Micro-goniotomy

Abstract

A surgical instrument for cutting intraocular tissue includes a body extending from a proximal end to a distal end, the body having an instrument section terminating at the distal end and handle section between the proximal end and the instrument section, a tip at the distal end comprising a cannula terminating at a trephine, an irrigation port in the instrument section proximate to the tip, an aspiration passage in communication between the cannula and an aspiration connector, and an irrigation passage in communication between the irrigation port and an irrigation connector.

Description

MICRO-GONIOTOMYTECHNICAL FIELD

[0001] This disclosure relates in general to the field of surgery, and more particularly, but not by way of limitation, to surgery of the eye.BACKGROUND

[0002] This section provides background information to facilitate a better understanding of the various aspects of the disclosure and is not an admission of prior art.

[0003] Glaucoma is a progressive disease of the eye with many risk factors with elevated intraocular pressure (“TOP”) being the sole modifiable risk factor. Elevated IOP is often associated with increased resistance to flow throughout the conventional outflow system with a majority of resistance residing in the trabecular meshwork and inner wall of Schlemm's canal, a porous tissue complex, separating the anterior chamber (fluid filled intraocular space) from Schlemm's canal and the distal collector system. Surgical techniques to improve drainage of aqueous fluid from the eye, such as goniotomy, trabeculotomy, and trabecular’ micro-bypass with micro-stents can be prohibitively expensive.SUMMARY

[0004] An example of a surgical instrument for cutting intraocular tissue includes a body extending from a proximal end to a distal end, the body having an instrument section terminating at the distal end and handle section between the proximal end and the instrument section, a tip at the distal end comprising a cannula terminating at a trephine, an irrigation port in the instrument section proximate to the tip, an aspiration passage in communication between the cannula and anaspiration connector, and an irrigation passage in communication between the irrigation port and an irrigation connector.

[0005] An example of a method for creating channels in intraocular tissue includes using a surgical instrument with a body extending from a proximal end to a distal end, the body having an instrument section terminating at the distal end and handle section between the proximal end and the instrument section, a tip at the distal end comprising a cannula terminating at a trephine, an irrigation port in the instrument section proximate to the tip, an aspiration passage in communication between the cannula and an aspiration connector, an irrigation passage in communication between the irrigation port and an irrigation connector, and an irrigation and aspiration machine connected to the aspiration connector and the irrigation connector. Inserting the tip and the irrigation port through a cornea, locating the irrigation port in an anterior chamber, placing the trephine against the intraocular tissue, introducing fluid through the irrigation port and into the anterior chamber, cutting the intraocular tissue with the trephine, and removing the cut intraocular tissue from the trephine in response to applying a vacuum to the cannula.

[0006] This summary is provided to introduce a selection of concepts that are further described below in the detailed description. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of claimed subject matter.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The disclosure is best understood from the following detailed description when read with the accompanying figures. It is emphasized that, in accordance with standard practice in the industry, various features are not drawn to scale. In fact, the dimensions of various features maybe arbitrarily increased or reduced for clarity of discussion. As will be understood by those skilled in the ait with the benefit of this disclosure, elements and arrangements of the various figures can be used together and in configurations not specifically illustrated without departing from the scope of this disclosure.

[0008] Figure 1 is a schematic illustration of a surgical instrument for cutting intraocular tissue according to one or more aspects of the disclosure.

[0009] Figure 2 is a perspective illustration of a surgical instrument for cutting intraocular tissue according to one or more aspects of the disclosure.

[0010] Figure 3 is a side view of a surgical instrument for cutting intraocular tissue according to one or more aspects of the disclosure.

[0011] Figure 4 is front view of a cutting tip of a surgical instrument for cutting intraocular tissue according to one or more aspects of the disclosure.

[0012] Figure 5 illustrates another example tip of a surgical instrument for cutting intraocular tissue according to one or more aspects of the disclosure.

[0013] Figure 6 illustrates a surgical instrument for cutting intraocular tissue connected to an aspiration and irrigation machine according to one or more aspects of the disclosure.

[0014] Figure 7 is a schematic view of an example surgical instrument inserted in an eye to cut intraocular tissue according to one or more aspects of the disclosure.

[0015] Figure 8 is a block diagram of a method according to one or more aspects of the disclosure.DETAILED DESCRIPTION

[0016] It is to be understood that the following disclosure provides many different embodiments, or examples, for implementing different features of various illustrative embodiments. Specific examples of components and arrangements are described below to simplify the disclosure. These are, of course, merely examples and are not intended to be limiting. For example, a figure may illustrate an exemplary embodiment with multiple features or combinations of features that are not required in one or more other embodiments and thus a figure may disclose one or more embodiments that have fewer features or a different combination of features than the illustrated embodiment. Embodiments may include some but not all the features illustrated in a figure and some embodiments may combine features illustrated in one figure with features illustrated in another figure. Therefore, combinations of features disclosed in the following detailed description may not be necessary to practice the teachings in the broadest sense and are instead merely to describe particularly representative examples. In addition, the disclosure may repeat reference numerals and / or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not itself dictate a relationship between the various embodiments and / or configurations discussed.

[0017] Surgical instruments and methods for performing surgery, such as goniotomy, on a patient’s eye are disclosed. The surgical instrument uses irrigation and aspiration (“I / A”) eliminating or mitigating the need for an ophthalmic viscosurgical device (“OVD”) to hold open the anterior chamber and the instrument includes two or more small trephines to create channels in the trabecular- meshwork. A purpose of the small channels is to increase fluid drainage from theeye while maintaining real estate for future innovations that are dependent on an existent trabecular meshwork or canal.

[0018] With reference to FIGS. 1-8 an example surgical instrument 10, referred to herein as a micro-goniotomy instrument, to cut or perforate intraocular’ tissue includes a body 12 extending from a proximal end 14 to a distal end 16. Body 12 has an instrument section 18 terminating at distal end 16 and a handle section 20 between proximal end 14 and instrument section 18. Handle section 20 is configured to be held by a surgeon and instrument section 18 is sized, at least proximate to distal end 16, to be inserted into an eye, e.g., the anterior chamber. For example, instrument section 18 may taper from handle section 20 to a reduced diameter at distal end 16.

[0019] A tip 22 according to various embodiments has two or more cannulas 24 (e.g., trephine cannulas) extending axially from distal end 16. Each cannula 24 terminates at a trephine 26 with an opening 28 into the cannula. Tip 22 may be removably attached to body 12 so that body 12 can be reused with a new tip 22. For example, tip 22 may include a cap 30 that removably connects to distal end 16. The trephines may be arranged to create a pattern of channels in the intraocular’ tissue (e.g., the trabecular meshwork). The trephines are smaller than conventional instruments, for example each creating an opening in a range of about 25 to 400 pm or about 50 to 200 pm.

[0020] In some embodiments, tip 22 includes two trephine cannulas 24 such as illustrated in FIG. 4. FIG. 5 is an end view of a tip 22 with four cannulas 24 each terminating with a trephine 26. Tip 22 may utilize various numbers of trephine cannulas. In FIGS. 4 and 5, trephines 26 are in a diamond shape, however, trephines 26 can be in other geometric shapes.

[0021] With reference in particular to FIG. 6, instrument 10 is connected to a phaco machine 42, e.g., an irrigation and aspiration machine. Body 12 includes an internal aspiration passage 32 in communication between the trephine cannulas 24 and an aspiration connector 34. Aspiration connector 34 may be located on handle section 20 to connect to irrigation and aspiration machine 42. Machine 42 can create a vacuum 44 (FIG. 1) in cannulas 24 to remove tissue 50 (FIG. 7) cut with trephines 26. Instrument section 18 has an irrigation port 36 proximate to distal end 16. An irrigation passage 38 inside of body 12 is in communication with irrigation port 36 and an irrigation connector 40. Irrigation connector 40 may be located on handle section 20 to connect to irrigation and aspiration machine 42 to pass fluid 46 (FIG. 1) through irrigation port 36 into the anterior chamber of an eye.

[0022] Figure 8 is a block diagram of an example method 800, described with additional reference to FIGS. 1-7, of creating channels 48 in an intraocular tissue 50 with a micro-goniotomy instrument 10. Method 800 is described with a micro-goniotomy instrument 10 carrying two or more trephine cannulas. At block 802, tip 22 and irrigation port 36 are inserted through a cornea 52 locating (block 804) irrigation port 36 in the anterior chamber 54 of the eye 56. At block 806, trephines 26 arc placed against intraocular tissue 50, e.g., the trabecular mesh. At block 808, fluid 46 is introduced into anterior chamber 54 through irrigation port 36. Fluid 46 maintains pressure in the anterior chamber while aspirating the tissue that has been trephined. At block 810, intraocular tissue 50 is cut (perforated) with trephines 26. At block 812, the cut intraocular tissue 50 is removed from trephines 26 by applying a vacuum 44 to cannulas 24. The trephines are smaller than conventional instruments, for example creating an opening of about 50 to 200 pm. During use, instrument 10 may repeatedly cut channels in the trabecular mesh, for example 10 or more channels, and in a non-limiting example between about 10 to 20 channels. Aspiration incombination with multiple micro-trephines facilitates creating an exact pattern and size of channels. The addition of aspiration to the trephine in conjunction with the smaller size trephine improves tissue removal, minimizes surrounding impact, and increases surgical efficiency.

[0023] Although relative terms such as “outer,” “inner,” “upper,” “lower,” and similar’ terms have been used herein to describe a spatial relationship of one element to another, it is understood that these terms are intended to encompass different orientations of the various elements and components in addition to the orientation depicted in the figures. Furthermore, as used herein, the terms “connect,” “connection,” “connected,” “in connection with,” and “connecting” may be used to mean in direct connection with or in connection with via one or more elements. Similarly, the terms “couple,” “coupling,” and “coupled” may be used to mean directly coupled or coupled via one or more elements. The terms “substantially,” “approximately,” “generally,” and “about” are defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. The extent to which the description may vary will depend on how great a change can be instituted and still have a person of ordinary skill in the art recognized the modified feature as still having the required characteristics and capabilities of the unmodified feature.

[0024] The foregoing outlines features of several embodiments so that those skilled in the ail may better understand the aspects of the disclosure. Those skilled in the art should appreciate that they may readily use the disclosure as a basis for designing or modifying other processes and structures for performing the same purposes and / or achieving the same advantages of the embodiments introduced herein. Those skilled in the art should also realize that such equivalent constructionsdo not depart from the spirit and scope of the disclosure and that they may make various changes, substitutions, and alterations herein without departing from the spirit and scope of the disclosure. The scope of the invention should be determined only by the language of the claims that follow. The term “comprising” within the claims is intended to mean “including at least” such that the recited listing of elements in a claim are an open group. The terms “a,” “an” and other singular terms are intended to include the plural forms thereof unless specifically excluded.

Claims

WHAT IS CLAIMED IS:

1. A surgical instrument to cut intraocular tissue, the surgical instrument comprising: a body extending from a proximal end to a distal end, the body having an instrument section terminating at the distal end and handle section between the proximal end and the instrument section; a tip at the distal end comprising a cannula terminating at a trephine; an irrigation port in the instrument section proximate to the tip; an aspiration passage in communication between the cannula and an aspiration connector; and an irrigation passage in communication between the irrigation port and an irrigation connector.

2. The surgical instrument of claim 1, wherein the trephine is in a range of about 25 to 400 pm.

3. The surgical instrument of claim 1, wherein the trephine is in a range of about 50 to 200 pm.

4. The surgical instrument of claim 1, wherein the tip comprises two or more cannulas each terminating at a trephine.

5. The surgical instrument of claim 4, wherein the two or more trephines are each in a range of about 25 to 400 pm each.

6. The surgical instrument of claim 4, wherein the two or more trephines are each in a range of about 50 to 200 pm.

7. A method of creating channels in an intraocular tissue, the method comprising: using a surgical instrument comprising:a body extending from a proximal end to a distal end, the body having an instrument section terminating at the distal end and handle section between the proximal end and the instrument section; a tip at the distal end comprising a cannula terminating at a trephine; an irrigation port in the instrument section proximate to the tip; an aspiration passage in communication between the cannula and an aspiration connector; an irrigation passage in communication between the irrigation port and an irrigation connector; and an irrigation and aspiration machine connected to the aspiration connector and the irrigation connector; inserting the tip and the irrigation port through a cornea; locating the irrigation port in an anterior chamber; placing the trephine against the intraocular tissue; introducing fluid through the irrigation port and into the anterior chamber; cutting the intraocular tissue with the trephine; and removing the cut intraocular tissue from the trephine in response to applying a vacuum to the cannula.

8. The method of claim 7, wherein the intraocular tissue is a trabecular meshwork.

9. The method of claim 7, repeating the cutting of the intraocular tissue thereby creating a plurality of channels in the intraocular tissue.

10. The method of claim 7, wherein the trephine is in a range of about 25 to 400 pm.

11. The method of claim 7, wherein the trephine is in a range of about 50 to 200 pm.

12. The method of claim 7, wherein the trephine is about 50pm.

13. The method of claim 7, wherein the tip comprises two or more cannulas each terminating at a trephine; and repeating the cutting the intraocular tissue thereby creating a plurality of channels in the intraocular tissue with the two or more trephines.

14. The method of claim 13, wherein the two or more trephines are each in a range of about 25 to 400 pm.

15. The method of claim 13, wherein the two or more trephines are each in a range of about 50 to 200 pm.

16. The method of claim 13, wherein each channel of the plurality of channels is about50pm.

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