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Oct. 11, 1960
`M
`Filed Dec. 29, 1955
`
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`DIAGNOSTIC INSTRUMENT
`
`2,955,592
`
`2 Sheets-Sheet 1
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`ATTORNEYS
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`Histologics, LLC
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`Exhibit 1003
`
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`

`

`Oct. 11, 1960
`
`Filed Dec. 29, 1955
`
`K. s. MacLEAN
`
`DIAGNOSTIC INSTRUMENT
`
`2,955,592
`
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`United States Patent Office
`
`2,955,592
`Patented Oct. 11, 1960.
`
`2,955,592
`
`DIAGNOSTIC INSTRUMENT
`
`Kenneth S. MacLean, 130 E. 65th St., New York, N.Y.
`Filed Dec. 29, 1955,,Ser. No. 556,182 '
`
`9 Claims.
`
`(Cl. 128—2)
`
`'
`
`10
`
`15
`
`20
`
`25
`
`30'
`
`35
`
`4O
`
`45
`
`2
`of the instrument and removed from the remainder of
`the mechanism.
`'
`Referring primarily to Figs. 1 and 2, the numeral 15
`indicates a tube conveniently formed of metal and pref-
`erably having an angularly extending'rear end portion,
`16. To the latter, there may be attached a handle or
`gripping part 17 which is bored to accommodate an
`actuator 18. This actuator is capable of limited recip-
`rocation within the, handle 17 and a spring 19 may be
`interposed between these parts to normally maintain the
`actuator to the position shown in dot-and-dash lines in
`Fig. 1.
`Tube 15 is continued adjacent its outer end in the form
`of a conduit conveniently comprising a compound wire
`coil sheath. This embraces an outer convoluted layer 20
`enclosing an inner similar layer 20’. The convolutions
`of the latter, as shown in the lower portion of Fig. 3,
`normally tend to expand. However, when they are forced
`into bearing engagement with each other, they will pro-
`vide a tube defining a substantially cylindrical sheath,
`the bore of which aligns with the bore of tube 15. A
`unit such as a wire 21 circular in section extends through
`the bore of tube 15.
`It is attached against movement
`in any suitable manner at its rear end to actuator 18.
`.At
`its forward end, it extends through the bore defined by ,
`the convolutions 20 and terminates adjacent the outer end
`of that sheath, at which point it is rigidly attached to the
`end of the compound sheath where it joins the hereinafter
`described chuck. This wire is so formed or treated that
`it has a pronounced curve or. “set.” To this end, the
`wire is preferably of steel and tempered. The direction
`and degree of the set
`is such that
`the wire normally
`tends to assume a position substantially at right angles.
`to the axis as defined by the outer end of tube 15. Oh-
`viously, a greater or lesser angle might be employed ac-
`cording to the wishes of the physician.
`Secured to the outer end of the sheath 20 and wire 21
`_is
`a mounting member functioning as achuck. AccOrd-
`ing to the illustration of Figs. 1 and 2, it will include a
`body 22 having a rearwardly extending bore to receive »
`the end zone of sheath 20 and will also have attached to
`' it the adjacent end of the wire 21.
`Additionally,
`this
`unit will embrace a provision for mounting a cell—collect-
`ing abrader element. That mounting may simply. in-:
`clude a screw-threaded socket within which the corre~
`spondingly threaded stem 23 of the element projects.
`"The element in these Views and in Fig. -4, conveniently
`includes a mounting core
`24 preferably of twisted wire
`strands, from which a row
`of bristles 25 extends radially in
`the form of a screw.
`If, in lieu of the socket structure shown in Fig. -2, it
`as
`desired to employ a gripping structure such as a true 1
`chuck, then as in Fig. 4 the body 26 to which the adjacent -.
`outer ends of the sheath 20—20’ and wire 21 are secured ~
`may terminate in a threaded annular flange 27. This.
`flange will have a flared surface 28 adjacenttits outer end
`and mount, by means of its threads, a constricting collar
`29.
`Jaws 30 are interposed between the constricted end
`of the collar and the flange.
`In this instance, the spindle
`of the collecting brush indicated at 31 will be in the form
`, of an unthreaded piece of stock of a diameter such that it
`may be received within the space defined between the
`jaws. Thereupon,
`the latter may be drawn together by-
`tightening collar 29. Under these circumstances,
`the
`brush will become fixed with respect to the outer portion .
`of the instrument.
`Where a brush abrader is employed, the bristles of the;
`latter should be relatively quite stiff. Their'ends should
`embody characteristics such that theyrwill scrape or scar-"
`ify the surface of tissues with which they are engaged. -.
`Also, it is definitely preferred that'the outer ends of the
`
`'
`
`.
`
`3
`
`This invention relates to a structurally and functionally
`improved diagnostic instrument and especially ran instru-
`ment, by means of which samples of cells may be readily
`collected from the areas of the upper lung or stomach
`and examined with a view of especially determing if a
`condition of cancer prevails.
`It is a primary object to furnish :a relatively simple
`apparatus, the use of which will involve an uncomplicated
`technique cap-able of being practiced by the usual physi-
`cian who will be able to reach definite conclusions based
`upon his findings.
`A further object is that of providing an appliance of
`this character which may readily. be manipulated by the
`physician with assurance that an adequate cell sample
`from the desired area will be rendered available;
`the
`entire technique requiring the expenditure of only a
`minimum amount of'time without substantial discomfort
`on the part of the patient.
`Still another object of the invention is that of furnishing
`for employment in an instrument assembly of this char-
`acter, a cell-collecting element, which will preferably
`have a “one—time” use, such that after the material has
`been rendered available that element may be discarded.
`An additional object is that of providing an assembly
`(if parts, each individually simple and rugged in construc-
`tion and capable of ready manufacture to provide a uni-
`tary mechanism operating over long periods of time with
`freedom from all difliculties.
`.
`With these and other objects in mind, reference is had
`to the attached sheets of drawings illustrating practical
`embodiments of the invention and in which:
`Fig. 1 is‘a side elevation of an instrument especially
`useful in connection with the sampling of lung cells;
`(Fig. 2 is a fragmentary sectional side view of them—
`strument and showing the same in operative condition;
`. Fig. 3 shows in its two illustrations the preferred com-
`ponents of the sheath structure; '
`Fig. 4 is an’ enlarged sectional View of the end portion
`of
`the instrument 'as shown in Figs. 1 and 2;
`Fig. 5 shows an alternative form of cell—collecting unit
`which may be associated with the instrument; .
`Fig. 6 is a transverse sectional view taken along'the
`line 6—6 in the direction of the arrows as indicated in
`Fig. 5;
`' Fig. 7 is a View similar to Fig. 1, but showing an in-
`strument primarily intended for use in connection with
`the sampling of stomach cells;
`.
`' Fig. 8 is an enlarged fragmentary sectional View of the
`instrument as illustrated in Fig. 7 and showing a collect-
`ing element in association therewith;
`'
`Fig. 9 is a view similar to Fig. 8 but showing the parts
`.
`. adjusted to expand the collecting element to an operative
`condition;
`_:Fig. 10 is a transverse sectional view taken along the
`line 10—10 in the direction of the arrows as shown in
`Fig. 9; and
`“Fig. 11 is a perspective view of the expandible portion
`
`50
`
`55
`
`60
`
`65
`
`70
`
`3
`
`

`

`2,955,592
`
`U!
`
`10
`
`20
`
`3
`bristles be disposed in a spiral path. As will be herein-
`after brought out, with such disposition and under con-
`ditions of rotation of the brush core 24 with respect to an
`adjacent tissue surface, the brush will function as a screw
`to traverse its body over the surface of the tissues. Thus,
`in addition to collecting samples of the cells at an initial
`location, where the brush is brought into engagement
`therewith, that brush will traverse an entire tissue zone
`and collect further samples throughout the area thereof.
`In this manner, a physician will be assured that a general
`evaluation of cells is being achieved rather than merely a
`limited zone sampling.
`In lieu of an element embracing a bristle structure,
`such as 25, a scarifying and cell-collecting abrade-r unit
`of the nature shown in Figs. 5 and 6 may be employed.
`In that view, the numeral 32 indicates a hollow body suit-
`ably attached in any desirable manner to the outer end of
`the flexible sheath. The body is conveniently of generally
`conical configuration and formed, in its side face, with an
`opening 33. A scraper blade 34 is attached to the body
`by, for example, a screw 35. So attached, it will extend
`slightly beyond the plane or outer face of body 32. This
`has been illustrated in somewhat exaggerated manner in
`Fig. 6.
`In any event, it is apparent that if body 32 trav-
`erses tissues and with the edge of blade 34 in contact with
`the latter, the surface of the tissue will be scraped and
`cells from the same will be diverted through the opening
`33 into the interior of the body. So diverted, it will re-
`main against all probability of displacement within that
`interior, which will
`thus serve as a sample-collecting
`chamber. With the removal of blade 34 or if body 32
`embraces a number of detachably coupled sections, it is
`apparent that the cell samples may readily be reached
`for inspection and examination according to accepted
`techniques.
`Considering the apparatus insofar as has been present—
`ly described,
`it
`is apparent that with the assembly as
`shown in Fig. 1 and the extensible parts of the same occu-
`pying positions such as have been indicated in dotted
`lines, a physician might ensleeve tube 15 and the outer
`or cell-collecting end of the instrument within a suit—
`able sleeve (not shown) of, for example, plastic material.
`Thus enclosed, the operative end of the instrument may
`be introduced to occupy a position adjacent
`the upper
`zone of the lungs.
`If employed,
`the plastic or other
`sleeve may now be retracted over the tube 15 so as to
`expose the coil 20 and the brush or its equivalent. Now,
`if the physician resorts to a projection of part 18 against
`the influence of spring 19, wire 21 will be projected.
`Under these circumstances, the convolutions of the coils
`20 and 20’ will be expanded. Therefore, with the afore-
`mentioned “set” of wire 21, the latter will, for example,
`extend at right angles to the axis of tube 15 and as shown
`in full lines in the right—hand portion of Fig. 1 and in
`Fig. 2. Accordingly, the cell-collecting element will as-
`sume a position at which it contacts the surface of the
`lung lobe adjacent its junction with the bronchial tube.
`Now, by rotating handle 17,
`tube 15 will be similarly
`moved as will also the brush 25. Accordingly, the outer
`ends of the bristles of the latter will traverse the lung sur-
`face and will lightly scarify the same.
`Now, by allowing the spring 19 to shift wire 21 rear-
`wardly or to the left, as viewed in Figs. 1 and 2, the outer
`end of the instrument is caused to assume a position sub-
`stantially in line with the axis of the adjacent end of tube
`15. Thereupon, by retracting the instrument within the
`plastic sheath or tube through which it was initially intro-
`duced, the ends of bristles 25 will be enclosed and pro-
`tected. Accordingly, the entire instrument may now be
`retracted with its sheath so as to be free of the patient.
`Thereupon cells adhering to the bristles may be removed
`and examined. Obviously, the same results are achieved
`if a collecting element of the nature shown in Figs. 5 and
`6 is employed.
`In lieu of the specific structure shown in Figs. 1 and
`
`4
`2, an assembly of the type illustrated in Figs. 7 and 8
`might be used.
`In those views, the numeral 21 again indi-
`cates a wire having a predetermined “set.” This wire
`is enclosed within a sheath, preferably formed of two
`layers of wire convolutions 20 and 20’ as heretofore trav-
`ersed. However, wire 21 is secured to an actuating stem
`36 which is slidably disposed within a guide 37. That
`‘ wire extends beyond the guide and is secured adjacent its
`outer end to a knob 38. An actuating assembly con-
`veniently embraces a disc—like member 39 provided with
`a tubular extension 40,
`the bore of which is screw-
`threaded. A clamping pin 41 is similarly threaded and
`has its end in a position at which it may bear against the
`actuator 36 and lock the latter against axial movement.
`A handle 42 may be integral with pin or stem 41 and
`project beyond guide 40. By means of this handle, the
`pin may be projected or retracted to thus lock or release
`part 36.
`In many respects, an instrument of this type may de--
`sirably be employed in connection with diagnoses of the
`stomach surfaces and permits a sampling of those cells
`adjacent the upper entrance end of the stomach. Ob~
`viou-sly, the instrument might be employed in connection
`with, for example, lung diagnosis and the instrument here-
`tofore described with especial reference to Figs.
`1 and
`2 might be utilized to secure samples of the surface of
`the stomach.
`In any event, as also illustrated in Figs. 7
`and 8, an enclosing or guiding tube 43 preferably formed
`of plastic material has been illustrated. This tube, when
`projected, encloses the scarifying and sample-collecting
`element of the instrument. When retracted,
`it will of
`course clear the operative end of the instrument. To
`permit of its being readily shifted,
`its inner end is con-
`veniently ensleeved within and attached to a collar 44, the
`bore of which adjacent its free end may present a flared
`surface 45. That surface may engage the tapered, outer
`edge zone of a truncated end portion 46, affixed to the
`manipulating element 39. With the friction fit thus estab-
`lished, tube 43 will be maintained in its retracted posi-
`tion. However, it may obviously be freed from restraint
`by simply gripping tube 44 and projecting the latter to
`cause the outer element of sleeve 43 to enclose the oper-
`ative portions at the outer end of coils 20 and 20’.
`Under certain circumstances, it may be preferred to
`not simply reciprocate wire 21 by a direct pull or push
`action exerted either manually or by, for example, a
`spring such as 19. With a view to furnishing a structure
`allowing of relatively slow axial movement of the wire
`with respect to the sheath 20 or corresponding elements,
`an actuator 47 (Fig. 9) may be furnished which in con— .
`figuration will be similar to actuator 39. This unit will
`be formed with a threaded bore, within which a similarly
`threaded stem 48 is disposed. At the outer end of the
`latter, a knob 49 is conveniently secured. At its inner
`end, the stem is attached to wire 21.
`It is apparent that
`by rotating actuator 47, with respect to stem 48, the wire
`will be gradually retracted or projected according to the
`direction of rotation.
`In lieu of employing a wire which
`is circular in cross—section, a wire or flexible member 51
`may be provided. This has been shoWn especially in Figs.
`9 and 10. That wire, as illustrated, is conveniently sub-
`stantially flat or oval. By embodying such a configuration,
`a more definite “set” may be imparted to it. The tube
`should, under these circumstances, have a substantially
`rectangular bore. Also, in the manipulation of the instru-
`ment, a more affirmative contact between the cell-collect-
`ing element and the surface of the tisgue may be main-
`tained without, however, sacrificing the desirable cush-
`ioned or yielding contact between these parts. Obviously,
`a flattened or oval wire such as 51 will function as here-
`tofore described to impart an angular bend to the outer
`or operative end of the instrument, when the parts are
`once adjusted to achieve this result.
`Especially in the case of diagnosis of the stomach tis—
`sues, it may be desirable to utilize a collecting and abrad-
`
`70
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`75
`
`4
`
`4
`
`

`

`2,955,592
`
`,
`
`.
`5
`ing element different from the types shown in Figs. 2,
`4 and 5. The abrader element may conveniently embrace
`a distendible body formed of natural or artificial rubber.
`Such an element has been shown in detail in Figs. 8 and
`9 and includes a hollow, cylindrical body 52 closed at
`one end and formed with a neck portion or opening to its
`interior. That opening accommodates the sheath 20 or
`its functional equivalent and, if desired, this neck portion
`may be constricted by employing a retaining element 53
`to maintain it against displacement with respect to the
`outer end of the instrument. Scarifying, collecting and
`retaining structures are associated with body 52, prefer-
`ably by mounting on the latter a number of strands in
`the form of tufts or bristles ‘54. These—as illustrated—
`may be arranged in the form of groups and be relatively
`short and stiff. Formed of suitable material, it is ap-
`jarent that when they are wiped across a tissue surface,
`they will remove and retain a certain amount of cells.
`In this connection, it will be understood that during the
`withdrawal of the instrument, the operative outer part of
`the same is preferably encased within the sheath 43 as
`illustrated in Fig. 7. Accordingly, the removed cells will
`not be wiped or otherwise freed from contact with the
`bristles 54.
`In the forms of the device shown for exam-
`ple in Figs. 7, 8 and 9, it is apparent that it is unnecessary
`to employ a chuck or gripping structure of the character
`shown in Figs. 2 or 4. Also, in the device as illustrated
`in these figures,
`the rear end of the sheath assembly
`20—20’ is received within a sleeve 52 which, in the last
`figure, is firmly attached against displacement with respect
`to the actuator ‘47. The outer end of the instrument
`terminates, insofar as the sheath is concerned, in a cap 55.
`The end of the wire 21 or 51 extends as at 56 beyond
`the sheath and cap structure.
`It is secured by soldering
`or riveting to the head portion 57 of an expansible element.
`Depending from that head portion are arms 58. These
`terminate in inwardly extending foot portions ‘59, each
`formed with a perforation 60. The wire 56 extends
`through all of these perforations and is thus slidably dis-
`posed with respect to these arms.‘
`It is apparent that when no tension is exerted on the
`wire, the expandible element as shown in disassembled
`condition in Fig. 11, will occupy a space, the diameter of
`which is substantially coextensive with that of cap 55.
`Therefore, if a collecting element as heretofore described
`in connection with Fig. 8, is ensleeved over this assembly,
`that element will have a relatively reduced diameter. So
`reduced,
`it may readily be ensleeved within the 'outer
`end of tube 43 or its equivalent. However, when pro-
`jected beyond that tube and upon a tension or pull being
`exerted upon Wire 21 or 51, the head portion 57 will be
`drawn towards the foot portions 59. Under these circum-
`stances, the legs 58 will bow outwardly as shown in Fig.
`9 tojdistend the abrador and tissue-collecting element.
`That element will also extend at an angle to the axis
`of the instrument so that cells may be collected from
`those areas of the organ which are immediately adjacent
`the passage through which the instrument has been in-
`troduced. Under these circumstances, it is apparent that
`cells may be adequately collected and thereafter exam—
`ined with full assurance that an effective diagnosis may
`be made.
`
`Thus among others, the several objects of the invention
`as specifically aforenoted are achieved. Obviously, nu—
`merous changes in construction and rearrangements of
`the parts might be resorted to without departing from the
`spirit of the invention as defined by the claims.
`
`10
`
`15
`
`20
`
`25
`
`3O
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`I claim:
`
`6
`
`including in combination
`1. A diagnostic instrument
`a flexible wire, a mounting for an abrasive cell-collecting
`element connected at one end thereof, an actuator con-
`nected at the opposite end of said wire, said wire at the
`end zone adjacent said mounting incorporating a “set”
`such that it tends to extend at an angle to the portions
`of its body short of that zone, a flexible and tubular
`sheath attached at one end to said mounting and enclos-
`ing said wire and at its opposite end being connected to
`said actuator, said sheath, in a zone adjacent said mount—
`ing, being compressible and when compressed incor-
`porating rigidity such that it defines a tube of substan-
`tially straight configuration, said actuator initially occu-
`pying a position to maintain said wire under tension and
`said sheath under compression, and said actuator being
`projectable toward said sheath to relieve the compression
`of the latter to cause said wire at said zone to extend
`angularly with respect to the portions of its body short
`of that zone and to cause a similar extension of the adja-
`cent sheath parts.
`2. In a diagnostic instrument as defined in claim 1,
`said sheathcomprising an outer body formed of spiral
`convolutions initially being in substantial contact with
`each other.
`

`
`3. In a diagnostic instrument as defined in claim 1,
`said sheath comprising an outer body formed of spiral
`convolutions initially being in substantial contact with
`each other, and an inner expansible convoluted body.
`4. In a diagnostic instrument as defined in claim 1,
`a substantially rigid tube enclosing said wire at a point
`between said sheath and actuator.
`5. In a diagnostic instrument as defined in claim 1, a
`chuck structure carried by and substantially contained
`within said mounting.
`.
`p
`6. In a diagnostic instrument as defined in claim 1,
`said wire within the zone of such “set” being non-cir-
`cular in cross section.
`7. In a diagnostic instrument as defined in claim 1,
`an expansible assembly carried by said mounting,
`the
`adjacent end of said wire being operatively connected to
`said assembly and said wire being shiftable to expand
`and constrict said assembly.
`8. In a diagnostic instrument as defined in claim 7,
`a distensible abrading element ensleeved over said asesm-
`bly and means for securing said element against detach-
`ment therefrom.
`9. In a diagnositic instrument as defined in claim 1,
`a brush comprising the collecting element coupled with
`said mounting and said brush including a support and a
`plurality of bristles arranged in spiral row formation
`around said support.
`
`654,763
`735,400
`1,092,914
`1,127,948
`1,425,435
`1,711,352
`2,022,065
`2,701,559
`2,729,210
`2,739,585
`
`References Cited in the file of this patent
`UNITED STATES PATENTS
`Russell _______________ July 31, 1900
`McCully _______________ Aug. 4, 1903
`Jones _________________ Apr. 14, 1914
`Wappler _______________ Feb. 9, 1915
`Allen _________________ Aug. 8, 1922
`Jeffreys _______________ Apr. 30, 1929
`Wappler ______________ Nov. 26, 1935
`Cooper ________________ Feb. 8, 1955
`Spencer ________________ Jan. 3, 1956
`Ayre _________________ Mar. 27, 1956
`FOREIGN PATENTS
`,
`Germany _-__-....____..___ Dec. 4, 1929
`
`487,198
`
`5
`
`

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