Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
EYE STENT
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

 
FIELD OF INVENTION
The present invention relates a medical device. More specifically, the present invention relates to an eye stent.
BACKGROUND OF INVENTION
Glaucoma is an eye condition generally caused by an imbalance in the production and drainage of aqueous humor, the fluid that maintains intraocular pressure (IOP). When drainage through the trabecular meshwork is blocked, IOP increases. Increased IOP damages the optic nerve. If left untreated, glaucoma can lead to vision loss.
Glaucoma treatments primarily aim to lower IOP by enhancing aqueous humor outflow through the trabecular meshwork into Schlemm’s canal. To achieve this, one or more eye stents may be implanted within the trabecular meshwork to create a bypass for aqueous humor. These eye stents often feature multiple channels, facilitating controlled fluid drainage into Schlemm’s canal, thereby reducing IOP.
However, the conventional eye stents may migrate from the site of deployment due to high IOP. Additionally, the surrounding trabecular meshwork tissue may proliferate and partially or fully occlude the stent’s drainage channels, reducing its efficacy over time. In severe cases, additional interventions, such as laser procedures or surgical revision, may be necessary to restore flow or replace the stent.
Thus, there arises a need of an eye stent that overcomes the problems associated with conventional eye stents.
SUMMARY OF INVENTION
The present disclosure relates to an eye stent having a tubular structure. The eye stent includes a lumen extending from a proximal end to a distal end of the eye stent, a proximal portion, residing in an anterior chamber of an eye, a distal portion residing in a Schlemm’s canal of the eye and a middle portion coupling the proximal portion and the distal portion and residing in a trabecular meshwork of the eye. The proximal portion includes a plurality of teeth at least partially protruding into the trabecular meshwork of the eye. The distal portion includes a plurality of elongated slots extending into the lumen and a plurality of protrusions with each protrusion provided between two adjacent elongated slots. The protrusions are configured to elevate tissues of the trabecular meshwork above the elongated slots.
The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
Fig. 1 depicts a side view of an eye stent 100, in accordance with an embodiment of the present disclosure.
Fig. 2 depicts a perspective view of the eye stent 100, in accordance with an embodiment of the present disclosure.
Fig. 3 depicts a longitudinal cross-sectional view of the eye stent 100, in accordance with an embodiment of the present disclosure.
Fig. 4 depicts a bottom view of the eye stent 100, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like; Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
In accordance with the present disclosure, an eye stent is disclosed. The eye stent of the present disclosure is implanted in the trabecular meshwork of a patient suffering from glaucoma. The eye stent creates a fluid outflow pathway between the anterior chamber of the eye and the Schlemm’s canal, facilitating the drainage of aqueous humor. This controlled outflow helps in reducing intraocular pressure (IOP), thereby managing glaucoma. The eye stent of the present disclosure has a proximal portion, a middle portion, and a distal portion. The proximal portion remains in the anterior chamber of the eye and the distal portion remains in the Schlemm’s canal. The middle portion remains in the trabecular meshwork.
In an embodiment, the eye stent includes a plurality of teeth provided at the proximal portion of the eye stent. Each tooth is configured to firmly grip the tissues of the trabecular meshwork thus, preventing any relative movement between the eye stent and the trabecular meshwork. The secure fixation between the trabecular meshwork and the teeth reduces the chances of migration of the eye stent from an implantation site. Further, the distal portion of the eye stent includes a plurality of elongated slots to radially distribute the flow of aqueous humor, enhancing flow dynamics and providing optimal drainage. This reduces pressure on the eye stent and enhances the longevity the eye stent. Further, the eye stent includes a plurality of tapered protrusions provided alongside each longitudinal slot. The plurality of protrusions prevents the tissues of trabecular meshwork surrounding the eye stent, from covering or occluding the elongated slots over a prolonged period of time. Thereby, reducing any chances of flow obstruction and enhancing the efficacy of the eye stent.
Now referring to Figures, Fig. 1 depicts a side view of an eye stent 100, in accordance with an embodiment of the present disclosure. The eye stent 100 has a proximal end 100a and a distal end 100b. The eye stent 100 may be fabricated as a single integral structure. Alternatively, different sections of the eye stent 100 may be fabricated and then couple to form the eye stent 100. In an embodiment, the eye stent 100 is integrally formed. The eye stent 100 may be fabricated using a fabrication technique, including but not limited to, molding, casting, laser micromachining, etc. In an embodiment, the eye stent 100 is fabricated using laser micromachining. The eye stent 100 may be made of a material including but not limited to titanium, stainless steel, medical-grade polymer, etc. In an embodiment, the eye stent 100 is made of biocompatible medical-grade stainless steel.
In an embodiment, the eye stent 100 has a varying outer diameter along the length defined by a plurality of portions. In an embodiment, the eye stent 100 includes a proximal portion 110, a distal portion 120, and a middle portion 130.
The proximal portion 110 is positioned towards the proximal end 100a of the eye stent 100. The proximal portion 110 remains in an anterior chamber of the eye. In an embodiment, the proximal portion 110 has a circular shape though, the proximal portion 110 may have any other shape including, but not limited to, elliptical, pentagonal, hexagonal, octagonal, etc. The proximal portion 110 has a larger outer diameter compared to the outer diameters of the distal portion 120 and the middle portion 130. The outer diameter of the proximal portion 110 may range between 0.23 mm and 0.38 mm. In an embodiment, the outer diameter of the proximal portion 110 is 0.23 mm.
The proximal portion 110 includes a plurality of teeth 111. The teeth 111 are arranged radially on the outer surface of the proximal portion 110. The teeth 111 may be made by carving a portion of the proximal portion 110. In an embodiment, each tooth 111 includes a substantially straight edge 111a and an inclined edge 111b (Figs. 1-2). The inclined edge 111b forms an angle A with the substantially straight edge 111a of the adjacent tooth 111 (shown in Fig. 1). The angle A may range between 45 degrees and 55 degrees. In an embodiment, the angle A is 53.93 degrees. The inclined edge 111b and the substantially straight edge 111a of each tooth 111 meet at a vertex 111c forming a substantially triangular shape of the tooth 111. Such shape of the teeth 111 facilitates firm grip of the proximal portion 110 in the trabecular meshwork, thereby minimizing the chance of migration of the eye stent 100 from an implantation site. The number of the teeth 111 may depend upon the outer diameter of the proximal portion 110. The number of the teeth 111 may range between three and seven. In an embodiment there are five teeth 111.
The distal portion 120 is positioned towards the distal end 100b of the eye stent 100. The distal portion 120 remains in the Schlemm’s canal of the eye. The distal portion 120 has a tapered profile. The diameter of the distal portion 120 decreases from a proximal end to a distal end of the distal portion 120. The tapered profile of the distal portion 120 facilitates easy deployment of the eye stent 100 into the trabecular meshwork of a patient. In an embodiment, the distal portion 120 includes a plurality of elongated slots 150 and a plurality of protrusions 121.
In an embodiment, the elongated slots 150 are arranged radially at an equal distance from each other on the distal portion 120 (shown in Fig. 1, 2 and 4). Alternately, the distance may be uneven, that is, the elongated slots 150 may be placed at increasing, decreasing or random intervals. The elongated slots 150 extend at least partially from the proximal end to the distal end of the distal portion 120. The elongated slots 150 may have a shape including but not limited to, rectangular with curved edges, circular, square, elliptical, trapezoidal, etc. In an embodiment, the elongated slots 150 have a rectangular profile with curved edges shape. The elongated slots 150 extend into the lumen 140. The elongated slots 150 are configured to radially distribute the outflow of aqueous humor from the lumen 140. This distribution helps reducing localized fluid pressure on the eye stent 100 caused by the increased flow of aqueous humor through the lumen 140.
The protrusions 121 may be integrally coupled to an outer surface of the distal portion 120. In an embodiment, the protrusions 121 are integrally formed with the distal portion 120. The protrusions 121 extend from the proximal end to the distal end of the distal portion 120. Each protrusion 121 tapers from the proximal end of the distal portion 120 to the distal end of the distal portion 120. The taper of the protrusion 121 corresponds to the tapered profile of the distal portion 120. The protrusions 121 are arranged radially over the outer surface of the distal portion 120. In an embodiment, the protrusions 121 are arranged radially at an equal distance from each other on the distal portion 120 (shown in Fig. 1, 2 and 4). Alternately, the distance may be uneven, that is, the protrusions 121 may be placed at increasing, decreasing or random intervals. In an embodiment, each protrusion 121 is positioned between two adjacent elongated slot 150 such that one elongated slot 150 remains between a pair of protrusions 121 (clearly shown in Fig. 4). The pair of protrusions 121 are configured to keep the tissues of the trabecular meshwork elevated above the elongated slot 150 to prevent the tissues from occluding or covering the elongated slots 150. This configuration enhances the long-term efficacy of the eye stent 100 by maintaining unobstructed fluid flow, even after prolonged implantation. The number of protrusions 121 may correspond to the number of elongated slots 150. The number of the protrusions 121 may range between three and five. In an embodiment, the number of the protrusions 121 is four.
The middle portion 130 is positioned between the proximal portion 110 and the distal portion 120. The middle portion 130 remains in the trabecular meshwork of the eye. The middle portion 130 couples the proximal portion 110 and the distal portion 120. The middle portion 130 may have a suitable shape including but not limited to cylindrical, tapered, conical, oval, etc. In an embodiment, the middle portion 130 has a cylindrical shape. The diameter of the middle portion 130 may range between 0.15 mm and 0.21 mm. In an embodiment, the diameter of the middle portion 130 is 0.16 mm.
In an embodiment, the eye stent 100 has a tubular structure defining a lumen 140 (shown in Fig. 2, 3 and 4) extending from the proximal end 100a to the distal end 100b. The lumen 140 allows aqueous humor to pass through. The diameter of the lumen 140 may range between 0.05 mm and 0.09 mm. In an embodiment, the diameter of the lumen 140 is 0.08 mm. Additionally, or optionally, the lumen 140 may have a tapered portion 141 (shown in Fig. 3) towards the proximal end 100a of the eye stent 100. The tapered portion 141 has a larger diameter at the proximal end 100a. The diameter of the tapered portion 141 gradually decreases from the proximal end 100a towards the distal end 100b till it becomes equal to the diameter of the lumen 140. The tapered portion 141 facilitates easy flow of the aqueous humor into the lumen 140.
The eye stent 100 is deployed into an eye of a patient. In a deployed state, the proximal portion 110 of the eye stent 100, at least partially, resides in the anterior chamber of the eye. The middle portion 130 of the eye stent 100 resides in the trabecular meshwork of the eye. The distal portion 120 resides in the Schlemm’s canal of the eye. The lumen 140 creates fluidic connection between the anterior chamber and Schlemm’s canal of the eye to provide a passage to aqueous humor. The vertex 111c of the teeth 111 may abut or partially protrude into the trabecular mesh work to secure the position of the eye stent 100 at the deployment site and prevent any relative rotational motion between the eye stent 100 and the trabecular meshwork. The proximal end of the distal portion 120 may abut a corresponding side of the trabecular meshwork. The teeth 111 of the proximal portion 110 and the proximal end of the distal portion 120, by abutting opposite sides of the trabecular meshwork, secure the position of the eye stent 100 at the deployment site and eliminate chances of migration of the eye stent 100 from the deployment site.
The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. An eye stent (100), comprising:
A. a tubular structure having:
i. a lumen (140), extending from a proximal end (100a) to a distal end (100b) of the eye stent (100);
ii. a proximal portion (110), residing in an anterior chamber of an eye, including a plurality of teeth (111) at least partially protruding into a trabecular meshwork;
iii. a distal portion (120) residing in a Schlemm’s canal of the eye including;
a. a plurality of elongated slots (150) extending into the lumen (140); and
b. a plurality of protrusions (121) with each protrusion (121) provided between two adjacent elongated slots (150), the protrusions (121) configured to elevate tissues of the trabecular meshwork above the elongated slots (150); and
iv. a middle portion (130) coupling the proximal portion (110) and the distal portion (120), residing in the trabecular meshwork of the eye.
2. The eye stent (100) as claimed in claim 1, wherein the distal portion (120) has a tapered profile.
3. The eye stent (100) as claimed in claim 1, wherein the teeth (111) are arranged radially on the proximal portion (110).
4. The eye stent (100) as claimed in claim 1, wherein each tooth (111) includes a substantially straight edge (111a) and an inclined edge (111b) meeting at a vertex (111c) forming a substantially triangular shape of the tooth (111).
5. The eye stent (100) as claimed in claim 4, wherein the inclined edge (111b) forms an angle A with a substantially straight edge (111a) of an adjacent tooth (111), ranging between 45 degrees and 55 degrees.
6. The eye stent (100) as claimed in claim 1, wherein at least one of the protrusions (121) and the elongated slots (150) are arranged radially on the distal portion (120).
7. The eye stent (100) as claimed in claim 1, wherein each protrusion (121) tapers from a proximal end of the distal portion (120) to a distal end of the distal portion (120).
8. The eye stent (100) as claimed in claim 1, wherein the lumen (140) includes a tapered portion (141).