Soft tip cannula and methods for use thereof

Details Soft tip cannula and methods for use thereof Soft tip cannula and methods for use thereof

2001-10-18

2004-10-05

Gibson, Roy D. (Department: 3739)

Surgery

Instruments

Light application

C606S006000, C128S898000

Reexamination Certificate

active

06800076

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a device used in connection with medical procedures, more particularly to cannulas used in ophthalmic procedures (e.g., retinal tear and retinal detachment surgery), as well as methods of use thereof.
BACKGROUND OF THE INVENTION
Cannulas are used in ophthalmic surgical procedures, such as retinal detachment surgery, to aspirate fluids such as blood, aqueous humor, and infused balanced saline solutions. The cannulas are typically connected by PVC tubing to a machine induced vacuum source and the fluids are collected in a disposable cassette in the machine. For ophthalmic surgical procedures, it is important that the cannula tip be specially designed for the delicate eye area. Thus, for example, such cannula tips are typically formed with rounded, smooth edges. Cannulas have also been made with a tip formed from a transparent soft material such as silicone. The soft silicone tip helps prevent damage to the delicate tissue of the eye in the event of physical contact with the eye.
Retinal detachment is a serious eye condition that, if not treated early, may lead to impairment or loss of vision. The condition typically affects older individuals, individuals with myopia (near-sightedness) and individuals with relatives having retinal detachment. In some instances, a hard, solid blow to the eye has lead to retinal detachment. Further, individuals who have undergone cataract surgery have, in some cases, subsequently developed retinal detachment.
The retina is a fine layer of nerve cells that covers the inside back portion of the eye (FIG.
2
). If the retina thins, one or more small tears or holes in the retina may result (FIG.
3
), leading to retinal detachment (FIG.
4
). More often, retinal detachment is caused by shrinkage of the vitreous. The vitreous is a clear, gel-like substance that fills the inside of the eye and is firmly attached to the retina in several places. As the vitreous shrinks, as a result of age, inflammation, injury or near-sightedness, it often separates from the retina and, in some cases, it may pull a piece of the retina away with it, leaving a tear or hole in the retina. If the retina tears or breaks, watery fluid from the vitreous may pass through the hole and flow between the retina and the back wall of the eye producing “subretinal” fluid. Over time, the flow of the vitreous fluid between the retina and the back of the eye separates the retina from the back of the eye and causes it to detach (FIG.
4
).
There are several procedures available to treat retinal detachment. The severity of the detachment or tear in the retina typically determines which of the procedures should be performed.
If the retina is torn but there is little or no retinal detachment, laser photocoagulation may be used to seal the retinal tears. During laser photocoagulation a laser is used seal the tear. Using the laser, small burns are placed around the edges of the tear. This produces scar tissue that seals the edges of the tear and prevents vitreous fluid from flowing through the tear.
Freezing or “cryopexy” is another procedure that is used to treat retinal tears. According to this procedure, the back wall of the eye behind the tear is frozen to produce scar tissue. As with laser photocoagulation, the scar tissue seals the edges of the tear and prevents vitreous fluid from flowing through the tear.
If the flow of the vitreous fluid between the retina and the back of the eye has caused the retina to detach, more complicated surgical procedures are required. In general, the detached portion of the retina is pressed against the back wall of the eye. Any subretinal fluid that is present must be drained from under the retina to allow the retina to settle back onto the back wall of the eye. The tears may then be sealed by use of, e.g., lasers, freezing, or an electrically heated needle which create scar tissue and seals the tear.
In severe cases, it is sometimes necessary to use a technique called vitrectomy. During this procedure, the vitreous body is cut away from the retina and removed from the eye. The vitreous cavity may then be filled with air or gas to push the retina back against the wall of the eye. In time, clear fluid from the blood seeps into and permanently fills the vitreous cavity.
During an ophthalmic procedure (e.g. retinal tear, retinal detachment, vitreoretinal procedure), the tip of a cannula is generally used to press a detached portion of the retina against the back wall of the eye, to fill the vitreous cavity with air or gas, and to remove the subretinal fluids from under the retina to allow the retina to return to its anatomically correct position.
A disadvantage of conventional cannulas is that the soft material of the cannula tip is transparent and, thus, difficult for the surgeon to discriminate during use, particularly during the fluid/air exchange when visibility is compromised by bubbles and a significant change in the refractive media from fluid to air.
There is a need for improved devices, systems and methods for use of these devices and systems during ophthalmic procedures. In particular, there is a need for improved devices, systems and methods for use during ophthalmic procedures wherein the device is easier for a user to detect and, thus, provides safe and easy manipulation around the particularly delicate eye area.
SUMMARY OF THE INVENTION
The present invention provides a novel surgical device and methods for use thereof.
More particularly, the present invention enables safe and easy manipulation of a surgical device during ophthalmic procedures (e.g., retinal tear and retinal detachment surgery), thereby minimizing the potential for damage to the delicate eye area.
In particular, the surgical device of the present invention is a soft tip cannula useful during ophthalmic surgery. The soft tip device may be an aspirating device or a non-aspirating device.
In a preferred embodiment, the surgical device is a soft tip cannula that assists in removing fluids during surgery. The soft tip cannula is particularly suitable for the removal of fluids from the posterior chamber of the eye during retinal detachment surgery.
In another embodiment, the surgical device is a non-aspirating soft tip device, such as a soft tip scraper cannula for assisting in the removal of membranes, such as the posterior hyaloid, internal limiting, and other membranes of the eye.
The soft tip device of the present invention provides enhanced visibility of the soft tip to the surgeon so that he/she may more easily manipulate the device safely and effectively.
According to one embodiment of the present invention, the properties of the typically transparent soft material comprising the soft tip portion of the device are modified in order to enhance visibility of the device to the surgeon.
In a preferred embodiment, the soft tip material is tinted, marked or stained to enhance visibility. The tinting, marking or stain is preferably of such a color that improves identification, visibility, position, and depth perception of the tip of the device. In one embodiment, the soft tip is stained with fluorescent material.
The entire soft tip may be tinted, marked or stained. Alternatively, the tip may be demarcated with an identifying mark, fiducial line, ring, characters, or stripe(s) to improve visibility/identification. One color or a combination of colors may be used as desired.
In preferred embodiments, the soft tip cannula is used with a fiber optic probe or similar illuminator by shining light from the fiber optic probe or similar illuminator onto the soft tip.
In another preferred embodiment, the soft tip cannula is connected to a fiber optic illuminator or a laser fiber and colored beams of light are transmitted by the soft tip to enhance visibility.
Other aspects and embodiments of the invention are discussed infra.


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patent: 5123902 (1992-06-01), Muller et al.
patent: 5441496 (1995-08-01), Easley et al.
patent: 6015403 (2000-01-01), Jones

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