Patent Grant
12274640
This is a priority patent application.
The present inventions relate to treatments for glaucoma, and more particularly, to an ocular implant for treating glaucoma.
Glaucoma is a blinding disease that is typically associated with elevation of intraocular pressure. Increased pressure in the eye can cause permanent damage to the optic nerve with loss of vision.
The eye is a complex structure made up of various tissues, including the cornea, lens, retina, and optic nerve, that work together to provide the sense of sight. The intraocular pressure in the eye is maintained by the production and drainage of aqueous humor (aqueous), a clear fluid that is produced by the ciliary body in the posterior chamber of the eye. The aqueous humor passes through the pupil and into the anterior chamber. The anterior chamber of the eye has a volume of 250 microliters. Aqueous humor then sequentially traverses through a sieve-like structure known as the trabecular meshwork and into Schlemm's canal. From Schlemm's canal, aqueous humor drains into collector channels. Aqueous humor normally drains from the anterior chamber through the trabecular meshwork of the eye and into outflow collector channels at a rate of 2 to 3 microliters per minute. Dysfunction in the pathway of aqueous humor drainage can result in elevated intraocular pressure, optic nerve damage, and progressive loss of vision.
Glaucoma is commonly caused by impaired drainage of aqueous humor at the level of the trabecular meshwork or outflow collector channels.
The effectiveness of pharmacologic treatment is limited by physiologic variations of intraocular pressure. Diurnal variation is the most notable example of physiologic fluctuation of intraocular pressure. The diurnal variation of intraocular pressure in normal subjects during daytime hours varies between 3-6 mm Hg. In patients with glaucoma, the 24-hour variation of intraocular pressure can be as much as 18 mm Hg. The pressure-lowering effect of medications applied during the day dissipates towards the end of the day and may not be present during nocturnal hours when intraocular pressure may be at its highest level.
Pharmacologic treatment for glaucoma is expensive and not available to many people who have limited income or who live in remote areas. Medications for glaucoma have significant risks for complications. Many patients with glaucoma require multiple forms of therapy to control their condition.
The present inventions provide a method and device for changing aqueous humor into gasses that dissipate into the atmosphere, thereby reducing the volume of aqueous humor in the eye and lowering the pressure in the eye.
In some aspects, the techniques described herein relate to an apparatus including an ocular implant with a curved longitudinal central axis with a bend in a curvature plane, the ocular implant including a central channel and an array of perforations along walls of the ocular implant, configured to be disposed within Schlemm's canal of an eye; a pair of electrodes lining an inside of the walls of the ocular implant; a controller electrically connected to the pair of the electrodes; and a power source within the ocular implant electrically connected to the controller.
In some aspects, the techniques described herein relate to an apparatus wherein the power source delivers electrical current to the electrodes.
In some aspects, the techniques described herein relate to an apparatus wherein the electrodes are arranged in a coil within the ocular implant.
In some aspects, the techniques described herein relate to an apparatus further including a pressure sensor electrically connecting to the controller, the pressure sensor configured to detect pressure within the ocular implant.
In some aspects, the techniques described herein relate to an apparatus further including an antenna electrically connected to the controller, said antenna configured to wirelessly communicate with a remote receiver.
In some aspects, the techniques described herein relate to an apparatus where the electrodes are made of stainless steel.
In some aspects, the techniques described herein relate to an apparatus where the ocular implant is made of polyurethane.
In some aspects, the techniques described herein relate to an apparatus further including a lumen at an end of the ocular implant, the lumen configured to receive aqueous humor from the eye.
In some aspects, the techniques described herein relate to a method including performing a fornix-based conjunctival peritomy; creating a scleral flap beneath a conjunctiva in a region of the fornix-based conjunctival peritomy; exposing Schlemm's canal; inserting a proximal end of the ocular implant into an incision into the Schlemm's canal, where the ocular implant includes a central channel and an array of perforations along walls of the implant, a pair of electrodes lining an inside of the walls of the ocular implant, a controller electrically connected to the pair of the electrodes, and a power source within the ocular implant electrically connected to the controller; suturing the scleral flap; and signaling the controller to perform electrolysis by energizing the electrodes.
In some aspects, the techniques described herein relate to a method where the signal determines that current is delivered by the power source to the electrodes.
In some aspects, the techniques described herein relate to a method where the signal from the controller to perform electrolysis regulates a level of current, a duration of the current, and a timing of the current.
In some aspects, the techniques described herein relate to a method where the perforations in the walls allow ingress of aqueous humor into the central channel of the ocular implant.
In some aspects, the techniques described herein relate to a method where the perforations in the walls allow egress of gas from the central channel of the ocular implant.
In some aspects, the techniques described herein relate to a method where the electrodes are made of aluminum.
In some aspects, the techniques described herein relate to a method where the electrodes are made of a polymer metal combination.
In some aspects, the techniques described herein relate to a method including: receiving a signal from a remote device at a controller in a ocular implant, where the ocular implant is located in Schlemm's canal of an eye, where the ocular implant includes a central channel and an array of perforations along walls of the ocular implant, a pair of electrodes lining an inside of the walls of the ocular implant, the controller electrically connected to the pair of the electrodes, a pressure sensor electrically connecting to the controller, and a power source within the ocular implant electrically connected to the controller; detecting a pressure within the ocular implant with the pressure sensor; analyzing the pressure with the controller and determining if electrolysis is required to reduce the pressure; energizing the electrodes based on a signal from the controller; monitoring the pressure with the pressure sensor until the pressure indicates that electrolysis needs to be subdued or no longer required; and reducing the energy to the electrodes based on the signal from the controller.
In some aspects, the techniques described herein relate to a method where the signal determines that current is delivered by the power source to the electrodes.
In some aspects, the techniques described herein relate to a method where the perforations in the walls allow ingress of aqueous humor into the central channel of the ocular implant.
In some aspects, the techniques described herein relate to a method where the perforations in the walls allow egress of gas from the central channel of the ocular implant.
In some aspects, the techniques described herein relate to a method where the ocular implant is made of silicone.
To easily identify the discussion of any particular element or act, the most significant digit or digits in a reference number refer to the figure number in which that element is first introduced.
All illustrations of the drawings are for the purpose of describing selected versions of the present invention and are not intended to limit the scope of the present invention.
The present document relates to an ocular implant 202 directed to the treatment of glaucoma. The described technique includes the insertion of a flexible tube-like implant 202 into Schlemm's canal 112 by utilizing an ab-externo and ab-interno canaloplasty. The implant 202 has a power supply and regulator that provides controlled electrical current to electrodes. Conversion of aqueous humor 124 to gas occurs when it is in contact with adequately charged electrodes. The implant 202 is designed to be disposed within Schlemm's canal 112 of an eye 100.
Described here is a method and implant 202 for decreasing the amount of aqueous humor 124 in the eye 100 to reduce intraocular pressure. The implant 202 consists of a flexible fenestrated implant that resides in Schlemm's canal 112. The implant 202 has an inner cylindrical wall that is lined by opposing electrodes. A source of power within the implant 202 delivers current to the aqueous humor 124 within the lumen 210 of the implant 202. Aqueous humor 124 converted into gas by means of electrolysis escapes through fenestrations in the implant 202 and passes into collector channels and into the venous plexus system where it either dissolves or is dissipated through the outer wall of the eye 100.
Aqueous Humor Fluid Dynamics
The aqueous humor 124, which is a clear fluid in the eye 100, flows through Schlemm's canal 112 as part of the eye's drainage system. The average rate of aqueous humor 124 outflow through Schlemm's canal 112 is about 2.5 microliters per minute. This outflow helps maintain the intraocular pressure within the eye 100, which is crucial for its proper function. On a daily basis, the total amount of aqueous humor 124 produced and drained is about 2.4 to 3.6 milliliters.
The aqueous humor 124 flows from Schlemm's canal 112 into the collector channels 122. The collector channels 122 are connected to the episcleral vein 106. This network of veins then transports the aqueous humor 124 into the systemic venous circulation. This is the major pathway for aqueous humor 124 drainage and is responsible for the majority of outflow from the anterior chamber 102 of the eye 100.
The conversion of aqueous humor 124 from liquid to gas, such as through evaporation, is typically negligible under normal physiological conditions. Aqueous humor 124 is contained within the eye 100 and does not normally undergo a phase change from liquid to gas in any significant quantity. The eye 100 maintains the aqueous humor 124 in a liquid state to help regulate intraocular pressure and provide nutrients to eye tissues. A change in the aqueous humor 124 from a liquid to a gas that is released from the eye 100 in a controlled manner would reduce the volume of aqueous humor in the eye and decrease intraocular pressure.
Electrolytic Conversion of Aqueous Humor
The first documented observation of electrolysis in 1800 by William Nicholson and Anthony Carlisle was reported in “A Journal of Natural Philosophy, Chemistry, and the Arts” where they reported that when a voltaic pile was connected to electrodes immersed in water, hydrogen gas evolved at the cathode, and oxygen gas evolved at the anode, effectively decomposing water into its constituent gases.
In 1834, Michael Faraday formulated two fundamental laws of electrochemical reactions. These laws form the basis of electrolysis of aqueous humor as described in this document. The first law describes the quantitative relationship between the amount of electrical charge passing through an electrolyte or fluid, and the amount of gas liberated as a result of an electrochemical reaction. Faraday's second law describes the need for ions dissolved in the fluid that is needed for electrolysis to occur. The amount of current needed for electrolysis is dependent on the capacity of the power source and the conductivity of the fluid. In the discussion herein the conductivity of aqueous humor is slightly less but still comparable with that of saline.
To determine the amount of electrical current needed to convert aqueous humor 124 to gas via electrolysis, we can refer to Faraday's laws of electrolysis. The key factors are the composition of the aqueous humor 124 (primarily water and electrolytes), and the specific chemical reactions involved in the electrolysis process.
Biochemical Calculations
The electrical current needed to achieve electrolysis is dependent on the duration over which electric current is applied, the total electric charge, electric current, and Faraday's constant (96,485 Coulombs per mole). Based on these parameters, electrolysis of 1 microliter of aqueous humor 124 would require a minimum current of approximately 0.37 milliamperes (mA).
The aqueous humor 124 flows through Schlemm's canal 112 as part of the eye's drainage system. The average rate of aqueous humor 124 outflow through Schlemm's canal 112 is about 2.5 microliters per minute, or approximately 3.6 milliliters of aqueous humor 124 each day.
Approximately 178 milliamperes (mA) of electrical current would be needed to electrolyze 1 microliter of aqueous humor 124 in one minute or 1,436 microliters in a 24-hour period of time. By comparison, a reasonable estimate is that a one-time application of 0.5% Timolol eye drops suppresses aqueous humor 124 production by approximately 0.75 microliters in one minute or 1080 microliters over a 24-hour period, assuming an average reduction rate of 30%.
Delivery of Implant for Electrolysis of Aqueous Humor
The implant 202 is an apparatus that is delivered into Schlemm's canal 112 utilizing either an approach from the outer surface of the eye 100 (ab-externo) or by means of a corneal and limbal incision (ab interno). The implant 202 contains paired electrodes that deliver current to aqueous humor 124 in the lumen 210 of the implant 202.
The wall of the implant 202 has multiple fenestrations, or perforations 204, that allow aqueous humor 124 to penetrate within the lumen 210 of the implant 202. As electrolysis is performed, aqueous humor 124 is allowed to ingress into the central channel of the implant 202, and the gas byproduct of the electrolysis is allowed to egress from the central channel of the implant 202. The lumen 210 is accessible via the distal end 208 of the implant 202. The perforations 204 do not interfere with the longitudinal placement of electrodes placed longitudinally along the inner wall of the implant 202. The electrode system is paired and located on opposite sides of the inner wall of the implant 202. Each electrode extends substantially along the inner length of the implant 202 and is between 10 microns to 250 microns in width. Alternatively, paired electrodes can be arranged as a coil that is freestanding or attached to the inner wall of the implant 202 (see
Ab-Externo Canaloplasty with Implant Insertion
The implant 202 can be delivered into Schlemm's canal 112, as seen in
Note that the implant 202 in
Ab-Interno Implant Insertion
The implant 202 can also be delivered into Schlemm's canal 112, as seen in
The implant 202 may have an outer diameter between 150 microns to about 750 microns to accommodate the wide range of diameters found in Schlemm's canal 112. The implant 202 may also be formed to have suitable internal dimensional profiles. Exemplary profiles without limitation include circular, elliptical, square, or rectangular.
The proximal tip 206 of the implant 202 contains a power source 606 such as a thin-film lithium micro-battery, solid-state lithium micro battery, miniature lithium-ion battery, coil, or micro-supercapacitor. The power source 606 may be integrated with electrodes 502 that line the internal wall of the implant 202 and a pressure sensor 602 within the lumen 210 of the implant 202. The current delivered to the electrodes 502 and the pressure sensor 602 could be regulated by a controller 604 contained within the body of the implant 202. The pressure sensor 602 is electrically coupled to the controller 604 and a transponder for converting the sensor signal to a remote receiver.
Electrodes 502 could be a parallel coil of wires that pass electricity through the aqueous humor 124, causing the electrolysis. In some embodiments, the gas from the electrolysis passes through the ports 704, then through the perforations 204, and into the collector channels and aqueous veins.
Electrodes 502 lining the internal wall of the implant are immersed with aqueous humor 124 that enters directly into the lumen 210 of the implant. Aqueous humor 124 can also flow through the perforations of the implant wall and pass into the lumen of the implant (202). Current delivered to the electrodes 502 results in electrolysis with conversion of aqueous humor 124 into gas. The pressure gradient between the aqueous humor 124 in the lumen 210 of the implant 202 and collector channels facilitates the exit of gas through the perforations of the implant 202 walls into collector channels and aqueous veins.
The electrodes 502 that line the inner walls of the implant 202 may be selected from a multiplicity of materials that includes platinum (Pt), graphite (Carbon), stainless steel, titanium (Ti), nickel (Ni), gold (Au), palladium (Pd), silver (Ag), Nitinol®, aluminum (Al), graphene, platinum gray, and polymer-based products such as polypyrrole, polystyrene sulfonate, Poly 3,4-ethylenedioxythiophene (PEDOT), and polymer metal combinations. The preparation of platinum gray as an electrode has been described in U.S. Pat. No. 6,794,533, incorporated herein by reference in its entirety, and its utility as a miniature biocompatible electrode exemplified in U.S. Pat. No. 2014/0222103, incorporated herein by reference in its entirety.
In the
The controller 604 may be connected to antenna 806 for sending signals to a computer or to a smartphone. In some embodiments, the communications is using the Bluetooth protocol. Other embodiments may use WiFi (IEEE 802.11). Still other embodiments may use cellular communications (commonly known as 3G, 4G, and/or 5G). Other standard or proprietary protocols could also be used.
The controller 604 could be electrically connected to the pressure sensor 602. In one embodiment, the controller 604 passes power to the pressure sensor 602. In other embodiments, the pressure sensor 602 is electrically connected to and receives power directly from power source 606. In some embodiments, the pressure sensor 602 both sends and receives signals from the controller 604. The signals may include current pressure readings and pressure sensor 602 configuration settings. In some embodiments, the pressure sensor 602 is connected to the power rail 808, and in other embodiments, it derives its power through the controller 604.
The controller 604 may also control, and may be electrically connected to, the electrodes 502. In some embodiments, the controller 604 will directly power the electrodes 502. Some controllers 604 have analog ports with sufficient power to create electrolysis directly from the chip. In other embodiments, a regulator 802 is used to regulate the power to the electrodes 502. In this case, the controller 604 is electrically connected to the electrodes 502 through the regulator 802. The regulator 802 in this embodiment electrically connects to the power source 606 (possibly through the power rail 808) to receive power and is electrically connected to the controller 604 to receive signals indicating the power characteristics to be sent to the electrodes 502. These characteristics may include voltage, current, frequency, and duration of discharge.
The electrolysis method 900 in
In block 904, the electrolysis method 900 detects the pressure of the aqueous humor 124 within the eye 100 (and thus within the implant 202) with the pressure sensor 602. The pressure sensor 602 communicates the pressure to the controller 604, either through an analog signal that an analog-digital converter (ADC) transforms into a digital value. The ADC could be in the pressure sensor 602, the controller 604, or a stand-alone device.
In block 906, the electrolysis method 900 analyzes the pressure with the controller 604 and determines if electrolysis is required to reduce the pressure by comparing the pressure to a threshold. If electrolysis is not needed, loop back to block 904. Otherwise, continue to block 908.
In block 908, the electrolysis method 900 energizes the electrodes 502 based on a signal from the controller 604. The signal could be power directly set on a pin of the controller 604. In other embodiments, a pin on the controller 604 triggers a relay to place power from power rail 808 into the electrodes 502. In still other embodiments, the controller pin signals a regulator 802 to provide power to the electrodes 502. In still another embodiment, the controller 604 provides an analog value powering the electrodes 502. In some embodiments, the controller 604 regulates the level of current sent to the electrodes 502. In some embodiments, the controller 604 regulates the duration of the current sent to the electrodes 502. In some embodiments, the controller 604 regulates the timing of the current sent to the electrodes 502.
In block 910, the electrolysis method 900 monitors the pressure with the pressure sensor 602 until the pressure indicates that electrolysis is no longer required. The monitoring requires frequent sampling of the pressure and transmitting the pressure value back to the controller 604. The controller 604 compares the pressure reading to either a fixed threshold value or to a threshold value received from the remote device.
In block 912, when the pressure is below the threshold, the controller 604 de-energizes the electrodes 502 by resetting the signal. The electrolysis method 900 then returns to block 904 to wait until the pressure sensor 602 and controller 604 determine that the pressure is above the threshold.
It is to be understood that the configurations and/or approaches described herein are exemplary in nature, and that these specific embodiments or examples are not to be considered in a limiting sense, because numerous variations are possible. The specific routines or methods described herein may represent one or more of any number of processing strategies.
The foregoing devices and operations, including their implementation, will be familiar to, and understood by, those having ordinary skill in the art. This specification contains numerous dimensions, all of which could be changed without deviating from the inventions herein.
The above description of the embodiments, alternative embodiments, and specific examples, are given by way of illustration and should not be viewed as limiting. Further, many changes and modifications within the scope of the present embodiments may be made without departing from the spirit thereof, and the present inventions include such changes and modifications.
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