CA2153993A1 - Method and apparatus for locating tumors - Google Patents
Method and apparatus for locating tumorsInfo
- Publication number
- CA2153993A1 CA2153993A1 CA002153993A CA2153993A CA2153993A1 CA 2153993 A1 CA2153993 A1 CA 2153993A1 CA 002153993 A CA002153993 A CA 002153993A CA 2153993 A CA2153993 A CA 2153993A CA 2153993 A1 CA2153993 A1 CA 2153993A1
- Authority
- CA
- Canada
- Prior art keywords
- sensor
- tissue
- tube
- tissue mass
- parameter
- 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
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
- A61B2090/3904—Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
Abstract
A lesion can be accurately located, its size and its biological potential estimated prior to surgery by measuring the interstitial fluid pressure of the lesion. A pressure-sensing biopsy needle, which is an inner pressure-sensing needle (2) within an outer needle (1), rapidly measures the interstitial fluid pressure of tissue and allows the operator to determine the location and estimate the size of a lesion. The interstitial fluid pressure of the lesion can be correlated with the biological potential and is used to determine whether surgical removal of the lesion is warranted. When surgical removal of the lesion is desired the inner pressure-sensing needle (2) is removed leaving the outer needle in situ, and a hookwire (15) is inserted into the tissue through the accurately placed outer needle (1) thus transfixing the lesion.
Description
2 1 5 3 9 9 3 Pcr/US931QO384 MEl~IOD AND APPARATUS FOR LOCATING ~ND DIAGNOSING
TUMORS PRIOR TO NEEDLE BIOPSY
Background of the Invention This invention was made in the course of work ~u~ cd in part by the United States GoY ~ , and the Go~.-..n.~ has certain righ~c in the invention.
This invention reIates to the locali7~tiQn and ~i~g~ Cic of lesions in uivo.
"I esion" as used herein is a pathologic change in tissue, such as for ~ .le a tumor. Tpsion.c that are too small to be found by p~1r~tion are ccollYe.n;~m~1~y10 located using im~gi~, ~ PS and surgically removed. For eY~n~r1e, breast lesions can be de~c~ d by 1~ Illllo~;l~ as much as four years earlier than by physical e~"~ inn However, a --An --G~ is unable to ~ J;~11 a benign.
from a m~ligr~nt lesion, and ~ Cl;O.. of a lesion by ~ n~ ography must be followed by biopsy. Rec~1~se a ~ logl~ has a ~silive pl~icli~c value of 20-15 30%, a large ~o~ollion of breast biopsies following ~ ~ld~ prove to befor nnnm~ nt lesions. A r tluel;~ in the m1mlxr of breast bic,p~ies pe,folllled for benign disease would be c~ ~cly i~.~ and b~ ;ci~l.
InCO.~ d scl~ g for breast ~ic~c~ a m~mmogram of the breast is made, and the resllltir~ image is ;..~l~c~1 for 20 I~ s;onc. If a srnall lesion appears, a radiopaque needle is inserted into the breast in a region as near as can be esl;~ d to the lesion. Then the region is im~ge~ withthe needle in place, the les~ image is ;~ e~-~ccl and the needle is re1~ e~t~d as lu'C~ to place it within the lesion. Once the needle ap~al~ to be po,c;tinntod within the lesion, the :iUl~On follows the needle to the lesion and removes the 25 lesion and SU11~ (1;~ tissue, and the pathological status of the lesion can be -";-~ Reç~11ce the im~gis~ yruCc~lul~_ p.o~ides only an e~ of t~e p~O~ ily of the biopsy needle to the lesion, it may often be .~cec~.y~ in ~e illLe,.,~l of l~mGVilly, all the lesion, to remove a s~ s~ u~li~y of nQrmal p tissue as well.
The ~o~;l;Q~ of a biopsy needle in soft tissue as a marker fo~ lesions has been found to be unreliable, bc~ ~ the biopsy needle can move dunng ~he ~rup~tion of the patient for su~ . Kopan,s et al. (1980, 12n<liolQgy Vol. 134, p. 781~ s~ihe i~e~ a hooKvire into the lesion via the lumen of the hollQw --~IVO 93/14694 PCr/US93/00384 needle used during the ;~ oce~lu~c to loc-q-Ti7P the lesion. A~ter the hookwire is in place the needle is willld~&w~l, leaving the hookwire in a pQ~itinn c~l;ll.~tr~ to be closest to the lesion. This needle-hookwire ~.oacll has beei used cp~r~tly to provide a more secure marker for breast ~ y~. ~ (Meyer et al., -5 1982, Arch. Surg., Vol. 117, pp. 65-68). However, once the hookwire is ;IIIp~ lrd in the tissue, it cannot be removed wi~uul tissue ~qma~ except by ~g~
Since the d~ of needle-hookwire -q~ nhly by Kl~pqn~ et al. 7 other breast biopsy needles have been d~ ~d. For ~Y ~ l,k biopsy n~prlT~s have 10 been de~i~n~ wi~ retrqrt-qbl~ barbs to . nchor the biopsy needle in tissue, and to fVqrilinqt~ the removal of ~he needle in case of j"ro. .~cl pos-l;o...~, or in case it is ~ irqhl~ to remove the l~nc~qli7~qtit~n needle during ~I.U'~ L,~ wil}louL ~e~r~i~ ;I*
surgical removal of excess tissue (U.S. Patent Nos. 4,986,279; 4,799,49~). In each of these biopsy needle ~ 7~tion s~t~ ~s, the ~ of the biopsy needle 1~ to a lesion is c~ 1 by ;.-~g;.~ tr~h....l~,es.
The t;rr~ivc~ss of ll~a~ieS C~ r used for the 1- ~1--~-l1 of I~P~;C?n~ as for eY~mrlP solid ~ rs, is limited by the cdpaciLy of the !1- ".~ l;r to reach the target in vivo in a~l~qll~t~ s. In a~imal studies, solid tumors have been shown to contain a greater volume of ;. l~ l fluid--that is, of fluid in the 20 eY~rPllnl~r and t:~Lrav~sl.;ulàl space, than normaI tissues cont~in, ~"gg~;,l;.,~ that tumors should be readily ;-~ t~bk by !1-- ,~ nl~- ~1PS. However, 3itinn~t animal studies have d~ n~c~ d that ~he ;..tt;~ 1 fluid ~ Ul~
("E:Pn) is higher in tumors ~an in normal tissues, re~ti~ in poor ~ ,r~.c;n~ of tumors by Ih- ~l~JI-r ~ D~ 1PS and a radially uuLwa~3 co,~ve.;~l of ;.~t. .~
25 fluid from ~mors (r~ w~d in Jain. 1987, Cancer Res., Vol. 47, pp. 3039-3051).An ~;....;,~,~linn of the ~ u~as~;~ar ~wulL~ of rat --~------~- ~
~1e~ Ç~ II.A tumors was C0~U1~J~ to aid i~...U~ "~",l~ ~e tt;~ l;n~ of blood flow and itS ;~n~ rC on ~he r~ and uptake of n~ Ya~1L mn1Pr ~S In .~l.f ..,,.!l " -l,~, i,,,,,---- ..!h. ,~ , or ~ I;o~ Ir. ~ eSS et al., 1991, C~ncer 30 Res., Vol. 51, 265-273). The results of ~his s~dy ;..~ t~d that ~e l~;rl~ n ~eom~try and lic~wul~ ~L u~ule in tumor v~c~lt~ r~ may be one ...~-~h,...;~...
WOi93/14694 ~ 2153993 PCr/US93/oO~
rP,sp. n~ihle for the il~lcasr~ r.,~ ..re to blood flow l~pol~ed in tumors (Sevick er al., 1989, Cancer Res., Vol. 49, pp. 3506 3512).
The elc~dt~d IFP of tumors was first ~ 1 by Young et al. (1950j Jour.
Pathol. Bacteriol., Vol. 62, pp. 313-333) after taking utissue pl~s;,u,e~ -S lneasu.c~e~l~ in rabbits. Each of three mPth~ for m~c~ n~ local i~ "~
ple~ e, known as ~e needle mPthod, wick-in-needle m~thf)d, and ~i~i~;pel m.oth~:1, has advantages and 1;...;~ c. In the needle mpth~ a needle filled withphysio~gjr~l saline and c~,uyled to a p~ n~ device is ins~te~ into -tissue. In the wick-in-needle mPthotl~ fibers of polyester or other mllltifilA...- ..lou~
10 m~teri~1 are placed within the lumen of the needle in order to provide a large surface area c~ with the i~ i~ and redllce oc~ sion Both of these mPth--tls can cause tissue distortion. In the ~icr~i~ 1.od a micropipet c~ .~..r~ d to a ærvo-null pl~ s~u~e~ J- ~ system is used, l.luc ;.~ some ~s pleæ,_ ~t~,d in the needle and wick-in-needle --- l~.~s, but the JlliClU~
15 are ~sce~1~hle to breakage.
The IFP of s~l~Lv~ lr~ c tumors wæ n~eas~cd in rats using miclupi~.ls (~o~her et al., l9gO, ~ancer Res., Vol. 50, 4478~484). This study describes a steep IFP gladie.~L that begins at the surface of the tumor, or the sk~T~/tumor ;. l~ r~e, and quickly l~aches a plateau value in the tumor mass within 0.2-1. 1 mln 20 of the tumor surface. These results co~-r. .--~ an earlier .~ A1 model of ;~t ,~t;l;~1 fluid ~ L in tumors (Jain et al., 1988, Cancer Res., Vol 48, pp.
7022-7032) ~vhich pl~os~ that very little filt~tinn of lu~cn nlecules into tllmor$
occurs even from blood vessels which pass ~o~l~ the tllmor, and that the CO~ Ye uuLwal`l flow of the ;-~t~ t fluid pushes solutés toward the . 25 periphery. These co~ ;ol.~ are also ~up~ulL~d by vork from DvQrak et al.
(1988, Am. Jour. Palhol., Vol. 133, pp. 95-105) who d~ at s all mol~ oæ can readily ~ 1mors, and large ~uL~ olp~ es are lîInited to the tissue-nlmor ;-~1~ r~rc. The inabili~r of 1~ Jl;~` drugs to reach th~ center of tuunors has grave i~plir~ti~n.c for ca~cer li~ ies, and based upon these- resuIts 30 Rol~rh~r et al. (l990) ~r~po~s m~thrJ~ls by which drug delivery to tumors could be h~ ed ~, 2153993 93114694 Pcr/uss3/oo384 T~e wick-in-needle t~ uc was developed by Fadnes et al. (1977, ,~
Microvasc. Res., Vol 14, pp. 27-36). Fad~es et a~ 5 a thin h~ . .n;r needle open at the end and having a side-hole, its lu~nen filled with mlllh~lz.-,~-lt~ s nylon thread and CQ~ d by polyethylene tubing to a ~ "'G
5 ~ n~J~ . Padnes et al. ~es~ s using this ~ e-3e~ needle to cQInrare ~e subcv~ P m ~ rats under normal a~LI d~L~d c~n~ih~ n~.
The ;nt.. ~ l fluid p~t~ of human .~fl .. ~c and uterine cervix c-~ s was mf ~ A using the wick-in-needle k~ in studies that ~ "~l Al~ for ~he first time in h-----_nc that IFP is higher i~ tumors than ~ normal tissue.
10 Rol--~ht~- et al. (1991), Cancer Res., Vol. 51, pp. 6691~694, (l_.no.~l._t~ that ~he IFPs of large human mf~ c far exceed the values c~l~ectr~ from ~
of rodeDt tumors or human ~e~ogrdrl~. Roh et al. (1991), Gancer Res., Vol. 51, pp. 669~-6698, ~e ~ t~d that a lu~,~g of the IFP m some cervical ~mors duri~g r.,.~ t~ ~ ~c~ CQ~ A~ s well with ~1- ~r~ , o"l~-u~
15 Bo~ U~1'F ~ et al. and Roh ct al. co~ dc that ~ P of tumorC will ~e valuable for ~ ;n~ future cancer ~herapies and ~Ic~ -n ~ "
l~.P. Wang, U.S. Pat. No. 4,799,494, Ae~- ;1~ a needle ~5~s~ ~bIy for collPctinn of lung tissue. T~e needle ~CsPrnbly ~ s a bluD~ hollow outer needle having a side-hole for tissue cQllPctinn, and a non-removable inner hollow needle 20 51~11ht`h&fl to a sûlid wire, slid~ly ~ A wifflin and snugly fit~g ~he lumen of ~he outer needle, uæd for ~ the tissue. The lumen of the outer needle is u~ ~,d to a crude b~lloQn 1 ~re sensor. The '494 paten~ states that ~he n~ 7~tit)n of the needIe tip in the lung lesion to be sampled results in a p~ e d~ letect~blf~ at the b~lloQn Summary of the l~ention We have dis~;o~_~ed that a lesion can be ~ located within a tissue mass by .. P~ , at several poi~s in a path l11L~U~I~ the tissue mass, a s~l~r-t~l hat is knowD to l~.tA -e l-rr~ in lesions (or at least in some types of lesions) and in normal tissues; a~d we have d~_lo~ .,.t~., for ca.~j~
30 out such ... ~---...,..~1~, p~ of i--t ~ fluidl'~ Y
Using the mPth~, the lor~;n.- and, at least to some exte~t the size and the q- l,o~ of a lesion can be ~t~ d a~ ly and wil~vu~ a ~ .P .l for ~ WO 93/14694 21 S 3 9 9 3 PCr/US93/0~384 -- S --d reim~i~ of the tissue mass. Mo~cov. l, some s~ led ~ t~ can, ~pf.~(1in~ upon the extent of d~,~Lion of their ~e from nnr~m~1, p~ovide il,rol...A~ir~n ,~ J.iQg the p~thr,logirA1 co~-lil;o.~ of the lesion; for eYAn-r1e, some ~a. -~ deviate more from normal in mA1ign~nt tumors than in benign lesions.
5 In one aspect, the i~ ion f~,at~ s a mPth~ for loc~ a lesion within a tissue mass, inrl~ .nP~...;ng a ~A- f~l~el~r at a plurali~ of points in at least one path l~u~ll the tissue mass, the ~eas~ of the p~.n.~- in lesions being dirr~d from the ~ea~, in normal tissue.
In ~.~fe,.~d e'mhOA;I-If.~1-i, the ~ t~ - is ;--t ~I;I;A1 fluU ~ Ul~., and 10 more than one p~ r may be ~ea~uled at one or more of the points; the m~thod may fur~er include a step of i.lsc.~ a tissue marker, such -as a hookwire, into the lesion along a portion of the path, to mark the le$ion for s~s. ~lu~ removal.
Typically, the method of the invention _ay be used to ark the loc~ti~n of, 15 and if desired to gain ad~l;lionAl i--r.,...,~l;Q.. as to the ~.~ .. of, a lesion located by :-..~,;-~ or by ~I~-I;o~ -In &lull~e~ general aspect, the invention Ç~ alules ~ ..c for ~I~f~ atissue ~i A.~t~ ~ at a ~ 'f r of points along at least o~e path through. the tissue mass, in~ in~ an insertion tube, sh~.cd at a distal end an~ made s~lmriently 20 rigid so that it can be inserted distal end fol~o~ into the dssue mass along the pa~h, ands i~.lil,lc ~vith the ~;c~ion tube, a sensor car~bla of ~ vidi~E; a 7svle of the tissue ~ t~ at a point in the tissue mass along the pa~h.
~ c~ to thc iu~-~dion, dW~..~ for lo~ a lesion in a tissue mass ;~-rh~des such ~ 5 for ~f'~ a setecte~ tissue ~æ~ at a l;lulllber of 25 points along one or more paths thluu~ the tissue mass; at any point in the tissue mass a measure by the sensor of the sel~ct~d p~ .e,t. ~ that is (~ hIy dirfe.~ from that in normal tissue i...lir~-s that the point is within a lesion.In ~.~f~ ho~ f~ s the tissue ~ is ;~t. ~ fluid ~ ;iUle and the sensor ;~ es a ~~ , sensor. The wall of the i~.~ion tube in~ es 30 a port near its distal end, and the sensor inrl.ll~les a sensor tube, c~
fil~ , slidably en~ f ~bl~ wi~in the lumen of the insertion tu~e; the sensor tube is distally closed and has a port near its distal end, and the ports are.
~o 93/14694 21 5 3 9 9 3 Pcr/US93/0~384 pocitiif)n~A so that when ~he sensor tube is e~e~ within the il.3.,,Li~n tube lumen the ports can be ~ "1;ally aligned to ~u~idc fluid CQ~ between the lumen of ~he sensor tube and t~e dssue ~ljac - ~1 the ports; a~ the sensor tu~e lumen is oyr~ ally cQn~ kA to a ~ -.-f n1 device such that it is ~e~o~ive ~o fluid yl~s~J~ wi~in ~he sensor tube lumen.
The ayQaLdLus of ~e J~ ~io~ makes use of a thin-walled ~Ine-gauge distally A needle for the inc~r.l;.~n tube, so that by use of the ~ ..c ~e mP.thr)d of the ~Yt:nLion can be carried out iL~uu~ a~ The ~L~.J~ ;u~
ap~LLalù~ C~ tothei~.lLiO"canbeusedto n~.-v~t~ the IO ;--t ~I;I;A1 ~,S~u~'~, wi~hin a lesion in ap~,o~ ly 10 """,it~ ,' time. The invention~io~ csfor ~ hlf~n~FJ~ F~P~ of;~Yt~ ;l;Atfluidl"~v~inany vanety of types of lesioDs in ally of a vanety of tissues with a .~.;ni~ n~ of n~rolL to the patient.
The iu~io~ can provide for c~ the ~ I;nn size and biological lS pO!~ of a lesion by ul~r --- ;Q~ the ;--t -`I;I;A1 fluid p~ , by passing thetube, with the ~ t~ ~ ænsing device, into tissue t~at has been shown by pAlrAtinn or imSI~ techniq~les to coD~ain a lesion (such as a tumor), in a path ~hat is e~ At~ t1 to pass l1LCVU~ the lesion, and ~ the pl.,S~ , at m points along the path. "Biological polF-~ t" as used herei~ ~n-~n...p~
20 pathological ~pes of lPCit~n~ inrl~ i~ benigll lesions.
'rhe higher ~P of a lesion allows the op~ o" mAh'~ several ~e&~
along the pa~h, to ~l~t~ f, when the ;.~ needle has bo~ entered and ex~ted the lesion. The IFP of a lesion can ad~ Ally be i~ of its biological In mAli~Ant lesions ~he IPP is el,~altd above the IFP of normal tissue 25 and the IFP i~,~a3cs wi~ lesion size. I~ benign lesions, on ~e other han~, ~he I~P may be con~ h1P to that of normal tissue.
T~ ;.... of the ænsor through ~e lesion along more tha~ o~e path allows ~he IFP and the eD~ry and exit poi~s to be ~e~ d along more than one C~ of t~e lesion. The size aDd extent of ~he Iesion aDd its biologi al ~t~ ~I;A130 can then be P~ lrd . p~ F~r . Ably, the IPP of the lesion is -lf A~ A in twol;rF~ ,~." ~ t;.~n~, and ~he IPP is l~co~ed frst of normal tissue then ~ Aly at close intervals or co..l;,~,o!~1y as the needle is a~va-,ced into t~e lesio~ and exits WO 93/~4694 ^ Pcr/~S93lO~384 the lesion into normal tissue again. The p~ n ading for t~e ~ ~ u~inn ~f the i~e.~iou needle along each path takes ap~ t~ly 10 ~ c, and ~he entire ~,vce~ takes a~ t Iy 20 ~ s to cn~
For s _ r~e, where p~lratiQn or ~ OgL~)~ has shown that a lesion is S present in the breast, the ;~tl ~ ;A1 fluid ~LeS~lLe of the lesion can be ~e~
as ~ rrihe~l above, and if the illt~ ;Al fluid ~JleS~L`~ t~_~ a benig~ lesion then ~e patient will not need to u,-de~:o surgery. If, on the other hand, the p~es~ ea~uLe~eL,~ t~s a m~ nt lesion, a hookwire can be ver~
t. ly placed within the lesion as a marker for the ~ se.l~f 1~ surgical 10 removaL
Description of the ~e~.c~ Embodiments Dlawing:i Fig. 1.1 is a lo~jt~din~l section of part of a ~..,s~ æhsiug needle z~ .hly, aceo.dinE; to the invention, show~ the ~o~ ;n,.c of the co...~ .t~.
Fig. 1.2 is a cross ~1;o~ view ~hru 1-1' of the l~le;.~ e~c 1~ needle ~s~mbly of Fig. 1.1.
Fig. 1.3 is a cross s~e~;o~ view thru 2-2' of the ~sule-~ needle ~s~rnhly of Fig. 1.1 .
Fig. 1.4 is a lo~ di~ section of a needle ~cs~ ..hly, acco~ing to tlle 20 iuvelllio~ h~,~vlng a hookwire wi~hin the lumen of ~he in~sc.lion needle.
General Deæe~tion In the .... 11~ acco,.li-lg to the iu~ ~li~, the loc~lir n of a lesion within a tissue mass is ac~ tel~ t ~ d by --- ~...i.~ a ~ ., Icnown to l"eas~
higher or lower within such lesions than in normal tissues, at a pluraliq of points 25 in one or more paths through the dssue mass. Any one or more of a variet~ of p~r~m~rS can be lllea~.-,cd acco~iug to the i~ ~ioll; in particular" clevdt d ;~t~ fluid ~ aul~ within a lesion can be a reLiable i~ atol not oDly of ~e location and size of the lesion, but also of its biolo~r~l ~ot~ ; for P~np)~, m~ nt ~mors can have i~ ;ql fluid p,~ s cl~,va~d to a greater degree 30 than benigll nlmors MO~G~- r, ~ atus for inL~ c;~ the sensor into the dssue mass can be Lno~idcd with two or more ~n~ors, c~r~hle of ~ more ~an one p~mpter~ Some such ~.d..~Ft~ ~ can be s~l~rl~d to aid in loc~tin~ ~e lesion ~0 g3/14694 _ 21 ~ 399 3 Pcr/ll593/00384 or in ~ g~ c;~ its p~thologjr~l cQn~ n, and o~hers can ~ovide ;~r~ .n that may be useful to mPflir~ 1 who ~)bS~ ly tre~t the lesion.
~ sensor for Cd~r~g out the mPthml of the invention can co,lveni~tly be ~c~ ; 3t~y~ with a fine-gauge, thi~walled tube, made ~..rri. j,r.,-ly S rigid and sl~led so that it can be passed into the tissue mass witho~t c~
intolPrah1e ~ o...r~,L to the s~;e~ l; a c~ fd hoIlow nePAle such as a f~e-gauge biopsy needle may be suitable, for ~ ~lc Where initial ;...~ .odc ;"~ the ~,. 5~ ~e of a lesion within a tissue mass, the holIow sha~d needle wi~h the I;~S~~ rfl sensor is ~s.,,~d into tbe tissue mass along a flirPct;nn 10 esl;..~ to pass into the lesion, and -lf ~ n- ~1S are made at cIose intervals. If the ~IPA~ ."r~ do not ;~ulic~t~ that the senspr has passed into a Iesion, the need}e and sensor can be withdrawn and ~e~,ttd along a dirr~,~ path. These steps can be ~p~AI~d u~il the lesion has been located arld ~--r~ rl....~A
has been obt-~;n d to ~o~idf an ;l~lkAI;~Il for biopsy; repeat~d r~ in~ is 15 ~ C.-5s~. Oncethesensori".1;. At~ thatthene~lehaspassedintoalesion, it can be passed filrther into the tissue mass and fi~ther ~f~ can be made along the path, un~il the vlf'7~.,~C~ ;~ie~l~ that the sensor has passed thro~
arld out from the lesion into normal tissue. A record of the po~itit~n~ a~ong the path where the ~ A.~ were made can provide an e,~ of the ~ f nc~
20 of the lesion along the line of the path. Then the needle c_n be pardy wil~Law~, so that its open dp is again within the lesion. Then a marlcer, such as for; ~T_a hookwire, c~ be ;-~t-., ~e~ ~ia the needle to a point within the lesion near the needle tdp, and the needle can be wi~Jla~ lea~ring the marker in place.
By way of e-S-...l,lc, an ~ .f ~1 of al~p~ for lesion l~li7~tion and 25 r~ nn~ic ~rco~ to the ~ is ~f~ below,; r~ , a~ ss~
sensor L3~h~le in~o a t~ walled hollow insertinn nee~e. The pl~ s. ~ sensor itself inrhld~Ps ahollowtube c~ t~ ;.~ fil~ , A;~ n~ if~A, and co~r~ A SO
that it slides within the lumen of ~he hollow in~Prtinn needIe in sealed ~
~he needle wall. The fil~mPnt~ sensor tube is closed at its distal end; and30 the walls of the sensor tube ar~ of the il-~, ti~ n needle are each provided wi~ a port near the distal end, and the ports are ~ n~l~lP to provide co~.. -~.~i ~I;.~. ..
beLw~n the ;..~ 1 fluid SUL1U~ the in~e ~;~... needle and fluid wi~hin t~e wo 93/14694 ~ 21 S 3g9 ~ PC~/US93/0038~
g lumen of the sensor tube. A ~es~ illg device is o~e.aLivcly cu~ PelP~ to the sensor hlbe so that it is l~O~;l.~ to the h~di~o~LaLic ~ lO within the sensor tube lumen, p~vidi~g a ~easul~, of the i,.~ .x~ t fluid p,~e~ in the tissue massnear the i~ .Lio.l needle ~7j~-~t the ports.
- S Appa~aLus The distal portion of an embo-7imPnt of Al~p~ for lesion l~li7~tion and .c ac~~ g to the ~ , ;",t~,d;,~ a ~ sensor .,~se.Lil~le into a thin-walled hollow i~ ,Lion needle, is shown by way of ~-~*."l~lr. in a .li~,~,." in Pig. 1.1, and in s~ction~l views in Figures 1.2 and 1.3.
Wi~ ~ ce now to Fig. 1.1, the p~esi~c-sensing a~ a distal portiûn of which is shown in~ 7Ps a fine-gauge, thin-walled hollow ~.~io~
needle 1 and, shown in opc.ali~ r~Pl~tir~n within ills~Lon needle 1, a ~o~able hollow inner sensor tube 2. Within the lumen 7 ll.,~ougl;.,~l the length of sensor tube 2 are fil,---~-~t~ 6. Sensor tube 2 is o~d~ c~ Clt(l to a ~ SD~
15 l.lea~ l device (not shown in the Figs.) in such a ~1 that the P1~,SDU1e ~e~ device is l~,S~I~ to hy~ost~t~c fluid p~DD~U~ withitl the lumen 7 of sensor tube 2. The distal tip 5 of sensor tube 2 iD plugged, while the inserlion needle I is left open. A port 3 in the wall of the insertion needle 1 and a port 8 in the wall of ænsor tube 2 are ~lhs~ 1y aligned w~en the illse,~ needle and 20 sensor tubc are in o~.alio~l ,~,lalion, as shown in ~e Figs.
In one c nho~ , the in.;e~liGJ~ needle 1 is a 20 gauge ~ n~ steel - needle, and port 3 is a 2-3 mm hob, located 2 cm from the open sharp distal ;.W~ needle tip 4. Sensor tube 2 is a ~ steel hollow needle, 23 gauge so that it fits snugly within ins."Lion needle 1, and port 8 is a 2-3 mm ~ole, located 25 about 2 cm from the distal sensor tube tip 5, which is sealed wi~ solder. The sensor tube 2 CQ~ within its lumen 7 and throughout its leng~ 4~5 mnnofi~ u~s surgical suture fibers 6, ~,.,~.ably ~0 ethilon or other ml~n~fil~-..P.~to~S nylon of the same size, which occupy the leng~ of the iDner needle 2.
Inse,lion needle 1 and sensor tube 2 are each provided at the p~u,uu~al end (not shown in the Figs.) with a plastic hub for ease in m~nirul~ti~ n by the user, as is well-known in the needle biopsy art. ~ ...nf.~1 marks on ~e plastic l~ubs (not ~o 93/14694 21 ~ 3 9 ~ 3 -PCr/USs3/00384 shown) are provided to aid the user in hr'~i~ the ports 3, 8 in ~li~.. .1 duringuse, as shown in Pigs. 1.1, 1.3. When ~he ports 3, 8 are ~ligned ;~ n;_lTy as shown in ~he Figs., dley provide for direct c~"....~ c~t;-~ (.'~h fluid in the sensor tube lumen 7 and the i~t~ l fluid in tissues outside ~he i~ needle 5 1 near ~e ports.
Sensor tuhe ~ is o~,.8livd~ co....~t~l to a ~les~ f ~S~ .. P-~1 device ~ot shown in the Pigs.), such as the model P23XL p~ ue ! ~ ~ available from S~ P~ Inc., Oxnard, CA, by way of non~ 7Pd pL~tic tubing filled with sterile kF~ ;>P~1 saline, ~Lefe,abl~ 70 Units/ml, CQn~fC~ beLw~c 10 the ~ d"~ f ~ and the p~ l end of the se~sor tube. The pL~,s~u~c t,~"~ t r is co..nt-~-~d to sig~ s~;n~ means, such æ, for example a çl~r ~ ;rl~r~ and a ,~,eon3f ~ or other data storage device. ~ one e~ ; .. n thesignal from the ~ -l,~e. is sent through a rn ~ lifier~ such as the model 11-4113~1 available from Gould Illc., Cle~_l~d, OH, and the a-.,rl;l;~ signal is 15 sent tO a dual~~ .n~l chart Icc~ , such as the model 3~V7202-11 availa~le from Gould Inc.; or the Z~ t;l;~d signal is ~ ; f~l and stored.
The lengths of the sen~sor tube 2 and ~n5~ needle 1 are s~lPc~l to be ~,~.rr;.~it..1ly long tO reach tO ~che ~ ~d path length within ~e ~ssue mæs ~o ~he ~l~epc~ 1 point. The lesion is located and the tip of ~he i~e.~
20 needle is ~ ~ within ~he lesion as tl~sc~ihed above, ~n~ral DfLS~;~lio~, and ~e sensor ~be is wilh~w~ from ~he in~ needle. Then, as shown in Fig.
1.4, a flf Yihte hoolcwire 15 s~lch as, for ~ , a 0.03 cm ~ hool~vire having 22,600 kg/cm2 tensile ~ .*1l., 11.4 kg br~ ln~ or, for ~ , a 0.~2 cm 1 ~.,-- t~ hookwire having 20,000 kg/cm~ teDsile t'~ -y.ll., 6.5 kg b~lrloa~ is 25 ;nsf,-~d in~o the tissue by way of the lumen 9 of the p~.l~ en.ll~reA ;~
needle. Ihen in~lortion needle 1 is withdrawn from the site, leav~g the hookwired in the lesion as a~ ~ marker of the po~iti~n of the lesion. The portion of the hoo~w~ that e~.,.g s f~om the wound (not shown) is taped to the ~l,jee~ s skin uDtil Sulg~ . If desired, ~e outer needle 1 can be ~ eeL~
30 over ~he hookwire during ~ ge,~r to ~u~idc a f~m guide for the ~eon's knife.
~1 21~39~
WO 93/14694 PCrlUSg3~0~384 Use The y~ss~ l.. c acco~ g to the ~_~Lioll can be usçd for ",r~ the ;.~t~ l fluid ~ in tissues. and for ~ til~ leSiQnS iIl thç
tissues, at any of various sites within the s.lkj~;l s body.
5 Preferably the a~ç~ ~h~c is c~lihratp~l just prior to use. Such c~lih~ can coL.~cn~ be ~ rol~ed using a water colllnln, and a zero ~f.,.e~ce point is plcfcrably 0~ ;..Pd by placing the sensor tube tip and i~e.LiQll need~e tip at skin level. The user then i~ ces the; ~ needle, CO ~ the sçnsor tube in proper ~1. ,--.. ~l as indicated by the ~ l marks on the hubs, into. the tissue 10 mass at a point where the ports can be c~rcct~ to be s;l~ in normal tissue.
Then proper co.~ I;o~. I~h..,~n the saline in the lumen of the sensor ~be and the ;--t~ l fluid in the tissues can be ch~ r~ æ follows. Pirst the plastic tubing co~nrc~ the ~ ~e ~ u~r wit~ the sensor tube is co~- sscd with a screw clamp. This ~ la~s a small a "lJ--"~ of fluid within~he tubi~g and the 15 lumen of the sensor tube, which should cause a ~ rise in the yles~
~ed by the !- ~ Jl,c~, the ~uid should, ~v.ided that there is proper fluid c~"""~";r-l;n." yui~ y Ihe.~ ar~r pass from the sensor tube ll~vugll the ports into the s,ulv~ dssues, allowing the p~ ulc~e.,ll tO renlrn quic~ to - - nnrrnstl, The clamp is then ~ ;e~ leco.n~ ss~ the tubing and ç~ a ZO l~ ..1d~l~;~inthe~ atthe~ eer,whichshouldagainquickly re~m to n9rm~1. The ~ies~e sensing tube lumen may be CQ~` cl~.~l tO have proper fluid co-~ ;--nl;h~ with the ;-~ ;I;A1 fluid of the tissues if, followingCO~ S;OIL and ~o-..~ .sion in such a test, the stable value ..~ u~-nf~ re within 15% of each other.
The a~ aluS iS then a~l~d into the tissue and the i-~t~ fluid ;,~c is co..1;..-~ c~ cof~ed (or ~ev~ded at closely-spaced intervals~. As the a~pzlalus enters a lesion, and the ;~t~ r~lrA~ ~h.~n nonnal tissue and a m~ t lesion i-lti ,f~ e is pierced, the p~ee ~ougll the ;.,t~,. r~e of the ports is e~l-e~d to be obs~ d as a sh~p and m~rlrpd ~l~5C in ~lC~ e depth of 30 the needle at the ;~lt. ~ r:-'`e i3 l~col~le~, and then the needle is a~l~,~d ~r~er into the tis~ue ~. u~l~ the lesion. As the ;l~ai~ s leaches the distal lesion~norma1 tissue ;~t~ - r~e the ~ s~&c through the ;.~t~- r~ce by the port3 as they leave the WO 93tl4694 ~ 2f S 399 3 PCl~/US931003g4 lesion mass is o~s~ d at the lesionlnormal ~ssue ;~.t ~ r~C as a sharp and m~rk~d -in ~he --r~ -uP~ t~ l fluid p~,~ c~ , the ~ islrP rapidly falIing f~om ~e int~n~ S~ of tihe lesion to the e~ d p.~ of no~ issue.
Using ~is mPth~ a series of - r~ .It~ along a path ~ s appr~ t~ ly lQ
S ......~ to c~mrl~
Proper fluid co~ he needle and the ;~ I;I.al fluid of ~e lesion can be co..l ;....rd by co~ .~s~;n~ C~ the ~bing whil~
the needle is ~ within ~he lesion. One may wish to cO~r~t~ this I jor ~1 step ~hen the ~IICd;~lL~d IFP wi~in a lesion is very low or c~ hl,e 10 to the ~lF~ s~u~ in normal tissues, in order to cnsure the ~c--~ y of the ~P~ , p~rtir~ rly as a low IFP within a lesion can be ;n~ ;ve that ~e lesion is benign.
The~ nl~ ~ u-~ d above canthenbe L~ using &~ull~er~
L_.ISlllg ~ n~ ata ~;rr~....~ 1~A1;0.. wi~hin~helesion. Two;-~
15 ~F~ F --r~ of the IFP wi~in a lesion can il~ the accuracy of the ~l:~..n.~:~, and ~e~ of the entry and exit points of the needle along two (or more) pa~hs wi~hin a lesion will allow a more ~ ~ e~ of the size of the lesion.
Once the lnr~tinn of the lesion has been ~ t~ l~r A~....;~r~ the sensor 20 tube is WillldLa~YlLfrom the ;~ Dee~e, leaving the ;.~ le in situ,and a Loohwi--_ is ;-- - . ~ via the in.~ Deedle lumen into the tissue at the ;~clF ~L;~. needIe tip. Tne ;~ ... Deedle is then ~ilh~awn from the tissue mass,leaving ~he hoG~w.re j",~l_"t~ in ~e lesion as an ~ ;iv~ and secure ~h, of the l~l~o~. of the lesion.
Other ~
Other ~...ho~l;~,,P..l~i are wi~ the following claims.
For ~ ", rA~ devices other ~han the fiber~ t~ tube des~ 1 above could be could be used in ~c~ with the ;~ eedle to u~e~ul~ ~he ;~ ;I;al ~ . Available l~lc~a~ devices ~hat can be 30 A~1al~ted for uce m the i~ ion include devices based upon ~he pL ~ 1r;r effect or upon ~exion of fi~er optic devices. Such ~lt~ te ~ devices . ~ . .
Wo 93/14694 2 I 5 3 9 9 3 Pcr/usg3~n3x4 may have the benefit of ~ ;r- a."l~ c;~ the length of time r~ui~ed to ~r~-~J-~t~ t~. - --;- ~ the ;-.~ fluid ~.~,. -Measul. ~e~ts of indicia other than IFP which show the l ,. ~c of a lesionat a given point in tissue, and ~c.. fv~ of the loc~tinn of the lesion withiD the 5 tissue mass, can be used in place of or in ad~ n to IFP ~Ul~ ,Yrn~. Ot~er t~ s which can be ,uea~ d in~lllde~, for e ~ lr~ t~ l fluid pH or oxygente~sion("PO2"). ~ results ~ -'h thatthe e~ lhll~r pH of a m~ nt lesion can be lower than that of nomlal tissue, and that ~he pO2 of a m~ nt lesion can be lower tban that of normal tissue. I~P~ c.lt~ of such 10 ~h.~.nt-t~ , p~ably CimIl~ ro~ with and at the same ~edD~ ~c~l points as ~he p~.DD~ e nf ~ C~Q col,~bG~ ; the ~i~no~;c pi~ided by the ,~ DDUl`~
l~e~SU1~ D~ MOLe~ , the choice of tI~e-, ~ ;c mPthod for lu~ a~l~, a lesion can be ;,~ t:.nl.~lly ben~ d by ~r~ CCrtain tiDSUe ~a.,.~ S wi~hin the lesion other than ~ . Somc th~ .t;t~ co~n~ ...C are knoum to be more 15 or less eff~cli~ than others at thc particular pH or at the PO2 ~ ~o~ h ~ within a given lesion. For i t~ e, a lesion having a low ;.~t~ ;I;al pH could ;-...n~A;~3,1y be treated with drugs which arc known to be more er~ , in acidic e,l~h~ . Thus the knowledge of the e n~ t within a lesion will provide the c l;,~;r;_l. with i~ .. which allows decisi~e and errcc~ in~
20 of drug or ~ tl~ pirs.
Th~ d ~ .bl~r acconlin~ to the i~ Qliun, as ~ n~lly and ~1~ above, can readily malce use of a sensor device, cap~hlf- of ...c~
one or more ~ -Ptr ,~ other than p,. s~, adapted for i~ ~h ~ 5,, by way of an ,.with(as,for~ rk, withinthclumen)ani~sc.liu~needle~ For 25 ;-~ e once the lesion has been located as ~le~- ;l-ed above, the ~ sensor ube can be willl h~wll and a fiber-op~c sensor put i~ its place, capable of ~ P~ - ;~ pH, PO2, PCO2, and the t~ within ~e lesion. A fber optic s~ ~ device capable of takiDg such ~c~ul~,l.e,l~ and ad~l~t-hle for use acco.~li~ to the i,l~_~ion has been d~_loped, for ~ le/ by Puritan ne~e.
Corp., (see, e.g., ~F~FEs~e~h~ January 1992, pp. 61 etseq.).
TUMORS PRIOR TO NEEDLE BIOPSY
Background of the Invention This invention was made in the course of work ~u~ cd in part by the United States GoY ~ , and the Go~.-..n.~ has certain righ~c in the invention.
This invention reIates to the locali7~tiQn and ~i~g~ Cic of lesions in uivo.
"I esion" as used herein is a pathologic change in tissue, such as for ~ .le a tumor. Tpsion.c that are too small to be found by p~1r~tion are ccollYe.n;~m~1~y10 located using im~gi~, ~ PS and surgically removed. For eY~n~r1e, breast lesions can be de~c~ d by 1~ Illllo~;l~ as much as four years earlier than by physical e~"~ inn However, a --An --G~ is unable to ~ J;~11 a benign.
from a m~ligr~nt lesion, and ~ Cl;O.. of a lesion by ~ n~ ography must be followed by biopsy. Rec~1~se a ~ logl~ has a ~silive pl~icli~c value of 20-15 30%, a large ~o~ollion of breast biopsies following ~ ~ld~ prove to befor nnnm~ nt lesions. A r tluel;~ in the m1mlxr of breast bic,p~ies pe,folllled for benign disease would be c~ ~cly i~.~ and b~ ;ci~l.
InCO.~ d scl~ g for breast ~ic~c~ a m~mmogram of the breast is made, and the resllltir~ image is ;..~l~c~1 for 20 I~ s;onc. If a srnall lesion appears, a radiopaque needle is inserted into the breast in a region as near as can be esl;~ d to the lesion. Then the region is im~ge~ withthe needle in place, the les~ image is ;~ e~-~ccl and the needle is re1~ e~t~d as lu'C~ to place it within the lesion. Once the needle ap~al~ to be po,c;tinntod within the lesion, the :iUl~On follows the needle to the lesion and removes the 25 lesion and SU11~ (1;~ tissue, and the pathological status of the lesion can be -";-~ Reç~11ce the im~gis~ yruCc~lul~_ p.o~ides only an e~ of t~e p~O~ ily of the biopsy needle to the lesion, it may often be .~cec~.y~ in ~e illLe,.,~l of l~mGVilly, all the lesion, to remove a s~ s~ u~li~y of nQrmal p tissue as well.
The ~o~;l;Q~ of a biopsy needle in soft tissue as a marker fo~ lesions has been found to be unreliable, bc~ ~ the biopsy needle can move dunng ~he ~rup~tion of the patient for su~ . Kopan,s et al. (1980, 12n<liolQgy Vol. 134, p. 781~ s~ihe i~e~ a hooKvire into the lesion via the lumen of the hollQw --~IVO 93/14694 PCr/US93/00384 needle used during the ;~ oce~lu~c to loc-q-Ti7P the lesion. A~ter the hookwire is in place the needle is willld~&w~l, leaving the hookwire in a pQ~itinn c~l;ll.~tr~ to be closest to the lesion. This needle-hookwire ~.oacll has beei used cp~r~tly to provide a more secure marker for breast ~ y~. ~ (Meyer et al., -5 1982, Arch. Surg., Vol. 117, pp. 65-68). However, once the hookwire is ;IIIp~ lrd in the tissue, it cannot be removed wi~uul tissue ~qma~ except by ~g~
Since the d~ of needle-hookwire -q~ nhly by Kl~pqn~ et al. 7 other breast biopsy needles have been d~ ~d. For ~Y ~ l,k biopsy n~prlT~s have 10 been de~i~n~ wi~ retrqrt-qbl~ barbs to . nchor the biopsy needle in tissue, and to fVqrilinqt~ the removal of ~he needle in case of j"ro. .~cl pos-l;o...~, or in case it is ~ irqhl~ to remove the l~nc~qli7~qtit~n needle during ~I.U'~ L,~ wil}louL ~e~r~i~ ;I*
surgical removal of excess tissue (U.S. Patent Nos. 4,986,279; 4,799,49~). In each of these biopsy needle ~ 7~tion s~t~ ~s, the ~ of the biopsy needle 1~ to a lesion is c~ 1 by ;.-~g;.~ tr~h....l~,es.
The t;rr~ivc~ss of ll~a~ieS C~ r used for the 1- ~1--~-l1 of I~P~;C?n~ as for eY~mrlP solid ~ rs, is limited by the cdpaciLy of the !1- ".~ l;r to reach the target in vivo in a~l~qll~t~ s. In a~imal studies, solid tumors have been shown to contain a greater volume of ;. l~ l fluid--that is, of fluid in the 20 eY~rPllnl~r and t:~Lrav~sl.;ulàl space, than normaI tissues cont~in, ~"gg~;,l;.,~ that tumors should be readily ;-~ t~bk by !1-- ,~ nl~- ~1PS. However, 3itinn~t animal studies have d~ n~c~ d that ~he ;..tt;~ 1 fluid ~ Ul~
("E:Pn) is higher in tumors ~an in normal tissues, re~ti~ in poor ~ ,r~.c;n~ of tumors by Ih- ~l~JI-r ~ D~ 1PS and a radially uuLwa~3 co,~ve.;~l of ;.~t. .~
25 fluid from ~mors (r~ w~d in Jain. 1987, Cancer Res., Vol. 47, pp. 3039-3051).An ~;....;,~,~linn of the ~ u~as~;~ar ~wulL~ of rat --~------~- ~
~1e~ Ç~ II.A tumors was C0~U1~J~ to aid i~...U~ "~",l~ ~e tt;~ l;n~ of blood flow and itS ;~n~ rC on ~he r~ and uptake of n~ Ya~1L mn1Pr ~S In .~l.f ..,,.!l " -l,~, i,,,,,---- ..!h. ,~ , or ~ I;o~ Ir. ~ eSS et al., 1991, C~ncer 30 Res., Vol. 51, 265-273). The results of ~his s~dy ;..~ t~d that ~e l~;rl~ n ~eom~try and lic~wul~ ~L u~ule in tumor v~c~lt~ r~ may be one ...~-~h,...;~...
WOi93/14694 ~ 2153993 PCr/US93/oO~
rP,sp. n~ihle for the il~lcasr~ r.,~ ..re to blood flow l~pol~ed in tumors (Sevick er al., 1989, Cancer Res., Vol. 49, pp. 3506 3512).
The elc~dt~d IFP of tumors was first ~ 1 by Young et al. (1950j Jour.
Pathol. Bacteriol., Vol. 62, pp. 313-333) after taking utissue pl~s;,u,e~ -S lneasu.c~e~l~ in rabbits. Each of three mPth~ for m~c~ n~ local i~ "~
ple~ e, known as ~e needle mPthod, wick-in-needle m~thf)d, and ~i~i~;pel m.oth~:1, has advantages and 1;...;~ c. In the needle mpth~ a needle filled withphysio~gjr~l saline and c~,uyled to a p~ n~ device is ins~te~ into -tissue. In the wick-in-needle mPthotl~ fibers of polyester or other mllltifilA...- ..lou~
10 m~teri~1 are placed within the lumen of the needle in order to provide a large surface area c~ with the i~ i~ and redllce oc~ sion Both of these mPth--tls can cause tissue distortion. In the ~icr~i~ 1.od a micropipet c~ .~..r~ d to a ærvo-null pl~ s~u~e~ J- ~ system is used, l.luc ;.~ some ~s pleæ,_ ~t~,d in the needle and wick-in-needle --- l~.~s, but the JlliClU~
15 are ~sce~1~hle to breakage.
The IFP of s~l~Lv~ lr~ c tumors wæ n~eas~cd in rats using miclupi~.ls (~o~her et al., l9gO, ~ancer Res., Vol. 50, 4478~484). This study describes a steep IFP gladie.~L that begins at the surface of the tumor, or the sk~T~/tumor ;. l~ r~e, and quickly l~aches a plateau value in the tumor mass within 0.2-1. 1 mln 20 of the tumor surface. These results co~-r. .--~ an earlier .~ A1 model of ;~t ,~t;l;~1 fluid ~ L in tumors (Jain et al., 1988, Cancer Res., Vol 48, pp.
7022-7032) ~vhich pl~os~ that very little filt~tinn of lu~cn nlecules into tllmor$
occurs even from blood vessels which pass ~o~l~ the tllmor, and that the CO~ Ye uuLwal`l flow of the ;-~t~ t fluid pushes solutés toward the . 25 periphery. These co~ ;ol.~ are also ~up~ulL~d by vork from DvQrak et al.
(1988, Am. Jour. Palhol., Vol. 133, pp. 95-105) who d~ at s all mol~ oæ can readily ~ 1mors, and large ~uL~ olp~ es are lîInited to the tissue-nlmor ;-~1~ r~rc. The inabili~r of 1~ Jl;~` drugs to reach th~ center of tuunors has grave i~plir~ti~n.c for ca~cer li~ ies, and based upon these- resuIts 30 Rol~rh~r et al. (l990) ~r~po~s m~thrJ~ls by which drug delivery to tumors could be h~ ed ~, 2153993 93114694 Pcr/uss3/oo384 T~e wick-in-needle t~ uc was developed by Fadnes et al. (1977, ,~
Microvasc. Res., Vol 14, pp. 27-36). Fad~es et a~ 5 a thin h~ . .n;r needle open at the end and having a side-hole, its lu~nen filled with mlllh~lz.-,~-lt~ s nylon thread and CQ~ d by polyethylene tubing to a ~ "'G
5 ~ n~J~ . Padnes et al. ~es~ s using this ~ e-3e~ needle to cQInrare ~e subcv~ P m ~ rats under normal a~LI d~L~d c~n~ih~ n~.
The ;nt.. ~ l fluid p~t~ of human .~fl .. ~c and uterine cervix c-~ s was mf ~ A using the wick-in-needle k~ in studies that ~ "~l Al~ for ~he first time in h-----_nc that IFP is higher i~ tumors than ~ normal tissue.
10 Rol--~ht~- et al. (1991), Cancer Res., Vol. 51, pp. 6691~694, (l_.no.~l._t~ that ~he IFPs of large human mf~ c far exceed the values c~l~ectr~ from ~
of rodeDt tumors or human ~e~ogrdrl~. Roh et al. (1991), Gancer Res., Vol. 51, pp. 669~-6698, ~e ~ t~d that a lu~,~g of the IFP m some cervical ~mors duri~g r.,.~ t~ ~ ~c~ CQ~ A~ s well with ~1- ~r~ , o"l~-u~
15 Bo~ U~1'F ~ et al. and Roh ct al. co~ dc that ~ P of tumorC will ~e valuable for ~ ;n~ future cancer ~herapies and ~Ic~ -n ~ "
l~.P. Wang, U.S. Pat. No. 4,799,494, Ae~- ;1~ a needle ~5~s~ ~bIy for collPctinn of lung tissue. T~e needle ~CsPrnbly ~ s a bluD~ hollow outer needle having a side-hole for tissue cQllPctinn, and a non-removable inner hollow needle 20 51~11ht`h&fl to a sûlid wire, slid~ly ~ A wifflin and snugly fit~g ~he lumen of ~he outer needle, uæd for ~ the tissue. The lumen of the outer needle is u~ ~,d to a crude b~lloQn 1 ~re sensor. The '494 paten~ states that ~he n~ 7~tit)n of the needIe tip in the lung lesion to be sampled results in a p~ e d~ letect~blf~ at the b~lloQn Summary of the l~ention We have dis~;o~_~ed that a lesion can be ~ located within a tissue mass by .. P~ , at several poi~s in a path l11L~U~I~ the tissue mass, a s~l~r-t~l hat is knowD to l~.tA -e l-rr~ in lesions (or at least in some types of lesions) and in normal tissues; a~d we have d~_lo~ .,.t~., for ca.~j~
30 out such ... ~---...,..~1~, p~ of i--t ~ fluidl'~ Y
Using the mPth~, the lor~;n.- and, at least to some exte~t the size and the q- l,o~ of a lesion can be ~t~ d a~ ly and wil~vu~ a ~ .P .l for ~ WO 93/14694 21 S 3 9 9 3 PCr/US93/0~384 -- S --d reim~i~ of the tissue mass. Mo~cov. l, some s~ led ~ t~ can, ~pf.~(1in~ upon the extent of d~,~Lion of their ~e from nnr~m~1, p~ovide il,rol...A~ir~n ,~ J.iQg the p~thr,logirA1 co~-lil;o.~ of the lesion; for eYAn-r1e, some ~a. -~ deviate more from normal in mA1ign~nt tumors than in benign lesions.
5 In one aspect, the i~ ion f~,at~ s a mPth~ for loc~ a lesion within a tissue mass, inrl~ .nP~...;ng a ~A- f~l~el~r at a plurali~ of points in at least one path l~u~ll the tissue mass, the ~eas~ of the p~.n.~- in lesions being dirr~d from the ~ea~, in normal tissue.
In ~.~fe,.~d e'mhOA;I-If.~1-i, the ~ t~ - is ;--t ~I;I;A1 fluU ~ Ul~., and 10 more than one p~ r may be ~ea~uled at one or more of the points; the m~thod may fur~er include a step of i.lsc.~ a tissue marker, such -as a hookwire, into the lesion along a portion of the path, to mark the le$ion for s~s. ~lu~ removal.
Typically, the method of the invention _ay be used to ark the loc~ti~n of, 15 and if desired to gain ad~l;lionAl i--r.,...,~l;Q.. as to the ~.~ .. of, a lesion located by :-..~,;-~ or by ~I~-I;o~ -In &lull~e~ general aspect, the invention Ç~ alules ~ ..c for ~I~f~ atissue ~i A.~t~ ~ at a ~ 'f r of points along at least o~e path through. the tissue mass, in~ in~ an insertion tube, sh~.cd at a distal end an~ made s~lmriently 20 rigid so that it can be inserted distal end fol~o~ into the dssue mass along the pa~h, ands i~.lil,lc ~vith the ~;c~ion tube, a sensor car~bla of ~ vidi~E; a 7svle of the tissue ~ t~ at a point in the tissue mass along the pa~h.
~ c~ to thc iu~-~dion, dW~..~ for lo~ a lesion in a tissue mass ;~-rh~des such ~ 5 for ~f'~ a setecte~ tissue ~æ~ at a l;lulllber of 25 points along one or more paths thluu~ the tissue mass; at any point in the tissue mass a measure by the sensor of the sel~ct~d p~ .e,t. ~ that is (~ hIy dirfe.~ from that in normal tissue i...lir~-s that the point is within a lesion.In ~.~f~ ho~ f~ s the tissue ~ is ;~t. ~ fluid ~ ;iUle and the sensor ;~ es a ~~ , sensor. The wall of the i~.~ion tube in~ es 30 a port near its distal end, and the sensor inrl.ll~les a sensor tube, c~
fil~ , slidably en~ f ~bl~ wi~in the lumen of the insertion tu~e; the sensor tube is distally closed and has a port near its distal end, and the ports are.
~o 93/14694 21 5 3 9 9 3 Pcr/US93/0~384 pocitiif)n~A so that when ~he sensor tube is e~e~ within the il.3.,,Li~n tube lumen the ports can be ~ "1;ally aligned to ~u~idc fluid CQ~ between the lumen of ~he sensor tube and t~e dssue ~ljac - ~1 the ports; a~ the sensor tu~e lumen is oyr~ ally cQn~ kA to a ~ -.-f n1 device such that it is ~e~o~ive ~o fluid yl~s~J~ wi~in ~he sensor tube lumen.
The ayQaLdLus of ~e J~ ~io~ makes use of a thin-walled ~Ine-gauge distally A needle for the inc~r.l;.~n tube, so that by use of the ~ ..c ~e mP.thr)d of the ~Yt:nLion can be carried out iL~uu~ a~ The ~L~.J~ ;u~
ap~LLalù~ C~ tothei~.lLiO"canbeusedto n~.-v~t~ the IO ;--t ~I;I;A1 ~,S~u~'~, wi~hin a lesion in ap~,o~ ly 10 """,it~ ,' time. The invention~io~ csfor ~ hlf~n~FJ~ F~P~ of;~Yt~ ;l;Atfluidl"~v~inany vanety of types of lesioDs in ally of a vanety of tissues with a .~.;ni~ n~ of n~rolL to the patient.
The iu~io~ can provide for c~ the ~ I;nn size and biological lS pO!~ of a lesion by ul~r --- ;Q~ the ;--t -`I;I;A1 fluid p~ , by passing thetube, with the ~ t~ ~ ænsing device, into tissue t~at has been shown by pAlrAtinn or imSI~ techniq~les to coD~ain a lesion (such as a tumor), in a path ~hat is e~ At~ t1 to pass l1LCVU~ the lesion, and ~ the pl.,S~ , at m points along the path. "Biological polF-~ t" as used herei~ ~n-~n...p~
20 pathological ~pes of lPCit~n~ inrl~ i~ benigll lesions.
'rhe higher ~P of a lesion allows the op~ o" mAh'~ several ~e&~
along the pa~h, to ~l~t~ f, when the ;.~ needle has bo~ entered and ex~ted the lesion. The IFP of a lesion can ad~ Ally be i~ of its biological In mAli~Ant lesions ~he IPP is el,~altd above the IFP of normal tissue 25 and the IFP i~,~a3cs wi~ lesion size. I~ benign lesions, on ~e other han~, ~he I~P may be con~ h1P to that of normal tissue.
T~ ;.... of the ænsor through ~e lesion along more tha~ o~e path allows ~he IFP and the eD~ry and exit poi~s to be ~e~ d along more than one C~ of t~e lesion. The size aDd extent of ~he Iesion aDd its biologi al ~t~ ~I;A130 can then be P~ lrd . p~ F~r . Ably, the IPP of the lesion is -lf A~ A in twol;rF~ ,~." ~ t;.~n~, and ~he IPP is l~co~ed frst of normal tissue then ~ Aly at close intervals or co..l;,~,o!~1y as the needle is a~va-,ced into t~e lesio~ and exits WO 93/~4694 ^ Pcr/~S93lO~384 the lesion into normal tissue again. The p~ n ading for t~e ~ ~ u~inn ~f the i~e.~iou needle along each path takes ap~ t~ly 10 ~ c, and ~he entire ~,vce~ takes a~ t Iy 20 ~ s to cn~
For s _ r~e, where p~lratiQn or ~ OgL~)~ has shown that a lesion is S present in the breast, the ;~tl ~ ;A1 fluid ~LeS~lLe of the lesion can be ~e~
as ~ rrihe~l above, and if the illt~ ;Al fluid ~JleS~L`~ t~_~ a benig~ lesion then ~e patient will not need to u,-de~:o surgery. If, on the other hand, the p~es~ ea~uLe~eL,~ t~s a m~ nt lesion, a hookwire can be ver~
t. ly placed within the lesion as a marker for the ~ se.l~f 1~ surgical 10 removaL
Description of the ~e~.c~ Embodiments Dlawing:i Fig. 1.1 is a lo~jt~din~l section of part of a ~..,s~ æhsiug needle z~ .hly, aceo.dinE; to the invention, show~ the ~o~ ;n,.c of the co...~ .t~.
Fig. 1.2 is a cross ~1;o~ view ~hru 1-1' of the l~le;.~ e~c 1~ needle ~s~mbly of Fig. 1.1.
Fig. 1.3 is a cross s~e~;o~ view thru 2-2' of the ~sule-~ needle ~s~rnhly of Fig. 1.1 .
Fig. 1.4 is a lo~ di~ section of a needle ~cs~ ..hly, acco~ing to tlle 20 iuvelllio~ h~,~vlng a hookwire wi~hin the lumen of ~he in~sc.lion needle.
General Deæe~tion In the .... 11~ acco,.li-lg to the iu~ ~li~, the loc~lir n of a lesion within a tissue mass is ac~ tel~ t ~ d by --- ~...i.~ a ~ ., Icnown to l"eas~
higher or lower within such lesions than in normal tissues, at a pluraliq of points 25 in one or more paths through the dssue mass. Any one or more of a variet~ of p~r~m~rS can be lllea~.-,cd acco~iug to the i~ ~ioll; in particular" clevdt d ;~t~ fluid ~ aul~ within a lesion can be a reLiable i~ atol not oDly of ~e location and size of the lesion, but also of its biolo~r~l ~ot~ ; for P~np)~, m~ nt ~mors can have i~ ;ql fluid p,~ s cl~,va~d to a greater degree 30 than benigll nlmors MO~G~- r, ~ atus for inL~ c;~ the sensor into the dssue mass can be Lno~idcd with two or more ~n~ors, c~r~hle of ~ more ~an one p~mpter~ Some such ~.d..~Ft~ ~ can be s~l~rl~d to aid in loc~tin~ ~e lesion ~0 g3/14694 _ 21 ~ 399 3 Pcr/ll593/00384 or in ~ g~ c;~ its p~thologjr~l cQn~ n, and o~hers can ~ovide ;~r~ .n that may be useful to mPflir~ 1 who ~)bS~ ly tre~t the lesion.
~ sensor for Cd~r~g out the mPthml of the invention can co,lveni~tly be ~c~ ; 3t~y~ with a fine-gauge, thi~walled tube, made ~..rri. j,r.,-ly S rigid and sl~led so that it can be passed into the tissue mass witho~t c~
intolPrah1e ~ o...r~,L to the s~;e~ l; a c~ fd hoIlow nePAle such as a f~e-gauge biopsy needle may be suitable, for ~ ~lc Where initial ;...~ .odc ;"~ the ~,. 5~ ~e of a lesion within a tissue mass, the holIow sha~d needle wi~h the I;~S~~ rfl sensor is ~s.,,~d into tbe tissue mass along a flirPct;nn 10 esl;..~ to pass into the lesion, and -lf ~ n- ~1S are made at cIose intervals. If the ~IPA~ ."r~ do not ;~ulic~t~ that the senspr has passed into a Iesion, the need}e and sensor can be withdrawn and ~e~,ttd along a dirr~,~ path. These steps can be ~p~AI~d u~il the lesion has been located arld ~--r~ rl....~A
has been obt-~;n d to ~o~idf an ;l~lkAI;~Il for biopsy; repeat~d r~ in~ is 15 ~ C.-5s~. Oncethesensori".1;. At~ thatthene~lehaspassedintoalesion, it can be passed filrther into the tissue mass and fi~ther ~f~ can be made along the path, un~il the vlf'7~.,~C~ ;~ie~l~ that the sensor has passed thro~
arld out from the lesion into normal tissue. A record of the po~itit~n~ a~ong the path where the ~ A.~ were made can provide an e,~ of the ~ f nc~
20 of the lesion along the line of the path. Then the needle c_n be pardy wil~Law~, so that its open dp is again within the lesion. Then a marlcer, such as for; ~T_a hookwire, c~ be ;-~t-., ~e~ ~ia the needle to a point within the lesion near the needle tdp, and the needle can be wi~Jla~ lea~ring the marker in place.
By way of e-S-...l,lc, an ~ .f ~1 of al~p~ for lesion l~li7~tion and 25 r~ nn~ic ~rco~ to the ~ is ~f~ below,; r~ , a~ ss~
sensor L3~h~le in~o a t~ walled hollow insertinn nee~e. The pl~ s. ~ sensor itself inrhld~Ps ahollowtube c~ t~ ;.~ fil~ , A;~ n~ if~A, and co~r~ A SO
that it slides within the lumen of ~he hollow in~Prtinn needIe in sealed ~
~he needle wall. The fil~mPnt~ sensor tube is closed at its distal end; and30 the walls of the sensor tube ar~ of the il-~, ti~ n needle are each provided wi~ a port near the distal end, and the ports are ~ n~l~lP to provide co~.. -~.~i ~I;.~. ..
beLw~n the ;..~ 1 fluid SUL1U~ the in~e ~;~... needle and fluid wi~hin t~e wo 93/14694 ~ 21 S 3g9 ~ PC~/US93/0038~
g lumen of the sensor tube. A ~es~ illg device is o~e.aLivcly cu~ PelP~ to the sensor hlbe so that it is l~O~;l.~ to the h~di~o~LaLic ~ lO within the sensor tube lumen, p~vidi~g a ~easul~, of the i,.~ .x~ t fluid p,~e~ in the tissue massnear the i~ .Lio.l needle ~7j~-~t the ports.
- S Appa~aLus The distal portion of an embo-7imPnt of Al~p~ for lesion l~li7~tion and .c ac~~ g to the ~ , ;",t~,d;,~ a ~ sensor .,~se.Lil~le into a thin-walled hollow i~ ,Lion needle, is shown by way of ~-~*."l~lr. in a .li~,~,." in Pig. 1.1, and in s~ction~l views in Figures 1.2 and 1.3.
Wi~ ~ ce now to Fig. 1.1, the p~esi~c-sensing a~ a distal portiûn of which is shown in~ 7Ps a fine-gauge, thin-walled hollow ~.~io~
needle 1 and, shown in opc.ali~ r~Pl~tir~n within ills~Lon needle 1, a ~o~able hollow inner sensor tube 2. Within the lumen 7 ll.,~ougl;.,~l the length of sensor tube 2 are fil,---~-~t~ 6. Sensor tube 2 is o~d~ c~ Clt(l to a ~ SD~
15 l.lea~ l device (not shown in the Figs.) in such a ~1 that the P1~,SDU1e ~e~ device is l~,S~I~ to hy~ost~t~c fluid p~DD~U~ withitl the lumen 7 of sensor tube 2. The distal tip 5 of sensor tube 2 iD plugged, while the inserlion needle I is left open. A port 3 in the wall of the insertion needle 1 and a port 8 in the wall of ænsor tube 2 are ~lhs~ 1y aligned w~en the illse,~ needle and 20 sensor tubc are in o~.alio~l ,~,lalion, as shown in ~e Figs.
In one c nho~ , the in.;e~liGJ~ needle 1 is a 20 gauge ~ n~ steel - needle, and port 3 is a 2-3 mm hob, located 2 cm from the open sharp distal ;.W~ needle tip 4. Sensor tube 2 is a ~ steel hollow needle, 23 gauge so that it fits snugly within ins."Lion needle 1, and port 8 is a 2-3 mm ~ole, located 25 about 2 cm from the distal sensor tube tip 5, which is sealed wi~ solder. The sensor tube 2 CQ~ within its lumen 7 and throughout its leng~ 4~5 mnnofi~ u~s surgical suture fibers 6, ~,.,~.ably ~0 ethilon or other ml~n~fil~-..P.~to~S nylon of the same size, which occupy the leng~ of the iDner needle 2.
Inse,lion needle 1 and sensor tube 2 are each provided at the p~u,uu~al end (not shown in the Figs.) with a plastic hub for ease in m~nirul~ti~ n by the user, as is well-known in the needle biopsy art. ~ ...nf.~1 marks on ~e plastic l~ubs (not ~o 93/14694 21 ~ 3 9 ~ 3 -PCr/USs3/00384 shown) are provided to aid the user in hr'~i~ the ports 3, 8 in ~li~.. .1 duringuse, as shown in Pigs. 1.1, 1.3. When ~he ports 3, 8 are ~ligned ;~ n;_lTy as shown in ~he Figs., dley provide for direct c~"....~ c~t;-~ (.'~h fluid in the sensor tube lumen 7 and the i~t~ l fluid in tissues outside ~he i~ needle 5 1 near ~e ports.
Sensor tuhe ~ is o~,.8livd~ co....~t~l to a ~les~ f ~S~ .. P-~1 device ~ot shown in the Pigs.), such as the model P23XL p~ ue ! ~ ~ available from S~ P~ Inc., Oxnard, CA, by way of non~ 7Pd pL~tic tubing filled with sterile kF~ ;>P~1 saline, ~Lefe,abl~ 70 Units/ml, CQn~fC~ beLw~c 10 the ~ d"~ f ~ and the p~ l end of the se~sor tube. The pL~,s~u~c t,~"~ t r is co..nt-~-~d to sig~ s~;n~ means, such æ, for example a çl~r ~ ;rl~r~ and a ,~,eon3f ~ or other data storage device. ~ one e~ ; .. n thesignal from the ~ -l,~e. is sent through a rn ~ lifier~ such as the model 11-4113~1 available from Gould Illc., Cle~_l~d, OH, and the a-.,rl;l;~ signal is 15 sent tO a dual~~ .n~l chart Icc~ , such as the model 3~V7202-11 availa~le from Gould Inc.; or the Z~ t;l;~d signal is ~ ; f~l and stored.
The lengths of the sen~sor tube 2 and ~n5~ needle 1 are s~lPc~l to be ~,~.rr;.~it..1ly long tO reach tO ~che ~ ~d path length within ~e ~ssue mæs ~o ~he ~l~epc~ 1 point. The lesion is located and the tip of ~he i~e.~
20 needle is ~ ~ within ~he lesion as tl~sc~ihed above, ~n~ral DfLS~;~lio~, and ~e sensor ~be is wilh~w~ from ~he in~ needle. Then, as shown in Fig.
1.4, a flf Yihte hoolcwire 15 s~lch as, for ~ , a 0.03 cm ~ hool~vire having 22,600 kg/cm2 tensile ~ .*1l., 11.4 kg br~ ln~ or, for ~ , a 0.~2 cm 1 ~.,-- t~ hookwire having 20,000 kg/cm~ teDsile t'~ -y.ll., 6.5 kg b~lrloa~ is 25 ;nsf,-~d in~o the tissue by way of the lumen 9 of the p~.l~ en.ll~reA ;~
needle. Ihen in~lortion needle 1 is withdrawn from the site, leav~g the hookwired in the lesion as a~ ~ marker of the po~iti~n of the lesion. The portion of the hoo~w~ that e~.,.g s f~om the wound (not shown) is taped to the ~l,jee~ s skin uDtil Sulg~ . If desired, ~e outer needle 1 can be ~ eeL~
30 over ~he hookwire during ~ ge,~r to ~u~idc a f~m guide for the ~eon's knife.
~1 21~39~
WO 93/14694 PCrlUSg3~0~384 Use The y~ss~ l.. c acco~ g to the ~_~Lioll can be usçd for ",r~ the ;.~t~ l fluid ~ in tissues. and for ~ til~ leSiQnS iIl thç
tissues, at any of various sites within the s.lkj~;l s body.
5 Preferably the a~ç~ ~h~c is c~lihratp~l just prior to use. Such c~lih~ can coL.~cn~ be ~ rol~ed using a water colllnln, and a zero ~f.,.e~ce point is plcfcrably 0~ ;..Pd by placing the sensor tube tip and i~e.LiQll need~e tip at skin level. The user then i~ ces the; ~ needle, CO ~ the sçnsor tube in proper ~1. ,--.. ~l as indicated by the ~ l marks on the hubs, into. the tissue 10 mass at a point where the ports can be c~rcct~ to be s;l~ in normal tissue.
Then proper co.~ I;o~. I~h..,~n the saline in the lumen of the sensor ~be and the ;--t~ l fluid in the tissues can be ch~ r~ æ follows. Pirst the plastic tubing co~nrc~ the ~ ~e ~ u~r wit~ the sensor tube is co~- sscd with a screw clamp. This ~ la~s a small a "lJ--"~ of fluid within~he tubi~g and the 15 lumen of the sensor tube, which should cause a ~ rise in the yles~
~ed by the !- ~ Jl,c~, the ~uid should, ~v.ided that there is proper fluid c~"""~";r-l;n." yui~ y Ihe.~ ar~r pass from the sensor tube ll~vugll the ports into the s,ulv~ dssues, allowing the p~ ulc~e.,ll tO renlrn quic~ to - - nnrrnstl, The clamp is then ~ ;e~ leco.n~ ss~ the tubing and ç~ a ZO l~ ..1d~l~;~inthe~ atthe~ eer,whichshouldagainquickly re~m to n9rm~1. The ~ies~e sensing tube lumen may be CQ~` cl~.~l tO have proper fluid co-~ ;--nl;h~ with the ;-~ ;I;A1 fluid of the tissues if, followingCO~ S;OIL and ~o-..~ .sion in such a test, the stable value ..~ u~-nf~ re within 15% of each other.
The a~ aluS iS then a~l~d into the tissue and the i-~t~ fluid ;,~c is co..1;..-~ c~ cof~ed (or ~ev~ded at closely-spaced intervals~. As the a~pzlalus enters a lesion, and the ;~t~ r~lrA~ ~h.~n nonnal tissue and a m~ t lesion i-lti ,f~ e is pierced, the p~ee ~ougll the ;.,t~,. r~e of the ports is e~l-e~d to be obs~ d as a sh~p and m~rlrpd ~l~5C in ~lC~ e depth of 30 the needle at the ;~lt. ~ r:-'`e i3 l~col~le~, and then the needle is a~l~,~d ~r~er into the tis~ue ~. u~l~ the lesion. As the ;l~ai~ s leaches the distal lesion~norma1 tissue ;~t~ - r~e the ~ s~&c through the ;.~t~- r~ce by the port3 as they leave the WO 93tl4694 ~ 2f S 399 3 PCl~/US931003g4 lesion mass is o~s~ d at the lesionlnormal ~ssue ;~.t ~ r~C as a sharp and m~rk~d -in ~he --r~ -uP~ t~ l fluid p~,~ c~ , the ~ islrP rapidly falIing f~om ~e int~n~ S~ of tihe lesion to the e~ d p.~ of no~ issue.
Using ~is mPth~ a series of - r~ .It~ along a path ~ s appr~ t~ ly lQ
S ......~ to c~mrl~
Proper fluid co~ he needle and the ;~ I;I.al fluid of ~e lesion can be co..l ;....rd by co~ .~s~;n~ C~ the ~bing whil~
the needle is ~ within ~he lesion. One may wish to cO~r~t~ this I jor ~1 step ~hen the ~IICd;~lL~d IFP wi~in a lesion is very low or c~ hl,e 10 to the ~lF~ s~u~ in normal tissues, in order to cnsure the ~c--~ y of the ~P~ , p~rtir~ rly as a low IFP within a lesion can be ;n~ ;ve that ~e lesion is benign.
The~ nl~ ~ u-~ d above canthenbe L~ using &~ull~er~
L_.ISlllg ~ n~ ata ~;rr~....~ 1~A1;0.. wi~hin~helesion. Two;-~
15 ~F~ F --r~ of the IFP wi~in a lesion can il~ the accuracy of the ~l:~..n.~:~, and ~e~ of the entry and exit points of the needle along two (or more) pa~hs wi~hin a lesion will allow a more ~ ~ e~ of the size of the lesion.
Once the lnr~tinn of the lesion has been ~ t~ l~r A~....;~r~ the sensor 20 tube is WillldLa~YlLfrom the ;~ Dee~e, leaving the ;.~ le in situ,and a Loohwi--_ is ;-- - . ~ via the in.~ Deedle lumen into the tissue at the ;~clF ~L;~. needIe tip. Tne ;~ ... Deedle is then ~ilh~awn from the tissue mass,leaving ~he hoG~w.re j",~l_"t~ in ~e lesion as an ~ ;iv~ and secure ~h, of the l~l~o~. of the lesion.
Other ~
Other ~...ho~l;~,,P..l~i are wi~ the following claims.
For ~ ", rA~ devices other ~han the fiber~ t~ tube des~ 1 above could be could be used in ~c~ with the ;~ eedle to u~e~ul~ ~he ;~ ;I;al ~ . Available l~lc~a~ devices ~hat can be 30 A~1al~ted for uce m the i~ ion include devices based upon ~he pL ~ 1r;r effect or upon ~exion of fi~er optic devices. Such ~lt~ te ~ devices . ~ . .
Wo 93/14694 2 I 5 3 9 9 3 Pcr/usg3~n3x4 may have the benefit of ~ ;r- a."l~ c;~ the length of time r~ui~ed to ~r~-~J-~t~ t~. - --;- ~ the ;-.~ fluid ~.~,. -Measul. ~e~ts of indicia other than IFP which show the l ,. ~c of a lesionat a given point in tissue, and ~c.. fv~ of the loc~tinn of the lesion withiD the 5 tissue mass, can be used in place of or in ad~ n to IFP ~Ul~ ,Yrn~. Ot~er t~ s which can be ,uea~ d in~lllde~, for e ~ lr~ t~ l fluid pH or oxygente~sion("PO2"). ~ results ~ -'h thatthe e~ lhll~r pH of a m~ nt lesion can be lower than that of nomlal tissue, and that ~he pO2 of a m~ nt lesion can be lower tban that of normal tissue. I~P~ c.lt~ of such 10 ~h.~.nt-t~ , p~ably CimIl~ ro~ with and at the same ~edD~ ~c~l points as ~he p~.DD~ e nf ~ C~Q col,~bG~ ; the ~i~no~;c pi~ided by the ,~ DDUl`~
l~e~SU1~ D~ MOLe~ , the choice of tI~e-, ~ ;c mPthod for lu~ a~l~, a lesion can be ;,~ t:.nl.~lly ben~ d by ~r~ CCrtain tiDSUe ~a.,.~ S wi~hin the lesion other than ~ . Somc th~ .t;t~ co~n~ ...C are knoum to be more 15 or less eff~cli~ than others at thc particular pH or at the PO2 ~ ~o~ h ~ within a given lesion. For i t~ e, a lesion having a low ;.~t~ ;I;al pH could ;-...n~A;~3,1y be treated with drugs which arc known to be more er~ , in acidic e,l~h~ . Thus the knowledge of the e n~ t within a lesion will provide the c l;,~;r;_l. with i~ .. which allows decisi~e and errcc~ in~
20 of drug or ~ tl~ pirs.
Th~ d ~ .bl~r acconlin~ to the i~ Qliun, as ~ n~lly and ~1~ above, can readily malce use of a sensor device, cap~hlf- of ...c~
one or more ~ -Ptr ,~ other than p,. s~, adapted for i~ ~h ~ 5,, by way of an ,.with(as,for~ rk, withinthclumen)ani~sc.liu~needle~ For 25 ;-~ e once the lesion has been located as ~le~- ;l-ed above, the ~ sensor ube can be willl h~wll and a fiber-op~c sensor put i~ its place, capable of ~ P~ - ;~ pH, PO2, PCO2, and the t~ within ~e lesion. A fber optic s~ ~ device capable of takiDg such ~c~ul~,l.e,l~ and ad~l~t-hle for use acco.~li~ to the i,l~_~ion has been d~_loped, for ~ le/ by Puritan ne~e.
Corp., (see, e.g., ~F~FEs~e~h~ January 1992, pp. 61 etseq.).
Claims (26)
1. A method for determining the locus of a pathologic change within a tissue mass, said pathologic change being characterized by a difference, with respect to normal tissue, in at least one tissue parameter, comprising the steps of:
inserting into the tissue mass a sensor including an insertion tube having a lumen and a sensor tube having a lumen, said sensor tube disposed within the lumen of said insertion tube, said sensor tube slidably engageable with the insertion tube, at least part of the sensor tube in fluid communication with the tissue mass, said sensor tube capable of measuring said at least one tissue parameter, measuring said tissue parameter at a plurality of points in at least one path through the tissue mass while at least part of the sensor tube is in fluid communication with the tissue mass, recording the tissue parameter, and comparing the recorded tissue parameter with a tissue parameter indicative of a pathologic change in a tissue mass said tissue parameter indicative of a pathologic change being within the locus of the pathologic change.
inserting into the tissue mass a sensor including an insertion tube having a lumen and a sensor tube having a lumen, said sensor tube disposed within the lumen of said insertion tube, said sensor tube slidably engageable with the insertion tube, at least part of the sensor tube in fluid communication with the tissue mass, said sensor tube capable of measuring said at least one tissue parameter, measuring said tissue parameter at a plurality of points in at least one path through the tissue mass while at least part of the sensor tube is in fluid communication with the tissue mass, recording the tissue parameter, and comparing the recorded tissue parameter with a tissue parameter indicative of a pathologic change in a tissue mass said tissue parameter indicative of a pathologic change being within the locus of the pathologic change.
2. The method of claim 1 wherein said parameter is interstitial fluid pressure.
3. The method of claim 1, further comprising measuring at least one further tissue parameter in at least one of said points in at least one of said paths.
4. The method of claim 1, further comprising inserting a tissue marker into the lesion along a portion of the path.
5. The method of claim 4, said tissue marker comprising a hookwire.
6. Apparatus for measuring a tissue parameter at a plurality of points in at least one path through the tissue mass, comprising an insertion tube, sharpened at a distal end and made sufficiently rigid so that said insertion tube can be inserted distal end foremost into the tissue mass along the path, and, insertible with said tube, a sensor capable of providing a measure of the tissueparameter at a point in the tissue mass along the path.
7. Apparatus for locating a lesion in a tissue mass, comprising an insertion tube, sharpened at a distal end and made sufficiently rigid so that said insertion tube can be inserted distal end foremost into the tissue mass along a path, and, insertible with said tube, a sensor capable of providing a measure of a selectedtissue parameter at a plurality of points in the tissue mass along the path, whereby a measure at a point in the tissue mass of the selected tissue parameterprovided by said sensor that is distinguishably different from measures of the selected tissue parameter in normal tissue indicates that the point is within a lesion.
8. The apparatus of claim 6 or 7, the tissue parameter being interstitial fluid pressure, wherein said sensor comprises a pressure sensor.
9. The apparatus of claim 8, a wall of said insertion tube including a first port near said distal end, said sensor comprising a sensor tube slidably engageable within the lumen of said insertion tube, said sensor tube being closed at a distal end, the wall of said sensor tube having a second port near said distal end, said first and second ports being positioned in relation to said respective distal ends such that when said sensor tube is engaged within said insertion tube lumen said ports can be substantially aligned, to provide fluid communication between the lumen of said sensor tube and the tissue adjacent said insertion tube port, said sensor tube lumen containing a plurality of filaments, and said sensor tube lumen being operationally connected to a pressure measurement device such that said pressure measurement device is responsive to fluid pressure within said sensor tube lumen.
10. The method of claim 1, wherein the step of inserting a sensor comprises inserting a sensor including an insertion tube and a sensor tube, said insertion tube provided with a first aperture adjacent an open end thereof, said sensor tube provided with a second aperture adjacent a closed end thereof, said sensor and insertion tubes arranged for movement from a first position, where the first and second apertures are substantially aligned, to a second position, where the first and second apertures are not substantially aligned, alignment of said apertures providing fluid communication between the tissue mass and the sensor tube.
11. The method of claim 10, wherein the step of inserting a sensor further comprises inserting a sensor including a means for measuring a tissue parameter disposed within the lumen of the sensor tube, said means capable of measurement when the sensor and insertion tubes are in the first position.
12. The method of claim 11, wherein the means for measuring a tissue parameter comprises a plurality of filaments within the lumen of the sensor tube, the filaments responsive to fluid within the tissue mass when the sensor and insertion tubes are in the first position.
13. A method for determining the locus of a pathologic change within a tissue mass, comprising the steps of:
providing a sensor to the tissue mass, said sensor capable of sensing a parameter of interstitial fluid in the tissue, said parameter of interstitial fluid including at least one of interstitial fluid pressure, interstitial fluid oxygen tension, or interstitial fluid pH;
inserting the sensor into the tissue mass along at least one path, positioning said sensor at a plurality of points within the tissue mass along said path;
recording the value of the sensed interstitial fluid parameter at said plurality of points within the tissue mass; and comparing the recorded parameter values to a parameter value known for normal tissue, said recorded parameter value that is altered from the normal parameter value indicative of a pathologic change in the tissue mass, wherein a parameter value that is indicative of a pathologic change in the tissue mass is identified as an increased interstitial fluid pressure, a decreased interstitial fluid oxygen tension or a decreased interstitial fluid pH.
providing a sensor to the tissue mass, said sensor capable of sensing a parameter of interstitial fluid in the tissue, said parameter of interstitial fluid including at least one of interstitial fluid pressure, interstitial fluid oxygen tension, or interstitial fluid pH;
inserting the sensor into the tissue mass along at least one path, positioning said sensor at a plurality of points within the tissue mass along said path;
recording the value of the sensed interstitial fluid parameter at said plurality of points within the tissue mass; and comparing the recorded parameter values to a parameter value known for normal tissue, said recorded parameter value that is altered from the normal parameter value indicative of a pathologic change in the tissue mass, wherein a parameter value that is indicative of a pathologic change in the tissue mass is identified as an increased interstitial fluid pressure, a decreased interstitial fluid oxygen tension or a decreased interstitial fluid pH.
14. The method of claim 13, wherein the step of providing a sensor comprises providing a sensor including an insertion tube having a lumen and a sensor tube having a lumen, said sensor tube disposed within the lumen of the insertion tube and slideably engageable therewith, at least part of said sensor tube is in fluid communication with the tissue mass.
15. The method of claim 14, wherein the sensor further comprises an insertion tube and a sensor tube, said insertion tube having a first aperture an open end thereof, said sensor tube having a second aperture adjacent a closed end thereof, said sensor and insertion tubes arranged for movement from first position, where the first and second apertures are substantially aligned, to a second position, where the first and second apertures are not substantially alignment of said apertures providing fluid communication between the tissue mass and the sensor.
16. The method of claim 15, wherein the step of inserting a sensor comprises inserting a sensor including a means for measuring a tissue parameter disposed within the lumen of the sensor tube, said means capable of measurement when the sensor and insertion tubes are in the first position.
17. The method of claim 16, wherein the means for measuring comprises a plurality of filaments within the lumen of the sensor tube, the filaments responsive to fluid within the tissue mass when the sensor and insertion tubes are in the first position.
18. The method of claim 14 further comprising the steps of removing said sensor tube from said insertion tube and inserting a tissue marker into the tissue at one of said plurality of points, said one point having an altered recorded parameter value than the parameter value for normal tissue.
19. The method of claim 18 further comprising the step of removing said insertion tube from said tissue mass and leaving said tissue marker in said tissue mass.
20. The method of claim 18 wherein the step of inserting a tissue marker comprises inserting a hookwire.
21. The method of claim 18 further comprising recording more than one parameter of the tissue interstitial fluid along the same path.
22. A method for determining the presence of a pathologic change within a tissue mass, comprising the steps of:
providing to the tissue mass a sensor capable of measuring interstitial fluid pressure within said tissue mass;
advancing said sensor along a path into the tissue mass;
measuring interstitial fluid pressure at a plurality of points within the tissue mass as the sensor is advanced; and recording the interstitial fluid pressures at said plurality of points, wherein a first increase in interstitial fluid pressure is indicative of an interface between the tissue mass and a pathologic change therein.
providing to the tissue mass a sensor capable of measuring interstitial fluid pressure within said tissue mass;
advancing said sensor along a path into the tissue mass;
measuring interstitial fluid pressure at a plurality of points within the tissue mass as the sensor is advanced; and recording the interstitial fluid pressures at said plurality of points, wherein a first increase in interstitial fluid pressure is indicative of an interface between the tissue mass and a pathologic change therein.
23. The method of claim 22, wherein the step of providing a sensor comprises providing a sensor including an insertion tube having a lumen and a sensor tube having a lumen, said sensor tube disposed within the lumen of said insertion tube and slideably engageable therewith.
24. The method of claim 23, further comprising removing said sensor tube from said insertion tube and inserting a tissue marker into the tissue mass at one of said plurality of points, said point having said first increase in interstitial fluid pressure.
25. The method of claim 24, further comprising removing said insertion tube from said tissue mass and leaving said tissue marker within said tissue mass with a distal end of said tissue marker at said point in said tissue mass having said first increase in interstitial fluid pressure.
26. The method of claim 24, wherein said step of inserting a tissue marker into the tissue mass comprises inserting a hookwire into said tissue mass.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US82170992A | 1992-01-16 | 1992-01-16 | |
| US07/821,709 | 1992-01-16 |
Publications (1)
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|---|---|
| CA2153993A1 true CA2153993A1 (en) | 1993-08-05 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002153993A Abandoned CA2153993A1 (en) | 1992-01-16 | 1993-01-15 | Method and apparatus for locating tumors |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US5396897A (en) |
| AU (1) | AU3475493A (en) |
| CA (1) | CA2153993A1 (en) |
| WO (1) | WO1993014694A1 (en) |
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1993
- 1993-01-15 AU AU34754/93A patent/AU3475493A/en not_active Abandoned
- 1993-01-15 CA CA002153993A patent/CA2153993A1/en not_active Abandoned
- 1993-01-15 WO PCT/US1993/000384 patent/WO1993014694A1/en active Application Filing
- 1993-05-03 US US08/058,682 patent/US5396897A/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| AU3475493A (en) | 1993-09-01 |
| US5396897A (en) | 1995-03-14 |
| WO1993014694A1 (en) | 1993-08-05 |
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| Date | Code | Title | Description |
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| FZDE | Discontinued |