Patent Description:
The Bard® Mission™ Disposable Core Biopsy Instrument available from BD / C. is a single insertion single sample (SISS) biopsy device configured as a fully mechanical assembly. The SISS core biopsy device under the Mission brand includes a handle, an operator, an inner stylet, and an outer cutting cannula. The inner stylet has a distal end portion that includes a sample notch. The operator is movable relative to a handle, wherein a rearward (proximal) movement of the operator moves both the inner stylet and the outer cutting cannula to a rearward position to cock the outer cutting cannula. When armed, the outer cutting cannula is latched in the rearward position and a cannula firing spring is compressed, so as to achieve an armed state. The operator is then slid forward (distally), which slides the stylet in a distal direction relative to the cutting cannula to expose a sample notch of the stylet beyond the distal end of the outer cutting cannula. A further forward movement of the operator fires, i.e., releases, the cutting cannula firing spring from the armed state to propel the outer cutting cannula forward to move over the sample notch of the inner stylet, so as to sever any tissue in the sample notch of the inner stylet.

<CIT> discloses a surgical biopsy apparatus including a housing, a first elongated tubular member removably mounted in the housing and defining a fluid passageway therein, the first elongated tubular member including a tapered closed distal end portion adapted to penetrate tissue.

<CIT> discloses a bone marrow biopsy, aspiration and transplant needles. The offset needle which allows a user to use their index finger to guide a needle into the patient is provided.

<CIT> discloses a soft tissue core biopsy instrument comprising a proximal outer barrel member having a distal end and a proximal end, a distal inner barrel member which is slidably received within the outer barrel member, cannular driver, and a cannula. The appended claims are novel over <CIT> at least in that the stylet hub is configured to be rotationally movable between an engaged position and a disengaged position.

What is needed in the art is a biopsy apparatus that, for example, is fully mechanical, and which is capable of being operated in either of a single insertion single sample (SISS) biopsy mode or in a single insertion multiple sample (SIMS) biopsy mode.

The present invention provides, for example, a biopsy apparatus that is fully mechanical, and which is capable of being operated in either of a single insertion single sample (SISS) biopsy mode or in a single insertion multiple sample (SIMS) biopsy mode. The present invention is directed to the biopsy apparatus of claim <NUM>. The dependent claims refer to preferred embodiments. According to claim <NUM>, the invention in one form is directed to a biopsy apparatus that includes a housing, a cannula assembly, a stylet assembly, a firing mechanism, and an operator mechanism. The housing has a cavity and is configured to define a longitudinal axis. The cannula assembly is movably coupled to the housing. The cannula assembly has a cannula hub affixed to a cutting cannula. The cutting cannula has a lumen arranged on the longitudinal axis. The stylet assembly is movably coupled to the housing. The stylet assembly has a stylet hub and a stylet. The stylet is coaxial with the cutting cannula. The stylet has a proximal portion and a distal portion. The proximal portion is affixed to the stylet hub. The distal portion has a distal tip and a sample notch proximal to the distal tip. The stylet hub is configured to be axially and rotationally movable relative to the longitudinal axis. The firing mechanism has a latch and a firing spring. The firing spring and the cannula hub are positioned in the cavity of the housing. The latch is configured to engage the cannula hub to hold the cutting cannula in a first axial position. The operator mechanism is configured to effect axial movement of the stylet hub and the cannula hub. The operator mechanism has a head portion and an arm member, wherein the arm member extends distally from the head portion. The head portion is configured to releasably engage the stylet hub and the arm member is configured to releasably engage the cannula hub. The stylet hub is configured to be rotationally movable between an engaged position and a disengaged position, wherein in the engaged position the stylet hub is releasably connected to the head portion of the operator mechanism, and when the stylet hub is in the disengaged position, the stylet hub is disconnected from the head portion of the operator mechanism to facilitate axial movement of the stylet assembly in a proximal direction independent of the operator mechanism.

The disclosure in another form is directed to a biopsy apparatus that includes a housing having a sample access window. A sample removal finger is connected to the housing. The sample removal finger is configured to extend in a cantilever manner from the housing in the sample access window. The sample removal finger has a free end. A cannula assembly is movably coupled to the housing. The cannula assembly has a cannula hub affixed to a cutting cannula. The cutting cannula has a sample access port and a distal cutting edge. The cutting cannula defines a longitudinal axis. The cutting cannula is positioned to distally extend from the housing. The cannula assembly is configured to axially transition between a first axial position and a second axial position. A stylet assembly is movably coupled to the housing. The stylet assembly is configured to axially transition between a retracted position, an extended position, and a sample retrieval position. The stylet assembly has a stylet hub affixed to a stylet. The stylet is coaxial with the cutting cannula. The stylet has a distal tip and a sample notch proximal to the distal tip. The stylet is positioned wherein the free end of the sample removal finger extends through the sample access port of the cutting cannula to contact an outer surface of the stylet. An operator mechanism is configured to effect axial movement of the stylet hub and the cannula hub. The operator mechanism has a head portion and an arm member, wherein the arm member extends distally from the head portion. The head portion is configured to releasably engage the stylet hub and the arm member is configured to releasably engage the cannula hub. The stylet hub is configured to be rotationally movable relative to the head portion of the operator mechanism between an engaged position and a disengaged position.

An advantage of the present invention is that the stylet assembly is releasably connectable with the operator mechanism of the biopsy apparatus, wherein the SIMS capability of the biopsy apparatus is achieved by mechanically disconnecting the stylet assembly from the operator mechanism to facilitate movement of the stylet assembly, e.g., initially in a proximal direction, independent from the operator mechanism and the cannula assembly.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate at least one embodiment of the invention, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

Referring now to drawings, and more particularly to <FIG>, there is shown a biopsy apparatus <NUM> in accordance with present invention, wherein biopsy apparatus <NUM> may be operated in either of a single insertion single sample mode (SISS) biopsy mode or in a single insertion multiple sample (SIMS) biopsy mode.

Biopsy apparatus <NUM> includes a housing <NUM>, a cannula assembly <NUM>, a stylet assembly <NUM>, a firing mechanism <NUM> (<FIG> and <FIG>), and an operator mechanism <NUM>. In accordance with an aspect of the present invention, stylet assembly <NUM> is releasably connectable with operator mechanism <NUM> by a connection mechanism <NUM>, wherein the SIMS capability of biopsy apparatus <NUM> is achieved by mechanically disconnecting stylet assembly <NUM> from operator mechanism <NUM> to facilitate movement of stylet assembly <NUM>, e.g., initially in a proximal direction <NUM>, independent from operator mechanism <NUM> and cannula assembly <NUM>.

Referring to <FIG> and <FIG>, housing <NUM> has and defines a cavity <NUM> that contains firing mechanism <NUM>. Also, housing <NUM> defines a longitudinal axis <NUM>, and slidably carries cannula assembly <NUM> and stylet assembly <NUM> to facilitate slidable axial movement of cannula assembly <NUM> and stylet assembly <NUM> along longitudinal axis <NUM> in each of a proximal direction <NUM> and a distal direction <NUM>.

Housing <NUM> includes a first proximal aperture <NUM>-<NUM> and a second proximal aperture <NUM>-<NUM>. First proximal aperture <NUM>-<NUM> lies on longitudinal axis <NUM>, and is sized and shaped to slidably receive a portion, e.g., a stylet, of stylet assembly <NUM>. Second proximal aperture <NUM>-<NUM> of housing <NUM> is sized and shaped to slidably receive a portion, e.g., an arm, of operator mechanism <NUM>. In the present embodiment, second proximal aperture <NUM>-<NUM> is radially offset from first proximal aperture <NUM>-<NUM> and from longitudinal axis <NUM>, and a portion of operator mechanism <NUM> is slidably movable in second proximal aperture <NUM>-<NUM> substantially parallel to longitudinal axis <NUM>.

Referring to <FIG>, housing <NUM> includes a distal nose portion <NUM>. Distal nose portion <NUM> of housing <NUM> includes a sample access window <NUM>, a proximal axial opening <NUM>, and a distal axial opening <NUM>. Each of proximal axial opening <NUM> (e.g., a cylindrical opening) and distal axial opening <NUM> (e.g., a cylindrical opening) are arranged on longitudinal axis <NUM>, with distal axial opening <NUM> being distally spaced along longitudinal axis <NUM> from proximal axial opening <NUM>. In addition, first proximal aperture <NUM>-<NUM> (see <FIG>; e.g., a cylindrical aperture) of housing <NUM> is aligned with, and axially spaced from, each of proximal axial opening <NUM> and distal axial opening <NUM> on longitudinal axis <NUM>. In the present embodiment, sample access window <NUM> is located in distal nose portion <NUM> of housing <NUM> and axially separates proximal axial opening <NUM> from distal axial opening <NUM> along longitudinal axis <NUM>.

Positioned within sample access window <NUM> of housing <NUM> is a sample removal finger <NUM>. Sample removal finger <NUM> is connected to housing <NUM> and distally extends in a cantilever manner from distal nose portion <NUM> of housing <NUM> in sample access window <NUM>. In the present embodiment, sample removal finger <NUM> is an elongate member, e.g., bowed or curved along its length, and has a free end <NUM>.

Cannula assembly <NUM> is movably coupled to housing <NUM>. Referring particularly to <FIG>, cannula assembly <NUM> includes a cannula hub <NUM> that is affixed, e.g., by overmolding, press fit and/or adhesive, to a cutting cannula <NUM>. It may be considered that a location of cutting cannula <NUM> in housing <NUM> and the longitudinal extent of cutting cannula <NUM> defines longitudinal axis <NUM>.

Referring also to <FIG>, cannula hub <NUM> includes cutting length indicia, e.g., cutting length indicia "<NUM>", "<NUM>", and "<NUM>" , wherein cutting length indicia "<NUM>" represents a fully extended position of cannula assembly <NUM> of <NUM> millimeters (mm), cutting length indicia "<NUM>" represents a retraction distance of cannula assembly <NUM> of <NUM>, and cutting length indicia "<NUM>" represents a retraction distance of cannula assembly <NUM> of <NUM>. Cannula hub <NUM> is contained within cavity <NUM>, and may be slidably coupled, e.g., by a rail arrangement, to housing <NUM>. Cutting cannula <NUM> is slidably disposed in, and distally extends through, proximal axial opening <NUM> and distal axial opening <NUM> of distal nose portion <NUM> of housing <NUM>. Cutting cannula <NUM> is positioned to distally extend from distal nose portion <NUM> of housing <NUM> along longitudinal axis <NUM>.

Referring to <FIG> and <FIG>, cutting cannula <NUM> includes a cannula wall <NUM> (<FIG>), a lumen <NUM> (<FIG>), a cannula portion <NUM>, and a distal cutting edge <NUM>. Cannula portion <NUM> is located distal to cannula hub <NUM>, and may be a central portion of cutting cannula <NUM> located between cannula hub <NUM> and distal cutting edge <NUM>. Cannula portion <NUM> has a sample access port <NUM> that radially extends through cannula wall <NUM> and is in fluid communication with lumen <NUM> of cutting cannula.

Referring also to <FIG>, cutting cannula <NUM>, as well as the entirety of cannula assembly <NUM>, is movable between a first axial position <NUM> and a second axial position <NUM>.

Referring to <FIG>, second axial position <NUM> corresponds to the length indicia "<NUM>", i.e., the fully extended position of cannula assembly <NUM>, as viewed through length window <NUM>-<NUM> of housing <NUM>. In the present embodiment, second axial position <NUM> also represents a fired, i.e., de-primed, state of cannula assembly <NUM>. For convenience, each of first axial position <NUM> and second axial position <NUM> of cannula assembly <NUM> is identified in <FIG> by the position of distal cutting edge <NUM> of cutting cannula <NUM>.

Referring to <FIG>, when cutting cannula <NUM> is in the second axial position <NUM>, then sample access port <NUM> of cutting cannula <NUM> is aligned (e.g., radially and longitudinally) with sample access window <NUM> of distal nose portion <NUM> of housing <NUM>, wherein cannula assembly <NUM> having cutting cannula <NUM> is in the fired, or de-primed, state, as further depicted by the cutting length indicia "<NUM>" shown in length window <NUM>-<NUM> of housing <NUM>.

Referring to <FIG>, cutting cannula <NUM> is moved in proximal direction <NUM> to first axial position <NUM> from second axial position <NUM> by operation of operator mechanism <NUM>, thereby arming firing mechanism <NUM> to thereby place biopsy apparatus <NUM> in the armed, i.e., primed, state. Cutting cannula <NUM> is moved in distal direction <NUM> from the first axial position <NUM> to the second axial position <NUM> by operation of firing mechanism <NUM> (see <FIG> and <FIG>).

Referring again to <FIG> and <FIG>, firing mechanism <NUM> is positioned in cavity <NUM> of housing <NUM>. Firing mechanism <NUM> includes a latch <NUM> and a firing spring <NUM>. Firing spring <NUM> is interposed between housing <NUM> and cannula hub <NUM>. Latch <NUM> may be configured to include one or more latch members (two shown in <FIG>) to define multiple cutting lengths, e.g., cutting length indicia "<NUM>" representing retraction length of <NUM>, and a cutting length indicia "<NUM>" representing retraction length of <NUM>, shown in <FIG>. Latch <NUM> is configured, i.e., positioned and arranged, to engage cannula hub <NUM> so as to hold cutting cannula <NUM> in the first axial position <NUM>, i.e., in an armed state, wherein firing spring <NUM> is compressed. In the present example, as shown in <FIG>, first axial position <NUM> corresponds to a retraction of distal cutting edge <NUM> of cutting cannula <NUM> of cannula assembly <NUM> a distance of <NUM>, as shown in length window <NUM>-<NUM> of housing <NUM>. Stated differently (with reference again to <FIG> and <FIG>), latch <NUM> is positioned and arranged to engage cannula hub <NUM> to hold cannula assembly <NUM> in an armed state, wherein cutting cannula <NUM> is in the first axial position <NUM> and firing spring <NUM> is compressed.

Referring to <FIG>, a portion of operator mechanism <NUM> is slidably movable in second proximal aperture <NUM>-<NUM> of housing <NUM> in a direction substantially parallel to longitudinal axis <NUM>. Operator mechanism <NUM> is configured, i.e., positioned and arranged, to effect an axial translation of cannula hub <NUM> in proximal direction <NUM>, wherein the axial translation of cannula hub <NUM> causes firing spring <NUM> of firing mechanism <NUM> to compress as cutting cannula <NUM> is moved from the second axial position <NUM> to the first axial position <NUM> (see <FIG>). Stated differently, operator mechanism <NUM> is constructed to effect simultaneous axial translation of stylet hub <NUM> and cannula hub <NUM> in proximal direction <NUM>, wherein the axial translation of cannula hub <NUM> causes firing spring <NUM> of firing mechanism <NUM> to compress as cutting cannula <NUM> is moved from the second axial position <NUM> to the first axial position <NUM>. Also, operator mechanism <NUM> is positioned and arranged to move in distal direction <NUM> to release latch <NUM> of firing mechanism <NUM>, wherein firing spring <NUM> decompresses to effect a distal axial movement of cutting cannula <NUM> from the first axial position <NUM> to the second axial position <NUM>.

In the present embodiment, with reference to <FIG>, stylet assembly <NUM> is movably coupled to each of operator mechanism <NUM>, housing <NUM>, and cutting cannula <NUM>. Referring particularly to <FIG>, stylet assembly <NUM> has a stylet hub <NUM> and a stylet <NUM>. Stylet <NUM> may be, for example, in the form of a solid metal rod. Stylet <NUM> has an outer surface <NUM>-<NUM>, a proximal portion <NUM>, and a distal portion <NUM>. Proximal portion <NUM> of stylet <NUM> is affixed, e.g., by overmolding, press fit and/or adhesive, to stylet hub <NUM>. Distal portion <NUM> of stylet <NUM> has a distal tip <NUM> and a sample notch <NUM> that is proximal to distal tip <NUM>.

As best shown in <FIG>, a bore <NUM>-<NUM> of operator mechanism <NUM>, first proximal aperture <NUM>-<NUM> of housing <NUM>, proximal axial opening <NUM> of housing <NUM>, distal axial opening <NUM> of housing <NUM>, and lumen <NUM> of cutting cannula <NUM> form a continuous through-path on longitudinal axis <NUM> for slidably and rotatably receiving and carrying stylet <NUM>. As such, stylet <NUM> of stylet assembly <NUM> is configured, i.e., in size and shape, to be axially and rotatably received in each of bore <NUM>-<NUM> of operator mechanism <NUM>, first proximal aperture <NUM>-<NUM> of housing <NUM>, proximal axial opening <NUM> of housing <NUM>, distal axial opening <NUM> of housing <NUM>, and lumen <NUM> of cutting cannula <NUM>. As such, stylet <NUM> is coaxial with cutting cannula <NUM> around and along longitudinal axis <NUM>. Stylet <NUM> is axially and rotationally movable, e.g., positionable, in lumen <NUM> of cutting cannula <NUM>. Accordingly, stylet hub <NUM> (along with stylet <NUM>) is axially and rotationally movable, e.g., positionable, relative to longitudinal axis <NUM> and cutting cannula <NUM>, and is axially and rotationally movable, e.g., positionable, relative to housing <NUM> and operator mechanism <NUM>.

In the present embodiment, with reference to <FIG> and <FIG>, stylet hub <NUM> is a single piece unitary structure, e.g., molded plastic, having a body <NUM>, an end plate <NUM>, a post <NUM>, and an engagement member <NUM>, wherein post <NUM> is interposed between end plate <NUM> and engagement member <NUM>. In the present embodiment, end plate <NUM> has distal surface <NUM>-<NUM> having a slight concave contour. End plate <NUM> extends (e.g., in a direction perpendicular to longitudinal axis <NUM>) beyond the radial extent of body <NUM>. Body <NUM> is affixed, e.g., by overmolding, press fit and/or adhesive, to proximal portion <NUM> of stylet <NUM>.

Referring to <FIG> and <FIG>, stylet hub <NUM> is constructed to be rotationally movable about longitudinal axis <NUM> between an engaged position <NUM> (<FIG>) and a disengaged position <NUM> (<FIG>), wherein stylet <NUM> serves as an axle (see also <FIG> and <FIG>) that rotates in lumen <NUM> of cutting cannula <NUM> for rotation about longitudinal axis <NUM>.

Also, referring to <FIG> and <FIG>, stylet assembly <NUM>, and thus stylet hub <NUM> and stylet <NUM>, is configured to axially transition between an extended position <NUM>, retracted position <NUM>, and a sample retrieval position <NUM> relative to housing <NUM>. For convenience, each of extended position <NUM>, retracted position <NUM>, and a sample retrieval position <NUM> of stylet assembly <NUM> is identified by the position distal tip <NUM> of stylet <NUM> of stylet assembly <NUM>. In the present embodiment, sample retrieval position <NUM> is proximal to retracted position <NUM>, and retracted position <NUM> is proximal to extended position <NUM>.

Referring to <FIG>, when stylet <NUM> is in sample retrieval position <NUM> and cutting cannula <NUM> is in the second axial position <NUM>, sample notch <NUM> of stylet <NUM> is aligned (e.g., radially and at least partially longitudinally) with sample access port <NUM> of cutting cannula <NUM>.

In the present embodiment, operator mechanism <NUM> is a single piece unitary structure, e.g., molded plastic, having a head portion <NUM> and an arm member <NUM>, wherein arm member <NUM> extends distally from head portion <NUM>. Arm member <NUM> is slidably movable in second proximal aperture <NUM>-<NUM> of housing <NUM>. In the present embodiment, head portion <NUM> has a proximal surface <NUM>-<NUM>, e.g., having a slight convex contour. A curvature of proximal surface <NUM>-<NUM> of head portion <NUM> of operator mechanism <NUM> corresponds to the curvature of distal surface <NUM>-<NUM> of end plate <NUM> of stylet hub <NUM> of stylet assembly <NUM>. It is also contemplated that the respective surface contours of proximal surface <NUM>-<NUM> of head portion <NUM> of operator mechanism <NUM> and distal surface <NUM>-<NUM> of end plate <NUM> of stylet hub <NUM> of stylet assembly <NUM> may have other complementary shapes, such as for example, flat.

Referring to <FIG>, head portion <NUM> of operator mechanism <NUM> further includes bore <NUM>-<NUM> that longitudinally extends through head portion <NUM>, and which is sized and shaped to slidably receive stylet <NUM> of stylet assembly <NUM>. As such, bore <NUM>-<NUM> of operator mechanism <NUM>, first proximal aperture <NUM>-<NUM> of housing <NUM>, proximal axial opening <NUM> of housing <NUM>, distal axial opening <NUM> of housing <NUM>, and lumen <NUM> of cutting cannula <NUM> form a continuous through-path for axially and rotatably receiving and carrying stylet <NUM> of stylet assembly <NUM> on longitudinal axis <NUM>.

Referring to <FIG>, operator mechanism <NUM> is configured, e.g., positioned and arranged, to effect axial movement of stylet hub <NUM> and cannula hub <NUM> in proximal direction <NUM>. Head portion <NUM> is configured, e.g., positioned and arranged, to releasably engage stylet hub <NUM> and arm member <NUM> is configured, e.g., with a hook member, to releasably engage cannula hub <NUM> when operator mechanism <NUM> is moved in proximal direction <NUM>. However, regardless of the rotational position of stylet hub <NUM> relative to head portion <NUM> of operator mechanism <NUM>, head portion <NUM> of operator mechanism <NUM> is capable of axial engagement with engagement member <NUM> of stylet hub <NUM>, e.g., to facilitate a limited longitudinal translation of stylet assembly <NUM> along longitudinal axis <NUM> from extended position <NUM> to a retracted position <NUM> in proximal direction <NUM>.

Referring to <FIG> and <FIG>, head portion <NUM> of operator mechanism <NUM> includes a body <NUM> and an end wall <NUM>. End wall <NUM> of head portion <NUM> includes proximal surface <NUM>-<NUM>, a distal surface <NUM>, and a perimeter edge <NUM>. In the present embodiment, end wall <NUM> is a plate that radially extends beyond the radial extent of body <NUM>. Perimeter edge <NUM> longitudinally extends between proximal surface <NUM>-<NUM> and distal surface <NUM>. Referring also to <FIG> and <FIG>, end wall <NUM> has a channel <NUM>, e.g., a slot, having an open end <NUM>-<NUM> and a closed end <NUM>-<NUM>, wherein open end <NUM>-<NUM> is adjacent to perimeter edge <NUM>.

Referring to <FIG> and <FIG>, channel <NUM> of end wall <NUM> of head portion <NUM> of operator mechanism <NUM> is configured, e.g., in size and shape, to receive post <NUM> of stylet hub <NUM> when stylet hub <NUM> is rotated to an engaged position <NUM>. Referring particularly to <FIG>, channel <NUM> has an elongate extent that begins at open end <NUM>-<NUM> and extends from perimeter edge <NUM> into an interior of end wall <NUM> to terminate at closed end <NUM>-<NUM>, and the elongate extent also extends from proximal surface <NUM>-<NUM> to distal surface <NUM>. Channel <NUM> of end wall <NUM> of head portion <NUM> of operator mechanism <NUM> is configured, e.g., in size and shape, to receive post <NUM> of stylet hub <NUM> when stylet hub <NUM> is rotated to engaged position <NUM>.

Referring to <FIG>, when stylet hub <NUM> is in engaged position <NUM>, then stylet hub <NUM> is releasably connected to head portion <NUM> of operator mechanism <NUM>. For example, referring also to <FIG> and <FIG>, in the present embodiment, when stylet hub <NUM> is in engaged position <NUM> depicted in <FIG>, then post <NUM> of stylet hub <NUM> is received in channel <NUM> of head portion <NUM> of operator mechanism <NUM>, and end wall <NUM> of head portion <NUM> of operator mechanism <NUM> is received between end plate <NUM> and engagement member <NUM> of stylet hub <NUM>. Stated differently, when stylet hub <NUM> is in engaged position <NUM>, then engagement member <NUM> of stylet hub <NUM> is positioned to axially engage distal surface <NUM> of end wall <NUM> of head portion <NUM> of operator mechanism <NUM>. Accordingly, stylet assembly <NUM> and operator mechanism <NUM> are axially (longitudinally) locked together when stylet hub <NUM> is in engaged position <NUM>. When locked together, biopsy apparatus <NUM> is operable in a single insertion single sample mode (SISS) biopsy mode.

However, referring to <FIG>, when stylet hub <NUM> is in disengaged position <NUM>, then stylet hub <NUM> is disconnected from head portion <NUM> of operator mechanism <NUM> to facilitate axial movement of stylet assembly <NUM> in a proximal direction <NUM> independent of operator mechanism <NUM>, as depicted in <FIG>. For example, referring also to <FIG> and <FIG>, in the present embodiment, when stylet hub <NUM> is rotated to the disengaged position <NUM> depicted in <FIG>, then post <NUM> of stylet hub <NUM> rotationally exits channel <NUM> of head portion <NUM> of operator mechanism <NUM>, and end wall <NUM> of head portion <NUM> of operator mechanism <NUM> is no longer located between end plate <NUM> and engagement member <NUM> of stylet hub <NUM>.

Accordingly, when stylet hub <NUM> is in disengaged position <NUM>, stylet assembly <NUM> and operator mechanism <NUM> are no longer locked together, and biopsy apparatus <NUM> is operable in a single insertion multiple sample (SIMS) biopsy mode. In the SIMS mode, biopsy apparatus <NUM> is capable of extracting multiple biopsy samples from the patient without removing cutting cannula <NUM> from the patient.

For example, when stylet hub <NUM> is in disengaged position <NUM> depicted in <FIG>, stylet assembly <NUM> is free to move axially in proximal direction <NUM> independent of operator mechanism <NUM> and cannula assembly <NUM> as depicted in <FIG>. Stated differently, when stylet hub <NUM> is in disengaged position <NUM>, then stylet hub <NUM> and stylet <NUM> (e.g., the entirety of stylet assembly <NUM>) are axially movable in proximal direction <NUM> without moving either of operator mechanism <NUM> or cannula assembly <NUM>. In the present embodiment, stylet assembly <NUM> is constructed such that stylet hub <NUM> must be in disengaged position <NUM> in order for stylet assembly <NUM> to be axially movable to sample retrieval position <NUM>.

Referring to <FIG>, with stylet hub <NUM> in disengaged position <NUM>, stylet assembly <NUM> may be moved axially toward sample retrieval position <NUM> by the user pulling on stylet hub <NUM> in proximal direction <NUM> (see also <FIG>). Sample removal finger <NUM> is configured (e.g., in position, size and shape) to extend in a cantilever manner from housing <NUM> toward stylet <NUM>, with free end <NUM> of sample removal finger <NUM> constructed (e.g., in position, size and shape) to contact outer surface <NUM>-<NUM> of stylet <NUM>. For example, sample removal finger <NUM> may form a leaf spring that is self-biasing in a direction toward stylet <NUM> so that free end <NUM> of sample removal finger <NUM> follows the contour of outer surface <NUM>-<NUM> of stylet <NUM> to enter and engage sample notch <NUM> as stylet <NUM> is retracted toward sample retrieval position <NUM>. Stated differently, as stylet <NUM> is retracted in proximal direction <NUM>, sample removal finger <NUM> rides along outer surface <NUM>-<NUM> of stylet <NUM>, such that free end <NUM> of sample removal finger <NUM> will then enter and engage sample notch <NUM> of stylet <NUM> to dislodge and lift any tissue present in sample notch <NUM>.

As shown in <FIG>, when stylet <NUM> is in sample retrieval position <NUM> and cutting cannula <NUM> is in the second axial position <NUM>, then sample notch <NUM> of stylet <NUM> is aligned (e.g., radially and at least partially longitudinally) with sample access port <NUM> of cutting cannula <NUM>, so as to facilitate removal of a tissue sample from sample notch <NUM> of stylet <NUM> through sample access port <NUM> of cutting cannula <NUM>. In the present embodiment, when cutting cannula <NUM> is in the second axial position <NUM> and stylet <NUM> is in sample retrieval position <NUM>, then each of sample access port <NUM> of cutting cannula <NUM> and sample notch <NUM> of stylet <NUM> is aligned (e.g., radially and at least partially longitudinally) with sample access window <NUM> of housing <NUM>, so as to facilitate removal of a tissue sample from sample notch <NUM> of stylet <NUM> through sample access window <NUM> of housing <NUM>.

The process of operating biopsy apparatus <NUM> will now be described in the sequence of <FIG>, <FIG>, and <FIG>.

With reference to <FIG>, biopsy apparatus <NUM> is shown in a "fired", i.e., de-primed, state, with each of cannula assembly <NUM> and stylet assembly <NUM> in its respective fully extended position. For example, as shown in <FIG>, cutting cannula <NUM> of cannula assembly <NUM> is in second axial position <NUM> and stylet <NUM> of stylet assembly <NUM> is in extended position <NUM>. Biopsy apparatus <NUM> is ready to be armed, i.e., primed, wherein the armed state is depicted in <FIG>. Stylet <NUM> and cutting cannula <NUM> of biopsy apparatus <NUM> may be inserted, in unison, into a patient, either before or after placing biopsy apparatus <NUM> in the armed state.

With reference to <FIG>, biopsy apparatus <NUM> is shown in the armed, i.e., primed, state, with each of cannula assembly <NUM> and stylet assembly <NUM> in its respective retracted position. For example, as depicted in <FIG>, cutting cannula <NUM> of cannula assembly <NUM> is in first axial position <NUM> and stylet <NUM> of stylet assembly <NUM> is in retracted position <NUM>. To achieve the armed, i.e., primed, state depicted in <FIG>, operator mechanism <NUM> is moved in proximal direction <NUM> to simultaneously move cannula assembly <NUM> to first axial position <NUM> and to move stylet assembly to retracted position <NUM>. Referring also to <FIG> and <FIG>, when in the armed state, cannula hub <NUM> attached to cutting cannula <NUM> is latched by latch <NUM>, such that cutting cannula <NUM> is held in first axial position <NUM> and firing spring <NUM> is compressed. Stylet <NUM> of biopsy apparatus <NUM> is now ready to be positioned to take a biopsy sample.

With cutting cannula <NUM> of cannula assembly <NUM> in first axial position <NUM> and stylet <NUM> of stylet assembly <NUM> in retracted position <NUM> as a result of biopsy apparatus <NUM> being in the armed state depicted in <FIG>, thereafter, operator mechanism <NUM> and stylet assembly <NUM> may then be moved in unison in distal direction <NUM> until stylet <NUM> is fully extended, e.g., in extended position <NUM>, thereby exposing sample notch <NUM> of stylet <NUM>, as depicted in <FIG>. Stated differently, the user may depress stylet hub <NUM> to in turn slide both of stylet assembly <NUM> and operator mechanism <NUM> forward in distal direction <NUM>, which in turn slides stylet <NUM> in distal direction <NUM> relative to cutting cannula <NUM> to expose sample notch <NUM> of stylet <NUM> beyond distal cutting edge <NUM> of cutting cannula <NUM>. Tissue in the region of sample notch <NUM> may then prolapse into sample notch <NUM>. Biopsy apparatus <NUM> is now ready to be fired to sever a tissue sample.

A further slight forward (distal) movement (e.g., <NUM>) of operator mechanism <NUM> moves arm member <NUM> in distal direction <NUM> to release latch <NUM> of firing mechanism <NUM>, so as to fire biopsy apparatus <NUM>, wherein firing spring <NUM> is released from the armed state to propel cutting cannula <NUM> forward to move over sample notch <NUM> of stylet <NUM>, so as to sever any tissue in sample notch <NUM> of stylet <NUM>. Biopsy apparatus <NUM> has now returned to the fired, i.e., de-primed, state depicted in <FIG>.

In either of the SISS mode or the SIMS mode of operating biopsy apparatus <NUM>, the tissue sample in sample notch <NUM> of stylet <NUM> now may be retrieved through sample access window <NUM> of housing <NUM> as follows.

Referring now also to <FIG>, stylet hub <NUM> is then rotated to the disengaged position <NUM> (if not already). Thereafter, with reference also to <FIG>, the user moves stylet assembly <NUM> axially in proximal direction <NUM>, and rotationally as needed, until sample notch <NUM> of stylet <NUM> is positioned in alignment (e.g., radially and at least partially longitudinally) with sample access port <NUM> of cutting cannula <NUM> at sample access window <NUM> of housing <NUM>. The tissue sample may then be removed from sample notch <NUM> of stylet <NUM> through sample access port <NUM> of cutting cannula <NUM> and sample access window <NUM> of housing <NUM>. To aid in tissue removal, free end <NUM> of sample removal finger <NUM> follows the contour of outer surface <NUM>-<NUM> of stylet <NUM> to enter and engage the issue sample in sample notch <NUM> as stylet <NUM> is retracted toward sample retrieval position <NUM> so as to dislodge and lift the tissue sample from sample notch <NUM>.

In some embodiments, stylet assembly <NUM> may be further axially moved in proximal direction <NUM> so that an entirety of stylet <NUM> is removed from operator mechanism <NUM>. For example, in some situations or procedures it may be desirable and/or advantageous to fully remove stylet assembly <NUM> from biopsy apparatus <NUM>, e.g., so as to facilitate cleaning or replacement of stylet assembly <NUM> (e.g., in a SIMS mode) during a biopsy procedure. However, optionally, operator mechanism <NUM> may include a catch feature located in or adjacent first proximal aperture <NUM>-<NUM> of housing <NUM>, or in or adjacent bore <NUM>-<NUM> of operator mechanism <NUM>, that is positioned to engage the distal end of sample notch <NUM> of stylet <NUM>, thereby resisting complete removal of stylet assembly from operator mechanism <NUM>.

In the SISS mode of operation, the entirety of biopsy apparatus <NUM> now may be removed from the patient. In the SISS mode, the user may defer the proximal retraction of stylet <NUM> of stylet assembly <NUM> to sample retrieval position <NUM> until after the entirety of biopsy apparatus <NUM> is removed from the patient, if desired.

However, in the SIMS mode of operation of biopsy apparatus <NUM>, e.g., wherein one or more additional tissue samples is desired while cutting cannula <NUM> remains in the patient, then stylet assembly <NUM> may be returned to extended position <NUM> to reposition the components of biopsy apparatus <NUM> in the fired, i.e., de-primed, state depicted in <FIG>. Thereafter, operator mechanism <NUM> may be moved in proximal direction <NUM> to simultaneously move cannula assembly <NUM> to first axial position <NUM> and to move stylet assembly <NUM> to retracted position <NUM> to achieve the armed, or primed, state, as depicted in <FIG>. Referring also to <FIG> and <FIG>, when armed, cutting cannula <NUM> is latched in first axial position <NUM> and firing spring <NUM> is compressed, so as to achieve the armed state. Operator mechanism <NUM> and stylet assembly <NUM> may then be slid forward in distal direction <NUM>, which in turn slides stylet <NUM> in distal direction <NUM> relative to cutting cannula <NUM> to expose sample notch <NUM> of stylet <NUM> beyond distal cutting edge <NUM> of cutting cannula <NUM>, as depicted in <FIG>, and tissue again may prolapse into sample notch <NUM>. A further slight forward (distal) movement of operator mechanism <NUM> fires, i.e., releases, firing spring <NUM> from the armed state to propel cutting cannula <NUM> forward to move over sample notch <NUM> of stylet <NUM>, so as to sever any tissue in sample notch <NUM> of stylet <NUM>, to again achieve the fired, i.e., de-primed, state depicted in <FIG>. Stylet hub <NUM> may then be rotated to the disengaged position <NUM> as depicted in <FIG> (if not already), and then, as depicted in <FIG>, the user moves stylet assembly <NUM> axially in proximal direction <NUM>, and rotationally as needed, until sample notch <NUM> of stylet <NUM> is positioned in alignment (e.g., radially and at least partially longitudinally) with sample access port <NUM> of cutting cannula <NUM> at sample access window <NUM> of housing <NUM>. The present tissue sample may then be removed from sample notch <NUM> of stylet <NUM> through sample access port <NUM> of cutting cannula <NUM> and sample access window <NUM> of housing <NUM>, as described above.

If further samples are desired, then the operational process described above may be repeated again.

As used herein, the terms "substantially", "slightly", and other words of degree are relative modifiers intended to indicate permissible variation from the characteristic so modified. Such terms are not intended to be limited to the absolute value of the characteristic which it modifies, but rather possessing more of the physical or functional characteristic than the opposite, and approaching or approximating such a physical or functional characteristic.

Claim 1:
A biopsy apparatus (<NUM>), comprising:
a housing (<NUM>) having a cavity (<NUM>) and configured to define a longitudinal axis (<NUM>);
a cannula assembly (<NUM>) movably coupled to the housing, the cannula assembly having a cannula hub (<NUM>) affixed to a cutting cannula (<NUM>), the cutting cannula having a lumen arranged on the longitudinal axis;
a stylet assembly (<NUM>) movably coupled to the housing (<NUM>), the stylet assembly having a stylet hub (<NUM>) and a stylet (<NUM>), the stylet (<NUM>) being coaxial with the cutting cannula, the stylet (<NUM>) having a proximal portion and a distal portion, the proximal portion being affixed to the stylet hub, the distal portion having a distal tip and a sample notch (<NUM>) proximal to the distal tip, the stylet hub (<NUM>) configured to be axially and rotationally movable relative to the longitudinal axis (<NUM>);
a firing mechanism (<NUM>) having a latch (<NUM>) and a firing spring (<NUM>), the firing spring and the cannula hub being positioned in the cavity (<NUM>) of the housing, the latch (<NUM>) configured to engage the cannula hub (<NUM>) to hold the cutting cannula in a first axial position;
an operator mechanism (<NUM>) configured to effect axial movement of the stylet hub (<NUM>) and the cannula hub (<NUM>), the operator mechanism having a head portion (<NUM>) and an arm member (<NUM>), wherein the arm member (<NUM>) extends distally from the head portion (<NUM>), the head portion configured to releasably engage the stylet hub (<NUM>) and the arm member configured to releasably engage the cannula hub (<NUM>),
the stylet hub (<NUM>) configured to be rotationally movable between an engaged position and a disengaged position, wherein in the engaged position the stylet hub (<NUM>) is releasably connected to the head portion (<NUM>) of the operator mechanism, and when the stylet hub (<NUM>) is in the disengaged position, the stylet hub (<NUM>) is disconnected from the head portion (<NUM>) of the operator mechanism to facilitate axial movement of the stylet assembly (<NUM>) in a proximal direction independent of the operator mechanism (<NUM>).