Ophthalmic blades and instruments, and methods of use thereof

Abstract

To provide a useful or commercially beneficial option capable of at least partially coping with problems or defects of a conventional technique in an ophthalmic surgical instrument to be used during ophthalmic surgery.SOLUTION: In one embodiment, the present invention relates to a multipurpose ophthalmic blade for making a primary incision and a side port incision for entry into the anterior chamber of an eye. In another embodiment, the invention relates to an ophthalmic surgical instrument for delivering a fluid into and / or removing a fluid from an eye. The instrument includes a hollow shaft connectable to a blade portion adapted for making the side port incision in an eye for delivering or removing the fluid.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] In one aspect, the present invention relates to a multi-purpose ophthalmic blade and method of use thereof. In another aspect, the present invention relates to an ophthalmic surgical instrument and method of use thereof. [Background technology]

[0002] There are many different sizes and shapes of surgical blades for ophthalmic surgery. During the course of a surgical procedure, an ophthalmologist may typically use two or more different blade types.

[0003] For example, during routine cataract extraction surgery, ophthalmologists typically use a paracentesis needle or side port blade to create the side port incision and a keratome or slit blade to create the primary clear corneal incision. Thus, during such a procedure, the ophthalmologist is handed the side port blade after creating the side port incision, and then is handed the next instrument to create the primary clear corneal incision or to inject the viscoelastic material.

[0004] The procedure is further complicated by the need for timely injection of viscoelastic material through a side port or primary incision to maintain anterior chamber depth and protect the corneal endothelium. Generally, the material is injected to deepen the anterior chamber of the eye, and it must be injected in a timely manner before the anterior chamber collapses due to fluid loss during one or both incisions, especially for surgeons in their early training. The procedure differs with some ophthalmologists injecting the viscoelastic material between incision creation and others injecting the viscoelastic material after both incisions are created.

[0005] A common problem with the above procedures is that handling multiple instruments can slow the procedure, particularly when the ophthalmologist is quickly applying the viscoelastic material after or between making incisions in the collapsed anterior chamber, thereby unnecessarily exposing the patient to a greater risk of surgical complications.

[0006] Another related problem is the risk of needlestick injuries to both the ophthalmologist and the assistants involved with handling multiple instruments.

[0007] A still further problem with the above procedures is the expense and waste associated with storing and supplying multiple instruments for each procedure, especially since the instruments are typically single-use items.

[0008] In contrast to the above procedure, more experienced ophthalmologists may create two corneal incisions using a single keratome. However, such alternative procedures are also not without problems. For example, creating two corneal incisions with a single keratome can lead to instability in the anterior chamber due to the creation of large side port incisions, which can lead to less predictable refractive changes.

[0009] Conventional instruments have been developed in an attempt to reduce the number of instruments required for a procedure.

[0010] For example, International Patent Publication No. WO2004 / 112665A discloses a blade for making and widening a single incision for cataract removal surgery. However, the blade is not suitable or applicable to modern cataract extraction surgery, which requires making and using multiple incisions simultaneously. Furthermore, the disclosed blade has a tendency to overextend into the anterior chamber of the eye.

[0011] Similarly, U.S. Patent No. 5,217,477 discloses a blade for creating and enlarging a single incision for phacoemulsification and subsequent IOL implantation. However, the inventors have recognized that the blade is again not suitable or applicable to modern cataract extraction surgery, which requires the creation of multiple precise incisions. The disclosed blade tends to create enlarged side port incisions.

[0012] It is expressly understood that where prior art publications are referred to herein, this reference is not to be regarded as an acknowledgement that the publications form part of the common general knowledge in the art in Australia or in any other country. [Prior art documents] [Patent documents]

[0013] [Patent Document 1] International Patent Publication No. WO2004 / 112665A [Patent Document 2] U.S. Patent No. 5,217,477 Summary of the Invention

[0014] Embodiments of the present invention provide multi-purpose ophthalmic blades, ophthalmic surgical instruments, and methods of use thereof that may at least partially address one or more of the problems or shortcomings discussed above, or may provide the public with a useful or commercially advantageous option.

[0015] According to a first aspect of the present invention, A shaft connectable to a handle; a first blade portion extending from the shaft along a central axis, the first blade portion including a pair of opposing side edges extending about the central axis, the side edges defining a first set of opposing cutting edges each oriented at a first angle relative to the central axis, the first set of opposing cutting edges at least partially converging toward a distal end of the first blade portion; a second blade portion extending distally forward from the first blade portion along the central axis to a blade tip, the second blade portion including a pair of opposing side edges each defining a second set of opposing cutting edges that converge to the blade tip, the second cutting edges each oriented at a second angle relative to the central axis; Including, the first blade portion is adapted to create a primary incision and the second blade portion is adapted to create a side port incision; A multi-purpose ophthalmic blade for use in cataract extraction surgery is provided.

[0016] Preferably, the first angle is greater than the second angle such that the first blade portion is adapted to make a primary incision and the second blade portion is adapted to make a side port incision.

[0017] According to a second aspect of the present invention, A shaft that can be connected to the handle, a first blade portion extending from the shaft along a central axis, the first blade portion including a pair of opposing side edges extending about the central axis, the side edges defining a first set of opposing cutting edges each oriented at a first angle relative to the central axis, the first set of opposing cutting edges at least partially converging toward a distal end of the first blade portion; a second blade section extending distally forward from the first blade section along a central axis to a blade tip, the second blade section including a pair of opposed parallel side edges and a pair of converging side edges extending distally forward from the parallel side edges, the converging side edges defining a second set of cutting edges that converge to the blade tip, the second set of cutting edges each oriented at a second angle relative to the central axis; Including, the first blade portion is adapted to create a primary incision and the second blade portion is adapted to create a side port incision; A multi-purpose ophthalmic blade for use in cataract extraction surgery is provided.

[0018] Typically, the second blade portion extends distally and forward from the first blade portion a distance no greater than 1.2 times, preferably 1.1 times, and more preferably 1.0 times the width of the second blade portion at its widest point.

[0019] According to a third aspect of the present invention, a hollow shaft connectable to a source for containing or receiving a fluid; and a blade adapted to create an incision in the eye for delivering or removing fluids through a shaft, the blade extending from the shaft along a central axis to a blade tip, the blade including at least one side edge having a cutting edge defined thereon, the cutting edge being oriented at an angle relative to the central axis and extending to the blade tip; An ophthalmic surgical instrument for delivering or removing fluids into or from an eye is provided.

[0020] According to a fourth aspect of the present invention, a hollow shaft connectable to a cannula in fluid communication with a source for containing or receiving a fluid; and a blade adapted to create an incision in the eye for delivering or removing fluids through a shaft, the blade extending from the shaft along a central axis to a blade tip, the blade including at least one side edge having a cutting edge defined thereon, the cutting edge being oriented at an angle relative to the central axis and extending to the blade tip; An ophthalmic surgical instrument for delivering or removing fluids into or from an eye is provided.

[0021] Advantageously, the multi-purpose blades and surgical instruments of the present invention allow ophthalmologists to work more efficiently during surgical procedures by reducing the number of instruments required. Secondly, by handling fewer instruments, surgical procedures are advantageously performed faster, thereby reducing the risk of infection, surgical complications and injuries such as needlesticks. Finally, by reducing the number of surgical instruments required, the present invention reduces waste and provides a cost-effective alternative to current practices.

[0022] As used herein, the term "eye" refers to the human eye.

[0023] The eye is not a perfect sphere, but rather a fused two-piece unit. The eye contains a small front portion called the "cornea," which is joined to a larger white portion called the "sclera." The cornea is transparent and more curved than the sclera.

[0024] As used herein, the term "sclerocorneal junction" or "limbus" refers to the border or transition area between the cornea and the sclera.

[0025] The eye further comprises a colored circular structure within the sclera called the "iris." The iris concentrically surrounds the eye's pupil, which appears black. The size of the pupil, which controls the amount of light entering the eye, is regulated by dilator and sphincter muscles in the iris.

[0026] Light enters the eye through the cornea, then the pupil, and then through the lens, which is controlled by the ciliary muscle. The light then reaches light-sensitive cells at the back of the eye, called the "retina." The light-sensitive cells in the retina convert the light into electrical signals that are carried by the optic nerve to the brain.

[0027] The crystalline lens is a transparent, biconvex structure that works with the cornea to refract light and focus it on the retina.

[0028] As used herein, the term "cataract" refers to the opacification of the lens of the eye, which causes impaired or lost vision. Metabolic changes in the lens fibers over time lead to the development of cataracts, which reduce the transmission of light to the retina. Cataract extraction surgery generally involves the removal of the lens and its replacement with an artificial lens, also known as an intraocular lens (IOL).

[0029] As used herein, the term "clear corneal incision" or "corneal incision" refers to an incision made anteriorly into the cornea, usually in a linear or curved manner, to the limbus.

[0030] As used herein, the term "primary clear corneal incision" or "primary incision" generally refers to a corneal incision made for emulsification and aspiration of the crystalline lens and implantation of an artificial lens as part of a cataract extraction procedure. Generally, the incision is sized to be self-closing. Typically, the incision is about 2.0 mm to about 4.0 mm in length and about 2 to 3 mm in width, typically about 2.2 mm to about 2.75 mm in width.

[0031] As used herein, the term "secondary clear corneal incision" or "side port incision" refers to a corneal incision made for delivery and removal of viscoelastic material and for general manipulation of the crystalline lens and implanted artificial lens during the surgical procedure. Again, the incision is typically sized to be self-closing. Typically, the incision is about 1.0 mm in length and about 0.6 to about 1.5 mm in width.

[0032] As used herein, the term "viscoelastic material" refers to a flowable substance that is delivered and removed from the anterior chamber of the eye to prevent loss of corneal endothelial cells, maintain intraocular pressure / anterior chamber depth, and / or expand the capsular bag during the course of a surgical procedure. The substance is also used to coat the endothelium, absorb ultrasonic energy, and mechanically protect the endothelium from surgical trauma.

[0033] As indicated above, the present invention according to the first and second aspects provides a multi-purpose ophthalmic blade for use in cataract extraction surgery. The blade may be of any size, shape and configuration and may be formed from any material or materials adapted to be suitable for ophthalmic surgery, preferably cataract extraction surgery.

[0034] Generally, the blade may be formed from any material or materials capable of forming a sharp cutting edge. Typically, the blade may be formed from a metal and / or one or more plastic materials, preferably stainless steel, titanium or aluminum. However, in some embodiments, it is envisaged that the blade, or at least the cutting edge, may be formed from diamond. Preferably, the blade may be integrally formed.

[0035] The shaft may be of any size, shape, and length suitable for spacing the blade portion relative to the handle portion.

[0036] Generally, the shaft may include a pair of opposing ends and may extend longitudinally therebetween, the opposing ends may include a proximal end connectable to a handle portion, and an opposing distal end from which a first blade portion extends.

[0037] The shaft may be of tubular or solid construction, typically a solid construction.

[0038] The shaft may have any suitable cross-sectional shape. For example, the shaft may have a substantially rectangular, triangular, pentagonal, hexagonal, heptagonal, octagonal, circular, or elliptical cross-section. Preferably, the shaft may have a substantially circular cross-section at or near the proximal end and may be tapered or flattened at or near the distal end from which the first blade portion extends.

[0039] In some embodiments, the shaft may extend in a linear direction between the handle portion and the first blade portion.

[0040] In other embodiments, the shaft may include one or more bends. For example, the shaft may include distal and proximal ends that are angled relative to one another. It is contemplated that the distal end may extend at an angle ranging from about 120° to about 150° relative to the proximal end, preferably at an angle ranging from about 130° to about 140°, and more preferably at an angle of about 135°.

[0041] As shown, the shaft may be connectable via a proximal end to a handle portion. The handle portion may typically have an elongated shape suitable for being held and manipulated by an ophthalmologist's hand. The handle portion may also include an elongated body extending longitudinally between two opposing ends in a linear direction.

[0042] The handle portion may be formed from metal and / or one or more plastic materials, typically a plastic material.

[0043] The shaft and handle portion may be connectable in any suitable manner known in the art. For example, in some embodiments where the blade is reusable, the shaft may be removably connectable to the handle portion via a connection mechanism. In other embodiments, the shaft may be fixedly connected, preferably integrally connected, to the handle portion. For example, in one such embodiment, the handle portion may be formed, preferably overmolded, over the proximal end of the shaft.

[0044] The shaft may extend any length between the connected handle and blade portions. For example, the shaft may extend about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or even about 20 mm between the connected handle and blade portions. Typically, the shaft may extend between the connected handle and blade portions with a length of about 6 mm to about 12 mm, and preferably, the shaft may extend about 9 mm between the connected handle and blade portions.

[0045] As shown, the shaft may be tapered or flattened, preferably flat, at or near the distal end from which the first blade extends, such that the first blade portion (and second blade portion) may extend at an angle relative to the shaft. For example, the first blade portion may extend at an angle relative to the shaft ranging from about 120° to about 150°, preferably at an angle ranging from about 130° to about 140°, and more preferably at an angle of about 135°.

[0046] The blade may include a body. The body may define first and second blade portions.

[0047] The body may be of any size, shape, and configuration suitable for defining the first blade portion and the second blade portion.

[0048] Typically, the body may extend from a distal end of the shaft along a central axis to a blade tip, preferably a pointed blade tip.

[0049] In general, the body may be in the form of a plate. The body may be substantially flat or planar and may have a polygonal shape. In some embodiments, the body may have a substantially diamond or kite shape. In other embodiments, the body may have a substantially trapezoidal shape.

[0050] The body may have two opposing surfaces, including an upper surface that faces the outside of the eye during surgery and an opposing lower surface, which may extend substantially parallel to one another and be interconnected by opposing edges, including opposing side edges, a proximal edge where the body (and first blade portion) extends from the shaft, and an opposing distal edge that defines the blade tip of the second blade portion.

[0051] The body may define a first blade portion at or near a proximal end of the body, a second blade portion at or near a distal end of the body, and a junction between the first and second blade portions.

[0052] As shown, the first blade portion (and the second blade portion) may extend from the shaft along a central axis. The first blade portion may include a pair of opposing side edges that preferably extend symmetrically about the central axis.

[0053] The first set of opposing cutting edges may be defined on at least a portion of the opposing side edge, which may correspond to a portion of a side edge of the blade body.

[0054] Generally, the side edges of one or both of the first blade bodies may at least partially flare and taper away from and toward the central axis, respectively, as they extend between the base end and the junction to partially define the blade shape and blade portion. The side edges may flare and taper in straight or curved directions, or a combination thereof.

[0055] For example, in some embodiments, one or both side edges may flare outwardly as they extend between the base end and the junction to define the widest portion of the blade, also known as the apex, and then taper again at or near the junction. In some such embodiments, the widest portion of the blade may be a distinct point. In other such embodiments, the widest portion of the blade may be a portion of both side edges that extend substantially parallel to one another.

[0056] In some embodiments, the apex can define a base-facing side edge extending between the base end and the apex, and a distal-facing side edge extending between the apex and the junction, preferably having a first set of cutting edges thereon.

[0057] In a preferred embodiment, both side edges of the first blade portion may gently flare outwardly away from the central axis as they extend at least partially from the proximal end along toward the junction to define an apex of the blade. The side edges may gently taper at least partially toward the central axis as they extend from the apex toward the junction of the first blade portion to define a distal-facing side edge.

[0058] The first set of cutting edges may define a distal-facing side edge of the first blade portion such that the first cutting edge forms an incision as the blade advances into the eye in a direction parallel to the central axis. Typically, the proximal-facing side edge has a rounded or non-edged edge so as not to alter, i.e., enlarge, the incision and cut the surface as the blade is pulled back.

[0059] Generally, the distally facing side edges may at least partially taper in a straight direction toward the center, although curved directions are also envisioned.

[0060] As shown, the second blade portion can extend distally forward from the first blade portion along the central axis to a blade tip. Like the first blade portion, the second blade portion can include a pair of opposing side edges that at least partially converge to the blade tip. A second set of cutting edges can be defined on at least a portion of the side edges.

[0061] The opposing side edge of the second blade portion may extend preferably symmetrically about the central axis.

[0062] The pair of opposing side edges may at least partially converge to the blade tip in a straight direction, although curved directions are also envisioned.

[0063] Again, the side edges may correspond to portions of the side edges of the body.

[0064] In a preferred embodiment, the second blade portion includes a pair of opposed substantially parallel side edges and a pair of converging side edges extending distally forward from the opposed substantially parallel side edges. The second set of cutting edges are preferably defined on the pair of converging side edges and may converge to the blade tip. The cutting edges may preferably not be defined on the substantially parallel side edges.

[0065] Advantageously, the substantially parallel side edges facilitate the formation of a side port incision of a precise width, the width being defined by the maximum width of the second blade portion, i.e., as measured between the substantially parallel side edges. Furthermore, the absence of a cutting edge on the substantially parallel side edges ensures that the side port incision is not inadvertently enlarged as the blade advances into the eye in a direction parallel to the central axis up to and not beyond the substantially parallel side edges of the second blade portion.

[0066] The substantially parallel sided edges may define, or at least partially define, a junction between the first and second blade portions.

[0067] In some embodiments, the first set of cutting edges may extend contiguously into the second set of cutting edges, while in other preferred embodiments the first and second sets of cutting edges may be separated from one another, for example by substantially parallel side edges of the second blade portion.

[0068] Generally, each set of cutting edges may be oriented at a different angle relative to the central axis, however, each set of cutting edges may be oriented relative to the central axis such that as the blade advances into the eye in a direction parallel to the central axis, the cutting edges point or at least partially point toward the blade tip to facilitate the formation of the incision.

[0069] In some embodiments, the first set of cutting edges may be oriented at a first angle relative to the central axis, the first angle being greater than a second angle at which the second set of cutting edges are oriented relative to the central axis. In other embodiments, the first angle may be less than the second angle. In yet other embodiments, the first angle and the second angle may be substantially the same.

[0070] The first angle, when measured between each of the first set of cutting edges and the central axis, can be about 15°, about 16°, about 17°, about 18°, about 19°, about 20°, about 21°, about 22°, about 23°, about 24°, about 25°, about 26°, about 27°, about 28°, about 29°, about 30°, about 31°, about 32°, about 33°, about 34°, about 35°, about 36°, about 37°, about 38°, about 39°, or even about 40°, typically between about 18° and about 35°, and preferably between about 25° and about 35°.

[0071] The first set of cutting edges may have a maximum width extending between opposing cutting edges, as measured at or near the apex, of about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2.0 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3.0 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, or even about 3.5 mm, typically ranging from about 1.3 mm to 3.2 mm, preferably from about 2.0 mm to about 2.2 mm.

[0072] In contrast, the second angle may be about 5°, about 6°, about 7°, about 8°, about 9°, about 10°, about 11°, about 12°, about 13°, about 14°, about 15°, about 16°, about 17°, about 18°, about 19°, about 20°, about 21°, about 22°, about 23°, about 24°, about 25°, about 26°, about 27°, about 28°, about 29°, about 30°, about 31°, about 32°, about 33°, about 34°, about 35°, about 36°, about 37°, about 38°, about 39°, about 40°, about 41°, about 42°, about 43°, about 44°, about 45°, about 46°, about 47°, about 48°, about 49°, about 50°, about 51°, about 52°, about 53°, about 54°, about 55°, about 56°, about 57°, about 58°, about 59°, about 60°, about 61°, about 62°, about 63°, about 64°, about 65°, about 66°, about 67°, about 68°, about 69°, about 70°, about 71°, about 72°, about 73°, about 74°, about 75°, about 76°, about 77°, about 78°, about 79°, about 80°, about 81°, about 82°, about 83°, about 84°, about 85°, about 86°, about 87°, about 88°, about 89 The angle may be about 35°, about 36°, about 37°, about 38°, about 39°, about 40°, about 41°, 42°, about 43°, about 44°, about 45°, about 46°, about 47°, about 48°, about 49°, about 50°, about 51°, about 52°, about 53°, about 54°, about 55°, about 56°, about 57°, about 58°, about 59°, about 60°, about 61°, about 62°, about 63°, about 64°, or even about 65°.

[0073] Similarly, the second set of opposed cutting edges can have a maximum width extending between the opposed cutting edges, as measured at or near the junction, of about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, or even about 2.0 mm, typically ranging from about 0.5 mm to about 1.2 mm, preferably about 1.0 mm.

[0074] In an embodiment of the blade according to the first aspect, the second blade portion may have a second angle of about 10° to about 15°, preferably 12.5°.

[0075] In an embodiment of the blade according to the second aspect, the second blade portion may have a second angle of between about 30° and about 60°.

[0076] Advantageously, the second blade portion has a smaller blade width relative to the first blade portion, thereby enabling precise and repeatable formation of secondary corneal incisions or side port incisions of precise widths as the second blade portion advances into the eye in a direction parallel to the central axis, typically to substantially parallel side edges.

[0077] Conversely, the larger blade width of the first blade portion allows for precise and repeatable formation of the primary incision as the first blade portion advances into the eye in a direction parallel to the central axis, typically to the apex.

[0078] The second blade portion may be of any suitable length as defined between the blade tip and the junction. Preferably, the second blade portion is not too long so as not to overextend into the anterior chamber and / or damage the endothelium when forming the lateral incision. For example, the second blade portion may have a length of about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.1 mm, or about 1.2 mm or more. Typically, the second blade portion may have a length of about 0.7 mm to about 1.2 mm, preferably about 0.7 mm to 1.1 mm, more preferably about 0.7 mm to 1.0 mm.

[0079] In a preferred embodiment, the second blade portion may have a length that is directly proportional to the width of the second blade portion, for example, the second blade portion may have a length that is less than or equal to 1.2 times the maximum width of the second blade portion, preferably 0.7 to 1.1 times the maximum width, and more preferably 0.7 to 1.0 times the maximum width.

[0080] In a more preferred embodiment, the second blade portion may have a length of about 1.0 mm or 1.0 times the maximum width of the second blade portion.

[0081] Advantageously, having a length of about 0.7 mm to about 1.2 mm significantly reduces the risk of traumatizing the endothelium or overextending the second blade into the anterior chamber when creating the side port incision. Additionally, the substantially parallel side edges of the second blade provide clear visual feedback to the surgeon when advancing the second blade into the anterior chamber of the eye and creating the side incision.

[0082] In some embodiments, the blade may include one or more markings or etchings to facilitate visualization by an ophthalmologist when at least the first blade portion is advanced into the eye, and preferably also when the second blade portion is advanced into the eye.

[0083] The marking or markings may be in any suitable form and may be provided at any suitable location on the blade.

[0084] For example, in some such embodiments, the markings may include one or more symbols or indicia painted or etched at least partially along the top surface.

[0085] In some such embodiments, the markings may include reflective or fluorescent dyes to facilitate visualization of the markings by an ophthalmologist during a surgical procedure.

[0086] In a preferred embodiment, the blade may include a first marking extending across the top surface of the blade in a direction substantially perpendicular to the central axis for indicating an appropriate insertion depth for making the primary incision, and a second marking extending across the top surface of the blade in a direction substantially perpendicular to the central axis for making the side port incision.

[0087] In some such examples, a first marking may be located at the apex and a second marking may be located at the junction.

[0088] In other such embodiments, the first marking may be located about 2.0 mm to about 4.0 mm from the blade tip, and the second marking may be located about 0.7 mm to about 1.0 mm from the blade tip.

[0089] As indicated, the present invention in another form provides an ophthalmic surgical instrument for delivering and / or removing fluids into and / or from an eye.

[0090] In some examples, the fluid may be a viscoelastic material used in cataract extraction surgery. In other examples, the fluid may be aqueous humor that is drained from the eye to reduce intraocular pressure within the eye in a glaucoma patient, i.e., a glaucoma bleb needling procedure. In yet other examples, the fluid may be a biopsy sample of fluid obtained from the eye.

[0091] The instrument may be of any size, shape, and configuration and formed from any material or materials that are adapted to be suitable for creating an incision in the eye for delivery or removal of fluid by a source such as a syringe, etc. Preferably, the incision may be a clear corneal incision for delivery or removal of fluid from the anterior chamber of the eye.

[0092] Generally, the shaft and blade of the instrument may be integrally formed and may be formed from any material or materials capable of forming a typically sharp cutting edge. Typically, the instrument may be formed from metal and / or one or more plastic materials, preferably stainless steel, titanium or aluminum.

[0093] The hollow shaft may be of any size, shape, and length suitable for connecting the blades to a source of fluid and providing a conduit therebetween.

[0094] Generally, the shaft includes a pair of opposing ends extending longitudinally therebetween. The opposing ends may include a proximal end connectable to a source or cannula, and an opposing distal end from which the blades extend. The opposing ends may preferably be open ended to allow for delivery and removal of fluid from the eye via the distal end.

[0095] The shaft is preferably of tubular construction and may have a substantially circular cross-section.

[0096] In some embodiments, the shaft may extend in a linear direction between the source and the blade portion. In other embodiments, the shaft may include one or more bends. For example, the shaft may include a distal end and a proximal end that are angled relative to one another. For example, it is contemplated that the distal end may extend relative to the proximal end at an angle ranging from about 120° to about 150°, preferably at an angle ranging from about 130° to about 140°, and more preferably at an angle of about 135°.

[0097] The proximal end may be connectable to a source or cannula in any manner suitable for providing fluid communication between the source and the distal end of the shaft and for ensuring that the parts are not inadvertently disconnected during a surgical procedure. For example, the proximal end may be directly or indirectly connectable to a source or cannula. Preferably, the proximal end may be removably connectable.

[0098] In some embodiments, the proximal end of the shaft may be connected to a source or cannula by one or more fasteners, such as, for example, one or more mechanical fasteners and / or one or more chemical fasteners, preferably the latter.

[0099] In such embodiments, the chemical fastener may include a wet adhesive, a dry adhesive, and / or a double-sided adhesive tape that may extend between the proximal end of the shaft, or a portion thereof, and the source or cannula, or a portion thereof.

[0100] In some embodiments, the proximal end of the shaft can be connected to the source or cannula by a connection mechanism or a portion of a connection mechanism. The connection mechanism can include a first portion that couples with the proximal end of the shaft and a second portion that couples with the source or cannula and is connectable to the first portion.

[0101] Each portion of the connection mechanism may include mateable male and female portions that mate together, including, for example, a threaded connection, an interference fit connection, or a bayonet connection.

[0102] For example, a first portion of the connection mechanism that couples with the proximal end of the shaft may include a male feature configured to be inserted into or mated with a female feature of a second portion of the connection mechanism that couples with the source or cannula. Conversely, a first portion of the connection mechanism that couples with the proximal end of the shaft may include a female feature configured to receive or mated with a male feature of a second portion of the connection mechanism that couples with the source or cannula.

[0103] In some preferred embodiments, the proximal end of the shaft and the source or cannula may be connectable by a Luer taper system. For example, the proximal end of the shaft may include a male or female Luer-Lok™ connection fastener configured to be engageable with one of a female or male Luer-Lok™ connection fastener coupled to the cannula or source, respectively. For example, in one such embodiment, the proximal end of the shaft may include a male Luer-Lok™ connection fastener engageable with a female Luer-Lok™ connection coupled to the syringe.

[0104] In other preferred embodiments, the proximal end of the shaft and the source or cannula may be connectable by a friction fit. For example, in one such embodiment, the proximal end of the shaft may include a slip-tip fitting configured to friction fit over the distal end of the cannula or syringe.

[0105] The shaft may be of any suitable length. For example, the shaft may be about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or even about 20 mm in length. Typically, the shaft may have a length of about 6 mm to about 12 mm.

[0106] In some embodiments, the shaft may be partially tapered or flattened, preferably partially flattened, at or near the distal end from which the blades extend. For example, in some such embodiments, the distal end of the shaft may have an elliptical or even triangular cross-sectional shape. Advantageously, this provides a more streamlined shape, making it easier to insert the distal end of the shaft into the incision formed by the corresponding blade.

[0107] As shown, the blade portion extends from the shaft along the central axis to a blade tip and can include at least one side edge having a cutting edge thereon. Preferably, the cutting edge is oriented at a first angle relative to the central axis and extends to the blade tip such that as the blade portion advances into the eye in a direction parallel to the central axis, the cutting edge faces or at least partially faces toward the blade tip to facilitate the formation of the incision.

[0108] Generally, the blade portion may extend from the distal end of the shaft along a central axis to a blade tip, preferably a pointed blade tip.

[0109] Typically, the blade portion may be in the form of a plate, which may usually be substantially flat or planar, although it is envisioned that a portion or section of the blade portion may extend at least partially around the distal end of the shaft.

[0110] The blades may be of any suitable size, shape and configuration, for example, the blades may have a substantially triangular, diamond, or kite-shaped shape.

[0111] The blade portion may have two opposing surfaces, including an inner surface and an opposing outer surface, that extend substantially parallel to one another and may be interconnected by opposing edges, including opposing side edges, a proximal edge where the blade portion extends from the distal end of the shaft, and an opposing distal edge that defines the blade tip.

[0112] In a preferred embodiment, the blade portion may include a pair of opposing side edges extending about a central axis from at or near the distal end of the shaft to the blade tip. The side edges may correspond to the side edges. The side edges may be symmetric or asymmetric.

[0113] In some embodiments, the side edges may extend in a linear direction from the distal end of the shaft to the blade tip. In other embodiments, at least one side edge may at least partially flare and taper away and toward the central axis, respectively, as it extends between the proximal and distal ends of the blade. Again, the side edges may flare and taper in a linear or curvilinear direction, or a combination thereof.

[0114] Typically, the proximal side edge has a rounded or blunt edge so as not to alter the incision, i.e., enlarge the incision and cut the surface, when the blade is pulled back.

[0115] In some embodiments, a single cutting edge may be defined on at least a portion of one of the side edges, typically the distal-facing side edge, while in other embodiments, a cutting edge may be defined on at least a portion of each side edge, again typically the distal-facing side edge.

[0116] In some embodiments, the blade portion may include a first side edge that extends linearly between the proximal and distal ends, and a second side edge that flares outwardly at or near the proximal end to define a proximal-facing side edge, a widest portion or apex of the blade portion, and a distal-facing side edge that tapers gently, preferably in a linear direction, toward the blade tip. The cutting edge in such embodiments may preferably be defined on the distal-facing side edge.

[0117] In other embodiments, the blade portion may include a pair of opposing side edges, each of which flares outwardly away from the central axis at or near a proximal end to define a proximal-facing side edge, a widest portion or apex of the blade portion, and a distal-facing side edge that gradually tapers or converges, preferably in a linear direction, at least partially toward the central axis to the blade tip. In such embodiments, cutting edges may preferably be defined on both distal-facing side edges.

[0118] In some embodiments, the distal end of the shaft and the proximal end of the blade may at least partially overlap, preferably such that at least one of the proximal-facing side edges overlaps the distal end of the shaft, advantageously allowing the distal end of the shaft to be easily inserted into the incision as the blade advances into the eye in a direction parallel to the central axis.

[0119] In other embodiments, the proximal ends of the blades can extend at least partially around the distal end of the shaft, which advantageously also allows the distal end of the shaft to be easily inserted into the incision as the blades are advanced into the eye in a direction parallel to the central axis.

[0120] As shown, preferably the cutting edge of the blade is oriented at an angle relative to the central axis so that as the blade advances into the eye in a direction parallel to the central axis, the cutting edge faces, or at least partially faces, toward the blade tip to facilitate the formation of the incision.

[0121] The angle may preferably be an acute angle. For example, the angle may be about 5°, about 6°, about 7°, about 8°, about 9°, about 10°, about 11°, about 12°, about 13°, about 14°, about 15°, about 16°, about 17°, about 18°, about 19°, or even about 20°, preferably about 12.5°.

[0122] Similarly, the blade portion may have a maximum width of about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, 1.9 mm, or even about 2.0 mm, typically ranging from about 0.5 mm to about 1.0 mm, preferably about 0.6 mm, when measured at the widest point between opposite edges or apexes in some embodiments.

[0123] According to a fifth aspect of the present invention there is provided a method of making primary and side port incisions during cataract surgery comprising the steps of: Providing a multi-purpose ophthalmic blade of the first or second aspect; forming a side port incision in the eye by advancing the blade at a first position at least partially into the anterior chamber of the eye to a junction between the first and second blade portions; and forming a primary incision in the eye by advancing the blade at least partially into the anterior chamber of the eye at a second position to an end of the first cutting edge opposite the first blade portion. A method is provided that includes:

[0124] The method may include one or more features or characteristics of the multi-purpose blade described above.

[0125] Preferably, the first and second locations may be positioned at approximately 60-90° relative to one another around the sclerocorneal junction of the eye.

[0126] Preferably, making the primary incision may involve advancing the blade into the anterior chamber of the eye to the apex of the blade to make an incision typically 2.2 mm (width) by 4 mm (length).

[0127] In some embodiments, forming the primary incision may be performed prior to forming the side port incision.

[0128] According to a sixth aspect of the invention there is provided a method of delivering or removing fluid into or from an eye, comprising the steps of: Providing an ophthalmic surgical instrument according to the third or fourth aspect; and forming a side port incision in the eye by advancing the blade portion at least partially into the eye until the outer end of the shaft is in fluid communication with the incision for delivering or removing fluid; A method is provided that includes:

[0129] The method may include one or more features or characteristics of the ophthalmic surgical instruments described above.

[0130] In some embodiments, forming can include advancing a blade portion into the eye until the blade is fully inserted into the anterior chamber of the eye, forming a preferably clear corneal incision.

[0131] In other embodiments, forming can include advancing a blade into the eye, preferably through the clear cornea of ​​the eye, all the way to the apex.

[0132] In some embodiments, the method may further include delivering or removing the fluid by a syringe operably coupled to the ophthalmic surgical instrument, hi other embodiments, delivering or removing the fluid may be by a pump operably coupled to the ophthalmic surgical instrument.

[0133] Any of the features described herein may be combined, in any combination, with any one or more of the other features described herein within the scope of the present invention.

[0134] The reference to any prior art in this specification is not, and should not be, considered as an acknowledgment or in any way a statement that the prior art forms part of the common general knowledge.

[0135] Preferred features, embodiments, and variations of the present invention may become apparent from the following detailed description, which provides sufficient information for one skilled in the art to practice the present invention. The detailed description should not be construed in any way as limiting the scope of the preceding Summary of the Invention. The detailed description refers to several drawings, which follow. [Brief description of the drawings]

[0136] [Figure 1] FIG. 1 is a top perspective view of a multi-purpose ophthalmic blade according to an embodiment of the present invention. [Diagram 2] FIG. 2 is a side view of the multipurpose ophthalmic blade shown in FIG. [Diagram 3] FIG. 2 is a top perspective view of a multi-purpose ophthalmic blade according to another embodiment of the present invention. [Figure 4] FIG. 2 is a plan view of a multi-purpose ophthalmic blade according to another embodiment of the present invention. [Diagram 5] FIG. 2 is a plan view of a multi-purpose ophthalmic blade according to another embodiment of the present invention. [Figure 6] FIG. 2 is a plan view of a multi-purpose ophthalmic blade according to another embodiment of the present invention. [Figure 7] FIG. 1 is a top perspective view of a surgical instrument in accordance with an embodiment of the present invention. [Figure 8] 8 is another top perspective view of the surgical instrument shown in FIG. 7 operatively coupled with a cannula. [Figure 9] FIG. 1 is a top perspective view of a surgical instrument according to another embodiment of the present invention; [Figure 10] 10 is another top perspective view of the surgical instrument shown in FIG. 9 operatively coupled with a cannula. [Figure 11] 1 is a top perspective view of a surgical instrument according to a further embodiment of the present invention; FIG. [Figure 12] 12 is another top perspective view of the surgical instrument shown in FIG. 11 operatively coupled with a cannula. [Figure 13] 13 is a top perspective view of a surgical instrument in accordance with yet another embodiment of the present invention; FIG. [Figure 14] 14 is another top perspective view of the surgical instrument shown in FIG. 13 operatively coupled with a cannula. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0137] 1-6 show an embodiment of a multi-purpose ophthalmic blade (100) according to the present invention for use in cataract extraction surgery.

[0138] 7-14 show an ophthalmic surgical instrument (300) according to different embodiments of the present invention.

[0139] 1 and 2, these figures show a multi-purpose ophthalmic blade (100) according to a first embodiment of the present invention. The multi-purpose ophthalmic blade (100) has a first blade portion (130) and a second blade portion (140) for making a primary incision and a side port incision, respectively, during cataract extraction surgery.

[0140] The blade (100) is integrally formed from stainless steel.

[0141] The blade (100) includes a shaft (110) connectable to a handle portion (900, only shown in FIG. 1), and a blade body (120) defining a first blade portion (130) and a second blade portion (140).

[0142] The shaft (110) extends longitudinally in a linear direction between a pair of opposed ends, including a proximal end (112) connectable to a handle portion (900) and an opposed distal end (114) from which extend the blade body (120) and blade portions (130, 140).

[0143] Shaft (110) is a solid structure having a substantially circular cross-section that tapers or flattens at or near its distal end (114).

[0144] The handle portion (900, shown only in FIG. 1) has an elongated shape suitable for being held and manipulated by an ophthalmologist's hand. The handle portion (900, shown only in FIG. 1) is formed from one or more plastic materials and is overmolded over the proximal end (112) of the shaft (110).

[0145] The shaft (110) extends between the handle portion (900) and the blade body (120) for a length of approximately 9 mm.

[0146] As shown, the shaft (110) is tapered or flattened at or near the distal end (114) where the blade body (120) extends at an angle (α) of approximately 135° relative to the shaft (110).

[0147] 1, a blade body (120) extends from the shaft distal end (114) along a central axis (A) to a sharp blade tip (122). The body (120) is in the form of a plate having a substantially diamond or kite shape.

[0148] The body (120) has two opposing surfaces, including an upper surface (124) that faces the outside of the eye during surgery, and an opposing lower surface (126). The opposing surfaces (124, 126) extend substantially parallel to one another and are interconnected by opposing edges, including opposing side edges, a proximal edge where the body (120) extends from the shaft (110), and opposing distal edges that define the blade tip (122) of the second blade portion (140).

[0149] The body (120) defines a first blade portion (130) at or near a proximal end of the body, a second blade portion (140) at or near a distal end of the body (120), and a junction (150) between the first and second blade portions (130, 140).

[0150] The first blade portion (130) and the second blade portion (140) extend along a central axis (A) from the shaft (110). The first blade portion (130) includes a pair of opposing side edges (132) that extend symmetrically about the central axis (A).

[0151] The side edges (132) gradually flare outwardly away from the central axis (A) as they extend at least partially along from the base end toward the junction (150) to define the widest portion or apex (B:B) of the blade. The side edges (132) then gradually taper at least partially toward the central axis (A) as they extend from the apex (B:B) toward the junction (150).

[0152] The apex (B:B) defines a base-facing side edge (134) extending between the base end and the apex (B:B), and a distal-facing side edge (136) extending between the apex (B:B) and the junction (150).

[0153] A first set of cutting edges (160) are defined on the distally facing side edge (136).

[0154] The proximal side edge (134) has a rounded or blunt edge so as not to alter the incision, i.e., to not enlarge the incision and not to cut the surface, when the blade portion (100) is pulled back.

[0155] The second blade portion (140) extends distally and forward from the first blade portion (130) along the central axis (A) to the blade tip (122). Like the first blade portion (130), the second blade portion (140) includes a pair of opposing side edges (142) that extend symmetrically about the central axis (A) and converge to the blade tip (122). A second set of cutting edges (170) are defined on the side edges (142).

[0156] The first set of cutting edges (160) extend contiguously with the second set of cutting edges (170), except that each set (160, 170) is oriented at a different angle relative to the central axis (A).

[0157] Each pair of cutting edges (160, 170) is oriented at a constant blade angle relative to the central axis (A) so that as the blade (100) advances into the eye in a direction parallel to the central axis (A), the cutting edges point at least partially toward the blade tip (122) to facilitate the formation of the incision.

[0158] The first set of cutting edges (160) each have a blade angle (β) of approximately 22° relative to the central axis (A), which is greater than the blade angle (γ) of 12.5° that the second set of cutting edges (170) are each oriented relative to the central axis (A).

[0159] The first set of cutting edges (160) have a maximum width extending between opposing cutting edges, as measured at or near the apex (B:B), of approximately 2.4 mm.

[0160] In contrast, the second set of opposing cutting edges (170) have a maximum width extending between the opposing cutting edges (170), as measured at or near the junction (150), of about 0.6 mm.

[0161] 1 and 2, in use, an ophthalmologist can create a side port incision by advancing a blade (100) into the cornea at a first location on the eye up to the junction (150).

[0162] The ophthalmologist can then make a primary incision with the same blade (100) by advancing the blade (100) into the cornea at a second location on the eye in a direction substantially parallel to the central axis (A) to the apex (B:B).

[0163] 3 shows a multi-purpose ophthalmic blade (100) according to a second embodiment of the present invention. For convenience, features similar or corresponding to those of the first embodiment are again designated with the same reference numerals.

[0164] The multi-purpose ophthalmic blade (100) has a first blade portion (130) and a second blade portion (140) for making the primary incision and the side port incision, respectively.

[0165] The blade (100) includes a shaft (110) connectable to a handle portion (900), and a blade body (120) defining a first blade portion (130) and a second blade portion (140).

[0166] The shaft (110) and handle portion (900) are the same as described above with respect to the first embodiment.

[0167] A blade body (120) extends from the shaft distal end (114) along the central axis (A) to a sharp blade tip (122). The body (120) is in the form of a plate.

[0168] The body (120) has two opposing surfaces, including an upper surface (124) that faces the outside of the eye during surgery, and an opposing lower surface (126). The opposing surfaces (124, 126) extend substantially parallel to one another and are interconnected by opposing edges, including opposing side edges, a proximal edge where the body (120) extends from the shaft (110), and opposing distal edges that define the blade tip (122) of the second blade portion (140).

[0169] The body (120) defines a first blade portion (130) at or near a proximal end of the body, a second blade portion (140) at or near a distal end of the body (120), and a junction (150) between the first and second blade portions (130, 140).

[0170] The first blade portion (130) and the second blade portion (140) extend along a central axis (A) from the shaft (110). The first blade portion (130) includes a pair of opposing side edges (132) that extend symmetrically about the central axis (A).

[0171] The side edges (132) gradually flare outwardly away from the central axis (A) as they extend at least partially along from the base end toward the junction (150) to define the widest portion or apex (B:B) of the blade. The side edges (132) then gradually taper at least partially toward the central axis (A) as they extend from the apex (B:B) toward the junction (150).

[0172] The apex (B:B) defines a base-facing side edge (134) extending between the base end and the apex (B:B), and a distal-facing side edge (136) extending between the apex (B:B) and the junction (150).

[0173] A first set of cutting edges (160) are defined on the distally facing side edge (136).

[0174] The proximal side edge (134) has a rounded or blunt edge so as not to alter the incision, i.e., to not enlarge the incision and not to cut the surface, when the blade portion (100) is pulled back.

[0175] The second blade portion (140) extends distally and forward from the first blade portion (130) along the central axis (A) to the blade tip (122). Like the first blade portion (130), the second blade portion (140) includes a pair of opposing side edges (142) that extend symmetrically about the central axis (A) and converge to the blade tip (122). A second set of cutting edges (170) are defined on the side edges (142).

[0176] The first set of cutting edges (160) extend contiguously with the second set of cutting edges (170), except that each set (160, 170) is oriented at a different angle relative to the central axis (A).

[0177] The first set of cutting edges (160) each have a blade angle (β) of approximately 22° relative to the central axis (A), which is greater than the blade angle (γ) of 12.5° at which the distal ends of the second set of cutting edges (170) are each oriented relative to the central axis (A) and converge to blade tips (122).

[0178] The first set of cutting edges (160) have a maximum width extending between opposing cutting edges, as measured at or near the apex (B:B), of approximately 2.4 mm.

[0179] In contrast, the second set of opposing cutting edges (170) have a maximum width extending between the opposing cutting edges (170), as measured at or near the junction (150), of about 0.6 mm.

[0180] Additionally, the second set of opposing cutting edges (170) include distal ends that converge to the blade tip (122) and bases where the opposing cutting edges (170) extend substantially parallel to one another from the distal ends to the junction (150).

[0181] 4 shows a multi-purpose ophthalmic blade (100) according to a third embodiment of the present invention. For convenience, features similar or corresponding to those of the first embodiment are designated here with the same reference numerals.

[0182] The multi-purpose ophthalmic blade (100) has a first blade portion (130) and a second blade portion (140) for making the primary incision and the side port incision, respectively, during cataract extraction surgery.

[0183] The first blade portion (130) includes a pair of opposing side edges (132) that extend symmetrically about a central axis (A).

[0184] The side edges (132) gradually flare outwardly away from the central axis (A) as they extend at least partially along from the base end toward the junction (150) to define the widest portion or apex (B:B) of the blade. The side edges (132) then gradually taper at least partially toward the central axis (A) as they extend from the apex (B:B) toward the junction (150).

[0185] The apex (B:B) defines a base-facing side edge (134) extending between the base end and the apex (B:B), and a distal-facing side edge (136) extending between the apex (B:B) and the junction (150).

[0186] A first set of cutting edges (160) are defined on the distally facing side edge (136).

[0187] The proximal side edge (134) has a rounded or blunt edge so as not to alter the incision, i.e., to not enlarge the incision and not to cut the surface, when the blade (100) is pulled back.

[0188] The second blade portion (140) extends distally and forward from the first blade portion (130) along the central axis (A) to a blade tip (122). The second blade portion (140) includes a pair of opposed parallel side edges (141) and a pair of converging side edges (142) extending distally and forward from the parallel side edges (141). The converging side edges (142) converge to the blade tip (122). A second set of cutting edges (170) are defined on the converging side edges (142).

[0189] The first set of cutting edges (160) and the second set of cutting edges (170) are oriented at different angles relative to the central axis (A).

[0190] The first set of cutting edges (160) each have a blade angle (β) of approximately 33° relative to the central axis (A), and the second set of cutting edges (170) each have a blade angle (γ) of approximately 60° relative to the central axis (A).

[0191] The first set of cutting edges (160) have a maximum width extending between opposing cutting edges, as measured at or near the apex (B:B), of approximately 2.2 mm.

[0192] In contrast, the second set of opposing cutting edges (170) have a maximum width extending between the opposing cutting edges (170) of about 1.0 mm, as measured at or near the junction (150), or between the opposing parallel side edges (141).

[0193] The second blade portion (140) has a length, as measured between the blade tip (122) and the junction (150), of approximately 1.0 mm or 1.0 times the maximum width of the second blade portion (140).

[0194] 5 shows a multi-purpose ophthalmic blade (100) according to a fourth embodiment of the present invention. For convenience, features similar or corresponding to those of the first embodiment are numbered the same here.

[0195] The blade (100) of the fourth embodiment is substantially the same as the blade (100) shown in the third embodiment, except that the second blade portion (140) has a blade angle (γ) of approximately 42° relative to the central axis (A).

[0196] 6 shows a multi-purpose ophthalmic blade (100) according to a fifth embodiment of the present invention. For convenience, features similar or corresponding to those of the first embodiment are designated here with the same reference numerals.

[0197] The blade (100) of the fifth embodiment is substantially the same as the blade (100) shown in the third and fourth embodiments, except that the second blade portion (140) has a blade angle (γ) of approximately 33° relative to the central axis (A).

[0198] FIG. 7 shows a surgical instrument (300) according to a first embodiment of the invention for delivering or removing a viscoelastic fluid into or from an eye in a direction substantially parallel to a central axis (A).

[0199] The instrument (300) includes a hollow shaft (310) connectable to a syringe or cannula in fluid communication with a source of viscoelastic fluid, and a blade portion (320) adapted to create a scleral-corneal tunnel or side incision in the eye to deliver or remove the viscoelastic fluid.

[0200] The shaft (310) and blade portion (320) are integrally formed from stainless steel.

[0201] The hollow shaft (310) is sized and shaped to connect the blade portion (320) to a source of viscoelastic fluid and provide a conduit therebetween.

[0202] The shaft (310) extends longitudinally therebetween and includes a pair of opposing ends, including a proximal end (312) connectable to a source or cannula, and an opposing distal end (314) from which extends a blade portion (320). The opposing ends (312, 314) are open ended to allow for delivery and removal of a viscoelastic fluid from the eye via the distal end (314).

[0203] The shaft (310) is of tubular construction and has a substantially circular cross-section.

[0204] The shaft (310) has a length of about 6 mm to about 12 mm and a diameter of about 0.6 to 0.8 mm.

[0205] As shown, the blade portion (320) extends from the shaft (310) along a central axis (A) to a blade tip (322) and includes a pair of asymmetric side edges (324) having a cutting edge (360) at least partially defined on one side edge (324A).

[0206] The cutting edge (360) is oriented at a blade angle (α) of approximately 12.5° relative to the central axis (A) and extends to the blade tip (322) so that as the blade portion (320) advances into the eye in a direction parallel to the central axis (A), the cutting edge (360) is at least partially directed toward the blade tip (322) to facilitate the formation of the incision.

[0207] The blade portion (320) is in the form of a plate having a substantially triangular, diamond, or kite-shaped configuration.

[0208] The blade portion (320) has two opposing surfaces, including an inner surface (324) and an opposing outer surface (326). The opposing surfaces (324, 326) extend substantially parallel to one another and are interconnected by opposing edges, including opposing side edges, a proximal edge where the blade portion (320) extends from the distal end (314) of the shaft (310), and an opposing distal edge that defines the blade tip (322).

[0209] In the embodiment shown, the side edge (324A) on which the cutting edge (360) is defined flares outwardly at or near the proximal end to define a proximal-facing side edge (332), a widest portion or apex (B:B) of the blade portion (320), and a distal-facing side edge (334) that tapers gradually in a linear direction toward the blade tip (322). The cutting edge (360) is defined on the distal-facing side edge (334).

[0210] The distal end (314) and proximal-facing side edges of the shaft (310) overlap, which advantageously allows the distal end (314) of the shaft (310) to be easily inserted into the incision as the blade portion (320) is advanced into the eye in a direction parallel to the central axis (A).

[0211] The blade portion (320) may have a maximum width, as measured at the apex (B:B), of about 0.8 mm.

[0212] The proximal side edge (332) has a rounded or blunt edge so as not to alter the incision, i.e., to not enlarge the incision and not to cut the surface, when the blade portion (320) is pulled back.

[0213] In the embodiment shown, the proximal end (312) of the shaft (310) may be connectable to the cannula via a friction fit.

[0214] Referring to FIG. 8, in this embodiment, the device (300) shown in FIG. 7 is shown in the form of a cannula (410) having a male Luer-Lok™ connection fixture (800) for connection to, for example, a syringe containing a viscoelastic fluid.

[0215] A male Luer-Lok™ connection fastener (800) is overmolded over the proximal end (312) of the shaft (310). Additionally, the shaft (310) includes a distal end that is angled relative to the proximal end at an angle of approximately 135°.

[0216] 9 shows a surgical instrument (300) for delivering or removing viscoelastic fluid into or from an eye according to a second embodiment of the invention. For convenience, features similar to or corresponding to those of the first embodiment are again designated with the same reference numerals.

[0217] In this embodiment, the surgical instrument (300) includes the shaft (310) previously described.

[0218] However, in contrast to the first embodiment, the blade portion (320), which extends from the shaft (310) along the central axis (A) to the blade tip (322), includes a pair of symmetrical side edges (324) having cutting edges (360) at least partially defined on both side edges (324).

[0219] In this embodiment, both side edges (324) flare outwardly at or near their proximal ends to define a proximal-facing side edge (332), a widest portion or apex (B:B) of the blade portion (320), and a distal-facing side edge (334) that tapers gradually in a linear direction toward the blade tip (322). A cutting edge (360) is defined on the distal-facing side edge (334).

[0220] The cutting edges (360) are each oriented at a blade angle (α) of approximately 12.5° relative to the central axis (A) and extend to the blade tip (322) so that as the blade portions (320) advance into the eye in a direction parallel to the central axis (A), the cutting edges (360) are at least partially directed toward the blade tip (322) to facilitate the formation of the incision.

[0221] The blade portion (320) has a maximum width, as measured at the apex (B:B), of about 0.8 mm.

[0222] The proximal side edges (322) each have a rounded or blunt edge so as not to alter the incision when the blade portion (320) is pulled back, i.e., to not enlarge the incision and not to cut the surface.

[0223] In the embodiment shown, the proximal end (312) of the shaft (310) is connectable to the cannula via a friction fit.

[0224] Referring to FIG. 7, in this embodiment, the device (300) shown in FIG. 6 is shown in the form of a cannula (610) having a male Luer-Lok™ connection fixture (800) for connection to, for example, a syringe containing a viscoelastic fluid.

[0225] A male Luer-Lok™ connection fastener (800) is overmolded over the proximal end (312) of the shaft (310). Additionally, the shaft (310) includes a distal end that is angled relative to the proximal end at an angle of approximately 135°.

[0226] 11 shows a surgical instrument (300) for delivering or removing viscoelastic fluid into or from an eye according to a third embodiment of the present invention. For convenience, features similar to or corresponding to features of the first or second embodiments are designated with the same reference numerals here.

[0227] In this embodiment, the surgical instrument (300) includes the shaft (310) previously described.

[0228] The blade portion (320) extends from the shaft (310) along a central axis (A) to a blade tip (322) and includes a pair of symmetrical side edges (324) having cutting edges (360) defined on both side edges (324).

[0229] The cutting edges (360) are each oriented at a blade angle (α) of approximately 12.5° relative to the central axis (A) and extend to the blade tip (322) so that as the blade portions (320) advance into the eye in a direction parallel to the central axis (A), the cutting edges (360) are at least partially directed toward the blade tip (322) to facilitate the formation of the incision.

[0230] In contrast to the first and second embodiments, the proximal end of the blade portion (320) extends at least partially around the distal end (312) of the shaft (310). Advantageously, this allows the distal end (312) of the shaft (310) to be easily inserted into the incision as the blade portion (320) is advanced into the eye in a direction parallel to the central axis (A).

[0231] Moreover, in this embodiment, both side edges (324) gradually taper or converge in a linear direction from the proximal end to the blade tip (322). Thus, the proximal end is the widest portion or apex (B:B) of the blade portion (320) and has a maximum width of approximately 0.6 mm.

[0232] In the embodiment shown, the proximal end (312) of the shaft (310) is connectable to the cannula via a friction fit.

[0233] Referring to FIG. 12, in this embodiment, the device (300) shown in FIG. 11 is shown in the form of a cannula (810) having a male Luer-Lok™ connection fixture (800) for connection to a syringe containing, for example, a viscoelastic fluid.

[0234] A male Luer-Lok™ connection fastener (800) is overmolded over the proximal end (312) of the shaft (310). Additionally, the shaft (310) includes a distal end that is angled relative to the proximal end at an angle of approximately 135°.

[0235] 13 shows a surgical instrument (300) for delivering or removing viscoelastic fluid into or from an eye in accordance with a fourth embodiment of the present invention. For convenience, features similar to or corresponding to features of the first or second embodiments are designated with the same reference numerals here.

[0236] In this embodiment, the surgical instrument (300) includes the shaft (310) previously described.

[0237] The blade portion (320) extends from the shaft (310) along a central axis (A) to a blade tip (322) and includes a pair of symmetrical side edges (324) having a cutting edge (360) defined on one side edge (324A).

[0238] The cutting edge (360) is oriented at a blade angle (α) of approximately 12.5° relative to the central axis (A) and extends to the blade tip (322) so that as the blade portion (320) advances into the eye in a direction parallel to the central axis (A), the cutting edge (360) is at least partially directed toward the blade tip (322) to facilitate the formation of the incision.

[0239] Similar to the third embodiment, the proximal end of the blade portion (320) extends at least partially around the distal end (312) of the shaft (310). Advantageously, this allows the distal end (312) of the shaft (310) to be easily inserted into the incision as the blade portion (320) is advanced into the eye in a direction parallel to the central axis (A).

[0240] Moreover, in this embodiment, both side edges (324) gradually taper or converge in a linear direction from the proximal end to the blade tip (322). Thus, the proximal end is the widest portion or apex (B:B) of the blade portion (320) and has a maximum width of approximately 0.6 mm.

[0241] In the embodiment shown, the proximal end (312) of the shaft (310) is connectable to the cannula via a friction fit.

[0242] Referring to FIG. 14, in this embodiment, the device (300) shown in FIG. 13 is shown in the form of a cannula (1010) having a male Luer-Lok™ connection fixture (800) for connection to, for example, a syringe containing a viscoelastic fluid.

[0243] A male Luer-Lok™ connection fastener (800) is overmolded over the proximal end (312) of the shaft (310). Additionally, the shaft (310) includes a distal end that is angled relative to the proximal end at an angle of approximately 135°.

[0244] In this specification and claims (where present), the word "comprising", as well as its derivatives including "comprises" and "comprise", includes each of the stated objects but does not exclude the inclusion of one or more further objects.

[0245] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearance of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more combinations.

[0246] In accordance with the statute, the invention has been described in language somewhat specific to structural or methodological features. It is to be understood that the invention is not limited to the specific features shown or described, since the means described herein constitute preferred forms of practicing the invention. The invention is therefore claimed in any of its forms or modifications within the proper scope of the appended claims (if any) as appropriately interpreted by those skilled in the art.

Claims

[Claim 1] 1. A multi-purpose ophthalmic blade for or when used in a cataract extraction procedure, comprising: a shaft connectable to a handle portion; a first blade portion extending from the shaft along a central axis, the first blade portion having a pair of opposing side edges extending about the central axis, the side edges defining a first set of opposing cutting edges each oriented at a first angle relative to the central axis, the first set of opposing cutting edges at least partially converging toward a distal end of the first blade portion; a second blade portion extending distally forward from the first blade portion along the central axis to a blade tip, the second blade portion having a pair of opposed parallel side edges and a pair of converging side edges extending distally forward from the parallel side edges, the converging side edges defining a second set of cutting edges that converge to the blade tip, the second set of cutting edges each being oriented at a second angle relative to the central axis; having A multi-purpose ophthalmic blade, wherein the first blade portion is adapted to make a primary incision and the second blade portion is adapted to make a side port incision.

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