Patent Description:
A biopsy may be performed on a patient to help in determining whether the tissue in a region of interest includes cancerous cells. One biopsy technique used to evaluate breast tissue, for example, involves inserting a biopsy probe into the breast tissue region of interest to capture one or more tissue samples from the region. Such a biopsy technique often utilizes a vacuum to pull the tissue to be sampled into a sample notch of the biopsy probe, after which the tissue is severed and collected. Efforts continue in the art to improve the ability of the biopsy device to sever a tissue sample, and to transport the severed tissue sample to a sample collection container.

What is needed in the art is a biopsy device that has the ability to promote effective severing of a tissue sample and effective transport of the tissue sample to a sample collection container. <CIT> discloses a biopsy device including coaxially disposed inner and outer needles in which the outer needle tip is configured for obtaining a tissue sample. The inner surface of the outer needle includes a tissue retention feature which includes a countersink having a predetermined length from the distal cutting edge of the outer needle. <CIT> discloses a needle set for a biopsy device. The needle set includes an outer member, a cylinder lumen within said outer member, an inner member having a cannula and an inner lumen. The inner member is slidably disposed within the cylinder lumen. The biopsy device also includes a cylinder seal member that is disposed within the cylinder lumen and a cannula seal member attached to the outer surface of the cannula. The cylinder seal member and the cannula seal member define a vacuum chamber therebetween. <CIT> discloses a biopsy rotary cutting device, comprising a dynamic sealing structure provided outside an inner knife tube. The dynamic sealing structure forms a cavity outside the inner knife tube. The inner knife tube comprises a first tube section and a second tube section that are sequentially arranged in the axial direction of the inner knife tube. The outer diameter of the second tube section is less than the outer diameter of the first tube section. The dynamic sealing structure is internally provided with a seal ring. The cavity comprises a first cavity and a second cavity. When the inner knife tube moves to a first position along the axial direction thereof, the seal ring is outside the second tube section, and there is an inter-cavity gap between the seal ring and the second tube section, to communicate the first cavity with the second cavity. <CIT> on which the preamble of claim <NUM> is based *+ discloses a biopsy apparatus including a biopsy probe assembly that is releasably attached to a driver assembly. The biopsy probe assembly has a vacuum cannula and a stylet cannula coaxially arranged. The vacuum cannula has a flared portion that extends distally from an elongate portion. The stylet cannula is movable between a first extended position and a first retracted position. The stylet cannula has a distal portion having a sample notch and a protrusion member that extends proximally in a lumen of stylet cannula along a portion of a longitudinal extent of the sample notch, wherein when the stylet cannula is in the first retracted position, the protrusion member is received within the flared portion of the vacuum cannula. The biopsy apparatus may further include a controller circuit that has a virtual energy reservoir, and the controller circuit executes program instructions to control current to motors when engaging dense tissue.

In one embodiment a biopsy apparatus, including a biopsy probe assembly having a cutter cannula, a vacuum cannula, and a stylet cannula coaxially arranged along a longitudinal axis. The vacuum cannula is positioned inside the stylet cannula to define a first intermediate lumen therebetween. The stylet cannula is positioned within the cutter cannula to define a second intermediate lumen therebetween. The vacuum cannula has a vacuum lumen. The stylet cannula is movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position. The stylet cannula has a plurality of vent openings, the plurality of vent openings including at least one longitudinal vent slot. The biopsy apparatus also includes a seal having a proximal seal portion and a distal seal portion, the distal seal portion having a distal seal lip that is positioned for radial engagement with an outside diameter of the cutter cannula, and the proximal seal portion having a proximal seal lip that is positioned for radial engagement with an outside diameter of the stylet cannula. When the stylet cannula is moved from the first extended position toward the first retracted position, the at least one longitudinal vent slot is longitudinally positioned under the proximal seal lip of the proximal seal portion of the seal so as to open a seal bypass path across a longitudinal extent of the proximal seal lip of the proximal seal portion of the seal so as to establish both a first air path at the first intermediate lumen between an outside diameter of the vacuum cannula and an inside diameter of the stylet cannula and a second air path at the second intermediate lumen between an inside diameter of the cutter cannula and the outside diameter of the stylet cannula. The first air path and the second air path are in fluid communication with a region proximal to the seal.

In another embodiment not forming part of the invention as claimed, a method includes applying vacuum via a vacuum cannula of a biopsy apparatus to a lumen of a stylet cannula of the biopsy apparatus at a sample notch of the stylet cannula. A cutter cannula of the biopsy apparatus, the vacuum cannula, and the stylet cannula, are coaxially arranged along a longitudinal axis. The vacuum cannula is positioned inside the stylet cannula to define a first intermediate lumen therebetween, the stylet cannula is positioned within the cutter cannula to define a second intermediate lumen therebetween, and the vacuum cannula has a vacuum lumen. The stylet cannula is movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position. The stylet cannula has a plurality of vent openings, the plurality of vent openings including at least one longitudinal vent slot. The biopsy apparatus includes a seal having a proximal seal portion and a distal seal portion, the distal seal portion having a distal seal lip that is positioned for radial engagement with an outside diameter of the cutter cannula, and the proximal seal portion having a proximal seal lip that is positioned for radial engagement with an outside diameter of the stylet cannula. The method also includes moving the stylet cannula toward the first retracted position to move a severed tissue sample into the vacuum cannula. When the stylet cannula is moved toward the first retracted position, the at least one longitudinal vent slot is longitudinally positioned under the proximal seal lip of the proximal seal portion of the seal so as to open a seal bypass path across a longitudinal extent of the proximal seal lip of the proximal seal portion of the seal so as to establish both a first air path at the first intermediate lumen between an outside diameter of the vacuum cannula and an inside diameter of the stylet cannula and a second air path at the second intermediate lumen between an inside diameter of the cutter cannula and the outside diameter of the stylet cannula. The first air path and the second air path are in fluid communication with a region proximal to the seal.

The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure will be better understood by reference to the following description of an embodiment of the disclosure taken in conjunction with the accompanying drawings, wherein:.

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

Referring now to the drawings, and more particularly to <FIG> and <FIG>, there is shown a biopsy apparatus <NUM> which generally includes a non-invasive, e.g., non-disposable, biopsy driver assembly <NUM> and an invasive, e.g., disposable, biopsy probe assembly <NUM>. As used herein, the term "non-disposable" is used to refer to a device that is intended for use on multiple patients during the lifetime of the device, and the term "disposable" is used to refer to a device that is intended to be disposed of after use on a single patient. Biopsy driver assembly <NUM> includes a driver housing <NUM> that is configured and ergonomically designed to be grasped by a user.

Referring to <FIG> and <FIG>, biopsy driver assembly <NUM> includes within driver housing <NUM> a controller circuit <NUM>, an electromechanical power source <NUM>, a vacuum source <NUM>, a vacuum sensor <NUM>, and a battery <NUM> (or alternatively an AC adapter). A user interface <NUM> (see <FIG>), such as a keypad, is located to be mounted to driver housing <NUM>, and externally accessible by the user with respect to driver housing <NUM>. Battery <NUM> may be, for example, a rechargeable battery, which may be charged by an inductive charging device coupled to inductive coil <NUM>, or alternatively, by an electrical connection to an electrical power supply. Battery <NUM> is electrically coupled to controller circuit <NUM>, electromechanical power source <NUM>, vacuum source <NUM>, and user interface <NUM>.

Referring to <FIG>, user interface <NUM> may include control buttons and visual/aural indicators, with the control buttons providing user control over various functions of biopsy apparatus <NUM>, and with the visual/aural indicators providing visual/aural feedback of the status of one or more conditions and/or positions of components of biopsy apparatus <NUM>. The control buttons may include a sample button <NUM>-<NUM> and a prime/pierce button <NUM>-<NUM>. The visual indicators may include a display screen <NUM>-<NUM> and/or one or more light emitting diodes (LED) <NUM>-<NUM>. The aural indicator may include a buzzer <NUM>-<NUM>. The control buttons may include tactile feedback to the user when activated.

Controller circuit <NUM> is electrically and communicatively coupled to electromechanical power source <NUM>, vacuum source <NUM>, vacuum sensor <NUM>, and user interface <NUM>, such as by one or more wires or circuit traces. Controller circuit <NUM> may be assembled on an electrical circuit board, and includes, for example, a processor circuit <NUM>-<NUM> and a memory circuit <NUM>-<NUM>.

Processor circuit <NUM>-<NUM> has one or more programmable microprocessors and associated circuitry, such as an input/output interface, clock, buffers, memory, etc. Memory circuit <NUM>-<NUM> is communicatively coupled to processor circuit <NUM>-<NUM>, e.g., via a bus circuit, and is a non-transitory electronic memory that may include volatile memory circuits, such as random access memory (RAM), and non-volatile memory circuits, such as read only memory (ROM), electronically erasable programmable ROM (EEPROM), NOR flash memory, NAND flash memory, etc. Controller circuit <NUM> may be formed as one or more Application Specific Integrated Circuits (ASIC).

Controller circuit <NUM> is configured via software and/or firmware residing in memory circuit <NUM>-<NUM> to execute program instructions to perform functions associated with the retrieval of biopsy tissue samples, such as that of controlling and/or monitoring one or more components of electromechanical power source <NUM>, vacuum source <NUM>, and vacuum sensor <NUM>.

Electromechanical power source <NUM> may include, for example, a cutter module <NUM>, a transport module <NUM>, and a piercing module <NUM>, each being respectively electrically coupled to battery <NUM>. Each of cutter module <NUM>, transport module <NUM>, and piercing module <NUM> is electrically and controllably coupled to controller circuit <NUM> by one or more electrical conductors, e.g., wires or circuit traces.

Cutter module <NUM> may include an electrical motor <NUM>-<NUM> having a shaft to which a drive gear <NUM>-<NUM> is attached. Transport module <NUM> may include an electrical motor <NUM>-<NUM> having a shaft to which a drive gear <NUM>-<NUM> is attached. Piercing module <NUM> may include an electrical motor <NUM>-<NUM>, a drive spindle <NUM>-<NUM>, and a piercing shot drive <NUM>-<NUM>. Each electrical motor <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> may be, for example, a direct current (DC) motor or stepper motor. As an alternative to the arrangement described above, each of cutter module <NUM>, transport module <NUM>, and piercing module <NUM> may include one or more of a gear, gear train, belt/pulley arrangement, etc., interposed between the respective motor and drive gear or drive spindle.

Piercing module <NUM> is configured such that an activation of electrical motor <NUM>-<NUM> and a drive spindle <NUM>-<NUM> causes a piercing shot drive <NUM>-<NUM> to move in a proximal direction <NUM>-<NUM> to compress a firing spring, e.g., one or more coil springs, and to latch piercing shot drive <NUM>-<NUM> in a ready position. Upon actuation of prime/pierce button <NUM>-<NUM> of user interface <NUM>, piercing shot drive <NUM>-<NUM> is propelled, i.e., fired, in a distal direction <NUM>-<NUM> (see <FIG>).

Vacuum source <NUM> is electrically and controllably coupled to battery <NUM> by one or more electrical conductors, e.g., wires or circuit traces. Vacuum source <NUM> may include, for example, an electric motor <NUM>-<NUM> that drives a vacuum pump <NUM>-<NUM>. Vacuum source <NUM> has a vacuum source port <NUM>-<NUM> coupled to vacuum pump <NUM>-<NUM> for establishing vacuum in biopsy probe assembly <NUM>. Electric motor <NUM>-<NUM> may be, for example, a rotary, linear or vibratory DC motor. Vacuum pump <NUM>-<NUM> may be, for example, a peristaltic pump or a diaphragm pump, or one or more of each connected in series or parallel.

Vacuum sensor <NUM> is electrically coupled to controller circuit <NUM> by one or more electrical conductors, e.g., wires or circuit traces. Vacuum sensor <NUM> may be a pressure differential sensor that provides vacuum (negative pressure) feedback signals to controller circuit <NUM>. In some implementations, vacuum sensor <NUM> may be incorporated into vacuum source <NUM>.

Referring to <FIG> and <FIG>, biopsy probe assembly <NUM> is configured for releasable attachment to biopsy driver assembly <NUM>. As used herein, the term "releasable attachment" means a configuration that facilitates an intended temporary connection followed by selective detachment involving a manipulation of disposable biopsy probe assembly <NUM> relative to biopsy driver assembly <NUM>, without the need for tools.

Referring to the exploded view of <FIG>, biopsy probe assembly <NUM> includes a probe housing <NUM>, a probe sub-housing <NUM>, a vacuum cannula <NUM>, a stylet cannula <NUM>, a stylet gear-spindle set <NUM> for linear stylet translation, a cutter cannula <NUM>, a cutter gear-spindle set <NUM> for rotary and linear cutter translation, a sample manifold <NUM>, and a sample cup <NUM>.

Referring to <FIG>, <FIG>, and <FIG>, probe housing <NUM> is formed as an L-shaped structure having an elongate portion <NUM>-<NUM> and a front plate <NUM>-<NUM>. When biopsy probe assembly <NUM> is attached to biopsy driver assembly <NUM>, front plate <NUM>-<NUM> is positioned distally adjacent to an entirety of front surface <NUM>-<NUM> of driver housing <NUM>, i.e., so as to shield the entirety of front surface <NUM>-<NUM> of the non-disposable driver assembly from contact with a patient.

Vacuum cannula <NUM>, stylet cannula <NUM>, and cutter cannula <NUM> are coaxially arranged along a longitudinal axis <NUM> in a nested tube arrangement, with vacuum cannula <NUM> being the innermost tube, cutter cannula <NUM> being the outermost tube, and stylet cannula <NUM> being the intermediate tube that is interposed between vacuum cannula <NUM> and cutter cannula <NUM>. In other words, vacuum cannula <NUM> is positioned inside stylet cannula <NUM>, and stylet cannula <NUM> is positioned inside cutter cannula <NUM>.

Vacuum cannula <NUM> is mounted to be stationary relative to probe sub-housing <NUM>. Vacuum cannula <NUM> is coupled in fluid communication with vacuum source <NUM> via sample manifold <NUM>.

Referring to <FIG>, <FIG>, and <FIG>, vacuum cannula <NUM> includes an elongate portion <NUM>-<NUM>, a flared portion <NUM>-<NUM> that extends distally from elongate portion <NUM>-<NUM>, and a vacuum lumen <NUM>-<NUM>. Elongate portion <NUM>-<NUM> has a first outside diameter D1. Flared portion <NUM>-<NUM> flares from elongate portion <NUM>-<NUM> in two stages, namely, a first flared stage <NUM>-<NUM> and a second flared stage <NUM>-<NUM>. First flared stage <NUM>-<NUM> diverges from elongate portion <NUM>-<NUM> at a first acute angle A1, and second flared stage <NUM>-<NUM> diverges from first flared stage <NUM>-<NUM> at a second acute angle A2 relative to elongate portion <NUM>-<NUM>, with acute angle A2 being larger than acute angle A1. A distal outside diameter D2 of second flared stage <NUM>-<NUM> is selected to be accommodated within, and in sliding contact with, lumen <NUM>-<NUM> of stylet cannula <NUM>. Each of first flared stage <NUM>-<NUM> and second flared stage <NUM>-<NUM> of flared portion <NUM>-<NUM> has a distally and gradually increasing diameter, which is larger than the diameter D1 of elongate portion <NUM>-<NUM>.

Referring to <FIG> and <FIG>, stylet cannula <NUM> includes a proximal portion <NUM>-<NUM> and a distal portion <NUM>-<NUM>. Distal portion <NUM>-<NUM> includes a sample notch <NUM>. Attached to distal portion <NUM>-<NUM> is a piercing tip <NUM>, which in turn forms part of stylet cannula <NUM>. Stylet gear-spindle set <NUM> threadably engages external threads of a transport spindle <NUM>-<NUM> that is fixedly attached (e.g., glued, welded or staked) to proximal portion <NUM>-<NUM> of stylet cannula <NUM>. Stylet gear-spindle set <NUM> is a unitary gear having a driven gear <NUM>-<NUM> fixedly attached to a threaded spindle <NUM>-<NUM>, and may be formed as a single molded component. Stylet cannula <NUM> is retracted or extended along longitudinal axis <NUM> by activation of transport module <NUM> of biopsy probe assembly <NUM>, with drive gear <NUM>-<NUM> of transport module <NUM> of biopsy driver assembly <NUM> being engaged with driven gear <NUM>-<NUM> of stylet gear-spindle set <NUM>.

Referring also to <FIG>, <FIG>, sample notch <NUM> is formed as an elongate opening in a side wall <NUM>-<NUM> of stylet cannula <NUM> to facilitate a reception of tissue <NUM> into a lumen <NUM>-<NUM> of stylet cannula <NUM>. Sample notch <NUM> has a longitudinal extent <NUM>-<NUM> that extends along longitudinal axis longitudinal axis <NUM>. Sample notch <NUM> does not extend in side wall <NUM>-<NUM> below a centerline of the diameter of stylet cannula <NUM>, and may include cutting edges around the perimeter of the opening formed by sample notch <NUM>, wherein the cutting edges of the elongate (linear) portions of sample notch <NUM> each have a cutting edge that diverges from a cutting edge along the side wall <NUM>-<NUM> to the centerline at a diameter of stylet cannula <NUM>.

Piercing tip <NUM> has a tip portion <NUM>-<NUM>, a mounting portion <NUM>-<NUM>, and a protrusion member <NUM>-<NUM>. Piercing tip <NUM> is inserted into lumen <NUM>-<NUM> of stylet cannula <NUM> at distal portion <NUM>-<NUM>, with mounting portion <NUM>-<NUM> being attached to distal portion <NUM>-<NUM> of stylet cannula <NUM>, such as an adhesive or weld. As such, tip portion <NUM>-<NUM> extends distally from distal portion <NUM>-<NUM> of stylet cannula <NUM>, and protrusion member <NUM>-<NUM> extends proximally (i.e., in proximal direction <NUM>-<NUM>) in lumen <NUM>-<NUM> along a portion of the longitudinal extent <NUM>-<NUM> of sample notch <NUM>. Accordingly, as depicted in <FIG> and <FIG>, when stylet cannula <NUM> is fully retraced in the proximal direction <NUM>-<NUM>, protrusion member <NUM>-<NUM> is received into flared portion <NUM>-<NUM> of vacuum cannula <NUM>. At least the proximal tip portion of protrusion member <NUM>-<NUM> has a proximally decreasing diameter.

Referring again to <FIG>, cutter cannula <NUM> includes a proximal portion <NUM>-<NUM> and a distal portion <NUM>-<NUM>. Distal portion <NUM>-<NUM> includes an annular cutting edge <NUM>. Cutter gear-spindle set <NUM> is fixedly attached (e.g., glued, welded or staked) to proximal portion <NUM>-<NUM> of cutter cannula <NUM>. Cutter gear-spindle set <NUM> is a unitary gear having a driven gear <NUM>-<NUM> fixedly attached to a threaded spindle <NUM>-<NUM>, and may be formed as a single molded component. Cutter cannula <NUM> is retracted or extended along longitudinal axis <NUM> by activation of cutter module <NUM> of biopsy probe assembly <NUM>, with drive gear <NUM>-<NUM> of cutter module <NUM> of biopsy driver assembly <NUM> being engaged with driven gear <NUM>-<NUM> of cutter gear-spindle set <NUM>. Thus, cutter cannula <NUM> has a rotational cutting motion and is translated axially along longitudinal axis <NUM>. The pitch of the threads of threaded spindle <NUM>-<NUM> determines the number of revolutions per axial distance (in millimeters (mm)) that cutter cannula <NUM> moves axially.

Referring to <FIG> and <FIG>, sample manifold <NUM> is configured as an L-shaped structure having a vacuum chamber portion <NUM>-<NUM> and a collection chamber portion <NUM>-<NUM>. Vacuum chamber portion <NUM>-<NUM> includes a vacuum input port <NUM>-<NUM> that is arranged to sealably engage vacuum source port <NUM>-<NUM> of vacuum source <NUM> of biopsy driver assembly <NUM> when biopsy probe assembly <NUM> is attached to biopsy driver assembly <NUM>. Vacuum chamber portion <NUM>-<NUM> is connected in fluid communication with collection chamber portion <NUM>-<NUM>. Proximal end of elongate portion <NUM>-<NUM> of vacuum cannula <NUM> passes through vacuum chamber portion <NUM>-<NUM> and is in direct fluid communication with collection chamber portion <NUM>-<NUM>. Collection chamber portion <NUM>-<NUM> has a cavity sized and arranged to removably receive sample cup <NUM>, such that sample cup <NUM> is in direct fluid communication with elongate portion <NUM>-<NUM> of vacuum cannula <NUM>, and sample cup <NUM> also is in direct fluid communication with vacuum input port <NUM>-<NUM> of vacuum chamber portion <NUM>-<NUM>. Blotting papers are placed in vacuum chamber portion <NUM>-<NUM> in a region between vacuum input port <NUM>-<NUM> and collection chamber portion <NUM>-<NUM>.

Accordingly, a tissue sample severed by cutter cannula <NUM> at sample notch <NUM> of stylet cannula <NUM> may be transported by vacuum applied by vacuum source <NUM> at sample cup <NUM>, through vacuum cannula <NUM>, and into sample cup <NUM>.

Referring again to <FIG>, <FIG> and <FIG>, probe sub-housing <NUM>, e.g., a probe carrier body, is a sub-housing that is slidably coupled to probe housing <NUM>, e.g., using a rail/slot arrangement. Probe sub-housing <NUM> includes a proximal threaded portion <NUM>-<NUM> and a distal threaded portion <NUM>-<NUM>. Also, probe sub-housing <NUM> is configured to be drivably coupled to piercing module <NUM>. Stated differently, piercing module <NUM> is drivably coupled to probe sub-housing <NUM> when biopsy driver assembly <NUM> is coupled to biopsy probe assembly <NUM> to form biopsy apparatus <NUM>.

Probe sub-housing <NUM> includes one or more piercing module engagement opening, e.g., slot(s). In the present embodiment, with reference to <FIG> and <FIG>, probe sub-housing <NUM> includes a piercing module engagement opening <NUM>-<NUM> and a piercing module engagement opening <NUM>-<NUM>, each of which is configured, e.g., in size and in shape, to receive a respective drive protrusion <NUM>-<NUM>, <NUM>-<NUM> of piercing shot drive <NUM>-<NUM> of piercing module <NUM> so as to effect longitudinal movement of probe sub-housing <NUM> in unison with longitudinal movement of piercing shot drive <NUM>-<NUM> during a piercing shot (firing) operation. For example, each of piercing module engagement opening <NUM>-<NUM> and piercing module engagement opening <NUM>-<NUM> may be a respective rectangular slot. While the present embodiment includes two piercing module engagement openings for symmetry and/or redundancy, an alternative embodiment may have, for example, only one piercing module engagement opening, e.g., piercing module engagement opening <NUM>-<NUM>.

Proximal threaded portion <NUM>-<NUM> in probe sub-housing <NUM> has a threaded hole that threadably receives threaded spindle <NUM>-<NUM> of stylet gear-spindle set <NUM>, such that rotation of driven gear <NUM>-<NUM> of stylet gear-spindle set <NUM> results in a linear translation of stylet cannula <NUM> along longitudinal axis <NUM>, with a direction of rotation correlating to a direction of translation of stylet cannula <NUM> in one of proximal direction <NUM>-<NUM> and distal direction <NUM>-<NUM>. Driven gear <NUM>-<NUM> of stylet gear-spindle set <NUM> engages drive gear <NUM>-<NUM> of transport module <NUM> when biopsy probe assembly <NUM> is attached to biopsy driver assembly <NUM> (see <FIG>).

Likewise, distal threaded portion <NUM>-<NUM> of probe sub-housing <NUM> has a threaded hole that threadably receives threaded spindle <NUM>-<NUM> of cutter gear-spindle set <NUM>, such that rotation of driven gear <NUM>-<NUM> of cutter gear-spindle set <NUM> results in a combined rotation and linear translation of cutter cannula <NUM> along longitudinal axis <NUM>, with a direction of rotation correlating to a direction of translation of cutter cannula <NUM>. Driven gear <NUM>-<NUM> of cutter gear-spindle set <NUM> engages drive gear <NUM>-<NUM> of cutter module <NUM> when biopsy probe assembly <NUM> is attached to biopsy driver assembly <NUM> (see <FIG>).

Also, when biopsy probe assembly <NUM> is attached to biopsy driver assembly <NUM>, referring also to <FIG> and <FIG>, probe sub-housing <NUM> is connected to piercing shot drive <NUM>-<NUM> of piercing module <NUM>. As such, upon a first actuation of prime/pierce button <NUM>-<NUM>, probe sub-housing <NUM> and piercing shot drive <NUM>-<NUM> are translated in unison in proximal direction <NUM>-<NUM> to position piercing shot drive <NUM>-<NUM> and probe sub-housing <NUM> carrying stylet cannula <NUM> and cutter cannula <NUM> in the ready, i.e., cocked position, and upon a second actuation of prime/pierce button <NUM>-<NUM> to effect a piercing shot, probe sub-housing <NUM> and piercing shot drive <NUM>-<NUM> are rapidly propelled in unison in distal direction <NUM>-<NUM> to position stylet cannula <NUM> and cutter cannula <NUM> at the distal most position of the combined elements, e.g., within the patient.

<FIG> collectively represent a tissue sample severing and transport sequence. <FIG> and <FIG> show stylet cannula <NUM> in its retracted position <NUM>-<NUM>. <FIG>, and <FIG> show stylet cannula <NUM> in its extended position <NUM>-<NUM>, sometimes also referred to as a zero position. <FIG>, <FIG> show stylet cannula <NUM> in various positions intermediate to retracted position <NUM>-<NUM> and extended position <NUM>-<NUM>. <FIG> show cutter cannula <NUM> in its retracted position <NUM>-<NUM>, which exposes sample notch <NUM> of stylet cannula <NUM> when stylet cannula <NUM> is in or near its extended position <NUM>-<NUM>. <FIG> and <FIG> show cutter cannula <NUM> in its extended position <NUM>-<NUM>, sometimes also referred to as a zero position, wherein cutter cannula <NUM> covers the sample notch <NUM> of stylet cannula <NUM>.

To effect the described movements of stylet cannula <NUM>, controller circuit <NUM> executes program instructions and sends respective control signals to transport module <NUM> of biopsy driver assembly <NUM>, which in turn transfers the motion to stylet gear-spindle set <NUM> of biopsy probe assembly <NUM>. Likewise, to effect the described movements of cutter cannula <NUM>, controller circuit <NUM> executes program instructions and sends respective control signals to cutter module <NUM> of biopsy driver assembly <NUM>, which in turn transfers the motion to cutter gear-spindle set <NUM> of biopsy probe assembly <NUM>. Controller circuit <NUM> may determine an axial position of each of stylet cannula <NUM> and cutter cannula <NUM>, relative to the respective zero position, by counting the respective number of motor drive pulses, or alternatively, the respective number of motor shaft revolutions.

<FIG> shows the relative positions of vacuum cannula <NUM>, stylet cannula <NUM>, and cutter cannula <NUM> before, during, and immediately after the piercing shot effected by piercing module <NUM>. As shown, distal portion <NUM>-<NUM> of cutter cannula <NUM> is extended over sample notch <NUM>.

In the sequence step illustrated in <FIG>, vacuum source <NUM> is actuated to deliver a vacuum via vacuum cannula <NUM> to lumen <NUM>-<NUM> of stylet cannula <NUM> at sample notch <NUM>, and cutter cannula <NUM> is retracted by actuation of cutter module <NUM> to expose sample notch <NUM>, thereby permitting tissue <NUM> to be drawn into lumen <NUM>-<NUM> of stylet cannula <NUM> through sample notch <NUM>. In the present embodiment, in order to expose sample notch <NUM>, cutter cannula <NUM> rotates counterclockwise to effect a linear translation of cutter cannula <NUM> in proximal direction <NUM>-<NUM> for a distance of approximately <NUM> millimeters (mm) to define the open length of sample notch <NUM>. As used herein, the relative term "approximately" means the base value in the indicated units (if any) plus or minus five percent, unless stated otherwise. The actual aperture size at sample notch <NUM>, corresponding to a desired sample size, may be user-selected at user interface <NUM>, wherein a distance that cutter cannula <NUM> is retracted toward retracted position <NUM>-<NUM> from extended position <NUM>-<NUM> is controlled by controller circuit <NUM> to correspond to the sample size selected by the user.

<FIG> and <FIG> illustrate a cutting sequence.

In the sequence step illustrated in <FIG>, in order to increase the size of tissue sample to be collected, stylet cannula <NUM> may be moved alternatingly in proximal direction <NUM>-<NUM> and distal direction <NUM>-<NUM> a short distance e.g., <NUM> to <NUM>, so as to shake sample notch <NUM>, thereby increasing the amount of tissue <NUM> that passes through sample notch <NUM> and into lumen <NUM>-<NUM> of stylet cannula <NUM>. The last move of the shake is defined to keep sample notch <NUM> in a <NUM> retracted position (see <FIG>) compared to the zero position of stylet cannula <NUM> as depicted in <FIG>. This is to ensure that cutter cannula <NUM> closes sample notch <NUM> during the cutting sequence (see <FIG>) and will cut <NUM> further, to thus ensure that connective tissue or strings are completely cut during the cutting sequence step illustrated in <FIG>.

In the cutting sequence step illustrated in <FIG>, cutter cannula <NUM> is rotated and translated in distal direction <NUM>-<NUM> to sever a tissue sample <NUM>-<NUM> from tissue <NUM>. In the present embodiment, cutter cannula <NUM> rotates clockwise to effect a linear translation of cutter cannula in distal direction <NUM>-<NUM> for a distance of approximately <NUM> in order to cut the tissue and return to the zero position.

<FIG> illustrate a tissue sample transport sequence.

In the sequence step illustrated in <FIG>, vacuum is applied by vacuum cannula <NUM>, and stylet cannula <NUM> is moved within cutter cannula <NUM> in proximal direction <NUM>-<NUM> to mechanically aid in moving tissue sample <NUM>-<NUM> into flared portion <NUM>-<NUM> of vacuum cannula <NUM>. More particularly, as stylet cannula <NUM> is moved within cutter cannula <NUM> in proximal direction <NUM>-<NUM>, protrusion member <NUM>-<NUM> of piercing tip <NUM> engages tissue sample <NUM>-<NUM> to assist tissue sample <NUM>-<NUM> into vacuum cannula <NUM>. Protrusion member <NUM>-<NUM> then engages flared portion <NUM>-<NUM> of vacuum cannula <NUM> to close off an air inflow into flared portion <NUM>-<NUM> of vacuum cannula <NUM>.

In the sequence step illustrated in <FIG>, with vacuum being applied by vacuum cannula <NUM>, stylet cannula <NUM> is moved within cutter cannula <NUM> in distal direction <NUM>-<NUM> to disengage protrusion member <NUM>-<NUM> from the flared portion <NUM>-<NUM> of vacuum cannula <NUM> to cause an abrupt change in air flow into vacuum cannula <NUM>, thereby helping the vacuum transport of tissue sample <NUM>-<NUM> through vacuum cannula <NUM>.

The sequence steps illustrated in <FIG> are essentially a repeat of sequence steps 6E and 6F.

In the sequence step illustrated in <FIG>, with vacuum applied to vacuum cannula <NUM> by vacuum source <NUM>, stylet cannula <NUM> is again moved within cutter cannula <NUM> in proximal direction <NUM>-<NUM>, such that protrusion member <NUM>-<NUM> of piercing tip <NUM> re-engages flared portion <NUM>-<NUM> of vacuum cannula <NUM> to again close off an air inflow into flared portion <NUM>-<NUM> of vacuum cannula <NUM>.

In the sequence step illustrated in <FIG>, with vacuum being applied to vacuum cannula <NUM> by vacuum source <NUM>, stylet cannula <NUM> is moved within cutter cannula <NUM> in distal direction <NUM>-<NUM> to again disengage protrusion member <NUM>-<NUM> from flared portion <NUM>-<NUM> of vacuum cannula <NUM> to cause an abrupt change in air flow into vacuum cannula <NUM>, thereby helping the vacuum transport of tissue sample <NUM>-<NUM> (if not already delivered by sequence steps of <FIG>) through vacuum cannula <NUM>. At the end of the sequence of <FIG>, stylet cannula <NUM> is re-positioned at the tissue receiving position i.e., extended position <NUM>-<NUM>, also referred to as the zero position, and is ready to receive tissue for a next tissue sample, in which the sequence steps of <FIG> would be repeated.

It is noted that the sample transport sequence illustrated in <FIG> may be repeated as many times as necessary to complete the vacuum transport of tissue sample <NUM>-<NUM> through vacuum cannula <NUM>. Also, the backward motion of protrusion member <NUM>-<NUM> of piercing tip <NUM> of stylet cannula <NUM> in proximal direction <NUM>-<NUM> may be implemented as incremental steps, alternating between a backward motion and then a forward motion (the forward distance being less than the backward distance) until the final position (retracted position <NUM>-<NUM>) is reached, as depicted in <FIG> and <FIG>.

<FIG> is a vacuum graph (normalized) depicting a baseline vacuum pressure at different positions during the tissue sample cutting and transport sequence depicted in <FIG>.

Referring to the vacuum graph of <FIG>, it is noted that vacuum is applied throughout the entire sequence depicted in <FIG>. At time T0, vacuum source <NUM> is activated, and vacuum (negative pressure) builds in vacuum cannula <NUM>. At time T1, maximum vacuum is achieved, which corresponds to the end of the cutting sequence step depicted in <FIG>. At time T2, the tissue stuffing sequence of <FIG> begins, and vacuum pressure abruptly drops due to a moment in which vent openings <NUM> in stylet cannula <NUM> are not restricted. Vacuum begins to build prior to time T3 as protrusion member <NUM>-<NUM> of piercing tip <NUM> approaches flared portion <NUM>-<NUM> of vacuum cannula <NUM>, and maximizes, representing the end of the first stuffing sequence depicted in <FIG>. At time T3, vacuum pressure abruptly drops due to protrusion member <NUM>-<NUM> of piercing tip <NUM> being moved away from flared portion <NUM>-<NUM> as depicted in <FIG>. In some instances, tissue sample <NUM>-<NUM> may have been delivered to sample cup <NUM>. At time T4, the second stuffing sequence depicted in <FIG> begins. Time T5 corresponds to the end of the second stuffing sequence depicted in <FIG>. At time T6, vacuum pressure drops due to protrusion member <NUM>-<NUM> of piercing tip <NUM> again being moved away from flared portion <NUM>-<NUM> as depicted in <FIG>, and back to the tissue receiving (zero) position.

By comparing an actual vacuum pressure to the baseline vacuum graph depicted in <FIG> at different stages of the tissue cutting and transport sequence depicted in <FIG>, cutting or tissue transport anomalies can be identified and corrective action can be attempted.

In accordance with an aspect of the disclosure, vacuum sensor <NUM> provides vacuum pressure feedback signals to controller circuit <NUM>, and controller circuit <NUM> executes program instructions to determine whether the actual vacuum pressure provided by vacuum sensor <NUM> deviates by more than a predetermined amount from the baseline pressure of the vacuum graph of <FIG> at a corresponding point in the tissue cutting and transport sequence. The predetermined amount may be, for example, the baseline vacuum pressure plus or minus <NUM> percent. If the deviation is outside the acceptable range of deviation, then corrective action may be taken depending upon when in the tissue cutting and transport sequence the anomaly occurred.

For example, if the vacuum pressure falls below the baseline by more than the allowable deviation during the time period between times T1 and T2, this may be an indication of an incomplete cut, and thus controller circuit <NUM> may repeat the cutting sequence depicted in <FIG> and <FIG> without user intervention, rather than immediately going into an error state. Similarly, if the vacuum pressure rises above the baseline by more than the allowable deviation between the times T3 to T5, this may be an indication of an incomplete tissue transport through vacuum cannula <NUM>, and thus controller circuit <NUM> may increase the number of iterations of sequence steps 6E and 6F without user intervention.

Referring again to <FIG> in conjunction with <FIG> and <FIG>, vacuum is maintained in biopsy probe assembly <NUM> by a series of seals. A seal <NUM>, e.g., a sleeve-type seal, is located to provide a seal between cutter cannula <NUM> and stylet cannula <NUM>. A seal <NUM>, e.g., an O-ring seal, is located to provide a seal between stylet cannula <NUM> and vacuum cannula <NUM>. A seal <NUM>, e.g., a sleeve-type seal or O-ring arrangement, is located to provide a seal between vacuum cannula <NUM> and vacuum chamber portion <NUM>-<NUM> of sample manifold <NUM>. Also, a seal <NUM> may be located in collection chamber portion <NUM>-<NUM> of sample manifold <NUM> and sample cup <NUM>. Finally, a seal is placed at vacuum input port <NUM>-<NUM> at the vacuum interface between biopsy probe assembly <NUM> and biopsy driver assembly <NUM>.

During operation, vacuum pump <NUM>-<NUM> of vacuum source <NUM> will build up vacuum (negative pressure) in the vacuum reservoir formed by sample manifold <NUM> and sample cup <NUM>. More particularly, the volume of sample cup <NUM> and sample manifold <NUM> will define the strength of a "vacuum boost", and also defines the cycle time for vacuum pump <NUM>-<NUM> of vacuum source <NUM>. In the present embodiment, for example, the volume is approximately <NUM> milliliters.

Regarding the "vacuum boost", stylet cannula <NUM> has one or more vent openings <NUM> longitudinally separated from sample notch <NUM>. Vent openings <NUM> may be annularly arranged at a predetermined distance proximal from sample notch <NUM> and tip portion <NUM>-<NUM>, and these vent openings <NUM> (see <FIG>) will be exposed to the atmosphere when the stylet cannula <NUM> is retracted to retracted position <NUM>-<NUM> (see <FIG> and <FIG>), wherein vent openings <NUM> slide under seal <NUM> between cutter cannula <NUM> and stylet cannula <NUM>. Once these vent openings <NUM> are exposed to the atmosphere, the system is 'open' and the build-up vacuum pressure will be equalized with the surrounding pressure so as to create the vacuum boost effect, in addition to the continuous flow delivered by vacuum pump <NUM>-<NUM> of vacuum source <NUM>.

Referring also to <FIG>, in the present embodiment, vent openings <NUM> in stylet cannula <NUM> include at least one longitudinal vent slot <NUM>, and in the present embodiment, may include a plurality of longitudinal vent slots <NUM> (e.g., longitudinal vent slot <NUM> and longitudinal vent slot <NUM>) and a plurality of circular vent holes <NUM>, e.g., two or more circular vent holes. In the present embodiment, longitudinal vent slot <NUM> and longitudinal vent slot <NUM> are diametrically opposed. Also, in the present embodiment, the proximal ends of the plurality of longitudinal vent slots <NUM>, e.g., proximal end <NUM>-<NUM> of longitudinal vent slot <NUM> and proximal end <NUM>-<NUM> of longitudinal vent slot <NUM> (see also <FIG>), are longitudinally aligned with the plurality of circular vent holes <NUM>.

With reference particularly to <FIG> and <FIG>, seal <NUM> includes a proximal seal portion <NUM> and a distal seal portion <NUM>. Distal seal portion <NUM> of seal <NUM> includes a distal seal lip <NUM>-<NUM> that is positioned for radial engagement with the outside diameter (OD) of cutter cannula <NUM>. Proximal seal portion <NUM> of seal <NUM> includes a proximal seal lip <NUM>-<NUM> that is positioned for radial engagement with the outside diameter (OD) of stylet cannula <NUM>.

Each longitudinal vent slot, e.g., the plurality of longitudinal vent slots <NUM>, of stylet cannula <NUM> is configured, in size and in shape, to facilitate an increased air flow to vacuum lumen <NUM>-<NUM> of vacuum cannula <NUM> over that of a corresponding number of circular vent holes, so as to aid in movement of the severed tissue sample <NUM>-<NUM> (see also <FIG>) in proximal direction <NUM>-<NUM>. In the present embodiment, for example, each longitudinal vent slot <NUM>, <NUM> of the plurality of longitudinal vent slots <NUM> of stylet cannula <NUM> may have a longitudinal length of <NUM> millimeters and a width of <NUM> millimeters.

More particularly, with reference to <FIG>, as stylet cannula <NUM> is retracted (see <FIG>) in proximal direction <NUM>-<NUM> toward retracted position <NUM>-<NUM>, each of the plurality of longitudinal vent slots <NUM> of stylet cannula <NUM> open a seal bypass path <NUM> (see <FIG> and <FIG>) across the longitudinal extent of proximal seal lip <NUM>-<NUM> of proximal seal portion <NUM> of seal <NUM> so as to establish both a first air path <NUM>-<NUM> at an intermediate lumen <NUM> between the outside diameter (OD) of vacuum cannula <NUM> and the inside diameter (ID) of stylet cannula <NUM> and a second air path <NUM>-<NUM> at an intermediate lumen <NUM> between the ID of cutter cannula <NUM> and the OD of stylet cannula <NUM>. Each of first air path <NUM>-<NUM> and second air path <NUM>-<NUM> is in fluid communication with the atmosphere in a region proximal to seal <NUM> when seal bypass path <NUM> is established, i.e., by positioning at least one longitudinal vent slot, e.g., longitudinal vent slot <NUM> and/or longitudinal vent slot <NUM>, of stylet cannula <NUM> to longitudinally bridge across the proximal seal lip <NUM>-<NUM> of proximal seal portion <NUM> of seal <NUM>.

With further reference to <FIG>, first air path <NUM>-<NUM> and second air path <NUM>-<NUM> converge at sample notch <NUM> of stylet cannula <NUM> to establish a combined air flow <NUM> of first air path <NUM>-<NUM> and second air path <NUM>-<NUM> to vacuum lumen <NUM>-<NUM> of vacuum cannula <NUM>, thus facilitating an increased air flow to vacuum lumen <NUM>-<NUM> of vacuum cannula <NUM> over that of the use of the plurality of circular vent holes <NUM> (e.g., six) without the use of longitudinal vent slots. Stated differently, <FIG> shows that with the use of at least one longitudinal vent slot <NUM>, and in the present embodiment, a plurality of longitudinal vent slots <NUM>, more air will flow through and from both of intermediate lumen <NUM> and intermediate lumen <NUM>, wherein the combined air flow <NUM> reaches the tissue sample <NUM>-<NUM>, and then pressure equalization will happen much faster and stronger as more air can be moved into vacuum lumen <NUM>-<NUM> of vacuum cannula <NUM> due to the additional (second) air path <NUM>-<NUM> so as to move tissue sample <NUM>-<NUM> through vacuum lumen <NUM>-<NUM> of vacuum cannula <NUM>. In the absence of the at least one longitudinal slot <NUM> and/or longitudinal vent slot <NUM> of stylet cannula <NUM>, the additional (second) air path <NUM>-<NUM> would not be established by the arrangement of components of the present embodiment.

As used herein, "substantially", "slightly", "approximately" and other words of degree are relative modifiers 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.

Also, as used herein, the term "coupled", and its derivatives, is intended to embrace any operationally functional connection, i.e., a direct connection or an indirect connection.

While this application has been described with respect to at least one embodiment, the present application can be further modified within scope of the invention as claimed.

Claim 1:
A biopsy apparatus (<NUM>), comprising:
a biopsy probe assembly (<NUM>) having a cutter cannula (<NUM>), a vacuum cannula (<NUM>), and a stylet cannula (<NUM>) coaxially arranged along a longitudinal axis (<NUM>), the vacuum cannula (<NUM>) being positioned inside the stylet cannula (<NUM>) to define a first intermediate lumen (<NUM>) therebetween, the stylet cannula (<NUM>) being positioned within the cutter cannula (<NUM>) to define a second intermediate lumen (<NUM>) therebetween, and the vacuum cannula (<NUM>) having a vacuum lumen (<NUM>-<NUM>), wherein:
the stylet cannula (<NUM>) is movable relative to the vacuum cannula (<NUM>) and the cutter cannula (<NUM>) between a first extended position (<NUM>-<NUM>) and a first retracted position (<NUM>-<NUM>); and
the stylet cannula (<NUM>) has a plurality of vent openings (<NUM>), the plurality of vent openings (<NUM>) including at least one longitudinal vent slot (<NUM>, <NUM>); and
a seal (<NUM>) having a proximal seal portion (<NUM>) and a distal seal portion (<NUM>), the distal seal portion (<NUM>) having a distal seal lip (<NUM>-<NUM>) that is positioned for radial engagement with an outside diameter of the cutter cannula (<NUM>), and the proximal seal portion (<NUM>) having a proximal seal lip (<NUM>-<NUM>) that is positioned for radial engagement with an outside diameter of the stylet cannula (<NUM>), wherein:
when the stylet cannula (<NUM>) is moved from the first extended position (<NUM>-<NUM>) toward the first retracted position (<NUM>-<NUM>), the at least one longitudinal vent slot (<NUM>, <NUM>) is longitudinally positioned under the proximal seal lip (<NUM>-<NUM>) of the proximal seal portion (<NUM>) of the seal (<NUM>) so as to open a seal bypass path (<NUM>) across a longitudinal extent of the proximal seal lip (<NUM>-<NUM>) of the proximal seal portion (<NUM>) of the seal (<NUM>) so as to establish both a first air path (<NUM>-<NUM>) at the first intermediate lumen (<NUM>) between an outside diameter of the vacuum cannula (<NUM>) and an inside diameter of the stylet cannula (<NUM>) and a second air path (<NUM>-<NUM>) at the second intermediate lumen (<NUM>) between an inside diameter of the cutter cannula (<NUM>) and the outside diameter of the stylet cannula (<NUM>), the first air path (<NUM>-<NUM>) and the second air path (<NUM>-<NUM>) being in fluid communication with a region proximal to the seal (<NUM>).