WO2016187436A1 - Multifocal, electromagnetic treatment of ocular tissues - Google Patents

Abstract

The present invention is directed generally to medical devices, systems, and methods, particularly for treatment of an eye. In particular, embodiments of the present invention are directed toward a handheld device with a cylindrical extension with a contacting surface for the delivery of electromagnetic energy, and more particularly to a handheld device with a cylindrical extension with a contacting surface that is used for lowering the intraocular pressure in human eyes afflicted with glaucoma or ocular hypertension. Even more specifically, the present invention is directed toward electromagnetic therapy for lowering intraocular pressure in glaucomatous eyes via transconjunctival/transcleral/translimbal ab-externo treatment with electromagnetic energy directed to the trabecular meshwork and/or the pigmented and/or non-pigmented cells of the pars plana and pars plicata and other ocular tissues.

Description

MULTIFOCAL, ELECTROMAGNETIC TREATMENT OF OCULAR TISSUES

CROSS-REFERENCE TO RELATED APPL ICATIONS

The present application claims the benefit of U.S. Provisional Patent Application No. 62/163,528, filed on May 19, 2015, which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention is directed generally to medical devices, systems, and methods, particularly for treatment of an eye. In particular, embodiments of the present invention are directed toward a handheld device with a cylindrical extension with a contacting surface for the delivery of energy, and more particularly to a handheld device with a cylindrical extension with a contacting surface that is used for lowering the intraocular pressure (IOP) in human eyes afflicted with glaucoma or ocular hypertension. Even more specifically, the present invention is directed toward electromagnetic therapy for lowering IOP in glaucomatous eyes via transconjunctival/transcleral/translimbal ab-externo treatment with electromagnetic energy directed to the trabecular meshwork and/or the pigmented and/or non-pigmented cells of the pars plana and pars plicata and other ocular tissues.

BACKGROUND OF THE INVENTION

Glaucoma is a leading cause of blindness. Glaucoma involves the loss of retinal ganglion cells in a characteristic pattern of optic neuropathy. Untreated glaucoma can lead to permanent damage of the optic nerve and resultant visual field loss, which can progress to blindness. The loss of visual field due to glaucoma often occurs gradually over a long time and may only be recognized when the loss is already quite advanced. Once lost, this damaged visual field can never be recovered.

Raised intraocular pressure (IOP) is a significant risk factor for developing glaucoma. IOP is a function of production of aqueous humor by the ciliary body of the eye and its drainage through the trabecular meshwork and all other outflow pathways including the uveoscleral pathway. Aqueous humor is a complex mixture of electrolytes, organics solutes, and other proteins that supply nutrients to the non-vascularized tissues of the anterior chamber of the eye. It flows from the ciliary bodies into the posterior chamber, bounded posteriorly by the lens and the ciliary zonule and bounded anteriorly by the iris. Aqueous humor then flows through the pupil of the iris into the anterior chamber, bounded posteriorly by the iris and anteriorly by the cornea. In the conventional aqueous humor outflow path, the trabecular meshwork drains aqueous humor from the anterior chamber via Schlemm's canal into scleral plexuses and the general blood circulation. In open angle glaucoma there is reduced flow through the trabecular meshwork. In angle closure glaucoma, the iris is pushed forward against the trabecular meshwork, blocking fluid from escaping.

Uveoscleral outflow is a non-conventional pathway that is assuming a growing importance in the management of glaucoma. In uveoscleral outflow, aqueous humor enters the ciliary muscles from the anterior chamber and exits through the supraciliary space and across the anterior or posterior sclera. Uveoscleral outflow may contribute significantly to total aqueous humor outflow.

Currently, glaucoma therapies aim to reduce IOP by either limiting the production of aqueous humor or by increasing the outflow of aqueous humor. Medications such as beta-blockers, carbonic anhydrase inhibitors, etc., are used as the primary treatment to reduce the production of aqueous humor. Medications may also be used as the primary therapy to increase the outflow of the aqueous humor. Miotic and cholinergic drugs increase the trabecular outflow, while prostaglandin drugs, for example, Latanoprost and Bimatoprost, increase the uveoscleral outflow. These drugs, however, are expensive and have undesirable side effects, which can cause compliance-dependent problems over time.

Surgery may also be used to increase the outflow or to lower the production of aqueous humor. Laser trabeculoplasty is the application of a laser beam over areas of the trabecular meshwork to increase the outflow. Cyclocryotherapy and laser cyclophotocoagulation are surgical interventions over the ciliary processes to lower the production of aqueous humor. Although they may be effective, these destructive surgical interventions are normally used as a last resource in the management of glaucoma due to the risk of the severe complication of phthisis bulbi. Other adverse side effects of cyclodestructive surgical procedures may include ocular hypotony and inflammation of the anterior eye segment, which may be associated with an increased incidence of macula complications. Still other adverse side effects include transient hyphaema and exudates in the anterior chamber, uveitis, visual loss, and necrotizing scleritis.

Selective laser trabeculoplasty is a method for treating glaucoma that requires coupling the eye with a gonioscopic lens to allow for bending the light through the cornea and towards the trabecular meshwork. The laser than treats the targeted tissue and enhances fluid outflow from the eye resulting in decreased intraocular pressure. Using a gonioscopic lens can lead to injury to the cornea and patient discomfort. The routine is to target a 400um area of the meshwork with each spot treatment. Some devices use a grid of several laser spots at a time, but this is still time consuming and inaccurate since some spots do not hit the targeted area due to patient movement and poor visualization. What is needed is a device that can address these deficiencies while also fulfilling the promise of glaucoma treatment. SUMMARY OF THE INVENTION

The present invention is directed generally to medical devices, systems, and methods, particularly for treatment of an eye. In particular, embodiments of the present invention are directed toward a handheld device with a cylindrical extension with a contacting surface for the delivery of electromagnetic energy, and more particularly to a handheld device with a cylindrical extension with a contacting surface that is used for lowering the intraocular pressure (IOP) in human eyes afflicted with glaucoma or ocular hypertension. Even more specifically, the present invention is directed toward electromagnetic therapy for lowering IOP in glaucomatous eyes via transconjunctival/transcleral/translimbal ab-externo treatment with electromagnetic energy directed to the trabecular meshwork and/or the pigmented and/or non-pigmented cells of the pars plana and pars plicata and other ocular tissues.

In one embodiment, the present invention contemplates a medical device comprising: an electromagnetic energy source and a cylindrical docking system comprising a cylindrical extension with a circular contacting surface connected to an electromagnetic energy source and an electromagnetic force barrier. In one embodiment, said contacting surface comprises a toroidal surface. In one embodiment, said contacting surface comprises at least one protrusion. In one embodiment, said contacting surface comprises a plurality of protrusions. In one embodiment, said protrusions are on the bottom of said contacting surface. In one embodiment, said protrusions are curved like a lens. In one embodiment, said cylindrical extension contains a protective inner circular section. In one embodiment, the device is a hand held device. In one embodiment, said electromagnetic energy source is an external source connected to said hand held device. In one embodiment, said electromagnetic energy source is a compact electromagnetic energy source within said hand held device. In one embodiment, the device further comprises at least one positional light source to aid in properly positioning said docking system. In one embodiment, said positional light sources are used to detect tilt or decentration of the docking system. In one embodiment, said positional light sources produce a cone of light to indicate proper positioning. In one embodiment, said positional light source comprises at least one light emitting diode. In one embodiment, said docking positional light comprises a helium-neon laser. In one embodiment, wherein said docking system further comprises at least one position stabilization feature. In one embodiment, said position stabilization feature comprises a suction source. In one embodiment, said contacting surface of said docking system comprises a first circumference. In one embodiment said contacting surface of said docking system comprises a second circumference. In one embodiment, said second circumference is larger than said first circumference. In one embodiment, said device further comprises at least one alignment beam. In one embodiment, said docking system further comprises a single focusing lens in line with a prism within said cylindrical extension connected to said circular contacting surface. In one embodiment, said device consists of two parts A and B. In one embodiment, Part A is "fixed" and non-disposable. In one embodiment, Part A, containing a refractive/diffractive optic and is non-disposable. In one embodiment, said refractive/diffractive optic is attached to a rotating mechanism. In one embodiment, Part B, containing a focusing/Delivery optic, is disposable. In one embodiment, Part B comprises said contacting surface.

In one embodiment, the present invention contemplates an electromagnetic energy treatment method for an eye, the eye having a cornea and a limbus and a pre-electromagnetic energy treatment intraocular pressure, providing a medical device comprising: an electromagnetic energy source and a cylindrical docking system comprising a circular contacting surface connected to an electromagnetic energy source and an electromagnetic force barrier, the method comprising: positioning the contacting surface of said device in contact with an outer surface of the sclera of the eye wherein the contacting surface encircles and is aligned with the limbus so that delivery of electromagnetic energy to the contacting surface is oriented upon outer surface of the limbus or sclera toward the targeted tissues of the eye directing an amount of electromagnetic energy from the contacting surface to the targeted tissues of the eye. In one embodiment, said contacting surface comprises at least one protrusion. In one embodiment, said protrusions indent the tissue of the eye. In one embodiment, said protrusions provide transmission of the electromagnetic energy from said device. In one embodiment, said cylindrical docking system contains a protective inner circular section for the protection of the cornea. In one embodiment, said docking system further comprises a single focusing lens in line with a prism and a single cylindrical extension connected to said circular contacting surface. In one embodiment, said electromagnetic energy source can only be activated in the presence of pressure applied perpendicular to the contact surface against the eye to ensure proper contact with the sclera. In one embodiment, suction may be applied through the docking system to maintain position over the targeted tissue. In one embodiment, said docking system can be expanded manually to accommodate different anatomy (diameter of limbus or posterior sclera). In one embodiment, the circumference of said contacting surface of said docking system can be expanded to accommodate different targeted anatomy. In one embodiment, said docking system may be positioned anywhere along the eye wall to expose the choroid, pars plana, pars plicata and/or retina to specific wavelengths of light. In one embodiment, said docking system may be coupled with agents that enhance transparency of the sclera. In one embodiment, said docking system further comprises at least one position stabilization feature. In one embodiment, said position stabilization feature comprises a source of suction. In one embodiment, said docking system further comprises a prism. In one embodiment, said docking system further comprises a prism. In one embodiment, a scan pattern using a prism is leveraged to sequentially treat adjacent points. In one embodiment, said points are directly adjacent without spacing, spaced. In one embodiment, said points overlap. In one embodiment, said device consists of two parts A and B. In one embodiment, Part A is "fixed" and non-disposable. In one embodiment, Part A, containing a refractive/diffractive optic and is non-disposable. In one embodiment, said refractive/diffractive optic is attached to a rotating mechanism. In one embodiment, Part B, containing a focusing/Delivery optic, is disposable. In one embodiment, Part B comprises said contacting surface. In one embodiment, said treatment further comprises previous injection or implantation of materials into the ocular tissues. In one embodiment, said treatment comprises transmission of electromagnetic energy towards ocular tissues previously injected or implanted with materials to affect a treatment. In one embodiment, said materials may be attracted by said electromagnetic energy. In one embodiment, said materials may be repelled by said electromagnetic energy. In one embodiment, said materials change conformation when activated by said electromagnetic energy. In one embodiment, said materials may be attracted by locations contacted with said electromagnetic energy. In one embodiment, said materials may be repelled by locations contacted with said electromagnetic energy. In one embodiment, said materials comprise medication. In one embodiment, said medication is activated by contact with electromagnetic energy. In one embodiment, said medication is released by contact with electromagnetic energy. In one embodiment, said treatment further comprises release of medication activated by contact with electromagnetic energy in targeted tissues. In one embodiment, the electromagnetic energy delivery from said device proceeds sequentially in a circular pattern so as to treat 360 degrees of the targeted tissues of the eye. In one embodiment, the electromagnetic energy delivery from said device proceeds simultaneously in a circular pattern so as to treat 360 degrees of the targeted tissues of the eye. In one embodiment, said targeted tissue is the trabecular meshwork. In one embodiment, said targeted tissue is the pars plana and/or the pars plicata. In one embodiment, said targeted tissue is selected from the group comprising: conjunctiva, sclera, cornea, choroid, retina, sclera, and the vitreous. In one embodiment, said treatment targets material injected into or surrounding the eye wherein the electromagnetic energy can be used to "release" drug from injected materials. In one embodiment, said treatment targets material injected into or surrounding the eye wherein the electromagnetic energy can be used to "activate" drug from injected materials. In one embodiment, said treatment targets material injected into or surrounding the eye wherein the electromagnetic energy can be used to "photo-release" drug from injected materials. In one embodiment, said treatment targets material injected into or surrounding the eye wherein the electromagnetic energy can be used to direct movement of materials sensitive to electromagnetic energy. In one embodiment, said electromagnetic energy delivery amount is not sufficient to effect therapeutic photocoagulation and is sufficient to maintain a reduction from the pre-electromagnetic energy treatment intraocular pressure. In one embodiment, said electromagnetic energy delivery amount is sufficient to effect therapeutic photocoagulation. In one embodiment, said device is rotationally repositioned while maintaining an orientation of the contacting surface at each application site so that the electromagnetic energy delivery is directed to untreated tissues. In one embodiment, wherein the amount of electromagnetic energy includes multiple pulses directed to the targeted tissues. In one embodiment, said energy is delivered such that permanent-thermal damage to the tissues is avoided. In one embodiment, said energy is delivered such that permanent-thermal damage to the tissues is achieved.

In one embodiment, the present invention contemplates a handheld device comprising an electromagnetic energy source and a docking system. In one embodiment, the docking system is configured to interface with an eye limbus of the eye. In one embodiment, the docking system is configured to protect an eye cornea. In one embodiment, said docking system comprises a cylindrical extension with a circular contacting surface. In one embodiment, the docking system is attached to an electromagnetic energy source. In one embodiment, said contacting surface comprises a toroidal surface. In one embodiment, said contacting surface comprises a doughnut shape. In one embodiment, said contacting surface comprises at least one protrusion. In one embodiment, said contacting surface comprises a plurality of protrusions. In one embodiment, said protrusions are on the bottom of said contacting surface. In one embodiment, said protrusions are evenly spaced upon said contacting surface. In one embodiment, said protrusions are adjacent to each other. In one embodiment, said protrusions abut each other. In one embodiment, said protrusions are spaced a protrusion diameter apart from each other. In one embodiment, said protrusions are curved like a lens. In one embodiment, said protrusions comprise an electromagnetic energy transmission conduit. In one embodiment, said cylindrical extension contains a protective inner circular section. In one embodiment, said electromagnetic energy source is an external energy source. In one embodiment, the external energy source is connected directly through an optical cable to said hand held device. In one embodiment, said electromagnetic energy source comprises a compact electromagnetic energy source within said hand held device. In one embodiment, the device further comprises at least one docking positional light or beam. In one embodiment, the device further comprises a light emitting diode (LED) In one embodiment, said docking positional light or beam comprises a light emitting diode. In one embodiment, said docking positional light or beam comprises a laser light. In one embodiment, said docking positional light or beam comprises a helium-neon (HeNe) laser.

DEFINITIONS

To facilitate the understanding of this invention, a number of terms are defined below.

Terms defined herein have meanings as commonly understood by a person of ordinary skill in the areas relevant to the present invention. Terms such as "a", "an" and "the" are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration. The terminology herein is used to describe specific embodiments of the invention, but their usage does not delimit the invention, except as outlined in the claims.

As used herein, the term "patient" "subject" refers to any recipient of the capsular tension ring devices and/or lens or ophthalmic lens systems described herein.

As used herein, the term "Prevention" or "preventing" is used throughout the specification to include: (1) inhibiting the onset of a disease in a subject or patient which may be at risk and/or predisposed to the disease but does not yet experience or display any or all of the pathology or symptomatology of the disease, and/or (2) slowing the onset of the pathology or symptomatology of a disease in a subject or patient which may be at risk and/or predisposed to the disease but does not yet experience or display any or all of the pathology or symptomatology of the disease.

As used herein, the terms "treat" and "treating" are not limited to the case where the subject (e.g. patient) is cured and the disease is eradicated. Rather, the present invention also contemplates treatment that merely reduces symptoms, improves (to some degree) and/or delays disease progression. It is not intended that the present invention be limited to instances wherein a disease or affliction is cured. It is sufficient that symptoms are reduced.

As used herein "goniotomy" refers to a surgical procedure primarily used to treat congenital glaucoma or other types of glaucoma.

As used herein "trabecular meshwork" refers to area of tissue in the eye located around the base of the cornea, near the ciliary body, (between the scleral spur and schwalbe's line) and is responsible for draining the aqueous humor from the eye via the anterior chamber (the chamber on the front of the eye covered by the cornea). The tissue is spongy and lined by trabeculocytes; it allows fluid to drain into a set of tubes called Schlemm's canal and eventually flowing into the blood system.

As used herein "Schlemm's canal" refers to a circular channel in the eye that collects aqueous humor from the anterior chamber and delivers it into the bloodstream via the collector channels and anterior ciliary veins.

As used herein "eye diseases" refers to various conditions of the eye including, but not limited to Glaucoma— optic neuropathy, Glaucoma suspect— ocular hypertension, Primary open-angle glaucoma, Primary angle-closure glaucoma, primary open angle glaucoma, normal or low tension glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma, angle closure glaucoma (acute, subacute, chronic), neovascular or inflammatory glaucoma, ocular hypertension, and other types of glaucoma that are related to dysregulation of intraocular pressure

As used herein "hypotony" refers to reduced intraocular pressure. The statistical definition of hypotony is intraocular pressure (IOP) less than 6.5 mmHg, which is more than three standard deviations below the mean IOP. The clinical definition of hypotony is IOP low enough to result in pathology (vision loss). The vision loss from low IOP may be caused by corneal edema, astigmatism, cystoid macular edema, maculopathy, or other condition. Hypotony maculopathy is characterized by a low IOP associated with fundus abnormalities, including chorioretinal folds, optic nerve head edema in the acute setting, and vascular tortuosity.

DESCRIPTION OF THE FIGURES

The accompanying figures, which are incorporated into and form a part of the specification, illustrate several embodiments of the present invention and, together with the description, serve to explain the principles of the invention. The figures are only for the purpose of illustrating a preferred embodiment of the invention and are not to be construed as limiting the invention.

Figure 1 A&B show diagrams of the eye highlighting various anatomical features. Figure 1 A shows a side view of the eye 1 , indentifying the conjunctiva 2, limbus 3, lens 4, cornea 5, and sclera 6. Figure IB shows a direct view of the eye, indentifying the pupil 7 , iris 8, sclera 6, and limbus 3.

Figure 2 shows a general design of the invention wherein the area along the cornea 9 is shielded from electromagnetic energy. The arrow 10 indicates energy is only transmitted to the limbus of the eye 1 . The area over the cornea is protected from the electromagnetic energy 11.

Figure 3 shows one embodiment wherein the device interfaces with the eye 1 through the contacting surface 15. In this embodiment, wherein the cylindrical extension 17 of the docking system 14 further comprises a protective inner circular section 18 which shields the cornea 5 of the eye. In one embodiment, a positional light beam 19 enables proper positioning of the device relative to the eye for targeted tissues. In one embodiment, an alignment light beam 20 provides a means for targeting tissues before application of the treatment electromagnetic source.

Figure 4 shows the design for illuminating the targeted tissues.

Figure 5 shows the pattern of illumination upon the targeted tissues.

Figure 6A&B show a side approach of the device, which may be used to improve alignment. A mirror 30 is employed to redirect the beams to enable a side approach to the eye of part A 12 into part B 13. Figure 6A shows the optics of the device and Figure 6B shows an illumination pattern upon the plane of the targeted tissues.

Figure 7 A&B show a side approach may be used to improve alignment articulated with the eye. A mirror 30 is employed to redirect the beams to enable a side approach to the eye of part A 12 into part B 13. Figure 7A shows the optics of the device and Figure 7B shows an illumination pattern upon the plane of the targeted tissues. In one embodiment, said device consists of two parts A and B. In one embodiment, Part A is "fixed" and non-disposable. In one embodiment, Part A, containing a refractive/diffractive optic and is non-disposable. In one embodiment, said refractive/diffractive optic is attached to a rotating mechanism. In one embodiment, Part B, containing a focusing/Delivery optic, is disposable.

Figure 8 shows a side view of one embodiment of the contacting surface of the device that the protrusion 16 is distinct from the bottom plane of the docking system. In one embodiment, said protrusion may extend up to 1.5 millimeters from the bottom surface of the docking system.

Figure 9 shows a bottom view of one embodiment of the contacting surface 15 of the device wherein twelve protrusions 16 are shown. The electromagnetic energy goes through the protrusions as they indent the tissues of the eye to deliver the electromagnetic energy to tissues directly.

LIST OF REFERENCE NUMERALS

1 eye

2 conjunctiva

3 limbus

4 lens

5 cornea

6 sclera

7 pupil

8 iris

9 area along cornea of the eye 10 electromagnetic energy unit positioned on eye 1 with energy delivered to limbus

11 area over the cornea is protected from the electromagnetic energy

12 Part A, a "fixed" and non-disposable part

13 Part B, containing a focusing/delivery optic, is disposable

14 docking system

15 contacting surface

16 protrusion

17 cylindrical extension

18 protective inner circular section

19 positional light/positional beam

20 alignment light/alignment beam

21 stabilization feature

22 incident beam (wi_n)

23 focal spot size (wf_0CUs)

24 refractive/diffractive optic or refractive/diffractive prism

25 distance

26 distance between the focal points

27 plane of focus of electromagnetic energy

28 lens focal length

29 focusing/delivery optic or focusing/delivery lens

30 mirror DETAILED DESCRIPTON OF THE INVENTION

1. LASER TRABECULOPLASTY

Argon laser trabeculoplasty (ALT) was introduced by Wise and Witter in 1979 for the treatment of medically uncontrolled glaucoma. Soon after its introduction, the efficacy and safety of this new technique was studied in a large multicenter prospective clinical trial funded by EI, Glaucoma Laser Trial (GLT), in which eyes receiving ALT 360 degrees were compared with timolol monotherapy. From 2.5 to 5.5 years of follow-up, GLT demonstrated that trabeculoplasty was as efficacious as medical therapy in treating early POAG. Despite these favorable results, laser therapy did not replace medications as primary therapy in patients with POAG. This was partly due to attrition seen in efficacy over time and introduction of more effective glaucoma medications, namely prostaglandin analogues. The role of laser trabeculoplasty was limited and it was used either as an adjunctive therapy or as an intermediate step between failed medical therapy and surgical intervention. Interest in laser trabeculoplasty has been re-ignited in the past few years with the introduction of selective laser trabeculoplasty (SLT). A number of studies comparing ALT and SLT have shown similar IOP reduction with the two lasers. Because SLT appears to be less destructive histopathologically, a potential benefit of repeatability has been advocated. However, additional studies are needed to confirm this advantage. Currently, the SLT/MED Study is being conducted to determine how SLT compares to available medications as a primary therapy in patients with POAG. This brief review will discuss proposed mechanisms of action for trabeculoplasty, describe the surgical technique and postoperative management, and review recent literature comparing these two modalities in terms of efficacy and safety profile.

Laser trabeculoplasty, both argon laser trabeculoplasty(ALT) and selective laser trabeculoplasty (SLT) types, is used to increase aqueous outflow facility through the trabecular meshwork (TM) in order to lower intraocular pressure (IOP) in cases of ocular hypertension and glaucoma [1].

Both ALT and SLT are indicated for the treatment of ocular hypertension, primary open angle and secondary open angle glaucomas, such as pseudoexfoliation and pigment dispersion glaucoma. Steroid induced glaucoma is another possible candidate for the procedure. Narrow angle glaucoma, where the trabecular meshwork is not obstructed by iris apposition or synechiae, may also benefit. If there is synechial closure, trabeculoplasty is not advised. Contraindications are inflammatory, iridocorneal endothelial (ICE) syndrome, developmental, and neovascular glaucoma. Laser trabeculoplasty is also not effective in angle recession glaucoma due to distortion of the angle anatomy and TM scarring. If there is a lack of effect in one eye, then it is relatively contraindicated in the fellow eye.

The exact mechanism of action of laser trabeculoplasty is not well established. Various theories have been proposed as explanations for the increased aqueous outflow facility seen following successful trabeculoplasty, [2, 3] including mechanical, cellular, and biochemical theories.

The mechanical theory for ALT suggests that the laser electromagnetic energy is converted to thermal energy when it contracts the TM. Tissue contraction and scar formation result in mechanical stretching of the surrounding untreated regions of the meshwork , facilitating flow into SC with subsequent reduction in IOP [4]. However, there is some evidence that the mechanical theory may be flawed [5].

The cellular theory for ALT is based on stimulation and increased cell division and repopulation of the trabecular meshwork [6]. An increase in DNA replication and cell division following argon laser treatment have been demonstrated [7, 8]. The biochemical theory for both ALT and SLT suggests a release of chemical mediators after laser treatment that increases aqueous outflow facility. ALT has been shown to increase macrophage recruitment at the site of treatment, resulting in remodeling of the extracellular matrix and increased outflow facility [9, 10]. ALT has also been shown to increase the release of interleukin-1 and tumor necrosis factor gene expression, which upregulate matrix metalloproteinase expression and remodeling of the extracellular matrix [11, 12]. It has been demonstrated that in cultured human trabecular meshwork irradiated with the SLT laser, interleukins 8, 1 -alpha, 1-beta, and tumor necrosis factor alpha are upregulated. When the trabecular meshwork medium was added to Schlemm's canal endothelial cells, the Schlemm's canal endothelium underwent a 4-fold increase in fluid permeability [13].

2. USE OF THE DEVICE

Laser trabeculoplasty (Selective, Diode, Micropulse, Argon) involves the use of light to treat the pigmented tissue of the trabecular meshwork (TM). The light is focused on the trabecular meshwork through use of a gonioscopic lens, which allows for aligning the light directly on the TM. The gonioscopic lens is uncomfortable for the patient and may cause injury to the eye including corneal abrasion. Typically, one spot is applied to the TM and then repeated with overlapping or non-overlapping spots for 90-360 degrees in one or more sessions.

Transcleral cyclophotocoagulation is a procedure designed to coagulate the tissue that produces aqueous humor in the eye so that intraocular pressure is lowered in patients with glaucoma or ocular hypertension. The procedure usually leverages a diode laser that may or may not be micropulsed. The light is aimed across the sclera using a probe (commonly called a G probe) which transmits one spot of light at each targeted area and is then sequentially moved around the limbus to treat 180-360 degrees of the parsplana/parsplicata. Selective laser trabeculoplasty is a method for treating glaucoma that requires coupling the eye with a gonioscopic lens to allow for bending the light through the cornea and towards the trabecular meshwork. The laser than treats the targeted tissue and enhances fluid outflow from the eye resulting in decreased intraocular pressure. Using a gonioscopic lens can lead to injury to the cornea and patient discomfort. The routine is to target a 400um area of the meshwork with each spot treatment. Some devices use a grid of several laser spots at a time, but this is still time consuming and inaccurate since some spots do not hit the targeted area due to patient movement and poor visualization.

The novel approach of the current invention involves a handheld electromagnetic energy unit that is seated outside of the eye and placed over the limbal area of the eye. The limbal area is the tissue where the cornea and sclera meet. The limbal area is directly above the underlying trabecular meshwork and acts as a natural marker for where to find the trabecular meshwork without use of a gonio lens or other techniques. The device of the current invention sits along the trabecular meshwork for 360 degrees and delivers a single or multiple electromagnetic energy pulses across the limbus and towards the trabecular meshwork without need to aim or repeat electromagnetic energy spot applications over and over. In other words, a single pulse with application along the circumference of the limbus will allow for targeting the trabecular meshwork in one-step and without need to aim or use a coupling goinioscopic lens.

In one embodiment, the electromagnetic energy is within the wavelength from 400 to 900nm and can be designed as a diode or YAG based system. In one embodiment, the unit can be disposable or multiuse. In one embodiment, the electromagnetic energy system can be activated after proper pressure is placed along the limbus to ensure 100% contact with limbal tissue prior to application of the energy. In one embodiment, the positioning unit along the limbus can also serve as a conduit for application of the energy in a circular pattern along the limbus while also ensuring that no energy is transmitted to the adjacent conjunctiva and cornea.

3. PRIOR ART DEVICES

There are various devices for laser treatment of the eye for the treatment of glaucoma. One such device is described in U.S. Patent 8,945,103 [14], however this device is designed for successive spot treatment with a laser device, unlike the straightforward direct application of the current invention circular device which does not require readjustment on the eye.

4. DEVICE DESCRIPTION

The approach of the current invention involves the use of a handheld system that provides for treatment of pigmented ocular tissues. In the case of treating the trabecular meshwork, this approach obviates the need for a gonioscopic lens and instead utilizes a transclera approach through a docking system that couples with the limbal area of the eye without touching the corneal surface. The electromagnetic energy is then micro patterned onto the limbal area simultaneously or in sequential spots to allow for transmission through the limbus/sclera and onto the posteriorly located trabecular meshwork.

In the case of targeting the parsplana/parsplicate, the approach of the current invention leverages a similar system as described above, however the micropattern of spots is targeted ~2 millimeters or more posterior to the limbus so as to target the pigmented (and adjacent non-pigmented tissue through a collateral effect) tissue of the ciliary body which produces aqueous humor. The approach allows for simultaneous or sequential treatment of the underlying tissue in one session as desired by the surgeon. The targeted spots may be 360 degrees around the limbus or less according to the surgeon's preference. The present invention relates generally to the fields of ophthalmology and glaucoma surgery. More specifically, the present invention relates to a hand held device articulated to the eye to specifically deliver electromagnetic energy to the eye while protecting the cornea of the eye. This invention is in the field of medical devices and relates to the treatment of glaucoma.

In one embodiment, the present invention contemplates a medical device comprising: an electromagnetic energy source and a cylindrical docking system comprising a circular contacting surface for the delivery of electromagnetic energy for specifically interfacing with the limbus of the eye while not in contact with the cornea of the eye.

In one embodiment, the present invention contemplates a device comprising an electromagnetic energy treatment method for an eye, the eye having a cornea and a limbus and a pre-electromagnetic energy treatment intraocular pressure, the method comprising: positioning the contacting surface of said device in contact with an outer surface of the sclera of the eye wherein the contacting surface encircles and is aligned with the limbus and protects the cornea of the eye so that an electromagnetic energy delivery to the contacting surface is oriented upon outer surface of the sclera toward the targeted tissues of the eye directing an amount of pulsed electromagnetic energy from the electromagnetic energy delivery from the contacting surface to the targeted tissues of the eye. In one embodiment, said electromagnetic energy delivery from said device proceeds sequentially in a circular pattern so as to treat 360 degrees of the targeted tissues of the eye. In one embodiment, said electromagnetic energy delivery from said device proceeds simultaneously in a circular pattern so as to treat 360 degrees of the targeted tissues of the eye. In one embodiment, said device further comprises a docking positional light or beam. In one embodiment, said docking positional light or beam provides proper docking of said device on the eye. In one embodiment, said targeted tissue is the trabecular meshwork. In one embodiment, said targeted tissue is the tissue of the ciliary body, which produces aqueous humor. In one embodiment, said targeted tissue is the pars plana posterior to a pars plicata. In one embodiment, said targeted tissue is the choroid. In one embodiment, said targeted tissue is the retina. In one embodiment, said targeted tissue is the sclera. In one embodiment, said targeted tissue is the vitreous. In one embodiment, said treatment targets material injected into or surrounding the eye wherein the electromagnetic energy can be used to "release" drug from injected materials. In one embodiment, said treatment targets material injected into or surrounding the eye wherein the electromagnetic energy can be used to "activate" drug from injected materials. In one embodiment, said treatment targets material injected into or surrounding the eye wherein the electromagnetic energy can be used to "photo-release" drug from injected materials. In one embodiment, said electromagnetic energy delivery amount is not sufficient to effect therapeutic photocoagulation and is sufficient to maintain a reduction from the pre-electromagnetic energy treatment intraocular pressure. In one embodiment, said electromagnetic energy delivery amount is sufficient to effect therapeutic photocoagulation. In one embodiment, said device is rotationally repositioned while maintaining an orientation of the contacting surface at each application site so that the electromagnetic energy delivery is directed to untreated tissues. In one embodiment, the amount of pulsed electromagnetic energy includes multiple pulses directed to the targeted tissues. In one embodiment, said energy is delivered such that permanent-thermal damage to the tissues is avoided. In one embodiment, said energy is delivered such that permanent-thermal damage to the tissues is achieved.

In one embodiment, the present invention relates to a medical device comprising: an electromagnetic energy source and a cylindrical docking system comprising a circular contacting surface for the delivery of electromagnetic energy for specifically interfacing with the limbus while providing for a barrier to electromagnetic force from crossing the transparent cornea.

In one embodiment, the present invention relates to a medical device comprising: an electromagnetic energy source and a cylindrical docking system comprising a circular contacting surface for the delivery of electromagnetic energy for specifically interfacing with the limbus of the eye while not in contact with the cornea of the eye. In one embodiment, said contacting surface comprises a toroidal surface. In one embodiment, said contacting surface comprises at least one protrusion. In one embodiment, contacting surface comprises a plurality of protrusions. In one embodiment, said protrusions are on the bottom of said contacting surface. In one embodiment, said protrusions are curved like a lens. In one embodiment, said protrusions indent the tissue of the eye. In one embodiment, said protrusions provide transmission of the electromagnetic energy from said device. In one embodiment, said cylindrical extension 17 contains a protective inner circular section for the protection of the cornea. In one embodiment, said electromagnetic energy source may be provided by an external source to a hand held device. In one embodiment, said electromagnetic energy source may be provided by a compact electromagnetic energy source within said hand held device. In one embodiment, said device further comprises a light emitting diode to aid in properly positioning said docking system. In one embodiment, said light emitting diode lights are used to detect tilt or decentration of the docking system. In one embodiment, said light emitting diode lights produce a cone of light to indicate proper positioning. In one embodiment, said electromagnetic energy source can only be activated in the presence of pressure applied perpendicular to the contact surface against the eye to ensure proper contact with the sclera. In one embodiment, the docking system further comprises a stabilization feature 21. In one embodiment, said stabilization feature 21 comprises a source of suction/vacuum. In one embodiment, suction may be applied through the docking system to maintain position over the targeted tissue. In one embodiment, the docking system is expandable. In one embodiment, the docking system may be manually expanded to accommodate different anatomy (diameter of limbus or posterior sclera). In one embodiment, the docking system may be positioned anywhere along the eye wall to expose the choroid, pars plana, pars plicata and/or retina to specific wavelengths of light. In one embodiment, the docking system may be coupled with agents that enhance transparency of the sclera. In one embodiment, said device further comprises at least one alignment beam. In one embodiment, said device further comprises at a single alignment beam. In one embodiment, said device further comprises multiple alignment beams. In one embodiment, a single focusing lens is used that is in line with a prism and a single cylindrical extension of the docking system with a circular contacting surface of the docking system. In one embodiment, a scan pattern using a prism is leveraged to sequentially treat adjacent points. In one embodiment, said points are directly adjacent without spacing, spaced. In one embodiment, said points overlap.

In one embodiment, the present invention relates to a device comprising an electromagnetic energy treatment method for an eye, the eye having an optical axis, a pars plana posterior to a pars plicata and a pre-electromagnetic energy treatment intraocular pressure, the method comprising: positioning a contacting surface in contact with an outer surface of the sclera of the eye so that an electromagnetic energy delivery tip of the contacting surface is oriented transverse to the outer surface of the sclera toward the pars plana of the eye to define a treatment axis that is angularly offset from the optical axis of the eye; directing an amount of pulsed electromagnetic energy from the oriented electromagnetic energy delivery tip of the contacting surface to the pars plana of the eye to a first application site in a target region, wherein the amount is not sufficient to effect therapeutic photocoagulation and is sufficient to maintain a reduction from the pre-electromagnetic energy treatment intraocular pressure; and repositioning the contacting surface to a plurality of additional application sites while maintaining an orientation of the contacting surface at each application site so that the electromagnetic energy delivery tip is transverse to the outer surface of the sclera toward the pars plana with a treatment axis angularly offset from the optical axis of the eye; wherein the amount of pulsed electromagnetic energy includes multiple pulses directed to the pars plana at additional application sites in the target region and the energy is delivered such that permanent-thermal damage to the pars plicata is avoided.

In one embodiment, the electromagnetic energy system can only be activated after pressure in place so that proper contact with the scleral is ensured. In one embodiment, a direct approach may be used, see Figure 4 and Figure 5. In one embodiment, a side approach may be used to improve alignment, see Figure 6 and Figure 7. In one embodiment, suction may be applied through the docking system to keep in line over the targeted tissue. In one embodiment, the electromagnetic energy has an on-off duty cycle that ranges from 1% on to 50% on. In one embodiment, the docking system can be expanded manually to accommodate different anatomy (diameter of limbus or posterior sclera). In one embodiment, the docking system may be positioned anywhere along the eye wall to expose the choroid, pars plana, pars plicata and/or retina to specific wavelengths of light. In one embodiment, the docking system may be coupled with agents that enhance transparency of the sclera. In one embodiment, said device further comprises at least one alignment beam. In one embodiment, said alignment beam enables proper alignment of the electromagnetic treatment energy towards the targeted locations. In one embodiment, said alignment beam comprises a light emitting diode source. In one embodiment, said alignment beam comprises a laser light source. In one embodiment, said alignment beam comprises a helium-neon (HeNe) laser source. In one embodiment, said alignment beam is used prior to treatment to ensure alignment of the subsequent light treatment along the limbus or to other desired locations. In one embodiment, the device further comprises at least one refractive/diffractive optics component 24. In one embodiment, said refractive/diffractive optics components comprise a prism or beam splitter. In one embodiment, a single focusing lens is used that is in line with a refractive/diffractive prism and a single cylindrical extension of the docking system with a circular contacting surface is used to dock the system over the eye. In one embodiment, a scan pattern using a prism is leveraged to sequentially treat adjacent points. In one embodiment, said prism is a Wollaston prism. In one embodiment, said points may be directly adjacent without spacing, spaced or overlap. In one embodiment, said device consists of two parts A and B. In one embodiment, Part A is "fixed" and non-disposable. In one embodiment, Part A, containing a refractive/diffractive optic and is non-disposable. In one embodiment, said refractive/diffractive optic is attached to a rotating mechanism. In one embodiment, Part B, containing a focusing/Delivery optic, is disposable. In one embodiment, the focal spot size 23 (w_f0CUS) of the device can be adjusted by changing the incident beam 22 (wi_n) and/or the focal length of the lens 28. In one embodiment, the distance between the focal points may be adjusted by a) Adjusting the distance 25 (S) and/or b) Substituting for part B (For treating the TM region or the ciliary body). In one embodiment, the wavelength or temporal property of the electromagnetic energy can be adjusted for maximum absorption/alteration of the targeted tissue. In one embodiment, the targeted tissue can be tagged topically or otherwise with external fluorophores or other exogenous markers for maximum and selective absorption/alteration by the incident electromagnetic energy beam. In one embodiment, said device transmit electromagnetic energy towards ocular tissues previously injected or implanted with materials to affect a treatment. In one embodiment, said materials may be attracted by said electromagnetic energy. In one embodiment, said materials may be repelled by said electromagnetic energy. In one embodiment, said materials change conformation when activated by said electromagnetic energy. In one embodiment, said materials may be attracted by locations contacted with said electromagnetic energy. In one embodiment, said materials may be repelled by locations contacted with said electromagnetic energy. In one embodiment, said materials are selected from the group consisting of large and small molecules, biologic and non-biologic agents, antibodies and aptamers. steroids and nonsteriodal medications, nanoparticles and nanogels.

In one embodiment, the refractive/diffractive optics 24 (prism or beam splitter) includes refractive/diffractive optics that produce two beams (Figure 4). In one embodiment, rotation of the prism will move the two beams circumferentially (180 degrees) in a discrete or continuous manner to form a pattern (Figure 5) on the targeted tissue. In one embodiment, refractive/diffractive optics to form a pattern (Figure 5) on the targeted tissue (for example the trabecular meshwork and/or the ciliary body). In one embodiment, the incident beams treat two tissues simultaneously. For example, the electromagnetic energy might treat both the trabecular meshwork and the ciliary body simultaneously. In one embodiment, the device may have a side approach to improve alignment and potentially ergonomics. In one embodiment, a mirror 30 is employed to redirect the beams to enable a side approach to the eye of part A 12 into part B 13 such as shown in Figure 6A. Figure 6A shows the optics of the device and Figure 6B shows an illumination pattern upon the plane of the targeted tissues.

The general approach of the current invention involves using a docking system that rests on the surface of the eye and indents the conjunctiva 2 and sclera 6 in consecutive points circumferentially to guide the electromagnetic energy treatment around the limbal tissue. Indenting the tissue is important since it will lessen the chance of injury to the sclera 6 or conjunctiva 2 and also allow for directed treatment to the underlying tissues. The indentation can take place by use of protrusions 16 from the end of the docking system that are curved on the terminal end (convex distal surface) and can range from 100 microns to 2 millimeters in diameter and protrude out from the surface of the docking system by 0.5 to 1.5 millimeters, see Figure 8.

Figure 4 shows the design for illuminating the targeted tissues. 1) The design consists of two parts A and B. Part A is "fixed" and non-disposable. Part B, containing a focusing/Delivery optic, is disposable. 2) The focal spot size (w_f0CUS) 23 can be adjusted by changing the incident beam 22 (wi_n) and/or the focal length of the lens 28. 3) The distance between the focal points (d) can be adjusted by: a) Adjusting the distance 25 (S), b) Substituting for part B (For treating the TM region or the ciliary body). 4) The wavelength of the electromagnetic energy can be adjusted for maximum absorption/alteration of the targeted tissue, a) The targeted tissue can topically or otherwise be tagged with external fluorophores or other exogenous markers for maximum and selective absorption/alteration by the incident electromagnetic energy beam. 5) The refractive/diffractive optics 24 (prism or beam splitter) can be: a) Refractive/diffractive optics that produce two beams (Figure 4). Rotation of the refractive/diffractive optics components 24 (prism or beam splitter) will move the two beams circumferentially (180 degrees) in a discrete or continuous manner to form a pattern (Figure 5) on the targeted tissue, b) Refractive/diffractive optics to form a pattern (Figure 5) on the targeted tissue (for example the trabecular meshwork and/or the ciliary body), c) The incident beams may treat two tissues simultaneously. For example, the electromagnetic energy might treat both the trabecular meshwork and the ciliary body simultaneously. In one embodiment, the device may have a side approach to improve alignment and potentially ergonomics. In one embodiment, a mirror 30 is employed to redirect the beams to enable a side approach to the eye of part A 12 into part B 13. Figure 6A shows the optics of the device and Figure 6B shows an illumination pattern upon the plane of the targeted tissues.

The present invention contemplates an electromagnetic energy treatment method for an eye, the eye having a cornea and a limbus and a pre-electromagnetic energy treatment intraocular pressure, the method comprising: positioning the contacting surface of said device in contact with an outer surface of the sclera of the eye wherein the contacting surface encircles and is aligned with the limbus so that an electromagnetic energy delivery to the contacting surface is oriented upon outer surface of the limbus or sclera toward the targeted tissues of the eye directing an amount of electromagnetic energy from the contacting surface to the targeted tissues of the eye. In one embodiment, the invention relates to a method of treating glaucoma in a subject comprising: providing a) a subject comprising at least one eye with glaucoma, and b) a hand held device comprising an electromagnetic energy source and a docking system comprising a contacting surface for specifically interfacing with the limbus of the eye while protecting the cornea of the eye, and wherein said hand held device is interfaced with the eye of the subject wherein the contacting surface of said device is aligned such that the cornea of the eye is protected and the application of electromagnetic energy is directed to tissues of the eye to enable treatment of said glaucoma. In one embodiment, said electromagnetic energy delivery from said device proceeds sequentially in a circular pattern so as to treat 360 degrees of the targeted tissues of the eye. In one embodiment, said electromagnetic energy delivery from said device proceeds simultaneously in a circular pattern so as to treat 360 degrees of the targeted tissues of the eye. In one embodiment, said device further comprises a docking positional light or beam. In one embodiment, said docking positional light or beam provides proper docking of said device on the eye. In one embodiment, the current invention involves using a docking system that rests on the surface of the eye and indents the conjunctiva 2 and sclera 6 in consecutive points circumferentially to guide the electromagnetic energy treatment around the limbal tissue. In one embodiment, indenting the tissue is important since it will lessen the chance of injury to the sclera 6 or conjunctiva 2 and also allow for directed treatment to the underlying tissues. In one embodiment, the indentation can take place by use of protrusions 16 from the end of the docking system that are curved on the terminal end (convex distal surface) and can range from 100 microns to 2 millimeters in diameter and protrude out from the surface of the docking system by 0.5 to 1.5 millimeters. In one embodiment, said docking system may be expanded or contracted to properly align the targeting of the electromagnetic energy and to protect the cornea of the eye. In one embodiment, the diameter of said docking system ranges between 8 and 20 millimeters in diameter. Not limiting the docking system to any particular embodiment, said docking system may comprise an interchangeable section which can be made with various diameters; a plurality of adjustable arcs; two half circles; a plurality of protrusions interspaced with adjustable material between the protrusions; and different sized contacting surfaces for different targeted tissues and sizes of eyes. In one embodiment, the device further comprises at least one docking positional light or beam. In one embodiment, said docking positional light or beam provides proper docking of said device on the eye. In one embodiment, the device further comprises a light emitting diode (LED) to aid in properly positioning said docking system. In one embodiment, said docking positional light or beam comprises a light emitting diode. In one embodiment, said docking positional light or beam comprises a laser light. In one embodiment, said docking positional light or beam comprises a helium-neon (HeNe) laser. In one embodiment, said docking positional light or beam is used to detect tilt or decentration of the docking system. In one embodiment, the cone of light will indicate proper positioning. In one embodiment, the electromagnetic energy system can only be activated after pressure in place so that proper contact with the scleral is ensured. In one embodiment, said electromagnetic energy treatment comprises a simultaneous application of electromagnetic energy through the contacting surface in a circular pattern. In one embodiment, said electromagnetic energy treatment comprises a sequential application of energy for the through the contacting surface in a circular pattern. In one embodiment, the electromagnetic energy is delivered through a spinning prism to produce a sequential application of energy for the through the contacting surface in a circular pattern. In one embodiment, said electromagnetic energy treatment can be segmental (turn some clock hours on and others off). In one embodiment, said electromagnetic energy treatment can provide for simultaneous treatment of multiple spots or sequential treatment of multiple spots. In one embodiment, said docking system may be positioned anywhere along the eye wall to expose the choroid, pars plana, pars plicata and/or retina to specific wavelengths of light. In one embodiment, said docking system may be coupled with agents that enhance transparency of the sclera. In one embodiment, said agent comprises glycerin. In one embodiment, said treatment further includes a wetting fluid for the interface of the contacting surface of the device and the eye of the subject. In one embodiment, said wetting fluid comprises water. In one embodiment, said treatment further includes an anesthetic medication for the eye of the subject during treatment. In one embodiment, said medication comprises a lidocaine gel. In one embodiment, said treatment further comprises previous injection or implantation of materials into the ocular tissues. In one embodiment, said treatment comprises transmission of electromagnetic energy towards ocular tissues previously injected or implanted with materials to affect a treatment. In one embodiment, said materials may be attracted by said electromagnetic energy. In one embodiment, said materials may be repelled by said electromagnetic energy. In one embodiment, said materials change conformation when activated by said electromagnetic energy. In one embodiment, said materials may be attracted by locations contacted with said electromagnetic energy. In one embodiment, said materials may be repelled by locations contacted with said electromagnetic energy. In one embodiment, said materials comprise medication activated by contact with electromagnetic energy. In one embodiment, said materials comprise medication released by contact with electromagnetic energy. In one embodiment, said treatment further comprises release of medication activated by contact with electromagnetic energy in targeted tissues. In one embodiment, said materials are selected from the group consisting of large and small molecules, biologic and non-biologic agents, antibodies and aptamers. steroids and nonsteriodal medications, nanoparticles and nanogels. In one embodiment, said device further comprises at least one alignment beam. In one embodiment, said alignment beam enables proper alignment of the electromagnetic treatment energy towards the targeted locations. In one embodiment, said alignment beam comprises a light emitting diode source. In one embodiment, said alignment beam comprises a laser light source. In one embodiment, said alignment beam comprises a helium-neon (HeNe) laser source. In one embodiment, said alignment beam is used prior to treatment to ensure alignment of the subsequent light treatment along the limbus or to other desired locations. In one embodiment, a single focusing lens 29 is used that is in line with a prism 24 and a single positioning cylindrical extension 17 with a circular contacting surface 15 is used to dock the system over the eye 1 . In one embodiment, a scan pattern using a prism is leveraged to sequentially treat adjacent points. In one embodiment, points may be directly adjacent without spacing, spaced or overlap.

While not limiting the present invention to any particular type of electromagnetic energy or electromagnetic energy source, the current invention may use diode lasers, fiber lasers, or solid-state lasers with wavelengths ranging from 400 nm to 1100 nm.

The present invention contemplating embodiments comprising multifocal, electromagnetic treatment of ocular tissues, are well adapted to attain the ends and advantages mentioned as well as those that are inherent therein. The particular embodiments disclosed above are illustrative only, as the present invention may be modified and practiced in different but equivalent manners apparent to those skilled in the art having the benefit of the teachings herein. Furthermore, no limitations are intended to the details of construction or design as herein shown. It is therefore evident that the particular illustrative embodiments disclosed above may be altered or modified and all such variations are considered within the scope and spirit of the present invention. Although the invention has been described with reference to these preferred embodiments, other embodiments can achieve the same results. The entire disclosures of all applications, patents, and publications cited above, and of the corresponding application are hereby incorporated by reference.

REFERENCES:

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Tonographic Outflow Facility: A Randomised Clinical Trial," Br. J. Ophthalmol.

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3. Brubaker, R. F. and Liesegang, T. J. (1983) "Effect of Trabecular Photocoagulation on the Aqueous Humor Dynamics of the Human Eye," Am. J. Ophthalmol. 96(2), 139-147.

4. van der Zypen, E. et al. (1979) "Morphologic Studies About the Efficiency of Laser

Beams Upon the Structure of the Angle of the Anterior Chamber. Facts and Concepts Related to the Treatment of the Chronic Simple Glaucoma," Int. Ophthalmol. I, 109-122.

5. Van Buskirk, E. M. et al. (1984) "Argon Laser Trabeculoplasty. Studies of Mechanism of Action," Ophthalmology 91(9), 1005-1010.

6. Acott, T. S. et al. (1989) "Trabecular Repopulation by Anterior Trabecular Meshwork Cells after Laser Trabeculoplasty, " Am. J. Ophthalmol. 107(1), 1-6.

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9. Parshley, D. E. et al. (1995) "Early Changes in Matrix Metalloproteinases and Inhibitors after in vitro Laser Treatment to the Trabecular Meshwork," Curr. Eye Res. 14(1), 537-544. Parshley, D. E. et al. (1996) "Laser Trabeculoplasty Induces Stromelysin Expression by Trabecular Juxtacanalicular Cells," Invest. Ophthalmol. Vis. Sci. 37(5), 795-804.

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Alvarado, J. A. et al. (2005) "A New Insight into the Cellular Regulation of Aqueous Outflow: How Trabecular Meshwork Endothelial Cells Drive a Mechanism That Regulates the Permeability of Schlemm's Canal Endothelial Cells," Br. J. Ophthalmol. 89(11), 1500-1505.

Chew, P. T. K. et al. "Contact Probe for the Delivery of Laser Energy," United States Patent 8,945, 103, Application 12/261,889, filed 10/30/2008. (issued 2/3/2015).

Claims

CLAIMS: We claim:

1. A medical device comprising: an electromagnetic energy source and a cylindrical docking system comprising a cylindrical extension with a circular contacting surface connected to an electromagnetic energy source and an electromagnetic force barrier.

2. The device of claim 1, wherein said contacting surface comprises a toroidal surface.

3. The device of claim 1, wherein said contacting surface comprises at least one protrusion.

4. The device of claim 1, wherein said contacting surface comprises a plurality of protrusions.

5. The device of claim 3, wherein said protrusions are on the bottom of said contacting surface.

6. The device of claim 3, wherein said protrusions are curved like a lens.

7. The device of claim 3, wherein said cylindrical extension contains a protective inner circular section.

8. The device of claim 1, wherein said electromagnetic energy source is an external source connected to a hand held device.

9. The device of claim 1, wherein said electromagnetic energy source is a compact electromagnetic energy source within a hand held device.

10. The device of claim 1, wherein the device further comprises at least one positional light source to aid in properly positioning said docking system.

11. The device of claim 10, wherein said positional light sources are used to detect tilt or decentration of the docking system.

12. The device of claim 10, wherein said positional light sources produce a cone of light to indicate proper positioning.

13. The device of claim 10, wherein said positional light source comprises at least one light emitting diode.

14. The device of claim 10, wherein said docking positional light comprises a helium-neon laser.

15. The device of claim 1, wherein said docking system further comprises at least one position stabilization feature.

16. The device of claim 15, wherein said position stabilization feature comprises a suction source.

17. The device of claim 1, wherein said contacting surface of said docking system comprises a first or second circumference, wherein said second circumference is larger than said first circumference.

18. The device of claim 1, wherein said device further comprises at least one alignment beam.

19. The device of claim 1, wherein said docking system further comprises a single focusing lens in line with a prism within said cylindrical extension connected to said circular contacting surface.

20. An electromagnetic energy treatment method for an eye, the eye having a cornea and a limbus and a pre-electromagnetic energy treatment intraocular pressure, providing a medical device comprising: an electromagnetic energy source and a cylindrical docking system comprising a circular contacting surface connected to an electromagnetic energy source and an electromagnetic force barrier, the method comprising: positioning the contacting surface of said device in contact with an outer surface of the sclera of the eye wherein the contacting surface encircles and is aligned with the limbus so that delivery of electromagnetic energy to the contacting surface is oriented upon outer surface of the limbus or sclera toward the targeted tissues of the eye directing an amount of electromagnetic energy from the contacting surface to the targeted tissues of the eye.

21. The method of claim 20, wherein said contacting surface comprises at least one protrusion.

22. The method of claim 21, wherein said protrusions indent the tissue of the eye.

23. The method of claim 21, wherein said protrusions provide transmission of the electromagnetic energy from said device.

24. The method of claim 20, wherein said cylindrical docking system contains a protective inner circular section for the protection of the cornea.

25. The method of claim 20, wherein said docking system further comprises a single focusing lens in line with a prism and a single cylindrical extension connected to said circular contacting surface.

26. The method of claim 20, wherein said electromagnetic energy source can only be activated in the presence of pressure applied perpendicular to the contact surface against the eye to ensure proper contact with the sclera.

27. The method of claim 20, wherein suction may be applied through the docking system to maintain position over the targeted tissue.

28. The method of claim 20, wherein said docking system can be expanded manually to accommodate different anatomy (diameter of limbus or posterior sclera).

29. The method of claim 20, wherein the circumference of said contacting surface of said docking system can be expanded to accommodate different targeted anatomy.

30. The method of claim 20, wherein said docking system may be positioned anywhere along the eye wall to expose the choroid, pars plana, pars plicata and/or retina to specific wavelengths of light.

31. The method of claim 20, wherein said docking system may be coupled with agents that enhance transparency of the sclera.

32. The method of claim 20, wherein said docking system further comprises at least one position stabilization feature.

33. The method of claim 20, wherein said position stabilization feature comprises a source of suction.

34. The method of claim 20, wherein said docking system further comprises a prism.

35. The method of claim 34, wherein a scan pattern using a prism is leveraged to sequentially treat adjacent points.

36. The method of claim 35, wherein said points are directly adjacent without spacing, spaced.

37. The method of claim 35, wherein said points overlap.

38. The method of claim 20, wherein said treatment further comprises previous injection or

implantation of materials into the ocular tissues.

39. The method of claim 38, wherein said treatment comprises transmission of electromagnetic energy towards ocular tissues previously injected or implanted with materials to affect a treatment.

40. The method of claim 39, wherein said materials may be attracted by said electromagnetic energy.

41. The method of claim 39, wherein said materials may be repelled by said electromagnetic energy.

42. The method of claim 39, wherein said materials change conformation when activated by said electromagnetic energy.

43. The method of claim 39, wherein said materials may be attracted by locations contacted with said electromagnetic energy.

44. The method of claim 39, wherein said materials may be repelled by locations contacted with said electromagnetic energy.

45. The method of claim 39, wherein said materials comprise medication.

46. The method of claim 45, wherein said medication is activated by contact with electromagnetic energy.

47. The method of claim 45, wherein said medication is released by contact with electromagnetic energy.

48. The method of claim 45, wherein said treatment further comprises release of medication

activated by contact with electromagnetic energy in targeted tissues.

49. The method of claim 20, wherein the electromagnetic energy delivery from said device proceeds sequentially in a circular pattern so as to treat 360 degrees of the targeted tissues of the eye.

50. The method of claim 20, wherein the electromagnetic energy delivery from said device proceeds simultaneously in a circular pattern so as to treat 360 degrees of the targeted tissues of the eye.

51. The method of claim 20, wherein said targeted tissue is the trabecular meshwork.

52. The method of claim 20, wherein said targeted tissue is the pars plana and/or the pars plicata.

53. The method of claim 20, wherein said targeted tissue is selected from the group comprising: conjunctiva, sclera, cornea, choroid, retina, sclera, and the vitreous.

54. The method of claim 20, wherein said treatment targets material injected into or surrounding the eye wherein the electromagnetic energy can be used to "release" drug from injected materials.

55. The method of claim 20, wherein said treatment targets material injected into or surrounding the eye wherein the electromagnetic energy can be used to "activate" drug from injected materials.

56. The method of claim 20, wherein said treatment targets material injected into or surrounding the eye wherein the electromagnetic energy can be used to "photo-release" drug from injected materials.

57. The method of claim 20, wherein said treatment targets material injected into or surrounding the eye wherein the electromagnetic energy can be used to direct movement of materials sensitive to electromagnetic energy.

58. The method of claim 20, wherein said electromagnetic energy delivery amount is not sufficient to effect therapeutic photocoagulation and is sufficient to maintain a reduction from the pre-electromagnetic energy treatment intraocular pressure.

59. The method of claim 20, wherein said electromagnetic energy delivery amount is sufficient to effect therapeutic photocoagulation.

60. The method of claim 20, wherein said device is rotationally repositioned while maintaining an orientation of the contacting surface at each application site so that the electromagnetic energy delivery is directed to untreated tissues.

61. The method of claim 20, wherein the amount of electromagnetic energy includes multiple pulses directed to the targeted tissues.

62. The method of claim 20, wherein said energy is delivered such that permanent-thermal damage to the tissues is avoided.

63. The method of claim 20, wherein said energy is delivered such that permanent-thermal damage to the tissues is achieved.