The present invention relates generally to ocular surgery. More particularly, the present invention relates to an apparatus and method for inserting an intracorneal lens into a corneal pocket to treat presbyopia.
Presbyopia is the gradual loss of near vision, which often accompanies the aging process and which ultimately results in cataracts. The eyes of a person suffering from presbyopia have a diminished ability to focus on near objects such as books, magazines, or a computer screen. Symptoms of presbyopia can include difficulty reading fine print and blurred vision when transitioning the focus of the eye between near and distant objects.
There are several common treatments for presbyopia. A dedicated pair of reading glasses is one such treatment. Reading glasses provide magnification of near objects to provide for improved vision. However, if a person also needs glasses to focus on distant objects switching between reading glasses and distance glasses can be inconvenient. Another treatment is bifocal glasses, which provide a portion of the glasses lens for assisting with distance vision and a portion for assisting with near vision. While bifocals provide a single pair of glasses for both near and distance vision correction, they can cause disorientation. Contact lenses for the surface of the eye have also been developed which provide vision correction for both near and distance vision. Although these treatments provide vision correction for a person suffering from presbyopia, each requires at least one an additional accessory or pair of contact lenses that must be worn or used daily.
In efforts to eliminate the limitations of the aforementioned vision correction methods, very small lenses for insertion into the eye, and in particular, a corneal pocket were recently developed. These lenses however, unlike intraocular lenses which are used replace the natural lens after a patient is diagnosed with cataracts, require precise and careful handling to successfully implant the lens without damaging the person's cornea. The assignee of the present application, for example, has disclosed new devices for the insertion of these lenses in U.S. patent application Ser. No. 13/908,557 (now issued as U.S. Pat. No. 9,017,401) and Ser. No. 15/038,700 from PCT/US14/066540 (published as WO 2015/080933 A1). Those insertion devices disclosed have been able to provide precise positioning while carefully handling the lens for insertion but still can present various sterilization and misalignment challenges. Another prior art device was described in U.S. Pat. App. Pub. No. 2012/0245592 A1, assigned to Neoptics A G. This device is based on a two-part design principle used to minimize handling of the micro-lens by the practitioner prior to insertion. More particularly, the device includes a reusable handle and a pre-load one-off use unit which is used to contain the lens and push off the lens onto the pocket using a slide having a front end that complements the shape of the perimeter of the lens. This device design may compromise the optical properties of the lens when it is pushed off from one side (limiting precision and complicating the insertion procedure), and/or prevent inspection of the lens prior to implantation.
While the available prior art seeks to preserve the integrity of the lens and ease insertion, additional further improved devices are desired to overcome one or more of: (A) provide an insertion tool that does not require alignment or assembly of highly delicate parts that are critical to the success of the procedure by the medical practitioner; (B) provide an insertion tool that is completely disposable to prevent re-use of parts that may be contaminated and/or damaged; (C) provide an insertion tool that reduces inadvertent operation by mechanizing the loading and offloading of the micro-lens in a precise manner; (D) provide an insertion tool that allows inspection of a micro-lens by a physician before insertion into a patient's eye; and (E) provide an insertion tool that doesn't require the micro-lens to be pushed off a carrier and enables precision placement.
Accordingly, it is desirable to provide additional apparatus and methods for inserting a lens into the cornea to improve a patient's presbyopia.
The foregoing needs are met, to a great extent, by the present invention, wherein in some aspects of embodiments of the invention are intended to address one or more of the above noted fundamental problems associated with devices for insertion of a lens into an eye that do not take into account the small and fragile size of intracorneal lenses and the characteristics of corneal pockets. More specifically, an improved lens inserter that can contain the lens throughout an insertion procedure for accurate placement inside a corneal pocket with minimal impact to the surrounding tissue.
According to some aspects of the disclosure, an apparatus for inserting a lens into an eye is disclosed. The apparatus for inserting a lens into an eye including a handle having a distal end and a proximal end and an outer wall of the handle defining a lumen extending through the handle; a plunger, including a top tine, a center tine, and a bottom tine, extending movably through the lumen of the handle having a distal end and a proximal end. A distal segment of the plunger extends beyond the distal end of the handle. A first actuator coupled to the plunger configured to provide horizontal sliding movement to the plunger and a second actuator configured to separate an end of the top tine from a lens supporting slot structure provided by one or both of said bottom tine and said center tine are also provided. The center tine can include a pin at an angle that causes it to protrude thru the top tine to secure the lens during insertion in a corneal pocket.
In some embodiments, a spring is disposed within the lumen of the handle against which the plunger is biased. Other springs may be included, including, for example, where at least one spring loaded decent configured to signal to a user when the horizontal sliding movement is at a pre-determined position. In addition, at least one spring disposed within the lumen and the second actuator may be included. This spring can be configured to displace, when the second actuator is disengaged, a structure that provides pressure to the top tine.
According to additional aspects of the disclosure, the plunger is configured to provide different sliding ranges of motion to the center, top, and bottom tines, via a single movement of the first actuator using mechanical features of the center, top and bottom tines. This may provide, for example, different sliding motion of the center tine in relation to a synchronized motion of the top and bottom tines when the first actuator is moved past an actuation point. In one non-limiting example, the bottom tine may move before one or both of the top and bottom tines when the first actuator is slid towards the proximate end of the handle.
Moreover, according to yet additional aspects of the disclosure, the actuation of the second actuator while the first actuator is slid towards/away from the proximate end of the handle can additionally provide articulated motion causing the center tine to remain fixed in relation to the top and bottom tines, allowing for loading of the lens onto a lens supporting structure and for positioning of the lens inside of a corneal pocket, accordingly.
There has thus been outlined, rather broadly, certain aspects of the invention in order that the detailed description thereof herein may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional aspects of the invention that will be described below and which will form the subject matter of the claims appended hereto.
In this respect, before explaining at least one aspect of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of aspects in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting.
As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the invention.
The accompanying drawings, which are included to provide a further understanding of the invention, are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the detailed description serve to explain the principles of the invention.
The present invention is further described in the detailed description that follows.
The invention will now be described with reference to the drawing figures, in which like reference numerals refer to like parts throughout. Going forward, various aspects of the steering device of the present disclose may be illustrated by describing components that are coupled, attached, and/or joined together. As used herein, the terms “coupled”, “attached”, and/or “joined” are used to indicate either a direct connection between two components or, where appropriate, an indirect connection to one another through intervening or intermediate components. In contrast, when a component is referred to as being “directly coupled”, “directly attached”, and/or “directly joined” to another component, there are no intervening elements present.
Relative terms such as “lower” or “bottom” and “upper” or “top” may be used herein to describe one element's relationship to another element illustrated in the drawings. It will be understood that relative terms are intended to encompass different orientations of steering device in addition to the orientation depicted in the drawings. By way of example, if aspects of steering device shown in the drawings are turned over, elements described as being on the “bottom” side of the other elements would then be oriented on the “top” side of the other elements. The term “bottom” can therefore encompass both an orientation, of “bottom” and “top” depending on the particular orientation of the apparatus.
Various aspects of the steering device may be illustrated with reference to one or more exemplary embodiments. As used herein, the term “exemplary” means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other embodiments of a steering arm disclosed herein.
In this description and claims directed to the disclosure, various terms may be used for which the following definitions will apply:
“Articulated motion”, as used herein, can refer to the different tine parts of the lens inserter device that allow sliding motion up to one or more pre-configured ranges via the first and sometimes second actuator before one or both a positioning signal is provided to the user and/or a rate or degree of movement of one or more part(s) becomes limited in relation to the others. The signal, for example, may include a click for the user to engage/disengage an actuator depending on the position of the device pieces. In some embodiments, the articulated motion can be used to assist the practitioner in the procedure by preventing unintended movement of device parts depending on the procedural stage.
“Lens” or “Intracorneal lens”, as used herein, can refer to a biocompatible optical correction device that can be placed inside a corneal pocket of an eye. Typically, the lens can include a micro-lens having a small diameter of, for example, 1 mm-7 mm, and more specifically, preferably a diameter of 2.5 mm-3.5 mm. The lens may include a small generally central hole that can be used to fasten and handle the lens to a tool structure during insertion, facilitate precise positioning of the lens in a corneal pocket, and, in some embodiments, to provide vision correction properties to the user after insertion.
“Lens supporting structure”, as used herein, can refer to the structure formed between the bottom tine, and in some embodiments center tine, of a lens inserter device that is used to support a lens during insertion and positioning inside a corneal pocket. In some embodiments, a top tine can be included to further protect top of the lens, and thus the optical properties of the lens during an insertion into a corneal pocket, without damaging the patient's cornea.
The embodiments of the invention and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments and examples that are described and/or illustrated in the accompanying drawings and detailed in the following description. It should be noted that the features illustrated in the drawings are not necessarily drawn to scale, and features of one embodiment may be employed with other embodiments as one skilled in the art would recognize, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the embodiments of the disclosure. The examples used herein are intended merely to facilitate an understanding of ways in which the disclosure may be practiced and to further enable those of skill in the art to practice the embodiments of the disclosure. Accordingly, the examples and embodiments herein should not be construed as limiting the scope of the disclosure, which is defined solely by the appended claims and applicable law. Moreover, it is noted that like reference numerals represent similar parts throughout the several views of the drawings.
The ophthalmic lens inserter and method can help enable precise insertion of an intracorneal lens into a pocket in the cornea without compromising the patient's cornea nor optical corrective properties of the lens during insertion. The corneal pocket can preferably be created by a femtosecond laser or any other precision surgical laser, such as, those used in Lasik™ surgery procedures. According to some aspects, the lens inserter includes a handle and an articulating plunger extending movably through the lumen of the handle. The articulating plunger includes a distal segment that extends beyond the distal end of the handle via at least one actuator coupled to the plunger and configured to provide predetermined movement that can facilitate placement of the lens on a lens supporting structure and insertion and placement of the lens into the corneal pocket. According to other aspects, the lens inserter is made to be disposable by including a limited number of parts and, in some embodiments, having only those parts that are inserted into the cornea and critical to the procedure of a surgical quality steel or include a coating. In some embodiments, for example, the surgical steel parts can be treated, and/or include a coating, to include anti-microbial nano-surface properties. In yet additional embodiments, the part(s) may alternatively or additionally be made to be hydrophobic and/or to have a lower friction coefficient to prevent the tool from sticking and damaging the cornea, for example. In addition, by having the entire lens inserter be disposable, not only can components be made at a lower cost, but also, by enabling disposable lens inserters using, plastics, such as those widely known epoxy compounds, coatings, and the like, the resulting inserter can be lightweight, include personalized features, and eliminate risk of misalignment of parts during sterilization.
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According to yet additional aspects, operation of the articulating plunger end 160 can be a function of the internal structure of the housing 103 and a top tine 105, center tine 110 and bottom tine 115 moving in relation to each other in predetermined manners. For example, by each of the top tine 105, center tine 110 and bottom tine 115 attaching to the slidable thumb rest 101, the different parts can move, in a range limited by their own structural design and that of the housing 103, to extend out of a distal end of the disposable lens inserter 100. Structural features of the top tine 105, center tine 110 and bottom tine 115, can include, for example, various channels for them to integrate one to another in a pre-determined range of lateral motion, depressions to allow the loading lens actuator to separate or unite the top tine 105 and the bottom tine 115 from one another, stoppers and other locking mechanisms, variations in thickness and/or materials, and the such.
The assembled aforementioned parts of the disposable lens inserter 100 can be shown in
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In accordance with some aspects of the disclosure, the bottom tine 115 can include articulating structural features and attaching features, such as articulating structure 120 and bottom tine slider fastening structure 121, for controlled movement. For example, in the present embodiment, bottom tine slider fastening structure 121 can be used to attach a corresponding portion 114 (shown in
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The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, because numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.