System and method for enhancing oxygen content of...

Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...

Reexamination Certificate

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Reexamination Certificate

active

06585679

ABSTRACT:

BACKGROUND
1. Field of the Invention
The present invention generally relates to ophthalmic surgery. More particularly, the invention relates to systems for maximizing the oxygen content of infusion/irrigation fluids used in ophthalmic surgical procedures, and to methods for using the same.
2. Background
The use of infusion/irrigation fluids during the course of ophthalmic surgical procedures is well known. These fluids provide structural support and fluidic balance that keep the eye inflated during the manipulation and/or removal of tissue from within the eye.
It also is know in the art that invasive surgical procedures can negatively effect ocular tissue at the cellular level. For example, representative of the complications which can arise as a result of invasive ophthalmic surgical procedures are both the opacification of ocular tissues, and a reduction in the functionality and sensitivity of those tissues.
Further, it is well understood by those in the art that intraocular infusing/irrigating solutions can have adverse effects upon ocular morphology and function. Indeed, significant effort has been expended in the search for an optimal chemical composition for use as an intraocular infusion/irrigating solution. More specifically, the goal of this effort has been (and is) to find a chemical composition that produces minimal negative effects upon the cellular structures of the eye, while at the same time, maximizing the patient's post-operative visual acuity. This effort has been successful to the extent in that some infusion fluids have been found to be less harmful to ocular anatomy and physiology than others. Nevertheless, a need still exists for an intraocular infusion/irrigation solution that will further minimize the negative effects of ophthalmic surgical stress.
SUMMARY OF THE INVENTION
The present invention provides an infusion/irrigation fluid administration system and method that maximizes the quantity of oxygen provided to the tissue of the eye during the course of ophthalmic surgical procedures.
In preferred embodiments, the invention includes a system that highly oxygenates the infusion/irrigation fluid used during the course of ophthalmic surgery substantially immediately prior to its introduction to the eye.
Addition of oxygen to infusion or irrigation fluid (i.e. infusion/irrigation fluid) can have a significantly positive effect to tissue affected by surgery, particularly in ophthalmic surgery. Accordingly, use of oxygenated fluids in accordance with the invention can positively impact potential surgical trauma particularly ophthalmic surgery, recovery from surgical procedures particularly ophthalmic surgery, and the like.
More particularly, in one preferred embodiment of the invention, an in-line, oxygenating chamber is provided in the infusion/irrigation fluid line between a fluid source and the infusion/irrigation site. Typically, the oxygenation chamber is located close to the operative site. This oxygenating chamber generally contains a gas permeable member (preferably diffusing member) that is supplied by an oxygen source. More specifically, the fluid flowing through the infusion/irrigation line is passed through the oxygenation chamber wherein oxygen travels through a gas permeable membrane or the like defining at least a portion of the diffusing gas permeable member, and diffuses into the fluid. This results in the provision of hyperoxic fluid directly to the ophthalmic surgical site.
In another preferred embodiment, an alternative oxygenating infusion/irrigation fluid administration system is provided. This system generally includes a fluid source; an I.V. administration spike; fluid tubing; atmospheric air vent tubing with a filter; a pressurized oxygen canister or lecture bottle; and appropriate adaptive connectors. In addition, the system may also optionally include a stopcock. In this embodiment, the oxygen is bubbled through the fluid in the source. Then the fluid is allowed to pass through the tubing to the operative site.
The invention can be employed with a wide variety of surgical procedures for delivery of fluid to a surgical site. However, the invention is particularly useful for delivery of oxygenated fluid to an opththalmic surgical site (e.g. to or proximate to a patient's eye), such as by infusing the oxygenated fluid into a patient's eye.


REFERENCES:
patent: 3628532 (1971-12-01), Magrath
patent: 5407426 (1995-04-01), Spears
patent: 5599296 (1997-02-01), Spears
patent: 5653685 (1997-08-01), Klatz et al.
patent: 5797874 (1998-08-01), Spears
patent: RE36460 (1999-12-01), Klatz et al.
Aaberg, Thomas. “Does Hyperoxygenation Limit Retinal Degeneration After Retinal Detachment?” American J. of Opthamology, Aug. 1999, 128(2)/231.
Lewis et al. “Limiting the Proliferation and Reactivity of Retinal Muller Cells During Experimental Retinal Detachment: The Value of Oxygen Supplementation” American J. of Opthamology, Aug. 1999; 128(2)/165-72.

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