# Patent

## Title
Surgical method

## Abstract

A method for using a smaller diameter infusion sleeve that reduces the potential for heat buildup and also provides adequate irrigation flow.

## Background
This application is a continuation-in-part of U.S. patent application Ser. No. 11/011,417, filed Dec. 14, 2004, now U.S. Pat. No. 7,094,229 B2, which is a continuation-in-part of U.S. patent application Ser. No. 10/937,065, filed Sep. 9, 2004, now U.S. Pat. No. 7,066,923 B2.


BACKGROUND OF THE INVENTION
This invention relates generally to the field of cataract surgery and more particularly to manipulation tools and irrigation sleeves used in phacoemulsification surgery.
The human eye in its simplest terms functions to provide vision by transmitting light through a clear outer portion called the cornea, and focusing the image by way of the lens onto the retina. The quality of the focused image depends on many factors including the size and shape of the eye, and the transparency of the cornea and lens.
When age or disease causes the lens to become less transparent, vision deteriorates because of the diminished light that can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. An accepted treatment for this condition is surgical removal of the lens and replacement of the lens function by an artificial intraocular lens (IOL).
In the United States, the majority of cataractous lenses are removed by a surgical technique called phacoemulsification. A typical surgical handpiece suitable for phacoemulsification procedures consists of an ultrasonically driven handpiece, an attached cutting tip, and irrigating sleeve and an electronic control console. The handpiece assembly is attached to the control console by an electric cable and flexible tubings. Through the electric cable, the console varies the power level transmitted by the handpiece to the attached cutting tip and the flexible tubings supply irrigation fluid to and draw aspiration fluid from the eye through the handpiece assembly.
The operative part of the handpiece is a centrally located, hollow resonating bar or horn directly attached to a set of piezoelectric crystals. The crystals supply the required ultrasonic vibration needed to drive both the horn and the attached cutting tip during phacoemulsification and are controlled by the console. The crystal/horn assembly is suspended within the hollow body or shell of the handpiece by flexible mountings. The handpiece body terminates in a reduced diameter portion or nosecone at the body's distal end. The nosecone is externally threaded to accept the irrigation sleeve. Likewise, the horn bore is internally threaded at its distal end to receive the external threads of the cutting tip. The irrigation sleeve also has an internally threaded bore that is screwed onto the external threads of the nosecone. The cutting tip is adjusted so that the tip projects only a predetermined amount past the open end of the irrigating sleeve.
Recently, a modified phacoemulsification technique called “bimanual” phacoemulsification has been adopted by many surgeons. With the bimanual technique, the irrigation sleeve is removed from around the ultrasonically drive tip. This allows for the small tip to be inserted into the eye through a smaller incision. Irrigation fluid is supplied by a second irrigating tip. The second tip may include a manipulation tool. Additional information concerning traditional phacoemulsification and bimanual phacoemulsification is included in U.S. Patent Publication No. US 2003/0069594 A1. And in particular, Paragraphs [0036] through [0037] and FIGS. 6-8, which are incorporated herein by reference. As described in this reference, the second instrument does not use an outer silicone infusion sleeve. Rather the shaft of the manipulation tool is either hollow with irrigation ports, or solid with a separate hollow irrigating conduit containing irrigation ports. Without the outer silicone sleeve, sealing of the wound is minimal. This allows excessive irrigating fluid to escape out of the eye through the wound. Excessive wound leakage can cause shallowing of the anterior chamber, excessive turbulence and premature removal of the protective viscoelastic material. Excessive wound leakage can also cause over-hydration of the wound tissue, possibly resulting in edema.
Recently, it has been suggested that traditional one-handed phacoemulsification can be conducted through a relatively small incision by reducing the diameter of the phacoemulsification tip/sleeve. A second irrigation/aspiration tip, with or without an attached manipulation tool, may also be used to provide addition irrigation and aspiration. Such an arrangement minimizes wound leakage, thereby helping to avoid over-hydration of the wound, low intraocular pressure, excessive turbulence and premature removal of the viscoelastic material. The annular gap between the phaco tip and sleeve is used as an irrigation fluid pathway. Irrigation ports are provided on the sides of the sleeve to direct irrigating fluid out of and away from the aspiration port. Reducing the diameter of the infusion sleeve also reduces the amount of irrigation fluid that can enter the eye. Also, smaller diameter infusion sleeves are more likely to be compressed by the wound against the ultrasonically vibrating tip, thereby increasing the amount of heat.
Therefore, a need continues to exist for a method of using a smaller diameter irrigation sleeve that reduces the likelihood of excessive heat buildup and provides adequate irrigation during cataract surgery.
BRIEF SUMMARY OF THE INVENTION
The present invention improves upon the prior art by providing a method for using a smaller diameter infusion sleeve that reduces the potential for heat buildup and also provides adequate irrigation flow.
Accordingly, one objective of the present invention is to provide an irrigation sleeve that fits around the shaft of the manipulation tool and seals the shaft.
Another objective of the present invention is to provide an irrigation sleeve that reduces or prevents the flow of irrigating fluid out of the sleeve from around the shaft.
These and other advantages and objectives of the present invention will become apparent from the detailed description and claims that follow.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a partial cross-section of the phacoemulsification and irrigation/aspiration tips that may be used with the present invention.
FIG. 2 is a schematic illustration of a phacoemulsification handpiece and irrigation/aspiration handpiece being used for a traditional bi-manual phacoemulsification surgical procedure.
FIG. 3 is a schematic illustration of a phacoemulsification handpiece and irrigation handpiece being used for the bi-manual phacoemulsification surgical procedure of the present invention.



DETAILED DESCRIPTION OF THE INVENTION
As seen in FIGS. 1 and 3, the method of the present invention is generally practiced using irrigation tip 10 and phacoemulsification tip 12 simultaneously in what is called a “Bi-Manual” surgical technique. Irrigation tip 10 may be any conventional irrigation tip and may include irrigation port 17 and flexible outer silicone sleeve 14 and inner tube 16. Inner tube 16 may also be formed with hook 15 or some other manipulation device. Space 18 between sleeve 14 and tube 16 defines a pathway for irrigating solution to flow out port 20 and into the surgical site. Port 17 can be used as an additional irrigation port, and irrigating solution may be expressed out of ports 17 and 20. Phacoemulsification tip 12 is of similar construction and generally contains flexible outer silicone sleeve 22 and inner tube 24 defining a first irrigating fluid path 26 that allows irrigating fluid to flow out of port 30. Inner tube 24 contains open distal end 28 allowing material to be aspirated through inner tube 24. Preferably, phacoemulsification tip 12 has a reduced overall diameter, on the order of 0.7 mm to 0.9 mm, and sleeve 22 has an outer diameter on the order of 1.4 mm to 1.8 mm. Such a small diameter permits an incision size of preferably less than around 2.4 mm in width, even more preferably less than around 2.2 mm in width, and even more preferably less than around 2.0 mm in width, and even more preferably less than around 1.8 mm in width and most preferably less than around 1.6 mm in width. Alternatively, tip may be a liquefracturing tip similar to the AQUALASE® tip sold by Alcon Laboratories, Inc., Fort Worth, Tex. and described more fully in U.S. Pat. No. 6,579,270 B2 (Sussman, et al.) at FIGS. 23 and 24 and column 7, lines 32-45, the contents of which being incorporated herein by reference.
As best seen in FIG. 2, in a traditional bimanual phacoemulsification technique, irrigation/aspiration handpiece 100 is connected to pressurized or elevated source of irrigation fluid 102 through tubing 103. Ultrasound handpiece 104 is connected to aspiration pump 106 through tubing 105 and to ultrasound driver 107 through cable 109. Ultrasound handpiece 104 is not connected to source 102 and does not have any irrigation capabilities.
As seen in FIGS. 1 and 3, in use, irrigation handpiece 200, having tip 10, is connected to pressurized or elevated source of irrigation fluid 202 through tubing 203. Ultrasound handpiece 204, having tip 12, is connected to aspiration pump 206 through tubing 205, to source 202 through tubing 211 and fitting 208 and to ultrasound driver 207 through cable 209. Accordingly, both handpiece 200 and handpiece 204 have a common irrigation source and both provide an irrigation function. Irrigation tip 10 is held in one hand by the surgeon and used in a conventional manner to provide an irrigating fluid, such as a saline solution, into eye 32 to help maintain the integrity of the eye and prevent anterior chamber collapse. Phacoemulsification tip 12 is held in the other hand by the surgeon and is connected to a suitable ultrasound handpiece. One suitable handpiece is the INFINITI® system handpiece available commercially from by Alcon Laboratories, Inc., Worth, Tex. Phacoemulsification tip 12 is used to conduct a traditional phacoemulsification technique during which an irrigating fluid, such as a saline solution, is introduced into eye 32 through fluid path 26 and port 30 and debris is aspirated from eye 32 through distal end 28 and inner tube 24. Such an arrangement prevents direct contact between vibrating inner tube 24.
In order to use a relative small diameter sleeve 22, the surgical system and the operating parameters used on the surgical system must be adjusted to provide adequate infusion flow and reduce the potential for heat buildup at the operative site. For example, a surgical system having a low compliance aspiration system may be used. By low compliance, a system that is capable of increasing vacuum from 0 mm Hg to 600 mm Hg in less than 3 seconds at a flow rate of 25 cc/minute may be consider a low compliance system. Such a system is commercially available as the INFINTI® Vision System from Alcon Laboratories, Inc., Fort Worth, Tex. Such a system will help to maintain a stable eye even when sleeve 22 is used. To help prevent excessive heat build up, the inventors have found that when sleeve 22 is used, delivering energy in short pulses rather than continuously and/or vibrating tip 12 in a twisting or torsional pattern rather than longitudinally helps to reduce heat build up.
This description is given for purposes of illustration and explanation. It will be apparent to those skilled in the relevant art that changes and modifications may be made to the invention described above without departing from its scope or spirit.

## Claims

1. A surgical method, comprising the steps of:
a) inserting an ultrasonic tip of a phacoemulsification handpiece into an eye, the ultrasonic tip having a hollow inner tube covered by an outer flexible sleeve, the hollow inner tube allowing aspiration, a space between the inner tube and the outer sleeve creating a first irrigation fluid path, the outer sleeve being sized so as to permit the ultrasonic tip to pass through an incision of less than 2.4 mm but larger than 1.6 mm in width;
b) simultaneously inserting an irrigation tip of an irrigation handpiece into the eye, the irrigation tip creating a second irrigation fluid path into the eye;
c) ultrasonically vibrating the ultrasonic tip in short pulses; and
d) irrigating the eye with fluid from the first irrigation fluid path and the second irrigation fluid path.

2. The method of claim 1 wherein the incision is less than around 2.2 mm but larger than around 1.6 mm in width.

3. The method of claim 1 wherein the incision is less than around 2.0 mm but larger than around 1.6 mm in width.

4. The method of claim 1 wherein the incision is less than around 1.8 mm but larger than around 1.6 mm in width.

5. A surgical method, comprising the steps of:
a) inserting an ultrasonic tip of a phacoemulsification handpiece into an eye, the ultrasonic tip having a hollow inner tube covered by an outer flexible sleeve, the hollow inner tube allowing aspiration, a space between the inner tube and the outer sleeve creating a first irrigation fluid path, the outer sleeve being sized so as to permit the ultrasonic tip to pass through an incision of less than 2.4 mm but larger than 1.6 mm in width;
b) simultaneously inserting an irrigation tip of an irrigation handpiece into the eye, the irrigation tip creating a second irrigation fluid path into the eye;
c) ultrasonically vibrating the ultrasonic tip in a torsional pattern; and
d) irrigating the eye with fluid from the first irrigation fluid path and the second irrigation fluid path.

6. The method of claim 5 wherein the incision is less than around 2.2 mm but larger than around 1.6 mm in width.

7. The method of claim 5 wherein the incision is less than around 2.0 mm but larger than around 1.6 mm in width.

8. The method of claim 5 wherein the incision is less than around 1.8 mm but larger than around 1.6 mm in width.

9. A surgical method, comprising the steps of:
a) inserting an ultrasonic tip of a phacoemulsification handpiece into an eye, the ultrasonic tip having a hollow inner tube covered by an outer flexible sleeve, the hollow inner tube allowing aspiration, a space between the inner tube and the outer sleeve creating a first irrigation fluid path, the outer sleeve being sized so as to permit the ultrasonic tip to pass through an incision of less than 2.4 mm but larger than 1.6 mm in width;
b) simultaneously inserting an irrigation tip of an irrigation handpiece into the eye, the irrigation tip creating a second irrigation fluid path into the eye;
c) ultrasonically vibrating the ultrasonic tip in short pulses and/or in a torsional pattern; and
d) irrigating the eye with fluid from the first irrigation fluid path and the second irrigation fluid path.

10. The method of claim 9 wherein the incision is less than around 2.2 mm but larger than around 1.6 mm in width.

11. The method of claim 9 wherein the incision is less than around 2.0 mm but larger than around 1.6 mm in width.

12. The method of claim 9 wherein the incision is less than around 1.8 mm but larger than around 1.6 mm in width.