Biopsy probe assembly

Abstract

This application relates to a biopsy probe assembly, comprising: a biopsy needle; a sample manifold connected to the biopsy needle, the sample manifold having a receiver and an insertion axis, the sample receiver having an inner sidewall and a mounting pin, the mounting pin protruding inward from the inner sidewall toward the insertion axis; and a sample container configured for insertion into the receiver, the sample container including a mounting channel, the mounting channel being sized and positioned to engage with and follow the mounting pin of the receiver during rotation of the sample container, wherein the mounting channel has an open end and a closed end, and 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 into the receiver of the sample manifold along the insertion axis.

Description

[0001] This divisional application is a divisional application of Chinese patent application No. 201880077285.5 (international application No. PCT / US2018 / 063055), filed on November 29, 2018, entitled “Sample container and coaxial introducer cannula for biopsy device”.

[0002] Cross-reference to related applications

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 592641 and U.S. Provisional Patent Application No. 62 / 669015, entitled “SAMPLE CONTAINER AND COAXIAL CANNULA FOR BIOPSY APPARATUS”, filed November 30, 2017, and U.S. Provisional Patent Application No. 62 / 669015, entitled “SAMPLE CONTAINER FOR A SIMS BIOPSY DEVICE”, filed May 9, 2018, which are cited herein. Technical Field

[0004] This invention relates to biopsy apparatus, and more particularly, to a biopsy apparatus having a coaxial introducer cannula and / or a sample container. Background Technology

[0005] Biopsies can be performed on patients to help determine whether tissue in an area of ​​interest contains cancer cells. For example, one biopsy technique for evaluating breast tissue involves inserting a biopsy probe into an area of ​​breast tissue of interest to capture one or more tissue samples from that area. This biopsy technique typically utilizes a vacuum to draw the tissue to be sampled into the sample recess of the biopsy probe, then cuts the tissue and collects it in a sample container. Efforts in the art have been focused on improving the ability of practitioners to access biopsy sites and / or deliver cut tissue samples to sample containers for collecting the cut tissue samples.

[0006] For example, after a biopsy guided by an ultrasound needle, some operators may be reluctant to handle the tissue sample and may prefer to place it directly into formalin, a preservative used for biological samples. Conversely, other operators may need to approach the tissue sample for examination before placing it into formalin. Furthermore, there is a risk of sample loss when using current devices (such as open sample trays) to retrieve the sample. Additionally, physician (including pathologist) anesthetical reports suggest that tissue handling performed by operators (physicians and technicians) during and after the biopsy may affect the quality of the sample used for pathological analysis.

[0007] Additionally, some operators prefer to use coaxial cannulas to maintain access to the lesion when using biopsy devices (such as biopsy actuators connected to biopsy probes or cannulas). In such a procedure, the operator may wish to place a tissue marker at the biopsy site. In this case, the biopsy probe can be withdrawn from the coaxial cannula, and the marker applicator can be inserted into the biopsy site through the coaxial cannula to maintain the position of the lesion / site after sampling without the need for ultrasound recalibration. However, connecting and / or disconnecting the coaxial cannula from the biopsy device typically requires two hands and can be clumsy or difficult.

[0008] There is a need in the art for a sample container for a biopsy device that facilitates efficient reception and processing of collected tissue samples, and / or for a coaxial introducer cannula that facilitates efficient connection and disconnection of the coaxial introducer cannula from the biopsy device. Summary of the Invention

[0009] The present invention provides a sample container for a biopsy device that facilitates efficient reception and processing of collected tissue samples, and / or relates to a coaxial introducer cannula that facilitates efficient connection and disconnection of the coaxial introducer cannula from the biopsy device.

[0010] In one embodiment, the present invention relates to a biopsy apparatus comprising a biopsy needle, a sample manifold, and a sample container. The sample manifold is connected to the biopsy needle. The sample manifold has a receiver and an insertion axis. The sample receiver has an inner sidewall and a mounting pin that projects inwardly from the inner sidewall toward the insertion axis. The sample container is configured for insertion into the receiver. The sample container includes a mounting channel sized and positioned to engage with and follow the mounting pin of the receiver during rotation of the sample container.

[0011] In another embodiment, the present invention relates to a coaxial introducer cannula for use with a biopsy apparatus. The biopsy apparatus includes: a front plate having a capture device; and a biopsy needle extending from the front plate along a longitudinal axis. The coaxial introducer cannula includes a coaxial tube and a hub portion. The coaxial tube is sized to be coaxially and slidably received on the biopsy needle. The hub portion is fixedly attached to a proximal portion of the coaxial tube. The hub portion has a hub portion body, a locking lever, and a locking bolt. The locking bolt is configured to rotatably engage with the capture device. The locking lever extends radially from the hub portion body relative to the longitudinal axis. The length of the locking lever is greater than the height of the front plate, allowing the locking lever to be reached and rotated to rotate the hub portion relative to the front plate of the biopsy apparatus, thereby facilitating one-handed rotation of the coaxial introducer cannula relative to the front plate, thereby engaging or disengaging the locking bolt of the coaxial introducer cannula from the capture device of the front plate.

[0012] One advantage of the sample container aspect of the present invention is that the sample container in the closed position can be removed from the biopsy device and placed directly into formalin without having to open the sample container or process the tissue sample.

[0013] Another advantage of the sample container aspect of the present invention is that it provides an easy-to-use opening mechanism that allows tissue to enter when needed, but keeps the sample container closed during removal from the biopsy system in order to help reduce the chance of tissue loss.

[0014] One advantage of the coaxial introducer cannula of the present invention is that the operator can detach the coaxial introducer cannula from the biopsy device with one hand, thereby improving the ease of use of the coaxial introducer cannula and the accuracy of any subsequent marker placement. Attached Figure Description

[0015] The above and other features and advantages of the present invention, as well as the ways in which they are implemented, will become clearer and the present invention will be better understood through the following description of embodiments of the present invention in conjunction with the accompanying drawings. In the drawings:

[0016] Figure 1 It is a perspective view of a biopsy apparatus having a sample container according to aspects of the present invention and a biopsy probe assembly attached to a driver assembly.

[0017] Figure 2 yes Figure 1 A block diagram of the driver components;

[0018] Figure 3A yes Figure 1 A perspective view of a portion of a biopsy probe assembly, which includes a sample manifold and a sample container according to one aspect of the invention.

[0019] Figure 3Byes Figure 1 An exploded perspective view of a portion of a biopsy probe assembly, which includes a sample manifold and a sample container, wherein the sample container is in the insertion orientation relative to the sample manifold.

[0020] Figure 3C yes Figure 3A and 3B Top view of the sample manifold;

[0021] Figure 4A yes Figure 3A and 3B A perspective view of the sample container, wherein the sample container is in the closed position;

[0022] Figure 4B yes Figure 3A and 3B An end view of the sample container, wherein the sample container is in the closed position;

[0023] Figure 4C yes Figure 3A and 3B A side view of the sample container, wherein the sample container is in the closed position;

[0024] Figure 4D yes Figure 3A and 3B A side view of the sample container, wherein the sample container is in the middle open position;

[0025] Figure 4E yes Figure 3A and 3B A side view of the sample container, wherein the sample container is in the fully open position;

[0026] Figure 5 yes Figure 1 A perspective view of a portion of a biopsy apparatus, wherein a coaxial introducer cannula according to one aspect of the invention is mounted on the biopsy probe assembly of the biopsy apparatus;

[0027] Figure 6A yes Figure 5 A perspective view of the coaxial inlet cannula;

[0028] Figure 6B yes Figure 5 End view of the coaxial introducer cannula;

[0029] Figure 6C yes Figure 5 Side view of the coaxial introducer cannula;

[0030] Figure 7A yes Figure 1 A perspective view of the probe housing of a biopsy device, showing an alternative construction for connection with a coaxial introducer cannula;

[0031] Figure 7B yes Figure 7A End view of the probe housing;

[0032] Figure 8A This is a perspective view of an alternative coaxial introducer cannula configured for connection. Figure 7A and 7B An alternative connection structure for the probe housing;

[0033] Figure 8B yes Figure 8A Rear perspective view of the alternative coaxial inlet cannula;

[0034] Figure 9 This is a perspective view of a cannula configured to be used with... Figure 8A and 8B It is used together with a coaxial introducer cannula.

[0035] In all views, corresponding reference numerals denote corresponding components. The examples set forth herein illustrate at least one embodiment of the invention, and these examples are in no way intended to limit the scope of the invention. Detailed Implementation

[0036] Please refer to the attached diagram below, and especially to the accompanying diagram. Figure 1 The figure illustrates a biopsy device 10, which typically includes a non-invasive (e.g., non-disposable) actuator assembly 12 and an invasive (e.g., disposable) biopsy probe assembly 14. As used herein, the term "non-disposable" refers to a device intended for use on multiple patients over its lifetime, while the term "disposable" refers to a device intended for disposal after use on a single patient. The actuator assembly 12 includes an actuator housing 16 configured and ergonomically designed for gripping by an operator.

[0037] Also refer to Figure 2 The driver assembly 12 includes a controller circuit 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. User interface 28 (see...) Figure 1 For example, the keypad is positioned to be mounted on the drive housing 16 and is accessible from the outside to the operator relative to the drive housing 16.

[0038] Battery 26 may be, for example, a rechargeable battery, which can be charged via an inductive charging device or optionally via an electrical connection to a power source. Battery 26 is electrically connected to controller circuitry 18, electromechanical power supply 20, vacuum source 22, and user interface 28.

[0039] The user interface 28 may include control buttons and visual / auditory indicators, wherein the control buttons provide user control over various functions of the biopsy device 10, while the visual / auditory indicators provide visual / auditory feedback on one or more conditions and / or component positions of the biopsy device 10. The control buttons may include a sample button 28-1 and an initiation injection / puncture button 28-2. The visual indicators may include a display screen 28-3 and / or one or more light-emitting diodes (LEDs) 28-4. The auditory indicators may include a buzzer 28-5. The control buttons may include tactile feedback to the operator during operation.

[0040] The controller circuit 18 is electrically and communicatively connected to the electromechanical power supply 20, the vacuum source 22, the vacuum sensor 24, and the user interface 28, for example, via one or more wires or circuit traces. The controller circuit 18 may be mounted on a circuit board and includes, for example, a processor circuit 18-1 and a memory circuit 18-2.

[0041] Processor circuit 18-1 has one or more programmable microprocessors and related circuitry, such as input / output interfaces, clocks, buffers, and memories. Memory circuit 18-2 is communicatively connected to processor circuit 18-1 via a bus circuit, and is a non-transitory electronic memory. It may include volatile memory circuitry such as random access memory (RAM) and non-volatile memory circuitry such as read-only memory (ROM), electronically erasable programmable ROM (EEPROM), NOR flash memory, NAND flash memory, etc. Controller circuit 18 can be configured as one or more application-specific integrated circuits (ASICs).

[0042] The controller circuit 18 is configured to execute program instructions via software and / or firmware present in the memory circuit 18-2 to perform functions related to the retrieval of biopsy tissue samples, such as controlling and / or monitoring the functions of one or more components of the electromechanical power supply 20, vacuum source 22, and vacuum sensor 24.

[0043] The electromechanical power supply 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. The cutter module 30, the delivery module 32, and the puncture module 34 are each electrically connected to and controlled by the controller circuitry 18 via one or more electrical conductors (e.g., wires or circuit traces).

[0044] The cutter module 30 may include an electric motor 30-1 with a shaft, to which a cutter driver 30-2 is driven. The conveying module 32 may include an electric motor 32-1 with a shaft, to which a conveying driver 32-2 is driven. The piercing module 34 may include an electric motor 34-1 with a shaft, to which a piercing launch driver 34-2 is driven. Each electric motor 30-1, 32-1, and 34-1 may be, for example, a direct current (DC) motor or a stepper motor. Each cutter driver 30-2, conveying driver 32-2, and piercing launch driver 34-2 may include one or more gears, gear transmission mechanisms, or belt / pulley assemblies.

[0045] Vacuum source 22 is electrically and controllably connected to battery 26 via one or more electrical conductors (e.g., wires or circuit traces). Vacuum source 22 may include, for example, an electric motor 22-1 that drives vacuum pump 22-2. Vacuum source 22 has a vacuum source port 22-3 connected to vacuum pump 22-2 for establishing a vacuum in biopsy probe assembly 14. Electric motor 22-1 may be, for example, a rotary, linear, or vibratory DC motor. Vacuum pump 22-2 may be, for example, a peristaltic pump or a diaphragm pump, or one or more pumps connected in series or parallel.

[0046] Vacuum sensor 24 is electrically connected to controller circuitry 18 via one or more electrical conductors (e.g., wires or circuit traces). Vacuum sensor 24 may be a differential pressure sensor that provides a vacuum (negative pressure) feedback signal to controller circuitry 18. In some embodiments, vacuum sensor 24 may be included in vacuum source 22.

[0047] See again Figure 1 The biopsy probe assembly 14 is configured for releasable attachment to the driver assembly 12. As used herein, the term "releasable attachment" 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.

[0048] refer to Figure 1 and 3A The biopsy probe assembly 14 includes a probe housing 36, a vacuum cannula 38, a core needle cannula 40, a cutter cannula 42, a sample manifold 48, and a sample container 50. The portion of the vacuum cannula 38, the core needle cannula 40, and the cutter cannula 42 that extends distally along the longitudinal axis 44 from the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10 is referred to herein as the biopsy needle 52.

[0049] The probe housing 36 is formed as an L-shaped structure with an elongated portion 36-1 and a front plate 36-2. When the biopsy probe assembly 14 is attached to the actuator assembly 12, the front plate 36-2 is positioned distally adjacent to the entire front surface 16-1 of the actuator housing 16, i.e., to shield the entire front surface 16-1 of the non-disposable actuator assembly from contact with the patient.

[0050] The vacuum cannula 38, the needle cannula 40, and the cutter cannula 42 are arranged coaxially along the longitudinal axis 44 in a nested tube structure. The vacuum cannula 38 is the innermost tube, the cutter cannula 42 is the outermost tube, and the needle cannula 40 is the intermediate tube located between the vacuum cannula 38 and the cutter cannula 42. In other words, the vacuum cannula 38 is located inside the needle cannula 40, and the needle cannula 40 is located inside the cutter cannula 42.

[0051] The vacuum cannula 38 is fluidly connected to the vacuum source 22 via the sample manifold 48.

[0052] The core needle cannula 40 includes a sample recess 40-1 and a puncture tip 40-2. The sample recess 40-1 is formed as an elongated opening in the core needle cannula 40 to facilitate tissue reception into the lumen of the core needle cannula 40. The cutter cannula 42 has a distal cutting end 42-1.

[0053] The needle cannula 40 and the cutter cannula 42 are connected together to the puncture firing driver 34-2. When the induction / puncture button 28-2 is activated for the first time, the needle cannula 40 and the cutter cannula 42 are translated in unison along the longitudinal axis 44 in the proximal direction 46-1 to position the puncture firing driver 34-2, the needle cannula 40, and the cutter cannula 42 in a ready (i.e., ready to fire) position. A second activation of the induction / puncture button 28-2 will execute the puncture firing, in which the puncture firing driver 34-2 is released from the ready-to-fire position and then rapidly pushed along the longitudinal axis 44 in the distal direction 46-2 toward the most distal position of the combined element (e.g., within the patient's body).

[0054] The cutter cannula 42 is connected to the cutter driver 30-2 and retracts or extends along the longitudinal axis 44 via the sample button 28-1 of the user interface 28, thereby driving the cutter module 30 of the biopsy probe assembly 14 to initiate a sample sequence. For example, the cutter cannula 42 can be axially translated and retracted along the longitudinal axis 44 to expose the sample groove 40-1 in the sample sequence, allowing tissue to be vacuum-drawn into the lumen of the core needle cannula 40 by the vacuum provided by the vacuum cannula 38. The cutter cannula 42 can then have a rotational cutting motion and can be axially translated along the longitudinal axis 44 to extend over the sample groove 40-1, such that the distal cutting end 42-1 of the cutter cannula 42 cuts the tissue vacuum-drawn into the lumen of the core needle cannula 40 by the vacuum provided by the vacuum cannula 38.

[0055] By driving the delivery module 32 of the biopsy probe assembly 14, the needle cannula 40 retracts or extends along the longitudinal axis 44 to facilitate the delivery of tissue samples into the lumen of the vacuum cannula 38. The vacuum cannula 38 then delivers the tissue sample to the sample manifold 48 by vacuum supplied by the vacuum source 22.

[0056] refer to Figures 3A-3C The sample manifold 48 is configured in an L-shape, having a vacuum chamber portion 48-1 and a collection chamber portion 48-2. The vacuum chamber portion 48-1 includes a vacuum input port 48-3, which is arranged to sealably engage the vacuum source port 22-3 of the vacuum source 22 of the driver assembly 12 when the biopsy probe assembly 14 is attached to the driver assembly 12 (see...). Figure 2 Absorbent paper can be arranged in the vacuum chamber section 48-1 and in the area between the vacuum input port 48-3 and the collection chamber section 48-2.

[0057] The vacuum chamber portion 48-1 is fluidly connected to 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 fluidly connected to the collection chamber portion 48-2.

[0058] refer to Figure 3B and 3C The collection chamber portion 48-2 of the sample manifold 48 defines a receiver 48-4, which is sized and constructed to detachably receive and mount the sample container 50. See also... Figure 1 , 2In 3A, when the sample container 50 is installed in the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48, the sample container 50 is placed between the vacuum source 22 and the proximal portion 38-1 of the vacuum tube 38, such that the sample container 50 is in direct fluid communication with the proximal portion 38-1 of the vacuum tube 38, and the sample container 50 is also in direct fluid communication with the vacuum input port 48-3 of the vacuum chamber portion 48-1.

[0059] Therefore, the vacuum generated by the vacuum source 22 is delivered to the proximal portion 38-1 of the vacuum cannula 38 through the sample manifold 48 and the 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, the vacuum passes through the sample container 50, allowing the tissue sample cut by the cutter cannula 42 at the sample groove 40-1 of the needle cannula 40 to be transported by vacuum through the vacuum cannula 38 into the sample container 50.

[0060] refer to Figure 3B and 3C The receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48 has an open end 48-5, an inner 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 inner sidewall 48-6 of the receiver 48-4 and protrudes inward from the inner sidewall 48-6 toward the insertion axis 48-8.

[0061] In this embodiment, the sample container 50 is configured to match 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 and one direction, thereby reducing operator error after removing and reloading the sample container 50 to obtain additional tissue samples.

[0062] Referring also to 4A-4E, the sample container 50 has a cap portion 54 and a basket portion 56, which are connected by a hinge 58 and are assembled together when in the closed position to define the cylindrical sidewall 50-1. The cap portion 54 and the basket portion 56 may each be made of rigid plastic and may have smooth surface features to reduce the impact on radiographic visibility when it is desired or necessary to organize the sample for radiography. The rigid plastic may also be selected to be compatible with formalin.

[0063] Also refer to Figure 3B and 3CThe sample container 50 is sized and structured to be removably received in the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48. For example, the inner sidewalls 48-6 of the sample container 50 and the receiver 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 receiver 48-4. As used herein, the term "cylindrical" refers to an annular profile of a generally arcuate shape, which may include planes, ledges, and / or other surface features not associated with a pure cylinder.

[0064] refer to Figures 4A-4E The sample container 50 includes a mounting channel 50-2, which is sized and positioned to engage with and follow the mounting pin 48-7 of the receiver 48-4 of the sample manifold 48 (see [link to sample container 50]). Figure 3C The mounting channel 50-2 extends spirally downwards from the cap portion 54 along the cylindrical sidewall 50-1 for a distance less than one revolution of the sample container 50, for example, 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. The open end 50-3 is positioned to receive the mounting pin 48-7 of the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48, and provides initial indexing (rotational orientation) of the sample container 50 relative to the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48 about the insertion axis 48-8.

[0065] 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 rotates, the rotation (clockwise in this example) of the sample container 50 causes the mounting pin 48-7 to move along the spiral shape of the mounting channel 50-2 toward the closed end 50-4, so as 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.

[0066] It is also considered that, when needed, the mounting channel 50-2 may include multiple spiral channels formed in the sample container 50. In this case, the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48 may have multiple mounting pins, the number of which corresponds to the number of spiral channels formed in 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, each mounting pin is received in the corresponding spiral channel of the sample container 50.

[0067] refer to Figures 4A-4E The cap portion 54 of the sample container 50 includes a cover 60 and a partial sidewall 62, which can be formed as a single-piece integral structure. The cover 60 includes a dome-shaped cap 60-1, an annular rim 60-2, and an annular lip 60-3. The annular rim 60-2 connects to the dome-shaped cap 60-1 to define the annular lip 60-3. A mounting channel 50-2 is formed in the annular rim 60-2 and spirals around it. The dome-shaped cap 60-1 may include an arrow mark 60-4, such as a raised or embossed mark, to indicate the direction of rotation for mounting the sample container 50 in the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48.

[0068] A seal 64 (e.g., an O-ring) may be arranged around the annular rim 60-2 such that when the sample container 50 is installed in the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48, the seal 64 provides a vacuum seal between the sample container 50 and the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48. Preferably, reverse rotation of the sample container 50 causes the mounting channel 50-2 to move along the helical shape of the mounting pin 48-7 toward the open end 50-3, thereby pulling the sample container 50 out of the receiver 48-4 along the insertion axis 48-8 to help release the vacuum seal.

[0069] In one embodiment, at least the dome-shaped cap 60-1 of the cap portion 54 is transparent or translucent to allow visual inspection of the contents of the sample container 50 without removing the sample container 50 from the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48. By making the dome-shaped cap 60-1 of the cap portion 54 circular, the interior of the sample container 50 can be viewed from multiple angles while holding the biopsy device 10 or observing the biopsy process. Furthermore, the dome-shaped cap 60-1 of the cap portion 54 may include magnifying features to further enhance the visibility of, for example, the contents of the sample container 50 during the biopsy process.

[0070] refer to Figure 4C-4E The basket portion 56 includes a base plate 66 and a partial sidewall 68, which can be formed as a single-piece integral structure. The partial sidewall 68 extends upward from the base plate 66. In this embodiment, the base plate 66 has a concave inner surface 66-1 and includes a plurality of holes 66-2 (see also...). Figure 4AThe multiple holes 66-2 in the base plate 66 of the sample container 50 allow vacuum to pass through the sample container 50 during the biopsy process, and the tissue sample is delivered from the biopsy needle 52 to the concave inner surface 66-1 of the base plate 66 of the sample container 50. Furthermore, after the biopsy process, the sample container 50 can be directly placed into a sample jar containing formalin, wherein the multiple holes 66-2 in the base plate 66 of the sample container 50 allow formalin to be injected into the sample container 50.

[0071] refer to Figures 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. This hinge 58 has engageable hinge features formed on the cap portion 54 and the basket portion 56. In this embodiment, for example, the hinge 58 includes: a pair of opposing holes 58-1 formed in the lower distal portion of a partial sidewall 62 of the cap portion 54; and a pair of opposing pins 58-2 extending radially outward from the partial sidewall 68 of the basket portion 56 just above the base plate 66, wherein the pair of opposing pins 58-2 are received in the pair of opposing holes 58-1 (e.g., holes) to form a pivot joint. This pivot joint facilitates easy access to the tissue sample contained in the sample container 50. The hinged action of the cap portion 54 and the basket portion 56 also produces a shovel action to assist in sample removal when the sample container 50 is opened.

[0072] It is also considered that, when needed, the engageable hinge feature of the pin / hole structure can be reversed, such that the pin is on the partial sidewall 62 of the cap portion 54, while the hole is on the partial sidewall 68 of the basket portion 56.

[0073] As an alternative to forming the hole 58-1 as a hole, it is also considered that the hole 58-1 may be formed as a slot or channel, so that when the sample container 50 is opened, a pair of opposing pins 58-2 of the hinge 58 can be easily disengaged from the hole 58-1, thereby facilitating the easy removal of the basket portion 56 from the cap portion 54 after the basket portion 56 has been opened to a predetermined position relative to the cap portion 54 when needed.

[0074] Figures 4A-4C The specimen container 50 is shown in the closed position, wherein a portion of the sidewall 62 of the cap portion 54 overlaps with a portion of the sidewall 68 of the basket portion 56 to form a snap-fit ​​engagement. Preferably, by connecting the cap portion 54 and the basket portion 56 with a hinge 58, the operator must take a special action to open the specimen container 50 to remove the tissue specimen, and there is no risk of accidentally detaching the container's cap or components when removing the container from the biopsy device 10. The tissue specimen (sample) remains in the specimen container 50 until it is opened, thereby reducing the risk of tissue specimen loss during transport.

[0075] Sample container 50 must be in Figures 4A-4C The closed position shown allows the sample container 50 to be received into the receiver 48-4 of the collection chamber portion 48-2 of the sample manifold 48 (see also...). Figure 3B and 3C Therefore, the sample container 50 can be located in and mounted on the sample manifold 48 (see also...). Figure 3A ). For example Figure 3B and 4A As shown, when the sample container 50 is in the closed position, the cap portion 54 and the basket portion 56 together define the orifice 50-5 and the internal sample chamber 50-6. The proximal portion 38-1 of the vacuum cannula 38 extends to the orifice 50-5 to deliver the tissue sample by vacuum from the biopsy needle 52 into the internal sample chamber 50-6 and onto the recessed inner surface 66-1 of the base plate 66, which has a plurality of holes 66-2 (see also...). Figure 4C In this embodiment, when the sample container 50 is in the closed position, the hole 50-5 of the sample container 50 is formed by arranging a semi-circular hole 62-1 in a partial sidewall 62 of the cap portion 54 adjacent to a semi-circular hole 66-3 located on the bottom plate 66 of the basket portion 56.

[0076] Figure 4D and Figure 4E This indicates the 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, thereby allowing access to the contents of the sample container 50. Figure 4D This indicates that the sample container 50 is in the middle open position. Figure 4E The sample container 50 is shown in the fully open position. When the sample container 50 is arranged in the fully open position and oriented in its side, the flat external feature 68-1 on the partial sidewall 68 of the basket portion 56 allows 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 the flat surface.

[0077] refer to Figure 5 Also refer to Figure 1 In some procedures, the operator may wish to use the coaxial introducer cannula 70 to maintain access to the biopsy site (e.g., the lesion), so that the biopsy needle 52 of the biopsy device 10 can be removed from the biopsy site while maintaining the ability to reinsert the biopsy needle 52 or insert another medical device (e.g., a tissue marker deployment device) at the biopsy site.

[0078] Also refer to Figures 6A-6CThe coaxial insertion cannula 70 includes a coaxial cannula 72 and a hub-shaped portion 74. The coaxial cannula 72 may be formed as an elongated tube, such as a metal tube or a stainless steel tube, having a proximal portion 72-1 and a distal end 72-2. The hub-shaped portion 74 is made of rigid plastic, which is fixedly attached (e.g., by overmolding, adhesive bonding, etc.) to the proximal portion 72-1 of the coaxial cannula 72.

[0079] The coaxial cannula 72 of the coaxial introducer cannula 70 is sized to be coaxially and slidably received on the biopsy needle 52 formed by the core needle cannula 40 and the cutter cannula 42 along the longitudinal axis 44. The hub-shaped portion 74 of the coaxial introducer cannula 70 is configured for releasable attachment to the front plate 36-2 of the probe housing 36 of the biopsy device 10.

[0080] In this embodiment, reference is also made to Figure 5 The front plate 36-2 of the probe housing 36 includes a trap 76, which is formed as a set of slotted protrusions 78-1 and 78-2 protruding outward from the front plate 36-2 of the probe housing 36 of the biopsy device 10. The slotted protrusions 78-1 and 78-2 have opposing slots 80-1 and 80-2, respectively, which face in the direction of the longitudinal axis 44.

[0081] refer to Figure 5 and 6A -6C, In this embodiment, the hub-shaped portion 74 includes a hub-shaped portion body 82, a locking lever 84, and a bolt 86. The locking lever 84 is an elongated arm extending radially from the hub-shaped portion body 82 relative to the longitudinal axis 44. The bolt 86 is configured to rotatably engage with the capture 76 of the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10. In this embodiment, the bolt 86 is in the form of a set of tabs 86-1, 86-2 that extend radially outward from the hub-shaped portion body 82.

[0082] like Figure 5 As shown, 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, so that the locking lever 84 can be reached and rotated by the operator's thumb or finger, while the operator uses the same hand to grasp the biopsy device 10, thereby facilitating the rotation of the coaxial introducer cannula relative to the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10 with one hand, so as to achieve the corresponding engagement and disengagement of the capture 76 of the coaxial introducer cannula 70 with the locking bolt 86 of the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10.

[0083] Alternatively, refer to Figure 5 , 6AIn conjunction with 6B, the first locking feature 88-1 can be located at the front plate 36-2 of the probe housing 36, and the second locking feature 88-2 can be located on the hub-shaped portion 74 of the coaxial introducer cannula 70. When engaged, they prevent the coaxial introducer cannula 70 from rotating about the longitudinal axis 44, i.e., from rotating relative to the biopsy device 10. More specifically, the second locking feature 88-2 can be positioned on or within the locking lever 84.

[0084] refer to Figure 5 and 6A -6C, during the process of installing 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 on the biopsy needle 52 formed by the core needle cannula 40 and the cutter cannula 42 along the longitudinal axis 44. A set of tabs 86-1, 86-2 on the hub-shaped portion 74 of the coaxial introducer cannula 70 and... Figure 5 When the slotted protrusions 78-1 and 78-2 of the front plate 36-2 of the probe housing 36 shown are not rotated and aligned, the coaxial inserter tube 70 moves axially along the longitudinal axis 44 until the hub-shaped portion 74 axially abuts against the front plate 36-2 of the probe housing 36. Figure 6C As shown, the locking lever 84 is inclined proximally relative to the hub-shaped body 82, such that the locking lever 84 is in contact with the front plate 36-2 before axially abutting against it. Figure 5 The front plate 36-2 shown is engaged, and the locking lever 84 deflects in the distal direction 46-2 as a cantilever spring.

[0085] Then, the locking lever 84 of the hub-shaped part 74 rotates about the longitudinal axis 44 to the locked position. Figure 5 As shown in the diagram, the locking bolt 86 of the hub-shaped portion 74 (e.g., a set of tabs 86-1, 86-2) is received in the catcher 76 of the front plate 36-2 of the probe housing 36, for example, a set of opposing slots 80-1, 80-2 of the slotted protrusions 78-1, 78-2, so that the coaxial introducer cannula 70 is connected to the biopsy device 10, thereby preventing the coaxial introducer cannula 70 from moving axially relative to the biopsy device 10 along the longitudinal axis 44. The rotational movement of the locking lever 84 can be clockwise or counterclockwise for very flexible operation. At this time, the first locking feature 88-1 of the front plate 36-2 of the probe housing 36 also engages with the second locking feature 88-2 on the locking lever 84 of the hub-shaped portion 74 of the coaxial introducer cannula 70 to prevent the coaxial introducer cannula 70 from rotating about the longitudinal axis 44.

[0086] In this embodiment, the first locking feature 88-1 of the front plate 36-2 of the probe housing 36 and the second locking feature 88-2 of the hub portion 74 of the coaxial introducer cannula 70 are complementary engagement features, such as hole / protrusion structures or magnetic structures, which, when engaged, prevent (but do not prohibit) rotation of the coaxial introducer cannula 70 about the longitudinal axis 44. For example, the second locking feature 88-2 may be a groove or opening formed in the proximal surface of the locking lever 84 of the hub portion 74, while the first locking feature 88-1 of the front plate 36-2 of the probe housing 36 may be a distally projecting facing area (e.g., a pin and / or headlight) on the front plate 36-2 that matches the groove formed in the locking lever 84, or vice versa, or both, to prevent rotation of the coaxial introducer cannula 70 about the longitudinal axis 44, i.e., rotation relative to the biopsy device 10.

[0087] To disengage the coaxial introducer cannula 70 from the biopsy device 10, the locking lever 84 rotates about the longitudinal axis 44, causing the latches 86 (e.g., a set of tabs 86-1, 86-2) of the hub portion 74 of the coaxial introducer cannula 70 to disengage from the traps 76 (e.g., a set of opposing slots 80-1, 80-2 of the slotted protrusions 78-1, 78-2) of the front plate 36-2 of the probe housing 36. The rotation of the locking lever 84 can be clockwise or counterclockwise for very dexterity. At this point, the coaxial introducer cannula 70 moves freely axially along the longitudinal axis 44 in the distal direction 46-2 away from the front plate 36-2 of the probe housing 36, thereby removing the coaxial introducer cannula 70 from the biopsy needle 52 of the biopsy device 10. Because the locking lever 84 is elastic, when the locking lever 84 returns to its pre-deflection position, the cantilever spring action generated by the locking lever 84 pushes against the front plate 36-2 to help the coaxial introducer cannula 70 move away from its placement position in the distal direction 46-2.

[0088] Alternatively, in a magnet configuration for the first locking feature 88-1 and the second locking feature 88-2, for example, the front plate 36-2 of the probe housing 36 may have a central magnet with polarity such that it attracts 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, thereby preventing 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 one side of the central magnet, with the same polarity as the hub magnet, so that it repels 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 has rotated to disengage the coaxial introducer cannula 70 from the biopsy device 10.

[0089] It is possible that the coaxial introducer cannula 70 can be used and connected with other types of biopsy devices, such as trocars, which are modified to include a capture device 76, such as a slotted protrusion 78-1, 78-2, and optionally include a first locking feature 88-1.

[0090] Figure 7A , 7B 8A and 8B relate to another embodiment of the connection between the coaxial introducer cannula and the probe housing 36 according to the invention.

[0091] Figure 7A , 7B 8A and 8B relate to another embodiment for connecting a coaxial introducer cannula to the probe housing 36 of the biopsy device 10.

[0092] refer to Figure 8A and 8B In this embodiment, the coaxial inserter cannula 170 includes a coaxial cannula 172 and a hub-shaped portion 174. The coaxial cannula 172 can be formed as an elongated tube having a proximal portion 172-1 and a distal end 172-2, such as a metal tube or a stainless steel tube. The hub-shaped portion 174 is made of rigid plastic, which is fixedly attached (e.g., by overmolding, adhesive bonding, etc.) to the proximal portion 172-1 of the coaxial cannula 172.

[0093] The coaxial cannula 172 of the coaxial introducer cannula 170 is sized to be coaxial along the longitudinal axis 44 and slidably received on the biopsy needle 52 formed by the core needle cannula 40 and the cutter cannula 42 (see also) Figure 1 The hub-shaped portion 174 of the coaxial introducer cannula 170 is configured to be releasably attached to the front plate 36-2 of the probe housing 36 of the biopsy device 10 (see...). Figure 7A and 7B ).

[0094] like Figure 7A and 7B As shown, in this embodiment, the front plate 36-2 of the probe housing 36 includes a trap 176, which is formed as a set of slotted protrusions 178-1, 178-2 protruding outward from the front plate 36-2 of the probe housing 36 of the biopsy device 10 in the distal direction 46-2. The slotted protrusions 178-1, 178-2 have corresponding opposing slots 180-1, 180-2 facing away from the longitudinal axis 44.

[0095] like Figure 8A and 8BAs shown, in this embodiment, the hub-shaped portion 174 includes a hub-shaped portion body 182, a locking lever 184, and a bolt 186. The bolt 186 is configured to rotatably engage with the capture device 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 extending radially from the hub-shaped portion body 182 relative to the longitudinal axis 44. Figure 8B As shown, the hub-shaped body 182 has a cylindrical recess 182-1 defining a sidewall 182-2. The locking bolt 186 is in the form of a set of tabs 186-1, 186-2, which extend radially inward from the sidewall 182-2 of the cylindrical recess 182-1 of the hub-shaped body 182 toward the longitudinal axis 44.

[0096] 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...). Figure 1 This allows the locking lever 184 to be reached and rotated by the operator's thumb or fingers, while the operator grips the biopsy device 10 with the same hand. This facilitates the use of one hand to rotate the coaxial introducer cannula 170 relative to the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10, so as to achieve the corresponding engagement and disengagement of the locking bolt 186 of the coaxial introducer cannula 170 with the capture device 176 of the front plate 36-2 of the biopsy probe assembly 14 of the biopsy device 10.

[0097] Alternatively, the first locking feature 188-1 may be disposed at the front plate 36-2 of the probe housing 36, and the second locking feature 188-2 may be disposed on the hub-shaped portion 174 of the coaxial introducer cannula 170, such that the coaxial introducer cannula 170 is prevented from rotating about the longitudinal axis 44, i.e., relative to the biopsy device 10, during engagement. More particularly, the second locking feature 188-2 may be positioned on or within the locking lever 184.

[0098] refer to Figure 7A , 7B 8A and 8B (reference) Figure 1 During the installation of the coaxial introducer cannula 170 onto the biopsy apparatus 10, the coaxial cannula 172 of the coaxial introducer cannula 170 is coaxially and slidably received along the longitudinal axis 44 on the biopsy needle 52 formed by the core needle cannula 40 and the cutter cannula 42 (see...). Figure 1With the locking bolts 186 (e.g., a set of tabs 186-1, 186-2) of the hub portion 174 of the coaxial introducer cannula 170 not rotated to align with the catchers 176 (e.g., slotted protrusions 178-1, 178-2) of the front plate 36-2 of the probe housing 36, the coaxial introducer cannula 170 moves axially along the longitudinal axis 44 until the hub portion 174 axially abuts against the front plate 36-2 of the probe housing 36. The locking lever 184 can be tilted proximally relative to the hub portion body 182, such that the locking lever 184 engages with the front plate 36-2 before axially abutting against it, and the locking lever 184 deflects distally in the direction 46-2 as a cantilever spring.

[0099] Then, the locking lever 184 of the hub 174 rotates about the longitudinal axis 44 to the locked position, wherein the locking bolts 186 of the hub 174 (e.g., a set of tabs 186-1, 186-2) are respectively received in the catchers 176 (e.g., a set of opposing slots 180-1, 180-2 of the slotted protrusions 178-1, 178-2) of the front plate 36-2 of the probe housing 36, so that the coaxial introducer cannula 170 is connected to the probe housing 36, and thus to the biopsy device 36, thereby preventing the coaxial introducer cannula 170 from moving axially relative to the biopsy device 10 along the longitudinal axis 44. The rotational movement of the locking lever 184 can be clockwise or counterclockwise for very flexible operation. At this time, the first locking feature 188-1 of the front plate 36-2 of the probe housing 36 also engages with the second locking feature 188-2 on the locking rod 184 of the hub portion 174 of the coaxial introducer cannula 170 in order to prevent the coaxial introducer cannula 170 from rotating about the longitudinal axis 44.

[0100] In this embodiment, the first locking feature 188-1 of the front plate 36-2 of the probe housing 36 and the second locking feature 188-2 of the hub portion 174 of the coaxial introducer cannula 170 are complementary engagement features, such as slot / protrusion structures, which, when engaged, prevent (but do not prohibit) rotation of the coaxial introducer cannula 170 about the longitudinal axis 44. For example, the second locking feature 188-2 may be an opening (e.g., a hole and / or slot) formed in the proximal surface of the locking lever 184 of the hub portion 174, while the first locking feature 188-1 of the front plate 36-2 of the probe housing 36 may be a distally projecting facing region (e.g., a pin and / or headlight) on the front plate 36-2 that matches the opening formed in the locking lever 184, or vice versa, or both, to prevent rotation of the coaxial introducer cannula 170 about the longitudinal axis 44, i.e., rotation relative to the biopsy device 10.

[0101] To disengage the coaxial introducer cannula 170 from the biopsy device 10, the locking lever 184 rotates about the longitudinal axis 44, causing the latches 186 (e.g., a set of tabs 186-1, 186-2) of the hub portion 174 of the coaxial introducer cannula 170 to disengage from the catchers 176 (e.g., a set of opposing slots 180-1, 180-2 of the slotted protrusions 178-1, 178-2) of the front plate 36-2 of the probe housing 36. The rotation of the locking lever 184 can be clockwise or counterclockwise for very dexterity. At this point, the coaxial introducer cannula 170 moves freely axially along the longitudinal axis 44 in the distal direction 46-2 away from the front plate 36-2 of the probe housing 36, thereby removing the coaxial introducer cannula 170 from the biopsy needle 52 of the biopsy device 10.

[0102] refer to Figure 9 It is also considered that the coaxial introducer cannula 170 can be used and connected with other types of biopsy devices, such as cannula 190, which is modified to include a capture device 176, such as a slotted protrusion 178-1, 178-2, and optionally includes a first locking feature 188-1.

[0103] The following items are also related to this invention:

[0104] In one embodiment, the present invention relates to a biopsy device, or alternatively, to a biopsy probe assembly comprising a biopsy needle, a sample manifold, and a sample container. The sample manifold is connected to the biopsy needle. The sample manifold has a receiver and an insertion axis. The sample receiver has an inner sidewall and a mounting pin that projects inwardly from the inner sidewall toward the insertion axis. The sample container is configured for insertion into the receiver. The sample container includes a mounting channel sized and positioned (structured) to engage with and follow the mounting pin of the receiver during rotation of the sample container.

[0105] Optionally, the mounting channel is configured such that the spiral extension of the arc is less than one circumference of the sample container.

[0106] Optionally, the mounting channel has an open end and a closed end. The open end is positioned as a mounting pin for receiving the sample manifold, so as to provide rotational orientation of the sample container relative to the receiver of the sample manifold about the insertion axis.

[0107] The biopsy device can be configured such that when the mounting pin of the receiver is received in the open end of the mounting channel of the sample container, the rotation of the sample container causes the mounting pin to move toward the closed end following the spiral shape of the mounting channel, so as to pull the sample container into the receiver of the manifold along the insertion axis.

[0108] The sample container may have a cap and a basket section connected by a hinge, allowing one or both of the cap and basket sections to pivot about the hinge between a closed position and an open position. The open position provides access to the contents of the sample container.

[0109] The biopsy device can be configured such that, when the sample container is in the closed position, a portion of the cap's sidewall overlaps with a portion of the basket's sidewall to form a snap-fit.

[0110] The cap portion of the sample container may include a lid and partial sidewalls. The lid may include a dome-shaped cap and an annular rim. The annular rim may connect to the dome-shaped cap to define an annular lip. Mounting channels may be formed in the annular rim and spirally surround it.

[0111] The dome-shaped cap can be transparent or semi-transparent to allow for visual inspection of the contents of the sample container without having to remove the sample container from the receiver of the manifold.

[0112] A dome-shaped cap may include magnification features.

[0113] The seal can be arranged around the annular rim to provide a vacuum seal between the sample container and the receiver in the manifold.

[0114] The basket portion may include a base plate having a concave inner surface and multiple holes. The biopsy device may be configured such that the multiple holes allow vacuum propagation through the sample container to deliver tissue samples from the biopsy needle to the concave inner surface of the base plate.

[0115] The cap and basket portions of the sample container together define the orifice and the internal sample chamber. The biopsy needle may include a vacuum cannula with a proximal portion extending to the orifice to deliver tissue samples from the biopsy needle to the internal sample chamber by vacuum.

[0116] When the sample container is in the closed position, the orifice of the sample container can be formed by the first semi-circular orifice of the cap portion, located near the second semi-circular orifice of the basket portion.

[0117] Any feature of paragraphs

[00102] to

[00114] may be incorporated into a biopsy device or into a biopsy probe assembly.

[0118] Optionally, a coaxial introducer cannula for use with a biopsy device can be provided. The biopsy device includes: a front plate having a capture device; and a biopsy needle extending from the front plate along a longitudinal axis. The coaxial introducer cannula includes a coaxial tube and a hub portion. The coaxial tube is sized to be coaxially and slidably received on the biopsy needle. The hub portion is fixedly attached to a proximal portion of the coaxial tube. The hub portion has a hub portion body, a locking lever, and a locking bolt. The locking bolt is configured to rotatably engage with the capture device. The locking lever extends radially from the hub portion body relative to the longitudinal axis. The length of the locking lever is greater than the height of the front plate, allowing the locking lever to be reached and rotated to rotate the hub portion relative to the front plate of the biopsy device, thereby facilitating one-handed rotation of the coaxial introducer cannula relative to the front plate, thereby engaging or disengaging the locking bolt of the coaxial introducer cannula from the capture device of the front plate.

[0119] The locking lever can rotate clockwise or counterclockwise to allow for very dexterous operation.

[0120] The locking lever can be tilted proximally relative to the hub body, such that the locking lever engages with the front plate before the hub axially abuts against the front plate, and the locking lever deflects in the distal direction.

[0121] The first locking feature may be on the front plate, and the second locking feature may be on the hub portion. When engaged, they will prevent but not prohibit the coaxial inserter cannula from rotating about the longitudinal axis.

[0122] The second locking feature can be located on or within the locking lever.

[0123] The first and second locking features can form a hole / protrusion structure or a magnetic structure.

[0124] The catcher can be a set of slotted protrusions projecting outward from the front plate in a distal direction. The slotted protrusions can have corresponding opposing slots facing away from the longitudinal axis. The hub-shaped body can have cylindrical recesses with defined sidewalls, wherein the latches are in the form of a set of tabs extending radially inward from the sidewalls of the cylindrical recesses of the hub-shaped body toward the longitudinal axis.

[0125] The terms “approximately” and other degree words used in this article are relative modifiers, indicating permissible variations in the modified feature. It is not limited to the absolute value or property being modified, but rather to having more physical or functional characteristics than its opposite, or being close to or approximating such physical or functional characteristics.

[0126] Although the invention has been described with respect to at least one embodiment, further variations are possible within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or modifications of the invention that utilize the general principles of the invention. Furthermore, this application is intended to cover variations derived from this disclosure that fall within the scope of the appended claims, as are known or customarily practiced in the field to which this invention pertains.

Claims

1. A biopsy probe assembly, comprising: Biopsy needle; A sample manifold connected to a biopsy needle, the sample manifold having a receiver and an insertion axis, the receiver having an inner sidewall and a mounting pin, the mounting pin protruding inward from the inner sidewall toward the insertion axis; and A sample container configured for insertion into a receiver, the sample container including a mounting channel sized and positioned to engage with and follow the mounting pin of the receiver during rotation of the sample container. The mounting channel has an open end and a closed end. When the mounting pin of the receiver is received in the open end of the mounting channel of the sample container, the rotation of the sample container causes the mounting pin to move toward the closed end following the spiral shape of the mounting channel, so as to pull the sample container into the receiver of the sample manifold along the insertion axis.

2. The biopsy probe assembly of claim 1, wherein: The arc distance of the spiral extension of the mounting channel is less than one turn of the sample container.

3. The biopsy probe assembly according to claim 1 or 2, wherein: The open end is positioned as a mounting pin for receiving the sample manifold, so as to provide rotational orientation of the sample container relative to the receiver of the sample manifold about the insertion axis.

4. The biopsy probe assembly according to claim 1 or 2, wherein: The sample container includes a cap portion, a basket portion, and a hinge, with the cap portion connected to the basket portion via the hinge.

5. The biopsy probe assembly according to claim 1 or 2, wherein: The sample container has a cap portion and a basket portion connected by a hinge to allow one or both of the cap portion and basket portion to pivot about the hinge between a closed position and an open position, the open position providing an inlet to the contents of the sample container.

6. The biopsy probe assembly according to claim 5, wherein: When the sample container is in the closed position, the partial sidewall of the cap overlaps with the partial sidewall of the basket to form a snap-fit.

7. The biopsy probe assembly according to claim 5, wherein: The cap portion of the sample container includes a lid and partial sidewalls. The lid includes a dome-shaped cap and an annular rim, the annular rim connecting to the dome-shaped cap to define an annular lip. Mounting channels are formed in the annular rim and spirally surround the annular rim.

8. The biopsy probe assembly according to claim 7, wherein: The dome-shaped cap is transparent or semi-transparent so that the contents of the sample container can be visually inspected without having to remove the sample container from the receiver of the sample manifold.

9. The biopsy probe assembly according to claim 8, wherein: The dome-shaped cap includes an enlarged component.

10. The biopsy probe assembly of claim 7 further includes a seal arranged around an annular rim to provide a vacuum seal between the sample container and the receiver of the sample manifold.

11. The biopsy probe assembly according to claim 5, wherein: The basket portion includes a base plate having a concave inner surface and a plurality of holes that allow a vacuum to pass through the sample container in order to deliver tissue samples from the biopsy needle to the concave inner surface of the base plate.

12. The biopsy probe assembly according to claim 5, wherein: The cap and basket portions of the sample container together define the orifice and the internal sample chamber. The biopsy needle includes a vacuum cannula with a proximal portion that extends to the orifice to deliver tissue samples from the biopsy needle to the internal sample chamber by vacuum.

Images