CA1259868A - Cassette for surgical irrigation and aspiration and sterile package therefor - Google Patents

Abstract

CASSETTE FOR SURGICAL IRRIGATION
AND ASPIRATION AND STERILE PACKAGE THEREFOR
ABSTRACT OF THE DISCLOSURE
A cassette is structurally adapted to receive at least a portion of an irrigation manifold and an aspiration manifold, so that when the cassette is firmly secured to a cassette mechanism on an emulsifier/aspirator unit: (1) the flow of irrigation solution through the irrigation manifold is regulated; (2) the flow of aspirated fluid and tissue from the surgical site is regulated; and (3) the vacuum control system (VCS) within the unit is applied to the aspiration manifold. The cassette defines, at its leading edge, an irrigation opening, an aspiration pump opening, and a vacuum control system opening. The cassette housing defines an irrigation boss having a flat leasing edge surface in register with the irrigation opening, while an aspiration boss is located in register with the aspiration pump opening. A
cassette mechanism is located on the emulsifier/aspirator unit and is structurally adapted to receive the cassette to complete the fluidic connection upon insertion of the cassette.

Description

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CASSETTE FOR SURGIC~ IRRIG~TION
AND ASPIRATION AND STERII,E PACKAGE TR E:R~FOR
, BAC~5~Rol~ND OF THE INV 13NTIO
This invelltio1rl relRtes to a cassette f~r surslical irrigation and a~piration alld a ter~ le pa~age for ~;uch cas~ette. More particl~larly, this invenl:ion relates to casse~te for use with aD ocular ultrasonis ~urgical device.
Still more particularly, th~ invention relates to a a~sette foæ an ultrason~c surgical device ~herein the cassette is ~upplied with both irrigation and aspiratlon tubes aDd a waste bag a~sembled and ~ackaged in a s~erile package.
In t:onnection with ~urgical procedure6 oP various types or, more generally, in connection with medical treatme~ts, a number of various type~ of apparatuses are known for ~ontrollin~ the flow of iEluid from a source to a patient. I~ ~uch devices, various mechan;sms have been developed fox c:ontrolling the flow of fluid through a fluid lniEusion or extract;on ~ystem at a designated rate. In .~iuch systems, it hss become desirable, for a number of reason~, to Z utili~è a ; rl~le u~e ~as~ette ~in connection with ~3uch device~ . In particular, device~ are known f or u~e in ~:onjunc;tion wit~ a prepackaged ~i~posable flu~d prs~ces~ng module of a type which includes a hou~ing wherein fluid c~ontainers, tubing segmerlt~, an~ other component~ re~auirea in ~5 the proc~s~ing of fluid are contained to ~:ooperate with various mean~ for est~blishing a fluid circuic and controlling the flvw of fluid through such a circuit.
On the other han~, an ocular ultra~olliLc ~;urgical dev~ce i~ Icnown ts:~ the art and de~cribed generall~y is~ ~SO
:- p.1~ o., 3,589,363. In that device, a hand-h~

vibrating tool is used to bre~k apart and remove unwa~ed material in a ~urqical procedure especially adapted for ~urgical operatio~9 ~u¢h a~ cataraet removal. I~ ~uch ~
device, ele~trical con~ections are prDv~ded for ~upplying ultrasoni~ power to the han~piece and fl~id connections are provided for oontrolling the ~upply of treatment fluid an~
the aspirative withdra~al of the ~u~pension of ti6sue particlefi in the fluid from the operative sîte. Such aevi~e~
include regulation technigues to control pre~sure within limits at the operative si~e. Thu~, emulsifier/a~pirator device~ have been available to the art ~or use in connection with cataract surgery.
~t is to an improvement in ~uch devices that thi8 invention is primarily directed, by providing a ca6sette which houses a portion of both the aspiration and irrigat$on manifold~ for a simple yet reliable connection to the emulsifier~2spirator device.
~he ~rgical team that performs a ~ataract procedure typically ~onsists of a primary surgeon~ . an optional assistant sur~eon, a ~crub nur~e, ~n anethesiologist, and a circulator or non-~terile nurse. The primary and a~sistant ~urgeon~ and the ~crub nur~e d~rectly perform the cataract proce~ure and are in the sterile ~ield.
Since a catara~t procedure reguire~ transfers between the ~terile and non-sterile fields, the ~irc~lator a~ts afi the liaison ~or the surgical team between the sterile and the non-~terile fieldsO A respons~bility of the cir~ulator ~s to deliver ~terile i~ems, such a~ ~isposables or emergency ~urgical device~, to the sterile field and accept transfer o~
J~ component~ necessary tv set up the equlpment belng usedO

In connec~ion with prior art op~th~l~ic Droce~urest the circulator genexally opened ~ pa~kaqe or sacka~e~
~omet~mes in the form of p~uche~ or trays, that containeA the irrigation and ~piration mani~olds for ulse in the opht~alm~c procedure~ and aseptically tran~ferred l:hem to t~e ~terile fiela. The ~crub nur~e then located those enas o~ e~h manifold that re~uired connection to the instru~ent and, ~hile h~lding each manifold at a different time~ trans~erred each manifold back to the circulator who res~ectively conne~ted the irrigation ~anifola to an irri~ation solenoid located on the equipment. A vent chamber on the irr.i~ation maniPold was then inserted into an appropriate irr~qation ~ource and the manifold was susPended on sn IV pole.
Thereafter, the c~rculator connected the as~iration manifola to the vacuum control ~ystem ~nd to a rotary peris~altic ~umD
located on the equipment. The circulator then took the manifold exiting the per;staltic p.ump and placed it5 ena into a draina~ ba~ which the c~rculator had Dreviou~ly sttached to the e~uipment. At thi~ point, the manifolds were readY
for priming and system ~eck~ut ~hus, in ~onnection with the a~paratus of the ~rior Art, the set up procedure prior to thi~ invention con~i~ted o five connection~ made bv the circulator to the equi~.ment.
~wo of the connections were for the irrigation ~anifold and three ~ere for the a6piration manifold. The attachmene of the irrigation manifold to the irrigation ~oleno~d con~iste~
of ~nser ing the irri~ation tubing in the irriqation solenoid. In addition, attachment o~ the ~ilicone ~umP
tubing on the aspiration manifol~ to the as~iration ~ump roller a~embly ~Ji th~ e~ en~ aiso required dexterity and 61~

knowledge of equipment functions. If either the va~uum cs~trol connection or the pump connection were $mproperly ~ade, ~he aspirat~on ~an~fold might be unable ~o ~chieve a proper varuum during tbe ~urgical procedures.
~he ~umber of transfers required prior to t~i~
inveDtion were variable, requiring three or four ~ransfers, and dep~nded upon the exact method of packaglng. If the manifolds were packaged in 6eparate ~îngle pou~he~, then th~
circulator opened each outer pouch an~ transferred each inner pou~h into the ~terile f~eld~ ~ither of these two ~ethods required two separate transfer into the sterile field. If the manifolds were packaged so that t~ey were doubly-wrapped in trays, only one txansfer was required into the sterile field. ~owever, in any ca~e, once the manifolds are in the ~terile fie~d, the 6crub nurse must lccate khose ends of each manifold that must be transferrea one at a time baek to the circulator for eq~ipment setup. In addition, e~treme ~are ~ust be taken when i~dividually transferring ~he maniPol~ to avoid a ri~k of con~amination of the scrub nur~e or s~r~le ~ield.
Thus, it is an overall obje~t of thi6 inven~on to provide a cas~ette for use in connection with a surgical procedure which make~ convenient an interchange between the ~terilQ and non-sterile field~ in an ophthalmic procedure.
It i~ another object o~-this i~vention ~o provide a ca~sette whi~h minimizes the ~teps between ~he sterile ~nd non-sterile fields to prepare the a~pira~lon and irrigat~on manifold~ ready for priming and system che~kout.
It i~ another objec of thi~ invention to provide a ca~5~tt~ ~r ~se ~J~I~h an ophthalmic device to minimi~e tlle connection6 made to the equipment.

It is still another object of thi~ inven~ion t~
provide a cassette which houses a portion o~ each o the irrigat~on and ~spiration tub~ng toqether ~ith ~ ~r~i~ baq ~tructured ~o ~hat all flui~i~ connection~ are prec~elv mafle to the equipment by insertion of the ca~ette into t~e equipment~ sc that the reliabillty of the ~luidic connect~on~
i~ transferred from a person ~o the constru~tion an~ q~ometry of the ca~sette and mating ca~se~e mechani~.
It is ~till ano~her objec~ of this ~nven~ion ~o proviae packaging for th2 casse~te which limi~s the minimum number of transfers to two, l.e. a transfer of a transfer tray into the ster~le fleld and a transfer of a transfer tray and the remaining portion of the cassette back to the non-sterile ~ield 80 that the remaining Dortion o~ the cassette stays in the transfer tray during this transfer, thus reducin~ the risk of contaminat~on.
These and other ob~ects of the ~nvention will be~ome apparent rom the following wr~tten descrlption of the : invention taken together with the accompanyin~ arawlnqs.
BRIFF SUMMARY OF T~E INV~NTIO~
Directed to achieving the aforementioned ob~ect~
and ;mprov~ng an emul~ifier/aspirator known to the art, a cassette according to thi~ invention is structurall~ adap~ed to receive at Peast a portion of an ~rrigation manifol~ a~d ~5 an aspiration manifold, ~o that when the cassette i~ firmlv fiecured to a cassette mechanism on an emulxif~er/a~pirator u~t~ the flow of irri~ation :solution throuq~ t~e irrigatiQn manifold i~ regulated; ~2) the flow of aspirate~
fluid and tis6ue from the sur~ical site is regulated; and ~3) ~n ~h~ V~cu~m control ~ystem (VCS) within the unit is aQpli~d t~

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the aspiration manifold to limit vacuum level~ attainable ~n t~e aspiration manifold~ The ca~sette is ~referablv ~niection ~olde~ to orm a top ca~sette ~ousing an~ a bQttom ca~sette hous~ng toge her definin~, at its le~inq edge~ an irrigation openlng, an aspira~ion pump opening, and a vacuum control ~ystem opening~ The bottom cassette hou~ing aef~nes a~ irrigation boss having a flat leadina e~e surfa~e ln register ~ith the irrigation opening, while an aspiration bo~ located in regi~ter ~ith the aspiration ~UmD openiDgo ~eans are provided fQr ~ecuring the top cassette hou~inq to the bottom cassette housing. The cassett~ further ~e~ines a dralnage bag opening on the trailing edge of the cassette ~o that the cassette when ready for use houses ~ortions of the irrigation and aspiration manifolds, as well as the drain bag.
A cassette mechanismg located on the emul~ifier/aspirator u~it, is stru~turally adapted to re~e~ve the ~assette and comprises a ca~sette latch bracket and a solenoid/pump mounting plate for mountin~ an irrigat~on soleno~d, an aspiration pump a~d roller a~se~bly, and VCS
fitting. Means for latching the cassette in the cassette mechani~m are al~o provided ~o that the cassette mechani~m provides an opening which accept~ the leading ed~e of the - cassette. When the cassette i~ firmly securea to the cassette mechanism, an occluder shaft of the ~rri~at~on solenoid pa~ses through tbe ~rrigation opening of the cassette to occlude the irrigation tubing ayainst the flat leading surface of the ~rrigation boss in the ca~set~e, thu~
to control the flow of irrigation ~olution throuqh the irrigation manifold by compressing the irrigatioll tubing -- , .

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between the oc~luder ~haft and the irriga~ion bofisO When the irrigation ~olenoid i~ energi~ed, the occluder shat i~
wi~hdrawD, allowing the ~rr$ga~ion ~ubing to open and irrigation flow to occur. When the ca~sette i~ firmly S attached to the cassette mechani~m~ a roller a~se~bly ~f the aspiration pump cooperates with the a~piration pump open~ng of the cassette to oc~lude the aspiration pump tubing against the asp~ratioD bo8s~ thu~ to effect flow o~ asp;rated ti~sue and fluid through the aspiration man~fold by the roller a~sembly of the aspirat~on pump. S;nce the a~piration pump tubing i~ co~pressed between the rollers of t~e roller assembly of the aspiration pump~ when the aspiration pump is energized, rotation of the roller assembly forces fluid and tissue to flow rom the surgi~al siteO
In~ertion of the cas~ette into the emulsifier/aspirator unit al~o allows a vacuum control ~ystem within the unit to limit vacuum lev~l~ attainable ~n the aspiration manifold by effecti~g a sealed connect~on between a YCS fitting mounted on ~he cassette me~hani~m which cooperate~ with a VCS connection on the ca~setter Thus~
insertion of the cas~e te into the cassette mechanism causes irrigation, aspiration, and vacuum fluidic ~onnect~ons to be readily made.
A ~teri~e packaye in the form of ~ transfer tray receives ~he prepare~ ca~sette, ~rain bag, ~rrigation tu~ing and a~piration tubing and is ~ealed so that removal of the outer tray lid permit~ the aseptic transfer of the tran~fer tr~y to the sterile f~eld. Retention o port;vnls of the irrigation tubing and a~piration tubing inside the ~assette housing permits t~e retrans~er o the transfer tray and remainin~ portion of the ca~sette to the non~terile field for insertion i~to the equipment for connections by ~nsertion of the ~as~ette as de~cribed.
The ~ethod of making and using ~uch a ca~ette a~d the operative pr~edure~ for e~tablishing connection~ are ~lso de~cribed~
BRIEF DESCRIPTION OF $~1E DRsAWINGS
Ir~ the drawings:
Fig~ a ~yl~zed schematlc~ of an emulsi~er/aspirator unit incorporating a ~a~;sette receiv~ng se~tion for receivirlg a cassette according to the i nvention and ~howing khe fluidic connections achieved by insertion of the cassette into the unit;
Fig. 2 i~ a per~pective view of a ca~ette according to the invention;
Fig. 3 i~ a view of ~he i~side of the botto~
ca~sette hou~ing;
Fig. 4 is a view of the in~i~e of the top c~as~ette hc~u~ g;
Fig. 5 ~8 a diagra~Lmatic vie~r of ara irrigation maniiEold us2d in connection with the inven~ion;
Fig. ~ is a ~iagrammatic view of a~ aspiratlon ~anifold used in conne~tion with the invention, . Fig. 7 î~ a diagrammatic view of a dr~in bag used in cvnnectlon with the invention;
Fig. 8 i~ an exploded perspective ~iew of the botto~ and top cassette housin~s of Figs. 3 an~ 4 when combined with the irr~gation manifold, aspiration manifold, ..
~nd drain bag of Figs. 5-7 to form a ~assette/m~nifola as~emb~;

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Figure 9 is a diagrammatic view of the structural ~eatures of the cassette mechanism on the emulsifier/aspirator unit shown in Figure 1, wherein Figure 9A is a front pictorial view;
Figure 9B i5 a left side pictorial view; Figure 9C is a right side pictoriaI view, and Figure 9D is a top pictorial view, together showing the components of the cassette mechanism for receiving the cassette according to the invention;
Figure 10 is side view, diagrammatically illustrated, showing the cassette mechanism of Figure 9 mounted on the emulsifier/aspirator unit of Figure 1, Figure 11 is a view of the interfacing between the cassette mechanism of Figures 9 and 10 and the cassette of Figures 2-7 wherein Figures llA, llB, and llC illustrate various stages of the insertion of the cassette into the cassette mechanism;
Figure 12 is a partial view of the fluidic connections between the cassette and the cassette mechanism when the cassette is completely inserted into the cassette mechanism on the emulsifier/aspirator unit; and Figure 13 is an exploded view of the packaging for the cassette according to the invention.
DETAILED DESCRIPTION OF THE PREFERRED ~MBODIMENTS
A cassette for surgical irrigation and aspiration is shown generally in Figure 1 by the reference numeral 20. The cassette is used with an occular ultrasonic surgical device, designated generally by the reference numeral 22, generally referred to in the art as an emulsifier/aspirator. The device uses a hand held ultrasonic vibrating tool of the type shown in 30 U.S. Patent No. 3,589,363 to break up a cataractous crystalline lens in the eye and aspirate the fragments. The unit 22 in-cludes a cabinet 23 which houses suitable electronic circuitry ~or supplying ultrasonic power to a handpiece, and controls for the irrigation fluid, and for the aspiration suction, as will be discussed in greater detail. The cassette 20 is supplied equipped with the irrigation and aspiration tubes and waste bag all assembled and packaged in a removable sterile package 2~.
The cassette 20 is removed from the sterile package 24 in the operating room, the appropriate ends o~ the tubes on the cas-sette are connected with a minimum number of transfers andconnections and the cassette is inserted into a slot 2~ in the side of the control cabinet 23 of the emulsifier/aspirator unit 22. The remaining tube connection is made to a source of fluid.
As depicted generally in Figure 1, the cassette carries a portion of both of the irrigation manifold and the aspiration manifold, in a structural cooperation with an irrigation opening, an aspiration opening, and a VCS opening defined on the leading edge of the cassette 20. The emulsifier/aspirator unit 22 includes an irrigation solenoid having an occluder shaft, an aspiration pump, and a vacuum control system. Insertion of the cassette 20 (after removal from the tray 24) into the slot 26 causes a cooperation between the cassette 20 and the cassette mechanism to: (1) achieve a control of the flow through the irrigation manifold by the coaction of an occluder shaft on an irrigation solenoid co-operating with the tubing through an irrigation opening in the cassette; (2) to effect a flow through the aspiration manifold by the coaction with an aspiration pump c~operating with an a~piration openin~ on the c~sette; and ~3i to apply VC5 control for the unit 22 to the asDir~tion tubing through a VCS open~ng on the cas~ette. ~hu~, ~nsertion of the ca~sette into the cassette mechanism establishe~ and controls the fluidic~ of the sy~tem~
Fig~. 2-4 collectively ~how the structure o~ the ca~sette 20. ~he ~assette 20 ~s Preferably an i~ect~d ~ol~a hou~ing made from a ~u~table pla~tic material and com~ri~e~ a bottom cassette ho~ g 28 ~n~ a top cassette h~using 29 whi~h are structurally compatible to def~ne at the leadi~g edge 27 thereof an irrigation opening 30, ~ vacuum control 6y~tem opening 31, and an aspiration pump openin~ 32.
The term alead~ng edge~ refers to the forwardmost ed~e o ~he cassette in the dire~tion of insertio~ into the unit 22 as : 15 shown by the arrow labeled with the reference character a.
The upper ~urface of the cassette 20 aefines a boss 33, and the trailing edqe of the unit 34 aefines an irri~atlon manifola opening 35.
A lateral edge 36 of the cas~ette 20 defines a~
~rrigation and aspiration man~fold opening 37~ The respective openings 32, 31, ~0, 35~ and 37 are ~referabl~
formed by positioning complementary openi~gs lscated in the respectiYe and mating edges of t~e top and bottom cassette housings 29 and 28.
As shown in Fiy. 3~ ~he bottom ~asset~ hou~ing 28 deflne~ on the bottom ~urface thereof a female irri~at~on b~ 40, a female aspirat~on bos~ 41, a pair of ~train rel~ef bosse~ 42~ 43, and a plural~ty of female dra~n ba~ bos~e~ 4~.
The irrigat~on bos~ 40 ha~ a flat leading edge ~urface 45 locat~d near the leading ed~e of ~he cassett:e. ~he . . .

irrigation opening 30 i~ located directly forward of and ~n register with the ~urace 45 to ~efine one half o~ ~he irrigation opening 30, the other h~lf of ~hich i# defined b~
the top ca~se~te ~ou~ing~ A~ will be ~een, the surface 45 cooperates with an occIuder shaft on an lrrigatlon ~olenoid to control flow thro~gh ~D irrigation nnanifol~ po~itioned adjacent to the ~urface 45, when the cass~ette 20 i8 inserted into the unit 22.
A semi-cir~olar aspiration ~umD o~eninq 32 i~
located directly in front of tbe female a~piration bos~ 41.
The pump opening 32 ~ooperate~, when the cas~ette 20 i8 in~erted into the unit ~2, with an a~Riration pump to effect flow through the aspiration tubing.
The vacuum control sy~tem (~CS) opening 31 ~s located between the aspiration pump opening 32. ana the irrigation opening 30 along the leading edge of the ~as~e~t~
20. The opening allows ~he ~S ~y~tem o~ the unit 22 to control the 6uctio~ vacuum of the a~piration of ti~sue ~aus~d when the cas~ette 20 i6 i~serted into the unit 22.
The irrigatio~ and aspiration manifold openlng 37 is defined in the lateral edge 36 of the cas~ette 20. A pair of rectangular latch openings 46 are also located on the bot~o~ cassette ~ou6i~g 28. One latch open~ng 46 i5 locatea behlnd the female irr~gation boss 40, while the other latch opening 46 i~ located behind the femalè asp~ration boss 41.
The trailing edge 34 also defines in the bo~tom ~assette housing 28 a drainage bag open~ng 47. ~ pair of female ~lot~
48 are also located on oppo~ite ~ides of the tralling ed~e of the bottom ca~sette hou~ing 28.

The top cassette hou~ing 29 as ~hown in lFig. 4 def ines ~ male ~rrigation bo~s 40~, a male aspiration bo~s "~f 41A, a plur2l1~ty ~f male ~ra$nag~ bag ~o~e~ 44A, and ~n elons~ated drainage bag hol~ do~n ~ember 49. The leading ~dge 27 of the tQE~ ca~sette hous~ng re~pe~tivRly de~ine~ tbe c:omplementary portion~ of tbe ~rrigation opening 30, lthe VCS
open~ng 31~ and the aspiration pump vpening 32r lrhe re~pective hou~ings ~hown in Fi5~l8~ 3 and 4 are secure~ to ~efir~e the cas6ette 20 ~hown in Fig. 1. ~hus, the ~structural portions of the cassette have been described.
I?igs. 5, 6, and 7 respectivel~r show diagrammatie views of an ~rrigat~on manifold 52, an asp~ratlon manifol~
53, and a drain bag S4. As w~ 11 be seen, the cassetl:e 20 sho~m in Fi~s. 1-3 house~ a portion of the ~rrigation lS manifold 52 and a portion of the aspiratior~ manifold 53, as well as portions of the drain bag 54. As sblOWn in Fig., 5, the irrigation manifold 52 include~ a drip chamber 56 connected to all irrig~tion tube 57, an irrigation ~ilicone tubing 58, and a second segment of irrigation tubing 59, terminating in a male 1 uer f ittir~g 60 . Preferably, lthe tubing ~e~:t~on~ 57 ~rld 59 are made f rom polyv~n~!l chloride ~PVC)O
As sh~w~ in Fig . 6 ~ the a~piration manifola S~ i8 ~imilarly constructed. The aspiration ~anifol~ 53 consi~s o a le~sgth o aspiration psmp ~ one tubing 62, Gonnectea lto a plasti~ tee 63, aspiration PVC tubing 64, a~d a female luer f itting 65. A check valve 66 and VC~ grommet S7 are al~o connected to the tee sectio~l of the plast~: tele C3.
~ig. 7 lx a diagrammatical illus~ration of the rain bag for receiving aspiratic~n product~ when the ~ys'cem ~ 2~

is $n use. The drain bag 54 i~ a polyethylene pla~ti~ bag which has a plurality of openings 68 located alon~ the top and which ~re preferably o~ a like number to ~be mem~ers 44 and 44A ~h~wn i~ Figs. 3 and 4 in the ~asset~e hou~lngs 28 and 29. The drain bag 54 al~o inc~u~es a drain plug 69 heat ~ealed to one leaf of the bag. ~he assembly of the ~as~ette fihown ~n Fig~. 2-4 and the manifola~ and drain bag shown ~n Fig~. 5-7 ~ thus shown in Fig. 8.
The ~rrigation PVC tubi~g 57 enter~ the cas~ette ~0 through the irrigation manifold opening 35 ln the top ~a~ ette housing 29. The ~rr~gation sili~one tubing 58 i6 routea around the female irrigation boss 40 betwee.n the $rrigatîon opening 30 ~nd the irrlgation boss flat leading edge surface 45O From that location, the irrigation s~licone tubing 58 i~ routed around one strain relief bo~s 42 where it joi~s the lrrigation PVC tubing 59 a~d exit~ the cassette throu~h the irrigat~on and aspiration manifold ; opening 37.
The aspiration PVC ~ubing 64 also enters the cas~e~e through the irrigat~o~ and aspiration manifold opening 37. The plasti~ tee 63 is placed between the two $tra~ relief bosses 42~ 43. The VCS grommet 47 fits wlth~n the VCS opening 31 ~n the leading ~dge of ~he cas~ette 20 - ~he a~piration manifold ~ilicone tubing 62 ~from the tee 63~
is rout a around the female aspiration boss 41 through .the ~emicircular aspirat~on pump opening 32. From that location, the aspira~ion pump tubin~ 62 join~ the drain plug 69 located on the drain ~ag 54 ~he drain bag 54 i~sel~ is attached ~o the bo~to~
cassette hvu~ing 28 by placing the four female drain bag bosse~ 4~ (Figa 3~ through the corresponding openinqs 68 on the ~rain bag 54. The drain ba~ and the ~ttache~ asD;ration pump tubi~g 62 fit through the dr~inage bag openinq 47 on the ~railing edge of ~he ca~se~e 20.
~ith the tubi~g thu~ positi~ned, the top cassette hou~ing 29 i~ press fitted into the ~ott:om cassette hou~inq 28 to ~e~ure by fri~tion fit ~he female aspiration bo~s 41 and the ~ale a~piration bo~s 41~; the female irriqation bos6 40 and male irrigation bo~s 40A; and t~e two opposed female ~lo 8 48; and the drainage bag hold-down 49~ The four ~ale ~rainage ba~ bosses 44A ~it inside the ~orresponding our female drainage bag bosse~ 44, thus entrapping the drain ba~
54 to the assembled cas~ette 20.
As shown diagrammatically ln Fig. 9 (i.e. in Fi~sc 9A-9D~, the ~assette mechanism consist~ o~ t~o ~a~or components: a cassette latch brac~et 75 and ~ soleno~d~pump ~oun~ing plate 76. The ~assette latch bracket 75 i~
~ationary whereas the soleno~a/pump mounting pla~e 76 ~8 movable and is atta~hed to the ~a~ette latch bra~ket 75 by a b2aring 77 and springs 7a, 79.
The ~olenoid/pump ~ounting plate 76 provides for mou~ting of an irrigation ~olenoid 80y an aspiration pump 81 and it~ a~sociated roller asse~bly 82, and a VCS fi~tin~ 83~
An occluder ~haft 84 of the irrigation solenoid 80 passes through an opening of t~e ~olenoid~pump mounting ~la~e 76.
The aspiration pump 81 and roller as~embly 82 ; 8 mounted to ~he ~olenoid/pump mounting plate 76 by a bearin~ mounting - plate 85. ~he bearing moun~ing plate 85 defines ~ ~lot ~6 and beveled eage 87. A ca~sette guide 88 ~ al~o mounted to the ~olenoia/pump mounting plate 76~ ~he cas~tte gui~e B$
define~ a beveled facing ed~e 89 and ~ncludes tWID ~lot~ 9~

~he cassette latch bra~ket 75 provi~e~ for mounting of the ~olenoid/pump mounting plate 76 and a ~a~ette latching ~echani~m 91o ~he ca~sette lat~h~g ~echa~i~ 91 includes a release ar~ 92, associated li~kage 93, an~ two latch ar~s 94. The trailing edges 95 of ~ach latch ar~ 94 are beveled. Both latch arms 94 protrude ab~ve the le~el of the cassette guide 88. A $pring 96 eonnects the latchlng ~echanis~ 91 to the ~olenoid pump ~ounti~g plate 76.
The entire a~embled cassette mechanism provi~e~ an open~ng 97 which acce~t~ the leading edge 27 of ~he ca~sette 20. The bevele~ edge 87 of the bearing mounting plate 85 provides the upper surface of the opening 97 and the cas~ette guide 88 provide~ the lower curface of the opening 97.
Locatea between these upper and lower ~urfaces are the o~cluder ~haft 84 of the irrigation ~olen~id 80~ the VCS
fitting 83~ and the roller assembly 82 of the aspiration pump 81u ~hu~, the 6tructure of the casset~e mechani~ loca$ed on the e~l~f~er/a~pirator unit 22 for receivi~ the ca~sette 20 to provide the described fluidic co~nection ha~ been ~escribed.
~he cassette ~echanism of Fig. 9 i~ mounted to the u~it 22 behind a pro~ective panel 98 attached to the unit 22.
The protectiYe panel 98 has an open~g 26 through whl~h the l~ading edge 27 of the cassette 20 is inserted. Lo~ated behi.nd thi 8 opening 26 ~ a spring-bia~ed door 99 which swing~ upward and out o~ the way when the cassette 20 ~
in~ertea and automatically close~ ~he openinq 26 when the cassette 20 is removed, An opening in the protective p~nel 98 located at a position throu~h which passes the release. arm 92 of the ca~sette latchin9 mechani~m 91r A relea~e l~nob ~no iB
a'ctached to tlle end of the release arm 92.
The ~nterfacing be~weerl the c~sse~te 2t! and ~he eas~ette mechani~m ~ ~hown ~n Fig~ nd 12.
S 11~ E;h~ n ~ig.. llA, the leadlin~ ed~e 27 of he ca~sette 20 i8 inserted throu~h the operllng 26 of the protective pane~ 98 attached to the u~i~ 22. A~ tbe casset~e 20 i~ pushed forwardO the spring-~ia~e~ door 99 i5 ~ushed upward and out of the way.
As ~hown in Fig~;,. 11 and 12, ~s the leadinq eage 27 oP the ca~sette 20 advances J it pushes the beveled traillng edge~ 95 of the latch arms 94 downwara to a po~ition beneath the cassette 2Q and the ~pring 96 ~ s ~tretched . ~ the cassette 20 i~ continued to be pu~hed forward a~ shown in Fi~g., llC, the leading edge 27 enters the openincl 97 delineate~ by the beveled edge of the bearing mountinq ~?late 85 and the cassette guide 88. The bo~x 33 on the leaainq edlge 27 of the cas~ette 20 (Fig~ . 2-4 ~ enters the ~lot 86 lo~ated on the bearin$~ mounting plate 85.
. Continued forward ~otion of the ca~sette cau~e~ the leading edge 27 s~f the c~assette 20 to com~3 into c~ontact wi~h the solenoid/pump mounting plate 7S. As lthe springs 78 and 79 are compresse~ the ~ntire s.olenoid/pu~p mountll~g pla~e 76 m~ves reaxwardly, a~llo~ing the latch arms 94 to ~n~er ~he re~:tangular latch openings 4 6 ~ Fig . 3 ) locatet~ o~ the bottom hou~ g 28 of the cassette 20.
At thi~ point 9 as best seen ~n F~g . 12, the casse~te 20 i~ f irmly attached to the cassette mechan ~ ~m 9 l`he o~cluder shaft 84 of the irri~at~on soleno~d 80 passe~;
3Q t,h.roug21 the irrigation opening 30 of the c~ls9e~ a 20 a}LdL

occlude~ the irrigation ~ilieone tubin~ 58 a~ain~t the flat l~ading edge surface 45 of the lrri~ation bo~s 40. ~he xoller assembly 82 of the a~piration Pu~np 81 occun~es the ~mi-circular aspira~io~ pump openinq 3~ of the sas~ette 20 and occludes the aspiration pump ~ one tubYnq 62 ~qainst the ~spiration boss 41 ~ig. 3). The comPre~sion force arise~ from ~ompression of the ~pring~ 78 and 79. The VCS
fitting 83 pa~ses through the lu~en of ~he VCS qrommet 67 (Fig. 6) and i~ ~elf-~ealing. At this poi~t, all 1~idic connections are made upon complete insertion o~ the cassette ~nto the cassette mechani~m of the em~lsifierjaspirato:r.
The ~ystem fluidlcs can now be dis~ussed, based on Figs. 5-8 and 12. ~he irrigation manifold 52 provi~es for the flow of irrigation fl~ld to the surgical ~ite. ~he irrigation manifold 52 ~onnect6 to an irrigation sour~e ~not ~hown~ via the drip ~hamber 56. ~he irrigation $1uia i~
delivered to the ~urgical ~ite v~a a co~nection to the male luer f~tting 60.
~he ~low of irrigation solution through the lrrigation manifold 52 i~ thu~ re~ulated by ~he o~luder ~haft 84 of the irrfgation soleno~d 80. When the ~assette 20 i~ atta~hed to the cassette mechani~m lFigs. llA; llBs llC), the irrigation ~ilicone tubing ~8 i~ compressed bet~e~n the occluder shaft 84 and the irrigatio~ ~o~s 40~ thus preventing flow of lrrigation fluid. When the irrigation ~oleno~d 80 is energizeds the occluder ~haft 84 moves to a witharawn position, ~llow~ng the lume~ of th~ irrigation silicone ~ub~ng 58 to open and irrl~ation flow to occur ~ hln the tubing~ Thu~, flow of irrigation flu~d i~ controlled~

.. . . ...

The aspiration man~fold 53 ~rovides for the regulated flvw of aspirated fluid and ti~ue from the ~urgial 61teO The sspirated flu~ and ~sue i~ removea from the ~urg~c~ te via a connection to the female luer f~t~ 65.
~he flow of aspirated ti~ue and fluia throu~h the aspiration man;old 53 is e~fectea by the roller assemblv 82 o~ the aspiration pump ~1. ~hen the cassette 20 i~ attachea to the cassette mechanism (Fig~. llA; llB; llC7, the a~piration pump ~ilicone tubing 62 is compre~ed between t~e rollers of the roller assembly 82 and the aspira~ion boss ~1.
When the aspiration pump 81 i8 energized~ ~he roller assemblY
82 rotates in a counter-clockwi~e a~rection Sas viewed ln Fig. 12) forcing fluid and ti~sue to flow from the ~urg~al site.
The vacuum control ~ystem ~VCS) ~ocated inside the u~it limits va~uum le~el~ att~inable ln the- a~pirat~o~
manifold 53. Th~ VCS fitting 83 mountea on the cassette mechani~m 1~ connected to the VCS of the u~it. A seale~
co~ne~tion i~ effe~ ed betw~en t~e VCS fit~ing 83 on th~
casse~te mechanism and the ~CS grommet 67 on the ~asset~e 20 when the cas~ette is attached to the cassette mechani6m a~
~escribed~ In turn, the VCS grommet 67 is at~ached ~ ~h~
aspiration manifold 53 v~a the plastic tee 63 ~Fi~. 6).
chec~ valve 66 inserted between the VCS grommet 67 and the plastic tee 63 [Fis~ 6) preYent~ ba~flow of aspirated flui~
and ti~ue rom the a~piration manifold 53 to the VCS and ~omplete~ the fl~ circuit. T~us the fluiaic connection~
for the ~y~tem are readily made upon insertion of ~he ca~sette 20 into the cassette mechanism. ~eference ma~ now -- 19 -- .

be made to JFl~. 13 for a ~i~cussion of the pac~caginq for ~he cassette .
Packagin~ of the ea~sette 20 consi~t~ of ~ r~sfer ~ray 111, an outer tray 112, a transiEer tray lld 113d an~ ~ID
outer tray l~d 114, as ~hown ln per~pective in Fig. 3., The cassette 20 is prepared for place~ent in the transfer tray 111 by ~oiling and banding 1:he irr~gation PVC
tubing 57, ~dhich exit8 the cassette 20 iErom the irris~atiorl manifQ d ope~ing 35, and by coil~ng and bandirlg the irrigation PVC tubing S9 an~ aspiration PVC tubing 64 which exits the cas52tte 20 from the irrigation and asp~ratiLon manifold opening 37. The drain bag 54 is wrapped aro~md the cassette 20.
The prepared cassette 20 i~ then placed into the transfer tray 1}1 placillg thQ cassette 20, the drail~ bag 54, and the banded irrigation PVC tubing on one ~ide ~f the transfer tray llly and the ~anded irrigation ~?VC tubing 59 and aspir~t~o~ tubing 64 on the other. The tran~fer tray 111 has formed protuberanees 121 orl it~ si~e~ whi~h immob~ e the casset~e 20. The filled transfer ~ray 11} i~ ~hen ~eale~ with a transfer tray lid 113 along ~t~ peri~eter. The filled and ~ealed tran~fer tray 113 i8 then placed into a~
outer tray 112 which i~ turn ~ 8 ~ealea with an outer tray lid 114. 7 ~5 ~hi~ entire a~embly i~ then steril~zed b~ a suitable pro~e~s, preferably ~ith ethylene oxide ~TO~ gas.
After ~terilization, th~ tran~fer tray 111 and itR con~ent~
are 6ter~le.
U~e of the sterili~ed transfer tray 111 dur~ng a surgical procedure can now be described.

A typical transfer between the circulator a~d s~rub nur~e and e~auipment ~et up by the circulator with ~he lnvention i~ ~ follows. The circulator removes the out~r tr~y lid 114 iErom the outer ~ray 112 and aseptically tra~nser~ the ~ter~le transfer tray 111 to the ~texlle field~
The scrub nur~e rsmoves the transfer tray l~a 113 from ~he transfer tray 111 arld re~oves the banded ~rrigation PVC:
tubing 59 and ~15piratiOn PVC tubing 64. The ~cxub nur~e then tran~fer~ the transfer tray 111 and rema~ning por ion of the cas~e'cte 2ID bac::lc to lthe cir~ulator., ~he c~r~ulator removes the cassette 20 f rom the transfer tray 111 and insert~ the cassette 2n into the opening 26 of the protective paa~l 98 as previously described until a distixlct snap is felt., ~he ~irculator ~hen remoY~s the banding from the PVC îrrigat~on tubing, inserts the ~Irip chamber 56 into an appropriate irrigation so~rce and ~u~pend~
it on ~ pole. At thi~ point,, the mar~ifolds ar~ ready for priming and ~y~e~ ~:heckout.
In contra~t to the prior art ~et~p~ the setup

2~ procedure uæiri~ the irlverltioll ~on~; ~t~ of only two connection~ t~at the circulator ~u~t ~aake to 'che eSIuipment;
i.e. ~n~ertioll o the drip chaD~er 56 to an appropr~te irrigation sou:rce and the insert1on of the cassette 20 lnto the eguipment . At 'chis pointd all f luidic connection~ are preci~ely ~ade to the eq~ipment" a~ descr~b~d. ~he re~pon~ibility of the reliability of the flu;dic coE~nectlonæ
is thus removed from the circula~-or and $6 tran~ferred to the specif ic con6truction and geometry of the cas~etta 20 and cassette mechani~m previou~ly de~cribedO

In s:ontrast to tbe number of ~ran~fers be~ween the ~terile ~nd ~on-sterile ield, ~he packaging of the inven~on limit~ the min~mum number of tran~ferE; to two; i.e. the transf~r of the tray 111 into the sterile f ield and the ~ranfifer of the transfer tr~y 111 and r emaining ~ortion of the cassette 21D back to tbe norl-~terlle field. Since the rema~ning portion oiE the cassette 20 remains in the transfer tray 111 duri~g t)li~ transfer, this redu~e~ the ri k of contaminatiorl to the scrub nur6e or ~terile ~ield ~ins~e th~
transfer txay pre~ents a large ~llxface area to hold alld grab on to.
The invention may be em~odied in other ~pec~f i~
forms w.itbout departing from its ~piriLt or essential chara~ter~ti~s.. The prese~t enbodiment~ are, therefore, to be eonsidered in ~11 respects a~ illu~trative and not res rictive, the scope oiE the ~vention being indic:ated by the claims rather than by the fore~oing description and all change~ wh~eh co~e w~thin ~he ~eaning a~d r~nge o~ the eguivalent~ of 'che ~laims are therefore intendea ~o b~
2~ embraced there~

-- 2~ -- , . .. ....

Claims (21)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY
OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. In combination:
a cassette having a housing defining an irrigation opening, an aspiration pump opening, and a VCS opening, the housing of said cassette defining an irrigation boss in register with said irrigation opening and having a leading edge surface;
a portion of an irrigation manifold located intermediate said leading edge surface of said irrigation boss and said irrigation opening;
an aspiration boss located in register with said aspiration pump opening;
a portion of an aspiration manifold connected intermediate said aspiration pump opening and said aspiration boss;
a cassette receiving mechanism which includes an irrigation solenoid having an occluder shaft, an aspiration pump and roller assembly, and a vacuum control system which includes a vacuum control system fitting;
said cassette mechanism and said cassette thus interfacing when connected so that said occluder shaft of the irrigation solenoid passes through the irrigation opening of the cassette to occlude said irrigation manifold against said leading edge surface of said irrigation boss, thereby to control flow of irrigation fluid through said irrigation manifold; and so that the roller assembly of said aspiration pump occupies said aspiration pump opening of said cassette and occludes said aspiration manifold against said aspiration boss, thereby to control the aspiration of fluid through said aspiration manifold;
said VCS fitting connecting with said VCS opening in a sealing manner.

2. A cassette for surgical irrigation and aspiration for use in cooperation with an apparatus which includes an irriga-tion control means for controlling a flow of irrigation fluid to an operative site, aspiration control means for controlling flow of aspirating fluid from an operative site, and vacuum control means for controlling the aspiration of such fluid from the operative site, comprising:
a housing having an edge defining an irrigation opening, an aspiration pump opening, and a vacuum control system (VCS) open-ing, said housing containing at least a portion of an irrigation manifold and an aspiration manifold which are structurally adapted and arranged within the housing so that, when the cassette is inserted into a predetermined cassette opening in said apparatus, said irrigation control means controls the flow of irrigation fluid through said irrigation manifold; said aspiration control means controls the flow of aspiration fluid through said aspiration manifold; and said vacuum control means controls the vacuum applied to said aspiration manifold, and wherein said housing includes an aspiration boss located in register with said aspiration pump opening, wherein a portion of said aspiration manifold is located intermediate said aspiration boss and said aspiration opening so that a pumping portion of an aspiration pump of said aspiration control means can effect pumping of aspirated fluid through said aspiration manifold.

3. The cassettes as set forth in claim 2, wherein said cassette includes an irrigation boss defining a control surface located in register with said irrigation opening so that, upon insertion of said cassette into said predetermined cassette opening, said irrigation control means controls the flow of irrigation fluid in said irrigation manifold by coacting with said irrigation boss.

4. The cassette as set forth in claim 3, wherein a portion of said irrigation manifold is located intermediate said control surface of said irrigation boss and said irrigation opening so that an occluding member of said irrigation control means can mate therewith to occlude flow of fluid through said irrigation manifold.

5. The cassette as set forth in claim 2, further includ-ing means for securing a drainage bag on the trailing edge of said cassette, said securing means including a plurality of drainage bag bosses and a drainage bag holddown for securing said drainage bag with said cassette.

6. The cassette as set forth in claim 2, wherein said aspiration manifold includes a VCS connector connected to said VCS opening on the leading edge of said cassette.

7. The cassette as set forth in claim 4, further in com-bination with a cassette mechanism mounted on said apparatus for receiving said cassette therein, said cassette mechanism com-prising a cassette latch member and means secured to said cassette latch member for mounting an irrigation solenoid, an aspiration pump and roller assembly, and a VCS fitting thereon in such a manner that irrigation, aspiration and vacuum fluidic connections are made upon insertion of said cassette into said cassette mechanism.

8. The combination as set forth in claim 7, wherein said aspiration and roller assembly is mounted to said mounting means by way of a bearing mounting plate defining a slot and including a beveled arm.

9. The combination as set forth in claim 8, further including a cassette latch bracket for latching an opening in the housing of said cassette.

10. The combinations as set forth in claim 9, further including means for releasing said latch.

11. The combination as set forth in claim 9, further including a cassette latching mechanism comprising a release arm, linkage, and a plurality of latch arms, the trailing edges of which are beveled, and structurally arranged so that inser-tion of said cassette into said cassette mechanism causes move-ment of the trailing edges of said latch arms downward and beneath the cassette.

12. In combination, a cassette for surgical irrigation and aspiration for use in cooperation with an apparatus which includes an irrigation control means for controlling a flow of irrigation fluid to an operative site, aspiration control means for controlling flow of aspirating fluid from an operative site, and vacuum control means for controlling the aspiration of such fluid from the operative site, comprising:
a housing having an edge defining an irrigation opening, an aspiration pump opening, and a vacuum control system (VCS) open-ing, said housing containing at least a portion of an irrigation manifold and an aspiration manifold which are structurally adapted and arranged within the housing so that, when the cassette is inserted into a predetermined cassette opening in said apparatus, said irrigation control means controls the flow of irrigation fluid through said irrigation manifold, said aspiration control means controls the flow of aspiration fluid through said aspiration manifold; and said vacuum control means controls the vacuum applied to said aspiration manifold;
said cassette being in combination with a cassette mechan-ism mounted on said apparatus for receiving said cassette there-in, said cassette mechanism comprising a cassette latch member and a solenoid/pump mounting means secured to said cassette latch member for mounting an irrigation solenoid, an aspiration pump and roller assembly, and a VCS fitting thereon in such a manner that irrigation, aspiration and vacuum fluidic connec-tions are made upon insertion of said cassette into said cassette mechanism.

13. The cassette as set forth in claim 12, wherein said cassette includes an irrigation boss defining a control surface located in register with said irrigation opening so that, upon insertion of said cassette into said predetermined cassette opening, said irrigation control means controls the flow of irrigation fluid in said irrigation manifold by coacting with said irrigation boss.

14. The cassette as set forth in claim 13, wherein a portion of said irrigation manifold is located intermediate said control surface of said irrigation boss and said irrigation opening so that an occluding member of said irrigation control means can mate therewith to occlude flow of fluid through said irrigation manifold.

15. The cassette as set forth in claim 12, further includ-ing means for securing a drainage bag on the trailing edge of said cassette, said securing means including a plurality of drainage bag bosses and a drainage bag holddown for securing said drainage bay with said cassette.

16. The cassette as set forth in claim 12, wherein said aspiration manifold includes a VCS connector connected to said VCS opening on the leading edge of said cassette.

17. The combination as set forth in claim 12, wherein said aspiration and roller assembly is mounted to said solenoid/pump mounting plate by way of a bearing mounting plate defining a slot and including a beveled arm.

18. The combination as set forth in claim 17, further including a cassette latch bracket for latching an opening in the housing of said cassette.

19. The combination as set forth in claim 18, further including means for releasing said latch.

20. A cassette and package for a medical instrument comprising:
a housing, comprising a bottom cassette housing and a top cassette housing, said bottom cassette housing including an irrigation boss, an aspiration boss, a strain relief boss, and drain bag bosses, said top and bottom cassette housings together defining a leading edge for the cassette which defines an irri-gation opening, an aspiration pump opening, and a VCS opening, said cassette housing portions of an irrigation manifold, an aspiration manifold, and a drain bag so that said cassette may be inserted into a mating cassette mechanism on a surgical instrument to establish fluidic control connections between said instrument and said irrigation and aspiration manifolds, packag-ing for said cassette, said packaging including a transfer tray, an outer tray, a transfer tray lid, and an outer tray lid, said cassette being placed in said transfer tray in such a manner that the cassette, an attached drain bag, and a portion of the irrigation manifold located outside of the cassette are placed on one side of the transfer tray, while a portion of the irriga-tion manifold and aspiration manifold are located on the other side of the tray, said transfer tray being sealed with said transfer tray lid along its perimeter so that the filled and sealed transfer tray is located in an outer tray respectively sealed with an outer tray lid along its perimeter.

21. The cassette as set forth in any one of claims 5 and 6, further in combination with a cassette mechanism mounted on said apparatus for receiving said cassette therein, said cassette mechanism comprising a cassette latch member and means secured to said cassette latch member for mounting an irrigation solenoid, an aspiration pump and roller assembly, and a VCS
fitting thereon in such a manner that irrigation, aspiration and vacuum fluidic connections are made upon insertion of said cassette into said cassette mechanism.