United States Patent
`
`[19]
`
`[11] Patent Number:
`
`4,966,162
`
`Oct. 30, 1990
`[45] Date of Patent:
`Wang
`
`[54] FLEXIBLE ENCOSCOPE ASSEMBLY
`
`[76]
`
`Inventor: K0 P. Wang, 11006 Nacirema La.,
`Stevenson, Md. 21153
`
`[21] Appl. No.: 301,132
`
`[22] Filed:
`
`Jan. 25, 1989
`
`Int. Cl.5 .............................................. A61B 10/00
`[51]
`[52] U.S. Cl. .................................... 128/750; 128/752;
`128/756
`
`[58] Field of Search ................................ 128/749—759;
`15/206, 182, 104.2
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`3,074,396
`1/1963 MacLean ............................ 128/756
`3,831,585
`8/1974 Brondy et al. .......... 128/757
`
`4,227,537 10/ 1980 Suciu et al. ................. 128/756
`
`
`
`4,465,072 8/1984 Taheri ................. 128/756
`8/1985 Wang............. 128/753
`4,532,935
`
`Primary Examiner—Randall L. Green
`Assistant Examiner—Randy Shay
`Attorney, Agent, or Firm—Cushman, Darby & Cushman
`
`ABSTRACT
`[57]
`A flexible assembly for use with a fiberoptic endoscope
`
`to collect tissue specimens from a site within the human
`body. The assembly includes a flexible outer catheter
`provided with a metal tip at its distal end, a flexible
`stylet, and a control structure at the proximal end of the
`catheter to control movement of the stylet within and
`axially along the catheter and for the introduction of
`fluids to the collection site and/or withdrawal of fluids
`within the catheter from the collection site. The stylet
`has a distal end provided with a brush terminating with
`a needle point or a looped type end at its distal end. The
`brush will be movable through an incision in tissue
`produced by the needle point allowing penetration
`through the body cavity wall into a tumor or lesion
`located therebeyond. The stylet can also include a
`coiled spring for providing a flexible connection be-
`tween the control structure and the tissue collection
`device. In addition to a brush, the tissue collection de-
`vice can include a hollow needle or a pair of selectively
`sliding needles. Specimen samples can be obtained and
`local flushing of the specimen collection site is possible.
`Specimen material can also be flushed from within the
`catheter.
`
`7 Claims, 9 Drawing Sheets
`
`[50% I40
`
`Exhibit 1010
`
`Histologics, LLC
`
`1
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`

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`US. Patent
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`Oct. 30, 1990
`
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`1
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`4,966,162
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`2
`
`SUMMARY OF THE PRESENT INVENTION
`
`FLEIHBLE ENCOSCOPE ASSEMBLY
`
`CROSS-REFERENCE TO RELATED
`INVENTIONS
`
`Reference is hereby made to the following applica-
`tions and patents that relate to the present invention:
`US. patent application Ser. Nos. 897,936 filed on Aug.
`19, 1986, now U.S. Pat. No. 4,791,937; 921,471 filed on
`Oct. 22, 1986, now US. Pat. No. 4,799,494; and 222,096
`filed on July 18, 1988, and US Pat. Nos. 532,.935,
`4,617,940, 4,702,260 and 4,766,906. The disclosure of
`each of these applications and patents is expressly and
`fully incorporated hereunto by reference.
`FIELD OF THE INVENTION
`
`The present invention relates to a flexible assembly
`for collecting tissue specimens such as for biopsy exami-
`nations. The assembly is designed for use with any type
`of inter-body scope, such as, for example, broncho-
`scopes, cystoscopes, laparascopes and proctoscopes or
`any other fiberoptic scope that can be used to enter
`body cavities and permit the undertaking of medical
`procedures or collection of tissue specimens. The pres-
`ent invention permits the obtaining of tissue specimens
`for biopsy purposes. Such specimens are collectable
`from tumors or lesions exposed directly on the interior
`of the body cavities and organs into which such a scope
`can pass. More importantly, the present invention per-
`mits collection of tissue specimens from sites located on
`the outer surfaces of tissue walls of various body cavi-
`ties or organs through non-invasive procedures.
`
`5
`
`10
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`
`20
`
`25
`
`The present invention relates to an improved brush
`type tissue specimen collection assembly for use with
`various types of endoscopes. The assembly includes a
`brush collection device designed to penetrate tissue in
`order to collect tissue specimens from tumors, lesions or
`growths located on or adjacent the outer surfaces of the
`tissue walls of body cavities or organs. Such body cavi-
`ties and organs include the lungs, bronchus or trachea,
`the stomach, the bladder, the abdominal cavity or other
`organs or body cavities that are subject to fiberoptic-
`/endoscopic inspection procedures. This allows the
`brush to reach tissue sites not previously available to the
`prior brush device. The sealing of the parts of the de-
`vice permits the use of flushing fluids to irrigate the
`specimen collection site, as an aid in tissue collection,
`the flushing of tissue specimen material from within the
`outer catheter, and/or the connection of aspiration
`means through the outer catheter directly to the collec-
`tion site. The catheter is also easily movable through an
`endoscope due to the use of a smooth tip member at the
`distal end of the outer catheter making the assembly,
`and in particular the tip, able to be correctly positioned
`at the desired location so that even a small tumor can be
`penetrated under fluoroscopic guidance.
`Other objects, features, and characteristics of the
`- present invention, as well as the methods and operation
`and functions of the related elements of the structure,
`30
`and to the combination of parts and economies of their
`manufacture, will become apparent upon consideration
`of the following description and the appended claims
`with reference to the accompanying drawings, all of
`which form a part of this specification, wherein like
`reference numerals designate corresponding parts in the
`various figures.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view of a prior art bronchial
`cytology brush;
`FIG. 2 is an enlarged view of the distal end of the
`cytology brush shown in FIG. 1;
`FIG. 3 is a perspective view of the improved endo-
`scope device according to the present invention with
`the control apparatus in an open condition and with the
`brush retracted within the outer catheter inwardly of
`the distal end thereof;
`FIG. 4 is a cross-sectional view of the control appara-
`tus at the proximal end of the present invention in a
`closed condition;
`FIG. 5 is a perspective view of the present invention
`that is similar to FIG. 3 but with the control apparatus
`in a closed condition and with the brush extended be-
`yond the distal end in an operating mode;
`FIG. 6 is an enlarged View of the brush collector
`according the present invention;
`FIG. 7 is an enlarged view of a modified brush struc-
`ture;
`FIG. 8 is a diagrammatic cross-sectional View of the
`catheter showing a stop mechanism for the stylet in an
`open position;
`FIG. 9 is a cross-section similar to that of FIG. 8 but
`showing the stop in a closed position;
`FIG. 10 is a perspective view of the present invention
`showing a modified form~ of the control cable;
`FIG. 11 is an enlarged view of a still further modified
`brush structure;
`
`BACKGROUND OF THE PRESENT INVENTION 35
`Prior to my earlier inventions, as cross-referenced
`above, invasive procedures would be required to obtain
`tissue specimens from tumors, lesions or other growths
`located within the body but not directly exposed within
`a body cavity. Invasive procedures included surgical
`opening of the body to expose the tumor or growth, or
`by the use of stiff, large gauge needles, such as disclosed
`in US. Pat. Nos. 3,628,524 and 3,630,192 to Jamshidi,
`which allowed percutaneous entry to the desired site.
`My earlier inventions have focused upon the use of 45
`needles as the means for collecting tissue samples. How-
`ever, other forms of tissue collection devices have use
`as well. Brushes and a brushing technique have been
`used for many years with endoscopes for the collection
`of tissue specimens located directly on interior walls of 50
`the lungs. One example of a bronchial or cytology
`brush, manufactured by Mill-Rose Laboratories, Inc. of
`Mentor, Ohio is shown in FIGS. 1 and 2.
`This brush is slidably retained in a hollow flexible
`tube and was connected to the distal end of a cable. The
`proximal end of the cable was connected to a handle
`which allowed the user to slide the brush relative to the
`tube so that the bristles could be moved over tissue
`exposed within the particular body cavity into which
`access could be easily reached. No seal is provided
`between the tube, brush, cable or handle. The distal end
`of the tube itself was not provided with any means for
`aiding the placement of the device within the body and
`there was no way to remove tissue from within the tube.
`Further, the brush was not capable of insertion into or
`through tissue. In fact, tissue penetration was specifi-
`cally prevented by the presence of a blunt shaped mem-
`ber fixed to the device at the distal end of the brush.
`
`55
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`11
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`

`

`3
`FIG. 12 is an enlarged cross-sectional view of an
`alternative embodiment for the distal end of the device
`shown in FIG. 10 using the modified control cable; and
`FIG. 13 is an enlarged cross-sectional View of still
`another embodiment of the device shown in FIG. 10
`employing the modified control cable.
`DETAILED DESCRIPTION OF THE
`PREFERRED EXEMPLARY EMBODIMENT OF
`THE PRESENT INVENTION
`
`The Prior Art
`
`Turning first to FIG. 1, the drawing shows a prior art
`bronchial cytology brush for collecting tissue by simply
`moving the brush against tissue exposed directly within
`the ling. The brush assembly, generally indicated at 10,
`includes an outer catheter or tube 12 within which is
`positioned a control wire 14. Catheter 12 is connected
`to a hollow cylindrical handle member 16. Wire 14 is
`connected to a shank 18 which is itself connected to
`another handle portion 20. Shank 18 extends through
`handle portion 16, as shown in FIG. 1, and on into a
`portion of the proximal end of catheter 12. The connec-
`tion between wire 14 and shank 18 is by crimping shank
`18 about wire 14.
`
`A connector 22 in the form of a hollow cylinder is
`crimped to the distal end of wire 14, as well as to proxi‘
`mal end of a second wire 24 comprised of twisted
`strands in which bristles 26, forming a bmsh, have been
`formed. The distal end of the wire strand 24 is provided
`with an end cap 28 soldered or otherwise fixed in place
`directly on wire 24. End cap 28 is in turn is provided
`with a blunt end 30. The distal end of catheter 12, indi-
`cated at 32,
`is comprised simply of the same plastic
`material as the main body of the catheter 12.
`The blunt end cap 28 at the distal end of wire 24 is
`provided to help assure that tissue is not penetrated or
`injured by movement of the brush past the tumor and
`was specifically not intended to penetrate skin or tissue.
`Rather, this device was used by inserting the brush in a
`bronchoscope and the brush area 26 was simply rubbed
`against tissue exposed within either the bronchial pas-
`sage or the lungs. Some amount of tissue would be
`collected within the bristles by this brushing contact.
`After samples had been obtained, the brush would be
`retracted into the distal end of catheter 12 by withdraw-
`ing handle portion 20 outwardly away from handle
`portion 16. Then the entire assembly would be with-
`drawn from the bronchoscope. Once removed from the
`bronchoscope the brush would be pushed outwardly
`from the distal end and samples could then be removed
`from brush 26 by shaking the brush against a collection
`surface or within a container filled with a liquid allow-
`ing the tissue specimens to leave the confines of brush
`26. There was no way to collect tissue material located
`within the tube 12.
`'
`The Present Invention
`
`Turning now to FIGS. 3 through 9, the present in-
`vention, generally indicated at 100, includes a proximal
`end portion generally indicated at 102, a distal end por-
`tion generally indicated at 104 and a stop assembly
`generally indicated at 106.
`Turning first to the proximal end 102, this includes a
`conventional two directional leur lock, generally indi-
`cated at 110, having three outwardly extending connec-
`tion members 112, 114 and 116, respectively. Connec-
`tions 112 and 114 each terminate with nipple members
`118 and 120, respectively, for threadedly engaging a
`conventional connector member as is used to connect
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`4
`needles on syringes. It should be understood, however,
`that any convenient connection arrangement can be
`used. Nipple 120 can be connected to a suitable source
`of fluid or to an aspirating means as shown at 122 which
`can, for example, be a syringe or other form of a device
`for injecting or withdrawing fluids from within the
`catheter device or for supplying a desired aspirating
`force. Nipple 118 is arranged to be threadedly engaged
`by a first coupling cap 124 that is provided with a hol-
`low cylindrical portion 123 in which internal threads
`125 are formed as shown in FIG. 4. A second coupling
`cap 126 is provided axially outwardly from cap 124 and,
`as will be explained below, is designed for connection to
`the first cap 124.
`An elongated, hollow cylindrical metal conduit 128 is
`connected to the first, cap 124 and extends outwardly
`from a cylindrical member 130 spaced radially inwardly
`from the hollow portion 123. The connection between
`cap 124 and conduit 128 can be accomplished by any
`suitable adhesive or conduit 128 can be molded in place
`together With cap 124. The leur lock connection 112
`includes a hollow interior passageway 142, connection
`114 includes a hollow interior or passageway 146, and
`connection 116 includes a hollow internal passageway
`147.
`
`FIG. 4 shows the leur lock assembly 110 and the caps
`124 and 126 in their closed positions. With cap 124 in
`this condition the cylindrical member 130 lies within
`passageway 142, threads 125 engage the threaded exte-
`rior of connection 112 and the end wall of connection
`
`112 abuts the interior wall of cap 124.
`FIG. 3‘ shows these same control elements in an open
`and slightly pulled apart condition.
`The first coupling cap 124 also includes a second
`cylindrical portion 132, which extends axially in a direc-
`tion opposite that of member 130 and from the opposite
`end of cap 124. Portion 132 has a hollow interior well
`144 and a threaded exterior rim 134 which is received
`within the threaded interior 135 of the lower portion
`136 of the second coupling cap 126. It should be noted
`that the hollow well 144 is not connected to the hollow
`interior portion 123 of the first cap 124. Rather, a wall
`seals one from the other and only stylet 140 passes
`through that wall via an aperture provided therein and
`through the interior of conduit 128 which is sealed to
`and within member 130.
`
`The second coupling cap 126 also includes an axially
`extending cylindrical mounting member 138 spaced
`radially inwardly from the interior of the threaded inte-
`rior of portion 136. Member 138 has a diameter de-
`signed to fit snugly within well 144 as shown in FIG. 4.
`The flexible stylet 140 passes through member 138 and
`is secured to cap 126, so that it will move therewith and
`be controllable thereby. Specifically, stylet 140 is se-
`cured within a hollow, outwardly opening rear recess
`or well 143 of cap 126 such as by adhesive 142 placed in
`well 143. It should be understood that the external di-
`ameter of stylet 140 has a tight sliding fit within the
`internal diameter of conduit 128. Consequently, when
`both caps 124 and 126 are in their closed position, as in
`FIGS. 4 and 5, fluid entering leur lock 110 will pass
`through passage 140 and directly into catheter 150.
`With suitable sealing it will not leak backwards between
`stylet 140 and conduit 128 or between conduit 128 and
`member 130. This assures that there will be a fluid seal
`within leur lock 110 and caps 124 and 126 will provide
`an effective seal for fluids moving there through.
`
`12
`
`12
`
`

`

`5
`An outer catheter 150 is secured to connection 116 of
`leur lock 110 by any convenient means such as an adhe-
`sive shown at 152 in FIG. 4. This connection between
`catheter 150 and connection 116 can be improved and
`strengthened by use of an additional overlapping sheath
`of material, as shown in phantom in FIG. 4 at 119.
`Sheath 119 is preferably comprised of a plastic, perhaps
`a fairly stiff plastic, but other materials could also be
`employed since its utility is to strengthen the joints that
`are connected together at that point. Sheath 119 can
`also be glued or otherwise sealed in place.
`An elongated, hollow cylindrical metal member or
`conduit 154 is attached to connection 116, specifically
`within passageway 147 where it is glued or otherwise
`fixed to the interior surface 117. This provides support
`for the outer catheter 150 in the area adjacent leur lock
`110, it provides a gripping point for the user, it prevents
`the collapse of catheter 150 when this area is gripped
`and also aids in positioning the stop means. Cylindrical
`member 154 extends axially along the interior of con-
`duit 150 and terminates an inch or two beyond leur lock
`110.
`The invention also includes a stop assembly to con-
`trol and limit the range of axial sliding movement per-
`mitted for conduit 128. This stop assembly includes a
`stop band 156, preferably metal, is crimped about the
`exterior of the outer flexible catheter 150. This crimping
`must be carefully controlled as it is not desirable to
`crimp band 156 so much that the catheter’s interior is
`constricted beyond that necessary to provide the de-
`sired stopping function. The stop assembly also includes
`a separate stop member 158 is secured to conduit 128 by
`soldering, adhesive, crimping or any other convenient
`method that will fix member in place. In terms of assem-
`bly, band member 156 is not crimped in place about
`catheter 150 until stylet 140 and member 128, with stop
`member 158 having been previously fixed in place, have
`been inserted through leur lock 1!!) and conduit 154 on
`catheter 150.
`With reference to FIGS. 8 and 9, FIG. 8 shows the
`stop assembly in its open condition. Stop member 158 is
`comprised of a first portion 160 having an outer diame-
`ter less than the inner diameter of outer catheter 150 so
`that a fluid passageway is defined therebetween. The
`diameter of portion 160 is also less than the internal
`diameter of conduit 154. A second portion 162 extends
`toward the proximal end of the assembly and has a still
`further reduced diameter so that it is less than the diam-
`eter of portion 160 yet sized to fit within the opening
`defined within the crimped portion of catheter 150 fol-
`lowing the mounting of band 156.
`As shown in FIG. 9, with the stop assembly in its
`closed or stopped condition, the placement of band 156
`will sufficiently change both the outer and inner diame-
`ter of the outer catheter 150 so that the portion 160 of
`stop member 158 will not be able to pass axially beyond
`band 156.
`Stop member 158 could be comprised of only a band
`type member equal to the dimensions of portion 160,
`thereby omitting the reduced diameter portion 162. The
`only requirement of stop member 158 is that it have a
`diameter sufficiently larger than the reduced diameter
`of the outer catheter 150 effected by the crimping of
`band 156 therearound.
`The distal end of outer catheter 150 includes an outer
`metal slip tip, generally indicated at 160, which includes
`a smooth rounded exterior surface 162 and a threaded
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`or grooved exterior portion 164 therebehind for en-
`gagement with the interior of outer catheter 150.
`The distal end of stylet 140 includes a wound wire
`member 170 connected to stylet 140 by means of a
`crimped, cylindrical connector 172, and a brush gener-
`ally shown at 176. The outer diameter of connector 172
`is also less than the inner diameter of outer catheter 150
`so that a fluid passage also exists between the interior of
`the catheter and that connection. Stylet 140 can be
`comprised of a solid flexible steel wire, a wound cable
`or any other similar material that can be used to apply
`axial force to the distal end of the stylet. The wound
`wire 170 terminates in a sharped, needle type point 174,
`as shown in FIGS. 6 and 7. This is a significant depar-
`ture from other brush arrangements and actually per-
`mits penetration by the brush into and through tissue.
`Wire 170 is formed from two wires wound over one
`another so that brush 176 can be formed therewith as
`those wires are wound. Such a formation is convention-
`ally made and further description thereof is not believed
`to be required. As shown in FIG. 6, a first embodiment
`of the brush includes bristles 178 that preferably extend
`substantially perpendicular relative to the axis of the
`wound wire 170. Bristles 178, preferably comprised of a
`sterilizable, plastic material, begin approximately 2-3
`mm from the sharpened tip although other dimensions
`could be used. The bristles preferably extend approxi-
`mately, for example, 10—15 mm along the length of the
`wound wire 170. This length could be modified to suit
`various collection or tissue situations. An alternative
`configuration is shown in FIG. 7 where bristles 180
`extend from wire 170' in a direction angled more rear-
`wardly toward the proximal end of the assembly. This
`alternative embodiment also includes a sharpened, nee-
`dle like tip 174’.
`Once the tip 174 or 174’ at the distal end of the brush
`has penetrated into tissue, bristles 178 or 180 would
`brush through the incision area made by tip 174 or 174’
`and into the interior of the tumor or lesion. Through
`repeated backward and forward strokes within that
`incision area, controlled by manipulating cap 126, tissue
`specimens will be collected by, on and within the bris-
`tles. In the FIG. 7 embodiment, by having bristles 180
`extend more rearwardly, additional collection force
`would be provided on the rearward stroke as wire 170’
`was withdrawn from the incision made by tip 174’.
`The tip of the distal end of the brush can be sharpened
`to a needlepoint or other varying degrees of sharpness
`so that it can easily penetrate deep into a tumor or
`through the bronchial wall, through the intestinal wall
`or through the tissue wall of the body cavity to reach a
`tumor positioned on the outside of the tissue wall. Such
`a tumor would not be reachable by the prior art brush
`assembly as shown in FIG. 1 since that brush would ‘
`only be able to move against the exposed surface of a
`tumor inside a lung or inside an intestinal tract. It would
`not be possible to use that brush assembly to penetrate
`either the bronchial wall or the wall of an intestine to
`extend into a tumor positioned on the opposite side of
`that bronchial or intestinal wall.
`The rounded metal tip 160 attached to a distal end of
`the outer catheter 150 provides a smooth surface that
`will easily and smoothly pass through an endoscope as
`well as a guidable member that can be seen on x-ray or
`fluoroscopic equipment so that the correct placement of
`the tip on the tissue wall exactly next to the tumor
`location can be guided under use of a fluoroscope and
`the tumor can be easily investigated.
`
`13
`
`13
`
`

`

`4,966,162
`
`7
`The brush 176 is movable by the operation of cou-
`pling cap 126 relative to the joint structure formed by
`having cap 124 locked to leur lock 110. Also, stop 156 is
`positioned so that when the caps 124 and 126 are con-
`nected together and cap 124 is disconnected from leur
`lock 110 and retracted, as shown in FIG. 3, the tip of the
`brush 176 will be properly withdrawn within catheter
`150, that is inside or adjacent the metal tip 160. This
`assures the brush will not interfere with the sliding of
`the entire assembly through the endoscope and that the
`brush will not be retracted too far into catheter 150.
`Following the correct placement of the tip adjacent
`the tumor cap 124 will be connected again to the leur
`lock thereby re-establishing the brush position beyond
`the distal end of the catheter. The device can then pene-
`trate through the tissue wall and pass into the tumor or
`lesion. Cap 126 can be retracted away from cap 124 so
`as to move the brush relative to the, catheter. Each
`movement will result in the collection of additional
`tissue specimens and when sufficient collection has
`occurred the brush can again be retracted into the flexi-
`ble outer catheter 150. During this collection process it
`will be possible to either apply suction at the collection
`site or to inject an amount of a normal saline solution,
`for example approximately 5cc, through leur lock 110
`and into and through the outer catheter 150, directly to
`the specimen collection site. This washing will assist in
`tissue collection. Following. the tissue collection proce-
`dure and after the entire device has been removed from
`the endoscope, fluid can be forced through outer cathe-
`ter 150 to flush any remaining tissue from within the
`catheter.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`
`
`8
`so that leur lock 110, cap 124 and cap 126 are all locked
`together and the point of the brush and the brush itself
`lie within the tumor. Then by uncoupling cap 126 from
`cap 124, the brush can be retracted and advanced within
`the tumor or lesion. By using saline solutions, such as 5
`to 10 cc of a normal saline, through the side extension
`114 of leur lock 110, local washing can be obtained from
`the lesion. Further, suction can be applied to the collec-
`tion site through the leur lock assembly. Then, brush
`170 can be retracted into catheter 150 by unlocking and
`retracting cap 126 from cap 124 or by simply unlocking
`cap 126 if cap 124 had already been unlocked before
`retracting and advancing movement. It should also be
`understood that advancing and retracting of the entire
`catheter structure could be accomplished with leur lock
`110, cap 124 and cap 126 all in a locked condition. How-
`ever, prior to withdrawing the device 100 from the
`endoscope the brush needs to be drawn inside catheter
`150. To accomplish this, either cap 126 needs to be
`unlocked from cap 124 to allow stylet 140 to be with-
`drawn or cap 124 needs to be unlocked from leur lock
`110 to allow conduit 128 and stylet 140 to be retracted.
`Retraction of conduit 128 can proceed until stop mem-
`ber 158 hits the stop band 156. Once the entire device
`100 is removed from the endoscope, specimens can be
`flushed into a container by again injecting normal saline
`solution through leur lock 110. Caps 124 and 126 can
`also be reconnected to leur lock 110 so that the brush
`will again extend outwardly away from the distal end of
`the device allowing tissue specimens to be removed.
`The outer catheter 150 is preferably constructed from
`suitable surgical plastic that can be sterilized. The leur
`lock and the control caps are also preferably made from
`similar surgical plastic. Hollow members 128 and 154
`are preferably stainless steel and are about, for example,
`95—100 mm and 15—25 mm long, respectively. Where
`the total length of the assembly is about 140 cm, the
`stroke of the stylet, as controlled by the stop means, can
`be, for example, about 25—30 mm and the tip 160 is about
`6—8 mm in length. The outer diameter of catheter 150 is
`about 2.0 mm and the inner diameter is about 1.5 mm.
`The gauge of stylet 140 is about 24.
`Turning now to FIGS. 10 and 11, another embodi-
`ment of the present invention is set forth. This embodi-
`ment of the tissue collection or flexible endoscope as-
`sembly, like those previously described, also includes a
`proximal end comprised in part of a leur lock generally
`indicated at 200, a distal end generally indicated at 202,
`and an interconnecting catheter assembly.
`Leur lock 200 includes three connection members
`
`generally indicated at 204, which is the main connection
`for providing other aspirating fluids for connection of a
`vacuum, 206 and 208. Connection 206, like 116 in the
`earlier embodiments, is provided with a hollow interior,
`similar to that shown at 147 in FIG. 4, in which a con-
`duit 154 is received and sealed thereto by any conve-
`nient means, such as by adhesive or by being molded
`integrally with the leur lock. Connection 206 also pro-
`vides a connection point for an outer catheter 210
`which, after having been slid over conduit 154, can be
`glued or otherwise sealed to the end of connection 206.
`This was also the method of connecting the outer cathe-
`ter 150 and connection 116 in the earlier embodiments.
`
`The proximal end also includes a control cap 212,
`which includes a hollowed cylindrical portion 214,
`similar to portion 123 in the first cap 124 of the embodi-
`ment shown in FIG. 3. The interior wall of portion 214
`
`14
`
`This type of flushing technique to remove specimens,
`not only from the brush but within the catheter, was not
`available with the prior art device. In practice, the ex-
`traction of specimens from the prior art brush was ac-
`complished by extending the brush beyond the end of
`the catheter and shaking it into a container. Any speci-
`men left inside the catheter of the prior art device
`would not be collectable for examination. This would of 40
`course, reduce the chance of positive diagnosis if signifi-
`cant tissue specimens remained within that catheter.
`The present invention also permits the local area near
`the tumor to be washed by a normal saline solution or
`aspirated in order to obtain even additional specimens
`and to increase the diagnostic yield. This aspiration or
`flushing procedure can occur simultaneously with the
`movement of the brush within the incision, while the
`brush remains in that incision or after the brush has been
`partially removed.
`Accordingly, the newly designed brush according to
`the present invention, including the needle tip, permits
`deep penetration into tumors as well as penetration
`through tissue walls of the body cavity being explored.
`Because of the presence of the metal tip at the distal end
`of the outer catheter 150, fluoroscopic guidance can be
`used to correctly pass the tip through an endoscope and
`properly position the tip adjacent the tumor.
`To summarize the method of using this invention, one
`would first assemble a device as shown and while cou-
`pling caps 124 and 126 together, cap 124 would be
`retracted from leur lock 110 so that the tip 174 of brush
`176 was housed either inside the metal hub 160 or in
`catheter 150. The catheter 100 could then be inserted
`through the desired scope to a location guided by the
`fluoroscope with the tip 162 being properly positioned
`adjacent the tumor. Cap point 124 can then be moved to
`its locked position on leur lock 110, as shown in FIG. 5,
`
`45
`
`50
`
`55
`
`65
`
`14
`
`

`

`9
`is threaded to receive the threaded portion 216 of con-
`nection 208.
`
`4,966,162
`
`10
`instance both the stylet 218 and stop member 258 will be
`hollow so that an elongated passageway is defined
`therewithin leading through to the distal end of the
`assembly. A stylet, similar to that shown at 140, would
`then be able to be pushed along and through that pas-
`sageway and through the hollow interior of the coil
`spring 252. Such a stylet is shown in FIG. 12 at 250.
`In this embodiment, however, the tissue collection
`assembly at the distal end is not comprised of a brush
`but rather a double needle assembly comprised of an
`outer needle 254 and an inner needle 256. The distal end
`of spring 252 is secured within the internal diameter of
`the outer hollow needle 254 by being crimped, soldered
`or otherwise fixed in place. The distal end of stylet 250
`is itself secured to the proximal end of the second or
`inner hollow needle 256 by soldering or other conve-
`nient means. Outer needle 254 is provided with a stop
`member 258