the performance of a phacoemulsification procedure for the treatment of cataracts. However, it will be apparent to those of skill in the art that the exemplary viscofluidic OVD 50 may be employed as part of a different system during the performance of a phacoemulsification procedure for the treatment of cataracts. It will be further apparent to those of skill in the art that the exemplary viscofluidic OVD 50 may be employed in systems and/or methods for performing other types of intraocular surgeries. In some embodiments, the viscofluidic OVD 50 is employed in a system and/or a method for performing intraocular glaucoma surgery, such as trabeculectomy, implantation of a shunt implant, and/or minimally invasive glaucoma surgery (“MIGS”). In some embodiments, the viscofluidic OVD 50 is employed in a system and/or a method for performing vitrectomy, such as anterior vitrectomy or pars plana vitrectomy. For example, in some embodiments, the viscofluidic OVD 50 is employed in a system for performing vitrectomy as part of an irrigation/aspiration module of such a system. In some embodiments, the viscofluidic OVD 50 is employed in a system and/or a method for performing corneal transplant surgery, such as penetrating keratoplasty or lamellar keratoplasty.
[68] While a number of embodiments of the present invention have been described, it is understood that these embodiments are illustrative only, and not restrictive, and that many modifications may become apparent to those of ordinary skill in the art. For example, all dimensions discussed herein are provided as examples only, and are intended to be illustrative and not restrictive.

Claims

CLAIMS What is claimed is:
1. A method, comprising: providing a viscofluidic solution, wherein the viscofluidic solution includes a quantity of sodium hyaluronate dissolved in a quantity of a saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the viscofluidic solution with a viscosity that is in a range of from 400 centipoise to 1200 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 60 to 500 dynes per centimeter; creating an incision in a cornea of an eye of a patient; and irrigating the eye of the patient with the viscofluidic solution.
2. The method of claim 1, further comprising: performing phacoemulsification to emulsify at least a portion of a lens of the eye of the patient; aspirating the portion of the eye of the patient; and injecting the viscofluidic solution into an anterior chamber of the eye of the patient, thereby to stabilize the anterior chamber and maintain an intraocular pressure within the eye of the patient.
3. The method of claim 1, wherein the viscofluidic solution has a surface tension that is in a range of from 60 to 90 dynes per centimeter.
4. The method of claim 3, wherein the viscofluidic solution has a viscosity that is in a range of from 700 centipoise to 900 centipoise at a shear rate of 0.1/second.
5. The method of claim 4, wherein the viscofluidic solution has an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg.
6. The method of claim 5, wherein the viscofluidic solution is isotonic.
7. The method of claim 1, wherein a concentration of the sodium hyaluronate in the viscofluidic solution is in a range of from 0.05% to 0.2%.
8. An ophthalmic composition for irrigating ocular tissues during an intraocular surgical procedure, the ophthalmic composition comprising: a quantity of a sodium hyaluronate; and a quantity of a saline solution, wherein the sodium hyaluronate is dissolved in the saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 400 centipoise to 1200 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 60 to 500 dynes per centimeter.
9. The ophthalmic composition of claim 8, wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a surface tension that is in a range of from 60 to 90 dynes per centimeter.
10. The ophthalmic composition of claim 9, wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 700 centipoise to 900 centipoise at a shear rate of 0.1/second.
11. The ophthalmic composition of claim 10, wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg.
12. The ophthalmic composition of claim 11, wherein the ophthalmic composition is isotonic.
13. The ophthalmic composition of claim 8, wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient such that a concentration of the sodium hyaluronate in the ophthalmic composition is in a range of from 0.05% to 0.2%.
14. A system, comprising: a reservoir containing an ophthalmic composition, wherein the ophthalmic composition includes a quantity of sodium hyaluronate dissolved in a quantity of a saline solution, and wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 400 centipoise to 1200 centipoise at a shear rate of 0.1/second and a surface tension that is in a range of from 60 to 500 dynes per centimeter; a delivery tip in fluid communication with the reservoir, wherein the delivery tip is configured to deliver the ophthalmic composition to an eye of a patient; a pressure mechanism configured to pressurize the ophthalmic composition; and a control system configured to control a flow rate and a pressure of the ophthalmic composition delivered to the eye.
15. The system of claim 14, wherein the control system is configured to control the flow rate and the pressure to thereby stabilize an intraocular pressure within the eye.
16. The system of claim 14, wherein the pressure mechanism includes a mechanism configured to apply pressure to the reservoir.
17. The system of claim 16, wherein the mechanism configured to apply pressure to the reservoir includes a pressurized gas or a mechanical compressing mechanism.
18. The system of claim 14, wherein the pressure mechanism includes a pump configured to apply pressure to a flow line conveying the ophthalmic composition.
19. The system of claim 14, wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a surface tension that is in a range of from 60 to 90 dynes per centimeter.
20. The system of claim 14, wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with a viscosity that is in a range of from 700 centipoise to 900 centipoise at a shear rate of 0.1/second.
21. The system of claim 14, wherein the quantity of the sodium hyaluronate and the quantity of the saline solution are sufficient to provide the ophthalmic composition with an osmolality that is in a range of from 258 mOsm/kg to 381 mOsm/kg.
PCT/IB2022/000075 2021-02-12 2022-02-14 Compound, method and system for ophthalmic surgery WO2022172089A1 (en)

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