Methods for trephination and irrigation of the frontal sinus...

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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C604S028000

Reexamination Certificate

active

06391016

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method and apparatus for trephination and irrigation of a cavity in the body, particularly the frontal sinus cavity.
2. Discussion of the Prior Art
In treatment of frontal sinus cavity disease, a hole or trephination is drilled in the sinus frontal bone, a needle is inserted through the hole into the frontal sinus cavity and the cavity is irrigated to relieve pain and flush out unwanted substances, such as purulent secretions contained within the cavity. The above procedure for flushing the frontal sinus cavity is referred to as trephination and irrigation of the frontal sinus cavity.
Some of the disadvantages of prior art procedures for trephination and irrigation of the frontal sinus cavity include difficulty in locating and maintaining the position of the trephination or hole after the trephine or drill is removed and associated time and trauma. More particularly, once the drill is removed, the small hole is often re-covered by the soft tissue or skin and an excessive amount of time is required to re-locate the hole, especially if the skin over the hole is loose or slack. Another disadvantage is that irrigation with a needle through the hole is complicated by irrigation fluid flowing back out of the hole around the needle. In the past, sealing around the needle has been attempted with finger pressure by pinching the needle proximate the hole in a largely unsuccessful attempt to stem a messy outflow resulting in possible fluid infiltration into the soft tissues around the eye.
Another procedure used in the prior art for trephination and irrigation of the frontal sinus cavity is frontal drill-out from the inside with a bur. The frontal drill-out procedure has the disadvantages of being technically challenging, difficult to perform with either manual or powered instruments (e.g., drills or shavers), and of destroying substantial tissue.
OBJECTS AND SUMMARY OF THE INVENTION
Accordingly, it is a primary object of the present invention to overcome the above-mentioned disadvantages associated with frontal sinus irrigation.
Another object of the present invention is locating and maintaining a trephine hole for accurate placement of an irrigation cannula in the frontal sinus cavity.
A further object of the present invention is to irrigate the frontal sinus through a trephine hole in the frontal bone without backflow through the hole by use of a sealing, tapered cannula.
A further object of the present invention is to use a soft tissue protective drill guide to drill a hole in bone in a manner to provide alignment for drilling and placement of an irrigating cannula.
The present invention has another object in a method of trephination and irrigation of the frontal sinus cavity in a safe and accurate manner with the use of a drill guide and a powered drill configured to prevent contact with the posterior wall of the frontal sinus cavity.
The aforesaid objects are achieved individually and in combination, and it is not intended that the present invention be construed as requiring two or more of the objects to be combined unless expressly required by the claims attached hereto.
In accordance with the present invention, a trephination and irrigation set or kit includes a drill guiding, soft tissue protector sleeve, a trephination instrument (e.g., drill or bur) having a length to extend a short distance beyond the protector sleeve when fully inserted, a guide pin or rod dimensioned to fit into the trephination or hole for locating and preserving the hole through the soft tissue defect or incision and a tapered, blunt irrigating cannula configured to sealingly lodge in the hole in the frontal bone for introducing irrigation fluid into the frontal sinus cavity.
In accordance with the method of the present invention, a trephination site is selected on the anterior front face of the frontal sinus, and an incision through the skin is made large enough to accept the tubular drill guide which is then inserted into the incision and depressed against the frontal bone of the skull, over the frontal sinus. The drill guide has teeth at its distal edge for securely gripping the bony surface. A trephine hole is drilled in the frontal bone by passing a trephination instrument through the lumen in the drill guide after which the trephination instrument is withdrawn from the drill guide. The guide pin is then inserted through the lumen of the drill guide and into the trephine hole, whereupon the drill guide is removed and the irrigation cannula is inserted over the guide pin and into the trephine hole. Irrigation fluid is then forced into the frontal sinus through the cannula.
The above and still further objects, features and advantages of the present invention will become apparent upon consideration of the following detailed description of a specific embodiment thereof, particularly when taken in conjunction with the accompanying drawings wherein like reference numerals in the various figures are utilized to designate like components.


REFERENCES:
patent: 3892232 (1975-07-01), Neufel
patent: 4549538 (1985-10-01), Schadrack, III et al.
patent: 5041082 (1991-08-01), Shiber
patent: 5049150 (1991-09-01), Cozad
patent: 5409493 (1995-04-01), Greenberg
patent: 5855579 (1999-01-01), James et al.
patent: 5895389 (1999-04-01), Schenk et al.
patent: 5951561 (1999-09-01), Pepper et al.
patent: 5976105 (1999-11-01), Marcove et al.
patent: 6083228 (2000-07-01), Michelson
Micro-France publication, 1 page, “E.N.T.-Basic Instruction Rhinology”, 1993.

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