WO1999062411A1

WO1999062411A1 - Improved irrigation sleeve for phacoemulsification apparatus

Info

Publication number: WO1999062411A1
Application number: PCT/US1999/010477
Authority: WO
Inventors: David M. Van Voorhis
Original assignee: Staar Surgical Company, Inc.
Priority date: 1998-06-01
Filing date: 1999-05-28
Publication date: 1999-12-09
Also published as: AU4076099A

Abstract

This invention is an irrigation sleeve (10) for use with a hand held portion (50) of a phacoemulsification apparatus. The irrigation sleeve includes a base portion (12) configured for removable attachment to the hand held portion (50) of the phacoemulsification apparatus, an extending portion (14) connected to the base portion (12), a passageway (16) extending through the base, and extending portions (12, 14). In a preferred embodiment, the irrigation sleeve (10) is substantially rigid, and at least the extending portion (14) is made from a plastic material selected from the group consisting of polysulfone, polycarbonate, polyimide, and polyetherimide. In another preferred embodiment, the irrigation sleeve (10) is made of silicone, and a substantially rigid wall portion is connected to an inner surface of the irrigation sleeve.

Description

IMPROVED IRRIGATION SLEEVE FOR PHACOEMULSIFICATION

APPARATUS

Field of the Invention

This invention relates to surgical instruments, and more particularly, to improved irrigation sleeves for use with phacoemulsification apparatus.

Background of the Invention

When the natural lens of the eye no longer functions well, it may be removed and replaced with, for example, a deformable intraocular lens. Today, the natural lens of the

eye may be removed through a relatively small incision in the eye with the use of phacoemulsification, a process in which the natural lens is disintegrated by the concentrated application of high frequency, low amplitude vibrations via a

phacoemulsification needle.

The conventional phacoemulsification apparatus used to remove the natural lens

of the eye has a hand held portion which includes an ultrasonic horn disposed within a

cylindrical irrigation head. The distal end of a through bore in the horn is threaded to

receive the threaded proximal end of a replaceable titanium phacoemulsification needle.

The phacoemulsification needle is provided with a hollow cutting tip. The distal end of

the irrigation head is externally threaded to receive the threaded proximal end of a

replaceable irrigation sleeve. When the cutting tip and irrigation sleeve are installed on the hand held portion of the phacoemulsification apparatus, an irrigation sleeve conduit

is formed by the concentric arrangement of the outer surface of the cutting tip and the inner surface of the irrigation sleeve.

During surgery, the cutting tip and the irrigation sleeve are introduced to the

capsule of the eye through a three to five millimeter incision in the outer tissue of the eye.

The hand held portion is maneuvered by the surgeon so that the distal end of the cutting tip is brought into contact with the natural lens. The resultant natural lens fragments combine with irrigation solution to form an emulsion. A vacuum provided to the through

bore of the ultrasonic horn and communicated through the hollow cutting tip aspirates the

emulsified lens from the eye.

Throughout the surgical removal of the lens, an irrigating fluid is pumped to the

irrigation head, through the irrigation sleeve conduit and into the eye. The irrigating fluid

pressurizes and inflates the eye and thus counteracts the tendency of the eye to collapse

due to the release of internal pressure through the surgical incision and the removal of the

emulsified lens by vacuum. Further, the irrigating fluid protects the delicate tissues of the

eye from the heat created by the ultrasonic vibration of the cutting tip, and also provides

a suspending fluid for aspirating the emulsified lens.

Thus, the supply of irrigating fluid to the eye is of crucial importance to the use

of phacoemulsification to remove the natural lens. Indeed, a patient's eyesight is

threatened when the flow of irrigation fluid is impeded, or worse, fully blocked during the

lens removal procedure. The most common cause of eye injury associated with an interruption in the delivery of irrigation fluid occurs when the force of the ocular incision against the irrigation sleeve causes the inner surface of the extending portion of the irrigation sleeve to contact the outer surface of the cutting tip, thus occluding the irrigating sleeve conduit.

To prevent the compression of the irrigation sleeve and the resultant impedance

to the flow of irrigation fluid through the irrigation sleeve conduit, it has been proposed to slightly enlarge the incision in the ocular tissue to better accommodate the irrigation sleeve. However, enlarging the ocular incision allows irrigating fluid to rapidly escape from space between the surface of the incision and the outer surface of the irrigation

sleeve. The irrigating fluid is thereby prevented from maintaining the eye in a pressurized

and inflated condition.

Background information pertaining to phacoemulsification devices including

irrigation sleeves is disclosed in U.S. Patent No. 4,787,889 to Steppe et al, U.S. Patent

No. 4,808,154 to Freeman, U.S. Patent No. 5,084,009 to Mackool, U.S. Patent No.

5,151,084 to Khak, U.S. Patent No. 5,188,584 to Wypych et al, and U.S. Patent No.

5,505,693 to Mackool. These patent references are incorporated herein by reference to

provide the context and environmental use of the irrigation sleeves according to the present invention. Summary of the Invention

Accordingly, it is a first object of the present invention to provide an irrigation sleeve which resists compression.

It is a second object of the present invention to provide an irrigation sleeve which

does not leak at the connection to the irrigation head.

It is a third object at the present invention to provide an irrigation sleeve which

decreases the loss of irrigation fluid at the interface of the irrigation sleeve and the ocular incision.

It is a fourth object of the present invention to provide an irrigation sleeve which

resists loosening during phacoemulsification.

It is a fifth object of the present invention to provide an irrigation sleeve which

dampens ultrasonic vibration transmitted though the irrigation sleeve.

It is a sixth object of the present invention to provide an irrigation sleeve which

decreases the amount of cavitation in the irrigating fluid.

It is a seventh object of the present invention to provide an irrigation sleeve which

allows for increased levels of ultrasonic energy to be applied to the cutting tip. It is an eighth object of the present invention to provide an irrigation sleeve which

decreases turbulence of the irrigating fluid.

It is a ninth object of the present invention to provide an irrigation sleeve with improved cutting tip maneuverability.

It is a tenth object of the present invention to provide an irrigation sleeve which includes a wall portion made of substantially rigid material and a coating portion made of a soft and resilient material.

It is an eleventh object of the present invention to provide an irrigation sleeve which includes a base portion, an intermediate portion, an extending portion, and a

longitudinal passageway.

It is a twelfth object of the present invention to provide an irrigation sleeve which

includes a multi-piece irrigation sleeve which is assembled immediately prior to use and allows for different base portion, intermediate portion and extending portion.

It is a thirteenth object of the present invention to provide an irrigation sleeve

which includes a base portion and an integral intermediate portion made of a substantially

rigid material coated with a soft and resilient material, and an extending portion made of

a substantially rigid material coated with a soft and resilient material. It is a fourteenth object of the present invention to provide an irrigation sleeve which includes a base portion and an integral intermediate portion made of a soft and

resilient material connected to an extending portion made of a substantially rigid material.

It is a fifteenth object of the present invention to provide an irrigation sleeve

having a base portion and an integral intermediate portion made of silicone and an

extending portion made of polysulfone.

The present invention is directed to an improved phacoemulsification apparatus, in particular to an improved irrigation sleeve.

The improved irrigation sleeve according to the present invention is arranged to

prevent compression or restriction of the irrigation sleeve conduit, and/or to improve the

seal between the irrigation sleeve and the irrigation head.

One preferred embodiment of the irrigation sleeve according to the present

invention utilizes a base portion made of a soft and resilient material connected to an

extending portion made of a substantially rigid material. For example, a molded silicone

base is connected to a polysulfone extending portion. The resilient nature of the silicone

base provides a leak-proof seal with the irrigation head while the polysulfone extending

portion significantly resists compression. Another preferred embodiment of the irrigation sleeve according to the present

invention utilizes a substantially rigid irrigation sleeve provided with a soft and resilient coating portion (e.g., internal threads only, or entire inner surface and/or outer surface.)

When extending portion of this preferred embodiment (utilizing a substantially

rigid irrigation sleeve provided with a soft and resilient coating portion) of the irrigation

sleeve of the present invention is placed within an ocular incision, the soft and resilient coating portion, for example, on a wall portion of the extending portion provides a gentle

surface which conforms to the contour of the ocular incision to inhibit the loss of irrigation

fluid therefrom. Also, the substantially rigid material of the wall portion of the extending

portion prevents the compressive force of the ocular incision from deforming the extending portion such that the inner surface thereof contacts the outer surface of the cutting tip. Further, the combination of the substantially rigid material of the wall portion

at the base portion, and the soft and resilient material of the coating portion on the wall

portion of the base portion prevent leakage and/or loosening of the sleeve at the

connection of the irrigation sleeve to the irrigation head.

Brief Description of the Drawings

Fig. 1 is a perspective view of a first embodiment of an irrigation sleeve according

to the present invention installed on the hand held portion of a conventional

phacoemulsification apparatus. Fig. 2 is a longitudinal cross-sectional view of the assembly shown in Fig. 1.

Fig. 3 is a broken away partial side view of an extending portion of an irrigation

sleeve according to the present invention.

Fig. 4 is a detailed longitudinal cross-sectional view of a second embodiment of an irrigation sleeve according to the present invention.

Fig. 5 is a detailed transverse cross-sectional view of the assembly as indicated in

Fig. 1.

Fig. 6 is a detailed longitudinal cross-sectional view of a third embodiment of an

irrigation sleeve according to the present invention.

Fig. 7 is a broken away detailed cross-sectional view of a fourth embodiment of an irrigation sleeve according to the present invention.

Fig. 8 is a broken away detailed cross-sectional view of a fifth embodiment of an

irrigation sleeve according to the present invention.

Fig. 9 is a detailed longitudinal cross-sectional view of a sixth embodiment of an

irrigation sleeve according to the present invention installed on the hand held portion of

a conventional phacoemulsification apparatus. Fig. 10 is a detailed longitudinal cross-sectional view of a seventh embodiment of an irrigation sleeve according to the present invention.

Fig. 11 is a detailed longitudinal cross-sectional view of a eighth embodiment of an irrigation sleeve according to the present invention.

Fig. 12 is a detailed longitudinal cross-sectional view of a ninth embodiment of an

irrigation sleeve according to the present invention.

Fig. 13 is a detailed longitudinal cross-sectional view of a tenth embodiment of an irrigation sleeve according to the present invention.

Fig. 14 is a detailed longitudinal cross-sectional view of the irrigation sleeve shown

in Fig. 9 installed on the hand held portion of a conventional phacoemulsification

apparatus.

Fig. 15 is a detailed longitudinal cross-sectional view of a tenth embodiment of an

irrigation sleeve according to the present invention.

Fig. 16 is a detailed longitudinal cross-sectional view of an eleventh embodiment

of an irrigation sleeve according to the present invention.

Fig. 17 is a detailed transverse cross-sectional view of the irrigation sleeve shown

in Fig. 16. Fig. 18 is a detailed longitudinal cross-sectional view of a twelfth embodiment of an irrigation sleeve according to the present invention.

Fig. 19 is a longitudinal planar side view of a thirteenth embodiment of an irrigation sleeve according to the present invention.

Fig.20 is a detailed longitudinal cross-sectional view of the irrigation sleeve shown

in Fig. 19.

Fig. 21 shows a perspective view of an alternative embodiment of a wall portion including a screen pattern according to the present invention.

Fig. 22 shows a perspective view of an alternative embodiment of a wall portion

including uniformly arranged deformation units according to the present invention.

Fig. 23 shows a perspective view of an alternative embodiment of a wall portion

including distally protruding flexible members according to the present invention.

Fig. 24 shows a perspective view of an alternative embodiment of a wall portion

Fig. 25 shows a perspective view of an alternative embodiment of a wall portion

including radially protruding offsets according to the present invention. Fig. 26 shows a detailed longitudinal cross-sectional view of an alternative

embodiment of a wall portion according to the present invention.

Detailed Description of the Preferred Embodiments

Figs. 1 and 2 show an irrigation sleeve 10 according to the present invention

installed on the hand held portion 50 of a conventional phacoemulsification apparatus.

The irrigation sleeve 10 is made of a substantially rigid plastic material resistant to

deformation. Specifically, the irrigation sleeve 10 is made of a substantially rigid plastic

material that resists inwardly directed compression from the eye incision that would tend to pinch the irrigation sleeve against the needle and restrict the flow of irrigation fluid

during use. Preferred plastic materials include polyolefins, in particular polyethylene and

polypropylene. However, these materials have melting points close to the temperature

and pressure required for autoclaving. Thus, polyolefins are particularly suitable for one

time use (i.e., disposable) applications. More preferred plastic materials including

polysulfone, polycarbonate, polyimide, and polyetherimide, provide irrigation sleeves that

can be sterilized by autoclaving.

Importantly, the irrigation sleeve 10 is designed or configured to tightly seal with

the hand held portion 50 of the phacoemulsification apparatus, even though the irrigation

sleeve 10 is made of substantially rigid plastic material compared to conventional silicone

irrigation sleeves, and without a separate sealing component (e.g., "O" ring). For

example, the internal threads of the irrigation sleeve 10 can be made slightly undersized,

or the thread design can be modified to cause one or more threads to undergo resilient or permanent deformation to provide a sealing function with the external threads of the handheld portion of the phacoemulsification apparatus. Alternatively, an additional

internal integral seal (e.g., ring) can be molded into the irrigation sleeve 10 to cause

sealing engagement with the hand held portion of the phacoemulsification apparatus, while

providing a one-piece molded design of the irrigation sleeve. Further, an adhesive and/or

sealing composition (e.g., silicone sealant) can be provided (e.g., coated) on the integral threads of the irrigation sleeve to enhance sealing with the external threads of the hand

held portion of the phacoemulsification apparatus.

The hand held portion 50 of the conventional phacoemulsification apparatus

includes an ultrasonic horn 34 disposed within a cylindrical irrigation head 38. The distal

end 41 of a through bore 35 in horn 34 includes an internally threaded portion 39a which

engages the externally threaded portion 39b of the proximal end 45 of a replaceable

hollow cutting tip 36 (i.e., phacoemulsification needle).

The distal end 47 of irrigation head 38 is configured for receiving the proximal end

28 of irrigation sleeve 10. In the preferred embodiment shown, the inner surface 44 of the

base portion 12 of irrigation sleeve 10 includes an internally threaded portion 26 which

engages an externally threaded portion 42 of the distal end 47 of irrigation head 38. Other

arrangements may be used for attaching irrigation sleeve 10 to irrigation head 38. For

example, base portion 12 may be attached to irrigation head 38 by a compression fit. In the embodiment shown in Figs 1 and 2, the outer surface 52 of irrigation sleeve

10 along base portion 12 is cylindrically shaped. However, outer surface 52 may be other

shapes. For example, outer surface 52 may define a substantially conical shape. Further,

the transverse cross-sectional shape of outer surface 52 is smooth and circular. However,

the transverse cross-sectional shape of outer surface 52 of base portion 12 may define

other shapes and textures. For example, the transverse cross-sectional shape of outer

surface 52 of base portion 12 may define a hexagonal shape, or a knurled surface for

mounting, by tool or by hands, respectfully, irrigation sleeve 10 onto irrigation head 38.

The base portion 12 of the irrigation sleeve 10 connects to an intermediate portion

22, and an extending portion 14 which extends towards, but terminates short of, the distal

end of cutting tip 36. The outer surface 52 of the irrigation sleeve 10 at the intermediate

portion 22 and extending portion 14 is conical. However, the outer surface 52 may define

a series of stepped components which define other shapes. For example, outer surface 52

may be cylindrically shaped along intermediate portion 22 and conically shaped along

extending portion 14. Further, base portion 12 may transition directly to extending

portion 14 with no intermediate portion 22 therebetween.

The inner surface 44 of base portion 12, intermediate portion 22, and extending

portion 14 forms a passageway 16 along the longitudinal axis of irrigation sleeve 10. In

the embodiment shown in Figs. 1-2, the longitudinal cross-sectional of inner surface 44

substantially parallels the shape of the outer surface 52 of irrigation sleeve 10. However, the base portion 12, intermediate portion 22, and extending portion 14 may be configured

so that the longitudinal cross-section of inner surface 44 defines a variety of different

shaped passageways along the longitudinal axis of irrigation sleeve 10. For example, in an alternative embodiment shown in Fig. 3, a portion of the longitudinal cross-section of

inner surface 44' within extending portion 14' may taper inwardly, and define a section

of a cone having an angle «, (e.g., two (2) degrees) relative to the longitudinal axis of

irrigation sleeve 10. The longitudinal cross-section of outer surface 52' of extending

portion 14' may define a section of a cylinder, and may be oriented parallel to the

longitudinal axis of the irrigation sleeve 10.

In the embodiment shown in Figs. 1 -2, the transverse cross-section of inner surface

44 defines a circle. However, the transverse cross-section of inner surface 44 may have

other suitable shapes, including, for example, a polygonal shape, an elliptical shape or

other shapes. Inner surface 44 may also be configured to include such features as rifling, texturing (e.g., ridged or bumped), or other suitable configurations.

The concentric arrangement of the outer surface of the horn 34 and the inner

surface of the irrigation head 38 forms an annular irrigation head conduit 40 as shown in

Fig. 2. Annular irrigation head conduit 40 communicates to the entrance 46 of an

irrigation sleeve conduit 54 formed by the outer surface of cutting tip 36 and the inner

surface 44 of irrigation sleeve 10. In the embodiment shown in Figs. 1 and 2, the cross-

sectional area of conduit 54 decreases from entrance 46 to an exit 48 located at the distal

end 32 of irrigation sleeve 10. During surgery, extending portion 14 of irrigation sleeve 10 and cutting tip 36 are

introduced to the capsule of the eye through a 0.5 to 5 millimeter (mm) incision in the

outer tissue of the eye. Irrigating fluid is pumped through annular conduit 40 and

irrigation sleeve conduit 54 into the surgical site from exit 48. When the cutting tip 36 is

sufficiently proximal to the natural lens, the ultrasonic horn 34 is activated causing the

ultrasonic vibration of the cutting tip 36 which emulsifies the natural lens. The remnants

of the natural lens and the irrigation fluid in which the remnants of the lens are suspended

are removed from the eye through the open distal end 37 of hollow cutting tip 36 by a

vacuum provided to tip 36 via through bore 35 in ultrasonic horn 34.

Fig. 4 shows a second embodiment of an irrigation sleeve 110. Irrigation sleeve

110 includes a wall portion 120 made of a substantially rigid material, for example

polysulfone, and a coating portion 124 made of a soft and resilient material such as

silicone. In the embodiment shown in Fig. 4, wall portion 120 is continuous and coating

portion 124 is applied uniformly to wall portion 120.

The substantially rigid material of wall portion 120 prevents improper deformation

of irrigation sleeve 110 and the soft and resilient material of coating portion 124 provides

an improved surface for irrigation sleeve 110. For example, when the distal end 132 of

extending portion 114 of irrigation sleeve 110 is inserted through the ocular incision, wall

portion 120 prevents extending portion 114 from splaying, folding outwardly or wrinkling

in an accordion-like manner along outer surface 152 of cutting tip 136. Further, coating portion 124 prevents the distal end 132 of extending portion 114 from cutting into or

otherwise damaging the ocular tissues as the cutting tip 136 and irrigation sleeve 110 are

passed therethrough.

While extending portion 114 of irrigation sleeve 110 is within the ocular incision,

wall portion 120 prevents the inner surface 144 of extending portion 114 from contacting

the outer surface of cutting tip 136. Wall portion 120 also prevents the radial and

longitudinal expansion or contraction of the irrigation sleeve 110 due to forces such as

fluctuation in fluid pressure at the irrigation head 138 or forces associated with the

maneuvering of the irrigation sleeve 110 and cutting tip 136 within the eye. Because wall

portion 120 resists deformation, in particular, those types of deformation which greatly

disturb the inner surface 144 of irrigation sleeve 110, the flow of irrigation fluid to the eye

is maintained in a substantially non-turbulent or laminar state.

Also, during insertion and while within the eye, coating portion 124 deforms

according to the contour of the ocular incision to inhibit the loss of irrigation fluid at the

interface between the outer surface 152 of the extending portion 114 of the irrigation

sleeve 110 and the surface of the ocular incision. Further, coating portion 124 at the

threaded portion 126 of base portion 112 engages the threaded surface of the irrigation

head to prevent irrigating fluid from leaking at the connection therebetween and also to

prevent the irrigation sleeve from becoming loose during phacoemulsification. Coating

portion 124 dampens ultrasonic vibration transmitted form the inner surface 144 and the

outer surface 152 of the cutting tip during phacoemulsification. Cavitation is thereby inhibited in the irrigating fluid thus improving the surgeon's view of the surgical site.

Furthermore, because of the improved vibration damping, power may be increased to

ultrasonic horn 134 and cutting tip 136 without damaging surrounding ocular tissue.

Preferably, materials of low thermal conductivity are used to make wall portion 120 and coating portion 124 so that the transfer of potentially damaging heat to the ocular

tissue is inhibited. Those of ordinary skill in the art can readily select and employ suitable

materials of low thermal conductivity. Further, embodiments of irrigation sleeve 110

having multiple internal boundaries provide improved vibration damping and heat insulating properties over embodiments including only one or no internal boundary.

An irrigation sleeve according to the present invention may also include a wall portion which is continuous or intermittent throughout any portion of the irrigation sleeve.

For example, in a third alternative embodiment of the present invention shown in Fig. 6,

wall portion 220 is made of a series of ribs 220. Multiple continuous wall portions may

also be included in irrigation sleeve. For example, in the partial broken away view of

extending portion 314 of the fourth alternative embodiment of irrigation sleeve 310 shown

in Fig. 7, a central corrugated wall portion 320a is enveloped by outer wall portions 320b.

Coating portion 124 may also be configured to be continuous or intermittent on

any portion of irrigation sleeve 110. For example, coating portion 124 might be provided

only on the threaded surface 126 of base portion 112 and/or on the outer surface 152 of

extending portion 114. Since coating portion 124 may be configured to provide a smooth inner surface

144 and a smooth outer surface 152, any feature included in wall portion 120 for

improving the heat insulating properties, vibration dampening properties, or other measure

of performance of irrigation sleeve 110 is prevented from posing a threat of injury to the

tissue of the eye. For example, the longitudinal or transverse cross-section of wall portion

420 may define a relatively high frequency saw tooth wave, or other non-smooth profile,

whereas the longitudinal and transverse cross-section on inner surface 444 and outer

surface 452 may be smooth, as shown in Fig. 8.

In other alternative embodiments of the present invention, the soft and resilient

material of coating portion 124 may be included in a structural component of irrigation

sleeve 510 independently of the substantially rigid (i.e., resists deformation) material of

wall portion 520. For example, in a sixth embodiment of the present invention shown in

Fig. 9, base portion 512 and intermediate portion 522 are made of a soft and resilient

material and extending portion 514 is made of a substantially rigid material.

In embodiments where a soft and resilient material is included as a structural

component independent of the substantially rigid material of wall portion 20, a means for

connecting components made of different materials is included in the irrigation sleeve. For

example, in the embodiment shown in Fig. 9, the interior surface 544 of irrigation sleeve

510 at the distal end of intermediate portion 522 includes a circumferential channel 562

for receiving a flange 564 at the proximal end of extending portion 514. It is important to note that the connection formed by flange 564 and circumferential channel 562 further

inhibits the transmission of ultrasonic vibration to extending portion 514 and thus provides

an irrigation sleeve 510 with improved vibration dampening properties.

A seventh embodiment of irrigation sleeve 610, shown in Fig. 10, is identical to

that shown in Fig. 9 except that in the place of a flange and channel connection, extending

portion 614 is connected to intermediate portion 622 by an adhesive 666. Alternatively,

or in addition to other forms of connection, a sonic weld may be used to connect

extending portion 614 to intermediate portion 622.

An eighth embodiment of an irrigation sleeve 710 according to the present

invention is shown in Fig. 11. Irrigation sleeve 710 includes a first base portion 712a,

made of a soft and resilient material. First base portion 712a includes a groove 768 in the

distal end thereof which is parallel to the longitudinal axis of the irrigation sleeve 710.

Groove 768 is configured to receive a tongue 772 on the proximal end of a second base

portion 712b. Second base portion 712b is made of a substantially rigid material. Second

base portion 712b includes a conical shaped intermediate portion 722 and cylindrical

extending portion 714, both also made of a substantially rigid material. Further, securing

means, such as an adhesive or a barb and catch assembly, may be provided on tongue 772

for further securing second base portion 712b to first base portion 712a.

A ninth embodiment of an irrigation sleeve 810 according to the present invention,

shown in Fig. 12, includes a conical extending portion 814. The outer surface 852 at the proximal end of conical extending portion 814 engages the inner surface 844 of

intermediate portion 822. In a tenth embodiment of irrigation sleeve 910 shown in Fig.

13, the inner surface 944 at the proximal end of conical extending portion 914 engages

the outer surface 952 of intermediate portion 922. In the embodiments shown in Figs.

12 and 13, extending portion 814 and 914, respectfully, is made of a substantially rigid

material and base portion 812 (912) with integral intermediate portion 822 (922) is made

of a soft and resilient material (e.g., a flexible sealing material). Also, a means of sealing,

such as an adhesive, is included at the connection between extending portion 814 (914)

and intermediate portion 822 (922).

During use, cutting tip 136 and extending portion 114 of the irrigation sleeve 110

are constantly maneuvered within the eye. Trauma to the ocular tissue is caused by the

frictional contact between the small ocular incision and extending portion 114 during this

movement. To alleviate or prevent some of this trauma and also to improve the maneuverability of the irrigation sleeve 110, irrigation sleeve 110 may be configured to

move relative to cutting tip 136. In the embodiment shown in Fig. 9, relative rotational

movement between extending portion 514 and intermediate portion 522 is provided by

increasing the volume of channel 562, thus allowing flange 564 to "float" within channel

562.

Maneuverability of cutting tip 136 may be further improved by the inclusion of

means for allowing a predetermined amount of relative movement, or "play", between

extending portion 114 and the rest of irrigation sleeve 110. For example, as shown in Fig. 14, the soft and resilient material of base portion 1012 and intermediate portion 1022 may

be configured to elastically deform to create an angle, <*', between the longitudinal axis of

the cutting tip 1036 and the normally collinear longitudinal axis of the extending portion

1014. Further, intermediate portion 1022 may be configured to elastically deform to

create a change in distance, d, between the distal end 1037 of the cutting tip 1036 and the

distal end 1032 of the irrigation sleeve 1010.

Further, the irrigation sleeve 1010 shown in Fig. 14 may be configured as part of

a kit. During use of the kit in surgery, the surgeon chooses various combination of kit

components to be connected in order to achieve desired characteristics of irrigation sleeve 1010. For example, a kit including a base portion 1012 with an integral intermediate

portion 1022 may include separate extending portions 1014 of various diameters and

lengths. After selecting desired components, the surgeon connects extending portion

1014 to base portion 1012 by placing the distal end of extending portion 1014 at the

proximal end 1028 of passageway 1016. Extending portion 1014 is then pushed through

base portion 1012 until the flange 1064 at the proximal end of the extending portion 1014

engages channel 1062 in intermediate portion 1022.

As disclosed hereinabove, an irrigation sleeve according to the present invention

may include a wall portion which is continuous or intermittent throughout any portion of

the irrigation sleeve. For example, Fig. 6 shows an irrigation sleeve including a wall

portion made of a series of ribs 220. As also disclosed hereinabove, a coating portion on an irrigation sleeve according to the present invention may be configured to be continuous

or intermittent on any portion of the irrigation sleeve.

Regardless of the manner in which the wall portion or the coating portion of an irrigation sleeve according to the present invention are configured, for example, whether

each is intermittent or continuous, it is important to note that the wall portion and the

coating portion of the irrigation sleeve are connected to each other to form an irrigation

sleeve according to the present invention. In some preferred embodiments of an irrigation

sleeve according to the present invention, the wall portion and the coating portion are

fixedly connected, as shown in the irrigation sleeve 110 of Fig. 4, in others, the material

of the wall portion and the material of the coating portion form a dynamic connection, for example, the irrigation sleeve according to the present invention shown in Fig. 9 may

include an extending portion 514 which rotates relative to intermediate portion 522.

Fig. 15 shows a tenth embodiment of an irrigation sleeve 1110 according to the

present invention in which the wall portion 1120 and the coating portion 1112 are fixedly

connected. Irrigation sleeve 1110 includes an intermittent wall portion 1120 made of a

series of ribs 1120. The coating portion 1124 of irrigation sleeve 1110 is provided

between and on the outer surface of ribs 1120 such that the inner surface and the outer

surface 1152 of irrigation sleeve 1110 are smooth and further such that the coating

portion 1224 holds each rib 1120 fixed relative to coating portion 1224. Note that the

exposed inner surface of each rib 1120 forms a fraction of the inner surface 1144 of

irrigation sleeve 1110. As disclosed hereinabove, the material of coating portion may be included in a structural component of irrigation sleeve independently of the substantially rigid (i.e., resists deformation) material of the wall portion in an irrigation sleeve according to the

present invention. Fig. 16 shows an eleventh embodiment of an irrigation sleeve 1210

according to the present invention in which the wall portion 1220 is made of a single rib

1220 which is inserted into extending portion 1214. As shown in Fig. 17, the transverse

outer cross-sectional diameter of the wall portion 1220 is slightly larger than the

transverse inner cross-sectional diameter of the extending portion 1214 along the

longitudinal axis of the irrigation sleeve, thus the wall portion 1220 is held fixed relative

to the coating portion 1224 by the force of the soft and resilient material of coating

portion 1214 against wall portion 1220. To further fixate wall portion 1220 relative to

coating portion 1212, a suitable adhesive may be applied to the outer surface of wall

portion 1220 prior to assembly.

Fig. 18 shows a twelfth embodiment of an irrigation sleeve 1310 according to the

present invention. The transverse outer cross-sectional diameter of a distal portion of the

wall portion 1320a is slightly larger than the transverse inner cross-sectional diameter of

a distal portion of the extending portion 1314a. The distal portion 1320a of wall portion

1320 transitions to a proximal portion 1320b. Note that the transverse outer cross-

sectional diameter of proximal portion 1320b is slightly smaller than the transverse inner

cross-sectional diameter of a proximal portion of the extending portion 1314b, thus

creating a space therebetween. Wall portion 1320 is preferably made of a material which

is less deformable than the material of extending portion 1314, thus, the combined resistance of extending portion 1314 and wall portion 1320 to deformation is considerably

greater than the resistance to deformation of the extending portion 1314 alone.

Irrigation sleeve base portion 1312, intermediate portion 1352 and extending

portion 1314 are preferably made of silicone and wall portion 1320 is preferably made of

polyimide.

It is important to note that wall portion 1320 of irrigation sleeve 1310 is fixed

longitudinally relative to irrigation sleeve 1310. Further, the distal wall portion 1320a is

fixed transversely relative to the distal portion of the extending portion 1314a. However,

proximal wall portion 1320a and proximal extending portion 1314a may move relatively

to each other transversely. In other words, when the extending portion 1314 of irrigation

sleeve 1310 is within the ocular incision, the soft and resilient material of extending

portion 1314b deforms according to the contour of the ocular incision independently of

proximal extending portion 1314a. When extending portion 1314b deforms to the extent

that contact occurs between proximal extending portion 1314b and proximal wall portion

1320b, further deformation is inhibited, since the force of the ocular incision against the

extending portion must overcome the combined resistance to deformation of the extending

portion 1314 and the wall portion 1320b.

Figs. 19 and 20 show a thirteenth embodiment of an irrigation sleeve 1410

according to the present invention. Irrigation sleeve 1410 includes an internally threaded

cylindrical base portion 1412 with a proximal flange 1412a. Base portion 1412 includes a tapered portion 1412b which tapers downwardly to an intermediate portion 1422.

Intermediate portion 1422 includes a tapered portion 1422a which tapers downwardly to

a tubular extending portion 1414. Irrigation sleeve 1410 terminates at a conical tip

portion 1414a having a transverse distal exit 1448 and a pair of transversely oriented

diametrically opposed ports 1448a. Preferably irrigation sleeve 1410 is made of silicone

which is preferably homogenous throughout the sleeve.

Irrigation sleeve 1410 also includes an internal tubular wall portion 1420 which

is connected to irrigation sleeve 1410. Wall portion 1420 extends distally from

intermediate portion 1422 and terminates short of conical tip portion 1414a. Wall portion

1420 is preferably fixated relative to irrigation sleeve 1410. Fixation of wall portion 1420

is preferably achieved by configuring wall portion 1420 to have a transverse outer cross-

sectional diameter slightly larger than the inner transverse cross-sectional diameter of the

extending portion 1414. An elastic force is created by the slightly expanded extending

portion 1414 against wall portion 1420 which fixates the wall portion 1420 relative to

irrigation sleeve 1410. To further promote fixation between wall portion 1420 and

irrigation sleeve 1410, the outer surface of wall portion 1420, or alternatively, the inner

surface of extending portion 1414, or both, may be textured. Other mechanical

connections may be used to fixate wall portion 1420 relative to irrigation sleeve 1410.

For example, wall portion 1420 may be adhered to irrigation sleeve 1410 with a suitable

adhesive. Alternatively, a pin (not shown) may be passed through intermediate portion 1422 and wall portion 1420 to create a fixed connection therebetween. Preferably, wall

portion 1420 is made of polyimide which is preferably homogenous throughout the wall portion 1420.

As discussed hereinabove, the purpose of wall portion 1420 is to increase the

resistance of the irrigation sleeve, and particularly, the extending portion 1414 thereof, to

deformation. Whereas some deformation is allowable, and in many cases, preferred, for

example, to allow the extending portion of the irrigation sleeve to conform somewhat to the ocular incision, excess deformation is undesirable. Excess deformation of the irrigation sleeve occurs when, for example, the extending portion deforms under the force

of the ocular incision to the extent that contact occurs between the extending portion of

the irrigation sleeve and the outer surface of the cutting tip (not shown). According to

the present invention, the material and configuration of a wall portion 1420 and the material and configuration of an irrigation sleeve 1410 are used in combination to control

the deformation of an irrigation sleeve 1410.

A wall portion, or the irrigation sleeve to which the wall portion is connected, may

according to the present invention, include a pattern, either random or repeating, to

enhance the performance of the irrigation sleeve, for example, to alter the manner in which

the wall portion deforms. Examples of alternative embodiments of a wall portion

including a regular or irregular pattern according to the present invention are shown in

Figs. 21-24. Fig. 21 shows a tubular wall portion 1520 having a screen or mesh-like

pattern. Fig.22 shows a tubular wall portion 1620 having uniformly arranged deformation

units 1621 including flexible members 1621a. Fig. 23 shows a wall portion 1720 including distally protruding flexible members 1721. Note that the slots 1723 between the flexible

members 1721 may be configured, for example, elongated, to adjust the degree to which

flexible members 1721 may flex. Fig. 24 shows a wall portion 1720' having distally

protruding flexible members 1721 which extend towards the longitudinal axis of the wall

portion. Thus, wall portion 1720' may be connected to an irrigation sleeve such that

distally protruding members 1721 extend into a conical tip portion of an irrigation sleeve

according to the present invention to further control the manner in which the conical tip

portion of the irrigation sleeve deforms.

As another example, Fig. 25 includes a wall portion 1820 including radially

protruding offsets in the form of nibs 1821. It is important to recognize that radially

protruding offsets 1821 may be provided on the surface of wall portion 1820 in sufficient

number and magnitude to slightly deform the irrigation sleeve to which the wall portion

is connected to anchor, and therefore, fixate, wall portion 1820 relative thereto. For

example, wall portion 1820 may be provided with nibs 1821 in a pattern similar to that

found on the back of a conventional table tennis racket pad. An irrigation sleeve including

a wall portion having radial protruding offsets provides a number of benefits. For

example, the offsets allow portions of the extending portion of the irrigation sleeve which

are not initially in contact with an offset to undergo a primary deformation prior to coming

into contact with the outer surface of the wall portion. Second, the offsets are preferably

arranged to allow for the flow of irrigation fluid between the outer surface of the wall

portion and the inner surface of the irrigation sleeve. Thus, even if the flow of irrigation

fluid is occluded between the outer surface of the cutting tip and the inner surface of wall

portion 1820, flow of irrigation fluid may proceed between the outer surface of the wall portion and the inner surface of the sleeve. It is important to recognize that offsets may, alternatively, be provided on the inner surface of the irrigation sleeve as opposed to the

outer surface of the wall portion.

The wall thickness of a wall portion may also be configured to control the manner in which an irrigation sleeve deforms according to the present invention. For example, the

wall thickness, D, of wall portion 1920 shown in Fig. 26 decreases in a distal direction

along the longitudinal axis of the wall portion 1920. The wall thickness of an irrigation

sleeve may be configured similarly. By varying the wall thickness of either the wall portion or the irrigation sleeve, the manner in which an irrigation sleeve deforms may be

configured as a function of the location along the longitudinal axis of the irrigation sleeve.

For example, a distal portion of an irrigation sleeve according to the present invention may

be more deformable than a proximal portion thereof.

The present invention provides an irrigation sleeve with specific deformation

characteristics, for example, the present invention provides an irrigation sleeve which

resists being deformed to such an extent that contact occurs between the irrigation sleeve

and the phacoemulsification cutting tip. The present invention provides an irrigation sleeve with specific deformation characteristics by including a wall portion connected to

the irrigation sleeve. An irrigation sleeve having specific deformation characteristics

according to the present invention may potentially also be provided by modifying the

material of which the irrigation sleeve is made and foregoing the connection of a wall

portion thereto. For example, a preferred irrigation sleeve according to the present

invention is made of injection molded silicone. During molding, the silicone irrigation sleeve, and particularly, the extending portion thereof, may be exposed to higher

temperatures, or as another example, allowed to cure for an increased period of time to

increase the resistance of the silicone to deformation.

As another example, the mold cavity may be infused with a chemical which increases the resistance of silicone to deformation.

Claims

What is claimed is:

1. An irrigation sleeve for use with a hand held portion of a

phacoemulsification apparatus, said irrigation sleeve comprising:

an irrigation sleeve base portion configured for removable attachment to the hand held portion of the phacoemulsification apparatus;

an irrigation sleeve extending portion connected to said base portion;

a passageway extending through said base and extending portions;

wherein said irrigation sleeve includes a wall portion connected to an inner surface

of said irrigation sleeve.

2. An irrigation sleeve according to claim 1, wherein said wall portion and

said irrigation sleeve are fixed longitudinally such that relative movement between said

wall portion and said irrigation sleeve along the longitudinal axis of the irrigation sleeve

is prevented.

3. An irrigation sleeve according to claim 2, wherein said wall portion and

said irrigation sleeve are fixed transversely such that relative movement between said wall

portion and said irrigation sleeve transverse to the longitudinal axis of the irrigation sleeve

is prevented.

4. An irrigation sleeve according to claim 1, wherein said wall portion is tubular.

5. An irrigation sleeve according to claim 4, wherein said wall portion is

provided along said extending portion of said irrigation sleeve.

6. An irrigation sleeve according to claim 1 , wherein said irrigation sleeve is made of an elastic material.

7. An irrigation sleeve according to claim 1, wherein said irrigation sleeve is made of silicone.

8. An irrigation sleeve according to claim 6, wherein a transverse outer cross-

sectional diameter of said wall portion is slightly larger than a transverse inner cross- sectional diameter of said irrigation sleeve, thereby causing said irrigation sleeve to

undergo a slight elastic deformation.

9. An irrigation sleeve according to claim 8, wherein said wall portion is made

of plastic.

10. An irrigation sleeve according to claim 9, wherein said wall portion is made

of polyimide.

11. An irrigation sleeve according to claim 1, wherein said irrigation sleeve includes a conical tip portion connected to said extending portion.

12. An irrigation sleeve according to claim 11, wherein said wall portion includes a conical tip portion which extends into said conical tip portion of said extending portion.

13. An irrigation sleeve according to claim 12, wherein said conical tip portion

of said wall portion includes at least one slot for facilitating deformation of said conical

tip portion of said wall portion.

14. An irrigation sleeve according to claim 13, wherein said conical tip portion

of said wall portion includes at least one flexible member defined by at least two said slots

for facilitating deformation of said conical tip portion of said wall portion.

15. An irrigation sleeve according to claim 5, wherein said wall portion

includes a screen portion for facilitating deformation of said wall portion.

16. An irrigation sleeve according to claim 5, wherein said wall portion

includes a plurality of offsets.

17. An irrigation sleeve according to claim 5, wherein a wall thickness of said

wall portion is constant along a longitudinal axis of said wall portion.

18. A method of providing specific deformation characteristics to an irrigation

sleeve for use with a hand held portion of a phacoemulsification apparatus comprising the

step of:

connecting a wall portion to an internal surface of said irrigation sleeve.