Scleral sinus drug elution device and method

Abstract

A method of delivering a pharmaceutical composition to the scleral sinus of an eye is disclosed. The method includes inserting a drug delivery device in conjunction with a microstent into the scleral sinus. The drug delivery device may include a bioerodible polymer and a pharmaceutical composition, and the drug delivery device is configured to erode over time and elute the pharmaceutical composition into aqueous humor within the scleral venous sinus when the drug delivery device erodes.

Description

Incorporated by Reference

[0001] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0002] The present invention as set forth in the appended claims relates generally to surgical implants, such as ophthalmic devices, including but not limited to ophthalmic drug delivery devices. Background Art

[0003] Glaucoma is an eye disease that causes a potentially damaging increase in intraocular pressure. Medical treatments for glaucoma are generally aimed at reducing the production of aqueous humor to reduce intraocular pressure. The goal of surgical treatment for glaucoma is the outflow pathway of aqueous humor from the anterior chamber through the trabecular meshwork to Schlemm's canal, where it then flows out of the eye via the outflow channels and episcleral veins. In addition, although there are drugs that can dilate the outflow channels and / or episcleral veins, there is currently no efficient method to deliver these drugs in sufficient concentrations over a sufficient period of time to provide sufficient dilation of the outflow channels and / or episcleral veins to reduce intraocular pressure. Summary of the invention

[0004] Novel and useful systems, devices and methods for eye surgery are set forth in the appended claims. Illustrative embodiments are also provided to enable one skilled in the art to make and use the claimed subject matter.

[0005] For example, some embodiments may include a method of delivering a pharmaceutical composition to Schlemm's Canal of an eye. The method may include: inserting a drug delivery device into Schlemm's Canal; inserting a microstent into Schlemm's Canal, the microstent including an open central channel partially defined by one or more wall supports; supporting a longitudinal cross-section of Schlemm's Canal with the microstent; and allowing the drug delivery device to erode over time. The drug delivery device may include a bioerodible polymer and a pharmaceutical composition, and the drug delivery device may erode over time to elute the pharmaceutical composition into aqueous humor within Schlemm's Canal as the drug delivery device erodes. The method may further include dilating one or more of the outflow channel and the episcleral vein with the pharmaceutical composition.

[0006] Features, elements and aspects described in the context of some embodiments may also be omitted, combined or replaced by alternative features.Other features, objects, advantages and preferred modes of implementing and using the claimed subject matter are described in more detail below with reference to the drawings of illustrative embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The novel features of the present invention are particularly set forth in the appended claims. The following detailed description sets forth illustrative embodiments utilizing the principles of the present invention, and a better understanding of the features and advantages of the present invention will be obtained by referring to the following detailed description and the accompanying drawings, in which:

[0008] Figure 1 The drug delivery device according to the present invention is shown in proximity to the micro-stent in Schlemm's Canal.

[0009] Figure 2 Shows Figure 1 drug delivery device. DETAILED DESCRIPTION

[0010] Drugs that dilate the outflow channel and episcleral vein downstream of Schlemm's Canal can help reduce intraocular pressure. The flow of aqueous humor from the anterior chamber to and through Schlemm's Canal can be enhanced by using a Schlemm's Canal microstent (such as those described in U.S. Pat. No. 7,740,604; U.S. Pat. No. 8,337,509; U.S. Pat. No. 8,425,449; and U.S. Pat. No. 8,512,404). One aspect of the present invention is to combine a Schlemm's Canal microstent with a timed-release drug delivery device disposed in Schlemm's Canal downstream of the microstent to more effectively deliver drugs to the outflow channel and episcleral vein over an extended period of time.

[0011] Figure 1An exemplary ocular micro-stent 400 is shown, wherein the body portion 404 of the micro-stent is disposed in Schlemm's Canal 484 and the inlet 450 of the micro-stent is disposed in the anterior chamber 480. As shown, the body of the micro-stent 400 has paired struts 420, openings 430, ridge regions 424, and an open channel 434 extending along the body portion and with one open side facing the outflow channel. The micro-stent 400 can be inserted from the anterior chamber 480 through an opening 483 in the trabecular meshwork 482 into the Schlemm's Canal 484, such that the inlet portion 450 remains in the anterior chamber 480. When in place in Schlemm's Canal, microstent 400 supports the wall of Schlemm's Canal so that aqueous humor can flow from anterior chamber 480 through channel 476 in inlet portion 450 and / or through trabecular meshwork 482 and opening 430 into open channel 434 of microstent body and then into collector channel 486 leading to episcleral vein (not shown). In some embodiments, microstent 400 supports at least 4 mm longitudinal length of Schlemm's Canal, at least 6 mm length of Schlemm's Canal, or at least 8 mm length of Schlemm's Canal. Microstent 400 can be, for example, one of the implants disclosed in U.S. Pat. No. 7,740,604; U.S. Pat. No. 8,337,509; U.S. Pat. No. 8,425,449; U.S. Pat. No. 8,512,404 (all of which are incorporated by reference in their entirety); or any other suitable Schlemm's Canal microstent. Microstent 400 can be made of one or more biocompatible materials having desired structural and mechanical properties. Both metallic and non-metallic materials may be suitable. Examples of suitable metallic materials may include stainless steel, tantalum, gold, titanium, and nickel-titanium alloys known in the art such as Nitinol. For example, Nitinol is commercially available from Memry Technologies (Brookfield, CT), TiNi Alloy Company (San Leandro, CA), and Shape Memory Applications (Sunnyvale, CA).

[0012] Figure 1 Also shown is a drug delivery device 500, which is disposed in Schlemm's Canal proximal to the micro-stent 400. Figure 2As shown in , the drug delivery device 500 is formed of a bioerodible polymer 502, such as poly(lactic-co-glycolic acid) (PLGA) or polyethylene glycol (PEG), or a mixture thereof. Other suitable bioerodible or bioabsorbable polymers and copolymers can be derived from monomers, such as glycolide, glycolic acid, lactide, lactic acid, caprolactone, p-dioxanone, trimethylene carbonate, and combinations thereof. In some cases, the bioerodible polymer 502 can additionally or alternatively include an amorphous or semi-crystalline form of such a polymer. The drug that expands the collector channel and the episcleral vein is compounded with the bioerodible polymer of the drug delivery device to form a drug capsule 504, so that when the drug delivery device 500 bioerodes, the drug is eluted into the aqueous humor flowing to the collector channel. Suitable drugs include rho kinase inhibitors and K (ATP) channel blockers, such as chromankalin.

[0013] In some embodiments, the drug delivery device 500 is 6-8 mm long and has a diameter of 7-10 mm. In some embodiments, the drug delivery device 500 is curved (e.g. Figure 2 In other embodiments, the drug delivery device 500 is flexible and conforms to the curve of Schlemm's Canal.

[0014] The drug delivery device 500 can be delivered into Schlemm's Canal through the same opening in the trabecular meshwork used to place the microstent. In some embodiments, prior to placement of the drug delivery device or microstent, the Schlemm's Canal can be dilated, such as by delivering a pressurized viscoelastic material into the Schlemm's Canal. For example, the Schlemm's Canal is dilated with a viscoelastic material using a surgical system or by using one of the devices described in US Application No. 63 / 236,598.

[0015] In some embodiments, the drug delivery device 500 is placed close enough to the microstent (e.g., within 1-3 mm of the distal end of the microstent 400) to be in the flow of aqueous humor from the microstent so that the device 500 will erode and deliver the drug to the flowing aqueous humor. In some embodiments, the drug delivery device erodes and delivers the drug over an extended period of time (e.g., months or even years).

[0016] Herein, when a feature or element is described as "on" another feature or element, the feature or element may be directly on the other feature or element, or there may be intermediate features and / or elements. On the contrary, when a feature or element is described as "directly on" another feature or element, there are no intermediate features or elements. It should also be understood that when a feature or element is described as "connected", "attached" or "coupled" to another feature or element, the feature or element may be directly connected, attached or coupled to the other feature or element, or there may be intermediate features or elements. On the contrary, when a feature or element is described as "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown with respect to one embodiment, the features and elements described or shown in this way may be applied to other embodiments. It should also be understood by those skilled in the art that the structure or feature mentioned as "adjacent" another feature setting may have a portion overlapping or located below the adjacent feature.

[0017] The terms used herein are only used to describe specific embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "a / an" and "said" are also intended to include plural forms, unless the context clearly indicates otherwise. It should be further understood that the term "including" when used in this specification indicates the presence of the features, steps, operations, elements and / or parts, but does not exclude the presence or increase of one or more other features, steps, operations, elements, parts and / or their groups. As used herein, the term "and / or" includes any and all combinations of one or more of the associated enumerated items, and can be abbreviated as " / ".

[0018] For ease of description, spatial relative terms such as "below", "below", "lower", "above", "upper" and the like may be used herein to describe the relationship of an element or feature as illustrated in the accompanying drawings relative to another element or feature. It should be understood that spatial relative terms are intended to cover different orientations of the device when in use or operation in addition to the orientation depicted in the accompanying drawings. For example, if the device in the accompanying drawings is inverted, the element described as "below" or "below" other elements or features will then be oriented to "above" the other elements or features. Thus, the exemplary term "below" can cover both the upper orientation and the lower orientation. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein are interpreted accordingly. Similarly, the terms "upward", "downward", "vertical", "horizontal", etc. are used herein only for explanation unless otherwise specifically stated.

[0019] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms can be used to distinguish one feature / element from another feature / element. Thus, the first feature / element discussed below can be referred to as the second feature / element, and similarly, the second feature / element discussed below can be referred to as the first feature / element without departing from the teachings of the present invention.

[0020] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprising" means that various components can be used together in methods and articles (e.g., compositions and devices including devices and methods). For example, the term "comprising" should be understood to mean including any stated elements or steps but not excluding any other elements or steps.

[0021] As used herein in the specification and claims, including as used in the examples, unless otherwise expressly provided, all numbers can be considered as being prefixed with the word "about" or "approximately", even if the term does not appear explicitly. When describing a magnitude and / or position, the words "about" or "approximately" can be used to indicate that the value and / or position described are within a reasonably expected value and / or position range. For example, the value of a numerical value can be + / -0.1% of the value (or value range), + / -1% of the value (or value range), + / -2% of the value (or value range), + / -5% of the value (or value range), + / -10% of the value (or value range), etc. Any numerical value given herein should also be understood to include approximately or about the value, unless otherwise indicated in the context. For example, if the value "10" is disclosed, "approximately 10" is also disclosed. Any numerical range set forth herein is intended to include all subranges contained therein. It should also be understood that when a value "less than or equal to" the value is disclosed, "greater than or equal to the value" and possible ranges between values ​​are also disclosed, as appropriately understood by the skilled person. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout this application, data are provided in a variety of different formats, and it should also be understood that the data represent the range of any combination of endpoints and starting points and data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that it is considered to disclose greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 and between 10 and 15. It should also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0022] Although various illustrative embodiments are described above, any of a variety of changes may be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, in alternative embodiments, the order in which the various method steps described are performed may generally be changed, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various device and system embodiments may be included in some embodiments and may not be included in other embodiments. Therefore, the above description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0023] The examples and illustrations included herein show specific embodiments in which the subject matter can be practiced by way of illustration but not limitation. As previously mentioned, other embodiments can be used and derived therefrom, so that structural and logical replacements and changes can be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the invention may be referred to herein individually or collectively as the term "invention", which is merely for convenience, and if more than one invention or inventive concept is actually disclosed, it is not intended that the scope of the present application is automatically limited to any single invention or inventive concept. Thus, although specific embodiments have been illustrated and described herein, any arrangement intended to achieve the same purpose can replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or changes of various embodiments. Upon reviewing the above description, the combination of the above embodiments with other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. A method for delivering a pharmaceutical composition to Schlemm's Canal of an eye, the method comprising: inserting a drug delivery device into Schlemm's Canal, the drug delivery device comprising a bioerodible polymer and the pharmaceutical composition, the drug delivery device being configured to erode over time and elute the pharmaceutical composition into aqueous humor within Schlemm's Canal as the drug delivery device erodes; inserting a microstent into Schlemm's Canal, the microstent comprising an open central channel defined in part by one or more wall supports; Supporting at least [4 mm] of the longitudinal cross-section of Schlemm's Canal with the micro-stent; allowing the drug delivery device to erode over time to elute the pharmaceutical composition into aqueous humor within Schlemm's Canal as the drug delivery device erodes; as well as The pharmaceutical composition is used to dilate one or more of the outflow channel and the episcleral vein.

2. The method of claim 1, wherein: The step of inserting the microstent into Schlemm's Canal comprises inserting the microstent from the anterior chamber of the eye through an opening in the trabecular meshwork, and wherein the step of inserting the drug delivery device comprises inserting the drug delivery device through the opening in the trabecular meshwork.

3. The method of claim 2, wherein: The drug delivery device is inserted into Schlemm's Canal before inserting the micro-stent into Schlemm's Canal.

4. The method of claim 2, wherein: After the micro-stent is inserted into Schlemm's Canal, the drug delivery device is inserted into Schlemm's Canal.

5. The method of claim 1, wherein: The step of inserting the drug delivery device includes placing the drug delivery device in Schlemm's Canal within [3-6 mm] of the micro-stent.

6. The method of claim 1, wherein: The micro-stent comprises an entrance portion and a main body portion, the open central channel and the one or more wall supports being arranged in the main body portion, the entrance portion comprising an open channel communicating with the open channel of the main body portion, the step of inserting the micro-stent into Schlemm's Canal comprising inserting the main body portion from the anterior chamber of the eye into Schlemm's Canal and arranging the entrance portion in the anterior chamber.

7. The method of claim 1, further comprising dilating Schlemm's Canal prior to inserting the microstent or the drug delivery device into Schlemm's Canal.

8. The method of claim 7, wherein: The step of dilating Schlemm's Canal includes injecting a substance into Schlemm's Canal.

9. The method of claim 8, wherein: The substance is a viscoelastic material.

Images