Automatic and semi-automatic disposable biopsy needle device

Surgery – Diagnostic testing – Sampling nonliquid body material

Reexamination Certificate

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Reexamination Certificate

active

06358217

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to biopsy needle devices, and more particularly to a disposable biopsy needle device that includes a safety latch and can be used in either an automatic or semi-automatic firing mode, the biopsy needle device having a dampening system that operates to minimize recoil when the device is fired.
2. Description of Related Art
Various biopsy needle devices are known in the art. A typical biopsy needle device known in the art uses a “stylet” in conjunction with a “cannula,” both described more fully, to cut a small tissue sample from a precise location within a patient. The stylet and cannula then function to remove the sample from the body for analysis. The typical biopsy needle device of the type comprising (a) an elongate housing, (b) a knob
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at the first end of the housing, (c) first and second pistons extending from the second end of the housing, (d) connections on the extending ends of the pistons for connecting the stylet and cannula respectively, (e) first and second springs in the housing against which the first and second pistons, respectively, are cocked so that the springs apply a biasing force against the respective pistons, (f) a trigger successive movements wherein the first piston moves force of the first spring while the second piston remains in its cocked position, and after the first piston has moved to its fully extended position, the second piston moves to its fully extended position under the biasing force of the second spring.
A state of the art stylet and cannula is described in Haaga, U.S. Pat. No. 5,718,237. Haaga describes a biopsy needle having coaxial, telescopically inter-engaged stylet, inner and outer cannulas, which are axially and rotatably displaceable relative to one another. The stylet has a distal portion provided with a cutting recess for severing a biopsy specimen from a site in a patient, and the inner cannula has a distal portion for cutting and capturing the specimen in the recess for removal from the site upon withdrawal of the needle from the patient. The distal portion of the inner cannula is partially cut away to provide an insert recess which supports a semi-circular insert of hemostatic collagen which remains at the site upon removal of the needle to minimize hemorrhagic complications by promoting blood clotting. The insert and the distal portion of the inner cannula have radially outer surfaces of corresponding radius whereby the distal portion of the inner cannula and the insert supported therein are received within the distal end of the outer cannula prior to use of the needle.
Bennett, U.S. Pat. No. 5,335,672 describes an improvement in the cocking mechanism wherein the first and second pistons are moved to their cocked positions in separate distinct operations. The improved cocking mechanism comprises an annular ring near the second end of the housing. As the annular ring is rotated, it moves the second piston into its cocked position. The knob on the first end of the housing is pulled in a direction away from the first end of the housing to move the first piston into its cocked position.
Schramm et al. U.S. Pat. No. 5,507,298 describes an apparatus for the automated and facilitated handling and operation of a biopsy needle system, having a first needle component and a second needle component. The first and second needles are provided with first and second handles, respectively, which are fitted into first and second yokes of the apparatus. The apparatus is configured to maintain the first and second needles in a first position, during insertion of the biopsy needle- point into the tissue being sampled. The apparatus is further configured to forwardly move the first and second needles into subsequent positions, respectively, in rapid, automated succession so as to segment and enclose a tissue sample, which may be tested after removal of the biopsy needle system from the tissue. A tissue sample inspection feature permits facilitated repositioning and maintenance of the lo first needle relative to the second needle after retrieval of the tissue sample to enable inspection of the retrieved tissue sample without removal of either needle from the apparatus. The apparatus is further configured so as to be actuatable form position adjacent the front or the rear of the apparatus housing.
Nottke U.S. Pat. No. 4,924,878 describes a spring-powered actuating device for operating the obturator and the cannula of a biopsy needle, and a cocking device removably attachable to the actuating device. The actuating device has a manually operated trigger slide which controls separately the release of spring-powered slides for moving the obturator and the cannula so the surgeon determines the time interval between the release of the obturator and the later release of the cannula. The extent to which the trigger slide can be displaced manually is controlled by a manually adjustable safety slide which may be set in a first position to permit the trigger slide to release the slide for the obturator only and in a second position to permit the trigger slide to release the slide for the cannula. The cocking device, when attached to the actuating device by squeezing them together manually and when so moved it retracts the slides for the obturator and the cannula to stress their springs which power them.
Akerfeldt U.S. Pat. No. 4,953,558 describes an invention referring to a driving unit for advice for tissue sampling. The device comprises in addition to the driving unit a needle unit comprising a hollow outer needle and slidably disposed therein an inner needle, the driving unit being used to propel the needles. The driving unit comprises a driving device for each mechanism adapted to be pretensioned. The driving unit in addition comprises an inner guide sleeve containing two successive needle holders adapted to be shifted in relation to each other in longitudinal direction of the sleeve and adapted to be pre-tensioned in the same direction for propelling the needles with the aid of one spring each and which are provided with releasable locking means. A manual triggering device is provided for releasing the one needle holder who in turn is adapted during the final phase of its propulsion to release the other needle holder. A tensioning sleeve which rotatable surrounds the guide sleeve is provided with cam surfaces cooperating with the needle holders to pre-tension them against he spring force.
Ohto et al., U.S. Pat. No. 5,505,211 describes the set of biopsy needles of the invention is provided with a shaft member for an inner needle which has an inner needle base at the front end to fix an inner needle, a shaft member for an outer needle which has an outer needle base at the front end to fix an outer needle, a gripping member for operation which fixes the shaft member for the inner needle and axially movable support the shaft for the outer needle, a actuating member which gives protrusion force to the shaft member for the outer needle, a holding member which holds the shaft member for the outer needle at the position before protrusion against the protrusion force of the actuating member and releases from holding the shaft member for the outer needle before protrusion by outside operation, and a rotation generating member which gives rotation force to the shaft member for the outer needle when the shaft member for the outer needle moves axially.
Taylor, U.S. Pat. No. 4,907,599 describes the soft tissue core biopsy instrument comprising a proximal outer barrel member and a distal inner barrel member, which is slidably received within the outer barrel member. A cannula driver is slidably received within the distal inner barrel member and has a distally extending cannula fixed thereto. A stylet extends distally from a stylet hub with a stylet hub being removably attached to the proximal outer barrel member. A spring is positioned within the inner barrel member between a proximal wall thereof and a proximal wall of the cannula driver for biasing the cannula driver forward

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