CA2030595C - Disposable soft tissue biopsy apparatus - Google Patents

Disposable soft tissue biopsy apparatus

Info

Publication number
CA2030595C
CA2030595C CA002030595A CA2030595A CA2030595C CA 2030595 C CA2030595 C CA 2030595C CA 002030595 A CA002030595 A CA 002030595A CA 2030595 A CA2030595 A CA 2030595A CA 2030595 C CA2030595 C CA 2030595C
Authority
CA
Canada
Prior art keywords
cannula
needle
housing
slide
stylet
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA002030595A
Other languages
French (fr)
Other versions
CA2030595A1 (en
Inventor
Harold G. Leigh
David L. O'dell
Hugh A. Bourassa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medical Device Technologies Inc
Original Assignee
Medical Device Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medical Device Technologies Inc filed Critical Medical Device Technologies Inc
Publication of CA2030595A1 publication Critical patent/CA2030595A1/en
Application granted granted Critical
Publication of CA2030595C publication Critical patent/CA2030595C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0266Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B2010/0208Biopsy devices with actuators, e.g. with triggered spring mechanisms

Abstract

Soft tissue biopsy apparatus (10) for obtaining a tissue specimen. An elongate housing (12) has an opening (20) at one end (14). A hollow cannula (26) is positioned within the housing, is reciprocally movable therewithin, and one end (28) of the needle extends through the opening for insertion into tissue (T) from which a specimen is to be taken. A needle (44) is positioned within the cannula, is reciprocally movable therewithin, and also has an end (46) extending through the opening for insertion into the tissue. This needle has a recess (50) adjacent its outer end in which a tissue specimen is captured. The needle is connected to a slide (68) by which the needle is moved independently of the cannula. A sleeve (110) installed over the housing is manually operable to move the slide to a selected and cocked position prior to insertion of the cannula/needle into the tissue. Movement of the slide moves the second needle from a first position to a second position while the cannula remains stationary. A release mechanism (114) operable by the user after insertion of the assembly into the tissue initially returns the needle to its first position and then moves the cannula from a first position to a second position. Movement of the cannula to its second position causes the end of the said cannula to cover the end of the needle to capture the tissue specimen within the recess.

Description

203~5~

This invention relates generally to a biopsy apparatus and more specifically pertains to a disposable biopsy apparatus for perfor~ing a soft tissue biopsy.
It has been noted that biopsies or sampling of . ` .
` the inner tissue of animals and humans has hecome ~
:, ., increasingly common. While there are a number of ways in which biopsies are performed, one method involves the use -~-of two needles. One of these is a cannula or hollow needle; and the other is a stylet or needle having a ~-recess along a portion of its length usually just behind ---the tip of the needle. In practice, the stylet is positioned within the cannula and the relative movements ;
of the two needles co-ordinated to extract a tissue specimen. Thus, when the subject's skin is punctured, the ' recess portion of the stylet is enclosed within the cannula. Once the needles are moved to within proximity -of the site from which the specimen is to be taken, the stylet is moved relative to the cannula so the recess is ---: ;-:
exposed and fillea with specimen tissue. Then, the 20 cannula is moved relative to the stylet so the cannula r~~~ -overcovers the recess and captures the tissue specimen.

The stylet and cannula are then withdrawn, the cannula ~-:.:
being maintained in its position covering the recess during extraction. Afterward, the cannula is pulled back from the stylet, exposing the recess, and allowing the captured tissue sample to be removed to a specimen container, or the like, for testing. The early patent to ; -Griffith, U.S. No. 3,477,423, shows this obturator-sheath ---relationship. ~ --,:Cf-:.
~ number of biopsy implements are known by which v-the above described procedure is accomplished. One such ~ ~
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~, , device is disclosed in the United States patent No. ~i , 4,667,684 which was invented by one of the same inventors ~-of the present application. The device of this invention features a stylet and a cannula which are fixed at their ends to respective hubs. B~th hubs are located in a -~
guideway in the upper end of a pistol grip style hand gripping device. The device is designed for single-handed usage wherein pressing on a trigger mechanism house~ in --.::. :, the grip results in a sequential movement of the stylet ~-~
and cannula to secure a tissue specimen. A second type of ~--~ implement is shown, for example, in United States patent No. 4,699,154. This device employs a series of slides and springs positioned within a box-shaped housing. A hook latch and push button release mechanism generally at the end of the device, are employed to move the stylet and ~-cannula assemblies within the device to obtain the tissue `-specimen. It appears to operate just the opposite from ~ -the current invention, and incorporates dual slide bars to achieve its functioning. ~-~
While both of the biopsy devices described above, ~--,. . . .
as well as others known in the art, function for their intended purpose of obtaining a biopsy sample, recent medical epidemics have imposed on the medical profession certain cautionary measures which did not have to be dealt with in the past. Of particular importance is limiting the use of needles to only one individual and, at the same =-~
time, protecting the user of the biopsy device from inadvertent exposure to potentially deadly infections.
Typically this means that the biopsy device is limited to ~-a single usage and then safely discarded. Given the number of biopsies currently.being performed, there is a -3- ~--'' ... .....
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need for a low-cost ! slmple to use (preferably by one person ~
uslng only one hand), lnstrument, whlch cannot accldentally ~-ln~ure elther the patlent or the user, and whlch cannot readlly and safely be dlscarded after appllcatlon.
Other patents relatlng to thls technology lnclude the Unlted States patent to Woods, No. 4,570,632, pertalnlng to a devlce ln the category of cystotome for use ln eye surgery. The Unlted States patent No. 4,476,864, to Tesel, shows a multiple punchlng devlce for use ln halr transplant. ~-~
The Unlted States patent No. 4,600,014, to Beraha, shows a transrectal prostate blopsy devlce and method. A Sovlet Unlon patent No. 175,611, shows an lnstrument for achlevlng puncture , ~, blopsy. A European Patent Offlce patent No. 0010~21, shows another form of blopsy device capable of belng operated wlth ,~-one hand. Flnally, what appears to be an Austrlan patent No. ~ -141,108, shows another for~ of endoscoplc sample exclsion lnstrument.
The present lnventlon provldes soft tlssue blopsy ~
apparatus for obtalnlng a tlssue speclmen comprlslng: an -elongate houslng havlng an openlng at the front end thereof~ -a hollow cannula means posltloned wlthln sald houslng and reclprocally moveable therewlthln, one end of sald cannula - ~-means extendlng through sald openlng for lnsertlon lnto tlssue --from whlch a speclmen is to be taken; a needle me~ns posltloned wlthln sald cannula means and reclprocally moveable therewlthln, sald needle means also havlng an end extendlng through sald openlng for lnsertlon lnto the tlssue and a ~- -sampllng means ad~acent sald end ln whlch a tlssue speclmen ls -, 62739-Z62 ' -~,~

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capturable~ sllde means to whlch the needle means ls operably ~ :
connected for movlng sald needle means lndependently of sald -;-cannula means~ cocklng means manually operable by a user of the apparatus for movlng the sllde means to a selected posltlon prlor to lnsertlon of sald cannula/ needle means lnto ---the tlssue, whereby rearward movement of side sllde means shlfts sald needle means and sald cannula means from a flrst posltlon to a second posltlon; and, release means operable by the user after lnsertlon of sald cannula/needle means lnto the . :
tlssue for lnltlally returnlng sald needle means to lts flrst ;
posltlon and for then movlng sald cannula means relatlve to ---sald needle means towards sald flrst posltlon, and movement of ~-sald cannula means to a posltlon causlng the end of the cannula means to cover the sampllng means of the needle whereby the tlssue speclmen ls captured between sald cannula and needle means. -The lnventlon also provldes a soft tlssue blopsy-~ `
apparatus for obtalnlng a tlssue speclmen comprlslng: an -~
elongate houslng havlng a forward end and a rearward end, sald - -, houslng havlng an openlng at sald forward end; a hollow cannula means posltloned wlthln sald houslng and reclprocally moveable therewlth, sald cannula means havlng a dlstal end -extendlng through sald openlng for lnsertlon lnto tlssue from whlch a speclmen ls to be taken; needle means mounted -~
concentrlcally wlth respect to sald cannula means to extend-:-therethrough and reclprocally moveable therewlthln, sald needle means havlng a dlstal end extendlng through sald openlng for lnsertlon lnto the tlssue and sampllng means -~:
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ad~acent sald distal end ln whlch a tlssue speclme'n ls '-capturable; blaslng means operatlvely coupled to sald needle -.-means near sald proxlmal end of sald needle means to urge sald needle means toward sald forward end of sald houslng;
reslllent means operatlvely assoclated wlth sald needle means and sald cannula means urglng sald needle means and sald ' ~--cannula means to respectlve at rest positlon; cocklng means ;
assoclated wlth sald needle means for manually movlng sald needle'means agalnst the force of sald blaslng'means to a -:
predetermlned selected posltlon prlor to lnsertlon of sald -'-dlstal ends of sald cannula means and sald needle means lnto '~:' the tls~ue; releaslng means assoclated wlth sal~ needle means ' --for enabllng sald needle means to move from sald Predetermlned ''-selected posltlon to a sampling posltlon under the force of '''~--sald blaslng means, and for subse~uently movlng sald cannula -' means relatlve to sald needle means to a posltlon whereat sald ~ ~
dlstal end of sald cannula means covers sald sampllng means of -;:' sald needle means to capture the tlssue speclmen ln sald '~' sampllng means of sald needle means, sald reslllent means restorlng sald needle means-and sald cannula means to thelr at ~ :~
rest posltlons after the tlssue speclmen has been captured ln '-~
sald sampllng means of sald needle means. '-' Preferably the blopsy apparatus can be used slngle- , handedly by a physlclan or-'a medlcal technlclan, ls very llght welght ln constructlon, and ls easlly manlpulated by the user . -~' for lnsertlon lnto the reglon of a body from whlch a speclmen -ls to be taken. ~ -The apparatus employs a slrnple, slngle trlggerlng ~-:
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mechanism, ls selectlve in the quantlty of speclmen obtalned, to lnltlally snd promptly collect a tlssue speclmen wlthln the recess of an extendlng needle or stylet and slmultaneously thereafter overcover the speclmen wlth a hollow needle or .. .
cannula.
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The apparatus ls dlsposable after the apparatus ls wlthdrawn from the body and the speclmen extracted from the recess thus to prevent usage of the same needle wlth more than ~ -one lndlvldual.
The lnventlon can provlde a low-cost blopsy ~ ~
apparatus whlch ls compact ln slze and llght-welght, and whlch ~ - -can be safely used by the physlclan or technlclan. ;-There are many other unlque features about thls lnventlon that make lt rather faclle of manufacture and assembly, unlque ln usage and appllcatlon, and whlch provldes -: ~
efflclent results for each blopsy taken, before lt ls readlly dlsposable after a slngle usage, or repeat usage upon the same patlent.
The entlre devlce ls preferably fabrlcated wlth -generally concentrlcally arranged parts and components.- For example, the relatlonshlp between the cannula and needle, as ~ -~
they are concentrlcally arranged wlth respect to each other, -provldes for axlal allgnment of the varlous means that provldes for the thrust of,-lnltlally the needle forwardly, once lnserted wlthln proxlmlty of the speclmen bel~g tested, ~
and then provldes for capture of the needle recessed speclmen ~ -by means of overlylng coverage through -- 6a -. 62739-262 . ~: , . ':

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the concentrically arranged cannula. Furthermore, the relationship between the depth of penetration, and - coverage, of the needle, by the cannula, can be controlled -~
by a spacer means that limits the extent of forward `~
movement of the needle, relative to the cannula, during -its specimen accepting manipulation. Also, the device can be coc~ed to different settings to control depth of penetration, and the strength of force of the forward ~ --movement of the needle and its cannula. Furthermore, this 10 invention provides means for initiating the triggering of -~
its actuation, quite distinct from those shown in the prior art, which usually require the initiation of a -trigger mechanism, normally located and disposed at thé
back end of any biopsy device, requiring the assistance of the second hand of the technician, whereas, in the current invention, the triggering means is acceptably located at c -the position of the same hand of the medical technician who has just inserted the device, and can immediately utilize an index and one other finger, of the same hand, for initiating a biopsy sample taking activity. Thus, this device is truly for a single handed operation, to provide an effective specimen of a biopsy for ready analysis by the medical personnel.
Other objects and features of this invention will become more apparent to those skilled in the art upon reviewing the summary of the invention herein, in ~-combination with a study of the descrip- ~-tion of the preferred embodiment, with respect to its drawings.
-Fig. 1 is an elevational view of a biopsy ~ -. - ::-apparatus of the present invention; -~.:''.

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Figs. 2 is an exploded view illustrating the ~ --sequence of assembly of the components comprising the apparatus;
Figs. 3a and 3b are respective elevational and bottom plan views of a cannula assembly used in the apparatus; ;~-Figs. 4a and 4b are respective side and front -~
elevational views of a stylet assembly used in the , apparatus;
Figs. 5a and 5b are respective side and front -elevational views of a slide for moving the stylet and -cannula assemblies;
Figs. 6a-6d are elevational views of the housing --- taken at respective quarter-turns of the said housing; `
Fig. 7 is a sectional view taken along line 7-7 `
in Fig. 6a;
Fig. 8 is an elevational view of a sleeve fitting ~,x -over the housing and used to initiate operation of the .~
apparatus; ``

- 20 Fig. 9 is a sectional view taken along line 9-9 l . ~: ::
in Fig. 8; and, -Figs. 10-13 are sectional views of the apparatus -illustrating the sequence of operations performed in ~ --obtaining a biopsy sample through usage of the apparatus. -~
Corresponding reference characters indicate corresponding parts throughout the drawings. ~ ~
Referring to the drawings, a soft tissue biopsy --apparatus of the present invention is indicated generally at 10. Apparatus 10 is a hand-held implement for use by a doctor or medical technician to obtain a tissue sample and specimen from a patient for laboratory testing. Its .,.............. ~ ., #

primary use therefore is as an aid in diagnosis. It is a feature of the apparatus that it be a light-weight, generally less than one and one-half ounces in weight, -safely disposable, easy to use implement that can be readily adjusted so a biopsy sample can be taken from any part of the body whether near the skin's surface or deeper within the body, so that the specimen from the suspected region can be tested and analyzed.
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The apparatus includes an elongate housing 12 ---10 having a tapered front end 14, a hollow, cylindric body ~
section 16, and an open back end 18 which is internally ---threaded proximate its back end. An opening 20 is formed in the front end of the housing, and a threaded cap 22 threadedly fits into the open, rear end of the housing. -The housing is made of a light-weight polymer material and ~-the length of the housing is such as to comfortably fit in one hand of the doctor or technician employing the apparatus.
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A first and hollow cannula means 24 is positioned 20 within housing 12. As particularly shown in Figs. 3a and -3b, means 24 comprises a cannula assembly including a hollow needle or cannula 26 the tip end 28 of which -~
extends through opening 20 for insertion into tissue from --which a specimen is to be taken. The other end 30 of the cannula is affixed to a circular pedestal 32. The pedestal has an upstanding, circular support 34 into which end 30 of the cannula tightly inserts. This support projects outwardly from the forward face of the pedestal.
An integral extension of the needle 36 extends rearwardly through and to the rear face of the pedestal, as can be seen. The pedestal, support, and extension all have a :~
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longitudinal bore which is of uniform diameter and concentric with the longitudinal bore 38 formed through the cannula providing an opening from end 28 of the cannula, and internally along its entire length. A spring 40 is insertable into the housing. The spring tapers to conform to the gradually tapering internal ~iameter of the , ~-housing at its forward end so the front end of the spring . - .., seats against the interior nose of the housing. Although, ~ - ., : :-springs of other shapes may likewise be used. The rear -~
end of the spring seats against the front face of the ~ ~~-pedestal to bias the cannula assembly toward the rear of the housing. As will be described hereinafter, the ~-cannula assembly is reciprocally movable within the housing lO for cooperating ln obtaining the tissue sample.
- ~ needle means 42 is also installed in the ~ ~-housing lO. As shown in Fig. 2, this needle means is -positioned within the first cannula means and is ; ---reciprocally movable therewithin. Referring to Figs, 4a and 4b, this needle means comprises a stylet assemhly. --The stylet assembly includes a stylet 44 having a tip end 46 for penetration of tissue. A tissue sampling means 48 ~,~f''-', comprises a recess or notch 50 adjacent end 46 of the ~~~ `~~~`~~
stylet, as known in the art. As will be described -~
hereinafter, a tissue specimen is captured in this notch during application of the apparatus. The ~iameter of ~-stylet 44 is such that the stylet can be slidably inserted within the cannula assembly, through its inner channel and the opening in the end of extension 36. The length of the stylet is such that when so installed, the tip end of the -~-stylet will extend sufficiently far enough through the open end 38 of the cannula that all of the recess is ',' , 2~}~r;~

exposed for tissue capturing, or retracted thereln for tissue confinement. The other end of the stylet extends through a base 52 and terminates at its pad 5~ of the assembly. Pad 54 is a circular pad while base 52 is a rectangular unit which sits atop the pad, the width of the base being greater than to the dimension of the pad, as can be seen.
The stylet assembly includes a means 56 for interlocking the stylet and cannula assemblies and for limiting movement of the stylet relative to the said cannula. Thus, even though the stylet is reciprocally movable within the cannula and independently of the movement of the cannula, the extent of the stylet movement is somewhat restricted. Pedestal 32 has a tongue portion 58 formed by two slots 60 which extend inwardly from the perimeter of the pedestal to respective sides of support 34. The radius of the tongue is less than that of the remaining portion of the pedestal so to create a recessed section about the periphery of the pedestal. Means 56 20 includes a bail 62 having legs 64 extending from pad 54, through base 52, and parallel to the stylet. The bail is generally U-shaped with the closed end portion turned at a right angle to the longitudinal axis of the bail. Thus, the upper ends of the legs are turned to form a lip 66 ~hich fits over tongue 58 of pedestal 32. As a result, the length of travel of the stylet corresponds to the length of the legs of the bail beyond the upper end of the base. It should be obvious that other forms of bail, such as one formed of a polymer, can be envisioned for usage herein.
~ext, apparatus 10 includes a slide means 68 to 2~3~

which the stylet assembly is connected for moving the stylet assembly independently of the cannula assembly.
Referring to Figs. 5a and 5b, the slide means includes a cylindrical, hollow tube 70 having a first section 72 and a second section 74. The inner diameter of the tube is uniform along its length and corresponds to the diameter of pad 54. However, the outer diameter of section 72 is greater than that of section 74 so as to create a shoulder 76 at the junction between the two sections. Further, the outer diameter of section 72 corresponds to the width of base 52.
Section 72, which is the forward of the two sections when the slide is installed in the housing, has a pair of opposed longitudinal slots 78 which extend rearwardly from the forward end of the section almost to the junction between the sections. Base 52 and pad 54 are inserted into the open, front end of the housing, the respective sides of the base being positioned in the slots. A pair of pins 80 extend transversely of section 72 on both sides of the slots. The pins are inserted after the base/pad comblnation is installed with the pins heing between the outer surface of the pad and the front end of the slide. The pins thus hold the base/pad combination in the slide. Further, a circumferential inwardly directed lip 82 is formed about the opening at the rear of section 74. A spring 84 inserts within the tube 70, and seats against this lip and bears against the backside of connected pad S4, urging the pa~ forwardly against the restraining force exerted by the pins.
Slide means 68 also includes a pair of flexi~le fingers 86 formed in section 72 of tube 70. The fingers r~

are formed on opposite sides of the section and are each arranged at a quarter-turn from the slots 78. ~ach finger is formed by a IJ-shaped channel 88 through the sidewall of section 72, the sides of the channel extending generally ~-longitudinally of the tube from near a forward end thereof, and the proximate base of the channel being ` slightly forwardly of the inner end of the slots. The ; fingers thus extend in a rearward direction of the tube.
Further, each finger has an outwardly projecting tah 90 at its distal end, as can be seen. Finally, a spring 92 bears against shoulder 76 of the slide, when it is installed in housing 12, to urge the entire slide assembly forwardly. This sprin~ seats against the inward end of cap 22 which, as previously noted, is threadahly received in the back end of the housing, with this spring 92 being disposed within the proximate opening, provided within the housing 12.
As thus far described, the base/pad combination of the stylet assembly is installed in section 72 of tube 70 with spring 84 urging the stylet assembly forwardly.
This spring 84 has equivalent or slightly greater strength than the spring 40. Although, other relative spring strengths can be utilized. Tip 46 of stylet 44 is inserted into the open end cannula extension 36 of the cannula asse~bly and pushed forward until the end of the extension strikes the outer end of base 52. Tip 46 of the stylet extends through the opening in the tip end 28 of the cannula when the insertion step is complete. The outer end of bail 62 is hooked over tongue 58 on the cannula assembly pedestal to interlock the two assemhlies together. Although, other forms of engagement of these ~0305~

components relative to each other may be utilized. Spring 40 is inserted into the back end of the housing and the combined cannula/stylet assemblies, tip ends first, are next inserted. The tip ends project through opening 20 at the front end of the housing when the insertion is complete. Housing 12 has a pair of opposed longitudinal guide slots 94 formed intermediate its length and the projecting tab portion of the fingers 90 fit in the respective slots.
In addition to the slots 94, a pair of base guide slots 96a, 96b are also formed in the sidewall of the housing. These slots, which are also longitudinal slots are formed to guide movement of the stylet assembly base.
For this purpose, threaded bores 98 extend inwardly into the base from its respective outer sides. When the slide or tube 70 is properly installed with the tabs 90 extending through the slots 94, the bores in the sides of the base are aligned with the slots 96. Pins 100 are then inserted through the slots and into the bores. The pins extend out heyond the sidewall of the housing when installed and so limit ~ovement of the slide with respect to the length of the slots 96 occurs. Also, a circular opening 102 is formed in the sidewalI of the housing immediately forward of the forward end of the respective slots 96a. A slotted pin 104 is insertable through one of ---the openings and extends across the housing, transverse to the stylet and cannula assemblies, and through the corresponding opening on the opposite side of the housing. Pin 104 has a longitudinal slot 106 in which is received the legs 64 of bail 62. The width of the slot is less than the width of the base 52 of the stylet assembly :

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so to act as a stop to forward movement of the assembly.
At the same time, the diameter of the pin is less than the width o the slots 78 formed in section 72 of the slide.
And, the ends of the pin are immediately forward of the outer ends of the slots and aligned therewith. Thus, while the pin acts as a stop to forward movement of the stylet assemhly, it does not inhibit forward movement of the slide.
~-- Apparatus 10 next includes cocking means 108 manually operable by a user of the apparatus for moving the slide to a selected position prior to insertion of combined cannula-stylet 26 and 44 into the tissue. Means 10~ comprises a hollow, cylindric sleeve 110 the inner diameter of which is slightly greater than the outer diameter of housing 12 for the sleeve to fit over the housing. The front end of the sleeve is threaded for a spacer 112 to be threaded onto the sleeve. The spacer varies the overall length of the sleeve and likewise can regulate the depth to which the stylet with respect to the ~0 cannula can be inserted into the tissue from which a specimen is to be taken. The sleeve is sli~ingly -~
installed over housing 12. This spacer as threaded onto the sleeve provides an adjustment to the extent of projection of the stylet 4~ out of the cannula 26, and therefore limits the amount of recess exposed and the amount of specimen obtained, because the inner threaded end of the sleeve can be contacted by the pins 100 to limit the forward movement of the stylet relative to the forward tip 28 of the cannula. Thus, the extent of exposure of recess 50 can be regulated, to limit the quantity of biopsy obtained.

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- A pair of opposed, flexible tabs 114, comprising - push-button like members are formed in the sidewall of the - -sleeve at the proximate rear end thereof. The tabs are each integrally formed with the sleeve and each is formed : :.
by a U-shaped channel 116 through the siAewall. The sides -~
- of the channel extend circumferentially about the sleeve, and the base of the channel extends longitudinally thereof. The tabs thus extend circumferentially about the sleeve, and are resilient in structure. Intermediate the tabs and the back end of the sleeve are a pair of threaded location holes 118. ~ousing 12 includes a pair of -elongate, longitudinal slots 120 and 122 (See Figs. ~-~
6b-6d). Slot 120 is slightly offset from slot 96a with - ~
the forward end of slot 120 communicating with the back - -end of slot 96b. Slot 122 is positioned intermediate one ~-of the slots 94 and slot 96b. Slot 122 has a reverse S-shape as does the combined slot formed by slots 96a and -~-120. At the rearward end of the slots is a nose section -124a, 124b respectively. After sleeve 110 is slipped over --housing 12, guide pins 126 are threaded into holes 118.
When installed, the outer end of the pins are flush with the outer surface of the sleeve, but the inner end of the -pins are inserted in the respective slots 120, 122 to -guide movement of the sleeve during cocking of the apparatus. Also, as noted, these pins may provide for a -half cocking of the sleeve upon the housing by locating ~ ~-said pins at the S-shaped curve, and the recesses thereat, so as to allow the device to trigger at an approximate one-half strength, and move an approximate half stroke.
The outer end of each tab 114 is immediately adjacent projecting tab portion 90 of each finger 86 in .......
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slide means 68. This projection extends sufficiently far past the outer surface of housing 12 that a lip 128 formed by the forward leg within the channel 116 contacts the tab as the sleeve is moved rearwardly over the housing. The force of the lip against the finger, as the sleeve moves, draws slide tube 70 rearwardly and moves stylet assembly 42 from a first position (see Fig. 10) to a second -position (see Fig. 11). Thereafter, when the user simultaneously presses in on the end of both tabs 114, the fingers are pushed into the housing, which releases the slide to return to its original position. A clearance section 130 of the sleeve immediately adjacent the lips 128 adjacent the free end of the tabs 114, provides for - ~ -greater depressing of the tab during triggering of the apparatus.
Operation of apparatus 10 to obtain a tissue specimen is best understood with reference to Figs.
10-13. As shown in Fig. 10, the relationship of the ~- stylet recess relative to the cannula can be seen. Prior ' to use, through, and before cocking, the stylet is normally retracted within the cannula in the working relationship as shown in Figure 11. During working, --spring 92 bears against shoulder 76 and urges slide 70 forwardly (to the right). Pin 104, acting as a stop, --limits movement of the slide. Spring 40 bearing against ~--the forward face of pedestal 32 urges cannula assembly 24 rearwardly (to the left). The tip end of the stylet extends only slightly beyond the tip end of the cannula at this time. Sleeve 110 is also at a forward position and the pins 126 are at a midpoint along the length of their respective slots 120, 122. Fingers 90 extend out past the 2~3059~ :

sides of the housing at a point to the rear (left) of the lips 114 of the sleeve.
Prior to inserting the tip end of the apparatus into the tissue, the user grasps the sleeve and draws it rearwardly (to the left) to cock the apparatus. As the sleeve moves, the lips 128 contact the extended fingers 90 and the sleeve pulls sliAe tube 70 rearwardly, compressing --the strong spring 92. Pins 80, bearing against the pad 54 of the stylet assembly, force the stylet assembly to the -- -10 rear of the housing as the slide moves. Movement of the slide is stopped when the pins 100 extending from the sides of base 52 reach the rearward end of the respective slots 96a, 96b. At this time, the pins 126 extending inwardly from sleeve 110 reach the rearward end of their -~
respective slots 120, 122. On the other hand, half - -cocking can be done by positioning the pins 126 at the -S-curve recesses. By now, with a slight turning of the -~
sleeve, the user can set the pins 126 into the recesses or -nose sections 124a, 124b of the slots to lock the sleeve 20 and the apparatus in a cocked position. The sleeve will remain as cocked because of the force of spring 92 on slide means 68. The tip end of the stylet is now ~
substantially withdrawn into and aligned with the tip end ~-of the cannula. Further, the tips of the stylet and cannula remain relatively close together as shown in Figure 11, which facilitates the insertion of them into the tissue T from which the biopsy sample is being taken.
After insertion of the apparatus within the skin, the user moves the housing about until they have the tip 30 ends of the apparatus positioned in proximity with ~he tumor or portion of the body to be specimened. During :: ,, ', ~ ~

2 ~ 3 ~

this time, the sleeve is maintained in its cocked and -locked position, as aforesaid. When the user is satisfied the apparatus is properly positioned, he simultaneously presses inward on both the tabs 114. This action pushes ~ ~-the the tabs 90 of fingers 86 inwardly and away from the ~
lips 128 of the sleeve which have held them in place. --Spring 92 now propels slide means 68 forwardly, driving -~
the slide 70 toward the nose end of the housing. As shown - --in Fig. 12, the stylet assembly is also driven forwardly, with additional pressure from the spring 84, with the tip -~
end of the stylet moving deeper into the tissue. The notch in the stylet is now exposed to the degree allowed by the spacer 112, and tissue fills the recess 50.
Forward movement of the slide is abruptly halted when base 52 of the stylet assembly contacts pin 104, and the spring 40 acting as a buffer.
During the interval in which the stylet assembly is moved from its retracted to its extended position, the cannula assembly remains reasonably stationary. Now, ;
however, the forward end of tube 70 strikes the rear face of pedestal 32 and, under the continued urging of spring . , ~
~ 92, the cannula assembly is driven forward. The outer end ~~
, .-~., of the cannula now overcovers or shrouds recess 50 in the stylet capturing a tissue sample within the notch. See ~
Fig. 13. The forward movement of the cannula assembly is ~ -halted by the forward face of the pedestal 32 striking lip 66 of bail 62.
During the above described latter movement, both spring 84 within slide 70, and spring 40 at the fcrward 30 end of the housing, are compressed, the latter acting as a buffer. Both springs now move to restore themselves to -19- ~ ~;

~ ,,"~
,, . . . ~ ~

~03059S

their original positions. In doing so, they push the slide means 6~ and the cannula assembly rearwardly in housing 12. This action serves to simultaneously help withdraw both the stylet and cannula assemblies from the tissue sampling site. The user now pulls on the housing to extract the cannula and stylet from the tissue. The apparatus can then be taken to a laboratory or testing facility at which the tissue sample is removed from the notch for testing. The apparatus can then be discarded.
Variations or modifications to the structure of this invention, as described, in addition to its method of operation, may occur to those skilled in the art upon reviewing the definition of the invention herein. Such -variations or modifications, if within the spirit of this invention, are intended to be encompassed within the scope of any claims to patent protection issuing upon this development. The description of the preferred embodiment set forth herein is done so for illustrative purposes only.
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Claims (31)

1. Soft tissue biopsy apparatus for obtaining a tissue specimen comprising:
an elongate housing having an opening at the front end thereof;
a hollow cannula means positioned within said housing and reciprocally movable therewithin, one end of said cannula means extending through said opening for insertion into tissue from which a specimen is to be taken;
a needle means positioned within said cannula means and reciprocally movable therewithin, said needle means also having an end extending through said opening for insertion into the tissue and a sampling means adjacent said end in which a tissue specimen is capturable;
slide means to which the needle means is operably connected for moving said needle means independently of said cannula means;
cocking means manually operable by a user of the apparatus for moving the slide means to a selected position prior to insertion of said cannula/needle means into the tissue, whereby rearward movement of side slide means shifts said needle means and said cannula means from a first position to a second position;
and, release means operable by the user after insertion of said cannula/needle means into the tissue for initially returning said needle means to its first position and for then moving said cannula means relative to said needle means towards said first position, and movement of said cannula means to a position causing the end of the cannula means to cover the sampling means of the needle whereby the tissue specimen is captured between said cannula and needle means.
2. The apparatus of claim 1 wherein further including spring means providing a force biasing the cannula/needle means to their respective first positions and a motive force for moving the respective means upon operation of the release means.
3. The apparatus of claim 2 wherein the cannula means includes a cannula assembly and the needle means includes a stylet assembly.
4. The apparatus of claim 3 wherein the cannula assembly includes a cannula, a pedestal at one end to which the cannula is connected and from the other end of which a concentric, hollow extension of the cannula extends.
5. The apparatus of claim 4 wherein the stylet assembly includes a stylet, a base which one end of the stylet is attached, and means interlocking with the pedestal to limit movement of the stylet assembly.
6. The apparatus of claim 5 wherein the sampling means comprises a recess formed adjacent the end of the stylet extending through the end of the housing.
7. The apparatus of claim 5 wherein the pedestal has a tongue formed thereon and the interlocking means comprises a bail having legs extending from the base parallel to the stylet with the outer end of the bail fitting over the tongue whereby the distance the stylet assembly is movable substantially corresponds to the height of the bail.
8. The apparatus of claim 7 wherein the spring means comprises a first spring insertable in the housing and fitting between the inner front end of the housing and the face of the pedestal facing that end of the housing, said first spring functioning as a buffer and biasing the cannula assembly toward the opposite end of the housing.
9. The apparatus of claim 8 wherein said slide means includes a hollow slide having a front end in which the base of the stylet assembly is inserted and means for holding the base therein.
10. The apparatus of claim 9 wherein the spring means comprises a second spring seated against the back end of the slide and bearing against said base to urge it against said holding means.
11. The apparatus of claim 10 wherein said housing includes at least one longitudinal guide slot in the side thereof and the slide includes a finger extending outwardly from the side of the slide through said slot.
12. The apparatus of claim 10 wherein said housing includes a pair of opposed longitudinal guide slots in the side thereof and the slide includes opposed fingers respectively extending outwardly from the side of the slide through said slots.
13. The apparatus of claim 11 wherein the spring means includes a third primary spring seated against the rear end of the housing and bearing against the slide to urge it toward the front end of the housing.
14. The apparatus of claim 13 wherein the cocking means includes a cylindrical sleeve slidingly installed over the housing for moving the slide rearwardly in the housing against the force of the said third spring.
15. The apparatus of claim 14 wherein the sleeve has a tab contacting the finger as the sleeve is moved rearwardly of the housing, said tab moving said finger in said guide slot to draw the slide rearwardly against the force of the third spring to cock the apparatus, said stylet moving from said first position to said second position as said slide moves, the recess in said stylet being withdrawn into the cannula as the apparatus is cocked.
16. The apparatus of claim 15 wherein the housing has a longitudinal cocking slot in the side thereof and the sleeve has a pin insertable in the slot, said pin moving in said loading slot as said sleeve is moved rearwardly, said cocking slot having a turned nose at the rearward end thereof in which the pin is received when the apparatus is fully cocked.
17. The apparatus of claim 16 wherein the housing includes a pair of opposed longitudinal cocking slots in the side and the sleeve has a pin insertable in each slot, each said pin moving in its respective cocking slot as said sleeve is moved rearwardly, and each said cocking slot having a turned nose at the rearward end thereof in which the pins are received when the apparatus is fully cocked to lock the sleeve in place.
18. The apparatus of claim 16 wherein the release means comprises a pushbutton on the side of the sleeve for pressing the finger inwardly into the housing after the cannula/needle means have been inserted into the tissue and positioned proximate the area from which the specimen is being taken, inward movement of the finger releasing the finger from the tab whereby said third primary spring propels the slide forwardly and moves the stylet assembly from its set position to its first position, the recess in the end of the stylet being uncovered by the movement thereof.
19. The apparatus of claim 18 further including stop means extending transversely of the housing for limiting forward movement of the stylet assembly.
20. The apparatus of claim 19 wherein the stop means includes a pin having a slot extending transversely of the housing, the legs of the bail of the stylet extending through the slot and the width of the slot being less than the width of the stylet assembly base.
21. The apparatus of claim 20 wherein the housing has a longitudinal base guide slot in the side thereof and the stopping means further includes a slot pin received in the base and fitting into the slot.
22. The apparatus of claim 20 wherein the slide has opposed longitudinal slots in which the base is positioned and through which the base moves the stylet assembly moves between its first and second positions, the width of said slots being greater than the diameter of the pin whereby the third spring propels the slide forwardly past the pin with the forward end of the slide contacting the backside of the pedestal to push the cannula assembly from its first position to its second position, against the buffer force of the first spring, and further movement of the cannula assembly causing the outer end of the cannula to overcome the recess and capture the specimen therein.
23. The apparatus of claim 14 and further including means for adjusting the degree of exposure of the stylet means from the cannula as the apparatus is released from its cocked position.
24. The apparatus of claim 23 wherein said means includes the forward end of the sleeve being threaded and the adjusting means includes a spacer threadably received in the sleeve, said spacer adjusting the length of the sleeve and the extent of forward movement of the stylet relative to the cannula during operation of the apparatus.
25. The invention of claim 1 and wherein said cocking means capable of moving said slide means to an approximate one-half cocked position.
26. A soft tissue biopsy apparatus for obtaining a tissue specimen comprising: an elongate housing having a forward end and a rearward end, said housing having an opening at said forward end; a hollow cannula means positioned within said housing and reciprocally movable therewith, said cannula means having a distal end extending through said opening for insertion into tissue from which a specimen is to be taken; needle means mounted concentrically with respect to said cannula means to extend therethrough and reciprocally movable therewithin, said needle means having a distal end extending through said opening for insertion into the tissue and sampling means adjacent said distal end in which a tissue specimen is capturable; biasing means operatively coupled to said needle means near said proximal end of said needle means to urge said needle means toward said forward end of said housing; resilient means operatively associated with said needle means and said cannula means urging said needle means and said cannula means to respective at rest position; cocking means associated with said needle means for manually moving said needle means against the force of said biasing means to a predetermined selected position prior to insertion of said distal ends of said cannula means and said needle means into the tissue;
releasing means associated with said needle means for enabling said needle means to move from said predetermined selected position to a sampling position under the force of said biasing means, and for subsequently moving said cannula means relative to said needle means to a position whereat said distal end of said cannula means covers said sampling means of said needle means to capture the tissue specimen in said sampling means of said needle means, said resilient means restoring said needle means and said cannula means to their at rest positions after the tissue specimen has been captured in said sampling means of said needle means.
27. The apparatus of claim 26, wherein said resilient means comprises first resilient means operatively coupled to said needle means and second resilient means operatively coupled to said cannula means.
28. The apparatus of claim 27, wherein said first resilient means comprises a first spring which is compressed in response to movement of said needle means to said sampling position; and said second resilient means comprises a second spring which is compressed in response to movement of said cannula means to said sampling position.
29. The apparatus of claim 26, wherein said biasing means comprises a spring which is compressed in response to rearward movement of said needle means.
30. The apparatus of claim 26, wherein said needle means includes a stylet having said sampling means at the distal end thereof and slide means constructed and arranged for reciprocating movement within said housing, said stylet being supported by said slide means and movable therewith, and said slide means including means adapted to engage said cannula means as said needle means is moved towards said sampling position for moving said cannula means to said sampling position.
31. The apparatus of claim 26, including means for adjusting the degree of exposure of said sampling means relative to said cannula means when said needle means is released from said predetermined position to move to said sampling position.
CA002030595A 1989-11-24 1990-11-23 Disposable soft tissue biopsy apparatus Expired - Fee Related CA2030595C (en)

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US07/440,647 US5036860A (en) 1989-11-24 1989-11-24 Disposable soft tissue biopsy apparatus
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JPH03210250A (en) 1991-09-13
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CA2030595A1 (en) 1991-05-25
EP0429390B1 (en) 1996-07-17
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EP0429390A1 (en) 1991-05-29
DE69027838D1 (en) 1996-08-22

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