Patent Application
20060036319
The present invention relates generally to prosthetic devices and more specifically to ophthalmic surgical conformers that are used post-operatively in such ophthalmic procedures as evisceration, enucleation, and exenteration.
The loss of sight in an eye is a traumatic, life-altering event which can occur for any number of reasons, such as trauma or disease. When this loss is accompanied by the removal of all or a portion of a patient's eyeball from an eye orbit, there is the additional trauma of loss of normal appearance, or disfigurement.
Surgical procedures that remove a portion, or all, of the eyeball and surrounding tissues within the orbit include evisceration, enucleation and exenteration. As these surgical procedures remove some, or all, of the eyeball and surrounding tissues, they create a volume in the orbit. The size of the volume depends on the procedure. For example, the eyeball can be broadly considered to comprise a sclera and a cornea that define a capsule that contains, among other structures, the uvea, retina, lens and vitreous. In an evisceration procedure, the cornea and the structures within the sclera are removed, leaving what is termed a scleral envelope. The enucleation procedure additionally removes the sclera and a portion of the optic nerve (a nerve connected to the eyeball a portion of which is within the orbit). This leaves in the orbit post-operative tissues, such as the rectus muscles, orbital fat and a residual envelope of fibrous connective tissue, termed Tenon's capsule. The exenteration procedure where the eyelids are spared, removes the remaining tissues in the orbit. In all these surgical procedure, the normal outward appearance of the eye is lost. Therefore, after such procedures as evisceration, enucleation, or exenteration, patients typically desire reconstruction to restore a more normal eye appearance.
Generally the restoration to create a more normal eye appearance employs an implant in combination with an artificial eye. The implant and artificial eye augment the volume created during the surgical procedure.
For an evisceration or enucleation surgical procedure, the implant is surgically placed within the scleral envelope or Tenon's capsule. This layer is then closed to prevent migration of the implant. After placement, conjunctiva (a membrane that covers most of the eyeball with a portion that is located between the back of the eyelids and the eyeball that during the procedure has had an incision made therein to gain access to the eyeball) is pulled over the implant and sutured back together thereby further securing the implant in the scleral envelope or Tenon's capsule. An ophthalmic surgical conformer (see Integrated Orbital Implants, Inc., Conformers, Part No. I00043) is then immediately placed over the conjunctiva in the eye socket proximate to the backside of the eyelids. After a healing period of weeks, a mold for an artificial eye will be made, and then some time later the artificial eye will be manufactured and fitted, which completes the augmentation of the volume, i.e., restoration.
In an exenteration procedure where the eyelids are retained, the implant, which is a dermis-fat graft, is placed within the orbit. The ophthalmic surgical conformer is placed between the graft and the eyelids to keep these tissues from adhering one to the other.
The ophthalmic surgical conformer is a temporary, transparent prosthetic device. It is recognized by the profession as separate and distinct from an artificial eye or even other conformers used in other ophthalmic surgical procedures, e.g., reconstruction due to congenital anophthalmia.
As mentioned above, the mold for the artificial eye is not taken until after a healing period. This healing period allows swelling, which naturally results from the surgical placement of the implant in the scleral envelope, Tenon's capsule or orbit, to subside. Due to this swelling, the volume has an initial residual volume into which the ophthalmic surgical conformer is placed that has a contour and volume that is different from a final residual volume into which the artificial eye will eventually be fitted and placed.
The ophthalmic surgical conformer has a therapeutic shape that allows it to fit into the initial residual volume, which is smaller than the final residual volume, and to act as part of a pressure system that maintains the shape and position of residual tissues, such as those in the conjunctiva. Pressure in the pressure system results from a monocular pressure dressing applied immediately post-operatively over the eye on the outside of the eyelids as firmly as possible to minimize swelling. It is the monocular pressure dressing that provides a force on the ophthalmic surgical conformer thereby permitting the ophthalmic surgical conformer to shape and position the residual tissues. This pressure is also thought to assist in preventing post-surgical hemorrhaging, as well as in maintaining the shape of the underlying tissues.
While the monocular pressure dressing is applied, the ophthalmic surgical conformer as well as the result of the surgical procedure is not viewable by an observer. Pressure, however, is only needed for a limited time after surgery, generally a matter of days. Therefore within days after surgery, the monocular pressure dressing is removed revealing to observers the missing eye. Unfortunately, it will be weeks, generally six to eight, until the final residual volume forms and can tolerate the molding procedure involved in making an artificial eye. Then additional time is required for the manufacturing of the artificial eye.
During the period after removal of the monocular pressure dressing and before the artificial eye is available and installed, the patient generally employs such items as sunglasses or an eye patch to obscure the view by observers of the eye socket. However, sunglasses appear out of place at certain times, particularly in the evening or inside. Eye patches also present issues that make them a less than desirable solution.
What is needed in the art is a cosmetically appealing prosthetic device for the period immediately after pressure bandage removal until an artificial eye is available for use.
This invention in one aspect is a cosmetic ophthalmic surgical conformer. The cosmetic ophthalmic surgical conformer has at least one eye representation that is visible to an observer. The eye representation can include, but is not limited to, a pupil, an iris, a sclera and episcleral blood vessels.
These and other features, aspects, and advantages of embodiments of the present invention will become apparent with reference to the following description in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed solely for the purposes of illustration and not as a definition of the limits of the invention.
As shown in
In a profile of the body 16, the profile is generally egg-shaped. Additionally, it has a thickness t between a convex surface 18 opposed to a concave surface 20, which is substantially constant.
The at least one eye representation 14 can be as realistic as one desires. As a general matter, however, the cosmetic ophthalmic surgical conformer 10, just as the ubiquitous ophthalmic surgical conformer, should be an off-the-shelf item, not custom made for the patient. Therefore, it is anticipated that at least one eye representation 14 will be made in standard configurations and the “best match” chosen by a surgeon.
Referring to
The contour of the initial residual volume 30 is defined by the conjunctiva 32 and backsides 34, 36 of the eyelids 24, 26 and is a function of any swelling resulting from the surgical procedure. A pressure bandage (not shown) is applied immediately post-operatively over the eyelids 24, 26 and removed after several days. The body 16 has a therapeutic shape with a volume that allows the cosmetic ophthalmic surgical conformer 10 to fit within the initial residual volume 30 and a shape that allows it to transmit the pressure created by the pressure bandage to the underlying tissues, e.g., conjunctiva 32, to aid in hemorrhage prevention and contouring of the underlying tissues.
After removal of the pressure bandage and with the eyelids 24, 26 parted, at least a portion of the cosmetic ophthalmic surgical conformer 10 and the at least one eye representation 14 is viewable by an observer. The cosmetic ophthalmic surgical conformer 10 can then be used until an artificial eye is available. While this depiction is for an enucleation procedure, it should be appreciated that the depiction would be similar for an evisceration or an exenteration procedure.
The standard placement of the cosmetic ophthalmic surgical conformer 10 in the eye socket 22 determines the nominal placement of the at least one eye representation 14. Referring to
The cosmetic ophthalmic surgical conformer 10 is made from a suitable material, such as plastic or silicone, without vision correcting optical characteristics, such as those found in contact lenses. It is possible that portions of the ophthalmic surgical conformer could be transparent so that as much of the underlying tissue, e.g., conjunctiva, can be viewed therethrough as needed. It is understood, however, that the pupil and iris representations may block viewing of the underlying tissues. That said, the cosmetic ophthalmic surgical conformer 10 may be merely translucent or even opaque.
The material that makes up the cosmetic ophthalmic surgical conformer 10 should make the body 16 rigid or semi-rigid, so the cosmetic ophthalmic surgical conformer can transmit pressure. The material should therefore be generally non-compressible or non-deformable. The materials of the member 12 and the at least one eye representation 14, if not encapsulated in the member, should also be approved for use in a human body.
Referring to
While there has been illustrated and described what is at present considered to be preferred and alternative embodiments of the claimed invention, it will be appreciated that numerous changes and modifications are likely to occur to those skilled in the art. It is intended in the appended claims to cover all those changes and modifications that fall within the spirit and scope of the claimed invention.
