EP1418864A4 - Method and intra sclera implant for treatment of glaucoma and presbyopia - Google Patents

Method and intra sclera implant for treatment of glaucoma and presbyopia

Info

Publication number
EP1418864A4
EP1418864A4 EP02768411A EP02768411A EP1418864A4 EP 1418864 A4 EP1418864 A4 EP 1418864A4 EP 02768411 A EP02768411 A EP 02768411A EP 02768411 A EP02768411 A EP 02768411A EP 1418864 A4 EP1418864 A4 EP 1418864A4
Authority
EP
European Patent Office
Prior art keywords
implant
body portion
scleral
intra
elongated
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP02768411A
Other languages
German (de)
French (fr)
Other versions
EP1418864A1 (en
Inventor
Research Technologies Glaucoma
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP1418864A1 publication Critical patent/EP1418864A1/en
Publication of EP1418864A4 publication Critical patent/EP1418864A4/en
Withdrawn legal-status Critical Current

Links

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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/147Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants
    • 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
    • A61F9/00781Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • A61P27/10Ophthalmic agents for accommodation disorders, e.g. myopia
    • 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir

Definitions

  • the disclosed device relates to a scleral implant. More particularly it relates to a device which is implanted in the sclera of the eye for the treatment of excess intraocular pressure which frequently accompanies Glaucoma and for the treatment of presbyopia or loss of accommodation of the eye.
  • Glaucoma is an e ⁇ e disease wherein the patient gradually loses sight. Such vision loss is caused by damage to the pptic nerve which acts like an electric cable and communicates images from the eye to the brain.1 High intraocular pressure frequently accompanies Glaucoma and is one of the main causes of the nerve damage causing this vision loss. It is thought that increased intraocular pressure is caused when the eye's drainage canals become clogged over time. The intraocular pressure rises to levels causing damage because the correct amount of fluid can't drain out of the eye in the normal fashion. If this excess intraocular pressure is not detected and treated, it can cause a gradual loss of vision Such a vision loss in some cases occurs over a long period of time. However, in some cases of glaucoma the eye pressure usually rises very fast. It is thought that this happens when the eye drainage canals are blocked or covered over, Like the clog in a sink when something is covering the drain
  • Drugs are frequently used on cases where intraocular pressure slowly builds and frequently work well. In
  • Another sight rek ted problem affecting patients is that of Presbyopia which is a vision condition in which the crystalline lens f a p nt'g ey t ⁇ g g jt ⁇ flexibility.
  • Tft ⁇ lOS ⁇ Of flexibility makes it difficult for a person to focus on close objects. While Presbyopia may seem to occur suddenly once the patient discovers the problem, it is generally accepted that the cause of the sight loss is actual loss of flexibility of the lens which takes place over a number of years and usually becomes noticeable in the early to mid-forties.
  • Treatment to help you compensate for presbyopia includes prescription reading glasses, bifocals, contact lenses, and laser surgery.
  • corrective lenses can be inconvenient to the wearer and laser surgery to the lens of the eye carries with it the inherent risk to the eyesight itself if a mistake is made.
  • U.S. Patent No. 6,280,468 discloses a scleral prosthesis for treatment of presbyopia and other eye disorders.
  • Schachar teaches the placement of a prostheses in a plurality of pockets slightly smaller than the implant, circumferentially around the pupil, to exert an outward pressure on the sclera thereby restoring the working distance of the ciliary muscle allowing the patient relief from presbyopia.
  • Schachar is oriented circumferentially around the pupil or front of the eye and lacks an anchoring means to hold the implants in proper position in the sclera over the long term which can result in shifting of the implant reducing or eliminating its effectiveness. Further, the use of tunnels smaller than the implant tends to cause broken implants.
  • Schachar also lacks a drug delivery means from the implant. Still further, actual dismounting of the implant can occur which would require removal from the eye especially if it pierces the outside surface of the eye when shifting in position. Additionally, the circumferential placement of the implants is not as effective at encouraging internal drainage and reduction of intraocular pressure.
  • U.S. Patent No. 6,102,045 discloses a method and apparatus for lowering intraocular pressure of the eye.
  • Nordquist is a filtering implant which extends into the anterior chamber of the eye through an opening in the limbus cornea.
  • Nordquist lacks the ability to correct presbyopia that a sclera-mounted device provides and because of its delicate positioning and communication directly with the anterior chamber Nordquist is harder to position correctly. It also lacks the ability to infuse drugs to the eye and the provision of direct communication between the anterior chamber and the exterior regions of the eye increases the risk of infection to the anterior chamber.
  • U.S. Patent No. 6,079,417 discloses a method and device for reshaping the cornea to change its topography.
  • Fugo lacks the ability to increase the drainage from the eye interior to lower intraocular pressure.
  • Fugo also is designed to mount directly into the cornea layer of the eye.
  • Such a device should be insertable into the eye in a relatively easy procedure for a trained surgeon. Such a device and procedure should avoid the more delicate structures of the eye and should also avoid communicating internal eye structures directly with the exterior of the eye to prevent infection. Such a device would provide additional utility by through the optional ability to provide a drug delivery system from the implant directly to the eye. Still further, the device implanted by this method should be dimensioned with an anchor structure to insure that the implant stays properly positioned in perpetuity thereby alleviating the need for replacement or removal caused by dislocatable implants and maintaining a fixed correction of vision.
  • the above problems, and others are overcome by the herein disclosed method and intra- sclera implant for the treatment of glaucoma and presbyopia.
  • the method of insertion of the implants requires incisions be made radially in the anterior sclera. A plurality of such incisions are made radially and only into the sclera with the current best number of incisions being four, with one incision in each quadrant of the eye.
  • one implant is positioned within the space of each of the incisions.
  • the scleral incision is then closed by opposition or using suture or other means of closure of the incision to urge the scleral flap toward the surface of the eye from where it was detached and reattach it to the sclera.
  • the implant is currently best formed in a unitary construction and formed of a material that is inert when in contact with body tissue.
  • Favored materials include one or a combination of materials from a group including hydroxiapartite, silicone, polymethylmethacrylate, acrylic, and tantalum.
  • the unitary body of the implant can optionally be serrated or have one or a plurality of apertures running through to contact scleral tissue and anchor it. Additionally, the body of the implant can also be impregnated with a drug which thereafter would be slowly delivered into the tissue of the eye or have an internal reservoir or coating of a slowly disburseable drug that can be modulated for dose and time frame to allow for long term delivery of medication to the eye and body of the patient, from the implant.
  • Yet another object of this invention is the provision of a method and apparatus for eye surgery that may be used to treat presbyopia as well as rising intraocular pressure.
  • Figure 1 depicts the placement of a plurality of implants radially in four quadrants of the eye and the steps of the method to do so.
  • Figure 2 shows the implant and its placement in the scleral layer of the eye.
  • Figure 3 depicts a preferred embodiment of the implant showing anchors and optional coating.
  • Figure 4 depicts another preferred embodiment of the device having an internal reservoir for holding a drug to be communicated to the exterior.
  • Figure 5 depicts another preferred embodiment of the device showing anchors about the exterior.
  • Figure 6 depicts another preferred embodiment of the device showing a round body and anchors extending from the surface.
  • figure 1 depicts the preferred location and steps in the operative method for the placement of
  • the eye 12 In its basic structure the eye 12 consists of a globe having an outer coat, a middle layer
  • the outer coat is made up of a tough fibrous, white layer - the sclera 16,
  • the conjunctiva 18 which communicates with the conjunctiva 18 which is a mucous membrane that lines the inner surfaces of the eyelids and folds back to cover the front surface of the eyeball, except for the
  • the middle layer contains
  • the inner layer is the light seeing layer or retina 24.
  • Presbyopia is a vision condition in which the
  • lens 26 loses some of its flexibility, or the zonules 30 become elongated making it harder for the
  • Intraocular pressure in the eye 12 is caused by a build up of fluid in the anterior chamber
  • Canal of Schlemm which is the sewer system duct of the eye getting rid of excess fluid
  • anterior chamber 36 and posterior chamber 38 are anterior chamber 36 and posterior chamber 38.
  • incisions 32 expose the sclera 16 wherein next, in each conjunctival incision 32, a radial incision
  • an implant device 10 is positioned within the space formed by the
  • the radial incision 34 may be closed using a means of closure
  • implant device 10 radially oriented away from the cornea 20 might be done in other fashions
  • the device 10 is placed radially oriented and surrounded by the sclera in a formed cavity and the
  • the device 10 is properly placed to improve both the vision and fluid drainage of the patient.
  • implant device 10 may be removed in the reverse order.
  • the implant device 10 used in combination with the surgical method, in the current best
  • the implant device is formed of a material that is inert when in contact with body tissue.
  • a tightening or tensioning of the sclera 16 layer is provided when the
  • radial incision 34 is closed and the scleral flap 21 is sutured or otherwise rejoined with the sclera 16 and stretched over the implant device 10 during closure.
  • Favored materials include one or a
  • the implant device 10 has body portion 46 and a means to anchor the device in radial
  • anchors 48 protruding from the body portion 46. Other means to anchor the device
  • the device 10 can be provided with a means to
  • This drug delivery system can be provided by one or a combination of micro
  • the material from which the device 10 is produced can be any material from which the device 10 is produced.
  • the material from which the device 10 is produced can be any material from which the device 10 is produced.
  • the dosage and delivery time can be modulated by adjusting the amount of communication
  • hypodermic needle 27 which would pierce the sclera 16 and refill the reservoir 60 through one of
  • Figure 6 depicts the device 10 with a body 46 that is round or barrel shaped rather than the cube or rectangular shape of figures 3-5.
  • the body 46 would work well in either configuration so long as one of the noted anchoring means projects from it to anchor the device 10 in the radial cavity. While the curved projections 52 are shown on all sides, it may be beneficial in some cases to omit them from one side for smooth transition of the scleral flap 21 over the implant device 10.

Abstract

An intra scleral implant (10) and method of implantation for use in the treatment of intraocular pressure and presbyopia. The implant features a body portion (46) and protrusions (48) from the body portion to anchor the device in a cavity (19) formed in the scleral wall (16) of the eye(12). Optionally a drug delivery function is provided to allow long term communication of drugs to tissue surrounding the implant.

Description

MJETHOD AND INTRA-SCLERA IMPLANT FOR TREATMENT OF GLAUCOMA AND PRESBYOPIA
Background of Invention
1. Field of Invention
This application cϊaims the benefit of U.S. Provisional Application No. 60/310,027 filed 08/03/01.
The disclosed device relates to a scleral implant. More particularly it relates to a device which is implanted in the sclera of the eye for the treatment of excess intraocular pressure which frequently accompanies Glaucoma and for the treatment of presbyopia or loss of accommodation of the eye.
Glaucoma is an eψe disease wherein the patient gradually loses sight. Such vision loss is caused by damage to the pptic nerve which acts like an electric cable and communicates images from the eye to the brain.1 High intraocular pressure frequently accompanies Glaucoma and is one of the main causes of the nerve damage causing this vision loss. It is thought that increased intraocular pressure is caused when the eye's drainage canals become clogged over time. The intraocular pressure rises to levels causing damage because the correct amount of fluid can't drain out of the eye in the normal fashion. If this excess intraocular pressure is not detected and treated, it can cause a gradual loss of vision Such a vision loss in some cases occurs over a long period of time. However, in some cases of glaucoma the eye pressure usually rises very fast. It is thought that this happens when the eye drainage canals are blocked or covered over, Like the clog in a sink when something is covering the drain
Drugs are frequently used on cases where intraocular pressure slowly builds and frequently work well. In|patients suffering a rapid rise in such pressure or a long term rise that has reached a dangerous plateau, severe eye damage and permanent loss of sight can result.
Surgery has also been used more recently to treat intraocular pressure. Clinical investigators have noted in recent years that intraocular pressure is lowered following radial incisions in the anterior solera, known as an anterior ciliary sclerotomy. Unfortunately, for patients undergoing such a procedure, the beneficial effects are negated over a period of time following the procedure as the incisions heal and scar. Consequently the potential for eyesight loss arises as pressure ag iin builds following the surgery.
Another sight rek ted problem affecting patients is that of Presbyopia which is a vision condition in which the crystalline lens f a p nt'g ey tøg g jtø flexibility. Tftδ lOSδ Of flexibility makes it difficult for a person to focus on close objects. While Presbyopia may seem to occur suddenly once the patient discovers the problem, it is generally accepted that the cause of the sight loss is actual loss of flexibility of the lens which takes place over a number of years and usually becomes noticeable in the early to mid-forties.
Treatment to help you compensate for presbyopia includes prescription reading glasses, bifocals, contact lenses, and laser surgery. However such corrective lenses can be inconvenient to the wearer and laser surgery to the lens of the eye carries with it the inherent risk to the eyesight itself if a mistake is made.
Still further, many diseases that attack the eye and eyesight require the long term administration of drugs to maintain eyesight. It is desirable to provide an easily placed device that would provide long term modulated direct communication of drugs into the eye concurrently with helping correct the internal pressure and possible vision problems of the patient.
Consequently, there is a continuing need for a medical treatment that would require simple surgical procedure that would have long-lasting effects to relieve internal eye pressure and for the correction of presbyopia to eliminate or reduce the need for prescription lenses and without risky surgery on the lens of the eye itself. Such a treatment would be further enhanced by the provision of a drug delivery system that can be modulated for dose and time that would aid in internal pressure relief as well as other eye ailments requiring precision or long term delivery of drugs.
2. PRIOR ART
Surgical procedures and implantable devices have recently been developed to address the presbyopia.
U.S. Patent No. 6,280,468 (Schachar) discloses a scleral prosthesis for treatment of presbyopia and other eye disorders. Schachar teaches the placement of a prostheses in a plurality of pockets slightly smaller than the implant, circumferentially around the pupil, to exert an outward pressure on the sclera thereby restoring the working distance of the ciliary muscle allowing the patient relief from presbyopia. However, Schachar is oriented circumferentially around the pupil or front of the eye and lacks an anchoring means to hold the implants in proper position in the sclera over the long term which can result in shifting of the implant reducing or eliminating its effectiveness. Further, the use of tunnels smaller than the implant tends to cause broken implants. Schachar also lacks a drug delivery means from the implant. Still further, actual dismounting of the implant can occur which would require removal from the eye especially if it pierces the outside surface of the eye when shifting in position. Additionally, the circumferential placement of the implants is not as effective at encouraging internal drainage and reduction of intraocular pressure.
U.S. Patent No. 6,102,045 (Nordquist) discloses a method and apparatus for lowering intraocular pressure of the eye. However Nordquist is a filtering implant which extends into the anterior chamber of the eye through an opening in the limbus cornea. Nordquist lacks the ability to correct presbyopia that a sclera-mounted device provides and because of its delicate positioning and communication directly with the anterior chamber Nordquist is harder to position correctly. It also lacks the ability to infuse drugs to the eye and the provision of direct communication between the anterior chamber and the exterior regions of the eye increases the risk of infection to the anterior chamber.
U.S. Patent No. 6,079,417 (Fugo) discloses a method and device for reshaping the cornea to change its topography. However Fugo lacks the ability to increase the drainage from the eye interior to lower intraocular pressure. Fugo also is designed to mount directly into the cornea layer of the eye.
U.S. Patent No. 5,178,604 (Baerveldt) teach the use of an implant for increasing eye drainage and reduce pressure caused by glaucoma. However Baerveldt is simply a tube which communicates directly with the interior chamber of the eye and offers no aid to rectifying presbyopia.
As such, there is a continuing need for a reliable operative method and prostheses that will aid physicians in interrupting the relentless cycle that results in vision loss and eye damage to patients suffering from building intraocular pressure in the eye. Such a device should be insertable into the eye in a relatively easy procedure for a trained surgeon. Such a device and procedure should avoid the more delicate structures of the eye and should also avoid communicating internal eye structures directly with the exterior of the eye to prevent infection. Such a device would provide additional utility by through the optional ability to provide a drug delivery system from the implant directly to the eye. Still further, the device implanted by this method should be dimensioned with an anchor structure to insure that the implant stays properly positioned in perpetuity thereby alleviating the need for replacement or removal caused by dislocatable implants and maintaining a fixed correction of vision.
SUMMARY OF THE INVENTION The above problems, and others are overcome by the herein disclosed method and intra- sclera implant for the treatment of glaucoma and presbyopia. The method of insertion of the implants requires incisions be made radially in the anterior sclera. A plurality of such incisions are made radially and only into the sclera with the current best number of incisions being four, with one incision in each quadrant of the eye.
Once the incisions are made in the proper quadrants and extend properly toward the rear of the eye, one implant is positioned within the space of each of the incisions. The scleral incision is then closed by opposition or using suture or other means of closure of the incision to urge the scleral flap toward the surface of the eye from where it was detached and reattach it to the sclera.
The implant is currently best formed in a unitary construction and formed of a material that is inert when in contact with body tissue. Favored materials include one or a combination of materials from a group including hydroxiapartite, silicone, polymethylmethacrylate, acrylic, and tantalum.
The unitary body of the implant can optionally be serrated or have one or a plurality of apertures running through to contact scleral tissue and anchor it. Additionally, the body of the implant can also be impregnated with a drug which thereafter would be slowly delivered into the tissue of the eye or have an internal reservoir or coating of a slowly disburseable drug that can be modulated for dose and time frame to allow for long term delivery of medication to the eye and body of the patient, from the implant.
Accordingly, it is the object of this invention disclosed herein to provide a reliable method of surgery for the placement of implants in the sclera is easy to accomplish for the trained surgeon.
It is another object of this invention to provide an implant that is easily insertable into the scleral layer of the eye during a surgical procedure.
It is still another object of this invention to provide such an implant that has an anchoring system to insure that the implant maintains the position intended by the surgeon implanting it.
Yet another object of this invention is the provision of a method and apparatus for eye surgery that may be used to treat presbyopia as well as rising intraocular pressure.
Still further, it is an object of this invention to provide such an implant with the option of long term drug delivery directly from the implant to the eye. These and further objectives of this invention will be brought out in the following part of the specification, wherein detailed description is for the purpose of fully disclosing the invention without placing limitations thereon.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
The accompanying drawings which are incorporated in and form a part of this specification illustrate embodiments of the disclosed device and together with the description, serve to explain the principles of the invention.
Figure 1 depicts the placement of a plurality of implants radially in four quadrants of the eye and the steps of the method to do so.
Figure 2 shows the implant and its placement in the scleral layer of the eye.
Figure 3 depicts a preferred embodiment of the implant showing anchors and optional coating.
Figure 4 depicts another preferred embodiment of the device having an internal reservoir for holding a drug to be communicated to the exterior.
Figure 5 depicts another preferred embodiment of the device showing anchors about the exterior.
Figure 6 depicts another preferred embodiment of the device showing a round body and anchors extending from the surface.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE DISCLOSED DEVICE
Referring now to figures 1-6 depicting the preferred embodiments of the disclosed device
10, figure 1 depicts the preferred location and steps in the operative method for the placement of
the device 10 into the eye 12. The method for surgical insertion of the implant device 10
requires incisions be made radially in the sclera 16 in relation to the cornea 22 and generally in
line with the center axis 14 of the eye 12 depicted as running along line 2-2 in figure 1.
In its basic structure the eye 12 consists of a globe having an outer coat, a middle layer
and an inner layer. The outer coat is made up of a tough fibrous, white layer - the sclera 16,
which communicates with the conjunctiva 18 which is a mucous membrane that lines the inner surfaces of the eyelids and folds back to cover the front surface of the eyeball, except for the
central clear portion of the outer eye which is the cornea 20. The middle layer contains
pigment and forms the iris 22. The inner layer is the light seeing layer or retina 24. The lens 26
is an oval disc which sits behind the iris 22. It is conventional belief that the cornea 20 focuses
approximately two-thirds of the light entering the eye 12 and the lens 26 about one third. Lens
accommodation or focusing is by simple explanation accomplished by the ciliary muscle 28
pulling upon zonules 30 communicating between the ciliary muscle 28 and the lens 26.
As people age, many suffer from Presbyopia which is a vision condition in which the
lens 26 loses some of its flexibility, or the zonules 30 become elongated making it harder for the
ciliary muscle 28 to focus the lens 26 as needed. Through implanting the device 10 using the
surgical method herein disclosed, it is thought that the rejoined sclera 16 tends to pull over the
device 10 and impart resulting tension to the ciliary muscle 28 giving it more working distance
or travel and resulting ability to pull upon the lens 26 for better accommodation as patients
receiving the device using the method of implantation have had improved vision thereafter. It is
also thought that a decrease in the lens 26 equatorial diameter and a slight stretching of the
zonules 30 increasing their working range also results from the scleral tension developed by the
rejoining of the sclera 16 over the inserted device 10, all combine to increase amplitude of
accommodation following the implantation surgery.
Intraocular pressure in the eye 12 is caused by a build up of fluid in the anterior chamber
36 and posterior chamber 38 when that fluid which is naturally produced in the eye 12, fails to
be communicated through the trabecular meshwork (similar to the grate on a manhole) into the
Canal of Schlemm which is the sewer system duct of the eye getting rid of excess fluid and the
waste products of the eye. It has been found that following the procedure using the
aforementioned method of implantation of the device 10 in the eye of patients, that the drainage of aqueous fluid from the eye increases resulting in a drop of intraocular pressure. As best can
be understood, the apparent tightening of the sclera 16 after implantation of the device in the
four quadrants of the eye 12, apparently has a tightening or tensioning effect on the ciliary
muscle 28 and its connection to the lens 26 and concurrently helps to improve the flow of fluid
through the trabecular meshwork in the same region to aid in evacuation of fluid from the
anterior chamber 36 and posterior chamber 38. Of course other explanations may be apparent to
those skilled in the art and such are anticipated however in the current best mode patients do
experience a drop in fluid pressure in the eye subsequent to the implantation of the device 10
using the method herein disclosed.
In exercising the surgical method for insertion of the implant device 10 the surgeon
would begin with a small limited conjunctival peritomy as shown by the conjunctival incisions
32 of figure 1. In the current best mode of the method a plurality of conjunctival incisions 32 are
performed with four being the current best number, with one in each quadrant of the eye 12
located in-between the muscles 48 attached to the exterior of the eye 12. The conjunctival
incisions 32 expose the sclera 16 wherein next, in each conjunctival incision 32, a radial incision
34 is made radially or generally inline with the axis 14 of the eye 12 running through the center
of the iris 22 and out the back of the eye 12. The radial incisions 34 it has been found, are best
made posteriorly .5 mm from the limbus and measuring substantially 3 mm in length and
approximately 600 microns in depth. However it does depend upon the dimensions of the device
10 implanted and the size of the radial incisions may change to accommodate differently
dimensioned devices 10. Such an substantial inline orientation of the radial incisions 34 to the
axis 14 or radial to the circle forming the iris 22, has been found to produce the best results for
both accommodation and increased drainage of the eye 12. Once the radial incisions 34 are complete and correctly axially oriented and positioned in
the aforementioned manner, an implant device 10 is positioned within the space formed by the
radial incision 34. At this point the radial incision 34 may be closed using a means of closure
such as a suture 44 which pulls the scleral flap 21 over the implant device 10 when so rejoined
exerting tension upon the sclera 16 and to communicating structures of the sclera 16. Those
skilled in the art will recognize that other means of closure of such incisions are available and
new means are continually being discovered and the use of such is anticipated. A radial cavity
19 is formed when the scleral flap 21 is rejoined to the sclera which surrounds the implant
device 10 was placed in the radial incision. It is also anticipated that the implantation of the
implant device 10 radially oriented away from the cornea 20 might be done in other fashions
such as drilling or injection or in the future, with a laser or means of mechanization, and such is
anticipated. The important aspect of the device and method herein described is that the implant
device 10 is placed radially oriented and surrounded by the sclera in a formed cavity and the
current best mode of achieving a radial cavity 19 to hold the implant device 10 radially oriented
respective to the cornea 20 is by the surgical method herein described.
Following closure of the radial incisions 34, the conjunctival incisions 32 are closed
using cautery or other means of such closure. The method now being complete, the implant
device 10 is properly placed to improve both the vision and fluid drainage of the patient. The
implant device 10 may be removed in the reverse order.
The implant device 10 used in combination with the surgical method, in the current best
mode, is formed of a material that is inert when in contact with body tissue. The implant device
10 as noted, occupies the radial cavity 19 formed when the radial incision 34 is closed in the
aforementioned method. A tightening or tensioning of the sclera 16 layer is provided when the
radial incision 34 is closed and the scleral flap 21 is sutured or otherwise rejoined with the sclera 16 and stretched over the implant device 10 during closure. Favored materials include one or a
combination of materials from a group including hydroxiapartite, silicone,
polymethylmethacrylate, acrylic, and tantalum. Those skilled in the art will recognize that other
materials could be used and new materials are continually being developed for implants and the
use of such is anticipated.
The implant device 10 has body portion 46 and a means to anchor the device in radial
cavity 19 to substantially prevent movement, which in a current preferred embodiment is
provided by anchors 48 protruding from the body portion 46. Other means to anchor the device
when placed in the radial cavity could accomplished be through the use of a serrated surface 50,
or curved projections 52, or detents 54 in the exterior surface of the body 46 or apertures 56
which would communicate through the body 46. Or, one or combinations of such means to
prevent movement of the implant device 10 can be used together.
Optionally, should the delivery of drugs to the point of implantation be desirable, which
with many illnesses such localized delivery is, the device 10 can be provided with a means to
communicate drugs from a device resident supply of drugs, to the device to the surrounding eye
tissue. This drug delivery system can be provided by one or a combination of micro
encapsulated drug coatings or other polymer or prolonged dissolving coatings 58 on the exterior
of the device, or through a reservoir 60 inside the body 46 which would hold a supply of the
drug of choice in either solid or liquid form and communicate the drugs through channels 62 to
the surrounding tissue. Or the material from which the device 10 is produced can be
impregnated with the appropriate drug and secrete the same over time. When a reservoir 60 is
used, the dosage and delivery time can be modulated by adjusting the amount of communication
achieved through the channels 62 or just as the coating can, by adjusting the polymer or other
substance in which the drug is dissolved to yield dissolution that will deliver the dose for amount of time desired for infusion. From the reservoir 60 the device would secrete the drugs over a
determined period at the determined dose and then can be refilled through a channel 62 by a
hypodermic needle 27 which would pierce the sclera 16 and refill the reservoir 60 through one of
the channels 62 or a similar passage designed for such a refill. Refill can thus be accomplished
without the need for the implant device 10 to be removed or disturbed from its secure mount
inside the radial cavity 19.
Figure 6 depicts the device 10 with a body 46 that is round or barrel shaped rather than the cube or rectangular shape of figures 3-5. The body 46 would work well in either configuration so long as one of the noted anchoring means projects from it to anchor the device 10 in the radial cavity. While the curved projections 52 are shown on all sides, it may be beneficial in some cases to omit them from one side for smooth transition of the scleral flap 21 over the implant device 10.
While all of the fundamental characteristics and features of the present invention have been described herein, with reference to particular embodiments thereof, a latitude of modification, various changes and substitutions are intended in the foregoing disclosure and it will be apparent that in some instance, some features of the invention will be employed without a corresponding use of other features without departing from the scope of the invention as set forth. It should be understood that such substitutions, modifications, and variations may be made by those skilled in the art without departing from the spirit or scope of the invention. Consequently, all such modifications and variations are included within the scope of the invention as defined by the following claims. What is claimed is:

Claims

1. An intra-scleral implant for lowering intraocular pressure and treating presbyopia comprising: an elongated body portion dimensioned for implantation into a radially oriented, elongated cavity, formed in the scleral tissue of the eye.
2. The intra-scleral implant of claim 1 further comprising: means to anchor said body portion in said elongated cavity, whereby movement of said elongated body portion in said elongated cavity is substantially prevented.
3. The intra-scleral implant of claim 2 wherein said means to anchor said body portion in said elongated cavity comprises: at least one post extending from said body portion.
4. The intra-scleral implant of claim 2 wherein said means to anchor said body portion in said elongated cavity comprises: at least one curved projection extending from said body portion.
5. The intra-scleral implant of claim 2 wherein said means to anchor said body portion in said elongated cavity comprises: serrations formed in an exterior surface of said body portion.
6. The intra-scleral implant of claim 2 wherein said means to anchor said body portion in said elongated cavity comprises: a plurality of posts extending from said body portion.
7. The intra-scleral implant of claim 2 wherein said means to anchor said body portion in said elongated cavity comprises: at least one aperture formed in a side wall of said body portion.
8. The intra-scleral implant of claim 2 wherein said means to anchor said body portion in said elongated cavity comprises one or a combination of means to anchor said body portion from a group of said means to anchor said body portion consisting of at least one post extending from said body portion, at least one aperture formed in a side wall of said body portion, at least one curved projection extending from said body portion, and serrations formed in an exterior surface of said body portion.
9. The intra-scleral implant of claim 1 further comprising: means to communicate a drug dose to surrounding tissue from an implant-resident supply of a drug.
10. The intra-scleral implant of claim 2 further comprising: means to communicate a drug dose to surrounding tissue from an implant-resident supply of said drug.
11. The intra-scleral implant of claim 8 further comprising: means to communicate a drug dose to surrounding tissue from an implant-resident supply of said drug.
12. The intra-scleral implant of claim 9 wherein said means to communicate a drug dose to surrounding tissue from an implant-resident supply of a drug comprises: a dissolvable coating on said intra-scleral implant.
13. The intra-scleral implant of claim 9 wherein said means to communicate a drug dose to surrounding tissue from an implant-resident supply of a drug comprises: a reservoir cavity inside said body portion; said reservoir holding a supply of said drug; and at least one channel communicating between said reservoir and tissue surrounding said intra-scleral implant.
14. The intra-scleral implant of claim 10 wherein said means to communicate a drug dose to surrounding tissue from an implant-resident supply of a drug comprises: a dissolvable coating on said intra-scleral implant.
15. The intra-scleral implant of claim 10 wherein said means to communicate a drug dose to surrounding tissue from an implant-resident supply of a drug comprises: a reservoir cavity inside said body portion; said reservoir holding a supply of said drug; and at least one channel communicating between said reservoir and tissue surrounding said intra-scleral implant.
16. The intra-scleral implant of claim 13 wherein said reservoir is refillable without dismounting said intra-scleral implant from said elongated cavity.
17. The intra-scleral implant of claim 15 wherein said reservoir is refillable without dismounting said intra-scleral implant from said elongated cavity.
18. A method for lowering the intraocular pressure of an eye which comprises positioning in radial orientation, at least one elongated implant within a cavity in the scleral layer of the eye.
19. A method for treating presbyopia which comprises positioning in a radial orientation in an eye, at least one elongated implant within a cavity in the scleral layer of said eye.
20. A method for lowering the intraocular pressure of an eye which comprises positioning in a radial orientation, a plurality of elongated implants within cavities formed in the scleral layer of the eye.
21. A method for treating presbyopia which comprises positioning in a radial orientation in an eye, a plurality of elongated implants within cavities formed in the scleral layer of said eye.
22. The method of claim 18 wherein said implant comprises: an elongated body portion; and means to anchor said body portion in said elongated cavity, whereby movement of said elongated body portion in said elongated cavity is substantially prevented.
23. The method of claim 20 wherein said implant comprises: an elongated body portion; and means to anchor said body portion in said elongated cavity, whereby movement of said elongated body portion in said elongated cavity is substantially prevented.
24. The method of claim 22 wherein said implant additionally comprises: means to communicate a drug dose to surrounding tissue from an implant-resident supply of said drug.
25. The method of claim 23 wherein said implant additionally comprises: means to communicate a drug dose to surrounding tissue from an implant-resident supply of said drug.
26. A method for lowering the intraocular pressure of an eye or treating presbyopia by surgically placing an implant comprising the steps of: making a small limited conjunctival peritomy in the eye to expose the sclera; making a radially oriented incision in the sclera to form a scleral flap; positioning an elongated implant device within the space formed by the radially oriented incision; and reattaching the scleral flap over said elongated implant device, to the sclera, to thereby form a cavity surrounding said elongated implant.
EP02768411A 2001-08-03 2002-08-02 Method and intra sclera implant for treatment of glaucoma and presbyopia Withdrawn EP1418864A4 (en)

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US31002701P 2001-08-03 2001-08-03
US310227P 2001-08-03
PCT/US2002/024646 WO2003015667A1 (en) 2001-08-03 2002-08-02 Method and intra sclera implant for treatment of glaucoma and presbyopia

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EP1418864A4 true EP1418864A4 (en) 2009-07-01

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EP (1) EP1418864A4 (en)
JP (1) JP4346438B2 (en)
KR (1) KR20040024873A (en)
CA (1) CA2455120A1 (en)
IL (1) IL160037A0 (en)
WO (1) WO2003015667A1 (en)

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WO2003015667A8 (en) 2004-12-16
KR20040024873A (en) 2004-03-22
WO2003015667A1 (en) 2003-02-27
JP4346438B2 (en) 2009-10-21
EP1418864A1 (en) 2004-05-19
IL160037A0 (en) 2004-06-20
CA2455120A1 (en) 2003-02-27
JP2005508213A (en) 2005-03-31

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