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Device for ocular access

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Device for ocular access


The present invention provides devices to access the suprachoroidal space or sub-retinal space in an eye via a minimally invasive transconjunctival approach. The devices may also be used after a partial dissection, for example after dissection of the outer scleral layer of the eye, and using the device within the dissection to access the suprachoroidal space or the sub-retinal space.
Related Terms: Dissection

Browse recent Iscience Interventional Corporation patents - Menlo Park, CA, US
Inventors: Amy Lee HAMMACK, Stanley R. CONSTON, Ronald YAMAMOTO
USPTO Applicaton #: #20120271272 - Class: 604500 (USPTO) - 10/25/12 - Class 604 
Surgery > Means For Introducing Or Removing Material From Body For Therapeutic Purposes (e.g., Medicating, Irrigating, Aspirating, Etc.) >Treating Material Introduced Into Or Removed From Body Orifice, Or Inserted Or Removed Subcutaneously Other Than By Diffusing Through Skin >Method

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The Patent Description & Claims data below is from USPTO Patent Application 20120271272, Device for ocular access.

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PRIORITY CLAIM

Priority is claimed pursuant to 35 U.S.C. 119(e)(1) of U.S. provisional application Ser. No. 61/393,741, filed Oct. 15, 2010, which is incorporated by reference in its entirety for all purposes

BACKGROUND OF INVENTION

The suprachoroidal space is a potential space in the eye that is located between the choroid, which is the middle layer or vascular tunic of the eye, and the sclera, the outer (white) layer of the eye. The suprachoroidal space extends from the anterior portion of the eye near the ciliary body to the posterior end of the eye adjacent to the optic nerve. Normally the suprachoroidal space is not evident due to the close apposition of the choroid to the sclera from the intraocular pressure of the eye. Since there is no substantial attachment of the choroid to the sclera, the tissues can separate to form the suprachoroidal space when fluid accumulation or other conditions occur. The suprachoroidal space provides a potential route of access from the anterior region of the eye to the posterior region for the delivery of treatments for diseases of the eye. Standard surgical access to the suprachoroidal space is achieved through incisions in the conjunctiva and the sclera, and is primarily performed in an operating room. Surgical access is useful in draining choroidal effusions or hemorrhage, and in placing microcatheters and cannulas into the suprachoroidal space for delivery of agents to the back of the eye. Treatments for diseases such as age-related macular degeneration, macular edema, diabetic retinopathy and uveitis may be treated by the appropriate active agent administered in the suprachoroidal space.

The sub-retinal space is a potential space in the eye that is located between the sensory retina and the choroid. The sub-retinal space lies under all portions of the retina, from the macular region near the posterior pole to the ora serrata, the anterior border of the retina. Normally the sub-retinal space is not evident as the retina needs to be apposed to the underlying choroid for normal health and function. In some disease states or as a result of trauma, a retinal detachment may occur, forming a fluid filled region in the sub-retinal space. Such spaces normally require treatment to reattach the retina before retinal function is irreversibly lost. However, it has been found that some treatments such as gene therapy or cell therapeutics may be applied to the sub-retinal space to provide maximum exposure to the retina. In a normally functioning retina, small injections in the sub-retinal space create a small area of retinal detachment which resolves in a short period of time, allowing direct treatment of the retina.

The sub-retinal space may be accessed ab-interno by piercing a small gauge needle through the retina. This procedure involves penetration of the intraocular space of the eye and forming a small retinotomy by the needle. A therapeutic agent injected into the sub-retinal space may flow out through the retinotomy into the vitreous cavity causing exposure of the therapeutic to the lens, ciliary body and cornea as it exits through the anterior aqueous outflow pathway.

It is desired to have a method whereby the suprachoroidal space or the sub-retinal space may be accessed in a minimally invasive method via an ab-externo transconjunctival approach. Such a method would provide a method to limit, guide or guard the penetration of a needle device into the suprachoroidal space or sub-retinal space to prevent further penetration. The present invention provides an apparatus to allow minimally invasive, transconjunctival access to the suprachoroidal space or sub-retinal space in the eye for the delivery of therapeutic or diagnostic materials.

SUMMARY

OF THE DISCLOSURE

The present invention provides a device comprising an elongated body having a distal end and proximal end, said ends in communication through an internal pathway within the body wherein:

the distal end is configured with a sharp edge or point to penetrate into ocular tissues of the outer shell of the eye, a moveable guarding element disposed in a first configuration to shield the ocular tissues from the sharp edge or point, and adapted to apply a distally directed force to the tissues at the distal end of the device to displace tissue away from the distal end of the device upon entry into the suprachoroidal space or subretinal space in an eye with the distal end; wherein the guarding element is moveable to a second configuration to expose said sharp edge or point to said tissues for penetration into the tissues, and an access port to deliver materials and substances through the pathway in the elongated body after deployment of the guarding element within the suprachoroidal space or subretinal space.

In some embodiments the guarding element is attached to a spring or compressible element that upon compression thereof provides a distally directed force on the guarding element.

In some embodiments the guarding element comprises a flowable material selected from a fluid or gas that is directed to flow out of the distal end of the device to provide a distally directed force.

In some embodiments the device further comprises a sealing element attached at the distal end of the elongated body adapted to reduce or prevent leakage of fluid or gas through a tissue tract created by the device.

In some embodiments the device accommodates a spring to apply a distal force on the sealing element to provide a sealing force of the element against the eye tissue.

In some embodiments the device comprises a reservoir at the proximal end for receiving a material to be delivered at the target space and the sealing element is in mechanical communication with an activating element for releasing the material from the reservoir.

In some embodiments the device comprises an associated sealing element adapted for retention on the surface of the eye to receive the distal end of the device to locate and stabilize the device during penetration into the eye.

The invention further provides a device for placement in the sclera of an eye, comprising a body having a proximal end adapted for location at or near the scleral surface and a distal end adapted for location within the suprachoroidal or subretinal space, where the device comprises a lumen and a mechanical stop at the proximal end for retaining the proximal end at or near the scleral surface.

Methods of using the devices of the invention to access the suprachoroidal or subretinal spaces of the eye are also provided.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic cross-section of the eye with a detail view of the layers of the eye.

FIG. 2 is a schematic of a device according to one embodiment of the invention comprising an angled tip.

FIG. 3 is a schematic of a device according to one embodiment of the invention comprising a guard element disposed in the lumen of the main shaft.

FIG. 4 is a schematic of a device according to one embodiment of the invention comprising a tubular guard element disposed about the outside of the main shaft.

FIG. 5 is a schematic of a device according to one embodiment of the invention comprising a reservoir element.

FIG. 6 is a schematic of a device according to one embodiment of the invention comprising a sealed reservoir activated by piercing said seal.

FIG. 7 is a schematic of a device according to one embodiment of the invention comprising a spring loaded distal element on a sliding shaft with a valve mechanism.

FIG. 8 is a schematic of a device according to one embodiment of the invention comprising a sliding distal element on a sliding shaft with a valve mechanism.

FIG. 9 is a schematic of a device according to one embodiment of the invention comprising a fixed shaft and a sliding outer element connected to a valve mechanism.

FIG. 10 is a schematic of a device according to one embodiment of the invention comprising a sealing element spring loaded about a main shaft.

FIG. 11 is a schematic of a device according to one embodiment of the invention comprising a separate sealing mechanism disposed upon the surface of the tissues and an injecting element inserted therethrough.

FIG. 12 is a schematic depiction of a device performing injections into the suprachoroidal and subretinal spaces.

FIG. 13 is a schematic of a device according to one embodiment of the invention comprising an access port on a trocar.

FIG. 14 is a schematic depiction of an access port placed in suprachoroidal space with a device.

FIG. 15 is a schematic depiction of a main shaft of a device according to the invention with a beveled tip and the tissue contacting surface of the device.

FIG. 16 is a graph of the results of the test described in Example 13.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention provides methods and devices to access the suprachoroidal space or sub-retinal space in an eye via a minimally invasive transconjunctival approach to eliminate the need for dissection and subsequent suture closure of the dissection. The devices may also be used after a partial dissection, for example after dissection of the outer scleral layer of the eye, whereby the device is used within the dissection to access the suprachoroidal space or the sub-retinal space. Specifically, the invention provides devices that advantageously may be used in an operating room- or treatment room based setting, to allow for the delivery of substances to the suprachoroidal space or sub-retinal space. Of particular utility is the use of the device to deliver drugs or drug containing materials which provide sustained availability of the drug to the eye. Drugs injected with the device to the suprachoroidal space are useful for treating the choroid and through the vasculature of the choroid, the inner tissues of the eye. Drugs injected with the device to the sub-retinal space are useful for treating the retinal pigment epithelia and the sensory retina. Some examples include polymer drug release materials in the form of injectable filaments or microspheres, or drugs with limited solubility that would provide slow release of drug to the eye. Limited solubility steroids such as triamcinolone acetonide or loteprednol etabonate are steroids which may be injected into the suprachoroidal in a suspension formulation.

The devices comprise an elongated body with a distal and a proximal ends, where the device is held by the operator at the proximal end. The distal end may be configured to penetrate the conjunctiva and the sclera, but not the choroid to access the suprachoroidal space. Alternatively, the distal end may be configured to penetrate the conjunctiva, sclera, and the choroid but not the retina to access the sub-retinal space. The device may contain substances to be delivered through the distal end once placed into the suprachoroidal or sub-retinal spaces. Alternatively, the proximal end may be configured to receive apparatus for the delivery of substances such as a syringe. The devices may also be adapted to place a thin-walled sleeve, as a port or introducer, into the suprachoroidal space or sub-retinal space to allow for subsequent placement and advancement of cannulae or catheters.

In certain preferred embodiments, the device is adapted to limit penetration depth and/or to safely displace the choroid or retina away from the overlying tissue, thereby allowing the distal tip to penetrate into the suprachoroidal space or sub-retinal space, but preventing the distal tip from penetrating or causing damage to the choroid or retina itself. Displacement-limiting or guarding elements may be provided through mechanical or fluidic mechanisms to provide a forward (distally) directed force to the tissues in the eye at the distal tip of the device. The guarding elements may be self-activated by the device or manually activated by the surgeon at the appropriate time. In conjunction with a fluidic mechanism acting as a guarding element, the device may incorporate a sealing element directed at the site of penetration of the eye to prevent leakage of the fluidic element that might cause undesired reduction of the degree of intended displacement of the underlying choroid or retina.

As shown in FIG. 1, the eye 1 is a globe with two main sections, the anterior segment containing the cornea 2, iris 3, ciliary body 4 and lens 5; and the posterior segment containing the choroid 6, retina 7 and vitreous 8. The outer shell of the eye is comprised of four main layers, said layers from outside to inside are: the conjunctiva, the thin, loosely adhered outer cover of the eye; the sclera 9, the white collagenous tissue making up the major structural component of the eye; the choroid 6, the vascular layer of the eye; and the retina 7, the sensory layer of the eye. The two targets being assessed by the invention are the potential space between the sclera and the choroid, the suprachoroidal space 10, and the potential space between the retina and the choroid, the sub-retinal space 11.

In one embodiment (FIG. 2), the device according to the invention comprises a main shaft 12 with a distal end and a proximal end in internal communication with each other, such as, through a lumen 15. The distal end may comprise a beveled, sharpened tip 13 configured to penetrate ocular tissues with a minimum amount of force to create a tract or passage in the sclera. Tip 13 may comprise a point, a single bevel or multiple bevel surfaces. Bevels (the angle swept by the surfaces with the pointed tip at the apex) in the range of 10°-30° are preferred. The proximal end may comprise attachment receiver 14 such as a female Luer connector to allow for attachment of a syringe or other delivery apparatus. The main shaft 12 may comprise a hollow tube with a lumen 15. The shaft may have an outer diameter in the range of 41 gauge (0.0028 inch, 0.071 mm) to 20 gauge (0.035 inch, 0.89 mm) and an inner lumen diameter in the range of 0.002 inch (0.05 mm) to 0.023 inch (0.58 mm). The tube may comprise a metal such as tungsten, Nitinol (nickel-titanium alloy) or stainless steel; or a polymer such as polyetheretherketone (PEEK), polycarbonate, nylon or other similar structural engineering polymer. In one embodiment, the shaft may incorporate an angle or bend 16 near the distal end. The angle or bend is used to direct the distal tip from an initial approach perpendicular to the surface which allows for ease of entry, to a path which enters the suprachoroidal space or sub-retinal space approximately tangential to the curve of the eye. The bend angles may be in the range of 10°-60°, and preferably in the range of 20°-40°.

In another embodiment (FIG. 3), the shaft 12 may incorporate a mechanical guard to displace the choroid or retina from the sharpened distal tip. The mechanical guard may comprise an element 18 slideably disposed within the lumen 15 or an element disposed outside the diameter of the shaft 12. In the first instance, the guard 18 may comprise a blunt tip, elongated member 17, slideably disposed within the lumen 15 of the main shaft, having the guard distal tip extending beyond the distal tip of the main shaft and connected to the body of the device by a compression spring 19. The guard member 17 is spring loaded in a manner such that when the blunt device tip encounters tissues with substantial mechanical resistance, such as the sclera, the guard member is compressed backwards into the lumen, exposing the sharpened tip of the device and allowing it to penetrate tissues. During advancement within the tissues with the sharpened tip, the spring provides a forward directed force to the guard. When the distal tip encounters an open space or tissues that may be displaced such as the choroid in the case of the suprachoroidal space or the retina in the case of the sub-retinal space, the guard member 17 again extends forward due to the reduced resistance against the tip, ahead of the sharpened tip of the device and thereby displacing the tissues away from the tip of the device. The tissue displacement spring rate for the guard is in the range of about 0.3 lb/in (0.05 N/mm) to 2.8 lb/in (0.50 N/mm) and preferably in the range of 4.6 lb/in (0.8 N/mm) to 1.4 lb/in (0.25 N/mm). The guard member may have a configuration to allow the flow of fluid through the lumen of the main shaft once the guard is deployed and the underlying tissue is displaced. Alternatively, the guard may be configured as part of a removable assembly such that once the sharpened tip is in the appropriate space, the guard assembly may be removed and a delivery device, such as a syringe may be attached to the proximal end to deliver a fluid, therapeutic agent or diagnostic substance.

Referring to FIG. 4, the mechanical guard may comprise a tube 20 slideably disposed on the outside of the main shaft 12, which is also connected to the main shaft by a compressive element 21 such as a metallic or plastic spring, a polymer with elastic properties or a compressible gas reservoir. The tube is sized and configured to enter the tract or passage in the sclera with the main shaft. The device is configured such that the compressive element 21 exerts a force on the mechanical guard to provide a forward directed force at the distal end. In a similar manner to the previous embodiment described in connection with FIG. 3, when the tubular guard encounters tissue with mechanical resistance greater than the choroid or retina (e.g. sclera) the tube is displaced backwards (in the proximal direction), exposing and allowing the sharpened tip to penetrate the tissues. When the guard enters the tissues and encounters an open space or soft tissue such as the choroid or retina, it slides forward due to the reduced resistance, effectively blocking the distal tip of the device from further penetration.

In another embodiment, the guard may comprise a flowable or fluidic guard, composed of either a fluid or gas, which is delivered through the distal end of the device to provide a forward directed force and displace the choroid as the device distal tip enters the suprachoroidal space or the displacement of the retina as the distal tip enters the sub-retinal space. The guard may comprise a fluid, such as sterile water, saline, balanced salt solution, silicone oil, surgical viscoelastic, polymer solution or an ophthalmically acceptable perfluorocarbon fluid such as perfluoro-n-octane. Alternately, the guard may comprise a gas, such as air, nitrogen (N2), carbon dioxide (CO2), or gases used in ophthalmology such as sulfur hexafluoride (SF6) or octafluoropropane (C3F8). Additionally the guard may comprise the fluid or gas of a therapeutic or diagnostic formulation to be delivered. Fluid or gas volumes and pressures to sufficiently displace the tissues without overinflating the eye but allowing enough space to safely perform an injection are usefully in the range of about 10 microliters to 500 microliters volume and about 0.05 mm Hg to 52 mm Hg gauge pressures, and preferably in the range of 50 microliters to 250 microliters volume and 4 mm Hg to 30 mm Hg gauge pressure. Such a fluidic guard may be delivered through a syringe filled with the fluid or gas attached to the proximal connector.

In another embodiment (FIG. 5), the device comprises a pressurized reservoir 22 for the delivery of a precise amount of the fluidic guard. The reservoir may be configured to deliver the material at a precise pressure and flow rate to achieve displacement of the choroid or retina, while preventing over-inflation of the space. The reservoir may be adapted to be prefilled to a desired volume and pressure. This may be accomplished, for example, by incorporating entries 23 to fill the reservoir, such as injection ports, valves, heat sealable caps or similar entries to allow sterile transfer of materials to the reservoir, which may be accomplished during the manufacture of the device. The reservoir may further be adapted to allow controlled access to the main shaft lumen to allow for the injection of the contents of the reservoir to the target site. Access may be achieved by a septum 24, seal or plug at the distal end of the reservoir, configured to accommodate an activating mechanism of the device. In another embodiment, the reservoir may be configured to deliver a therapeutic or diagnostic substance with a flowable material to act as a fluidic guard.



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stats Patent Info
Application #
US 20120271272 A1
Publish Date
10/25/2012
Document #
13273775
File Date
10/14/2011
USPTO Class
604500
Other USPTO Classes
604263, 604198, 604244, 604247, 604257, 604117
International Class
/
Drawings
9


Dissection


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