|Publication number||USRE34307 E|
|Application number||US 07/695,607|
|Publication date||Jul 6, 1993|
|Filing date||May 3, 1991|
|Priority date||Oct 19, 1987|
|Publication number||07695607, 695607, US RE34307 E, US RE34307E, US-E-RE34307, USRE34307 E, USRE34307E|
|Inventors||Arthur C. Perry|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (9), Non-Patent Citations (8), Referenced by (6), Classifications (9), Legal Events (8)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This invention relates to orbital implants following enucleation or evisceration of the eye. In another aspect, it relates to materials for use as orbital implants.
Enucleation or envisceration of the eye is performed because of disease or trauma that make the removal of the eye necessary. Following such a procedure, the patient normally desires to have an artificial eye in order to restore a more normal appearance. In order to satisfactorily fit an artificial eye into the orbital socket, an orbital implant must be placed within the orbit to replace the volume within the orbit that was lost when the eye was removed. The use of an orbital implant and the subsequent fitting of the artificial eye confer more than a cosmetic benefit, however. They help maintain the normal structure of the eyelids and eyebrows; they aid in normal tear drainage; and, when used in children, they help stimulate normal growth of the orbital bones.
An early, and still typical, implant is a simple orbital implant in the form of a sphere or globe of plastic or other suitable inert material. When, after surgery, the socket (the area in the orbit that once held the eye) is healed, the socket is fitted with an artificial eye which lies on the tissues that have healed over the implant. Even though an artificial eye can be made today which has a very realistic appearance, the results from the patient's point of view are far from satisfactory. Without attachment of the eye muscles to the artificial eye, the artificial eye drifts within the socket and cannot be made to track with the normal eye. This lack of tracking is quite apparent and disconcerting to even a casual observer, creating a sense of self-consciousness on the part of the patient. As a result of this shortcoming of simple implants, efforts have been made to attach the eye muscles to the implant and then to attach the artificial eye to the implant. This procedure works quite satisfactorily in producing good tracking of the artificial eye. However, the success is short-lived because, in a brief period of time, the implant is extruded from the orbit. The reason for the extrusion of the implant is that the fixing of the artificial eye to the implant material exposes the implant to the outside environment. This permits bacteria to enter and the implant becomes chronically infected. This exposure is necessary, however, to produce the attachment between the implant and the artificial eye.
As previously noted, the typical implant is made of a non-natural material, at least as far as the patient is concerned. Materials that have been used include ivory spheres, gold globes, silk, catgut and a host of other materials. Acrylic plastics or silicones remain the materials of choice, however. To overcome the shortcomings of these materials, it has been proposed to use other more "natural" materials. Among these may be mentioned autoclaved human bone from cadavers, G. C. Sood et al., International Surgery, vol. 54, No. 1, p. 1 (1970), and antigenfree cancellous calf bone, so called "Kiel Bone", A.C.B. Molteno, et al., Brit. J. Opthal., vol. 57, p. 615 (1973) and A.C.B. Molteno, Trans: of the Ophthal. Soc. New Zealand, vol. 32, p. 36 (1980). Although varying degrees of success have been claimed for these materials, the method of choice remains, to this say, a simple implantation of an orbital implant which is typically made of acrylic, plastic or silicone, even though this deprives the implant of natural movement. No attempt is made to attach the implant to the artificial eye. However, extrusion of the implant is usually avoided and the implants is long-lasting.
As a result of the shortcomings of prior implants, there remains unfilled a long-felt need for an orbital implant which can be readily implanted in a manner which provides tracking of the artificial eye without the eventual extrusion of the implant, a problem which has characterized implants in the past.
FIG. 1 is a view of a sphere of hydroxyapatite used as an orbital implant according to the present invention.
FIG. 2 is a view in cross-section of an orbital implant of the invention after insertion into the eye and after healing has occurred and which has been drilled to received an artificial eye.
FIG. 3 is a view illustrative of the relationship between an artificial eye useful in the invention and the orbital implant of the invention.
FIG. 4 is a view of the implant and artificial eye of FIG. 3 in which the artificial eye has been inserted into the implant.
FIG. 5 is a view of an embodiment of an artificial eye useful in the invention.
FIG. 6 is a view of an implant of the invention into which the artificial eye of FIG. 5 has been inserted.
It has been found that the shortcomings of prior implants can be avoided by using sterile hydroxyapatite as the implant material. In a less preferred embodiment of the invention, granular high-density hydroxyapatite, such as that used as a bone grafting material, is used as the implant. This material can be used either to fill a residual scleral sac after an evisceration or, in the case of an enucleation, placed within a scleral sac obtained from a tissue bank, the scleral sac sewn closed and the filled scleral sac used as the orbital implant by being sutured to the eye muscles. Preserved dura or other homologous or autologous collagen graft material may be used in place of the scleral sac. As part of the healing process, the granular material becomes incorporated into the scar tissue and fibrovascular tissue that develops following surgery. After this incorporation occurs, the implant can be drilled or otherwise modified to permit coupling with the artificial eye.
In a presently more preferred embodiment of the invention, the implant is granular or, preferably, as shown in FIG. 1 a sphere of a low-density, porous hydroxyapatite of the kind obtained from coral or by synthetic means. The sphere is machined to an appropriate size to be used as an implant from a larger block of porous hydroxyapatite. Prior to the use of the implant in the procedure, it is sterilized. If the damaged eye has been eviscerated (all the inner contents removed), the implant is inserted into the remaining scleral sac of the patient's own eye and the scleral sac is sewn closed. If an enucleation is performed (removal of the entire eyeball after severing it from the eye muscles and the optic nerve), the implant can be sewn within a scleral sac, preserved dura or other homologous or autologous collagen graft material. Such tissue is available from eye banks or tissue banks. The muscles which move the eye are attached to the implant by suturing them to the cover material. Alternatively, the implant may be inserted into the orbit without being covered by the graft material and the eye muscles sutured directly into small holes drilled into the implant for that purpose.
After implantation, the socket is allowed to heal for approximately six months. During the healing process, scar tissue and fibrovascular tissue penetrate the porous structure of the sphere and the implanted scleral sac or other covering is gradually absorbed. After sufficient healing has occurred, the implant can be drilled as shown in FIG. 2 to provide a hole 12 or otherwise modified to permit the artificial eye to be coupled with it. As shown in FIG. 2, tissue also grows into and provides a lining 13 for the drilled hole.
In one embodiment of the invention, the artificial eye 14 is permanently fitted with a peg which then fits into the drilled hole 13 of the implant, thus coupling the implant with the artificial eye as shown in FIG. 4.
In another embodiment of the invention illustrated in FIGS. 5 and 6, a protruding peg 16 is placed into the drilled hole of the implant and the artificial eye 17 is recessed as at 18 to receive the peg and thus be coupled with the implant via the peg. In either embodiment, the artificial eye and peg can be readily removed to permit cleaning.
The resulting implants are very satisfactory from the patient's point of view. The implant does not extrude from the orbit. Instead, it becomes an integral part of the residual eye structure because of the intrusion of the scar tissue and fibrovascular tissue into the porous material. Being fixed to the eye muscle, the implant is capable of tracking with the normal eye. When an artificial eye is fixed to the implant to complete the prosthesis, a very satisfactory, natural appearance results.
To date, 27 patients have had this material implanted into the orbit. There have been no chronic infections or extrusions of the implant in patients who have had implants for up to 26 months. In those patients who have had the hole drilled into the implant so that it is coupled to the artificial eye, the tracking has been very satisfactory.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US2571721 *||Jan 30, 1948||Oct 16, 1951||American Optical Corp||Artificial eye|
|US2649590 *||Dec 9, 1946||Aug 25, 1953||Cutler Norman L||Eye implant and prosthesis|
|US3436763 *||Mar 28, 1966||Apr 8, 1969||Milauskas Albert T||Orbital implant of fused acrylic plastic and process of implanting|
|US3480971 *||Feb 21, 1967||Dec 2, 1969||Smith Leonard Donald||Artificial eyes having a changeable pupil and movable iris portion actuated by muscle tissue|
|US4087867 *||Aug 5, 1976||May 9, 1978||Horst R. Hickmann||Ophthalmic prosthesis implant|
|US4097935 *||Jan 31, 1977||Jul 4, 1978||Sterling Drug Inc.||Hydroxylapatite ceramic|
|US4186448 *||Nov 21, 1977||Feb 5, 1980||Brekke John H||Device and method for treating and healing a newly created bone void|
|US4314380 *||Sep 26, 1980||Feb 9, 1982||Koken Co., Ltd.||Artificial bone|
|SU633525A1 *||Title not available|
|1||*||A. C. B. Molteno, Antigen Free Cancellous Bone Implants After Removal of an Eye, Trans. Ophthal., Soc., N.Z., 32, 36 39 (1980).|
|2||A. C. B. Molteno, Antigen-Free Cancellous Bone Implants After Removal of an Eye, Trans. Ophthal., Soc., N.Z., 32, 36-39 (1980).|
|3||A. C. B. Molteno, et al, "Physiological" Orbital Implant, Brit. J. Ophthal., 57, 615-621 (1973).|
|4||*||A. C. B. Molteno, et al, Physiological Orbital Implant, Brit. J. Ophthal., 57, 615 621 (1973).|
|5||Datton, "New eye implant is being tested locally", San Diego Union, Dec. 1985.|
|6||*||Datton, New eye implant is being tested locally , San Diego Union, Dec. 1985.|
|7||*||G. C. Sood et al, Human Bone as Buried Implant After Enucleation, Inter. Surgery, 54, 1 3 (1970).|
|8||G. C. Sood et al, Human Bone as Buried Implant After Enucleation, Inter. Surgery, 54, 1-3 (1970).|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US5584880 *||Apr 28, 1994||Dec 17, 1996||Martinez; Miguel||Orbital implant|
|US6248130||Aug 3, 1999||Jun 19, 2001||Arthur C. Perry||Pegs for orbital implants|
|US6468313||Sep 22, 2000||Oct 22, 2002||Bio-Vascular, Inc.||Implants and method of making|
|US20020193886 *||Aug 12, 2002||Dec 19, 2002||Anne Claeson||Implants and method of making|
|US20090309274 *||Aug 20, 2009||Dec 17, 2009||Eyeborn (Proprietary) Limited||Orbital implant|
|WO1998049973A1 *||May 6, 1998||Nov 12, 1998||Orbital Implants Technology||Orbital implant pegs|
|International Classification||A61F2/00, A61L27/12, A61F2/14|
|Cooperative Classification||A61F2310/00293, A61L27/12, A61F2/141|
|European Classification||A61L27/12, A61F2/14B|
|Jul 19, 1994||REMI||Maintenance fee reminder mailed|
|Aug 15, 1994||FPAY||Fee payment|
Year of fee payment: 4
|Aug 15, 1994||SULP||Surcharge for late payment|
|Jul 7, 1998||REMI||Maintenance fee reminder mailed|
|Aug 13, 1998||SULP||Surcharge for late payment|
|Aug 13, 1998||FPAY||Fee payment|
Year of fee payment: 8
|Nov 9, 1998||AS||Assignment|
Owner name: PERRY FAMILY LIMITED PARTNERSHIP, THE, CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:PERRY, ARTHUR C.;REEL/FRAME:009570/0186
Effective date: 19981028
|Jun 7, 2002||FPAY||Fee payment|
Year of fee payment: 12