Classifications

• • 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
  • A61F2/00—Filters 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
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• • 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
  • A61F2/00—Filters 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
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
  • A61F2/147—Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants
• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P27/00—Drugs for disorders of the senses
  • A61P27/02—Ophthalmic agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P27/00—Drugs for disorders of the senses
  • A61P27/02—Ophthalmic agents
  • A61P27/10—Ophthalmic agents for accommodation disorders, e.g. myopia
• • 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
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
  • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
  • A61F2250/0068—Means 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.

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• Health & Medical Sciences (AREA)
• Ophthalmology & Optometry (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Heart & Thoracic Surgery (AREA)
• Biomedical Technology (AREA)
• Vascular Medicine (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• General Chemical & Material Sciences (AREA)
• Transplantation (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Chemical & Material Sciences (AREA)
• Organic Chemistry (AREA)
• Medicinal Chemistry (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Pharmacology & Pharmacy (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Surgery (AREA)
• Prostheses (AREA)
• Medicinal Preparation (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

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Publications (2)

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Citations (5)

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• 2002
  • 2002-08-02 KR KR10-2004-7001249A patent/KR20040024873A/ko not_active Application Discontinuation
  • 2002-08-02 CA CA002455120A patent/CA2455120A1/en not_active Abandoned
  • 2002-08-02 IL IL16003702A patent/IL160037A0/xx unknown
  • 2002-08-02 JP JP2003520429A patent/JP4346438B2/ja not_active Expired - Fee Related
  • 2002-08-02 WO PCT/US2002/024646 patent/WO2003015667A1/en active Search and Examination
  • 2002-08-02 EP EP02768411A patent/EP1418864A4/de not_active Withdrawn

Patent Citations (5)

Non-Patent Citations (1)

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