CA2241137A1

CA2241137A1 - Fiber optic sleeve for surgical instruments

Info

Publication number: CA2241137A1
Application number: CA002241137A
Authority: CA
Inventors: Michael Reynard
Original assignee: Individual
Current assignee: Individual
Priority date: 1995-12-20
Filing date: 1995-12-21
Publication date: 1997-06-26
Also published as: AU4646796A; JP2002515774A; US5651783A; EP0869741A1; WO1997022304A1; EP0869741A4

Abstract

A fiber optic integrated phacoemulsification system is disclosed comprising surgical handpieces (1) for cataract surgery which incorporate fiber optic bundles (4) that transmit visible light to enhance visualization by intraocular illumination. Patient safety is improved by the oblique lighting to the retina, thereby reducing the necessity of direct coaxial light from the surgical microscope. The fiber optic bundles (4) enable the application of laser energy or visible light and permit endoscope visualization of intraocular structures either through the surgical handpiece (1) or through an end piece attachment (3).

Description

WO g7/22304 PCT/US95/16936 FIBER OPTIC SLEE:VE: FOR SURGICI~L INSTRUMENTS

I3~CKGROUNI) OF 'l'~IE INVENTION
l. ~ield o~ the Inven~ion.
This invention relates to surgical devices al~d, more particularly, to ~evlce~ for e~fecting the transmission ~r light for endoilluminatiol-, intraocular endoscopy, or laser application to intraocular tissue.

2. ~iscussioll of the Relatecl ~rt.
The most widely accepte~ prior art means for 1~ per~orming intraoaular surgery in tlle anterior segment o~ tlle eye comprise a variety o~ instrumel-ts designed ~or irrigation, ablation, cutting and removal o~
tissue. Separate instruments for irrigation, illuminatioll and laser applicatioll are known, but they have tlle disadvantage o~ requirillg multiple surgical openings in tlle eye and may be cumbersome to operate ~or tlle surgeon. Multiple surqical openings in the eye and multiple surgical instruments add to tlle risk of complications and increasè the di~ficulty o~ t}~e 2V surgica3 procedure. Surgical illstruments that combine water illEusioll, suction and light conductiny elements in a sillgle probe have beell ~escribe~, but they have the inllerent physical limitations imposed by side-by-side ro~lductillg chanllels. ~nother problem tllat arises ~5 in the use o~ complex multiple-elemellt surgical illstrumellts is the cost and labor o~ repeated sterilizatioll.
Examples of oplltl~lmic instruments o~ the WC) 97/22304 PCT/IJS9~;/16936 type described are commercially available from Griesllaber ~ Co., Inc., 3~0U Cabot Boulevard West, ~anghorne, P~ 19047. Tllese are shown in company brochures under the title "q'he Grieshaber Light Source and Family o~ Accessories".
necent reports o~ specific cases in which prior art instruments of tlle type described are used m~y be ~ound ill ~rcll Ophtllalmol Vol. 111, July 1993:
"Neo~ymium-Y~G Laser Phacolysis oE t~le }luman lo Cataractous Letls" and ODhtllalmoloaY, Vol. 100, Number 7 r July 1993: "Experimental Endoscopic Goniotomy".
The ~ormer describes a performance of Nd-Y~G laser pllacolysis on a particular patient ~or the removal of a nuclear sclerotic cataract-. 'l'lle latter xeport describes the use oE an endoscope coupled to another 6urgical illstrument in experimental surgery on porcine cadaver eyes designed to lead to tlle use o~ a tiny endosco~e attac~led to a golliotomy needle ~or the treatment o~ primary infantile glaucoma. Botll of these arrangements are subject to the deficiencies described ~ereinabove .

Q~ECTS Q~ 'l'ilE INVENTION
The primary object of the present invention i~ to provide an attachment for surgical devices, ~peciEically adaptable ~or intraocular surgery, that provides illumillatiol-, eh~oendoscopy, and a means ~or laser beam delivery. The device îs economical in its construction so as to be inexpensively re-sterilized and reused or simply discarded after each use because 3U of it~ low cost. The device comprises a ~iber optic sleeve wllich is easily and inexpensively fabricated and useful in conjunction Wit~l a variety o~ ~urgical proce~ures. For purposes of illu~tration, arrangements of tlle invention will be di~cus~ed in relation to a _ W0 97n2304 PCT/US95/16936 preferred embodiment for ophthalmic use and with respect to various considerations involved in the recommended util~zat~on of the arrangements disclosed herein. The invention is not 80 limited, however, and it is entitled to the scope of protection afforded by the accompanying claims.

Illumitla i~.
Tlle vast major~ty of intraocular sur~ical procedures i~volve visualization by the surgeon through lo a higll-powered micro~cope U5ill9 intense coaxial illumination. It i8 well-documented that direct and intetlse microscope illumination may be damaging to the retina: macular edema witll corresponding reduction of visioll is tlle primary side errect. ~s an alternative, focal illumillation directed at an oblique angle and in a direc~ion away Prom the re~ina can enable tl-e surgeon to reduce the amount o~ direct microscope light necessary to perform ocular surgery, thereby minimizing potential retinal light toxicity.
~ common problem in the present ~tate of the art is that visualization of ~he proximal tip of the curgical device i8 often impeded when blood, acar tissue, or inflammatory debris i8 present. During normal phacoemulsification of a cataract in the presellce o~ a small pupil, t~le proximal tip of the surgical device is obscured behind the iris.
Consequently, there is a l~igller risk of inadvertent rupture of the lens capsule, vitreous prolapse into the anterior chamber and retinal problems, all of Which are associated with visual loss. Use of a fiber optic sleeve in accordance witl~ the invention permits visuAlization of the anterior portion of the surgical instrument by virtue of transillumination through the iris leaf or opaque media. Moreover, it is often WO 97n2304 PcT/llJs9stl6936 dif~icult for the operating surgeon to judge the depth oE cataract or other intraocular structures. Surg~cal intervelltioll to an excessive depth can lead to compllcations resulting in visual 10s8. Focal illumination at an oblique angle with a ~iber optic sleeve o~ tlle invention can enhance the operating ~urgeon's ability to judge the dept~l o~ intraocular structure~ an~ tl~ereby les~en the possibility of surgical mi8hap.

10 E;ndoscoPY-Virect visualization of vital in~raocular structures during surgery can be realized with the image-carrying capacity o~ the fiber optic sleevQ of t~le inventioll. Intraocular microendoscopy can be utilize~ to confirm positioning o~ haptic~ of a posterior chamber intraocular lens. ~t present, the surgeon is not able to vi~ually inspect and confirm the location of posterior chamber intraocular lens haptics.
Malpositioned haptics may result in lens decentration ~ubsequent to surgery. Decentratloll oE lens implants causing visual loss or distortion necessitates corrective surgical procedures. Visualization of intraocular lens haptics in combination with positioning ad~ustments at t~le time o~ surgery can prevent intraocular lens decentration.

Laser ~Pulication.
~ inally, the fiber optic ~leeve of my inventiol- permits application o~ laser illumination for intraocular tissue coagulation and ablation. The present inventioll provides a means to couple laser energy delivery with simultaneous illumination and vi~ualization. Lasers capable of transmission through .

WO 97/22304 PCT~US9Stl6936 the fiber optic sleeve include llolmium:YAG (2.1 um wavelength), Thulium:YAG (1.96 um wavelength), Erbium:~G (2.94 um wavelengtll)~ }~ydrogen Fluoride (2.7

- 3.Q um wavelength), Deuterium Fluoride ~3.7 - 4.1 um wavelength), Carbon Monoxide ~5.3 - 5.7 um wavelength), Carbon Vioxide (10.6 um wavelength), ~rgon Fluor~de (193 nm wavelength), Krypton Fluoride (248 nm wavelellgt~l), Diode Red (67~ nm wavelengtll), Xenon Cllloride (308 nm wavelengtl~ rgon Blue (488 nm wavelengtll), and ~rgon Green (514 nm wavelength).
Laser ablation o~ ciliary body p~ e5 responslble ~or producing excessive intraocular fluid, and ~or creatLon o~ a drainage fistula through the ~clera, permits control of elevated intraocular pressure and glaucoma. Laser photocoagulation of ciliary body processes for treatment of ~laucoma used in t~e presellt art involves external treatment through periplleral iridectomies. The e~ectiveness of this trea~ment is signi~~calltly limite~ because ot-ly a ~mall number o~ cil~ary processes can be treated. In the presently preferred embodiment, the endolaser and endoscopic capabilities permit treatment of the ciliary processes for at least 180 ~egrees, allowing for an enhanced laser therapeutic ef ~ect.
Manual methods used fior anterior len~
capsulotomy have inllerent ~isadvantages that includes inadvertent radial capsule tears. Sign~ficant radial capsule tears are likely ~o result in compl~cations . 8UC11 as vitreous prolapse or implant subluxation. SUCh disturbarlces can reduce or eliminate the visual bene~it o~ nn eye operatioll, or ~lelay tlle healing process.
~nterior capsulotomy wi~h laser allows for controlled and precision capsulotomy ed~e5 unattainable by manual metho~s.
In addition, laser application through the

4 PCT/US9S/16936 Eiber optic sleeve is useful as a substitute or adjunct ~or ultrasonic pllacoemulsificatioll itl cataract surgery.
ln summary, from the foregoing discussion ~t will be apE)reciated that the ~iber optic sleeve of the present invention is particularly bene~icial when used with implements for intraocular surgery, It i8 of simple and inexpensive construction ~o that it may be re-sterili7,ed ~y gas or readily disposable a~ter a single use. In addition, the fi~er optic sleeve lo provides an advantage for the anterior segment surgeon because it provides focal illumillation and capability for simultalleous laser application.

SUMM~Y OF TIIE ~Nv~.~TION
In brief, arrangements in accordance with the present invetltion comprise a fiber optic ~leeve device particularly adapted to be installed on a pllacoemulsification instrumet-t so as to provide a focal light source at the point of ~urgery. ~rhe conventional phacoemulsification instrument for whiCIl the fibQr ZO optic ~leeve o~ the present invelltion is adapted consi5t5 o~ a llandpiece containing a magneto-strictive ultrasonic mechani~m that activates a hollow, 1 mm titanium needle covered with a soft silicone sleeve.
'rhe needle is drive by the ultrasonic mechanism to ,vibrate ~orty tt~ousand times per second longltudinally in the axis of the needle. The mechanical vibration trans~orms the patient's lens into an emulsion, hence the name ~hacoemulsification". One such instrument i8 marketed by Mentor 0&0, Inc., 3000 Longwater ~rive, Norwell, M~ 02061 ~s t~le cataract is di~sected by the high ~requency phacoemulsificatioll probe, ~t is sucked into the hollow titan~um needle. Since removal of intraocular ~luid must be balanced with the , WO 97/22304 PCT/US95/16g36 introduction into the eye wit)l an equivalent amount of flu~d an irrigating 801ution is passed between th~
silicone sleeve and outer wall of tlle titanium needle.
The silicone sleevQ presently in use serves only as a conduit to direct flow o~ saline solution.
The present invention involves the incorporatioll of a ~pecially designed fiber optic sleeve tltat sub~t~tutes ~or tlle presently used silicone sleeve. Thus t~le fiber optic sleeve of the present lo inventioll provides ~or the trans~i~sion o~ the irrigating solution to the s~te o~ the cataract while ~lso transmittillg focal ligllt to the point of surgery.

~RIEF DESCRIPTION OF TliE DR~WINGS
~ better unders~andillg o~ the present inventioll may be realized ~rom a consideration o~ the ~ollowing detailed description taken in conjunction witll ~he accompanying drawing in which:
FIG. 1 is a general schematic view showing a human eye in the process o~ undergoing a surgical ZO procedure;
FIG. 2 is an enlarge~ schematic cross-sectional view showing a fiber optic sleeve and phacoemulsi~ication instrument combination of the invention as used in the removal of a cataract ~rom a human eye;
FIG. 3 is an enlarged schematic seational view of the fiber optic sleeve oE FIG. 2:
FIG. 3~ is a schematic view partially broken away of a portion of the ~iber optic sleeve of FIG.
sllowing one particular coupling arrangement;
FIG. 3B is a schematic view partially broken away o~ an alternative arrangement to that of FIG. 3A;
FIG. 4 i~ a schematic sectional view of an alternative em~odiment of the invention;

WO 97/22304 PCT/US9~/16936 FIGS. 4~ and 4B show alternative termination elements for use wit2t the arrangement o~ FrG. 4;
FIG. 5 i~ a schematic sectional v;ew o~ still anotller embodime~t of the invention;
FIG. 5~ is an enlarged scllematic view of a portion of the embodiment of FIG. 5; and FIG. 6 i8 an enlarged cchematic cross-sectional view showing details of the embodiment Or Fl~. ~.

T~ILE~ ~ES~RTP'~'lON OF TIIE PI~EFERREP EMBOVIMENTS
FIG. 1 shows a human eye in the process of undergoltlg a surgical procedure using a phacoemulsificatioll instrumellt 1 of conventional type with a sleeve 1~ and needle 2. 'l'he instrument 1 is inserted througll a ~cleral flap eye incision A and into tlle anterior chamber B.
FIG. 2 schematically represents a similar procedure being performed with the substitution of a fiber optic sleeve in accordance witl~ the present ZO invention. FIG. 2 sl~ows an enlarged cross-~ectional view of the eye. The cataract has beell removed by conventional extracapsular ~urgical technique, including phacoemulsification, and the posterior cap~ule c remains ~ntact. The fiber optic ~leeve 3 i~
attached at the forefro~lt of a ~t~coemulsi~cat~on instrument 1. Optical fiber bundles 4 are shown extendillg ~rom tlle sleeve 3. For the application disclosed, tlle ~iber optic sleeve 3 is utilized ~or the purposes of endoillumination, video transmission, and application o~ photoablatiYe laser energy to the pars plicata of t~e ciliary body for treatment of glaucoma.
FIG. 3 is an enlarged longitudinal schematic cross-sectional view of the present invention. The fiber optic sleeve has a proximal (leading) end 5 and a distal (trailing~ end 6. With continuing reference to FIG. 3, the flber op~ic as~embly 3 cons~sts o~ an elongated standard cannula a~aptor 7 at the distal end 6 t~lat is continuous witll a ~rustoconical nipple 8, extendiltg to cap 9, and then to a tapered appl~cator tip lo. ~n annular chamfer 11 and adjacent lipped flange 12 on the inter~or sur~ace of the frustoconical nipple 8 pQrm~t ~nsertion nl~d secur~ng of sn intern~l coupler ill t11e chamber 13 or for receiving an O-ring 14, wllich prov~des a liquid-tight seal when the 61eeve is assembled on tlle surgical instrument. It is contemplated that other types of securing means such as locking rings can ~e use~ to secure the f iber optic sleeve member to the forefront of a surgical ins~rument. ~ circumferential lip 27 is prov$ded at the distal end for facilitating installation of the sleeve 3 on a surgical il~s~rument in preparation for use. '~~he entire longitudinal len~tll of the fiber optic sleeve 3 i8 approxlmately one incl~.
Tlle fiber optlc sleeve 3 of the present islvel~tioll is constructed of so~t plastic material containing one or multiple fiber optic bundles.
~iber bundle 15 is shown in FIG. 3~ and FIG. 3B.
Material use~ in construction consists of vinyl plaqtic or other commercially available non-toxic medical grade plastic. ~iber optic bundle~ 15 contained within the body o~ the sleeve are constructed of commercially available ~uartz or zlrconium fluoride optical fibers.
'l'he size of the central cylindrical bore 16 can be 3~ controlled during tlle manu~acturing process, so that - the fiber optic sleeve may ~e adaptable to a variety of surgical instruments. One or two portals 29 at the proximal end o~ the sleeve can be constructed at the time of manu~acture to allow for ~low of fluid between the fiber optic sleeve an~ the surgical instrument , contained in its bore. Fluid entry allows maintenance of globe pressure and prevents excess lleating of the laser element.
Tlle cap 9, nipple 8 an~ cannula adaptor 7 are prefetably encased by opaque silicone, tetrafluoretllylelle coating, or E)olyethylene cladding, W}liC}l enhances optical transmission and also forms a protective slleatll. The extent of cladding can be varie~ depending on the amount and direction of light lo transmi~sion desired: cladding tllat terminates one millimeter from tlle proximal en~ o~ the applicator tip 10 would provide di~Euse illuminatioll, wherea~ cla~ding to the most anterior edge of the applicator tip lo may be de~irable in situations where a more Eocused beam is necessary. ~r~le ~ace 18 of tlle proximal tip 10 is unclad alld unencapsulated to provi~e uninterrupted ap~lication or ligl~t for illumina~ion, microendoscopy, or laser beam applicat~on.
Coupling to standard sources ~or ~ideo, illumination or video is secured at the distal portion of the ~iber optic sleeve 3 by ~tandard method~.
Optical fiber couplers are well kl-own in tlle prior art, for example see patent 4,~89,5~ ~E Christopher E.
Polczyllski. In FlG. 3 a recessed, ~emale receptor well 19 at the distal face of the cannula adaptor 7 serves to connect to an external male fiber optic cable (not ~hown~. Vetails o~ alternative embodiments are shown in FIGS. 3~ and 3B. The embo~iment of FIG. 3A
comprises an interllally tllreaded anllular ~emale well ~0 1s~ ~aving an accurately machined surEace of revolution to interfit with a correspon~ing threaded male connector fiber optic source (no~ 5}10WIl) ~ The ~lat base of tlle receptor well 19~ allows for a secure fit and good ligl-t transmitting conllectioll between the Eiber op~ic ~undle from the llyll~ source and the optic~l fibers 15 in the sleeve 3. 'rhe number and placemen~ of individual optical ~ibers arranged in receptacles in the receptor well 19 can be controlled during Ule manufacturinq process.
~lternatively, the receptacle well of FIG. 3B
is shown as a thread~ess cone l9B having a gradual internal taper for receiving a similarly tapered, mating en~ of the fiber optic cable from the light source tto nl~ annular diameter smaller than the connectillg fiber optic ~ource]. In th~s arrangement~
a~l exterllnl fiber optic cable is precision for~ed to mate ~nugly within the receptacle well l9B. In nd~itioll, tlle posterior el~d G can ~e attaclle~ to a laser catlleter assembly by means of a conventional coupler or heat shrink wrap.
FIG. 4 shows a tangelltial cross-sectional representatioll of the present invention. The flber optlc sleeve 3 consists of individual tracts of f~ber optic bun(lles 15 of 500 to G00 micron quartz fiber~
havillg a ~end radius of 4 centimeters or less that are incorp~rated within the body of tlle sleeve 3. The fiber optic bundles 15 Wit~ l the sleeve 3 can be a~ranged in distinct radially-spaced coherent light conducting portions, or in fi~er bundles havinq spatial fiber distribution. In accor~ance with one particular ~eature of the invention, the tips of the optical fibers witlli~l the bore of tlle sleeve are recessed slightly ~or providing a collimated output beam. It i8 contemplated that a lens sucll as the lens 28 of FIG. 4A
3~ can be fused at the proximal eild of the fiber optic bundle for rOcusing laser energy 30, ~r at tlle proximal end of tlle fiber optic bundle for illumination 31, or at tlle proximal end of the fiber optic bundle for endoscopy 32. ~lternatively, an end piece 33 bearing a plurality of lenses 28 for t~e respective bundles 15 CA 02241137 1998-06-lg W097/22304 PCT~S9S/16936 at t11eir respective terminations 30, 31 and 32 can be installed a~ tl~e elld ~ace 18 of tl-e 51eeve 3. SUch a let~s may be mat~ufactured with a combina'tion of convex, concave or ~lat surfaces. In tlle example of FIG. 4A, a plano-cotlcave lens is shown.
FIG. S shows an alternative embodiment o~ the present invet~tion con~ist~ng o~ a sleeve 3' of opt~cally cle~r rlexible plastic 20 encased on its outer 21 and inner 22 sur~aces by a thin layer of lo silicone clad~ing or opaq~e, non-toxic plastic capsule with a low index of refraction, or by a reflective coating, SUCII as polytetrafluoretllylene, which enhances the optical transmission of the ~iber optic sleeve. In this embodiment, the fiber optic bundles 15 are omitted because the entire sleeve 3' serves as an opt~cal wavegu~de. Tlle couplers 19', of wllich two are shown, are regularly spaced about the periphery and serve to couple tlle ~iber optic bundles from a light source (not shown) illtO the optically clear plastic 20 for 2U transmissioll oE ligllt to tlle tip ell~ 5. ~lternatively a difEusing collar may be provided, interposed between the light cable(s) and the ~leeve 3'.
Preferably, the end ~ace at the tip end 5 of the sleeve 3' should be beveled or angled inwardly so tllat the light emanating from tl~e end face is directed at an angle rad~ally inward toward the centerline of t}~e e~bodiment. Tlli8 i~ represented schematically in the enlarged schematic view o~ ~IG. 5~ which show~ the end o~ the sleeve 3' encompassing a needle 4 and having a beveled end sur~ace 30 extending at an angle ~ to a plane normal to t~le needle 4. 'l'he central axis o~ the needle ~ is represented by the broken line 32. The conical beam of ligh~ emanating from the beveled sur~ace 30 i~ represented by t~le das~led lines 34, 35.
The das11ed line 3~ intersects the axis line 32 at the -wog7n2304 PCT~S95/16936 same angle a . The inner surface 22 of the sleeve 3' is space~ ~rom the needle 4 by a dimenslon ~.
In practice, the anqle ~ is a function of the dimensions of the needle 4 and the sleeve 3'. For a needle ~ having a diameter o~ 1 mm and projecting from the end 5 o~ the ~leeve 3' by 2 mm, with sleeve wall thicknes~ equal to O. 5 mm and spacing s also e~ual to 0.5 mm, tl~e nllgle Q 5~10Ul~ ~e approximately 23 degrees.
I~ tlle spacing S is re~uced to 0.25 mm, the angle ~
lu slloul~ be slig~ltly less tllall 20 ~egrees. ~ngle a can actually be calcula~ed ~y ~etermini~g its tangent:
i.e., tlle distance from the outer sur~ace o~ the ~leeve 3' to the centerline 32 divided by the distance from the en~ 5 to the intersection o~ the light cone line 34 witll tlle centerline 32. In sucll an arrangement, tlle ligllt cone illuminates tlle ~ield of view for approxlmately 1.5 mm beyol~ tlle needle tip and approximately .75 mm o~ t~le end o~ the nee~le 4.
FIG. 6 lllustrates an alternative embodiment of the ~i~er optic sleeve 3" that incorporates multiple bundle groups of optically segregated fibers for purposes of illumination 23, laser delivery 24, and microendoscopy 25 containe~ within the body of the sleeve. Segregated optical fiber bundle groups are couple~ at the distal end to convelltional delivery systems for illumination, laser delivery and microendoscopy for video broadcast. It will be understood that the optical fibers in the bundle ~or microetldoscopy must be maintained in the ~ame o~ientation throughout their lengtll in order that the pixel juxtAposition of t~le display will accurately represent the optical ~ield of view. Optical segregation is accomplisl~ed by encapsulatioll of optic fiber bulldles by optically opaque claddlllg 26 identical to tllat use~ Oll tlle external and internal surfaces of W097/22304 PCT~S95/16936 ttle sleeve 3' in t}~e embodimellt oE FIG. 5.

ODeration in U8e.
Tlle operation o~ the 6ystem i5 as follows:
~ light cable, la~er cable or video cable

5 (not sllowll) is connected at a receptacle well 19 situated in tlle terminal rim 27 o~ the ~iber optic sleeve 3. ~ ~iber optlc bundle ~onclucts light between t~e attacllmellt at the receptacle well 19, througl) the wall o~ e riber optic sleeve cn~nula 7, CAp 8, cap 9 lo and proximal face o~ the fiber optic applicator tip 10.
Flber optic ~undles 1~ terminating at the proximal ~ace o~ the fiber opt~c sleeve 3 provide light to illuminate the operative area of regard, or may provide laser energy ~or treatment o~ intraocular structure~.
Separ~te and coherent fiber optic bundles 25 similarly coursing witl~ tlle walls oE tlle fiber optic sleeve, provi~e intraocular endoscopy. Saline ~lui~ to maintaill glo~e pressure enters ~rom the contained surgical instrument and travels within the hypodermic lumen to be discharged at the open applicator tip 16 or portals 29 Or the ~iber optic sleeve. Operation is the same for illumination using t~le sleeve 3' o~ FIG. 5 by coupling tlle liqht cable directly to the sleeve 3'.
~ ough there have been described hereinabove various specific arrangemellts o~ a fiber optic sleeve for surgical instruments in accordance Wittl the invelltioll ~or tl~e purpose o~ illustratillg the mallller in wl~icll tlle inventiolt may ~e use~ ~o advantage, it will be appreciated that t~e invention is not limited tt~ereto. ~ccordi.ngly, any and all modi~ications, variations or equivalent arrangements wlllcll may occur to those skilled in the art should be con~idered to be within t~te scope of the inven~ion as de~ined in t~le annexed claims.

CA 0224ll37 l998-06-ls W097/22304 PCT~S9~/16936 In addition to using the ~iber optic sleeve as an optical wave guide, as shown in FIGS. 1 - 6, optical fibers also can be incorporated in a phacoemulsification instrument for illumination, endoscopy and laser treatment, as shown in FIGS. 7 - 13 to produce an obli~ue illumination of the retina. These optical fiber components can be inserted through a vibrating needle; along a longitudina1 axis between the central barrel and instrument casing; centrally into the instrument body by means o~ a connecting electrical power cable; through fluid irrigation and aspiration channels; through the connector coupling with the working vibrating needle or ~iber optic sleeve; transmission through an accessory irrigation-aspiration handpiece; and transmission through an accessory cystotome or cannula.
Obliquelighting, providedbyopticalfibers integrated with phacoemulsification instrumentation provides decided advantages ~or the patient and operating surgeon. In the present state of the art, illumination of the surgical site is provided by direct coaxial illumination from an operating microscope. Direct and intense light from this source i8 associated with retinal phototoxicity and impaired vision.
Thus, focal illumination from optical ~ibers integrated with phacoemulsification instruments are directed obliquely away from the retina, since the instruments are directed from a side incision. Illumination provided in this manner allows the operating surgeon to reduce the amount of direct light necessary to perform ocular surgery, which in turn minimizes the potential for retinal phototoxicity. In addition, visibility of intraocular structures is enhanced. The need for oblique lighting is further confirmed by a Public Health Advisory issued by the Food and Drug Administration (FDA) - on October 16, l99S and incorporated herein by reference.

CA 0224ll37 l998-06-ls W097/22304 PCT~S95/16936 The intent of the FDA Public Health Advisory is to remind and caution ophthalmic surgeons o~ the "...retinal hazards from operating microscopes....and recom~n~R actions to minimize the risk of retinal photic injury from operating microscopes... ". The FDA Public Health Advisory recommends that ophthalmic 6urgeons "...use oblique lighting if it is available...to reduce risk o~ retinal photic injury."
~ence, the present invention combines a phaco-emulsification instrument ~or cataract surgery using integrated optical fibers to produce lighting at an oblique angle to the retina. A suitable device ~or effecting the objects of this invention is shown in FIG. 7. The phacoemulsi~ication device 39 o~ this invention comprises a hand held, elongate casing 40 defining a distal end 41 and a proximal end 42. An inlet port 43, connecting channel 43a and outlet port 43b enable infusion of ~luid between an infusion sleeve and a working, vibrating needle to intraocular structures during surgery.
Mounted within the casing 40 is an acoustic transformer comprising a coupling member 44 bolted to the casing and connected or abuttiny a metallic coupling 45 such as stainless steel or titanium. Elastomeric 0-rings 46, 47 ~orm a water tight seal between the coupling member 44 and the casing 40 during fluid infusion through inlet port 43.
A magnetostrictive orpiezoelectric transducer 50 is mounted on the metallic coupling 45 and is actuated by current through an electric coil 51 which is supplied by current through a power cable 52 secured in distal end 41.
Actuation of the transducer produces high ~requency longitudinal vibrations which are transmitted to a hollow, titanium, plastic or ceramic needle 48 de~ining a working needle tip 48a and a needle base 48b, the needle being threadably mounted on the metallic coupling 45. Vibration o~ the hollow needle di6integrates ti6sue which contacts the working needle tip.

W097/22304 PCT~S95/16936 A coincident aspiration channel 53 extends from the channels 54 and 55 of the coupling member 44 and the - metallic coupling 45, respectively. Tissue disintegrated by the working needle tip ~8a at the surgical site is removed by aspiration through the needle 48 to the aspiration channel 53 using suction means (not shown) provided at the distal end 41 o~ the device 39.
A protective, non-toxic plastic infusion sleeve 57 for the needle 48 i9 mounted on the casing 40, and an annular space 58 is formed between the sleeve and the needle. Fluid infusion from the inlet port 43 passes through the annu~ar space 58 to irrigate the surgery site and cool the vibrating needle. The working needle tip 48a extends slightly beyond the end o~ the infusion sleeve.
In one e~bodiment of the invention, a fiber optic bundle 60 containing one or more fiber optic lines enters the device 39 from its distal end, preferably in combination with the power cable 52. Alternatively, the fiber optic bundle 60 may be isolated from the power cable and enters the device at a separate port located at the distal end of the device. Also, the fiber optic bundle and electric power cable may supplied either by a common line or by separate lines into a single unit 61. The fiber optic bundle is threaded axially along the device, through the coupling 44 where it is secured, into the aspiration channel 53 at an angled inlet 63 adjacent to the base 48b of the needle 48, where it terminates. ~ather than terminating at base 48b of the needle, the fiber optic bundle may extend partially or entirely through the needle. Alternatively, the proximal end of fiber optic bundle 60 may be coupled by standard means to the infusion sleeve 57 functioning as an optical wave guide, similar to FI~. 4. The aspiration channel 53 and inner surface of the needle may be machine polished or coated with a reflective coating such as TEFLON to enhance optical transmission.

CA 0224ll37 l998-06-ls W097/22304 PCT~S95/16936 Typically, the fiber optic bundle is encased in a protective jacket, and the surface of the jacket may be roughened or configured with protuberances to contact the inside wall of the casing 40 and minimize movement of the fiber optic bundle. If desired, the fiber optic bundle can be coated by a reflective material such as polyethylene, silicone, polytetrafluoroethylene (TEFLON), or a ceramic, to enhance reflectivity. A cone of light is formed at the proximal end of the fiber optic bundle which obliquely illuminates the retina similarly to FIG. 5A.

FIG. 8 is a schematic view of a fiber optic bundle fed through a central aspiration channel in addition to a fiber optic bundle on each side of the aspiration channel. The transducer components have been omitted for clarity.

The phacoemulsification device 63 in FIG. 8 provides a hand held, elongate, outer casing 64, infusion channel 65, aspiration channel 67, a hollow needle element 68 terminating the end of the channel 67, outer fiber optic lines 69 and 70 mounted within the outer casing 64, and a central fiber optic line 71 leading through the central aspiration channel 67. The fiber optic lines 69 and 70 are supplied by an Injection Laser Diode (I~D) source 72 or Light Emitting Diodes (LED), mounted within the device, and powered through a cable 73 ~rom an external power supply (not shown). Alternatively, the fiber optic lines 69, 70 may be supplied by an external source o~ light (not shown).
The proximal ends of the fiber optic lines terminate in standard fiber optic couplers ~uch as ferrules which are manufactured by AMP. Suitable materials ~or ferrules include plastic, stainless steel metal, and ceramics such as alumina oxide or zirconia oxide.

W097/22304 PCT~S95/16936 A Y-shaped plastic adaptor 75 ~which may be disposable) is mounted at the distal end of the aspiration channel 67, ~ one branch 76 of the adaptor being supplied with a fiber optic bundle which leads through the central fiber optic line 71, and the other branch 77 of the adaptor being used to aspirate fluid and tissue remnants. The bore size of the aspiration channel 67 can be controlled during manufacturing so that it may accommodate a wide variety of ~iber optic bundle sizes.
Alternatively, the fiber optic bundle can be supported by a fenestrated spoke wheel 80, as shown in FIG. 8a. A
rim portion 81 mounts a plurality of spokes 82 which terminate in an annular hub 83 through which are threaded ~iber optic bundles. The rim portion 81 of the spo~e wheel functions as a supporting strut secured along the inside wall of the aspiration channel. The fiber optic bundles can extend for a variable length through the aspiration channel as a free floating member, and the number of spoke wheels employed depends on the extension length o~ the ~iber optic bundles within the channel.

FIG. 9 shows an alternative embodiment of a phaco-emulsification device 90, the transducer components being omitted for purposes of simplification. The device 90 comprises a hand held, elongate casing 9l, a central aspirating channel 92, an infusion channel 93, and a hollow needle 94 mounted at the end of the aspirating channel. A
light source for the device 90 is threaded through the distal end of the device and can be diverted into a plurality of isolated fiber optic bundles by means o~ a standard fiber optic star, or tree coupler 95. A plurality of optic bundles, two bundles 96, 97 being shown, are mounted within the casing 9l and terminate in connecting ferrules 98 and 99, respectively.

W097/22304 PCT~S95/16936 In addition to using fiber optic illumination by means of a phacoemulsification device illustrated in FIGS. 7 - 9, to produce oblique illumination, fiber optic bundles can be integrated with accessory cataract surgery instruments, as shown in FIGS. l0 - 13. FIG. l0 shows an irrigation-aspiration hand piece used for removal o~ cortical cataract remnants following removal of the cataract nucleus by phacoemulsification. The irrigation and aspiration tubing lines are connected to the irrigation-aspiration handpiece.

Typical devices, one of which is shown in FIG. lO are sold by Alcon Surgical having trademark names SERIES 8000 I/A HANDPIECE and ULTR~FLOW I/A HANDPIECE. These Alcon Surgical products are described in their brochure numbered 905-2000-502, which is incorporated herein, by reference.

In FIG. lO, a hollow, cataract surgical handpiece lO0 (SERIES 8000 l/A HANDPIECE~ with channels for aspiration and irrigation provides a distal end l0l with ports 102 and 103 which connect with non-toxic plastic tubing to an irrigation fluid supply and a fluid aspiration pump (not illustrated) shown in the directions of the arrows. The proximal end 104 of the hand piece mounts an irrigation-aspiration tip 105 connected to the handpiece l00 at its base 106. The tip is used to remove cataract remnants by aspiration while maintaining intraocular pressure by irrigation. Fiber optic bundles are mounted through the irrigation supply port 102 and through the core of the handpiece body, Alternatively, the optic bundles may be mounted through the open distal end l0l. As shown in the enlargement of FIG. l0a, a plurality o~ fiber optic bundles, two bundles 107 and 108 being shown, are mounted along the periphery of the base 106. Optic fiber couplers l09 and ll0 connect the proximal ends of the ~iber optic bundles to a light transmitting plastic infusion sleeve (not shown~ similarly to the preceding examples.

CA 0224ll37 l998-06-ls FIG. 11 illustrates a view of a hollow, cataract surgical hand piece 115 for supplying irrigation only, and onto which is mounted a cystotome 116 constructed of a light conducting material such as a plastic or a ceramic. This hand piece i8 used by the surgeon to per~orm an anterior capsulotomy after the entry incision is constructed. The irrigation hand piece i8 utilized to control the cystotome and deliver fluid to maintain intraocular pressure.

Fiber optic bundles, two bundles ll9, 120 being shown, are incorporated in the irrigation hand piece in a similar manner to the irrigation-aspiration hand piece previously described. The fiber optic bundle~3 terminate at the proximal tip 118 of the handpiece to couple with the plastic cystotome 116 and obliquely illuminate the retina. In this embodiment, optical fiber couplers 121 and 122 connect to recessed female receptor wells (not shown) at the distal face of the cystotome.

FIG. 12 illustrates a hollow, irrigation handpiece 130 of the same type as the hand piece 115 for supplying irrigation only, and to which is attached an irrigating scraping tip 131 that i~ similarly constructed o~ a light conducting material such as a plastic or ceramic. This instrument is used to polish the anterior surface oE the posterior lens capsule. The distal end base 132 of the scraping tip 131 is connected to a plurality o~ fiber optic bundles, two bundles 133 and 134 being shown. Optical fiber couplers 135 and 136 function to transmit light to the irrigating scraping tip 131.

CA 0224ll37 l998-06-ls W097/22304 PCT~S95/16936 FIG. 13 illustrates a hollow, irrigating handpiece 140 similar to the hand pieces 115 and 130, and similarly constructed, and to which is attached a cyclodialysis cannula 141. The cyclodialysis cannula is used by the operating surgeon to sever intraocular tissue adhesions and manipulate the position of the intraocular lens. The distal end base 142 of the cannula is connected to a plurality of fiber optic bundles, two bundles 143 and 144 being shown.
Optical couplers 145 and 146 connect the fiber optic bundles 1~ to the distal end of the cyclodialysis cannula.

It will be appreciated that a fiber optic bundle can extend either partly or completely through the accessory instruments 116, 131 and 141, instead of terminating at their respective bases, to produce oblique illumination of the retina.

Claims

CLAIMS:

CLAIM 1. A disposable light transmitting sleeve, for use with a surgical instrument, comprising:
a generally tubular structure shaped for attachment to a surgical instrument and formed of a soft, flexible, nontoxic medical grade plastic; and, means for controlling and directing optical radiation internally and substantially along the length of the sleeve.
CLAIM 2. A phacoemulsification instrument and disposable fiber optic sleeve comprising, in combination:
a.) a phacoemulsification instrument having a hollow needle tip mounted in the forward end of the instrument;
b.) a disposable light transmitting sleeve mounted on the forward end of the instrument and extending about said needle to near the terminal end thereof;
c.) said sleeve being in the form of a generally tubular structure removably mounted on said surgical instrument and formed of soft, flexible, non-toxic medical grade plastic;
and, d.) further including means for controlling and directing optical radiation internally of the sleeve and substantially along the length thereof for illuminating the terminal end of said needle.
CLAIM 3. A surgical instrument comprising in combination:
a.) a phacoemulsification instrument having a forward end with a hollow needle mounted therein;
b.) a disposable light transmitting sleeve mounted on the forward end of said instrument and extending about said needle to near the tip thereof, said tip comprising:
c.) a generally cylindrical body of soft medical grade plastic material in the form of a shell extending about a hollow interior;

d.) the interior of said body having means for engaging the terminal end of said surgical instrument;
e.) said body having a proximal end and a distal end, the distal end being larger in diameter than the proximal end and sized to fit the terminal end of said surgical end of said surgical instrument;
f.) a plurality of optical fibers extending within the shell between the distal and proximal ends for conducting optical radiation to illuminate a surgical field adjacent the proximal end; and, g.) means at the distal end for coupling the optical fibers to an external source of optical radiation.
CLAIM 4. A disposable light transmitting sleeve device for use with surgical instruments for endoscopy and the treatment of intracorporeal structures with optical radiation, comprising:
a.) a sleeve formed of flexible, non-toxic medical grade plastic bounded by inner and outer wall surfaces and having a hollow lumen shaped and sized to fit the forefront of a surgical instrument on which the sleeve is to be mounted, the sleeve having a proximal end to be located adjacent the terminal end of the surgical instrument and a distal end remote from said proximal end, the distal end being larger in diameter than the proximal end;
b.) coupling means for removably mounting the sleeve on the forefront of a surgical instrument; and, c.) light transmitting means mounted within the plastic material of said sleeve and extending from the distal end to the proximal end in order to transmit optical radiation the length of said sleeve within said plastic between said surfaces.
CLAIM 5. A phacoemulsification device for oblique illumination of a retina field, comprising:
a.) a hollow body hand piece portion comprising port and channel means including a proximal inlet infusion port, a connecting infusion channel, a distal outlet aspiration port and a connecting aspiration channel;
b.) a working end piece mounted proximally of the device and defining a hollow portion, a base portion, and a working tip; and, c.) a fiber optic bundle mounted within the hand piece and secured therein;
d.) means to provide illumination radiation to the fiber optic bundle; and, e.) means to couple radiation output from the fiber optic bundle to illuminate an area adjacent to, and including the hollow portion of the working end piece, thereby obliquely illuminating a surgical field within the area, and including the working tip of the end piece.
CLAIM 6. The device of Claim 5, in which the fiber optic bundle is disposed within the infusion channel.
CLAIM 7. The phacoemulsification device of Claim 5, in which the fiber optic bundle is disposed within the aspiration channel.
CLAIM 8. The phacoemulsification device of Claim 5, in which the fiber optic bundle is disposed within the infusion channel and the aspiration channel.
CLAIM 9. The phacoemulsification device of Claim 5, in which the end piece includes one of: a cannula, an irrigation device, an irrigation-aspiration device, a light transmitting infusion sleeve and a working, vibrating needle.
CLAIM 10. The phacoemulsification device of Claim 9, in which the cannula consists of a cyclodialysis cannula and a cystotome cannula.
CLAIM 11. The phacoemulsification device of Claim 5, in which the channels are coated with a reflective coating to improve radiation transmission from a fiber optic bundle.
CLAIM 12. The phacoemulsification device of Claim 5, in which the end piece is coated with a reflective coating to improve radiation transmission from the fiber optic bundle.
CLAIM 13. The phacoemulsification device of Claim 5, in which the working end piece comprises a vibrating needle, and power for the vibrating needle and power for the fiber optic bundle are formed into a combined cable.
CLAIM 14. The phacoemulsification device of Claim 5, in comprising a vibrating needle working end piece, and a single unit for supplying power to the vibrating needle and radiation for the fiber optic bundle.
CLAIM 15. The device of Claim 5, comprising means to secure the fiber optic bundle within the hand piece.
CLAIM 16. The device of Claim 15, providing an optical coupler including tree and star coupler means to for the fiber optic bundle.
CLAIM 17. The device of Claim 5, comprising radiation producing means disposed within the hand piece.
CLAIM 18. The phacoemulsification device of Claim 5, in which the port and channel means comprises an inlet port and an infusion channel.
CLAIM 19. The phacoemulsification device of Claim 5, in which the fiber optic bundle terminates at the base of the device.
CLAIM 20. The phacoemulsification device of Claim 5, in which the fiber optic bundle extends into the working end piece.
CLAIM 21. The phacoemulsification device of Claim 5, comprising a Y-connector mounted at the distal port of the device for mounting the fiber optic bundle and the distal aspiration channel.
CLAIM 22. The phacoemulsification device of Claim 5, comprising strut means to support the fiber optic bundle within the device.