WO1996020742A1 - Improve eye implant for relief of glaucoma - Google Patents
Improve eye implant for relief of glaucoma Download PDFInfo
- Publication number
- WO1996020742A1 WO1996020742A1 PCT/US1995/000134 US9500134W WO9620742A1 WO 1996020742 A1 WO1996020742 A1 WO 1996020742A1 US 9500134 W US9500134 W US 9500134W WO 9620742 A1 WO9620742 A1 WO 9620742A1
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- Prior art keywords
- implant
- eye
- suprachoroidal space
- end section
- section
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
- A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F9/00—Methods 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
- A61F9/007—Methods or devices for eye surgery
- A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
Definitions
- This invention relates to a device and method for draining fluid from the limbal angle of the eye to the suprachoroidal space, for example to relieve glaucoma or to convey medicament from the anterior chamber to the posterior segment of the eye.
- the invention also relates to a method for installing such a device in the eye.
- Glaucoma is a condition of the eye in which the normal body mechanisms for removing or draining off fluid generated in the eye do not operate effectively, with the result that the internal pressure of the eye rises excessively. With the passage of time, this excessively high internal pressure adversely affects the optic nerve, first causing a severe reduction in peripheral vision and finally complete blindness, unless the condition is successfully treated.
- Another object is to provide such an eye implant suitable for use in relieving eye pressure due to glaucoma, or for delivering medication to the posterior segment, and which will remain effective over long periods of time.
- a further object is to provide such an implant which will not be substantially degraded or blocked through overgrowth by surrounding tissue.
- Still another object is to provide an implant and method of installing it which causes the implant to remain fixed in position, long after installation, without requiring that the implant be sutured to the adjacent eye tissue.
- An additional object is to provide a method for inserting such an implant into the eye, and to provide a method for using the implant to supply medicament to the eye.
- the implant preferably presents a flow resistance which permits little or no flow when the eye pressure is in a normal range, but permits suf icient flow to relieve and hold down the eye pressure when it tends to rise above the normal range.
- T may be provided by selection of the diameter of the interi of the implant, by selection of the size of the openings a one or both ends of the implant, by using a flexible restrictor or valve in the implant which opens more widel when the eye pressure increases, or by any combination of these techniques which tends to present higher resistance liquid flow at lower differential pressures than at highe differential pressures.
- the suprachoroidal end section of the implant i preferably of larger cross-section than the closed centra section and may be provided with apertures or, as in a presently-preferred embodiment, it may be entirely open along one side of the end section to facilitate dispensin of the effluent eye fluid over a large area of the suprachoroid, thereby to increase the rate of absorption of the fluid by the suprachoroid; use of a widened dimension, or flaring, of the suprachoroidal end section of the implant also serves to enhance the positional stability of the drain when implanted.
- the implant or drain is preferably made of a semi ⁇ rigid, plastic, bioco patible material, and may have a curvature corresponding generally to that of the choroid.
- the medicament is released into the anterior chamber of the eye, as by topical application of drops, and travels with the normal eye fluid (the aqueous humor) through the drain to the suprachoroidal space, where it suffuses the posterior segment of the eye sufficiently to exert a medicinal effect.
- the implant is positioned with a first end section in the limbal angle, with the opposite end section in the suprachoroidal space, and with the intervening closed central section extending into the sclera and along the interior of the sclera, between adjacent layers thereof, before exiting into the suprachoroidal space. It has been found that fibrous connective tissue of Tenon's capsule and of the subconjunctiva tend to be stimulated into fibroblastic activity following surgery, and that the resultant scar tissue will tend to overgrow, and grow into, any adjacent openings in the tube, thereby tending to shut off the desired liquid flow. By assuring that the central section of the implant tube is closed, such interference with the desired flow of aqueous humor is obviated.
- fixation of the implant is assured by providing the implant with integral lateral wings, providing in the scleral a depression the periphery of which substantially matches the outline of the wings, placing the winged implant in the depression, passing the end sections through respective anterior and posterior incisions into the limbal angle and the suprachoroidal space, and then, with suturing the implant to the eye tissue, reclosing the scleral and conjunctive flaps and suturing them closed ov the implant.
- Figure 1 is a diagrammatic front elevational vie of a normal human eye, showing the major relevant parts an omitting irrelevant details;
- Figure 2 is an enlarged fragmentary sectional view, taken along lines 2-2 of Fig. 1;
- Figure 3 is a greatly enlarged fragmentary sectional view similar to Fig. 2, but showing only a quadrant of the eye, with a drain according to a preferred embodiment of the invention implanted in the eye in one preferred location;
- Figure 4 is a side elevational view of an alternative form of drain, with parts broken away;
- Figure 5 is a top plan view of the drain of Fig.
- Figure 6A is an enlarged fragmentary side elevational view, with parts broken away, of the limbal e section of the drain of Fig. 3;
- Figure 6B is an enlarged fragmentary side elevational view of another form for the limbal end sectio of the drain
- Figure 6C is a view like Figs. 6A and 6B, but showing another, limbal end arrangement using a plug to provide the fluid inlet aperture;
- Figure 6D is a view like that of Fig. 6C, showi another form of plug providing the inlet aperture;
- Figure 7 is a fragmentary side elevational view, and
- Figure 8 is a fragmentary top plan view, of another f of the suprachoroid end section of the drain which can be used in place of that shown in Fig. 3;
- Figure 9 and 10 are fragmentary side elevation and top plan view of another form of suprachoroidal end section;
- Figure 11 is a side elevation of still another form for the suprachoroidal end section of the drain of the invention, in this case comprising a simple open-ended tube;
- Figures 12-20 are top plan views of an eye during successive steps of implanting into it a drain like that of Fig. 3;
- Figure 21 is a view similar to that of Fig. 3, but with a drain installed in it in a different location so as to lie partly between the conjunctiva and the sclera, and using the simple type of tubular suprachoroidal end section shown in Fig. 11;
- Figures 22 and 23 are views, similar to Figs. 18 and 19, but showing use of a winged implant in a conforming cut in the scleral bed, according to the presently preferred embodiment of the invention; and Figures 24 and 25 are a lateral cross-sectional view and a longitudinal cross-sectional view, respectively, of the preferred form of implant, in the scleral bed, according to the preferred embodiment of the invention.
- FIG. 1 and 2 are presented to show schematically the relevant parts of a human eye, as an aid in understanding the anatomical terminology employed; it will be understood that many irrelevant anatomical details are omitted in the interest of clarity.
- the transparent cornea 10 at the front of the eye merges into the generally spheroidal sclera 12 at an annular junction designated as the limbus 14.
- the sclera is covered with a very thin covering of fibrous connective tissue 12A called Tenon's capsule which is too thin to be shown in the drawings.
- the conjunctiva 16 extends posteriorly from the limbus over the front half of the eye and then projects in a forward direction, underlying the upper and lower eyelids.
- the interior side 16A of the conjunctiva is known as the subconjunctiva.
- the ciliary body 18 extends posteriorly until at 2 it becomes the choroid 22, a layer containing many blood vessels.
- the choroid 22 extends further rearwardly around the back of the interior of the eye, and in turn is cover on its interior surface with the retina 24.
- the diaphragm-like iris 28 extends radially inwardly of the ey to provide automatic control of the amount of light reachi the lens 29, which is positioned just behind the iris. T cavity positioned forward of the lens is called the anteri chamber.
- the posterior portion 30 of the eye rearward of the iris is designated as the vitreous cavity or posterior cavity, while the portion forward of the iris is designate as the anterior chamber 32, and contains the so-called aqueous humor, a rather thin, watery, eye fluid.
- aqueous humor is primarily generated rearward of the iris the ciliary body 18, including the ciliary processes such 18a, and reaches the anterior chamber 32 through the pupil 33, as indicated by the arrows in Fig. 2.
- Excess of the aqueous humor is believed normally to be removed through structures such as 35 located in the Canal of Schlemm, adjacent the peripheral limbal angle 36 of the anterior chamber. Purportedly, it is the failure of this drainage function which, in the glaucomatous eye, causes the inter pressure of the eye to rise excessively as new fluid is generated and delivered to the anterior chamber of the ey at a rate faster than it is removed by normal processes.
- Figure 3 shows a vertical cross-section of a posterior quadrant of the eye of Figs. 1 and 2, but fitt with an implant or drain 40 constructed and positioned in accordance with one preferred embodiment of the invention.
- the drain 40 comprises a simple tubular central section 42 of uniform diameter, typically about 0.64 mm in outer diameter and about 0.3 mm in inner diameter, with a rectangular, open-bottomed end section 44 at one end, the overall length of the drain in this example being between about 5 and 10 mm.
- the implant When the implant is used to deliver medication to the posterior eye, it may be somewhat longer,for example about 25 mm.
- a biocompatible material wettable by aqueous humor such as polymethyl methacrylate or silicone
- a curvature along its length substantially as shown in this embodiment.
- This form of drain is preferred when a combination of simplicity of manufacture, low cost, and positional stability in the eye are primary considerations; other forms of the drain described hereinafter may be preferred where another set of considerations are of greater importance.
- the drain 40 has a first end section 50 which when installed lies entirely within the limbal angle 36; an opposite, second end section 44 lies entirely within the suprachoroidal space 58, and an intervening central section 42 extends through the sclera 12 and pierces the interior surface 60 of the sclera at 62 and 64.
- the only openings in the tubular drain 40 in this example are in its end sections 50 and 44, which lie, respectively, entirely within the limbal angle 36 and within the suprachoroidal space 58. Accordingly, the only openings in the drain are not exposed to the possibility of overgrowth by episcleral or subconjunctival tissue, which in the past has produced substantial overgrowth problems.
- FIGS 4 and 5 show an alternative form of the implant of the invention, in which the suprachoroidal end section 44' is in the form of a box-like, right parallelepiped having four holes such as 67 extending through each of its major faces.
- the inlet aperture 70 in the limbal end section of the drain of either Fig. 3 or Fig. is provided by a closure 72, axially perforated at its center; the aperture has a diameter suited for the patien A diameter of about 0.1 mm is typical for an average glaucomatous patient, using a tube the remainder of which has an inner diameter of about 0.3 mm.
- FIG. 6B to 11 illustrate possible variations in the limbal e section of the drain
- Figs. 7 through 11 illustrate possible variations of the suprachoroidal end section of drain.
- Any of the types of limbal end section shown may used with any of the suprachoroidal end sections, but the sizes and numbers of the apertures in the drain should be selected to provide the desired total flow resistance desired for the specific application.
- larger limba end apertures may require smaller suprachoroidal aperture and vice versa; similarly, if a valve-type of flow restrictor is used, the outlet aperture(s) may be relativ large, with flow controlled primarily by the valve structure.
- FIG. 6B shows an end section comprising an axially apertured plug 76, the aperture 78 being of small diameter compared with that of the inner diameter of the section tube 42'.
- Such an inlet construction is preferab employed with a suprachoroidal end section having substantially less total resistance to fluid flow, so tha the axial aperture 78 primarily determines the total rate flow of eye fluid.
- FIG. 6C shows a limbal end section using anothe type of plug 80 acting more like a flapper valve in that is preferably elastomeric and is provided with a constric portion 82 of small axial length which will "give" slight when the eye pressure is elevated, to provide a higher fl rate per mm of eye pressure than when the eye pressure is lower, thereby providing a greater ability to hold the ey pressure near a fixed, desired value.
- Fig. 6D shows a limbal end section using a flow- control plug 86 somewhat similar to that of Fig. 6C in that it is elastomeric and has a restriction at 88 which is of short axial length, again serving to present lower resistance to flow for higher eye pressure.
- Figs. 7 and 8 show a suprachoroidal end section comprising a reservoir 100 in the shape of a circular pill box, i.e. having two opposed circular major faces 102 and 104, through each of which apertures such as 106 extend.
- Figs. 9 and 10 show another form of suprachoroidal end section comprising a reservoir 110 having opposed major faces 112 and 114 of triangular form through which apertures such as 120 for discharging eye fluid extend.
- applicant's preferred embodiment uses as implant a cylindrical tube 105 having a central section with wings 106 and 107 integral therewith and extending from opposite sides as shown in Figs. 22-25 to provide a simple, inexpensive drain with good positional stability as will be described further below.
- Any of the drains shown or described may be molded by conventional techniques, with apertures drilled out if appropriate.
- conventional surgical techniques analogous to those described in the above- identified patent of Wong may be used. For example, the embodiment using the limbal end section 50 of Fig. 6A with the suprachoroidal end section 44 of Fig.
- a surgical limbal- based conjunctival flap 200 is first formed surgically and folded forwardly, as shown in Figs. 12 and 13.
- a split- thickness scleral flap 202 measuring about 2x5 to 5x5 mm made and reflected forwardly toward the limbus as shown i Figs.
- a anterior incision 220 is made at the surgical limbus into the anterior chamber of eye to accommodate passage of the limbal end section of t implant, and another parallel posterior incision 222 just wide enough to pass the rectangular suprachoroidal end section 44 is made posteriorly of the anterior incision, expose the choroid.
- the anterior tip 230 of the drain 40 urged through the anterior incision 220 and about 2-3 mm into the anterior chamber as shown in Fig. 18.
- the suprachoroidal end section is then slid through posterior incision 222 into the suprachoroidal space 58 by about 5 as shown in Fig. 19, and the anterior and posterior incisions closed tightly with sutures; the scleral flap a the conjunctival flap are then closed with interrupted or running sutures (see Fig. 20) .
- an eye implant in the form of a drain which transfers eye fluid, with or withou medicament therein, from the limbal angle to the suprachoroidal space for absorption therein, to relieve e pressure and/or to transfer medicament into the posterior segment of the eye, and which is capable of continuing su transfer of fluid over long periods of time.
- the drain may readily be provided with at le one pressure-sensitive aperture which provides higher resistance to flow for lower pressures, thereby minimizin excessive lowering of internal eye pressure which might otherwise be encountered in some cases.
- the aperture system is such that a pressure head (excess of pressure in anterior chamber over that in the suprachoroi space) of at least about 15 mm of mercury must be achieve before appreciable flow occurs through the drain.
- a simple tube 44" of uniform inner diameter through may be used, as shown in Fig. 11.
- the drain 40' may be placed so that its central 42 PCIYUS95/00134
- section 42" extends between layers in the sclera as shown in Fig. 3; or, it may extend in part between conjunctiva 16 and sclera 12 as shown in Fig. 21, in which this simple form of tubular drain is used. Alternatively, it may extend between the inner side of the sclera and the ciliary body 18 and the choroid 58 as illustrated in Fig. 4 of the above-cited Wong patent.
- the drain is entirely closed in the region between limbal angle 36 and suprachoroidal space 58, to minimize or eliminate problems due to tissue overgrowth. There is then no leakage of anterior chamber fluid from the central section of the implant, which might otherwise find its way (through the incisions, for example) to Tenon's capsule and/or the subconjunctival region, and no opportunity for scar tissue or the like to be stimulated into growth and enter the implant so as to interfere with liquid flow.
- the implant 110 comprising the tube 105 and the lateral wings 106 and 107 is nestled in the corresponding surgically formed depression 120 in the scleral bed.
- the anterior and posterior incisions 220 and 222 may be formed by surgical techniques similar to those previously described for the other embodiments of the invention.
- the winged implant is placed in the prepared bed as shown in Fig. 22, and as shown in Fig. 23, the scleral and conjunctival flaps are folded back again, over the implant, and sutured in place.
- the implant is preferably of a flexible biocompatible plastic, and extends from the limbal angle to the suprachoroidal space.
- the wings may each be about 5 mm by 5 mm with a thickness of the order of the outer diameter of the tube 105, although other dimensions may be used. Valves of the type referred to in connection with other embodiments may also be used in the tube 105, for similar purposes.
- the implant fixated without requirin the suturing to the adjacent eye tissue, but it also prevents leakage of aqueous humor into the scleral bed.
Abstract
A tubular eye implant (40) and method are disclosed for transferring eye fluid from the anterior chamber to the posterior segment of the eye, to relieve glaucoma and/or to supply medicament to the posterior segment. The implant (40) extends entirely within the eye, from within the limbal angle to within the supra-choroidal space; the two end sections (72, 44') of the implant are apertured to permit flow of aqueous humor, but the sides of the central section (42) are closed to prevent leakage and resultant interference with fluid drainage due to overgrowth by adjacent tissue.
Description
IMPROVE EYE IMPLANT FOR RELIEF OF GLAUCOMA
F-telfl of h? In ention This invention relates to a device and method for draining fluid from the limbal angle of the eye to the suprachoroidal space, for example to relieve glaucoma or to convey medicament from the anterior chamber to the posterior segment of the eye. The invention also relates to a method for installing such a device in the eye.
Background of the Invention Glaucoma is a condition of the eye in which the normal body mechanisms for removing or draining off fluid generated in the eye do not operate effectively, with the result that the internal pressure of the eye rises excessively. With the passage of time, this excessively high internal pressure adversely affects the optic nerve, first causing a severe reduction in peripheral vision and finally complete blindness, unless the condition is successfully treated.
Various liquid medicaments are known which can be dropped periodically into the eye to limit the elevation of pressure. However, with many patients this procedure is not effective because they do not properly follow the treatment
prescribed, often due to negligence or to the relatively high cost of the medication. In other cases, the medicaments available may lose their effectiveness for th patient over long periods of treatment. It has also been known to employ surgical procedures which, in effect, produce leaks in the eyeball through which the excess fluid can escape to the exterior Surgical attempts have also been made to relieve the pressure by implanting wires, tubes or strips of various materials in the angle between the ciliary body and the sclera, where the absorption of excess fluid take place b natural means, or by implanting drains which extend direc through the frontal portion of the eyeball to the exterio A procedure known as cyclodialysis is also known, in whic cut is made to separate opposed surfaces of the ciliary b and the adjacent sclera. However, difficulties have been encountered after such surgical procedures due to subsequ natural reapposition of sclera and ciliary body.
In any event, despite the existence of useful medicaments and the availability of various surgical and implant techniques, there still remain large numbers of patients who can no longer be helped by such procedures, who become blind, or substantially so, as a result.
U.S. Patent No. 4,521,210 of Vernon G. Wong, issued June 4, 1985, describes and claims a surgically inserted implant for relieving the elevated eye pressure characteristic of glaucoma by providing a path along the surface of an implant for the flow of eye fluid from the limbal angle, through the sclera or between sclera and choroid, and thence to the suprachoroidal space, where it absorbed. While quite effective in many cases in relievi internal eye pressure, it has been found that, over a substantial period of time, this implant tends to become clogged, and the desired flow is reduced or eventually cu off nearly completely, sometimes necessitating a surgical insertion of a new implant. The cause of this is believe to be overgrowth of the exposed surfaces of the implant b
ingrowth of connective tissue from Tenon's capsule and of connective tissue from the subconjunctiva as the result of the surgery. This previously-known type of implant contains surface channels extending along its length, from limbal angle to suprachoroidal space, and it is along at least a part of the central section of the implant extending between limbal angle and suprachoroid that the deleterious overgrowth tends to occur, blocking the desired fluid flow. Further, in some cases it is desirable to be able to deliver medicament from the anterior chamber of the eye to the posterior segment of the eye. In the past this has been done by direct injection through the exterior wall of the posterior segment, with attendant difficulties and possible complications such as infection; frequent injections of this type over a long period of time are not considered to be feasible.
It is therefore an object of the present invention to provide a new and useful eye implant effective to deliver fluid from the limbal angle to the suprachoroidal space of the eye.
Another object is to provide such an eye implant suitable for use in relieving eye pressure due to glaucoma, or for delivering medication to the posterior segment, and which will remain effective over long periods of time. A further object is to provide such an implant which will not be substantially degraded or blocked through overgrowth by surrounding tissue.
Still another object is to provide an implant and method of installing it which causes the implant to remain fixed in position, long after installation, without requiring that the implant be sutured to the adjacent eye tissue.
An additional object is to provide a method for inserting such an implant into the eye, and to provide a method for using the implant to supply medicament to the eye.
Sμmiηarv Of the Invention These and other objects of this invention are achieved by the provision of an eye implant having a centr section comprising a closed tube extending from the limbal angle to the suprachoroidal space, along a path lying between the exterior of the choroid and the interior of t conjunctiva; in a preferred form, the implant lies entirel within the sclera, although in other embodiments it may extend along a path between sclera and conjunctiva or between sclera and choroid. One end section of the implan extends into the limbal angle, where it is provided with o or more apertures, and its other end extends into the suprachoroidal space, where it is also provided with one o more apertures, to permit fluid to flow from the limbal angle into the implant and thence to the suprachoroidal space in response to fluid pressure in the anterior chambe without leakage of the fluid from the intervening central section, thereby preventing blockage of flow by tissue overgrowth. As used to relieve glaucoma, the implant preferably presents a flow resistance which permits little or no flow when the eye pressure is in a normal range, but permits suf icient flow to relieve and hold down the eye pressure when it tends to rise above the normal range. T may be provided by selection of the diameter of the interi of the implant, by selection of the size of the openings a one or both ends of the implant, by using a flexible restrictor or valve in the implant which opens more widel when the eye pressure increases, or by any combination of these techniques which tends to present higher resistance liquid flow at lower differential pressures than at highe differential pressures.
The suprachoroidal end section of the implant i preferably of larger cross-section than the closed centra section and may be provided with apertures or, as in a presently-preferred embodiment, it may be entirely open along one side of the end section to facilitate dispensin
of the effluent eye fluid over a large area of the suprachoroid, thereby to increase the rate of absorption of the fluid by the suprachoroid; use of a widened dimension, or flaring, of the suprachoroidal end section of the implant also serves to enhance the positional stability of the drain when implanted.
The implant or drain is preferably made of a semi¬ rigid, plastic, bioco patible material, and may have a curvature corresponding generally to that of the choroid. To use the drain as a means for delivering medicament to the interior of the eye, the medicament is released into the anterior chamber of the eye, as by topical application of drops, and travels with the normal eye fluid (the aqueous humor) through the drain to the suprachoroidal space, where it suffuses the posterior segment of the eye sufficiently to exert a medicinal effect.
In the presently preferred embodiment, the implant is positioned with a first end section in the limbal angle, with the opposite end section in the suprachoroidal space, and with the intervening closed central section extending into the sclera and along the interior of the sclera, between adjacent layers thereof, before exiting into the suprachoroidal space. It has been found that fibrous connective tissue of Tenon's capsule and of the subconjunctiva tend to be stimulated into fibroblastic activity following surgery, and that the resultant scar tissue will tend to overgrow, and grow into, any adjacent openings in the tube, thereby tending to shut off the desired liquid flow. By assuring that the central section of the implant tube is closed, such interference with the desired flow of aqueous humor is obviated.
Furthermore, fixation of the implant is assured by providing the implant with integral lateral wings, providing in the scleral a depression the periphery of which substantially matches the outline of the wings, placing the winged implant in the depression, passing the end sections through respective anterior and posterior incisions into the
limbal angle and the suprachoroidal space, and then, with suturing the implant to the eye tissue, reclosing the scleral and conjunctive flaps and suturing them closed ov the implant.
Brief Pesςrjption of Figures
These and other objects and features of the invention will be more readily understood from a consideration of the following detailed description, take with the accompanying drawings, in which: Figure 1 is a diagrammatic front elevational vie of a normal human eye, showing the major relevant parts an omitting irrelevant details;
Figure 2 is an enlarged fragmentary sectional view, taken along lines 2-2 of Fig. 1; Figure 3 is a greatly enlarged fragmentary sectional view similar to Fig. 2, but showing only a quadrant of the eye, with a drain according to a preferred embodiment of the invention implanted in the eye in one preferred location; Figure 4 is a side elevational view of an alternative form of drain, with parts broken away;
Figure 5 is a top plan view of the drain of Fig.
4;
Figure 6A is an enlarged fragmentary side elevational view, with parts broken away, of the limbal e section of the drain of Fig. 3;
Figure 6B is an enlarged fragmentary side elevational view of another form for the limbal end sectio of the drain; Figure 6C is a view like Figs. 6A and 6B, but showing another, limbal end arrangement using a plug to provide the fluid inlet aperture;
Figure 6D is a view like that of Fig. 6C, showi another form of plug providing the inlet aperture; Figure 7 is a fragmentary side elevational view, and Figure 8 is a fragmentary top plan view, of another f
of the suprachoroid end section of the drain which can be used in place of that shown in Fig. 3;
Figure 9 and 10 are fragmentary side elevation and top plan view of another form of suprachoroidal end section; Figure 11 is a side elevation of still another form for the suprachoroidal end section of the drain of the invention, in this case comprising a simple open-ended tube; Figures 12-20 are top plan views of an eye during successive steps of implanting into it a drain like that of Fig. 3;
Figure 21 is a view similar to that of Fig. 3, but with a drain installed in it in a different location so as to lie partly between the conjunctiva and the sclera, and using the simple type of tubular suprachoroidal end section shown in Fig. 11;
Figures 22 and 23 are views, similar to Figs. 18 and 19, but showing use of a winged implant in a conforming cut in the scleral bed, according to the presently preferred embodiment of the invention; and Figures 24 and 25 are a lateral cross-sectional view and a longitudinal cross-sectional view, respectively, of the preferred form of implant, in the scleral bed, according to the preferred embodiment of the invention.
Detailed Description of Preferred Embodiments Before describing the specific embodiments of the invention shown in Figs. 3-25 by way of example only, Figs. 1 and 2 are presented to show schematically the relevant parts of a human eye, as an aid in understanding the anatomical terminology employed; it will be understood that many irrelevant anatomical details are omitted in the interest of clarity.
As shown, the transparent cornea 10 at the front of the eye merges into the generally spheroidal sclera 12 at an annular junction designated as the limbus 14. The sclera is covered with a very thin covering of fibrous connective tissue 12A called Tenon's capsule which is too thin to be
shown in the drawings. The conjunctiva 16 extends posteriorly from the limbus over the front half of the eye and then projects in a forward direction, underlying the upper and lower eyelids. The interior side 16A of the conjunctiva is known as the subconjunctiva. In appositio with the interior side of the sclera, and beginning at th limbus, the ciliary body 18 extends posteriorly until at 2 it becomes the choroid 22, a layer containing many blood vessels. The choroid 22 extends further rearwardly around the back of the interior of the eye, and in turn is cover on its interior surface with the retina 24.
Near the forward end of the ciliary body 18, the diaphragm-like iris 28 extends radially inwardly of the ey to provide automatic control of the amount of light reachi the lens 29, which is positioned just behind the iris. T cavity positioned forward of the lens is called the anteri chamber. The posterior portion 30 of the eye rearward of the iris is designated as the vitreous cavity or posterior cavity, while the portion forward of the iris is designate as the anterior chamber 32, and contains the so-called aqueous humor, a rather thin, watery, eye fluid.
Research in ophthalmology indicates that the aqueous humor is primarily generated rearward of the iris the ciliary body 18, including the ciliary processes such 18a, and reaches the anterior chamber 32 through the pupil 33, as indicated by the arrows in Fig. 2. Excess of the aqueous humor is believed normally to be removed through structures such as 35 located in the Canal of Schlemm, adjacent the peripheral limbal angle 36 of the anterior chamber. Purportedly, it is the failure of this drainage function which, in the glaucomatous eye, causes the inter pressure of the eye to rise excessively as new fluid is generated and delivered to the anterior chamber of the ey at a rate faster than it is removed by normal processes. Figure 3 shows a vertical cross-section of a posterior quadrant of the eye of Figs. 1 and 2, but fitt with an implant or drain 40 constructed and positioned in
accordance with one preferred embodiment of the invention. In this example, the drain 40 comprises a simple tubular central section 42 of uniform diameter, typically about 0.64 mm in outer diameter and about 0.3 mm in inner diameter, with a rectangular, open-bottomed end section 44 at one end, the overall length of the drain in this example being between about 5 and 10 mm. When the implant is used to deliver medication to the posterior eye, it may be somewhat longer,for example about 25 mm. It is preferably made of a biocompatible material wettable by aqueous humor, such as polymethyl methacrylate or silicone, and preferably has a curvature along its length substantially as shown, in this embodiment. This form of drain is preferred when a combination of simplicity of manufacture, low cost, and positional stability in the eye are primary considerations; other forms of the drain described hereinafter may be preferred where another set of considerations are of greater importance.
More particularly, the drain 40 has a first end section 50 which when installed lies entirely within the limbal angle 36; an opposite, second end section 44 lies entirely within the suprachoroidal space 58, and an intervening central section 42 extends through the sclera 12 and pierces the interior surface 60 of the sclera at 62 and 64. The only openings in the tubular drain 40 in this example are in its end sections 50 and 44, which lie, respectively, entirely within the limbal angle 36 and within the suprachoroidal space 58. Accordingly, the only openings in the drain are not exposed to the possibility of overgrowth by episcleral or subconjunctival tissue, which in the past has produced substantial overgrowth problems.
Figures 4 and 5 show an alternative form of the implant of the invention, in which the suprachoroidal end section 44' is in the form of a box-like, right parallelepiped having four holes such as 67 extending through each of its major faces.
As shown in Fig. 6A, the inlet aperture 70 in the
limbal end section of the drain of either Fig. 3 or Fig. is provided by a closure 72, axially perforated at its center; the aperture has a diameter suited for the patien A diameter of about 0.1 mm is typical for an average glaucomatous patient, using a tube the remainder of which has an inner diameter of about 0.3 mm.
Other embodiments of the drain of the invention are illustrated by Figs. 6B to 11 and in Fig. 21. Figs. through 6D illustrate possible variations in the limbal e section of the drain, and Figs. 7 through 11 illustrate possible variations of the suprachoroidal end section of drain. Any of the types of limbal end section shown may used with any of the suprachoroidal end sections, but the sizes and numbers of the apertures in the drain should be selected to provide the desired total flow resistance desired for the specific application. Thus, larger limba end apertures may require smaller suprachoroidal aperture and vice versa; similarly, if a valve-type of flow restrictor is used, the outlet aperture(s) may be relativ large, with flow controlled primarily by the valve structure.
Thus Fig. 6B shows an end section comprising an axially apertured plug 76, the aperture 78 being of small diameter compared with that of the inner diameter of the section tube 42'. Such an inlet construction is preferab employed with a suprachoroidal end section having substantially less total resistance to fluid flow, so tha the axial aperture 78 primarily determines the total rate flow of eye fluid. Fig. 6C shows a limbal end section using anothe type of plug 80 acting more like a flapper valve in that is preferably elastomeric and is provided with a constric portion 82 of small axial length which will "give" slight when the eye pressure is elevated, to provide a higher fl rate per mm of eye pressure than when the eye pressure is lower, thereby providing a greater ability to hold the ey pressure near a fixed, desired value.
Fig. 6D shows a limbal end section using a flow- control plug 86 somewhat similar to that of Fig. 6C in that it is elastomeric and has a restriction at 88 which is of short axial length, again serving to present lower resistance to flow for higher eye pressure.
Figs. 7 and 8 show a suprachoroidal end section comprising a reservoir 100 in the shape of a circular pill box, i.e. having two opposed circular major faces 102 and 104, through each of which apertures such as 106 extend. Figs. 9 and 10 show another form of suprachoroidal end section comprising a reservoir 110 having opposed major faces 112 and 114 of triangular form through which apertures such as 120 for discharging eye fluid extend.
At present, applicant's preferred embodiment uses as implant a cylindrical tube 105 having a central section with wings 106 and 107 integral therewith and extending from opposite sides as shown in Figs. 22-25 to provide a simple, inexpensive drain with good positional stability as will be described further below. Any of the drains shown or described may be molded by conventional techniques, with apertures drilled out if appropriate. To implant them, conventional surgical techniques analogous to those described in the above- identified patent of Wong may be used. For example, the embodiment using the limbal end section 50 of Fig. 6A with the suprachoroidal end section 44 of Fig. 3 may be made by molding the drain, using removable plugs where the limbal and suprachoroidal apertures are to be formed, or by molding the drain without apertures and drilling-out one or more of the apertures, if this is more convenient. For increased positional stability of the implant, it may be provided with laterally extending stabilizing portions, such as the wing¬ like cross-arm used in the implant of my 4,521,210 patent, for example. To install a drain in the eye, a surgical limbal- based conjunctival flap 200 is first formed surgically and folded forwardly, as shown in Figs. 12 and 13. A split-
thickness scleral flap 202 measuring about 2x5 to 5x5 mm made and reflected forwardly toward the limbus as shown i Figs. 14 and 15 to form a rectangular "trap door" 210. A anterior incision 220, typically 1 to 3 mm in length, is made at the surgical limbus into the anterior chamber of eye to accommodate passage of the limbal end section of t implant, and another parallel posterior incision 222 just wide enough to pass the rectangular suprachoroidal end section 44 is made posteriorly of the anterior incision, expose the choroid. The anterior tip 230 of the drain 40 urged through the anterior incision 220 and about 2-3 mm into the anterior chamber as shown in Fig. 18. The suprachoroidal end section is then slid through posterior incision 222 into the suprachoroidal space 58 by about 5 as shown in Fig. 19, and the anterior and posterior incisions closed tightly with sutures; the scleral flap a the conjunctival flap are then closed with interrupted or running sutures (see Fig. 20) .
There is thereby provided an eye implant in the form of a drain which transfers eye fluid, with or withou medicament therein, from the limbal angle to the suprachoroidal space for absorption therein, to relieve e pressure and/or to transfer medicament into the posterior segment of the eye, and which is capable of continuing su transfer of fluid over long periods of time. Where appropriate, the drain may readily be provided with at le one pressure-sensitive aperture which provides higher resistance to flow for lower pressures, thereby minimizin excessive lowering of internal eye pressure which might otherwise be encountered in some cases. Preferably the aperture system is such that a pressure head (excess of pressure in anterior chamber over that in the suprachoroi space) of at least about 15 mm of mercury must be achieve before appreciable flow occurs through the drain. In som cases a simple tube 44" of uniform inner diameter through may be used, as shown in Fig. 11.
The drain 40' may be placed so that its central
42 PCIYUS95/00134
- 13 -
section 42" extends between layers in the sclera as shown in Fig. 3; or, it may extend in part between conjunctiva 16 and sclera 12 as shown in Fig. 21, in which this simple form of tubular drain is used. Alternatively, it may extend between the inner side of the sclera and the ciliary body 18 and the choroid 58 as illustrated in Fig. 4 of the above-cited Wong patent.
In all cases, the drain is entirely closed in the region between limbal angle 36 and suprachoroidal space 58, to minimize or eliminate problems due to tissue overgrowth. There is then no leakage of anterior chamber fluid from the central section of the implant, which might otherwise find its way (through the incisions, for example) to Tenon's capsule and/or the subconjunctival region, and no opportunity for scar tissue or the like to be stimulated into growth and enter the implant so as to interfere with liquid flow.
Considering now the preferred embodiment shown in Figs. 22-25, the implant 110 comprising the tube 105 and the lateral wings 106 and 107 is nestled in the corresponding surgically formed depression 120 in the scleral bed. In a typical example, the anterior and posterior incisions 220 and 222 may be formed by surgical techniques similar to those previously described for the other embodiments of the invention. The winged implant is placed in the prepared bed as shown in Fig. 22, and as shown in Fig. 23, the scleral and conjunctival flaps are folded back again, over the implant, and sutured in place. However, no suturing of the implant is necessary, it being held in place by the wings, which sit down in the prepared scleral bed; it is also held at its ends by insertion of the ends into anterior and posterior incisions 220 and 222. The implant is preferably of a flexible biocompatible plastic, and extends from the limbal angle to the suprachoroidal space. Merely as an example, the wings may each be about 5 mm by 5 mm with a thickness of the order of the outer diameter of the tube 105, although other dimensions may be used. Valves of the
type referred to in connection with other embodiments may also be used in the tube 105, for similar purposes.
Not only is the implant fixated without requirin the suturing to the adjacent eye tissue, but it also prevents leakage of aqueous humor into the scleral bed.
While the invention has been described with particular reference to specific embodiments in the intere of complete definiteness, it will be understood that it ma be embodied in a variety of forms diverse from those specifically shown and described, without departing from t spirit and scope of the invention.
Claims
1. An eye implant for transferring fluid from the limbal angle of the eye to the suprachoroidal space, comprising: an elongated body of biocompatible material having a length to extend from within the limbal angle of the anterior chamber of the eye to within the suprachoroidal space, along a path extending entirely within the eye; said body having a first end section adapted to be located entirely within said limbal angle and a second end section adapted simultaneously to be located entirely within said suprachoroidal space; said body also having a hollow central section extending between and connecting said first and second end sections, the sides of which central section are closed to the exterior to prevent tissue growth into it, said central section having a length at least as great as the distance along said body between the angle of the eye and the suprachoroidal space; said first end section being apertured to receive eye fluid present in said limbal angle and deliver it to said central section, and said second end section being apertured to deliver eye fluid from said central section to said suprachoroidal space.
2. The implant of claim 1, wherein said body is a tube, the opposite ends of which are open.
3. The implant of claim 1, wherein said second end section has a greater cross-sectional area than said central section, to provide a reservoir therein for said fluid and to stabilize said implant in position in said suprachoroidal space.
4. The implant of claim 2, wherein said second end section is provided with openings through its side surfaces for afflux of said eye fluid therefrom into said suprachoroidal space.
5. The implant of claim 1, wherein said first section comprises an aperture structure presenting a lowe resistance to liquid flow for higher pressures applied to it.
6. The implant of claim 1, wherein said first section comprises a tube and a plug within said tube, sai plug having an axial opening through it.
7. The implant of claim 5, wherein said apertu structure comprises a plug of an elasto eric material.
8. The method of providing for transfer of liq from the limbal angle of the eye to the suprachoroidal space, comprising: inserting into said eye a tubular drain with on end section lying entirely within said angle and the opposite end section thereof lying entirely within said suprachoroidal space, said drain being closed throughout central section thereof extending between said first and second end sections.
9. The method of supplying medicament to the posterior segment of the eye, comprising: implanting in said eye an implant having a clos central section adapted to extend from the limbal angle t the suprachoroidal space, and having a first end section adapted to be placed in said suprachoroidal space, to provide fluid communication between the interior of said central section and said limbal angle and said suprachoroidal space, respectively; and administering medicament to the anterior chambe of said eye, whereby it is carried to said posterior segm by flow through said implant in response to the fluid pressure in said anterior chamber.
10. The implant of claim 1, wherein said implant comprises integral lateral wings on opposite sides of said hollow central section, said wings being adapted to be embedded conformingly in a corresponding surgically prepared depression in the scleral bed of said eye.
11. The method of claim 8, comprising providing integral lateral wings on opposing sides of said central section of said drain, exposing the scleral bed of said eye by surgically forming a conjunctival flap and a scleral flap, preparing in said scleral bed a depression into which said wings fit conformingly, placing said implant into said scleral bed with said wings fitting conformingly into said depression, and then suturing said eye to reclose said scleral flap and said conjunctival flap over said scleral bed and said implant without suturing said implant to adjacent eye tissue.
12. The implant of claim 10, wherein and first and second sections of said implant are of dimensions to fit closely within and through incisions leading to the limbal angle and the suprachoroidal space, respectively.
13. The implant of claim 11, comprising the steps of forming an anterior incision for permitting said first end section of said drain to be slipped into said limbal angle and forming a posterior incision for permitting said opposite end of said drain to be slipped into said suprachoroidal space, and while said scleral bed is exposed, slipping said first end section through said anterior incision into said limbal angle and slipping said opposite end section through said posterior incision into said suprachoroidal space, said anterior and posterior incisi being sized to fit closely about said first end section said opposite end section respectively.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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PCT/US1995/000134 WO1996020742A1 (en) | 1995-01-06 | 1995-01-06 | Improve eye implant for relief of glaucoma |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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PCT/US1995/000134 WO1996020742A1 (en) | 1995-01-06 | 1995-01-06 | Improve eye implant for relief of glaucoma |
Publications (1)
Publication Number | Publication Date |
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WO1996020742A1 true WO1996020742A1 (en) | 1996-07-11 |
Family
ID=22248459
Family Applications (1)
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PCT/US1995/000134 WO1996020742A1 (en) | 1995-01-06 | 1995-01-06 | Improve eye implant for relief of glaucoma |
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WO (1) | WO1996020742A1 (en) |
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