WO2004082541A1 - Device for staining an interior eye structure - Google Patents

Device for staining an interior eye structure Download PDF

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Publication number
WO2004082541A1
WO2004082541A1 PCT/US2003/008075 US0308075W WO2004082541A1 WO 2004082541 A1 WO2004082541 A1 WO 2004082541A1 US 0308075 W US0308075 W US 0308075W WO 2004082541 A1 WO2004082541 A1 WO 2004082541A1
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WO
WIPO (PCT)
Prior art keywords
intra
ocular
fluid
surgery
cannula
Prior art date
Application number
PCT/US2003/008075
Other languages
French (fr)
Inventor
Lawrence M. Buono
Original Assignee
Infinite Vision, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Infinite Vision, Llc filed Critical Infinite Vision, Llc
Priority to AU2003225829A priority Critical patent/AU2003225829A1/en
Priority to PCT/US2003/008075 priority patent/WO2004082541A1/en
Publication of WO2004082541A1 publication Critical patent/WO2004082541A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3937Visible markers
    • A61B2090/395Visible markers with marking agent for marking skin or other tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
    • A61M5/3291Shafts with additional lateral openings

Definitions

  • the present invention relates to lens capsule staining as part of a diagnostic or therapeutic endeavor (e.g., cataract surgery).
  • this invention relates to the use of injectable dyes and to a delivery device arranged for spraying or dispensing the dye to an intra-ocular surface in the anterior chamber of a human eye or another mammalian eye.
  • an adjuvant dye or stain to differentiate between different structures.
  • dyes used to stain intra-ocular structure including but not limited to fluorescein, indocyanine green, and methylene blue.
  • cataract surgery One type of such an intra-ocular surgery is cataract surgery.
  • cataract surgery it is desirable to easily distinguish the anterior lens capsule from surrounding structures and perform a continuous curvilinear capsulorrhexis so that the natural lens can be removed by phacoemulsification or other methods and replaced with an artificial lens.
  • the present invention is intended to decrease that difficulty by staining the anterior lens capsule, thereby aiding in its visualization for safe removal.
  • a method of cataract surgery is as follows. A small paracentesis incision is made peripherally into the clear cornea. The aqueous humor of the anterior chamber is subsequently drained and replaced with air. A dye is then applied to the anterior lens surface (e.g. , anterior lens capsule) using a syringe. The dye is allowed to contact the lens surface for an amount of time sufficient to stain that surface. The dye solution is drained or irrigated (using balanced salt solution) from the anterior chamber. Next, the anterior chamber is filled with an optically clear viscoelastic polymer (e.g., hyaluronate, chondroitin sulfate).
  • an optically clear viscoelastic polymer e.g., hyaluronate, chondroitin sulfate
  • a rent is made in the anterior lens capsule using a cystotome and a continuous curvilinear capsulorrhexis is the made under direct visualization of the stained anterior lens capsule. Removal of the natural lens material may be accomplished by a variety of methods including phacoemulsification.
  • the lens assumes a convex configuration. This occurs because the fluid from the anterior chamber is replaced with air and the pressure in this compartment of the eye is lower than the pressure in the vitreous compartment of the eye and the lens is pushed forward. This physical phenomenon of the lens assuming a convex configuration can cause difficulty with the application of a dye or stain to the anterior lens capsule surface.
  • the fluid dye or stain When the fluid dye or stain is applied to the anterior lens surface of an air-filled anterior chamber, it tends to roll off to one side and collect in the gutter space created by the iris lens interface and the angle of the anterior chamber. Because of this, the dye or stain must be massaged into the capsule to achieve adequate staining. This maneuver of massaging the dye into the lens capsule causes the risk of inadvertently tearing the capsule and thereby complicating the remainder of the surgical procedure. Also, a larger volume than is necessary to adequately stain the lens capsule must be utilized.
  • the current method of delivering a fluid dye or stain to the anterior chamber to stain the anterior lens capsule is accomplished in an uncontrolled fashion.
  • the dye or stain is applied to the surface of the anterior lens capsule for an amount of time sufficient to stain that surface. Because of the current design of the tip of the cannula, the dye or stain encounters intra-ocular structures that are not intended and may have a deleterious effect, including a toxic effect as well as diminishing the effect of selective staining.
  • the present invention is also related to the staining of the vitreo-retinal surface. A pathological process can occur at the vitreo-retinal interface that can alter the natural architecture.
  • vitreo-retinal surgical techniques an attempt is made to separate this interface and restore the normal anatomical architecture. This surgical technique at times may be difficult to accomplish because of a variety of reasons, including difficulty in properly visualizing various tissues.
  • the present invention is intended to decrease that difficulty by staining the vitreo-retinal surface, thereby aiding in its visualization for safe removal.
  • the process of the invention is a method of staining an ocular structure, said structure being a mammalian eye (especially a human eye) or portion thereof, said method comprising staining said structure with a dye selected from the group consisting of indigotindisulfonate, Patent Blue V, Sulphan Blue, tolonium chloride, or Evans Blue, said staining done by direct application of said dye.
  • a dye selected from the group consisting of indigotindisulfonate, Patent Blue V, Sulphan Blue, tolonium chloride, or Evans Blue
  • the dye includes one of the following: Indigo Carmine (indigotindisulfonate), Patent Blue V, Sulphan Blue, tolonium chloride, or Evans Blue.
  • Indigo Carmine indigotindisulfonate
  • Patent Blue V Patent Blue V
  • Sulphan Blue Sulphan Blue
  • tolonium chloride or Evans Blue.
  • Evans Blue it is preferred to use a single dye when staining a given structure, the invention contemplates staining with a combination of two or more of the five dyes.
  • the staining is performed during intraocular surgery, especially cataract surgery or vitreo-retinal surgery.
  • Intra-ocular structures of particular interest are the lens capsule, especially the anterior lens capsule, and the internal limiting membrane of the retina.
  • the preferred delivery devices are arranged to dispense a dye or stain in a controlled fashion to a target tissue or structure (e.g., anterior lens capsule) located in the anterior chamber of an eye for differentiating the target tissue or structure during a surgical procedure or any diagnostic or therapeutic endeavor.
  • the device is designed to control the area to which the dye or stain can be delivered, thereby eliminating detrimental effects resulting from dispensing the dye or stain in an undesired area.
  • the delivery device is constructed to have the dye or stain exit from an orifice located on an inferior surface of the cannula as opposed to a currently used dispensing orifice located at the distal tip of the cannula.
  • a preferred dye for staining the target tissue or structure is indigo carmine, as discovered by the inventor of the present invention.
  • a dispensing device arranged to deliver a fluid into an eye includes a reservoir, a cannula and a pressurizer.
  • the reservoir is arranged to house the fluid to be delivered.
  • the a cannula has a distal tip for insertion into the eye, is in fluid communication with the reservoir and includes an orifice located inward of the cannula's distal tip.
  • the pressurizer e.g., plunger or mechanism that applies pressure into the reservoir
  • the pressurizer is arranged to move the fluid from the reservoir through the orifice to an intra-ocular structure within the eye.
  • the cannula has a distal portion extending from a location inward of the orifice to the distal tip.
  • the device may also include a fin extending longitudinally around the distal portion.
  • the orifice may include a sleeve surrounding and extending from the orifice in a direction desired for the fluid delivery. Preferably, this sleeve is flared outward from the orifice.
  • the orifice of the invention is preferably designed to disperse the dye or stain in a spray form rather than stream form, so as to allow the dye or stain to better adhere to the tissue or structure.
  • the orifice is preferably arranged with an opening having a size and shape sufficient to discharge liquid in spray form. This feature obviates the need to massage the dye into the lens capsule and prevents the possibility of the complication of inadvertently tearing the lens capsule. Also, this spray feature further prevents the dye or stain from leaking onto adjacent tissue; thereby staining tissue or structures not intended to be stained.
  • This spray feature also allows for delivery of a smaller amount of the dye or stain to the intra-ocular compartment, thereby reducing any potential toxic effect of the dye or stain.
  • a method for delivering a fluid to an intraocular structure uses a spray device having the fluid in a reservoir, a cannula in fluid communication with the reservoir and having a distal tip and an orifice located inward of the distal tip, and a pressurizer arranged to move the fluid 5 from the reservoir through the orifice.
  • the method includes inserting the cannula through an opening of an eye, aligning the orifice over the intra-ocular structure, and spraying the intra-ocular structure with the fluid by moving the fluid from the reservoir through the orifice.
  • a spray device arranged to deliver a fluid l o into a cavity includes a reservoir, a cannula and a pressurizer.
  • the reservoir is arranged to house the fluid to be delivered.
  • the cannula has a distal tip for access into the cavity, is in fluid communication with the reservoir, and includes an orifice located inward of the distal tip.
  • the pressurizer is arranged to move the fluid from the reservoir through the orifice to a tissue within the cavity.
  • Fig. 1 is a top view of the invention including the reservoir and dispensing cannula with characteristic shape in accordance with an exemplary embodiment of the invention
  • Fig. 2 is a partial side view of the cannula illustrated in Fig. 1;
  • Fig. 3 is a partial top view of the cannula shown in Fig. 1;
  • Fig. 4 is a partial side view of a cannula in accordance with another exemplary embodiment of the invention;
  • Fig. 5 is a partial top view of the cannula illustrated in Fig. 4.
  • Fig. 6 is a top view of the cannula of Fig. 3 shown partially inserted in an anterior chamber of a human eye.
  • the dyes are preferably administered in a non-solid form.
  • Preferred formulations of the dye are solutions, suspensions, and gels.
  • An example of preferred solution formulation is an aqueous solution buffered to a physiologically acceptable pH.
  • the amount of dye administered to the ocular structure is enough to stain the structure. Nevertheless excess amounts of the dye are avoided so as to minimize or eliminate undesired staining of structures, especially those other than the anterior lens capsule.
  • the dye concentration is preferably about 0.1% to 6.5%, depending on the type of dye and the amount of injection.
  • the dye concentration can also vary from less than 0.1 % to over 6.5%, as desired for the particular use.
  • the dye is preferably administered so as to stain the anterior lens capsule while sparing other intra-ocular structures, especially the posterior surface of the cornea, as much as possible.
  • the dyes are also described in greater detail below as used for staining.
  • Indigotindisulfonate 's alternative names, formulations, designations, and applicable information include, but are not limited to the following: indigo carmine; Blue X, ceruleinum; CI Food Blue 1 ; Colour Index No. 73015; Disodium Indigotin-5,5'- disulphonate; El 32; FD & C Blue No.2; Indigocarminium; Indigotindisulfonate Sodium (USAN); Indigotine; Sodium Indigotindisulphonate; Disodium 3,3'-dioxo-2,2'-bi- indolinylidene-5,5'-disulphonate.
  • C 16 H 8 N 2 Na 2 O 8 S 2 466.4.
  • CAS - 860-22-0 466.4.
  • Indigotindisulfonate is, for example, available from American Reagent Laboratories, Inc., Shirley NY, which has a formulation of the dye under the trade name of Indigo Carmine Injection (Indigotindisulfonate sodium, USP). It is supplied as a 5 ml sterile ampule containing 40 mg of indigotindisulfonate sodium in water for intravenous injection and pH when necessary with citric acid and/or sodium citrate.
  • Sulphan Blue e.g., (BAN) Acid Blue 1; Alphazurine 2G; Blue VRS; Colour Index No. 42045; Isosulfan Blue (USAN); Patent Blue V; Sulphanum Caeruleum.
  • Tolonium chloride e.g., Toluidine Blue O, 3-Amino-7-(Dimethylamino)-2- Methylphenothiazin-5-ium Chloride; CI Basic Blue 17
  • Tolonium chloride must be used carefully so as to avoid injury to the cornea and conjunctiva.
  • Evans Blue e.g. Azovan Blue (BAN) Azovanum Caeruleum; CI Direct Blue 53; Colour Index No. 23860; Evans Blue (USAN); T-1824. Tetrasodium 6.6'-[3,3'- dimethylbiphenyl-4,4'-diylbis(azo)]bis[4-amino-t-hydroxynaphthalene-l,3-disulphonate].
  • the U.S.P. injection has a pH of 5.5 to 7.5. Preferably it is stored in airtight containers.
  • a novel reason to use the dyes is during cataract surgery: surgery in which the natural lens is removed while leaving the lens capsule in its natural anatomic location and in which an artificial lens is inserted in its place.
  • the purpose of the dyes is to make the anterior lens capsule more easily visible to the surgeon.
  • a spray device is arranged to deliver a fluid (e.g., a dye or stain) in a precise and controlled manner.
  • a fluid e.g., a dye or stain
  • a user controls the direction of delivering the dye or stain by directing the dispensing orifice.
  • flared extensions on the sides of the cannula prevent the dye or stain from dispersing in a retrograde fashion.
  • a flared sleeve around the dispensing orifice assists in controlled delivery of the dye or stain.
  • the spray device preferably delivers the fluid in spray form. While not being limited to a particular theory, the term spray form generally refers to fine droplets or vapor that scatter or fall from the orifice. In the exemplary embodiments described below the spray is generally a fluid moved by pressure out of the orifice.
  • Example forms of spray include but are not limited to: aerosol, mist, atomized, rarified liquid, droplets, vapor, drizzle, froth, fog, splash, or sprinkle.
  • distal refers to the end or direction of the device that is applied toward an injection site for delivery.
  • proximate refers to the end or direction of the device that is opposite the distal end.
  • the structural elements described in the exemplary embodiments can by formed of any suitable material, e.g. plastic, metal, rubber.
  • the device 10 includes a reservoir 12, a plunger 14, and a cannula 16.
  • the reservoir 12 is designed to store the dye or stain fluid that is intended to be delivered into the anterior chamber.
  • the reservoir 12 is generally cylindrical in shape and has a surface 18 preferably with calibrated markings 20 imprinted thereon.
  • the reservoir 12 is preferably constructed, at least in part, of a material that allows a user to see and measure fluid contained in the reservoir 12, such as a transparent or translucent plastic.
  • the plunger 14 extends within a first end 22 of the reservoir 12.
  • the plunger 14 is mobile and is used as a pressurizer to assert pressure within the reservoir 12. While the plunger 14 is shown in Fig. 1 as having a particular form, a skilled artisan would readily understand that the plunger 14 could be of any mechanical, electrical or chemical form that allows the plunger 14 to assert pressure within the reservoir 12. As such, the plunger 14 can be separable or integral with the reservoir 12, and may have contact with other elements as desired to assert the pressure.
  • the reservoir 12 has a second end 24 with a cannula hub 26 that holds the cannula 16.
  • the cannula hub 26 includes threads that allow for a coupling with opposing threads of the cannula 16. That is, the proximate end of the cannula 16 is arranged to be screwed into the threads of the cannula hub 26.
  • the cannula 16 includes a tip 28 and an orifice 30.
  • the tip 28 is located at the distal end of the cannula 16, and is closed. That is, the tip 28 does not have an opening for dispensing fluid.
  • a user e.g., surgeon
  • the tip 28 is preferably blunt. In fact, the tip 28 should be blunt and rounded to avoid accidental harm caused if the tip 28 was pressed or placed in contact with another object.
  • the cannula 16 is preferably a cylindrical hollow tube. As best seen in Figs. 1, 3, 5 and 6, the body of the cannula 16 bends at an elbow 26 inward of the distal tip 28. The degree of the angle at the elbow 26 may be variable as desired with preferred angulation between about 15 degrees and about 60 degrees.
  • the cannula 16 is bent at the elbow 26 to make it easier for a user (e.g., surgeon) to hold and control the spray device 10 during fluid delivery into an eye.
  • the reservoir 12 and plunger 14 are arranged to extend away from the face of the patient, thereby keeping the user's fingers away from the patient's face.
  • the device 10 would work even if the cannula 16 were substantially straight along its entire length.
  • the dispensing orifice 30 is located inward of the tip 28 on the underside of the cannula 16.
  • the orifice 30 is located on the underside of the cannula 16 to control the direction of delivery toward a specific intra-ocular structure, such as the anterior lens capsule in the anterior chamber. While not being limited to a particular distance, the orifice 30 is positioned a predetermined distance from the tip 28, preferably ranging from about 1 mm to about 3 mm inward of the tip 28.
  • the orifice 30 is of sufficient size to dispense the fluid dye or stain in an spray fashion, as readily understood by a skilled artisan.
  • Figs.2 and 3 illustrate a cannula 16 in accordance with an exemplary embodiment of the invention.
  • the cannula 16 is attached to a fin 34 (e.g., flared extension) longitudinally attached to the sides and distal tip 28 of the cannula 16.
  • the fin 34 is arranged to prevent the spray fluid dye or stain from projecting upward opposite the underside of the cannula 16. Accordingly, the fin 34 provides the benefit of preventing dispensed fluid from projecting away from the intended delivery site (e.g., anterior lens), thereby allowing for more controlled delivery of the fluid dye or stain.
  • the fin 34 extends away from the cannula 16 by a predefined distance at a plane substantially perpendicular to the underside of the cannula.
  • the preferred distance is about 1 mm from the cannula tip 28, but may be constructed to be larger or smaller as desired. It is understood that the cannula 16 may be constructed without the fin 34 for situations where the cannula must be inserted through an incision too small to readily accept the fin 34.
  • Figs. 4 and 5 illustrate a cannula 16 in accordance with another exemplary embodiment of the invention.
  • a sleeve 36 surrounding the orifice 30 extends from the orifice 30 in a direction desired for the fluid delivery to further control the direction of the dye or stain dispersion.
  • the sleeve 36 extends a predefined distance from the base of the cannula 16 and projects outward at a flared angle.
  • the preferred distance that the sleeve 36 projects from the cannula 16 is about 0.25 mm, although it is understood that the preferred distance depends on various factors, including the size of the cannula 16, the orifice 30, and incision.
  • the cannula 16 shown in Figs. 4 and 5 is substantially similar to the cannula 16 shown in Figs. 2 and 3.
  • the cannula 16 shown in Figs. 4 and 5 includes the sleeve 36 surrounding and extending from the orifice 30 in a direction desired for the fluid delivery
  • the cannula 16 shown in Figs. 2 and 3 includes the fin 34 extending longitudinally around its distal portion, as described in more detail above. It is understood that the spray device 10 could be constructed at least with either the sleeve 36 or the fin 34, or with both the sleeve 36 and the fin 34.
  • a delivery device 10 in accordance with the invention is illustrated in use during an operation, such as cataract surgery.
  • a natural anterior lens 38 of an eye 40 is removed while leaving a lens capsule 42 in its natural anatomic location, and an artificial lens is inserted in place of the natural lens 38.
  • a fluid dye is delivered to a surface 44 of the lens to stain the surface. This can be accomplished by first draining aqueous fluid from an anterior chamber 46 of the eye 40 to provide an air-filled anterior chamber 46, and then by delivering the fluid dye into the air-filled chamber 46. The dye is allowed to contact the lens surface 44 for an amount of time sufficient to stain the surface 44, and then traditionally the excess dye may be drained out.
  • the spray device 10 is shown with a portion of the cannula 16 inserted into the anterior chamber 46.
  • the cannula 16 is inserted through a small paracentesis incision 48 at the cornea 50 of the eye 40.
  • the orifice 30 and flared sleeve 36 are preferably aligned between an iris 52 of the eye 40 for dispersing the fluid dye or stain onto the anterior lens surface 44.
  • the fin 34 is also provided for preventing the fluid dye or stain from projecting upward opposite the dispensing orifice 30 side of the cannula 16 upon delivery of the fluid.
  • cataract surgery is as follows: A small paracentesis incision is made peripherally into the clear cornea. The aqueous humor of the anterior chamber is subsequently drained and replaced with air. The indigotindisulfonate dye is then applied to the anterior lens surface (anterior lens capsule). If the dye is applied using the spray device 10, the user (e.g., surgeon) moves the plunger 14 into the reservoir 12, which moves fluid from the reservoir 12 through the cannula 16 and out of the orifice 30 onto the anterior lens surface 44 to stain the surface. The dye is allowed to contact the lens surface for an amount of time sufficient to stain that surface.
  • an optically clear viscoelastic polymer e.g., hyaluronate, chondroitin sulfate.
  • a rent is made in the anterior lens capsule using a cystosome and a continuous curvilinear capsulorrhexis is then made under direct visualization of the stained anterior lens capsule.
  • the fluid dye is delivered directly to the lens surface 44, the fluid is more efficiently and more effectively delivered. Therefore there is no need to dispense excess amounts of dye as before to ensure that the lens 38 will be sufficiently stained. Accordingly there is no need for the additional step of draining excess fluid because there should be no more than an insubstantial amount of excess fluid in the anterior chamber 46.
  • the indigotindisulfonate dye is applied as has been done for a number of years with other dyes to stain the anterior lens capsule. That is, the dye is applied to the anterior lens surface using a syringe. After the dye has contacted the lens surface for an amount of time sufficient to stain that surface, the dye is drained or irrigated (using balanced salt solution) from the anterior chamber.
  • the spray delivery device 10 of the invention thus makes it possible to control the dispersion of a fluid dye or stain during a surgical procedure or any diagnostic or therapeutic endeavor on a human or other mammalian eye 40.
  • the spray device could also be used during procedures in other areas, such as in medical procedures (e.g., dentistry, gynecology) where it is desirable to deliver a fluid to a particular region in a gaseous or air-filled environment.
  • An advantage of using one of the listed dyes compared to using currently used dyes such as indocyanine green, is that the listed dyes are relatively inexpensive.
  • Another advantage is that the lens capsule stained with any of those dyes is more easily visualized than lens capsule stained with either indocyanine green or fluorescein.
  • Another reason to use the listed dyes is during vitreo-retinal surgery to restore the natural architecture of the vitreo-retinal surface. The purpose of the dye is to make the distinction between the interface of the vitreous and the retina more easily visible.
  • a method of vitreo-retinal surgery is as follows: A standard three-port vitrectomy is employed. After a partial or complete vitrectomy is performed, the vitreous compartment is filled with gas. The dye is then applied to the surface of the vitreo-retinal interface using an appropriate delivery device as described above. The dye is allowed to contact the vitreo-retinal interface for an amount of time sufficient to stain that interface. Next, the desired tissue (e.g., posterior hyaloid membrane and/or internal limiting membrane), now more easily visible, is removed using appropriate forceps.
  • tissue e.g., posterior hyaloid membrane and/or internal limiting membrane
  • the cannula 16 shown in Fig 2 could be constructed at least: with a sleeve 36 surrounding the orifice 30 as shown in Fig. 5, with a smaller sleeve 36 as shown in Fig. 3, or without a sleeve 36.
  • the device of the invention can be used, providing they perform the same or equivalent functions as described above.

Abstract

A spray or delivery device is arranged to dispense a dye into the anterior chamber of an eye for staining a specific ocular structure or tissue (e.g., anterior lens capsule, vitreo-retinal interface). The spray device includes a cannula having a distal end arranged for insertion into the anterior chamber of the eye. The cannula preferably has a dispensing orifice located at a side of the cannula offset from the distal end. In a method for conducting intra-ocular surgery, the delivery device would dispense a dye in a particular fashion so as to control its application to the intended target tissue, thereby limiting delivery of the dye to undesired surrounding tissue structures. Another exemplary embodiment discloses a method of staining an ocular structure, including staining the ocular structure with either indigotindisulfonate, Patent Blue V, Sulphan Blue, tolonium chloride, or Evans Blue.

Description

DEVICE FOR STAINING AN INTERIOR EYE STRUCTURE
FIELD OF THE INVENTION
The present invention relates to lens capsule staining as part of a diagnostic or therapeutic endeavor (e.g., cataract surgery). In particular, this invention relates to the use of injectable dyes and to a delivery device arranged for spraying or dispensing the dye to an intra-ocular surface in the anterior chamber of a human eye or another mammalian eye.
BACKGROUND OF THE INVENTION
During intra-ocular surgery it is often desirable to distinguish between different intra-ocular structures. One means of accomplishing this desired effect is to use an adjuvant dye or stain to differentiate between different structures. There are several different types of dyes used to stain intra-ocular structure, including but not limited to fluorescein, indocyanine green, and methylene blue.
One type of such an intra-ocular surgery is cataract surgery. In modern cataract surgery, it is desirable to easily distinguish the anterior lens capsule from surrounding structures and perform a continuous curvilinear capsulorrhexis so that the natural lens can be removed by phacoemulsification or other methods and replaced with an artificial lens.
It is common in modern cataract surgery to remove a portion of the anterior lens capsule while preserving the majority of the capsular bag structure in order to facilitate artificial lens implantation. This surgical method at times may be difficult to accomplish because of a variety reasons, including difficulty in properly visualizing the lens capsule. The present invention is intended to decrease that difficulty by staining the anterior lens capsule, thereby aiding in its visualization for safe removal.
A method of cataract surgery is as follows. A small paracentesis incision is made peripherally into the clear cornea. The aqueous humor of the anterior chamber is subsequently drained and replaced with air. A dye is then applied to the anterior lens surface (e.g. , anterior lens capsule) using a syringe. The dye is allowed to contact the lens surface for an amount of time sufficient to stain that surface. The dye solution is drained or irrigated (using balanced salt solution) from the anterior chamber. Next, the anterior chamber is filled with an optically clear viscoelastic polymer (e.g., hyaluronate, chondroitin sulfate). A rent is made in the anterior lens capsule using a cystotome and a continuous curvilinear capsulorrhexis is the made under direct visualization of the stained anterior lens capsule. Removal of the natural lens material may be accomplished by a variety of methods including phacoemulsification.
In the above-outlined step of removing the aqueous humor from the anterior chamber and replacing it with air, the lens assumes a convex configuration. This occurs because the fluid from the anterior chamber is replaced with air and the pressure in this compartment of the eye is lower than the pressure in the vitreous compartment of the eye and the lens is pushed forward. This physical phenomenon of the lens assuming a convex configuration can cause difficulty with the application of a dye or stain to the anterior lens capsule surface.
When the fluid dye or stain is applied to the anterior lens surface of an air-filled anterior chamber, it tends to roll off to one side and collect in the gutter space created by the iris lens interface and the angle of the anterior chamber. Because of this, the dye or stain must be massaged into the capsule to achieve adequate staining. This maneuver of massaging the dye into the lens capsule causes the risk of inadvertently tearing the capsule and thereby complicating the remainder of the surgical procedure. Also, a larger volume than is necessary to adequately stain the lens capsule must be utilized.
Furthermore, the current method of delivering a fluid dye or stain to the anterior chamber to stain the anterior lens capsule is accomplished in an uncontrolled fashion. The dye or stain is applied to the surface of the anterior lens capsule for an amount of time sufficient to stain that surface. Because of the current design of the tip of the cannula, the dye or stain encounters intra-ocular structures that are not intended and may have a deleterious effect, including a toxic effect as well as diminishing the effect of selective staining. The present invention is also related to the staining of the vitreo-retinal surface. A pathological process can occur at the vitreo-retinal interface that can alter the natural architecture. Using modern vitreo-retinal surgical techniques, an attempt is made to separate this interface and restore the normal anatomical architecture. This surgical technique at times may be difficult to accomplish because of a variety of reasons, including difficulty in properly visualizing various tissues. The present invention is intended to decrease that difficulty by staining the vitreo-retinal surface, thereby aiding in its visualization for safe removal.
BRIEF SUMMARY OF THE INVENTION
In a general aspect, the process of the invention is a method of staining an ocular structure, said structure being a mammalian eye (especially a human eye) or portion thereof, said method comprising staining said structure with a dye selected from the group consisting of indigotindisulfonate, Patent Blue V, Sulphan Blue, tolonium chloride, or Evans Blue, said staining done by direct application of said dye.
In particular exemplary embodiments, the dye includes one of the following: Indigo Carmine (indigotindisulfonate), Patent Blue V, Sulphan Blue, tolonium chloride, or Evans Blue. Although it is preferred to use a single dye when staining a given structure, the invention contemplates staining with a combination of two or more of the five dyes.
In particular embodiments of the invention, the staining is performed during intraocular surgery, especially cataract surgery or vitreo-retinal surgery. Intra-ocular structures of particular interest are the lens capsule, especially the anterior lens capsule, and the internal limiting membrane of the retina.
The preferred delivery devices are arranged to dispense a dye or stain in a controlled fashion to a target tissue or structure (e.g., anterior lens capsule) located in the anterior chamber of an eye for differentiating the target tissue or structure during a surgical procedure or any diagnostic or therapeutic endeavor. The device is designed to control the area to which the dye or stain can be delivered, thereby eliminating detrimental effects resulting from dispensing the dye or stain in an undesired area. The delivery device is constructed to have the dye or stain exit from an orifice located on an inferior surface of the cannula as opposed to a currently used dispensing orifice located at the distal tip of the cannula. This new location allows an operating surgeon to more precisely control the area to which the dye or stain is applied, thereby sparing the neighboring intra-ocular structures from unwanted staining. A preferred dye for staining the target tissue or structure is indigo carmine, as discovered by the inventor of the present invention.
In an exemplary embodiment, a dispensing device arranged to deliver a fluid into an eye includes a reservoir, a cannula and a pressurizer. The reservoir is arranged to house the fluid to be delivered. The a cannula has a distal tip for insertion into the eye, is in fluid communication with the reservoir and includes an orifice located inward of the cannula's distal tip. The pressurizer (e.g., plunger or mechanism that applies pressure into the reservoir) is arranged to move the fluid from the reservoir through the orifice to an intra-ocular structure within the eye.
The cannula has a distal portion extending from a location inward of the orifice to the distal tip. As such, the device may also include a fin extending longitudinally around the distal portion. Further, the orifice may include a sleeve surrounding and extending from the orifice in a direction desired for the fluid delivery. Preferably, this sleeve is flared outward from the orifice.
Moreover, the orifice of the invention is preferably designed to disperse the dye or stain in a spray form rather than stream form, so as to allow the dye or stain to better adhere to the tissue or structure. In other words, the orifice is preferably arranged with an opening having a size and shape sufficient to discharge liquid in spray form. This feature obviates the need to massage the dye into the lens capsule and prevents the possibility of the complication of inadvertently tearing the lens capsule. Also, this spray feature further prevents the dye or stain from leaking onto adjacent tissue; thereby staining tissue or structures not intended to be stained. This spray feature also allows for delivery of a smaller amount of the dye or stain to the intra-ocular compartment, thereby reducing any potential toxic effect of the dye or stain.
Figure imgf000007_0001
emoo iment, a method for delivering a fluid to an intraocular structure is disclosed. The method uses a spray device having the fluid in a reservoir, a cannula in fluid communication with the reservoir and having a distal tip and an orifice located inward of the distal tip, and a pressurizer arranged to move the fluid 5 from the reservoir through the orifice. The method includes inserting the cannula through an opening of an eye, aligning the orifice over the intra-ocular structure, and spraying the intra-ocular structure with the fluid by moving the fluid from the reservoir through the orifice.
In yet another exemplary embodiment, a spray device arranged to deliver a fluid l o into a cavity includes a reservoir, a cannula and a pressurizer. The reservoir is arranged to house the fluid to be delivered. The cannula has a distal tip for access into the cavity, is in fluid communication with the reservoir, and includes an orifice located inward of the distal tip. The pressurizer is arranged to move the fluid from the reservoir through the orifice to a tissue within the cavity.
5 The described characteristics of the invention are easily discernable from the drawings. Moreover, further scope of applicability of the present invention will become apparent in the description given hereafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since the invention will become
) apparent to those skilled in the art from this detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS The invention will be described in conjunction with the following drawings, in which like-referenced numerals designate like elements, and wherein:
Fig. 1 is a top view of the invention including the reservoir and dispensing cannula with characteristic shape in accordance with an exemplary embodiment of the invention;
Fig. 2 is a partial side view of the cannula illustrated in Fig. 1; Fig. 3 is a partial top view of the cannula shown in Fig. 1; Fig. 4 is a partial side view of a cannula in accordance with another exemplary embodiment of the invention;
Fig. 5 is a partial top view of the cannula illustrated in Fig. 4; and
Fig. 6 is a top view of the cannula of Fig. 3 shown partially inserted in an anterior chamber of a human eye.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The dyes are preferably administered in a non-solid form. Preferred formulations of the dye are solutions, suspensions, and gels. An example of preferred solution formulation is an aqueous solution buffered to a physiologically acceptable pH. The amount of dye administered to the ocular structure is enough to stain the structure. Nevertheless excess amounts of the dye are avoided so as to minimize or eliminate undesired staining of structures, especially those other than the anterior lens capsule.
Commercial formulations of the dyes are available from many companies (e.g., Akorn, May & Baker, ICI Pharmaceuticals, and American Regent Laboratories). The dye concentration is preferably about 0.1% to 6.5%, depending on the type of dye and the amount of injection. The dye concentration can also vary from less than 0.1 % to over 6.5%, as desired for the particular use. The dye is preferably administered so as to stain the anterior lens capsule while sparing other intra-ocular structures, especially the posterior surface of the cornea, as much as possible. The dyes are also described in greater detail below as used for staining.
Indigotindisulfonate 's alternative names, formulations, designations, and applicable information include, but are not limited to the following: indigo carmine; Blue X, ceruleinum; CI Food Blue 1 ; Colour Index No. 73015; Disodium Indigotin-5,5'- disulphonate; El 32; FD & C Blue No.2; Indigocarminium; Indigotindisulfonate Sodium (USAN); Indigotine; Sodium Indigotindisulphonate; Disodium 3,3'-dioxo-2,2'-bi- indolinylidene-5,5'-disulphonate. C16H8N2Na2O8S2 = 466.4. CAS - 860-22-0.
Indigotindisulfonate is, for example, available from American Reagent Laboratories, Inc., Shirley NY, which has a formulation of the dye under the trade name of Indigo Carmine Injection (Indigotindisulfonate sodium, USP). It is supplied as a 5 ml sterile ampule containing 40 mg of indigotindisulfonate sodium in water for intravenous injection and pH when necessary with citric acid and/or sodium citrate.
Patent Blue V (e.g., Acid Blue 3; CI Food Blue 5; Colour Index No. 42051 ; El 31. Calcium α-(4-diethylaminophenyl)-α-(4-diethyliminiocyclohexa-2,5-dienylidene)- 5-hydroxytoluene-2,4-disulphonate (C27H31N2O7S2)Ca=l 159.4) is a dark blue-violet powder. Aqueous solutions are blue in color. Preferred injections of Patent Blue V are 2.5%, in ampoules of 2 mL.
Sulphan Blue (e.g., (BAN) Acid Blue 1; Alphazurine 2G; Blue VRS; Colour Index No. 42045; Isosulfan Blue (USAN); Patent Blue V; Sulphanum Caeruleum. Sodium α-(4-diethylaminophenyl)-α-(4-diethyliminiocyclo-hexa-2,5-dienylidene) toluene-2,5-disulphonate. C27H;uN2NaO6S2=:566.7) is a violet powder. Solutions are blue in color. Traditionally, injections of Sulphan Blue are 6.2% in ampoules of 10 mL.
Tolonium chloride (e.g., Toluidine Blue O, 3-Amino-7-(Dimethylamino)-2- Methylphenothiazin-5-ium Chloride; CI Basic Blue 17), is a dark green powder and is slightly soluble in water. Tolonium chloride must be used carefully so as to avoid injury to the cornea and conjunctiva.
Evans Blue (e.g. Azovan Blue (BAN) Azovanum Caeruleum; CI Direct Blue 53; Colour Index No. 23860; Evans Blue (USAN); T-1824. Tetrasodium 6.6'-[3,3'- dimethylbiphenyl-4,4'-diylbis(azo)]bis[4-amino-t-hydroxynaphthalene-l,3-disulphonate]. C34H24N6Na4O,4S4=960.8) is a green, bluish-green, or brown, odorless powder. It is very soluble in water. The U.S.P. injection has a pH of 5.5 to 7.5. Preferably it is stored in airtight containers.
A novel reason to use the dyes is during cataract surgery: surgery in which the natural lens is removed while leaving the lens capsule in its natural anatomic location and in which an artificial lens is inserted in its place. The purpose of the dyes is to make the anterior lens capsule more easily visible to the surgeon.
In another preferred embodiment of this invention, a spray device is arranged to deliver a fluid (e.g., a dye or stain) in a precise and controlled manner. A user controls the direction of delivering the dye or stain by directing the dispensing orifice. In one embodiment flared extensions on the sides of the cannula prevent the dye or stain from dispersing in a retrograde fashion. In another embodiment a flared sleeve around the dispensing orifice assists in controlled delivery of the dye or stain.
The spray device preferably delivers the fluid in spray form. While not being limited to a particular theory, the term spray form generally refers to fine droplets or vapor that scatter or fall from the orifice. In the exemplary embodiments described below the spray is generally a fluid moved by pressure out of the orifice. Example forms of spray include but are not limited to: aerosol, mist, atomized, rarified liquid, droplets, vapor, drizzle, froth, fog, splash, or sprinkle.
The term distal refers to the end or direction of the device that is applied toward an injection site for delivery. The term proximate refers to the end or direction of the device that is opposite the distal end. The structural elements described in the exemplary embodiments can by formed of any suitable material, e.g. plastic, metal, rubber.
Referring to Fig. 1, a spray device is schematically illustrated at 10. The device 10 includes a reservoir 12, a plunger 14, and a cannula 16. The reservoir 12 is designed to store the dye or stain fluid that is intended to be delivered into the anterior chamber. Without being limited to a particular theory, the reservoir 12 is generally cylindrical in shape and has a surface 18 preferably with calibrated markings 20 imprinted thereon. The reservoir 12 is preferably constructed, at least in part, of a material that allows a user to see and measure fluid contained in the reservoir 12, such as a transparent or translucent plastic.
The plunger 14 extends within a first end 22 of the reservoir 12. The plunger 14 is mobile and is used as a pressurizer to assert pressure within the reservoir 12. While the plunger 14 is shown in Fig. 1 as having a particular form, a skilled artisan would readily understand that the plunger 14 could be of any mechanical, electrical or chemical form that allows the plunger 14 to assert pressure within the reservoir 12. As such, the plunger 14 can be separable or integral with the reservoir 12, and may have contact with other elements as desired to assert the pressure. Referring in particular to Fig. 1, the reservoir 12 has a second end 24 with a cannula hub 26 that holds the cannula 16. Preferably the cannula hub 26 includes threads that allow for a coupling with opposing threads of the cannula 16. That is, the proximate end of the cannula 16 is arranged to be screwed into the threads of the cannula hub 26.
The cannula 16 includes a tip 28 and an orifice 30. The tip 28 is located at the distal end of the cannula 16, and is closed. That is, the tip 28 does not have an opening for dispensing fluid. While not being limited to a particular theory, a user (e.g., surgeon) cuts an incision in an eye and the cannula 16 is inserted into the eye through the incision. Accordingly, the cannula 16 is not used to poke through layered tissue. Because the cannula 16 is inserted through an existing incision, the tip 28 is preferably blunt. In fact, the tip 28 should be blunt and rounded to avoid accidental harm caused if the tip 28 was pressed or placed in contact with another object.
While not being limited to a particular theory, the cannula 16 is preferably a cylindrical hollow tube. As best seen in Figs. 1, 3, 5 and 6, the body of the cannula 16 bends at an elbow 26 inward of the distal tip 28. The degree of the angle at the elbow 26 may be variable as desired with preferred angulation between about 15 degrees and about 60 degrees. The cannula 16 is bent at the elbow 26 to make it easier for a user (e.g., surgeon) to hold and control the spray device 10 during fluid delivery into an eye. In operation, the reservoir 12 and plunger 14 are arranged to extend away from the face of the patient, thereby keeping the user's fingers away from the patient's face. However, it is understood that the device 10 would work even if the cannula 16 were substantially straight along its entire length.
The dispensing orifice 30 is located inward of the tip 28 on the underside of the cannula 16. The orifice 30 is located on the underside of the cannula 16 to control the direction of delivery toward a specific intra-ocular structure, such as the anterior lens capsule in the anterior chamber. While not being limited to a particular distance, the orifice 30 is positioned a predetermined distance from the tip 28, preferably ranging from about 1 mm to about 3 mm inward of the tip 28. The orifice 30 is of sufficient size to dispense the fluid dye or stain in an spray fashion, as readily understood by a skilled artisan.
Figs.2 and 3 illustrate a cannula 16 in accordance with an exemplary embodiment of the invention. As best seen in ^ig.2, the cannula 16 is attached to a fin 34 (e.g., flared extension) longitudinally attached to the sides and distal tip 28 of the cannula 16. The fin 34 is arranged to prevent the spray fluid dye or stain from projecting upward opposite the underside of the cannula 16. Accordingly, the fin 34 provides the benefit of preventing dispensed fluid from projecting away from the intended delivery site (e.g., anterior lens), thereby allowing for more controlled delivery of the fluid dye or stain. Preferably, the fin 34 extends away from the cannula 16 by a predefined distance at a plane substantially perpendicular to the underside of the cannula. The preferred distance is about 1 mm from the cannula tip 28, but may be constructed to be larger or smaller as desired. It is understood that the cannula 16 may be constructed without the fin 34 for situations where the cannula must be inserted through an incision too small to readily accept the fin 34.
Figs. 4 and 5 illustrate a cannula 16 in accordance with another exemplary embodiment of the invention. Referring to Figs. 4 and 5, a sleeve 36 surrounding the orifice 30 extends from the orifice 30 in a direction desired for the fluid delivery to further control the direction of the dye or stain dispersion. As shown by example in Fig. 5, the sleeve 36 extends a predefined distance from the base of the cannula 16 and projects outward at a flared angle. The preferred distance that the sleeve 36 projects from the cannula 16 is about 0.25 mm, although it is understood that the preferred distance depends on various factors, including the size of the cannula 16, the orifice 30, and incision.
The cannula 16 shown in Figs. 4 and 5 is substantially similar to the cannula 16 shown in Figs. 2 and 3. However, the cannula 16 shown in Figs. 4 and 5 includes the sleeve 36 surrounding and extending from the orifice 30 in a direction desired for the fluid delivery, whereas the cannula 16 shown in Figs. 2 and 3 includes the fin 34 extending longitudinally around its distal portion, as described in more detail above. It is understood that the spray device 10 could be constructed at least with either the sleeve 36 or the fin 34, or with both the sleeve 36 and the fin 34.
In Fig 6, an exemplary delivery device 10 in accordance with the invention is illustrated in use during an operation, such as cataract surgery. During cataract surgery, a natural anterior lens 38 of an eye 40 is removed while leaving a lens capsule 42 in its natural anatomic location, and an artificial lens is inserted in place of the natural lens 38. To make the anterior lens 38 more easily visible to a surgeon, a fluid dye is delivered to a surface 44 of the lens to stain the surface. This can be accomplished by first draining aqueous fluid from an anterior chamber 46 of the eye 40 to provide an air-filled anterior chamber 46, and then by delivering the fluid dye into the air-filled chamber 46. The dye is allowed to contact the lens surface 44 for an amount of time sufficient to stain the surface 44, and then traditionally the excess dye may be drained out.
Referring to Fig. 6, the spray device 10 is shown with a portion of the cannula 16 inserted into the anterior chamber 46. In this procedure, the cannula 16 is inserted through a small paracentesis incision 48 at the cornea 50 of the eye 40. As shown in Fig. 6, the orifice 30 and flared sleeve 36 are preferably aligned between an iris 52 of the eye 40 for dispersing the fluid dye or stain onto the anterior lens surface 44. The fin 34 is also provided for preventing the fluid dye or stain from projecting upward opposite the dispensing orifice 30 side of the cannula 16 upon delivery of the fluid.
An example of cataract surgery is as follows: A small paracentesis incision is made peripherally into the clear cornea. The aqueous humor of the anterior chamber is subsequently drained and replaced with air. The indigotindisulfonate dye is then applied to the anterior lens surface (anterior lens capsule). If the dye is applied using the spray device 10, the user (e.g., surgeon) moves the plunger 14 into the reservoir 12, which moves fluid from the reservoir 12 through the cannula 16 and out of the orifice 30 onto the anterior lens surface 44 to stain the surface. The dye is allowed to contact the lens surface for an amount of time sufficient to stain that surface. Next the anterior chamber is filled with an optically clear viscoelastic polymer (e.g., hyaluronate, chondroitin sulfate). A rent is made in the anterior lens capsule using a cystosome and a continuous curvilinear capsulorrhexis is then made under direct visualization of the stained anterior lens capsule.
Since the fluid dye is delivered directly to the lens surface 44, the fluid is more efficiently and more effectively delivered. Therefore there is no need to dispense excess amounts of dye as before to ensure that the lens 38 will be sufficiently stained. Accordingly there is no need for the additional step of draining excess fluid because there should be no more than an insubstantial amount of excess fluid in the anterior chamber 46.
For an example of cataract surgery where a spray device as generally described herein is not available, the indigotindisulfonate dye is applied as has been done for a number of years with other dyes to stain the anterior lens capsule. That is, the dye is applied to the anterior lens surface using a syringe. After the dye has contacted the lens surface for an amount of time sufficient to stain that surface, the dye is drained or irrigated (using balanced salt solution) from the anterior chamber.
The spray delivery device 10 of the invention thus makes it possible to control the dispersion of a fluid dye or stain during a surgical procedure or any diagnostic or therapeutic endeavor on a human or other mammalian eye 40. A skilled artisan would readily understand that the spray device could also be used during procedures in other areas, such as in medical procedures (e.g., dentistry, gynecology) where it is desirable to deliver a fluid to a particular region in a gaseous or air-filled environment.
Although not important for carrying out the present invention, it is theorized here that the staining occurs at the lens capsule basement membrane.
An advantage of using one of the listed dyes (e.g., Indigo Carmine, Patent Blue V, Sulphan Blue, tolonium chloride, Evans Blue), compared to using currently used dyes such as indocyanine green, is that the listed dyes are relatively inexpensive. Another advantage is that the lens capsule stained with any of those dyes is more easily visualized than lens capsule stained with either indocyanine green or fluorescein. Another reason to use the listed dyes is during vitreo-retinal surgery to restore the natural architecture of the vitreo-retinal surface. The purpose of the dye is to make the distinction between the interface of the vitreous and the retina more easily visible.
A method of vitreo-retinal surgery is as follows: A standard three-port vitrectomy is employed. After a partial or complete vitrectomy is performed, the vitreous compartment is filled with gas. The dye is then applied to the surface of the vitreo-retinal interface using an appropriate delivery device as described above. The dye is allowed to contact the vitreo-retinal interface for an amount of time sufficient to stain that interface. Next, the desired tissue (e.g., posterior hyaloid membrane and/or internal limiting membrane), now more easily visible, is removed using appropriate forceps.
It should be apparent from the aforementioned description and attached drawings that the concept of the present application may be readily applied to a variety of preferred embodiments, including those disclosed herein. For example, the cannula 16 shown in Fig 2 could be constructed at least: with a sleeve 36 surrounding the orifice 30 as shown in Fig. 5, with a smaller sleeve 36 as shown in Fig. 3, or without a sleeve 36. Naturally, variant embodiments of the device of the invention can be used, providing they perform the same or equivalent functions as described above. Without further elaboration, the foregoing will so fully illustrate the invention that others may, by applying current or future knowledge, readily adapt the same for use under various conditions of service.

Claims

1. A spray device arranged to deliver a fluid into an eye, comprising a reservoir arranged to house the fluid to be delivered, a cannula having a distal tip for insertion into the eye, said cannula in fluid communication with said reservoir and having an orifice located inward of said distal tip, and a pressurizer arranged to move the fluid from said reservoir through said orifice to an intra-ocular structure within the eye.
2. The device of Claim 1 , wherein the cannula is constructed so as to allow for the control of the direction of the fluid delivery.
3. The device of Claim 2, wherein the cannula is arranged to deliver the fluid into the anterior chamber of the eye, and the orifice is located a predetermined distance from the distal tip.
4. The device of Claim 2, said orifice including a sleeve surrounding and extending from said orifice in a direction desired for the fluid delivery.
5. The device of Claim 4, wherein said sleeve is flared outward from said orifice.
6. The device of Claim 2, said cannula having a distal portion extending from a location inward of said orifice to said distal tip, said device further comprising a fin extending longitudinally around said distal portion.
7. The device of Claim 1, said cannula arranged for facilitating controlled dispersion of the fluid.
8. The device of Claim 1, said pressurizer including a plunger inserted into said reservoir and arranged to deliver a specified aliquot of the fluid to the anterior chamber.
9. The device of Claim 1 , wherein the fluid is a dye or stain in liquid, aqueous, or gel form.
10. The device of Claim 1, wherein said orifice is arranged to deliver the fluid towards the anterior lens capsule.
11. The device of Claim 1 , said reservoir including a cannula hub attached to said cannula.
12. The device of Claim 11 , further comprising an elbow at a bend in said cannula between said cannula hub and said distal tip.
13. The device of Claim 1, wherein said orifice is structured to deliver the fluid in a spray form.
14. The device of Claim 1 , further comprising the fluid contained in said reservoir that is delivered into the eye.
15. The device of Claim 14, wherein the fluid contained in said reservoir is indigo carmine.
16. A method for delivering a fluid to an intra-ocular structure with a spray device having the fluid in a reservoir, a cannula in fluid communication with the reservoir and having a distal tip and an orifice located inward of the distal tip, and a pressurizer arranged to move the fluid from the reservoir through the orifice, the method comprising: a) inserting the cannula through an opening of an eye; b) aligning the orifice over the intra-ocular structure; and c) spraying the intra-ocular structure with the fluid by moving the fluid from the reservoir through the orifice.
17. A spray device arranged to deliver a fluid into a cavity, comprising a reservoir arranged to house the fluid to be delivered, a cannula having a distal tip for access into the cavity, said cannula in fluid communication with said reservoir and having an orifice located inward of said distal tip, and a pressurizer arranged to move the fluid from said reservoir through said orifice to a tissue within the cavity.
18. The device of Claim 17, said orifice including a sleeve surrounding and extending from said orifice in a direction desired for the fluid delivery.
19. The device of Claim 18, wherein said sleeve is flared outward from said orifice.
20. The device of Claim 17, said cannula having a distal portion extending from a location inward of said orifice to said distal tip, said device further comprising a fin extending longitudinally around said distal portion.
21. A method of staining an ocular structure, said structure being a mammalian eye or portion thereof, said method comprising staining said structure with a dye selected from the group consisting of indigotindisulfonate, Patent Blue V, Sulphan Blue, tolonium chloride, or Evans Blue, said staining done by direct application of said dye.
22. The method of Claim 21 wherein the mammalian eye is a human eye.
23. The method of Claim 22 wherein the staining is performed during intra-ocular surgery.
24. The method of Claim 23 wherein the intra-ocular surgery is cataract surgery.
25. The method of Claim 23 wherein the intra-ocular surgery is vitreo-retinal surgery.
26. The method of Claim 22 wherein the ocular structure is an intra-ocular structure.
27. The method of Claim 26 wherein the intra-ocular structure is a lens capsule.
28. The method of Claim 26 wherein the lens capsule is an anterior lens capsule.
29. The method of Claim 26 wherein the intra-ocular structure is the internal limiting membrane of the retina.
30. The method of Claim 26 wherein the intra-ocular structure is the vitreous.
31. The method of Claim 21 wherein the dye is indigotindisulfonate.
32. The method of Claim 31 wherein the mammalian eye is a human eye.
33. The method of Claim 32 wherein the staining is performed during intra-ocular surgery.
34. The method of Claim 33 wherein the intra-ocular surgery is cataract surgery.
35. The method of Claim 33 wherein the intra-ocular surgery is vitreo-retinal surgery.
36. The method of Claim 32 wherein the ocular structure is an intra-ocular structure.
37. The method of Claim 36 wherein the intra-ocular structure is a lens capsule.
38. The method of Claim 36 wherein the lens capsule is an anterior lens capsule.
39. The method of Claim 36 wherein the intra-ocular structure is the internal limiting membrane of the retina.
40. The method of Claim 36 wherein the intra-ocular structure is the vitreous.
41. The method of Claim 21 wherein the dye is Patent Blue V.
42. The method of Claim 41 wherein the mammalian eye is a human eye.
43. The method of Claim 42 wherein the staining is performed during intra-ocular surgery.
44. The method of Claim 43 wherein the intra-ocular surgery is cataract surgery.
45. The method of Claim 43 wherein the intra-ocular surgery is vitreo-retinal surgery.
46. The method of Claim 42 wherein the ocular structure is an intra-ocular structure.
47. The method of Claim 46 wherein the intra-ocular structure is a lens capsule.
48. The method of Claim 46 wherein the lens capsule is an anterior lens capsule.
49. The method of Claim 46 wherein the intra-ocular structure is the internal limiting membrane of the retina.
50. The method of Claim 46 wherein the intra-ocular structure is the vitreous.
51. The method of Claim 21 wherein the dye is Sulphan Blue.
52. The method of Claim 51 wherein the mammalian eye is a human eye.
53. The method of Claim 52 wherein the staining is performed during intra-ocular surgery.
54. The method of Claim 53 wherein the intra-ocular surgery is cataract surgery.
55. The method of Claim 53 wherein the intra-ocular surgery is vitreo-retinal surgery.
56. The method of Claim 52 wherein the ocular structure is an intra-ocular structure.
57. The method of Claim 56 wherein the intra-ocular structure is a lens capsule.
58. The method of Claim 56 wherein the lens capsule is an anterior lens capsule.
59. The method of Claim 56 wherein the intra-ocular structure is the internal limiting membrane of the retina.
60. The method of Claim 56 wherein the intra-ocular structure is the vitreous.
61. The method of Claim 21 wherein the dye is tolonium chloride.
62. The method of Claim 61 wherein the mammalian eye is a human eye.
63. The method of Claim 62 wherein the staining is performed during intra-ocular surgery.
64. The method of Claim 63 wherein the intra-ocular surgery is cataract surgery.
65. The method of Claim 63 wherein the intra-ocular surgery is vitreo-retinal surgery.
66. The method of Claim 62 wherein the ocular structure is an intra-ocular structure.
67. The method of Claim 66 wherein the intra-ocular structure is a lens capsule.
68. The method of Claim 66 wherein the lens capsule is an anterior lens capsule.
69. The method of Claim 66 wherein the intra-ocular structure is the internal limiting membrane of the retina.
70. The method of Claim 66 wherein the intra-ocular structure is the vitreous.
71. The method of Claim 21 wherein the dye is Evans Blue.
72. The method of Claim 71 wherein the mammalian eye is a human eye.
73. The method of Claim 72 wherein the staining is performed during intra-ocular surgery.
74. The method of Claim 73 wherein the intra-ocular surgery is cataract surgery.
75. The method of Claim 73 wherein the intra-ocular surgery is vitreo-retinal surgery.
76. The method of Claim 72 wherein the ocular structure is an intra-ocular structure.
77. The method of Claim 76 wherein the intra-ocular structure is a lens capsule.
78. The method of Claim 76 wherein the lens capsule is an anterior lens capsule.
79. The method of Claim 76 wherein the intra-ocular structure is the internal limiting membrane of the retina.
80. The method of Claim 76 wherein the intra-ocular structure is the vitreous.
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Cited By (7)

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FR2912901A1 (en) * 2007-02-26 2008-08-29 Jacques Strouk Locating tool for e.g. injection point of aqueous humor of patient eye, has plate terminated from side by proximal reference side, where surface of plate equipped with tip or sprocket is placed opposite to gripping device
WO2009059357A1 (en) * 2007-11-05 2009-05-14 Srilakshmi Sharma A medical tool and a method of injecting a fluid
GB2547437A (en) * 2016-02-17 2017-08-23 Owen Mumford Ltd Apparatus for needle handling
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TWI643598B (en) * 2013-06-21 2018-12-11 瑞士商諾華公司 Systems and techniques for tissue manipulation during ocular surgery
WO2019173877A1 (en) * 2018-03-16 2019-09-19 Minas Theodore Coroneo Ophthalmic compositions, and ocular uses thereof, of indigo carmine

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7338477B2 (en) * 2004-03-05 2008-03-04 Dutch Ophthalmic Research Center B.V. Apparatus for applying fluid in the eye
US7524310B2 (en) * 2004-03-05 2009-04-28 Dutch Ophthalmic Research Center B.V. Apparatus for applying fluid in the eye
FR2912901A1 (en) * 2007-02-26 2008-08-29 Jacques Strouk Locating tool for e.g. injection point of aqueous humor of patient eye, has plate terminated from side by proximal reference side, where surface of plate equipped with tip or sprocket is placed opposite to gripping device
WO2009059357A1 (en) * 2007-11-05 2009-05-14 Srilakshmi Sharma A medical tool and a method of injecting a fluid
TWI643598B (en) * 2013-06-21 2018-12-11 瑞士商諾華公司 Systems and techniques for tissue manipulation during ocular surgery
GB2547437A (en) * 2016-02-17 2017-08-23 Owen Mumford Ltd Apparatus for needle handling
RU177228U1 (en) * 2017-10-05 2018-02-13 Федеральное государственное автономное учреждение "Межотраслевой научно-технический комплекс "Микрохирургия глаза" имени академика С.Н. Федорова" Министерства здравоохранения Российской Федерации Microsurgical cannula for staining the anterior lens capsule
WO2019173877A1 (en) * 2018-03-16 2019-09-19 Minas Theodore Coroneo Ophthalmic compositions, and ocular uses thereof, of indigo carmine
US11679167B2 (en) 2018-03-16 2023-06-20 Minas Theodore Coroneo Ophthalmic compositions, and ocular uses thereof, of indigo carmine

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