Ophthalmic incision treatment instrument and method

Abstract

A cutting instrument and method of use for creating precise, reproducible surgical incisions. One exemplary embodiment includes a cutting instrument configured to be attached to a patient's eye and used to perform an arcuate limbal relaxation incision (LR1). The cutting instrument is composed of two coaxial, interconnecting pieces: a docking piece and a cutting piece. The docking piece includes a suction mechanism and is configured to be secured to the patient's eye just outside the limbus. The cutting piece is configured to fit flush within the docking piece. When assembled, the cutting blade extends into the patient's eye to a desired LRI depth. One embodiment further includes an arcuate guide template with stops to provide a lateral arcuate stop for precise cutting at the desired LRI location. An LRI method includes utilizing the cutting instrument in an ophthalmic LRI procedure.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of and claims priority to U.S. Patent Application No. 17 / 028,660, filed September 22, 2020, which is a continuation-in-part of and claims priority to U.S. Patent Application No. 15 / 899,784, now U.S. Patent No. 10,779,990, filed February 20, 2018, which claims priority to U.S. Provisional Patent Application No. 62 / 460,660, filed February 17, 2017, all of which are incorporated herein by reference.

[0002] The present invention relates generally to cutting instruments and methods for performing surgical incisions, and more particularly to ophthalmic cutting instruments for the surgical correction of astigmatism, and corresponding methods for performing surgical procedures. [Background technology]

[0003] Astigmatism is a type of visual refractive error caused by an abnormal meridian curvature around the cornea or lens, which are normally spherical. This mismatch in curvature causes images to not focus properly on the retina, resulting in blurred or distorted vision. Other symptoms of astigmatism include eye strain, discomfort, headaches, decreased night vision, and squinting. Astigmatism is very common, with studies showing that approximately 15% to 30% of the adult population has astigmatism greater than 1 diopter.

[0004] Incisions to correct corneal astigmatism have been popular since the 1980s. Initially, incisions to correct corneal astigmatism were placed in the paracentral cornea. However, over the years, ophthalmologists have gradually moved these incisions away from the center of the eye due to issues with healing, predictability, and glare. Today, incisions to correct corneal astigmatism are placed at the surgical limbus, at the intersection of the cornea and sclera. These incisions are commonly called limbal relaxing incisions (LRIs). Based on the degree and distribution of the corneal astigmatism to be corrected, surgeons plan the arc and depth of the incisions to make the cornea more spherical and improve the patient's vision.

[0005] Cataracts are another very common visual disorder in which the lens of the eye becomes cloudy, distorting vision. Cataract surgery, which removes the lens and replaces it with an artificial intraocular lens (IOL) to restore vision in patients with cataracts, is currently one of the most common surgical procedures in the United States. Because most people develop cataracts as they age, many patients undergo cataract surgery in both eyes to correct their vision. As cataract treatment becomes more widespread, many ophthalmologists are recommending that patients undergo astigmatism correction surgery at the same time as cataract surgery. When combined with spherical correction with newer IOLs, astigmatism correction surgery often gives patients the opportunity to completely eliminate the need for glasses and contact lenses, making this option very popular among patients.

[0006] Currently, there are two common methods for performing LRI: manual dissection and the use of femtosecond lasers. Manual dissection procedures typically involve the surgeon marking the paired incision areas using a marking pen and then cutting the LRI using a blade, usually made of diamond, but sometimes metal. However, this manual dissection method typically relies on the surgeon to perform the LRI at the correct depth, length, and curvature.

[0007] Femtosecond lasers allow for the automation of many elements of LRI. This method utilizes a suction cup to hold the patient's eye in place while the laser generates a beam of light to create an incision from above, and a scanner to deflect the beam and deliver a treatment pattern to the surgical limbus. Femtosecond lasers are versatile because they can be used to further automate other steps required for cataract surgery. However, the costs associated with using femtosecond lasers tend to be relatively high. Additionally, some current literature suggests that the use of such lasers does not improve outcomes in cataract surgery.

[0008] Therefore, there is a strong need for a simple, inexpensive instrument and method of use to assist ophthalmologists in performing accurate and reproducible manual limbal relaxing incisions (LRIs). Such an instrument could make LRIs during cataract surgery much more common and provide numerous benefits to patients. These benefits include the cosmetic benefit of not having to wear glasses and not having to deal with the hassle and risk of corneal ulcers or abrasions caused by contact lenses. Additionally, it could reduce the financial burden of having to continually purchase glasses and contact lenses. Furthermore, such an instrument could help provide better access to improved vision to many patients in low-resource areas of the world who do not have the means to regularly obtain appropriate glasses.

[0009] Currently, there are ophthalmic incision instruments on the market that consist of a spring-loaded rod with a cutting blade whose exposed length can be controlled with a micrometer screw. However, with such instruments, the surgeon is still responsible for precisely guiding the instrument along the limbus and making the incision to the desired length.

[0010] Another instrument called the Universal Limbal Relaxing Incision Guide, disclosed in U.S. Patent No. 5,629,299, includes two concentric rings to guide the surgeon's blade to make an incision of the proper measured length. This instrument helps alleviate some of the issues related to the incision length and blade position of the LRI. However, the Universal Limbal Relaxing Incision Guide is not attached or fixed to the eye during surgery, and the accuracy of the LRI relies on the surgeon or assistant to hold the instrument in the proper position without moving it. Additionally, the Universal Limbal Relaxing Incision Guide does not have a cutting blade, meaning a separate blade must be used to cut the LRI.

[0011] Heretofore, no system or method has been available for performing LRI with the advantages and features of the present invention. [Prior art documents] [Patent documents]

[0012] [Patent Document 1] U.S. Patent No. 8,231,643 Summary of the Invention [Means for solving the problem]

[0013] The present invention provides an ophthalmic lancing instrument and method for creating accurate and reproducible surgical incisions. In one embodiment of the present invention, the ophthalmic lancing instrument is configured to be attached to a patient's eye and used to cut a peripheral limbal relaxing incision (LRI) of a desired depth, length, and curvature. In one exemplary embodiment, the lancing instrument includes two concentrically connected pieces: a docking piece and a cutting piece.

[0014] The docking piece includes a suction mechanism and is configured to be secured to the patient's eye just outside the limbus. The cutting piece is configured to fit flush inside the docking piece and includes two cutting blades and one or more handles configured to rotate the cutting piece relative to the docking piece. When assembled, the cutting blades of the cutting piece extend beyond the bottom inner portion of the docking piece by a length equal to the desired depth of the LRI to be cut. Furthermore, the cutting piece is sized and the cutting blades are positioned such that when the instrument is assembled, the cutting piece is configured to make an incision along the limbus. The docking piece can also include measurement markings on its circumference, and the cutting piece can also include markings configured to match the markings on the docking piece for proper positioning and measurement of the incision.

[0015] In practicing one embodiment of the present invention, the desired LRI to be cut is first marked on the patient's eye. Next, a docking piece is docked to the eye at the desired location using suction. The surgeon then aligns the cutting blade to make the incision at the desired location by matching the markings on the cutting piece with the appropriate measurement markings on the docking piece. Once the markings are properly aligned, the cutting piece is fully inserted into the docking piece so that the cutting piece is flush with the docking piece, resulting in the cutting blade being inserted into the patient's eye to the predetermined desired depth. Using the measurement markings on the docking piece as a reference, the surgeon then rotates the cutting piece relative to the docking piece via one or more handles in a predetermined direction and length to create a pair of LRIs, each with a precise depth, length, and arcuate path.

[0016] In another embodiment of the present invention, the dissection instrument further includes an arcuate guide template configured to attach to the docking piece and having raised stops for providing a lateral arcuate mechanical stop for the cutting piece, the raised stops being configured to contact guides on the cutting piece to prevent over-rotation of the cutting piece outside of the designated area for the LRI procedure.

[0017] In another aspect of the invention, the docking piece includes a handle and grip for a user to easily grasp and hold the docking piece in place. The docking piece may also include an internal housing for the vacuum tube.

[0018] The present invention allows for efficient, accurate, and reproducible creation of LRIs without requiring the use of lasers.

[0019] The drawings constitute a part of this specification and include illustrative embodiments that illustrate various objects and features of the present invention. [Brief explanation of the drawings]

[0020] [Figure 1] 1 is a vertical cross-sectional view of an ophthalmic incision (eg, LRI) instrument comprising one embodiment or aspect of the present invention shown positioned on the eye of an LRI treatment patient. [Figure 2] FIG. 2 is an exploded top perspective view of the dissection instrument. [Figure 3] FIG. 1 is a top assembled perspective view of the dissection instrument. [Figure 4] FIG. 1 is a side elevation view of the assembled dissection instrument. [Figure 5] FIG. 2 is a vertical cross-sectional view of the dissection instrument. [Figure 6] 6 is an enlarged partial cross-sectional view of the dissection instrument showing the cutting blade extending beyond the proximal end of the docking piece in an assembled configuration, taken generally within circle 6 in FIG. 5. [Figure 7] FIG. [Figure 8] FIG. 1 is a bottom view of the cutting tool. [Figure 9] 1 is a top perspective view of an improved lancing instrument including a first alternative embodiment of the present invention; FIG. [Figure 10] FIG. [Figure 11] FIG. [Figure 12] 12 is a horizontal cross-sectional view taken generally along line 12-12 in FIG. 11. [Figure 13] FIG. 1 is an elevational view of the distal end. [Figure 14] FIG. [Figure 15] 15 is a cross-sectional view taken generally along line 15-15 in FIG. 14. [Figure 16] 16 is a cross-sectional view taken generally along line 16-16 in FIG. 14. [Figure 17] 17 is an enlarged cross-sectional view taken generally within circle 17 in FIG. 16. FIG. [Figure 18] FIG. 10 is a partial bottom perspective view of the cutting ring assembly with the cutting blade removed. [Figure 19] FIG. 10 is a top perspective view of the docking piece shown connected to a suction source. [Figure 20] FIG. [Figure 21] FIG. 1 is a top perspective view of an improved lancing instrument comprising a second alternative embodiment of the present invention. [Figure 22] FIG. [Figure 23] FIG. [Figure 24] FIG. [Figure 25] FIG. 10 is a bottom perspective view of an ophthalmic LRI device including a third modified or alternative embodiment of the present invention. [Figure 26] FIG. [Figure 27] FIG. 10 is a top perspective view of an ophthalmic LRI device including a fourth modified or alternative embodiment of the present invention. [Figure 28] FIG. [Figure 29] FIG. [Figure 30] FIG. [Figure 31] 30 is a cross-sectional view of the docking piece and attached distal spacer or template taken generally along section line 31 in FIG. 29. DETAILED DESCRIPTION OF THE INVENTION

[0021] I. Introduction and Environment As required, detailed embodiments of the present invention are disclosed herein. However, it should be understood that the disclosed embodiments are merely exemplary of the present invention, which can be embodied in various forms. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art how to variously use the present invention in substantially any suitable detailed structure.

[0022] In the following description, certain terms are used for convenience only and as a reference, and not as a limitation. For example, upper, lower, front, back, right, and left refer to the invention as oriented in the referenced figures. The words "inward" and "outward" refer to directions toward and away from, respectively, the geometric center of the embodiment being described and its designated portion. In addition, anatomical terms are given their ordinary meaning. For example, proximal means closer to the body trunk, and distal means further from the body trunk. The terms include the specifically mentioned words, derivatives thereof, and words of similar meaning.

[0023] II. Ophthalmic incision instrument 2 In a preferred embodiment of the present invention, shown in Figures 1-8, incision instrument 2 is configured for use in cutting precise and reproducible limbal relaxing incisions (LRIs) for correcting corneal astigmatism. However, alternative embodiments of the present invention can be used to make any other type of arcuate surgical incision or any other non-surgical arcuate cutting. In a preferred embodiment, incision instrument 2 includes two coaxial pieces: docking piece 4 and cutting piece 6. Pieces 4, 6 are generally coaxial about axis of rotation 12. Cutting piece 6 is configured to be inserted into docking piece 4 and is rotatable within docking piece 4.

[0024] In this embodiment, each piece is generally cylindrical in shape and has an open center. The docking piece 4 is configured to be secured to the patient's eye with suction. The cutting piece 6, in this embodiment, carries a pair of cutting blades 8 and is configured to fit coaxially within the docking piece 4 when the instrument 2 is assembled. Each cutting blade 8 of the cutting piece 6 is precisely lengthened so that when the cutting piece 6 is flush within the docking piece 4, each cutting blade 8 extends beyond the bottom, or proximal, side of the docking piece 4 by a distance equal to the desired depth of the incision to be made. The cutting piece 6 also includes one or more handles 10 for rotating the cutting piece 6 relative to the docking piece 4 to make the arc incision.

[0025] The docking piece 4 has a cylindrical surface 22 and includes a suction chamber 14 opening at its proximal or bottom side so that it can be securely and releasably attached to the sclera just outside the limbus of the patient's eye 42 by suction. The docking piece 4 is made of a rigid material that retains its shape under force or pressure. In a preferred embodiment, the docking piece 4 is made of a rigid plastic, although other embodiments can be made of other rigid materials, such as, but not limited to, metal or ceramic. The outer peripheral surface of the docking piece 4, in this embodiment, includes a side opening 16 to the suction chamber 14 through which subatmospheric pressure, i.e., negative pressure, or suction, can be applied to the suction chamber 14. In a preferred embodiment, the side opening 16 is sized to fit over and seal around a tube connected to a syringe 18 for applying subatmospheric pressure, i.e., negative pressure, to the suction chamber 14, as shown in FIG. 1 . However, alternative embodiments may include a tube connected to a vacuum or subatmospheric pressure source configured to apply subatmospheric pressure to the suction chamber 14 through the side opening 16, or any other mechanism for applying subatmospheric pressure to the suction chamber 14 through the opening 16.

[0026] The docking piece 4 further includes an aperture center 24 configured to receive the cutting piece 6 therein and for the surgeon to view the patient's eye 42 below through the docking piece 4. The docking piece aperture center 24 forms a receptacle for the cutting piece 6. The docking piece aperture center 24 includes a large central opening at its distal end and a stepped portion 26 that provides a mechanical stop for the cutting piece 6 when the cutting piece is inserted into the docking piece 4. The large opening above the stepped portion 26 is sized to fit snugly around the outer cylindrical surface 30 of the cutting piece 6, such that the step 26 contacts the proximal, or underside, of the cylindrical surface 30 of the cutting piece 6 when the dissection instrument 2 is fully assembled. The portion of the docking piece 4's central aperture 24 proximal to, or below, the stepped portion 26 is sized to fit snugly around the cutting blade 8 of the cutting piece 6.

[0027] In the exemplary embodiment shown in FIGS. 1-8 , the cutting piece 6 includes a cylindrical outer surface 30 having an open center 32 and carrying two cutting blades 8. The cutting blades 8 are configured to be equal in length, mounted from the proximal end of the cylindrical outer surface 30 of the cutting piece 6, and positioned 180 degrees apart. In this arrangement, the cutting blades 8 are configured to make two symmetrical cuts of equal length, depth, and curvature. In an alternative embodiment, the cutting piece 6 can carry only one cutting blade 8 configured to make one arcuate cut at a time. In a further alternative embodiment, the cutting piece 6 can include more than two cutting blades 8, spaced as needed for the desired cutting configuration. The cutting piece 6 also includes one or more handles 10 for rotating the cutting piece 6 relative to the docking piece 4. In the embodiment shown in FIGS. 1-8 , the cutting piece 6 includes two handles 10, which provide torque to effectively rotate the cutting piece 6 in either direction. Alternate embodiments may include only one handle 10, or any desired number of handles 10, for rotating the cutting piece 6 relative to the docking piece 4. Further embodiments may include a cutting piece 6 without a central opening 32.

[0028] The mechanical stop for the cutting piece 6 in its assembled position within the docking piece 4, provided by the stepped portion 26 of the docking piece 4, is configured to keep the cutting blade 8 exposed beyond the proximal end, or bottom, of the docking piece 4 by a length equal to the desired incision depth. In one exemplary embodiment, the cutting blade 8 is constructed of a metal capable of making precise surgical incisions. In alternative exemplary embodiments, the cutting blade 8 may be diamond-shaped for making surgical incisions, or any other configuration of a suitable material capable of making precise incisions. Cutting blades 8 of different lengths may be used as desired to make incisions having different desired depths.

[0029] In one exemplary embodiment, the cutting blade 8 is removable from the cutting piece 6 and replaceable with a cutting blade 8 of a different length. In such an embodiment, the cutting blade 8 can be connected to the inner surface of the cutting piece cylindrical surface 30. In other embodiments, the cutting blade 8 is permanently fixed to the cutting piece 6. In such an embodiment, different cutting pieces 6 having different sized cutting blades 8 will be available to the surgeon depending on the desired depth of the incision. Similarly, in a preferred embodiment, different sized docking pieces 4 having various diameters and corresponding cutting pieces 6 with corresponding various diameters will be available to the surgeon depending on the dimensions of the patient's eye to be treated. In various embodiments, the cutting blade 8 may be disposable or configured to be reused after appropriate sterilization. Additionally, in some embodiments, the entire dissection instrument 2 may be disposable or configured to be reused after appropriate sterilization. Other embodiments may include a reusable docking piece 4 with a disposable cutting piece 6, or any other combination of disposable and reusable individual pieces.

[0030] The incision instrument 2 of the present invention further includes measurement markings 36 and one or more reference markings 38 for measuring the arcuate incision made with the instrument 2. In a preferred embodiment, the docking piece 4 includes measurement markings 36 on the distal side, i.e., top, of the docking piece cylindrical surface 22. In the exemplary embodiment shown in FIGS. 1-8 , the measurement markings 36 represent angles from 0 to 360 degrees, with a representative rotational indicator 34 providing a reference for the surgeon. However, in alternative embodiments, the measurement markings 36 may represent radians, gradians, revolutions, or any other angular measurement unit. Optionally, the docking piece 4 may further include one or more rotational indicator measurement markings 28 on the outer edge of the docking piece cylindrical surface 22 for reference by the surgeon, as shown by the “0” markings on the outer edge of the docking piece cylindrical surface 22 in FIGS. 2 and 3 .

[0031] The lancing instrument 2 further includes one or more fiducial markings 38 on the cutting piece 6 for aligning the measurement markings 36 on the docking piece 4 with the cutting piece 6. The measurement markings 36 and fiducial markings 38 allow the user to effectively cut with the cutting blade 8 at the precise desired incision location. Preferably, the cutting piece fiducial markings 38 are located directly above the cutting blade 8, i.e., distal to the cutting blade 8, at the distal side, i.e., the top, of the cutting piece cylindrical surface 30. However, in alternative embodiments, the cutting piece fiducial markings 38 may be offset from the cutting blade 8, e.g., 90 degrees from the cutting blade 8. In the preferred embodiment shown in FIGS. 1-8 , the handle 10 of the cutting piece 6 is offset 90 degrees from the cutting blade 8 and the fiducial markings 38, allowing for easy alignment of the measurement markings 36 and the fiducial markings on the docking piece 4. Alternatively, the handle 10 may be directly above the cutting blade 8, i.e., distal to the cutting blade 8, or any other handle configuration.

[0032] Before performing a symmetrical and precise limbal relaxation incision (LRI) using the incision instrument 2 of the present invention, the surgeon first marks the desired incision starting point at the surgical limbus of the patient's eye 42 with a marking pen. Next, the surgeon places the docking piece 4 of the incision instrument 2 on the patient's eye 42 adjacent to the surgical limbus and just outside the desired incision location. With the docking piece 4 in the proper position on the eye 42, subatmospheric pressure is applied to the suction chamber 14 of the docking piece 4 through the side opening 16 via a syringe 18 or some other subatmospheric or negative pressure mechanism. Applying subatmospheric pressure to the suction chamber 14 attaches the docking piece 4 to the eye 42 and docks the docking piece 4 in the proper position. Next, using the measurement markings 36 and reference markings 38, the surgeon properly aligns the cutting piece 6 with the docking piece 4, with the cutting blade 8 of the desired length to achieve the desired incision depth, so that the cutting blade 8 is aligned with the desired incision starting point. Once properly aligned, the cutting piece 6 is inserted into the docking piece central opening 24, the stepped portion 26 providing a mechanical stop for the cutting piece 6, and the cutting blade 8 incises the patient's eye 42 to the desired incision depth. Once assembled, with the cutting blade 8 incising the patient's eye 42, the handle 10 is used to rotate the cutting piece 6 relative to the docking piece 4 and eye 42 the desired incision length while measuring the incision using the measurement markings 36 and reference markings 38. This process guides the cutting blade 8 to create two symmetrical arc-shaped incisions of equal depth, length, and curvature. Typically, when performing LRI, a surgeon will rotate the cutting piece 6 with their dominant hand while holding the docking piece 4 with their non-dominant hand. Once the incision is made, the cutting piece 6 is removed from the docking piece 4, the subatmospheric pressure is removed from the docking piece suction chamber 14 to release the docking piece 4 from the patient's eye 42, and the docking piece 4 is then removed from the patient's eye 42.

[0033] FIG. 1 shows a cross-sectional peripheral view of one embodiment of the incision tool 2 of the present invention, with a cutting blade 8 making an incision at the surgical limbus of a patient's eye 42. For reference, FIG. 1 includes several anatomical features of the human eye, including references to the location of the corneal dome, i.e., the cornea, sclera, iris, pupil, lens, suspensory ligament, ciliary body, and retina. The surgical limbus, also known as the limbus or simply the limbus, is located at the intersection of the cornea and sclera and is the desired location for making a limbal relaxing incision (LRI). In this embodiment, subatmospheric pressure is applied to the suction chamber 14 via a syringe 18 through a side opening 16 to the chamber. The subatmospheric pressure within the chamber 14 attaches the docking piece 4 to the sclera of the patient's eye 42, docking the docking piece 4 adjacent to and just outside the limbus. The cutting piece 6 fits flush within the opening center 24 of the cylindrical surface 22 of the docking piece. The stepped portion 26 of the docking piece 4 provides a mechanical stop for the cylindrical surface 30 of the cutting piece 6. When the proximal side of the cutting piece's cylindrical surface 30 is flush with the stepped portion 26 of the docking piece 4, the cutting blade 8, mounted from the cylindrical surface 30 of the cutting piece, is flush with the side of the narrow portion of the docking piece's aperture center 24 proximal to the stepped portion 26. The cutting blade 8 extends proximally beyond the proximal end of the docking piece 4 and further into the patient's eye 42 at the surgical limbus for the desired length to create an incision of the desired depth. FIG. 1 also shows the handle 10 of the cutting piece 6, which the surgeon can use to rotate the cutting piece 6 relative to the docking piece 4 and the patient's eye 42 as needed to perform the desired LRI.

[0034] FIG. 2 shows an exploded view of the dissection instrument 2, with the cutting piece 6 separated from and above the docking piece 4. FIG. 2 shows the docking piece 4, having an aperture center 24, and the cutting piece 6, also having an aperture center 32. The cylindrical surface 30 of the cutting piece 6 is sized to fit within the docking piece aperture center 24. Additionally, FIG. 2 specifically shows measurement markings 36 and a representative rotational indicator 34 on the distal side of the docking piece 4, as well as a fiducial marking 38 on the distal side of the cutting piece 6 for alignment with the measurement marking 36 on the docking piece 4. This embodiment also includes a rotational indicator 28 on the side of the cylindrical surface 22 of the docking piece for reference by the surgeon. In this embodiment, the measurement marking 36 represents an angle. However, as discussed above, alternative units of angular measurement can be used instead. FIG. 2 shows a preferred embodiment in which a fiducial marking 38 is located distal to the cutting piece 6 and above the cutting blade 8 to identify the location of the cutting blade 8. In this embodiment, the handle 10 is offset 90 degrees from the cutting blade 8 and reference markings 38 to facilitate alignment with the measurement markings 36 on the docking piece 4. Figure 2 also shows the side opening 16 that passes through the exterior of the cylindrical surface 22 of the docking piece and leads to the suction chamber 14.

[0035] FIG. 3 is an assembled view of the cutting instrument 2 of the present invention, with the cutting piece 6 fully inserted into the center of the docking piece 4, with the pieces 4, 6 sharing a rotational axis 12. The cutting piece aperture center 32 allows the surgeon using the cutting instrument 2 to view the patient's underlying eye 42 with the cutting instrument 2 in the assembled position. FIG. 3 illustrates the alignment of the reference marking 38 with the measurement marking 36 in the assembled position to properly position and measure the incision being made with the cutting instrument 2. The directional arrow 46 indicates that the handle 10 can be used to rotate the cutting piece 6 in either rotational direction relative to the docking piece 4, as desired.

[0036] FIG. 4 is a side elevation view of the dissection tool 2. Primarily, FIG. 4 shows the cutting blade 8 extending beyond the proximal end of the cylindrical surface 22 of the docking piece 4. FIG. 5 shows a vertical cross-section of the dissection tool 2. The cross-section cuts the side opening 16 from the outer edge of the docking piece cylindrical surface 22 to the suction chamber 14, as generally indicated by line 5 in FIG. 4. The cross-section in FIG. 5 shows a stepped portion 26 of the docking piece 4, which provides a stop for the cylindrical surface 30 of the cutting piece 6 in the assembled position. In the assembled position, the cutting blade 8 is mounted from the cutting piece cylindrical surface 30 in a narrower position than the portion of the docking piece central opening 24 proximal to the stepped portion 26, and extends proximally from the cutting piece cylindrical surface 30 beyond the proximal end of the docking piece 4. 6 shows an enlarged partial vertical cross-sectional view of the cutting blade 8 of the incision instrument 2, taken generally from within the circle 6 in FIG. 5, extending proximally beyond the proximal end of the docking piece 4 by a dimension d, where d is equal to the desired depth of the incision.

[0037] FIG. 7 shows a top view of the lancing instrument 2. FIG. 7 shows the aperture center 32 of the cutting piece 6, the measurement marking 36 on the docking piece 4, and the reference marking 38 on the cutting piece 6, with the handle 10 offset 90 degrees from the reference marking 38. FIG. 7 also shows the reference rotation index 34. In this embodiment, the measurement marking 36 and the rotation index 34 represent angles from 0 to 360 degrees. FIG. 8 shows a bottom view of the lancing instrument 2. FIG. 8 shows the aperture center 32 of the cutting piece 6. FIG. 8 also shows the open proximal end of the suction chamber 14 of the docking piece 4, which is configured to be attached to a patient's eye 42. The cutting blade 8 is mounted from the cutting piece 6. In this embodiment, the handle 10 is radially spaced approximately 90 degrees from the location of the cutting blade 8 relative to the axis 12, although other cutting blade and handle configurations, spacings, and multiples are within the scope of the present invention.

[0038] III. First Alternate Embodiment Ophthalmic Lancing Instrument 102 An ophthalmic lancing instrument 102 for performing limbal relaxing incisions (LRIs) embodying a first modified or alternative embodiment of the present invention is shown in Figures 9-20. The instrument 102 includes a docking piece 104 and a cutting piece 106. The docking piece 104 includes a generally cylindrical body 108 and a laterally extending docking piece lever 110. The body 108 of the docking piece 104 includes a coaxial bore 112 that rotatably receives the cutting piece 106.

[0039] The cutting piece 106 includes a proximal end 114 that opens into a pair of blade receivers 116. A pair of blades 118 each include a shaft 120 that is received in the respective receivers 116. Each blade includes a proximal, sharp cutting tip 122. The blade tips 122 are configured to form an LRI. The docking piece 104 and the cutting piece 106 each include depth stop shoulders 124, 126. In operation, the cutting piece shoulder 126 engages and rotatably slides against the docking piece shoulder 124. Penetration of the blade cutting tips 122 into the annulus is thus controlled with the goal of optimizing the LRI procedure results.

[0040] The cutting piece 106 further includes a distal end 128 with a pair of laterally extending cutting piece levers 130. A physician can conveniently position the docking piece 104 on the patient's cornea by grasping the docking piece levers 110. As shown in FIG. 19 , a suction source 132 can be connected to the docking piece 104 via a suction tube 134. A negative partial vacuum can be applied to secure the docking piece 104 in place on the patient's cornea. Similar to the ophthalmic lancing instrument 2 described above, the docking piece 104 is configured to be releasably attached to the patient's eye by suction (negative pressure). The ophthalmic lancing instrument 102 includes a coaxial arcuate guide template 136 attached to the docking piece and configured to provide an arcuate mechanical stop for the cutting piece 106 in the assembled state. The arcuate guide template 136 is configured to add safety and precision for the LRI procedure by preventing the cutting piece from rotating laterally beyond the designated incision area for the cutting blade 118.

[0041] Another safety feature includes a blade safety 138 having a generally cylindrical configuration and a plurality of radially spaced, distally opening notches 140. The docking and cutting pieces 104, 106 include detents 142 engageable by other elements for fine adjustment (e.g., 5°-10°). The arcuate guide template 136 can be provided for multiple LRI arc lengths. For example, the guide template 136 shown in FIGS. 11 and 12 creates a 45° LRI arc as defined by the rotational range of the docking piece 104 relative to the cutting piece 106. Additionally, the LRI instrument components and templates can be provided with appropriate internal markings and reticles to aid in alignment with the patient's eye for making relatively precise, precisely placed arcuate incisions.

[0042] IV. Second Alternate Embodiment Ophthalmic Lancing Instrument 202 A second alternative embodiment tool 202 is shown in Figures 21-24. Tool 202 generally includes a docking piece 204 and a cutting piece 206. A guide template 208 is provided to control rotation of docking piece 204 relative to cutting piece 206. A pair of grips 207 extend from cutting piece 206 and allow cutting piece 206 to be manually rotated. A pair of blades 210 are mounted to and depend downwardly from cutting piece 206.

[0043] V. Third Alternate Embodiment Ophthalmic Lancing Instrument 302 A third alternative embodiment instrument 302 is shown in Figures 25-26 and includes a cutting piece 306 with a cylindrical gripping ring 308. Instrument 302 is otherwise structurally and functionally similar to instruments 2, 102 and 202 described above.

[0044] VI. Fourth Alternate Embodiment Ophthalmic Lancing Instrument 402 A fourth alternative embodiment instrument 402 is shown in Figures 27-31 and generally includes a docking piece 404 and a cutting piece 406 carrying a pair of proximally extending blades 407. A proximal spacer 408 is received in the docking piece 404. A distal spacer 410 is received in the proximal spacer 408 and in the cutting piece 406.

[0045] Without limiting the versatility of materials useful for manufacturing the dissection instrument 402, the docking piece 404, the cutting piece 406, and the distal spacer or template 410 can be made of a thermoplastic polymer such as acrylonitrile butadiene styrene (ABS). The ABS parts can be formed by injection molding. The proximal spacer 408 can include a thermoplastic elastomer (TPE), which is softer and more flexible than ABS plastic.

[0046] The proximal spacer 408 can be formed by overmolding the docking piece 404. TPE elastomer is injected through a gate opening 412 and exits through an overflow opening 414. Openings 412 and 414 are sealed by the TPE material of the finished spacer 408. The proximal spacer 408 provides a proper mating and friction fit for the distal spacer or template 410, which rests in the pocket formed by the proximal spacer 408. The template 410 is allowed to rotate, but offers slight resistance due to the increased coefficient of friction with the TPE material, which helps prevent inadvertent rotational movement during the LRI procedure.

[0047] Similar manufacturing techniques and material selections can be utilized for other LRI embodiments disclosed herein, for example, various polymers can be used to form parts by injection molding and other suitable processes.

[0048] VII. Limbal Relaxation Incision (LRI) Procedure The ophthalmic lancing instruments 2, 102, 202, 302, and 402 disclosed herein can be provided with axial alignment markings to further facilitate proper and accurate alignment of the ophthalmic lancing device to a patient's eye for an LRI procedure. In a preferred embodiment, the docking piece of the present invention includes markings representing the x- and y-axes of the patient's eye to be lancing. Such x- and y-axis markings on the docking piece can then be aligned with the x- and y-axes, respectively, of the patient's eye to be operated on to aid in accurate alignment before releasably attaching the docking piece to the patient's eye via suction. If desired, the x- and y-axes can be first marked on the patient's eye with a marking pen before placing the docking piece, or alternative alignment tools or computing devices can be utilized. In embodiments of the present invention, the docking piece can include alternative or additional markings for alignment with the eye, such as, but not limited to, degrees, radians, gradians, rotations, or any other angular measurement units.

[0049] Once the docking piece is properly positioned on the patient's eye, the alignment markings on the arcuate guide template can be used to precisely align the arcuate guide template with the x- and y-axes of the docking piece and the patient's eye, as desired for the LRI procedure to be performed. For example, an ophthalmologist using the present ophthalmic incision device can use a nomogram to determine the cutting location for the LRI procedure. Based on the associated nomogram readings, the user can align the axial alignment markings with the horizontal axis of the patient's eye and the docking piece, as desired for the particular LRI procedure. Alternatively, other alignment or prediction tools and / or anatomical modeling software can be utilized to determine the LRI cutting location and the size and position of the arcuate guide template relative to the docking piece.

[0050] The arcuate guide template and docking piece of the present invention may optionally further include a locking mechanism for securing the arcuate guide template in place relative to the docking piece. Such a locking mechanism may include a telescoping clamp, a pin and associated groove, a locking button, or any other type of locking mechanism.

[0051] As discussed above, the docking and cutting piece levers allow for manual positioning of the LRI instrument. Preferably, the docking piece lever has an ergonomic shape that makes it easy to grasp and hold the docking piece in any configuration.

[0052] The docking piece lever also provides a housing for the vacuum tubing that connects the docking piece aspiration chamber to a suction device such as a syringe and an automated pneumatic aspiration pump. Such a vacuum tubing base handle housing holds the tubing properly in place, keeping the vacuum tubing out of the way of the LRI procedure and helping to prevent the vacuum tubing from being unintentionally withdrawn from the docking piece aspiration chamber during the LRI procedure. The vacuum tubing can be connected to the aspiration chamber via a Luer lock connection, an O-ring connection, or an alternative sealed connection.

[0053] It should be understood that the present invention may be embodied in a variety of forms and should not be limited to the examples specifically discussed above. The range of components and configurations that can be utilized in practicing the present invention is virtually limitless.

[0054] Having thus described the invention, what is claimed to be new and desired to be protected by Letters Patent is the following: [Explanation of symbols]

[0055] 2 Cutting instrument 4 Docking Pieces 6 Cutting Pieces 8 Cutting Blades 10 Handle 12 Rotation axis 14 Suction chamber 16 Side opening 18 syringes 22 Cylindrical Surface 26 Step part 28 Rotational Index Measurement Markings 30 Cylinder outer surface 32 Center of opening 34 Typical rotation indicators 36 Measurement markings 38 Reference Markings 42 eyes 102 Cutting instruments 104 Docking Piece 106 Cutting Piece 108 Main Unit 110 Docking piece lever 112 coaxial hole 116 Blade receiving part 118 Blade 124 Docking piece shoulder 126 Cutting piece shoulder 128 Distal End 130 Cutting piece lever 132 Suction source 134 Suction tube 136 Arc guide template 138 Blade Safety 140 notches 142 Detent 202 Cutting instruments 204 Docking Piece 206 Cutting Piece 207 Grip 208 Guide Templates 210 Blade 302 Cutting instruments 306 Cutting Piece 308 Grip Ring 402 Cutting instruments 404 Docking Piece 406 Cutting Piece 407 Blade 408 Proximal Spacer 410 Distal Spacer 412 Gate Opening 414 Overflow opening

Claims

1. 1. An ophthalmic incision instrument for performing a limbal relaxing incision (LRI) in a patient's eye having a sclera, a cornea, and a limbus, comprising: a docking piece having a proximal end and a distal end, a docking piece, the proximal end of the docking piece configured to be placed on the sclera of the patient's eye; a cutting piece having a proximal end and a distal end, an axis of rotation extending between the ends of the cutting piece; the cutting piece is configured to be inserted into the docking piece and to rotate relative to the docking piece about the axis of rotation in an assembled configuration of the ophthalmic lancing instrument; a cutting piece carrying two cutting blades, each cutting blade configured to extend into the patient's eye in the assembled configuration; and A guide template having a proximal end and a distal end, the proximal end of the guide template is configured to be attached to the distal end of the docking piece in the assembled configuration; a guide template, the distal end of the guide template including a raised stop configured to provide a lateral arcuate stop for the cutting piece in the assembled configuration and prevent the cutting piece from rotating beyond a desired LRI location; Including, the docking piece further includes a stepped portion configured to provide a mechanical stop for the cutting piece in the assembled configuration and prevent the cutting blade from extending further into the patient's eye beyond a desired LRI cutting depth; the docking piece further includes a suction chamber opening at the proximal end of the docking piece; the docking piece is configured to be releasably attached to the sclera of the patient's eye via subatmospheric pressure in the suction chamber; The cutting blade is configured to form an arcuate LRI in the patient's eye that is coaxial with the axis of rotation. Cutting instrument.

2. the docking piece further includes an aperture center that allows alignment of the docking piece with the sclera of the patient's eye. The dissection instrument of claim 1 .

3. The cutting piece further includes an aperture center that allows for better visibility of the LRI. The dissection instrument of claim 1 .

4. the docking piece further includes an opening to the suction chamber; the opening of the suction chamber is configured to be sealably attached to a subatmospheric pressure source; The dissection instrument of claim 1 .

5. the docking piece further includes a base handle; the base handle includes a housing; the opening of the suction chamber connects to the housing of the base handle; the housing of the base handle is configured to receive a tube connecting the aspiration chamber to the subatmospheric pressure source; The incision instrument according to claim 4.

6. The cutting blades are arranged in 180 degree opposed relationship; The cutting blade is configured to make symmetrical incisions of equal length, depth, and curvature. The dissection instrument of claim 1 .

7. the cutting piece further includes a handle at the distal end of the cutting piece; The handle allows for efficient rotation of the cutting piece relative to the docking piece. The dissection instrument of claim 1 .

8. the docking piece further includes an axial alignment marking; the guide template further includes fiducial markings for alignment with the docking piece; The dissection instrument of claim 1 .

9. the cutting blade includes a depth control blade to prevent perforation of the patient's eye. The dissection instrument of claim 1 .

10. the cutting instrument is substantially translucent and configured to absorb ambient light; The dissection instrument of claim 1 .

11. The cutting blade is removable; The cutting blade is configured to be removed and replaced with a cutting blade of a desired alternative length. The dissection instrument of claim 1 .

12. 1. An ophthalmic incision instrument for performing a limbal relaxing incision (LRI) in a patient's eye having a sclera, a cornea, and a limbus, comprising: a docking piece having a proximal end and a distal end, a docking piece, the proximal end of the docking piece configured to be placed on the sclera of the patient's eye; a cutting piece having a proximal end and a distal end, an axis of rotation extending between the ends of the cutting piece; the cutting piece is configured to be inserted into the docking piece and to rotate relative to the docking piece about the axis of rotation in an assembled configuration of the ophthalmic lancing instrument; a cutting piece carrying two cutting blades, each cutting blade configured to extend into the patient's eye in the assembled configuration; and A guide template having a proximal end and a distal end, the proximal end of the guide template is configured to be attached to the distal end of the docking piece in the assembled configuration; a guide template, the distal end of the guide template including a raised stop configured to provide a lateral arcuate stop for the cutting piece in the assembled configuration and prevent the cutting piece from rotating beyond a desired LRI location; Including, the docking piece further includes a stepped portion configured to provide a mechanical stop for the cutting piece in the assembled configuration and prevent the cutting blade from extending further into the patient's eye beyond a desired LRI cutting depth; the docking piece further includes a suction chamber opening at the proximal end of the docking piece; the docking piece is configured to be releasably attached to the sclera of the patient's eye via subatmospheric pressure in the suction chamber; the cutting blade is configured to form an arcuate LRI in the patient's eye that is coaxial with the axis of rotation; the docking piece further includes an aperture center that allows alignment of the docking piece with the sclera of the patient's eye; the docking piece includes a reticle marking configured to position and measure the LRI on the patient's eye; The cutting piece further includes an aperture center that allows for better visibility of the LRI; the docking piece further includes an opening to the suction chamber; the opening of the suction chamber is configured to be sealably attached to a subatmospheric pressure source; the docking piece further includes a base handle; the base handle includes a housing; the opening of the suction chamber connects to the housing of the base handle; the housing of the base handle is configured to receive a tube connecting the aspiration chamber to the subatmospheric pressure source; The cutting blades are arranged in 180 degree opposed relationship; the cutting blade is configured to make symmetrical incisions of equal length, depth, and curvature; the cutting piece further includes a handle at the distal end of the cutting piece; the handle allows for efficient rotation of the cutting piece relative to the docking piece; the docking piece further includes an axial alignment marking; the guide template further includes a reference marking for alignment with the docking piece; the cutting blade includes a depth control blade to prevent perforation of the patient's eye; a spacer mounted on the distal end of the docking piece and configured to frictionally engage the cutting piece; the docking piece comprises a first relatively rigid polymer and the spacer comprises a second relatively soft elastomeric polymer; Ophthalmological cutting instrument.

13. 1. An ophthalmic method for performing a limbal relaxation incision (LRI) with a cutting instrument on a patient's eye having a sclera, a cornea, and a limbus, the cutting instrument including: a docking piece having proximal and distal ends, a suction chamber opening at the proximal end of the docking piece, and a stepped portion; a cutting piece having proximal and distal ends and an axis of rotation extending between the ends of the cutting piece, the cutting piece configured to be inserted into the docking piece and to rotate relative to the docking piece about the axis of rotation in an assembled configuration of the cutting instrument, the cutting piece carrying two cutting blades; and a guide template having proximal and distal ends, the proximal end of the guide template configured to be attached to the distal end of the docking piece in the assembled configuration, the distal end of the guide template including a raised stopper; aligning the proximal end of the docking piece on the sclera of the patient's eye; applying a subatmospheric pressure to the suction chamber and attaching the docking piece to the sclera of the patient's eye; aligning the guide template with the docking piece and the patient's eye as desired and attaching the guide template to the docking piece; aligning the docking piece, the guide template, and the patient's eye with the cutting piece as desired; placing the cutting piece within the docking piece at the assembly position and inserting the cutting blade into the patient's eye at a desired LRI location; the stepped portion stops the cutting piece and prevents the cutting blade from extending further into the patient's eye beyond a desired LRI depth; rotating the cutting piece relative to the docking piece about the rotation axis to form an arcuate LRI in the patient's eye that is coaxial with the rotation axis; the raised stop on the guide template stops the cutting piece from rotating beyond a desired LRI location; removing the cutting piece and the docking piece from the patient's eye; An ophthalmic method comprising:

14. the docking piece further includes an opening to the suction chamber; the opening of the suction chamber is configured to be sealably attached to a subatmospheric pressure source; The method of claim 13.

15. the docking piece further includes a base handle; the base handle includes a housing; the opening of the suction chamber connects to the housing of the base handle; the housing of the base handle is configured to receive a tube connecting the aspiration chamber to the subatmospheric pressure source; 15. The method of claim 14.

16. Removing the subatmospheric pressure from the suction chamber of the docking piece.

14. The method of claim 13, further comprising:

17. The cutting blades are arranged in 180 degree opposed relationship; The cutting blade is configured to make symmetrical incisions of equal length, depth, and curvature. The method of claim 13.

18. the docking piece further includes an axial alignment marking; the guide template further includes fiducial markings for alignment with the docking piece; The method of claim 13.

19. marking an axis on the patient's eye further comprising 20. The method of claim 18, wherein the step of aligning the proximal end of the docking piece on the sclera of the patient's eye comprises the step of aligning the axis marked on the patient's eye with the axis alignment marking on the docking piece.

20. wherein the step of rotating the cutting piece relative to the docking piece about the axis of rotation comprises holding the cutting piece in a fixed position and rotating the cutting piece relative to the docking piece about the axis of rotation. The method of claim 13.

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