CA2015104A1 - Apparatus for cryosurgery - Google Patents

Apparatus for cryosurgery

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Publication number
CA2015104A1
CA2015104A1 CA002015104A CA2015104A CA2015104A1 CA 2015104 A1 CA2015104 A1 CA 2015104A1 CA 002015104 A CA002015104 A CA 002015104A CA 2015104 A CA2015104 A CA 2015104A CA 2015104 A1 CA2015104 A1 CA 2015104A1
Authority
CA
Canada
Prior art keywords
control means
tlle
housing
fluid
expansion chamber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002015104A
Other languages
French (fr)
Inventor
Nir Merry
Michael Smidebush
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cryo Instruments Inc
Original Assignee
Nir Merry
Michael Smidebush
Cryo Instruments, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nir Merry, Michael Smidebush, Cryo Instruments, Inc. filed Critical Nir Merry
Publication of CA2015104A1 publication Critical patent/CA2015104A1/en
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00084Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00084Temperature
    • A61B2017/00092Temperature using thermocouples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00464Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for use with different instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00041Heating, e.g. defrosting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00059Material properties
    • A61B2018/00089Thermal conductivity
    • A61B2018/00095Thermal conductivity high, i.e. heat conducting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231Characteristics of handpieces or probes
    • A61B2018/0262Characteristics of handpieces or probes using a circulating cryogenic fluid
    • A61B2018/0268Characteristics of handpieces or probes using a circulating cryogenic fluid with restriction of flow
    • A61B2018/0281Characteristics of handpieces or probes using a circulating cryogenic fluid with restriction of flow using a tortuous path, e.g. formed by fins or ribs

Abstract

ABSTRACT OF THE INVENTION
An apparatus for cryosurgery having the ability to precisely control the rate and degree of freezing of diseased tissue by means of a cryoprobe having a plurality of removable cryotips, and a compensating temperature control system operably associated with the cryoprobe.

Description

2 ~

~ I)e present inventlon relates generally to cryosurglcal devices. More particularly, the lnvention concerns a surglcal apparatus that has the ability to control the freezing process both in space and in tlme by means of a cryoprobe having a plurality of removable cryotips, and a compensating temperature control system operably assoclated with the cryoprobe.
Dl~cussion of Prior ~rt -cryosurgery ls a surglcal procedure that uses freezing temperatures to destroy tlssue James Arnott, an Engl~sh physician, was the first to introduce th~s metllod in 1865 for treatment of cancer of tl-e skin. ~etween 1920 and 194~, the commercializatlon of liquid alr led a number of surgeons to employ freezing to accompllsh the destructlon of nondesirable tissue. ~y 1930 tl~e flrst monograpl~ on the method was published (Lortat-Jacobs and Solente, 1930).
Modern cryosurgery started with the wor~ of a New York surgeon, I. Cooper, who in 1961 developed a new apparatus for cryosurgery. This apparatus consl~ted of a hollow metal tube which was vacuum ~n6ulated, except at the tip, through wl~ich llquid nltrogen was clrculated. cooper was able to localize the freezlng and, thereby, treat the tissue in a controlled way. Tl~e method was used first for treatment of Parkinsonlsm, and later extended to the destructlon of non desirable tlssue in otl)er areas, ~uch a~ dermatology, proctology, gynecology. The appllca-tions of cryosurgery are numerous and have been described in 6everal texts and review papers, (Rand et al.. l96a~ Ablin 1980:
oa~e 19~2; Zacarlan, 1985: ~gL, 1988s ~aae nn~ ~o~e, 198~s QnY~

and Rublns~~, 1988). 2 ~
Untll recently there were two ma~or problems tl~at hindered tl~e efflcient apRlication ~f ~ryo~urgery t~ the treatment of cancer aod other nondeslrable t~6ue. Fir6t, it wa~
impossible to observe the extent of the frozen reglon during cryosurgery, and second tl-ere was no good understanding of the mechanism by wl~ich tissue is destroyed dur~ng freezing.
Consequently, cryosurgery was typlcally used for treatment of disease ~n easily accessible areas w~ere the extent of the frozen tissue could be observed vlsually. ~urthermore, ~ince the proce~s of freezing was associated with damage to t~ssue, it was assumed that the lower the tempe~ature to which tt~e tissue is frozen, tlle greater the cilances for destructlon of the tissue.
Therefore, the standard prior art approach to cryosurgery was to expose the tissue to as low a temperature as possible. More partlcularly, lt was as~umed that lowering the temperature of the tissue to -50 degrees C would ensure the destruction of the - ti~ue. The ex~stlng devices for cryosurgery reflect th~s partlcular ~tate of knowledge.
The prlor art devlces are, ln general, of the epray type, wherelll the cold refrigerant ls sprayed d~rectly onto the tlssue to be destroyed, or tl-e closed end cryotlp type, in wh~cl th2 refrlg2rant 1~ dellvered to ~ portlon o~ the tip that is ~n~erted ~n the tissue to be necrosed. ~pparatus described ln U.S. Letters Patent No. 4,376,376 16sued to Gregory i~ exemplary of the 6pray type devices. qhe devlce descrlbed in U.S. Letters Patent No. 4,211,231 is exe~plary o~ the closed end cryotip devlces.~ Typlcal to all the prior art devlces, wlllch were developed in response to the known science at th~t time, i~ the fact that the extent of the freezlng reglon is not controlled ; accurately because there wa~ no way to observa the dimen~on of the tumor and of the. tumors deep ln the body. Therefore, an 2~ L~

~ccurate control would not have been useEul ln any event. ~150, tlle prlor art ~y~tem~ were deslgned to ~cl~ieve the l~we~t possible tem~erature on t11e tlp, ~g ~ast ~B pos~ible, to ensure t11at as ~ucll of tlle tlp as pos61b1e ls frozell to ae low a te~eratllre ~9 ~05glble.
~ wo ma~r new adv~ncea were made recent1y in tl)e ~rea of cryosurgery. Tlley are revlewed ln tlle paper by ~ublnskY and ~99, rrOc., n. soc. L~lld. D23~, 3~3-358 ~19a~). lt wa~ foul~d tllat ultrasound can be use~ lntraoperat1vely to determllle, ill real tlme, tlle extent of tlle tumor6, as well ag tllat of tlle frozen tlssue dur1ng cryosurgery. Ultrasound works by 6enslng a pre~sure wave rom a ~re6~ur~ tran~du~er. Tll~ w~ve 13 r~lected rom bou~ldarles between regt~ns tllat l-ave dlfference~ in acou~tlc lmpedal-ce ~ucl~ a~ betweell tumor~ nnd normal tl~6ue, bloo~ ve~sel~
and tlssue a~ld frozen a~ld unfrozell tl~sue. Tlle reflscted wave ls ldentlfled by tlle pressure transducer and the extent of t~le tumor, or of tlle frozen reglon, 19 ~l~own on a monltor. Followlng com~uterlze~ lnterpretat10l- Or t1le dat~, til1s procedure facllltate~ an accurate ldentll1catloll of tl~e extent o tlle tumor and of t11e frozell reglon dur11lg cryosurgery. ~l~o, recent exparlmente descrlbed il~ the prevlou~ly mentloned artlcle by nub1n~y alld Deqa, llave ~lled new llgllt on tl~e proce~ ol lreezlllg ~n tlesun. Tlle results sllow that freezlng ln t1ss~e is etrongly afected by tlle structure of the ti~sue. Ice does not ~orm ~nl~ormly tllrougllout tl~e tlssue. natller, it was shown tllat lce orms flrst in tlle blood vesael~, wl-lle tlle cells surroundlllg the ~rozen blood vessel0 remaln unfrozen. Tl~e re-~ect~on o~
~allne durlng tlJe reezing of tl~e blood ve~sels causes atl increa~e ln tl)e salille conce1ltratl0n 11- tlle eolut10l1 lns1~e the blood veasel~ B c~u~e~ water to leave the un~rozell cells tllrough tl~e cell membrane lnto t)~e blood ves~el. The con~equellt ~xp~ns10n of tlle blood v~ols leade to t~le de~tru~tion of the ves6els. ~pparently tl~e destruction uf tile .

frozen tlssue is promoted by the fact that dur1ny freezlng tlle vasculature network ~s destroyed and, therefore, cancerous and ot1~er nondeslrable cells ln the regivn that has been fro~en are deprived oE tlleir blo~d supply after t1~awlng ~nd dle ~ecause of lscllemic necrosls. It was shown ~n tlle ~me paper tl1at tissue can be destroyed hy free~ing to temperatures as hlgh as -2 degrees C, and tllat temperatures as low as -50 degrees C are not required for tissue destruction ~f the freezing process is done in suc11 a manner as to ensure t1~e destruction of the vasculature network. Destruct1011 of the vasculature network can be acl1ieved by varying tlle temperature of the cryosurgical tlp ln a predetermlned controlled way. It ls tl1is aspect o cryosur~ery to w13ich the apparatus of the present lnvent~on ls dlrected.
To summarize t1~e new developmenta: (a) lt ~s now possible to ldentify accurately both the tumor deep ln the body and to observe, ln real tlme, the extent of the frozen reglon:
and ~b) lt 1~as been establisi1ed that.a more efflc~e11t metllod of cryosurgery oan be achieved by varylng the temperature of the oryosurgical probe ln a controlled way to en~ure the destruction of tl6~ue. These new development~ can be compared to the previous state of the art ~n wllici7, ~a~ it wa~ lmposslble to determine accurately the tumor and the frozen region deep ~n the ti~sue: and (b) it wa~ taught that to in~ure the destruction of the tissue, lt i~ necessary to cool the t~6sue as fast as possible and to temperature~ ac low as possible. Consequently, the previous cryosurgical devices were de~igned ln 8Ucll a way that, (a) no importance was glven to the exact extent vf the frozen reglon because there was no way to know how much ti~sue l~
frozen during cryosurgery, or whet~er the w11ole tumor was frozen:
and (b) tlle devlce wa~ deslgned to del~ver ~s much cooling power as po~slble locally to freeze tl)e tl6sue to a temperature ~s low as pos~ible wit11out any concern being g~ven to oontrol over the ~ 2 ~ ~ 7 ~

It ~9 ~n ob~ect o t7~ pr~ t lnventlot- to provl~e met10d and apparatu~ fo~ cryo~urgery w1~lo1~ wlll æn~bl~ precl~e co~1trol over tlle exte~t oE tl1e freezlng of tiYBUe ln aucll a way tllat only the noadesirable tlss11e le frozen. More partlcul~rly lt ls an o~ect o t1~e lnve1-tlol1 to provlde an ~pparatus wl1lc enables preclse control over tlle tl1ermal i1l~tory o the cryosurglcal probe to ~acllltate freezing of tlle t~ssue ln a manner to l11sure t1~e e~flclent ~estructloo o tlle non deslrable tlssue.
It 19 anot11er ob~ect o tlle present lnventlo~- to provlc1e an apparatus of t1~e aforeme1ltloned cllaracter in w1~lc1 several dlrrerently conElgure~ probe~ can be operate~ slmulta11-eously wlt1) lndepe11de11t control.
~ not1~er ob~ect of the lnventlo1- la to prov~de a cryo-probe l1avlng replacea~le cryo~urglcal tlps t1~at can ba exc1~anged rapldly ~o as to provlde t1~e be~t flt wlth the a1~ape and locatlon of t1~e tumor as seen on lntraoperat've lmaglng dev'ces (ul trasouncl ) .
~ nother ob-~ect of ti~e lnve11tion i~ t~ prov~de a cryo-probe 1~ving ~trategically located, low power eleotrlcal ~1eaters wl1lc11 provide a mec11~nl~m for con~ g the free~ng to de~ired actlv~ arens.
stlll anotller o~ect oE tlle lnve11tlon l~ to provlde a cryoprobe of l~niq~1e deslgn in w11lc1) a ~peclRl fluid flow p~ttern 18 generated inside the active tlp of ~1le cryoprobe by means of a multlpllclty of~lg1-tt~ermal co11ductlvity 8p1~eres dl~posed wlt11ln tl1e tlp to lnsure a u11irorm tip temperature.
Yet anotl1er o~ect oL tl1e l1)ventlo11 15 to provlde an apparatua for cryo6urgery w1iic1~ e1)a~les preci~e control over tl)e tllermal hlstory o~ ti1e tlp by meaos of ~ontrol cver low power 2~ 'k electrlcal l~eaters pr~vlded proxlmbte tl~e tlp and by means oE
~lmultaneous caotrol over tlle flow o~ low tem~erature fluld~
tl~rougl) tl)e t~. Sucll control i~ accompll~hed ln a way tl~at tlle compensatltlg errect o coollng by tl~e re~rigerant snd l)ea~ing by tl~e heatll-g elements le ad~u~ted to acllleve poeltive control over tl~e tllermal 1~istory ln the probe.

}lgure 1 l~ a 61de elevat~onal cross ~ectlonal vlew of tlle cryo~urglcal probe o tl~e pre6ent invent10ll.
Flgure 2 le an enlarged cro6~ ~ectlonal vlew o~ tlle area deslgnated ln ~igure 1 by the numeral 2.
Flgure ~ ls R greatly enlarged cros~ ~ectlonal view of tlle area deslgnated ln Figure 1 by the numeral 3.
Flgure 4 19 a generally d1agrammatlc view of tlle cryostlrgery ap~aratus o~ tlle in~elltlon.
Flgllre 5 19 a dlagrammatlc vlew lllustratillg a ~ample coollng reglmen of the cryopr~be.
~ lgure 6 1~ a generally ~cl~ematlc vlew illustratlng one orm of control ~ystem of ths a~paratus of ~lle inventloll.

~ e~errll)g to tl~e drawlng~, and particul~rly ~o Flgures 1 tllrougll ~, one ~orm of cryo~urgical probe of tl~e lnventioll, alld one form of col-trol ~y~tem o~ the lnventlon embodylng the probe ~lgure ~) 1B tlséres11own. Tlle cryoprobe, generally deslgnated by the numeral ln, comprlees a tubular central l~ouelng 12 havlng a f~r~t upper end 12a and a ~econd lower end 12b. carr1ed wltlllll llou~lng 12 1~ a 1u~d ll~let tube 1~ wllicll, along wlth a concentrlc central ~ube 15, de11le0 longitudlnally extendlllg fluld inlet and outlet p~age~ 16 and 1~ re~pectlvely.
Connected to housll-g 12, proxlmate the flrbt upper end 12a tl~ereof, i~ a ~upply head ~embly 2~. ~upply ll~ad a~embly `~-" 2 ~

20 has a cooling fluld inlet 22 11l communlcatlon w~th inlet passageway 16 oE housing 12 and an exhaust passageway 24 in communication wltll outlet passageways 13 of housing 12.
Referring also to Flgure 3, a freezlng tip 26 is removably connected to houslng 12 proximate its second or lower end 12b. Freezing tip 26 ~s closed at ~ts lower end 26a to deflne an expansl~n chamber 30 and is connected at its oppo~ite end 26b to the second end 12b of housing 12. Freezing tlp 26 ~s coaxlally allgned wlth fluld lnlet tube 14 whlch deflnes a supply passageway 28 extendlng longltudlnally of the freezlng tip.
Supply passageway 28 llas an open end 28a dlsposed proximate expanslon chamber 30 and in comm~nlcatlon tllerewith. ~t lts opposlte, or upper, end, supply passageway 28 ls in communlcation with fluid ~nlet passageway 16 whlch ls def~ned by inlet tube 14.
Proximate the upper end of freezing tip 26 are exhaust passage-ways 32 whicll are ln communicatlon wlth expanslon chamber 30 and also witll outlet passageways 18 of housing 12.
~ hlghly lmportant feature of the presellt inventlon comprises means disposed within expanslon chamber 30 for inter-action with cooling flu~ds flowing therethrough for enhancing heat transfer wlth~n the expanslon chamber and for providing a clrcuitous cooling fluld flow path through the expansion chamber.
In the embodiment oP the invention sllown in the drawings, these means comprlse a multipllclty of dlscrete spherlcal member~ 34 dlsposed in a spaced apart relatlonship axlally of exhau~t chamber 3~. ~g best seen in Flgure 3, members 34 deflne a circultous path through the expanslon chamber as lndlcated by the arrows 35. Members 34 are shown in the drawlngs ~g being spherlcal. It to be under~tood, however, that the member~ may take on any shape de6irable for ~u6tomlzlng the fluid flow characteristics and, concomltantly, ~he coollng characterlstics of the freezing tip.

`` ?, ~ ~ 3 ~
will be dl;:cussed ln greater detail llerelnafter, members 34 can be cDnstructed from a wide varlety of dlfferen'c materials and can be formed In numerou~ configurations to enable fu11 customlzing o~ the cooling characterlstcs of tl~e freezillg tip. For example, membexs 34 may be constructed of a hlgh ther-mal conductivlty material ~uch as copper or E:~ lver or they may be constructed of a lower tl-ermal conductlvity materlal 6uch as teflon or nylon. It i5 apparent that through selection of the material from wl~ich members 34 are constructed, dlfferent cooling characteristics can be acl~leved as the liquld nitrogen flows into tlle expansion chamber and is gassified to cool the outer ~;urfaces of tlle freezlng tlp. Depending upor the partlcular surgery be~ ng perforred, tlle 6urgeon can predetermiJle the ideal temperature characteristics of the freezing tip (6ee for example, Figure 5) And select a probe assembly, or tlp, whlcll wlll to provide the co;lfiguration, thermal conduct~vity and the circ~itous path configuration optimum for providing the temperature desired at the exterior ~urfaces of the freezing tip.
Referrlng to Figure 2, tl~e freezing t~p 26 is normally mad~ of a hlgll tl~ermal conductiY~ty material ~ucl~ aB copper or 611ver. ~t the upper, or open, end 26b of the free~lng tlp, tllere is provided a reduced diameter portion deslgnated ln Figure 2 by the numeral 27. This reduced diameter portion 27 is closely receivable within t~le lower, or second, end 12b of llouslng 12.
By careEully dimensioning the componellt parts, a tlght press flt ~eal can be ~chleved between thQ houslng 12 and the freezing tip 26. Di~po~ed internalty of the ~unction of housing 12 and tip 26 is a freezing tip lnsert 29 whicll ~55i8t~ in the alignment ~nd interconnection vf the part6.
~ e~erxlng again to ~lgure 1, the upper end 12a of housing 12 i~ threaded 60 that the ~upply as~embly 20 call be threadably interconnected thereto by ~eans of an lnternally threaded ~onnector ring 3a. ~llgnment pin6 4~ ~r~ provided to 2 ~
en~ure proper l1~dexlng o tlle ~upply l)ead to tl)e l~ou~ g 12.
Formlllg ~otl~er importallt aspect oE tlle probe of tl~e pre~ent illVent1011 i9 i~eater mean~ or controllably l~eatll~g ~elected portions oE ti~e ~reezlllg tlp. In tl~e pre~ent embodlmel~t o~ tl~e lnventlon tlll~ henter mean~ l~ provlded ln tl~e form of a l~e~ter element ~2 (Flgure 1) wl~lcll ~ dl~posed wltl~ln ~n lnterllal eil~mber 4~ provl~ed ~ll llou~lng 12 and deflned by tl~e outer wall Or tl~e l~ouslng al~d an in~ler col~centrlc ~klrt portleil 29a whlcll extends upwardly from freezl~g tlp lnsert 29. Ileater elemellt ~2 19 coll sll~ped and may be construc~ed o a nlckel alloy or otller ~uitable electrlcally reslstlve material. Preferably a tl)lll fllm lllsul~tlon materlal 43 is placed around tlle heater element 42.
Prov~de~ at tlle u~per end o tlle ~upply head 2~ n electrlcal COIll~eCtOr assembly ~a to wl~lcl) one end of~n electrlcal conductor 5~ ls conllected. ~`lle opposlte end of con~uctor 5~ i9 terconllected wltl) a female conllector 52 wlllcl~, ln turn, 15 conllected to a male con~lector 56. Male connector 56 ls electrlcally llltercollnected wltll heater element 4Z by means o~ an electrlcal ~onductor 57 wllicl) extends dow~wardly tl)rougll llouslllg 1~ .
Ileater element 42 ls ~trateglcally po~ltloned wltl~ln l)ouslllg 12 ~nd accompll~l)ea ~everal impor~tlt functlotl~. F~rst, ln a manller pre~e~tly to be descrlbed, It, along wltll tlle 1uld flow control meatls o tl)e lnventlon, permit~ preclse control of tl~e temperature of tl~e probe. 6econd, lt supplles energy to prevent ul~deslrable rreezillg oF tlssue to tl~e houslt~g. q~îlir~, on demand, lt ~upplie6 energy to tlle freszllly tlp to ree tlle tlp from tl~aue wlllcl~ llas been ~rozen durl!~g treatment. ~t tl~e same time, lleat ~upplled by tlle heater 21emellt ~unctlon~ to ~auterlze bloo~ ve~sels in tlle proxlmlty o tlle llou~lng. Flnal1y, the lleatlllg element ~upplies energy to the exl)auat ~a~ ~lowlng througl) tlle l~ouslng to w~rm tile eupply head Por eurgeon ~om~ort.

2 ~

element 42, a temperature sen~or 60, i~ provided wlthln houslng 12 at a ~elected ~trategic location dependlng upon the nature ~f tl~e surgery to be performed. Tl~e ~ensor i~ allown l~ere as being located proximate the lower extremity of the heating coil 42. ~
indicated in ~igure 1, the sensor lead wires 62 ~re entralned tl~rougll tl~e l~ouslllg 12 and 6upply llead 2~ and exlt the unlt tllrougl~ tlle electrlcal connector assembly 48. Tlle 6ensor 60 and the heatlng coil 42 are operably a~sociated with a heater control means for preclsely controllltlg tl)e operat~on of tl~e ~eater means. The detail~ of tlle constructlon, installation and operation of tile lleater element, tlle temperature sensor and the heater control means is well known to those ~killed ~n the art.
Tl~e heater control means of the lnventl~ll forms a part ~f the broader control means of the Inventlon whicl~ also includes a fluld flow control means for controlllng the flow of liquld nltrogen to tl~e probe. In a manl-er preselltly to be described, tlle control means functlolls to praclsely control tlle heating and cooling of the freez4ng tlp of the cryoprobe. Tlle control mean~
al~o includes a microprocessor means into whlch predetermined temperature control reglmen programs can be lnputted ~o that each probe being used durlng a partlcular surgery can be ~ndependently colltrolled in a prescribed manner. The mlcroproce~sor means can ~ake several forms, but a commerclally avallable computer 5uch a~
that manufactured ~nd 601d by Eneryl~ne Corporatloll under the name and style MULTIT~SKING ha~ proven ~atlsfactory for the present application. In addltion to controlling the heater means and tlle fluld ~low control means, tt~e control means of the 4nventlon is capable of recordlng all relevant data chosen lnteractlvely by the user, for example, temper~tures, duratlons, alarms and tlle like. Tlle monitored data can be stored In the computer for later reference or can be outputted to a printer wl~lcll i~ Interconnected wlth the computer.
3 ~3 ~k 'lurrlll)g now to tl~ure 5, tl)e contr~l meal~ o tlle ll-ve~lti~n b~s1cally runctlon~ to permlt tlle ~urgeon t~ input a predetermltled, de~ired co~ g curve, or reglme~l, or a partlcular surgery. ~IIls Eeature call be lmplemellted by ~1vldlng tlle freezll~g pr~cess into several coollng ~eg~ent~. Eac)) co~ g segmellt is gpecl~led by ltr3 lnitial temper~t~re I r)~ lts end1ng temperature ( c)~ ltg cool~ng rate ~ C/Sec ~r C/Mln) alld tlle way in wlllcl~ tlle co~ g proceed~ once tl)e endlng temperature l~
acllleved. For example, ~ llldlcated ln Flgure 5, segment No.
ls speclt~e~ by tlle ~ollowlllg parameters: Start Temp - -3~ C, En~illg Temp = -75 C, Coollng nate = 9 de~reeD/~1nute, '~rallsltlon = Mallual. ~g lllu~trated 1ll Flgure 5, if a mallual trallsitlon ls ~elected, the sy13tem co~trol~ tl~e probe until lt reaclles tl)e endlng temperature ~nd lt would malntall) tlle tempera-ture constatlt unt11 ~I-e ~ser 1ssueg ~ ~ommand to proceed wltll the rreezlng proces6. ~utomatlc trallr3lt10n slmply indlcates proceed-lng autom~tlca1ly to tlle next re~ment once tlle temperature reaclles tlle end1ng temper~ture. 8egmel1ts 3 and 5 Rre term~nated wltll an automatic tr~nsltlon. In a tnanller well knDwll to t1lo6e ~kllled ln tlle art, several d1fferent control mode~ can be lmple-mented by tlle computar ll7clud1llg aut~matlc ~ree~1ny, manual free~1llg ~nd automatlc tllawing. Tlle dea1gtl Gf the contrul me~n~
i13 ~3UCIl tllat tlla ~urgeon can ~elect t11e des1red operatlng mode by a ~lngle key pres6. Whell multlple probes are used ln a partl-cular 6urgery, eacl~ o tlle ~ryo~urglcal probes ~per~tes lndepell-dently from tlle re6t allowlng lt to be operated in ~ny des~red operatl~lg mode and temperature reglmell.
~urlllg tl~e automatlc ~reezillg procesa, tlle control ~ystem contllluou~ly controle tlle probe temperature ln order to ~ccurately follow tlle p~rtlcular coollllg cUrve ~elected by tl~e user. In tl~l~ mode o~ operati~7, tl~e probe tempetature ~etpo~lt ~s contllluously updated ~ccordlng to tl~e preselected coolltlg 2 ~
curve. More particularly, the probe temperature ie controlled to the deslred temperat~lre 6etp~int by implementlng a P-I algorlthm tPro~ort~nal & Iotegral actl~~
~ ~cllematic of tlle control ~:ystem of one embodlmellt of the invention i~ deplcted in Flgure 6. In Pigure 6, tlle elem~nt labeled T/C represents the ~ensor, or T-Type thermocouple 60 ~llicl) is carried witl~in llousillg 12 of the probe. The tllermo-couple ~gnal from sensor 60 i6 ampllfled and condlt~oned by an accurate, optlcally isolated, tllermocouple transmlLtter T. ~\t tllis poillt tl~e siqnal ls tran6mltted to the computer, qenerally designated as Comp., and ls converted into dlg' tal ~orm by the computer ~ t~nalog to Digital Con~rerter A/D. Next, tlle digltal temperature readillg is 6ampled at specified tlme lntervals ~for example, every 5 ~econds) by tlle Sample llold algorit}lm in the computer designated ln Flgure 6 as Sll. I\t every 6ampling interval tlle temperature is compared wlth tlle 6etpolnt SP by a c~omparator C. Tlle result vf the comparlson 1~ used to compute the P-I algorlthm PI Eor the next change ln duty cycle to cooling control valve 70 ~see als~ Figure 4). In the manner earllsr de~crlbed, the freezing c~ntrol valve modulates tlle ~low of 1~ quid nitrogen into tlle cryosurglcal probe . Nc~te tllat the re6ults c~f tl~e P-I algoritl)m i6 ill the form oE pulse widtll modulatlon (shown schematlcally in Flgure 6 and identlfied as PWM) where the contrc~lled variable i~3 tl~e time durlng which liquid nitrogen i6 allowed to flow lnto the probe.
~ t the E ame time the fl~w ~f llquid nitrogen ~o the probe iB being contr~lled by the control means, the control means i8 aleo controlling the heatlllg elemellt 42 whlcll 18 hc>used witll~n the probe . More partlcularly the heater element ~ 5 approprlately regulated to maintaln ~onstant temperature ln the upper cylindrlcal part o~ the ~ryosurg~cal probe. The heater element i~ also ~ontrolled u~ing P-I actloll witll the only difference being that tlle contro~led variable ~g the heater ON/OFF tlme.

~ t any polnt during the automated freezlng process the surgeon can overrlde the prepreg~am~ed ~urve and 1mplement an alternative freezing strategy. In the manual freez~ng mode the control ~yste~ contlnues to lmplement P-I temperatur~ contr~l exc~pt that the des~red ~etpo~nt l~ 6et by th~ ~urgeon using an adjustable rotary knob.
~ utomatic thaw~ng i5 accompl~shed 1n a slmllar manner as automat~c freezing and the temperature ls controlled to a preselected thawing curve. Wl~en it 19 deslred to maintaln a particular temperature, the control ~ean~ ~lll, on command, memorlze the selected temperature ~nd wil~ control the probe to maintain tllls temperature.
The actual construction and programmlng of the computer control system described ln the precedlng paragraphs ~s well understood by those skilled in the art. ~ll of the components necessary to implement tl1e ~ystem, as ~hown in Figure 6, are readlly commercially avallable and their inter~onnection to cooperate in the manner descrlbed herein i~ well under6tood.

OperAtion 8efore commenclng the cryosurgery, tl1e ~urgeon wlll typically study tl1e location, depth and conflguratlon of tl1e diseased tissue uslng ultra sound tech11lques. Based upon tl1is tudy, one ~r more appropr~ately conf~gured cryoprobes will be ~hosen. A temperature curve, or regimen, wlll then be selected, or developed, for each probe and will be lnputted into t31e computer. ~lternatlvely~ the 6urgeon may elect to control temperatures manually in tl1e manner previously described. In either case, the control means, t11roug11 ~ooperative interaction between the fluid flow control means and the heater control mean~, will precisely regulate the temperature of the probes belng used, 60 as to freeze the undeslrable tls6ue ln the most effl~ient manner po~slble.

. ~ 2 ~

~ efer~ g to ~gure ~ tl~e baslc oper~tloll of tll2 a~paratuq of t1~e embodlment Or tlle inventiol) 61~0w~ ln tlle dr~wl~gs 1~ n~ lollow~: wltl~ tl~e oo~trol ~trDtegy ~pproprlately lllputted to tl~e com~uter 11l tl~e tnanller de~cr5bed ln tl~e preced~ng paragra~1~s tl~e fluld flow cc~ntrol mean~ w111 cau~e liquld nltr~gell nt a temperature Or approximately mlnu~ 325 degree~ F.
aod at a predetermllled pre6sure of about 35 p.~. ~ ., to flow lnto a coadult 66 rom a dewar 6~ col~talning tlle llqald nitrogerl.
Coatlul t 66 i~ collllected witl~ a solenold valve 70 wl~lcl~ 11l turl~
lg conaected to E:U~I 1y tube 1~1. solel~o~d valve 7~ f~rms a part of tl~e prevlously ldentilled flu1d flow control mean~. Wl~en valve 7~ open tlle llquld ~lt~ogen flow~ tl~r~uyll t~e ~u~ply tube tl~rougl~ tl~e 1nlet pa~sageway 16 and tllence lnto tl~e F:uE-ply passageway 28 of tl~e tlp 26. ~ tlle llquld nltrogen flowa from passageway 2n lllto tl~e expanslon ollamber 30, lt wlll boll al~d extract l~eat rl~m botll tl~e tlp and all tlle tlssue ~n c~ tact wltll tlle tlp. Next, tl~e n~trogell ~ WE~ back tllrougll tl~e ll~strumel~t vla exllaust pa~6ageway~ 32 al~d 1~ alld t~en outwardly frotn tl~e U~1~ t tllrouq11 outlet 24 . E reerably outlet 24 ~ terc~nllected wltl~ a llquld tlltroge~ evaporator 72 wl~lcll ~ncl-ldes a l~eater 74 a~d ia~ 76 to evaporate tl~e rema1n1t-g tl~e llquld Illtroge~.
Wl~en valve 70 1~ ~pen a portlon of the llqu~d n~trogen can al~o 1ow tl~rougl~ a bypa~a co~ldult 73. ~ ~olenold vslve ~0, wl~lcll al~o forms a part of tlle fluld flow ~ontrol me~lls, 1~
provlded 1~ co~du1t 73 to cvl~trol tl~e flow o~ llquld nltrogen tl~rougl~ co~ldult 73. 1~ ormal operat1on, valve ~ c1osed and tt~e flow to tl~e probe ~ xegulated by ~olenold valve 7~.
llowever, duril~g inltial c~ol down, wl~ere xapid cooling 1~
deslred, botll valve 7~ ~nd ~U are ope~ prevlou~ly mentione~, ln many prlor art devlce~ the llquld nltrogen u~ed as tlle ~oolll~g me-llum become~ entralned 11~ tlle re6u1tltlg gaa ~low nnd exltE~ e lnstrument tl~rougîl tlle exllaust tube wltl~out maxlmlzation o lts cool~ng potential. In the appar~tus ol the present inventlon, these cooling potential los6es are mlnimlzed by pass~ng tlle llqu~d n~trogen tilrc~ugh the matr~x ~ )~lgh thermal c~nductlvity ~pl~eres 34 and along the clrcultous path de~lgnated by tl-e arrows 35 in Figure 3. The matrix increases the heat transfer ~rea and tlle clrcultous path defined by the matri~
breaks up tl)e gas/liquid flow to produce maxlmum gassiflcation and concomitant coollng.
Upon completion of tl~e surgery, the control means stops the flow of liquld nitrogen to the probe and approprlately controls the l~eating coll to permit the expeditious removal of tl~e cryotip from tlle ~roximity of the tl6sue.
It is to be noted that only one probe ls shown in ~lgure 4. ln pract~ce ~everal probes can be lnterconnected wlth the source of 1iquid nitrogetl and precisely controlled by tl)e control means in the manner previously descrlbed hereln. The several probes used can be of varled configuration to meet tlle needs of the particular surgery.
~ s previously discussed, when it i6 de~ired to vary the configuration or temperature characteristics of a partlcular probel the hou6ing and tip assembly can qulckly and ea~ily be removed from the æupply head and replaced wltl~ an assembly of ~
dlfferent, more convenient con~iguratlon. For example, an assembly can be ~elected wherein the spherlcal members are of a different material end, if desired, of a di~ferent alze and con-figuratlon. More particularly, lnstead of ~slng a high thermal conductivlty material 6uch a~ silver for the ~pheres 34, lower thermal conductivlty materlal 8UCIl as 6tainles~ ~teel mlght be advantageou~ for certain types of treatment. In practice, the doctor can take lnto th~ operating room an ~seortment of t~p and housing assemblles of various external ~l~ap~ ~nd lnternal con-f~guratlons havlng dlferlng characteri~tlcs 60 that the ~ptimum assemDly can be quickly ~elected and used.

Ilaving now descr~bed tlle inventlon ln detail ln accordance with tlle requiremsnts of tlle patent ~tatutes, tll~e skilled in tllis art wlll have no ~lfficulty in making cilanges and modificatlons ln tl~e ~ndiv~dual part6 or their relative assembly in order to meet ~pecific requ~rement6 or ccndltlons.
Sucll cllanges and modificatlolls may be made wltl~out de~artlng from the scope and ~pirit of tl~e invention, as ~et forth in the ~ollowing claims.

Claims (8)

1. An apparatus for cryosurgery comprising:
a. a source of low temperature cooling fluid, b. at least one cryosurgical probe having:
(1) a housing having first and second ends and fluid inlet and outlet passageways extending therethrough, said fluid inlet passageway being in communication with said source of low temperature cooling fluid.
(2) a freezing tip closed at one end to define an expansion chamber and being removably connected at its opposite end to said housing, said freezing tip having:
(a) a supply passageway having an open end disposed proximate said expansion chamber of said freezing tip and being in communication at its opposite end with said fluid inlet passageway of said housing: and (b) an exhaust passageway in communication with said expansion chamber and with said outlet passageway of said housing; and (3) heater means for controllably heating selected portions of said freezing tip and said housing: and (4) sensor means for sensing the temperature of selected portions of said freezing tip and said housing;

c. control means for precisely controlllng the heating and cooling of said cryosurglcal probe in accordance with a desired temperature regimen, said control means includlng:

(1) fluid flow control means operably associated with said cryosurgical probe for controlling the flow of fluid from said source of low temperature cooling fluid to said cryosurgical probe; and (2) heater control means operably associated w~th ~aid sensor ~ean~ and ~ald l~eater means for controll~ng sa~d i~eater means, said l~eater means operatlng in cooperation witl~ ~aid fluid flow control means to control the rate and degree of cool-ing of sald cryosur9lcal probe.
2. ~n apparatus as defined in Claim 1 ln whlch sa~d l~eater means comprlses an electrlcally energized heating element carried witllln sald housing.
3. An apparatus as defilled in claim 1 in wllich said control means ~s adapted to control the heating and cooling of said cryosurgical probeln accurdance witll a predetermined tempera ture regimen.
4. An apparatus as defined in Claim 3 in which said control means further includes microprocessor means operably associated with said sensor means, said fluid flow control means and said heater control means for receiving a plurality of temperature regimen programs and, on command, selectively controlling said fluid flow control means and said heater control means to heat and cool said cryosurgical probe in accordance with a selected, predetermined temperature regimen.
5. An apparatus as defined in Claim 4 further including means disposed within said expansion chamber for interaction with cooling fluids flowing therethrough for enhancing heat transfer in a manner to uniformly cool said freezing tip and to minimize cooling potential losses.
6. An apparatus as defined in Claim 5 in which said means disposed within said expansion chamber comprises. a multiplicity of discrete members disposed in a spaced apart relationship within said expansion chamber for increasing the heat transfer area along the path of flow of the cooling fluid.
7. An apparatus for cryosurgery comprising-a. a source of liquid nitrogen:
b. at least one cryosurgical probe having:
(1) a housing having first and second ends and fluid inlet and outlet passageways extending therethrough, said fluid inlet passageway being in communication with said source of liquid nitrogen;

(2) a freezing tip closed at one end to define an expansion chamber and being removably connected at its opposite end to said housing, said freezing tip having:
(a) a supply passageway having an open end disposed proximate said expansion chamber of said freezing tip and being in communication at its opposite end with said fluid inlet passageway of said housing;
(b) an exhaust passageway in communication with said expansion chamber and with said outlet passageway of said housing; and (c) a plurality of discrete spheres disposed within said expansion chamber for interaction with cooling fluids flowing therethrough for enhancing heat transfer in a manner to uniformly cool said freezing tip;
(3) heater means for controllably heating selected portions of said freezing tip and said housing; and (4) sensor means for sensing the temperature of selected portions of said freezing tip and said housing;
c. control means for precisely controlling the heating and cooling of said cryosurgical probe in accordance with a predetermined temperature regimen, said control means including:

(1) fluid flow control means operably associated with said cryosurgical probe for controlling the flow of fluid from said source of low temperature cooling fluid to said cryosurgical probe; and (2) heater control means operably associated with said sensor means and said heater means for controlling said heater means.
(3) microprocessor means operably associated with said sensor means and with said fluid flow control means and said heater control means for receiving a plurality of temperature regimen programs for controlling said fluid flow control means and said heater control means to heat and cool said cryosurgical probe in accordance with a selected temperature regimen.
8. An apparatus as defined in Claim 7 in which said fluid flow control means comprises a first conduit connecting said source of liquid nitrogen with said cryosurgical probe, a second bypass conduit connected to said first conduit and first and second valves for controlling the flow of liquid nitrogen through said first and second conduits.
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