Patent Application
20220387215
The subject matter described herein relates generally to systems, methods, and devices for ocular surgery, and particularly for capsulotomy.
The capsulotomy is an early and critical part of cataract surgery in which a circular incision is made in the anterior capsule of the eye's lens. Its purpose is to enable access to the cataractous lens for extraction and later for anchoring/centering an intraocular lens (IOL). There are a number of potential complications that can arise when performing the capsulotomy, including: 1) creating too small a capsulotomy, which increases the complexity of cataract removal; 2) creating too large a capsulotomy, which reduces the capsule's ability to retain an IOL and can introduce post-operative optical complications such as posterior capsular opacification (PCO), IOL tilt, IOL decentration, and lead to a less effective IOL position; 3) creating a radialized capsulotomy, which increases the complexity of cataract removal and the potential for vitreous prolapse into the anterior segment; and 4) creating a discontinuous or non-circular capsulotomy, which limits surgeon's comfort in manipulating the lens due to concerns of creating capsulotomy tears.
In addition to the potential complications that can arise when creating the capsulotomy, there are a number of problematic scenarios that at the outset increase the difficulty of the procedure and the risk of complications occurring, including: 1) the presence of zonular instability, such as zonular weakness, missing zonules, or zonules that are too long as in Marfan Syndrome patients, which all can lead to a lack of lens capsule stability during the capsulotomy; 2) white intumescent cataract cases, where the capsule is prone to tear out radially once punctured due to higher than normal intracapsular pressure as a result of cortex liquefaction instead of cortex solidification; and 3) young patients, which have highly elastic capsules that are difficult to puncture.
Current methods to perform an anterior capsulotomy include manually creating the capsulotomy using a cystatome (i.e., a bent needle), manually creating the capsulotomy using forceps, or employing powered systems that automatically create the capsulotomy.
Current powered systems include: 1) the Zepto device by Mynosys Cellular Devices, which utilizes suction and the energizing of a metal ring to thermally cause a phase change in water molecules at the ring-to-capsule contact area and cleave the capsule; 2) the Aperture CTC device by International BioMedical Devices, which utilizes the energizing of a metal ring to thermally cut the capsule; 3) the CAPSULaser device by EXCEL-LENS Inc., which utilizes a continuous laser to thermally cut the capsule after it has been stained with a special Trypan blue formulation that selectively absorbs the continuous laser energy; and 4) numerous femtosecond laser systems, which utilize ultra-short laser pulses to thermally ablate tissue focused in the laser path. The price and complexity of the aforementioned methods/devices vary considerably, and each have their own pros and cons.
Thus, there exists a need for a simple, cost effective, and reliable method and device to aid in or perform the capsulotomy procedure.
Provided herein are example embodiments of cost effective and reliable systems, devices and methods to aid in or perform the capsulotomy procedure. Furthermore, with the trend towards minimally invasive surgeries, systems, devices and methods can aid in or perform the capsulotomy via access into an eye through a small incision, for example of 2.2 mm or less. In some embodiments, to meet these needs and give confidence to surgeons performing the capsulotomy, embodiments of the present disclosure may employ the unique characteristics of shape-memory materials to enable device access into the eye through the requisite small incision size, and via simple mechanical means either to create a template circle for surgeons to follow in order to create a circular and appropriately-sized capsulotomy, or to create such a capsulotomy via cutting, tearing, or abrading the lens capsule.
In some embodiments, the present disclosure may include a capsulotomy device comprising: an outer shell, a cannula housed within the outer shell, having proximal and distal ends, a shape-memory filament housed within the cannula and extendable through the distal end of the cannula, the shape-memory filament having distal and proximal ends, wherein the shape-memory filament has a bend at the shape-memory filament's distal end; and an actuator located on the outer shell and operably coupled to the shape-memory filament to cause the filament to extend and retract to and from the cannula's distal end.
In some embodiments, the present disclosure may include a capsulotomy device comprising: a cannula having proximal and distal ends, a shape-memory element housed within the cannula and extendable through the distal end of the cannula, the shape-memory element having distal and proximal ends, wherein the shape memory wire has a bend at the shape memory wire's distal end, and an actuator operably coupled to the shape memory wire to cause said wire to extend and retract to and from the cannula's distal end.
In some embodiments, the present disclosure may include a capsulotomy method comprising: introducing a cannula containing a shape-memory element into an anterior chamber of an eye, extending the shape-memory element out of the cannula, placing the shape-memory element into contact with a lens capsule of the eye, centering the shape-memory element on the lens capsule, and while maintaining contact between the shape-memory element and the lens capsule, retracting the shape-memory element into the cannula.
This summary and the following detailed description are merely exemplary, illustrative, and explanatory, and are not intended to limit, but to provide further explanation of the invention as claimed. Additional features and advantages of the invention will be set forth in the descriptions that follow, and in part will be apparent from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the structure particularly pointed out in the written description, claims and the appended drawings.
The present invention may be better understood by referring to the following figures. The components in the figures are not necessarily to scale. Emphasis instead being placed upon illustrating the principles of the disclosure. In the figures, reference numerals designate corresponding parts throughout the different views.
The following disclosure describes various embodiments of the present invention and method of use in at least one of its preferred, best mode embodiments, which is further defined in detail in the following description. Those having ordinary skill in the art may be able to make alterations and modifications to what is described herein without departing from its spirit and scope. While this invention is susceptible to different embodiments in different forms, there is shown in the drawings and will herein be described in detail a preferred embodiment of the invention with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the embodiment illustrated. All features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substitutable with those from any other embodiment unless otherwise stated. Therefore, it should be understood that what is illustrated is set forth only for the purposes of example and should not be taken as a limitation on the scope of the present invention.
As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.
In general, terms such as “coupled to,” and “configured for coupling to,” and “secure to,” and “configured for securing to” and “in communication with” (for example, a first component is “coupled to” or “is configured for coupling to” or is “configured for securing to” or is “in communication with” a second component) are used herein to indicate a structural, functional, mechanical, electrical, signal, optical, magnetic, electromagnetic, ionic or fluidic relationship between two or more components or elements. As such, the fact that one component is said to be in communication with a second component is not intended to exclude the possibility that additional components may be present between, and/or operatively associated or engaged with, the first and second components.
In the following description and in the figures, like elements are identified with like reference numerals. The use of “e.g.,” “etc.,” and “or” indicates non-exclusive alternatives without limitation, unless otherwise noted. The use of “including” or “includes” means “including, but not limited to,” or “includes, but not limited to,” unless otherwise noted.
As used herein, the term “and/or” placed between a first entity and a second entity means one of (1) the first entity, (2) the second entity, and (3) the first entity and the second entity. Multiple entities listed with “and/or” should be construed in the same manner, i.e., “one or more” of the entities so conjoined. Other entities may optionally be present other than the entities specifically identified by the “and/or” clause, whether related or unrelated to those entities specifically identified. Thus, as a non-limiting example, a reference to “A and/or B,” when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including entities other than B); in another embodiment, to B only (optionally including entities other than A); in yet another embodiment, to both A and B (optionally including other entities). These entities may refer to elements, actions, structures, steps, operations, values, and the like.
Provided herein are example embodiments of cost effective and reliable systems, devices and methods to aid in or perform the capsulotomy procedure.
To help in the descriptions herein,
Generally, a capsulotomy device of the present disclosure may include a handle, an actuator, and a proximal end portion. The proximal portion (illustrated, for example, in
In some embodiments, the cannula may be made of steel, stainless steel, plastic, composite, etc., and preferably of a biocompatible material. The cannula may be made drawn, molded, extruded, formed, etc.
In some embodiments, the size of the cannula may be 17 gauge, 19 gauge, 20 gauge, 21 gauge, 22 gauge, 23 gauge, 24 gauge, 25 gauge, 26 gauge, 27 gauge, 28 gauge, 29 gauge, or of any wall thickness designation. Alternatively, the cannula may be sized between 0.3 mm to 2.2 mm in any cross-sectional outer dimension.
In some embodiments, the cannula may have a distal end that may be ground or polished, for example, to remove any/all burrs or irregularities that could catch on and/or tear tissue. The distal end may be flared or shaped, for example, to accept variations of shape-memory element(s) and/or their distal end(s). The distal end may be over-molded, for example, to accept and guard variations of shape-memory element(s) and/or their distal end(s).
In some embodiments, the capsulotomy device of the present disclosure may include cutting/tearing element(s) (e.g., in the form of separate blade(s)), which are shown further in FIGS. 4A to 4AI, and
The cutting/tearing element(s) may be located at the distal end of a shape-memory element, or any location on the shape-memory element with variable or regular spacing when two or more are utilized.
The cutting/tearing element(s) may be made of metal, carbon steel, stainless steel, titanium, any metal or steel alloy, plastic, ruby, sapphire, diamond, any gem, glass, obsidian, volcanic glass, ceramic, composite, etc.
The cutting/tearing element(s) may have any orientation (towards the lens capsule, at an angle to the lens capsule, etc.).
The cutting/tearing element(s) may have any joining method to join/adhere, examples include welding, sonic welding, soldering, gluing/epoxying, etc. In some embodiments, biocompatible method may be preferred.
In some embodiments, the capsulotomy device of the present disclosure may include shape-memory element(s) and shown further in
The shape-memory element may have an outer diameter of 0.006″, 0.008″, 0.010″, 0.012″, 0.014″, 0.015″, or any diameter that can slidably fit inside the paired cannula. Alternatively, the shape-memory element may be sized between 0.1 mm to 2.1 mm in any cross-sectional outer dimension.
The surface of the shape-memory element may be smooth/in as-drawn condition, sharpened on one edge, sharpened on two edges, sharpened on several edges, roughened through filing, roughened through sandblasting, roughened through sanding, roughened through tumbling with abrasives, roughened/grooved through pressing, or given an abrasive surface via adhering an abrasive compound (e.g., diamond dust), etc.
The shape-memory element may be made of shape-memory alloy (e.g., nitinol), shape-memory polymer, suture material (e.g., nylon, polypropylene), super-elastic material, steel, stainless steel, steel alloy, plastic, composite, etc.
The shape-memory element may have a circular shape, oval shape, or any amorphous shape. In the example case of nitinol material, the shape of the shape-memory element may be set by fixturing and heat treating. In some embodiments, the shape memory element may be formed to have a circular distal portion and an essentially straight proximal portion (the straight portion may interface with an actuator or handpiece). In some embodiments, the circular distal portion may have a 2.75 mm radius (but can vary from 2 mm to 3.25 mm). The circular distal portion may be formed into a coiled configuration such that a complete circle is created when viewed from the top, and it may have a pitch or minimal pitch (e.g., pitch of 1 mm, pitch of 0.5 mm, or essentially no pitch), and may wrap around greater than 360 degrees (e.g., greater than 360 degrees, approximately 370 degrees, approximately 730 degrees, approximately 1090 degrees, etc.). In some embodiments, the shape-memory element may take the form of an outward spiral (with no pitch or with pitch), an inward spiral (with no pitch or with pitch), or a cross-arm configuration.
In some embodiments, the distal end may be in as-drawn condition, ground or polished smooth (e.g., to prevent inadvertent puncturing or piercing of tissue), given a sharp pencil-point tip, flattened and sharpened, bent at any angle relative to the longitudinal axis of the shape-memory element (less than, at, or greater than 90 degrees), capped with a separate structural element (to either protect the end from causing any potential damage to tissue, or to instead purposely be used to create the template/capsulotomy), covered in an epoxy/adhesive or other means to encapsulate the end (to prevent inadvertent puncturing or piercing of tissue), made with means to accept a rotatable cutting element, or any combination of the above.
In some embodiments, the capsulotomy device of the present disclosure may include an actuator, which is shown further in
In some embodiments, the capsulotomy device of the present disclosure may also include a handpiece or shaft, which is shown further in
Turning now to the drawings,
It should be noted that the above configurations of the shape-memory wire element are examples and not meant to be limiting.
It should be noted that the above configurations of the shape-memory element are examples and not meant to be limiting.
It should be noted that the above configurations of the shape-memory element are examples and not meant to be limiting.
It should be noted that the above surface treatments are examples and not meant to be limiting.
It should be noted that the above configurations of the shape-memory are examples and not meant to be limiting.
FIGS. AD to 4AH illustrate side views of various exemplary shape-memory elements coupled to various rotating cutting elements, according to some embodiments. For example, the rotating cutting element may include or may have a configuration as:
It should be noted that the above configurations of the rotating cutting element are examples and not meant to be limiting
It should be noted that other configurations and combinations are also contemplated.
Turning to
At Step 616, while maintaining contact between the shape-memory element and the lens capsule, the shape-memory element 604 may be retracted, leaving either a visible path or groove 606 where it traveled (e.g., a circular template), a cut (e.g., a complete (360 degrees) or near complete (<360 degrees) cut to form the capsulotomy), or a tear (e.g., a complete (360 degrees) or near complete (<360 degrees) tear to form the capsulotomy).
In some alternative embodiments, a cutting element may be included on a portion of the shape-memory element, and during operation, only the cutting element portion touches the lens capsule.
At Step 618, the shape-memory element 604 may be fully retracted, leaving behind either a visible path or groove 606 where it traveled (e.g., a circular template), a cut (e.g., a complete (360 degrees) or near complete (<360 degrees) cut to form the capsulotomy), or a tear (e.g., a complete (360 degrees) or near complete (<360 degrees) tear to form the capsulotomy).
At Step 620, the cannula containing shape-memory element may be removed from the eye, leaving behind either a visible path or groove 606 where it traveled (e.g., a circular template), a cut (e.g., a complete (360 degrees) or near complete (<360 degrees) cut to form the capsulotomy), or a tear (e.g., a complete (360 degrees) or near complete (<360 degrees) tear to form the capsulotomy).
Variations of this method may include operation in the reverse, e.g., making a template, cut, or tear while extending the shape-memory element instead of during retraction. Another variation may include making a template, cut, or tear via both the extension and retraction movements of the shape-memory element. Yet another variation may include the use of an additional surgical tool to either grab and hold the capsule at its center, pierce through the capsule at its center, push down on the capsule at its center, or pull suction on the capsule at its center, all while the device per embodiments described herein is operated.
The device of the present disclosure may also be used in another operation method, which may be referred to as bottom-up method. This method may include similar steps to the top-down method, however upon initial extension of the shape-memory element, the shape-memory element may be directed to pierce through the capsule and extend underneath the capsule. Making the template, cut, or tear in the capsule can then commence via the same variations in method listed for the top-down method.
In some embodiments, contact of the shape-memory element to the lens capsule may be confirmed by the visible change in reflection/refraction of the lens capsule in the area immediately surrounding the shape-memory element; in other words, contact of the shape-memory element to the lens capsule may be confirmed by the visual presence of a “halo” that surrounds the shape-memory element.
In some embodiments, Purkinje images may be used for centering/aligning the shape-memory element, and thus the resultant capsulotomy template or capsulotomy.
As an example, a template-making device (meaning, a device that leaves a “template” circle for the surgeon to later follow after use of the device) includes a 0.008″ diameter nitinol wire sanded with a 36-grit sanding block (3 longitudinal strokes per wire side, with an additional 5 transverse strokes to create a cross-hatched pattern in the wire surface) formed into an approximately 370 degree circle with a 2.75 mm radius and with minimal pitch at its distal end via fixturing and heat treating at 500 degrees Celsius for 15 minutes followed by water quench. The formed nitinol wire is then placed into a steel cannula that has been bent at its distal end to match the radius of the formed nitinol wire, then operated as described herein
For example,
As illustrated in
As used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.
The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substitutable with those from any other embodiment. If a certain feature, element, component, function, or step is described with respect to only one embodiment, then it should be understood that that feature, element, component, function, or step can be used with every other embodiment described herein unless explicitly stated otherwise. This paragraph therefore serves as antecedent basis and written support for the introduction of claims, at any time, that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions, and steps from one embodiment with those of another, even if the following description does not explicitly state, in a particular instance, that such combinations or substitutions are possible. It is explicitly acknowledged that express recitation of every possible combination and substitution is overly burdensome, especially given that the permissibility of each and every such combination and substitution will be readily recognized by those of ordinary skill in the art.
In many instances, entities are described herein as being coupled to other entities. It should be understood that the terms “coupled” and “connected” (or any of their forms) are used interchangeably herein and, in both cases, are generic to the direct coupling of two entities (without any non-negligible (e.g., parasitic) intervening entities) and the indirect coupling of two entities (with one or more non-negligible intervening entities). Where entities are shown as being directly coupled together or described as coupled together without description of any intervening entity, it should be understood that those entities can be indirectly coupled together as well unless the context clearly dictates otherwise.
While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that these embodiments are not to be limited to the particular form disclosed, but to the contrary, these embodiments are to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any features, functions, steps, or elements of the embodiments may be recited in or added to the claims, as well as negative limitations that define the inventive scope of the claims by features, functions, steps, or elements that are not within that scope.
The present application claims priority to U.S. Provisional Patent Application No. 62/948,733, filed Dec. 16, 2019, the disclosure of which is hereby incorporated by reference in its entirety for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 62948733 | Dec 2019 | US |
