CA2181545A1

CA2181545A1 - Endoscopic multiple sample bioptome

Info

Publication number: CA2181545A1
Application number: CA002181545A
Authority: CA
Inventors: Charles Raymond Slater; Matthew Albert Palmer; Saul Gottlieb; Jurgen Andrew Kortenbach; Michael Sean Mcbrayer
Original assignee: Individual
Current assignee: Boston Scientific Miami Corp
Priority date: 1994-02-01
Filing date: 1995-01-17
Publication date: 1995-08-10
Also published as: DE69530130T2; DE69530130D1; US5647115A; AU1568695A; JPH09508540A; US5951488A; JP3589671B2; ES2194901T3; EP0843533A1; US5542432A; EP0843533B1; CN1143899A; WO1995020914A1; EP0843533A4; ATE235189T1; AU694757B2

Abstract

An endoscopic multiple sample bioptome (10) includes a hollow outer member (16) and an axially displaceable inner member (18) extending therethrough. The proximal ends of the outer and inner members are coupled to an actuator (24) for axially displacing one relative to the other. The distal end of the outer member (16) is coupled to one of a cylinder (40) having a sharp distal edge (42) and a jaw assembly (44), while the distal end of the inner member (18) is coupled to the other. The jaw assembly includes a pair of opposed preferably toothed jaw cups (46a and 46b) each of which is coupled by a resilient arm (50a and 50b) to a base member (52).

Description

WO 9S/20914 r~l,L,.. C ~ ~3 -e ~ TTIPI~ 8AXPLB BI~E_ TECHNICAL FIELD
1. Field of the Invention This invention relates to ~n~scopl ~ surgical in:,~L t~. Nore particularly, this invention relates to an il.~LL, ~ for taking multiple biopsy tissue samples.

2. State of the Art vyic biopsy pLc,~e.luL~=s are typically peL~
with an - ~ l ~sc~,l,e and ~n ~ s~ ic biopsy forceps device (bioptome) . The o~lo5~ -~e is a long floY~h~o tube carrying fiber optics and having a narrow lumen through which the bioptome is inserted. The bioptome typically 1 n ~ oc a long fl oYihle coil having a pair of opposed ~awC at the distal end and manual actuation means at the proximal end.
~In1r~llation of the actuation means opens and closes the j~ws. During ~ biopsy tissue ~ l ~n~ operation, the surgeon guides the ~ s~ ,~e to the biopsy site while viewing the biopsy site through the fiber optics of the 6u~,,e. The bi~ is inserted through the narrow 2 0 lumen of the ~ c<,~e until the opposed j aws arrive at the biopsy site. While viewing the biopsy site through the fiber optics of the ~ c- ~ e, the surgeon positions the jaws around a tissue to be sampled and ~-n~ tes the actuation means so that the jaws close around the tissue. A
sample of the tissue is then cut and/or torn away from the biopsy site while it is trapped between the jaws of the bioptome. Kecping the jaws closed, the surgeon withdraws the bioptome from the ~-nl~sa,le and then opens the jaws to collect the biopsy tissue sample.
A biopsy tissue 11 n~ p~ e~1UL~ often requires the taking of several tissue samples either from the same or from different biopsy sites. UnfuL l.u~ately, most bioptomes WOgS120914 r~ ,.cc6^~ --~8~

are limited to taking a single tissue sample, after which the device must be withdrawn from the P l~6c.,~,e and the tissue cnl 1 P~ Pd befo~e the device can be used again to take a sQcond tissue sample. The single _ 1 e limitatlon Or most bioptomes is due to the limited space between the biopsy forceps jaws. Several attempts have been made to provide an irl ,~L~ ~ which will allow the taking of several tissue samples before the ina~L~ must be withdrawn and the samples c~ c~ed. Problems in providing such an ira-L~ ~ include the ~.~L~ -ly small size required by the narrow lumen of the ~ 5~ ,e and the fact that the il.n~L must be flPY;h]P in order to be inserted through the lumen of the ~ ac ,l,e. Thus, several known multiple sample biopsy ih~L ~a are precluded from use with an e~ ,l,e because of their size and rigidity. These include the "punch ~nd suction type" i~a~L - which are li~nlo~
in the prior art. Such devices have a hollow tube with a punch at the distal end and a vacuum source coupled to the proYimal end. A tissue sample is cut with the punch and 6l~c~ioned away from the biopsy site through the hollow tube.
It is gPnPrally rPco7ni~d~ however, that sll~tion1n~ tissue samples through a long narrow ~lPYihle bioptome is virtually 1 _ ~hle.
}!:fforts have been made to provide a multiple -ability to an irla-L, ~ which must LL~v~Lae the narrow lumen of an ~ e. These efforts have c~ e.ted on providing a cylindrical storage space at the distal end of the ifi-- LL, : wherein several tissue samples can be ac l~ted before the ir. ~LL~ is withdrawn from the ~ o~lc~l,e. U.S. Patent No. 4,651,753 to Lifton, for example, discloses a rigid cylindrical member ~tt~hP~l to the distal end of a first flexible tube. The cylindrical member has a lateral opening and a cu~ rlc cylindrical knife blade is slidably mounted within the cylindrical 35 member. A second flexible tube, ~ ~.- I,Lrlc to the ~irst WO 95/20914 1 ~
~1~154~

., ~ , . . .
., ~
tube is coupled to the hnife blade for moving the hnife blade relative to the lateral opening in the cylindrical member. A third ~l PY; hl e tube having a plunger tip is mounted within the second fleYible tube and a vacuum source 5 (a syringe) is coupled to the proximal end of the third tuhe. A tissue saLple is taken by bringing the lateral opening of the cylindrical member upon the biopsy site, applying vacu~L with the ,syringe to draw tissue into the lateral opening, ,and pushing the second flPY;hle tube 10 forward to move the knife blade across the lateral opening.
A tissue sample is thereby cut and trapped inside the cylindrical hnife within the cylindrical memher. The third flPY;hle tube is then pushed forward moving its plunger end against the tissue sample and pushing it forward into a 15 cylindrical storage space at the distal end o~ the cylindrical member. ApproYimately six samples can be stored in the cylindrical member, after which the inDLL, ~ is withdrawn from the ~I f~ c ~. A distal plug on the cylindrical member is removed and the six samples are 20 c-~llP~tPd by pushing the third tube 80 that its plunger end ej ects the samples .
The device of the Lifton patent surfers from several rP~o~r;~hle dL ~ &chs. First, it is often ~ ;r~lt to obtain a tissue sample laterally of the device. Second, in 25 order to eYpedite the obtaining of a lateral sample, a syringe is used to help draw the tissue into the lateral opening. However, this causes what was once a two-step pLUCf d~lL~ (position and cut), to become a three-step pIu~ d~ (po8ition, suction, cut~. In addition, the use of 30 a syringe re~uires an additional hand. Third, the Lifton patent adds a fourth step to the biopsy pLu~f duL~ by re~uiring that the tissue sample be pushed into the storage space. Thus, in all, the Lifton patent re~uires D~ DL~ A
ef~ort on the part of the surgeon and an assistant and much 35 û~ this effûrt is involved in pushing tUbes, an action which wo 95/20914 F~llu~ ;q~ --is counter-intuitive to cl s~ A l biopsy 1 ~ nq ~ The preferred mode of operation of virtually all ~ ,L,ic toolfi is that a gripping action at the distal end of the il.oLL ~ is efrected by a similar action at the proximal 5 end of the illoLL~ lA~icS~l biopsy forceps jaws are closed by 8-~7PP7 - n~ a manual actuation me~ber in a syringe-like manner.
A more convenient -n~ln~a<" ic ~ultiple sample biopsy device is r.'.--ln~Q~', in U.S. Patent No. 5,171,255 to ~ydQll.
10 Rydell provides a flexible ~- loscv~ic ir. LLI ~ with a knife-sharp cutting cylinder at its distal end. A coaxial anvil is coupled to a pull wire and i8 actuated in the same manner as convpnti~ns7l biopsy rOrceps. When the anvil is drawn into th~ cylinder, tissue located between t~e anvil 15 and the cylinder is cut and pushed into a storage space within the cylinder. Several samples may be taken and held in the storage space before the device is witldrawn from the ~-nr7n~cope . While t le device o~ Rydell is effective in providing a multiple sample tool where each sample is 20 obtained with a traditional; , ol~ ~Lv~,e-lULe: (position and cut), it is still limited to lateral cutting which is often problematic. Traditional biopsy forceps provide jaws whic'.
can grasp tissue frontally or laterally. Even as such, it is difficult to position the jaws about the tissue to be 25 sampled. Lateral ~ l inq ig even more ~'i f~ t.
In addition to the biopsy pLV~.tSdUL~a described abovo, it is also sometimes 7~P~-~S~ y to obtain biopsy samples using an ~ cv~ i c tool which is inserted into a body cavity t'~rough a trocar tube or directly into a body cavity. These 30 PLUI3~I1UL~O typically involve t'le taking o~ tissue samples from the cerviY. .~any of the problems facing the "flexible"
biopsy ~orceps which are used in an ~ - ~'na~ v~e are not present in tle gynPcnl oq7.-;~l biopsy ~/LV.J~dULC.
Nevertheless, it is still often nP-~ or desirable to 35 take multiple cervical samples and the repeated insertion Wo 95/20914 r~.l/U.~ S/'~
~1815~5 and wit' ' 1 of the bi-L, prolongs the E~ ~;6du~ and in~iL.ascs the trauma to the patient.
DISCLOSURE OF lNV~,.._ It is thererore an object Or the invention to provide 5 an r~ c.,~ic multiple sample bioptl. - which is not limit~d to lateral tissue ~ l; n~.
It i8 also an object of the invention to provide an .,l, 4~VL.i ~ multiple 8ample bioptome which is easy to operate.
It is another object of the invention to provide an e~ L~; n multiple sample bioptome which is ; nF~ n~ive to r -nllfa~1-llre.
It is still another object of the invention to provide v~i c- multiple sample bioptome which has all of the 15 ~-~va~ a~e~ Or traditional biopsy forceps with the added ability to collect multiple ~;amples.
In accord with these objects which will be ~i~Cll~-e~l in detail below, the, . l~.~, ''L'~ C multiple ~;ample bioptome Or the present invention ;n~ a relatively long ~l~Y;hle member 20 having a lumen with an axially A~plA~eAhle wire extending LII~L~:thLu~yll. The proximal ends Or the ~lexible member and wire are coupled to a manual actuation means for axially p~ r;n~ one of the fleYible member and wire relative to the other. The distal end of the fl~Y;hl~ member is coupled 25 to one of a cylinder having a knife sharp distal edge and a ; aw assembly . The distal end Or the wire i8 coupled to the other o~ the cylinder and the jaw assembly. The jaw assembly includes a pair of opposed toothed jaw cups each of which is coupled by a narrow arm to a base member. The 30 narrow arm of each jaw is a rP~ nt member which urges each jaw away from the other. The base member of the ~aw assembly is mounted inside the cylinder and axial - .
Or one of the jaw assembly and cylinder relative to the other draws the necks of the jaws into the cylinder or moves Wo 95t209l4 . ~~
2~

the cylinder over the necks o~ the j aws to bring the ~ aw CUp5 t~cJ~I l..~r in a biting action.
Preferred aspects of the invention include: forming the jaw assembly from a single piece of spring steel:
5 col~rl in7 the distal end of the coil to the jaw asse_bly;
co~rl in~ the cylinder to the axially (iicplAceAhle wire; and providing the coil with a stiffening sheath or wire along ~i~lLDI _~L;A1 ly its entire length. It is additionally ~Le~eLL~ that the distal end of the wire be coupled to the 10 cylinder by welding, but other means such as a Z-bend in the distal end of the wire which enters and engages a punched ~nd bent portion of the cylinder wall may be used.
According to another ' ~ of the invention, an 6~ ,ic multiple sample bioptome is provided with a 15 relatively rigid hollow tube having ~ relatively rigid rod Q~nrlin~ th~:LeLIILu~ .. The distal end o~ the rod is coupled to a ~ aw assembly and the distal end of the tube is provided with a knife- sharp edge. The proximal end of the rod is coupled to a f iYed portion of a handle and the proximal end of the tube is coupled to a movable portion of the handle. IIJ~ L of the movable portion of the handle results in longitudinal ~ ~ of the tube relative to the rod and effects and closing of the jaws as described above.
The fixed portion of the handle is preferably provided with a thumb ring and the movable portion of the handle is preferably provided with a finger ring. The handle is gripped in pistol-like manner and sq~PYin~ the movable portion towards the fixed portion effects a closing of the ~ aws .
According to yet another . ' ; of the invention, the jaw assembly is formed from a single cylindrical piece of spring steel having a ~uL~-LA~I iAl ly hcmicrh~rical end.
The cylinder 15 cut by wire EDM (electrical discharge r-rhinin~) and/or lager r--hinin~ to provide a lower ~aw having a larger jaw cup than the upper jaw. The lower jaw .

~ wo ssl20sl4 r~
21~15~5 .
i5 also provided with a pair of proximally extending wings.
- The jaw teeth are preferably formed so that they are as s~all as p~ hl ~ but with the proYimal teeth havinq greater clearance than the distal teeth, e.g. by providing the 5 proximal teeth with a sharper angle than the distal teeth.
Additional objects and adv~ es o~ the invention will become ~aL~ to those skilled in the art upon reference to the detailed description taken in ~,o..~ Lion with the provided f igures .
BRIEF DES~;K~ OF n~ -Figure l is a side elevation view in partial section of the proximal end of a first ~ of the invention:
Figure 2 is an enlarged L~ side elevation view of the distal end of a first: ~ ~1- t of the invention 15with the jaws open;
Figure 3 is an enlarged LL ~r~D~a~ top view of the distal end of a first ' ~ of the invention;
Figure 4 is a view similar to Figure 2, but with the ; aws closed;
Figures 5a through 5e are views similar to Figures 2 and 4 showing a 5~ of biopay ~ n~ operations;
Figures 5f and 5g are views similar to Figure 3 showing the cutting action of the knife-sharp distal edge of the cylinder;
Figure 6 is a view similar to Figure l of the proximal end of a second ~-~ir ~ of the invention;
Figure 7 is a view similar to Figure 2 of the distal end of a second . ' 'i- ' of the invention with the jaws open;
Figure 8 is a view similar to Figure 7, but with the jaws closed;
Figure 9 is an enlarged top pl~n view of a sheet of punched steel which is rolled to form the jaw assembly of the invention;

WO 95/20gl4 , ,~ ,,,''C ~
a ~
218~45 Figure 10a is an enlarged ~2roken side elevation view of a different ' '; L Or control wire ro~rl ;n~;
Figure 10b is a cross sectional view along line B-B in Figure 10a;
Figure lla is a view similar to Figure 10a but of yet another: ' ~ ';- ' of control wire courl ;n~;
Figure llb is a cross sect1-~n2tl view along line B-B of Figure lla;
Figure 12 is a broken side elevation view in partial section Or third: ' -~;r t of the invention;
~igure 13 is a side elevation view of a different t Or the jaw assembly;
Figure 13a is a cross 2sectional view along line A-A in Figure 13; and Figure 13b is a cross Eec~ n2~l view along line B-B in Figure 13.
~ODE FOR r~ YT~ - OUT TEIE lhVl~
Referring now to Figures 1 through 4, a first c ' ~'; ~ of the multiple sample bioptome 10 inrlll~P~ a proximal handle 12 and a distal end effector 14. A long 1'1PY;hle coil 16 having an axially fl;cplAre2~hle control wire 18 PYtPnrl1n~ therethrough couples the handle 12 and the end effector 14. The coil 16 is pre~erably covered with a PTFE, FEP or polyolefin sheath 15 along substAnti2l11y all of its length and a strain relief sleeve 17 covering a portion of the coil which extends from the handle 12. The control wire 18 is preferably flPY;hle but longi~ ;n2~11y inelastic and is ideally formed from 304 Steel and provided with and outer ~; 2 t --r of approYimately . 018 inch. The proximal handle 12 ;nrl~ P a central shaft 20 and 2I tl;cpl2~r~2t~1e 2spool 22.
The proximal ~nd of the sh2lft 20 is provided with a thumb ring 24 and a longitudinal bore 26 is provided at the di2~tal end Or the shaft 20. A longitudinal slot 28 extends from the proYimal end of bore 26 to a point di2~tal of the thumb -~ Woss/20914 p~ 75~r~
~81~5 -ring 24. The Aicrl~re~hle spool 22 is provided with a cross member 30 which passes through the slot 28 in the central sha~t 20. The cross member 30 is provided with a central through hole 32 and a radially ~n~a~in~ set screw 34.
According to the first . i of the invention, a short bore 36 and a radially ~n~a~in~ set screw 38 are provided in the shaft 20 distal of the thumb ring 24 with the bore 36 ;r~ting with the longitudinal slot 28. In the first L of the invention, the proximal end of the coil 16 extends into the central through hole 32 in the cross member 30 and is fiYed there by the set screw 34. The proximal end of the control wire 18, passes through slot 28, is inserted into the short bore 36, and held there by the set screw 38.
From the foregoing, those skilled in the art will appreciate that relative ~ of the shaft 20 and spool 22 results in - ~ ~ t Or the control wire 18 relative to the coil 16 .
Such action results in actuation o~ the end e~fector 14 as described in detail below.
Turning now to Figures 2 through 4, the end effector 14 includes a cylindrical sleeve 40 having a knife-sharp distal edge 42, and a jaw assembly 44. The jaw assembly 44 inrll-A~c a pair of opposed jaw cups 46a, 46b each preferably having a plurality of sharp teeth 48a, 48b. A r~C~ nt, preferably narrow, arm 50a, 50b extends proximally from each jaw cup 46a, 46b. A cylindrical base member 52 joins the proximal ends of the arms 50a, 50b. Because the arms 50a, 50b and the jaws 46a, 46b are preferably formed from a deep drawn piece of spring steel as di~c~ ed in more detail below, as seen best in Figure 2, the narrow resilient arms 50a, 50b may be bent apart from each other, thereby urging the jaw cups 46a, 46b apart. According to the first ';- L of the invention, the cylindrical base member 52 is coupled to the distal end of the fl~Yihle coil 16 by welding, soldering, crimping, or any other suitable manner.
The cylindrical sleeve 40 is coupled to the distal end of Wo s5J2/~9l4 ~15~

the control wire 18 by providing the sleeve 40 with a lateral hole which engages a b~nt ~nd 18a Or the control wire 18. As ~hown in Figures 2 through 4, the bent end 18a of the control wire 18 is welded to the hole 45 in the side 5 of the sleeve 40. ~owever, as will be described in detail herein below, other methods of col~rl;n~ the control wire to the sleeve are poc~hl e. The cylindrical sleeve 40 is slidably mounted over the cylindrical base member 52 as shown in Figures 2 and 3 and is axially movable over the rc-c;l ;~nt arms 50a, 50b as shown in Figure 4.
As seen in Figure 3, the jaw cups 46a, 46b have an ~CC6..LL1C cross section with their widest point indicated by the line 47. Distal of the line 47, the jaw cups arQ
subs~nt;F~lly hPmicrh~rical and proximal of the line 47, the 15 jaw cups are ..~ l ly hemi-elliptical. The teeth 48a, 48b are arranged so that the ~ aws ; ntarl orl~ when closed as shown in Figure 4. I~ the jaws are formed by wire EDM, teeth are formed only on the sides of the jaws. If the jaws are formed by laser cutting, however, it is po~C;hle to 20 arrange the teeth radially along the sides and the front of the jaws. It will also be seen that the side walls of the ~aw cups 46a, 46b taper towards the arms 50a, 50b to prov$de a smooth transition from the jaw cups to the arms.
From the foregoing description and with L~feLe..ce to 25 Figures 1 through 4, those skilled in the art ~ill appreciate that when the Lpool 22 and the shaft 20 are axially ~;rrlnr~ relative to each other, the cylindrical sleeve 40 and the jaw assembly 44 are similarly axially tl;crli~recl relative to each other, from the positions shown 30 in Figure 2 to the positions shown in Figure 4 and vice versa. It will also be appreciated that when the spool 22 and shaft 20 ~re in the approximate position shown in Figure 1, the cylindrical sleeve 40 and the ~aw assembly 44 will be in the approximate position shown in Figure 2; i. e., with 35 the jaws open. Thus, those skilled in the art will further ~ Wo s5/2o9l4 r~
~18~5~5 appreciate that when the spool 22 is moved towards the thumb ring 24,;!or viice versa, the cylindrical ~;leeve 40 and the ~aw assembly 44 will be brought into the approximate position shown in Figure 4; i.e., with the ~aws closed.
Il ~L~ ,.Cr, it will also be appreciated that it is preferable to move the thumb ring 24 relative to the spool 22, rather than vice versa æince that will move the cylindrical sleeve 40 relative to the j8W as~embly 44 rather than vice versa.
This is desirable 80 that the jaw assembly is not moved away from a tissue sample while the ~aws are being closed.
Turning now to Figures 5a through 5e, the operation of the multiple sample bioptome or the invention is illustrated lly in 8~ . A8 seen in Figure 5a, a first tissue sample is taken by positioning the ~aw cups 46a, 46b around a tissue 60 to be sampled. The handle of the bioptome is u~cL~ted as described above 80 that the cylindrical sleeve 40 is moved distally over the narrow arms 50a, 50b of the j~w assembly 44 to the position ~pproximately shown in Figure 5b. When the sleeve 40 is moved toward this po6ition, the jaw cups 46a, 46b are brought close to each other and the teeth 48a, 48b of the ~aw cups 46a, 46b engage the tissue 60 and bite into it.
Cont~ .a~,u~ly, and as seen with reference to Figures 5f - 5h, the knife sharp edge 42 Or the sleeve 40 severs any tissue 60 ~Yt~nAing from the lateral sides of the jaw cups 46a, 46b. A first sample 60a of the tissue 60 is thereby trapped between the ~aw cups 46a, 46b and severed rrom the tissue 60. It should be noted that while taking the bite, the coil 16 i~ not free to stretch, as it is kept longit~lA~n~lly stirf by the shrink wrap or sheath 15 which extends along the length o~ the coil. If desired, a wire can be used instead of the shrink wrap or sheath. The wire, which would typically be flat, would be attached to the proximal and distal ends of the coil to keep the coil in tension and prevent it from 8tretching as the sleeve is WogS/20914 r~ .,sc ,~ --I .

moved rorward and a bite taken.
With the end effector 14 in the position approximately shown in Figure 5b, the multiple sample bioptome may be relocated to another tissue area for 1 ln~. The handle 5 Or the bioF ~ i5 operated as described above 80 that the cylindrical sleeve 40 is moved proximally over the narrow arms 50a, 50b Or the jaw assembly 44 to the position approximately shown in Figure 5c. When the sleeve 40 is moved towards this position, the jaw cups 46a, 46b are 10 biased apart by the ro~;l ;on/-~o Or their respective arms 50a, 50b. The jaw cups can then be positioned around a second tissue 61 for _lirl~. The yL;ICe~lULe: described above with L~reL~ e to Figures 5a and 5b is repeated. In this instance, how~aver, as the jaw cups 46a, 46b are brought into 15 position, the tissue 61 pushes the first sample 60a proximally away from the jaw cups 46a, 46b and into the space between the narrow arms 50a, 50b as seen in Figure 5c.
Those skilled in the art will appreciate that the tissue sample 60a is typically gummy and pliant and will stick to 20 and move along one or both Or the narrow arms 50a, 50b Or the jaw assembly 44. The samples will also stick to each other. Upon the taking of a sample 61a from the tissue 61, both samples 60a and 61a are safely trapped between the narrow arms 50a, 50b of the jaw assembly 44 as shown in 25 Figure 5d. The yL~ce-luLe described above with rererence to Figures 5a through 5d is then repeated as suggested in Figure 5e until the space between the arms 50a, 50b is filled with samples 60a, 61a, etc. According to a presently prererred ~ of the invention, six samples may be 30 ~;ay~uL~d between the arms of the ~aw assembly. The presently preferred A;- -iO''I'' Or the jaw assembly are approximately . 45 inch long by approximately . 095 outer 11;~ ' .
Figures 5f - 5h show a top view Or the se~lon~ e of 35 operations ~loritod in side views in Figures 5a ~md 5b.

WO 9~/2091~ P~ J"~

From the top view of Figure 5f, lt can be seen that the tissue 60 extends beyond the sides of the jaw cup8 46a, 46b.
The knife-sharp distal edge 42 of the cylinder 40 trims the tissue 60 which extends beyond the jaw cups to completely sever the sample 60a from the tissue 60 as shown in Figures 5g and 5h.
A second ~ o~ the invention is shown Figures 6 through 8. In this ~ -'; It, a proximal handle 112 and a distal end effector 114 are coupled by a long ~1PV1h]e coil 16 having an aYially ~ plA~e:~hle control wire 18 eYtPnd~
th~I~thLuu~h. The proximal handle 112 inrl~ a central shaft 120 and a fl~pl~AcPAhle spool 122. The proximal end of the shaft 120 i8 provided with a thu~b ring 124 and a stepped longitudinal bore 126 i5 provided at the distal end of the shaft 120. A longitudinal slot 128 extends from the proximal end of bore 126 to a point distal of the thumb ring 124. The d;~plA~A~h~A spool 122 is provided with a cross member 130 which passes through the slot 128 in the central shaft 120. The cross member 130 is provided with a central hole 132 and a radially en~ ~in~ set screw 134. According to this second . ';- of the invention, the proximal end Or the coil 16 is fixedly mounted in the longitudinal bore 126 and the proximal end of the control wore 18 extends into the central hole 132 in the cross member 130 and is fixed there by the set screw 134. From the foregoing, those skilled in the art will appreciate that .~ ~ of the shaft 120 relative to the spool 122 results in r . ~ t of the control wire 18 relative to the coil 16. Such action results in actuation of the end erfector 114 as described in detail below.
As seen in Figures 7 and 8, the end effector 114 according to the second : ';- L of the invention includes a cylindrical leeve 140 having a knife-sharp distal edge 142 and a jaw assembly 144. The jaw assembly 144 includes a 35 pair of oppo8ed jaw cupS 146a, 146b each having a plurality Wo 95120914 1 ~ ~ C ~q . ~, of sharp teeth 148a, 148b. A resilient, preferably narrow arm 150a, 150b extends proximally from each jaw cup 146a, 146b. A cylindrical base me_ber 152 ~oins the proximal ends of the arms 150a, 150b. As seen best in Figure 7, the narrow rP~ Pnt arls 150a, 150b are bent apart from each other urging the ~aw cups 146a, 146b apart. According to the second ~ t of the invention, the proximal end or the cylindrical sleeve 140 is coupled to the distal end of the fleY;hle coil 16 by welding, soldering, crimping, or any other suitable manner. The cyl ~n~ArioAl base member 152 o~
the jaw assembly 144 is coupled to the distal end of the control wire 18 by providing the base member 152 with a lateral hole 154 which engages a bent end 18a o~ the control wire 18 in a manner similar to that shown in Figure 3 in the description o~ the first ` ~ of the invention.
~owever, as will be described in detail herein below, ot'ler methods of col~rl n~ the control wire to the base me~l~ber are po~hl~. The base memher 152 and thus the entire ~aw assembly 144 is slidably mounted and axially movable within the cylindrical sleeve 140 as shown in Figures 7 and 8.
Those skilled in the art will appreciate that this Decond ~1- of the invention is quite similar to the first _ A; - ' described above except that the sleeve 14 0 is coupled to the coil 16 which is coupled to the central ~haft 120 of the handle 112 and the jaw assembly 144 is coupled to the control wire 18 which is coupled to the spool 122.
Operation Or this: ~ is D''~ y the same as the first ' ~ ~ described above.
The ~aws 44, 144 of the multiple sample bioptome of the invention may be formed in different ways. According to the presently ~ILCL~:LLe:d: ' _'i- ', a cylinder of 304 or 17-7 st--nlecs spring steel preferably having a 817: Pr just slightly smaller than the r'1; ~r of the 81eeve 40, 140 i8 deep drawn to provide an P~ r~ r~:D~ hPmi ~rhPrical bottom. The bottom of the cylinder is then cut u8ing wire electrical Wo 9S/20914 21~15~

-discharge ; n i n~ (EDN) and/or laser ~h i n i n~ .
Preferably, reciprocal teeth are cut into the periphery of the cylinder bottom, thereby forming the opposed ~aw cups.
However, even if no teeth are formed, the opposed ~aw cups 5 are provided with sharp cutting surfaces. Continuing away from the distal jaw cups, the arms zlre formed by tapering up a cutout of an approximately 100 - 135 degree section on two sides leaving arms which each extend about 45 - 80 degrees around the periphery o~ the cylinder. The so-formed jaws 10 are then bent away from each other to provide pre-loaded springy arms ( i . e ., leaf spring beams) which can be closed by the sleeve 40, 140 as described above.
According to another . ' i- L o~ the invention, the jaw assembly 44, 144 of either the first or the second 15 . ~ may be formed from a single sheèt of .005 inch thick 304, 17-7 steel which is cut and rolled. Figure 9 shows a plan view of a steel sheet 244 which has been cut to form the base member 252, the narrow arms 250a, 250b, the jaw cups 246a, 246b and the jaw cup teeth 248a, 248b. Those 20 skilled in the art will appreciate that the cutting of the sheet 244 may be ~ i F hQd in several ways, although photn-h~ l milling (PCN) is preferred. To facilitate automation in PCN, inti~Y;n~ holes 251a, 251b are provided in the base member portion of the sheet 244. These holes are 25 used to align the strip of PCN cutters in the pLu~Lc ssive forming dies. After the sheet is cut, it is pressed ~nd rolled to form an integral unitary ~aw assembly as shown in Figures 2-4, 7 and 8.
As mentioned herein above, there ~re several ways in 30 which the distal end 18a of the control wire 18 may be coupled to the cylindrical sleeve 40 or the base member 152 of the ~aw asEembly 144. While welding is the presently preferred method, Figures lOa through llb show two other methods of co.lrl i n~ the distal end of the control wire 18 35 with either the sleeve or the jaw assembly.

WO 95/2091~ "
218t 5i~S 16 As shown in Figures lOa and lOb, the distal Qnd 18a of the control wire 18 i8 provided with a Z-bend. ThQ side wall of the cylindrical sleeve 40 or the base member 152 is punched with two spaced apart semicircular holes 145a, 145b leaving a bPnt3Ahle narrow strip 145c between them. The narrow strip 145c is bent radially inward a distance 81''~ ClQnt to A~ te the distal end 18a of the control wire 18. The Z-bend of th~ distal end 18a of the control wire 18 is inserted through the space formed between the narrow strip 145c and the semicircular holes 145a, 145b as shown in Figures lOa and lOb.
As ~hown in Figures lla, and llb, the side wall o~ the cylindrical sleeve 40 or the base meLber 152 is punched with a first hole 245a and a second hole 245c which is ci~ ibed by the first hole 245a. The first hole 245a is preferably ~ JIlAr, semicircular, or trarezQit3~l in shape to form a bQn~3~hl P tab 245b which is bent radially inward as shown best in Figure llb. The Z-bend Or the distal end 18a of the control wire 18 i8 inserted through the second hole 245c in the bQn~ hlP- tab 245b as shown in Figures lla and llb.
F~ gure 12 shows another ' ' ~ ~~ of a multiple sample bi~rt ~ 310 Or the invention which is particularly ~uited for ce~vical biopsy ~L~JCÇ:~lUL~3 or other biopsy ~L.,c~,luL. 3 where the biopsy site is ~L ~t l AhlP in a relatively short and direct path ral:her than through the long tortuous path of the lumen o~ an t~ ns~ æ. In this ~ , a proximal handle 312 is provided with a fixed portion 324 and a movable lever portion 322 which is coupled to the fixed portion by a pivot pin 323. A hollow tube 340 i6 coupled at its proximal end to the movable lever portion 322 of the handle 312 by a cross pin 341 or other suitable fastening means. A relatively rigid rod 318 extends through the tube 340 and is coupled at its proximal end to the fixed portion 35 324 of the handle 312 by means of a cro6s pin 319 or other wo9sl2o9l4 P~ ,,5l s~
~lgl~

suitable fastening means. The distal Qnd of the tube 340 18 provided with a knife sharp edge 342 and the distal end of the rod 318 is coupled to a jaw assembly 344 as described herein above. As shown in Pigure 12, the fixed portion 324 5 i5 provided with a lower thumb ring 324a and the movable lever portion 322 is provided with a lower finger ring 322a.
The upper end 322b of the movable lever portion 322 i5 provided with a slot 322c for ~n~gin~ the cross pin 341 and the rod 318 is provided with a slot 317 through which the 10 cross pin passes. Those skilled in the art will appreciate that the handle 312 is 1--n1rll1 ~ted using a convention hand-grip. Pivotal .~ L. of the movable lever portion 322 of the handle 312 as indicated by the arrows 321 results in 1 inear . ~ ~ of the tube 3 4 0 as indicated by the arrows 339. It will aLso be appreciated that the slots 317 and 322c may be di -i-n~ to limit ~ of the tube 340.
IIJ~ ~ of the tube 340 relative to the rod 318 results in opening and closing of the jaw assembly 344 as described herein above. The handle 312 described above may be used with the fl~Y~hle coil and pull wire described with reference to Figures 1 and 2 and c~ c.Dely, the handle 12 described with reference to Figure 1 may be used with the tube and rod aL.~.I, L described above with reference to Figure 12.
It will be appreciated that all of the ~ of the multiple sample bioptome ~hown in Figs. 1-12 can be provided with a cautery ~-~r~hil~ty. For example, as seen in Fig. 12, a cautery contact 398 is provided which cnnt~n~:
the rigid rod 318 and extends out o~ the fixed portion 324 of the handle 312. In addition, the tube 340 is provided with shrink wrap or other insulation 399. With the provided aL._I, t, when a cautery current is ~pplied to the cautery contact 398, the jaw assembly 344 is electrified via its cnrm~rti orl to the rod 318 . Typically, cauterization would be carried out after a 8ample i8 obtained and severed WO 9~20914 P~ J?~ ~
.
54~ 18 from the surgical ~ite with the jaws still located at the surgical site. B~cause the body o~ the patient acts as the second electrode (ground), current flows from the ~aws into the patient at the surgical site, thereby effecting a 5 cauterization o~ the surgical site rather than cauterizing the sample in the ; aws .
Figure 13 shows another '~ of a jnw asse_bly 444. The jaw assemhly 444 is prererably formed from an oblate &pring steel cylinder 443 having a ~ ;Al ly 10 ham1~rhD~-ical distal end 445 an somewhat flattened sides 441, 442. The cylinder 443 is cut using wire ED~ or laser r-r~hin;n~ along a zigzag lina 448 from the distal end 445 to form ~aw teeth 448a, 448b ~nd then along an upwardly ~n~ nr~ line 449 to form the jaw cups 446a, 446b. A
~ Ally C-shaped cut 450 forms the arms 450a, 450b which extend from the base portion 452 to the ~aw cups 446a, 446b. It is prererred that the arms 450a, 450b be as long as po~hle so that the ~aws can be spread ~ ciPntly far apart. In the presently preferred: -'; , the arms extend appr~Y1r~t~ly .5 - .6 inch from the base portion to the jaw cups. The cut lines 448 and 449 are axially offset so that the lower jaw cup 446b is larger than the upper ~aw cup 446a as seen best in Figure 13b. In addition, another substAnt~Ally C-shaped cut 451 is made at the proximal end of the lower jaw cup 446b to form two wings 453, 454 which are seen best in Figure 13a. After forming the ~aw assembly 444, the arms 4~0a, 450b are bent apart as shown in Figure 13c. The spring steel rrO~ which the jaw assembly was formed maintains this spread apart position with resilience so that the jaws can be squ~7r~ l together to the position shown in Figure 13 and spring apart to the position shown in Figure 13c. According to a pregently preferred:
the ~aw cups ~re bent approximately .25 inch apart, then closed and opened several times until the resulting opening 35 is about .18 inch. The upper edges 446c, 446d of the lower Wo 95120914 r~-,u~
~1~15~:

jaw cup 446b ~re bent slightly inward as shown in Figure 13b 80 that they ~re: ..ced by the upper jaw cup 446a when the jaws are closed. Similarly, the wings 453, 454 are bent radially inward as shown in Figure 13a. The jaw assembly 5 444 can be used with any o~ the bioptome:
described above.
The jaw assembly 444 described above provides several L~lrL a~lva--La~s. The oblate sides 441, 442 of the cylinder 443 help the teeth 448a, 448b to mesh without gaps.
The long arm6 450a, 450b allow for a wide opening o~ the jaws and for locating the spring area in the arms a sufficient A;~:ts~n~e from the distal end of the jaws 80 that the bending moments on the arms is low enough to avoid plastic deLc,~ ,tion. The wings 453, 454 s~Ah;li70 the jaws 15 against rotation during opening and closing and also protect biopsy samples in several ways. The wings form a storage chamber 455 (Figure 13a) which extends proximally from the lower jaw cup 446b and lJL~ v~l~L~ 1ated biopsy samples ~rom beiny s~oPzo~l laterally out ~rom between the jaws 20 during repeated opening and closing and protects them from being repeatedly trimmed by the sharp edge of the sliding tube. The larger lower ~aw cup 446b Pnh~nl~oa - ~ of biopsy sample~ into the storage chamber 455.
There ha~e been described and illustrated herein 25 several . ';- of an o~ 1oscvpic multiple sample bioptome. While particular ~ L,i of the invention have been described, it is not ; nton~lPd that the invention be limited thereto, as it is inton~lPd that the invention be as broad in scope as the art will allow and that the 30 ~re~; fiaation be read likewise. Thus, while particular configurations of the handle have been ~ lsF~ 7, it will be appreciated that other types of handles could be utilized.
Also, while spec;fi~ ~ollrl inq~ of the ends of the coil a}~d control wire have been shown, it will be rPcoqn;~e~ that 35 other types o~ co~rlin~s could be used with similar results Wo 95/20914 P~

obtained. Similarly, while spe~-~fic collrl in7~ Or the ends Or the rigid tube and rod have been shown, it will be uld_LD~ood that other types Or co~rl in~ could be used.
2~ I, while particular rnnfi~rations have been 5 ~i cCloced in reference to the ~aw assembly, it wlll be appreciated that other c~nf~ ations could be used as well.
For eYample, while it is pLefeLL~ d to provide jaws with teeth, it will be appreciated that in lieu of teeth, the j aws can be provided with shary edges which, in con~ unction 10 with the sharp cylinder, will provide a cutting ability.
FUL; ~~ ~, while the jaw assembly has been rlicrtl~ac-rl as being formed ~rom a single piece of spring steel, it will be understood that dirrerent rormations Or the ~aw assembly can achieve the same or similar function as ~1 ~ ccloged herein.
15 Further yet, it will be appreciated that while the ayJ,~l~L
Or the invention was described a8 adv~ J~ l y permitting the obtaining of multiple bi opsi-~C without removal ~rom the surgical site, the apparatus Or the invention, ir desired, could still be used ror ~ht~1nin~ single bioFci~ç~ at a time.
20 It will therefore be appreciated by those skilled in the art that yet other ~~ f i ~ ~tions could be made to the provided invention without deviating rrom its spirit and scope as 80 claimed.

Claims

1. An endoscopic bioptome, comprising:
a) a hollow outer member having a proximal and a distal end;
b) an inner control member having a proximal and a distal end and extending throuqh said hollow outer member;
c) a cylinder having a sharp distal edge, said cylinder being coupled to said distal end of one of said hollow outer member and said inner control member;
d) a jaw assembly including a base member and a pair of resilient arms extending distally from said base member, each of said resilient arms terminating in a jaw cup, said base member being coupled to said distal end of the other of said hollow outer member and said inner control member; and e) actuation means coupled to said proximal end of said hollow outer member and to said proximal end of said inner control member for axially displacing one of said hollow outer member and said inner control member relative tot he other of said hollow outer member and said inner control member, whereby said cylinder extends around said pair of resilient arms and closes said jaws, thereby effecting a cutting action.

2. An endoscopic bioptome according to claim 1, wherein:
said hollow outer member is a flexible member having a lumen and said inner control member is a flexible control wire.

3. An endoscopic bioptome according to claim 1, wherein:
said hollow outer member and said inner control member are both substantially rigid.

4. An endoscopic bioptome according to claim 1, wherein:
said manual actuation means includes i) a shaft having a distal bore, a proximal thumb ring, and a central slot, and ii) a displaceable spool having a cross member extending through said central slot.

5. An endoscopic bioptome according to claim 1, wherein:
said manual actuation means includes i) a fixed handle having a thumb ring, and ii) a movable lever pivotally coupled to said fixed handle, said movable lever having a ringer ring.

6. An endoscopic bioptome according to claim 4, wherein:
said proximal end of said hollow outer member is coupled to said cross member of said spool, and said proximal end of said inner control member is coupled to said shaft.

7. An endoscopic bioptome according to claim 5, wherein:
said proximal end of said hollow outer member is coupled to said movable lever, and said proximal end of said inner control member is coupled to said fixed handle.

8. An endoscopic bioptome according to claim 4, wherein:
said proximal end of said hollow outer member is coupled to said shaft, and said proximal end of said inner control member is coupled to said spool.

9. An endoscopic bioptome according to claim 6, wherein:
said cylinder is coupled to said distal end of said inner control member, and said base member of said jaw assembly is coupled to said distal end of said outer hollow member.

10. An endoscopic bioptome according to claim 8, wherein:
said cylinder is coupled to said distal end of said hollow outer member, and said base member of said jaw assembly is coupled to said distal end of said inner control member.

11. An endoscopic bioptome according to claim 1, wherein:
said resilient arms each includes a portion which circumscribes at most 80 degrees and each jaw is formed as a cup having a sharp edge.

12. An endoscopic bioptome according to claim 11, wherein:
one of said cups is larger than the other, said larger of said cups being provided with a pair of proximally extending wings which are bent radially inward.

13. An endoscopic bioptome according to claim 12, wherein:
an upper edge of the larger of said cups is bent radially inward so that it enters the smaller of said cups when said jaws are closed.

14. An endoscopic bioptome according to claim 11, wherein:
each said sharp edge comprises a plurality of teeth, and said resilient arms are bent apart from each other approximately .18 to .25 inches.

15. An endoscopic bioptome according to claim 14, wherein:
actuation of said manual actuation means moves one of said jaw assembly and said cylinder relative to the other so that said resilient arms are substantially covered by said cylinder and said jaws are moved towards each other.

16. An endoscopic bioptome according to claim 15, wherein:
said movement of said one of said jaw assembly and said cylinder relative to the other is approximately .5 to .6 inch.

17. An endoscopic bioptome according to claim 11, wherein:
said jaw assembly is formed from a single sheet of steel which is cut and rolled.

18. An endoscopic bioptome according to claim 13, wherein:
said jaw assembly is formed from a deep drawn cylinder of steel which is machined by one of electrical discharge machining and laser cutting.

19. An endoscopic bioptome according to claim 9, wherein:
said cylinder has a radial hole and said distal end of said control member is bent and coupled to said radial hole.

20. An endoscopic bioptome according to claim 9, wherein:
said cylinder has a radially inward extending tab and said distal end of said control member is bent and coupled to said tab.

21. An endoscopic bioptome according to claim 9, wherein:
said cylinder has a radially inward extending strip and said distal end of said control member is bent and coupled to said strip.

22. An endoscopic bioptome according to claim 10, wherein:
said base member has a radial hole and said distal end of said control member is bent and coupled to said radial hole.

23. An endoscopic bioptome according to claim 10, wherein:
said base member has a radially inward extending tab and said distal end of said control member is bent and coupled to said tab.

24. An endoscopic bioptome according to claim 10, wherein:
said base member has a radially inward extending strip and said distal end of said control member is bent and coupled to said strip.

25. An endoscopic bioptome according to claim 18, wherein:
said cylinder is oblate with an hemispherical end.

26. A method for forming the jaw assembly of claim 1, comprising:
a) obtaining a cylinder of spring metal having a substantially hemispherical end, a middle portion and an open second end;
b) cutting said substantially hemispherical end with electrical discharge machining equipment or laser machining equipment to provide the opposed jaw cups;
c) cutting out metal from said middle portion of said cylinder with electrical discharge machining equipment or laser machining equipment to form two tapered arms which taper from a larger circumference at said opposed jaw cups to a smaller circumference away from said opposed jaw cups, at least one of said two tapered arms having a portion which extends less than 80 degrees around a periphery of said cylinder, said two tapered arms terminating at a cylindrical portion of said open second end; and d) bending at least one of said two tapered arms away from the other of said two tapered arms.

27. A method according to claim 26, wherein:
said step of cutting said substantially hemispherical end includes forming reciprocal teeth in said opposed jaw cups.

28. A method according to claim 26, wherein:
said step of cutting said substantially hemispherical end comprises causing one of said jaw cups to be larger than the other, and said method further comprises cutting said larger of said jaw cups to provide a pair of proximally extending wings, and bending said proximally extending wings radially inwardly.

29. A method according to claim 28, wherein:
an upper edge of the larger of said jaw cups proximal of said hemispherical end is bent radially inward so that it enters the smaller of said jaw cups when said jaws cups are closed.