Patent Description:
The present invention relates to a biopsy apparatus for collecting tissue samples, and, more particularly, to a biopsy apparatus having a sample collection container.

A biopsy may be performed on a patient to help in determining whether the cells in a tissue lesion to be biopsied are cancerous. A typical biopsy apparatus may include a hand-held driver assembly and a disposable biopsy probe assembly configured for releasable attachment to the driver assembly. The biopsy probe assembly may include a biopsy stylet coaxial with a cutting cannula. The biopsy stylet may include a tubular member having a lumen, a distal piercing tip, and a sample port for receiving the tissue to be sampled. The cutting cannula may be a tubular member having a distal cutting edge, which is axially moved over the sample port for severing tissue received in the sample port. The hand-held driver assembly may include a vacuum source to move a severed tissue sample via vacuum to a sample reservoir. The sample reservoir may include a removable plastic sample container to collect the tissue samples. The sample container is interposed in a fluid path between the sample port of the biopsy stylet and the vacuum source. Accordingly, the sample container typically has a grid of vent holes to facilitate vacuum communication between the sample port of the biopsy stylet and the vacuum source, and in turn, to facilitate transport of the tissue sample from the sample port of the biopsy stylet to the sample container.

However, it has been observed that micro-calcifications may get stuck in the holes of the sample container. In such a case, additional efforts and imaging of the sample container are needed in order to ensure that the micro-calcifications were in fact biopsied and collected during the procedure. Imaging of the micro-calcification can be difficult with use of such a sample container because the samples can become stuck within the holes of the sample container. Moreover, there is the possibility for the micro-calcifications to pass through the holes of the sample container and be unavailable for diagnostic evaluation. <CIT> discloses a device for incapsulating tissue specimens, wherein the device include a wand assembly, a sheath and a guide assembly. <CIT> discloses an endoscope including multiple lumens for tissue acquisition and removal. <CIT> discloses a tissue collecting and stating apparatus which is operable with a minimally invasive percutaneous tissue removal system to collect a mass of tissue bits and provide an ordered or staged version of the bulk tissue prior to removal The apparatus comprises a tissue collection container which can be constructed of cloth and which is attached to a sealing ring.

What is needed in the art is a biopsy apparatus having a sample collection container configured to capture all pieces of the tissue sample, including micro-calcifications.

The present invention is directed to the sample collection container of claim <NUM> and the biopsy apparatus of claim <NUM>. The dependent claims refer to preferred embodiments. Specifically, the present invention provides a biopsy apparatus having a sample collection container configured to capture all pieces of the tissue sample, including micro-calcifications.

The invention in one form is directed in particular to a sample collection container for a biopsy apparatus that includes a sample capture body defining an interior space. The sample capture body is made of a fabric and has an interior sample capture surface that at least partially surrounds the interior space. The fabric has at least one fold.

The invention in another form is directed to a biopsy apparatus that includes a driver assembly and a biopsy probe assembly, including the sample collection container of claim <NUM>. The driver assembly includes a housing having a proximal end. A vacuum source is contained within the housing. The biopsy probe assembly is releasably mounted to the housing. The biopsy probe has an elongate sample receiving member and a cutting cannula coaxial with the elongate sample receiving member. A sample receptacle is removably mounted to the proximal end of the housing. The sample receptacle is coupled in fluid communication with each of the biopsy probe assembly and the vacuum source. A sample collection container is removably carried by the sample receptacle. The sample collection container includes a sample capture body that defines an interior space. The sample capture body is made of a fabric and has an interior sample capture surface that at least partially surrounds the interior space. The fabric has at least one fold.

An advantage of the present invention is that the sample capture body can be unfolded to remove any tissue sample received by the sample capture body, and then refolded and reused to capture additional tissue samples, from the same patient.

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

Referring now to the drawings, and more particularly to <FIG>, there is shown a biopsy apparatus <NUM> configured in accordance with an embodiment of the invention.

Biopsy apparatus <NUM> includes a driver assembly <NUM> and a biopsy probe assembly <NUM>. Driver assembly <NUM> is configured to provide operative control over biopsy probe assembly <NUM>.

Driver assembly <NUM> has a housing <NUM> that is configured, e.g., ergonomically designed, to be grasped by a user, e.g., a physician. Housing <NUM> defines a compartment <NUM> into which biopsy probe assembly <NUM> is at least partially positioned when biopsy probe assembly <NUM> is attached to driver assembly <NUM>, at which time biopsy probe assembly <NUM> is drivably coupled to driver assembly <NUM>.

Driver assembly <NUM> includes a user interface <NUM>, a controller circuit <NUM>, an electromechanical drive <NUM>, a vacuum source <NUM>, and a sample receptacle <NUM>. Each of controller circuit <NUM>, electromechanical drive <NUM>, and vacuum source <NUM> is contained within housing <NUM>. Sample receptacle <NUM> is removably mounted to a proximal end <NUM>-<NUM> of housing <NUM>, and extends distally into compartment <NUM>. Sample receptacle <NUM> may be, for example, a removable tray that carries a removable sample collection container <NUM> that is configured in accordance with an aspect of the present invention.

User interface <NUM> is located to be externally accessible to the user with respect to housing <NUM>. User interface <NUM> may be in the form of a touch screen display that is configured to receive operation commands from the user, e.g., through one or more pushbuttons, and to display visual indicators on a display, e.g., one or more lights, text and/or icons, to display information to the user.

Controller circuit <NUM> is electrically and communicatively coupled to each of user interface <NUM>, electromechanical drive <NUM>, and vacuum source <NUM> via a communication link, such as for example, wire cabling and/or printed circuit traces. Controller circuit <NUM> may include, for example, a microprocessor circuit <NUM>-<NUM> and an electronic memory circuit <NUM>-<NUM>. Controller circuit <NUM> is configured to execute program instructions to communicate with user interface <NUM>, and is configured to execute program instructions to control electromechanical drive <NUM> and vacuum source <NUM> to perform functions associated with the collection of biopsy tissue samples during a biopsy procedure.

Electromechanical drive <NUM> is drivably coupled (illustrated by a dashed line at the <NUM>/<NUM> interface) to the biopsy probe assembly <NUM> and is drivably coupled to vacuum source <NUM> (illustrated by a dashed line between <NUM> and <NUM>), to selectively and operatively control biopsy probe assembly <NUM> and vacuum source <NUM>. Electromechanical drive <NUM> may include, for example, one or more of a linear drive that converts rotational motion to linear motion (e.g., a worm gear arrangement, rack and pinion arrangement, solenoid-slide arrangement, etc.) and a rotational drive that may include one or more of a gear, gear train, belt/pulley arrangement, etc., for effecting operation of biopsy probe assembly <NUM> and/or vacuum source <NUM>.

Vacuum source <NUM> may be, for example, a peristaltic pump, a diaphragm pump, syringe-type pump, etc. Vacuum source <NUM> may be integrated into driver assembly <NUM>. Alternatively, vacuum source <NUM> may be integrated as a part of the biopsy probe assembly <NUM>. In the present embodiment, vacuum source <NUM> is configured to generate negative pressure (vacuum).

Sample receptacle <NUM> is coupled in sealing engagement with, and in fluid communication with, each of biopsy probe assembly <NUM> and vacuum source <NUM> to define a fluid path <NUM>, represented by dashed lines, between biopsy probe assembly <NUM> and vacuum source <NUM>. Sample receptacle <NUM> is coupled in fluid communication with vacuum source <NUM> via a conduit <NUM>. Sample collection container <NUM>, which is removably carried by sample receptacle <NUM>, is interposed between biopsy probe assembly <NUM> and vacuum source <NUM>, with fluid path <NUM> passing through sample collection container <NUM>.

Biopsy probe assembly <NUM> is releasably attached to driver assembly <NUM>. Biopsy probe assembly <NUM> is intended for use on a single patient, and thus is disposed of after use. Biopsy probe assembly <NUM> includes a frame <NUM>, a biopsy probe <NUM>, and a probe drive <NUM>. Biopsy probe <NUM> includes an elongate sample receiving member <NUM> and a cutting cannula <NUM> operably coupled to probe drive <NUM>.

In the present embodiment, probe drive <NUM> includes at least one gear connected to each of sample receiving member <NUM> and a cutting cannula <NUM> to effect respective rotational movement of each of sample receiving member <NUM> and cutting cannula <NUM>. In addition, probe drive <NUM> includes a worm gear to facilitate longitudinal movement of cutting cannula <NUM> relative to sample receiving member <NUM>. Probe drive <NUM> is drivably engaged with electromechanical drive <NUM> of driver assembly <NUM> when biopsy probe assembly <NUM> is attached to driver assembly <NUM>.

Sample receiving member <NUM> and cutting cannula <NUM> are mounted as a coaxial unit to frame <NUM>. Sample receiving member <NUM> and cutting cannula <NUM> are arranged coaxially with respect to a longitudinal axis <NUM>, and are movable relative to one another along longitudinal axis <NUM>. In the embodiment of <FIG>, sample receiving member <NUM> is positioned within lumen <NUM>-<NUM> of cutting cannula <NUM>, and cutting cannula <NUM> is axially slidable over the outer surface of sample receiving member <NUM>. Alternatively, it is contemplated that the coaxial arrangement may be constructed having cutting cannula <NUM> re-sized and positioned in lumen <NUM>-<NUM> of sample receiving member <NUM> for axial sliding movement in lumen <NUM>-<NUM> of sample receiving member <NUM>.

In the present embodiment illustrated in <FIG>, for example, sample receiving member <NUM> may include, for example, an elongate cylindrical tube, e.g., a metal tube formed from stainless steel, having a proximal end <NUM>-<NUM>, a distal end portion <NUM>-<NUM>, a tissue receiving notch <NUM>-<NUM>, and a lumen <NUM>-<NUM> (shown by dashed lines). Tissue receiving notch <NUM>-<NUM> is formed in the side wall of the elongate cylindrical tube, e.g., by cutting away a portion of the side wall, so as to expose a distal portion of lumen <NUM>-<NUM>. A piercing tip <NUM> is connected to distal end portion <NUM>-<NUM>, distal to tissue receiving notch <NUM>-<NUM>, to close off distal end portion <NUM>-<NUM>. Lumen <NUM>-<NUM> extends from tissue receiving notch <NUM>-<NUM> to proximal end <NUM>-<NUM> and is sealably connected to the removable sample receptacle <NUM>, e.g., by an O-ring or rubber sleeve, so as to extend fluid path <NUM> to tissue receiving notch <NUM>-<NUM>.

Cutting cannula <NUM> may be a cylindrical tube, e.g., a metal tube formed from stainless steel, having a lumen <NUM>-<NUM> and a distal cutting edge <NUM>-<NUM>. In the present embodiment, sample receiving member <NUM> is positioned in lumen <NUM>-<NUM> of cutting cannula <NUM>, such that cutting cannula <NUM> slides longitudinally over sample receiving member <NUM>, and is rotatable about sample receiving member <NUM>, so as to sever tissue received in tissue receiving notch <NUM>-<NUM>.

Piercing tip <NUM> is a sharpened tip configured to penetrate tissue to position tissue receiving notch <NUM>-<NUM> at the biopsy site. Tissue receiving notch <NUM>-<NUM> is configured to receive the tissue to be biopsied, and to collect the tissue sample cut from the tissue by cutting cannula <NUM> during a biopsy procedure.

Referring also to <FIG>, sample receiving member <NUM> and cutting cannula <NUM> are movable relative to one another along longitudinal axis <NUM> between a first relative position <NUM> (<FIG>) and a second relative position <NUM> (<FIG>). Referring to <FIG>, in first relative position <NUM>, cutting cannula <NUM> is retracted to an open position so as to expose tissue receiving notch <NUM>-<NUM> of sample receiving member <NUM>, such that sample receiving member <NUM> may receive tissue to be biopsied. Vacuum may be applied before, or during, the retraction of cutting cannula <NUM> by activation of vacuum source <NUM>, so as to pull tissue that is in the vicinity of tissue receiving notch <NUM>-<NUM> into tissue receiving notch <NUM>-<NUM>.

Referring to <FIG>, in second relative position <NUM>, cutting cannula <NUM> is moved over tissue receiving notch <NUM>-<NUM> to an extended position so as to cover tissue receiving notch <NUM>-<NUM> of sample receiving member <NUM>. Thus, when cutting cannula <NUM> is moved over tissue receiving notch <NUM>-<NUM> to cover tissue receiving notch <NUM>-<NUM>, any tissue present in tissue receiving notch <NUM>-<NUM> is severed by distal cutting edge <NUM>-<NUM> of cutting cannula <NUM>, and the cut tissue sample is received in lumen <NUM>-<NUM> of sample receiving member <NUM> adjacent tissue receiving notch <NUM>-<NUM>.

Referring again to <FIG>, vacuum applied by vacuum source <NUM> will then transport the tissue sample through lumen <NUM>-<NUM> of sample receiving member <NUM> and expel the tissue sample from proximal end <NUM>-<NUM> of sample receiving member <NUM> into sample collection container <NUM>.

<FIG> show an embodiment of sample collection container <NUM> configured in accordance with an aspect of the present invention. In the present embodiment, sample collection container <NUM> is side-loaded into sample receptacle <NUM>, and is suspended above a floor <NUM>-<NUM> of sample receptacle <NUM> by a support ledge <NUM>-<NUM> that projects inwardly from the inner side walls of sample receptacle <NUM>.

Referring to <FIG>, sample collection container <NUM> includes a frame <NUM> and a sample capture body <NUM>. Frame <NUM> may be made of plastic or metal. Sample capture body <NUM> is made of a fabric, such as a polypropylene woven fabric. The fabric is a finely woven fabric to prevent micro-calcifications from passing through the fabric.

Sample capture body <NUM> is removably attached to frame <NUM>. Sample capture body <NUM>, when assembled, defines an interior space <NUM>-<NUM> that is held open when sample capture body <NUM> is attached to frame <NUM>. Sample capture body <NUM> has an interior sample capture surface <NUM>-<NUM> that at least partially surrounds interior space <NUM>-<NUM>, and in the present embodiment, defines an opening <NUM>-<NUM> at an upper portion <NUM>-<NUM> of interior space <NUM>-<NUM>. In the present embodiment, the fabric has a single fold (pleat) <NUM>-<NUM> (see <FIG>) formed at a fold line <NUM> (see <FIG>).

Referring also to <FIG>, in the present embodiment, frame <NUM> is an annular member <NUM>-<NUM> having a frame opening <NUM>-<NUM>, and has at least two mounting protrusions, referenced as a group as mounting protrusions <NUM>-<NUM>, that extend outwardly from annular member <NUM>-<NUM>. Referring again to <FIG>, mounting protrusions <NUM>-<NUM> are positioned to engage support ledge <NUM>-<NUM> of sample receptacle <NUM> to suspend sample capture body <NUM> above floor <NUM>-<NUM> of sample receptacle <NUM>. Annular member <NUM>-<NUM> has a mounting surface <NUM>-<NUM> that surrounds frame opening <NUM>-<NUM>.

Mounting surface <NUM>-<NUM> has a releasable attachment device configured to releasably attach to the fabric of sample capture body <NUM>. The releasable attachment device comprises a plurality of mechanical fasteners <NUM>-<NUM>. In the present embodiment, the mechanical fasteners <NUM>-<NUM> are located around frame opening <NUM>-<NUM>, e.g., near frame opening <NUM>-<NUM>, and are in the form of a plurality of pinch-points configured to attach to the fabric of sample capture body <NUM>. The pinch-points forming mechanical fasteners <NUM>-<NUM> may be, for example, a plurality of slots into which the fabric of sample capture body <NUM> is forced, e.g., by poking with a narrow blunt instrument. Alternatively, each of mechanical fasteners <NUM>-<NUM> may be formed as a burr protrusion, e.g., to form a plurality of pairs of barbs, that projects away from mounting surface <NUM>-<NUM> of annular member <NUM>-<NUM> so as to engage, e.g., by snagging, the fabric of sample capture body <NUM>.

In the embodiment of <FIG>, sample capture body <NUM> has an assembly shape (<FIG>), an intermediate assembly shape (<FIG>) and a pre-assembly shape (<FIG>). In the present embodiment, referring to <FIG>, sample capture body <NUM> has a rectangular pre-assembly shape having a first side edge <NUM>-<NUM>, a second side edge <NUM>-<NUM>, a third side edge <NUM>-<NUM>, and a fourth side edge <NUM>-<NUM>. First side edge <NUM>-<NUM> is orthogonal to third side edge <NUM>-<NUM> and fourth side edge <NUM>-<NUM>. Second side edge <NUM>-<NUM> is orthogonal to third side edge <NUM>-<NUM> and fourth side edge <NUM>-<NUM>, and second side edge <NUM>-<NUM> is laterally spaced apart from first side edge <NUM>-<NUM>.

The rectangular pre-assembly shape of the fabric of sample capture body <NUM> has a first end surface portion <NUM>-<NUM> that is adjacent first side edge <NUM>-<NUM>. First end surface portion <NUM>-<NUM> is divided at fold line <NUM> to define a first attachment surface portion <NUM>-<NUM> and a second attachment surface portion <NUM>-<NUM>. A second end surface portion <NUM>-<NUM> is adjacent the second side edge <NUM>-<NUM>. Second end surface portion <NUM>-<NUM> is divided at fold line <NUM> to define a third attachment surface portion <NUM>-<NUM> and a fourth attachment surface portion <NUM>-<NUM>. At least one of first attachment surface portion <NUM>-<NUM> and second attachment surface portion <NUM>-<NUM> is coated with a non-permanent adhesive, sometimes also referred to in the art as "repositionable adhesive". Likewise, at least one of third attachment surface portion <NUM>-<NUM> and fourth attachment surface portion <NUM>-<NUM> is coated with the non-permanent adhesive.

Referring to <FIG>, to form sample capture body <NUM>, the rectangular pre-assembly is folded at fold line <NUM> to create fold (pleat) <NUM>-<NUM>, with first attachment surface portion <NUM>-<NUM> being attached to second attachment surface portion <NUM>-<NUM> by adhesive, and with third attachment surface portion <NUM>-<NUM> being attached to fourth attachment surface portion <NUM>-<NUM> by adhesive, and wherein third side edge <NUM>-<NUM> and fourth side edge <NUM>-<NUM> are oriented to form opening <NUM>-<NUM> at the upper portion of interior space <NUM>-<NUM>. In the assembly shape, of the present invention, as depicted in <FIG>, the fabric of sample capture body <NUM> having pleat <NUM>-<NUM> forms an upwardly extending V-shape that will tend to consolidate, i.e., funnel, tissue particles of a collected tissue sample to pleat <NUM>-<NUM>.

To assemble sample collection container <NUM>, the end portion of sample capture body <NUM> having third side edge <NUM>-<NUM> and fourth side edge <NUM>-<NUM>, i.e. opposite to fold line <NUM>, is threaded through opening <NUM>-<NUM> of annular member <NUM>-<NUM>, and in doing so, the fabric is bunched, thus forming a plurality of side undulations <NUM> (see <FIG>) along the sides of sample capture body <NUM>. The portion of sample capture body <NUM> that extends through opening <NUM>-<NUM> of annular member <NUM>-<NUM> is folded over to engage the plurality of mechanical fasteners <NUM>-<NUM> of mounting surface <NUM>-<NUM> of annular member <NUM>-<NUM> of frame <NUM>.

A method of collecting a tissue sample using biopsy apparatus <NUM> having sample collection container <NUM> is described as follows. A biopsy is performed using biopsy apparatus <NUM> to receive a tissue sample and to deliver the received tissue sample, via vacuum assisted transportation, to the sample collection container <NUM>. The V-shape of the fabric of sample capture body <NUM> that extends upwardly from pleat <NUM>-<NUM> tends to consolidate, i.e., funnel, tissue particles of the collected tissue sample to pleat <NUM>-<NUM>. Sample collection container <NUM> containing the tissue sample is removed from biopsy apparatus <NUM>. Sample capture body <NUM> is then removed, i.e., detached, from frame <NUM>. Then, the pleated fabric forming sample capture body <NUM> is unfolded by separating the adhesion at first end surface portion <NUM>-<NUM> and second end surface portion <NUM>-<NUM> so as to facilitate removal of the consolidated tissue particles associated with the received tissue sample from interior sample capture surface <NUM>-<NUM> e.g. near pleat <NUM>-<NUM>.

If desired, sample collection container <NUM> can be reassembled by reversing the disassembly process to permit reuse of the current frame <NUM> and sample capture body <NUM>, and then reinstalled into biopsy apparatus <NUM> for collection of a next tissue sample. Alternatively, sample collection container <NUM> may be reassembled using the current frame <NUM> and a new sample capture body <NUM>.

<FIG> shows an embodiment of a sample collection container <NUM> configured in accordance with an aspect of the present invention. In the present embodiment, sample collection container <NUM> is side-loaded into sample receptacle <NUM>, and is suspended above a floor <NUM>-<NUM> of sample receptacle <NUM> by a support ledge <NUM>-<NUM> that projects inwardly from the inner side walls of sample receptacle <NUM>.

Referring also to <FIG>, sample collection container <NUM> includes a frame <NUM> and a sample capture body <NUM>. Frame <NUM> may be made of plastic or metal. Sample capture body <NUM> is made of a fabric, such as a polypropylene woven fabric. The fabric is a finely woven fabric to prevent micro-calcifications from passing through the fabric.

Frame <NUM> includes an annular member <NUM>-<NUM>, and a cylindrical sleeve <NUM>-<NUM> that is joined to annular member <NUM>-<NUM>. Annular member <NUM>-<NUM> and cylindrical sleeve <NUM>-<NUM> define a frame opening <NUM>-<NUM>. Annular member <NUM>-<NUM> has a drive surface <NUM>-<NUM>. Cylindrical sleeve <NUM>-<NUM> has a mounting surface <NUM>-<NUM> for mounting sample capture body <NUM>.

Mounting surface <NUM>-<NUM> has a releasable attachment device configured to releasably attach to the fabric of sample capture body <NUM>. The releasable attachment device comprises a plurality of mechanical fasteners, such as mechanical fasteners <NUM>-<NUM> described above with respect to the embodiment of <FIG>, so as to engage, e.g., by snagging, the fabric of sample capture body <NUM>.

In accordance with the present embodiment, biopsy apparatus <NUM> further includes a rotational drive <NUM> for applying a driving force to drive surface <NUM>-<NUM> of annular member <NUM>-<NUM> of frame <NUM> of sample collection container <NUM> so as to effect a one-to-one rotational correspondence between the incremental (indexed) rotation of tissue receiving notch <NUM>-<NUM> of sample receiving member <NUM> about longitudinal axis <NUM> (e.g., in rotational direction <NUM>-<NUM>) and the rotation of sample collection container <NUM> about rotational axis <NUM> (e.g., rotational direction <NUM>-<NUM>). (See also <FIG>). As such, as tissue receiving notch <NUM>-<NUM> of sample receiving member <NUM> is indexed, e.g., through a plurality of angular positions about longitudinal axis <NUM>, by operation of controller circuit <NUM> and electromechanical drive <NUM>, sample collection container <NUM> is indexed by rotational drive <NUM> to corresponding angular positions so as to segregate and identify tissue samples collected at each specific angular position of tissue receiving notch <NUM>-<NUM> of sample receiving member <NUM>.

The application of drive force from rotational drive <NUM> to drive surface <NUM>-<NUM> of annular member <NUM>-<NUM> of frame <NUM> of sample collection container <NUM> may be via a friction drive, e.g., a rubber wheel, or a gear drive, having a drive roller or gear fixed to sample receiving member <NUM>. It is to be understood that rotational drive <NUM> includes appropriate gearing to effect the desired one-to-one rotational correspondence between the incremental (indexed) rotation of tissue receiving notch <NUM>-<NUM> of sample receiving member <NUM> about longitudinal axis <NUM> (see also <FIG>) and the rotation of sample collection container <NUM> about rotational axis <NUM> (see <FIG>).

A cannula extension <NUM> is slidably received over proximal end <NUM>-<NUM> of sample receiving member <NUM>. Cannula extension <NUM> is mounted in a fixed relationship to sample receptacle <NUM>, such that sample receiving member <NUM> is rotatable about longitudinal axis <NUM> within cannula extension <NUM>, so as to facilitate the rotational positioning of tissue receiving notch <NUM>-<NUM> of sample receiving member <NUM> at the desired angular position. After severing a tissue sample and with application of vacuum to sample receptacle <NUM>, the severed tissue sample is transported by vacuum through cannula extension <NUM> to sample collection container <NUM>, with sample collection container <NUM> being rotationally indexed about rotational axis <NUM> in unison with the rotational indexing of tissue receiving notch <NUM>-<NUM> of sample receiving member <NUM> by operation of rotational drive <NUM>.

In the embodiment of <FIG>, sample capture body <NUM> has an assembly shape (<FIG>, and <FIG>) and a pre-assembly shape (<FIG>).

In the embodiment of <FIG>, sample capture body <NUM> has an assembly shape (<FIG>, and <FIG>) and a pre-assembly shape (<FIG>). In the present embodiment, referring to <FIG>, sample capture body <NUM> has a rectangular pre-assembly shape having a first elongate side edge <NUM>-<NUM>, a second elongate side edge <NUM>-<NUM>, a first lateral edge <NUM>-<NUM>, and a second lateral edge <NUM>-<NUM>. First elongate side edge <NUM>-<NUM> is orthogonal to first lateral edge <NUM>-<NUM> and second lateral edge <NUM>-<NUM>. Also, second elongate side edge <NUM>-<NUM> is orthogonal to the first lateral edge <NUM>-<NUM> and second lateral edge <NUM>-<NUM>, and second elongate side edge <NUM>-<NUM> is spaced apart, widthwise, from first elongate side edge <NUM>-<NUM>. A first end surface portion <NUM>-<NUM> is adjacent first lateral edge <NUM>-<NUM> and a second end surface portion <NUM>-<NUM> is adjacent the second lateral edge <NUM>-<NUM>. One, or both, of first end surface portion <NUM>-<NUM> and second end surface portion <NUM>-<NUM> has a non-permanent adhesive, e.g., a non-permanent adhesive layer.

An elongate fold line <NUM>-<NUM> is defined between first elongate side edge <NUM>-<NUM> and second elongate side edge <NUM>-<NUM>. Elongate fold line <NUM>-<NUM> divides the rectangular pre-assembly shape depicted in <FIG> into a first region <NUM>-<NUM> between the first elongate side edge <NUM>-<NUM> and the elongate fold line <NUM>-<NUM> and a second region <NUM>-<NUM> between the elongate fold line <NUM>-<NUM> and the second elongate side edge <NUM>-<NUM>.

Referring to <FIG>, a plurality of pairs of pleat lines <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> is located in second region <NUM>-<NUM> that respectively define locations of respective pleats (folds) for the assembled sample capture body <NUM> (see <FIG>). Each of the plurality of pairs plurality of pairs of pleat lines <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> includes a first pleat line <NUM> and a second pleat line <NUM>. In the present embodiment, each of the pleat lines <NUM>, <NUM> extends from the elongate fold line <NUM>-<NUM> to the second elongate side edge <NUM>-<NUM>, and each pair of pleat lines <NUM>/<NUM> of the plurality of pairs plurality of pairs of pleat lines <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> are joined at only one end at elongate fold line <NUM>-<NUM>, so as to form a plurality of right-triangular patterns, as depicted in <FIG>.

During assembly, the rectangular pre-assembly depicted in <FIG> is creased at elongate fold line <NUM>-<NUM>, and is alternatingly folded at each of the pleat lines <NUM>, <NUM> to form a plurality of annular structures (see <FIG>) that define a plurality of sample pockets <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> that are arranged in an annular pattern along elongate fold line <NUM>-<NUM>, and wherein first end surface portion <NUM>-<NUM> is adhesively attached to second end surface portion <NUM>-<NUM> to complete the assembly of sample capture body <NUM>. In the present embodiment, the plurality of sample pockets <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> define a plurality of interior spaces, and with each of the plurality of sample pockets having an interior sample capture surface <NUM> (see <FIG>) that at least partially surrounds the respective interior space. In the present embodiment, the plurality of sample pockets <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> are arranged to respectively receive tissue samples from each of ten angular positions, e.g., angular positions <NUM>-<NUM>, of tissue receiving notch <NUM>-<NUM> of sample receiving member <NUM> about longitudinal axis <NUM>. It is to be understood that the number of sample pockets may be increased or decreased from that of the present embodiment, if desired.

In the present embodiment, when assembled, sample capture body <NUM> has a circular side wall at first region <NUM>-<NUM> that transitions at a circular crease (fold) at elongate fold line <NUM>-<NUM> to an annular pleated wall that is formed at second region <NUM>-<NUM>. As shown in <FIG>, the annular pleated wall is oriented at an acute angle at the circular crease at elongate fold line <NUM>-<NUM> with respect to the circular side wall at first region <NUM>-<NUM>.

Referring again to <FIG>, to complete assembly of sample collection container <NUM>, first region <NUM>-<NUM> of the fabric of sample capture body <NUM> is attached to mounting surface <NUM>-<NUM> of frame <NUM> by a plurality of mechanical fasteners, so as to form sample collection container <NUM>.

Thus, advantageously, sample capture body <NUM> may be detached from frame <NUM> and unfolded to aid in the removal of any tissue sample received by the plurality of sample pockets <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> of sample capture body <NUM>, and thereafter, refolded along the fold/pleat lines, reattached to frame <NUM>, and reused to capture additional tissue samples, from the same patient.

As an alternative to the above, it is contemplated that in some embodiments, it may be desirable to use sample capture body <NUM> in the absence of frame <NUM>.

As a further alternative, it is contemplated that the side structure of either of sample capture body <NUM> or sample capture body <NUM> may be reinforced, e.g., via a wire frame, such as a wire spiral, to maintain an open top for receiving tissue samples. Also, it is contemplated that in some embodiments, such reinforcement may be provided in addition to, or in lieu of, the respective frames described above.

The following items also relate to the invention:
In one form, the invention relates to a sample collection container for a biopsy apparatus according to claim <NUM>. The fabric may be configured to prevent micro-calcifications from passing through the fabric. In particular, the fabric is a (finely) woven fabric.

The sample collection container includes a frame, and the sample capture body is removably attached to the frame.

In a preferred embodiment, the fabric has a rectangular pre-assembly shape including a first side edge, a second side edge, a third side edge and a fourth side edge. In one implementation, for example, the first side edge is orthogonal to the third side edge and the fourth side edge, and the second side edge is orthogonal to the third side edge and the fourth side edge. The second side edge is laterally spaced apart from the first side edge. A first end surface portion is adjacent the first side edge. The first end surface portion is divided at a fold line to define a first attachment surface portion and a second attachment surface portion. A second end surface portion is adjacent the second side edge. The second end surface portion is divided at the fold line to define a third attachment surface portion and a fourth attachment surface portion. The rectangular pre-assembly folds at the fold line to create a fold, with the first attachment surface portion being attached to the second attachment surface portion by adhesive, and with the third attachment surface portion being attached to the fourth attachment surface portion by adhesive, and wherein the third side edge and the fourth side edge are oriented to form an opening.

The frame, according to the invention, is an annular member having a mounting surface that surrounds a frame opening. The annular surface has a plurality of mechanical fasteners around the frame opening that are configured to attach to the fabric. In one implementation, for example, each of the plurality of mechanical fasteners may be a slot formed in the mounting surface. In another implementation, for example, each of the plurality of mechanical fasteners may be a burr protrusion that projects away from the mounting surface to engage the fabric.

In any of the preceding variations, the fabric may have at least one or a plurality of side undulations.

Further, the fabric may have a plurality of pleats. For example, the plurality of pleats may be arranged in an annular pattern.

In one implementation, the sample capture body may have a circular side wall that transitions at a circular crease to an annular pleated wall. The annular pleated wall may be oriented at an acute angle at the crease with respect to the circular side wall. The annular pleated wall may have a plurality of pleats that form a plurality of cavities, with the plurality of cavities being arranged in an annular pattern.

The fabric of the sample collection container may have a rectangular pre-assembly shape that includes a first elongate side edge, a second elongate side edge, a first lateral edge, and a second lateral edge. In one implementation, for example, the first elongate side edge is orthogonal to the first lateral edge and the second lateral edge, and second elongate side edge is orthogonal to the first lateral edge and the second lateral edge. The second elongate side edge is spaced apart from the first elongate side edge. A first end surface portion is adjacent the first lateral edge and a second end surface portion is adjacent the second lateral edge, wherein at least one of the first end surface portion and the second end surface portion has a non-permanent adhesive. An elongate fold line is defined between the first elongate side edge and the second elongate side edge. The elongate fold line divides the rectangular pre-assembly shape into a first region between the first elongate side edge and the elongate fold line and a second region between the elongate fold line and the second elongate side edge. A plurality of pairs of pleat lines is located in the second region, wherein each pleat line extends from the elongate fold line to the second side edge. Each pair of pleat lines is joined at only one end at the elongate fold line to form a triangular pattern. The rectangular pre-assembly is creased at the elongate fold line and is alternatingly folded at each of the pleat lines to form an annular structure. The first end surface portion may be adhesively attached to the second end surface portion.

The first region of the fabric of the sample capture body may be attached to a frame by a non-permanent adhesive or a mechanical fastener.

The invention also relates to a biopsy apparatus, according to claim <NUM>. The biopsy apparatus includes a driver assembly that includes a housing having a proximal end. A vacuum source may be contained within the housing. A biopsy probe assembly is releasably mounted to the housing. The biopsy probe has an elongate sample receiving member and a cutting cannula coaxial with the elongate sample receiving member. A sample receptacle may be removably mounted to the proximal end of the housing. The sample receptacle is coupled in fluid communication with each of the biopsy probe assembly and the vacuum source. A sample collection container is removably carried by the sample receptacle. The sample collection container includes a sample capture body defining an interior space. The sample capture body is made of a fabric and has an interior sample capture surface that at least partially surrounds the interior space. The fabric has at least one fold. The sample collection container is configured in accordance with any one of the previously described embodiments, implementations, and/or variations thereof.

A non-claimed example also relates to the use of a sample collection container in a biopsy apparatus. For example, the example relates to the use of a sample collection container for a biopsy apparatus, the sample collection container comprising a sample capture body defining an interior space, the sample capture body being made of a fabric and having an interior sample capture surface that at least partially surrounds the interior space, the fabric having at least one fold, wherein the biopsy apparatus comprises a driver assembly that includes a housing having a proximal end; a vacuum source contained within the housing; a biopsy probe assembly releasably mounted to the housing, the biopsy probe having an elongate sample receiving member and a cutting cannula coaxial with the elongate sample receiving member; and a sample receptacle removably mounted to the proximal end of the housing, the sample receptacle being coupled in fluid communication with each of the biopsy probe assembly and the vacuum source; wherein the sample collection container is removably carried by the sample receptacle. The sample collection container may be configured in accordance with any of the previously described embodiments, implementations and/or variations thereof.

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

Claim 1:
A sample collection container (<NUM>) for being removably carried by a sample receptacle (<NUM>) of a biopsy apparatus (<NUM>), sample collection container (<NUM>) comprising
a sample capture body (<NUM>) defining an interior space (<NUM>-<NUM>), the sample capture body being made of a fabric and having an interior sample capture surface (<NUM>-<NUM>) that at least partially surrounds the interior space (<NUM>-<NUM>), the fabric having a fold (<NUM>-<NUM>), the sample capture body (<NUM>) having a pair of opposed surfaces that extend from the fold to form a V-shape of the fabric; and
a frame (<NUM>), the sample capture body (<NUM>) being removably attached to the frame, wherein the frame is an annular member (<NUM>-<NUM>) having an annular mounting surface (<NUM>-<NUM>) that surrounds a frame opening (<NUM>-<NUM>), the annular mounting surface (<NUM>-<NUM>) having a plurality of mechanical fasteners (<NUM>-<NUM>) around the frame opening (<NUM>-<NUM>) that are configured to attach to the fabric.