Surgical instrument sleeve

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

Reexamination Certificate

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C606S107000

Reexamination Certificate

active

06428501

ABSTRACT:

TECHNICAL FIELD
The invention generally pertains to phacoemulsification instruments that are used to remove a cataract lens from a human eye, and, more particularly, to a resilient sleeve attached to the forefront of an ultrasonic surgical instrument.
BACKGROUND ART
Previously, many types of sleeves have been attached to a surgical instrument for ultrasonically removing the natural lens of a human eye. One type of surgical sleeve is positioned about the forefront of a phacoemulsification instrument and defines a conduit for the passage of fluid around the vibratory tip of the instrument. Many approaches have been taken for the configuration of this sleeve for various purposes, such as providing a clear passage for cooling fluid, conformance to a wound shape, automatic retraction, addition of guide ribs and conduit for light.
A search of the prior art did not disclose any patents that read directly on the claims of the instant invention, however the following U.S. patents are considered related:
U.S. Pat. No.
Inventor
Issue Date
6,033,376
Rockley
Mar. 7, 2000
5,984,904
Steen et al.
Nov. 16, 1999
5,941,887
Steen et al.
Aug. 24. 1999
5,807,310
Hood
Sep. 15. 1998
5,478,338
Reynard
Dec. 26, 1995
5,464,389
Stahl
Nov. 7, 1995
5,354,265
Mackool
Oct. 11, 1994
5,286,256
Mackool
Feb. 15, 1994
5,282,786
Ureche
Feb. 1, 1994
5,188,589
Wypych et al.
Feb. 23, 1993
5,084,009
Mackool
Jan. 28, 1992
4,983,160
Steppe et al.
Jan. 8, 1991
4,897,079
Zaleski et al.
Jan. 30, 1990
4,808,154
Freeman
Feb. 28, 1989
4,652,255
Martinez
Mar. 24, 1987
Rockley in U.S. Pat. No. 6,033,376 teaches a wound shaper sleeve having a wall configuration for controlling compression of the sleeve in order to cause the sleeve to shape and conform to the wound and limit fluid egress therefrom. A syringe attachment hub enables the syringe to be angularly displaced within the sleeve during phacoemulsification.
Steen et al in U.S. Pat. No. 5,984,904 discloses an array of spaced-apart protuberances on the interior wall surface to reduce the surface contact by defining a uniform network of fluid flow channels.
U.S. Pat. No. 5,941,887 issued to Steen, et al. is for a surgical sleeve having a series of spaced-apart rings on its interior wall for encircling the cutting tip. The sleeve encircles the tip in an unstressed condition and automatically retracts during use to expose the free end of the tip. The sleeve is able to remove heat from the tip eliminating the risk of burning the corneal tissue.
Hood in U.S. Pat. No. 5,807,310 teaches an irrigation sleeve having an outside band with a inner bore that extends the full length of the sleeve. The sleeve is constructed from silicone rubber and a band of a rigid material, such as TEFLON, which will not collapse in use.
Michael Reynard's own U.S. Pat. No. 5,478,338 is for a disposable sleeve in a tubular shape that has a plurality of fiber-optic bundles for transmission of light to enhance intraocular visualization during surgical use. Additional bundles of optical fibers may provide the application of laser beam and video transmission to the intraocular tissue.
Stahl in U.S. Pat. No. 5,464,389 teaches a sleeve and tip arrangement with the end of the working tip slotted and the sleeve having a first end portion that extends to the end of the tip and a second end portion terminating well before the tip end.
Mackool in U.S. Pat. No. 5,354,265 discloses two hollow infusion sleeves, with an outer sleeve conforming an incision and an inner sleeve preventing the outer sleeve from collapsing into a vibrating needle.
U.S. Pat. No. 5,286,256 issued to Mackool is for two hollow infusion sleeves with one conforming a surgical incision, thereby preventing leakage from the incision and the other preventing an outer sleeve from collapsing.
U.S. Pat. No. 5,282,786 issued to Ureche is for a sleeve having a flexible portion which permits retraction of the distal end, thus allowing contact between the tip of the tool and the body tissue removed. A rigid portion prevents collapse of the sleeve and permits fluid flow, thereby preventing overheating of the tip.
Wypych et al. in U.S. Pat. No. 5,188,589 teaches a sleeve having a rough texture of random bumps and pits on the interior surface of the tube for reducing the amount of surface contact between the cutting tip and the interior surface of the tube, thus assuring compression and bathing the cutting tip continuously in lubricant.
U.S. Pat. No. 5,084,009 issued to Mackool is for a hollow infusion sleeve conforming a surgical incision, thereby preventing leakage from the incision. A second embodiment has two sleeves with only the outer sleeve conforming to the incision.
Steppe et al. in U.S. Pat. No. 4,983,160 teaches a thin-walled tubular sleeve that extends from a hollow body to surround the aspiration conduit of the instrument. The body and sleeve are homogeneously molded from transparent thermoplastic which permits a rigid sleeve with a wall thickness of no more than 0.006 inches and a length-to-wall ratio of more that two.
U.S. Pat. No. 4,897,079 issued to Zaleski, et al. has a sleeve that includes a hollow sleeve portion with at least one fluid outlet at or near its distal end and a hub secured to the sleeve. The sleeve, which is disposable after use, is made of one or more organic polymeric materials and provides an effective fluid seal.
Freeman in U.S. Pat. No. 4,808,154 teaches a cylindrical sleeve member connected to the base of the tip having at least one internal longitudinally-extending rib to guide a flushing fluid through the cylindrical member and to isolate the interior wall portions of the sleeve from the tip.
U.S. Pat. No. 4,652,255 issued to Martinez discloses a flexible irrigating sleeve with a passage in the tip member with the irrigating sleeve providing an exit port in the distal end. A length of flexible aspirating tubing extends within the irrigating member and aspirates the material thorough the port in the distal end of the aspirating tip member.
For background purposes and as indicative of the art to which the invention is related, reference may be made to the following remaining patents found in the search:
U.S. Pat. No.
Inventor
Issued
3,896,811
Storz
July 1975
4,014,333
McIntyre
March 1977
4,417,578
Banko
November 1983
4,531,934
Kossovsky et al
July 1985
4,553,957
Williams et al
November 1985
4,573,979
Blake
March 1986
4,787,889
Steppe et al
November 1989
4,816,017
Hood
March 1989
4,816,018
Parisi
March 1989
5,024,654
Tyler
June 1991
5,151,084
Khek
September 1992
5,199,943
Wypych
April 1993
5,486,162
Brumbach
January 1996
5,634,912
Injev
February 1996
5,558,669
Reynard
September 1996
5,591,160
Reynard
January 1997
5,645,530
Boukhny
July 1997
5,634,912
Injev
June 1997
5,685,841
Mackool
November 1997
5,741,226
Strukel et al
April 1998
5,746,713
Hood et al
May 1998
5,873,851
Nilsson
February 1999
5,879,356
Geuder
March 1999
5,957,928
Kirwan
September 1999
5,989,209
Barrett
November 1999
6,013,049
Rockley
January 2000
DISCLOSURE OF THE INVENTION
The invention is an improvement of a surgical sleeve that is placed on the forefront of a phacoemulsification instrument or an irrigation/aspiration handpiece for ophthalmic surgery. The instrument consists of a handpiece containing a magneto-strictive mechanism which, using high frequency impulses, activates a hollow needle which is covered by the surgical sleeve. When the needle contacts an eye lens, a high-frequency vibration emulsifies the surrounding tissue and the displaced tissue particles are drawn under negative pressure into the hollow needle. Simultaneously, a saline solution is delivered between the sleeve and the outer wall of the needle for cooling and irrigation purposes.
A common problem in the state of the art removal of the lens tissue during cataract surgery in the presence of a constricted small pupil, is that the proximal tip of the vibrating needle is obscured behind the iris. Consequently, there is a higher risk of inadvertent rupture of lens zonules and lens capsule, which can result in vitreous prolapse into the anterior chamber and retinal problems, all of

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