阅读说明：本技术 用于活检装置的试样容器和同轴引入器插管 (Sample container and coaxial introducer cannula for biopsy device ) 是由 A·K·詹森 S·F·奥尔茨 J·J·霍尔姆 于 2018-11-29 设计创作，主要内容包括：本申请公开了一种活检装置或者可选择的活检探针组件,包括活检针、试样歧管和试样容器。试样歧管与活检针连接。试样歧管有接收器和插入轴线。试样接收器有内部侧壁和安装销,该安装销从内部侧壁朝向插入轴线向内凸出。试样容器设置成用于插入接收器中。试样容器包括安装槽道,该安装槽道的尺寸和位置设置成在试样容器旋转时与接收器的安装销接合和跟随该安装销运动。可选地,可以提供与活检装置一起使用的同轴引入器插管,该同轴引入器插管包括固定地附接在同轴插管的近侧部分上的毂形部。该毂形部有毂形部本体、锁定杆和锁栓。锁定杆从毂形部本体径向延伸。(A biopsy device or alternative biopsy probe assembly includes a biopsy needle, a sample manifold, and a sample container. The sample manifold is connected to a biopsy needle. The sample manifold has a receiver and an insertion axis. The sample receiver has an interior sidewall and a mounting pin projecting inwardly from the interior sidewall toward the insertion axis. The sample container is configured for insertion into the receptacle. The sample container includes a mounting channel sized and positioned to engage and follow a mounting pin of the receiver as the sample container is rotated. Optionally, a coaxial introducer cannula for use with a biopsy device may be provided that includes a hub fixedly attached to a proximal portion of the coaxial cannula. The hub has a hub body, a locking bar and a lock bolt. The locking lever extends radially from the hub body.)

1. A biopsy device, comprising:

a biopsy needle;

a sample manifold coupled to the biopsy needle, the sample manifold having a receiver and an insertion axis, the sample receiver having an interior sidewall and a mounting pin projecting inwardly from the interior sidewall toward the insertion axis; and

a sample container configured for insertion into the receiver, the sample container including a mounting channel sized and positioned to engage and follow a mounting pin of the receiver as the sample container is rotated.

2. The biopsy device of claim 1, wherein: the mounting channel extends helically an arcuate distance less than one revolution of the sample container.

3. The biopsy device of claim 1 or 2, wherein: the mounting channel has an open end and a closed end, the open end positioned to receive a mounting pin of the sample manifold to provide rotational orientation of the sample container about the insertion axis relative to a receiver of the sample manifold.

4. The biopsy device of claim 3, wherein: when the mounting pin of the receiver is received in the open end of the mounting channel of the sample container, rotation of the sample container causes the mounting pin to follow the helical shape of the mounting channel toward the closed end so as to pull the sample container along the insertion axis into the receiver of the sample manifold.

5. The biopsy device of any one of claims 1-4, wherein: the sample container has a cap portion and a basket portion connected by a hinge to facilitate pivoting of one or both of the cap portion and the basket portion about the hinge between a closed position and an open position, the open position providing access to the contents of the sample container.

6. The biopsy device of claim 5, wherein: when the sample container is in the closed position, the partial side walls of the cap portion overlap the partial side walls of the basket portion to form a snap fit.

7. The biopsy device of claim 5, wherein: the cap portion of the specimen container includes a lid and a partial sidewall, the lid including a dome-shaped cap and an annular rim connecting the dome-shaped cap to define an annular lip, a mounting channel being formed in and spirally surrounding the annular rim.

8. The biopsy device of claim 7, wherein: the dome-shaped cap is transparent or translucent to enable visual inspection of the contents of the sample container without having to remove the sample container from the receptacle of the sample manifold.

9. The biopsy device of claim 8, wherein: the dome-shaped cap includes an enlarged member.

10. The biopsy device of any one of claims 7-9, further comprising a seal disposed about the annular rim to provide a vacuum seal between the sample container and the receptacle of the sample manifold.

11. The biopsy device of any one of claims 5-10, wherein: the basket portion includes a floor having a concave inner surface and a plurality of apertures that allow a vacuum to pass through the sample container for delivering a tissue sample from the biopsy needle onto the concave inner surface of the floor.

12. The biopsy device of any one of claims 5-11, wherein: the cap portion and the basket portion of the sample container together define an aperture and an internal sample chamber, and the biopsy needle includes a vacuum cannula having a proximal end portion that extends to the aperture for delivering a tissue sample from the biopsy needle into the internal sample chamber by vacuum.

13. The biopsy device of claim 12, wherein: the aperture of the sample container is formed by a first semi-circular aperture of the cap portion located adjacent to a second semi-circular aperture of the basket portion when the sample container is in the closed position.

14. A coaxial introducer cannula for use with a biopsy device according to any preceding claim, the biopsy device having: a front plate having a catch; and a biopsy needle extending from the front plate on a longitudinal axis, the coaxial introducer cannula comprising:

a coaxial cannula sized to be coaxially and slidably received over a biopsy needle; and

a hub fixedly attached to a proximal portion of the coaxial cannula, the hub having a hub body, a locking lever and a lock bolt, the lock bolt being disposed for rotatable engagement with the catch, wherein the locking lever extends radially from the hub body with respect to the longitudinal axis, the locking lever having a length greater than the height of the front plate such that the locking lever can be reached and rotationally manipulated to rotate the hub relative to the front plate of the biopsy device to facilitate one-handed rotation of the coaxial introducer cannula relative to the front plate to effect engagement or disengagement of the lock bolt of the coaxial introducer cannula with the catch of the front plate.

15. The coaxial introducer cannula for use with a biopsy device of claim 14, wherein: the rotational movement of the locking lever can be clockwise or counterclockwise, so that a very dexterous operation is possible.

16. The coaxial introducer cannula for use with a biopsy device of claim 14 or 15, wherein: the locking lever is inclined proximally relative to the hub body such that the locking lever engages the front plate before the hub axially abuts against the front plate and deflects the locking lever in a distal direction.

17. The coaxial introducer cannula for use with a biopsy device according to any one of claims 14-16, further comprising: a first locking component on the front plate and a second locking component on the hub that when engaged will prevent, but not inhibit, rotation of the coaxial introducer cannula about the longitudinal axis.

18. The coaxial introducer cannula for use with a biopsy device of claim 17, wherein: the second locking member is located on or in the locking bar.

19. The coaxial introducer cannula for use with a biopsy device according to any one of claims 14-18, wherein: the first and second locking members form a hole/protrusion structure or a magnetic structure.

20. The coaxial introducer cannula for use with a biopsy device according to any one of claims 14-19, wherein:

the catch is a set of slotted projections projecting outwardly from the front plate in a distal direction, the slotted projections having respective opposing slots facing away from the longitudinal axis; and

the hub body has a cylindrical recess defining a sidewall, wherein the lock latch is in the form of a set of tabs extending radially inward from the sidewall of the cylindrical recess of the hub body toward the longitudinal axis.

21. A biopsy probe assembly comprising:

a biopsy needle;

a sample manifold coupled to the biopsy needle, the sample manifold having a receiver and an insertion axis, the sample receiver having an interior sidewall and a mounting pin projecting inwardly from the interior sidewall toward the insertion axis; and

a sample container configured for insertion into the receiver, the sample container including a mounting channel sized and positioned to engage and follow a mounting pin of the receiver as the sample container is rotated.

22. The biopsy probe assembly of claim 21, wherein: the mounting channel extends helically an arcuate distance less than one revolution of the sample container.

23. The biopsy probe assembly of claim 21 or 22, wherein: the mounting channel has an open end and a closed end, the open end positioned to receive a mounting pin of the sample manifold to provide rotational orientation of the sample container about the insertion axis relative to a receiver of the sample manifold.

24. The biopsy probe assembly of claim 23, wherein: when the mounting pin of the receiver is received in the open end of the mounting channel of the sample container, rotation of the sample container causes the mounting pin to follow the helical shape of the mounting channel toward the closed end so as to pull the sample container along the insertion axis into the receiver of the sample manifold.

25. The biopsy probe assembly of any one of claims 21-24, wherein: the sample container has a cap portion and a basket portion connected by a hinge to facilitate pivoting of one or both of the cap portion and the basket portion about the hinge between a closed position and an open position, the open position providing access to the contents of the sample container.

26. The biopsy probe assembly of claim 25, wherein: when the sample container is in the closed position, the partial side walls of the cap portion overlap the partial side walls of the basket portion to form a snap fit.

27. The biopsy probe assembly of claim 25, wherein: the cap portion of the specimen container includes a lid and a partial sidewall, the lid including a dome-shaped cap and an annular rim connecting the dome-shaped cap to define an annular lip, a mounting channel being formed in and spirally surrounding the annular rim.

28. The biopsy probe assembly of claim 27, wherein: the dome-shaped cap is transparent or translucent to enable visual inspection of the contents of the sample container without having to remove the sample container from the receptacle of the sample manifold.

29. The biopsy probe assembly of claim 28, wherein: the dome-shaped cap includes an enlarged member.

30. The biopsy probe assembly of any one of claims 27-29, further comprising a seal disposed around the annular rim to provide a vacuum seal between the sample container and the receptacle of the sample manifold.

31. The biopsy probe assembly of any one of claims 25 to 30, wherein: the basket portion includes a floor having a concave inner surface and a plurality of apertures that allow a vacuum to pass through the sample container for delivering a tissue sample from the biopsy needle onto the concave inner surface of the floor.

32. The biopsy probe assembly of any one of claims 25 to 31, wherein: the cap portion and the basket portion of the sample container together define an aperture and an internal sample chamber, and the biopsy needle includes a vacuum cannula having a proximal end portion that extends to the aperture for delivering a tissue sample from the biopsy needle into the internal sample chamber by vacuum.

Technical Field

The present invention relates to biopsy devices, and more particularly, to a biopsy device having a coaxial introducer cannula and/or a sample container.

Background

A biopsy may be taken of the patient to help determine whether tissue in the region of interest includes cancer cells. For example, one biopsy technique for evaluating breast tissue involves inserting a biopsy probe into a breast tissue region of interest to capture one or more tissue samples from the region. Such biopsy techniques typically utilize a vacuum to pull tissue to be sampled into a sample recess of a biopsy probe, which is then severed and collected in a sample container. There is a continuing effort in the art to improve the ability of practitioners to access biopsy sites and/or deliver severed tissue samples to sample containers for collection of the severed tissue samples.

For example, after performing a biopsy under the guidance of an ultrasonic needle, some operators may not be willing to process the tissue sample, but may prefer to place the tissue sample directly into formalin, which is a preservative for biological samples. Conversely, other operators may need to access the tissue sample for examination before it is placed in formalin. Also, when using current devices (e.g., open sample trays) to take samples, there may be a risk of sample loss. In addition, physician (including pathologist) case (anecdotal) reports suggest that the tissue processing performed by the operator (physician and technician) during and after the biopsy may affect the quality of the samples used for pathology analysis.

In addition, some operators prefer to use a coaxial cannula to maintain access to the lesion when using a biopsy device (e.g., a biopsy driver coupled to a biopsy probe or trocar). In one such procedure, the operator may wish to place a tissue marker at the biopsy site, in which case the biopsy probe may be withdrawn from the coaxial introducer cannula and a marker applicator may be inserted into the biopsy site through the coaxial introducer cannula to maintain the location of the lesion/site after sampling without having to recalibrate the lesion location using ultrasound. However, the connection and/or disconnection of a coaxial introducer cannula to a biopsy device typically requires the use of two hands and can be awkward or difficult.

There is a need in the art for a sample container for a biopsy device that facilitates efficient receipt and processing of collected tissue samples, and/or for a coaxial introducer cannula that facilitates efficient connection and disconnection of the coaxial introducer cannula to the biopsy device.

Disclosure of Invention

The present invention provides a sample container for a biopsy device that facilitates efficient receipt and processing of collected tissue samples, and/or a coaxial introducer cannula that facilitates efficient connection and disconnection of the coaxial introducer cannula to the biopsy device.

In one form, the present invention is directed to a biopsy device that includes a biopsy needle, a sample manifold, and a sample container. The sample manifold is connected to a biopsy needle. The sample manifold has a receiver and an insertion axis. The sample receiver has an interior sidewall and a mounting pin projecting inwardly from the interior sidewall toward the insertion axis. The sample container is configured for insertion into the receptacle. The sample container includes a mounting channel sized and positioned to engage and follow a mounting pin of the receiver as the sample container is rotated.

In another form, the invention is directed to a coaxial introducer cannula for use with a biopsy device. A biopsy device comprising: a front plate having a catch; and a biopsy needle extending from the front plate on the longitudinal axis. A coaxial introducer cannula includes a coaxial cannula and a hub. The coaxial cannula is sized to be coaxially and slidably received over the biopsy needle. A hub is fixedly attached to the proximal portion of the coaxial cannula. The hub has a hub body, a locking bar and a lock bolt. The latch is disposed in rotatable engagement with the catch. The locking lever extends radially from the hub body relative to the longitudinal axis. The locking lever has a length greater than the height of the front plate such that the locking lever can be reached and rotationally operated to rotate the hub relative to the front plate of the biopsy device to facilitate one-handed rotation of the coaxial introducer cannula relative to the front plate to effect engagement or disengagement of the coaxial introducer cannula lock with the front plate catch.

One advantage of the sample container aspect of the present invention is that the sample container in the closed position may be removed from the biopsy device and placed directly into formalin without having to open the sample container or process the tissue sample.

Another advantage of the sample container aspect of the present invention is that it provides an easy to use opening mechanism that allows tissue access when needed, but will also keep the sample container closed during removal from the biopsy system to help reduce the chance of tissue loss.

One advantage of the coaxial introducer cannula aspect of the present invention is that the operator can detach the coaxial introducer cannula from the biopsy device with a single hand, thereby improving the ease of use of the coaxial introducer cannula and the accuracy of any subsequent marker placement.

Drawings

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

In the drawings:

FIG. 1 is a perspective view of a biopsy device having a sample container according to aspects of the present invention and having a biopsy probe assembly attached to a driver assembly;

FIG. 2 is a block diagram of the driver assembly of FIG. 1;

FIG. 3A is a perspective view of a portion of the biopsy probe assembly of FIG. 1 including a sample manifold and a sample container according to one aspect of the present invention;

FIG. 3B is an exploded perspective view of a portion of the biopsy probe assembly of FIG. 1 including a sample manifold and a sample container, wherein the sample container is in an insertion orientation with respect to the sample manifold;

FIG. 3C is a top view of the sample manifold of FIGS. 3A and 3B;

FIG. 4A is a perspective view of the sample container of FIGS. 3A and 3B, with the sample container in a closed position;

FIG. 4B is an end view of the sample container of FIGS. 3A and 3B, with the sample container in a closed position;

FIG. 4C is a side view of the sample container of FIGS. 3A and 3B, with the sample container in a closed position; .

FIG. 4D is a side view of the sample container of FIGS. 3A and 3B, with the sample container in an intermediate open position;

FIG. 4E is a side view of the sample container of FIGS. 3A and 3B, with the sample container in a fully open position;

FIG. 5 is a perspective view of a portion of the biopsy device of FIG. 1 with a coaxial introducer cannula mounted on a biopsy probe assembly of the biopsy device in accordance with an aspect of the present invention;

fig. 6A is a perspective view of the coaxial introducer cannula of fig. 5;

fig. 6B is an end view of the coaxial introducer cannula of fig. 5;

fig. 6C is a side view of the coaxial introducer cannula of fig. 5;

FIG. 7A is a perspective view of a probe housing of the biopsy device of FIG. 1 having an alternative configuration for coupling with a coaxial introducer cannula;

FIG. 7B is an end view of the probe housing of FIG. 7A;

FIG. 8A is a perspective view of an alternative coaxial introducer cannula configured in an alternative coupling configuration for coupling with the probe housing of FIGS. 7A and 7B;

fig. 8B is a rear perspective view of the alternative coaxial introducer cannula of fig. 8A;

fig. 9 is a perspective view of a trocar configured for use with the coaxial introducer cannula of fig. 8A and 8B.

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.

Detailed Description

Referring now to the drawings, and more particularly to FIG. 1, there is shown a biopsy device 10, which biopsy device 10 generally includes a non-invasive (e.g., non-disposable) driver assembly 12 and an invasive (e.g., disposable) biopsy probe assembly 14. As used herein, the term "non-disposable" is used to refer to devices that will be used on multiple patients over the life of the device, while the term "disposable" is used to refer to devices that will be discarded after use on a single patient. The actuator assembly 12 includes an actuator housing 16, the actuator housing 16 being configured and ergonomically designed to be grasped by an operator.

Referring also to fig. 2, the driver assembly 12 includes controller circuitry 18, an electromechanical power supply 20, a vacuum source 22, a vacuum sensor 24, and a battery 26 (or, alternatively, an AC adapter) within the driver housing 16. A user interface 28 (see fig. 1), such as a keypad, is positioned to be mounted on the drive housing 16 and externally accessible to an operator relative to the drive housing 16.

The battery 26 may be, for example, a rechargeable battery that may be charged by an inductive charging device or, alternatively, by an electrical connection to a power source. The battery 26 is electrically connected to the controller circuit 18, the electromechanical power source 20, the vacuum source 22, and the user interface 28.

User interface 28 may include control buttons that provide user control of various functions of biopsy device 10 and visual/audible indicators that provide visual/audible feedback of one or more conditions and/or component positions of biopsy device 10. control buttons may include a sample button 28-1 and an initiate fill/puncture button 28-2. visual indicators may include a display screen 28-3 and/or one or more light emitting diodes (L ED) 28-4. audible indicators may include a buzzer 28-5. control buttons may include tactile feedback to an operator when actuated.

The controller circuit 18 is electrically and communicatively coupled to the electromechanical power source 20, the vacuum source 22, the vacuum sensor 24, and the user interface 28, such as via one or more wires or circuit traces (trace). The controller circuit 18 may be mounted on a circuit board and include, for example, a processor circuit 18-1 and a memory circuit 18-2.

The processor circuit 18-1 has one or more programmable microprocessors and associated circuitry, such as input/output interfaces, clocks, buffers, memory, etc. The memory circuit 18-2 is communicatively connected to the processor circuit 18-1, such as by 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), Electrically Erasable Programmable ROM (EEPROM), NOR flash, NAND flash, and the like. The controller circuit 18 may be formed as one or more Application Specific Integrated Circuits (ASICs).

Controller circuitry 18 is configured to execute program instructions via software and/or firmware resident in memory circuitry 18-2 to perform functions associated with the retrieval of a biopsy tissue sample, such as controlling and/or monitoring the functions of one or more of electromechanical power source 20, vacuum source 22, and vacuum sensor 24.

The electromechanical power source 20 may include, for example, a cutter module 30, a delivery module 32, and a puncture module 34, each of which is electrically connected to the battery 26, respectively. Cutter module 30, delivery module 32, and puncture module 34 are each electrically and controllably connected to controller circuit 18 by one or more electrical conductors, such as wires or circuit traces.

Cutter module 30 may include an electric motor 30-1 having a shaft with cutter drive 30-2 drivingly connected thereto. The transport module 32 may include an electric motor 32-1 having a shaft with a transport drive 32-2 drivingly connected thereto. Lancing module 34 may include an electric motor 34-1 having a shaft with a lancing firing drive 34-2 drivingly connected thereto. Each electric motor 30-1, 32-1, 34-1 may be, for example, a Direct Current (DC) motor or a stepper motor. Each cutter drive 30-2, transport drive 32-2, and puncture firing drive 34-2 may include one or more gears, gear trains, or belt/pulley arrangements.

Vacuum source 22 is electrically connected and in control connection with battery 26 via one or more electrical conductors, such as wires or circuit traces. The vacuum source 22 may include, for example, an electric motor 22-1 that drives a vacuum pump 22-2. Vacuum source 22 has a vacuum source port 22-3, and vacuum source port 22-3 is coupled to vacuum pump 22-2 for establishing a vacuum in biopsy probe assembly 14. The electric motor 22-1 may be, for example, a rotary, linear, or vibratory DC motor. The vacuum pump 22-2 may be, for example, a peristaltic pump or a diaphragm pump, or one or more pumps each connected in series or in parallel.

The vacuum sensor 24 is electrically connected to the controller circuit 18 by one or more electrical conductors, such as wires or circuit traces. The vacuum sensor 24 may be a differential pressure sensor that provides a vacuum (negative pressure) feedback signal to the controller circuit 18. In some embodiments, vacuum sensor 24 may be included in vacuum source 22.

Referring again to FIG. 1, biopsy probe assembly 14 is configured for releasable attachment to driver assembly 12. The term "releasably attached" as used herein refers to a configuration that facilitates a predetermined temporary connection and subsequent selective detachment, involving manipulation of the disposable biopsy probe assembly 14 relative to the driver assembly 12 without the need for tools.

Referring to fig. 1 and 3A, biopsy probe assembly 14 includes a probe housing 36, a vacuum cannula 38, a stylet cannula 40, a cutter cannula 42, a sample manifold 48, and a sample container 50. The portions of the vacuum cannula 38, the stylet cannula 40, and the cutter cannula 42 that extend distally on the longitudinal axis 44 from the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10 are referred to herein as a biopsy needle 52.

Probe housing 36 is formed as an L-shaped structure having an elongated portion 36-1 and a front plate 36-2 when biopsy probe assembly 14 is attached to driver assembly 12, front plate 36-2 is positioned distally adjacent the entire front surface 16-1 of driver housing 16, i.e., so as to shield the entire front surface 16-1 of the non-disposable driver assembly from contact with the patient.

The vacuum cannula 38, the stylet cannula 40, and the cutter cannula 42 are coaxially arranged along a longitudinal axis 44 in a nested tube configuration, wherein the vacuum cannula 38 is the innermost tube, the cutting cannula 42 is the outermost tube, and the stylet cannula 40 is an intermediate tube disposed between the vacuum cannula 38 and the cutter cannula 42. In other words, the vacuum cannula 38 is located inside the stylet cannula 40, and the stylet cannula 40 is located inside the cutter cannula 42.

Vacuum cannula 38 is connected in fluid communication with vacuum source 22 through sample manifold 48.

The stylet cannula 40 includes a sample recess 40-1 and a piercing tip 40-2. The sample recess 40-1 is formed as an elongated opening in the stylet cannula 40 to facilitate tissue reception into the lumen of the stylet cannula 40. The cutter cannula 42 has a distal cutting end 42-1.

The stylet cannula 40 and cutter cannula 42 are commonly connected to the puncture firing drive 34-2. When the priming/piercing button 28-2 is actuated for the first time, the stylet cannula 40 and cutter cannula 42 translate in unison along the longitudinal axis 44 in the proximal direction 46-1 to position the piercing firing drive 34-2, stylet cannula 40 and cutter cannula 42 in a cocked (i.e., cocked) position. Initiating a second actuation of the priming/piercing button 28-2 will perform a piercing firing wherein the piercing firing drive 34-2 is released from the cocked position and then rapidly advances the stylet cannula 40 and cutter cannula 42 in the distal direction 46-2 along the longitudinal axis 44 toward the distal most position of the combined elements (e.g., within the patient).

The cutter cannula 42 is coupled to the cutter driver 30-2 and is retracted or extended along the longitudinal axis 44 by driving the sample button 28-1 of the user interface 28, respectively, by driving the cutter module 30 of the biopsy probe assembly 14 to begin a sample sequence. For example, the cutter cannula 42 may be axially translated and retracted along the longitudinal axis 44 to expose the sample recess 40-1 in the sample sequence such that tissue may be pulled by vacuum into the lumen of the stylet cannula 40 by the vacuum provided by the vacuum cannula 38. The cutter cannula 42 may then have a rotational cutting motion and may be axially translated along the longitudinal axis 44 to extend over the sample recess 40-1 such that the distal cutting end 42-1 of the cutter cannula 42 cuts tissue pulled by vacuum into the lumen of the stylet cannula 40 by the vacuum provided by the vacuum cannula 38.

By actuating the delivery module 32 of the biopsy probe assembly 14, the stylet cannula 40 is retracted or extended, respectively, along the longitudinal axis 44 to facilitate delivery of the tissue sample into the lumen of the vacuum cannula 38. Vacuum cannula 38 then delivers the tissue sample to sample manifold 48 via vacuum by the vacuum supplied to sample manifold 48 by vacuum source 22.

Referring to FIGS. 3A-3C, sample manifold 48 is provided in an L-shaped configuration having a vacuum chamber portion 48-1 and a collection chamber portion 48-2 vacuum chamber portion 48-1 includes a vacuum input port 48-3 arranged to sealingly engage vacuum source port 22-3 (see FIG. 2) of vacuum source 22 of driver assembly 12 when biopsy probe assembly 14 is attached to driver assembly 12. absorbent paper may be disposed in vacuum chamber portion 48-1 in the area between vacuum input port 48-3 and collection chamber portion 48-2.

The vacuum chamber portion 48-1 is connected in fluid communication with the collection chamber portion 48-2. The proximal portion 38-1 of the vacuum cannula 38 enters the vacuum chamber portion 48-1 and is in fluid communication with the collection chamber portion 48-2.

Referring to fig. 3B and 3C, collection chamber portion 48-2 of sample manifold 48 defines a receptacle 48-4, which receptacle 48-4 is sized and configured to removably receive and mount sample container 50. Referring also to fig. 1, 2 and 3A, when sample container 50 is installed in receiver 48-4 of collection chamber portion 48-2 of sample manifold 48, sample container 50 is disposed between vacuum source 22 and proximal end portion 38-1 of vacuum cannula 38 such that sample container 50 is in direct fluid communication with proximal end portion 38-1 of vacuum cannula 38 and sample container 50 is also in direct fluid communication with vacuum input port 48-3 of vacuum chamber portion 48-1.

Accordingly, the vacuum generated by vacuum source 22 is delivered to proximal portion 38-1 of vacuum cannula 38 through sample manifold 48 and sample container 50. Thus, when a vacuum is applied by the vacuum source 22 at the vacuum input port 48-3 of the vacuum chamber portion 48-1 of the sample manifold 48, a vacuum is passed through the sample container 50 such that a tissue sample severed by the cutter cannula 42 at the sample notch 40-1 of the stylet cannula 40 can be delivered by vacuum through the vacuum cannula 38 into the sample container 50.

Referring to fig. 3B and 3C, receptacle 48-4 of collection chamber portion 48-2 of sample manifold 48 has an open end 48-5, an interior sidewall 48-6, and a mounting pin 48-7. The collection chamber portion 48-2 has an insertion axis 48-8. The mounting pin 48-7 is formed on the interior sidewall 48-6 of the receiver 48-4 and projects inwardly from the interior sidewall 48-6 toward the insertion axis 48-8.

In this embodiment, the sample container 50 is configured to mate with the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48 such that the sample container 50 can only be loaded into the receiver 48-4 in one orientation, thereby reducing operator error after removing and reloading the sample container 50 for additional tissue samples.

Referring also to fig. 4A-4E, the sample container 50 has a cap portion 54 and a basket portion 56 that are connected by a hinge 58 and that fit together when in the closed position to define the cylindrical sidewall 50-1. Cap portion 54 and basket portion 56 may each be made of a hard plastic and may have smooth surface features to reduce the effects on radiographic visibility when radiography of a tissue sample is desired or required. The hard plastic may also be selected to be compatible with formalin.

Referring also to fig. 3B and 3C, sample container 50 is sized and configured to be removably received in receptacle 48-4 of collection chamber portion 48-2 of sample manifold 48. For example, the sample container 50 and the interior sidewall 48-6 of the receptacle 48-4 may have complementary cylindrical shapes and be axially aligned along the insertion axis 48-8. The cylindrical sidewall 50-1 of the sample container 50 has an outer diameter selected to be slidably received by the cylindrical inner sidewall 48-6 of the receptacle 48-4. The term "cylindrical" as used herein refers to a generally arcuate shaped annular profile that may include flats, ledges and/or other surface features not associated with a pure cylinder.

Referring to fig. 4A-4E, the specimen container 50 includes a mounting channel 50-2, the mounting channel 50-2 being sized and positioned to engage and follow the mounting pin 48-7 of the receiver 48-4 of the specimen manifold 48 (see fig. 3C). The mounting channel 50-2 extends helically downward from the cap portion 54 along the cylindrical sidewall 50-1 for an arcuate distance less than one revolution of the sample container 50, such as one-eighth to one-quarter of the circumference of the sample container 50 (depending on design parameters). The mounting channel 50-2 has an open end 50-3 and a closed end 50-4. Open end 50-3 is positioned to receive mounting pin 48-7 of receiver 48-4 of collection chamber portion 48-2 of sample manifold 48 and provide an initial identification (indexing) of sample container 50 about insertion axis 48-8 relative to receiver 48-4 of collection chamber portion 48-2 of sample manifold 48.

When the mounting pin 48-7 of the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48 is received in the open end 50-3 of the mounting channel 50-2 of the sample container 50, as the sample container 50 is rotated, the sample container 50 is rotated (clockwise in this example) such that the mounting pin 48-7 moves along the spiral shape of the mounting channel 50-2 toward the closed end 50-4 to pull the sample container 50 into the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48 along the insertion axis 48-8.

It is also contemplated that the mounting channel 50-2 may comprise a plurality of helical channels formed in the sample container 50, if desired. In this case, the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48 may have a number of mounting pins that corresponds to the number of helical channels formed in the sample container 50, each mounting pin being received in a corresponding helical channel of the sample container 50 when the sample container 50 is received in the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48.

Referring to fig. 4A-4E, the cap portion 54 of the sample container 50 includes a lid 60 and a partial sidewall 62, and the lid 60 and partial sidewall 62 may be formed as a one-piece, unitary structure. The cap 60 includes a dome-shaped cap 60-1, an annular rim 60-2, and an annular lip 60-3. The annular rim 60-2 is connected to the dome-shaped cap 60-1 to define an annular lip 60-3. The mounting channel 50-2 is formed in the annular rim 60-2 and spirally surrounds the annular rim 60-2. Dome cap 60-1 may include arrow markings 60-4, such as bumps or reliefs, to indicate the direction of rotation for enabling mounting of sample container 50 in receptacle 48-4 of collection chamber portion 48-2 of sample manifold 48.

A seal 64 (e.g., an O-ring) may be disposed around the annular rim 60-2 such that the seal 64 provides a vacuum seal between the sample vessel 50 and the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48 when the sample vessel 50 is installed in the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48. Preferably, the reverse rotation of the sample container 50 causes the mounting channel 50-2 to move along the spiral shape of the mounting pin 48-7 toward the open end 50-3, thereby pulling the sample container 50 out of the receptacle 48-4 along the insertion axis 48-8 to help release the vacuum seal.

In one embodiment, at least the dome-shaped cap 60-1 of the cap portion 54 is transparent or translucent to enable visual inspection of the contents of the sample container 50 without having to remove the sample container 50 from the receptacle 48-4 of the collection chamber portion 48-2 of the sample manifold 48. By rounding the dome-shaped cap 60-1 of the cap portion 54, the interior of the sample container 50 may be viewed from multiple angles while maintaining the biopsy device 10 or viewing the biopsy procedure. Also, the dome-shaped cap 60-1 of the cap portion 54 may include an enlarged feature to further enhance visibility of the contents of the sample container 50, such as during a biopsy procedure.

Referring to fig. 4C-4E, the basket portion 56 includes a floor 66 and partial side walls 68, and the floor 66 and partial side walls 68 may be formed as a one-piece, unitary structure. Partial side walls 68 extend upwardly from the floor 66. In the present embodiment, the bottom plate 66 has a concave inner surface 66-1 and includes a plurality of apertures 66-2 (see also FIG. 4A). The plurality of apertures 66-2 in the floor 66 of the specimen container 50 enable a vacuum to pass through the specimen container 50 during a biopsy procedure and a tissue sample will be delivered from the biopsy needle 52 onto the concave inner surface 66-1 of the floor 66 of the specimen container 50. Additionally, after the biopsy procedure, the specimen container 50 may be placed directly into a specimen jar containing formalin, wherein the plurality of apertures 66-2 in the floor 66 of the specimen container 50 allow for the injection of formalin into the specimen container 50.

Referring to fig. 4A-4E, the cap portion 54 and the basket portion 56 are connected by a hinge 58 located at the bottom portion of the sample container 50. The hinge 58 has engageable hinge features formed on the cap portion 54 and the basket portion 56. In the present embodiment, for example, the hinge 58 includes: a pair of opposed apertures 58-1, the pair of apertures 58-1 being formed in a lower distal portion of the partial side walls 62 of the cap portion 54; and a pair of opposed pins 58-2, the pair of pins 58-2 extending radially outward from a partial side wall 68 of the basket section 56 just above the floor 66, wherein the pair of opposed pins 58-2 are received in the pair of opposed holes 58-1 (e.g., holes) to form a pivot joint. The pivot joint provides easy access to the tissue sample contained in the specimen container 50. The hinged action of the cap portion 54 and the basket portion 56 may also create a scooping action to assist in sample removal when the sample container 50 is opened.

It is also contemplated that the engageable hinge features of the pin/hole arrangement may be reversed, if desired, such that the pins are on the partial side wall 62 of the cap portion 54 and the holes are on the partial side wall 68 of the basket portion 56.

As an alternative to forming the aperture 58-1 as a hole, it is also contemplated that the aperture 58-1 may be formed as a slot or channel such that a pair of opposing pins 58-2 of the hinge 58 may be easily disengaged from the aperture 58-1 when opening the sample container 50, thereby facilitating easy removal of the basket portion 56 from the cap portion 54 after the basket portion 56 is opened to a predetermined position relative to the cap portion 54, if desired.

Fig. 4A-4C illustrate the sample container 50 in a closed position, wherein a partial sidewall 62 of the cap portion 54 overlaps a partial sidewall 68 of the basket portion 56 to form a snap fit. Preferably, by connecting the cap portion 54 and the basket portion 56 with the hinge 58, the operator must take deliberate action to open the sample container 50 in order to remove a tissue sample without the risk of accidentally disengaging the lid or components of the container when removing the container from the biopsy device 10. The tissue sample (specimen) remains in the sample container 50 until opened, thereby reducing the risk of tissue sample loss during transport.

The sample vessel 50 must be in the closed position shown in fig. 4A-4C so that the sample vessel 50 can be received into the receptacle 48-4 of the collection chamber portion 48-2 of the sample manifold 48 (see also fig. 3B and 3C) so that the sample vessel 50 can be located in the sample manifold 48 and mounted on the sample manifold 48 (see also fig. 3A). As also shown in fig. 3B and 4A, when the sample container 50 is in the closed position, the cap portion 54 and the basket portion 56 together define the aperture 50-5 and the interior sample chamber 50-6. Proximal portion 38-1 of vacuum cannula 38 extends to aperture 50-5 for delivering a tissue sample from biopsy needle 52 by vacuum into internal sample chamber 50-6 and onto recessed interior surface 66-1 of floor 66, which recessed interior surface 66-1 has a plurality of apertures 66-2 (see also fig. 4C). In this embodiment, when the sample container 50 is in the closed position, the aperture 50-5 of the sample container 50 is formed by disposing the semi-circular aperture 62-1 in the partial sidewall 62 of the cap portion 54 adjacent the semi-circular aperture 66-3 located above the floor 66 of the basket portion 56.

Fig. 4D and 4E illustrate a sequence of opening the sample container 50, wherein one or both of the cap portion 54 and the basket portion 56 pivot about the hinge 58 to provide access to the contents of the sample container 50. Fig. 4D shows the sample container 50 in an intermediate open position and fig. 4E shows the sample container 50 in a fully open position. When the sample container 50 is disposed in the fully open position and oriented on its side, the flat outer feature 68-1 on the partial side wall 68 of the basket portion 56 enables the sample container 50 to rest on a flat surface, such as a table or processing tray, thereby reducing the risk of the sample container 50 rolling off of a flat surface.

Referring to fig. 5 and also to fig. 1, during some procedures, an operator may wish to use a coaxial introducer cannula 70 to maintain access to a biopsy site (e.g., lesion) so that the biopsy needle 52 of the biopsy device 10 may be withdrawn from the biopsy site while maintaining the ability to reinsert the biopsy needle 52 at the biopsy site or to insert another medical device (e.g., a tissue marker deployment device).

Referring also to fig. 6A-6C, coaxial introducer cannula 70 includes a coaxial cannula 72 and a hub 74. The coaxial cannula 72 may be formed as an elongated tube, such as a metal tube, e.g., a stainless steel tube, having a proximal portion 72-1 and a distal end 72-2. Hub 74 is made of a hard plastic that is fixedly attached (e.g., overmolded, adhesively attached, etc.) to proximal portion 72-1 of coaxial cannula 72.

Coaxial cannula 72 of coaxial introducer cannula 70 is sized to be coaxially and slidably received along longitudinal axis 44 over biopsy needle 52 formed by stylet cannula 40 and cutter cannula 42. Hub 74 of coaxial introducer cannula 70 is provided for releasable attachment to front plate 36-2 of probe housing 36 of biopsy device 10.

In the present embodiment, and with further reference to FIG. 5, the front plate 36-2 of the probe housing 36 includes a catch 76, the catch 76 being formed as a set of slotted projections 78-1, 78-2 projecting outwardly from the front plate 36-2 of the probe housing 36 of the biopsy device 10. The slotted projections 78-1, 78-2 have opposing slots 80-1, 80-2, respectively, with the slots 80-1, 80-2 facing in a direction toward the longitudinal axis 44.

Referring to fig. 5 and 6A-6C, in the present embodiment, the hub 74 includes a hub body 82, a locking bar 84 and a lock bolt 86. The locking lever 84 is an elongated arm that extends radially from the hub body 82 relative to the longitudinal axis 44. Latch 86 is configured to rotatably engage catch 76 of front plate 36-2 of biopsy probe assembly 14 of biopsy device 10. In the present embodiment, the latch 86 is in the form of a set of tabs 86-1, 86-2, the set of tabs 86-1, 86-2 extending radially outwardly from the hub body 82.

As shown in FIG. 5, the length of the locking lever 84 is greater than the height of the front plate 36-2 of the probe housing 36 and the driver assembly 12, such that the locking lever 84 can be reached and rotated by the operator's thumb or finger while the operator is grasping the biopsy device 10 with the same hand, thereby facilitating rotation of the coaxial introducer cannula with respect to the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10 with a single hand to effect corresponding engagement and disengagement of the catch 76 of the coaxial introducer cannula 70 with the latch 86 of the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10.

Further alternatively, referring to fig. 5, 6A and 6B, a first locking feature 88-1 may be provided at the front plate 36-2 of the probe housing 36 and a second locking feature 88-2 may be provided on the hub 74 of the coaxial introducer cannula 70 that, when engaged, prevent the coaxial introducer cannula 70 from rotating about the longitudinal axis 44, i.e., relative to the biopsy device 10. More particularly, the second locking feature 88-2 may be positioned on or in the locking lever 84.

Referring to fig. 5 and 6A-6C, during installation of the coaxial introducer cannula 70 onto the biopsy device 10, the coaxial cannula 72 of the coaxial introducer cannula 70 is coaxially and slidably received along the longitudinal axis 44 over the biopsy needle 52 formed by the stylet cannula 40 and the cutter cannula 42. With the set of tabs 86-1, 86-2 of hub 74 of coaxial introducer cannula 70 not rotationally aligned with slotted projections 78-1, 78-2 of front plate 36-2 of probe housing 36 shown in fig. 5, coaxial introducer cannula 70 is axially displaced along longitudinal axis 44 until hub 74 axially abuts front plate 36-2 of probe housing 36. As shown in FIG. 6C, the locking lever 84 is tilted proximally relative to the hub body 82 such that the locking lever 84 engages the front plate 36-2 shown in FIG. 5 before axially abutting against the front plate 36-2 and the locking lever 84 deflects in the distal direction 46-2 as a cantilever spring.

The locking lever 84 of the hub 74 is then rotated about the longitudinal axis 44 to a locked position (shown in fig. 5) in which the latch 86 of the hub 74 (e.g., a set of tabs 86-1, 86-2) is received in the catch 76 of the front plate 36-2 of the probe housing 36, e.g., the opposing slots 80-1, 80-2 of a set of slotted bosses 78-1, 78-2, to couple the coaxial introducer cannula 70 with the biopsy device 10 to prevent axial movement of the coaxial introducer cannula 70 along the longitudinal axis 44 relative to the biopsy device 10. The rotational movement of the locking lever 84 can be clockwise or counterclockwise to enable very dexterous operation. At this point, first locking feature 88-1 of front plate 36-2 of probe housing 36 also engages with second locking feature 88-2 on locking lever 84 of hub 74 of coaxial introducer cannula 70 to prevent coaxial introducer cannula 70 from rotating about longitudinal axis 44.

In this embodiment, first locking feature 88-1 of front plate 36-2 of probe housing 36 and second locking feature 88-2 of hub 74 of coaxial introducer cannula 70 are complementary engagement features, such as a hole/protrusion structure or a magnetic structure, that when engaged will prevent (but not inhibit) rotation of coaxial introducer cannula 70 about longitudinal axis 44. For example, the second locking feature 88-2 may be a recess or opening formed in a proximal surface of the locking lever 84 of the hub 74, while the first locking feature 88-1 of the front plate 36-2 of the probe housing 36 may be a facing area (e.g., a pin and/or a headlight) projecting distally on the front plate 36-2 that mates with the recess formed in the locking lever 84, or vice versa, or both, so as to prevent the coaxial introducer cannula 70 from rotating about the longitudinal axis 44, i.e., relative to the biopsy device 10.

To disengage the coaxial introducer cannula 70 from the biopsy device 10, the locking lever 84 is rotated about the longitudinal axis 44 to disengage the latch 86 (e.g., a set of tabs 86-1, 86-2) of the hub 74 of the coaxial introducer cannula 70 from the catch 76 (e.g., the opposing slots 80-1, 80-2 of a set of slotted projections 78-1, 78-2) of the front plate 36-2 of the probe housing 36. The rotational movement of the locking lever 84 can be clockwise or counterclockwise to enable very dexterous operation. At this point, the coaxial introducer cannula 70 is free to move axially along the longitudinal axis 44 in the distal direction 46-2 away from the front plate 36-2 of the probe housing 36 to allow the coaxial introducer cannula 70 to be removed from the biopsy needle 52 of the biopsy device 10. Because locking lever 84 is resilient, when locking lever 84 returns to its pre-deflected position, the cantilever spring action created by locking lever 84 pushes against front plate 36-2 to assist in moving coaxial introducer cannula 70 in distal direction 46-2 away from its resting position.

Alternatively, in one magnet configuration for the first and second locking features 88-1 and 88-2, for example, the front plate 36-2 of the probe housing 36 may have a central magnet with a polarity to attract a magnet embedded in or attached to the locking lever 84 of the hub 74 when the coaxial introducer cannula 70 is in the locked position to prevent the coaxial introducer cannula 70 from rotating relative to the biopsy device 10. The front plate 36-2 of the probe housing 36 may also have two rotationally spaced magnets, one on either side of the central magnet, of the same polarity as the hub magnet so as to repel the hub magnet in the distal direction 46-2, thereby assisting the operator in axially removing the coaxial introducer cannula 70 from the biopsy probe assembly 14 of the biopsy device 10 after the locking lever 84 is rotated to disengage the coaxial introducer cannula 70 from the biopsy device 10.

It is contemplated that the coaxial introducer cannula 70 can be used and connected with other types of biopsy devices, such as trocars, modified to include the catch 76, such as slotted projections 78-1, 78-2, and optionally the first locking feature 88-1.

Fig. 7A, 7B, 8A and 8B relate to another embodiment of a coaxial introducer cannula in connection with a probe housing 36 in accordance with the present invention.

Fig. 7A, 7B, 8A and 8B relate to another embodiment for coupling a coaxial introducer cannula to a probe housing 36 of biopsy device 10.

Referring to fig. 8A and 8B, in this embodiment, coaxial introducer cannula 170 includes coaxial cannula 172 and hub 174. Coaxial cannula 172 may be formed as an elongated tube, such as a metal tube, e.g., a stainless steel tube, having a proximal portion 172-1 and a distal end 172-2. Hub 174 is made of a hard plastic that is fixedly attached (e.g., overmolded, adhesively attached, etc.) to proximal portion 172-1 of coaxial cannula 172.

Coaxial cannula 172 of coaxial introducer cannula 170 is sized to be coaxially and slidably received along longitudinal axis 44 over biopsy needle 52 formed by stylet cannula 40 and cutter cannula 42 (see also fig. 1). Hub 174 of coaxial introducer cannula 170 is configured to releasably attach to front plate 36-2 of probe housing 36 of biopsy device 10 (see fig. 7A and 7B).

As shown in FIGS. 7A and 7B, in the present embodiment, the front plate 36-2 of the probe housing 36 includes a catch 176 formed as a set of slotted projections 178-1, 178-2 projecting outwardly in the distal direction 46-2 from the front plate 36-2 of the probe housing 36 of the biopsy device 10. The slotted projections 178-1, 178-2 have respective opposing slots 180-1, 180-2, the slots 180-1, 180-2 facing away from the longitudinal axis 44.

As shown in fig. 8A and 8B, in the present embodiment, the hub 174 includes a hub body 182, a locking bar 184 and a lock bolt 186. The latch 186 is disposed to rotatably engage the catch 176 of the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10. The locking lever 184 is an elongated arm that extends radially from the hub body 182 relative to the longitudinal axis 44. As shown in FIG. 8B, the hub body 182 has a cylindrical recess 182-1 defining a sidewall 182-2. The latch 186 is in the form of a set of tabs 186-1, 186-2, the set of tabs 186-1, 186-2 extending radially inward from the sidewall 182-2 of the cylindrical recess 182-1 of the hub body 182 toward the longitudinal axis 44.

The length of the locking lever 184 is greater than the height of the front plate 36-2 of the probe housing 36 and the driver assembly 12 (see fig. 1) such that the locking lever 184 can be reached and rotated by the thumb or finger of the operator while the operator grasps the biopsy device 10 with the same hand to facilitate rotation of the coaxial introducer cannula 170 with respect to the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10 with a single hand to effect corresponding engagement and disengagement of the latch 186 of the coaxial introducer cannula 170 with the catch 176 of the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10.

Additionally, optionally, a first locking feature 188-1 may be provided at the front plate 36-2 of the probe housing 36 and a second locking feature 188-2 may be provided on the hub 174 of the coaxial introducer cannula 170 such that, when engaged, the coaxial introducer cannula 170 is prevented from rotating about the longitudinal axis 44, i.e., relative to the biopsy device 10. More particularly, the second locking feature 188-2 may be located on or in the locking bar 184.

Referring to fig. 7A, 7B, 8A and 8B (see fig. 1), during installation of coaxial introducer cannula 170 onto biopsy device 10, coaxial cannula 172 of coaxial introducer cannula 170 is coaxially and slidably received along longitudinal axis 44 over biopsy needle 52 (see fig. 1) formed by stylet cannula 40 and cutter cannula 42. With the latch 186 (e.g., a set of tabs 186-1, 186-2) of the hub 174 of the coaxial introducer cannula 170 not rotationally aligned with the catch 176 (e.g., slotted projections 178-1, 178-2) of the front plate 36-2 of the probe housing 36, the coaxial introducer cannula 170 is moved axially along the longitudinal axis 44 until the hub 174 axially abuts the front plate 36-2 of the probe housing 36. The locking lever 184 may be angled proximally relative to the hub body 182 such that the locking lever 184 engages the front plate 36-2 before axially abutting against the front plate 36-2 and the locking lever 184 deflects in the distal direction 46-2 as a cantilever spring.

The locking lever 184 of the hub 174 is then rotated about the longitudinal axis 44 to a locked position, wherein the latch 186 (e.g., a set of tabs 186-1, 186-2) of the hub 174 is received in the catch 176 (e.g., the opposing slots 180-1, 180-2 of a set of slotted projections 178-1, 178-2) of the front plate 36-2 of the probe housing 36, respectively, to couple the coaxial introducer cannula 170 with the probe housing 36 and, thus, with the biopsy device 36, thereby preventing axial movement of the coaxial introducer cannula 170 relative to the biopsy device 10 along the longitudinal axis 44. The rotational movement of the locking lever 184 may be clockwise or counterclockwise to enable very dexterous operation. At this point, first locking feature 188-1 of front plate 36-2 of probe housing 36 also engages with second locking feature 188-2 on locking lever 184 of hub 174 of coaxial introducer cannula 170 to prevent coaxial introducer cannula 170 from rotating about longitudinal axis 44.

In this embodiment, first locking feature 188-1 of front plate 36-2 of probe housing 36 and second locking feature 188-2 of hub 174 of coaxial introducer cannula 170 are complementary engagement features, such as a slot/protrusion arrangement, that when engaged will prevent (but not inhibit) rotation of coaxial introducer cannula 170 about longitudinal axis 44. For example, the second locking feature 188-2 may be an opening (e.g., a hole and/or slot) formed in a proximal surface of the locking lever 184 of the hub 174, while the first locking feature 188-1 of the front plate 36-2 of the probe housing 36 may be a facing region (e.g., a pin and/or a headlight) projecting distally on the front plate 36-2 that mates with the opening formed in the locking lever 184, or vice versa, or both, so as to prevent the coaxial introducer cannula 170 from rotating about the longitudinal axis 44, i.e., relative to the biopsy device 10.

To disengage the coaxial introducer cannula 170 from the biopsy device 10, the locking lever 184 is rotated about the longitudinal axis 44 to disengage the latch 186 (e.g., a set of tabs 186-1, 186-2) of the hub 174 of the coaxial introducer cannula 170 from the catch 176 (e.g., opposing slots 180-1, 180-2 of a set of slotted projections 178-1, 178-2) of the front plate 36-2 of the probe housing 36. The rotational movement of the locking lever 184 may be clockwise or counterclockwise to enable very dexterous operation. At this point, coaxial introducer cannula 170 is free to move axially along longitudinal axis 44 in distal direction 46-2 away from front plate 36-2 of probe housing 36 to allow coaxial introducer cannula 170 to be removed from biopsy needle 52 of biopsy device 10.

Referring to fig. 9, it is also contemplated that the coaxial introducer cannula 170 can be used and connected with other types of biopsy devices, such as a trocar 190, modified to include the catch 176, such as slotted projections 178-1, 178-2, and optionally a first locking feature 188-1.

The following items are also relevant to the present invention:

in one form, the present invention is directed to a biopsy device, or alternatively a biopsy probe assembly, comprising a biopsy needle, a sample manifold, and a sample container. The sample manifold is connected to a biopsy needle. The sample manifold has a receiver and an insertion axis. The sample receiver has an interior sidewall and a mounting pin projecting inwardly from the interior sidewall toward the insertion axis. The sample container is configured for insertion into the receptacle. The sample container includes a mounting channel sized and positioned (e.g., configured) to engage and follow a mounting pin of the receiver as the sample container is rotated.

Optionally, the mounting channel is arranged to extend helically an arcuate distance less than one revolution of the sample container.

Optionally, the mounting channel has an open end and a closed end. The open end is positioned to receive a mounting pin of the sample manifold to provide rotational orientation of the sample container about the insertion axis relative to a receiver of the sample manifold.

The biopsy device may be arranged such that when the mounting pin of the receiver is received in the open end of the mounting channel of the sample container, rotation of the sample container causes the mounting pin to follow the helical shape of the mounting channel towards the closed end so as to pull the sample container along the insertion axis into the receiver of the manifold.

The sample container may have a cap portion and a basket portion connected by a hinge to facilitate pivoting of one or both of the cap portion and the basket portion about the hinge between a closed position and an open position. The open position provides access to the contents of the sample container.

The biopsy device may be arranged such that when the sample container is in the closed position, the partial side walls of the cap portion overlap with the partial side walls of the basket portion so as to form a snap fit.

The cap portion of the sample container may include a lid and a partial sidewall. The cover may include a dome-shaped cap and an annular rim. The annular rim may be connected to a dome-shaped cap to define an annular lip. The mounting channel may be formed in and spiral around the annular rim.

The dome-shaped cap may be transparent or translucent to enable visual inspection of the contents of the sample container without having to remove the sample container from the receptacle of the manifold.

The dome-shaped cap may include an enlarged feature.

A seal may be disposed around the annular rim to provide a vacuum seal between the sample container and the receptacle of the manifold.

The basket portion may include a bottom plate having a concave inner surface and a plurality of apertures. The biopsy device may be configured such that the plurality of apertures allow vacuum to propagate through the sample container for delivering a tissue sample from the biopsy needle onto the concave inner surface of the floor.

The cap portion and the basket portion of the sample container may together define an aperture and an interior sample chamber. The biopsy needle may include a vacuum cannula having a proximal portion extending to the aperture for delivering the tissue sample from the biopsy needle into the internal sample chamber by vacuum.

The aperture of the sample container may be formed by a first semi-circular aperture of the cap portion located adjacent to a second semi-circular aperture of the basket portion when the sample container is in the closed position.

Any of the features of paragraphs [00102] to [00114] may be combined in a biopsy device or in a biopsy probe assembly.

Optionally, a coaxial introducer cannula for use with a biopsy device may be provided. The biopsy device has: a front plate having a catch; and a biopsy needle extending from the front plate on the longitudinal axis. A coaxial introducer cannula includes a coaxial cannula and a hub. The coaxial cannula is sized to be coaxially and slidably received over the biopsy needle. A hub is fixedly attached to the proximal portion of the coaxial cannula. The hub has a hub body, a locking bar and a lock bolt. The latch is disposed in rotatable engagement with the catch. The locking lever extends radially from the hub body relative to the longitudinal axis. The locking lever has a length greater than the height of the front plate such that the locking lever can be reached and rotationally operated to rotate the hub relative to the front plate of the biopsy device to facilitate one-handed rotation of the coaxial introducer cannula relative to the front plate to effect engagement or disengagement of the coaxial introducer cannula lock with the front plate catch.

The rotational movement of the locking lever can be clockwise or counter-clockwise to enable a very dexterous operation.

The locking lever may be inclined proximally relative to the hub body such that the locking lever engages the front plate before the hub axially abuts against the front plate and the locking lever deflects in a distal direction.

The first locking feature may be on the front plate and the second locking feature may be on the hub, which when engaged, will prevent, but not prohibit, rotation of the coaxial introducer cannula about the longitudinal axis.

The second locking feature may be located on or in the locking bar.

The first and second locking features may form a hole/protrusion structure or a magnetic structure.

The catch may be a set of slotted projections projecting outwardly from the front plate in the distal direction. The slotted projection may have a corresponding opposing slot facing away from the longitudinal axis. The hub body may have a cylindrical recess defining a sidewall, wherein the lock bolt is in the form of a set of tabs extending radially inward from the sidewall of the cylindrical recess of the hub body toward the longitudinal axis.

As used herein, "substantially" and other terms of degree are relative to each other and are intended to indicate permissible variation of the modified characteristic. It is not limited to the absolute value or characteristic modified but has more physical or functional characteristics than it is, and is close to or similar to such physical or functional characteristics.

While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.