Devices in accordance with certain embodiments of the present sulcus speculum are designed to be placed into the sulcus of an eye to perform one or more of the following functions: evacuation of fluid, opening of the lids, and application of drugs such as anesthetic or antibiotics. The present devices can include a sponge positioned around (a) an aspiration tube for withdrawing fluid and (b) an arm of a speculum. Other variations of the present devices include those with an aspiration tube for withdrawing fluid, the tube being positioned in a trough defined by an arm of a speculum. Alternatively, the speculum arm can define a passage for holding the aspiration tube. In that alternate embodiment, the portion of the speculum arm defining the passage has openings for passing fluid into the passage so that the aspiration tube in the passage can then remove fluid.

FIELD OF THE INVENTION

Aspects of the present invention are directed to the field of ophthalmic devices. More particularly, aspects of the present invention are directed to speculums for placement adjacent the sulcus, which is the region under the eyelid where the covering of the lid and globe fold back on themselves, during ophthalmic procedures.

BACKGROUND OF THE INVENTION

A class of instruments known as speculums facilitates access to the eye during ophthalmic procedures by spreading the lids. Speculums are of many designs but lid speculums work by using a wire or blade to wrap around the eyelid margin several millimeters near the midpoint to spread the eyelids gaining exposure of the ocular surfaces.

Problems with conventional speculums occur when the lid length is short, limiting the distance that the lids can be retracted, or when the eye is deep-set. These two problems lead to a “squaring” of the view and limit the working area and visibility. Additionally the lids tend to rise up when stretched tight, creating a potential space for fluid to pool. Pooling of fluid limits visibility of the surgeon further and allows for bacteria and eye secretions to potentially enter the eye, especially in cataract surgery where a large amount of water is used in the extraction of the lens. Elderly eyes become recessed from the loosening of the fat pads, which further complicates the view with water filling into the space formed by the recession. Cataract surgery is the most common ophthalmic procedure with over a million procedures performed each year.

A tube connected to a suction source at one end and having an opening at the other end can be used to suction water from the surgical site. Such a suction tube is rarely used in ophthalmic procedures as it represents an additional source of obstruction to view and free movement.

Another method to solve the problem of pooling includes a wick of sponge that works slowly by osmosis to provide a drain out of the side of the lid. This passive method is reasonably effective in removing small amounts of fluid but fails in deep-set eyes and the wick often floats out of the eye. Positioning the patient's head to be angled to the side can be helpful but often limits the microscopic view into the eye from obstruction by the nose or brow.

Some lid speculums for opening eyelids have hollow tubing with openings or holes formed therein, the tubing being attached to suction for removal of water or fluids from the orbital/ocular area. These lid speculums can perform aspiration, however, the aspiration is often ineffective because the holes in these speculums are adjacent the lid margin which is often well above the corneal surface, making the holes incapable of removing the water. The poor visibility encountered by the surgeon while operating on a patient increases the risk of a poor surgical outcome. Viewing the eye under water affects the surgeon's view into the eye altering depth perception and magnification. The risk of infection from this water getting into the eye is also increased.

Recently, a popular procedure using ultraviolet laser to reshape the cornea to change the refractive power of the eye was developed. In this procedure the front surface of the cornea is exposed to 193-nanometer (nm) light to remove a precise amount of tissue to change the curvature of the anterior cornea. In a small eye, the problem of fluid clearance is made worse by the tendency of the inner part of the cornea (stroma) to absorb water when the stroma is exposed. Tear film or water from the device (known as a microkeratome and used to open the anterior cornea) quickly absorbs into the inner tissue of the cornea. The water slows the absorption of the 193 nm laser and alters the treatment shape leading to problems with the patient's vision correction including aberrational vision. Currently, wicking methods and aspirating speculums are used but are often inadequate due to the raising of the ports of conventional aspirating speculums above the ocular surface. Wicking dams can be helpful but are often overwhelmed by the tear film. By the time wicking dams are in place the fluid is often already on and in the stromal bed. Manual removal of fluid by employing a sponge necessitates stopping the surgical procedure, which changes the hydration and dehydration of the cornea and reduces the precise standardization required to attain good surgical results for the patient.

Many ophthalmic procedures are performed using topical anesthetic. These drugs are applied as topical drops and are ideally applied under the lids to reach the sulcus, the sulcus being the point under the lid where the covering of the lid and globe fold back on themselves. A sponge can be soaked with anesthetic and placed under the lid to keep the drug from diffusing away in the tear film. These drugs are somewhat toxic to the anterior corneal surface and especially in refractive surgery many surgeons try to avoid drug exposure to the front surface by using a soaked sponge. The topical drugs are fairly short acting, so to add more drugs by conventional topical methods required using a sponge and stopping surgery temporarily to apply additional drugs. Other techniques involve drugs that are injected under the conjunctiva, called peribulbar. The peribulbar techniques largely work by continuous leakage of the drugs out of the wound created. To avoid this peribulbar injection technique, a continuous drug delivery system is desirable. Thus, there is a desire to find another device for applying topical drugs during ophthalmic procedures.

In certain emergency situations, like acid or alkali exposure to the eye, where continuous flushing of the eye is used to normalize the PH, no current device exists to secure a flow system into the eye. Furthermore, in certain infectious emergencies it would be advantageous to have a comfortable system to allow for continuous infusion of antibiotic or other drugs onto the ocular surfaces.

In refractive surgery called Lasik, a device known as a microkeratome is used on the front surface of the eye to create a thin slice of tissue. This thin slice of tissue is folded back and the exposed inner surface of the cornea is lasered. The microkeratome is a mechanized device with an oscillating blade that is driven across the eye either manually or with a motor drive. The device is held on the eye by a vacuum ring that pulls the cornea up into the ring to come into contact with the blade. If the microkeratome contacts an obstruction during the pass it slows down or is deflected up. The result of slowing down or stopping is a wave on the surface to be lasered that can cause irregular vision. If the obstruction is hard enough, the ring can be dislodged and a partial flap is created usually leading to an aborted procedure. The most common cause of an obstruction is the microkeratome bumping into a lid speculum, especially in a tight eye. Thus a device to hold the lid open, without obstructing the microkeratome, would be particularly advantageous.

The lowest point in the eye when the patient is laying flat is the sulcus or the point where the clear covering of the eye folds back on itself around the globe. Conventional fluid removal systems do not adequately reach the sulcus because such systems are attached to the lid margin and tend to rise away from the sulcus when lids are spread open, especially when such systems are attached to a small lid.

SUMMARY OF THE INVENTION

Some embodiments of the present sulcus speculum address some of the above problems by placing an instrument into the sulcus for one or more of the following: evacuation of fluid, opening of the lids, and application of drugs such as anesthetic or antibiotic. In one embodiment, a device for placement adjacent a sulcus during ophthalmic surgery includes a speculum having an arm, an aspiration tube having at least one opening formed therein, and a porous member. The porous member receives at least a portion of the aspiration tube and at least a portion of the speculum arm.

In another embodiment, a device for placement adjacent a sulcus during ophthalmic surgery includes a speculum having an arm, wherein a portion of the arm defines a trough, and an aspiration tube having at least one opening formed therein. At least a portion of the aspiration tube is disposed in the trough.

In a further embodiment, a device for placement adjacent a sulcus during ophthalmic surgery includes a speculum having at least one arm having a portion defining a passage and an aspiration tube having at least one opening formed therein. At least a portion of the aspiration tube is disposed in the passage.

A further aspect of the present sulcus speculum is a device for placement adjacent a sulcus during ophthalmic surgery including a speculum having an arm with curvature adapted to reach the sulcus associated with an eyelid, wherein the arm has a opening formed therein.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT(S)

FIGS. 1 and 2depict a conventional wire speculum10, which is used to access the eye during ophthalmic procedures by spreading the lids. The speculums depicted inFIGS. 1 and 2employ a wire or blade to wrap around the eyelid margin several millimeters near the midpoint to spread the eyelids, thereby exposing the ocular surface.

An embodiment of the present sulcus speculum is shown inFIG. 3and includes a speculum10. The speculum10includes a pair of arms12and can include a mechanism14for spreading the arms apart. At least one of the pair of arms12has a portion with a shape adapted for reaching under the eyelid of a patient to the sulcus. The arm portion with that shape will be referred to as the sulcus arm portion16. In some embodiments the sulcus arm portion16can help hold the eyelid open during ophthalmic procedures.

As shown inFIG. 3, the sulcus arm portion16can have a hole or holes18for receiving fluid from the sulcus or for delivering drugs to the sulcus. (Herein, the term “hole” is intended to be interchangeable with the term “opening”.) During eye surgery, water and other fluids accumulate in the sulcus. The water can come from a patient's tear ducts, or can be from the operating equipment. To keep the surgical area relatively free of liquid so that the surgeon can clearly see the working area, suction is applied and fluid from the sulcus flows through the hole or holes18in the sulcus arm portion16, through the length of the sulcus arm portion16, and into a collection area (not shown) located away from the patient's eye.

Alternatively, the sulcus arm portion16can be used to deliver drugs to the sulcus. Pumping drugs through the sulcus arm portion16so that the drugs exit the holes or openings18and enter the sulcus permits drug delivery.

A pump or suction device (not shown) is connected to or is in communication with the speculum10to provide suction or pressure depending on the function performed by the sulcus arm portion16. Also not shown in the Figures is a collection area for collecting fluid from the sulcus or a source of drugs to be pumped to the sulcus.

If the speculum10has a spreading mechanism14, such as the mechanism14inFIG. 1, the sulcus arm portion16of the speculum10can be positioned by the mechanism14to open the eyelid a desired amount, positioning the sulcus arm portion16adjacent the sulcus, thereby increasing fluid removal from or drug delivery to the sulcus.

The embodiment ofFIG. 3shows the sulcus arm portions16opening the eyelid in conjunction with a wire speculum10wrapping around the eyelid margin.FIG. 4shows the sulcus arm portions16holding the eyelid open from the sulcus.

As shown inFIGS. 5 through 10, in some embodiments, at least a portion of the sulcus arm portion16can be covered with a porous member100made of a porous material such as a sponge or other absorbent or wicking material. In some embodiments, the porous member100is shaped to be slipped easily over or onto the sulcus arm portion16. The porous member100can be a disposable member, which can be slipped off of the sulcus arm portion16after a single procedure and replaced with a new porous material member100.

Porous material members100can be provided in different lengths so that the system can be used with different size eyes without changing the size of the speculum10or the sulcus arm portion16. If different length porous material members100are provided, the longer members will extend farther past the end of the sulcus arm portion16of the speculum10than will the shorter members.

The porous material member100prevents particulate matter suspended in the fluid from clogging the hole or holes18of the sulcus arm portion16. In addition to preventing clogging, the porous material member100provides a relatively soft surface for the eyeball to contact, thereby preventing trauma to the eyeball during suction. The porous material member100also permits anesthesia or other topical drugs to be applied to the eye. The drugs can be applied by soaking the porous member100in the drugs and then positioning the porous member100in the sulcus. Because the porous member100can be elongated and curved, application of drugs in the sulcus can be relatively uniform.

The porous member100and sulcus arm portion16can be shaped with a curvature that approximates the curvature of the sulcus. A curvature similar to the curvature of the sulcus increases the contact of the porous material100with the fluid of the sulcus to increase the efficiency in removing fluid or delivering drugs through the sulcus arm portion16.

As seen inFIG. 5, a porous material member100, such as a sponge can be used to receive at least a portion of the sulcus arm portion16of the speculum arm12and at least a portion of an aspiration tube110. In the embodiment ofFIG. 5, the sulcus arm portion16of the speculum arm12need not have holes18because the aspiration tube110has at least one hole112for receiving fluid from a sulcus of a patient.

As seen inFIGS. 5 and 6, the porous material100can have a wide portion114and a relatively narrow portion116. The wide portion114can be positioned nearest the working area of the eye during an ophthalmic procedure, because the wide portion114can help keep an eyelid propped open. The narrow portion116can be positioned in or adjacent the sulcus to absorb fluid. Fluid from the sulcus enters the hole or holes112in the aspiration tube110and flows to a collection area (not shown). A pump or other mechanism (not shown) can provide suction in the aspiration tube110. Alternatively, the aspiration tube110can be used to deliver drugs to the sulcus. Pumping drugs through the aspiration tube110so that the drugs exit the hole or holes112and enter the sulcus permits drug delivery. The aspiration tube110can also be used on the sulcus to provide continuous flow of antibiotics or steroids, or to neutralize ph on the eye for lye or acid injuries.

The porous member100can have shapes other than the shape shown inFIG. 5. For example, instead of sharp corners and edges or wide portions114and narrow portions116, some or all of the corners and edges can be tapered. The porous member100can be oval in cross-section, circular in cross-section, square in cross-section, U-shaped in cross-section, or other suitable shape.FIGS. 7 and 8illustrate a U-shaped cross-section andFIGS. 9 and 10illustrate a circular cross-section.

The aspiration tube110can be made of a suitable material such as, for example, a plastic material like silicone, so that the aspiration tube can be disposable. Alternatively, the tube can be made of metal, such as titanium, which can be easily sterilized. If the tube is made of plastic, the tube can also have a thin wire extending along the tube length to allow a physician to shape the plastic tube, effectively giving the tube a flexibly adjustable shape.

An embodiment similar to the embodiment ofFIG. 5has a porous member100that receives an aspiration tube110with holes112but does not receive a portion of the speculum10. A physician can position the porous member100adjacent the sulcus by using the speculum arm12to push the porous member100toward the sulcus even though the speculum arm12is not received in the porous member100. Fluid can be pumped into or suctioned out of the sulcus as described in connection with the embodiment ofFIG. 3.

FIGS. 7 and 8depict an embodiment of a device having a speculum10that has at least one arm12with a sulcus arm portion16defining a trough118. An aspiration tube110is disposed in the trough118and has at least one hole112for receiving fluid from the sulcus. The fluid enters the hole or holes112in the aspiration tube110and flows to a collection area (not shown). A pump or other mechanism (not shown) can provide suction in the aspiration tube110. In use, the convex side of the sulcus arm portion16is placed in the sulcus and an interior of the sulcus arm portion16(which defines the trough118) is positioned to face the surgical site. The embodiment ofFIGS. 7 and 8can help prop an eyelid open. As an alternative to removing fluid, the embodiment ofFIGS. 7 and 8can be used to deliver drugs to the sulcus through the hole or holes112of the aspiration tube110as described for the aspiration tube110ofFIG. 5.

In some embodiments, a porous member100such as a sponge can be disposed around at least a portion of the speculum arm12. The member100can extend around an exterior of the arm12and cover at least a portion of the trough118, as seen inFIGS. 7 and 8. Porous material members100can be produced in different lengths so that the fluid removal system can be used with different size eyes without changing the size of the speculum10. The porous member100can provide the same advantages to the embodiment ofFIGS. 7 and 8as discussed above in connection with the embodiment ofFIGS. 5 and 6.

In the embodiment ofFIGS. 9 and 10, a speculum10has at least one arm12with a sulcus arm portion16defining a passage120. The sulcus arm portion16defining the passage120can have a circular cross-section, an oval cross-section or other shape that can define a passage. The sulcus arm portion16has at least one hole18for receiving fluid from the sulcus. An aspiration tube110is disposed in the passage120and has at least one hole112for receiving fluid that has passed into the passage120through the hole or holes18in the sulcus arm portion16that defines the passage120. Although shown as coaxial with the sulcus arm portion inFIGS. 9 and 10, the aspiration tube110need not be coaxial with the sulcus arm portion16.

In operation in the embodiment ofFIGS. 9 and 10, fluid enters the hole or holes18in the sulcus arm portion16and then passes through the hole or holes112in the aspiration tube110and flows to a collection area (not shown). A pump or other mechanism (not shown) can provide suction in the aspiration tube110. As an alternative to removing fluid, the embodiment ofFIGS. 9 and 10can be used to deliver drugs to the sulcus through the holes18of the sulcus arm portion16. The embodiment ofFIGS. 9 and 10can help prop an eyelid open in addition to or instead of providing aspiration or drug delivery.

In some embodiments, a porous member100such as a sponge or other absorbent or wicking material can be disposed around at least a portion of the sulcus arm portion16that defines the passage120, as seen inFIGS. 9 and 10. The porous member100can provide the same advantages to the embodiment ofFIGS. 9 and 10as discussed above in connection with the embodiment ofFIGS. 5 and 6. Porous material members100can be produced in different lengths so that the fluid removal system can be used with different size eyes without changing the size of the speculum. The present sulcus speculum can be used without a porous member100to prop an eyelid open.

The device ofFIGS. 9 and 10can include at least one support member122to connect the aspiration tube110to the interior of the arm12for stability.

One or more of the sulcus arm portion16embodiments discussed in connection withFIGS. 5 through 10can be attached or removably attachable to a lid speculum10, the lid speculum10thus having one or more sulcus arm portions16when one of the embodiments ofFIGS. 5 through 10is attached to the lid speculum10. The lid speculum10has a loop or loops20or a blade or blades for engaging one or both eyelids. Alternatively, a speculum can have a pair of arms12including sulcus arm portions16and at least one additional arm with a loop20or blade for engaging an eyelid.

Because the sulcus arm portion16is positioned in or adjacent the sulcus, there can be room for placing a conventional lid speculum on the eyelid margins without interfering with operation of some embodiments of the present sulcus speculum10. This embodiment is depicted inFIG. 3.

FIG. 3shows an embodiment in which the sulcus arm portions16are each part of a lid speculum10. The lid speculum10has loops20for engaging the lid margin. Although the sulcus arm portions16can help open eyelids, the loops20of the lid speculum10ensure that eyelids remains fixed open. AlthoughFIG. 3depicts a pair of speculum arms12each having a sulcus arm portion16and a loop20, embodiments are contemplated in which only one of the pair of arms12has a sulcus arm portion16. Also, embodiments are contemplated similar to the embodiment ofFIG. 3but having a blade or blades rather than loops20. The sulcus arm portions16ofFIG. 3can be one of the embodiments discussed above in connection withFIGS. 5 through 10, such as a sulcus arm portion16with holes18(FIGS. 3 and 4), a sulcus arm portion16and an aspiration tube110received in a sponge (FIGS. 5 and 6), an aspiration tube110in a trough118defined by the sulcus arm portion16(FIGS. 7 and 8), and an aspiration tube110in a passage120defined by the sulcus arm portion16(FIGS. 9 and 10).

FIG. 3shows a speculum10having a pair of arms12, each arm12having at least one loop20engaging a lid margin. The loops20of the speculum10ensure that the eyelids remains fixed open. Connected to the speculum arms12are sulcus arm portions16, which are shown to be under the eyelids and adjacent the sulcus. A speculum10in accordance with some embodiments of the present sulcus speculum10can have a particular sulcus arm portion16embodiment for one eyelid but a different type of sulcus arm portion10for the other eyelid. In other words, the embodiments discussed in connection withFIGS. 5 through 10can be paired in combination to form a speculum10in accordance with some embodiments of the present sulcus speculum10.

In some embodiments, the present speculum10can have a pair of arms12, but only a single sulcus arm portion16. The sulcus arm portion16fits under the eyelid and adjacent the sulcus. The sulcus arm portion16is attached to a speculum arm12having a loop20for engaging a lid margin. The speculum arm12without a sulcus arm portion16has a loop20for engaging an eyelid margin. The embodiments described in connection withFIGS. 5 through 10can be configured so that only a single speculum arm12has the sulcus arm portion16. In embodiments with only a single sulcus arm portion16, the speculum10lacks symmetry and therefore has either a left-handedness or right-handedness.

In some embodiments, the present speculum10can have a pair of arms12and a sulcus arm portion16for each arm12. The sulcus arm portion16could be similar to the embodiment ofFIG. 4except that the speculum arms12could each include a loop20for engaging the lid margin as shown inFIG. 2. The sulcus arm portions16are shown under the eyelids and adjacent the sulcus. The embodiments discussed above in connection withFIGS. 5 through 10can be employed as sulcus arm portions16in connection with the embodiments shown inFIGS. 3 and 4.

As shown inFIG. 11, the sulcus arm portion16can also have a hooked section that turns back generally toward the handle of the speculum10. The hooked section provides extra area to the sulcus arm portion16, which can improve the ability of the sulcus arm portion16to keep the eyelid propped open. Each of the embodiments discussed above in connection withFIGS. 5 through 10can have a hooked section. The hooked section can be unshaped or other shapes that turn back generally toward the handle of the speculum10.

In each of the embodiments discussed above having a porous member100, removal of fluid can be accomplished without using a suction mechanism (for example, a pump). Rather, a porous member100can absorb fluid from the sulcus and facilitate movement of the fluid out of the eye by osmotic pressure as the material is draped out and below the level of the eye. Further, a portion of the porous member100can extend beyond an end of the sulcus arm portion16. The portion of the porous member100extending beyond the sulcus arm portion16end can provide additional wicking and allow a doctor flexibility in positioning the porous member100because that portion of the porous member100is not restricted by the relatively rigid sulcus arm portion16of the speculum10. Furthermore, because the portion of the porous member100extending beyond the sulcus arm portion16is attached to the sulcus arm portion16, the porous member100cannot float away. Often, the porous material100is a sponge that can float. In conventional wicking techniques, the sponge wicking material tended to float out of the sulcus.

While particular elements, embodiments and applications of the present invention have been shown and described, it will be understood, of course, that the invention is not limited thereto since modifications can be made by those skilled in the art, particularly in light of the foregoing teachings. It is therefore contemplated by the appended claims to cover such modifications as incorporate those features that come within the scope of the invention.