WO2016060538A1 - Valve for compensating and regulating intraocular pressure - Google Patents

Valve for compensating and regulating intraocular pressure Download PDF

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Publication number
WO2016060538A1
WO2016060538A1 PCT/MX2014/000165 MX2014000165W WO2016060538A1 WO 2016060538 A1 WO2016060538 A1 WO 2016060538A1 MX 2014000165 W MX2014000165 W MX 2014000165W WO 2016060538 A1 WO2016060538 A1 WO 2016060538A1
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WO
WIPO (PCT)
Prior art keywords
valve
body
contact
spring
valve seat
Prior art date
Application number
PCT/MX2014/000165
Other languages
Spanish (es)
French (fr)
Inventor
Manuel Humberto Gallardo Inzunza
Original Assignee
Manuel Humberto Gallardo Inzunza
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Manuel Humberto Gallardo Inzunza filed Critical Manuel Humberto Gallardo Inzunza
Priority to US201414056018A priority Critical
Priority to US14/056,018 priority
Publication of WO2016060538A1 publication Critical patent/WO2016060538A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery

Abstract

The invention relates to a valve for compensating and regulating intraocular pressure, said valve being fitted to the cornea of the eye, and comprising: a valve body that has a valve seat on one end; a mobile element that is in contact with the valve seat under normal intraocular pressure conditions in the eye, said mobile element being designed such that it can separate from the valve seat when the intraocular pressure exceeds an intraocular pressure limit in order to allow the flow of aqueous humour outside the valve; and an element for keeping the mobile element in contact with the valve seat.

Description

COMPENSATING PRESSURE AND THROTTLE

INTRAOCULAR

FIELD OF THE INVENTION

The present invention relates to devices for use in treatment of glaucoma, and specifically to a device for reducing intraocular pressure.

BACKGROUND OF THE INVENTION

Glaucoma is an eye disease that is characterized as a neuropathy in which various mechanisms causing damage or death of ganglion cells, one of the important factors and so far controllable factor is the intraocular pressure involved, as such intent it is to keep it at a normal level. One theory of damage to cells is caused by elevated intraocular pressure which by causing mechanical theory compression of nerve fibers and consequently optic nerve damage, which can lead certainly gradually irreversible damage ganglion cells, nerve fibers and optic nerve atrophy and consequently reducing damage and visual field to be able to reach completely lose.

The front of the eye is filled with a clear fluid called aqueous humor, which is produced mostly in cilares processes that lie behind the iris. It leaves (is displaced) eye through channels in the front of it, in an area called the anterior chamber angle or simply the angle.

A normal eye is generally considered an intraocular pressure (10-20 mm Hg) as the appropriate normally by the circulation within the eye of aqueous humor, which is secreted from the ciliary body, it passes through the pupil into the anterior chamber of the eyeball, and is filtered out of the eyeball via the trabeculum and to Schlemm's Canal. When the excretory aqueous humor is blocked, the aqueous humor can not get out of the eyeball at an adequate rate, the IOP rises, the eyeball becomes hard, and direct damage occurs to further develop atrophy optic nerve which Glaucoma is called. A characteristic optic neuropathy develops, resulting in progressive death of retinal ganglion cell, restriction of the visual field and ultimately blindness occurs. Advanced stages of the disease are also characterized by significant pain.

Glaucoma treatment, if initiated early in the course of the disease, can prevent further deterioration and preserve most of the ocular functions. The goal of glaucoma treatment is to reduce intraocular pressure to a level that is considered safe for the particular view, but that is not so low as to cause poor performance or retinal eye complications.

There are many different techniques for treating high intraocular pressure "divert" aqueous humor to adjacent tissues contained within the eyeball, all these under the sclera or conjunctiva, this technique is subject to the absorptive capacity of each of tissues in the liquid causing the elevated intraocular pressure is channeled.

Typical ophthalmic implants have a valve mechanism for regulating the flow of aqueous humor from the anterior chamber; defects in and / or failure of such valve mechanisms could lead to excessive loss of aqueous humor from the eyeball and possible hypotony. The implants also tend to clog over time, either from the inside by tissue, such as the iris, being sucked into the inlet, or from the outside by the proliferation of cells, for example by scarring. In addition, the typical operation of implant insertion is complicated, high-level traumatic, costly and time consuming.

US 3788327 patent shows the implant of the prior art which uses a valve mechanism for regulating the flow of aqueous humor from the eyeball toward its exterior.

Deficiency and main disadvantage of this device is the existence of a gap or cavity between the top of the release mechanism of liquid and the outlet port is located outside the eye is in direct contact with the environment and eyelids; and it said cavity is highly prone to sedimentation of organic and inorganic matter to restrict or prevent the free movement of the release mechanism and / or generate an obstruction (clogging) in the outlet duct of the aqueous humor, which will result in deficiency in performance and capacity of drainage of aqueous humor and causing increased pressure ntraocular.

The operation of this device and drainage capacity is unsafe as it is conditioned to freedom of movement in the release mechanism, to free fluid conduction and the lack of obstacles in the duct that leaves the aqueous humor towards the outside of the eye and It does not have any mechanism or measures to prevent the formation of these restrictions and / or obstructions.

Another drawback or deficiency device is in its high feasibility of establishing bacterial colonies in the cavity between the top of the release mechanism of liquid and the outlet port is located outside the eye, as this duct does not It has no mechanism or measure to prevent the formation and accumulation of bacteria as well as their own eye secretions.

This device has a high risk of endophthalmitis, because when plugging the duct that exists in the top of the release mechanism will cause a stagnation of aqueous humor inside and thus occur bacteria find here a favorable niche for its rapid development and admission into the eye.

As stated above, defects in and / or failure in the mechanism and drain valve could lead to increased intraocular pressure.

The device of the invention is not subject to the absorption capacity of any tissue and perform an eviction of aqueous humor unobstructed between its mechanism and outside, and that the implantation process is as smooth as possible, if permitted by surgery alone ambulatory, is why the device or valve of the invention is supported in its simplicity of design and components; the valve comprises an inner part or chassis and a shaft which is moved outward on the corneal surface (on the epithelium), the valve stem is subject to a strain caused by a compression spring or repulsion between two permanent magnets, this spring or magnetic repulsion are calibrated to a given (10-20 mm Hg) pressure, and when the eyeball reaches a value of greater than spring or repulsion voltage, achieves the movement of the rod out of the cornea, for so this way drain out aqueous humor of the eye causing elevated intraocular pressure. Once the pressure is regulated, the rod returns to its initial position sealing the valve and preventing any ingress of foreign to the eye (dust, microorganisms etc.) objects.

There are clear and precise advantages between the device of the invention and devices stage of technique:

- The regulation of the pressure is always constant and the flow of aqueous humor is free of obstacles.

- Their smooth outer surface allows superior cleaning and constant lubrication by the natural movement of the eyelids to prevent sludge formation and accumulation of bacteria.

- Lack of internal and external cavities that will prevent sludge formation and accumulation of bacteria. - The drainage mechanism is always free and has no restrictions on their movement which has no operating conditions.

'This type of configuration allows achieving laminar aqueous humor through the walls of the device to achieve a sweeping effect and thus prevent adherence of bacterial strains flow.

The present invention provides a compensating and pressure regulating valve intraocular installed in a cornea of ​​an eye, comprising: a valve body having a valve seat at one end; a movable member is in contact with the valve seat under normal intraocular pressure in the eye, the movable member is configured such that it can be separated from the valve seat when the intraocular pressure exceeds a limit pressure Intraocular; and means for maintaining the plunger in contact with the valve seat. The valve body has an outer portion with fasteners for retaining the valve to the cornea and the intraocular pressure limit is 10 to 20 mm Hg.

In a first embodiment the element for maintaining the plunger in contact with the valve seat is a spring positioned in an inner portion of the valve body, and the movable member is a rod comprising a tubular body having an internal channel therein the stem has at its upper perforations to allow egress of aqueous humor out of the valve.

In a second embodiment the element for maintaining the plunger in contact with the valve seat is constituted by two permanent magnets with the same polarity placed in an inner portion of the valve body and the movable member is a rod comprising a tubular body with an internal channel therein, the stem has on its upper perforations to allow egress of aqueous humor out of the valve.

In a third embodiment the movable member is a rod comprising a tubular body having an internal channel therein and means for maintaining the plunger in contact with the valve seat is constituted by two springs placed in contact with one end of the body opposite the end where valve seat and a ring is located in the stem valve, the stem has on its upper perforations to allow egress of aqueous humor out of the valve.

In a fourth embodiment the means for maintaining the plunger in contact with the valve seat is a spring having first and second ends, the spring is disposed in an inner portion of the valve body, and the movable member is a head It is having at its bottom a ring to hold a first end of the spring; the second end of the spring is fixed to a fastening element located on the inside of the valve body.

BRIEF DESCRIPTION OF THE FIGURES

To give a better understanding of the invention, there follows a description thereof is provided, along with the accompanying drawings, in which: Figure 1 is a sectional view of an eye showing the location of the valve shown of the invention;

Figure 2 shows a side view of the valve of the invention in a first embodiment;

Figure 3 shows a longitudinal sectional view of the first embodiment of the valve of the invention;

4 shows a side view of the valve of the invention in a second embodiment;

Figure 5 shows a longitudinal sectional view of the second embodiment of the valve of the invention;

6 shows a side view of the valve of the invention in a third embodiment;

Figure 7 shows a longitudinal sectional view of the third embodiment of the valve of the invention;

8 shows a side view of the valve of the invention in a fourth embodiment; Y

Figure 9 shows a longitudinal sectional view of the fourth embodiment of the valve of the invention. DETAILED DESCRIPTION OF THE INVENTION

Referring to Figure 1, an eye 10 indicates the eyeball 1 1, the optic nerve 12 and the cornea 13 in which the compensating and regulating valve is implanted intraocular pressure 14. The valve 14 allows the release shown aqueous humor of the eye to the outside when a threshold pressure at which the valve 14 is calibrated is exceeded.

A first embodiment of the compensating and pressure regulating valve 100 is illustrated intraocular in Figures 2 and 3, and comprises a valve body or frame 1 10, a stem 120 and a spring 130. The valve body 1 10 has a body tubular hollow 1 1 1 and a flange January 12 at one end of the tubular body 1 1 1. The shaft 120 comprises a tubular body 121 with an internal channel 122 having at one end a conical portion 123 which rests on a seat 1 13 also conical in the portion where the flange 1 12 in the valve body 1 10. the tubular body 121 of the stem 120 below the tapered portion 123 has radial bores 124 in communication with the internal channel 122 of the tubular body 1 1 1 of the rod 120.

The valve body 1 10 includes a spring 130 in the inside of the hollow tubular body 1 1 1, to hold the rod 120 so that the tapered portion 123 is seated in the seat 1 13 of the valve body 1 10. The tubular hollow body 1 1 1 includes fasteners 14 January gripping or retaining the valve 100 to the cornea. The spring 130 is press-fit to the rod 120 and the other end of the spring is snap fitted to the shaft but exists a gap with the shaft 120 of between 5 to 10 microns so that the rod 120 can move out of valve body 10 January.

In normal intraocular pressure (10-20 mm Hg), the valve 100 remains closed and there is no flow of aqueous humor to the outside. However when the intraocular pressure exceeds the limit to which the spring 130 is calibrated, the stem 120 is moved against the force of spring 130 and thus the tapered portion 123 of the stem 120 is separated from the seat 1 13 of valve body 10 January allowing the aqueous humor to flow through the internal channel 122 and radial bores 124 of the stem 120 making the output of humor accused the outside. Once the pressure is regulated, the rod 120 returns to its original position sealing the valve 1 00 thereby preventing any ingress of foreign to the eye (dust, microorganisms etc.) objects.

In a second embodiment, as illustrated in Figures 4 and 5, the buffer and intraocular pressure regulator valve 200 comprises a valve body 210 or armor, a stem 220 and two circular magnets (230 and 231). The valve body 210 has a hollow tubular body and a flange 21 January 212 at one end of the tubular body 21 January. The shaft 220 comprises a tubular body 221 with an internal channel 222 having at one end, a conical portion 223 which rests on a seat 213 also conical in the portion where the flange 212 on the valve body 210. The tubular stem body 220, below the tapered portion 223 has radial bores 224 in communication with the internal channel 222 of the stem 220 tubular body 221.

The valve body 210 includes a first permanent circular magnet 230 placed the inside of the hollow tubular body 21 1 at the end where the flange 212 of the valve body 210. A second permanent circular magnet 231 is placed on the stem 220 is level of the other end of the valve body 210 so that the magnets (230 and 231) are a distance apart. The polarity of the first and second manes is equal to obtain a repulsion force between them, and keep the tapered portion 223 seated in the seat 213 of the valve body 210. The tubular body 1 includes gap 21 fasteners 214 for gripping or retaining valve 200 to the cornea. The second magnet 231 is press fit to shaft 220 and the first magnet 230 is press-fitted to the stem but there is a gap with the shaft 220 of between 5 to 10 microns so that the rod 220 can move outside the body valve 210.

When intraocular pressure exceeds the limit (10-20 mm Hg) which is calibrated repulsion force, the stem 220 is moved against the force of repulsion and thus the tapered portion 223 of the stem 220 is separated from the seat 213 of the body valve 210 allowing aqueous humor to flow through the internal channel 222 and radial bores 224 of the stem 220 making the output of humor accused the outside. Once the pressure is regulated, the rod 220 returns to its original position sealing the valve 200 and preventing any entry of foreign to the eye (dust, microorganisms etc.) objects.

A third embodiment of the compensating and pressure regulating valve 300 is illustrated intraocular in Figures 6 and 7, and comprises a valve body 310, a shaft 320 and elastic lamellae or springs 330 and 331. The valve body 310 has a hollow tubular body and a flange 31 January 312 at one end of the tubular body 31 January. The shaft 320 comprises a tubular body 321 with an internal channel 322 having at one end, a conical portion 323 which rests on a seat 313 also conical in the portion where the flange 312 on the valve body 310. The tubular body 320 of the stem 321 below the tapered portion 323 has radial bores 324 in communication with the internal channel 322 of the stem 320 tubular body 321.

Between the valve body 310 opposite the flange 312 end and a ring or disk 325 located in the rod 320 there is a spring 330 to hold the rod 320 so that the tapered portion 323 is seated on the seat 313 of the body valve body 310. the tubular recess 31 1 includes fasteners 314 for gripping or retaining valve 300 to the cornea. Between the tubular hollow body Jan. 31 of the valve body 310 and the stem 320, there is a separation of between 0.5 to 3 microns so that the rod 320 can move out of the valve body 310.

In normal intraocular pressure (10-20 mm Hg), the valve 300 remains closed and there is no flow of aqueous humor to the outside. However when the intraocular pressure exceeds the limit to which the spring 330 is calibrated, the stem 320 is moved against the force of spring 330 and thus the tapered portion 323 of the stem 320 is separated from the seat 313 of the valve body 310 allowing aqueous humor flow 322 by the internal channel 324 and radial bores 320 of the rod making the output of humor accused the outside. Once the pressure is adjusted, the stem 320 returns to its original position sealing the valve 300 and preventing any entry of foreign to the eye (dust, microorganisms etc.) objects.

In a fourth embodiment, as illustrated in Figures 8 and 9, the buffer and intraocular pressure regulating valve 400 comprises a main body 410, a head 420, a spring 430. The main body 410 is tubular with an inner channel 41 1 and an element spring clip 412 and a flange 413. the main body 410 includes a fastening member 414 for gripping or retaining valve 400 to the cornea.

The head 420 comprises a conical portion 421 which rests on a seat 415 also taper at one end of the main body 410. A rear head 420 includes a collar 423 in which a first end 431 of spring 430 is secured, and a second end 432 of the spring 430 is secured to the fastener 412. the spring is the internal channel 41 of the main body 1 410.

In normal intraocular pressure (10-20 mm Hg), the valve 400 remains closed and there is no flow of aqueous humor to the outside. However when the intraocular pressure exceeds the limit to which the spring 430 is calibrated, the head 420 is moved against the force of spring 430 and thereby forming a gap between the ram 420 and the seat 415 of the main body 410 allowing humor aqueous flow through the internal channel 41 and one outlet gap formed managing mood accused the outside. Once the pressure is regulated, the head returns to its original position sealing the valve and preventing any ingress of foreign to the eye (dust, microorganisms etc.) objects.

The present invention has been described and illustrated in its preferred embodiment, however, modifications can be made, for example, geometric in valve parts, which are within the scope of the following claims.

Claims

What is claimed
1 . And a compensating control valve installed in an intraocular pressure of an eye cornea, comprising: a valve body having a valve seat at one end; a movable member is in contact with the valve seat under normal intraocular pressure in the eye, the movable member is configured such that it can be separated from the valve seat when the intraocular pressure exceeds a L imit of intraocular pressure; and means for maintaining the plunger in contact with the valve seat.
2. The valve according to claim 1, wherein the valve body has an outer portion with fasteners for retaining the valve to the cornea and the intraocular pressure limit is 10 to 20 mm Hg.
3. The valve according to claim 1, wherein the element for maintaining the plunger in contact with the valve seat is a spring positioned in an inner portion of the valve body, and the movable member is a rod comprising a tubular body having an internal channel therein, the stem has on its upper perforations to allow egress of aqueous humor out of the valve.
4. The valve according to claim 2, wherein the element for maintaining the plunger in contact with the valve seat is a spring positioned in an inner portion of the valve body, and the movable member is a rod comprising a tubular body having an internal channel therein, the stem has on its upper perforations to allow egress of aqueous humor out of the valve.
5. The valve according to claim 1, wherein the element for maintaining the plunger in contact with the valve seat is constituted by two permanent magnets with the same polarity placed in an inner portion of the valve body and the movable member is a rod comprising a tubular body having an internal channel therein, the stem has on its upper perforations to allow egress of aqueous humor out of the valve.
6. The valve according to claim 2 wherein the means for maintaining the plunger in contact with the valve seat is constituted by two permanent magnets with the same polarity placed in an inner portion of the valve body and the movable member is a rod comprising a tubular body having an internal channel therein, the stem has on its upper perforations to allow egress of aqueous humor out of the valve.
7. The valve according to claim 1, wherein the movable member is a rod comprising a tubular body having an internal channel therein and means for maintaining the plunger in contact with the valve seat is composed of two springs placed in contact with one end of the body opposite the end where valve seat and a ring is located in the stem valve, the stem has on its upper perforations to allow egress of aqueous humor out of the valve.
8. The valve according to claim 2, wherein the movable member is a rod comprising a tubular body having an internal channel therein and means for maintaining the plunger in contact with the valve seat is constituted by two springs placed in contact with one end of the body opposite the end where valve seat and a ring is located in the stem valve, the stem has on its upper perforations to allow egress of aqueous humor out of the valve.
9. The valve according to claim 1 wherein the means for maintaining the plunger in contact with the valve seat is a spring having first and second ends, the spring is disposed in an inside of the body valve, and the movable member is a head having at its bottom a ring to hold a first end of the spring; the second end of the spring is fixed to a fastening element located on the inside of the valve body.
10. The valve according to claim 2 wherein the means for maintaining the plunger in contact with the valve seat is a spring having first and second ends, the spring is disposed in an inside of the body valve, and the movable member is a head having at its bottom a ring to hold a first end of the spring; the second end of the spring is fixed to a fastening element located on the inside of the valve body.
PCT/MX2014/000165 2014-10-17 2014-10-17 Valve for compensating and regulating intraocular pressure WO2016060538A1 (en)

Priority Applications (2)

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US201414056018A true 2014-10-17 2014-10-17
US14/056,018 2014-10-17

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3788327A (en) * 1971-03-30 1974-01-29 H Donowitz Surgical implant device
SU1738279A1 (en) * 1989-12-04 1992-06-07 Туркменский Научно-Исследовательский Институт Глазных Болезней Magnetic valve for eyeball drainage
WO2003099175A1 (en) * 2002-05-29 2003-12-04 University Of Saskatchewan Technologies Inc. A shunt and method treatment of glaucoma
ES2299218T3 (en) * 1997-11-20 2008-05-16 Optonol Ltd. Flow control implant.
US20080228127A1 (en) * 2006-11-10 2008-09-18 Glaukos Corporation Uveoscleral shunt and methods for implanting same
DE102010029396A1 (en) * 2010-05-27 2011-12-01 Gudrun Brümmer-Schillke Eye implant for regulating intraocular pressure, has base body comprising turning tool contact surface at proximal end and external thread winding around axis in middle part, and liquid entry port aligned radial to axis
ES2396088T3 (en) * 2006-04-26 2013-02-19 Eastern Virginia Medical School Systems to monitor and control the internal pressure of an eye or a body part

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3788327A (en) * 1971-03-30 1974-01-29 H Donowitz Surgical implant device
SU1738279A1 (en) * 1989-12-04 1992-06-07 Туркменский Научно-Исследовательский Институт Глазных Болезней Magnetic valve for eyeball drainage
ES2299218T3 (en) * 1997-11-20 2008-05-16 Optonol Ltd. Flow control implant.
WO2003099175A1 (en) * 2002-05-29 2003-12-04 University Of Saskatchewan Technologies Inc. A shunt and method treatment of glaucoma
ES2396088T3 (en) * 2006-04-26 2013-02-19 Eastern Virginia Medical School Systems to monitor and control the internal pressure of an eye or a body part
US20080228127A1 (en) * 2006-11-10 2008-09-18 Glaukos Corporation Uveoscleral shunt and methods for implanting same
DE102010029396A1 (en) * 2010-05-27 2011-12-01 Gudrun Brümmer-Schillke Eye implant for regulating intraocular pressure, has base body comprising turning tool contact surface at proximal end and external thread winding around axis in middle part, and liquid entry port aligned radial to axis

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