Methods and devices for performing a temporary tarsorrhaphy

Surgery – Instruments – Sutureless closure

Reexamination Certificate

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C128S898000

Reexamination Certificate

active

06206906

ABSTRACT:

TECHNICAL FIELD
The present invention relates generally to medical technology and to methods and devices for performing a temporary tarsorrhaphy.
BACKGROUND OF THE INVENTION
Tarsorrhaphy is a common ophthalmic procedure performed on damaged eyes involving surgical fusion of the upper and lower eyelid margins. The procedure has the effect of partially or fully narrowing the palpebral fissure, thereby reducing exposure of the damaged eye to the external environment, allowing the damaged eye to heal. This procedure is performed most commonly to protect an injured cornea. Examples of conditions which often call for a tarsorrhaphy include keratitis associated with severe dry eyes, non-healing corneal abrasions or ulcers due to any cause, and corneas which are in poor condition immediately following surgical procedures such as corneal transplant, vitrectomy, or glaucoma surgery with the use of antimetabolites, which in themselves are often injurious to the cornea.
The tarsorrhaphy may be one of two varieties. A permanent tarsorrhaphy may be formed wherein the eyelid margins are sealed indefinitely. More common is a procedure known as a temporary tarsorrhaphy wherein the eyelids are fastened together for a time period ranging from six weeks to several months.
Although several techniques exist for performing a temporary tarsorrhaphy, this fundamental procedure implies a surgery that is usually carried out by sewing the top and bottom eyelids together, using a fine suture. The simplest method of creating a tarsorrhaphy is to mark off the opposing areas of the upper and lower eyelids to be fused by means of scratch marks. The eyelids are then sutured together at the marks.
Several problems have been associated with temporary tarsorrhaphies. The sutures used to create the tarsorrhaphy may loosen or pull out before their function is fully accomplished. This may occur in lids whose vitality has been lowered by severe trauma or frequent surgical procedure. This also occurs in lids narrowed congenitally or by loss of tissue due to trauma. Various other techniques have been used in performing a temporary tarsorrhaphy to try to prevent the integrity of the sutures used in performing a tarsorrhaphy from being negatively impacted.
A complex tarsorrhaphy technique has been designed in which a tongue and groove are created in the lower and upper eyelids, respectively, and the tongue is then drawn up to fill the groove in the upper lid and sewn into place. However, in addition to the usual surgical problems associated with sewn-in-place tarsorrhaphies, this method requires more surgery, additional tissue disruption, and may require a longer healing time.
Other techniques also exist for performing a temporary tarsorrhaphy. Small rectangular pieces of material, known as “pegs”, may be placed opposite each other on the upper and lower eyelids. The pegs are sewn to the eyelids and then to each other to accomplish the temporary tarsorrhaphy. Although this procedure is of some help in preventing loosening or tearing of the sutures, none of the temporary tarsorrhaphy methods to date have addressed the additional problem of being able to allow the eyelids to be separated in order to visualize the cornea or other parts of the eye without removing the temporary tarsorrhaphy itself.
Although it is possible to sew only a portion of the eyelids together in performing a temporary tarsorrhaphy, this allows only partial protection of the eye and allows only a portion of the eye to be inspected by the ophthalmic practitioner without removing the tarsorrhaphy. Since the purpose of the temporary tarsorrhaphy is to protect the eye and/or to promote healing, it would be advantageous to be able to easily open and reclose the eyelids at will to assess the status of the eye.
Temporary tarsorrhaphies are intended to last for a period of time ranging from six weeks to several months. However, it has been found that by using any of the known methods for a temporary tarsorrhaphy, the tarsorrhaphy can be expected to last a maximum of six weeks. Due to the very thin sutures used to tie the lids together, the sutures have a tendency to pull through or “cheesewire” through the thin tissue of the eyelids. It would be of great advantage if a temporary tarsorrhaphy could be performed which would prevent “cheesewiring”, as well as allowing the entire eye to be viewed and allow the eyelids to be easily opened and reclosed without having to re-perform the tarsorrhaphy.
SUMMARY OF THE INVENTION
One object of the present invention is a method for performing a temporary tarsorrhaphy wherein a first tube is inserted in a linear fashion through a portion of the upper eyelid of an eye so that a portion of the first tube lies beneath the skin of the eyelid and each end of the first tube protrudes from the upper eyelid. A second tube having first and second ends is inserted through a portion of the lower eyelid of the eye in a linear fashion so that each end of the second tube also protrudes from the lower eyelid. The protruding ends of the first and second tubes preferably lie approximately parallel to the eyelid margin. The first ends of the first and second tubes are drawn and secured together in a reversible manner. The second ends of the first and second tubes are also drawn and secured together in a reversible manner to complete a temporary tarsorrhaphy.
Another object of the present invention is a device comprising a tarsorrhaphy clip further comprising a tube having first and second ends and a connecting means having first and second ends. A clip may be attached to each eyelid of an eye, and the clips are secured together in a reversible manner with one or more fasteners. To attach the first clip to the upper eyelid, a first tube is inserted in a linear fashion through a portion of the upper eyelid of an eye so that a portion of the tube lies beneath the skin of the eyelid, and each end of the tube protrudes from the upper eyelid. Preferably, the end portions of the tube that lie outside the skin of the eyelid are parallel to the palpebral fissure. A first connecting means is then placed between the two protruding ends of the first tube, and a portion of the first tube located proximate the first end of the tube is attached to the first end of the first connecting means. The first tube is then drawn taut, and the second end of the first connecting means tube is attached to a portion of the tube proximate the second end of the first tube, such that the connecting means secures portions of the first tube which protrude from the eyelid, completing placement of the first clip. Once secured in place, the first clip lies approximately parallel to the palpebral fissure.
A similar procedure is used to attached the second clip to the lower eyelid of the eye. A second tube having first and second ends is inserted through a portion of the lower eyelid of the eye in a linear fashion so that each end of the second tube also protrudes from the lower eyelid. A portion of the second tube proximate to the first end of the tube is attached to the first end of a second connecting means. The second tube is then drawn taut, and a portion of the second tube proximate the second end of the tube is firmly secured to the second end of the second connecting means. The second clip is positioned on the eyelid approximately parallel to the palpebral fissure.
In a preferred embodiment, the connecting means each comprise a metal rod, each have a cylindrical sleeve covering the mid portion of each rod to protect the eyelid from abrasion. Additionally, in the preferred embodiment, each end of each connecting means comprises a small jawed clamp which can be locked down to hold a portion of a tube. In the preferred embodiment, after the ends of each tube have been secured by the connecting means, a small cap is placed over the ends of each jawed clamp to lock the clamp closed, if the jawed clamps are not self-locking.
After the first and second clips are attached to the eyelids, the eye is then closed so that the first connecting means on the upper eyelid and the secon

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